WorldWideScience

Sample records for regulatory instrument review

  1. Regulatory instrument review: Management of aging of LWR [light water reactor] major safety-related components

    International Nuclear Information System (INIS)

    Werry, E.V.

    1990-10-01

    This report comprises Volume 1 of a review of US nuclear plant regulatory instruments to determine the amount and kind of information they contain on managing the aging of safety-related components in US nuclear power plants. The review was conducted for the US Nuclear Regulatory Commission (NRC) by the Pacific Northwest Laboratory (PNL) under the NRC Nuclear Plant Aging Research (NPAR) Program. Eight selected regulatory instruments, e.g., NRC Regulatory Guides and the Code of Federal Regulations, were reviewed for safety-related information on five selected components: reactor pressure vessels, steam generators, primary piping, pressurizers, and emergency diesel generators. Volume 2 will be concluded in FY 1991 and will also cover selected major safety-related components, e.g., pumps, valves and cables. The focus of the review was on 26 NPAR-defined safety-related aging issues, including examination, inspection, and maintenance and repair; excessive/harsh testing; and irradiation embrittlement. The major conclusion of the review is that safety-related regulatory instruments do provide implicit guidance for aging management, but include little explicit guidance. The major recommendation is that the instruments be revised or augmented to explicitly address the management of aging

  2. Regulatory instrument review: Aging management of LWR cables, containment and basemat, reactor coolant pumps, and motor-operated valves

    International Nuclear Information System (INIS)

    Werry, E.V.; Somasundaram, S.

    1995-09-01

    The results of Stage 2 of the Regulatory Instrument Review are presented in this volume. Selected regulatory instruments, such as the Code of Federal Regulations (CFR), US Nuclear Regulatory Commission (NRC), Regulatory Guides, and ASME Codes, were investigated to determine the extent to which these regulations apply aging management to selected safety-related components in nuclear power plants. The Regulatory Instrument Review was funded by the NRC under the Nuclear Plant Aging Research (NPAR) program. Stage 2 of the review focused on four safety-related structures and components; namely, cables, containment and basemat, reactor coolant pumps, and motor-operated valves. The review suggests that the primary-emphasis of the regulatory instruments was on the design, construction, start-up, and operation of a nuclear power plant, and that aging issues were primarily addressed after an aging-related problem was recognized. This Stage 2 review confirms the results of the prior review; (see Regulatory Instrument Review: Management of Aging of LWR Major Safety-Related Components NUREG/CR-5490. The observations indicate that the regulations generally address management of age-related degradation indirectly. Specific age-related degradation phenomena frequently are dealt with in bulletins and notices or through generic issues, letters, etc. The major recommendation of this report, therefore, is that the regulatory instruments should more directly and explicitly address the aging phenomenon and the management of the age-related degradation process

  3. Review of regulatory requirements relevant to calibration of monitoring instruments in research reactors

    Energy Technology Data Exchange (ETDEWEB)

    Gomaa, Hassan; Khedr, Ahmed; El-Din Talha, Kamal [Egyptian Nuclear and Radiological Regulatory Authority, Cairo (Egypt). Nuclear Safety Engineering Dept.

    2015-05-15

    The objective of this work is to demonstrate the regulatory requirements pertaining to calibration of monitoring instruments in research reactors. The regulatory statements concerning this subject in IAEA safety standards and the implementation of such regulations in twelve countries with different levels of nuclear programs are surveyed: Australia, Bulgaria, Canada, Egypt, Finland, Germany, Hungary, Slovenia, South Korea, Spain, United Kingdom of England and United States of America. In addition, the requirements of ISO/IEC17025 and NUPIC (Nuclear Utilities Procurement Issues Committee) are compared. Seven technical and administrate aspects are suggested as the comparison criteria and the explicit expression of the statements, the level of document (i.e.: act, requirement or guide) are the considered resources. The main differences and similarities between the different approaches are identified in order to provide an input for future development of the national regulations.

  4. Research and regulatory review

    International Nuclear Information System (INIS)

    Macleod, J.S.; Fryer, D.R.H.

    1979-01-01

    To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

  5. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

  6. 'Green' preferences as regulatory policy instrument

    International Nuclear Information System (INIS)

    Brennan, Timothy J.

    2006-01-01

    We examine here the suggestion that if consumers in sufficient numbers are willing to pay the premium to have power generated using low-emission technologies, tax or permit policies become less necessary or stringent. While there are implementation difficulties with this proposal, our purpose is more fundamental: Can economics make sense of using preferences as a regulatory instrument? If 'green' preferences are exogenously given, to what extent can or should they be regarded as a substitute for other policies? Even with 'green' preferences, production and consumption of polluting goods continue to impose social costs not borne in the market. Moreover, if green preferences are regarded as a policy instrument, the 'no policy' baseline would require a problematic specification of counterfactual 'non-green' preferences. Viewing green preferences as a regulatory policy instrument is conceptually sensible if the benchmark for optimal emissions is based on value judgments apart from the preferences consumers happen to have. If so, optimal environmental protection would be defined by reference to ethical theory, or, even less favorably, by prescriptions from policy advocates who give their own preferences great weight while giving those of the public at large (and the costs they bear) very little consideration. (author)

  7. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission`s dispositions

    Energy Technology Data Exchange (ETDEWEB)

    Watanabe, Norio; Suzudo, Tomoaki [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission`s (USNRC`s) responses to the recommendations made by the NRC`s study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC`s dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  8. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission's dispositions

    International Nuclear Information System (INIS)

    Watanabe, Norio; Suzudo, Tomoaki

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission's (USNRC's) responses to the recommendations made by the NRC's study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC's dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  9. Regulatory requirements on the calibration and use of survey instruments

    International Nuclear Information System (INIS)

    Domondon, D.B.

    1989-01-01

    Regulatory requirements on the provision, calibration and occasions of use of survey instruments are enumerated for a number of licensed activities. Two methods of calibrating survey instruments are described. Factors that must be taken into consideration in conducting calibrations, contents of calibration reports and of the sticker attached to the instrument which are needed for the correct use of the instrument are discussed. The precautions to be observed in order to insure correct use of survey instruments are described. (Auth.)

  10. Regulatory Review Committee update

    Energy Technology Data Exchange (ETDEWEB)

    Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

    2001-07-01

    The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

  11. Literature Review of Multicultural Instrumentation

    Science.gov (United States)

    Sarraj, Huda; Carter, Stacy; Burley, Hansel

    2015-01-01

    Demographic changes at the national level emphasize a critical need for multicultural education to be included as part of undergraduate education. This critical review of the literature examines 10 multicultural instruments that are suitable for use in K-12 or higher education institutions. This is a novel literature review in that it is the first…

  12. Review of accelerator instrumentation

    International Nuclear Information System (INIS)

    Pellegrin, J.L.

    1980-05-01

    Some of the problems associated with the monitoring of accelerator beams, particularly storage rings' beams, are reviewed along with their most common solutions. The various electrode structures used for the measurement of beam current, beam position, and the detection of the bunches' transverse oscillations, yield pulses with sub-nanosecond widths. The electronics for the processing of these short pulses involves wide band techniques and circuits usually not readily available from industry or the integrated circuit market: passive or active, successive integrations, linear gating, sample-and-hold circuits with nanosecond acquisition time, etc. This report also presents the work performed recently for monitoring the ultrashort beams of colliding linear accelerators or single-pass colliders. To minimize the beam emittance, the beam position must be measured with a high resolution, and digitized on a pulse-to-pulse basis. Experimental results obtained with the Stanford two-mile Linac single bunches are included

  13. Regulatory requirements and quality assurance of radiation monitoring instruments

    International Nuclear Information System (INIS)

    Narasimharao, K.L.; Sharma, Ranjit

    2005-01-01

    The successful utilisation of radiation sources in the fields of medicine and industry requires the accurate measurement of activity, exposure rate and dose. Many varieties of instruments are in use for measurement of these parameters and new ones are being developed. The criteria for the design of the radiation monitoring instrument include the type and intensity of the radiation, purpose of measurement and ruggedness of the instrument. Quality and reliability of radiation monitoring instruments ensure that individuals are adequately protected. Accuracy, response time and ruggedness are required to be as per the approved/ prescribed guidelines. Regulatory authorities outline the design and performance criteria for radiation monitoring instruments and prescribe the recommendations of international agencies such as IAEA, ICRU and ISO for radiological measurement assurance programme. National Standards Laboratories all over the world prescribe procedures for calibration of various radiation monitoring instruments. The instruments should be calibrated as per these guidelines and should be traceable to national standards. The calibration traceable to national/ international standards and documentation as well as limits stipulated by the competent authority ensures the expected performance of the instrument. (author)

  14. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

    This paper presents views on the role of the licensing engineer in the design process with specific emphasis on design reviews and the automated information management tools that support design reviews. The licensing engineer is seen as an important member of a design review team. The initial focus of the licensing engineer during design reviews is shown to be on ensuring that applicable regulatory requirements are addressed by the design. The utility of an automated tool, such as a commitments management system, to support regulatory requirements identification is discussed. The next responsibility of the licensing engineer is seen as verifying that regulatory requirements are transformed into measurable performance requirements. Performance requirements are shown to provide the basis for developing detailed design review criteria. Licensing engineer input during design reviews is discussed. This input is shown to be especially critical in cases where review findings may impact application of regulatory requirements. The use of automated tools in supporting design reviews is discussed. An information structure is proposed to support design reviews in a regulated environment. This information structure is shown to be useful to activities beyond design reviews. Incorporation of the proposed information structure into the Licensing Support System is proposed

  15. Review of NRC Regulatory processes and functions

    International Nuclear Information System (INIS)

    1980-01-01

    The Advisory Committee on Reactor Safeguards (ACRS) has spent much time over many years observing and examining the NRC licensing process. The Committee is, consequently, in a position to comment on the situation, and it believes this review will be helpful to those examining the regulatory process by discussing how it works, where it is weak, and the opportunities for improvement. The Committee's review may also help put current proposals and discussions in perspective

  16. Use of risk information in regulatory reviews

    International Nuclear Information System (INIS)

    Sagar, B.; Benke, R.; Mohanty, S.

    2004-01-01

    The regulatory framework for licensing any high-level waste repository at Yucca Mountain in the United States, calls for appropriate use of risk information to ensure operational safety during the pre-closure period and long-term safety during the post-closure period. This paper focuses on the post-closure period. Regulations in the Code of Federal Regulations (CFR), Title 10, Part 63, apply to any repository at Yucca Mountain and envision use of probabilistic methods to develop quantitative risk information. Accumulated engineering and scientific experience at Yucca Mountain and analog sites and quantitative risk information from studies conducted by the implementer, regulator, and others are combined to formulate 'risk insights,' which are then used to plan and execute regulatory reviews. The U.S. Nuclear Regulatory Commission (NRC) and the Center for Nuclear Waste Regulatory Analyses (CNWRA) recently consolidated the knowledge gained during several g ears and developed such risk insights for the potential repository at Yucca Mountain. This paper discusses the types of risk information used to generate risk insights and how the risk insights will be used in regulatory reviews. A companion paper presents more details on sensitivity analysis methods used to generate risk information. (authors)

  17. 76 FR 59066 - Notice of Regulatory Review Plan

    Science.gov (United States)

    2011-09-23

    ... [No. 2011-N-10] Notice of Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION... of and requesting comments on the FHFA interim regulatory review plan for review of existing... comments on all aspects of the interim regulatory review plan, including legal and policy considerations...

  18. Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants

    International Nuclear Information System (INIS)

    Korsah, Kofi; Wood, Richard Thomas

    2008-01-01

    To help reduce the uncertainty associated with application of digital instrumentation and controls (I and C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I and C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I and C Regulation, Communication issues, Human Factors and the Digital I and C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I and C systems.

  19. Appetitive Pavlovian-instrumental Transfer: a review

    OpenAIRE

    Cartoni, Emilio; Balleine, Bernard; Baldassarre, Gianluca

    2016-01-01

    Reward-related cues are an important part of our daily life as they often influence and guide our actions. This paper reviews one of the experimental paradigms used to study the effects of cues, the Pavlovian to Instrumental Transfer paradigm. In this paradigm, cues associated with rewards through Pavlovian conditioning alter motivation and choice of instrumental actions. The first transfer experiments date back to the 1940s, but only in the last decade has it been fully recognised that there...

  20. Review of regulatory requirements for digital I and C systems

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo [and others

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system.

  1. Review of regulatory requirements for digital I and C systems

    International Nuclear Information System (INIS)

    Kwon, Kee Choon; Lee, Cheol Kwon; Lee, Jang Soo

    2001-11-01

    This work analyzed and summarized systematically various regulatory requirements that are necessary to develop digital nuclear instrumentation and control (I and C) systems, especially safety systems. The requirements are categorized into system, hardware, software, and quality assurance aspects. This report provides the explanations of terms and abbreviations to help readers understand. Furthermore, appendices of this report summarize the code and standards corresponding to each principal regulatory requirement. The hierarchical structure of regulatory requirements has Nuclear Energy Laws, Enforcement Regulations of Nuclear Energy Laws, and Notifications of Ministry of Science and Technology as utmost level requirements [In case of the US, 10 CFR 50 Appendix A, 10 CFR 50 Appendix B, 10 CFR 50.55a(h), 10 CFR 50.49, etc.]. The requirements include the Draft Regulatory Guidelines for Digital I and C Systems [In case of the US, Standard Review Plan (NUREG-0800), Regulatory Guide, Branch Technical Position (BTP)], KEPIC as standards [In case of the US, IEEE Standards, IEC Standards, ISA, Military Standard, etc.], and various reports issued by Korea Institute of Nuclear Safety [In case of the US, NUREG reports, EPRI reports, etc.]. This report can be referred for the development of safety grade control equipment, plant protection system, and engineered safety feature actuation system

  2. Technical and regulatory challenges for digital instrumentation and control and control room systems in nuclear plants

    International Nuclear Information System (INIS)

    Torok, R.; Naser, J.; Harris, T.; Keithline, K.

    2006-01-01

    There are several unsettled technical and licensing issues in the areas of instrumentation and control (I and C), human factors, and updated control room designs that need coordinated, proactive industry attention. Some of these issues are already causing protracted regulatory reviews for existing plants, and left untreated, may cause substantial delays and increased costs for new plant combined construction and operating license approvals. Both industry and the NRC will have roles in resolving the key issues and addressing them in future design efforts and regulatory reviews. Where action is needed, the industry will want to minimize costs and risks by defining industry consensus solutions with corresponding technical bases. NEI has formed a working group to coordinate industry efforts and communications with NRC staff. The working group will also help determine priorities and coordinate both new and existing plant resources. EPRI will provide technical input and guidance for the working group. In order to be able to conduct reviews in a timely fashion, the NRC will likely need to enhance and expand staff resources as existing plants are upgraded and new plant reviews become more active. The industry initiative began with a workshop sponsored by EPRI and NEI on March 28-29, 2006, which led to the creation of the NEI working group. The working group has now identified and prioritized important generic issues, established resolution paths and schedules, and identified the roles of various stakeholders including utility companies, EPRI, NEI, vendors and the NRC. Through the course of this initiative I and C issues for both existing and new plants are being addressed. This paper describes the key I and C related technical and regulatory issues and their implications for new and operating plants, and provides a status report on the efforts to resolve them. (authors)

  3. A Review of the LHC Beam Instrumentation

    CERN Document Server

    Fischer, Cl

    1998-01-01

    This is a review of the diagnostics presently considered for LHC running in and operation. The purpose of each instrument is given and, except for the pick-ups of the Beam Position Monitoring system w hich have their position already reserved, the optimal location and an estimate of the required length along the vacuum chamber are given.

  4. Regulatory review of NPP Krsko Periodic Safety Review

    International Nuclear Information System (INIS)

    Lovincic, D.; Muehleisen, A.; Persic, A.

    2004-01-01

    At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)

  5. Regulatory Review of Early Site Permit Applications

    International Nuclear Information System (INIS)

    Scott, Michael L.

    2004-01-01

    The U.S. Nuclear Regulatory Commission (NRC) has received and is reviewing three applications for early site permits (ESPs). The ESP process allows early resolution of site-related issues affecting possible construction and operation of a new nuclear power plant. The nuclear industry views a successful and predictable ESP process as an important step in assessing whether to seek authorization to construct and operate a new generation of nuclear power reactors in the United States. Because consideration of ESP applications is a first-of-a-kind activity, a number of issues have emerged prior to and during the reviews of the first three applications. Issues have included the need for design information at the ESP stage, accident analyses, quality assurance, and seismic analyses. The NRC has been working to resolve identified issues to support a Commission decision on whether to issue an ESP approximately 33-37 months after receipt of each ESP application. (authors)

  6. Regulatory Research of the PWR Severe Accident. Information Needs and Instrumentation for Hydrogen Control and Management

    International Nuclear Information System (INIS)

    Park, Gun Chul; Suh, Kune Y.; Lee, Jin Yong; Lee, Seung Dong

    2001-03-01

    The current research is concerned with generation of basic engineering data needed in the process of developing hydrogen control guidelines as part of accident management strategies for domestic nuclear power plants and formulating pertinent regulatory requirements. Major focus is placed on identification of information needs and instrumentation methods for hydrogen control and management in the primary system and in the containment, development of decision-making trees for hydrogen management and their quantification, the instrument availability under severe accident conditions, critical review of relevant hydrogen generation model and phenomena In relation to hydrogen behavior, we analyzed the severe accident related hydrogen generation in the UCN 3·4 PWR with modified hydrogen generation model. On the basis of the hydrogen mixing experiment and related GASFLOW calculation, the necessity of 3-dimensional analysis of the hydrogen mixing was investigated. We examined the hydrogen control models related to the PAR(Passive Autocatalytic Recombiner) and performed MAAP4 calculation in relation to the decision tree to estimate the capability and the role of the PAR during a severe accident

  7. Regulatory Research of the PWR Severe Accident. Information Needs and Instrumentation for Hydrogen Control and Management

    Energy Technology Data Exchange (ETDEWEB)

    Park, Gun Chul; Suh, Kune Y.; Lee, Jin Yong; Lee, Seung Dong [Seoul Nat' l Univ., Seoul (Korea, Republic of)

    2001-03-15

    The current research is concerned with generation of basic engineering data needed in the process of developing hydrogen control guidelines as part of accident management strategies for domestic nuclear power plants and formulating pertinent regulatory requirements. Major focus is placed on identification of information needs and instrumentation methods for hydrogen control and management in the primary system and in the containment, development of decision-making trees for hydrogen management and their quantification, the instrument availability under severe accident conditions, critical review of relevant hydrogen generation model and phenomena In relation to hydrogen behavior, we analyzed the severe accident related hydrogen generation in the UCN 3{center_dot}4 PWR with modified hydrogen generation model. On the basis of the hydrogen mixing experiment and related GASFLOW calculation, the necessity of 3-dimensional analysis of the hydrogen mixing was investigated. We examined the hydrogen control models related to the PAR(Passive Autocatalytic Recombiner) and performed MAAP4 calculation in relation to the decision tree to estimate the capability and the role of the PAR during a severe accident.

  8. Appetitive Pavlovian-instrumental Transfer: A review.

    Science.gov (United States)

    Cartoni, Emilio; Balleine, Bernard; Baldassarre, Gianluca

    2016-12-01

    Reward-related cues are an important part of our daily life as they often influence and guide our actions. This paper reviews one of the experimental paradigms used to study the effects of cues, the Pavlovian to Instrumental Transfer paradigm. In this paradigm, cues associated with rewards through Pavlovian conditioning alter motivation and choice of instrumental actions. The first transfer experiments date back to the 1940s, but only in the last decade has it been fully recognised that there are two types of transfer, specific and general. This paper presents a systematic review of both the neural substrates and the behavioral factors affecting both types of transfer. It also examines the recent application of the paradigm to study the effect of cues on human participants, both in normal and pathological conditions, and the interactions of transfer with drugs of abuse. Finally, the paper analyses the theoretical aspects of transfer to build an overall picture of the phenomenon, from early theories to recent hierarchical accounts. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  9. Globalisation and Governance: Educational Policy Instruments and Regulatory Arrangements

    Science.gov (United States)

    Mok, Ka-Ho

    2005-07-01

    For more than a decade, the economic, social, political and cultural effects of globalisation have been central topics of debate. Those who see globalisation as a combination of economic transactions and worldwide telecommunications tend to believe that its impact is profound, inasmuch as it is fundamentally altering the way in which we live and creating hybrid cultural styles. No country is immune from the effects of globalisation, and controversy continues to reign about its positive and negative consequences. The present study identifies and examines numerous challenges posed by globalisation and their implications for educational restructuring, with special attention being given to new forms of governance; the relation between the state, the market and civil society; and governmental policy instruments for education.

  10. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    1993-04-01

    This document is intended to be used by International regulatory review teams in reviewing the activities of a regulatory body as applicable to the regulation of nuclear power plants. The mission will, however, take note of any other activities of the regulatory body when drawing up the review report. The document does not specifically deal with the functions of a regulatory body responsible for other types of nuclear facilities or related nuclear activities, but it is intended that the concepts presented in the document could be applied where appropriate. Refs

  11. Gender and Instrument Associations, Stereotypes, and Stratification: A Literature Review

    Science.gov (United States)

    Wych, Gina M. F.

    2012-01-01

    This literature review examines and synthesizes 30 years of research into the relationship between gender and musical instruments. Specifically, the review focuses on how this relationship affects instrument selection by grade school students entering a school music program. Topics include the gender typing of musical instruments, instrument…

  12. Regulatory review - on the brink of renewal

    International Nuclear Information System (INIS)

    Braunstein, L.A.

    1993-01-01

    Under the Atomic Energy Act of 1954, US commercial nuclear energy plants are licensed to operate for 40 years each. Congress selected the 40-year term not on the basis of safety, technical, or environmental issues, but on the basis of the 40-year amortization period generally used by electric utilities for large capital investments. And nuclear power plants may apply to have their licenses renewed. Licenses for about 47 plants - totalling about 34,000 megawatts (MW) of capacity - will expire between 2000 and 2014. By 2000, 63 reactors will be more than 20 years old. Without license renewal, utilities would have to retire about 5,000 MW of capacity every year between 2010 and 2030. Moreover, the Department of Energy (DOE) estimates that renewing licenses of existing nuclear plants for 20 years would save the nation's consumers about $350 billion. The NRC has concluded that the current safety of plants, as they operate today, is adequate. Therefore, in promulgating the final rule, the commission wanted to ensure that the applicants address those technical matters that are unique to the period of plant operation beyond the initial 40 years. For this reason, the rule includes language stating that the relicensing process would examine age-related degradation unique to license renewal. Interpretation of this language is adding regulatory uncertainty to the license renewal process. NRC is reviewing its interpretation; it also has indicated that it would like to smooth out the process through the review of an actual renewal application. Utility executives, however, seem unwilling to make proposals to their boards to commit large capital investments without a clear end-point in sight. It appears that the industry is now hesitating at the renewal office door - with NRC waiting for an application, and the industry holding back

  13. Regulatory issues of digital instrumentation and control system in Lungmen project

    International Nuclear Information System (INIS)

    Chuang, C.F.; Chou, H.P.

    2004-01-01

    The Lungmen Nuclear Power Station (LNPS) is currently under construction in Taiwan, which consists of 2 advanced boiling water reactor (ABWR) units. The instrumentation and control (IC) systems of the LNPS are based on the state-of-the-art modernized fully integrated digital design. These IC systems possess many advantages and distinguished features comparing to traditional analog IC systems, they enjoy set-point stability, self-diagnostic and automatic testing ability, fault tolerance and avoidance, low power requirements, data handling and storage capability, as well as enhanced human-machine interfaces. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital IC systems in the Lungmen Project

  14. A regulatory review for products containing glutathione

    Directory of Open Access Journals (Sweden)

    Nur Hidayah Abd Rahim

    2016-01-01

    Full Text Available Glutathione is a potent antioxidant as well as has important role for DNA synthesis and repair, protein synthesis, amino acid transport, and enzyme activation. Besides this, Glutathione products are now mainly selling as whitening agent which are mainly marketing through social media (Facebook and different websites. Information is not available whether glutathione product are following the regulatory guidelines of National Pharmaceutical Control Bureau of Malaysia (NPCB for selling, advertisement and promotion. This review was carried out by extracting information about glutathione from scientific database using PubMed, Cochrane Library and Embase. Analysis of the available information, case example of glutathione products showed that a brand of glutathione (Glutacaps HQ did not show the product's registration number from NPCB, and also did not show the name, address, contact number of the advertiser, and even not found the name of the manufacture. Without providing the above mentioned information, the product is selling and promoting through social media (fb which is not allowed by the NPCB guidelines part 4.14. So far, only two clinical trials were conducted on glutathione supplementation for 4 weeks duration. There was no serious or systematic adverse effects reported in clinical trials. As the two clinic trials resulted contradictory outcomes, further studies needed for conformation of the clinic benefits of glutathione. Otherwise, random use of glutathione may be risk for the health of the people. Besides, the marketer mainly promoting glutathione as the skin whitening beauty product instead of using as health supplement, it may cause additional and serious risk to the users as the manufacturer not providing sufficient information about the product, its registration number, manufacturing company, etc.

  15. Regulatory review of safety cases and safety assessments - associated challenges

    International Nuclear Information System (INIS)

    Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

    2006-01-01

    Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

  16. 76 FR 18457 - Regulatory Review Schedule; Tribal Consultation

    Science.gov (United States)

    2011-04-04

    ... that the NIGC provide tribal gaming commissions access to licensing information via an online database... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule; Tribal Consultation AGENCY: National Indian Gaming Commission. ACTION: Notice of Regulatory...

  17. Institutional review board and regulatory solutions in the dental PBRN

    DEFF Research Database (Denmark)

    Gilbert, Gregg H; Qvist, Vibeke; Moore, Sheila D

    2010-01-01

    Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network...

  18. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

  19. Alternative approaches to pollution control and waste management: Regulatory and economic instruments

    International Nuclear Information System (INIS)

    Bernstein, J.D.

    1993-01-01

    The purpose of the paper is to present an overview of the most common strategies and policy instruments (that is, regulatory and economic) used in developed and developing countries to achieve pollution control and waste management objectives. Although this topic has been at the center of theoretical controversy both within and outside the World Bank, the paper is not intended to contribute to this debate. Rather, its purpose is to explore how regulatory and economic instruments are used to control air and water pollution, protect ground water, and manage solid and hazardous wastes. The paper is directed to policy makers at the national, state, and local levels of government, as well as to other parties responsible for pollution control and waste management programs

  20. A Review on Regulatory Enforcement Policy

    International Nuclear Information System (INIS)

    Lim, Ji Han; Lee, Kyung Joo; Choi, Young Sung

    2017-01-01

    This paper examine the meaning and principle of enforcement through examples from other countries. Regulatory enforcement is the last stage of safety regulation and how it is exercised when one failing to meet regulatory requirements can have significant ripple effect across the industry. Thus, right philosophy and principle should be established. It is not recommended to emphasize neither deterrence approach nor behavior modification approach. This should be also taken into consideration when setting up the principle and system of regulatory enforcement. In the process of Vienna Declaration, Europe and the U.S showed the fundamental differences in their approaches to safety regulation. Considering this, it is required to remain cautious at all times on what to be improved in the aspect of internal consistency within our system and also in the aspect of procedure.

  1. Carbon Capture and Storage Legal and Regulatory Review. Edition 2

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    The International Energy Agency (IEA) estimates that 100 carbon capture and storage (CCS) projects must be implemented by 2020 and over 3000 by 2050 if CCS is to fully contribute to the least-cost technology portfolio for CO2 mitigation. To help countries address the many legal and regulatory issues associated with such rapid deployment, the IEA launched the Carbon Capture and Storage Legal and Regulatory Review (CCS Review) in October 2010. The CCS Review gathers contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum that supports national-level CCS regulatory development. Each contribution provides a short summary of recent and anticipated developments and highlights a particular regulatory theme (such as financial contributions to long-term stewardship). To introduce each edition, the IEA provides a brief analysis of key advances and trends. Produced bi-annually, the CCS Review provides an up-to-date snapshot of global CCS regulatory developments. The theme for the second edition of the CCS Review, released in May 2011, is long-term liability for stored CO2. Other key issues addressed include: national progress towards implementation of the EU CCS Directive; developments in marine treaties relevant to CCS; international climate change negotiations; and the development process for CCS regulation.

  2. The regulatory instruments for the correction of energy-related environmental externalities

    International Nuclear Information System (INIS)

    Labanderia Villot, X.; Lopez Otero, X.; Rodriguez Mendez, M.

    2007-01-01

    In this paper we deal with the different regulatory instruments for the correction of energy-related environmental externalities. This objective is justified by the size and general occurrence of this type of externalities in contemporary societies. In this sense, we distinguish between three main generations of instruments: conventional regulations, market mechanisms and voluntary approaches. In all cases, some practical examples of their application are presented, albeit emphasizing the experience with the so-called market instruments and the results of hypothetical simulations for the Spanish case. As a general conclusion we underline the role of economic analysis in the design, choice and evaluation of those mechanisms, which also explains the structure and contents of the article. (Author)

  3. Regulatory review of probabilistic safety assessment (PSA) level 1

    International Nuclear Information System (INIS)

    2000-02-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from the deterministic analysis. Many regulatory authorities consider that the current state of the art in PSA (especially Level 1 PSA) is sufficiently well developed that it can be used centrally in the regulatory decision making process - referred to as 'risk informed regulation'. For these applications to be successful, it will be necessary for regulatory authorities to have a high degree of confidence in PSA. However, at the IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process in 1994 and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' Meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997 the IAEA and OECD Nuclear Energy Agency agreed to produce in co-operation a technical document on the regulatory review of PSA. This publication is intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable standard so that it can be used as the basis for taking risk informed decisions within a regulatory decision making process. The document gives guidance on how to set about reviewing a PSA and on the technical issues that need to be addressed. This publication gives guidance for the review of Level 1 PSA for

  4. Regulatory aspects of control and instrumentation: role of SCCI and a case study

    International Nuclear Information System (INIS)

    Patil, R.K.; Suresh Babu, R.M.; Roy, D.A.; Shriwalkar, Varsha

    2017-01-01

    Standing Committee for Control, Instrumentation and Computer based Systems (SCCI) was constituted in the year 2001 as an expert committee under Operating Plant Safety Review Committee (OPSRC) of BARC Safety Council (BSC). The terms of reference of SCCI include: review C and I aspects of systems affecting safety of operating plants, suggest modifications/improvements, conduct periodic review/audit and advise OPSRC on C and I matters. In this paper we share our experience in the review of safety cases of computer-based systems, specifically, review of three systems that are part of Dhruva C and I upgradation

  5. Carbon Capture and Storage Legal and Regulatory Review. Edition 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA estimates that emissions can be reduced to a level consistent with a 2°C global temperature increase through the broad deployment of low-carbon energy technologies – and that CCS would contribute about one-fifth of emission reductions in this scenario. Achieving this level of deployment will require that regulatory frameworks – or rather a lack thereof – do not unnecessarily impede environmentally safe demonstration and deployment of CCS, so in October 2010 the IEA launched the IEA Carbon Capture and Storage Legal and Regulatory Review. The CCS Review is a regular review of CCS regulatory progress worldwide. Produced annually, it collates contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum to support CCS framework development. Each two page contribution provides a short summary of recent and anticipated CCS regulatory developments and highlights a particular, pre-nominated regulatory theme. To introduce each edition, the IEA provides a brief analysis of key advances and trends, based on the contributions submitted. The theme for this third edition is stakeholder engagement in the development of CO2 storage projects. Other issues addressed include: regulating CO2-EOR, CCS and CO2-EOR for storage; CCS incentive policy; key, substantive issues being addressed by jurisdictions taking steps to finalise CCS regulatory framework development; and CCS legal and regulatory developments in the context of the Clean Energy Ministerial Carbon Capture, Use and Storage Action Group.

  6. IAEA Mission Concludes Peer Review of Jordan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an 11-day International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service (IRRS) mission to review the regulatory framework for nuclear and radiation safety in Jordan. The mission team said in its preliminary findings that Jordan's nuclear regulator, the Energy and Minerals Regulatory Commission (EMRC), faces challenges because it is a relatively new body that handles a high workload while also working to recruit, train and keep competent staff. The team also noted that a recent merger provided the regulator with more of the resources it needs to perform its duty. The team made recommendations and suggestions to the regulatory body and the Government to help them strengthen the effectiveness of Jordan's regulatory framework and functions in line with IAEA Safety Standards. The main observations of the IRRS Review team comprised the following: The regulatory body, founded in 2007 and merged with other regulators in April 2014 to form EMRC, faces large challenges in terms of its regulatory workload, management system building and staff recruitment and training; The new EMRC structure and revision of the radiation and nuclear safety law represents an important opportunity to strengthen Jordan's radiation and nuclear safety infrastructure; The Government has shown commitment to radiation and nuclear safety through measures including becoming party to international conventions. It could further demonstrate its commitment by adopting a formal national policy and strategy for safety that defines the role of the Minister of Energy in relation to EMRC and protects the independence of regulatory decision-making

  7. Nuclear Regulatory Commission staff approaches to improving the integration of regulatory guidance documents and prelicensing reviews

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-01-01

    The Nuclear Regulatory Commission staff is conducting numerous activities to improve the integration of its regulatory guidance documents (i.e., License Application Review Plan (LARP) and open-quotes Format and Content for the License Application for the High-Level Waste repositoryclose quotes (FCRG)) and pre-license application (LA) reviews. Those activities related to the regulatory guidance documents consist of: (1) developing an hierarchy of example evaluation findings for LARP; (2) identifying LARP review plan interfaces; (3) conducting an integration review of LARP review strategies; (4) correlating LARP to the ongoing technical program; and (5) revising the FCRG. Some of the more important strategies the staff is using to improve the integration of pre-LA reviews with the LA review include: (1) use of the draft LARP to guide the staff's pre-LA reviews; (2) focus detailed pre-LA reviews on key technical uncertainties; (3) identify and track concerns with DOE's program; and (4) use results of pre-LA reviews in LA reviews. The purpose of this paper is to describe these ongoing activities and strategies and discuss some of the new work that is planned to be included in LARP Revision 1 and the final FCRG, which are scheduled to be issued in late 1994. These activities reflect both the importance the staff has placed on integration and the staff's approach to improving integration in these areas. The staff anticipates that the results of these activities, when incorporated in the FCRG, LARP, and pre-LA reviews, will improve its guidance for DOE's ongoing site characterization program and LA annotated outline development

  8. Concept Teaching in Instrumental Music Education: A Literature Review

    Science.gov (United States)

    Tan, Leonard

    2017-01-01

    This article is a review of research literature on the teaching of concepts in instrumental music education. It is organized in four parts (a) the value of concept teaching in large instrumental ensembles, (b) time spent teaching concepts during rehearsals, (c) approaches to concept teaching, and (d) implications for music education. Research has…

  9. Instruments for measuring mental health recovery: a systematic review.

    Science.gov (United States)

    Sklar, Marisa; Groessl, Erik J; O'Connell, Maria; Davidson, Larry; Aarons, Gregory A

    2013-12-01

    Persons in recovery, providers, and policymakers alike are advocating for recovery-oriented mental health care, with the promotion of recovery becoming a prominent feature of mental health policy in the United States and internationally. One step toward creating a recovery-oriented system of care is to use recovery-oriented outcome measures. Numerous instruments have been developed to assess progress towards mental health recovery. This review identifies instruments of mental health recovery and evaluates the appropriateness of their use including their psychometric properties, ease of administration, and service-user involvement in their development. A literature search using the Medline and Psych-INFO databases was conducted, identifying 21 instruments for potential inclusion in this review, of which thirteen met inclusion criteria. Results suggest only three instruments (25%) have had their psychometric properties assessed in three or more unique samples of participants. Ease of administration varied between instruments, and for the majority of instruments, development included service user involvement. This review updates and expands previous reviews of instruments to assess mental health recovery. As mental health care continues to transform to a recovery-oriented model of service delivery, this review may facilitate selection of appropriate assessments of mental health recovery for systems to use in evaluating and improving the care they provide. © 2013.

  10. Regulatory review of safety cases and safety assessments for near surface

    International Nuclear Information System (INIS)

    Nys, V.

    2003-01-01

    The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

  11. Information transmission in genetic regulatory networks: a review

    International Nuclear Information System (INIS)

    Tkacik, Gasper; Walczak, Aleksandra M

    2011-01-01

    Genetic regulatory networks enable cells to respond to changes in internal and external conditions by dynamically coordinating their gene expression profiles. Our ability to make quantitative measurements in these biochemical circuits has deepened our understanding of what kinds of computations genetic regulatory networks can perform, and with what reliability. These advances have motivated researchers to look for connections between the architecture and function of genetic regulatory networks. Transmitting information between a network's inputs and outputs has been proposed as one such possible measure of function, relevant in certain biological contexts. Here we summarize recent developments in the application of information theory to gene regulatory networks. We first review basic concepts in information theory necessary for understanding recent work. We then discuss the functional complexity of gene regulation, which arises from the molecular nature of the regulatory interactions. We end by reviewing some experiments that support the view that genetic networks responsible for early development of multicellular organisms might be maximizing transmitted 'positional information'. (topical review)

  12. Regulatory dendritic cells in autoimmunity: A comprehensive review.

    Science.gov (United States)

    Liu, Juan; Cao, Xuetao

    2015-09-01

    Dendritic cells (DCs) are professional antigen-presenting cells (APC) with significant phenotypic heterogeneity and functional plasticity. DCs play crucial roles in initiating effective adaptive immune responses for elimination of invading pathogens and also in inducing immune tolerance toward harmless components to maintain immune homeostasis. The regulatory capacity of DCs depends on their immature state and distinct subsets, yet not restricted to the immature state and one specialized subset. The tolerogenicity of DC is controlled by a complex network of environmental signals and cellular intrinsic mechanisms. Regulatory DCs play an important role in the maintenance of immunological tolerance via the induction of T cell unresponsiveness or apoptosis, and generation of regulatory T cells. DCs play essential roles in driving autoimmunity via promoting the activation of effector T cells such as T helper 1 and T helper 17 cells, and/or suppressing the generation of regulatory T cells. Besides, a breakdown of DCs-mediated tolerance due to abnormal environmental signals or breakdown of intrinsic regulatory mechanisms is closely linked with the pathogenesis of autoimmune diseases. Novel immunotherapy taking advantage of the tolerogenic potential of regulatory DCs is being developed for treatment of autoimmune diseases. In this review, we will describe the current understanding on the generation of regulatory DC and the role of regulatory DCs in promoting tolerogenic immune responses and suppressing autoimmune responses. The emerging roles of DCs dysfunction in the pathogenesis of autoimmune diseases and the potential application of regulatory DCs in the treatment of autoimmune diseases will also be discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. 78 FR 27169 - Regulatory Flexibility Act Review

    Science.gov (United States)

    2013-05-09

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Chapter... parts 174, 177, 191, and 192... 2013 2014 Transportation of Natural and Other Gas by Pipeline; Annual... review of some of 49 CFR parts 106, 107, 171. The full analysis document for the hazardous materials...

  14. CMOS Electrochemical Instrumentation for Biosensor Microsystems: A Review

    Directory of Open Access Journals (Sweden)

    Haitao Li

    2016-12-01

    Full Text Available Modern biosensors play a critical role in healthcare and have a quickly growing commercial market. Compared to traditional optical-based sensing, electrochemical biosensors are attractive due to superior performance in response time, cost, complexity and potential for miniaturization. To address the shortcomings of traditional benchtop electrochemical instruments, in recent years, many complementary metal oxide semiconductor (CMOS instrumentation circuits have been reported for electrochemical biosensors. This paper provides a review and analysis of CMOS electrochemical instrumentation circuits. First, important concepts in electrochemical sensing are presented from an instrumentation point of view. Then, electrochemical instrumentation circuits are organized into functional classes, and reported CMOS circuits are reviewed and analyzed to illuminate design options and performance tradeoffs. Finally, recent trends and challenges toward on-CMOS sensor integration that could enable highly miniaturized electrochemical biosensor microsystems are discussed. The information in the paper can guide next generation electrochemical sensor design.

  15. IAEA Mission Concludes Peer Review of Slovenia's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an eight-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety at the Slovenian Nuclear Safety Administration (SNSA). The team reviewed measures taken to address the recommendations and suggestions made during an earlier Integrated Regulatory Review Service (IRRS) mission conducted in 2011. The IRRS team said in its preliminary findings that Slovenia had made significant progress since the review in 2011. The team identified a good practice in the country's nuclear regulatory system additional to those identified in 2011 and made new recommendations and suggestions to SNSA and the Government to strengthen the effectiveness of the country's regulatory framework in line with IAEA Safety Standards. ''By hosting a follow-up mission, Slovenia demonstrated its commitment to enhance its regulatory programmes, including by implementing the recommendations of the 2011 mission,'' said Petr Krs, mission leader and Vice Chairman of the Czech Republic's State Office for Nuclear Safety. SNSA's Director, Andrej Stritar, welcomed the progress noted by the team, while also emphasizing that the mission highlighted important future nuclear safety challenges for Slovenia. The five-member review team, comprising experts from Belgium, the Czech Republic, France and Romania, as well as four IAEA staff members, conducted the mission at the request of the Slovenian Government from 9 to 16 September 2014. The main observations of the IRRS Review team included the following: SNSA has made significant progress in addressing the findings of the 2011 IRRS mission and has demonstrated commitment to effective implementation of the IRRS programme; The economic situation in Slovenia might in the short and long term affect SNSA's ability to maintain its capacity and competence; and A radioactive waste disposal project is stalled and the licensing

  16. 76 FR 6094 - FAA Public Forum To Conduct Regulatory Review

    Science.gov (United States)

    2011-02-03

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 27 and 29 FAA Public Forum To Conduct Regulatory Review AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of public meeting. SUMMARY: The FAA announces an informal meeting to discuss the FAA rotorcraft rules, 14...

  17. 78 FR 23199 - NASA FAR Supplement Regulatory Review No. 1

    Science.gov (United States)

    2013-04-18

    ... 2700-AE01 NASA FAR Supplement Regulatory Review No. 1 AGENCY: National Aeronautics and Space Administration. ACTION: Proposed rule. SUMMARY: NASA is updating the NASA FAR Supplement (NFS) with the goal of... existing regulations. The revisions to this rule are part of NASA's retrospective plan under EO 13563...

  18. IAEA Mission Concludes Peer Review of Pakistan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    An international team of senior nuclear safety experts today concluded a nine-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for the safety of operating nuclear power plants in the United States of America (USA). The Integrated Regulatory Review Service (IRRS) mission was a follow-up to the IRRS mission to the US Nuclear Regulatory Commission (NRC) that was conducted in 2010, with the key additional aim of reviewing whether the response of the US regulatory regime to the implications of the accident at TEPCO's Fukushima Daiichi Plant had been timely and effective. The mission team concluded that the recommendations and suggestions made by the 2010 IRRS mission have been taken into account systematically under the NRC's subsequent action plan, with significant progress in many areas and many improvements carried out. One of two recommendations and 19 out of 20 suggestions made by the 2010 IRRS mission have been effectively addressed and can therefore be considered closed. The outstanding recommendation relates to the NRC's review of its Management System, which is in the process of being finalised. The IRRS team also found that the NRC acted promptly and effectively after the Fukushima accident in the interests of public health and safety, and that the report of its Near-Term Task Force represents a sound and ample basis for taking into account the lessons learned from the accident

  19. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    2002-01-01

    The IAEA International Regulatory Review Team (IRRT) programme provides advice and assistance to Member States to strengthen and enhance the effectiveness of the nuclear regulatory body whilst recognizing the ultimate responsibility of each Member State for nuclear safety. The IRRT programme, initiated in 1989, is not restricted to any particular group of Member States, whether developing or industrialized, but is available to all countries with nuclear installations in operation or approaching operation. The basic concepts, purposes and functions of a national regulatory body are well recognized in all Member States having a nuclear power programme. The IAEA Safety Standards Series publication entitled 'Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety: Requirements', No. GS-R-1 (2000), provides a general consensus reference for the practices necessary for a national organization to fulfil the regulatory purposes and discharge the regulatory functions. The Requirements also defines the terms used in these guidelines. The guidance given in the Requirements recognizes that the organizational structure and regulatory processes will vary from country to country depending on their existing constitutional, legal and administrative systems; the size and structure of their nuclear programme; the technical skills and professional and financial resources available to their regulatory body, and social customs and cultural traditions. The objective of this report is to provide guidance on the basic structure of an IRRT mission and provide a common reference both across the various areas covered by an IRRT mission and across all the missions in the programme. As such, it is addressed, principally, to the team members of IRRT missions but it also provides guidance to a host regulatory body receiving a mission. This report identifies the objectives of the IRRT mission and sets out the scope of the topic areas that are

  20. Review of SFR Design Safety using Preliminary Regulatory PSA Model

    International Nuclear Information System (INIS)

    Na, Hyun Ju; Lee, Yong Suk; Shin, Andong; Suh, Nam Duk

    2013-01-01

    The major objective of this research is to develop a risk model for regulatory verification of the SFR design, and thereby, make sure that the SFR design is adequate from a risk perspective. In this paper, the development result of preliminary regulatory PSA model of SFR is discussed. In this paper, development and quantification result of preliminary regulatory PSA model of SFR is discussed. It was confirmed that the importance PDRC and ADRC dampers is significant as stated in the result of KAERI PSA model. However, the importance can be changed significantly depending on assumption of CCCG and CCF factor of PDRC and ADRC dampers. SFR (sodium-cooled fast reactor) which is Gen-IV nuclear energy system, is designed to accord with the concept of stability, sustainability and proliferation resistance. KALIMER-600, which is under development in Korea, includes passive safety systems (e. g. passive reactor shutdown, passive residual heat removal, and etc.) as well as active safety systems. Risk analysis from a regulatory perspective is needed to support the regulatory body in its safety and licensing review for SFR (KALIMER-600). Safety issues should be identified in the early design phase in order to prevent the unexpected cost increase and delay of the SFR licensing schedule that may be caused otherwise

  1. Regulatory perspective on digital instrumentation and control systems for future advanced nuclear power plants

    International Nuclear Information System (INIS)

    Chiramal, M.

    1993-01-01

    This paper deals with the question of using digital technology in instrumentation and control systems for modern nuclear power reactors. The general opinion in the industry and among NRC staff is that such technology provides the opportunity for enhanced safety and reliable reactor operations. The major concern is the safe application of this technology so as to avoid common mode or common cause failures in systems. There are great differences between digital and analog system components. SECY-91-292 identifies some general regulatory concerns with regard to digital systems. There is clearly a lack of adequate regulatory direction on the application of digital equipment at this time, but the issue is being addressed by the industry, outside experts, and NRC staff. NRC staff presents a position on the issue of defense-in-depth and diversity with regard to insuring plant safety. Independent manual controls and readouts must be available to allow safe shutdown and monitoring of the plant in the event of safety system failures

  2. IAEA Mission Concludes Peer Review of UK's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: Senior international nuclear safety and radiation protection experts today concluded a ten-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in the United Kingdom (UK). The Integrated Regulatory Review Service (IRRS) mission team said in its preliminary findings that the UK had made considerable progress since reviews in 2006 and 2009. It also identified good practices in the country's nuclear regulatory system. In addition to following up previous missions, a key objective was to review the effectiveness of the role of the Office of Nuclear Regulation (ONR), the UK's nuclear regulator, in ensuring the safety of radioactive waste management and decommissioning, occupational radiation protection, and public and environmental exposures, including emergency planning and response. The mission also considered the response of the UK's regulatory regime to the implications of the Fukushima Daichi accident had been timely and effective. Recommendations and suggestions were made to the ONR and the Government aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards, the control of radioactive discharges and environmental monitoring. 'The staff of ONR is clearly dedicated to their mission to secure the protection of people and society from the hazards of the nuclear industry. I am confident that ONR will use the results of this mission to further enhance their regulatory programs', said Bill Borchardt, mission leader and former Executive Director of the United States Nuclear Regulatory Commission (NRC). 'The staff were open and cooperative in their discussions; they provided the fullest practicable assistance, and accepted advice from the Team for continuous improvement in their regulatory work'. ONR's Chief Executive, John Jenkins, said that the full report of the IRRS mission will enhance regulatory effectiveness in the UK

  3. Transportation of Large Wind Components: A Permitting and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron [National Renewable Energy Lab. (NREL), Golden, CO (United States); Cook, Jeff [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2016-09-01

    This report summarizes permitting and regulatory issues associated with transporting wind turbine blades, towers, and nacelles as well as large transformers (wind components). These wind components are commonly categorized as oversized and overweight (OSOW) and require specific permit approvals from state and local jurisdictions. The report was developed based on a Quadrennial Energy Review (QER) recommendation on logistical requirements for the transportation of 'oversized or high-consequence energy materials, equipment, and components.'

  4. Breastfeeding Self-efficacy: A Critical Review of Available Instruments

    Science.gov (United States)

    Tuthill, Emily L.; McGrath, Jacqueline M.; Graber, Melanie; Cusson, Regina M.; Young, Sera L.

    2016-01-01

    Increasing breastfeeding rates in the United States is a national priority. Yet, initiation and duration of breastfeeding remains below national targets. Breastfeeding self-efficacy has been shown to be a strong predictor of both breastfeeding initiation and duration and is therefore an important characteristic to be able to measure. However, there is currently a myriad of instruments for measuring breastfeeding self-efficacy, which makes selection of an appropriate instrument difficult. Thus, our aim was to identify, compare, and critically review available breastfeeding self-efficacy instruments. In a systematic review, 6 breastfeeding self-efficacy instruments were identified. The instruments’ purposes, theoretical framework, final scale development, and application in 5 most recent settings were analyzed. The 6 breastfeeding self-efficacy instruments apply a number of theoretical and conceptual frameworks in their development, with Bandura’s social cognitive theory being most common. Content, construct, and predictive validity were strong for most scales. Some, but not all, have been successfully adapted to novel settings. In sum, there are several measurements of breastfeeding self-efficacy that can and should be employed to better understand reasons for suboptimal breastfeeding rates and the effects of interventions on breastfeeding self-efficacy. Instrument selection should be based on domains of primary interest, time available, peripartum timing, and assessment of previous adaptations. Failure to apply appropriate measures in research may garner results that are inconclusive, inaccurate, or nonrepresentative of true study effects. PMID:26319113

  5. Instruments Measuring Integrated Care: A Systematic Review of Measurement Properties.

    Science.gov (United States)

    Bautista, Mary Ann C; Nurjono, Milawaty; Lim, Yee Wei; Dessers, Ezra; Vrijhoef, Hubertus Jm

    2016-12-01

    Policy Points: Investigations on systematic methodologies for measuring integrated care should coincide with the growing interest in this field of research. A systematic review of instruments provides insights into integrated care measurement, including setting the research agenda for validating available instruments and informing the decision to develop new ones. This study is the first systematic review of instruments measuring integrated care with an evidence synthesis of the measurement properties. We found 209 index instruments measuring different constructs related to integrated care; the strength of evidence on the adequacy of the majority of their measurement properties remained largely unassessed. Integrated care is an important strategy for increasing health system performance. Despite its growing significance, detailed evidence on the measurement properties of integrated care instruments remains vague and limited. Our systematic review aims to provide evidence on the state of the art in measuring integrated care. Our comprehensive systematic review framework builds on the Rainbow Model for Integrated Care (RMIC). We searched MEDLINE/PubMed for published articles on the measurement properties of instruments measuring integrated care and identified eligible articles using a standard set of selection criteria. We assessed the methodological quality of every validation study reported using the COSMIN checklist and extracted data on study and instrument characteristics. We also evaluated the measurement properties of each examined instrument per validation study and provided a best evidence synthesis on the adequacy of measurement properties of the index instruments. From the 300 eligible articles, we assessed the methodological quality of 379 validation studies from which we identified 209 index instruments measuring integrated care constructs. The majority of studies reported on instruments measuring constructs related to care integration (33%) and patient

  6. Instruments Measuring Integrated Care: A Systematic Review of Measurement Properties

    Science.gov (United States)

    BAUTISTA, MARY ANN C.; NURJONO, MILAWATY; DESSERS, EZRA; VRIJHOEF, HUBERTUS JM

    2016-01-01

    Policy Points: Investigations on systematic methodologies for measuring integrated care should coincide with the growing interest in this field of research.A systematic review of instruments provides insights into integrated care measurement, including setting the research agenda for validating available instruments and informing the decision to develop new ones.This study is the first systematic review of instruments measuring integrated care with an evidence synthesis of the measurement properties.We found 209 index instruments measuring different constructs related to integrated care; the strength of evidence on the adequacy of the majority of their measurement properties remained largely unassessed. Context Integrated care is an important strategy for increasing health system performance. Despite its growing significance, detailed evidence on the measurement properties of integrated care instruments remains vague and limited. Our systematic review aims to provide evidence on the state of the art in measuring integrated care. Methods Our comprehensive systematic review framework builds on the Rainbow Model for Integrated Care (RMIC). We searched MEDLINE/PubMed for published articles on the measurement properties of instruments measuring integrated care and identified eligible articles using a standard set of selection criteria. We assessed the methodological quality of every validation study reported using the COSMIN checklist and extracted data on study and instrument characteristics. We also evaluated the measurement properties of each examined instrument per validation study and provided a best evidence synthesis on the adequacy of measurement properties of the index instruments. Findings From the 300 eligible articles, we assessed the methodological quality of 379 validation studies from which we identified 209 index instruments measuring integrated care constructs. The majority of studies reported on instruments measuring constructs related to care

  7. Satisfaction measurement instruments for healthcare service users: a systematic review

    OpenAIRE

    Almeida, Renato Santos de; Bourliataux-Lajoinie, Stephane; Martins, Mônica

    2015-01-01

    Patient satisfaction surveys can be an interesting way to improve quality and discuss the concept of patient-centered care. This study aimed to conduct a systematic review of the validated patient satisfaction measurement instruments applied in healthcare. The systematic review searched the MEDLINE/PubMed, LILACS, SciELO, Scopus and Web of Knowledge. The search strategy used the terms: "Patient Satisfaction" AND "Patient centered care" AND "Healthcare survey OR Satisfaction questionnaire" AND...

  8. Selecting Suicide Ideation Assessment Instruments: A Meta-Analytic Review

    Science.gov (United States)

    Erford, Bradley T.; Jackson, Jessica; Bardhoshi, Gerta; Duncan, Kelly; Atalay, Zumra

    2018-01-01

    Psychometric meta-analyses and reviews were provided for four commonly used suicidal ideation instruments: the Beck Scale for Suicide Ideation, the Suicide Ideation Questionnaire, the Suicide Probability Scale, and Columbia--Suicide Severity Rating Scale. Practical and technical issues and best use recommendations for screening and outcome…

  9. Post-implementation review of inadequate core cooling instrumentation

    International Nuclear Information System (INIS)

    Anderson, J.L.; Anderson, R.L.; Hagen, E.W.; Morelock, T.C.; Huang, T.L.; Phillips, L.E.

    1988-01-01

    Studies of Three Mile Island (TMI) accident identified the need for additional instrumentation to detect inadequate core cooling (ICC) in nuclear power plants. Industry studies by plant owners and reactor vendors supported the conclusion that improvements were needed to help operators diagnose the approach to or existence of ICC and to provide more complete information for operator control of safety injection, flow to minimize the consequences of such an accident. In 1980, the US Nuclear Regulatory Commission (NRC) required further studies by the industry and described ICC instrumentation design requirements that included human factors and environmental considerations. On December 10, 1982, NRC issued to Babcock and Wilcox (BandW) licensees' orders for Modification of License and transmitted to all pressurized water reactor (PWR) licensees Generic Letter 82-28 to inform them of the revised NRC requirements. The instrumentation requirements for detection of ICC include upgraded subcooling margin monitors (SMMs), upgraded core exit thermocouples (CETs), and installation of a reactor coolant inventory tracking system (RCITS)

  10. Instrumentation

    International Nuclear Information System (INIS)

    Muehllehner, G.; Colsher, J.G.

    1982-01-01

    This chapter reviews the parameters which are important to positron-imaging instruments. It summarizes the options which various groups have explored in designing tomographs and the methods which have been developed to overcome some of the limitations inherent in the technique as well as in present instruments. The chapter is not presented as a defense of positron imaging versus single-photon or other imaging modality, neither does it contain a description of various existing instruments, but rather stresses their common properties and problems. Design parameters which are considered are resolution, sampling requirements, sensitivity, methods of eliminating scattered radiation, random coincidences and attenuation. The implementation of these parameters is considered, with special reference to sampling, choice of detector material, detector ring diameter and shielding and variations in point spread function. Quantitation problems discussed are normalization, and attenuation and random corrections. Present developments mentioned are noise reduction through time-of-flight-assisted tomography and signal to noise improvements through high intrinsic resolution. Extensive bibliography. (U.K.)

  11. Averting Regulatory Enforcement: Evidence from New Source Review

    Energy Technology Data Exchange (ETDEWEB)

    Keohane, N.O.; Mansur, E.T.; Voynov, A. [Yale University, New York, NY (USA)

    2009-09-15

    This paper explores firms' response to regulatory enforcement. New Source Review (NSR), a provision of the Clean Air Act, imposes stringent emissions limitations on significantly modified older power plants. In 1999, the Environmental Protection Agency (EPA) sued owners of 46 plants for NSR violations. We study how electricity companies respond to both the perceived threat of future action, and the action itself. A discrete choice model estimates plants likelihood of being named in lawsuits increases with large historic emissions and investments. On the eve of the lawsuits, emissions at plants with a one standard deviation greater probability of being sued fell approximately 10%.

  12. Strengthening of the nuclear safety regulatory body. Field evaluation review

    International Nuclear Information System (INIS)

    1996-10-01

    As a result of a request from the Preparation Committee of the Nuclear Regulatory Authority (NRA) in 1992, and as recommended by the CEC/RAMG (Commission of European Communities/Regulatory Assistance Management Group) and the Agency mission in July 1993 to the Slovak Republic, the project SLR/9/005 was approved in 1993 as a model project for the period 1994-1996. Current budge is $401,340 and disbursements to date amount to $312,873. The project time schedule has been extended to 1997. The major conclusions of this evaluation are as follows: The project responded to an urgent national need, as well as to a statutory mandate of the Agency, and was adequately co-ordinated with other international assistance programmes to NRA. The project was designed as a structured programme of assistance by means of expert missions, scientific visits and a limited amount of equipment, acting upon several key areas of NRA regulatory responsibilities. Agency assistance was provided in a timely manner. A high concentration of expert missions was noticed at the initial stages of the project, which posed some managements problems. This was corrected to some extent in the course of implementation. Additionally, some overlapping of expert mission recommendations suggests that improvements are needed in the design of such missions. The exposure to international regulatory practice and expertise has resulted in substantial developments of NRA, both in organizational and operational terms. The project can claim to have contributed to NRA having gained governmental and international confidence. NRA's role in the safety assessment of Bohunice V1 reconstruction, as well as in Bohunice V2 safety review, Bohunice A1 decommissioning and in informing the public, also points at the success achieved by the project. The institutional and financial support of the Government contributed decisively to the project achievements. (author). Figs, tabs

  13. Theory, Instrumentation and Applications of Magnetoelastic Resonance Sensors: A Review

    Science.gov (United States)

    Grimes, Craig A.; Roy, Somnath C.; Rani, Sanju; Cai, Qingyun

    2011-01-01

    Thick-film magnetoelastic sensors vibrate mechanically in response to a time varying magnetic excitation field. The mechanical vibrations of the magnetostrictive magnetoelastic material launch, in turn, a magnetic field by which the sensor can be monitored. Magnetic field telemetry enables contact-less, remote-query operation that has enabled many practical uses of the sensor platform. This paper builds upon a review paper we published in Sensors in 2002 (Grimes, C.A.; et al. Sensors 2002, 2, 294–313), presenting a comprehensive review on the theory, operating principles, instrumentation and key applications of magnetoelastic sensing technology. PMID:22163768

  14. Theory, Instrumentation and Applications of Magnetoelastic Resonance Sensors: A Review

    Directory of Open Access Journals (Sweden)

    Craig A. Grimes

    2011-03-01

    Full Text Available Thick-film magnetoelastic sensors vibrate mechanically in response to a time varying magnetic excitation field. The mechanical vibrations of the magnetostrictive magnetoelastic material launch, in turn, a magnetic field by which the sensor can be monitored. Magnetic field telemetry enables contact-less, remote-query operation that has enabled many practical uses of the sensor platform. This paper builds upon a review paper we published in Sensors in 2002 (Grimes, C.A.; et al. Sensors 2002, 2, 294-313, presenting a comprehensive review on the theory, operating principles, instrumentation and key applications of magnetoelastic sensing technology.

  15. Intelligence Assessment Instruments in Adult Prison Populations: A Systematic Review.

    Science.gov (United States)

    van Esch, A Y M; Denzel, A D; Scherder, E J A; Masthoff, E D M

    2017-10-01

    Detection of intellectual disability (ID) in the penitentiary system is important for the following reasons: (a) to provide assistance to people with ID in understanding their legal rights and court proceedings; (b) to facilitate rehabilitation programs tailored to ID patients, which improves the enhancement of their quality of life and reduces their risk of reoffending; and (c) to provide a reliable estimate of the risk of offence recidivism. It requires a short assessment instrument that provides a reliable estimation of a person's intellectual functioning at the earliest possible stage of this process. The aim of this systematic review is (a) to provide an overview of recent short assessment instruments that provide a full-scale IQ score in adult prison populations and (b) to achieve a quality measurement of the validation studies regarding these instruments to determine which tests are most feasible in this target population. The Preferred Reporting Items for Systematic reviews and Meta-Analyses Statement is used to ensure reliability. The Satz-Mögel, an item-reduction short form of the Wechsler Adult Intelligence Scale, shows the highest correlation with the golden standard and is described to be most reliable. Nevertheless, when it comes to applicability in prison populations, the shorter and less verbal Quick Test can be preferred over others. Without affecting these conclusions, major limitations emerge from the present systematic review, which give rise to several important recommendations for further research.

  16. Measurement Properties of Instruments for Measuring of Lymphedema: Systematic Review.

    Science.gov (United States)

    Hidding, Janine T; Viehoff, Peter B; Beurskens, Carien H G; van Laarhoven, Hanneke W M; Nijhuis-van der Sanden, Maria W G; van der Wees, Philip J

    2016-12-01

    Lymphedema is a common complication of cancer treatment, resulting in swelling and subjective symptoms. Reliable and valid measurement of this side effect of medical treatment is important. The purpose of this study was to provide best evidence regarding which measurement instruments are most appropriate in measuring lymphedema in its different stages. The PubMed and Web of Science databases were used, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Clinical studies on measurement instruments assessing lymphedema were reviewed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) scoring instrument for quality assessment. Data on reliability, concurrent validity, convergent validity, sensitivity, specificity, applicability, and costs were extracted. Pooled data showed good intrarater intraclass correlation coefficients (ICCs) (.89) for bioimpedance spectroscopy (BIS) in the lower extremities and high intrarater and interrater ICCs for water volumetry, tape measurement, and perometry (.98-.99) in the upper extremities. In the upper extremities, the standard error of measurement was 3.6% (σ=0.7%) for water volumetry, 5.6% (σ=2.1%) for perometry, and 6.6% (σ=2.6%) for tape measurement. Sensitivity of tape measurement in the upper extremities, using different cutoff points, varied from 0.73 to 0.90, and specificity values varied from 0.72 to 0.78. No uniform definition of lymphedema was available, and a gold standard as a reference test was lacking. Items concerning risk of bias were study design, patient selection, description of lymphedema, blinding of test outcomes, and number of included participants. Measurement instruments with evidence for good reliability and validity were BIS, water volumetry, tape measurement, and perometry, where BIS can detect alterations in extracellular fluid in stage 1 lymphedema and the other measurement instruments can detect alterations in volume

  17. Review of probabilistic safety assessments by regulatory bodies

    International Nuclear Information System (INIS)

    2002-01-01

    This report provides guidance to assist regulatory bodies in carrying out reviews of the PSAs produced by utilities. In following this guidance, it is important that the regulatory body is able to satisfy itself that the PSA has been carried out to an acceptable standard and that it can be used for its intended applications. The review process becomes an important phase in determining the acceptability of the PSA since this provides a degree of assurance of the PSA scope, validity and limitations, as well as a better understanding of plants themselves. This report is also intended to assist technical experts managing or performing PSA reviews. A particular aim is to promote a standardized framework, terminology and form of documentation for the results of PSA reviews. The information presented in this report supports IAEA Safety Guide No. GS-G-1.2. Recommendations on the scope and methods to be used by the utility in the preparation of a PSA study is provided in IAEA Safety Guide No. NSG- 1.2. Information on these Safety Guides and other IAEA safety standards for nuclear power plants can be found on the following Internet site: http://www.iaea.org/ns/coordinet. The scope of this report covers the review of Level 1, 2 and 3 PSAs for event sequences occurring in all modes of plant operation (including full power, low power and shutdown). Where the scope of the analysis is narrower than this, a subset of the guidance can be identified and used. Information is provided on carrying out the review of a PSA throughout the PSA production process, i.e. from the initial decision to carry out the PSA through to the completion of the study and the production of the final PSA report. However, the same procedure can be applied to a completed PSA or to one already in progress. As a result of the performance of a PSA, changes to the design or operation of the plant are often identified that would increase the level of safety. This might include the addition of further safety

  18. Preparing and Conducting Review Missions of Instrumentation and Control Systems in Nuclear Power Plants

    International Nuclear Information System (INIS)

    2011-06-01

    The mission for Independent Engineering Review of Instrumentation and Control (I and C) Systems (IERICS) in Nuclear Power Plants (NPPs) has been established with the aim of conducting peer reviews of I and C design documents, implementation processes, prototype I and C systems, and actual systems already deployed in operating NPPs. Organizations in IAEA Member States, such as nuclear utilities, regulators, and technical support organizations can benefit from I and C technical reviews through requesting IERICS missions that provide a detailed technical assessment on I and C systems, as well as recommendations for improvement. The IERICS mission is conducted by a team of international subject matter experts from various complementing technical areas. The review is based on appropriate IAEA documents, such as Safety Guides and Nuclear Energy Series, and the mission's findings are summarized in a mission report, including a list of recommendations, suggestions, and identified good practices. The review is not intended to be a regulatory inspection or an audit against international codes and standards. Rather, it is a peer review aimed at improving design and implementation procedures through an exchange of technical experiences and practices at the working level. The IERICS mission is applicable at any stages of the life cycle of I and C systems in NPPs and it is initiated based on a formal request through official IAEA channels from an organization of a Member State. The formation of the IERICS mission is based on the recommendation of the IAEA Technical Working Group on Nuclear Power Plant Instrumentation and Control (TWG-NPPIC). The recommendation came from the recognition that the IAEA can play an important role in the independent assessment and review of NPP I and C systems in terms of their compliance with IAEA safety guides and technical documents.

  19. A review of NRC regulatory processes and functions

    International Nuclear Information System (INIS)

    1981-05-01

    A reexamination by the ACRS of the Regulatory Process has been made. Objectives were to provide in a single source, ACRS' understanding of the Regulatory Process and to point out perceived weaknesses and to make appropriate recommendations for change

  20. International nuclear safety experts conclude IAEA peer review of Canada's regulatory system

    International Nuclear Information System (INIS)

    2009-01-01

    that indicate areas in which improvements are necessary or desirable to continue improving effectiveness of regulatory controls,' he said. 'These are made to an organization that seeks to improve its performance. Many of them are related to areas in which CNSC has already or is in the process of implementing a programme for change.' Mr. Tomihiro Taniguchi, IAEA Deputy Director General and Head of the Department for Nuclear Safety and Security, added: 'Through the IRRS missions, both a host country and the reviewers share their experiences and lessons learned for regulatory improvements. Canada, as a mature nuclear country has also significantly contributed to this goal.' Among the particular strengths of CNSC, its policy, its regulatory framework and its regulatory activities identified by the IRRS team were: - The Canadian legislative and regulatory framework is very comprehensive, and the legal regime is effectively applied through an appropriate range of instruments; - CNSC has done commendable work over the last years in establishing and implementing a strong management system that seeks continuous improvement within the organization; - The consistent harmonized plan that considers the results of all recent audits and assessments brings together all improvement initiatives under one plan and optimizes the use of resources to deliver further improvements in key areas; - The recommendations made by the Talisman International LLC report on the NRU and reviewed by the IRRS team have been adequately addressed by the CNSC. The IRRS team also made recommendations and suggestions that may significantly enhance the overall performance of the regulatory system. Examples include: - CNSC should initiate a periodic strategic planning programme to define both short- and long-term research activities needed to support pending and potential regulatory decisions. Sufficient resources should be allocated to support the results of the programme; - CNSC should continue developing a

  1. A risk-based review of Instrument Air systems at nuclear power plants

    International Nuclear Information System (INIS)

    DeMoss, G.; Lofgren, E.; Rothleder, B.; Villeran, M.; Ruger, C.

    1990-01-01

    The broad objective of this analysis was to provide risk-based information to help focus regulatory actions related to Instrument Air (IA) systems at operating nuclear power plants. We first created an extensive data base of summarized and characterized IA-related events that gave a qualitative indication of the nature and severity of these events. Additionally, this data base was used to calculate the frequencies of certain events, which were used in the risk analysis. The risk analysis consisted of reviewing published PRAs and NRC Accident Sequence Precursor reports for IA-initiated accident sequences, IA interactions with frontline systems, and IA-related risk significant events. Sensitivity calculations were performed when possible. Generically, IA was found to contribute less to total risk than many safety systems; however, specific design weaknesses in safety systems, non-safety systems, and the IA system were found to be significant in risk. 22 refs., 13 figs., 24 tabs

  2. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Science.gov (United States)

    2012-05-02

    ... exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval...] Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza AGENCY: Food and Drug... regulatory review period for Victoza and is publishing this notice of that determination as required by law...

  3. Instrumentation

    International Nuclear Information System (INIS)

    Prieur, G.; Nadi, M.; Hedjiedj, A.; Weber, S.

    1995-01-01

    This second chapter on instrumentation gives little general consideration on history and classification of instrumentation, and two specific states of the art. The first one concerns NMR (block diagram of instrumentation chain with details on the magnets, gradients, probes, reception unit). The first one concerns precision instrumentation (optical fiber gyro-meter and scanning electron microscope), and its data processing tools (programmability, VXI standard and its history). The chapter ends with future trends on smart sensors and Field Emission Displays. (D.L.). Refs., figs

  4. Instrumentation in Developing Chlorophyll Fluorescence Biosensing: A Review

    Directory of Open Access Journals (Sweden)

    Jesus R. Millan-Almaraz

    2012-08-01

    Full Text Available Chlorophyll fluorescence can be defined as the red and far-red light emitted by photosynthetic tissue when it is excited by a light source. This is an important phenomenon which permits investigators to obtain important information about the state of health of a photosynthetic sample. This article reviews the current state of the art knowledge regarding the design of new chlorophyll fluorescence sensing systems, providing appropriate information about processes, instrumentation and electronic devices. These types of systems and applications can be created to determine both comfort conditions and current problems within a given subject. The procedure to measure chlorophyll fluorescence is commonly split into two main parts; the first involves chlorophyll excitation, for which there are passive or active methods. The second part of the procedure is to closely measure the chlorophyll fluorescence response with specialized instrumentation systems. Such systems utilize several methods, each with different characteristics regarding to cost, resolution, ease of processing or portability. These methods for the most part include cameras, photodiodes and satellite images.

  5. Instrumentation in Developing Chlorophyll Fluorescence Biosensing: A Review

    Science.gov (United States)

    Fernandez-Jaramillo, Arturo A.; Duarte-Galvan, Carlos; Contreras-Medina, Luis M.; Torres-Pacheco, Irineo; de J. Romero-Troncoso, Rene; Guevara-Gonzalez, Ramon G.; Millan-Almaraz, Jesus R.

    2012-01-01

    Chlorophyll fluorescence can be defined as the red and far-red light emitted by photosynthetic tissue when it is excited by a light source. This is an important phenomenon which permits investigators to obtain important information about the state of health of a photosynthetic sample. This article reviews the current state of the art knowledge regarding the design of new chlorophyll fluorescence sensing systems, providing appropriate information about processes, instrumentation and electronic devices. These types of systems and applications can be created to determine both comfort conditions and current problems within a given subject. The procedure to measure chlorophyll fluorescence is commonly split into two main parts; the first involves chlorophyll excitation, for which there are passive or active methods. The second part of the procedure is to closely measure the chlorophyll fluorescence response with specialized instrumentation systems. Such systems utilize several methods, each with different characteristics regarding to cost, resolution, ease of processing or portability. These methods for the most part include cameras, photodiodes and satellite images. PMID:23112686

  6. Environmental policy and economic efficiency: tradable permits versus regulatory instrument to control air pollution: a comparative approach USA/France

    International Nuclear Information System (INIS)

    Cros, Ch.

    1998-12-01

    The key issue of the thesis paradox of the weak implementation of economic instruments whereas 1) they are theoretically and also empirically considered as efficient; 2) the market imposes itself as the central reference to modem economies; and 3) economic efficiency is nowadays a legitimacy measure of public policies. Two different answers can be given: either theoretical analysis does not enable to explain the real economic efficiency of a political instrument, or environmental policies do not have economic efficiency as their main objective. The analysis take place in a context of a limited rationality and an inter-temporal consistency of public policies. The purpose is to understand the role of economic efficiency criteria during the adoption, building, and evolution of an environmental policy with an analytical point of view, and not a normative one. The institutional analysis of the American and the French pollution control policies, representative of the implementation of a trading permit system for the first, and of a regulatory instrument for the second, prove that the theoretical analysis of an instrument can not explain a real coordination, but only one organizational form among others. An institutional trajectory is the interpretation of policy instruments of policy instruments from 5 fundamental elements: the nature of the legitimacy of the policy; the nature of the regulator hypothesis on the information; the nature of the decision-making basis; the nature of the collective action. A coordination changes when the occurrence of an event moves one of the fundamental elements, and disorganizes the satisfying equilibrium of the agents. Then, the economic efficiency becomes a negotiation point. A political instrument is adopted for its own ability to solve a dysfunction without disrupting the coordination. (author)

  7. Cryogenic instrumentation with cold electronics-A review

    International Nuclear Information System (INIS)

    Rao, M.G.; Scurlock, R.G.

    1986-01-01

    The low level signals from cryogenic sensors and transducers are usually carried to the electronic signal conditioning and data handling systems at ambient temperatures by long electrical leads running from the cyrogenic environment to ambient. There are many applications, outside those using superconducting devices, in which there are advantages to be gained by placing part or all of the electronic system in the cryogenic environment adjacent to the measuring point. This paper discusses the requirements for an ideal cold electronic instrumentation system and then reviews the present state of the art in relation to off-the-shelf electronic components, devices and integrated circuits, and the published literature. The integration of sensors/transducers with cold electronics is discussed and areas for development are outlined

  8. Instrumentation

    International Nuclear Information System (INIS)

    Decreton, M.

    2000-01-01

    SCK-CEN's research and development programme on instrumentation aims at evaluating the potentials of new instrumentation technologies under the severe constraints of a nuclear application. It focuses on the tolerance of sensors to high radiation doses, including optical fibre sensors, and on the related intelligent data processing needed to cope with the nuclear constraints. Main achievements in these domains in 1999 are summarised

  9. Instrumentation

    Energy Technology Data Exchange (ETDEWEB)

    Decreton, M

    2001-04-01

    SCK-CEN's research and development programme on instrumentation involves the assessment and the development of sensitive measurement systems used within a radiation environment. Particular emphasis is on the assessment of optical fibre components and their adaptability to radiation environments. The evaluation of ageing processes of instrumentation in fission plants, the development of specific data evaluation strategies to compensate for ageing induced degradation of sensors and cable performance form part of these activities. In 2000, particular emphasis was on in-core reactor instrumentation applied to fusion, accelerator driven and water-cooled fission reactors. This involved the development of high performance instrumentation for irradiation experiments in the BR2 reactor in support of new instrumentation needs for MYRRHA, and for diagnostic systems for the ITER reactor.

  10. Instrumentation

    International Nuclear Information System (INIS)

    Decreton, M.

    2001-01-01

    SCK-CEN's research and development programme on instrumentation involves the assessment and the development of sensitive measurement systems used within a radiation environment. Particular emphasis is on the assessment of optical fibre components and their adaptability to radiation environments. The evaluation of ageing processes of instrumentation in fission plants, the development of specific data evaluation strategies to compensate for ageing induced degradation of sensors and cable performance form part of these activities. In 2000, particular emphasis was on in-core reactor instrumentation applied to fusion, accelerator driven and water-cooled fission reactors. This involved the development of high performance instrumentation for irradiation experiments in the BR2 reactor in support of new instrumentation needs for MYRRHA, and for diagnostic systems for the ITER reactor

  11. NRC review of passive reactor design certification testing programs: Overview, progress, and regulatory perspective

    Energy Technology Data Exchange (ETDEWEB)

    Levin, A.E.

    1995-09-01

    New reactor designs, employing passive safety systems, are currently under development by reactor vendors for certification under the U.S. Nuclear Regulatory Commission`s (NRC`s) design certification rule. The vendors have established testing programs to support the certification of the passive designs, to meet regulatory requirements for demonstration of passive safety system performance. The NRC has, therefore, developed a process for the review of the vendors` testing programs and for incorporation of the results of those reviews into the safety evaluations for the passive plants. This paper discusses progress in the test program reviews, and also addresses unique regulatory aspects of those reviews.

  12. Survey of regulatory agency review of generating unit performance

    International Nuclear Information System (INIS)

    Roach, E.M. Jr.; Tarletz, D.B.

    1985-01-01

    Regulatory agencies across the country are being called upon increasingly to monitor the management of electric utilities. Such activity, which once was relatively rare, is now common. Most frequently this oversight centers around the operating performance of generating units, both nuclear and fossil. There are, perhaps, several reasons for this increased interest in the efficient operation of generating units: increased fuel costs and fuel cost differentials, increased lead times and costs for construction of new generating units, and increased dependence on existing units because of construction programs being revised to meet decreased load growth. The monitoring of generating units has taken the form of after the fact evaluation of performance on a case-by-case basis and the implementation of productivity incentive programs. Performance standards are used in these contexts both to measure the adequacy of unit performance and to implement incentives in the form of rewards or penalties. The standard used may be a subjective test of prudent performance or some numerical index of plant performance, e.g., equivalent availability, capacity factor or heat rate. Some of the activity by regulators is reviewed in applying subjective and numerical standards and the considerations involved in applying such standards are discussed

  13. The IAEA Integrated Regulatory Review Service (IRRS) - Information Meeting Dublin

    International Nuclear Information System (INIS)

    Al Khatibeh, Ahmad

    2014-05-01

    IRRS is developed to help States evaluate the current status of compliance of their regulatory infrastructures for safety with IAEA Standards. This report discusses the function of IRRS missions as a tool for evaluating the regulatory structure for Member States. It was presented to RPII staff in a Powerpoint document in preparation for the IRRS Mission to Ireland in August 2015

  14. INSTRUMENTS OF HIGH RISK SEXUAL BEHAVIOR ASSESSMENT: A SYSTEMATIC REVIEW.

    Science.gov (United States)

    Mirzaei, Mojtaba; Ahmadi, Khodabakhsh; Saadat, Seyed-Hassan; Ramezani, Mohammad Arash

    2016-02-01

    Sexual behavior is a complex activity affecting all aspects of human's life. Risky sexual behaviors impose negative outcomes on family, relationships and health. Unsafe sex is the second most leading cause of disability adjusted life years worldwide. Valid and reliable tools for assessment of risky sexual behaviors are necessary for implementing preventive measures. we searched Medline and the Cochrane Library of Systematic Reviews, with the keywords of "risky sexual behavior assessment", "sexual risk assessment", "high risk sexual behavior", "sexual risk taking". By reviewing references of the articles, some complementary studies were added. Assessment can be performed by questionnaire or non-questionnaire instruments. Questionnaires vary depending on their target population, evaluation of risky sexual behavior as a whole or focusing on an associated risk factor. In order to avoid usual biases in self reports, objective biomarker assessment of unprotected sex are employed. These markers include prostate specific antigen, chromosome Y DNA and Seminogelin. Risky sexual behavior can be assessed by various subjective and objective methods. While self-reports are more feasible, objective methods offer a higher degree of reliability. Further studies for finding more feasible methods of using biomarkers are recommended.

  15. Scoping review of pediatric tonsillectomy quality of life assessment instruments.

    Science.gov (United States)

    Kao, Stephen Shih-Teng; Peters, Micah D J; Dharmawardana, Nuwan; Stew, Benjamin; Ooi, Eng Hooi

    2017-10-01

    Sleep-disordered breathing or recurrent tonsillitis have detrimental effects on the child's physical health and quality of life. Tonsillectomy is commonly performed to treat these common conditions and improve the child's quality of life. This scoping review aims to present a comprehensive and descriptive analysis of quality of life questionnaires as a resource for clinicians and researchers when deciding which tool to use when assessing the quality of life effects after tonsillectomy. A comprehensive search strategy was undertaken across MEDLINE (PubMed), CINAHL, Embase, and Cochrane CENTRAL. Quality of life questionnaires utilized in studies investigating pediatric patients undergoing tonsillectomy for chronic tonsillitis or sleep-disordered breathing were included. Methodological quality and data extraction were conducted as per Joanna Briggs Institute methodology. Ten questionnaires were identified, consisting of six generic and four disease-specific instruments. The Pediatric Quality of Life Inventory was the most commonly utilized generic questionnaire. The Obstructive Sleep Apnea-18 was the most commonly utilized disease-specific questionnaire. This review identified a range of generic and disease-specific quality of life questionnaires utilized in pediatric patients who have undergone tonsillectomy with or without adenoidectomy for sleep-disordered breathing or chronic tonsillitis. Important aspects of each questionnaire have been summarized to aid researchers and clinicians in choosing the appropriate questionnaire when evaluating the quality of life effects of tonsillectomy. NA Laryngoscope, 127:2399-2406, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  16. Instrumentation

    International Nuclear Information System (INIS)

    Decreton, M.

    2002-01-01

    SCK-CEN's R and D programme on instrumentation involves the development of advanced instrumentation systems for nuclear applications as well as the assessment of the performance of these instruments in a radiation environment. Particular emphasis is on the use of optical fibres as umbilincal links of a remote handling unit for use during maintanance of a fusion reacor, studies on the radiation hardening of plasma diagnostic systems; investigations on new instrumentation for the future MYRRHA accelerator driven system; space applications related to radiation-hardened lenses; the development of new approaches for dose, temperature and strain measurements; the assessment of radiation-hardened sensors and motors for remote handling tasks and studies of dose measurement systems including the use of optical fibres. Progress and achievements in these areas for 2001 are described

  17. Instrumentation

    Energy Technology Data Exchange (ETDEWEB)

    Decreton, M

    2002-04-01

    SCK-CEN's R and D programme on instrumentation involves the development of advanced instrumentation systems for nuclear applications as well as the assessment of the performance of these instruments in a radiation environment. Particular emphasis is on the use of optical fibres as umbilincal links of a remote handling unit for use during maintanance of a fusion reacor, studies on the radiation hardening of plasma diagnostic systems; investigations on new instrumentation for the future MYRRHA accelerator driven system; space applications related to radiation-hardened lenses; the development of new approaches for dose, temperature and strain measurements; the assessment of radiation-hardened sensors and motors for remote handling tasks and studies of dose measurement systems including the use of optical fibres. Progress and achievements in these areas for 2001 are described.

  18. Instrumentation

    Energy Technology Data Exchange (ETDEWEB)

    Decreton, M

    2000-07-01

    SCK-CEN's research and development programme on instrumentation aims at evaluating the potentials of new instrumentation technologies under the severe constraints of a nuclear application. It focuses on the tolerance of sensors to high radiation doses, including optical fibre sensors, and on the related intelligent data processing needed to cope with the nuclear constraints. Main achievements in these domains in 1999 are summarised.

  19. Instrumentation

    International Nuclear Information System (INIS)

    Umminger, K.

    2008-01-01

    A proper measurement of the relevant single and two-phase flow parameters is the basis for the understanding of many complex thermal-hydraulic processes. Reliable instrumentation is therefore necessary for the interaction between analysis and experiment especially in the field of nuclear safety research where postulated accident scenarios have to be simulated in experimental facilities and predicted by complex computer code systems. The so-called conventional instrumentation for the measurement of e. g. pressures, temperatures, pressure differences and single phase flow velocities is still a solid basis for the investigation and interpretation of many phenomena and especially for the understanding of the overall system behavior. Measurement data from such instrumentation still serves in many cases as a database for thermal-hydraulic system codes. However some special instrumentation such as online concentration measurement for boric acid in the water phase or for non-condensibles in steam atmosphere as well as flow visualization techniques were further developed and successfully applied during the recent years. Concerning the modeling needs for advanced thermal-hydraulic codes, significant advances have been accomplished in the last few years in the local instrumentation technology for two-phase flow by the application of new sensor techniques, optical or beam methods and electronic technology. This paper will give insight into the current state of instrumentation technology for safety-related thermohydraulic experiments. Advantages and limitations of some measurement processes and systems will be indicated as well as trends and possibilities for further development. Aspects of instrumentation in operating reactors will also be mentioned.

  20. Comparison of ISO 9000 and recent software life cycle standards to nuclear regulatory review guidance

    International Nuclear Information System (INIS)

    Preckshot, G.G.; Scott, J.A.

    1998-01-01

    Lawrence Livermore National Laboratory is assisting the Nuclear Regulatory Commission with the assessment of certain quality and software life cycle standards to determine whether additional guidance for the U.S. nuclear regulatory context should be derived from the standards. This report describes the nature of the standards and compares the guidance of the standards to that of the recently updated Standard Review Plan

  1. Instruments

    International Nuclear Information System (INIS)

    Buehrer, W.

    1996-01-01

    The present paper mediates a basic knowledge of the most commonly used experimental techniques. We discuss the principles and concepts necessary to understand what one is doing if one performs an experiment on a certain instrument. (author) 29 figs., 1 tab., refs

  2. 77 FR 26016 - Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial...

    Science.gov (United States)

    2012-05-02

    ... approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period... asthma is not well controlled [[Page 26017

  3. 75 FR 76741 - Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL

    Science.gov (United States)

    2010-12-09

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... adults. It should be used as adjunctive therapy in patients who have responded inadequately to several...

  4. 76 FR 36927 - Determination of Regulatory Review Period for Purposes of Patent Extension; Fusilev, Levoleucovorin

    Science.gov (United States)

    2011-06-23

    ... drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA... after high-dose methotrexate therapy in osteosarcoma and is also indicated to diminish the toxicity and...

  5. 77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

    Science.gov (United States)

    2012-05-03

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... chronic gout in adult patients refractory to conventional therapy. Subsequent to this approval, the Patent...

  6. 75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

    Science.gov (United States)

    2010-12-06

    ..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... or systemic therapy. Subsequent to this approval, the Patent and Trademark Office received a patent...

  7. 76 FR 14671 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTODAX

    Science.gov (United States)

    2011-03-17

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... in patients who have received at least one prior systemic therapy. Subsequent [[Page 14672

  8. 77 FR 59567 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2012-09-28

    ... #0;notices is to give interested persons an opportunity to participate in #0;the rule making prior to... Immigration Review 8 CFR Parts 1003, 1103, 1208, 1211, 1212, 1215, 1216, 1235 [EOIR No. 178] RIN 1125-AA71 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Executive Office for Immigration Review, Department of...

  9. Review of the Instruments Most Frequently Employed to Assess Tactics in Physical Education and Youth Sports

    Science.gov (United States)

    Arias, Jose L.; Castejon, Francisco Javier

    2012-01-01

    Investigators' increased interest in teaching game tactics requires generalizable assessment instruments that are appropriate to whatever is needed by the tactic. This literature review aims to provide information about the instruments most frequently used to assess tactics in youth sports. We found that very few studies used instruments that…

  10. Experts Complete IAEA Follow-up Review of Spanish Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts today concluded an eight-day mission to review Spain's nuclear regulator, the Nuclear Safety Council (CSN). At the request of the Spanish Government, the International Atomic Energy Agency assembled a peer-review team of five high-level regulatory experts from four nations and two IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined CSN's progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety and security regulatory aspects of all facilities and activities in Spain. The first mission reviewed Spain's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. The mission also included a peer review of the security activities within the regulatory framework. IRRS team leader Luis Reyes, Senior Executive of the US Nuclear Regulatory Commission, said today, 'In 2008, the mission found particular strengths in CSN's policy, its regulatory framework and its regulatory activities. We made a number of suggestions and recommendations for further improvement of the regulatory framework. CSN should be commended for the significant amount of efforts in addressing all the findings identified in 2008 mission.' The review team found that CSN has made significant progress toward improving its regulatory activities. Most of the findings identified in the 2008 report have been effectively addressed and therefore can be considered closed. Additional findings are being addressed in accordance with a comprehensive and systematic action plan, in particular efforts to revise the CSN Statute. Complementing the CSN strengths identified during the 2008 mission, the 2011 IRRS team noted the following strengths: Improvements in regulatory

  11. The quality of systematic reviews of health-related outcome measurement instruments.

    Science.gov (United States)

    Terwee, C B; Prinsen, C A C; Ricci Garotti, M G; Suman, A; de Vet, H C W; Mokkink, L B

    2016-04-01

    Systematic reviews of outcome measurement instruments are important tools for the selection of instruments for research and clinical practice. Our aim was to assess the quality of systematic reviews of health-related outcome measurement instruments and to determine whether the quality has improved since our previous study in 2007. A systematic literature search was performed in MEDLINE and EMBASE between July 1, 2013, and June 19, 2014. The quality of the reviews was rated using a study-specific checklist. A total of 102 reviews were included. In many reviews the search strategy was considered not comprehensive; in only 59 % of the reviews a search was performed in EMBASE and in about half of the reviews there was doubt about the comprehensiveness of the search terms used for type of measurement instruments and measurement properties. In 41 % of the reviews, compared to 30 % in our previous study, the methodological quality of the included studies was assessed. In 58 %, compared to 55 %, the quality of the included instruments was assessed. In 42 %, compared to 7 %, a data synthesis was performed in which the results from multiple studies on the same instrument were somehow combined. Despite a clear improvement in the quality of systematic reviews of outcome measurement instruments in comparison with our previous study in 2007, there is still room for improvement with regard to the search strategy, and especially the quality assessment of the included studies and the included instruments, and the data synthesis.

  12. The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

    Science.gov (United States)

    Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

    2018-01-01

    The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

  13. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  14. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  15. Tendances Carbone no. 69 'The EU ETS within the financial instrument regulatory framework: what are the implications?'

    International Nuclear Information System (INIS)

    Patay, Magali

    2012-01-01

    Among the publications of CDC Climat Research, 'Tendances Carbone' bulletin specifically studies the developments of the European market for CO 2 allowances. This issue addresses the following points: The European Commission added carbon allowances and international credits eligible for the EU ETS to Section C, Annex I of Directive 2004/39/EC, as part of its proposal to review the Markets in Financial Instruments Directive (MiFID) on October 20 2011

  16. A review of instrumental variable estimators for Mendelian randomization.

    Science.gov (United States)

    Burgess, Stephen; Small, Dylan S; Thompson, Simon G

    2017-10-01

    Instrumental variable analysis is an approach for obtaining causal inferences on the effect of an exposure (risk factor) on an outcome from observational data. It has gained in popularity over the past decade with the use of genetic variants as instrumental variables, known as Mendelian randomization. An instrumental variable is associated with the exposure, but not associated with any confounder of the exposure-outcome association, nor is there any causal pathway from the instrumental variable to the outcome other than via the exposure. Under the assumption that a single instrumental variable or a set of instrumental variables for the exposure is available, the causal effect of the exposure on the outcome can be estimated. There are several methods available for instrumental variable estimation; we consider the ratio method, two-stage methods, likelihood-based methods, and semi-parametric methods. Techniques for obtaining statistical inferences and confidence intervals are presented. The statistical properties of estimates from these methods are compared, and practical advice is given about choosing a suitable analysis method. In particular, bias and coverage properties of estimators are considered, especially with weak instruments. Settings particularly relevant to Mendelian randomization are prioritized in the paper, notably the scenario of a continuous exposure and a continuous or binary outcome.

  17. 76 FR 8940 - Regulatory Review of Existing DOT Regulations

    Science.gov (United States)

    2011-02-16

    ... interested in comments about factors that the Department should consider in setting priorities and selecting... set forth in our semi-annual Regulatory Agenda published in the Federal Register (see Appendix D to... rulemaking priorities. Moreover, under 49 CFR part 5, anyone may petition the Department for rulemaking or...

  18. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls - A review.

    Science.gov (United States)

    Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J Pablo; Garcia-Jares, Carmen

    2016-04-07

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005-2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. Copyright © 2016

  19. Advanced Measuring (Instrumentation Methods for Nuclear Installations: A Review

    Directory of Open Access Journals (Sweden)

    Wang Qiu-kuan

    2012-01-01

    Full Text Available The nuclear technology has been widely used in the world. The research of measurement in nuclear installations involves many aspects, such as nuclear reactors, nuclear fuel cycle, safety and security, nuclear accident, after action, analysis, and environmental applications. In last decades, many advanced measuring devices and techniques have been widely applied in nuclear installations. This paper mainly introduces the development of the measuring (instrumentation methods for nuclear installations and the applications of these instruments and methods.

  20. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    International Nuclear Information System (INIS)

    Wilmot, Roger D.

    2011-02-01

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  1. Analyzing policy support instruments and regulatory risk factors for wind energy deployment-A developers' perspective

    International Nuclear Information System (INIS)

    Luethi, Sonja; Praessler, Thomas

    2011-01-01

    A transition to a renewable energy system is high on the policy agenda in many countries. A promising energy source for a low-carbon energy future is wind. Policy-makers can attract wind energy development by providing attractive policy frameworks. This paper argues that apart from the level of financial support, both the risks stemming from the regulatory environment (legal security, administrative process and grid access) and the ability to finance projects play a critical role in determining the attractiveness of the development environment. It sheds light on how project developers trade off these different aspects and to what extent the attractiveness of a certain policy framework increases with the introduction of specific measures. Conjoint analysis is employed to provide empirical evidence on the preference of wind energy developers in the EU and the US. The analysis shows that developers' preferences are very similar across the studied regions and for different types of developers. Which policy measures could be most valuable depends on the specific existing environment. In some southeastern European countries, a reduction of administrative process duration may yield the highest utility gains, whereas, in the US, improvements in grid access regulation and an increase in remuneration levels may be more effective. - Highlights: → Paper suggests conjoint analysis as scenario tool for estimating potential effects of specific policy measures. → It provides a quantitative, empirical dataset of 119 onshore wind energy developers' preferences. → Results suggest that the aspects 'Legal security' and 'Remuneration' are important attributes. → Cluster analyses yields slightly different preferences for developers from EU and US.

  2. Treatment of differing professional opinions in the regulatory review process

    International Nuclear Information System (INIS)

    Shapar, H.K.

    1978-01-01

    The Nuclear Regulatory Commission is an independent body whose purpose is to assure that civilian nuclear activities are consistent with the public health and safety and environmental protection. To this effect, Congress has vested it with the necessary control powers. The question here is how to reconcile diverging opinions expressed within NRC by executives and technicians during the enquiry pocedure for licensing of nuclear installations. The diversity of professional viewpoints should be viewed as a positive factor strengthening the regulatory process and should therefore be maintained. However, decisions must be made; therefore some viewpoints will not prevail but that should not be construed as a signal that the internal discussion process is condemned. NRC staff are entitled to express their views and not subjected to professional and administrative sanctions for doing so. (NEA) [fr

  3. Nuclear regulatory review of licensee self-assessment (LSA)

    International Nuclear Information System (INIS)

    2003-01-01

    Licensee self-assessment (LSA) by nuclear power plant operators is described as all the activities that a licensee performs in order to identify opportunities for improvements. An LSA is part of an organisation's holistic management system, which must include other process elements. Particularly important elements are: a process for choosing which identified potential improvements should be implemented and a process of project management for implementing the improvements chosen. Nuclear regulators expect the licensee to run an effective LSA programme, which reflects the licensee's 'priority to safety'. Based on contributions from members of the NEA Committee on Nuclear Regulatory Activities (CNRA), this publication provides an overview of the current regulatory philosophy on and approaches to LSA as performed by licensees. The publication's intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  4. Review Paper: Review of Instrumentation for Irradiation Testing of Nuclear Fuels and Materials

    International Nuclear Information System (INIS)

    Kim, Bong Goo; Rempe, Joy L.; Villard, Jean-Francois; Solstadd, Steinar

    2011-01-01

    Over 50 years of nuclear fuels and materials irradiation testing has led to many countries developing significant improvements in instrumentation to monitor physical parameters and to control the test conditions in material test reactors (MTRs). Recently, there is increased interest to irradiate new materials and reactor fuels for advanced pressurized water reactors and Gen-IV reactor systems, such as sodium-cooled fast reactors, very high temperature reactors, supercritical water-cooled reactors, and gas-cooled fast reactors. This review paper documents the current state of instrumentation technologies in MTRs in the world and summarizes ongoing research efforts to deploy new sensors. As described in this paper, a wide range of sensors is available to measure key parameters of interest during fuels and materials irradiations in MTRs. Ongoing development efforts focus on providing MTR users a wider range of parameter measurements with smaller, higher accuracy sensors.

  5. Completed EO 12866 Regulatory Reviews by Calendar Year

    Data.gov (United States)

    Executive Office of the President — Annual data set of draft rules reviewed by OMB under Executive Orders 12291 and 12866. The data provide information by agency, length of review in days, and economic...

  6. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

    International Nuclear Information System (INIS)

    Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

    2016-01-01

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights:

  7. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

    Energy Technology Data Exchange (ETDEWEB)

    Lores, Marta, E-mail: marta.lores@usc.es; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

    2016-04-07

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights:

  8. Nuclear Regulatory Commission's antitrust review process: an analysis of the impacts

    International Nuclear Information System (INIS)

    1981-06-01

    The Nuclear Regulatory Commission's (NRC) antitrust process is reviewed and its impacts to small systems and applicant systems are studied. This process takes the form of a description of the NRC's antitrust review process as implemented, a generic categorization of potential impacts and individual case-by-case studies of four different utilities

  9. Problems and experience of regulatory review associated with plant construction and commissioning

    International Nuclear Information System (INIS)

    Commander, W.

    1979-01-01

    The work of the Assessment Branch of NII covering the regulatory review during design safety assessment, construction, commissioning and operation is described commencing with the nuclear licensing procedure through licence variations and conditions attached to the licence, to the final stages of plant construction up to commercial operation and full power production. The importance of the application of safety assessment principles is outlined, the importance of the Safety Inspectorate Schedule described, and the need to retain organisational and regulatory flexibility emphasised. (author)

  10. Instruments to assess self-care among healthy children: A systematic review of measurement properties.

    Science.gov (United States)

    Urpí-Fernández, Ana-María; Zabaleta-Del-Olmo, Edurne; Montes-Hidalgo, Javier; Tomás-Sábado, Joaquín; Roldán-Merino, Juan-Francisco; Lluch-Canut, María-Teresa

    2017-12-01

    To identify, critically appraise and summarize the measurement properties of instruments to assess self-care in healthy children. Assessing self-care is a proper consideration for nursing practice and nursing research. No systematic review summarizes instruments of measurement validated in healthy children. Psychometric review in accordance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) panel. MEDLINE, CINAHL, PsycINFO, Web of Science and Open Grey were searched from their inception to December 2016. Validation studies with a healthy child population were included. Search was not restricted by language. Two reviewers independently assessed the methodological quality of included studies using the COSMIN checklist. Eleven studies were included in the review assessing the measurement properties of ten instruments. There was a maximum of two studies per instrument. None of the studies evaluated the properties of test-retest reliability, measurement error, criterion validity and responsiveness. Internal consistency and structural validity were rated as "excellent" or "good" in four studies. Four studies were rated as "excellent" in content validity. Cross-cultural validity was rated as "poor" in the two studies (three instruments) which cultural adaptation was carried out. The evidence available does not allow firm conclusions about the instruments identified in terms of reliability and validity. Future research should focus on generate evidence about a wider range of measurement properties of these instruments using a rigorous methodology, as well as instrument testing on different countries and child population. © 2017 John Wiley & Sons Ltd.

  11. Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

    Science.gov (United States)

    McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

    2012-07-01

    There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

  12. Overall review strategy for the Nuclear Regulatory Commission's High-Level Waste Repository Program

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-11-01

    The Overall Review Strategy gives general guidance to the Nuclear Regulatory Commission staff for conducting it's license application and pre-license application reviews. These reviews are in support of the Commission's construction authorization decision for a geologic repository for the disposal of high-level radioactive waste. Objectives and strategies are defined that focus the staff's reviews on determining compliance with requirements of 10 CFR Part 60. These strategies define how the staff prioritizes its reviews on those key technical uncertainties considered to be most important to repository performance. Strategies also give guidance for developing, in an integrated way, the License Application Review Plan together with supporting performance assessments, analyses, and research

  13. Measurement of shared decision making - a review of instruments

    NARCIS (Netherlands)

    Scholl, I.; Koelewijn-van Loon, M.; Sepucha, K.; Elwyn, G.; Legare, F.; Harter, M.; Dirmaier, J.

    2011-01-01

    The last years have seen a clear move towards shared decision making (SDM) and increased patient involvement in many countries. However, as the field of SDM research is still relatively young, new instruments for the measurement of (shared) decision making (process, outcome and surrounding elements)

  14. School Climate: Historical Review, Instrument Development, and School Assessment

    Science.gov (United States)

    Zullig, Keith J.; Koopman, Tommy M.; Patton, Jon M.; Ubbes, Valerie A.

    2010-01-01

    This study's purpose is to examine the existing school climate literature in an attempt to constitute its definition from a historical context and to create a valid and reliable student-reported school climate instrument. Five historically common school climate domains and five measurement tools were identified, combined, and previewed by the…

  15. Applications of Calendar Instruments in Social Surveys: a review

    NARCIS (Netherlands)

    Glasner, T.J.; Vaart, van der W.

    2009-01-01

    Retrospective reports in survey interviews and questionnaires are subject to many types of recall error, which affect completeness, consistency, and dating accuracy. Concerns about this problem have led to the development of so-called calendar instruments, or timeline techniques. These aided recall

  16. A review of instruments developed to measure food neophobia

    DEFF Research Database (Denmark)

    Damsbo-Svendsen, Marie; Frøst, Michael Bom; Olsen, Annemarie

    2017-01-01

    Food choices are influenced by an individual's attitude towards foods. Food neophobia may be associated with less variety of diets, inadequate nutrient intake and high product failure rate for new food products entering the market. To quantify the extent of these challenges, instruments to measur...

  17. Calibration and assessment of electrochemical air quality sensors by co-location with regulatory-grade instruments

    Science.gov (United States)

    Hagan, David H.; Isaacman-VanWertz, Gabriel; Franklin, Jonathan P.; Wallace, Lisa M. M.; Kocar, Benjamin D.; Heald, Colette L.; Kroll, Jesse H.

    2018-01-01

    The use of low-cost air quality sensors for air pollution research has outpaced our understanding of their capabilities and limitations under real-world conditions, and there is thus a critical need for understanding and optimizing the performance of such sensors in the field. Here we describe the deployment, calibration, and evaluation of electrochemical sensors on the island of Hawai`i, which is an ideal test bed for characterizing such sensors due to its large and variable sulfur dioxide (SO2) levels and lack of other co-pollutants. Nine custom-built SO2 sensors were co-located with two Hawaii Department of Health Air Quality stations over the course of 5 months, enabling comparison of sensor output with regulatory-grade instruments under a range of realistic environmental conditions. Calibration using a nonparametric algorithm (k nearest neighbors) was found to have excellent performance (RMSE 0.997) across a wide dynamic range in SO2 ( 2 ppm). However, since nonparametric algorithms generally cannot extrapolate to conditions beyond those outside the training set, we introduce a new hybrid linear-nonparametric algorithm, enabling accurate measurements even when pollutant levels are higher than encountered during calibration. We find no significant change in instrument sensitivity toward SO2 after 18 weeks and demonstrate that calibration accuracy remains high when a sensor is calibrated at one location and then moved to another. The performance of electrochemical SO2 sensors is also strong at lower SO2 mixing ratios (pollutant species in other areas (e.g., polluted urban regions), the calibration and validation approaches described here should be widely applicable to a range of pollutants, sensors, and environments.

  18. Report of the Survey on the Design Review of New Reactor Applications. Volume 1 - Instrumentation and Control

    International Nuclear Information System (INIS)

    Downey, Steven

    2014-06-01

    At the tenth meeting of the CNRA Working Group on the Regulation of New Reactors (WGRNR) in March 2013, the members agreed to present the responses to the Second Phase, or Design Phase, of the Licensing Process Survey as a multi-volume text. As such, each report will focus on one of the eleven general technical categories covered in the survey. The general technical categories were selected to conform to the topics covered in the International Atomic Energy Agency (IAEA) Safety Guide GS-G-4.1. This report, which is the first volume, provides a discussion of the survey responses related to Instrumentation and Control (I and C). The Instrumentation and Control category includes the twelve following technical topics: Reactor trip system, actuation systems for Engineered Safety Features (ESF), safe shutdown system, safety-related display instrumentation, information and interlock systems important to safety, controls systems, main control room, supplementary control room, diverse I and C systems, data communication systems, software reliability and cyber-security. For each technical topic, the member countries described the information provided by the applicant, the scope and level of detail of the technical review, the technical basis for granting regulatory authorisation, the skill sets required and the Level of effort needed to perform the review. Based on a comparison of the information provided in response to the survey, the following observations were made: - Among the regulatory organisations that responded to the survey, there are similarities in the design information provided by an applicant. In most countries, the design information provided by an applicant includes, but is not limited to, a description of the I and C system design and functions, a description of the verification and validation programmes, and provisions for analysis, testing, and inspection of various I and C systems. - In addition to the regulations, it is a common practice for countries

  19. A comparative review of measurement instruments to inform and evaluate effectiveness of disability inclusive development.

    Science.gov (United States)

    Goujon, Nicolas; Devine, Alexandra; Baker, Sally M; Sprunt, Beth; Edmonds, Tanya J; Booth, Jennifer K; Keeffe, Jill E

    2014-01-01

    A review of existing measurement instruments was conducted to examine their suitability to measure disability prevalence and assess quality of life, protection of disability rights and community participation by people with disabilities, specifically within the context of development programs in low and middle-income countries. From a search of PubMed and the grey literature, potentially relevant measurement instruments were identified and examined for their content and psychometric properties, where possible. Criteria for inclusion were: based on the WHO's International Classification of Functioning Disability and Health (ICF), used quantitative methods, suitable for population-based studies of disability inclusive development in English and published after 1990. Characteristics of existing instruments were analysed according to components of the ICF and quality of life domains. Ten instruments were identified and reviewed according to the criteria listed above. Each version of instruments was analysed separately. Only three instruments included a component on quality of life. Domains from the ICF that were addressed by some but not all instruments included the environment, technology and communication. The measurement instruments reviewed covered the range of elements required to measure disability-inclusion within development contexts. However no single measurement instrument has the capacity to measure both disability prevalence and changes in quality of life according to contemporary disability paradigms. The review of measurement instruments supports the need for developing an instrument specifically intended to measure disability inclusive practice within development programs. Implications for Rehabilitation Surveys and tools are needed to plan disability inclusive development. Existing measurement tools to determine prevalence of disability, wellbeing, rights and access to the community were reviewed. No single validated tool exists for population

  20. Regulatory requirements on PSA level 2: Review, aspects and applications

    International Nuclear Information System (INIS)

    Husarcek, J.

    2003-01-01

    The general requirements concerning utility obligations, probabilistic safety criteria (CDF should not exceed 1.0E-4/reactor year and LERF should not exceed 1.0E-5/reactor year), documentation and results, living PSA requirements and major steps in level 2 PSA are presented. PSA developments in Slovakia, collection and assembly of information, plant damage states, containment performance and failure modes, severe accident progression analyses, containment failure modes and source terms as a part of performed level 2 PSA are discussed. The PSA applications in design and operation evaluation, support to plant upgrade and modifications are also described. At the end, the following conclusion is made: more extensive PSA application needs to foster the exchange of experience and communication between PSA specialists, non-PSA engineers, designers, and the regulatory body staff responsible for safety assessment, inspection and enforcement

  1. Reviewing the regulatory barriers for nanomedicine: global questions and challenges.

    Science.gov (United States)

    Bowman, Diana M; Gatof, Jake

    2015-01-01

    Nanomedicine will play an increasing role in prevention and treatment across the entire healthcare spectrum. However, their precise market size, economic value and areas of application remain unclear. This opacity, including the question of what constitutes nanomedicine matters, especially when considered alongside the key regulatory questions and concerns. This article begins by placing these key questions into context in relation to the current scientific state of the art, focusing particular attention on the human health and safety context. In exploring these central questions surrounding the regulation of nanomedicine, this perspective also explores existing and suggested frameworks that aim to deal with emerging technologies more generally. It then outlines priority areas for action and general conclusions specific to nanomedicine.

  2. Observation of nurse-patient interaction in oncology: review of assessment instruments.

    NARCIS (Netherlands)

    Caris-Verhallen, W.; Timmermans, L.; Dulmen, S. van

    2004-01-01

    The aim of this review is to identify assessment instruments that can be used for analyzing sequences and can be applied to research into nurse-patient communication in cancer care. A systematic search of the literature revealed a variety of methods and instruments applicable to studies recording

  3. Reliability and validity of instruments measuring job satisfaction - a systematic review

    NARCIS (Netherlands)

    van Saane, N.; Sluiter, J. K.; Verbeek, J. H. A. M.; Frings-Dresen, M. H. W.

    2003-01-01

    Background Although job satisfaction research has been carried out for decades, no recent overview of job satisfaction instruments and their quality is available. Aim The aim of this systematic review is to select job satisfaction instruments of adequate reliability and validity for use as

  4. Organization and practices on regulatory review in the licensing process of nuclear power plants in Spain

    International Nuclear Information System (INIS)

    Trueba, P.

    1979-01-01

    The actual organisation, practices and experience of the JEN Nuclear Safety Department on the regulatory review in the licensing process of nuclear power plants in Spain, are presented. Topics to be covered are: The structure, organisation, staff and principal functional areas of the NSD, the academic qualifications and work experience of the NSD personnel, recruiting and training, the conduct of the regulatory review during the licensing process and working procedures, the manpower and coverage of the different technical areas, the principal problems and conclusions. (author)

  5. Taking spiritual history in clinical practice: a systematic review of instruments.

    Science.gov (United States)

    Lucchetti, Giancarlo; Bassi, Rodrigo M; Lucchetti, Alessandra L Granero

    2013-01-01

    To facilitate the addressing of spirituality in clinical practice, several authors have created instruments for obtaining a spiritual history. However, in only a few studies have authors compared these instruments. The aim of this study was to compare the most commonly used instruments for taking a spiritual history in a clinical setting. A systematic review of spiritual history assessment was conducted in five stages: identification of instruments used in the literature (databases searching); relevant articles from title and initial abstract review; exclusion and Inclusion criteria; full text retrieval and final analysis of each instrument. A total of 2,641 articles were retrieved and after the analysis, 25 instruments were included. The authors independently evaluated each instrument on 16 different aspects. The instruments with the greatest scores in the final analysis were FICA, SPIRITual History, FAITH, HOPE, and the Royal College of Psychiatrists. Concerning all 25 instruments, 20 of 25 inquire about the influence of spirituality on a person's life and 17 address religious coping. Nevertheless, only four inquire about medical practices not allowed, six deal with terminal events, nine have mnemonics to facilitate their use, and five were validated. FICA, SPIRITual History, FAITH, HOPE, and Royal College of Psychiatrists scored higher in our analysis. The use of each instrument must be individualized, according to the professional reality, time available, patient profile, and settings. Copyright © 2013 Elsevier Inc. All rights reserved.

  6. A systematic review of instruments to measure depressive symptoms in patients with schizophrenia

    NARCIS (Netherlands)

    Lako, Irene M.; Bruggeman, R.; Knegtering, H.; Wiersma, D.; Schoevers, R. A.; Slooff, C. J.; Taxis, K.

    Background: Depressive symptoms require accurate recognition and monitoring in clinical practice of patients with schizophrenia. Depression instruments developed for use in depressed patients may not discriminate depressive symptoms from negative psychotic symptoms. Objective: We reviewed depression

  7. The Society for Implementation Research Collaboration Instrument Review Project: a methodology to promote rigorous evaluation.

    Science.gov (United States)

    Lewis, Cara C; Stanick, Cameo F; Martinez, Ruben G; Weiner, Bryan J; Kim, Mimi; Barwick, Melanie; Comtois, Katherine A

    2015-01-08

    Identification of psychometrically strong instruments for the field of implementation science is a high priority underscored in a recent National Institutes of Health working meeting (October 2013). Existing instrument reviews are limited in scope, methods, and findings. The Society for Implementation Research Collaboration Instrument Review Project's objectives address these limitations by identifying and applying a unique methodology to conduct a systematic and comprehensive review of quantitative instruments assessing constructs delineated in two of the field's most widely used frameworks, adopt a systematic search process (using standard search strings), and engage an international team of experts to assess the full range of psychometric criteria (reliability, construct and criterion validity). Although this work focuses on implementation of psychosocial interventions in mental health and health-care settings, the methodology and results will likely be useful across a broad spectrum of settings. This effort has culminated in a centralized online open-access repository of instruments depicting graphical head-to-head comparisons of their psychometric properties. This article describes the methodology and preliminary outcomes. The seven stages of the review, synthesis, and evaluation methodology include (1) setting the scope for the review, (2) identifying frameworks to organize and complete the review, (3) generating a search protocol for the literature review of constructs, (4) literature review of specific instruments, (5) development of an evidence-based assessment rating criteria, (6) data extraction and rating instrument quality by a task force of implementation experts to inform knowledge synthesis, and (7) the creation of a website repository. To date, this multi-faceted and collaborative search and synthesis methodology has identified over 420 instruments related to 34 constructs (total 48 including subconstructs) that are relevant to implementation

  8. Organisation and experience of the regulatory review in the United Kingdom

    International Nuclear Information System (INIS)

    Gausden, R.; Woods, P.B.

    1979-01-01

    Regulatory requirements and stages of the review in the UK are outlined. The organisation, management and working procedures of the Inspectorate are described and the effort and timescale which have been found necessary for a satisfactory safety review is discussed. A number of problem areas in the review situation have been identified from experience and these are discussed and possible solutions proposed. They include the importance of early review of generic aspects of systems which are being considered for licensing, the place of safety principles and of detailed engineering assessment in the review process, the independence of the regulatory group's activities in its study of major technical issues and the use which should be made of outside expertise. (auth.)

  9. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yong Suk; Jung, Dae Wook [Future and Challenges Inc., Seoul (Korea, Republic of); Cho, Nam Chul [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2008-10-15

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future.

  10. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    International Nuclear Information System (INIS)

    Lee, Yong Suk; Jung, Dae Wook; Cho, Nam Chul

    2008-01-01

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future

  11. A review of instruments to measure interprofessional team-based primary care.

    Science.gov (United States)

    Shoemaker, Sarah J; Parchman, Michael L; Fuda, Kathleen Kerwin; Schaefer, Judith; Levin, Jessica; Hunt, Meaghan; Ricciardi, Richard

    2016-07-01

    Interprofessional team-based care is increasingly regarded as an important feature of delivery systems redesigned to provide more efficient and higher quality care, including primary care. Measurement of the functioning of such teams might enable improvement of team effectiveness and could facilitate research on team-based primary care. Our aims were to develop a conceptual framework of high-functioning primary care teams to identify and review instruments that measure the constructs identified in the framework, and to create a searchable, web-based atlas of such instruments (available at: http://primarycaremeasures.ahrq.gov/team-based-care/ ). Our conceptual framework was developed from existing frameworks, the teamwork literature, and expert input. The framework is based on an Input-Mediator-Output model and includes 12 constructs to which we mapped both instruments as a whole, and individual instrument items. Instruments were also reviewed for relevance to measuring team-based care, and characterized. Instruments were identified from peer-reviewed and grey literature, measure databases, and expert input. From nearly 200 instruments initially identified, we found 48 to be relevant to measuring team-based primary care. The majority of instruments were surveys (n = 44), and the remainder (n = 4) were observational checklists. Most instruments had been developed/tested in healthcare settings (n = 30) and addressed multiple constructs, most commonly communication (n = 42), heedful interrelating (n = 42), respectful interactions (n = 40), and shared explicit goals (n = 37). The majority of instruments had some reliability testing (n = 39) and over half included validity testing (n = 29). Currently available instruments offer promise to researchers and practitioners to assess teams' performance, but additional work is needed to adapt these instruments for primary care settings.

  12. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    International Nuclear Information System (INIS)

    Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga

    2009-06-01

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  13. Review of Legislation and Regulatory Framework in Ukraine with Regard to Environmental Radiation Monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Goldammer, Wolfgang; Batandjieva, Borislava (Private Consultants (Ukraine)); Nasvit, Oleg (National Security and Defence Council of Ukraine, Kyiv (Ukraine)); German, Olga (Swedish Radiation Safety Authority, Stockholm (Sweden))

    2009-06-15

    The aim of this review is to compare the current legal basis and regulatory framework in Ukraine to the relevant international safety requirements and to identify shortcomings, such as deficiencies and internal contradictions. However, no assessment of its practical implementation is made beyond the aspects related to environmental radiation monitoring. The report focuses on 13 areas present in the in the Ukrainian legislation and regulatory framework: R-1 Radiation monitoring R-2 Definition of responsibilities R-3 Normal situations R-4 Emergencies R-5 Long-term monitoring R-6 Intervention in cases of lasting exposure R-7 Use of monitoring data R-8 Record keeping R-9 Reporting to the regulatory authority R-10 Public information R-11 Human and financial resources R-12 Transboundary aspects R-13 Quality assurance. For each topic a description of the current situation and an evaluation is carried out. Ranking is then supplied supported by its evaluation. In brief these categories are: A: The national legal and regulatory documents are harmonised in substance with the international safety requirements; B: Substantial differences exist between the national and international requirements which should be addressed with the view to harmonise the legislation; C: Substantial deficiencies exist in the legal and/or regulatory bases which results in no or at least partial compliance with international safety requirements. P: In addition practical issues are also provided to indicates where practical implementation of the legislation and regulatory basis is not adequate in all respects. This report then presents main observations and conclusions of the review. On this basis, the report derives general suggestions for improvement of the legal and regulatory bases. These should be considered by the Ukrainian Government and the regulatory authorities within an action plan to improve the legal basis for radiological monitoring of the environment and to facilitate its implementation

  14. Review of decametric radio astronomy - instruments and science

    International Nuclear Information System (INIS)

    Erickson, W.C.; Cane, H.V.

    1987-01-01

    The techniques and instruments used in Galactic and extragalactic radio astronomy at dkm wavelengths are surveyed, and typical results are summarized. Consideration is given to the large specialized phased arrays used for early surveys, the use of wideband elements to increase frequency agility, experimental VLBI observations, and limitations on ground-based observations below about 10 MHz (where the proposed LF Space Array, with resolution 0.5-5 arcmin, could make a major contribution). Observations discussed cover the Galactic center, the Galactic background radiation, SNRs, compact Galactic sources, the ISM, and large extragalactic sources. 38 references

  15. Regulatory review of releases from HIFAR of radioactive airborne effluent

    International Nuclear Information System (INIS)

    Westall, D.J.; Macnab, D.I.

    1996-01-01

    Full text: The Nuclear Safety Bureau (NSB) was set up by legislation in 1992 as an independent Commonwealth corporate body reporting to the Minister for Health and Family Services. Its functions include monitoring and reviewing the safety of nuclear plant owned or operated by the Australian Nuclear Science and Technology Organisation (ANSTO). The NSB sets requirements for authorisation of the operation of the HIFAR research reactor, and may impose restrictions and conditions on its operation. The authorisation for the operation of HIFAR includes a requirement for arrangements for the treatment, safe storage and disposal of solid, liquid and gaseous radioactive wastes from the reactor. The objective is to establish conditions which would ensure that radiation exposure to plant personnel and the public from radioactive wastes are within acceptable limits and that releases are maintained as low as reasonably achievable. The NSB has developed expectations based on international best practice, against which to review HIFAR's arrangements for satisfying the requirement and achieving the objective. Arrangements for the release of airborne radioactive effluent from HIFAR were reviewed by the NSB as part of an overall review of the upgrade of safety documentation for HIFAR. The NSB's expectations for the review were drawn from the International Atomic Energy Agency (IAEA) Basic Safety Standards (Safety Series No 115-I) and the National Health and Medical Research Council (NHMRC) Recommendations for Limiting Exposure to Ionizing Radiation (1995). These expectations included a hierarchy of primary dose limits, stack discharge limits and reference levels for HIFAR aimed at ensuring that radiation doses to the public due to airborne effluent are less than the national dose limits and ANSTO's dose constraints, and are as low as reasonably achievable. An approach favoured by the operator is to work directly to a primary dose limit using an airborne dispersion computer program to

  16. International Nuclear Safety Experts Conclude IAEA Peer Review of Korea's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts concluded today a two-week mission to review the regulatory framework for nuclear safety in the Republic of Korea. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Korea, while the final report will be submitted by the end of summer 2011. At the request of the Korean Government, the IAEA assembled a team of 16 senior regulatory experts from 14 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Korean Ministry for Education, Science and Technology (MEST) and the Korean Institute for Nuclear Safety (KINS). The mission is a peer-review based on the IAEA Safety Standards. ''This was the first IRRS mission organized after Japan's Fukushima Daiichi nuclear accident and it included a review of the regulatory implications of that event,' explains Denis Flory, IAEA Deputy Director General and Head of the Department of Nuclear Safety and Security. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission and Team Leader of this mission commended the Korean authorities for their openness and commitment to sharing their experience with the world's nuclear safety community. ''IRRS missions such as the one that was just concluded here in the Republic of Korea are crucial to the enhancement of nuclear safety worldwide,'' he said. The IRRS team reviewed Korea's current regulatory framework while acknowledging the fact that the country's Government has already decided to establish, as of October 2011, a new independent regulatory body to be called Nuclear Safety Commission (NSC). As a consequence, KINS role will be as a regulatory expert organization reporting to the NSC, while MEST's role will be restricted to promoting the utilization of nuclear energy. The IRRS team identified particular strengths in the Korean regulatory system

  17. The quantitative measurement of organizational culture in health care: a review of the available instruments.

    Science.gov (United States)

    Scott, Tim; Mannion, Russell; Davies, Huw; Marshall, Martin

    2003-06-01

    To review the quantitative instruments available to health service researchers who want to measure culture and cultural change. A literature search was conducted using Medline, Cinahl, Helmis, Psychlit, Dhdata, and the database of the King's Fund in London for articles published up to June 2001, using the phrase "organizational culture." In addition, all citations and the gray literature were reviewed and advice was sought from experts in the field to identify instruments not found on the electronic databases. The search focused on instruments used to quantify culture with a track record, or potential for use, in health care settings. For each instrument we examined the cultural dimensions addressed, the number of items for each questionnaire, the measurement scale adopted, examples of studies that had used the tool, the scientific properties of the instrument, and its strengths and limitations. Thirteen instruments were found that satisfied our inclusion criteria, of which nine have a track record in studies involving health care organizations. The instruments varied considerably in terms of their grounding in theory, format, length, scope, and scientific properties. A range of instruments with differing characteristics are available to researchers interested in organizational culture, all of which have limitations in terms of their scope, ease of use, or scientific properties. The choice of instrument should be determined by how organizational culture is conceptualized by the research team, the purpose of the investigation, intended use of the results, and availability of resources.

  18. IAEA Mission Concludes Peer Review of Viet Nam's Radiation and Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded a 10-day International Atomic Energy Agency (IAEA) mission to review how Viet Nam's regulatory framework for nuclear and radiation safety has incorporated recommendations and suggestions from an earlier review, conducted in 2009. The Integrated Regulatory Review Service (IRRS) follow-up mission, requested by the Viet Nam Agency for Radiation and Nuclear Safety (VARANS), also reviewed the development of the regulatory safety infrastructure to support Viet Nam's nuclear power programme. The eight-member team comprised senior regulatory experts from Canada, France, Pakistan, Slovenia, United Arab Emirates and the United States of America, as well as three IAEA staff members. The IRRS team said in its preliminary assessment that Viet Nam had made progress since 2009, but that some key recommendations still needed to be addressed. Particular strengths identified by the team included: The commitment of VARANS staff to develop legislation and regulations in the field of nuclear and radiation safety; VARANS' efforts to implement practices that are in line with IAEA Safety Standards and internationally recognized good practices; A willingness to receive feedback regarding the efforts to establish and implement a regulation programme; and Progress made in developing the regulatory framework to support the introduction of nuclear power. The team identified the following areas as high-priority steps to further strengthen radiation and nuclear safety in Viet Nam: The effective independence of the regulatory decision-making process needs to be urgently addressed; Additional resources are needed to regulate existing radiation facilities and activities, as well as the country's research reactor; Efforts to increase the capacity of VARANS to regulate the developing nuclear power programme should continue; The draft Master Plan for the Development of Nuclear Power Infrastructure should be finalized

  19. Regulatory research of the PWR severe accident information needs and instrumentation availability for hydrogen control and management

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jae-Hong; Park, Gun-Chul; Suh, Kune Y.; Kang, Yun-Moon; Lee, Un-Jang; Oh, Se-Chul; Lee, Jin-Yong [Seoul Nationl Univ., Seoul (Korea, Republic of)

    1998-03-15

    During the current research period, we have set forth the methodology for identification of a severe accident, developed a framework for hydrogen management decision trees, and analyzed the literature on hydrogen management and experimental data for hydrogen bum. Specifically, we have summarized me results for information needs in a severe accident obtained in the U.S. and other countries, and applied the methodology to the reference plant YGN 3 and 4 as part of severe accident management. We have also examined the existing instruments in terms of their availability and survivability during a severe accident, and identified additionally needed information needs and instruments. We have identified dominant accident sequences for me reference plant YGN 3 and 4 to construct decision trees, and extracted available data from the IPE study of the plant. Based upon the data we have performed preliminary study on the decision tree and decision node. Last, we have examined various mechanisms for hydrogen generation and reIevant experimental data to predict me amount of hydrogen generation and governing factors in me process. We have also reviewed the hydrogen generation related models in the severe accident analysis.

  20. 77 FR 26768 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

    Science.gov (United States)

    2012-05-07

    ... postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the Patent and..., FDA-2010-E-0660, and FDA-2010-E-0659] Determination of Regulatory Review Period for Purposes of Patent... the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which...

  1. Safety research and development in relation to regulatory review in the UKAEA

    International Nuclear Information System (INIS)

    Ablitt, J.F.

    1979-01-01

    The basic functions of the regulatory review process are defined in principle, and the need for constructive interplay between regulation on the one hand and research and development on the other, in order to avoid the dangers of being over-restrictive or too permissive, is established. A number of practical examples from operating experience are quoted, which illustrate the chosen theme. (author)

  2. 76 FR 15322 - Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV

    Science.gov (United States)

    2011-03-21

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... therapy for pediatric and adult patients with type 1 Gaucher Disease. Subsequent to this approval, the...,138,262) from Shire Human Genetic Therapies, Inc., and the Patent and Trademark Office requested FDA's...

  3. 76 FR 47527 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2011-08-05

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Chapter VII [Docket No. 110711380-1379-01] RIN 0694-XA37 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Bureau of Industry and Security, Commerce. ACTION: Notice of inquiry. SUMMARY: The Bureau of Industry and Security (BIS...

  4. A Review of International Telecommunications Industry Issues, Structure, and Regulatory Problems.

    Science.gov (United States)

    Cole, Jack E.; And Others

    Industry structure studies prior to 1968 are briefly reviewed, and an overview of industrial and technological developments up to the present is provided through synopses of more recent studies. Areas covered include overseas telephone and record carriers; the creation of the Communications Satellite Corporation; the current regulatory and…

  5. Integrated Regulatory Review Service (IRRS) Guidelines for the Preparation and Conduct of IRRS Missions

    International Nuclear Information System (INIS)

    2013-01-01

    The IAEA Integrated Regulatory Review Service (IRRS) was established to strengthen and enhance the effectiveness of national regulatory infrastructure for nuclear safety, radiation safety, radioactive waste and transport safety, and the security of radioactive sources, while recognizing the ultimate responsibility of each Member State to ensure safety in these areas. The IRRS process sets out to accomplish this expressed purpose through consideration of both technical and policy issues of a regulatory nature against IAEA safety standards and, where appropriate, good practice elsewhere. The regulatory review process directly draws upon the wide-ranging international experience and expertise of IRRS review team members. Peer exchange on technical and policy issues gives insight into the efficiency and effectiveness of the legal and governmental framework and regulatory infrastructure for safety. Through this process, opportunities for improvement are explored and potential improvement strategies identified which may be shared with other States. IRRS missions provide an opportunity for sharing regulatory experiences, harmonizing regulatory approaches among States, and creating mutual learning opportunities among regulators. IRRS discussions focus on issues arising from the State's self-assessment and the evaluation of technical areas and policy issues. The IAEA Fundamental Safety Principles (IAEA Safety Standards Series No. SF-1) provide the basis for IAEA safety standards and IAEA safety related programmes. In support of effective regulation, the IAEA has established safety standards in the area of the Governmental, Legal and Regulatory Framework for Safety (IAEA Safety Standards Series No. GSR Part 1). These safety standards form a core component of an IRRS review. Other requirements and guidance, such as The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3) and Radiation Protection and Safety of Radiation Sources

  6. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    Energy Technology Data Exchange (ETDEWEB)

    Wilmot, Roger D. (Galson Sciences Limited (United Kingdom))

    2011-02-15

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  7. Calibration and assessment of electrochemical air quality sensors by co-location with regulatory-grade instruments

    Directory of Open Access Journals (Sweden)

    D. H. Hagan

    2018-01-01

    Full Text Available The use of low-cost air quality sensors for air pollution research has outpaced our understanding of their capabilities and limitations under real-world conditions, and there is thus a critical need for understanding and optimizing the performance of such sensors in the field. Here we describe the deployment, calibration, and evaluation of electrochemical sensors on the island of Hawai`i, which is an ideal test bed for characterizing such sensors due to its large and variable sulfur dioxide (SO2 levels and lack of other co-pollutants. Nine custom-built SO2 sensors were co-located with two Hawaii Department of Health Air Quality stations over the course of 5 months, enabling comparison of sensor output with regulatory-grade instruments under a range of realistic environmental conditions. Calibration using a nonparametric algorithm (k nearest neighbors was found to have excellent performance (RMSE < 7 ppb, MAE < 4 ppb, r2 > 0.997 across a wide dynamic range in SO2 (< 1 ppb, > 2 ppm. However, since nonparametric algorithms generally cannot extrapolate to conditions beyond those outside the training set, we introduce a new hybrid linear–nonparametric algorithm, enabling accurate measurements even when pollutant levels are higher than encountered during calibration. We find no significant change in instrument sensitivity toward SO2 after 18 weeks and demonstrate that calibration accuracy remains high when a sensor is calibrated at one location and then moved to another. The performance of electrochemical SO2 sensors is also strong at lower SO2 mixing ratios (< 25 ppb, for which they exhibit an error of less than 2.5 ppb. While some specific results of this study (calibration accuracy, performance of the various algorithms, etc. may differ for measurements of other pollutant species in other areas (e.g., polluted urban regions, the calibration and validation approaches described here should be widely applicable

  8. Workplace Discrimination, Prejudice, and Diversity Measurement: A Review of Instrumentation.

    Science.gov (United States)

    Burkard, Alan W.; Boticki, Michael A.; Madson, Michael B.

    2002-01-01

    Critically reviews diversity measures in terms of item development, psychometric evidence, and utility for counseling and development: Workplace Prejudice/Discrimination Inventory, Attitudes toward Diversity Scale; Organizational Diversity Inventory, Workforce Diversity Questionnaire, Perceived Occupational Opportunity Scale-Form B, and Perceived…

  9. Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

    Science.gov (United States)

    Asano, K; Tanaka, A; Sato, T; Uyama, Y

    2013-08-01

    Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

  10. Safety Experts Complete IAEA Nuclear Regulatory Review of the United States

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the United States. The team identified good practices within the U.S. system and offered suggestions for ways the U.S. Nuclear Regulatory Commission (NRC) could improve. The IAEA has conveyed the team's main conclusions to the NRC, and a final report will be submitted to the NRC in about two months. At the request of the United States, the IAEA assembled a team of 19 international experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission was a peer review based on the IAEA Safety Standards. It was not an inspection, nor an audit. The experts came from 14 different countries: Canada, China, the Czech Republic, Finland, France, Italy, Japan, Mexico, the Republic of Korea, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Team leader Jukka Laaksonen of Finland said: ''We found a comprehensive, consistent, and mature regulatory system run by the NRC, which has a strong drive for continuous improvement.' The scope of the mission included the U.S. regulatory framework and the regulation of the nuclear plant operation. The mission was conducted from 18 to 29 October, mainly at NRC headquarters outside of Washington, D.C. To study U.S. regulatory activities, the mission conducted a series of interviews and discussions with NRC staff and other organizations to help assess the effectiveness of the regulatory system. In addition, the team observed regulatory activities at two operating nuclear power reactors and an emergency preparedness exercise. The IAEA's IRRS coordinator Gustavo Caruso said, ''This mission represents a milestone for the IRRS program because the U.S. regulatory system is the largest in the world and many nations look to it. The IRRS is a useful tool that allows host nations to gain guidance from experienced

  11. International nuclear safety experts complete IAEA peer review of German regulatory system

    International Nuclear Information System (INIS)

    2008-01-01

    Full text: An international expert team has today completed a two-week IAEA review of Germany's nuclear regulatory system. The team identified good practices within the system and gave advice on some areas for further improvement. The IAEA has conveyed the initial findings to German authorities but the final report will be submitted within two months. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency (IAEA) assembled a team of 14 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. Experts from Canada, the Czech Republic, Finland, France, Japan, the Netherlands, Republic of Korea, Spain, Switzerland, the UK, the US and from the IAEA took part in the mission, which was conducted from 7 to 19 September in Bonn, Stuttgart and Berlin. The main basis for the review was a well-prepared self-assessment made by the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wuerttemberg (UM BW). 'The team members were impressed by the extensive preparation and dedication of the staff both at BMU and UM BW to excellence in nuclear safety,' said Mike Weightman, IRRS Team Leader and Chief Inspector of the UK nuclear regulatory body, the Nuclear Directorate of the Health and Safety Executive. 'We hope the IRRS mission will facilitate further improvements in the safety regulation of nuclear power in Germany and throughout the world.' 'Germany's invitation to undergo such a detailed review is a clear demonstration of its openness and commitment to continuously improve nuclear safety regulation,' said Philippe Jamet, Director of the IAEA's Nuclear Installation Safety Division. Among the particular strengths of BMU and UM BW associated with their

  12. International Expert Team Concludes IAEA Peer Review of Poland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: International safety experts last week concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Poland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that Poland's nuclear regulator, Panstwowa Agencja Atomistyki (PAA), has a clear commitment to safety, a high level of transparency, competent staff and leadership, and a good recognition of challenges ahead related to Poland's efforts to develop nuclear power. ''Poland's regulatory framework and the work of PAA give high confidence of strong radiation protection for the Polish people. Further, there has been significant progress in the development of Poland's regulatory framework in preparation for the challenge of regulating nuclear power,'' said team leader Robert Lewis, a senior executive in the US Nuclear Regulatory Commission. The mission was conducted at the request of the Government of Poland from 15-25 April. The team was made up of 11 regulatory experts from Belgium, the Czech Republic, Finland, France, the Republic of Korea, Slovakia, Slovenia, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as five IAEA staff members. The IRRS review team was very thorough in its review, and we welcome its advice on how to continue to improve our programmes to protect people and the environment , said Janusz Wlodarski, President of PAA. The team interviewed members of PAA and officials from various ministries, as well as key players in the Polish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. Among its main observations the IRRS review team identified the following good practices: Applying the considerable experience of PAA's senior management to regulatory issues; The introduction of changes to Poland's laws and regulations following broad public consultation at an early stage in

  13. A Review on the Regulatory Strategy of Human Factors Engineering Consideration in Pakistan Nuclear Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Sohail, Sabir [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Choi, Seong Nam [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-10-15

    In this paper, the legal and regulatory infrastructure available in Pakistan for HFE requirements is assessed, and the methodology for strengthening of legal infrastructure is presented. The regulatory strategy on evaluation of HFE consideration should provide reviewers with guidance on review process. Therefore, the suggested methodology is based on preparation of guidance documents such as checklist, working procedures, S and Gs etc.; incorporation of PRM elements in regulatory system; and finally the development of PRM implementation criteria. Altogether, the scheme provide the enhancement in regulatory infrastructure and also the effective and efficient review process. The Three Mile Island (TMI) accident brought the general consensus among the nuclear community on the integration of human factors engineering (HFE) principles in all phases of nuclear power. This notion has further strengthened after the recent Fukushima nuclear accident. Much effort has been put over to incorporate the lesson learned and continuous technical evolution on HFE to device different standards. The total of 174 ergonomics standards are alone identified by Dul et al. (2004) published by International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) and number of standards and HFE guidelines (S and Gs) are also published by organizations like Institute for Electrical and Electronics Engineering (IEEE), International Electrotechnical Commission (IEC), International Atomic Energy Agency (IAEA), United States Nuclear Regulatory Commission (USNRC), etc. The ambition of effective review on HFE integration in nuclear facility might be accomplished through the development of methodology for systematic implementation of S and Gs. Such kind of methodology would also be beneficial for strengthening the regulatory framework and practices for countries new in the nuclear arena and with small scale nuclear program. The objective of paper is to review the

  14. Knowledge management for efficient quantitative analyses during regulatory reviews.

    Science.gov (United States)

    Krudys, Kevin; Li, Fang; Florian, Jeffry; Tornoe, Christoffer; Chen, Ying; Bhattaram, Atul; Jadhav, Pravin; Neal, Lauren; Wang, Yaning; Gobburu, Joga; Lee, Peter I D

    2011-11-01

    Knowledge management comprises the strategies and methods employed to generate and leverage knowledge within an organization. This report outlines the activities within the Division of Pharmacometrics at the US FDA to effectively manage knowledge with the ultimate goal of improving drug development and advancing public health. The infrastructure required for pharmacometric knowledge management includes provisions for data standards, queryable databases, libraries of modeling tools, archiving of analysis results and reporting templates for effective communication. Two examples of knowledge management systems developed within the Division of Pharmacometrics are used to illustrate these principles. The benefits of sound knowledge management include increased productivity, allowing reviewers to focus on research questions spanning new drug applications, such as improved trial design and biomarker development. The future of knowledge management depends on the collaboration between the FDA and industry to implement data and model standards to enhance sharing and dissemination of knowledge.

  15. Experts Complete IAEA Follow-up Review of Australia's Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear and radiation safety experts today concluded an eight-day mission to review the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), the country's nuclear regulator. At the request of the Australian Government, the International Atomic Energy Agency (IAEA) assembled a peer-review team of five regulatory experts from as many nations and three IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2007. This follow-up IRRS mission examined ARPANSA's progress in acting upon the recommendations and suggestions made during the 2007 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety regulatory aspects of all facilities and activities regulated by ARPANSA. IRRS team leader Kaare Ulbak, Chief Advisor of Denmark's National Institute of Radiation Protection, said: ''ARPANSA should be commended for the significant amount of efforts in addressing all the findings identified in the 2007 mission and for inviting this follow-up review.'' The review team found that ARPANSA has made significant progress toward improving its regulatory activities, as most of the findings identified in the 2007 report have been effectively addressed and therefore can be considered closed. Complementing the ARPANSA strengths identified during the 2007 mission, the 2011 IRRS team noted the following strengths: Response to the Tepco Fukushima Dai-ichi accident; High level of in-house technical expertise in radiation safety; Recognition of the need and willingness to re-organize ARPANSA; Timely development of the national sealed source register in good coordination with other relevant organizations; and Creation of the Australian clinical dosimetry service and the national dose reference levels database. The 2011 IRRS team also made recommendations and suggestions to further strengthen ARPANSA's regulatory system, including: Making full

  16. Nuclear Experts Complete IAEA Follow-up Review of German Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts concluded a seven-day mission to review the German Regulatory System, conducted from 4-10 September in Bonn, Stuttgart and Berlin. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency assembled a peer-review team of six high-level regulatory experts from six nations (Finland, France, the Netherlands, Switzerland, the UK, the US and three IAEA senior staff members) to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined the progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review at both the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wurttemberg (UM BW). The first mission reviewed Germany's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. IRRS team leader, Mr. McCree, of the US Nuclear Safety Commission (USNRC), said, ''This was an important IRRS mission, particularly given the recent Fukushima Daiichi Nuclear Power Plant accident and the related insights which underscore the importance of having an independent, credible nuclear safety regulator.'' ''The IRRS team identified several strengths of the German nuclear safety regulators, including the prompt and coordinated incident response activities of BMU and UM BW to the Fukushima accident. Some suggestions were also made to further strengthen nuclear safety regulations concerning the future work of BMU,'' he said. The review team found that important progress has been made toward

  17. A Systematic Review of Instruments to Assess Organizational Readiness for Knowledge Translation in Health Care

    Science.gov (United States)

    Gagnon, Marie-Pierre; Attieh, Randa; Ghandour, El Kebir; Légaré, France; Ouimet, Mathieu; Estabrooks, Carole A.; Grimshaw, Jeremy

    2014-01-01

    Background The translation of research into practices has been incomplete. Organizational readiness for change (ORC) is a potential facilitator of effective knowledge translation (KT). However we know little about the best way to assess ORC. Therefore, we sought to systematically review ORC measurement instruments. Methods We searched for published studies in bibliographic databases (Pubmed, Embase, CINAHL, PsychINFO, Web of Science, etc.) up to November 1st, 2012. We included publications that developed ORC measures and/or empirically assessed ORC using an instrument at the organizational level in the health care context. We excluded articles if they did not refer specifically to ORC, did not concern the health care domain or were limited to individual-level change readiness. We focused on identifying the psychometric properties of instruments that were developed to assess readiness in an organization prior to implementing KT interventions in health care. We used the Standards for Educational and Psychological Testing to assess the psychometric properties of identified ORC measurement instruments. Findings We found 26 eligible instruments described in 39 publications. According to the Standards for Educational and Psychological Testing, 18 (69%) of a total of 26 measurement instruments presented both validity and reliability criteria. The Texas Christian University –ORC (TCU-ORC) scale reported the highest instrument validity with a score of 4 out of 4. Only one instrument, namely the Modified Texas Christian University – Director version (TCU-ORC-D), reported a reliability score of 2 out of 3. No information was provided regarding the reliability and validity of five (19%) instruments. Conclusion Our findings indicate that there are few valid and reliable ORC measurement instruments that could be applied to KT in the health care sector. The TCU-ORC instrument presents the best evidence in terms of validity testing. Future studies using this instrument could

  18. A systematic review of instruments to assess organizational readiness for knowledge translation in health care.

    Directory of Open Access Journals (Sweden)

    Marie-Pierre Gagnon

    Full Text Available The translation of research into practices has been incomplete. Organizational readiness for change (ORC is a potential facilitator of effective knowledge translation (KT. However we know little about the best way to assess ORC. Therefore, we sought to systematically review ORC measurement instruments.We searched for published studies in bibliographic databases (Pubmed, Embase, CINAHL, PsychINFO, Web of Science, etc. up to November 1st, 2012. We included publications that developed ORC measures and/or empirically assessed ORC using an instrument at the organizational level in the health care context. We excluded articles if they did not refer specifically to ORC, did not concern the health care domain or were limited to individual-level change readiness. We focused on identifying the psychometric properties of instruments that were developed to assess readiness in an organization prior to implementing KT interventions in health care. We used the Standards for Educational and Psychological Testing to assess the psychometric properties of identified ORC measurement instruments.We found 26 eligible instruments described in 39 publications. According to the Standards for Educational and Psychological Testing, 18 (69% of a total of 26 measurement instruments presented both validity and reliability criteria. The Texas Christian University -ORC (TCU-ORC scale reported the highest instrument validity with a score of 4 out of 4. Only one instrument, namely the Modified Texas Christian University - Director version (TCU-ORC-D, reported a reliability score of 2 out of 3. No information was provided regarding the reliability and validity of five (19% instruments.Our findings indicate that there are few valid and reliable ORC measurement instruments that could be applied to KT in the health care sector. The TCU-ORC instrument presents the best evidence in terms of validity testing. Future studies using this instrument could provide more knowledge on its

  19. Motor assessment instruments and psychometric procedures: A systematic review

    Directory of Open Access Journals (Sweden)

    Pâmella de Medeiros

    2017-03-01

    Full Text Available It was our objective to identify the psychometric elements to an epistemological reflection through a systematic review of cross-cultural validation procedures of TGMD-2 batteries, MABC-2 and KTK. Searches were carried out by two evaluators independently without year and language restrictions in six databases: Web of Science, Science Direct, Lilacs, Scopus, Pubmed and The ScientificElectronic Library Online - SciELO. The key words used were: "MABC", "TGMD" and "KTK" all of them combined with the word "validity". There was a total of 734 articles, of which, after the exclusion criteria, remained only 11 studies. It was found that there are differences between the authors in relation to the psychometric factors taken into account in cross-cultural validation. So that there was a lack of unanimity of the validation criteria of all studies in this field.

  20. Assessing EU’s Transatlantic Regulatory Powers Using the Choice of Policy Instruments as Measurement of Preference Attainment

    DEFF Research Database (Denmark)

    Löfgren, Karl; Lynggaard, Kennet

    2015-01-01

    concern are the implications of the still present financial and economic crisis for global regulatory power. Both cases suggest that the actual role of the EU is more complex than either exercising or subject to global regulatory power. This concerns the relationship between the EU and the member states...

  1. Measuring teamwork in health care settings: a review of survey instruments.

    Science.gov (United States)

    Valentine, Melissa A; Nembhard, Ingrid M; Edmondson, Amy C

    2015-04-01

    Teamwork in health care settings is widely recognized as an important factor in providing high-quality patient care. However, the behaviors that comprise effective teamwork, the organizational factors that support teamwork, and the relationship between teamwork and patient outcomes remain empirical questions in need of rigorous study. To identify and review survey instruments used to assess dimensions of teamwork so as to facilitate high-quality research on this topic. We conducted a systematic review of articles published before September 2012 to identify survey instruments used to measure teamwork and to assess their conceptual content, psychometric validity, and relationships to outcomes of interest. We searched the ISI Web of Knowledge database, and identified relevant articles using the search terms team, teamwork, or collaboration in combination with survey, scale, measure, or questionnaire. We found 39 surveys that measured teamwork. Surveys assessed different dimensions of teamwork. The most commonly assessed dimensions were communication, coordination, and respect. Of the 39 surveys, 10 met all of the criteria for psychometric validity, and 14 showed significant relationships to nonself-report outcomes. Evidence of psychometric validity is lacking for many teamwork survey instruments. However, several psychometrically valid instruments are available. Researchers aiming to advance research on teamwork in health care should consider using or adapting one of these instruments before creating a new one. Because instruments vary considerably in the behavioral processes and emergent states of teamwork that they capture, researchers must carefully evaluate the conceptual consistency between instrument, research question, and context.

  2. Which Instruments Can Detect Submaximal Physical and Functional Capacity in Patients With Chronic Nonspecific Back Pain? A Systematic Review

    NARCIS (Netherlands)

    van der Meer, Suzan; Trippolini, Maurizio A.; van der Palen, Job; Verhoeven, Jan; Reneman, Michiel F.

    2013-01-01

    Study Design. Systematic review. Objective. To evaluate the validity of instruments that claim to detect submaximal capacity when maximal capacity is requested in patients with chronic nonspecific musculoskeletal pain. Summary of Background Data. Several instruments have been developed to measure

  3. Self-administered health literacy instruments for people with diabetes: systematic review of measurement properties.

    Science.gov (United States)

    Lee, Eun-Hyun; Kim, Chun-Ja; Lee, Jiyeon; Moon, Seung Hei

    2017-09-01

    The aims of this study were to identify all available self-administered instruments measuring health literacy in people with diabetes and to determine the current instrument that is the most appropriate for applying to this population in both practice and research. A systematic review of measurement properties. MEDLINE, EMBASE and CINAHL electronic databases from their inception up to 28 March 2016. The methodological quality of each included study was assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. The reported results for measurement properties in the studies were assessed according to Terwee's quality criteria. Thirteen self-administered instruments measuring health literacy in people with diabetes were identified, of which six (44%) were diabetes-specific instruments. The instruments that covered the broadest contents of health literacy were the Health Literacy Scale and Health Literacy Questionnaire. The (test-retest) reliability, measurement error and responsiveness were not evaluated for any instrument, while internal consistency and hypothesis testing validity were the most frequently assessed measurement properties. With the current evidence, the Health Literacy Scale may be the most appropriate instrument for patients with diabetes in practice and research. However, the structural validity of this scale needs to be further established, particularly in other language versions. It is also recommended to use the Diabetes Numeracy Test-15 along with the Health Literacy Scale to complement the lack of numeracy measures in the Health Literacy Scale. © 2017 John Wiley & Sons Ltd.

  4. International Nuclear Safety Experts Conclude IAEA Peer Review of Swiss Regulatory Framework

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: A team of international nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the regulatory framework for nuclear safety in Switzerland. The Integrated Regulatory Review Service (IRRS) mission noted good practices in the Swiss system and also made recommendations for the nation's nuclear regulatory authority, the Swiss Federal Nuclear Safety Inspectorate (ENSI). ''Our team developed a good impression of the independent Swiss regulator - ENSI - and the team considered that ENSI deserves particular credit for its actions to improve Swiss safety capability following this year's nuclear accident in Japan,'' said IRRS Team Leader Jean-Christophe Niel of France. The mission's scope covered the Swiss nuclear regulatory framework for all types of nuclear-related activities regulated by ENSI. The mission was conducted from 20 November to 2 December, mainly at ENSI headquarters in Brugg. The team held extensive discussions with ENSI staff and visited many Swiss nuclear facilities. IRRS missions are peer reviews, not inspections or audits, and are conducted at the request of host nations. For the Swiss review, the IAEA assembled a team of 19 international experts from 14 countries. The experts came from Belgium, Brazil, the Czech Republic, Finland, France, Germany, Italy, the Republic of Korea, Norway, Russia, Slovakia, Sweden, the United Kingdom, and the United States. ''The findings of the IRRS mission will help us to further improve our work. That is part of our safety culture,'' said ENSI Director General Hans Wanner. ''As Switzerland argued at international nuclear safety meetings this year for a strengthening of the international monitoring of nuclear power, we will take action to fulfil the recommendations.'' The IRRS team highlighted several good practices of the Swiss regulatory system, including the following: ENSI requires Swiss nuclear operators to back-fit their facilities by continuously upgrading

  5. Informal caregiving in COPD: A systematic review of instruments and their measurement properties.

    Science.gov (United States)

    Cruz, Joana; Marques, Alda; Machado, Ana; O'Hoski, Sachi; Goldstein, Roger; Brooks, Dina

    2017-07-01

    Increasing symptoms and activity restriction associated with COPD progression greatly impact on the lives of their informal caregivers, who play a vital role in maintaining their health. An understanding of this impact is important for clinicians to support caregivers and maintain a viable patient environment at home. This systematic review aimed to identify the instruments commonly used to assess informal caregiving in COPD and describe their measurement properties in this population. Searches were conducted in PubMed, Scopus, Web of Science, CINAHL and PsycINFO and in references of key articles, until November 2016 (PROSPERO: CRD42016041401). Instruments used to assess the impact of COPD on caregivers were identified and their properties described. Quality of studies was rated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Quality of the measurement properties of instruments was rated as 'positive', 'negative' or 'indeterminate'. Patients cared for, had moderate to very severe COPD and the sample of caregivers ranged from 24 to 406. Thirty-five instruments were used in fifty studies to assess caregivers' psychological status and mood (9 instruments), burden/distress (12 instruments), quality of life (5 instruments) or other (9 instruments). Eighteen studies assessed the measurement properties of 21 instruments, most commonly hypothesis testing (known validity) and internal consistency. Study quality varied from 'poor' to 'fair' and with many properties rated as 'indeterminate'. Although several instruments have been used to assess the impact of COPD on caregivers, an increased understanding of their properties is needed before their widespread implementation. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. International Nuclear and Radiation Safety Experts Conclude IAEA Peer Review of Slovenia's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts today concluded a 10-day mission to review the regulatory framework for nuclear and radiation safety in Slovenia. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Slovenia and a final report will be submitted by the end of 2011. At the request of the Slovenian Government, the IAEA assembled a team of 10 senior regulatory experts from nine nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Slovenian Nuclear Safety Administration (SNSA). The mission is a peer review based on the IAEA Safety Standards. Andrej Stritar, Director of Slovenian Nuclear Safety Administration, stressed ''how important it is for a small country like Slovenia to tightly follow international standards in the area of nuclear safety.'' He also expressed his gratitude to the IAEA, and the countries from which team members came, for their support and for their intensive work during the last ten days. Mission Team Leader Colin Patchett, Deputy Chief Inspector from the UK's Office for Nuclear Regulation commended ''the Slovenian authorities for their commitment to nuclear and radiation safety regulation and for sharing their experience.'' The IRRS team reviewed Slovenia's current regulatory framework and all SNSA-regulated facilities and activities, as well as the regulatory implications of the TEPCO Fukushima Daiichi accident. The IRRS team identified particular strengths in the Slovenian regulatory system, including: Through its legal framework, the Slovenian government has appointed SNSA to regulate its nuclear safety program and SNSA has in place an effective process for carrying out this responsibility; and Slovenia's response to the accident at the TEPCO Fukushima Daiichi power plant has been prompt and effective. Communications with the public, development of actions for improvement

  7. Regulatory requirements on the design and construction of nuclear power plant control and instrumentation systems in Finland

    International Nuclear Information System (INIS)

    Heikkila, M.A.

    1978-01-01

    The Department of Reactor Safety of the Institute of Radiation Protection, being the nuclear regulatory authority in Finland, has set up regulations which govern the design and construction of NPP systems and components. The regulations are partly compiled from existing codes and standards, published primarily in the United States and Federal Republic of Germany, and partly worked out at the Institute. The regulations are collected to a special set of YVL guides (guides for nuclear power plants), and one of these gives requirements on the design and construction of NPPCI systems and components. The scope of the requirements is based on the safety classification of the CI systems and components. Three safety classes have been singled out: the first for CI systems which take part in reactor protection, the second for other directly safety related, and the third for remaining CI systems important enough to deserve supervision. The safety class for CI components is inherited from the system they belong to. The safety classification of IC systems has direct bearing on the initial assumptions of plant accident analysis. The design principles of IC systems are inspected as part of the preliminary and final safety reports. Focus is directed on the principles of redundancy, separation, diversity, testability, etc. The requirements on IC components are directed to different stages of manufacture, installation and operation. The type tests shall be adequate and acceptably documented. The manufacture of components is followed, the test reports reviewed and the efficiency of manufacturers quality assurance program evaluated. Further requirements concern the installation phase and tests at the end of it, and finally guides include directions for maintenance and testing during the operations phase. (author)

  8. Validity of instruments to measure physical activity may be questionable due to a lack of conceptual frameworks: a systematic review

    Science.gov (United States)

    2011-01-01

    Background Guidance documents for the development and validation of patient-reported outcomes (PROs) advise the use of conceptual frameworks, which outline the structure of the concept that a PRO aims to measure. It is unknown whether currently available PROs are based on conceptual frameworks. This study, which was limited to a specific case, had the following aims: (i) to identify conceptual frameworks of physical activity in chronic respiratory patients or similar populations (chronic heart disease patients or the elderly) and (ii) to assess whether the development and validation of PROs to measure physical activity in these populations were based on a conceptual framework of physical activity. Methods Two systematic reviews were conducted through searches of the Medline, Embase, PsycINFO, and Cinahl databases prior to January 2010. Results In the first review, only 2 out of 581 references pertaining to physical activity in the defined populations provided a conceptual framework of physical activity in COPD patients. In the second review, out of 103 studies developing PROs to measure physical activity or related constructs, none were based on a conceptual framework of physical activity. Conclusions These findings raise concerns about how the large body of evidence from studies that use physical activity PRO instruments should be evaluated by health care providers, guideline developers, and regulatory agencies. PMID:21967887

  9. A Review on the Needs of Independent Information Channel for Regulatory Body

    International Nuclear Information System (INIS)

    Raza, Hamid Saeed; Choi, Kwang Sik

    2010-01-01

    For a regulatory body it is very important to be independent not only in its actions but also in its information gathering channels. It is thus required for an organization to get requisite information for their decision making, as well as to prevail over information asymmetries. For corporate culture, information channels sometimes prove to be extensive enough to rune valuable resources and sometime base delays. The paper will reveal nature of an independent information channel. This review will additionally confer a scenario; a regulatory body may face in case of solely depending upon licensee for its information gathering. Working in the wake of this paper comprises review of allied published materials. It might be more helpful for interested ones to persist this effort by ensuring stakeholder involvement i.e. by making this sensitive topic alive through seminars and working groups

  10. IAEA Team Concludes Peer Review of Sweden's Nuclear Regulatory Framework, 17 February 2012, Stockholm, Sweden

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Sweden. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of Sweden, noted good practices in the country's nuclear regulatory system and also made recommendations and suggestions for the Swedish Radiation Safety Authority (SSM) and the government. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''Throughout the mission, the IRRS team received full cooperation from SSM staff in its review of Sweden's regulatory, technical and policy issues,'' said Georg Schwarz, mission leader and Deputy Director General of the Swiss nuclear regulator (ENSI). 'The staff were open and candid in their discussions and provided the fullest practicable assistance', he commented. The main observations of the IRRS Review team included the following: SSM operates as an independent regulator in an open and transparent manner with well-organized regulatory processes; SSM is receptive to feedback and strives to maintain a culture of continuous learning; and Following the TEPCO Fukushima Daiichi accident, SSM responded promptly to public demand for information and communicated effectively with the national government, the public and other interested parties. Good practices identified by the IRRS team included, though they are not limited to, the following: The consolidation of the two previous national regulatory authorities into SSM was successful; Overall, SSM's management system is comprehensive and contributes to staff efficiency and effectiveness; The nuclear power plant refurbishment programme as required by SSM enhanced safety; and Sweden's regulatory framework for high-level waste disposal is comprehensive and technically sound. The IRRS Review team identified

  11. Experience and regulatory activities on advanced instrumentation and control systems applied to nuclear power plants in Korea

    International Nuclear Information System (INIS)

    Kim, B.R.

    1995-01-01

    This paper describes the status for applying microprocessor-based systems to nuclear power plants in Korea and the regulatory activities performed by Korea Institute of Nuclear Safety (KINS). And this presents the development of safety and regulatory technology for advanced I and C systems that has been carried out as a part of the next generation reactor development program in Korea. (author). 3 refs, 4 figs, 1 tab

  12. International nuclear safety experts conclude IAEA peer review of China's regulatory system

    International Nuclear Information System (INIS)

    2010-01-01

    Full text: An international team of senior experts on nuclear safety regulation today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the People's Republic of China. The team identified good practices within the system and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of the People's Republic of China. The final report will be submitted to China by Autumn 2010. At the request of Chinese authorities, the IAEA assembled a team of 22 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission is a peer review based on the IAEA Safety Standards . It is not an inspection, nor an audit. The experts came from 15 different countries: Australia, Canada, the Czech Republic, Finland, France, Hungary, Japan, Pakistan, the Republic of Korea, Slovenia, South Africa, Sweden, the United Kingdom, Ukraine and the United States. Mike Weightman, the United Kingdom's Head of Nuclear Directorate, HSE and HM Chief Inspector of Nuclear Installations said: ''I was honoured and pleased to lead such a team of senior regulatory experts from around the world, and I was impressed by their commitment, experience and hard work to provide their best advice possible. We had very constructive interactions with the Chinese authority to maximize the beneficial impact of the mission.'' The scope of the mission included the regulation of nuclear and radiation safety of the facilities and activities regulated by the Ministry of Environmental Protection (MEP) National Nuclear Safety Administration (NNSA). The mission was conducted from 18 to 30 July, mainly in Beijing. To observe Chinese regulatory activities, the IRRS team visited several nuclear facilities, including a nuclear power plant, a manufacturer of safety components for nuclear power plants, a research reactor, a fuel cycle facility, a waste management facility

  13. Assessing health status and quality-of-life instruments: attributes and review criteria.

    Science.gov (United States)

    Aaronson, Neil; Alonso, Jordi; Burnam, Audrey; Lohr, Kathleen N; Patrick, Donald L; Perrin, Edward; Stein, Ruth E

    2002-05-01

    The field of health status and quality of life (QoL) measurement - as a formal discipline with a cohesive theoretical framework, accepted methods, and diverse applications--has been evolving for the better part of 30 years. To identify health status and QoL instruments and review them against rigorous criteria as a precursor to creating an instrument library for later dissemination, the Medical Outcomes Trust in 1994 created an independently functioning Scientific Advisory Committee (SAC). In the mid-1990s, the SAC defined a set of attributes and criteria to carry out instrument assessments; 5 years later, it updated and revised these materials to take account of the expanding theories and technologies upon which such instruments were being developed. This paper offers the SAC's current conceptualization of eight key attributes of health status and QoL instruments (i.e., conceptual and measurement model; reliability; validity; responsiveness; interpretability; respondent and administrative burden; alternate forms; and cultural and language adaptations) and the criteria by which instruments would be reviewed on each of those attributes. These are suggested guidelines for the field to consider and debate; as measurement techniques become both more familiar and more sophisticated, we expect that experts will wish to update and refine these criteria accordingly.

  14. International Expert Team Concludes IAEA Peer Review of Bulgaria's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Bulgaria. The Integrated Regulatory Review Service (IRRS) mission, conducted at the request of the Government of Bulgaria, identified a series of good practices and made recommendations to help enhance the overall performance of the regulatory system. IRRS missions, which were initiated in 2006, are peer reviews based on the IAEA Safety Standards; they are not inspections or audits. ''Bulgaria has a clear national policy and strategy for safety, which are well in line with international standards and practices and contribute to a high level of nuclear safety,'' said Mission Team Leader Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of the Slovak Republic. The mission team, which conducted the review from 8 to 19 April, was made up of 16 senior regulatory experts from 16 nations, and six IAEA staff. ''The results of the IRRS mission will be valuable for the future development and reinforcement of the Bulgarian Nuclear Safety Agency (BNRA). The use of international standards and good practices helps to improve global harmonization in all areas of nuclear safety and radiation protection,'' said Sergey Tzotchev, Chairman of the BNRA. Among the main observations in its preliminary report, the IRRS mission team found that BNRA operates as an independent regulatory body and conducts its regulatory processes in an open and transparent manner. In line with the IAEA Action Plan on Nuclear Safety, the mission reviewed the regulatory implications for Bulgaria of the March 2011 accident at TEPCO's Fukushima Daiichi Nuclear Power Station in Japan. It found that the BNRA's response to the lessons learned from that accident was both prompt and effective. Strengths and good practices identified by the IRRS team include the following: A no-blame policy is enshrined in law for

  15. Measurement properties of adult quality-of-life measurement instruments for eczema: a systematic review.

    Science.gov (United States)

    Heinl, D; Prinsen, C A C; Deckert, S; Chalmers, J R; Drucker, A M; Ofenloch, R; Humphreys, R; Sach, T; Chamlin, S L; Schmitt, J; Apfelbacher, C

    2016-03-01

    The Harmonising Outcome Measures for Eczema (HOME) initiative has identified quality of life (QoL) as a core outcome domain to be evaluated in every eczema trial. It is unclear which of the existing QoL instruments is most appropriate for this domain. Thus, the aim of this review was to systematically assess the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in adult eczema. We conducted a systematic literature search in PubMed and Embase identifying studies on measurement properties of adult eczema QoL instruments. For all eligible studies, we assessed the adequacy of the measurement properties and the methodological quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis summarizing findings from different studies was the basis to assign four degrees of recommendation (A-D). A total of 15 articles reporting on 17 instruments were included. No instrument fulfilled the criteria for category A. Six instruments were placed in category B, meaning that they have the potential to be recommended depending on the results of further validation studies. Three instruments had poor adequacy in at least one required adequacy criterion and were therefore put in category C. The remaining eight instruments were minimally validated and were thus placed in category D. Currently, no QoL instrument can be recommended for use in adult eczema. The Quality of Life Index for Atopic Dermatitis (QoLIAD) and the Dermatology Life Quality Index (DLQI) are recommended for further validation research. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. The quality of instruments to assess the process of shared decision making: A systematic review

    Science.gov (United States)

    Bomhof-Roordink, Hanna; Smith, Ian P.; Scholl, Isabelle; Stiggelbout, Anne M.; Pieterse, Arwen H.

    2018-01-01

    Objective To inventory instruments assessing the process of shared decision making and appraise their measurement quality, taking into account the methodological quality of their validation studies. Methods In a systematic review we searched seven databases (PubMed, Embase, Emcare, Cochrane, PsycINFO, Web of Science, Academic Search Premier) for studies investigating instruments measuring the process of shared decision making. Per identified instrument, we assessed the level of evidence separately for 10 measurement properties following a three-step procedure: 1) appraisal of the methodological quality using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist, 2) appraisal of the psychometric quality of the measurement property using three possible quality scores, 3) best-evidence synthesis based on the number of studies, their methodological and psychometrical quality, and the direction and consistency of the results. The study protocol was registered at PROSPERO: CRD42015023397. Results We included 51 articles describing the development and/or evaluation of 40 shared decision-making process instruments: 16 patient questionnaires, 4 provider questionnaires, 18 coding schemes and 2 instruments measuring multiple perspectives. There is an overall lack of evidence for their measurement quality, either because validation is missing or methods are poor. The best-evidence synthesis indicated positive results for a major part of instruments for content validity (50%) and structural validity (53%) if these were evaluated, but negative results for a major part of instruments when inter-rater reliability (47%) and hypotheses testing (59%) were evaluated. Conclusions Due to the lack of evidence on measurement quality, the choice for the most appropriate instrument can best be based on the instrument’s content and characteristics such as the perspective that they assess. We recommend refinement and validation of

  17. Safety experts complete second IAEA regulatory review of UK nuclear regulator

    International Nuclear Information System (INIS)

    2009-01-01

    Full text: Nuclear safety experts today concluded a 10-day mission to peer-review the UK Nuclear Regulator: Health and Safety Executive (HSE), Nuclear Directorate (ND). At the request of the UK Government, the International Atomic Energy Agency assembled a team of ten high-level regulatory experts from eight nations to conduct the Integrated Regulatory Review Service (IRRS) mission. The mission was the second of three planned IRRS missions for the United Kingdom. The first was held in March 2006 to begin a process to assess the nation's readiness to regulate and license new reactor designs, considered as a result of the Energy Policy review initiated by the British Prime Minister and the Secretary of State for Trade and Industry (DTI) in 2005. The IRRS team leader Mr. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission, stated, ''The IAEA IRRS serves an important role in both benchmarking against its safety standards and in promoting dialogue between nuclear safety regulators from around the world.'' During the 2nd mission the IRRS the team reviewed HSE/ND progress since the first IRRS mission and recent regulatory developments, the regulation of operating power plants and fuel cycle facilities, the inspection and enforcement programme for nuclear power plants and fuel cycle facilities, and the emergency preparedness and response programme. The IAEA found that HSE/ND has made significant progress toward improving its effectiveness in regulating existing nuclear power plants and in preparing to license new nuclear reactors designs. Many of the findings identified in the 2006 report had been fully addressed and therefore could be considered closed, the others are being addressed in accordance with a comprehensive action plan. IRRS team members visited the Heysham 1 Nuclear Power Plant near Lancaster, the Sellafield site at Cumbria and the Strategic Control Centre at Hutton, and they met senior managers from HSE and a UK

  18. VALIDATION OF ANALYTICAL METHODS AND INSTRUMENTATION FOR BERYLLIUM MEASUREMENT: REVIEW AND SUMMARY OF AVAILABLE GUIDES, PROCEDURES, AND PROTOCOLS

    Energy Technology Data Exchange (ETDEWEB)

    Ekechukwu, A

    2009-05-27

    Method validation is the process of evaluating whether an analytical method is acceptable for its intended purpose. For pharmaceutical methods, guidelines from the United States Pharmacopeia (USP), International Conference on Harmonisation (ICH), and the United States Food and Drug Administration (USFDA) provide a framework for performing such valications. In general, methods for regulatory compliance must include studies on specificity, linearity, accuracy, precision, range, detection limit, quantitation limit, and robustness. Elements of these guidelines are readily adapted to the issue of validation for beryllium sampling and analysis. This document provides a listing of available sources which can be used to validate analytical methods and/or instrumentation for beryllium determination. A literature review was conducted of available standard methods and publications used for method validation and/or quality control. A comprehensive listing of the articles, papers and books reviewed is given in the Appendix. Available validation documents and guides are listed therein; each has a brief description of application and use. In the referenced sources, there are varying approches to validation and varying descriptions of the valication process at different stages in method development. This discussion focuses on valication and verification of fully developed methods and instrumentation that have been offered up for use or approval by other laboratories or official consensus bodies such as ASTM International, the International Standards Organization (ISO) and the Association of Official Analytical Chemists (AOAC). This review was conducted as part of a collaborative effort to investigate and improve the state of validation for measuring beryllium in the workplace and the environment. Documents and publications from the United States and Europe are included. Unless otherwise specified, all referenced documents were published in English.

  19. A systematic review of instruments that measure attitudes toward homosexual men.

    Science.gov (United States)

    Grey, Jeremy A; Robinson, Beatrice Bean E; Coleman, Eli; Bockting, Walter O

    2013-01-01

    Scientific interest in the measurement of homophobia and internalized homophobia has grown over the past 30 years, and new instruments and terms have emerged. To help researchers with the challenging task of identifying appropriate measures for studies in sexual-minority health, we reviewed measures of homophobia published in the academic literature from 1970 to 2012. Instruments that measured attitudes toward male homosexuals/homosexuality or measured homosexuals' internalized attitudes toward homosexuality were identified using measurement manuals and a systematic review. A total of 23 instruments met criteria for inclusion, and their features were summarized and compared. All 23 instruments met minimal criteria for adequate scale construction, including scale development, sampling, reliability, and evidence of validity. Validity evidence was diverse and was categorized as interaction with gay men, HIV/AIDS variables, mental health, and conservative religious or political beliefs. Homophobia was additionally correlated with authoritarianism and bias, gender ideology, gender differences, and reactions to homosexual stimuli. Internalized homophobia was validated by examining relationships with disclosing one's homosexuality and level of homosexual identity development. We hope this review will make the process of instrument selection more efficient by allowing researchers to easily locate, evaluate, and choose the proper measure based on their research question and population of interest.

  20. Movement kinematics and cyclic fatigue of NiTi rotary instruments: a systematic review.

    Science.gov (United States)

    Ferreira, F; Adeodato, C; Barbosa, I; Aboud, L; Scelza, P; Zaccaro Scelza, M

    2017-02-01

    The aim of this review was to provide a detailed analysis of the literature concerning the correlation between different movement kinematics and the cyclic fatigue resistance of NiTi rotary endodontic instruments. From June 2014 to August 2015, four independent reviewers comprehensively and systematically searched the Medline (PubMed), EMBASE, Web of Science, Scopus and Google Scholar databases for works published since January 2005, using the following search terms: endodontics; nickel-titanium rotary files; continuous rotation; reciprocating motion; cyclic fatigue. In addition to the electronic searches, manual searches were performed to include articles listed in the reference sections of high-impact published articles that were not indexed in the databases. Laboratory studies in English language were considered for this review. The electronic and manual searches resulted in identification of 75 articles. Based on the inclusion criteria, 32 articles were selected for analysis of full-text copies. Specific analysis was then made of 20 articles that described the effects of reciprocating and continuous movements on cyclic fatigue of the instruments. A wide range of testing conditions and methodologies have been used to compare the cyclic fatigue resistance of rotary endodontic instruments. Most studies report that reciprocating motion improves the fatigue resistance of endodontic instruments, compared to continuous rotation, independent of other variables such as the speed of rotation, the angle or radius of curvature of simulated canals, geometry and taper, or the surface characteristics of the NiTi instruments. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  1. Validation of online psychometric instruments for common mental health disorders: a systematic review.

    Science.gov (United States)

    van Ballegooijen, Wouter; Riper, Heleen; Cuijpers, Pim; van Oppen, Patricia; Smit, Johannes H

    2016-02-25

    Online questionnaires for measuring common mental health disorders such as depression and anxiety disorders are increasingly used. The psychometrics of several pen-and-paper questionnaires have been re-examined for online use and new online instruments have been developed and tested for validity as well. This study aims to review and synthesise the literature on this subject and provide a framework for future research. We searched Medline and PsycINFO for psychometric studies on online instruments for common mental health disorders and extracted the psychometric data. Studies were coded and assessed for quality by independent raters. We included 56 studies on 62 online instruments. For common instruments such as the CES-D, MADRS-S and HADS there is mounting evidence for adequate psychometric properties. Further results are scattered over different instruments and different psychometric characteristics. Few studies included patient populations. We found at least one online measure for each of the included mental health disorders and symptoms. A small number of online questionnaires have been studied thoroughly. This study provides an overview of online instruments to refer to when choosing an instrument for assessing common mental health disorders online, and can structure future psychometric research.

  2. A systematic review of instruments that assess the implementation of hospital quality management systems.

    NARCIS (Netherlands)

    Groene, O.; Botje, D.; Suñol, R.; Lopez, M.A.; Wagner, C.

    2013-01-01

    Purpose: Health-care providers invest substantial resources to establish and implement hospital quality management systems. Nevertheless, few tools are available to assess implementation efforts and their effect on quality and safety outcomes. This review aims to (i) identify instruments to assess

  3. Instruments used to assess functional limitations in workers applying for disability benefit : a systematic review

    NARCIS (Netherlands)

    Spanjer, Jerry; Groothoff, Johan W.; Brouwer, Sandra

    2011-01-01

    Purpose. To systematically review the quality of the psychometric properties of instruments for assessing functional limitations in workers applying for disability benefit. Method. Electronic searches of Medline, Embase, CINAHL and PsycINFO were performed to identify studies focusing on the

  4. Review of risk assessment instruments for juvenile sex offenders : What is next?

    NARCIS (Netherlands)

    Hempel, I.; Buck, N.M.L.; Cima-Knijff, M.J.; van Marle, H.

    2013-01-01

    Risk assessment is considered to be a key element in the prevention of recidivism among juvenile sex offenders (JSOs), often by imposing long-term consequences based on that assessment. The authors reviewed the literature on the predictive accuracy of six well-known risk assessment instruments used

  5. Clinical assessment of spasticity in children with cerebral palsy: a critical review of available instruments

    NARCIS (Netherlands)

    Scholtes, Vanessa A. B.; Becher, Jules G.; Beelen, Anita; Lankhorst, Gustaaf J.

    2006-01-01

    This study reviews the instruments used for the clinical assessment of spasticity in children with cerebral palsy, and evaluates their compliance with the concept of spasticity, defined as a velocity-dependent increase in muscle tone to passive stretch. Searches were performed in Medline, Embase,

  6. Attention to gender in communication skills assessment instruments in medical education: a review.

    NARCIS (Netherlands)

    Dielissen, P.W.; Bottema, B.J.A.M.; Verdonk, P.; Lagro-Janssen, T.

    2011-01-01

    CONTEXT: Gender is increasingly regarded as an important factor in doctor-patient communication education. This review aims to assess if and how gender is addressed by current assessment instruments for communication skills in medical education. METHODS: In 2009 at Radboud University Nijmegen

  7. International Expert Team Concludes IAEA Peer Review of Slovakia's Regulatory Framework for Nuclear Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded an 11-day mission to review the regulatory framework for nuclear safety in Slovakia. At the request of the Slovak Government, the IAEA assembled a team of 12 senior regulatory experts from 12 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Nuclear Regulatory Authority of the Slovak Republic (UJD SR). The international experts also met officials from the Public Health Authority of the Slovak Republic (UVZ SR) regarding the regulation of occupational radiation protection in nuclear facilities. The mission is a peer review based on the IAEA Safety Standards. Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of Slovak Republic, declared that ''The IRRS mission has a great value for the future development and orientation of the UJD SR.'' ''Slovakia has established a regulatory framework for nuclear safety which is in line with international standards and practice,'' said Mission Team Leader Andrej Stritar, Director of the Slovenian Nuclear Safety Administration. The main observations of the IRRS Review team included: UJD SR operates with independence and transparency; UJD SR has developed and implemented a systematic training approach to meet its competence needs; and in response to the accident at TEPCO's Fukushima Daiichi Nuclear Power Station, UJD SR has reacted and communicated to interested parties, including the public. The good practices identified by the IRRS Review Team include: UJD SR has a comprehensive and well-formalized strategic approach to informing and consulting interested parties; UJD SR has developed and implemented a structured approach to training and developing its staff; and Detailed legal requirements provide a solid basis for on-site and off-site response in nuclear emergencies coordinated with local authorities. The IRRS Review team identified areas for further improvement and believes

  8. 75 FR 21299 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254

    Science.gov (United States)

    2010-04-23

    ... additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under...). VIMPAT injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in...

  9. 75 FR 21298 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253

    Science.gov (United States)

    2010-04-23

    ... additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under... (lacosamide). VIMPAT tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in...

  10. Risk Assessment Review Group report to the U.S. Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Lewis, H.W.; Budnitz, R.J.; Kouts, H.J.C.; Loewenstein, W.B.; Rowe, W.D.; von Hippel, F.; Zachariasen, F.

    1978-09-01

    The Risk Assessment Review Group was organized by the U.S. Nuclear Regulatory Commission on July 1, 1977, with four elements to its charter: clarify the achievements and limitations of WASH-1400, the ''Rasmussen Report''; assess the peer comments thereon, and responses to those comments; study the present state of such risk assessment methodology; and recommend to the Commission how (and whether) such methodology can be used in the regulatory and licensing process. Areas of study include: risk assessment methodologies; statistical issues; completeness; the data base; and the WASH-1400 assessment of the damage to human health from radiation after a postulated accident. Specific items discussed include: Browns Ferry; common cause failure; human factors; format and scrutability; the peer review process; earthquakes; risk perception; allegations by UCS concerning WASH-1400 treatment of quality assurance and quality control; current role of probabilistic methods in the regulatory process; acts of violence; ATWS; influence of design defects in quality assurance failures; and calculation of population doses from given releases of radionuclides

  11. INSTRUMENTS MEASURING PERCEIVED RACISM/RACIAL DISCRIMINATION: REVIEW AND CRITIQUE OF FACTOR ANALYTIC TECHNIQUES

    Science.gov (United States)

    Atkins, Rahshida

    2015-01-01

    Several compendiums of instruments that measure perceived racism and/or discrimination are present in the literature. Other works have reviewed the psychometric properties of these instruments in terms of validity and reliability and have indicated if the instrument was factor analyzed. However, little attention has been given to the quality of the factor analysis performed. The aim of this study was to evaluate the exploratory factor analyses done on instruments measuring perceived racism/racial discrimination using guidelines from experts in psychometric theory. The techniques used for factor analysis were reviewed and critiqued and the adequacy of reporting was evaluated. Internet search engines and four electronic abstract databases were used to identify 16 relevant instruments that met the inclusion/exclusion criteria. Principal component analysis was the most frequent method of extraction (81%). Sample sizes were adequate for factor analysis in 81 percent of studies. The majority of studies reported appropriate criteria for the acceptance of un-rotated factors (81%) and justified the rotation method (75%). Exactly 94 percent of studies reported partially acceptable criteria for the acceptance of rotated factors. The majority of articles (69%) reported adequate coefficient alphas for the resultant subscales. In 81 percent of the studies, the conceptualized dimensions were supported by factor analysis. PMID:25626225

  12. International Expert Team Concludes IAEA Peer Review of Finland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: International safety experts today concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Finland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that the Radiation and Nuclear Safety Authority of Finland (STUK) is a competent and highly credible regulator that is open and transparent and derives great strength from the technical competence of its staff. ''Finland's comprehensive regulatory framework allows STUK to operate in practice as an independent regulatory body,'' said team leader Philippe Jamet, a commissioner of the French regulatory body ASN. The mission was conducted at the request of the Government of Finland from 15-26 October. The team interviewed members of STUK and officials from various ministries, as well as key players in the Finnish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. The team was made up of 18 members from Bulgaria, Canada, the Czech Republic, France, Germany, Iceland, Ireland, Romania, the Russian Federation, South Africa, Slovakia, Slovenia, Spain, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as six IAEA staff members. 'The IRRS mission and preparation for it was a unique occasion that involved the whole organization, provided motivation for improvement of the safety framework in Finland and assists STUK review its mission', said Tero Varjoranta, Director General of STUK. The IRRS team identified a number of good practices and achievements, including: - STUK's excellence in its safety assessment of nuclear power plants and waste repositories, in particular its demonstration that long-term political commitment is a necessity to sustain the creation of a waste repository as well as its regulatory oversight of medical applications of radiation sources; and - STUK's excellent record in

  13. Health literacy screening instruments for eHealth applications: a systematic review.

    Science.gov (United States)

    Collins, Sarah A; Currie, Leanne M; Bakken, Suzanne; Vawdrey, David K; Stone, Patricia W

    2012-06-01

    To systematically review current health literacy (HL) instruments for use in consumer-facing and mobile health information technology screening and evaluation tools. The databases, PubMed, OVID, Google Scholar, Cochrane Library and Science Citation Index, were searched for health literacy assessment instruments using the terms "health", "literacy", "computer-based," and "psychometrics". All instruments identified by this method were critically appraised according to their reported psychometric properties and clinical feasibility. Eleven different health literacy instruments were found. Screening questions, such as asking a patient about his/her need for assistance in navigating health information, were evaluated in seven different studies and are promising for use as a valid, reliable, and feasible computer-based approach to identify patients that struggle with low health literacy. However, there was a lack of consistency in the types of screening questions proposed. There is also a lack of information regarding the psychometric properties of computer-based health literacy instruments. Only English language health literacy assessment instruments were reviewed and analyzed. Current health literacy screening tools demonstrate varying benefits depending on the context of their use. In many cases, it seems that a single screening question may be a reliable, valid, and feasible means for establishing health literacy. A combination of screening questions that assess health literacy and technological literacy may enable tailoring eHealth applications to user needs. Further research should determine the best screening question(s) and the best synthesis of various instruments' content and methodologies for computer-based health literacy screening and assessment. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. The impact of the long-term playing of musical instruments on the stomatognathic system - review.

    Science.gov (United States)

    Głowacka, Arleta; Matthews-Kozanecka, Maja; Kawala, Maciej; Kawala, Beata

    2014-01-01

    In this article, we have made a review of the influence of playing musical instruments on the formation of malocclusion and TMJ disorders in musicians. Primary attention was paid to the effects of wind and stringed instruments. The aim of the article was the presentation of research and opinions about this problem in the last 25 years. It is reported that long-term and repetitive playing of musical instruments, particularly stringed (violin and viola) and wind instruments can cause dysfunctions of the stomatognathic system. The impact of wind instruments was assessed in terms of the type of mouthpiece. We studied the possibility of repositioning the front teeth and reducing the width of the upper dental arch and overbite. There were also reports on the use of a specific instrument to improve the child's occlusion. Studies have also been performed on the usefulness of relaxation plates in order to improve, and even prevent, dysfunction caused by the constant stress on the same parts of the stomatognathic system. The experiments were mainly based on interviews, dental cast analyses and cephalometric analyses. Additional methods were dynamometer tests and muscle tension palpation.

  15. Attention to gender in communication skills assessment instruments in medical education: a review.

    Science.gov (United States)

    Dielissen, Patrick; Bottema, Ben; Verdonk, Petra; Lagro-Janssen, Toine

    2011-03-01

    Gender is increasingly regarded as an important factor in doctor-patient communication education. This review aims to assess if and how gender is addressed by current assessment instruments for communication skills in medical education. In 2009 at Radboud University Nijmegen Medical Centre, an online search was conducted in the bibliographic databases PubMed, PsycINFO and ERIC for references about communication skills assessment instruments designed to be completed by trained faculty staff and used in medical education. The search strategy used the following search terms: 'consultation skills'; 'doctor-patient communication'; 'physician-patient relations'; 'medical education'; 'instruments'; 'measurement', and 'assessment'. Papers published between January 1999 and June 2009 were included. The assessment instruments identified were analysed for gender-specific content. The search yielded 21 communication skills assessment instruments. Only two of the 17 checklists obtained explicitly considered gender as a communication-related issue. Only six of 21 manuals considered gender in any way and none gave specific details to explain which aspects of communication behaviour should be assessed with regard to gender. Very few communication assessment instruments in medical education focus on gender. Nevertheless, interest exists in using gender in communication skills assessment. The criteria for and purpose of assessing gender in communication skills in medical education are yet to be clarified. © Blackwell Publishing Ltd 2011.

  16. Regulatory review and barriers for the electricity supply system for distributed generation in EU-15

    DEFF Research Database (Denmark)

    Ropenus, Stephanie; Skytte, Klaus

    2005-01-01

    When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from di...... distributed generation. This paper reviews the current regulation of the grids with respect to distributed generation in EU-15 Member States and compares the different systems. Several barriers are identified.......When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from...

  17. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation.

    Science.gov (United States)

    Kisakye, Angela N; Tweheyo, Raymond; Ssengooba, Freddie; Pariyo, George W; Rutebemberwa, Elizeus; Kiwanuka, Suzanne N

    2016-01-01

    A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1) organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs); 2) prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3) contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4) multifaceted work interventions being implemented in most settings; 5) the possibility of using financial and incentive regulatory mechanisms in LMICs; 6) health intervention mechanisms reducing absenteeism when integrated with exercise programs; and 7) attendance by legislation during emergencies being criticized for violating human rights in the United States and not being effective in curbing absenteeism. Most countries have applied multiple strategies to mitigate health care worker absenteeism. The success of these

  18. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation

    Science.gov (United States)

    Kisakye, Angela N; Tweheyo, Raymond; Ssengooba, Freddie; Pariyo, George W; Rutebemberwa, Elizeus; Kiwanuka, Suzanne N

    2016-01-01

    Background A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. Methods A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Results Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1) organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs); 2) prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3) contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4) multifaceted work interventions being implemented in most settings; 5) the possibility of using financial and incentive regulatory mechanisms in LMICs; 6) health intervention mechanisms reducing absenteeism when integrated with exercise programs; and 7) attendance by legislation during emergencies being criticized for violating human rights in the United States and not being effective in curbing absenteeism. Conclusion Most countries have applied multiple strategies to mitigate health care

  19. Assessing patient-centred communication in teaching: a systematic review of instruments.

    Science.gov (United States)

    Brouwers, Marianne; Rasenberg, Ellemieke; van Weel, Chris; Laan, Roland; van Weel-Baumgarten, Evelyn

    2017-11-01

    Patient-centred communication is a key component of patient centredness in medical care. Therefore, adequate education in and assessment of patient-centred communication skills are necessary. In general, feedback on communication skills is most effective when it is provided directly and is systematic. This calls for adequate measurement instruments. The aim of this study was to provide a systematic review of existing instruments that measure patient centredness in doctor-patient communication and can be used to provide direct feedback. A systematic review was conducted using an extensive validated search strategy for measurement instruments in PubMed, EMBASE, PsycINFO and CINAHL. The databases were searched from their inception to 1 July 2016. Articles describing the development or evaluation of the measurement properties of instruments that measure patient centredness (by applying three or more of the six dimensions of a published definition of patient centredness) in doctor-patient communication and that can be used for the provision of direct feedback were included. The methodological quality of measurement properties was evaluated using the COSMIN checklist. Thirteen articles describing 14 instruments measuring patient centredness in doctor-patient communication were identified. These studies cover a wide range of settings and patient populations, and vary in the dimensions of patient centredness applied and in methodological quality on aspects of reliability and validity. This review gives a comprehensive overview of all instruments available for the measurement of patient centredness in doctor-patient communication that can be used for the provision of direct feedback and are described in the literature. Despite the widely felt need for valid and reliable instruments for the measurement of patient-centred communication, most of the instruments currently available have not been thoroughly investigated. Therefore, we recommend further research into and

  20. A review of modern instrumental methods of elemental analysis of petroleum related material. Part 2

    International Nuclear Information System (INIS)

    Nadkarni, R.A.

    1991-01-01

    In this paper a review is presented of the state of the art in elemental analysis of petroleum-related materials (crude oil, gasoline, additives, and lubricants) using modern instrumental analysis techniques. The major instrumental techniques used for elemental analysis of petroleum products include atomic absorption spectrometry (both with flame and with graphite furnace atomizer), inductively coupled plasma atomic emission spectrometry, ion chromatography, microelemental methods, neutron activation, spark source mass spectrometry, and x-ray fluorescence. Each of these techniques is compared for its advantages, disadvantages, and typical applications in the petroleum field

  1. The cross-cultural equivalence of participation instruments: a systematic review.

    Science.gov (United States)

    Stevelink, S A M; van Brakel, W H

    2013-07-01

    Concepts such as health-related quality of life, disability and participation may differ across cultures. Consequently, when assessing such a concept using a measure developed elsewhere, it is important to test its cultural equivalence. Previous research suggested a lack of cultural equivalence testing in several areas of measurement. This paper reviews the process of cross-cultural equivalence testing of instruments to measure participation in society. An existing cultural equivalence framework was adapted and used to assess participation instruments on five categories of equivalence: conceptual, item, semantic, measurement and operational equivalence. For each category, several aspects were rated, resulting in an overall category rating of 'minimal/none', 'partial' or 'extensive'. The best possible overall study rating was five 'extensive' ratings. Articles were included if the instruments focussed explicitly on measuring 'participation' and were theoretically grounded in the ICIDH(-2) or ICF. Cross-validation articles were only included if it concerned an adaptation of an instrument developed in a high or middle-income country to a low-income country or vice versa. Eight cross-cultural validation studies were included in which five participation instruments were tested (Impact on Participation and Autonomy, London Handicap Scale, Perceived Impact and Problem Profile, Craig Handicap Assessment Reporting Technique, Participation Scale). Of these eight studies, only three received at least two 'extensive' ratings for the different categories of equivalence. The majority of the cultural equivalence ratings given were 'partial' and 'minimal/none'. The majority of the 'none/minimal' ratings were given for item and measurement equivalence. The cross-cultural equivalence testing of the participation instruments included leaves much to be desired. A detailed checklist is proposed for designing a cross-validation study. Once a study has been conducted, the checklist can

  2. A comprehensive review of sensors and instrumentation methods in devices for musical expression.

    Science.gov (United States)

    Medeiros, Carolina Brum; Wanderley, Marcelo M

    2014-07-25

    Digital Musical Instruments (DMIs) are musical instruments typically composed of a control surface where user interaction is measured by sensors whose values are mapped to sound synthesis algorithms. These instruments have gained interest among skilled musicians and performers in the last decades leading to artistic practices including musical performance, interactive installations and dance. The creation of DMIs typically involves several areas, among them: arts, design and engineering. The balance between these areas is an essential task in DMI design so that the resulting instruments are aesthetically appealing, robust, and allow responsive, accurate and repeatable sensing. In this paper, we review the use of sensors in the DMI community as manifested in the proceedings of the International Conference on New Interfaces for Musical Expression (NIME 2009-2013). Focusing on the sensor technologies and signal conditioning techniques used by the NIME community. Although it has been claimed that specifications for artistic tools are harder than those for military applications, this study raises a paradox showing that in most of the cases, DMIs are based on a few basic sensors types and unsophisticated engineering solutions, not taking advantage of more advanced sensing, instrumentation and signal processing techniques that could dramatically improve their response. We aim to raise awareness of limitations of any engineering solution and to assert the benefits of advanced electronics instrumentation design in DMIs. For this, we propose the use of specialized sensors such as strain gages, advanced conditioning circuits and signal processing tools such as sensor fusion. We believe that careful electronic instrumentation design may lead to more responsive instruments.

  3. A Comprehensive Review of Sensors and Instrumentation Methods in Devices for Musical Expression

    Directory of Open Access Journals (Sweden)

    Carolina Brum Medeiros

    2014-07-01

    Full Text Available Digital Musical Instruments (DMIs are musical instruments typically composed of a control surface where user interaction is measured by sensors whose values are mapped to sound synthesis algorithms. These instruments have gained interest among skilled musicians and performers in the last decades leading to artistic practices including musical performance, interactive installations and dance. The creation of DMIs typically involves several areas, among them: arts, design and engineering. The balance between these areas is an essential task in DMI design so that the resulting instruments are aesthetically appealing, robust, and allow responsive, accurate and repeatable sensing. In this paper, we review the use of sensors in the DMI community as manifested in the proceedings of the International Conference on New Interfaces for Musical Expression (NIME 2009–2013. Focusing on the sensor technologies and signal conditioning techniques used by the NIME community. Although it has been claimed that specifications for artistic tools are harder than those for military applications, this study raises a paradox showing that in most of the cases, DMIs are based on a few basic sensors types and unsophisticated engineering solutions, not taking advantage of more advanced sensing, instrumentation and signal processing techniques that could dramatically improve their response. We aim to raise awareness of limitations of any engineering solution and to assert the benefits of advanced electronics instrumentation design in DMIs. For this, we propose the use of specialized sensors such as strain gages, advanced conditioning circuits and signal processing tools such as sensor fusion. We believe that careful electronic instrumentation design may lead to more responsive instruments.

  4. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation

    Directory of Open Access Journals (Sweden)

    Kisakye AN

    2016-11-01

    Full Text Available Angela N Kisakye,1 Raymond Tweheyo,1 Freddie Ssengooba,1 George W Pariyo,2 Elizeus Rutebemberwa,1 Suzanne N Kiwanuka1 1Department of Health Policy Planning and Management, Makerere University School of Public Health, Kampala, Uganda; 2Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA Background: A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. Methods: A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Results: Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1 organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs; 2 prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3 contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4 multifaceted work interventions being implemented in most settings; 5 the possibility of using financial and incentive regulatory mechanisms

  5. Measurement properties of instruments assessing permanent functional impairment of the spine: a systematic review protocol

    Science.gov (United States)

    Trask, Catherine M; Boden, Catherine; Bath, Brenna; Hendrick, Paul; Clay, Lynne; Zeng, Xiaoke; Milosavljevic, Stephan

    2018-01-01

    Introduction Permanent functional impairment (PFI) of the spine is a rating system used by compensation authorities, such as workers compensation boards, to establish an appropriate level of financial compensation for persistent loss of function. Determination of PFI of the spine is commonly based on the assessment of spinal movement combined with other measures of physical and functional impairments; however, the reliability and validity of the measurement instruments used for these evaluations have yet to be established. The aim of this study is to systematically review and synthesise the literature concerning measurement properties of the various and different instruments used for assessing PFI of the spine. Methods Three conceptual groups of terms (1) PFI, (2) spinal disorder and (3) measurement properties will be combined to search Medline, EMBASE, CINAHL, Web of Science, Scopus, PEDro, OTSeeker and Health and Safety Science Abstracts. We will examine peer-reviewed, full-text articles over the full available date range. Two reviewers will independently screen citations (title, abstract and full text) and perform data extraction. Included studies will be appraised as to their methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments criteria. Findings will be summarised and presented descriptively, with meta-analysis pursued as appropriate. Ethics and dissemination This review will summarise the current level of evidence of measurement properties of instruments used for assessing PFI of the spine. Findings of this review may be applicable to clinicians, policy-makers, workers’ compensation boards, other insurers and health and safety organisations. The findings will likely provide a foundation and direction for future research priorities for assessing spinal PFI. PROSPERO registration number CRD42017060390. PMID:29374671

  6. Measurement properties of instruments assessing permanent functional impairment of the spine: a systematic review protocol.

    Science.gov (United States)

    Goes, Suelen Meira; Trask, Catherine M; Boden, Catherine; Bath, Brenna; Ribeiro, Daniel Cury; Hendrick, Paul; Clay, Lynne; Zeng, Xiaoke; Milosavljevic, Stephan

    2018-01-27

    Permanent functional impairment (PFI) of the spine is a rating system used by compensation authorities, such as workers compensation boards, to establish an appropriate level of financial compensation for persistent loss of function. Determination of PFI of the spine is commonly based on the assessment of spinal movement combined with other measures of physical and functional impairments; however, the reliability and validity of the measurement instruments used for these evaluations have yet to be established. The aim of this study is to systematically review and synthesise the literature concerning measurement properties of the various and different instruments used for assessing PFI of the spine. Three conceptual groups of terms (1) PFI, (2) spinal disorder and (3) measurement properties will be combined to search Medline, EMBASE, CINAHL, Web of Science, Scopus, PEDro, OTSeeker and Health and Safety Science Abstracts. We will examine peer-reviewed, full-text articles over the full available date range. Two reviewers will independently screen citations (title, abstract and full text) and perform data extraction. Included studies will be appraised as to their methodological quality using the COnsensus-based Standards for the selection of health Measurement INstruments criteria. Findings will be summarised and presented descriptively, with meta-analysis pursued as appropriate. This review will summarise the current level of evidence of measurement properties of instruments used for assessing PFI of the spine. Findings of this review may be applicable to clinicians, policy-makers, workers' compensation boards, other insurers and health and safety organisations. The findings will likely provide a foundation and direction for future research priorities for assessing spinal PFI. CRD42017060390. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise

  7. The measurement of collaboration within healthcare settings: a systematic review of measurement properties of instruments.

    Science.gov (United States)

    Walters, Stephen John; Stern, Cindy; Robertson-Malt, Suzanne

    2016-04-01

    There is a growing call by consumers and governments for healthcare to adopt systems and approaches to care to improve patient safety. Collaboration within healthcare settings is an important factor for improving systems of care. By using validated measurement instruments a standardized approach to assessing collaboration is possible, otherwise it is only an assumption that collaboration is occurring in any healthcare setting. The objective of this review was to evaluate and compare measurement properties of instruments that measure collaboration within healthcare settings, specifically those which have been psychometrically tested and validated. Participants could be healthcare professionals, the patient or any non-professional who contributes to a patient's care, for example, family members, chaplains or orderlies. The term participant type means the designation of any one participant; for example 'nurse', 'social worker' or 'administrator'. More than two participant types was mandatory. The focus of this review was the validity of tools used to measure collaboration within healthcare settings. The types of studies considered for inclusion were validation studies, but quantitative study designs such as randomized controlled trials, controlled trials and case studies were also eligible for inclusion. Studies that focused on Interprofessional Education, were published as an abstract only, contained patient self-reporting only or were not about care delivery were excluded. The outcome of interest was validation and interpretability of the instrument being assessed and included content validity, construct validity and reliability. Interpretability is characterized by statistics such as mean and standard deviation which can be translated to a qualitative meaning. The search strategy aimed to find both published and unpublished studies. A three-step search strategy was utilized in this review. The databases searched included PubMed, CINAHL, Embase, Cochrane Central

  8. Special committee review of the Nuclear Regulatory Commission's severe accident risks report (NUREG--1150)

    International Nuclear Information System (INIS)

    Kouts, H.J.C.; Apostolakis, G.; Kastenberg, W.E.; Birkhofer, E.H.A.; Hoegberg, L.G.; LeSage, L.G.; Rasmussen, N.C.; Teague, H.J.; Taylor, J.J.

    1990-08-01

    In April 1989, the Nuclear Regulatory Commission's (NRC) Office of Nuclear Regulatory Research (RES) published a draft report ''Severe Accident Risks: An Assessment for Five US Nuclear Power Plants,'' NUREG-1150. This report updated, extended and improved upon the information presented in the 1974 ''Reactor Safety Study,'' WASH-1400. Because the information in NUREG-1150 will play a significant role in implementing the NRC's Severe Accident Policy, its quality and credibility are of critical importance. Accordingly, the Commission requested that the RES conduct a peer review of NUREG-1150 to ensure that the methods, safety insights and conclusions presented are appropriate and adequately reflect the current state of knowledge with respect to reactor safety. To this end, RES formed a special committee in June of 1989 under the provisions of the Federal Advisory Committee Act. The Committee, composed of a group of recognized national and international experts in nuclear reactor safety, was charged with preparing a report reflecting their review of NUREG-1150 with respect to the adequacy of the methods, data, analysis and conclusions it set forth. The report which precedes reflects the results of this peer review

  9. Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials.

    Science.gov (United States)

    Hung, H M James; Wang, Sue-Jane; Yang, Peiling; Jin, Kun; Lawrence, John; Kordzakhia, George; Massie, Tristan

    2016-01-01

    There are several challenging statistical problems identified in the regulatory review of large cardiovascular (CV) clinical outcome trials and central nervous system (CNS) trials. The problems can be common or distinct due to disease characteristics and the differences in trial design elements such as endpoints, trial duration, and trial size. In schizophrenia trials, heavy missing data is a big problem. In Alzheimer trials, the endpoints for assessing symptoms and the endpoints for assessing disease progression are essentially the same; it is difficult to construct a good trial design to evaluate a test drug for its ability to slow the disease progression. In CV trials, reliance on a composite endpoint with low event rate makes the trial size so large that it is infeasible to study multiple doses necessary to find the right dose for study patients. These are just a few typical problems. In the past decade, adaptive designs were increasingly used in these disease areas and some challenges occur with respect to that use. Based on our review experiences, group sequential designs (GSDs) have borne many successful stories in CV trials and are also increasingly used for developing treatments targeting CNS diseases. There is also a growing trend of using more advanced unblinded adaptive designs for producing efficacy evidence. Many statistical challenges with these kinds of adaptive designs have been identified through our experiences with the review of regulatory applications and are shared in this article.

  10. Health Literacy Screening Instruments for eHealth Applications: A Systematic Review

    Science.gov (United States)

    Collins, Sarah A.; Currie, Leanne M.; Bakken, Suzanne; Vawdrey, David K.; Stone, Patricia W.

    2012-01-01

    Objective To systematically review current health literacy (HL) instruments for use in consumer-facing and mobile health information technology screening and evaluation tools. Design The databases, PubMed, OVID, Google Scholar, Cochrane Library and Science Citation Index, were searched for health literacy assessment instruments using the terms “health”, “literacy”, “computer-based,” and “psychometrics”. All instruments identified by this method were critically appraised according to their reported psychometric properties and clinical feasibility. Results Eleven different health literacy instruments were found. Screening questions, such as asking a patient about his/her need for assistance in navigating health information, were evaluated in 7 different studies and are promising for use as a valid, reliable, and feasible computer-based approach to identify patients that struggle with low health literacy. However, there was a lack of consistency in the types of screening questions proposed. There is also a lack of information regarding the psychometric properties of computer-based health literacy instruments. Limitations Only English language health literacy assessment instruments were reviewed and analyzed. Conclusions Current health literacy screening tools demonstrate varying benefits depending on the context of their use. In many cases, it seems that a single screening question may be a reliable, valid, and feasible means for establishing health literacy. A combination of screening questions that assess health literacy and technological literacy may enable tailoring eHealth applications to user needs. Further research should determine the best screening question(s) and the best synthesis of various instruments’ content and methodologies for computer-based health literacy screening and assessment. PMID:22521719

  11. Review of voluntary and regulatory carbon reporting by companies around the world

    International Nuclear Information System (INIS)

    Borie, Sylvain; Decq, Juliette; Wang, Xin; Alberola, Emilie; Afriat, Marion; Gourdon, Thomas

    2016-01-01

    What countries have instituted regulations requiring companies to measure their greenhouse gas (GHG) emissions? How could these regulations be strengthened to help meet the '2 deg. C' goal adopted by all member countries at the COP21 summit? In what ways do new French regulations on reporting of significant GHG emissions constitute a major advance in carbon reporting? To complement recent news focusing on reporting of carbon emissions in France, Carbone 4 offers its readers this review to put voluntary and regulatory carbon reporting mechanisms used by companies in a global perspective

  12. IAEA Team Concludes Peer Review of Greece's Regulatory Framework for Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts yesterday concluded an 11-day mission to review the regulatory framework for nuclear and radiation safety in Greece. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of the Government of the Hellenic Republic, noted good practices in the country's nuclear regulatory system and also identified issues for improvement for the Greek Atomic Energy Commission (GAEC) and the Greek competent authorities. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''The IRRS team enjoyed excellent cooperation from the GAEC throughout its mission,'' said Tom Ryan, mission leader and Director of Regulations and Information Management at the Radiological Protection Institute of Ireland. ''The GAEC staff were very open and candid in their discussions and provided the fullest practicable assistance.'' The main observations of the IRRS Review team included: While the Greek Government's commitment to safety is being demonstrated through its actions, the development of a comprehensive national policy and strategy expressed in a consolidated statement would provide a valuable framework and guidance for future actions in terms of safety; and GAEC has effective independence. The Greek government has ensured that GAEC is effectively independent in its safety-related decision-making and that it has functional separation from entities having responsibility or interests that could unduly influence its decision making. Strengths and good practices identified by the IRRS team included: Greece actively participates in the global safety regime including all relevant safety conventions; The nation's radiation monitoring system for the detection of illicit trafficking contributes significantly to identifying potential radiation emergencies due to events within or outside the country

  13. Development of regulatory guidance for risk-informing digital system reviews

    International Nuclear Information System (INIS)

    Arndt, S. A.

    2006-01-01

    In 1995, the U.S. Nuclear Regulatory Commission (NRC) issued the Probabilistic Risk Assessment (PRA) Policy Statement, which encourages the increased use of PRA and associated analyses in all regulatory matters to the extent supported by the state-of-the-art in PRA and the data. This policy applies, in part, to the review of digital systems, which offer the potential to improve plant safety and reliability through such features as increased hardware reliability and stability and improved failure detection capability. However, there are presently no universally accepted methods for modeling digital systems in current-generation PRAs. Further, there are ongoing debates among the PRA technical community regarding the level of detail that any digital system reliability model must have to adequately model the complex system interactions that can contribute to digital system failure modes. Moreover, for PRA modeling of digital reactor protection and control systems, direct interactions between system components and indirect interactions through controlled/supervised plant processes may necessitate the use of dynamic PRA methodologies. This situation has led the NRC to consider developing performance based rather than prescriptive regulatory guidance in this area. This paper will discuss the development of this guidance and some preliminary concepts. (authors)

  14. Psychometric properties of assessment instruments for autism spectrum disorder: a systematic review of Brazilian studies

    Directory of Open Access Journals (Sweden)

    Bárbara Backes

    2014-07-01

    Full Text Available Objective To systematically review the scientific literature on the psychometric properties of international instruments for the assessment of autism spectrum disorder (ASD in the Brazilian population. Methods A search of bibliographic references was conducted in six electronic databases: PsycINFO, PubMed, IndexPsi, Lilacs, Capes (theses and dissertations and SciELO. The studies were selected by two independent researchers. Results The procedure identified 11 studies of the Brazilian population that encompassed six ASD assessment tools. Given the information provided, the adaptation of the M-CHAT, a screening instrument, was the best conducted. All steps of the adaptation process were described and the changes made to the final version of the instrument were presented, which was not addressed in other studies. In terms of reliability, all of the instruments that assessed internal consistency showed adequate values. In addition, the ADI-R and the CARS adaptations also satisfactorily contemplated inter-rater reliability and test-retest indices, respectively. Finally, all studies aiming to validate instruments showed evidence of validity and sensitivity, and specificity values above 0.90 were observed in the ASQ, ADI-R and ABC. Conclusion Considering both the psychometric aspects and the copyright information, the screening instrument that currently appears to be best indicated for clinical and research use is the M-CHAT. It was also noticed that there are still no specific ASD diagnostic tools available for use in Brazil. This lack of diagnostic instruments consists in a critical situation for the improvement of clinical practice and the development of research in this area.

  15. [Validated Instruments for the Psychological Assessment of Unaccompanied Refugee Minors - a Systematic Review].

    Science.gov (United States)

    Rassenhofer, Miriam; Fegert, Jörg Michael; Plener, Paul L; Witt, Andreas

    2016-01-01

    The German care system faces a growing number of unaccompanied refugee minors (URM). URM show high levels of traumatization, a variety of psychological symptoms and lack important resilience factors. Therefore an early and valid psychological assessment is important for intervention and service planning. Yet, no systematic review on validated instruments for the assessment of this group exists. Literature search revealed one study about translators in the assessment of URM and five validated instruments for proxy and self-report. These instruments are available in several languages and showed good psychometric properties. It has to be critically stated that all instruments have been validated by a single work group within a single population. Especially with regards to changing definitions of Posttraumatic Stress Disorder within the new (and upcoming) classification systems ICD-11 and DSM-5, increased awareness for diagnostic procedures is necessary. Additionally, more validated instruments for specific psychological disorders in multiple languages are needed. Under an economic perspective the use of open access questionnaires that are available in different languages seems useful, even if they are not especially validated for URM.

  16. Instruments used in the assessment of expectation toward a spine surgery: an integrative review

    Directory of Open Access Journals (Sweden)

    Eliane Nepomuceno

    Full Text Available Abstract OBJECTIVE To identify and describe the instruments used to assess patients' expectations toward spine surgery. METHOD An integrative review was carried out in the databases PubMed, CINAHL, LILACS and PsycINFO. RESULTS A total of 4,402 publications were identified, of which 25 met the selection criteria. Of the studies selected, only three used tools that had confirmed validity and reliability to be applied; in five studies, clinical scores were used, and were modified for the assessment of patients' expectations, and in 17 studies the researchers developed scales without an adequate description of the method used for their development and validation. CONCLUSION The assessment of patients' expectations has been methodologically conducted in different ways. Until the completion of this integrative review, only two valid and reliable instruments had been used in three of the selected studies.

  17. Preparing and Conducting Review Missions of Instrumentation and Control Systems in Nuclear Power Plants

    International Nuclear Information System (INIS)

    2016-07-01

    The IERICS (Independent Engineering Review of Instrumentation and Control Systems) mission is a comprehensive engineering review service directly addressing strategy and the key elements for implementation of modern instrumentation and control (I&C) systems, noting in applicable cases, specific concerns related to the implementation of advanced digital I&C systems and the use of software and/or digital logic in safety applications of a nuclear power plant. The guidelines outlined in this publication provide a basic structure, common reference and checklist across the various areas covered by an IERICS mission. Publications referenced in these guidelines could provide additional useful information for the counterpart while preparing for the IERICS mission. A structure for the mission report is given in the Appendix. In 2016, this publication was revised by international experts who had participated in previous IERICS missions. The revision reflects experiences and lessons learned from the preparation and conduct of those missions

  18. Review of modern instrumentation for magnetic measurements at high pressure and low temperature

    International Nuclear Information System (INIS)

    Wang, X.; Kamenev, K.V.

    2015-01-01

    High-pressure magnetic susceptibility experiments can provide insights into the changes in magnetic behavior and electric properties which can accompany extreme compressions of material. Instrumentation plays an important role in the experimental work in this field since 1990s. Here we present a comprehensive review of the high-pressure instrumentation development for magnetic measurement from the engineering perspective in the last 20 years. Suitable nonmagnetic materials for high pressure cell are introduced initially. Then we focus on the existing cells developed for magnetic property measurement system (MPMS) SQUID magnetometer from Quantum Design (USA). Two categories of high pressure cells for this system are discussed in detail respectively. Some high pressure cells with built-in magnetic measurement system are also reviewed

  19. A systematic review of instruments that assess the implementation of hospital quality management systems.

    Science.gov (United States)

    Groene, Oliver; Botje, Daan; Suñol, Rosa; Lopez, Maria Andrée; Wagner, Cordula

    2013-10-01

    Health-care providers invest substantial resources to establish and implement hospital quality management systems. Nevertheless, few tools are available to assess implementation efforts and their effect on quality and safety outcomes. This review aims to (i) identify instruments to assess the implementation of hospital quality management systems, (ii) describe their measurement properties and (iii) assess the effects of quality management on quality improvement and quality of care outcomes. We performed a systematic literature search from 1990 to 2011 in PubMed, CINAHL, EMBASE, Cochrane Library and Web of Science. In addition, we used snowball strategies, screened the reference lists of eligible papers, reviewed grey literature and contacted experts in the field. and data extraction Two reviewers screened eligible papers based on pre-defined inclusion and exclusion criteria and all authors extracted data. Eligible papers are described in terms of general characteristics (settings, type and level of respondents, mode of data collection), methodological properties (sampling strategy, item derivation, conceptualization of quality management, assessment of reliability and validity, scoring) and application/implementation (accounting for context, organizational adaptations, sensitivity to change, deployment and effect size). Eighteen papers were deemed eligible for inclusion. While some common domains emerged in measurement conceptualization, substantial differences in scope persist. The instruments' measurement properties were insufficiently described and only few instruments assessed links between the implementation of quality management systems (QMS) and improvement strategies or outcomes. There is currently no well-established measure to assess the implementation and effectiveness of quality management systems. Future research should address this gap.

  20. The IAEA Integrated Regulatory Review Service Mission to Sweden in February 2012

    International Nuclear Information System (INIS)

    2012-01-01

    The Swedish Government decided on January 22, 2009 to mandate the Swedish Radiation Safety Authority, SSM, to apply for an international review of the Authority and its areas of supervision, an 'IRRS' (Integrated Regulatory Review Service) carried out by the International Atomic Energy Agency (IAEA). On February 25, 2009, SSM made a formal request to the IAEA for an IRRS in Sweden. The time period for the IRRS mission was later agreed to be 6-17 February, 2012. This report summarises the project's progress immediately prior to the IRRS mission in February 2012. The report contains the findings from the self assessment performed by SSM staff. It also contains a plan to implement measures to remedy deficiencies that have been identified and to improve the radiation safety work of the Authority

  1. Conduct of regulatory review and assessment during the licensing process for nuclear power plants

    International Nuclear Information System (INIS)

    1980-01-01

    This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Code of Practice on Governmental Organization for the Regulation of Nuclear Power Plants (IAEA Safety Series No. 50-C-G) and is concerned with the review and assessment by the regulatory body of all information submitted in support of licence applications, in the various phases of the licensing process. The purpose of the Guide is to provide information, recommendations and guidance for the conduct of these activities. The scope of the review and assessment will encompass the safety aspects of siting, construction, commissioning, operation and decommissioning of each nuclear power plant

  2. Applications of pharmacogenomics in regulatory science: a product life cycle review.

    Science.gov (United States)

    Tan-Koi, W C; Leow, P C; Teo, Y Y

    2018-05-22

    With rapid developments of pharmacogenomics (PGx) and regulatory science, it is important to understand the current PGx integration in product life cycle, impact on clinical practice thus far and opportunities ahead. We conducted a cross-sectional review on PGx-related regulatory documents and implementation guidelines in the United States and Europe. Our review found that although PGx-related guidance in both markets span across the entire product life cycle, the scope of implementation guidelines varies across two continents. Approximately one-third of Food and Drug Administration (FDA)-approved drugs with PGx information in drug labels and half of the European labels posted on PharmGKB website contain recommendations on genetic testing. The drugs affected 19 and 15 World Health Organization Anatomical Therapeutic Chemical drug classes (fourth level) in the United States and Europe, respectively, with protein kinase inhibitors (13 drugs in the United States and 16 drugs in Europe) being most prevalent. Topics of emerging interest were novel technologies, adaptive design in clinical trial and sample collection.

  3. Evolution in performance assessment modeling as a result of regulatory review

    Energy Technology Data Exchange (ETDEWEB)

    Rowat, J.H.; Dolinar, G.M.; Stephens, M.E. [AECL Chalk River Labs., Ontario (Canada)] [and others

    1995-12-31

    AECL is planning to build the IRUS (Intrusion Resistant Underground Structure) facility for near-surface disposal of LLRW. The PSAR (preliminary safety assessment report) was subject to an initial regulatory review during mid-1992. The regulatory authority provided comments on many aspects of the safety assessment documentation including a number of questions on specific PA (Performance Assessment) modelling assumptions. As a result of these comments as well as a separate detailed review of the IRUS disposal concept, changes were made to the conceptual and mathematical models. The original disposal concept included a non-sorbing vault backfill, with a strong reliance on the wasteform as a barrier. This concept was altered to decrease reliance on the wasteform by replacing the original backfill with a sand/clinoptilolite mix, which is a better sorber of metal cations. This change lead to changes in the PA models which in turn altered the safety case for the facility. This, and other changes that impacted performance assessment modelling are the subject of this paper.

  4. Is there an association between temporomandibular disorders and playing a musical instrument? A review of literature.

    Science.gov (United States)

    Attallah, M M; Visscher, C M; van Selms, M K A; Lobbezoo, F

    2014-07-01

    Temporomandibular disorders (TMDs) have a multifactorial etiology. Among others, parafunctions and oral habits have been suggested as important initiating and perpetuating factors. Playing a musical instrument that loads the masticatory system, like wind instruments and the violin or viola, has been suggested to be part of this group of etiological factors. However, the evidence base for this suggestion is lacking. Therefore, the aim of this study was to review the literature on the possible association between playing a musical instrument and developing and/or having a TMD. A PubMed search, using the query ['Music'(Mesh) AND 'Craniomandibular Disorders'(Mesh)], yielded 19 articles, 14 of which were included in this review. Six of 14 papers had a case-control or pre-test-post-test design; the remaining eight papers were case reports of expert opinions. The former papers were analysed and tabulated according to the PICO (Patient/population-Intervention-Control/comparison-Outcome/results) system; the latter ones were only summarised and tabulated. All articles with a case-control or pre-test-post-test design suggested a possible association between TMD and playing a musical instrument, especially the violin and viola. However, no clear-cut conclusion could be drawn as to whether playing a musical instrument is directly associated with TMD, or only in combination with other factors. More and better research on this topic is needed, as to enable a better counselling and possibly even a better treatment of the suffering musician. © 2014 John Wiley & Sons Ltd.

  5. Is playing string or wind musical instruments a risk factor for temporomandibular dysfunction? A Systematic Review.

    Directory of Open Access Journals (Sweden)

    Alessandro Leite Cavalcanti

    2017-11-01

    Full Text Available Aim. Medical problems specifically affecting professional musicians are commonly mentioned in the literature. The present study is aimed to evaluate, through a systematic review, the possible association between the practice of string with bow and wind musical instruments and the occurrence of Temporomandibular Dysfunction (TMD. Methods. The search for articles was conducted in PubMed/Medline, Web of Science, Scopus, Lilacs, Cochrane Library, and Open Gray databases, and there was no restriction on language or date of publication. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA guidelines were followed. The MeSH terms used were: “music”; “temporomandibular joint”; “temporomandibular joint disorders”; “temporomandibular joint dysfunction syndrome”; and “occupational diseases”. Cross-sectional studies, case-control, cohort and clinical trials were included that involved the practice of string with bow and wind musical instruments and the occurrence of Temporomandibular Dysfunction (TMD. Articles were previously selected by title and abstract. Qualitative evaluation was done through the Newcastle-Ottawa Scale. Results. The literature search identified 732 studies, of which 10 met the inclusion criteria, nine of them cross-sectional studies and one a clinical intervention study. The TMD prevalence ranged from 47.0% to 89.0%. Recruitment of participants took place in professional schools and orchestras, and in bands of professional musicians. All studies reported associations between TMD and the practice of musical instruments, and violinists presented higher prevalence rates when compared to other instrument groups. Conclusion. All studies pointed to a possible association between TMD and the practice of string and wind musical instruments. More longitudinal and clinical trials studies are needed to verify any possible interrelationship.

  6. Regulatory Aspect of Periodic Safety Review Performed in Nuclear Power Plants in the Slovak Republic

    International Nuclear Information System (INIS)

    Baszo, Z.

    2010-01-01

    The paper deals with the regulatory aspect of Nuclear Power Plant (NPP) Periodic Safety Review (PSR) as a part of license renewal process in the Slovak Republic. It summarizes the history of activities similar to PSR performed in the past for NPPs operated in the Slovak Republic. Furthermore, it describes both the requirements involved in the current Slovak legislation to be met by licensee in the Slovak Republic in this field and the procedures concerning the PSR as well. The objective and rules of PSR to be performed for NPPs in the Slovak Republic were derived from the internationally accepted International Atomic Energy Agency (IAEA) document and have been implemented into national legislation. PSR of two twin units located in Bohunice NPP and Mochovce NPP, respectively, has been initiated in the Slovak Republic based on evaluation of each area to be reviewed (safety factors) using recent methodology and practice. Other significant factors, such as ageing, modifications of NPP and the safe operation for a specified future period, have to be assessed in the frame of PSR. Report on performed PSR outlines the results of review for each area, the corrective plan, which considering mutual relations between assessed areas specifies the issues to be solved with the aim to eliminate shortcomings identified in the frame of PSR and to adopt safety improvements. The findings from PSR in the evaluated areas also serve as a source of information for updating of all documents to be attached to the written application of licensee for renewal of a nuclear power plant operating license. The presented procedure describes how the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) has reviewed the documents submitted during PSR. Based on results of submitted documents evaluation and licensee application for license renewal the license for next 10 years operation has been issued for Bohunice NPP. At present, similar procedure for Mochovce NPP unit 1 and 2 is underway.(author).

  7. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  8. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of nuclear facilities such as: enrichment and fuel manufacturing plants. Nuclear power plants. Other reactors such as research reactors and critical assemblies. Spent fuel reprocessing plants. And facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  9. Recent Findings on Tax-Related Regulatory Burden on SMMEs in South Africa. Literature Review and Policy Options

    OpenAIRE

    Doubell Chamberlain; Anja Smith

    2006-01-01

    Regulatory compliance costs impose a deadweight burden on firms and therefore should be minimised. In achieving this goal, it is necessary to embrace a process of smart regulation, rather than focus on deregulation. Tax compliance cost is one type of regulatory costs that is often viewed to have a large negative impact on SMMEs. To gauge the impact of this cost on small business in South Africa, this document reviews three available studies on the impact of tax compliance costs on South Afric...

  10. Systematic review of measurement properties of self-reported instruments for evaluating self-care in adults.

    Science.gov (United States)

    Matarese, Maria; Lommi, Marzia; De Marinis, Maria Grazia

    2017-06-01

    The aims of this study were as follows: to identify instruments developed to assess self-care in healthy adults; to determine the theory on which they were based; their validity and reliability properties and to synthesize the evidence on their measurement properties. Many instruments have been developed to assess self-care in many different populations and conditions. Clinicians and researchers should select the most appropriate self-care instrument based on the knowledge of their measurement properties. Systematic review of measurement instruments according to the protocol recommended by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) panel. PubMed, Embase, PsycINFO, Scopus and CINAHL databases were searched from inception to December 2015. Studies testing measurement properties of self-report instruments assessing self-care in healthy adults, published in the English language and in peer review journals were selected. Two reviewers independently appraised the methodological quality of the studies with the COSMIN checklist and the quality of results using specific quality criteria. Twenty-six articles were included in the review testing the measurement properties of nine instruments. Seven instruments were based on Orem's Self-care theory. Not all the measurement properties were evaluated for the identified instruments. No self-care instrument showed strong evidence supporting the evaluated measurement properties. Despite the development of several instruments to assess self-care in the adult population, no instrument can be fully recommended to clinical nurses and researchers. Further studies of high methodological quality are needed to confirm the measurement properties of these instruments. © 2016 John Wiley & Sons Ltd.

  11. The regulatory review: general comments, current status of review, identification of critical issues

    International Nuclear Information System (INIS)

    Vigfusson, J.; Franck, E.

    2004-01-01

    Typically, a lot of interesting and important details add up to give a coherent and convincing picture of a safe repository. A good portion of these details must be studied and the scientific basis of the system must be clearly understood by the reviewing authority in order to be able to pass a judgement on the safety case. HSK has already received a large part of the documentation relating to the project, including the three high level documents that summarize the synthesis of the geological information, the demonstration of repository design and construction feasibility and the safety case. After a first look at the contents of the documentation we would like to complement Nagra on the maturity and clarity of the presentation in these reports. At this early stage, we shall not present any review judgements. The reviewer usually is dependent upon having not only the high level documents but also all the detailed reference reports in front of him in order to do his job, and HSK is still receiving very relevant documents. Thus we are still at the very beginning of our review. Here, we offer some comments of general nature about the review process and mention a few points that seem to be uppermost in our mind at this stage. (author)

  12. Systematic review regulatory principles of non-coding RNAs in cardiovascular diseases.

    Science.gov (United States)

    Li, Yongsheng; Huo, Caiqin; Pan, Tao; Li, Lili; Jin, Xiyun; Lin, Xiaoyu; Chen, Juan; Zhang, Jinwen; Guo, Zheng; Xu, Juan; Li, Xia

    2017-08-16

    Cardiovascular diseases (CVDs) continue to be a major cause of morbidity and mortality, and non-coding RNAs (ncRNAs) play critical roles in CVDs. With the recent emergence of high-throughput technologies, including small RNA sequencing, investigations of CVDs have been transformed from candidate-based studies into genome-wide undertakings, and a number of ncRNAs in CVDs were discovered in various studies. A comprehensive review of these ncRNAs would be highly valuable for researchers to get a complete picture of the ncRNAs in CVD. To address these knowledge gaps and clinical needs, in this review, we first discussed dysregulated ncRNAs and their critical roles in cardiovascular development and related diseases. Moreover, we reviewed >28 561 published papers and documented the ncRNA-CVD association benchmarking data sets to summarize the principles of ncRNA regulation in CVDs. This data set included 13 249 curated relationships between 9503 ncRNAs and 139 CVDs in 12 species. Based on this comprehensive resource, we summarized the regulatory principles of dysregulated ncRNAs in CVDs, including the complex associations between ncRNA and CVDs, tissue specificity and ncRNA synergistic regulation. The highlighted principles are that CVD microRNAs (miRNAs) are highly expressed in heart tissue and that they play central roles in miRNA-miRNA functional synergistic network. In addition, CVD-related miRNAs are close to one another in the functional network, indicating the modular characteristic features of CVD miRNAs. We believe that the regulatory principles summarized here will further contribute to our understanding of ncRNA function and dysregulation mechanisms in CVDs. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  13. Review of NRC Commission Papers on Regulatory Basis for Licensing and Regulating Reprocessing Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jae Yeong; Shin, Hyeong Ki [KINS, Daejeon (Korea, Republic of)

    2016-05-15

    Spent nuclear fuel (SNF) accumulated in nuclear power plant has been a serious issue in most countries with operating nuclear power plants. Direct disposal of SNF could be a solution of the problem but many countries including the Republic of Korea have had a hard time selecting a site for high level waste repository because of low public acceptance. SNF recycling technologies consisting of reprocessing and transmutation have been developed so as to reduce the final volume of the disposed radioactive waste and to diminish the radiotoxicity of the waste. The Republic of Korea is now developing pyroprocessing and sodium-cooled fast reactor (SFR) technology to be used for the recycling of the wastes. KAERI has a plan to construct a pyroprocessing facility with a capacity of 30 tHM/y and a facility manufacturing TRU fuel for SFR by 2025. However, to license these facility and secure the safety, the current regulatory system related to SNF treatment needs to be improved and amended since the system has been developed focusing on facilities to examine irradiated nuclear materials. Status of reprocessing facility regulations developed by U.S.NRC was reviewed based on SECY papers. U.S.NRC has approved the development of a new rule referred to nationally as '10CFR Part 7x'. Existing 10CFR 50 and 70 has been evolved mainly for nuclear power plants and fuel cycle facilities whose radiological hazard is much lower than reprocessing plants respectively. U.S.NRC also derived many regulatory gaps including safety assessment methods, technical specification, general design criteria and waste classification and continue to develop the regulatory framework limited in scope to the resolution of Gap 5.

  14. Review of Technical Studies in the United States in Support of Burnup Credit Regulatory Guidance

    International Nuclear Information System (INIS)

    Wagner, John C.; Parks, Cecil V.; Mueller, Don; Gauld, Ian C.

    2010-01-01

    Taking credit for the reduction in reactivity associated with fuel depletion can enable more cost-effective, higher-density storage, transport, disposal, and reprocessing of spent nuclear fuel (SNF) while maintaining sufficient subcritical margin to establish an adequate safety basis. Consequently, there continues to be considerable interest in the United States (U.S.), as well as internationally, in the increased use of burnup credit in SNF operations, particularly related to storage, transport, and disposal of commercial SNF. This interest has motivated numerous technical studies related to the application of burnup credit, both domestically and internationally, as well as the design of SNF storage, transport and disposal systems that rely on burnup credit for maintaining subcriticality. Responding to industry requests and needs, the U.S. Nuclear Regulatory Commission (NRC) initiated a burnup credit research program in 1999, with support from the Oak Ridge National Laboratory (ORNL), to develop regulatory guidance and the supporting technical bases for allowing and expanding the use of burnup credit in pressurized-water reactor SNF storage and transport applications. Although this NRC research program has not been continuous since its inception, considerable progress has been achieved in many key areas in terms of increased understanding of relevant phenomena and issues, availability of relevant information and data, and subsequently updated regulatory guidance for expanded use of burnup credit. This paper reviews technical studies performed by ORNL for the U.S. NRC burnup credit research program. Examples of topics include reactivity effects associated with reactor operating characteristics, fuel assembly characteristics, burnable absorbers, control rods, spatial burnup distributions, cooling time, and assembly misloading; methods and data for validation of isotopic composition predictions; methods and data for validation of criticality calculations; and

  15. Economic instruments for population diet and physical activity behaviour change: a systematic scoping review.

    Directory of Open Access Journals (Sweden)

    Ian Shemilt

    Full Text Available Unhealthy diet and low levels of physical activity are common behavioural factors in the aetiology of many non-communicable diseases. Recent years have witnessed an upsurge of policy and research interest in the use of taxes and other economic instruments to improve population health.To assemble, configure and analyse empirical research studies available to inform the public health case for using economic instruments to promote dietary and physical activity behaviour change.We conducted a systematic scoping review of evidence for the effects of specific interventions to change, or general exposure to variations in, prices or income on dietary and physical activity behaviours and corollary outcomes. Systematic electronic searches and parallel snowball searches retrieved >1 million study records. Text mining technologies were used to prioritise title-abstract records for screening. Eligible studies were selected, classified and analysed in terms of key characteristics and principal findings, using a narrative, configuring synthesis focused on implications for policy and further research.We identified 880 eligible studies, including 192 intervention studies and 768 studies that incorporated evidence for prices or income as correlates or determinants of target outcomes. Current evidence for the effects of economic instruments and exposures on diet and physical activity is limited in quality and equivocal in terms of its policy implications. Direct evidence for the effects of economic instruments is heavily skewed towards impacts on diet, with a relative lack of evidence for impacts on physical activity.The evidence-based case for using economic instruments to promote dietary and physical activity behaviour change may be less compelling than some proponents have claimed. Future research should include measurement of people's actual behavioural responses using study designs capable of generating reliable causal inferences regarding intervention

  16. A selective review of the first 20 years of instrumental variables models in health-services research and medicine.

    Science.gov (United States)

    Cawley, John

    2015-01-01

    The method of instrumental variables (IV) is useful for estimating causal effects. Intuitively, it exploits exogenous variation in the treatment, sometimes called natural experiments or instruments. This study reviews the literature in health-services research and medical research that applies the method of instrumental variables, documents trends in its use, and offers examples of various types of instruments. A literature search of the PubMed and EconLit research databases for English-language journal articles published after 1990 yielded a total of 522 original research articles. Citations counts for each article were derived from the Web of Science. A selective review was conducted, with articles prioritized based on number of citations, validity and power of the instrument, and type of instrument. The average annual number of papers in health services research and medical research that apply the method of instrumental variables rose from 1.2 in 1991-1995 to 41.8 in 2006-2010. Commonly-used instruments (natural experiments) in health and medicine are relative distance to a medical care provider offering the treatment and the medical care provider's historic tendency to administer the treatment. Less common but still noteworthy instruments include randomization of treatment for reasons other than research, randomized encouragement to undertake the treatment, day of week of admission as an instrument for waiting time for surgery, and genes as an instrument for whether the respondent has a heritable condition. The use of the method of IV has increased dramatically in the past 20 years, and a wide range of instruments have been used. Applications of the method of IV have in several cases upended conventional wisdom that was based on correlations and led to important insights about health and healthcare. Future research should pursue new applications of existing instruments and search for new instruments that are powerful and valid.

  17. A desk evaluation review of project RAF/4/004 nuclear instruments maintenance. Project desk evaluation

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-04-15

    A Project Desk Evaluation (PDE) is an intensive review process, using agreed guidelines, of the design, implementation, and the outputs of a project. This project was originally intended for six selected countries in Africa, namely, Algeria, Egypt, Ghana, Libya, Zaire and Zambia. Ethiopia and Tanzania joined in 1993 and it has now been extended to two other countries, Madagascar and Sudan. This is a step forward towards developing the infrastructure for nuclear instrumentation and maintenance is as many countries in Africa as require this service. A project summary along with financial data and recommendations for improvements are given. A table where total assistance provided to ten selected african countries is included.

  18. A Technological Review of the Instrumented Footwear for Rehabilitation with a Focus on Parkinson's Disease Patients.

    Science.gov (United States)

    Maculewicz, Justyna; Kofoed, Lise Busk; Serafin, Stefania

    2016-01-01

    In this review article, we summarize systems for gait rehabilitation based on instrumented footwear and present a context of their usage in Parkinson's disease (PD) patients' auditory and haptic rehabilitation. We focus on the needs of PD patients, but since only a few systems were made with this purpose, we go through several applications used in different scenarios when gait detection and rehabilitation are considered. We present developments of the designs, possible improvements, and software challenges and requirements. We conclude that in order to build successful systems for PD patients' gait rehabilitation, technological solutions from several studies have to be applied and combined with knowledge from auditory and haptic cueing.

  19. A desk evaluation review of project RAF/4/004 nuclear instruments maintenance. Project desk evaluation

    International Nuclear Information System (INIS)

    1994-01-01

    A Project Desk Evaluation (PDE) is an intensive review process, using agreed guidelines, of the design, implementation, and the outputs of a project. This project was originally intended for six selected countries in Africa, namely, Algeria, Egypt, Ghana, Libya, Zaire and Zambia. Ethiopia and Tanzania joined in 1993 and it has now been extended to two other countries, Madagascar and Sudan. This is a step forward towards developing the infrastructure for nuclear instrumentation and maintenance is as many countries in Africa as require this service. A project summary along with financial data and recommendations for improvements are given. A table where total assistance provided to ten selected african countries is included

  20. Institutional barriers to DSM (demand side management): Reviewing the regulatory bargain

    Energy Technology Data Exchange (ETDEWEB)

    Warwick, W.M.

    1990-09-01

    The paper discusses traditional arguments for utility regulation in the context of the current utility environment. It reviews several DSM delivery options using a matrix of key financial considerations for utilities and consumers. The strengths and weaknesses of each option are discussed and an assessment of current prospects for DSM implementation is provided. The premise of the paper is that adoption of DSM by utilities and consumers has lagged because of technical and behavioral uncertainties. In addition, regulatory practices and DSM delivery mechanisms have not provided adequate means to extract the benefits of DSM and allocate the risks in a way that offers clear advantages over generating options. The paper concludes with a brief discussion of the potential for value of service approaches to resolve these problems.

  1. Safety and regulatory review of dyes commonly used as excipients in pharmaceutical and nutraceutical applications.

    Science.gov (United States)

    Pérez-Ibarbia, Leire; Majdanski, Tobias; Schubert, Stephanie; Windhab, Norbert; Schubert, Ulrich S

    2016-10-10

    Color selection is one of the key elements of building a strong brand development and product identity in the pharmaceutical industry, besides to prevent counterfeiting. Moreover, colored pharmaceutical dosage forms may increase patient compliance and therapy enhancement. Although most synthetic dyes are classified as safe, their regulations are stricter than other classes of excipients. Safety concerns have increased during the last years but the efforts to change to natural dyes seem to be not promising. Their instability problems and the development of "non-toxic" dyes is still a challenge. This review focuses specifically on the issues related to dye selection and summarizes the current regulatory status. A deep awareness of toxicological data based on the public domain, making sure the compliance of standards for regulation and safety for successful product development is provided. In addition, synthetic strategies are provided to covalently bind dyes on polymers to possibly overcome toxicity issues. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. Yellin's review of the Nuclear Regulatory Commission's Reactor Safety Study: comment

    International Nuclear Information System (INIS)

    Wilson, R.

    1976-01-01

    Joel Yellin (Bell J. Economics, Vol. 7, No. 1 (Spr. 1976)) reviewed the Reactor Safety Study (WASH-1400, or Rasmussen Report) published by the Nuclear Regulatory Commission and makes several criticisms. Wilson finds that some of these criticisms are much overstated, while others, although valid, are mainly criticisms of presentation. To be useful for public policy, reactor risks--and indeed all nuclear risks--must be compared with other risks society faces. Wilson feels that the Rasmussen Report is weak in these comparisons, primarily because there exist few estimates of risk in other places, but that the comparisons he does make indeed confirm that the risk is smaller than Yellin suggests. 20 references

  3. Regulatory role of prolactin in paternal behavior in male parents: A narrative review

    Directory of Open Access Journals (Sweden)

    F Hashemian

    2016-01-01

    Full Text Available In all mammalian species, a combination of neuroendocrine and experiential factors contributes to the emergence of remarkable behavioral changes observed in parental behavior. Yet, our understanding of neuroendocrine bases of paternal behavior in humans is still preliminary and more research is needed in this area. In the present review, the authors summarized hormonal bases of paternal behavior in both human and nonhuman mammalian species and focused on studies on the regulatory role of prolactin in occurrence of paternal behavior. All peer-reviewed journal articles published before 2015 for each area discussed (parental brain, hormonal bases of maternal behavior, hormonal bases of paternal behavior and the role of prolactin in regulation of paternal behavior in nonhuman mammalian species, hormonal bases of paternal behavior and the role of prolactin in regulation of paternal behavior in humans were searched by PubMed, Medline, and Scopus for original research and review articles. Publications between 1973 and 2015 were included. Similar to female parents, elevated prolactin levels in new fathers most probably contribute to child-caring behavior and facilitate behavioral and emotional states attributed to child care. Moreover, elevated parental prolactin levels after childbirth decrease the parents′ libidos so that they invest more in parental care than in fertility behavior. According to the available clinical studies, elevation in the amounts of prolactin levels after childbirth in male parents are probably associated with paternal behavior observed in humans.

  4. NRC review of passive reactor design certification testing programs: Overview and regulatory perspective

    International Nuclear Information System (INIS)

    Levin, A.E.

    1993-01-01

    Reactor vendors are developing new designs for future deployment, including open-quotes passiveclose quotes light water reactors (LWRs), such as General Electric's (G.E.'s) simplified boiling water reactor (SBWR) and Westinghouse's AP600, which depend primarily on inherent processes, such as national convection and gravity feed, for safety injection and emergency core cooling. The U.S. Nuclear Regulatory Commission (NRC) has implemented a new process, certification of standardized reactor designs, for licensing these Plants. Part 52 of Title 10 of the Code of Federal Regulations (10CFR52) contains the requirements that vendors must meet for design certification. One important section, 10CFR52.47, reads open-quotes Certification of a standard design which . . . utilizes simplified, inherent, passive, or other innovative means to accomplish its safety functions will be granted only if: (1) The performance of each safety feature of the design has been demonstrated through either analysis, appropriate test programs, experience, or a combination thereof; (2) Interdependent effects among the safety features have been found acceptable by analysis, appropriate test programs, experience, or a combination thereof; and (3) Sufficient data exist on the safety features of the design to assess the analytical tools used for safety analyses. . . . The vendors have initiated programs to test innovative features of their designs and to develop data bases needed to validate their analytical codes, as required by the design certification rule. Accordingly, the NRC is reviewing and evaluating the vendors programs to ensure that they address adequately key issues concerning safety system performance. This paper provides an overview of the NRC's review process and regulatory perspective

  5. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2002-06-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  6. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2001-05-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  7. Resolution of digital instrumentation and control and human factors technical and regulatory issues for new plants and for modernization of operating plants

    International Nuclear Information System (INIS)

    Naser, J.A.; Torok, R.C.; Canavan, K.T.

    2008-01-01

    There are several technical and regulatory issues in the areas of digital I and C, human factors, and control rooms needing generic resolution. If they are not generically resolved, they can contribute to protracted regulatory reviews for operating plant license amendments and substantial delays and increased costs for new plant COL approvals. Therefore; a coordinated, proactive program has been established to resolve key issues. Both Industry and NRC have roles in resolving these key issues and addressing them in future design efforts and regulatory reviews. The Industry initiative is led by the NEI Digital I and C and Human Factors Working Group. NRC has established Task Working Groups under the NRC Digital I and C Steering Committee to address the issues and interact with Industry. EPRI is providing technical input and resolution leadership for some of the issues being addressed in three of the task working groups. For the Highly Integrated Control Room - Human Factors Task area, EPRI has taken the lead in developing draft industry position technical reports for the following three issues: 1) Minimum inventory of human system interfaces, 2) Computerized procedures and associated topics of automation and soft controls, and 3) Methodology to determine the acceptability of manual operator actions response times for a BTP 7-19 software common cause failure. For the Diversity and Defense-in-Depth area, EPRI has taken the lead in developing two draft industry position technical papers on the following topics: 1) Integrating defensive measures and diversity attributes to protect against digital common cause failures and 2) Susceptibility of digital devices and components to common cause failures. For the Risk Informing area, EPRI has taken the lead in developing two draft industry position technical papers on the following topics: 1) Clarifying how to use current methods to model digital systems in a PRA and 2) Application of PRA to specific digital I and C issues

  8. Systematic Review of Measurement Property Evidence for 8 Financial Management Instruments in Populations With Acquired Cognitive Impairment.

    Science.gov (United States)

    Engel, Lisa; Chui, Adora; Beaton, Dorcas E; Green, Robin E; Dawson, Deirdre R

    2018-03-07

    To critically appraise the measurement property evidence (ie, psychometric) for 8 observation-based financial management assessment instruments. Seven databases were searched in May 2015. Two reviewers used an independent decision-agreement process to select studies of measurement property evidence relevant to populations with adulthood acquired cognitive impairment, appraise the quality of the evidence, and extract data. Twenty-one articles were selected. This review used the COnsensus-based Standards for the selection of health Measurement Instruments review guidelines and 4-point tool to appraise evidence. After appraising the methodologic quality, the adequacy of results and volume of evidence per instrument were synthesized. Measurement property evidence with high risk of bias was excluded from the synthesis. The volume of measurement property evidence per instrument is low; most instruments had 1 to 3 included studies. Many included studies had poor methodologic quality per measurement property evidence area examined. Six of the 8 instruments reviewed had supporting construct validity/hypothesis-testing evidence of fair methodologic quality. There is a dearth of acceptable quality content validity, reliability, and responsiveness evidence for all 8 instruments. Rehabilitation practitioners assess financial management functions in adults with acquired cognitive impairments. However, there is limited published evidence to support using any of the reviewed instruments. Practitioners should exercise caution when interpreting the results of these instruments. This review highlights the importance of appraising the quality of measurement property evidence before examining the adequacy of the results and synthesizing the evidence. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  9. Assessment of the measurement properties of the post stroke motor function instruments available in Brazil: a systematic review.

    Science.gov (United States)

    Lima, Elaine; Teixeira-Salmela, Luci F; Simões, Luan; Guerra, Ana C C; Lemos, Andrea

    2016-03-15

    While there are several instruments in Brazil that measure motor function in patients after stroke, it is unknown whether the measurement properties of these instruments are appropriate. To identify the motor function instruments available in Brazil for patients after stroke. To assess the methodological quality of the studies and the results related to the measurement properties of these instruments. Two independent reviewers conducted searches on PubMed, LILACS, CINAHL, Web of Science, and Scopus. Studies that aimed to cross-culturally adapt an existing instrument or create a Brazilian instrument and test at least one measurement property related to motor function in patients after stroke were included. The methodological quality of these studies was checked by the COSMIN checklist with 4-point rating scale and the results of the measurement properties were analyzed by the criteria developed by Terwee et al. A total of 11 instruments were considered eligible, none of which were created in Brazil. The process of cross-cultural adaptation was inadequate in 10 out of 11 instruments due to the lack of back-translation or due to inappropriate target population. All of the instruments presented flaws in the measurement properties, especially reliability, internal consistency, and construct validity. The flaws observed in both cross-cultural adaptation process and testing measurement properties make the results inconclusive on the validity of the available instruments. Adequate procedures of cross-cultural adaptation and measurement properties of these instruments are strongly needed.

  10. Assessment of the measurement properties of the post stroke motor function instruments available in Brazil: a systematic review

    Directory of Open Access Journals (Sweden)

    Elaine Lima

    2016-01-01

    Full Text Available Background While there are several instruments in Brazil that measure motor function in patients after stroke, it is unknown whether the measurement properties of these instruments are appropriate. Objective To identify the motor function instruments available in Brazil for patients after stroke. To assess the methodological quality of the studies and the results related to the measurement properties of these instruments. Method Two independent reviewers conducted searches on PubMed, LILACS, CINAHL, Web of Science, and Scopus. Studies that aimed to cross-culturally adapt an existing instrument or create a Brazilian instrument and test at least one measurement property related to motor function in patients after stroke were included. The methodological quality of these studies was checked by the COSMIN checklist with 4-point rating scale and the results of the measurement properties were analyzed by the criteria developed by Terwee et al. Results A total of 11 instruments were considered eligible, none of which were created in Brazil. The process of cross-cultural adaptation was inadequate in 10 out of 11 instruments due to the lack of back-translation or due to inappropriate target population. All of the instruments presented flaws in the measurement properties, especially reliability, internal consistency, and construct validity. Conclusion The flaws observed in both cross-cultural adaptation process and testing measurement properties make the results inconclusive on the validity of the available instruments. Adequate procedures of cross-cultural adaptation and measurement properties of these instruments are strongly needed.

  11. Analyzing policy support instruments and regulatory risk factors for wind energy deployment-A developers' perspective

    Energy Technology Data Exchange (ETDEWEB)

    Luethi, Sonja, E-mail: sonja.luethi@unisg.ch [University of St. Gallen, 9000 St. Gallen (Switzerland); Praessler, Thomas [Potsdam Institute for Climate Impact Research (Germany)

    2011-09-15

    A transition to a renewable energy system is high on the policy agenda in many countries. A promising energy source for a low-carbon energy future is wind. Policy-makers can attract wind energy development by providing attractive policy frameworks. This paper argues that apart from the level of financial support, both the risks stemming from the regulatory environment (legal security, administrative process and grid access) and the ability to finance projects play a critical role in determining the attractiveness of the development environment. It sheds light on how project developers trade off these different aspects and to what extent the attractiveness of a certain policy framework increases with the introduction of specific measures. Conjoint analysis is employed to provide empirical evidence on the preference of wind energy developers in the EU and the US. The analysis shows that developers' preferences are very similar across the studied regions and for different types of developers. Which policy measures could be most valuable depends on the specific existing environment. In some southeastern European countries, a reduction of administrative process duration may yield the highest utility gains, whereas, in the US, improvements in grid access regulation and an increase in remuneration levels may be more effective. - Highlights: > Paper suggests conjoint analysis as scenario tool for estimating potential effects of specific policy measures. > It provides a quantitative, empirical dataset of 119 onshore wind energy developers' preferences. > Results suggest that the aspects 'Legal security' and 'Remuneration' are important attributes. > Cluster analyses yields slightly different preferences for developers from EU and US.

  12. Nuclear instrumentation and measurement: a review based on the ANIMMA conferences

    Science.gov (United States)

    Giot, Michel; Vermeeren, Ludo; Lyoussi, Abdallah; Reynard-Carette, Christelle; Lhuillier, Christian; Mégret, Patrice; Deconinck, Frank; Gonçalves, Bruno Soares

    2017-12-01

    The ANIMMA conferences offer a unique opportunity to discover research carried out in all fields of nuclear measurements and instrumentation with applications extending from fundamental physics to fission and fusion reactors, medical imaging, environmental protection and homeland security. After four successful editions of the Conference, it was decided to prepare a review based to a large extent but not exclusively on the papers presented during the first four editions of the conference. This review is organized according to the measurement methodologies: neutronic, photonic, thermal, acoustic and optical measurements, as well as medical imaging and specific challenges linked to data acquisition and electronic hardening. The paper describes the main challenges justifying research in these different areas, and summarizes the recent progress reported. It offers researchers and engineers a way to quickly and efficiently access knowledge in highly specialized areas.

  13. 76 FR 13549 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-03-14

    ...'s regulatory program more effective and less burdensome in achieving its regulatory objectives by... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Chapter IX 50 CFR.... 13563 AGENCY: National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Request for...

  14. A historical review of portable health physics instruments and their use in radiation protection programs at Hanford, 1944 through 1988

    Energy Technology Data Exchange (ETDEWEB)

    Howell, W.P.; Kenoyer, J.L.; Kress, M.L.; Swinth, K.L.; Corbit, C.D.; Zuerner, L.V.; Fleming, D.M.; DeHaven, H.W.

    1989-09-01

    This historical review covers portable health physics instruments at Hanford from an applications viewpoint. The review provides information on specific instruments and on the general kinds of facility work environments in which the instruments have been and are being used. It provides a short, modestly technical explanation of the types of nuclear radiations, the way radiation units are quantified, and the types of nuclear radiations, the way radiation units are quantified, and the types of detection media used in portable health physics instruments. This document does not, however, cover the history of the entire Hanford program that was required to develop and/or modify the subject instruments. 11 refs., 34 figs., 2 tabs.

  15. A historical review of portable health physics instruments and their use in radiation protection programs at Hanford, 1944 through 1988

    International Nuclear Information System (INIS)

    Howell, W.P.; Kenoyer, J.L.; Kress, M.L.; Swinth, K.L.; Corbit, C.D.; Zuerner, L.V.; Fleming, D.M.; DeHaven, H.W.

    1989-09-01

    This historical review covers portable health physics instruments at Hanford from an applications viewpoint. The review provides information on specific instruments and on the general kinds of facility work environments in which the instruments have been and are being used. It provides a short, modestly technical explanation of the types of nuclear radiations, the way radiation units are quantified, and the types of nuclear radiations, the way radiation units are quantified, and the types of detection media used in portable health physics instruments. This document does not, however, cover the history of the entire Hanford program that was required to develop and/or modify the subject instruments. 11 refs., 34 figs., 2 tabs

  16. A review of psychological assessment instruments for use in bariatric surgery evaluations.

    Science.gov (United States)

    Marek, Ryan J; Heinberg, Leslie J; Lavery, Megan; Merrell Rish, Julie; Ashton, Kathleen

    2016-09-01

    Bariatric surgery is a viable treatment option for patients with extreme obesity and associated medical comorbidities; however, optimal surgical outcomes are not universal. Surgical societies, such as the American Society for Metabolic and Bariatric Surgery (ASMBS), recommend that patients undergo a presurgical psychological evaluation that includes reviewing patients' medical charts, conducting a comprehensive clinical interview, and employing some form of objective psychometric testing. Despite numerous societies recommending the inclusion of self-report assessments, only about 2/3 of clinics actively use psychological testing-some of which have limited empirical support to justify their use. This review aims to critically evaluate the psychometric properties of self-report measures when used in bariatric surgery settings and provide recommendations to help guide clinicians in selecting instruments to use in bariatric surgery evaluations. Recommended assessment batteries include use of a broadband instrument along with a narrowband eating measure. Suggestions for self-report measures to include in a presurgical psychological evaluation in bariatric surgery settings are also provided. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  17. Outlines and Outcomes of Instrumented Posterior Fusion in the Pediatric Cervical Spine: A Review Article

    Directory of Open Access Journals (Sweden)

    Kaveh Haddadi

    2016-01-01

    Full Text Available Context The most common source of cervical spine arthrodesis in the pediatric populace is the instability related to congenital or traumatic damage. Surgery of cervical spine can be challenging given slighter anatomical constructions, fewer hardened bone, and upcoming growth potential and growth. Evidence Acquisition Trainings in adult patients recommended that consuming screw constructs results in enhanced consequences with inferior amounts of instrumentation catastrophe. But, the pediatric literature is inadequate for minor retrospective series. Authors reviewed the existing pediatric cervical spine arthrodesis literature. They studied 184 abstracts from January 1976 to December 2014. An entire of 883 patients in 82 articles were involved in the evaluation. Patients were characterized as taking either posterior cervical fusion with wiring or posterior cervical fusion with screws or occipitocervical fusion. Results The etiologies faced most frequently were inherited abnormalities (54% shadowed by trauma (28%, Down syndrome (8%, and infectious, oncological, iatrogenic, or mixed causes (10%. The mean duration of follow-up was 32.5 months. Conclusions The consequences of this training are restricted by deviations in construct policy, usage of orthoses, follow-up period and fresher adjuvant produces stimulating fusions. But, a literature review recommend that instrumentation of the cervical spine in children may be harmless and more effective than using screw concepts rather than wiring methods.

  18. Nuclear Regulatory Commission staff development of the license application review plan for a high-level radioactive waste repository

    International Nuclear Information System (INIS)

    Johnson, R.L.; Holonich, J.J.; Lee, M.P.; Delligatti, M.S.

    1993-01-01

    The Nuclear Regulatory Commission staff has recently started a new initiative to develop the License Application Review Plan (LARP) which the staff will use in its reviews of the U.S. Department of Energy's (DOE's) license application (LA) for a geologic repository for the disposal of high-level radioactive waste (HLW). This paper describes the staff's approach for developing the LARP, the development schedule and current status, the organization and content of the LARP, and the staff's LA review strategy. Therefore, it gives a preview of the draft LARP which will be made available in late 1993. It also describes how the LARP will be used as guidance to the staff in conducting reviews of regulatory and technical issues important to the licensing of a geologic repository. Finally, the benefits to the NRC staff, DOE, and other parties are discussed

  19. Review and evaluation of the Nuclear Regulatory Commission safety research program for Fiscal Year 1983. Report to the Congress

    International Nuclear Information System (INIS)

    1982-02-01

    Public Law 95-209 includes a requirement that the Advisory Committee on Reactor Safeguards submit an annual report to Congress on the safety research program of the Nuclear Regulatory Commission. This report presents the results of the ACRS review and evaluation of the NRC safety research program for Fiscal Year 1983. The report contains a number of comments and recommendations

  20. 75 FR 34749 - Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent...

    Science.gov (United States)

    2010-06-18

    ... and FDA-2008-E-0267] Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040 AGENCY: Food and Drug Administration, HHS. ACTION... determination because of the submission of applications to the Director of Patents and Trademarks, Department of...

  1. Standard Review Plan for a petition for rulemaking on radioactive waste streams below regulatory concern: Expedited review in accordance with Appendix B to 10 CFR, Part 2

    International Nuclear Information System (INIS)

    Larkins, P.M.

    1989-10-01

    The Standard Review Plan (SRP) provides guidance to staff reviewers acting on rulemaking petitions in an expeditious manner to exempt from regulation radioactive waste determined to be Below Regulatory Concern (BRC), as called for in the Low-Level Radioactive Waste Policy Amendments Act of 1985. The review plan is designed to ensure the quality and uniformity of staff reviews and to present a well-defined basis for the staff's evaluation of BRC petitions. The plan serves to improve the understanding of the staff's review by interested members of the public and the industry. It also provides information about the BRC rulemaking process to a wider audience. 6 refs., 7 figs

  2. Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective.

    Science.gov (United States)

    Sheets, Rebecca L; Zhou, TieQun; Knezevic, Ivana

    2016-03-01

    Clinical development of prophylactic HIV/AIDS vaccines presents many scientific challenges that result in challenges for regulators reviewing clinical trial applications (CTAs). The World Health Organization (WHO) has the responsibility to provide technical support to these regulators. The search for an HIV/AIDS vaccine will only succeed through well-designed, -conducted and -controlled human efficacy studies reviewed and approved by regulators in countries worldwide, particularly in countries where the epidemic has hit hardest, such as in sub-Saharan Africa and Asia. This review summarizes the current candidates in development and focuses on challenges regulators face when reviewing CTAs, such as the evolving landscape of "standard of prevention," trials in adolescents, adaptive trial designs, correlates of protection and their analysis, and access to successful vaccines. There are many unknowns in the field of HIV/AIDS vaccine development and often, there is not a clear right or wrong approach because of the scientific challenges described in this review. Consequently, regulators should not feel that decisions need be made in isolation, when there are many available international collaborative efforts and opportunities to seek expert advice. The WHO provides many such opportunities and support to regulators across the globe. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review

    Science.gov (United States)

    Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

    2017-01-01

    Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine. PMID:29629018

  4. The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review.

    Science.gov (United States)

    Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

    2017-01-01

    Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.

  5. Factor analysis methods and validity evidence: A systematic review of instrument development across the continuum of medical education

    Science.gov (United States)

    Wetzel, Angela Payne

    Previous systematic reviews indicate a lack of reporting of reliability and validity evidence in subsets of the medical education literature. Psychology and general education reviews of factor analysis also indicate gaps between current and best practices; yet, a comprehensive review of exploratory factor analysis in instrument development across the continuum of medical education had not been previously identified. Therefore, the purpose for this study was critical review of instrument development articles employing exploratory factor or principal component analysis published in medical education (2006--2010) to describe and assess the reporting of methods and validity evidence based on the Standards for Educational and Psychological Testing and factor analysis best practices. Data extraction of 64 articles measuring a variety of constructs that have been published throughout the peer-reviewed medical education literature indicate significant errors in the translation of exploratory factor analysis best practices to current practice. Further, techniques for establishing validity evidence tend to derive from a limited scope of methods including reliability statistics to support internal structure and support for test content. Instruments reviewed for this study lacked supporting evidence based on relationships with other variables and response process, and evidence based on consequences of testing was not evident. Findings suggest a need for further professional development within the medical education researcher community related to (1) appropriate factor analysis methodology and reporting and (2) the importance of pursuing multiple sources of reliability and validity evidence to construct a well-supported argument for the inferences made from the instrument. Medical education researchers and educators should be cautious in adopting instruments from the literature and carefully review available evidence. Finally, editors and reviewers are encouraged to recognize

  6. Mild cognitive impairment and deficits in instrumental activities of daily living: a systematic review.

    Science.gov (United States)

    Jekel, Katrin; Damian, Marinella; Wattmo, Carina; Hausner, Lucrezia; Bullock, Roger; Connelly, Peter J; Dubois, Bruno; Eriksdotter, Maria; Ewers, Michael; Graessel, Elmar; Kramberger, Milica G; Law, Emma; Mecocci, Patrizia; Molinuevo, José L; Nygård, Louise; Olde-Rikkert, Marcel Gm; Orgogozo, Jean-Marc; Pasquier, Florence; Peres, Karine; Salmon, Eric; Sikkes, Sietske Am; Sobow, Tomasz; Spiegel, René; Tsolaki, Magda; Winblad, Bengt; Frölich, Lutz

    2015-01-01

    There is a growing body of evidence that subtle deficits in instrumental activities of daily living (IADL) may be present in mild cognitive impairment (MCI). However, it is not clear if there are IADL domains that are consistently affected across patients with MCI. In this systematic review, therefore, we aimed to summarize research results regarding the performance of MCI patients in specific IADL (sub)domains compared with persons who are cognitively normal and/or patients with dementia. The databases PsycINFO, PubMed and Web of Science were searched for relevant literature in December 2013. Publications from 1999 onward were considered for inclusion. Altogether, 497 articles were retrieved. Reference lists of selected articles were searched for potentially relevant articles. After screening the abstracts of these 497 articles, 37 articles were included in this review. In 35 studies, IADL deficits (such as problems with medication intake, telephone use, keeping appointments, finding things at home and using everyday technology) were documented in patients with MCI. Financial capacity in patients with MCI was affected in the majority of studies. Effect sizes for group differences between patients with MCI and healthy controls were predominantly moderate to large. Performance-based instruments showed slight advantages (in terms of effect sizes) in detecting group differences in IADL functioning between patients with MCI, patients with Alzheimer's disease and healthy controls. IADL requiring higher neuropsychological functioning seem to be most severely affected in patients with MCI. A reliable identification of such deficits is necessary, as patients with MCI with IADL deficits seem to have a higher risk of converting to dementia than patients with MCI without IADL deficits. The use of assessment tools specifically designed and validated for patients with MCI is therefore strongly recommended. Furthermore, the development of performance-based assessment instruments

  7. Instruments to assess patients with rotator cuff pathology: a systematic review of measurement properties.

    Science.gov (United States)

    Longo, Umile Giuseppe; Saris, Daniël; Poolman, Rudolf W; Berton, Alessandra; Denaro, Vincenzo

    2012-10-01

    The aims of this study were to obtain an overview of the methodological quality of studies on the measurement properties of rotator cuff questionnaires and to describe how well various aspects of the design and statistical analyses of studies on measurement properties are performed. A systematic review of published studies on the measurement properties of rotator cuff questionnaires was performed. Two investigators independently rated the quality of the studies using the Consensus-based Standards for the selection of health Measurement Instruments checklist. This checklist was developed in an international Delphi consensus study. Sixteen studies were included, in which two measurement instruments were evaluated, namely the Western Ontario Rotator Cuff Index and the Rotator Cuff Quality-of-Life Measure. The methodological quality of the included studies was adequate on some properties (construct validity, reliability, responsiveness, internal consistency, and translation) but need to be improved on other aspects. The most important methodological aspects that need to be developed are as follows: measurement error, content validity, structural validity, cross-cultural validity, criterion validity, and interpretability. Considering the importance of adequate measurement properties, it is concluded that, in the field of rotator cuff pathology, there is room for improvement in the methodological quality of studies measurement properties. II.

  8. Seismic isolation of Advanced LIGO: Review of strategy, instrumentation and performance

    International Nuclear Information System (INIS)

    Matichard, F; Mittleman, R; Mason, K; Biscans, S; Barnum, S; Evans, M; Foley, S; Lantz, B; Celerier, C; Clark, D; DeBra, D; Kissel, J; Allwine, E; Abbott, B; Abbott, R; Abbott, S; Coyne, D; McIver, J; Birch, J; DeRosa, R

    2015-01-01

    The new generation of gravitational waves detectors require unprecedented levels of isolation from seismic noise. This article reviews the seismic isolation strategy and instrumentation developed for the Advanced LIGO observatories. It summarizes over a decade of research on active inertial isolation and shows the performance recently achieved at the Advanced LIGO observatories. The paper emphasizes the scientific and technical challenges of this endeavor and how they have been addressed. An overview of the isolation strategy is given. It combines multiple layers of passive and active inertial isolation to provide suitable rejection of seismic noise at all frequencies. A detailed presentation of the three active platforms that have been developed is given. They are the hydraulic pre-isolator, the single-stage internal isolator and the two-stage internal isolator. The architecture, instrumentation, control scheme and isolation results are presented for each of the three systems. Results show that the seismic isolation sub-system meets Advanced LIGO’s stringent requirements and robustly supports the operation of the two detectors. (paper)

  9. Inflammatory bowel disease-specific health-related quality of life instruments: a systematic review of measurement properties.

    Science.gov (United States)

    Chen, Xin-Lin; Zhong, Liang-Huan; Wen, Yi; Liu, Tian-Wen; Li, Xiao-Ying; Hou, Zheng-Kun; Hu, Yue; Mo, Chuan-Wei; Liu, Feng-Bin

    2017-09-15

    This review aims to critically appraise and compare the measurement properties of inflammatory bowel disease (IBD)-specific health-related quality of life instruments. Medline, EMBASE and ISI Web of Knowledge were searched from their inception to May 2016. IBD-specific instruments for patients with Crohn's disease, ulcerative colitis or IBD were enrolled. The basic characteristics and domains of the instruments were collected. The methodological quality of measurement properties and measurement properties of the instruments were assessed. Fifteen IBD-specific instruments were included, which included twelve instruments for adult IBD patients and three for paediatric IBD patients. All of the instruments were developed in North American and European countries. The following common domains were identified: IBD-related symptoms, physical, emotional and social domain. The methodological quality was satisfactory for content validity; fair in internal consistency, reliability, structural validity, hypotheses testing and criterion validity; and poor in measurement error, cross-cultural validity and responsiveness. For adult IBD patients, the IBDQ-32 and its short version (SIBDQ) had good measurement properties and were the most widely used worldwide. For paediatric IBD patients, the IMPACT-III had good measurement properties and had more translated versions. Most methodological quality should be promoted, especially measurement error, cross-cultural validity and responsiveness. The IBDQ-32 was the most widely used instrument with good reliability and validity, followed by the SIBDQ and IMPACT-III. Further validation studies are necessary to support the use of other instruments.

  10. A review of instrumentation for determination of radon and its daughters concentration

    International Nuclear Information System (INIS)

    Kurosawa, Ryuhei

    1989-01-01

    The aim of the review is to provide the aid for selection and understanding of the radon and its daughters measurement techniques which have been developed for radiation protection activities in various environments such as working of living environment. The practical purpose of the measurement for surveillance in environmental situation is the dose estimation for the public due to the inhalation of natural occurring radioactive materials. The techniques for the determination of radon and thoron concentratin by the active methods with the grab and continuous sampling, and also structures of radon monitors of various passive type are described. Explanation was made on the typical instruments for the determination of the potential alpha energy concentration (PAEC) of radon daughters by the various detecting systems such as solid state detector, and for the estimation of integrated PAEC in the various environments by the PAEC monitors using the cellulose nitrate film or TLD elements (author)

  11. A review of modern instrumental techniques for measurements of ice cream characteristics.

    Science.gov (United States)

    Bahram-Parvar, Maryam

    2015-12-01

    There is an increasing demand of the food industries and research institutes to have means of measurement allowing the characterization of foods. Ice cream, as a complex food system, consists of a frozen matrix containing air bubbles, fat globules, ice crystals, and an unfrozen serum phase. Some deficiencies in conventional methods for testing this product encourage the use of alternative techniques such as rheometry, spectroscopy, X-ray, electro-analytical techniques, ultrasound, and laser. Despite the development of novel instrumental applications in food science, use of some of them in ice cream testing is few, but has shown promising results. Developing the novel methods should increase our understanding of characteristics of ice cream and may allow online testing of the product. This review article discusses the potential of destructive and non-destructive methodologies in determining the quality and characteristics of ice cream and similar products. Copyright © 2015. Published by Elsevier Ltd.

  12. A review of instruments to measure interprofessional collaboration for chronic disease management for community-living older adults.

    Science.gov (United States)

    Bookey-Bassett, Sue; Markle-Reid, Maureen; McKey, Colleen; Akhtar-Danesh, Noori

    2016-01-01

    It is acknowledged internationally that chronic disease management (CDM) for community-living older adults (CLOA) is an increasingly complex process. CDM for older adults, who are often living with multiple chronic conditions, requires coordination of various health and social services. Coordination is enabled through interprofessional collaboration (IPC) among individual providers, community organizations, and health sectors. Measuring IPC is complicated given there are multiple conceptualisations and measures of IPC. A literature review of several healthcare, psychological, and social science electronic databases was conducted to locate instruments that measure IPC at the team level and have published evidence of their reliability and validity. Five instruments met the criteria and were critically reviewed to determine their strengths and limitations as they relate to CDM for CLOA. A comparison of the characteristics, psychometric properties, and overall concordance of each instrument with salient attributes of IPC found the Collaborative Practice Assessment Tool to be the most appropriate instrument for measuring IPC for CDM in CLOA.

  13. Patient-Reported Outcome Measures in Dysphagia: A Systematic Review of Instrument Development and Validation

    Science.gov (United States)

    Patel, Dhyanesh A.; Sharda, Rohit; Hovis, Kristen L.; Nichols, Erin E.; Sathe, Nila; Penson, David F.; Feurer, Irene D.; McPheeters, Melissa L.; Vaezi, Michael F.; Francis, David O.

    2017-01-01

    Objective Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to 1) identify all currently available measures and 2) to evaluate each for the presence of important measurement properties that would affect their applicability. Design MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: 1) conceptual model, 2) content validity, 3) reliability, 4) construct validity, 6) scoring and interpretation, and 7) burden and presentation. Results Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987 – 2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson’s disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: 1) direct patient involvement in content development, 2) empirically justified dimensionality, 3) demonstrable responsiveness to change, 4) plan for interpreting missing responses, and 5) literacy level assessment. Conclusion This is the first comprehensive systematic review assessing developmental properties of all available dysphagia

  14. Patient-reported outcome measures in dysphagia: a systematic review of instrument development and validation.

    Science.gov (United States)

    Patel, D A; Sharda, R; Hovis, K L; Nichols, E E; Sathe, N; Penson, D F; Feurer, I D; McPheeters, M L; Vaezi, M F; Francis, David O

    2017-05-01

    Patient-reported outcome (PRO) measures are commonly used to capture patient experience with dysphagia and to evaluate treatment effectiveness. Inappropriate application can lead to distorted results in clinical studies. A systematic review of the literature on dysphagia-related PRO measures was performed to (1) identify all currently available measures and (2) to evaluate each for the presence of important measurement properties that would affect their applicability. MEDLINE via the PubMed interface, the Cumulative Index of Nursing and Allied Health Literature, and the Health and Psychosocial Instrument database were searched using relevant vocabulary terms and key terms related to PRO measures and dysphagia. Three independent investigators performed abstract and full text reviews. Each study meeting criteria was evaluated using an 18-item checklist developed a priori that assessed multiple domains: (1) conceptual model, (2) content validity, (3) reliability, (4) construct validity, (6) scoring and interpretation, and (7) burden and presentation. Of 4950 abstracts reviewed, a total of 34 dysphagia-related PRO measures (publication year 1987-2014) met criteria for extraction and analysis. Several PRO measures were of high quality (MADS for achalasia, SWAL-QOL and SSQ for oropharyngeal dysphagia, PROMIS-GI for general dysphagia, EORTC-QLQ-OG25 for esophageal cancer, ROMP-swallowing for Parkinson's Disease, DSQ-EoE for eosinophilic esophagitis, and SOAL for total laryngectomy-related dysphagia). In all, 17 met at least one criterion per domain. Thematic deficiencies in current measures were evident including: (1) direct patient involvement in content development, (2) empirically justified dimensionality, (3) demonstrable responsiveness to change, (4) plan for interpreting missing responses, and (5) literacy level assessment. This is the first comprehensive systematic review assessing developmental properties of all available dysphagia-related PRO measures. We

  15. Economic instruments for obesity prevention: results of a scoping review and modified delphi survey

    Directory of Open Access Journals (Sweden)

    LaFrance Jeffrey

    2011-10-01

    Full Text Available Abstract Background Comprehensive, multi-level approaches are required to address obesity. One important target for intervention is the economic domain. The purpose of this study was to synthesize existing evidence regarding the impact of economic policies targeting obesity and its causal behaviours (diet, physical activity, and to make specific recommendations for the Canadian context. Methods Arksey and O'Malley's (2005 methodological framework for conducting scoping reviews was adopted for this study and this consisted of two phases: 1 a structured literature search and review, and 2 consultation with experts in the research field through a Delphi survey and an in-person expert panel meeting in April 2010. Results Two key findings from the scoping review included 1 consistent evidence that weight outcomes are responsive to food and beverage prices. The debate on the use of food taxes and subsidies to address obesity should now shift to how best to address practical issues in designing such policies; and 2 very few studies have examined the impact of economic instruments to promote physical activity and clear policy recommendations cannot be made at this time. Delphi survey findings emphasised the relatively modest impact any specific economic instrument would have on obesity independently. Based on empirical evidence and expert opinion, three recommendations were supported. First, to create and implement an effective health filter to review new and current agricultural polices to reduce the possibility that such policies have a deleterious impact on population rates of obesity. Second, to implement a caloric sweetened beverage tax. Third, to examine how to implement fruit and vegetable subsidies targeted at children and low income households. Conclusions In terms of economic interventions, shifting from empirical evidence to policy recommendation remains challenging. Overall, the evidence is not sufficiently strong to provide clear policy

  16. Advanced Instrumentation, Information, and Control Systems Technologies Pathway: FY 2016 External Review

    Energy Technology Data Exchange (ETDEWEB)

    Thomas, Kenneth David [Idaho National Lab. (INL), Idaho Falls, ID (United States); Hallbert, Bruce Perry [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2016-11-01

    This report describes an External Review conducted by the LWRS Program Advanced Instrumentation, Information, and Control (II&C) Systems Technologies Pathway to solicit feedback on the topics and results of the ongoing II&C research program. This review was held in conjunction with the Nuclear Energy Institute (NEI) Digital I&C Working Group meeting that was held at Idaho National Laboratory (INL) on August 9-10, 2016. Given the opportunity to visit INL and see the pathway research projects, NEI agreed that the Working Group would serve as the External Review panel for the purpose of obtaining expert input on the value and timing of the research projects. This consisted of demonstrations in the Human Systems Simulation Laboratory followed by presentations on the II&C research program in general as well as the five technology development areas. Following the meeting, the presentations were sent to each of the attendees so they could review them in more detail and refer to them in completing the feedback form. Follow-up activities were conducted with the attendees following the meeting to obtain the completed feedback forms. A total of 13 forms were returned. The feedback forms were reviewed by the pathway to compile the data and comments received, which are documented in the report. In all, the feedback provided by the External Review participants is taken to be a strong endorsement of the types of projects being conducted by the pathway, the value they hold for the nuclear plants, and the general timing of need. The feedback aligns well with the priorities, levels of efforts allocated for the research projects, and project schedules. The feedback also represents realistic observations on the practicality of some aspects of implementing these technologies. In some cases, the participants provided thoughtful challenges to certain assumptions in the formulation of the technologies or in deployment plans. These deserve further review and revision of plans if warranted

  17. Advanced Instrumentation, Information, and Control Systems Technologies Pathway: FY 2016 External Review

    International Nuclear Information System (INIS)

    Thomas, Kenneth David; Hallbert, Bruce Perry

    2016-01-01

    This report describes an External Review conducted by the LWRS Program Advanced Instrumentation, Information, and Control (II&C) Systems Technologies Pathway to solicit feedback on the topics and results of the ongoing II&C research program. This review was held in conjunction with the Nuclear Energy Institute (NEI) Digital I&C Working Group meeting that was held at Idaho National Laboratory (INL) on August 9-10, 2016. Given the opportunity to visit INL and see the pathway research projects, NEI agreed that the Working Group would serve as the External Review panel for the purpose of obtaining expert input on the value and timing of the research projects. This consisted of demonstrations in the Human Systems Simulation Laboratory followed by presentations on the II&C research program in general as well as the five technology development areas. Following the meeting, the presentations were sent to each of the attendees so they could review them in more detail and refer to them in completing the feedback form. Follow-up activities were conducted with the attendees following the meeting to obtain the completed feedback forms. A total of 13 forms were returned. The feedback forms were reviewed by the pathway to compile the data and comments received, which are documented in the report. In all, the feedback provided by the External Review participants is taken to be a strong endorsement of the types of projects being conducted by the pathway, the value they hold for the nuclear plants, and the general timing of need. The feedback aligns well with the priorities, levels of efforts allocated for the research projects, and project schedules. The feedback also represents realistic observations on the practicality of some aspects of implementing these technologies. In some cases, the participants provided thoughtful challenges to certain assumptions in the formulation of the technologies or in deployment plans. These deserve further review and revision of plans if warranted

  18. A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers.

    Science.gov (United States)

    Henry, Barbara J; Carlin, Joseph P; Hammerschmidt, Jon A; Buck, Robert C; Buxton, L William; Fiedler, Heidelore; Seed, Jennifer; Hernandez, Oscar

    2018-05-01

    Per- and polyfluoroalkyl substances (PFAS) are a group of fluorinated substances that are in the focus of researchers and regulators due to widespread presence in the environment and biota, including humans, of perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA). Fluoropolymers, high molecular weight polymers, have unique properties that constitute a distinct class within the PFAS group. Fluoropolymers have thermal, chemical, photochemical, hydrolytic, oxidative, and biological stability. They have negligible residual monomer and oligomer content and low to no leachables. Fluoropolymers are practically insoluble in water and not subject to long-range transport. With a molecular weight well over 100 000 Da, fluoropolymers cannot cross the cell membrane. Fluoropolymers are not bioavailable or bioaccumulative, as evidenced by toxicology studies on polytetrafluoroethylene (PTFE): acute and subchronic systemic toxicity, irritation, sensitization, local toxicity on implantation, cytotoxicity, in vitro and in vivo genotoxicity, hemolysis, complement activation, and thrombogenicity. Clinical studies of patients receiving permanently implanted PTFE cardiovascular medical devices demonstrate no chronic toxicity or carcinogenicity and no reproductive, developmental, or endocrine toxicity. This paper brings together fluoropolymer toxicity data, human clinical data, and physical, chemical, thermal, and biological data for review and assessment to show that fluoropolymers satisfy widely accepted assessment criteria to be considered as "polymers of low concern" (PLC). This review concludes that fluoropolymers are distinctly different from other polymeric and nonpolymeric PFAS and should be separated from them for hazard assessment or regulatory purposes. Grouping fluoropolymers with all classes of PFAS for "read across" or structure-activity relationship assessment is not scientifically appropriate. Integr Environ Assess Manag 2018;14:316-334. © 2018 The Authors

  19. A systematic review of instruments for assessing parent satisfaction with family-centred care in neonatal intensive care units.

    Science.gov (United States)

    Dall'Oglio, Immacolata; Mascolo, Rachele; Gawronski, Orsola; Tiozzo, Emanuela; Portanova, Anna; Ragni, Angela; Alvaro, Rosaria; Rocco, Gennaro; Latour, Jos M

    2018-03-01

    This systematic review synthesised and described instruments measuring parent satisfaction with the increasing standard practice of family-centred care (FCC) in neonatal intensive care units. We evaluated 11 studies published from January 2006 to March 2016: two studies validated a parent satisfaction questionnaire, and nine developed or modified previous questionnaires to use as outcome measures in their local settings. Most instruments were not tested on reliability and validity. Only two validated instruments included all six of the FCC principles and could assess parent satisfaction with FCC in neonatal intensive care units and be considered as outcome indicators for further research. ©2017 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  20. Evaluating the Impact of Radio Frequency Identification Retained Surgical Instruments Tracking on Patient Safety: Literature Review.

    Science.gov (United States)

    Schnock, Kumiko O; Biggs, Bonnie; Fladger, Anne; Bates, David W; Rozenblum, Ronen

    2017-02-22

    Retained surgical instruments (RSI) are one of the most serious preventable complications in operating room settings, potentially leading to profound adverse effects for patients, as well as costly legal and financial consequences for hospitals. Safety measures to eliminate RSIs have been widely adopted in the United States and abroad, but despite widespread efforts, medical errors with RSI have not been eliminated. Through a systematic review of recent studies, we aimed to identify the impact of radio frequency identification (RFID) technology on reducing RSI errors and improving patient safety. A literature search on the effects of RFID technology on RSI error reduction was conducted in PubMed and CINAHL (2000-2016). Relevant articles were selected and reviewed by 4 researchers. After the literature search, 385 articles were identified and the full texts of the 88 articles were assessed for eligibility. Of these, 5 articles were included to evaluate the benefits and drawbacks of using RFID for preventing RSI-related errors. The use of RFID resulted in rapid detection of RSI through body tissue with high accuracy rates, reducing risk of counting errors and improving workflow. Based on the existing literature, RFID technology seems to have the potential to substantially improve patient safety by reducing RSI errors, although the body of evidence is currently limited. Better designed research studies are needed to get a clear understanding of this domain and to find new opportunities to use this technology and improve patient safety.

  1. Quality of life instruments for economic evaluations in health and social care for older people: a systematic review.

    Science.gov (United States)

    Makai, Peter; Brouwer, Werner B F; Koopmanschap, Marc A; Stolk, Elly A; Nieboer, Anna P

    2014-02-01

    Gaining health may not be the main goal of healthcare services aimed at older people, which may (also) seek to improve wellbeing. This emphasizes the need of finding appropriate outcome measures for economic evaluation of such services, particularly in long-term care, capturing more than only health-related quality of life (HrQol). This review assesses the usefulness of HrQol and wellbeing instruments for economic evaluations specifically aimed at older people, focusing on generic and preference-based questionnaires measuring wellbeing in particular. We systematically searched six databases and extracted instruments used to assess HrQol and wellbeing outcomes. Instruments were compared based on their usefulness for economic evaluation of services aimed at older people (dimensions measured, availability of utility scores, extent of validation). We identified 487 articles using 34 generic instruments: 22 wellbeing (two of which were preference-based) and 11 HrQol instruments. While standard HrQol instruments measure physical, social and psychological dimensions, wellbeing instruments contain additional dimensions such as purpose in life and achievement, security, and freedom. We found four promising wellbeing instruments for inclusion in economic evaluation: Ferrans and Powers QLI and the WHO-Qol OLD, ICECAP-O and the ASCOT. Ferrans and Powers QLI and the WHO-Qol OLD are widely validated but lack preference-weights while for ICECAP-O and the ASCOT preference-weights are available, but are less widely validated. Until preference-weights are available for the first two instruments, the ICECAP-O and the ASCOT currently appear to be the most useful instruments for economic evaluations in services aimed at older people. Their limitations are that (1) health dimensions may be captured only partially and (2) the instruments require further validation. Therefore, we currently recommend using the ICECAP-O or the ASCOT alongside the EQ-5D or SF-6D when evaluating interventions

  2. A Technological Review of the Instrumented Footwear for Rehabilitation with a Focus on Parkinson’s Disease Patients

    DEFF Research Database (Denmark)

    Maculewicz, Justyna; Kofoed, Lise; Serafin, Stefania

    2016-01-01

    In this review article, we summarize systems for gait rehabilitation based on instrumented footwear and present a context of their usage in Parkinson’s disease (PD) patients’ auditory and haptic rehabilitation. We focus on the needs of PD patients, but since only a few systems were made with this......In this review article, we summarize systems for gait rehabilitation based on instrumented footwear and present a context of their usage in Parkinson’s disease (PD) patients’ auditory and haptic rehabilitation. We focus on the needs of PD patients, but since only a few systems were made...

  3. Content Validity of Patient-Reported Outcome Instruments used with Pediatric Patients with Facial Differences: A Systematic Review.

    Science.gov (United States)

    Wickert, Natasha M; Wong Riff, Karen W Y; Mansour, Mark; Forrest, Christopher R; Goodacre, Timothy E E; Pusic, Andrea L; Klassen, Anne F

    2018-01-01

    Objective The aim of this systematic review was to identify patient-reported outcome (PRO) instruments used in research with children/youth with conditions associated with facial differences to identify the health concepts measured. Design MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from 2004 to 2016 to identify PRO instruments used in acne vulgaris, birthmarks, burns, ear anomalies, facial asymmetries, and facial paralysis patients. We performed a content analysis whereby the items were coded to identify concepts and categorized as positive or negative content or phrasing. Results A total of 7,835 articles were screened; 6 generic and 11 condition-specific PRO instruments were used in 96 publications. Condition-specific instruments were for acne (four), oral health (two), dermatology (one), facial asymmetries (two), microtia (one), and burns (one). The PRO instruments provided 554 items (295 generic; 259 condition specific) that were sorted into 4 domains, 11 subdomains, and 91 health concepts. The most common domain was psychological (n = 224 items). Of the identified items, 76% had negative content or phrasing (e.g., "Because of the way my face looks I wish I had never been born"). Given the small number of items measuring facial appearance (n = 19) and function (n = 22), the PRO instruments reviewed lacked content validity for patients whose condition impacted facial function and/or appearance. Conclusions Treatments can change facial appearance and function. This review draws attention to a problem with content validity in existing PRO instruments. Our team is now developing a new PRO instrument called FACE-Q Kids to address this problem.

  4. Assessment of the wish to hasten death in patients with advanced disease: A systematic review of measurement instruments.

    Science.gov (United States)

    Bellido-Pérez, Mercedes; Monforte-Royo, Cristina; Tomás-Sábado, Joaquín; Porta-Sales, Josep; Balaguer, Albert

    2017-06-01

    Patients with advanced conditions may present a wish to hasten death. Assessing this wish is complex due to the nature of the phenomenon and the difficulty of conceptualising it. To identify and analyse existing instruments for assessing the wish to hasten death and to rate their reported psychometric properties. Systematic review based on PRISMA guidelines. The COnsensus-based Standards for the selection of health Measurement INstruments checklist was used to evaluate the methodological quality of validation studies and the measurement properties of the instrument described. The CINAHL, PsycINFO, Pubmed and Web of Science databases were searched from inception to November 2015. A total of 50 articles involving assessment of the wish to hasten death were included. Eight concerned instrument validation and were evaluated using COnsensus-based Standards for the selection of health Measurement INstruments criteria. They reported data for between two and seven measurement properties, with ratings between fair and excellent. Of the seven instruments identified, the Desire for Death Rating Scale or the Schedule of Attitudes toward Hastened Death feature in 48 of the 50 articles. The Schedule of Attitudes toward Hastened Death is the most widely used and is the instrument whose psychometric properties have been most often analysed. Versions of the Schedule of Attitudes toward Hastened Death are available in five languages other than the original English. This systematic review has analysed existing instruments for assessing the wish to hasten death. It has also explored the methodological quality of studies that have examined the measurement properties of these instruments and offers ratings of the reported properties. These results will be useful to clinicians and researchers with an interest in a phenomenon of considerable relevance to advanced patients.

  5. 76 FR 39234 - Federal Acquisition Regulation; Unique Procurement Instrument Identifier

    Science.gov (United States)

    2011-07-05

    ..., therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated... for procurement actions, such as delivery and task orders or basic ordering agreements, the order or... Instrument Identifier (PIID). Agencies shall have in place a process that ensures that each PIID reported to...

  6. Implementation outcome assessment instruments used in physical healthcare settings and their measurement properties: a systematic review protocol

    Science.gov (United States)

    Vitoratou, Silia; Sevdalis, Nick; Hull, Louise

    2017-01-01

    Introduction Over the past 10 years, research into methods that promote the uptake, implementation and sustainability of evidence-based interventions has gathered pace. However, implementation outcomes are defined in different ways and assessed by different measures; the extent to which these measures are valid and reliable is unknown. The aim of this systematic review is to identify and appraise studies that assess the measurement properties of quantitative implementation outcome instruments used in physical healthcare settings, to advance the use of precise and accurate measures. Methods and analysis The following databases will be searched from inception to March 2017: MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library. Grey literature will be sought via HMIC, OpenGrey, ProQuest for theses and Web of Science Conference Proceedings Citation Index-Science. Reference lists of included studies and relevant reviews will be hand searched. Three search strings will be combined to identify eligible studies: (1) implementation literature, (2) implementation outcomes and (3) measurement properties. Screening of titles, abstracts and full papers will be assessed for eligibility by two reviewers independently and any discrepancies resolved via consensus with the wider team. The methodological quality of the studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. A set of bespoke criteria to determine the quality of the instruments will be used, and the relationship between instrument usability and quality will be explored. Ethics and dissemination Ethical approval is not necessary for systematic review protocols. Researchers and healthcare professionals can use the findings of this systematic review to guide the selection of implementation outcomes instruments, based on their psychometric quality, to assess the impact of their implementation efforts. The findings will also provide a useful guide for

  7. Gadolinium for neutron detection in current nuclear instrumentation research: A review

    Science.gov (United States)

    Dumazert, J.; Coulon, R.; Lecomte, Q.; Bertrand, G. H. V.; Hamel, M.

    2018-02-01

    Natural gadolinium displays a number of remarkable physical properties: it is a rare earth element, composed of seven stable or quasi-stable isotopes, with an exceptionally high magnetization and a Curie point near room temperature. Its use in the field of nuclear instrumentation historically relates to its efficiency as a neutron poison in power reactors. Gadolinium is indeed the naturally occurring element with the highest interaction probability with neutrons at thermal energy, shared between Gd-157 (15.65%, 254000 b cross section) and Gd-155 (14.8%, 60900 b) isotopes. Considering that neutron capture results in an isotopic change, followed by a radiative rearrangement of nuclear and atomic structures, Gd may be embodied not merely as a neutron poison but as a neutron converter into a prompt photon and an electron source term. Depending on the nature and energy of the reaction products (from a few-keV Auger electrons up to 8 MeV gamma rays) that the detector aims at isolating as an indirect neutron signature, a variety of sensor media and counting methods have been introduced during the last decades. This review first draws a theoretical description of the radiative cascade following Gd(n , γ) capture. The cascade may be subdivided into regions of interest, each corresponding to dedicated detection designs and optimizations whose current status is detailed. This inventory has allowed the authors to extract and benchmark key figures of merit for the definition of a detection scheme: neutron attenuation, neutron sensitivity (cps/nv), gamma rejection, neutron detection limit in a mixed field, intrinsic or extrinsic moderation, and transportability. On this basis, the authors have identified promising paths for Gd-based neutron detection in contemporary instrumentation.

  8. Review on the seismic safety of JRR-3 according to the revised regulatory code on seismic design for nuclear reactors

    Energy Technology Data Exchange (ETDEWEB)

    Kobayashi, Tetsuya; Araki, Masaaki; Ohba, Toshinobu; Torii, Yoshiya [Japan Atomic Energy Agency, Tokai, Ibaraki (Japan); Takeuchi, Masaki [Nuclear Safety Commission (Japan)

    2012-03-15

    JRR-3(Japan Research Reactor No.3) with the thermal power of 20MW is a light water moderated and cooled, swimming pool type research reactor. JRR-3 has been operated without major troubles. This paper presents about review on the seismic safety of JRR-3 according to the revised regulatory code on seismic design for nuclear reactors. In addition, some topics concerning damages in JRR-3 due to the Great East Japan Earthquake are presented. (author)

  9. Safety cases for radioactive waste disposal facilities: guidance on confidence building and regulatory review IAEA-ASAM co-ordinated research project

    International Nuclear Information System (INIS)

    Ben Belfadhel, M.; Bennett, D.G.; Metcalf, P.; Nys, V.; Goldammer, W.

    2008-01-01

    The IAEA has been conducting two co-ordinated research programmes (CRPs) projects to develop and apply improved safety assessment methodologies for near-surface radioactive waste disposal facilities. The more recent of these projects, ASAM (application of safety assessment methodologies), included a Regulatory Review Working Group (RRWG) which has been working to develop guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides an overview of the ASAM project, focusing on the safety case and regulatory review. (authors)

  10. Regulatory analysis for amendments to regulations for the environmental review for renewal of nuclear power plant operating licenses. Final report

    International Nuclear Information System (INIS)

    1996-05-01

    This regulatory analysis provides the supporting information for a proposed rule that will amend the Nuclear Regulatory Commission's environmental review requirements for applications for renewal of nuclear power plant operating licenses. The objective of the proposed rulemaking is to improve regulatory efficiency by providing for the generic evaluation of certain environmental impacts associated with nuclear plant license renewal. After considering various options, the staff identified and analyzed two major alternatives. With Alternative A, the existing regulations would not be amended. This option requires that environmental reviews be performed under the existing regulations. Alternative B is to assess, on a generic basis, the environmental impacts of renewing the operating license of individual nuclear power plants, and define the issues that will need to be further analyzed on a case-by-case basis. In addition, Alternative B removes from NRC's review certain economics-related issues. The findings of this assessment are to be codified in 10 CFR 51. The staff has selected Alternative B as the preferred alternative

  11. An Integrative Review of Self-Efficacy Measurement Instruments in Youth with Type 1 Diabetes (T1DM)

    Science.gov (United States)

    Rasbach, Lisa; Jenkins, Carolyn; Laffel, Lori

    2014-01-01

    Purpose The purpose of this study is to assess the extant literature on instruments used to measure self-efficacy in youth with type 1 diabetes (T1DM) and their caregivers and to critically evaluate these measurements. Methods An integrative review (2003–2013) was conducted searching PsycINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and U.S. National Library of Medicine PubMed service (PubMed) databases using key words diabetes, type 1 diabetes, and self-efficacy. The authors reviewed the resulting294 references for inclusion criteria of (a) sample of youth with T1DM or sample of caregivers of youth with T1DM, (b) description of the self-efficacy instrument as primary research, and (c) the instrument measured self-efficacy specifically related to diabetes management. Forty-five articles out of the initial 294 met criteria. Results Of the 45 articles, 10 different self-efficacy instruments were identified. The primary theoretical framework used was Bandura’s social cognitive theory and model of self-efficacy. Most participants were white middle class T1DM youth. Evaluations to assess validity often were not reported; however, a majority of studies reported high internal consistency of the instruments. Conclusions Sample homogeneity could limit the applicability of results to certain patient populations. Further psychometric analysis, including validity assessments, should be conducted in more diverse samples. Development of valid and reliable instruments for measuring self-efficacy that are sensitive to change across a wider caregiver base over time is necessary. While this review examined reliable and valid instruments used in research, future opportunities include evaluation of measuring self-efficacy in T1DM youth exposed to recent advances in diabetes management technologies. PMID:25216655

  12. Measuring spirituality and religiosity in clinical research: a systematic review of instruments available in the Portuguese language.

    Science.gov (United States)

    Lucchetti, Giancarlo; Lucchetti, Alessandra Lamas Granero; Vallada, Homero

    2013-01-01

    Despite numerous spirituality and/or religiosity (S/R) measurement tools for use in research worldwide, there is little information on S/R instruments in the Portuguese language. The aim of the present study was to map out the S/R scales available for research in the Portuguese language. Systematic review of studies found in databases. A systematic review was conducted in three phases. Phases 1 and 2: articles in Portuguese, Spanish and English, published up to November 2011, dealing with the Portuguese translation and/or validation of S/R measurement tools for clinical research, were selected from six databases. Phase 3: the instruments were grouped according to authorship, cross-cultural adaptation, internal consistency, concurrent and discriminative validity and test-retest procedures. Twenty instruments were found. Forty-five percent of these evaluated religiosity, 40% spirituality, 10% religious/spiritual coping and 5% S/R. Among these, 90% had been produced in (n = 3) or translated to (n = 15) Brazilian Portuguese and two (10%) solely to European Portuguese. Nevertheless, the majority of the instruments had not undergone in-depth psychometric analysis. Only 40% of the instruments presented concurrent validity, 45% discriminative validity and 15% a test-retest procedure. The characteristics of each instrument were analyzed separately, yielding advantages, disadvantages and psychometric properties. Currently, 20 instruments for measuring S/R are available in the Portuguese language. Most have been translated (n = 15) or developed (n = 3) in Brazil and present good internal consistency. Nevertheless, few instruments have been assessed regarding all their psychometric qualities.

  13. Measurement properties of instruments that assess participation in young people with autism spectrum disorder: a systematic review.

    Science.gov (United States)

    Lami, Francesca; Egberts, Kristine; Ure, Alexandra; Conroy, Rowena; Williams, Katrina

    2018-03-01

    To systematically review the measurement properties of instruments assessing participation in young people with autism spectrum disorder (ASD). A search was performed in MEDLINE, PsycINFO, and PubMed combining three constructs ('ASD', 'test of participation', 'measurement properties'). Results were restricted to articles including people aged 6 to 29 years. The 2539 identified articles were independently screened by two reviewers. For the included articles, data were extracted using standard forms and their risk of bias was assessed. Nine studies (8 cross-sectional) met the inclusion criteria, providing information on seven different instruments. The total sample included 634 participants, with sex available for 600 (males=494; females=106) and age available for 570, with mean age for these participants 140.58 months (SD=9.11; range=36-624). Included instruments were the school function assessment, vocational index, children's assessment of participation and enjoyment/preferences for activities of children, experience sampling method, Pediatric Evaluation of Disability Inventory, Computer Adaptive Test, adolescent and young adult activity card sort, and Patient-Reported Outcomes Measurement Information System parent-proxy peer relationships. Seven studies assessed reliability and validity; good properties were reported for half of the instruments considered. Most studies (n=6) had high risk of bias. Overall the quality of the evidence for each tool was limited. Validation of these instruments, or others that comprehensively assess participation, is needed. Future studies should follow recommended methodological standards. Seven instruments have been used to assess participation in young people with autism. One instrument, with excellent measurement properties in one study, does not comprehensively assess participation. Studies of three instruments that incorporate a more comprehensive assessment of participation have methodological limitations. Overall, limited

  14. An integrative review of literature examining psychometric properties of instruments measuring anxiety or fear in hospitalized children.

    Science.gov (United States)

    Foster, Roxie L; Park, Jeong-hwan

    2012-06-01

    Anxiety and fear are among the most frequently reported emotional responses to hospitalization and are known to be contributing factors to pain and other negative patient outcomes. The first step in confronting unnecessary anxiety and fear is to identify valid and clinically feasible assessment instruments. The purpose of this paper is to review and evaluate instruments that measure children's fear or anxiety associated with hospitalization or painful procedures. A search was conducted of published English-language literature from 1980 through 2010 with the use of Ovid Health and Psychosocial Instruments, Medline, Nursing/Academic Edition, Cinahl, and Google Scholar. Inclusion criteria specified that the self-report instrument: 1) was developed in English; 2) was developed for and/or widely used with hospitalized children or children undergoing medical procedures or treatment; and 3) had research evidence of psychometric properties from at least five different studies. A comprehensive review of the literature revealed only five fear or anxiety instruments with adequate testing for evaluation of reliability and validity. Although all instruments have beginning psychometric adequacy, no one tool stands out as superior to the others. Therefore, we recommend that researchers and clinicians exercise caution in choosing assessment instruments, balancing potential strengths with reported limitations. Using more than one tool (triangulating) may be one way to achieve more credible results. Knowledge of credible existing instruments alerts us to what is possible today and to the imperative for research that will improve communication with children tomorrow. Copyright © 2012 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  15. Measuring spirituality and religiosity in clinical research: a systematic review of instruments available in the Portuguese language

    Directory of Open Access Journals (Sweden)

    Giancarlo Lucchetti

    Full Text Available CONTEXT AND OBJECTIVES Despite numerous spirituality and/or religiosity (S/R measurement tools for use in research worldwide, there is little information on S/R instruments in the Portuguese language. The aim of the present study was to map out the S/R scales available for research in the Portuguese language. DESIGN AND SETTING Systematic review of studies found in databases. METHODS A systematic review was conducted in three phases. Phases 1 and 2: articles in Portuguese, Spanish and English, published up to November 2011, dealing with the Portuguese translation and/or validation of S/R measurement tools for clinical research, were selected from six databases. Phase 3: the instruments were grouped according to authorship, cross-cultural adaptation, internal consistency, concurrent and discriminative validity and test-retest procedures. RESULTS Twenty instruments were found. Forty-five percent of these evaluated religiosity, 40% spirituality, 10% religious/spiritual coping and 5% S/R. Among these, 90% had been produced in (n = 3 or translated to (n = 15 Brazilian Portuguese and two (10% solely to European Portuguese. Nevertheless, the majority of the instruments had not undergone in-depth psychometric analysis. Only 40% of the instruments presented concurrent validity, 45% discriminative validity and 15% a test-retest procedure. The characteristics of each instrument were analyzed separately, yielding advantages, disadvantages and psychometric properties. CONCLUSION Currently, 20 instruments for measuring S/R are available in the Portuguese language. Most have been translated (n = 15 or developed (n = 3 in Brazil and present good internal consistency. Nevertheless, few instruments have been assessed regarding all their psychometric qualities.

  16. Selected review of regulatory standards and licensing issues for nuclear power plants

    International Nuclear Information System (INIS)

    Stevenson, J.D.; Thomas, F.A.

    1982-11-01

    This report presents a compilation and description of current foreign regulatory standards and licensing issues in the areas of interest associated with Siting, Structural Engineering, Metallurgy and Materials, and Mechanical Engineering. In addition, summary comparisons of the requirements of both the US and foreign nuclear power plant regulatory standards are provided. The selected foreign countries surveyed include Canada, France, Japan, Sweden, United Kingdom of Great Britain and Northern Ireland, and the Federal Republic of Germany

  17. Clinimetric properties of instruments to assess activities in patients with hand injury: a systematic review of the literature.

    NARCIS (Netherlands)

    Ven-Stevens, L.A.W. van de; Munneke, M.; Terwee, C.B.; Spauwen, P.H.M.; Linde, H. van der

    2009-01-01

    OBJECTIVE: To perform a systematic review of the literature to assess the clinimetric properties of instruments measuring limitations of activity. DATA SOURCES: The Medline, Cochrane Library, Picarta, Occupational Therapy-seeker, and CINAHL databases were searched for English or Dutch language

  18. Investigating the Quality of Project-Based Science and Technology Learning Environments in Elementary School: A Critical Review of Instruments

    Science.gov (United States)

    Thys, Miranda; Verschaffel, Lieven; Van Dooren, Wim; Laevers, Ferre

    2016-01-01

    This paper provides a systematic review of instruments that have the potential to measure the quality of project-based science and technology (S&T) learning environments in elementary school. To this end, a comprehensive literature search was undertaken for the large field of S&T learning environments. We conducted a horizontal bottom-up…

  19. Diagnostic accuracy of portable instrumental devices to measure sleep bruxism: a systematic literature review of polysomnographic studies

    NARCIS (Netherlands)

    Manfredini, D.; Ahlberg, J.; Castroflorio, T.; Poggio, C.E.; Guarda-Nardini, L.; Lobbezoo, F.

    2014-01-01

    This study systematically reviews the sleep bruxism (SB) literature published in the MEDLINE and Scopus databases to answer the following question: What is the validity of the different portable instrumental devices that have been proposed to measure SB if compared with polysomnographic (PSG)

  20. Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

    Science.gov (United States)

    Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

    2012-07-01

    Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

  1. The regulatory review of construction license application and the supporting safety case

    International Nuclear Information System (INIS)

    Heinonen, Jussi

    2014-01-01

    Finland is one of the foremost countries in the world in developing the disposal of spent fuel. The construction license application for the Olkiluoto spent fuel disposal facility was submitted to the authorities at the end of 2012 and the facility is expected to start operation around 2020. This has been a long-term project with over 30 years of parallel development of the repository project and the regulatory approach to spent fuel management. In 1983 the government made a strategic decision on the objectives and target time schedule for the research, development and technical planning of nuclear waste management. While an export and international disposal solution was still the preferred option, this decision required the licensees without this possibility to prepare for disposal in Finland and it also gave the time line for the milestones on the way to an operating disposal facility by 2020. The licensing procedure for a disposal facility has several steps that are similar to all nuclear facilities in Finland and are defined in Nuclear Energy Act and Decree (1987, 1988). These licensing steps are: - Decision-in-principle is required for a nuclear facility having considerable general significance. This is essentially a political decision: the government decides if the construction project is in line with the overall good of society. The decision can be applied for one or more sites, the host municipality has a veto right and the parliament has the choice of ratifying or not ratifying the decision. - Construction license is granted by the government and authorises the construction of the disposal facility. The actual construction is regulated by STUK and includes several review and approval steps, hold points and viewpoints. - Operational license is granted by the government and authorises the operation of the facility for a certain period. The operational license is needed before nuclear waste can be disposed. The first step in the licensing process was reached

  2. Review of decision methodologies for evaluating regulatory actions affecting public health and safety

    International Nuclear Information System (INIS)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels

  3. Invited review article: IceCube: an instrument for neutrino astronomy.

    Science.gov (United States)

    Halzen, Francis; Klein, Spencer R

    2010-08-01

    Neutrino astronomy beyond the Sun was first imagined in the late 1950s; by the 1970s, it was realized that kilometer-scale neutrino detectors were required. The first such instrument, IceCube, is near completion and taking data. The IceCube project transforms 1 km(3) of deep and ultratransparent Antarctic ice into a particle detector. A total of 5160 optical sensors is embedded into a gigaton of Antarctic ice to detect the Cherenkov light emitted by secondary particles produced when neutrinos interact with nuclei in the ice. Each optical sensor is a complete data acquisition system including a phototube, digitization electronics, control and trigger systems, and light-emitting diodes for calibration. The light patterns reveal the type (flavor) of neutrino interaction and the energy and direction of the neutrino, making neutrino astronomy possible. The scientific missions of IceCube include such varied tasks as the search for sources of cosmic rays, the observation of galactic supernova explosions, the search for dark matter, and the study of the neutrinos themselves. These reach energies well beyond those produced with accelerator beams. The outline of this review is as follows: neutrino astronomy and kilometer-scale detectors, high-energy neutrino telescopes: methodologies of neutrino detection, IceCube hardware, high-energy neutrino telescopes: beyond astronomy, and future projects.

  4. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.

    Science.gov (United States)

    Ibarra-Cabrera, Ricardo; Mena-Pérez, Sandra Carolina; Bondani-Guasti, Augusto; García-Arrazola, Roeb

    2013-12-01

    The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries. Copyright © 2013 Elsevier Inc. All rights reserved.

  5. Diabetes-related emotional distress instruments: a systematic review of measurement properties.

    Science.gov (United States)

    Lee, Jiyeon; Lee, Eun-Hyun; Kim, Chun-Ja; Moon, Seung Hei

    2015-12-01

    The objectives of this study were to identify all available diabetes-related emotional distress instruments and evaluate the evidence regarding their measurement properties to help in the selection of the most appropriate instrument for use in practice and research. A systematic literature search was performed. PubMed, Embase, CINAHL, and PsycINFO were searched systematically for articles on diabetes-related emotional distress instruments. The Consensus-based Standards for the Selection of Health Measurement Instruments checklist was used to evaluate the methodological quality of the identified studies. The quality of results with respect to the measurement properties of each study was evaluated using Terwee's quality criteria. An ancillary meta-analysis was performed. Of the 2345 articles yielded by the search, 19 full-text articles evaluating 6 diabetes-related emotional distress instruments were included in this study. No instrument demonstrated evidence for all measurement properties. The Problem Areas in Diabetes scale (PAID) was the most frequently studied and the best validated of the instruments. Pooled summary estimates of the correlation coefficient between the PAID and serum glycated hemoglobin revealed a positive but weak correlation. No diabetes-related emotional distress instrument demonstrated evidence for all measurement properties. No instrument was better than another, although the PAID was the best validated and is thus recommended for use. Further psychometric studies of the diabetes-related emotional distress instruments with rigorous methodologies are required. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. The use of fiscal instruments in European environmental policy: review essay

    Energy Technology Data Exchange (ETDEWEB)

    Deketelaere, K. [University of Leuven, Leuven (Belgium). Inst. for Environmental and Energy Law

    1999-08-01

    Once a government has defined its environmental goals, it can execute them by means of different policy instruments. The following environmental policy instruments can be distinguished: (1) instruments of social regulation, such as transfer of information (environmental education, environmental labels, environmental impact reports, etc.), self-regulation (environmental policy agreements, self-control), and environmental care systems; (2) instruments of financial aid, such as subsidies, soft loans, and fiscal incentives (investment deduction, tax reduction and tax exemption); (3) instruments of planning such as macro-planning and micro-planning, binding planning and non-binding planning, sectoral planning and non-sectoral planning; (4) instruments of direct regulation, such as permits, prohibitions and restrictions, and different sorts of requirements (quality-demands, product-demands, emission-demands, design demands, construction demands and production demands); (5) instruments of market regulation, such as liability rules, marketable emission rights, deposit and refund system, enforcement incentives and environmental levies. In this contribution, each of these environmental policy instruments is analyzed in general. After that, the instruments which have already been used in European environmental policy are examined. Finally, attention paid to the use of fiscal instruments in European environmental policy. 80 refs.

  7. Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

    Science.gov (United States)

    Bujar, Magdalena; McAuslane, Neil; Walker, Stuart R; Salek, Sam

    2017-01-01

    Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general

  8. Innovation and organisational performance: A critical review of the instruments used to measure organisational performance

    Directory of Open Access Journals (Sweden)

    Tebogo Sethibe

    2016-10-01

    Full Text Available Background: Innovation is recognised as one of the most important determinant of organisational performance. Yet, the results of studies that investigate the relationship between innovation and organisational performance are inconclusive. The inconsistency has been attributed to a number of factors, which include, among others, the measures used to evaluate organisational performance. Aim: This study was set out to identify, categorise and critically analyse the instruments used to assess organisational performance when investigating the relationship between innovation and organisational performance. Setting: The study focuses on all scientific publications reporting on organisational performance, inclusive of both financial and non-financial indicators of performance, and are not limited to any specific country or industry. Methods: The systematic literature review methodology was used to identify studies which investigated the relationship between innovation and organisational performance. Once identified, articles were analysed on the way organisational performance was measured. Classification was done with reference to financial and non-financial indicators, accounting and market-based, as well as objective and subjective measures. Results: The findings show that profitability, sales growth and return on assets (ROA are the most preferred accounting-based financial measures of organisation performance. In addition, Tobin’s Q was found to be the most favoured market-based financial measure of organisational performance. The study further reveals that market share, customer satisfaction and productivity are the most popular non-financial-based measures of organisational performance. Conclusion: The use of measures of organisational performance is often left to the discussion of the researcher, which is not implicitly wrong, but does little to contribute to the body of knowledge on this important topic. Researchers are firstly urged to

  9. Telephone-based screening tools for mild cognitive impairment and dementia in aging studies: a review of validated instruments

    Directory of Open Access Journals (Sweden)

    Teresa Costa Castanho

    2014-02-01

    Full Text Available The decline of cognitive function in old age is a great challenge for modern society. The simultaneous increase in dementia and other neurodegenerative diseases justifies a growing need for accurate and valid cognitive assessment instruments. Although in-person testing is considered the most effective and preferred administration mode of assessment, it can pose not only a research difficulty in reaching large and diverse population samples, but it may also limit the assessment and follow-up of individuals with either physical or health limitations or reduced motivation. Therefore, telephone-based cognitive screening instruments pose an alternative and attractive strategy to in-person assessments. In order to give a current view of the state of the art of telephone-based tools for cognitive assessment in aging, this review highlights some of the existing instruments with particular focus on data validation, cognitive domains assessed, administration time and instrument limitations and advantages. From the review of the literature, performed using the databases EBSCO, Science Direct and PubMed, it was possible to verify that while telephone-based tools are useful in research and clinical practice, providing a promising approach, the methodologies still need refinement in the validation steps, including comparison with either single instruments or neurocognitive test batteries, to improve specificity and sensitivity to validly detect subtle changes in cognition that may precede cognitive impairment.

  10. Development and testing of an assessment instrument for the formative peer review of significant event analyses.

    Science.gov (United States)

    McKay, J; Murphy, D J; Bowie, P; Schmuck, M-L; Lough, M; Eva, K W

    2007-04-01

    To establish the content validity and specific aspects of reliability for an assessment instrument designed to provide formative feedback to general practitioners (GPs) on the quality of their written analysis of a significant event. Content validity was quantified by application of a content validity index. Reliability testing involved a nested design, with 5 cells, each containing 4 assessors, rating 20 unique significant event analysis (SEA) reports (10 each from experienced GPs and GPs in training) using the assessment instrument. The variance attributable to each identified variable in the study was established by analysis of variance. Generalisability theory was then used to investigate the instrument's ability to discriminate among SEA reports. Content validity was demonstrated with at least 8 of 10 experts endorsing all 10 items of the assessment instrument. The overall G coefficient for the instrument was moderate to good (G>0.70), indicating that the instrument can provide consistent information on the standard achieved by the SEA report. There was moderate inter-rater reliability (G>0.60) when four raters were used to judge the quality of the SEA. This study provides the first steps towards validating an instrument that can provide educational feedback to GPs on their analysis of significant events. The key area identified to improve instrument reliability is variation among peer assessors in their assessment of SEA reports. Further validity and reliability testing should be carried out to provide GPs, their appraisers and contractual bodies with a validated feedback instrument on this aspect of the general practice quality agenda.

  11. Instruments to measure anxiety in children, adolescents, and young adults with cancer: a systematic review.

    Science.gov (United States)

    Lazor, Tanya; Tigelaar, Leonie; Pole, Jason D; De Souza, Claire; Tomlinson, Deborah; Sung, Lillian

    2017-09-01

    The primary objective was to describe anxiety measurement instruments used in children and adolescents with cancer or undergoing hematopoietic stem cell transplantation (HSCT) and summarize their content and psychometric properties. We conducted searches of MEDLINE, Embase, PsycINFO, HAPI, and CINAHL. We included studies that used at least one instrument to measure anxiety quantitatively in children or adolescents with cancer or undergoing HSCT. Two authors independently identified studies and abstracted study demographics and instrument characteristics. Twenty-seven instruments, 14 multi-item and 13 single-item, were used between 78 studies. The most commonly used instrument was the State-Trait Anxiety Inventory in 46 studies. Three multi-item instruments (Children's Manifest Anxiety Scale-Mandarin version, PROMIS Pediatric Anxiety Short Form, and the State-Trait Anxiety Inventory) and two single-item instruments (Faces Pain Scale-Revised and 10-cm Visual Analogue Scale, both adapted for anxiety) were found to be reliable and valid in children with cancer. We identified 14 different multi-item and 13 different single-item anxiety measurement instruments that have been used in pediatric cancer or HSCT. Only three multi-item and two single-item instruments were identified as being reliable and valid among pediatric cancer or HSCT patients and would therefore be appropriate to measure anxiety in this population.

  12. A Structured Review of Generic and Specific Instruments for Measuring the Subjectively Assessed Quality of Life of Seniors

    Directory of Open Access Journals (Sweden)

    Monika Kacmarova

    2015-12-01

    Full Text Available The objective of the study is to offer a review of the instruments designed for measuring the subjectively assessed quality of life of seniors. At present it is possible to notice an increase of interest in the issue of the quality of life of specific groups of population; in addition, there is a large number of tools for its measuring. The aim of the present study is to provide a systematic review of generic and specific instruments for measuring quality of life of seniors which have been published in peer-reviewed journals and whose psychometric parameters have been verified. The search procedure formed a part of a larger retrieval search in which we analyzed 4829 abstracts in EBSCO and ProQuest Central full-text databases. We found 831 instruments which claimed to be measuring quality of life and were verified their reliability or validity. We identified 3 groups of instruments suitable for use in the senior age-group: generic methodologies applicable to adults in general, 7 generic tools and 9 specific tools designed exclusively for the senior age. The paper presents the measures designed for seniors who were analyzed and compared with regard to their psychometric parameters, purpose and theoretical framework utilized for their construction. In conclusion the authors of the study provide recommendations for the use of the selected methodologies for measuring the subjectively assessed quality of life of seniors.

  13. Measurement properties of adult quality-of-life measurement instruments for eczema: protocol for a systematic review.

    Science.gov (United States)

    Apfelbacher, Christian J; Heinl, Daniel; Prinsen, Cecilia A C; Deckert, Stefanie; Chalmers, Joanne; Ofenloch, Robert; Humphreys, Rosemary; Sach, Tracey; Chamlin, Sarah; Schmitt, Jochen

    2015-04-16

    Eczema is a common chronic or chronically relapsing skin disease that has a substantial impact on quality of life (QoL). By means of a consensus-based process, the Harmonising Outcome Measures in Eczema (HOME) initiative has identified QoL as one of the four core outcome domains to be assessed in all eczema trials (Allergy 67(9):1111-7, 2012). Various measurement instruments exist to measure QoL in adults with eczema, but there is a great variability in both content and quality (for example, reliability and validity) of the instruments used, and it is not always clear if the best instrument is being used. Therefore, the aim of the proposed research is a comprehensive systematic assessment of the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in adults with eczema. This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for adults with eczema. Medline via PubMed and EMBASE will be searched using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for adult patients with eczema. Eligibility assessment and data abstraction will be performed independently by two reviewers. Evidence tables will be generated for study characteristics, instrument characteristics, measurement properties, and interpretability. The quality of the measurement properties will be assessed using predefined criteria. Methodological quality of studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. A best evidence synthesis will be undertaken if more than one study has investigated a particular measurement property. The proposed systematic review will produce a comprehensive assessment of measurement properties of existing QoL instruments in

  14. Instruments evaluating the quality of the clinical learning environment in nursing education: A systematic review of psychometric properties.

    Science.gov (United States)

    Mansutti, Irene; Saiani, Luisa; Grassetti, Luca; Palese, Alvisa

    2017-03-01

    The clinical learning environment is fundamental to nursing education paths, capable of affecting learning processes and outcomes. Several instruments have been developed in nursing education, aimed at evaluating the quality of the clinical learning environments; however, no systematic review of the psychometric properties and methodological quality of these studies has been performed to date. The aims of the study were: 1) to identify validated instruments evaluating the clinical learning environments in nursing education; 2) to evaluate critically the methodological quality of the psychometric property estimation used; and 3) to compare psychometric properties across the instruments available. A systematic review of the literature (using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines) and an evaluation of the methodological quality of psychometric properties (using the COnsensus-based Standards for the selection of health Measurement INstruments guidelines). The Medline and CINAHL databases were searched. Eligible studies were those that satisfied the following criteria: a) validation studies of instruments evaluating the quality of clinical learning environments; b) in nursing education; c) published in English or Italian; d) before April 2016. The included studies were evaluated for the methodological quality of the psychometric properties measured and then compared in terms of both the psychometric properties and the methodological quality of the processes used. The search strategy yielded a total of 26 studies and eight clinical learning environment evaluation instruments. A variety of psychometric properties have been estimated for each instrument, with differing qualities in the methodology used. Concept and construct validity were poorly assessed in terms of their significance and rarely judged by the target population (nursing students). Some properties were rarely considered (e.g., reliability, measurement error

  15. Quality appraisal of generic self-reported instruments measuring health-related productivity changes: a systematic review

    Science.gov (United States)

    2014-01-01

    Background Health impairments can result in disability and changed work productivity imposing considerable costs for the employee, employer and society as a whole. A large number of instruments exist to measure health-related productivity changes; however their methodological quality remains unclear. This systematic review critically appraised the measurement properties in generic self-reported instruments that measure health-related productivity changes to recommend appropriate instruments for use in occupational and economic health practice. Methods PubMed, PsycINFO, Econlit and Embase were systematically searched for studies whereof: (i) instruments measured health-related productivity changes; (ii) the aim was to evaluate instrument measurement properties; (iii) instruments were generic; (iv) ratings were self-reported; (v) full-texts were available. Next, methodological quality appraisal was based on COSMIN elements: (i) internal consistency; (ii) reliability; (iii) measurement error; (iv) content validity; (v) structural validity; (vi) hypotheses testing; (vii) cross-cultural validity; (viii) criterion validity; and (ix) responsiveness. Recommendations are based on evidence syntheses. Results This review included 25 articles assessing the reliability, validity and responsiveness of 15 different generic self-reported instruments measuring health-related productivity changes. Most studies evaluated criterion validity, none evaluated cross-cultural validity and information on measurement error is lacking. The Work Limitation Questionnaire (WLQ) was most frequently evaluated with moderate respectively strong positive evidence for content and structural validity and negative evidence for reliability, hypothesis testing and responsiveness. Less frequently evaluated, the Stanford Presenteeism Scale (SPS) showed strong positive evidence for internal consistency and structural validity, and moderate positive evidence for hypotheses testing and criterion validity. The

  16. Joint IAEA/NEA workshop proceedings on regulatory review of plant safety analysis - Abstracts, Summary and Conclusions

    International Nuclear Information System (INIS)

    Lacey, Derek; Drozd, Andrzej; Husarcek, Jan; Modro, Mike

    1999-01-01

    Based on the final discussion, the seminar was a valuable exchange of information and helpful in understanding the safety analysis and regulatory review issues. It gave a chance for some countries to see 'where they are' regulatory-wise with respect to other countries. There was a strong support for a follow-up workshop within the next two years. A general opinion expressed by most of the participants was that the suggested next seminar should be based more on an 'overall safety analysis' review rather than on very detailed presentations on specific issues. Also, there should be more discussions on Emergency Operating Procedures (EOPs) and emergency planning. In addition, to establish a 'common language', the development of a glossary of terms would be most helpful. In general, all of the participating countries are adapting regulatory and licensing practices previously developed by other countries. Such an approach allows to utilise and rely on a broad experience of countries with a well established nuclear power industry, strong regulatory organisation and licensing practices. Since there are obvious differences in engineering traditions and in countries' legal/regulatory frameworks, questions arise about how to reconcile these differences in adapting and developing practices suitable for a given country. It was advised as a good practice to identify from the very beginning what needs to be done and the goals to be accomplished not only in the perspective of safety and technical requirements but also in the context of the economical, political, legal and regulatory situation in a given country. There has to be a consistency in any approach, but one can never follow 'blindly' the others. It became quite obvious that the needs of countries with a big nuclear program are very different from those of 'small' countries. Adaptation of other countries' rules is a big effort in itself (e.g., Romania applying Canadian regulations). In addition, the French-German co

  17. An Instrument for a Legal Review of Public School Curriculum Policies and Procedures.

    Science.gov (United States)

    Zirkel, Perry A.

    The "Legal Audit Instrument for Public School Curriculum" described in this paper is intended for those making decisions in curricular matters. The instrument has been derived from court decisions that are based on the Federal Constitution, legislation, and regulations. Corresponding cases and provisions within each state will require…

  18. Is there an association between temporomandibular disorders and playing a musical instrument? A review of literature

    NARCIS (Netherlands)

    Atallah, M.M.; Visscher, C.M.; van Selms, M.K.A.; Lobbezoo, F.

    2014-01-01

    Temporomandibular disorders (TMDs) have a multifactorial etiology. Among others, parafunctions and oral habits have been suggested as important initiating and perpetuating factors. Playing a musical instrument that loads the masticatory system, like wind instruments and the violin or viola, has been

  19. Feedback to Managers, Volume II: A Review and Comparison of Sixteen Multi-Rater Feedback Instruments.

    Science.gov (United States)

    Van Velsor, Ellen; Leslie, Jean Brittain

    "Feedback to Managers" is a two-volume report. Volume 2 compares 16 of the better feedback instruments available. The following are the instruments: (1) ACUMEN Group Feedback; (2) BENCHMARKS; (3) the Campbell Leadership Index; (4) COMPASS: the Managerial Practices Survey; (5) the Executive Success Profile; (6) Leader Behavior Analysis…

  20. The integration of the quality assurance approach into the regulatory review stages in Italy

    International Nuclear Information System (INIS)

    Maniori, D.

    1979-01-01

    The control activities of CNEN, the Italian Regulatory Body on Nuclear Power Plant Installations, are carried out on the basis of two main lines of action. These are a thorough and detailed examination of the project at different stages of its development, and a careful assessment of the reliability of the organizations involved in respect of their capability to perform their duties correctly. The paper illustrates in some detail the different stages in which the project examinations are carried out, the documents pertinent to each stage, and the way in which the organizational requirements match the different steps. The regulatory guides and documents prepared on this subject are also briefly presented. (author)

  1. Evaluation of the measurement properties of symptom measurement instruments for atopic eczema: a systematic review.

    Science.gov (United States)

    Gerbens, L A A; Prinsen, C A C; Chalmers, J R; Drucker, A M; von Kobyletzki, L B; Limpens, J; Nankervis, H; Svensson, Å; Terwee, C B; Zhang, J; Apfelbacher, C J; Spuls, P I

    2017-01-01

    Symptoms have been identified as a core outcome domain for atopic eczema (AE) trials. Various instruments exist to measure symptoms in AE, but they vary in quality and there is a lack of standardization between clinical trials. Our objective was to systematically evaluate the quality of the evidence on the measurement properties of AE symptom instruments, thereby informing consensus discussions within the Harmonising Outcome Measures for Eczema (HOME) initiative regarding the most appropriate instruments for the core outcome domain symptoms. Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and predefined criteria for good measurement properties on identified development and validation studies of AE symptom instruments, a best evidence synthesis was performed to draw an overall conclusion on quality of the instruments and to provide recommendations. Eighteen instruments were identified and evaluated. When the quality and results of the studies were considered, only five of these instruments had sufficient validation data to consider them for the core outcome set for the core outcome domain symptoms. These were the paediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCOring Atopic Dermatitis (PO-SCORAD), Self-Administered Eczema Area and Severity Index (SA-EASI) and adapted SA-EASI. ISS (paediatric version), POEM, PO-SCORAD, SA-EASI and adapted SA-EASI are currently the most appropriate instruments and therefore have the potential to be recommended as core symptom instrument in future clinical trials. These findings will be utilized for the development of a core outcome set for AE. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. The Diagnostic Accuracy of Dementia-Screening Instruments With an Administration Time of 10 to 45 Minutes for Use in Secondary Care : A Systematic Review

    NARCIS (Netherlands)

    Appels, Bregje A.; Scherder, Erik

    Early screening for dementia is crucial for identifying reversible causes as well as managing, counseling, and other therapeutic interventions. Many reviews have compared the suitability of very brief screening instruments for use in primary care, but reviews on more extensive instruments in

  3. 76 FR 63276 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-10-12

    ... submitted either via the Board's e-filing process or in the traditional paper format. Any person using e... objectives. The order also called for public participation in this regulatory process. Although Executive... Uniform Rail Costing System, which is the Board's general purpose costing methodology for the nation's...

  4. Measurement properties of quality of life measurement instruments for infants, children and adolescents with eczema: protocol for a systematic review.

    Science.gov (United States)

    Heinl, Daniel; Prinsen, Cecilia A C; Drucker, Aaron M; Ofenloch, Robert; Humphreys, Rosemary; Sach, Tracey; Flohr, Carsten; Apfelbacher, Christian

    2016-02-09

    Eczema is a common chronic or chronically relapsing, inflammatory skin disease that exerts a substantial negative impact on quality of life (QoL). The Harmonising Outcome Measures for Eczema (HOME) initiative has used a consensus-based process which identified QoL as one of the four core outcome domains to be assessed in all eczema clinical trials. A number of measurement instruments exist to measure QoL in infants, children, and adolescents with eczema, and there is a great variability in both content and quality of the instruments used. Therefore, the objective of the proposed research is to comprehensively and systematically assess the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in infants, children, and adolescents with eczema. This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for infants, children, and adolescents with eczema. A systematic literature search will be carried out in MEDLINE via PubMed and EMBASE using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for infants, children, and adolescents with eczema. Two reviewers will independently perform eligibility assessment and data abstraction. Evidence tables will be used to record study characteristics, instrument characteristics, measurement properties, and interpretability. The adequacy of the measurement properties will be assessed using predefined criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist will be used to evaluate the methodological quality of included studies. A best evidence synthesis will be undertaken if more than one study has examined a particular measurement property. The proposed systematic review will yield a comprehensive assessment

  5. Instruments evaluating the self-directed learning abilities among nursing students and nurses: a systematic review of psychometric properties.

    Science.gov (United States)

    Cadorin, Lucia; Bressan, Valentina; Palese, Alvisa

    2017-11-25

    Modern healthcare institutions are continuously changing, and Self-Directed Learning (SDL) abilities are considered a prerequisite for both nursing students and nurses in order to be proactive about these demanding challenges. To date, no systematic reviews of existing instruments aimed at detecting and critically evaluating SDL abilities have been published. Therefore, the aims of this review are: 1) identify the instruments for assessment of SDL abilities among nursing students and nurses; 2) critically evaluate the methodological studies quality; and 3) compare the psychometric properties of the available instruments. A psychometric-systematic-review was performed. CDSR, CINAHL, ERIC, MEDLINE, PROSPERO, SCOPUS databases were searched without restrictions in time and setting. All primary studies involving nursing students or nurses, written in English and aimed at validating SDL assessment tools, were included. Studies retrieved were evaluated according to the COnsensus-based-Standards for the selection of health Measurement-INstruments (COSMIN) panel. Study inclusion, data extraction and quality assessment were performed by researchers independently. Eleven studies were included and four tools based on Knowles's theory have emerged: 1) the Self-Directed Learning Readiness Scale; 2) the Self-Directed Learning Readiness Scale for Nursing Education; 3) the Self-Rating Scale of Self-Directed Learning, and 4) the Self-Directed Learning Instrument. A few psychometric properties have been considered in each study, from two to four out of the ten required. The quality of the methodologies used was in general, from fair to poor with the exception of one instrument (the Self-Directed-Learning-Instrument). The psychometric proprieties that emerged across the tools were good in general: the Cronbach α was from 0.73 to 0.91; structural validities have also reported good indexes both in the explorative and in the confirmative factor analyses. On the basis of the findings

  6. Instruments evaluating the self-directed learning abilities among nursing students and nurses: a systematic review of psychometric properties

    Directory of Open Access Journals (Sweden)

    Lucia Cadorin

    2017-11-01

    Full Text Available Abstract Background Modern healthcare institutions are continuously changing, and Self-Directed Learning (SDL abilities are considered a prerequisite for both nursing students and nurses in order to be proactive about these demanding challenges. To date, no systematic reviews of existing instruments aimed at detecting and critically evaluating SDL abilities have been published. Therefore, the aims of this review are: 1 identify the instruments for assessment of SDL abilities among nursing students and nurses; 2 critically evaluate the methodological studies quality; and 3 compare the psychometric properties of the available instruments. Methods A psychometric-systematic-review was performed. CDSR, CINAHL, ERIC, MEDLINE, PROSPERO, SCOPUS databases were searched without restrictions in time and setting. All primary studies involving nursing students or nurses, written in English and aimed at validating SDL assessment tools, were included. Studies retrieved were evaluated according to the COnsensus-based-Standards for the selection of health Measurement-INstruments (COSMIN panel. Study inclusion, data extraction and quality assessment were performed by researchers independently. Results Eleven studies were included and four tools based on Knowles’s theory have emerged: 1 the Self-Directed Learning Readiness Scale; 2 the Self-Directed Learning Readiness Scale for Nursing Education; 3 the Self-Rating Scale of Self-Directed Learning, and 4 the Self-Directed Learning Instrument. A few psychometric properties have been considered in each study, from two to four out of the ten required. The quality of the methodologies used was in general, from fair to poor with the exception of one instrument (the Self-Directed-Learning-Instrument. The psychometric proprieties that emerged across the tools were good in general: the Cronbach α was from 0.73 to 0.91; structural validities have also reported good indexes both in the explorative and in the confirmative

  7. Instruments for the assessment of suicide risk: A systematic review evaluating the certainty of the evidence.

    Directory of Open Access Journals (Sweden)

    Bo Runeson

    Full Text Available Instruments have been developed to facilitate suicide risk assessment. We aimed to evaluate the evidence for these instruments including assessment of risk of bias and diagnostic accuracy for suicide and suicide attempt.PubMed (NLM, PsycInfo, Embase, Cinahl and the Cochrane Library databases were searched until December 2014. We assessed risk of bias with QUADAS-2. The average sensitivity and specificity of each instrument was estimated and the certainty of the evidence was assessed with GRADE. We considered instruments with a sensitivity > 80% and a specificity > 50% to have sufficient diagnostic accuracy.Thirty-five relevant studies were identified but 14 were considered to have high risk of bias, leaving 21 studies evaluating altogether 15 risk assessment instruments. We could carry out meta-analyses for five instruments. For the outcome suicide attempt SAD PERSONS Scale had a sensitivity of 15% (95% CI 8-24 and specificity of 97% (96-98, and the Manchester Self-Harm Rule (MSHR a sensitivity of 97% (97-97 and a specificity of 20% (20-21. ReACT, which is a modification of MSHR, had a similar low specificity, as did the Sodersjukhuset Self Harm Rule. For the outcome suicide, the Beck Hopelessness Scale had a sensitivity of 89% (78-95 and specificity of 42% (40-43.Most suicide risk assessment instruments were supported by too few studies to allow for evaluation of accuracy. Among those that could be evaluated, none fulfilled requirements for sufficient diagnostic accuracy.

  8. Systematic review of qualitative literature on occupational health and safety legislation and regulatory enforcement planning and implementation.

    Science.gov (United States)

    MacEachen, Ellen; Kosny, Agnieszka; Ståhl, Christian; O'Hagan, Fergal; Redgrift, Lisa; Sanford, Sarah; Carrasco, Christine; Tompa, Emile; Mahood, Quenby

    2016-01-01

    The ability of occupational health and safety (OHS) legislation and regulatory enforcement to prevent workplace injuries and illnesses is contingent on political, economic, and organizational conditions. This systematic review of qualitative research articles considers how OHS legislation and regulatory enforcement are planned and implemented. A comprehensive search of peer-reviewed, English-language articles published between 1990 and 2013 yielded 11 947 articles. We identified 34 qualitative articles as relevant, 18 of which passed our quality assessment and proceeded to meta-ethnographic synthesis. The synthesis yielded four main themes: OHS regulation formation, regulation challenges, inspector organization, and worker representation in OHS. It illuminates how OHS legislation can be based on normative suppositions about worker and employer behavior and shaped by economic and political resources of parties. It also shows how implementation of OHS legislation is affected by "general duty" law, agency coordination, resourcing of inspectorates, and ability of workers to participate in the system. The review identifies methodological gaps and identifies promising areas for further research in "grey" zones of legislation implementation.

  9. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

    Science.gov (United States)

    Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

    2017-07-01

    The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

  10. Implementation outcome assessment instruments used in physical healthcare settings and their measurement properties: a systematic review protocol.

    Science.gov (United States)

    Khadjesari, Zarnie; Vitoratou, Silia; Sevdalis, Nick; Hull, Louise

    2017-10-08

    Over the past 10 years, research into methods that promote the uptake, implementation and sustainability of evidence-based interventions has gathered pace. However, implementation outcomes are defined in different ways and assessed by different measures; the extent to which these measures are valid and reliable is unknown. The aim of this systematic review is to identify and appraise studies that assess the measurement properties of quantitative implementation outcome instruments used in physical healthcare settings, to advance the use of precise and accurate measures. The following databases will be searched from inception to March 2017: MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library. Grey literature will be sought via HMIC, OpenGrey, ProQuest for theses and Web of Science Conference Proceedings Citation Index-Science. Reference lists of included studies and relevant reviews will be hand searched. Three search strings will be combined to identify eligible studies: (1) implementation literature, (2) implementation outcomes and (3) measurement properties. Screening of titles, abstracts and full papers will be assessed for eligibility by two reviewers independently and any discrepancies resolved via consensus with the wider team. The methodological quality of the studies will be assessed using the COnsensus-based Standards for the selection of health Measurement INstruments checklist. A set of bespoke criteria to determine the quality of the instruments will be used, and the relationship between instrument usability and quality will be explored. Ethical approval is not necessary for systematic review protocols. Researchers and healthcare professionals can use the findings of this systematic review to guide the selection of implementation outcomes instruments, based on their psychometric quality, to assess the impact of their implementation efforts. The findings will also provide a useful guide for reviewers of papers and grants to determine the

  11. Pulmonary embolism in the elderly: a review on clinical, instrumental and laboratory presentation

    Directory of Open Access Journals (Sweden)

    Luca Masotti

    2008-06-01

    Full Text Available Luca Masotti1,8, Patrick Ray2, Marc Righini3, Gregoire Le Gal4, Fabio Antonelli5, Giancarlo Landini1, Roberto Cappelli6, Domenico Prisco7, Paola Rottoli81Internal Medicine, Cecina Hospital, Cecina, Italy; 2Department of Emergency Medicine, Centre Hospitalo-Universitaire Pitié-Salpêtrière, Université Pierre et Marie Curie-Paris 6, Paris, France; 3Division of Angiology and Hemostasis, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland; 4Department of Internal Medicine and Chest Diseases, Brest University Hospital, Brest, France; 5Clinical Chemistry, Cecina Hospital, Cecina, Italy; 6Department of Internal, Cardiovascular and Geriatric Medicine, University of Siena, Siena, Italy; 7Department of Critical Care Medicine, Thrombosis Centre, Careggi Hospital, Florence, Italy; 8Departiment of Clinical Medicine and Immunological Sciences, Division of Respiratory Diseases, University of Siena, Siena, ItalyObjective: Diagnosis of pulmonary embolism (PE remains difficult and is often missed in the elderly due to nonspecific and atypical presentation. Diagnostic algorithms able to rule out PE and validated in young adult patients may have reduced applicability in elderly patients, which increases the number of diagnostic tools use and costs. The aim of the present study was to analyze the reported clinical presentation of PE in patients aged 65 and more.Materials and Methods: Prospective and retrospective English language studies dealing with the clinical, instrumental and laboratory aspects of PE in patients more than 65 and published after January 1987 and indexed in MEDLINE using keywords as pulmonary embolism, elderly, old, venous thromboembolism (VTE in the title, abstract or text, were reviewed.Results: Dyspnea (range 59%–91.5%, tachypnea (46%–74%, tachycardia (29%–76%, and chest pain (26%–57% represented the most common clinical symptoms and signs. Bed rest was the most frequent risk factor for VTE (15%–67%; deep vein

  12. Instruments assessing attitudes toward or capability regarding self-management of osteoarthritis: a systematic review of measurement properties.

    Science.gov (United States)

    Eyles, J P; Hunter, D J; Meneses, S R F; Collins, N J; Dobson, F; Lucas, B R; Mills, K

    2017-08-01

    To make a recommendation on the "best" instrument to assess attitudes toward and/or capabilities regarding self-management of osteoarthritis (OA) based on available measurement property evidence. Electronic searches were performed in MEDLINE, EMBASE, CINAHL and PsychINFO (inception to 27 December 2016). Two reviewers independently rated measurement properties using the Consensus-based Standards for the selection of Health Measurement Instruments (COSMIN) 4-point scale. Best evidence synthesis was determined by considering COSMIN ratings for measurement property results and the level of evidence available for each measurement property of each instrument. Eight studies out of 5653 publications met the inclusion criteria, with eight instruments identified for evaluation: Multidimensional Health Locus of Control (MHLC), Perceived Behavioural Control (PBC), Patient Activation Measure (PAM), Educational Needs Assessment (ENAT), Stages of Change Questionnaire in Osteoarthritis (SCQOA), Effective Consumer Scale (EC-17) and Perceived Efficacy in Patient-Physician Interactions five item (PEPPI-5) and ten item scales. Measurement properties assessed for these instruments included internal consistency (k = 8), structural validity (k = 8), test-retest reliability (k = 2), measurement error (k = 1), hypothesis testing (k = 3) and cross-cultural validity (k = 3). No information was available for content validity, responsiveness or minimal important change (MIC)/minimal important difference (MID). The Dutch PEPPI-5 demonstrated the best measurement property evidence; strong evidence for internal consistency and structural validity but limited evidence for reliability and construct validity. Although PEPPI-5 was identified as having the best measurement properties, overall there is a poor level of evidence currently available concerning measurement properties of instruments to assess attitudes toward and/or capabilities regarding osteoarthritis self-management. Further

  13. Applying a Developmental Framework to the Self-Regulatory Difficulties of Young Children with Prenatal Alcohol Exposure: A Review.

    Science.gov (United States)

    Reid, Natasha; Petrenko, Christie L M

    2018-06-01

    Prenatal alcohol exposure (PAE) can be associated with significant difficulties in self-regulatory abilities. As such, interventions have been developed that focus on improving varying aspects of self-regulation for this population. The application of a multilevel theoretical framework that describes the development of self-regulation during early childhood could further advance the field. First, this framework could assist in elucidating mechanisms in the trajectories of early adjustment problems in this population and, second, informing the development of more precise assessment and interventions for those affected by PAE. The aims of the current review were to provide an overview of the self-regulatory framework proposed by Calkins and colleagues (e.g., Calkins, 2007; Calkins and Fox, 2002); examine the self-regulatory difficulties that are commonly experienced during infancy (i.e., 0 to 2 years) and early childhood (i.e., 3 to 8 years) in children with PAE in the context of the developmental framework; and describe how the framework can inform the development of future assessment and intervention provision for young children with PAE. The application of a developmental framework, such as proposed by Calkins and colleagues, allows for a systematic and theoretically driven approach to assessment and intervention programs for young children with PAE. Copyright © 2018 by the Research Society on Alcoholism.

  14. IOT Overview: IR Instruments

    Science.gov (United States)

    Mason, E.

    In this instrument review chapter the calibration plans of ESO IR instruments are presented and briefly reviewed focusing, in particular, on the case of ISAAC, which has been the first IR instrument at VLT and whose calibration plan served as prototype for the coming instruments.

  15. Cross-cultural feigning assessment: A systematic review of feigning instruments used with linguistically, ethnically, and culturally diverse samples.

    Science.gov (United States)

    Nijdam-Jones, Alicia; Rosenfeld, Barry

    2017-11-01

    The cross-cultural validity of feigning instruments and cut-scores is a critical concern for forensic mental health clinicians. This systematic review evaluated feigning classification accuracy and effect sizes across instruments and languages by summarizing 45 published peer-reviewed articles and unpublished doctoral dissertations conducted in Europe, Asia, and North America using linguistically, ethnically, and culturally diverse samples. The most common psychiatric symptom measures used with linguistically, ethnically, and culturally diverse samples included the Structured Inventory of Malingered Symptomatology, the Miller Forensic Assessment of Symptoms Test, and the Minnesota Multiphasic Personality Inventory (MMPI). The most frequently studied cognitive effort measures included the Word Recognition Test, the Test of Memory Malingering, and the Rey 15-item Memory test. The classification accuracy of these measures is compared and the implications of this research literature are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  16. Assessing medical professionalism: A systematic review of instruments and their measurement properties

    Science.gov (United States)

    Li, Honghe; Liu, Yang; Wen, Deliang

    2017-01-01

    Background Over the last three decades, various instruments were developed and employed to assess medical professionalism, but their measurement properties have yet to be fully evaluated. This study aimed to systematically evaluate these instruments’ measurement properties and the methodological quality of their related studies within a universally acceptable standardized framework and then provide corresponding recommendations. Methods A systematic search of the electronic databases PubMed, Web of Science, and PsycINFO was conducted to collect studies published from 1990–2015. After screening titles, abstracts, and full texts for eligibility, the articles included in this study were classified according to their respective instrument’s usage. A two-phase assessment was conducted: 1) methodological quality was assessed by following the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist; and 2) the quality of measurement properties was assessed according to Terwee’s criteria. Results were integrated using best-evidence synthesis to look for recommendable instruments. Results After screening 2,959 records, 74 instruments from 80 existing studies were included. The overall methodological quality of these studies was unsatisfactory, with reasons including but not limited to unknown missing data, inadequate sample sizes, and vague hypotheses. Content validity, cross-cultural validity, and criterion validity were either unreported or negative ratings in most studies. Based on best-evidence synthesis, three instruments were recommended: Hisar’s instrument for nursing students, Nurse Practitioners’ Roles and Competencies Scale, and Perceived Faculty Competency Inventory. Conclusion Although instruments measuring medical professionalism are diverse, only a limited number of studies were methodologically sound. Future studies should give priority to systematically improving the performance of existing

  17. Regulatory requirements for nuclear power plant site selection in Malaysia-a review.

    Science.gov (United States)

    Basri, N A; Hashim, S; Ramli, A T; Bradley, D A; Hamzah, K

    2016-12-01

    Malaysia has initiated a range of pre-project activities in preparation for its planned nuclear power programme. Clearly one of the first steps is the selection of sites that are deemed suitable for the construction and operation of a nuclear power plant. Here we outline the Malaysian regulatory requirements for nuclear power plant site selection, emphasizing details of the selection procedures and site characteristics needed, with a clear focus on radiation safety and radiation protection in respect of the site surroundings. The Malaysia Atomic Energy Licensing Board (AELB) site selection guidelines are in accord with those provided in International Atomic Energy Agency (IAEA) and United Stated Nuclear Regulatory Commission (USNRC) documents. To enhance the suitability criteria during selection, as well as to assist in the final decision making process, possible assessments using the site selection characteristics and information are proposed.

  18. Integrated resource planning for local gas distribution companies: A critical review of regulatory policy issues

    International Nuclear Information System (INIS)

    Harunuzzaman, M.; Islam, M.

    1994-08-01

    According to the report, public utility commissions (PUCs) are increasingly adopting, or considering the adoption of integrated resource planning (IRP) for local gas distribution companies (LDCs). The Energy Policy Act of 1992 (EPAct) requires PUCs to consider IRP for gas LDCs. This study has two major objectives: (1) to help PUCs develop appropriate regulatory approaches with regard to IRP for gas LDCs; and (2) to help PUCs respond to the EPAct directive. The study finds that it is appropriate for PUCs to pursue energy efficiency within the traditional regulatory framework of minimizing private costs of energy production and delivery; and PUCs should play a limited role in addressing environmental externalities. The study also finds that in promoting energy efficiency, PUCs should pursue policies that are incentive-based, procompetitive, and sensitive to rate impacts. The study evaluates a number of traditional and nontraditional ratemaking mechanisms on the basis of cost minimization, energy efficiency, competitiveness, and other criteria. The mechanisms evaluated include direct recovery of DSM expenses, lost revenue adjustments for DSM options, revenue decoupling mechanisms, sharing of DSM cost savings, performance-based rate of return for DSM, provision of DSM as a separate service, deregulation of DSM service, price caps, and deregulation of the noncore gas market. The study concludes with general recommendations for regulatory approaches and ratemaking mechanisms that PUCs may wish to consider in advancing IRP objectives

  19. The Effects of Degraded Digital Instrumentation and Control Systems on Human-system Interfaces and Operator Performance: HFE Review Guidance and Technical Basis

    International Nuclear Information System (INIS)

    O'Hara, J.M.; Gunther, W.; Martinez-Guridi, G.

    2010-01-01

    New and advanced reactors will use integrated digital instrumentation and control (I and C) systems to support operators in their monitoring and control functions. Even though digital systems are typically highly reliable, their potential for degradation or failure could significantly affect operator performance and, consequently, impact plant safety. The U.S. Nuclear Regulatory Commission (NRC) supported this research project to investigate the effects of degraded I and C systems on human performance and plant operations. The objective was to develop human factors engineering (HFE) review guidance addressing the detection and management of degraded digital I and C conditions by plant operators. We reviewed pertinent standards and guidelines, empirical studies, and plant operating experience. In addition, we conducted an evaluation of the potential effects of selected failure modes of the digital feedwater system on human-system interfaces (HSIs) and operator performance. The results indicated that I and C degradations are prevalent in plants employing digital systems and the overall effects on plant behavior can be significant, such as causing a reactor trip or causing equipment to operate unexpectedly. I and C degradations can impact the HSIs used by operators to monitor and control the plant. For example, sensor degradations can make displays difficult to interpret and can sometimes mislead operators by making it appear that a process disturbance has occurred. We used the information obtained as the technical basis upon which to develop HFE review guidance. The guidance addresses the treatment of degraded I and C conditions as part of the design process and the HSI features and functions that support operators to monitor I and C performance and manage I and C degradations when they occur. In addition, we identified topics for future research.

  20. The Effects of Degraded Digital Instrumentation and Control Systems on Human-system Interfaces and Operator Performance: HFE Review Guidance and Technical Basis

    Energy Technology Data Exchange (ETDEWEB)

    O' Hara, J.M.; W. Gunther, G. Martinez-Guridi

    2010-02-26

    New and advanced reactors will use integrated digital instrumentation and control (I&C) systems to support operators in their monitoring and control functions. Even though digital systems are typically highly reliable, their potential for degradation or failure could significantly affect operator performance and, consequently, impact plant safety. The U.S. Nuclear Regulatory Commission (NRC) supported this research project to investigate the effects of degraded I&C systems on human performance and plant operations. The objective was to develop human factors engineering (HFE) review guidance addressing the detection and management of degraded digital I&C conditions by plant operators. We reviewed pertinent standards and guidelines, empirical studies, and plant operating experience. In addition, we conducted an evaluation of the potential effects of selected failure modes of the digital feedwater system on human-system interfaces (HSIs) and operator performance. The results indicated that I&C degradations are prevalent in plants employing digital systems and the overall effects on plant behavior can be significant, such as causing a reactor trip or causing equipment to operate unexpectedly. I&C degradations can impact the HSIs used by operators to monitor and control the plant. For example, sensor degradations can make displays difficult to interpret and can sometimes mislead operators by making it appear that a process disturbance has occurred. We used the information obtained as the technical basis upon which to develop HFE review guidance. The guidance addresses the treatment of degraded I&C conditions as part of the design process and the HSI features and functions that support operators to monitor I&C performance and manage I&C degradations when they occur. In addition, we identified topics for future research.

  1. Guidelines for the regulatory review of the human reliability analysis in PSAs

    International Nuclear Information System (INIS)

    Reer, Bernhard; Dang, V.N.; Hirschberg, Stefan; Meyer, Patrick

    2000-01-01

    In the review guidelines recently developed for the Swiss Federal Nuclear Inspectorate, the Human Reliability Analysis (HRA) is reviewed in two stages. The preliminary review is aimed at identifying major shortcomings and potential issues to be examined in the detailed review. The detailed review comprehensively addresses the overall adequacy and transparency of the HRA. For the two review stages, 97 indicators are defined in terms of questions focusing on verifiable features of the methodology, implementation and results. The guidelines provide steps for information gathering and present examples of acceptable practices as well as of potential deficiencies. Both review stages may result in requests for clarification, additional documentation or analyses. The first applications of the guidelines consist of the preliminary reviews of two HRAs. (author)

  2. Assessing Social Networks in Patients with Psychotic Disorders: A Systematic Review of Instruments.

    Science.gov (United States)

    Siette, Joyce; Gulea, Claudia; Priebe, Stefan

    2015-01-01

    Evidence suggests that social networks of patients with psychotic disorders influence symptoms, quality of life and treatment outcomes. It is therefore important to assess social networks for which appropriate and preferably established instruments should be used. To identify instruments assessing social networks in studies of patients with psychotic disorders and explore their properties. A systematic search of electronic databases was conducted to identify studies that used a measure of social networks in patients with psychotic disorders. Eight instruments were identified, all of which had been developed before 1991. They have been used in 65 studies (total N of patients = 8,522). They assess one or more aspects of social networks such as their size, structure, dimensionality and quality. Most instruments have various shortcomings, including questionable inter-rater and test-retest reliability. The assessment of social networks in patients with psychotic disorders is characterized by a variety of approaches which may reflect the complexity of the construct. Further research on social networks in patients with psychotic disorders would benefit from advanced and more precise instruments using comparable definitions of and timescales for social networks across studies.

  3. Review of the Tandem Mirror Experiment-Upgrade (TMX-U) machine-parameter-instrumentation system

    International Nuclear Information System (INIS)

    Kane, R.J.; Coffield, F.E.; Coutts, G.W.; Hornady, R.S.

    1983-01-01

    The Tandem Mirror Experiment-Upgrade (TMX-U) machine consists of seven major machine subsystems: magnet system, neutral beam system, microwave heating (ECRH), ion heating (ICRH), gas fueling, stream guns, and vacuum system. Satisfactory performance of these subsystems is necessary to achieve the experimental objectives planned for TMX-U operations. Since the performance quality of the subsystem is important and can greatly affect plasma parameters, a 233-channel instrumentation system has been installed. Data from the instrumentation system are acquired and stored with the plasma diagnostic information. Thus, the details of the machine performance are available during post-shot analysis. This paper describes all the machine-parameter-instrumentation hardware, presents some typical data, and outlines how the data are used

  4. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 2. Evaluation of seismic designs: a review of seismic design requirements for Nuclear Power Plant Piping

    Energy Technology Data Exchange (ETDEWEB)

    1985-04-01

    This document reports the position and recommendations of the NRC Piping Review Committee, Task Group on Seismic Design. The Task Group considered overlapping conservation in the various steps of seismic design, the effects of using two levels of earthquake as a design criterion, and current industry practices. Issues such as damping values, spectra modification, multiple response spectra methods, nozzle and support design, design margins, inelastic piping response, and the use of snubbers are addressed. Effects of current regulatory requirements for piping design are evaluated, and recommendations for immediate licensing action, changes in existing requirements, and research programs are presented. Additional background information and suggestions given by consultants are also presented.

  5. Regulatory categories of probiotics across the globe: A review representing existing and recommended categorization

    Directory of Open Access Journals (Sweden)

    M Arora

    2015-01-01

    Full Text Available Probiotics are friendly live microorganisms (in most cases, bacteria that are similar to beneficial micro-organisms found in the human gut, whenever consumed, have potential to confer benefit to the health of consumers by maintaining, or improving their intestinal microbial flora and are available to consumers mainly in the form of dietary supplements and foods. All-time high interest in the field of probiotics is due to emerging probiotic industry. Probiotics are available in foods and dietary supplements, even as pharmaceutical formulations (capsules, tablets and powders and in some other forms as well, but their claims of health benefits may challenge the traditional border between food and medicine. A number of probiotic products have been already introduced into the international market as food supplements, dietary supplements, natural health products, functional foods and many more other categories; as a result, the position of regulatory system for probiotics within existing categories become vague and quite unclear. Common terminology for probiotic products has become a necessity to achieve adequate regulatory control for discussion of probiotic-related issues among government, producers and consumers. The lack of a consistent terminology across the globe leads to legal uncertainty and confusion instead of being a direct obstacle for development of a mature market. This article will explain differences in regulatory categorizations across the globe; discuss the terms like food and drugs with a close relationship to probiotics, the problems associated with unsatisfactorily approached categorization as well as suggestive consolidations for the new categorization which will demarcate probiotics into categories explaining their nutritive claims, health claims or both.

  6. Technical bases for regulatory review; comparison of practices, standards and guides

    International Nuclear Information System (INIS)

    Vinck, W.; Naurer, H.; Van Reijen, G.

    1979-01-01

    In first place, national licensing and regulatory scenes are presentd, as well as correlations between: a) Correlations and industrial standards; b) national and international developments. The purpose of harmonisation efforts and ongoing activities, especially within the EC, are highlighted. For the purpose of being sufficiently specific, three specific areas are dealt with as examples, explaining how actual application of practices and criteria in EC Member States correlate (or not) to one another including the points of convergence and divergences: protection against aircraft crash, seismic effects, protection against fuel handling accidents. Conclusive remarks deal with the origin in and relative importance of discrepancies in safety practices and criteria. (author)

  7. Assessment of psychosocial outcomes in adolescents and young adults with cancer: a systematic review of available instruments

    Directory of Open Access Journals (Sweden)

    Wakefield CE

    2013-02-01

    Full Text Available Claire E Wakefield,1,2 Pandora Patterson,3 Fiona E J McDonald,3 Helen L Wilson,1,2 Esther Davis,3 Ursula M Sansom-Daly2,41School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, NSW, Australia; 2Centre for Children's Cancer and Blood Disorders, Sydney Children's Hospital, Sydney, NSW, Australia; 3CanTeen, Sydney, NSW, Australia; 4School of Psychology, University of New South Wales, Sydney, NSW, AustraliaPurpose: Given the burgeoning body of research relating to the psychosocial needs of adolescents and young adults (AYAs with cancer, this review aimed to evaluate the psychometric properties and appropriateness of the instruments available for use in this unique population. Specifically, we reviewed published instruments developed to assess psychological distress (depression, anxiety, stress, and fear of recurrence, psychological growth (resilience, posttraumatic growth, and benefit finding, unmet needs, coping, quality of life, identity, and mindfulness-based practices and skills in AYAs with cancer. Given the dearth of validated instruments targeting AYAs with cancer, this review also provides a summary of promising measures yet to be formally validated in this population.Methods: Five electronic databases were searched by a team of six researchers, and studies involving AYAs (who have or have had cancer aged 15–30 years, and published between 1982 and 2012 were reviewed. Of 410 abstracts, 7 instruments were identified as validated in this population, with a further 19 identified as promising.Results: While there are numerous scales to assess psychosocial outcomes in cancer, few have been specifically validated for AYAs affected by cancer, particularly in the domains of psychological distress, psychological growth, coping, unmet needs, and identity. There are relatively more instruments validated, or promising, for assessment of quality of life than scales for other domains.Conclusion: In the AYA context

  8. 77 FR 55217 - Submission for OMB Review; Comment Request: Cognitive Testing of Instrumentation and Materials...

    Science.gov (United States)

    2012-09-07

    ... instrumentation, supporting materials, consent forms, and methods of administration (e.g., computer assisted personal interviews [CAPI], audio computer assisted self- interviews [ACASI], web-based interviews... participation Youth 200 1 1 \\30/60\\ 300 in PATH study. Consent forms for Adult 200 1 1 \\30/60\\ 300 participation...

  9. Mild cognitive impairment and deficits in instrumental activities of daily living: a systematic review

    NARCIS (Netherlands)

    Jekel, K.; Damian, M.; Wattmo, C.; Hausner, L.; Bullock, R.; Connelly, P.J.; Dubois, B.; Eriksdotter, M.; Ewers, M.; Graessel, E.; Kramberger, M.G.; Law, E.; Mecocci, P.; Molinuevo, J.L.; Nygard, L.; Olde Rikkert, M.G.M.; Orgogozo, J.M.; Pasquier, F.; Peres, K.; Salmon, E.; Sikkes, S.A.; Sobow, T.; Spiegel, R.; Tsolaki, M.; Winblad, B.; Frolich, L.

    2015-01-01

    INTRODUCTION: There is a growing body of evidence that subtle deficits in instrumental activities of daily living (IADL) may be present in mild cognitive impairment (MCI). However, it is not clear if there are IADL domains that are consistently affected across patients with MCI. In this systematic

  10. A qualitative review of instrumental activities of daily living in dementia: what's cooking?

    NARCIS (Netherlands)

    Sikkes, S.A.M.; de Rotrou, J.

    2014-01-01

    The measurement of instrumental activities of daily living (IADL) is common in clinical practice and research into dementia. IADL are cognitively complex daily activities, such as cooking and doing finances. Their measurement is required for the diagnostic process of dementia, and also useful for

  11. A review of instruments for screening and diagnosis of cocaine use

    NARCIS (Netherlands)

    Barrio, P.; López-Pelayo, H.; Schellekens, A.F.A.; Batalla, A.; Preedy, V.R.

    2017-01-01

    Cocaine is the second most used illicit drug worldwide. Identification of cocaine use disorders (CUD) and related aspects such as craving and CUD severity are relevant for clinical practice, public health programs, and research. There are a wide variety of instruments available for assessing CUD,

  12. Special Report on China and Chinese Provinces. Policy and Regulatory Review

    International Nuclear Information System (INIS)

    Song, A.; Hinostroza Parades, J.A.; O'Leary, M.; Owen, G.

    2010-06-01

    This review outlines the legislation and policies and roles of institutions involved in sustainable energy (renewable energy and energy efficiency) in China at Central and Provincial Government level.

  13. Reviews in Modern Astronomy 12, Astronomical Instruments and Methods at the turn of the 21st Century

    Science.gov (United States)

    Schielicke, Reinhard E.

    The yearbook series Reviews in Modern Astronomy of the Astronomische Gesellschaft (AG) was established in 1988 in order to bring the scientific events of the meetings of the society to the attention of the worldwide astronomical community. Reviews in Modern Astronomy is devoted exclusively to the invited Reviews, the Karl Schwarzschild Lectures, the Ludwig Biermann Award Lectures, and the highlight contributions from leading scientists reporting on recent progress and scientific achievements at their respective research institutes. Volume 12 continues the yearbook series with 16 contributions which were presented during the International Scientific Conference of the AG on ``Astronomical Instruments and Methods at the Turn of the 21st Century'' at Heidelberg from September 14 to 19, 1998

  14. A review of human biomonitoring data used in regulatory risk assessment under Canada's Chemicals Management Program.

    Science.gov (United States)

    Zidek, Angelika; Macey, Kristin; MacKinnon, Leona; Patel, Mikin; Poddalgoda, Devika; Zhang, Yi

    2017-03-01

    As a part of the Chemicals Management Plan launched in 2006, the Government of Canada is assessing and managing, where appropriate, the potential health and ecological risks associated with approximately 4300 substances under the Canadian Environmental Protection Act (1999). Since that time, nearly 3000 substances have been assessed, with human biomonitoring (HBM) data playing an increasingly important role for some substances. Case studies are presented, including both inorganic and organic substances (i.e., selenium, triclosan, phthalates), which highlight the impact and overall role HBM has had in regulatory decision making in Canada for these three substances as well as criteria used in the application of HBM data in human health risk assessment. An overview of its limitations in terms of how and when HBM data can be applied, when assessing human health in a regulatory setting, is discussed as well as the role HBM data can play in priority setting. Crown Copyright © 2016. Published by Elsevier GmbH. All rights reserved.

  15. Forum of Nuclear Regulatory Bodies in Africa: A Peer Review Mechanism

    International Nuclear Information System (INIS)

    Elegba, S.B.

    2010-01-01

    Uses of Radiation Sources in Africa has Safety and Security Implications that include exposure of workers in all and exposure of Patients in Medical Application. The Safety Principle is primarily: the prevention of harm and protection of health, safety and the environment. The Security Principle recognizes the importance of preventing diversion or malicious acts. Security of Radioactive Sources during use, storage, transportation and Disposal of radioactive waste is of great concern. IAEA Model Project on the “Establishment of Radiation Protection Infrastructure” in Member Sates started in 1995. During the 49. General Conference Statements made by several African Member States revealed the desire of the various Member States to embark on nuclear power for electricity generation. This development thus expanded the original scope of the discussion from radiation protection to now include nuclear safety and nuclear security. During the 50. General Conference of September 2006 Special Event entitled “New Framework for the Utilization of Nuclear Energy in the 21. Century: Assurances of Nuclear Supply and Non-Proliferation was established. Basic Safety Fundamentals SF-1, 2006 shows those basic safety principles for nuclear safety, radiation protection; Waste management and transport safety are similar. Regional Cooperation formed an organization to be known as the Forum of Nuclear Regulatory Bodies in Africa (FNRBA) to provide for the enhancement, strengthening and harmonization of the radiation protection, nuclear safety and security regulatory infrastructure and framework among the members of FNRBA

  16. Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.

    Science.gov (United States)

    Lysaght, Tamra; Kerridge, Ian H; Sipp, Douglas; Porter, Gerard; Capps, Benjamin J

    2017-06-01

    Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

  17. Minimum quality requirements for water reuse in agricultural irrigation and aquifer recharge - Towards a water reuse regulatory instrument at EU level Réédition

    OpenAIRE

    ALCALDE SANZ LAURA; GAWLIK BERND

    2017-01-01

    As an input to the design of a Legal Instrument on Water Reuse in Europe, this report recommends minimum quality requirements for water reuse in agricultural irrigation and aquifer recharge based on a risk management approach.

  18. Use of FPGA and CPLD in nuclear reactor safety systems and its regulatory review requirements for reactor safety

    International Nuclear Information System (INIS)

    Roy, Suvadip; Biswas, Animesh; Pradhan, S.K.

    2015-01-01

    Field Programmable Gate Arrays (FPGA) and Complex Programmable Logic Devices (CPLD) is being used widely in safety critical and safety related systems in nuclear power plans like in trip logic units, Engineered Safety Feature (ESF) actuation decision logic and neutronic signal processing for their reprogrammability feature and compact design. These HDL Programmable devices (HPD) are complex devices consisting of both hardware and software which is used to implement the logic on the FPGA. It is observed that these Programmable devices suffer from various modes of failure and the major failures in these devices are due to Single Event Upset (SEU), where a highly energetic ionizing radiation may lead to device failure which can even occur in radiologically benign environment. Other failures can occur during steps of developing the hardware using software tools like during Synthesis and placement and routing of the desired hardware. Here a study on use of such devices in Nuclear Reactors, study on mode of failures of these devices, way to tackle such failure and development of review guidelines for review of such devices used in safety critical and safety related systems with special emphasis on choice of software tools, way to mitigate effects of SEU and simulation and hardware testing results to be reviewed by regulatory body during design safety review is done. (author)

  19. A desk evaluation review of project VIE/4/009 design and production of nuclear instruments. Project desk evaluation

    International Nuclear Information System (INIS)

    1994-01-01

    A Project Desk Evaluation (PDE) is an intensive review process, using agreed guidelines, of the design, implementation, and the output of a project. This project is exclusively dealing with the design and production of nuclear instruments. The aim of this project would be to develop a viable capability for maintenance and repair of the nuclear instruments at the Dalat Research Institute (DNRI), the premier nuclear centre in Viet Nam, and also to meet the steadily increasing needs of DNRI, as well as of other national institutions, hospitals and universities engaged in the application of nuclear technologies, particularly in the southern part of the country. Project Summary with financial data is given along with training programme. 1 tab

  20. Comparative effectiveness of manipulation, mobilisation and the Activator instrument in treatment of non-specific neck pain: a systematic review

    Directory of Open Access Journals (Sweden)

    Miller Peter

    2006-04-01

    Full Text Available Abstract Background Neck pain is a common problem and different forms of manual therapy are used in its treatment. The purpose of this systematic review was to critically appraise the literature that directly compared manipulation, mobilisation and the Activator instrument for non-specific neck pain. Methods Electronic databases (MEDLINE, MANTIS and CINAHL were searched from their inception to October 2005 for all English language randomised clinical trials that directly compared manipulation, mobilisation and the Activator instrument. Inclusion and exclusion criteria were applied to select the studies and these studies were then evaluated using validated criteria. Results Five such studies were identified. The methodological quality was mostly poor. Findings from the studies were mixed and no one therapy was shown to be more effective than the others. Conclusion Further high quality research has to be done before a recommendation can be made as to the most effective manual method for non-specific neck pain.

  1. A desk evaluation review of project VIE/4/009 design and production of nuclear instruments. Project desk evaluation

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-12-09

    A Project Desk Evaluation (PDE) is an intensive review process, using agreed guidelines, of the design, implementation, and the output of a project. This project is exclusively dealing with the design and production of nuclear instruments. The aim of this project would be to develop a viable capability for maintenance and repair of the nuclear instruments at the Dalat Research Institute (DNRI), the premier nuclear centre in Viet Nam, and also to meet the steadily increasing needs of DNRI, as well as of other national institutions, hospitals and universities engaged in the application of nuclear technologies, particularly in the southern part of the country. Project Summary with financial data is given along with training programme. 1 tab.

  2. Financial Planning and Financial Instruments: 2013 in Review, 2014 in Prospect

    Directory of Open Access Journals (Sweden)

    Mark Brimble

    2013-09-01

    Full Text Available The Global Financial Crisis (GFC; changes in regulation; issues in public perception and trust have contributed to a troubled 2013 for financial planners. As financial planning and wealth management providers seek to bolster their professional status, the Financial Planning Education Council’s National Curriculum and Accreditation Framework and ASIC’s minimum training requirements are also a space to watch. In prospect, 2014 will offer opportunities and challenges in the form of a changed government; regulatory changes; accreditation challenges and the hope of the recruitment of strong financial planning and wealth management professionals for the future.

  3. Review: The Use of Real-Time Fluorescence Instrumentation to Monitor Ambient Primary Biological Aerosol Particles (PBAP

    Directory of Open Access Journals (Sweden)

    Mehael J. Fennelly

    2017-12-01

    Full Text Available Primary biological aerosol particles (PBAP encompass many particle types that are derived from several biological kingdoms. These aerosol particles can be composed of both whole living units such as pollen, bacteria, and fungi, as well as from mechanically formed particles, such as plant debris. They constitute a significant proportion of the overall atmospheric particle load and have been linked with adverse health issues and climatic effects on the environment. Traditional methods for their analysis have focused on the direct capture of PBAP before subsequent laboratory analysis. These analysis types have generally relied on direct optical microscopy or incubation on agar plates, followed by time-consuming microbiological investigation. In an effort to address some of these deficits, real-time fluorescence monitors have come to prominence in the analysis of PBAP. These instruments offer significant advantages over traditional methods, including the measurement of concentrations, as well as the potential to simultaneously identify individual analyte particles in real-time. Due to the automated nature of these measurements, large data sets can be collected and analyzed with relative ease. This review seeks to highlight and discuss the extensive literature pertaining to the most commonly used commercially available real-time fluorescence monitors (WIBS, UV-APS and BioScout. It discusses the instruments operating principles, their limitations and advantages, and the various environments in which they have been deployed. The review provides a detailed examination of the ambient fluorescent aerosol particle concentration profiles that are obtained by these studies, along with the various strategies adopted by researchers to analyze the substantial data sets the instruments generate. Finally, a brief reflection is presented on the role that future instrumentation may provide in revolutionizing this area of atmospheric research.

  4. VALIDATION OF ANALYTICAL METHODS AND INSTRUMENTATION FOR BERYLLIUM MEASUREMENT: REVIEW AND SUMMARY OF AVAILABLE GUIDES, PROCEDURES, AND PROTOCOLS

    Energy Technology Data Exchange (ETDEWEB)

    Ekechukwu, A.

    2008-12-17

    This document proposes to provide a listing of available sources which can be used to validate analytical methods and/or instrumentation for beryllium determination. A literature review was conducted of available standard methods and publications used for method validation and/or quality control. A comprehensive listing of the articles, papers, and books reviewed is given in Appendix 1. Available validation documents and guides are listed in the appendix; each has a brief description of application and use. In the referenced sources, there are varying approaches to validation and varying descriptions of validation at different stages in method development. This discussion focuses on validation and verification of fully developed methods and instrumentation that have been offered up for use or approval by other laboratories or official consensus bodies such as ASTM International, the International Standards Organization (ISO) and the Association of Official Analytical Chemists (AOAC). This review was conducted as part of a collaborative effort to investigate and improve the state of validation for measuring beryllium in the workplace and the environment. Documents and publications from the United States and Europe are included. Unless otherwise specified, all documents were published in English.

  5. Outcome of instrumented spinal fusion for chronic low back pain: review of 100 patients

    International Nuclear Information System (INIS)

    Qureshi, M.A; Pasha, I.F.; Malik, A.S.; Asad, A.; Aebi, M.

    2010-01-01

    Objective of this study was to evaluate the outcome of instrumented spinal fusion in selected patients with Chronic Low Back Pain (CLBP) in our setup. Consecutive first one hundred patients were selected from spine unit database that underwent instrumented spinal fusion for chronic low back pain lasting more than one year, due to degenerative disease of spine. Average age was 42 years. There were 62 males and 38 females. Diagnosis included; spinal stenosis (26%), failed disc surgery (22%), spondylolisthesis (19%), degenerative disc disease (17%), and instability (16%). Operations performed; Pedicle Screw Fixation (PSF) with Postero-lateral Fusion (PLF) in 3% patients. Trans Laminar Facet Screw (TLFS) with PLF in 24% patients. Anterior Lumbar Inter-body Fusion (ALIF) in 9% patients. Posterior Lumbar Inter-body Fusion (PLIF) in 40% patients and Trans-foraminal Lumbar Inter-body Fusion (TLIF) in 24% patients. Average follow up was for 30 months. 86% patients had full spinal fusion. 71% patients were fully satisfied with treatment, 28% were partially satisfied. Post-operatively, on average, visual analogue scale (VAS) showed 48 points significant improvement and Oswestry Disability Index (ODI) showed 53 points significant improvement. Instrumented Spinal Fusion is effective in our set up for relieving symptoms and improving functional outcome in selected patients with debilitating Chronic Low Back Pain due to degenerative disease of spine. Single fusion technique is not ideal for all types of patients and surgeon has to be versatile and trained in using different fusion techniques as the situation demands. (author)

  6. Instrumented Measurement of Balance and Postural Control in Individuals with Lower Limb Amputation: A Critical Review

    Science.gov (United States)

    Jayakaran, Prasath; Johnson, Gillian M.; Sullivan, S. John; Nitz, Jennifer C.

    2012-01-01

    Measurement of balance and postural performance that underpins activities of daily living is important in the rehabilitation of individuals with a lower limb amputation (LLA), and there are a number of methods and strategies available for this purpose. To provide an evidence-based choice of approach, this review aims to critically review the tasks…

  7. A comprehensive review of regulatory test methods for endocrine adverse health effects.

    Science.gov (United States)

    Manibusan, M K; Touart, L W

    2017-07-01

    Development of new endocrine disruption-relevant test methods has been the subject of intensive research efforts for the past several decades, prompted in part by mandates in the 1996 Food Quality Protection Act (FQPA). While scientific understanding and test methods have advanced, questions remain on whether current scientific methods are capable of adequately addressing the complexities of the endocrine system for regulatory health and ecological risk assessments. The specific objective of this article is to perform a comprehensive, detailed evaluation of the adequacy of current test methods to inform regulatory risk assessments of whether a substance has the potential to perturb endocrine-related pathways resulting in human adverse effects. To that end,  approximately 42 existing test guidelines (TGs) were considered in the evaluation of coverage for endocrine-related adverse effects. In addition to evaluations of whether test methods are adequate to capture endocrine-related effects, considerations of further enhancements to current test methods, along with the need to develop novel test methods to address existing test method gaps are described. From this specific evaluation, up to 35 test methods are capable of informing whether a chemical substance perturbs known endocrine related biological pathways. Based on these findings, it can be concluded that current validated test methods are adequate to discern substances that may perturb the endocrine system, resulting in an adverse health effect. Together, these test methods predominantly form the core data requirements of a typical food-use pesticide registration submission. It is recognized, however, that the current state of science is rapidly advancing and there is a need to update current test methods to include added enhancements to ensure continued coverage and public health and environmental protection.

  8. Risk prediction in the community: A systematic review of case-finding instruments that predict adverse healthcare outcomes in community-dwelling older adults.

    LENUS (Irish Health Repository)

    O'Caoimh, Rónán

    2015-09-01

    Few case-finding instruments are available to community healthcare professionals. This review aims to identify short, valid instruments that detect older community-dwellers risk of four adverse outcomes: hospitalisation, functional-decline, institutionalisation and death. Data sources included PubMed and the Cochrane library. Data on outcome measures, patient and instrument characteristics, and trial quality (using the Quality In Prognosis Studies [QUIPS] tool), were double-extracted for derivation-validation studies in community-dwelling older adults (>50 years). Forty-six publications, representing 23 unique instruments, were included. Only five were externally validated. Mean patient age range was 64.2-84.6 years. Most instruments n=18, (78%) were derived in North America from secondary analysis of survey data. The majority n=12, (52%), measured more than one outcome with hospitalisation and the Probability of Repeated Admission score the most studied outcome and instrument respectively. All instruments incorporated multiple predictors. Activities of daily living n=16, (70%), was included most often. Accuracy varied according to instruments and outcomes; area under the curve of 0.60-0.73 for hospitalisation, 0.63-0.78 for functional decline, 0.70-0.74 for institutionalisation and 0.56-0.82 for death. The QUIPS tool showed that 5\\/23 instruments had low potential for bias across all domains. This review highlights the present need to develop short, reliable, valid instruments to case-find older adults at risk in the community.

  9. Reliability and Validity of Survey Instruments to Measure Work-Related Fatigue in the Emergency Medical Services Setting: A Systematic Review

    Science.gov (United States)

    2018-01-11

    Background: This study sought to systematically search the literature to identify reliable and valid survey instruments for fatigue measurement in the Emergency Medical Services (EMS) occupational setting. Methods: A systematic review study design wa...

  10. 76 FR 38328 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-06-30

    ... process? 2. What criteria should the Commission use to prioritize the review of existing regulations? 3... the spirit of the Executive Orders. The Commission states that ``Phase One'' of a retrospective...

  11. Development of Risk Insights for Regulatory Review of a Near-Surface Disposal Facility for Radioactive Waste

    International Nuclear Information System (INIS)

    Esh, D.W.; Ridge, A.C.; Thaggard, M.

    2006-01-01

    Section 3116 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA) requires the Department of Energy (DOE) to consult with the Nuclear Regulatory Commission (NRC) about non-High Level Waste (HLW) determinations. In its consultative role, NRC performs technical reviews of DOE's waste determinations but does not have regulatory authority over DOE's waste disposal activities. The safety of disposal is evaluated by comparing predicted disposal facility performance to the performance objectives specified in NRC regulations for the disposal of low-level waste (10 CFR Part 61 Subpart C). The performance objectives contain criteria for protection of the public, protection of inadvertent intruders, protection of workers, and stability of the disposal site after closure. The potential radiological dose to receptors typically is evaluated with a performance assessment (PA) model that simulates the release of radionuclides from the disposal site, transport of radionuclides through the environment, and exposure of potential receptors to residual contamination for thousands of years. This paper describes NRC's development and use of independent performance assessment modeling to facilitate review of DOE's non-HLW determination for the Saltstone Disposal Facility (SDF) at the Savannah River Site. NRC's review of the safety of near-surface disposal of radioactive waste at the SDF was facilitated and focused by risk insights developed with an independent PA model. The main components of NRC's performance assessment model are presented. The development of risk insights that allow the staff to focus review efforts on those areas that are most important to satisfying the performance objectives is discussed. Uncertainty analysis was performed of the full stochastic model using genetic variable selection algorithms. The results of the uncertainty analysis were then used to guide the development of simulations of other scenarios to understand the key risk

  12. INTEGRATED ON-BOARD COMPUTING SYSTEMS: PRESENT SITUATION REVIEW AND DEVELOPMENT PROSPECTS ANALYSIS IN THE AVIATION INSTRUMENT-MAKING INDUSTRY

    Directory of Open Access Journals (Sweden)

    P. P. Paramonov

    2013-03-01

    Full Text Available The article deals with present situation review and analysis of development prospects for integrated on-board computing systems, used in the aviation instrument-making industry. The main attention is paid to the projects carried out in the framework of an integrated modular avionics. Hierarchical levels of module design, crates (onboard systems and aviation complexes are considered in detail. Examples of the existing products of our country and from abroad and their brief technical characteristics are given and voluminous bibliography on the subject matter as well.

  13. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 5. Summary - Piping Review Committee conclusions and recommendations

    International Nuclear Information System (INIS)

    1985-04-01

    This document summarizes a comprehensive review of NRC requirements for Nuclear Piping by the US NRC Piping Review Committee. Four topical areas, addressed in greater detail in Volumes 1 through 4 of this report, are included: (1) Stress Corrosion Cracking in Piping of Boiling Water Reactor Plants; (2) Evaluation of Seismic Design; (3) Evaluation of Potential for Pipe Breaks; and (4) Evaluation of Other Dynamic Loads and Load Combinations. This volume summarizes the major issues, reviews the interfaces, and presents the Committee's conclusions and recommendations for updating NRC requirements on these issues. This report also suggests research or other work that may be required to respond to issues not amenable to resolution at this time

  14. Antisocial personality disorder and psychopathy in women: a literature review on the reliability and validity of assessment instruments.

    Science.gov (United States)

    Dolan, Mairead; Völlm, Birgit

    2009-01-01

    Crime rates are low in women compared to men. The two disorders most commonly associated with offending behaviour, antisocial personality disorder (ASPD) and psychopathy, are also less prevalent in female samples. However, developments in forensic psychiatry have often ignored gender, and the utility of constructs such as psychopathy and their assessment instruments in female samples remains unclear. This article presents a review of studies looking at rates of ASPD and psychopathy and on the reliability and validity of assessment instruments of these disorders in women. Gender differences in symptom patterns will be considered. The literature seems to suggest that DSM-IV criteria for ASPD may lead to an underestimation of the prevalence of the disorder in women due to the requirement of childhood conduct disorder symptoms. The Psychopathy Checklist-Revised (PCL-R) is a valid and reliable instrument to identify psychopathy in women but there are gender differences in the factor structure and item loadings on this measure. Research to date seems to suggest a three-factor model may be most strongly supported in females. Preliminary evidence suggests the PCL-R may have some value in predicting future offending while the PCL:SV may be useful in predicting institutional violence. Clinical implications are discussed.

  15. Fifty Years of Safeguards under the EURATOM Treaty. A Regulatory Review

    International Nuclear Information System (INIS)

    Patel, B.; Chare, P.

    2007-01-01

    March 2007 marked the 50th anniversary of the signing of one of the founding treaties of the European Community. The EURATOM Treaty has its origins at a time when the stability of energy supplies in Europe was a major concern. Recently, much debate has centred on the possible reform or repeal of some parts of the treaty, given that its original aim was to promote and oversee the development of nuclear energy in Europe. This debate has focused attention on the future contribution of nuclear power to increasing energy demands in an enlarged Europe. However, despite these issues there is near universal agreement that the EURATOM Treaty has played a vital role in the protection of European citizens through the controls required for nuclear materials. Chapter 7 of the treaty (Safeguards) confers wide regulatory powers to the European Commission to ensure that civil nuclear materials are not diverted from their intended use as declared by the operators. This paper describes the early period of operation of the safeguards inspectorate, and gives statistics on the numbers and types of inspections carried out by the EURATOM inspectors, and discusses from an operational point of view the value of inspection activities. Further, a critical appraisal of Articles 77-85 within Chapter 7 is made. The paper also considers those safeguards requirements that are important to strengthen, in order to maintain a strong regulatory system to oversee future challenges, particularly in the context of increasing decommissioning activities within Europe. It is noteworthy that fifty-years after the founding of the treaty, many of the concerns about security of energy supply have re-emerged. It is a measure of the vision and forward thinking of its founders that the treaty has successfully overseen the safe and secure development of nuclear power in Europe (which currently provides a third of its electricity needs) and despite the many changes and developments that have occurred, that the

  16. 76 FR 39343 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-07-06

    ... proposes to use to set priorities for the retrospective review of its regulations; (2) identifies an... agency use in setting priorities? The factors ED will use in setting priorities for the retrospective... existing regulations), and priorities, requirements, definitions, and selection criteria governing...

  17. 76 FR 79141 - List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act

    Science.gov (United States)

    2011-12-21

    ... initial notice within a reasonable time after establishing a customer relationship in two additional..., requires an agency to review its rules that have a significant economic impact upon a substantial number of... be amended or rescinded * * * to minimize any significant economic impact of the rules upon a...

  18. 76 FR 13532 - Reducing Regulatory Burden; Retrospective Review Under Executive Order 13563

    Science.gov (United States)

    2011-03-14

    ... maintain and strengthen the Nation's economy by enabling the establishment and viability of small... review existing rules to remove outdated regulations that stifle job creation and make the U.S. economy... needs fixing and why. Comments do not necessarily have to address how to fix the perceived problem...

  19. 77 FR 71743 - List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act

    Science.gov (United States)

    2012-12-04

    ... complexity of the rule; The extent to which the rule overlaps, duplicates or conflicts with other federal... 19251 (Mar. 30, 1981). List of Rules To Be Reviewed Title: Role of Independent Directors of Investment... solely of independent directors that oversees the fund's accounting and auditing processes; (ii) adopts...

  20. 76 FR 18134 - Reducing Regulatory Burden; Review Under E.O. 13563

    Science.gov (United States)

    2011-04-01

    ... regulations for review, alternative approaches, etc.--to help prepare the preliminary plan. There will be... private defined benefit plans. PBGC receives no funds from general tax revenues. Operations are financed... participants, improve transparency, simplify filing, provide relief for small businesses, and assist plans to...

  1. 76 FR 17572 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-03-30

    ... businesses and the public. Agencies must consider approaches that maintain freedom of choice and flexibility... regulations, invites interested members of the public to submit comments on its preliminary plan to review....regulations.gov . Additional Instructions. In general, comments received, including attachments and other...

  2. Diagnostic accuracy of portable instrumental devices to measure sleep bruxism: a systematic literature review of polysomnographic studies.

    Science.gov (United States)

    Manfredini, D; Ahlberg, J; Castroflorio, T; Poggio, C E; Guarda-Nardini, L; Lobbezoo, F

    2014-11-01

    This study systematically reviews the sleep bruxism (SB) literature published in the MEDLINE and Scopus databases to answer the following question: What is the validity of the different portable instrumental devices that have been proposed to measure SB if compared with polysomnographic (PSG) recordings assumed as the gold standard? Four clinical studies on humans, assessing the diagnostic accuracy of portable instrumental approaches (i.e. Bitestrip, electromyography (EMG)-telemetry recordings and Bruxoff) with respect to PSG, were included in the review. Methodological shortcomings were identified by QUADAS-2 quality assessment. Findings showed contrasting results and supported only in part the validity of the described diagnostic devices with respect to PSG. The positive predictive value (PPV) of the Bitestrip device was 59-100%, with a sensitivity of 71-84·2%, whilst EMG-telemetry recordings had an unacceptable rate of false-positive findings (76·9%), counterbalanced by an almost perfect sensitivity (98·8%). The Bruxoff device had the highest accuracy values, showing an excellent agreement with PSG for both manual (area under ROC = 0·98) and automatic scoring (0·96) options as well as for the simultaneous recording of events with respect to PSG (0·89-0·91). It can be concluded that the available information on the validity of portable instrumental diagnostic approaches with respect to PSG recordings is still scarce and not solid enough to support any non-PSG technique's employ as a stand-alone diagnostic method in the research setting, with the possible exception of the Bruxoff device that needs to be further confirmed with future investigations. © 2014 John Wiley & Sons Ltd.

  3. Validity and reliability of instruments to assess potential mediators of children's physical activity: A systematic review

    NARCIS (Netherlands)

    Brown, H.; Hume, C.; Chin A Paw, J.M.M.

    2009-01-01

    This paper aimed to (1) identify potential mediators reported in children's physical activity interventions; and (2) review the psychometric properties of measures of potential mediators included in such interventions. A systematic search of the literature was conducted and studies that reported

  4. Instrumental investigations in primary headache. An updated review and new perspectives

    DEFF Research Database (Denmark)

    Friberg, Lars; Sandrini, Giorgio; Jänig, Wilfrid

    2003-01-01

    of Neurological Societies has recently proposed guidelines and recommendations on the use of neurophysiological tests and neuroimaging procedures in non-acute headache. This article reviews many of the most important literature references relevant to this topic and looks at the prospects for future research....

  5. The U.S. Nuclear Regulatory Commission's antitrust review of nuclear power plants: the conditioning of licenses

    International Nuclear Information System (INIS)

    Penn, D.W.; Delaney, J.B.; Honeycutt, T.C.

    1976-04-01

    The 1970 amendments to Section 105 of the Atomic Energy Act require the Nuclear Regulatory Commission to conduct a prelicensing antitrust review of applications for licenses to construct and operate nuclear power plants. The Commission must make a finding as to whether the granting of a license 'would create or maintain a situation inconsistent with the antitrust laws,' and it has the authority to issue or continue a license, to refuse to issue a license, to rescind or amend a license, and to issue a license with conditions that it deems appropriate. This report provides information about the antitrust license conditions that have resulted from the NRC's antitrust review process. The process itself is described and a catalog of the applications requiring antitrust license conditions is presented. For each application, the license conditions are put into the general categories of unit access, transmission services, coordination, and contractual provisions. For completeness, the report also catalogs applications requiring no antitrust license conditions, and lists applications that were exempted from the 1970 amendments, are the subject of litigation, or have been withdrawn

  6. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 3. Evaluation of potential for pipe breaks

    Energy Technology Data Exchange (ETDEWEB)

    1984-11-01

    The Executive Director for Operations (EDO) in establishing the Piping Review Committee concurred in its overall scope that included an evaluation of the potential for pipe breaks. The Pipe Break Task Group has responded to this directive. This report summarizes a review of regulatory documents and contains the Task Group's recommendations for application of the leak-before-break (LBB) approach to the NRC licensing process. The LBB approach means the application of fracture mechanics technology to demonstrate that high energy fluid piping is very unlikely to experience double-ended ruptures or their equivalent as longitudinal or diagonal splits. The Task Group's reommendations and discussion are founded on current and ongoing NRC staff actions as presented in Section 3.0 of this report. Additional more detailed comments and discussion are presented in Section 5.0 and in Appendices A and B. The obvious issues are the reexamination of the large pipe break criteria and the implications of any changes in the criteria as they influence items such as jet loads and pipe whip. The issues have been considered and the Task Group makes the following recommendations.

  7. Insight from a Critical Review on the Safety Analysis of Nuclear Fuel Cycle Facility for Domestic Regulatory System

    International Nuclear Information System (INIS)

    Hong, Soon Joon; Chung, Young Wook; Jeong, Seung Young

    2010-01-01

    Korea has 20 nuclear power plants in operation, and 10,761 ton of spent fuel deposited in plant sites. The capacity of reservoir for spent fuel in plant sites is to begin to be full in 2016. The light water reactors of 16 units generate around 320 ton/year and the heavy water reactors of 4 units around 380 ton/year in Korea. And the electricity generated by nuclear power plants is planned to increase up to 59% share by 2030. Spent fuel classified as high level radioactive waste in law is characterized by high level radiation, high heat generation, and high radiological toxicity. In the contrary, it is also a very useful domestic energy source. Thus, the safe management of spent fuel is very important confronting job in nuclear industry. Advanced fuel cycle (AFC) using pyro-process is an innovative technology, by which environmental load is drastically relieved because the extracted long-lived fission products are burn in fast breeder reactors. Domestic nuclear industry also has a perspective road map for the construction of AFC facilities. However, there is not a sufficiently detailed licensing regulatory system yet. Moreover, there is no systematic frame for the safety evaluation. This paper reviews the safety analysis system of foreign fuel cycle facilities. Critical review leads to the insight for setting-up safety analysis system of domestic AFC facilities

  8. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 3. Evaluation of potential for pipe breaks

    International Nuclear Information System (INIS)

    1984-11-01

    The Executive Director for Operations (EDO) in establishing the Piping Review Committee concurred in its overall scope that included an evaluation of the potential for pipe breaks. The Pipe Break Task Group has responded to this directive. This report summarizes a review of regulatory documents and contains the Task Group's recommendations for application of the leak-before-break (LBB) approach to the NRC licensing process. The LBB approach means the application of fracture mechanics technology to demonstrate that high energy fluid piping is very unlikely to experience double-ended ruptures or their equivalent as longitudinal or diagonal splits. The Task Group's reommendations and discussion are founded on current and ongoing NRC staff actions as presented in Section 3.0 of this report. Additional more detailed comments and discussion are presented in Section 5.0 and in Appendices A and B. The obvious issues are the reexamination of the large pipe break criteria and the implications of any changes in the criteria as they influence items such as jet loads and pipe whip. The issues have been considered and the Task Group makes the following recommendations

  9. Weight of evidence approaches for the identification of endocrine disrupting properties of chemicals: Review and recommendations for EU regulatory application.

    Science.gov (United States)

    Gross, Melanie; Green, Richard M; Weltje, Lennart; Wheeler, James R

    2017-12-01

    A Weight-of-evidence (WoE) evaluation should be applied in assessing all the available data for the identification of endocrine disrupting (ED) properties of chemicals. The European Commission draft acts specifying criteria under the biocidal products and plant protection products regulations require that WoE is implemented for the assessment of such products. However, only some general considerations and principles of how a WoE should be conducted are provided. This paper reviews WoE approaches to distil key recommendations specifically for the evaluation of potential ED properties of chemicals. In a manner, which is consistent with existing, published WoE frameworks, the WoE evaluation of ED properties can be divided into four phases: 1) Definition of causal questions and data gathering and selection, 2) Review of individual studies, 3) Data integration and evaluation, and 4) Drawing conclusions based on inferences. Recommendations are made on how to conduct each phase robustly and transparently to help guide the WoE evaluation of potential endocrine disrupting properties of chemicals within a European regulatory context. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  10. The NEA International FEP Database and its use in support of regulatory review

    International Nuclear Information System (INIS)

    Sumerling, T.

    1999-01-01

    A working group of the Nuclear Energy Agency has developed a database of features, events and processes (FEPs) relevant to the assessment of the long-term safety of radioactive waste disposal facilities. The Environment Agency participated in this work as described in a previous report, R and D Technical Report P97. This report describes work done in order to (i) provide an electronic version of the NEA International FEP Database in a convenient form suited to the Agency's needs; (ii) determine procedures for use of the Database in support of the Agency's review of an applicant's safety case for solid radioactive disposal, and in other appropriate Agency activities. Section 1 of the report outlines the objectives and work done. Section 2 gives an overview of the current status, development and international use of the NEA FEP Database. Alternative uses of the Database by the Agency, and procedures for use, are discussed in Section 3. Two alternative procedures for use of the Database in scientific and technical review of an applicant's safety case are outlined and compared; these provide a framework for orderly identification and discussion of technical issues within the review. It is concluded that the way in which the Database is used will depend on the circumstances and also the aims and preferences of the Agency. Detailed procedures for the use of the Database are best defined for the specific circumstances, taking account of the level of information available from the applicant, and the time and resources which the Agency may wish to devote to a given phase of review. The NEA FEP Database has been developed as a tool to assist in performing or reviewing safety assessments of radioactive waste disposal facilities. The principle of the Database, and also the software framework, may be equally applicable to other technical or scientific assessments, e.g. of landfill facilities or river catchment pollution studies. Since the Database is now available to the Agency

  11. Does playing a musical instrument impose a risk for temporomandibular disorders? A review of literature: Stellt das Spielen eines Instruments ein Risiko für kraniomandibuläre Dysfunktionen dar? Eine Übersichtsarbeit

    NARCIS (Netherlands)

    van Selms, M.K.A.; Attallah, M.M.; Visscher, C.M.; Ahlberg, J.; Lobbezoo, F.

    2015-01-01

    Playing a musical instrument that loads the masticatory system, such as the violin or oboe, has been suggested to be part of the group of etiological factors for temporomandibular disorders (TMDs). In 2014, a review of literature was published that explicitly focused on the possible association

  12. Food marketing to children in India: comparative review of regulatory strategies across the world.

    Science.gov (United States)

    Bhatnagar, Nidhi; Kaur, Ravneet; Dudeja, Puja

    2014-11-01

    Food marketing directed to children is an issue of concern in the present day society. Revolution in food industry, increasing globalization and boom in information technology has introduced various types of food products and the way they are placed in front of likely consumers. This has resulted in rising trend of obesity and switch from communicable to non-communicable diseases, which is not cost effective for nation as a whole. Multinational companies have targeted children as a naïve audience to boost their sales. In-ethical practice of misleading claims in the advertisements is instrumental in many cases. Food marketing to children has been assumed a public health threat since times of yore. World Health Organization has resolutions and recommendations on this subject. Member countries, including India are a signatory to this declaration. However, much needs to be done to counter these multinational food giants. Regulations and policies need to be enforced at national and institutional levels. Parents must be educated; schools and social organizations to be made proactive on this aspect.

  13. Patient-reported outcome instruments that evaluate adherence behaviours in adults with asthma: A systematic review of measurement properties.

    Science.gov (United States)

    Gagné, Myriam; Boulet, Louis-Philippe; Pérez, Norma; Moisan, Jocelyne

    2018-04-30

    To systematically identify the measurement properties of patient-reported outcome instruments (PROs) that evaluate adherence to inhaled maintenance medication in adults with asthma. We conducted a systematic review of six databases. Two reviewers independently included studies on the measurement properties of PROs that evaluated adherence in asthmatic participants aged ≥18 years. Based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), the reviewers (1) extracted data on internal consistency, reliability, measurement error, content validity, structural validity, hypotheses testing, cross-cultural validity, criterion validity, and responsiveness; (2) assessed the methodological quality of the included studies; (3) assessed the quality of the measurement properties (positive or negative); and (4) summarised the level of evidence (limited, moderate, or strong). We screened 6,068 records and included 15 studies (14 PROs). No studies evaluated measurement error or responsiveness. Based on methodological and measurement property quality assessments, we found limited positive evidence of: (a) internal consistency of the Adherence Questionnaire, Refined Medication Adherence Reason Scale (MAR-Scale), Medication Adherence Report Scale for Asthma (MARS-A), and Test of the Adherence to Inhalers (TAI); (b) reliability of the TAI; and (c) structural validity of the Adherence Questionnaire, MAR-Scale, MARS-A, and TAI. We also found limited negative evidence of: (d) hypotheses testing of Adherence Questionnaire; (e) reliability of the MARS-A; and (f) criterion validity of the MARS-A and TAI. Our results highlighted the need to conduct further high-quality studies that will positively evaluate the reliability, validity, and responsiveness of the available PROs. This article is protected by copyright. All rights reserved.

  14. Review of light water reactor regulatory requirements: Assessment of selected regulatory requirements that may have marginal importance to risk: Postaccident sampling system, Turbine missiles, Combustible gas control, Charcoal filters

    International Nuclear Information System (INIS)

    Scott, W.B.; Jamison, J.D.; Stoetzel, G.A.; Tabatabai, A.S.; Vo, T.V.

    1987-05-01

    In a study commissioned by the Nuclear Regulatory Commission (NRC), Pacific Northwest Laboratory (PNL) evaluated the costs and benefits of modifying regulatory requirements in the areas of the postaccident sampling system, turbine rotor design reviews and inspections, combustible gas control for inerted Boiling Water Reactor (BWR) containments, and impregnated charcoal filters in certain plant ventilation systems. The basic framework for the analyses was that presented in the Regulatory Analysis Guidelines (NUREG/BR-0058) and in the Handbook for Value-Impact Assessment (NUREG/CR-3568). The effects of selected modifications to regulations were evaluated in terms of such factors as public risk and costs to industry and NRC. The results indicate that potential modifications of the regulatory requirements in three of the four areas would have little impact on public risk. In the fourth area, impregnated charcoal filters in building ventilation systems do appear to limit risks to the public and plant staff. Revisions in the severe accident source term assumptions, however, may reduce the theoretical value of charcoal filters. The cost analysis indicated that substantial savings in operating costs may be realized by changing the interval of turbine rotor inspections. Small to moderate operating cost savings may be realized through postulated modifications to the postaccident sampling system requirements and to the requirements for combustible gas control in inerted BWR containments. Finally, the use of impregnated charcoal filters in ventilation systems appears to be the most cost-effective method of reducing radioiodine concentrations

  15. The role of efficiency estimates in regulatory price reviews: Ofgem's approach to benchmarking electricity networks

    International Nuclear Information System (INIS)

    Pollitt, Michael

    2005-01-01

    Electricity regulators around the world make use of efficiency analysis (or benchmarking) to produce estimates of the likely amount of cost reduction which regulated electric utilities can achieve. This short paper examines the use of such efficiency estimates by the UK electricity regulator (Ofgem) within electricity distribution and transmission price reviews. It highlights the place of efficiency analysis within the calculation of X factors. We suggest a number of problems with the current approach and make suggestions for the future development of X factor setting. (author)

  16. Rotary science and its impact on instrument separation: A focused review

    Science.gov (United States)

    Khasnis, Sandhya Anand; Kar, Prem Prakash; Kamal, Apoorva; Patil, Jayaprakash D.

    2018-01-01

    Efficient endodontic treatment demands thorough debridement of the root canal system with minimal procedural errors. The inherent weakness of nickel–titanium alloys is their unexpected breakage. Modifications in the design, manufacturing, thermomechanical and surface treatment of alloys and advancements in movement kinetics have shown to improve the fatigue properties of the alloys, reducing the incidence of separation. This review enlightens the impact of these factors on fatigue properties of the alloy. PMID:29674810

  17. The alignment of the LHC low beta triplets. Review of instrumentation and methods

    International Nuclear Information System (INIS)

    Coosemans, W.; Mainaud Durand, H.; Marin, A.; Quesnel, J-P.

    2003-01-01

    Alignment tolerances for the LHC insertions are particularly stringent regarding the low beta quadrupoles, which induce strict positioning tolerances, in a severe environment (high radiation fluxes and magnetic fields): positioning of one inner triplet with respect to the other (left/right side): ±0.5 mm (3σ), stability of the positioning of one quadrupole inside its triplet: a few microns. We propose to continuously monitor the relative position of the quadrupoles of one inner triplet with respect to a reference frame materialized by a wire and a water surface, and to use common references to link a triplet on one side to the triplet on the other side of the experiment. When the offset between real and reference position becomes too great, the quadrupole will be moved using remote motorized jacks. Instrumentation (HLS, WPS, radial measuring system, etc.) and methods will be detailed as well as the first results obtained on a cryo-magnet prototype named TAP used as test facility. The TAP is equipped with HLS linked by two types of hydraulic networks (two pipes with air and water separated, one pipe half filled), WPS and one inclinometer. It is installed on three polyurethane motorized jacks in order to study and compare servo positioning using the different sensors. (author)

  18. Probabilistic safety assessment for digital instrumentation and control systems in nuclear power plants - a review

    International Nuclear Information System (INIS)

    Lu, L.; Jiang, J.

    2003-01-01

    Deregulation in electricity market has created a great deal of challenges for nuclear power industries [1]. To stay competitive, Nuclear Power Plants (NPPs) will have to find ways to reduce their operational costs and to improve the plant safety. Instrumentation and Control (I and C) systems play an important role in this regard. Thus, new methodologies need to be developed to manage the operation of I and C systems more economically without jeopardizing the overall plant safety. Probabilistic Safety Assessment (PSA) technique is one of the promising methods to deal with such an issue, because PSA analyzes various system operational issues from a probabilistic sense, rather than a worst-case approach. However, there are several limitations when PSA is applied to I and C systems directly. A possible solution to this problem can be found by incorporating PSA with several other approaches. To better understand the issues involved, an attempt has been made in this paper to carry out a literature survey on this and related subject, particularly the effort will be made on: 1) the development of digital I and C systems in NPP, 2) PSA and its potential benefits and limitations, and 3) applications of PSA in various aspects of I and C systems including the resource allocation, the determination of surveillance testing strategies and the design of I and C systems. Finally, some solutions to overcome the aforementioned obstacles when applying PSA in I and C systems are also examined critically. (author)

  19. Review of Regulatory Quality Assurance Requirements for the Operation of Nuclear R and D Facilities

    International Nuclear Information System (INIS)

    Kwon, Hyuk Il; Lim, Nam Jin

    2005-01-01

    Korea Atomic Energy Research Institute (KAERI) has many R and D facilities in operation, including HANARO research reactor, radioactive waste treatment facility (RWTF), post-irradiation examination facility (PIEF) and irradiated material test facility (IMEF). Recently, nation-wide interest is focused on the safety and security of major industrial facilities. Safe operation of nuclear facilities is imperative because of the consequence of public disaster by radiological release/ contamination, in case of an accident. Recently, Ministry of Science and Technology (MOST) of the Korean government announced amendments of Atomic Energy laws to enforce requirements of the physical protection and radiological emergency. In this paper, the context of amended Atomic Energy laws were reviewed to confirm quality assurance measures and identify additional QA activities, if any, that is required by the amendment

  20. Development of regulatory guide for review of aging management of the operating NPP

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Tae Myung; Lee, Jae Kyung [Cheongju Univ., Cheongju (Korea, Republic of); Kim, Young Ryul [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    2001-03-15

    This is the final report of the second year study. Based on the first year study, proposal of revised guidelines, analysis of revised or newly issued IAEA safety guides and reference guidelines of developed countries, and proposal of detailed guidelines of aging management in PSR have been performed in the second year study. The summary of results in the study so far can be summarized as below, overall view on PSR and idea of effective domestic application were leaded through additional investigation and comparison of legal basis, experiences and current status of PSR implementation among the countries having operating NPPs including Korea. Strategies of adequate application of PSR are roughly reevaluated and totally reestablished in summary from the analysis in factor by factor basis of PSR implementation experience in foreign countries and background of IAEA guidelines. Models and draft framework of PSR report in the first year study were summarized and reevaluated, and structure and outline options of PSR guidelines for judging the PSR report are newly proposed with comparison of their strengths and weaknesses based on the first year study. Among the opt ions, guidelines framework equivalent to the PSR report was picked up as the best. For the judgement of aging management, the most appropriate one was chosen for the detailed judgement of aging management review in our PSR being based on the Standard Review Plan for License Renewal (SRP-LR) in United States considering potential future usage in the judgement for continued operation of old NPP at the time of expiration of its design life. A draft PSR guidelines is prepared and attached by revision of basic guidelines issued in 2000, considering the issues discussed for the draft revision of IAEA PSR guide, the draft IAEA document about 'experience of PSR implementation of member states', and the characteristics of Hungarian PSR Guidelines.

  1. Limitation of liability for maritime claims: Chronological critical review (international instruments and Croatian solutions

    Directory of Open Access Journals (Sweden)

    Vasilj Aleksandra V.

    2016-01-01

    Full Text Available Limitation of liability of shipowner can based on property or can be personal - shipowner responds to certain part of the property (for example ship or his entire assets to a certain amount. In the first case it is a real, and in the other the personal limitation of liability. On these principles all international instruments in this legal field have been developed. One of the well-known 'universal' principle of civil law says that the injurer must pay for a damage in full, in full extent and amount. However, when we are applying provisions of maritime law (as well as transport law in general on the liability for damages and its compensation, the situation is quite opposite. Though, that the amount of suffered damages is coming closer to said universal principle of civil law has been confirmed by Amendments to the Protocol to the Convention on Limitation of Liability for Maritime Claims 1996 (LLMC 1996. These Amendments increased amount of general (global limitation of liability for maritime claims by 51% compared to the amounts in LLMC. Increased amounts are applicable from 8th June 2015. Regarding these amendments, a number of issues can be placed: justification for introducing the institute of limitation of liability in general; reasons why the injurer is privileged in maritime (and broader in transport, in the context of the amount of the obligation of compensation for damage; and whether the application of the institute undermine the principle that is enshrined in the legal system of every modern country, according to which the injured party has the right to just compensation. On the other hand, justice can be taken as well as an argument just to implement the limitation of liability system.

  2. Posterior Rigid Instrumentation of C7: Surgical Considerations and Biomechanics at the Cervicothoracic Junction. A Review of the Literature.

    Science.gov (United States)

    Bayoumi, Ahmed B; Efe, Ibrahim E; Berk, Selim; Kasper, Ekkehard M; Toktas, Zafer Orkun; Konya, Deniz

    2018-03-01

    The cervicothoracic junction is a challenging anatomic transition in spine surgery. It is commonly affected by different types of diseases that may significantly impair stability in this region. The seventh cervical vertebra (C7) is an atypical cervical vertebra with unique anatomic features compared to subaxial cervical spine (C3 to C6). C7 has relatively broader laminae, larger pedicles, smaller lateral masses, and a long nonbifid spinous process. These features allow a variety of surgical methods for performing posterior rigid instrumentation in the form of different types of screws, such as lateral mass screws, pedicle screws, transfacet screws, and intralaminar screws. Many biomechanical studies on cadavers have evaluated and compared different types of implants at C7. We reviewed PubMed/Medline by using specific combinations of keywords to summarize previously published articles that examined C7 posterior rigid instrumentation thoroughly in an experimental fashion on patients or cadavers with additional descriptive radiologic parameters for evaluation of the optimum surgical technique for each type. A total of 44 articles were reported, including 22 articles that discussed anatomic considerations (entry points, sagittal and axial trajectories, and features of screws) and another 22 articles that discussed the relevant biomechanical testing at this transitional region if C7 was directly involved in terms of receiving posterior rigid implants. C7 can accommodate different types of screws, which can provide additional benefits and risks based on availability of bony purchase, awareness of surgical technique, biomechanics, and anatomic considerations. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. A Systematic Review of Statistical Methods Used to Test for Reliability of Medical Instruments Measuring Continuous Variables

    Directory of Open Access Journals (Sweden)

    Rafdzah Zaki

    2013-06-01

    Full Text Available   Objective(s: Reliability measures precision or the extent to which test results can be replicated. This is the first ever systematic review to identify statistical methods used to measure reliability of equipment measuring continuous variables. This studyalso aims to highlight the inappropriate statistical method used in the reliability analysis and its implication in the medical practice.   Materials and Methods: In 2010, five electronic databases were searched between 2007 and 2009 to look for reliability studies. A total of 5,795 titles were initially identified. Only 282 titles were potentially related, and finally 42 fitted the inclusion criteria. Results: The Intra-class Correlation Coefficient (ICC is the most popular method with 25 (60% studies having used this method followed by the comparing means (8 or 19%. Out of 25 studies using the ICC, only 7 (28% reported the confidence intervals and types of ICC used. Most studies (71% also tested the agreement of instruments. Conclusion: This study finds that the Intra-class Correlation Coefficient is the most popular method used to assess the reliability of medical instruments measuring continuous outcomes. There are also inappropriate applications and interpretations of statistical methods in some studies. It is important for medical researchers to be aware of this issue, and be able to correctly perform analysis in reliability studies.

  4. Proceedings of the advanced research and technology development direct utilization, instrumentation and diagnostics contractors' review meeting

    Energy Technology Data Exchange (ETDEWEB)

    Geiling, D.W. (USDOE Morgantown Energy Technology Center, WV (USA)); Goldberg, P.M. (eds.) (USDOE Pittsburgh Energy Technology Center, PA (USA))

    1990-01-01

    The 1990 Advanced Research and Technology Development (AR TD) Direct Utilization, and Instrumentation and Diagnostics Contractors Review Meeting was held September 16--18, 1990, at the Hyatt at Chatham Center in Pittsburgh, PA. The meeting was sponsored by the US Department of Energy (DOE), Office of Fossil Energy, and the Pittsburgh and Morgantown Energy Technology Centers. Each year the meeting provides a forum for the exchange of information among the DOE AR TD contractors and interested parties. This year's meeting was hosted by the Pittsburgh Energy Technology Center and was attended by 120 individuals from industry, academia, national laboratories, and other governmental agencies. Papers were presented on research addressing coal surface, science, devolatilization and combustion, ash behavior, emission controls for gases particulates, fluid bed combustion and utilization in diesels and turbines. Individual reports are processed separately for the data bases.

  5. Special regulatory T-cell review: T-cell dependent suppression revisited.

    Science.gov (United States)

    Basten, Antony; Fazekas de St Groth, Barbara

    2008-01-01

    The concept of T-cell dependent regulation of immune responses has been a central tenet of immunological thinking since the delineation of the two cell system in the 1960s. Indeed T-cell dependent suppression was discovered before MHC restriction. When reviewing the data from the original wave of suppression, it is intriguing to reflect not just on the decline and fall of suppressor T cells in the 1980s, but on their equally dramatic return to respectability over the past decade. Hopefully their resurgence will be supported by solid mechanistic data that will underpin their central place in our current and future understanding of the immune system. Cannon to right of them, Cannon to left of them, Cannon in front of them Volley'd and thunder'd Storm'd at with shot and shell, Boldly they rode and well, Into the jaws of Death, Into the mouth of Hell, Rode the six hundred (suppressionists). (Adapted from The Charge of the Light Brigade, Alfred, Lord Tennyson)

  6. A review of diazinon use, contamination in surface waters, and regulatory actions in California across water years 1992-2014.

    Science.gov (United States)

    Wang, Dan; Singhasemanon, Nan; Goh, Kean S

    2017-07-01

    Diazinon is an organophosphorus insecticide that has been widely used in the USA and in California resulting in contamination of surface waters. Several federal and state regulations have been implemented with the aim of reducing its impact to human health and the environment, e.g., the cancellation of residential use products by the USEPA and dormant spray regulations by the California Department of Pesticide Regulation. This study reviewed the change in diazinon use and surface water contamination in accordance with the regulatory actions implemented in California over water years 1992-2014. We observed that use amounts began declining when agencies announced the intention to regulate certain use patterns and continued to decline after the implementation of those programs and regulations. The reduction in use amounts led to a downward trend in concentration data and exceedance frequencies in surface waters. Moreover, we concluded that diazinon concentrations in California's surface waters in recent years (i.e., water years 2012-2014) posed a de minimis risk to aquatic organisms.

  7. BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES – BRIEF REVIEW ON SOME DENTISTRY PRODUCTS.

    Directory of Open Access Journals (Sweden)

    Maya Lyapina

    2015-02-01

    Full Text Available Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD, or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.

  8. A Review on the VHTR PIRT Development Status of Both Regulatory Authority and Licensee

    International Nuclear Information System (INIS)

    Hwang, Su Hyun; Jeon, Seong Su; Hong, Soon Joon; Lee, Byung Chul; Huh, Chang Wook; Jin, Chang Yong; Kim, Kyun Tae

    2011-01-01

    characteristics among NRC, KAERI and ANL will be reviewed here. The typical shape for each PIRT is shown in Figure 1

  9. Measurement of obesity prevention in childcare settings: A systematic review of current instruments.

    Science.gov (United States)

    Stanhope, Kaitlyn K; Kay, Christi; Stevenson, Beth; Gazmararian, Julie A

    The incidence of childhood obesity is highest among children entering kindergarten. Overweight and obesity in early childhood track through adulthood. Programs increasingly target children in early life for obesity prevention. However, the published literature lacks a review on tools available for measuring behaviour and environmental level change in child care. The objective is to describe measurement tools currently in use in evaluating obesity-prevention in preschool-aged children. Literature searches were conducted in PubMed using the keywords "early childhood obesity," "early childhood measurement," "early childhood nutrition" and "early childhood physical activity." Inclusion criteria included a discussion of: (1) obesity prevention, risk assessment or treatment in children ages 1-5 years; and (2) measurement of nutrition or physical activity. One hundred thirty-four publications were selected for analysis. Data on measurement tools, population and outcomes were abstracted into tables. Tables are divided by individual and environmental level measures and further divided into physical activity, diet and physical health outcomes. Recommendations are made for weighing advantages and disadvantages of tools. Despite rising numbers of interventions targeting obesity-prevention and treatment in preschool-aged children, there is no consensus for which tools represent a gold standard or threshold of accuracy. Copyright © 2016 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

  10. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

    The aim of this paper is to show that regulatory risk is due to the discretionary behaviour of regulatory agencies, caused by a too extensive regulatory mandate provided by the legislator. The normative point of reference and a behavioural model of regulatory agencies based on the positive theory of regulation are presented. Regulatory risk with regard to the future behaviour of regulatory agencies is modelled as the consequence of the ex ante uncertainty about the relative influence of inter...

  11. Net Reclassification Indices for Evaluating Risk-Prediction Instruments: A Critical Review

    Science.gov (United States)

    Kerr, Kathleen F.; Wang, Zheyu; Janes, Holly; McClelland, Robyn L.; Psaty, Bruce M.; Pepe, Margaret S.

    2014-01-01

    Net reclassification indices have recently become popular statistics for measuring the prediction increment of new biomarkers. We review the various types of net reclassification indices and their correct interpretations. We evaluate the advantages and disadvantages of quantifying the prediction increment with these indices. For pre-defined risk categories, we relate net reclassification indices to existing measures of the prediction increment. We also consider statistical methodology for constructing confidence intervals for net reclassification indices and evaluate the merits of hypothesis testing based on such indices. We recommend that investigators using net reclassification indices should report them separately for events (cases) and nonevents (controls). When there are two risk categories, the components of net reclassification indices are the same as the changes in the true-positive and false-positive rates. We advocate use of true- and false-positive rates and suggest it is more useful for investigators to retain the existing, descriptive terms. When there are three or more risk categories, we recommend against net reclassification indices because they do not adequately account for clinically important differences in shifts among risk categories. The category-free net reclassification index is a new descriptive device designed to avoid pre-defined risk categories. However, it suffers from many of the same problems as other measures such as the area under the receiver operating characteristic curve. In addition, the category-free index can mislead investigators by overstating the incremental value of a biomarker, even in independent validation data. When investigators want to test a null hypothesis of no prediction increment, the well-established tests for coefficients in the regression model are superior to the net reclassification index. If investigators want to use net reclassification indices, confidence intervals should be calculated using bootstrap

  12. Treatment of thoracolumbar burst fractures with variable screw placement or Isola instrumentation and arthrodesis: case series and literature review.

    Science.gov (United States)

    Alvine, Gregory F; Swain, James M; Asher, Marc A; Burton, Douglas C

    2004-08-01

    The controversy of burst fracture surgical management is addressed in this retrospective case study and literature review. The series consisted of 40 consecutive patients, index included, with 41 fractures treated with stiff, limited segment transpedicular bone-anchored instrumentation and arthrodesis from 1987 through 1994. No major acute complications such as death, paralysis, or infection occurred. For the 30 fractures with pre- and postoperative computed tomography studies, spinal canal compromise was 61% and 32%, respectively. Neurologic function improved in 7 of 14 patients (50%) and did not worsen in any. The principal problem encountered was screw breakage, which occurred in 16 of the 41 (39%) instrumented fractures. As we have previously reported, transpedicular anterior bone graft augmentation significantly decreased variable screw placement (VSP) implant breakage. However, it did not prevent Isola implant breakage in two-motion segment constructs. Compared with VSP, Isola provided better sagittal plane realignment and constructs that have been found to be significantly stiffer. Unplanned reoperation was necessary in 9 of the 40 patients (23%). At 1- and 2-year follow-up, 95% and 79% of patients were available for study, and a satisfactory outcome was achieved in 84% and 79%, respectively. These satisfaction and reoperation rates are consistent with the literature of the time. Based on these observations and the loads to which implant constructs are exposed following posterior realignment and stabilization of burst fractures, we recommend that three- or four-motion segment constructs, rather than two motion, be used. To save valuable motion segments, planned construct shortening can be used. An alternative is sequential or staged anterior corpectomy and structural grafting.

  13. Measurement properties of instruments evaluating self-care and related concepts in people with chronic obstructive pulmonary disease: A systematic review.

    Science.gov (United States)

    Clari, Marco; Matarese, Maria; Alvaro, Rosaria; Piredda, Michela; De Marinis, Maria Grazia

    2016-01-01

    The use of valid and reliable instruments for assessing self-care is crucial for the evaluation of chronic obstructive pulmonary disease (COPD) management programs. The aim of this review is to evaluate the measurement properties and theoretical foundations of instruments for assessing self-care and related concepts in people with COPD. A systematic review was conducted of articles describing the development and validation of self-care instruments. The methodological quality of the measurement properties was assessed using the COSMIN checklist. Ten studies were included evaluating five instruments: three for assessing self-care and self-management and two for assessing self-efficacy. The COPD Self-Efficacy Scale was the most studied instrument, but due to poor study methodological quality, evidence about its measurement properties is inconclusive. Evidence from the COPD Self-Management Scale is more promising, but only one study tested its properties. Due to inconclusive evidence of their measurement properties, no instrument can be recommended for clinical use. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Regulatory review and confidence building in post-closure safety assessments and safety cases for near surface disposal facilities-IAEA ASAM coordinated research programme

    International Nuclear Information System (INIS)

    Gonzales, A.; Simeonov, G.; Bennett, D.G.; Nys, V.; Ben Belfadhel, M.

    2005-01-01

    Some years ago, the IAEA successfully concluded a Coordinated Research Program (CRP) called Islam, which focussed on the development of an Improved Safety Assessment Methodology for near-surface radioactive waste disposal facilities. In November 2002, and as an extension of ISAM, the IAEA launched a new CRP called ASAM, designed to test the Application of the Safety Assessment Methodology by considering a range of near-surface disposal facilities. The ASAM work programme is being implemented by three application working groups and two cross-cutting working groups. The application working groups are testing the applicability of the ISAM methodology by assessing an existing disposal facility in Hungary, a copper mine in South Africa, and a hypothetical facility containing heterogenous wastes, such as disused sealed sources. The first cross-cutting working group is addressing a number of technical issues that are common to all near-surface disposal facilities, while the second group, the Regulatory Review Working Group (RRWG) is developing guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides a brief overview of the work being conducted by the Regulatory Review Working Group. (author)

  15. Can we forget the Mini-Mental State Examination? A systematic review of the validity of cognitive screening instruments within one month after stroke.

    Science.gov (United States)

    Van Heugten, Caroline M; Walton, L; Hentschel, U

    2015-07-01

    To review systematically studies investigating the convergent, criterion, and predictive validity of multi-domain cognitive screening instruments in the first four weeks after stroke. Electronic databases (Pubmed, PsycINFO, CINAHL, Embase) were searched until June 2014. Studies concerning screening for cognitive dysfunction in stroke patients using multi-domain instruments, within four weeks postinfarct or haemorrhagic stroke, using tests taking no longer than one hour. Convergent, criterion, and predictive validity were examined. A total of 51 studies investigating 16 cognitive screening instruments were identified. None of the instruments covered all of the most affected cognitive domains. Only one study investigated the convergent validity of a multi-domain test during the (sub)acute phase after stroke. A total of 15 studies examined the criterion validity of cognitive measurements during the acute phase after stroke. The Montreal Cognitive Assessment and Higher Cortical Function Deficit Test had good criterion validity. A total of 24 studies examined the predictive ability of multi-domain cognitive instruments applied in the acute phase after stroke. The Cognistat, Montreal Cognitive Assessment, and Functional Independence Measure-cognitive showed good predictive validity. The Mini-Mental State Examination is the most widely used cognitive screening instrument, but shows insufficient criterion validity. None of the existing instruments fulfils all criteria. The Montreal Cognitive Assessment is the best candidate at present, provided items measuring speed of information processing are added, and further studies investigating the optimal cut-offs are conducted. © The Author(s) 2014.

  16. Digital Signal Processing. A review of DSP formalism, algorithms and networks for the beam instrumentation workshop, Vancouver, Canada, October 4, 1994

    International Nuclear Information System (INIS)

    Linscott, I.

    1995-01-01

    The formalism of Digital Signal Processing (DSP), is reviewed with the objective of providing a framework for understanding the utility of DSP techniques for Beam Instrumentation and developiong criteria for assessing the merits of DSP applications. copyright 1995 American Institute of Physics

  17. Review of decision methodologies for evaluating regulatory actions affecting public health and safety. [Nuclear industry site selection

    Energy Technology Data Exchange (ETDEWEB)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels.

  18. Reliability and Validity of Survey Instruments to Measure Work-Related Fatigue in the Emergency Medical Services Setting: A Systematic Review.

    Science.gov (United States)

    Patterson, P Daniel; Weaver, Matthew D; Fabio, Anthony; Teasley, Ellen M; Renn, Megan L; Curtis, Brett R; Matthews, Margaret E; Kroemer, Andrew J; Xun, Xiaoshuang; Bizhanova, Zhadyra; Weiss, Patricia M; Sequeira, Denisse J; Coppler, Patrick J; Lang, Eddy S; Higgins, J Stephen

    2018-02-15

    This study sought to systematically search the literature to identify reliable and valid survey instruments for fatigue measurement in the Emergency Medical Services (EMS) occupational setting. A systematic review study design was used and searched six databases, including one website. The research question guiding the search was developed a priori and registered with the PROSPERO database of systematic reviews: "Are there reliable and valid instruments for measuring fatigue among EMS personnel?" (2016:CRD42016040097). The primary outcome of interest was criterion-related validity. Important outcomes of interest included reliability (e.g., internal consistency), and indicators of sensitivity and specificity. Members of the research team independently screened records from the databases. Full-text articles were evaluated by adapting the Bolster and Rourke system for categorizing findings of systematic reviews, and the rated data abstracted from the body of literature as favorable, unfavorable, mixed/inconclusive, or no impact. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology was used to evaluate the quality of evidence. The search strategy yielded 1,257 unique records. Thirty-four unique experimental and non-experimental studies were determined relevant following full-text review. Nineteen studies reported on the reliability and/or validity of ten different fatigue survey instruments. Eighteen different studies evaluated the reliability and/or validity of four different sleepiness survey instruments. None of the retained studies reported sensitivity or specificity. Evidence quality was rated as very low across all outcomes. In this systematic review, limited evidence of the reliability and validity of 14 different survey instruments to assess the fatigue and/or sleepiness status of EMS personnel and related shift worker groups was identified.

  19. Liquid chromatography coupled to on-line post column derivatization for the determination of organic compounds: A review on instrumentation and chemistries

    International Nuclear Information System (INIS)

    Zacharis, Constantinos K.; Tzanavaras, Paraskevas D.

    2013-01-01

    Graphical abstract: -- Highlights: •Review on liquid chromatography coupled to post-column derivatization. •Overview of instrumentation for post-column derivatization. •Post-column chemistries for analysis of organic compounds. -- Abstract: Analytical derivatization either in pre or post column modes is one of the most widely used sample pretreatment techniques coupled to liquid chromatography. In the present review article we selected to discuss the post column derivatization mode for the analysis of organic compounds. The first part of the review focuses to the instrumentation of post-column setups including not only fundamental components such as pumps and reactors but also less common parts such as static mixers and back-pressure regulators; the second part of the article discusses the most popular “chemistries” that are involved in post column applications, including reagent-less approaches and new sensing platforms such as the popular gold nanoparticles. Some representative recent applications are also presented as tables

  20. Liquid chromatography coupled to on-line post column derivatization for the determination of organic compounds: A review on instrumentation and chemistries

    Energy Technology Data Exchange (ETDEWEB)

    Zacharis, Constantinos K., E-mail: zacharis@chem.auth.gr [Laboratory of Analytical Chemistry, Department of Chemistry, Aristotelian University of Thessaloniki, GR-54124 Thessaloniki (Greece); Department of Food Technology, School of Food Technology and Nutrition, Alexander Technological Educational Institute (ATEI) of Thessaloniki, 57400 Thessaloniki (Greece); Tzanavaras, Paraskevas D., E-mail: ptzanava@chem.auth.gr [Laboratory of Analytical Chemistry, Department of Chemistry, Aristotelian University of Thessaloniki, GR-54124 Thessaloniki (Greece)

    2013-10-10

    Graphical abstract: -- Highlights: •Review on liquid chromatography coupled to post-column derivatization. •Overview of instrumentation for post-column derivatization. •Post-column chemistries for analysis of organic compounds. -- Abstract: Analytical derivatization either in pre or post column modes is one of the most widely used sample pretreatment techniques coupled to liquid chromatography. In the present review article we selected to discuss the post column derivatization mode for the analysis of organic compounds. The first part of the review focuses to the instrumentation of post-column setups including not only fundamental components such as pumps and reactors but also less common parts such as static mixers and back-pressure regulators; the second part of the article discusses the most popular “chemistries” that are involved in post column applications, including reagent-less approaches and new sensing platforms such as the popular gold nanoparticles. Some representative recent applications are also presented as tables.

  1. Diagnostic performance of major depression disorder case-finding instruments used among mothers of young children in the United States: A systematic review.

    Science.gov (United States)

    Owora, Arthur H; Carabin, Hélène; Reese, Jessica; Garwe, Tabitha

    2016-09-01

    Growing recognition of the interrelated negative outcomes associated with major depression disorder (MDD) among mothers and their children has led to renewed public health interest in the early identification and treatment of maternal MDD. Healthcare providers, however, remain unsure of the validity of existing case-finding instruments. We conducted a systematic review to identify the most valid maternal MDD case-finding instrument used in the United States. We identified articles reporting the sensitivity and specificity of MDD case-finding instruments based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) by systematically searching through three electronic bibliographic databases, PubMed, PsycINFO, and EMBASE, from 1994 to 2014. Study eligibility and quality were evaluated using the Standards for the Reporting of Diagnostic Accuracy studies and Quality Assessment of Diagnostic Accuracy Studies guidelines respectively. Overall, we retrieved 996 unduplicated articles and selected 74 for full-text review. Of these, 14 articles examining 21 different instruments were included in the systematic review. The 10 item Edinburgh Postnatal Depression Scale and Postpartum Depression Screening Scale had the most stable (lowest variation) and highest diagnostic performance during the antepartum and postpartum periods (sensitivity range: 0.63-0.94 and 0.67-0.95; specificity range: 0.83-0.98 and 0.68-0.97 respectively). Greater variation in diagnostic performance was observed among studies with higher MDD prevalence. Factors that explain greater variation in instrument diagnostic performance in study populations with higher MDD prevalence were not examined. Findings suggest that the diagnostic performance of maternal MDD case-finding instruments is peripartum period-specific. Published by Elsevier B.V.

  2. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

    Ensuring that nuclear installations are operated and maintained in such a way that their impact on public health and safety is as low as reasonably practicable has been and will continue to be the cornerstone of nuclear regulation. In the past, nuclear incidents provided the main impetus for regulatory change. Today, economic factors, deregulation, technological advancements, government oversight and the general requirements for openness and accountability are leading regulatory bodies to review their effectiveness. In addition, seeking to enhance the present level of nuclear safety by continuously improving the effectiveness of regulatory bodies is seen as one of the ways to strengthen public confidence in the regulatory systems. This report covers the basic concepts underlying nuclear regulatory effectiveness, advances being made and future requirements. The intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  3. Development of regulatory guidance on safety reviews of nuclear power plants in Germany. A survey on accomplished and current PSA activities

    International Nuclear Information System (INIS)

    Berg, H.-P.; Froehmel, T.; Goertz, R.; Rehs, B.

    2005-01-01

    The paper describes the key points of the accomplished and current regulatory activities in order to revise PSA guide and the corresponding technical documents in Germany. The regulatory German PSA guide covers the fundamental requirements concerning the performance of PSAs in the frame of comprehensive safety reviews. The technical details regarding the performance of PSA are set out in two technical documents (PSA Methods and PSA Data) that have been developed by a working group of PSA experts (FAK PSA). Based on the experiences from the first series of PSRs, international experiences and the fact that PSR is mandatory since April 2002 revisions of all guides are underway. The first guide to be updated is the PSA guide together with the corresponding technical documents. The working programme and the revision process of FAK PSA was finished at the end of 2004 and the technical documents have recently been republished. (author)

  4. Seismic instrumentation

    International Nuclear Information System (INIS)

    1984-06-01

    RFS or Regles Fondamentales de Surete (Basic Safety Rules) applicable to certain types of nuclear facilities lay down requirements with which compliance, for the type of facilities and within the scope of application covered by the RFS, is considered to be equivalent to compliance with technical French regulatory practice. The object of the RFS is to take advantage of standardization in the field of safety, while allowing for technical progress in that field. They are designed to enable the operating utility and contractors to know the rules pertaining to various subjects which are considered to be acceptable by the Service Central de Surete des Installations Nucleaires, or the SCSIN (Central Department for the Safety of Nuclear Facilities). These RFS should make safety analysis easier and lead to better understanding between experts and individuals concerned with the problems of nuclear safety. The SCSIN reserves the right to modify, when considered necessary, any RFS and specify, if need be, the terms under which a modification is deemed retroactive. The aim of this RFS is to define the type, location and operating conditions for seismic instrumentation needed to determine promptly the seismic response of nuclear power plants features important to safety to permit comparison of such response with that used as the design basis

  5. Meteorological instrumentation

    International Nuclear Information System (INIS)

    1982-06-01

    RFS or ''Regles Fondamentales de Surete'' (Basic Safety Rules) applicable to certain types of nuclear facilities lay down requirements with which compliance, for the type of facilities and within the scope of application covered by the RFS, is considered to be equivalent to compliance with technical French regulatory practice. The object of the RFS is to take advantage of standardization in the field of safety , while allowing for technical progress in that field. They are designed to enable the operating utility and contractors to know the rules pertaining to various subjects which are considered to be acceptable by the ''Service Central de Surete des Installations Nucleaires'' or the SCSIN (Central Department for the Safety of Nuclear Facilities). These RFS should make safety analysis easier and lead to better understanding between experts and individuals concerned with the problems of nuclear safety. The SCSIN reserves the right to modify, when considered necessary any RFS and specify, if need be, the terms under which a modification is deemed retroactive. The purpose of this RFS is to specify the meteorological instrumentation required at the site of each nuclear power plant equipped with at least one pressurized water reactor

  6. Assessment of sexual difficulties associated with multi-modal treatment for cervical or endometrial cancer: A systematic review of measurement instruments.

    Science.gov (United States)

    White, Isabella D; Sangha, Amrit; Lucas, Grace; Wiseman, Theresa

    2016-12-01

    Practitioners and researchers require an outcome measure that accurately identifies the range of common treatment-induced changes in sexual function and well-being experienced by women after cervical or endometrial cancer. This systematic review critically appraised the measurement properties and clinical utility of instruments validated for the measurement of female sexual dysfunction (FSD) in this clinical population. A bibliographic database search for questionnaire development or validation papers was completed and methodological quality and measurement properties of selected studies rated using the Consensus-based Standards for the selection of health Measurement Instrument (COSMIN) checklist. 738 articles were screened, 13 articles retrieved for full text assessment and 7 studies excluded, resulting in evaluation of 6 papers; 2 QoL and 4 female sexual morbidity measures. Five of the six instruments omitted one or more dimension of female sexual function and only one instrument explicitly measured distress associated with sexual changes as per DSM V (APA 2013) diagnostic criteria. None of the papers reported measurement error, responsiveness data was available for only two instruments, three papers failed to report on criterion validity, and test-retest reliability reporting was inconsistent. Heterosexual penile-vaginal intercourse remains the dominant sexual activity focus for sexual morbidity PROMS terminology and instruments lack explicit reference to solo or non-coital sexual expression or validation in a non-heterosexual sample. Four out of six instruments included mediating treatment or illness items such as vaginal changes, menopause or altered body image. Findings suggest that the Female Sexual Function Index (FSFI) remains the most robust sexual morbidity outcome measure, for research or clinical use, in sexually active women treated for cervical or endometrial cancer. Development of an instrument that measures sexual dysfunction in women who are

  7. The relationship between time perspective and self-regulatory processes, abilities and outcomes: a protocol for a meta-analytical review.

    Science.gov (United States)

    Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M

    2017-07-05

    Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first author’s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  8. Which Instruments can Detect Submaximal Physical and Functional Capacity in Patients With Chronic Nonspecific Back Pain?: A Systematic Review

    NARCIS (Netherlands)

    van der Meer, Suzan; Trippolini, Maurizio A.; van der Palen, Jacobus Adrianus Maria; Verhoeven, Jan; Reneman, Michiel F.

    2013-01-01

    Objective. To evaluate the validity of instruments that claim to detect submaximal capacity when maximal capacity is requested in patients with chronic nonspecific musculoskeletal pain. Summary of Background Data. Several instruments have been developed to measure capacity in patients with chronic

  9. Systematic review of the adjunctive use of diode and Nd:YAG lasers for nonsurgical periodontal instrumentation.

    Science.gov (United States)

    Roncati, Marisa; Gariffo, Annalisa

    2014-04-01

    The aims of this study were (1) to conduct a literature search and systematically evaluate the additional therapeutic effects of pulsed Nd:YAG or diode laser use in patients with periodontitis, (2) to assess evidence supporting the additional benefit of laser-mediated periodontal treatment in conjunction with scaling and root planning (SRP) (not as monotherapy), and (3) to interpret the evidence presented in retrieved publications. Opinions about the additional use of diode lasers in the nonsurgical treatment of plaque-induced periodontal lesions are conflicting. The April 2011 American Academy of Periodontology's "Statement on the Efficacy of Lasers in the Non-Surgical Treatment of Inflammatory Periodontal Disease" asserted that the use of a laser as monotherapy or in addition to nonsurgical periodontal instrumentation conveyed no advantage. After initial screening, 23/77 potentially relevant articles and abstracts identified through electronic and manual searches of the MEDLINE(®)/PubMed database and the Cochrane Central Register of Controlled Trials (1990-2012) were included in this review. A meta-analysis could be performed. The results indicate that Nd:YAG or diode laser, used in an adjunctive capacity to SRP, may provide some additional benefit, in 6 month studies, compared with mechanical debridement. The results show the adjunctive benefits that diode laser treatment can provide when it is used as an adjunct to nonsurgical periodontal treatment in adults with chronic periodontitis. Further long-term, well-designed, parallel randomized clinical trials are needed to assess the effectiveness of the adjunctive use of the diode laser, as well as the appropriate dosimetry and laser settings.

  10. Measurement properties of quality-of-life measurement instruments for infants, children and adolescents with eczema: a systematic review.

    Science.gov (United States)

    Heinl, D; Prinsen, C A C; Sach, T; Drucker, A M; Ofenloch, R; Flohr, C; Apfelbacher, C

    2017-04-01

    Quality of life (QoL) is one of the core outcome domains identified by the Harmonising Outcome Measures for Eczema (HOME) initiative to be assessed in every eczema trial. There is uncertainty about the most appropriate QoL instrument to measure this domain in infants, children and adolescents. To systematically evaluate the measurement properties of existing measurement instruments developed and/or validated for the measurement of QoL in infants, children and adolescents with eczema. A systematic literature search in PubMed and Embase, complemented by a thorough hand search of reference lists, retrieved studies on measurement properties of eczema QoL instruments for infants, children and adolescents. For all eligible studies, we judged the adequacy of the measurement properties and the methodological study quality with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Results from different studies were summarized in a best-evidence synthesis and formed the basis to assign four degrees of recommendation. Seventeen articles, three of which were found by hand search, were included. These 17 articles reported on 24 instruments. No instrument can be recommended for use in all eczema trials because none fulfilled all required adequacy criteria. With adequate internal consistency, reliability and hypothesis testing, the U.S. version of the Childhood Atopic Dermatitis Impact Scale (CADIS), a proxy-reported instrument, has the potential to be recommended depending on the results of further validation studies. All other instruments, including all self-reported ones, lacked significant validation data. Currently, no QoL instrument for infants, children and adolescents with eczema can be highly recommended. Future validation research should primarily focus on the CADIS, but also attempt to broaden the evidence base for the validity of self-reported instruments. © 2016 British Association of Dermatologists.

  11. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

  12. Regulatory Forum Review*: Utility of in Vitro Secondary Pharmacology Data to Assess Risk of Drug-induced Valvular Heart Disease in Humans: Regulatory Considerations.

    Science.gov (United States)

    Papoian, Thomas; Jagadeesh, Gowraganahalli; Saulnier, Muriel; Simpson, Natalie; Ravindran, Arippa; Yang, Baichun; Laniyonu, Adebayo A; Khan, Imran; Szarfman, Ana

    2017-04-01

    Drug-induced valvular heart disease (VHD) is a serious side effect linked to long-term treatment with 5-hydroxytryptamine (serotonin) receptor 2B (5-HT 2B ) agonists. Safety assessment for off-target pharmacodynamic activity is a common approach used to screen drugs for this undesired property. Such studies include in vitro assays to determine whether the drug is a 5-HT 2B agonist, a necessary pharmacological property for development of VHD. Measures of in vitro binding affinity (IC 50 , K i ) or cellular functional activity (EC 50 ) are often compared to maximum therapeutic free plasma drug levels ( fC max ) from which safety margins (SMs) can be derived. However, there is no clear consensus on what constitutes an appropriate SM under various therapeutic conditions of use. The strengths and limitations of SM determinations and current risk assessment methodology are reviewed and evaluated. It is concluded that the use of SMs based on K i values, or those relative to serotonin (5-HT), appears to be a better predictor than the use of EC 50 or EC 50 /human fC max values for determining whether known 5-HT 2B agonists have resulted in VHD. It is hoped that such a discussion will improve efforts to reduce this preventable serious drug-induced toxicity from occurring and lead to more informed risk assessment strategies.

  13. Learning from nuclear regulatory self-assessment. International peer review of the CSN report on lessons learnt from the essential service water system degradation event at the Vandellos nuclear power plant

    International Nuclear Information System (INIS)

    2006-01-01

    Nuclear regulatory self-assessment together with the benchmarking of regulatory practices against those of other countries operating nuclear power plants are key elements in maintaining a high level of nuclear safety. In that light, the Spanish Consejo de Seguridad Nuclear (CSN) formally asked the OECD Nuclear Energy Agency (NEA) to establish an international peer review team to assess the CSN report on the lessons learnt as a result of the 2004 Vandellos II event involving essential service water system degradation. The International Review Team considers the CSN report prepared in follow-up to the Vandellos event to be a commendable effort in regulatory self-assessment. The report, complemented by this international peer review, should enable the CSN to take appropriate action to ensure that its regulatory supervision is in line with best international practice. (authors)

  14. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

    Science.gov (United States)

    Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

    2014-01-01

    The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

  15. A review from the regulatory position of the control of occupational exposure associated with the first 20 years of the United Kingdom commercial nuclear power programme

    International Nuclear Information System (INIS)

    Emmerson, B.W.

    1980-01-01

    The control of occupational exposure received at commercial nuclear generating plants in the United Kingdom has been subject to regulatory requirements embodied in site licence conditions since 1959, and at commercial fuel production and reprocessing plants since 1971. The paper indicates the main radiological control objectives which have applied, reviews the statutory measures introduced for their achievement and indicates some of the administrative arrangements made by site operators in order to comply. The principal sources of occupational exposure associated with each stage of the fuel cycle are identified and exposure data since licensed operations commenced are reviewed. The effectiveness of the United Kingdom site licensing procedure in ensuring adequate radiological control procedures, including the minimisation of occupational exposure, is examined in relation to the relevant ICRP recommendations and against the background of the first 20 years of commercial nuclear power production. The impact on these procedures of more recently introduced legislation relating to health and safety at all places of employment in the United Kingdom is discussed. The paper considers the changes in current regulatory procedures that may result from the introduction of ICRP-26 and the recommendations of ICRP Committee 2, and concludes with a review of the more important problems facing the licensee and the Nuclear Inspectorate with regard to the implementation of future radiological control procedures. (H.K.)

  16. Validity and reliability of instruments aimed at measuring Evidence-Based Practice in Physical Therapy: a systematic review of the literature.

    Science.gov (United States)

    Fernández-Domínguez, Juan Carlos; Sesé-Abad, Albert; Morales-Asencio, Jose Miguel; Oliva-Pascual-Vaca, Angel; Salinas-Bueno, Iosune; de Pedro-Gómez, Joan Ernest

    2014-12-01

    Our goal is to compile and analyse the characteristics - especially validity and reliability - of all the existing international tools that have been used to measure evidence-based clinical practice in physiotherapy. A systematic review conducted with data from exclusively quantitative-type studies synthesized in narrative format. An in-depth search of the literature was conducted in two phases: initial, structured, electronic search of databases and also journals with summarized evidence; followed by a residual-directed search in the bibliographical references of the main articles found in the primary search procedure. The studies included were assigned to members of the research team who acted as peer reviewers. Relevant information was extracted from each of the selected articles using a template that included the general characteristics of the instrument as well as an analysis of the quality of the validation processes carried out, by following the criteria of Terwee. Twenty-four instruments were found to comply with the review screening criteria; however, in all cases, they were found to be limited as regards the 'constructs' included. Besides, they can all be seen to be lacking as regards comprehensiveness associated to the validation process of the psychometric tests used. It seems that what constitutes a rigorously developed assessment instrument for EBP in physical therapy continues to be a challenge. © 2014 John Wiley & Sons, Ltd.

  17. Choice of outcomes and measurement instruments in randomised trials on eLearning in medical education: a systematic mapping review protocol.

    Science.gov (United States)

    Law, Gloria C; Apfelbacher, Christian; Posadzki, Pawel P; Kemp, Sandra; Tudor Car, Lorainne

    2018-05-17

    There will be a lack of 18 million healthcare workers by 2030. Multiplying the number of well-trained healthcare workers through innovative ways such as eLearning is highly recommended in solving this shortage. However, high heterogeneity of learning outcomes in eLearning systematic reviews reveals a lack of consistency and agreement on core learning outcomes in eLearning for medical education. In addition, there seems to be a lack of validity evidence for measurement instruments used in these trials. This undermines the credibility of these outcome measures and affects the ability to draw accurate and meaningful conclusions. The aim of this research is to address this issue by determining the choice of outcomes, measurement instruments and the prevalence of measurement instruments with validity evidence in randomised trials on eLearning for pre-registration medical education. We will conduct a systematic mapping and review to identify the types of outcomes, the kinds of measurement instruments and the prevalence of validity evidence among measurement instruments in eLearning randomised controlled trials (RCTs) in pre-registration medical education. The search period will be from January 1990 until August 2017. We will consider studies on eLearning for health professionals' education. Two reviewers will extract and manage data independently from the included studies. Data will be analysed and synthesised according to the aim of the review. Appropriate choice of outcomes and measurement tools is essential for ensuring high-quality research in the field of eLearning and eHealth. The results of this study could have positive implications for other eHealth interventions, including (1) improving quality and credibility of eLearning research, (2) enhancing the quality of digital medical education and (3) informing researchers, academics and curriculum developers about the types of outcomes and validity evidence for measurement instruments used in eLearning studies. The

  18. Radioisotope instruments

    CERN Document Server

    Cameron, J F; Silverleaf, D J

    1971-01-01

    International Series of Monographs in Nuclear Energy, Volume 107: Radioisotope Instruments, Part 1 focuses on the design and applications of instruments based on the radiation released by radioactive substances. The book first offers information on the physical basis of radioisotope instruments; technical and economic advantages of radioisotope instruments; and radiation hazard. The manuscript then discusses commercial radioisotope instruments, including radiation sources and detectors, computing and control units, and measuring heads. The text describes the applications of radioisotop

  19. 12 CFR 914.1 - Regulatory Report defined.

    Science.gov (United States)

    2010-01-01

    ... Bank. (b) Examples. Regulatory Report includes: (1) Call reports and reports of instrument-level risk... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Regulatory Report defined. 914.1 Section 914.1... DATA AVAILABILITY AND REPORTING § 914.1 Regulatory Report defined. (a) Definition. Regulatory Report...

  20. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2016-01-01

    This section treats of the following National legislative and regulatory activities: 1 - France: General legislation, regulations and instruments; Nuclear trade (including non-proliferation); International co-operation; 2 - India: Licensing and regulatory infrastructure; Liability and compensation; 3 - Ireland: Nuclear safety and radiological protection (including nuclear emergency planning); Transport of radioactive material; Nuclear trade (including non-proliferation); 4 - Lithuania: Licensing and regulatory infrastructure; Nuclear safety and radiological protection (including nuclear emergency planning); Radioactive waste management; 5 - Luxembourg: Nuclear safety and radiological protection (including nuclear emergency planning); 6 - Slovak Republic: International co-operation; General legislation, regulations and instruments; 7 - Spain: Radioactive materials (including physical protection); Radioactive waste management; 8 - United States: Licensing and regulatory infrastructure

  1. Report of the consultant meeting for review of procedure for NPP operational events reporting and investigation for the nuclear regulatory administration of Ukraine in Vienna, Austria 18-20 December 1995

    International Nuclear Information System (INIS)

    Lipar, M.; Koltakov, V.; Rodionov, A.; Razzell, R.; Tolstykh, V.; Kriz, Z.

    1995-12-01

    In response to a request from the Nuclear Regulatory Administration of Ukraine, the IAEA carried out an expert review of the Procedure for NPP Operational Events Reporting and Investigation developed by the Scientific and Technical Centre on Nuclear and Radiation Safety of the Nuclear Regulatory Administration. This report contains the recommendations and suggestions made by experts as a result of the Consultants Meeting held in Vienna between 18-20 December 1995

  2. Jones' instrument technology

    CERN Document Server

    Jones, Ernest Beachcroft; Kingham, Edward G; Radnai, Rudolf

    1985-01-01

    Jones' Instrument Technology, Volume 5: Automatic Instruments and Measuring Systems deals with general trends in automatic instruments and measuring systems. Specific examples are provided to illustrate the principles of such devices. A brief review of a considerable number of standards is undertaken, with emphasis on the IEC625 Interface System. Other relevant standards are reviewed, including the interface and backplane bus standards. This volume is comprised of seven chapters and begins with a short introduction to the principles of automatic measurements, classification of measuring system

  3. Review of nuclear regulatory activities associated with safety culture and the management of safety in the United Kingdom

    International Nuclear Information System (INIS)

    Woodhouse, P.A.

    1995-01-01

    This paper describes some of the key regulatory activities which have taken place in the United Kingdom in recent years in the areas of safety culture and management of safety. It explains how the UK's nuclear licensing regime, regulated and enforced by the Nuclear Installations Inspectorate, (NII), provides the framework for a viable safety management system and identifies a management of safety model which a NII Task Force has developed. It finally identifies further work which is being undertaken by the NII. (author). 4 refs, 2 figs

  4. Review of Regulatory Emphasis on Transportation Safety in the United States, 2002-2009: Public versus Private Modes.

    Science.gov (United States)

    Waycaster, Garrett C; Matsumura, Taiki; Bilotkach, Volodymyr; Haftka, Raphael T; Kim, Nam H

    2018-05-01

    The U.S. Department of Transportation is responsible for implementing new safety improvements and regulations with the goal of ensuring limited funds are distributed to where they can have the greatest impact on safety. In this work, we conduct a study of new regulations and other reactions (such as recalls) to fatal accidents in several different modes of transportation implemented from 2002 to 2009. We find that in the safest modes of commercial aviation and bus transport, the amount of spending on new regulations is high in relation to the number of fatalities compared to the regulatory attention received by less safe modes of general aviation and private automobiles. Additionally, we study two major fatal accident investigations from commercial aviation and two major automotive recalls associated with fatal accidents. We find differences in the cost per expected fatality prevented for these reactions, with the airline accident investigations being more cost effective. Overall, we observe trends in both the automotive and aviation sectors that suggest that public transportation receives more regulatory attention than private transport. We also observe that the types of safety remedies utilized, regulation versus investigation, have varying levels of effectiveness in different transport modes. We suggest that these differences are indicative of increased public demand for safety in modes where a third party may be held responsible, even for those not participating in the transportation. These findings have important implications for the transportation industry, policymakers, and for estimating the public demand for safety in new transport modes. © 2017 Society for Risk Analysis.

  5. Instrumented fusion in a 12-month-old with atlanto-occipital dislocation: case report and literature review of infant occipitocervical fusion.

    Science.gov (United States)

    Hale, Andrew T; Dewan, Michael C; Patel, Bhairav; Geck, Matthew J; Tomycz, Luke D

    2017-08-01

    The treatment of atlantoaxial dislocation in very young children is challenging and lacks a consensus management strategy. We review the literature on infantile occipitocervical (OC) fusion is appraised and technical considerations are organized for ease of reference. Surgical decisions such as graft type and instrumentation details are summarized, along with the use of bone morphogenic protein and post-operative orthoses. We present the case of a 12-month-old who underwent instrumented occipitocervical (OC) fusion in the setting of traumatic atlanto-occipital dislocation (AOD). Occipitocervical (OC) arthrodesis is obtainable in very young infants and children. Surgical approaches are variable and use a combination of autologous grafting and creative screw and/or wire constructs. The heterogeneity of pathologic etiology leading to OC fusion makes it difficult to make definitive recommendations for surgical management.

  6. Instrumental interaction

    OpenAIRE

    Luciani , Annie

    2007-01-01

    International audience; The expression instrumental interaction as been introduced by Claude Cadoz to identify a human-object interaction during which a human manipulates a physical object - an instrument - in order to perform a manual task. Classical examples of instrumental interaction are all the professional manual tasks: playing violin, cutting fabrics by hand, moulding a paste, etc.... Instrumental interaction differs from other types of interaction (called symbolic or iconic interactio...

  7. The Effectiveness of Singing or Playing a Wind Instrument in Improving Respiratory Function in Patients with Long-Term Neurological Conditions: A Systematic Review.

    Science.gov (United States)

    Ang, Kexin; Maddocks, Matthew; Xu, Huiying; Higginson, Irene J

    2017-03-01

    Many long-term neurological conditions adversely affect respiratory function. Singing and playing wind instruments are relatively inexpensive interventions with potential for improving respiratory function; however, synthesis of current evidence is needed to inform research and clinical use of music in respiratory care. To critically appraise, analyze, and synthesize published evidence on the effectiveness of singing or playing a wind instrument to improve respiratory function in people with long-term neurological conditions. Systematic review of published randomized controlled trials and observational studies examining singing or playing wind instruments to improve respiratory function in individuals with long-term neurological conditions. Articles meeting specified inclusion criteria were identified through a search of the Medline, Embase, PsycINFO, Cochrane Library, CINAHL, Web of Science, CAIRSS for Music, WHO International Clinical Trials Registry Platform Search Portal, and AMED databases as early as 1806 through March 2015. Information on study design, clinical populations, interventions, and outcome measures was extracted and summarized using an electronic standardized coding form. Methodological quality was assessed and summarized across studies descriptively. From screening 584 references, 68 full texts were reviewed and five studies included. These concerned 109 participants. The studies were deemed of low quality, due to evidence of bias, in part due to intervention complexity. No adverse effects were reported. Overall, there was a trend toward improved respiratory function, but only one study on Parkinson's disease had significant between-group differences. The positive trend in respiratory function in people with long-term neurological conditions following singing or wind instrument therapy is of interest, and warrants further investigation. © the American Music Therapy Association 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  8. University Reactor Instrumentation Program

    International Nuclear Information System (INIS)

    Vernetson, W.G.

    1992-11-01

    Recognizing that the University Reactor Instrumentation Program was developed in response to widespread needs in the academic community for modernization and improvement of research and training reactors at institutions such as the University of Florida, the items proposed to be supported by this grant over its two year period have been selected as those most likely to reduce foreed outages, to meet regulatory concerns that had been expressed in recent years by Nuclear Regulatory Commission inspectors or to correct other facility problems and limitations. Department of Energy Grant Number DE-FG07-90ER129969 was provided to the University of Florida Training Reactor(UFTR) facility through the US Department of Energy's University Reactor Instrumentation Program. The original proposal submitted in February, 1990 requested support for UFTR facility instrumentation and equipment upgrades for seven items in the amount of $107,530 with $13,800 of this amount to be the subject of cost sharing by the University of Florida and $93,730 requested as support from the Department of Energy. A breakdown of the items requested and total cost for the proposed UFTR facility instrumentation and equipment improvements is presented

  9. Alignment of Outcome Instruments Used in Hand Therapy With the Occupational Therapy Practice Framework: Domain and Process and the International Classification of Functioning, Disability and Health: A Scoping Review.

    Science.gov (United States)

    Lesher, Danielle Ann-Marie; Mulcahey, M J; Hershey, Peter; Stanton, Donna Breger; Tiedgen, Andrea C

    We sought to identify outcome instruments used in rehabilitation of the hand and upper extremity; to determine their alignment with the constructs of the International Classification of Functioning, Disability and Health (ICF) and the Occupational Therapy Practice Framework: Domain and Process; and to report gaps in the constructs measured by outcome instruments as a basis for future research. We searched CINAHL, MEDLINE, OTseeker, and the Cochrane Central Register of Controlled Trials using scoping review methodology and evaluated outcome instruments for concordance with the ICF and the Framework. We identified 18 outcome instruments for analysis. The findings pertain to occupational therapists' focus on body functions, body structures, client factors, and activities of daily living; a gap in practice patterns in use of instruments; and overestimation of the degree to which instruments used are occupationally based. Occupational therapy practitioners should use outcome instruments that embody conceptual frameworks for classifying function and activity. Copyright © 2017 by the American Occupational Therapy Association, Inc.

  10. Review and evaluation of the Nuclear Regulatory Commission Safety Research Program for Fiscal Years 1984 and 1985

    International Nuclear Information System (INIS)

    1983-02-01

    This is the sixth report by the Advisory Committee on Reactor Safeguards (ACRS) that has been prepared in response to the Congressional requirement for an annual report on the Nuclear Regulatory Commission (NRC) Reactor Safety Research Program. Part I is a compilation of our general comments and recommendations regarding the NRC Safety Research Program, and includes budget recommendations and an identification of matters of special importance that deserve increased emphasis. It is intended to serve as an Executive Summary. Part II is divided into ten chapters, each of which represents a Decision Unit of the NRC research program. In each chapter, specific comments are included on the research involved in the Decision Unit, an assessment of priorities, and recommendations regarding new directions and levels of funding

  11. Review of various approaches for assessing public health risks in regulatory decision making: choosing the right approach for the problem.

    Science.gov (United States)

    Dearfield, Kerry L; Hoelzer, Karin; Kause, Janell R

    2014-08-01

    Stakeholders in the public health risk analysis community can possess differing opinions about what is meant by "conduct a risk assessment." In reality, there is no one-size-fits-all risk assessment that can address all public health issues, problems, and regulatory needs. Although several international and national organizations (e.g., Codex Alimentarius Commission, Office International des Epizooties, Food and Agricultural Organization, World Health Organization, National Research Council, and European Food Safety Authority) have addressed this issue, confusion remains. The type and complexity of a risk assessment must reflect the risk management needs to appropriately inform a regulatory or nonregulatory decision, i.e., a risk assessment is ideally "fit for purpose" and directly applicable to risk management issues of concern. Frequently however, there is a lack of understanding by those not completely familiar with risk assessment regarding the specific utility of different approaches for assessing public health risks. This unfamiliarity can unduly hamper the acceptance of risk assessment results by risk managers and may reduce the usefulness of such results for guiding public health policies, practices, and operations. Differences in interpretation of risk assessment terminology further complicate effective communication among risk assessors, risk managers, and stakeholders. This article provides an overview of the types of risk assessments commonly conducted, with examples primarily from the food and agricultural sectors, and a discussion of the utility and limitations of these specific approaches for assessing public health risks. Clarification of the risk management issues and corresponding risk assessment design needs during the formative stages of the risk analysis process is a key step for ensuring that the most appropriate assessment of risk is developed and used to guide risk management decisions.

  12. Regulatory Review: Delay of Effective Dates of Final Rules Subject to the Administration's January 20, 2001, Memorandum

    National Research Council Canada - National Science Library

    Rezendes, Victor

    2002-01-01

    ... taken effect.Citing the desire to ensure that the President s appointees have the opportunity to review any new or pending regulations, on January 20,,2001,Assistant to the President and Chief of Staff...

  13. Lessons Learned from Characterization, Performance Assessment, and EPA Regulatory Review of the 1996 Actinide Source Term for the Waste Isolation Pilot Plant

    International Nuclear Information System (INIS)

    Larson, K.W.; Moore, R.C.; Nowak, E.J.; Papenguth, H.W.; Jow, H.

    1999-01-01

    The Waste Isolation Pilot Plant (WIPP) is a US Department of Energy (DOE) facility for the permanent disposal of transuranic waste from defense activities. In 1996, the DOE submitted the Title 40 CFR Part 191 Compliance Certification Application for the Waste Isolation Pilot Plant (CCA) to the US Environmental Protection Agency (EPA). The CCA included a probabilistic performance assessment (PA) conducted by Sandia National Laboratories to establish compliance with the quantitative release limits defined in 40 CFR 191.13. An experimental program to collect data relevant to the actinide source term began around 1989, which eventually supported the 1996 CCA PA actinide source term model. The actinide source term provided an estimate of mobile dissolved and colloidal Pu, Am, U, Th, and Np concentrations in their stable oxidation states, and accounted for effects of uncertainty in the chemistry of brines in waste disposal areas. The experimental program and the actinide source term included in the CCA PA underwent EPA review lasting more than 1 year. Experiments were initially conducted to develop data relevant to the wide range of potential future conditions in waste disposal areas. Interim, preliminary performance assessments and actinide source term models provided insight allowing refinement of experiments and models. Expert peer review provided additional feedback and confidence in the evolving experimental program. By 1995, the chemical database and PA predictions of WIPP performance were considered reliable enough to support the decision to add an MgO backfill to waste rooms to control chemical conditions and reduce uncertainty in actinide concentrations, especially for Pu and Am. Important lessons learned through the characterization, PA modeling, and regulatory review of the actinide source term are (1) experimental characterization and PA should evolve together, with neither activity completely dominating the other, (2) the understanding of physical processes

  14. Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature

    Directory of Open Access Journals (Sweden)

    Wafula Francis N

    2012-07-01

    Full Text Available Abstract Background Specialized drug shops such as pharmacies and drug shops are increasingly becoming important sources of treatment. However, knowledge on their regulatory performance is scarce. We set out to systematically review literature on the characteristics, knowledge and practices of specialized drug shops in Sub-Saharan Africa. Methods We searched PubMed, EMBASE, WEB of Science, CAB Abstracts, PsycINFO and websites for organizations that support medicine policies and usage. We also conducted open searches using Google Scholar, and searched manually through references of retrieved articles. Our search included studies of all designs that described characteristics, knowledge and practices of specialized drug shops. Information was abstracted on authors, publication year, country and location, study design, sample size, outcomes investigated, and primary findings using a uniform checklist. Finally, we conducted a structured narrative synthesis of the main findings. Results We obtained 61 studies, mostly from Eastern Africa, majority of which were conducted between 2006 and 2011. Outcome measures were heterogeneous and included knowledge, characteristics, and dispensing and regulatory practices. Shop location and client demand were found to strongly influence dispensing practices. Whereas shops located in urban and affluent areas were more likely to provide correct treatments, those in rural areas provided credit facilities more readily. However, the latter also charged higher prices for medicines. A vast majority of shops simply sold whatever medicines clients requested, with little history taking and counseling. Most shops also stocked popular medicines at the expense of policy recommended treatments. Treatment policies were poorly communicated overall, which partly explained why staff had poor knowledge on key aspects of treatment such as medicine dosage and side effects. Overall, very little is known on the link between regulatory

  15. Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature.

    Science.gov (United States)

    Wafula, Francis N; Miriti, Eric M; Goodman, Catherine A

    2012-07-27

    Specialized drug shops such as pharmacies and drug shops are increasingly becoming important sources of treatment. However, knowledge on their regulatory performance is scarce. We set out to systematically review literature on the characteristics, knowledge and practices of specialized drug shops in Sub-Saharan Africa. We searched PubMed, EMBASE, WEB of Science, CAB Abstracts, PsycINFO and websites for organizations that support medicine policies and usage. We also conducted open searches using Google Scholar, and searched manually through references of retrieved articles. Our search included studies of all designs that described characteristics, knowledge and practices of specialized drug shops. Information was abstracted on authors, publication year, country and location, study design, sample size, outcomes investigated, and primary findings using a uniform checklist. Finally, we conducted a structured narrative synthesis of the main findings. We obtained 61 studies, mostly from Eastern Africa, majority of which were conducted between 2006 and 2011. Outcome measures were heterogeneous and included knowledge, characteristics, and dispensing and regulatory practices. Shop location and client demand were found to strongly influence dispensing practices. Whereas shops located in urban and affluent areas were more likely to provide correct treatments, those in rural areas provided credit facilities more readily. However, the latter also charged higher prices for medicines. A vast majority of shops simply sold whatever medicines clients requested, with little history taking and counseling. Most shops also stocked popular medicines at the expense of policy recommended treatments. Treatment policies were poorly communicated overall, which partly explained why staff had poor knowledge on key aspects of treatment such as medicine dosage and side effects. Overall, very little is known on the link between regulatory enforcement and practices of specialized drug shops

  16. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment; Evaluacion mediante examen por pares de la efectividad de un programa regulador para la seguridad radiologica. Informe provisional para formular comentarios

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-06-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State.

  17. Ansiedade infantil e instrumentos de avaliação: uma revisão sistemática Childhood anxiety and assessment instruments: a systematic review

    Directory of Open Access Journals (Sweden)

    Wildson Vieira da Silva

    2005-12-01

    Full Text Available OBJETIVO: Fazer um levantamento dos principais instrumentos de avaliação da ansiedade em crianças, quando surgiram, que tipos de estudos foram realizados com os mesmos, verificando os países de maior incidência de aplicação dos testes, bem como a realidade dos instrumentos no Brasil. MÉTODOS: Revisão sistemática em bancos de dados eletrônicos _ Psychoinfo (1940 _ Maio 2002, Psyclit (1887 _ maio 2002, Medline (1966 _ maio 2002 e Eric (1966 _ maio 2002. Busca de informações fundamentada em comunicação pessoal e capítulos de livros. O critério de inclusão foi: estudos realizados com crianças, nos quais o construto ansiedade foi avaliado por algum instrumento psicométrico. Critérios de exclusão: artigos alusivos à pesquisa com adolescentes, adultos e animais; artigos utilizando testes projetivos ou sem a indicação do instrumento. Os artigos indexados repetidamente em dois ou mais bancos foram considerados apenas uma vez. RESULTADOS: Esta revisão apontou 1.911 estudos que utilizaram, no mínimo, um instrumento de avaliação de ansiedade; 118 instrumentos foram usados para este fim. Conclusões: Atualmente, existem inúmeros instrumentos disponíveis para avaliação da ansiedade em crianças; entretanto, no Brasil, a escala disponível no mercado está desatualizada e as mais modernas encontram-se somente em centros clínicos acadêmicos.OBJECTIVE: To make a survey of the principal anxiety instruments available for children, when they appeared, the type of methods used, verifying which countries have the highest number of children anxiety instruments and also how is the Brazilian reality on this matter. METHODS: A systematic review on electronic databases _ Psychoinfo (1940 _ May 2002, Psyclit (1887 _ May 2002, Medline (1966 _ May 2002 e Eric (1966 _ May 2002. Information collected on personal communications and books chapters. The inclusion criterion utilized: studies realized with children, where the anxiety were

  18. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 4. Evaluation of other loads and load combinations

    International Nuclear Information System (INIS)

    1984-12-01

    Six topical areas were covered by the Task Group on Other Dynamic Loads and Load Combinations as described below: Event Combinations - dealing with the potential simultaneous occurrence of earthquakes, pipe ruptures, and water hammer events in the piping design basis; Response Combinations - dealing with multiply supported piping with independent inputs, the sequence of combinations between spacial and modal components of response, and the treatment of high frequency modes in combination with low frequency modal responses; Stress Limits/Dynamic Allowables - dealing with inelastic allowables for piping and strain rate effects; Water Hammer Loadings - dealing with code and design specifications for these loadings and procedures for identifying potential water hammer that could affect safety; Relief Valve Opening and Closing Loads - dealing with the adequacy of analytical tools for predicting the effects of these events and, in addition, with estimating effective cycles for fatigue evaluations; and Piping Vibration Loads - dealing with evaluation procedures for estimating other than seismic vibratory loads, the need to consider reciprocating and rotary equipment vibratory loads, and high frequency vibratory loads. NRC staff recommendations or regulatory changes and additional study appear in this report

  19. Technical and regulatory review of the Rover nuclear fuel process for use on Fort St. Vrain fuel

    International Nuclear Information System (INIS)

    Hertzler, T.

    1993-02-01

    This report describes the results of an analysis for processing and final disposal of Fort St. Vrain (FSV) irradiated fuel in Rover-type equipment or technologies. This analysis includes an evaluation of the current Rover equipment status and the applicability of this technology in processing FSV fuel. The analyses are based on the physical characteristics of the FSV fuel and processing capabilities of the Rover equipment. Alternate FSV fuel disposal options are also considered including fuel-rod removal from the block, disposal of the empty block, or disposal of the entire fuel-containing block. The results of these analyses document that the current Rover hardware is not operable for any purpose, and any effort to restart this hardware will require extensive modifications and re-evaluation. However, various aspects of the Rover technology, such as the successful fluid-bed burner design, can be applied with modification to FSV fuel processing. The current regulatory climate and technical knowledge are not adequately defined to allow a complete analysis and conclusion with respect to the disposal of intact fuel blocks with or without the fuel rods removed. The primary unknowns include the various aspects of fuel-rod removal from the block, concentration of radionuclides remaining in the graphite block after rod removal, and acceptability of carbon in the form of graphite in a high level waste repository

  20. Instrumentation Facility

    Data.gov (United States)

    Federal Laboratory Consortium — Provides instrumentation support for flight tests of prototype weapons systems using a vast array of airborne sensors, transducers, signal conditioning and encoding...

  1. 75 FR 28517 - 2004 and 2006 Biennial Regulatory Reviews-Streamlining and Other Revisions of the Commission's...

    Science.gov (United States)

    2010-05-21

    ... Commission for the transmission of radio energy, the owner of the tower shall maintain the prescribed.... FOR FURTHER INFORMATION CONTACT: John Borkowski, Wireless Telecommunications Bureau, (202) 418-0626, e... its 2004 Biennial Review Comments, PCIA--the Wireless Infrastructure Association (PCIA) states that...

  2. Development of a Symptom-Based Patient-Reported Outcome Instrument for Functional Dyspepsia: A Preliminary Conceptual Model and an Evaluation of the Adequacy of Existing Instruments.

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