Draft Test Guideline: Aquatic Food Chain Transfer

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Draft Test Guideline: Aquatic Invetebrate Acute Toxicity, Test, Freshwater Daphnids

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Draft Test Guideline: Fish Acute Toxicity Test, Freshwater And Marine

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Draft Test Guideline: Whole Sediment Acute Toxicity Invertebrates, Freshwater

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Draft Test Guideline: Whole Sediment Acute Toxicity Invertebrates, Marine

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

76 FR 57031 - Draft Harmonized Test Guidelines; Notice of Availability and Request for Comments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-15

...EPA is announcing the availability of the draft test guidelines for Series 810--Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents, concerning specifically air, textiles, and water.

Draft Test Guideline: Fish Acute Toxicity Mitigated By Humic Acid

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Draft Test Guideline: Special Considerations for Conducting Aquatic Laboratory Studies

EPA Pesticide Factsheets

The following draft test guideline is part of a series of test guidelines that have been developed by EPA for use in the testing of pesticides and toxic substances, and the development of test data for submission to the Agency for review.

Comments from the Behavioral Teratology Committee of the Japanese Teratology Society on OECD guideline for the testing of chemicals, proposal for a new guideline 426, developmental neurotoxicity study, draft document (September 2003).

PubMed

Fukui, Yoshihiro; Ema, Makoto; Fujiwara, Michio; Higuchi, Hashihiro; Inouye, Minoru; Iwase, Takayuki; Kihara, Takahide; Nishimura, Tatsuya; Oi, Akihide; Ooshima, Yojiro; Otani, Hiroki; Shinomiya, Mitsuhiro; Sugioka, Kozo; Yamano, Tsunekazu; Yamashita, Keisuke H; Tanimura, Takashi

2004-09-01

In September 2003, a new revision of the draft guideline (Organization for Economic Co-operation and Development [OECD] Guideline for the Testing of Chemicals, Proposal for a New Guideline 426, Developmental Neurotoxicity Study) was distributed. The draft guideline consists of 51 paragraphs and an appendix. The National Coordinators were requested to arrange national expert reviews of the guideline proposal in their member countries. The member of the Behavioral Teratology (BT) Committee of the Japanese Teratology Society (JTS) reviewed, discussed and commented on the draft Test Guideline proposal. The BT Committee of the JTS also commented that the International Collaborative Study to validate this protocol should be definitely performed. These comments were sent to the OECD Secretariat. The BT Committee of the JTS expects that the comments are useful for further discussion.

76 FR 52355 - NUREG-1482, Revision 2, “Guidelines for Inservice Testing at Nuclear Power Plants, Draft Report...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

... Testing at Nuclear Power Plants, Draft Report for Comment'' AGENCY: Nuclear Regulatory Commission. ACTION... Testing at Nuclear Power Plants, Draft Report for Comment,'' and subtitled ``Inservice Testing of Pumps and Valves, and Inservice Examination and Testing of Dynamic Restraints (Snubbers) at Nuclear Power...

Proceedings of the Joint Logistics Commanders Joint Policy Coordinating Group on Computer Resource Management; Computer Software Management Software Workshop, 2-5 April 1979.

DTIC Science & Technology

1979-08-21

Appendix s - Outline and Draft Material for Proposed Triservice Interim Guideline on Application of Software Acceptance Criteria....... 269 Appendix 9...AND DRAFT MATERIAL FOR PROPOSED TRISERVICE INTERIM GUIDELINE ON APPLICATION OF SOFTWARE ACCEPTANCE CRITERIA I I INTRODUCTION The purpose of this guide...contract item (CPCI) (code) 5. CPCI test plan 6. CPCI test procedures 7. CPCI test report 8. Handbooks and manuals. Al though additional material does

77 FR 38282 - Final Test Guidelines; OCSPP 850 Series; Notice of Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-27

... conditions. EPA is changing the title of OPPTS 850.4450 ``Aquatic Plants Field Study, Tier III'' test....4300 ``Terrestrial Plants Field Study, Tier III'' test guideline. Public Draft OPPTS 850.4025 ``Target..., OCSPP 850.4300 ``Terrestrial Plants Field Study.'' The target area test guideline covers a special case...

Best practice guidelines for the molecular genetic diagnosis of Type 1 (HFE-related) hereditary haemochromatosis

PubMed Central

King, Caitriona; Barton, David E

2006-01-01

Background Hereditary haemochromatosis (HH) is a recessively-inherited disorder of iron over-absorption prevalent in Caucasian populations. Affected individuals for Type 1 HH are usually either homozygous for a cysteine to tyrosine amino acid substitution at position 282 (C282Y) of the HFE gene, or compound heterozygotes for C282Y and for a histidine to aspartic acid change at position 63 (H63D). Molecular genetic testing for these two mutations has become widespread in recent years. With diverse testing methods and reporting practices in use, there was a clear need for agreed guidelines for haemochromatosis genetic testing. The UK Clinical Molecular Genetics Society has elaborated a consensus process for the development of disease-specific best practice guidelines for genetic testing. Methods A survey of current practice in the molecular diagnosis of haemochromatosis was conducted. Based on the results of this survey, draft guidelines were prepared using the template developed by UK Clinical Molecular Genetics Society. A workshop was held to develop the draft into a consensus document. The consensus document was then posted on the Clinical Molecular Genetics Society website for broader consultation and amendment. Results Consensus or near-consensus was achieved on all points in the draft guidelines. The consensus and consultation processes worked well, and outstanding issues were documented in an appendix to the guidelines. Conclusion An agreed set of best practice guidelines were developed for diagnostic, predictive and carrier testing for hereditary haemochromatosis and for reporting the results of such testing. PMID:17134494

Progress Towards the Development of a Fathead Minnow Embryo Test and Comparison to the Zebrafish Embryo Test for Assessing Acute Fish Toxicity

EPA Science Inventory

The Zebrafish Embryo Test (ZFET) for acute fish toxicity is a well developed method nearing adoption as an OECD Test Guideline. Early drafts of the test guideline (TG) envisioned a suite of potential test species to be covered including zebrafish, fathead minnow, Japanese Medaka...

Guidance for Classifying Studies Conducted Using the OECD Test Guideline 223 (TG223) (Acute Avian Oral Sequential Dose Study)

EPA Pesticide Factsheets

Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.

75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-22

...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

75 FR 34146 - Draft Guideline for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Draft Guideline for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in Healthcare Settings AGENCY... and comment on the Draft Guideline for the Prevention and Control of Norovirus Gastroenteritis...

The New US Preventive Services Task Force "C" Draft Recommendation for Prostate Cancer Screening.

PubMed

Cooperberg, Matthew R

2017-09-01

The US Preventive Services Task Force has issued a new draft guideline, with a "C" recommendation that men aged 55-69 yr should be informed about the benefits and harms of screening for prostate cancer, and offered prostate-specific antigen testing if they choose it. For men aged ≥70 yr, the recommendation remains "D", or "do not screen." This draft represents substantial progress in the right direction towards offering men a fair opportunity to discuss the risks and benefits of screening with their primary care providers. However, the evidence review underlying the draft remains fundamentally inadequate, leading to biased presentations of both benefits and harms of screening. The final guideline and future revisions should reflect formal engagement with subject matter experts to optimize the advise given to men and their physicians. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Evidence-based Draft Guideline for Prevention of Midwifery Malpractices based on Referred Cases to the Forensic Medicine Commission and the Medical Council from 2006-2011.

PubMed

Asadi, Leila; Beigi, Marjan; Valiani, Mahbube; Mardani, Fardin

2017-01-01

Medical errors are the main concerns in health systems, which considering their ascending rate in the recent years, especially in the field of midwifery, have caused a medical crisis. Considering the importance of evidence-based health services as a way to improve health systems, the aim of this study was to suggest a guideline for preventing malpractice in midwifery services. In this cross-sectional study that was conducted in 2013, we investigated 206 cases that were referred to the Isfahan Legal Medicine Organization and Medical Council of Forensic Medicine from 2006-2011. Data were collected by a checklist and were analyzed using SPSS-16 software. Descriptive statistical tests (mean, maximum, minimum, standard deviation, frequency, and percentage agreement) were used to describe the data. Then, we used the Delphi technique with the participation from 17 experts in midwifery, gynecology, and legal medicine to provide an evidence-based draft guideline for prevention of midwifery errors. A total of 206 cases were reviewed. In 66 cases (32%) the verdict for malpractice in midwifery services was approved. A practical draft guideline for preventing clinical errors for midwifery in the fields of pregnancy, delivery, and postpartum period was developed. This evidence-based draft guideline can improve the attention of all the healthcare providers, especially midwives and physicians to prevent urgent problems and offer effective health services for mothers and infants.

Evidence-based Draft Guideline for Prevention of Midwifery Malpractices based on Referred Cases to the Forensic Medicine Commission and the Medical Council from 2006–2011

PubMed Central

Asadi, Leila; Beigi, Marjan; Valiani, Mahbube; Mardani, Fardin

2017-01-01

Background: Medical errors are the main concerns in health systems, which considering their ascending rate in the recent years, especially in the field of midwifery, have caused a medical crisis. Considering the importance of evidence-based health services as a way to improve health systems, the aim of this study was to suggest a guideline for preventing malpractice in midwifery services. Materials and Methods: In this cross-sectional study that was conducted in 2013, we investigated 206 cases that were referred to the Isfahan Legal Medicine Organization and Medical Council of Forensic Medicine from 2006–2011. Data were collected by a checklist and were analyzed using SPSS-16 software. Descriptive statistical tests (mean, maximum, minimum, standard deviation, frequency, and percentage agreement) were used to describe the data. Then, we used the Delphi technique with the participation from 17 experts in midwifery, gynecology, and legal medicine to provide an evidence-based draft guideline for prevention of midwifery errors. Results: A total of 206 cases were reviewed. In 66 cases (32%) the verdict for malpractice in midwifery services was approved. A practical draft guideline for preventing clinical errors for midwifery in the fields of pregnancy, delivery, and postpartum period was developed. Conclusions: This evidence-based draft guideline can improve the attention of all the healthcare providers, especially midwives and physicians to prevent urgent problems and offer effective health services for mothers and infants. PMID:28904546

Measure Guideline: Combustion Safety for Natural Draft Appliances Through Appliance Zone Isolation

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

Fitzgerald, J.; Bohac, D.

2014-04-01

This measure guideline covers how to assess and carry out the isolation of natural draft combustion appliances from the conditioned space of low-rise residential buildings. It deals with combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage. This subset of houses does not require comprehensive combustion safety tests and simplified prescriptive procedures can be used to address safety concerns. This allows residential energy retrofit contractors inexperienced in advanced combustion safety testing to effectively address combustion safety issues and allow energy retrofitsmore » including tightening and changes to distribution and ventilation systems to proceed.« less

[Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research and commentary].

PubMed

Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

2011-07-01

This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

[Draft of guidelines for human body dissection for clinical anatomy education and research and commentary].

PubMed

Shichinohe, Toshiaki; Kondo, Satoshi; Ide, Chizuka; Higuchi, Norio; Aiso, Sadakazu; Sakai, Tatsuo; Matsumura, George; Yoshida, Kazunari; Kobayashi, Eiji; Tatsumi, Haruyuki; Yaginuma, Hiroyuki; Hishikawa, Shuji; Sugimoto, Maki; Izawa, Yoshimitsu; Imanishi, Nobuaki

2011-06-01

This article analyses the Draft of Guidelines for Human Body Dissection for Clinical Anatomy Education and Research drawn by the Study Group for Future Training Systems of Surgical Skills and Procedures established by the Fiscal Year 2010 research program of the Ministry of Health, Labor and Welfare. The purpose of the Draft of Guidelines is: First, to lay out the required basic guidelines for human cadaver usage to allow medical and dental faculty to conduct clinical education and research in accordance with existing regulations. Second, the guidelines are expected to give physicians a regulatory framework to carry out cadaver training in accordance with the current legal framework. This article explains the Draft of Guidelines in detail, outlines the future of cadaver training, and describes issues which must still be solved.

Towards a national certification scheme for Rubus in the United States

USDA-ARS?s Scientific Manuscript database

Guidelines for a National Certification Scheme for Rubus in the United States have been drafted and are being evaluated in states with a tradition of Rubus propagation. The major components of the guidelines describe the procedures for propagating, testing and maintaining plants at four successive s...

76 FR 63565 - Event Reporting Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-13

...-2011-0237] Event Reporting Guidelines AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG... comments on Draft NUREG-1022, Revision 3, ``Event Reporting Guidelines: 10 CFR 50.72 and 50.73''. The NUREG-1022 contains guidelines that the NRC staff considers acceptable for use in meeting the event reporting...

Publication guidelines for quality improvement in health care: evolution of the SQUIRE project

PubMed Central

Davidoff, F; Batalden, P; Stevens, D; Ogrinc, G; Mooney, S

2008-01-01

In 2005, draft guidelines were published for reporting studies of quality improvement interventions as the initial step in a consensus process for development of a more definitive version. This article contains the full revised version of the guidelines, which the authors refer to as SQUIRE (Standards for QUality Improvement Reporting Excellence). This paper also describes the consensus process, which included informal feedback from authors, editors and peer reviewers who used the guidelines; formal written commentaries; input from a group of publication guideline developers; ongoing review of the literature on the epistemology of improvement and methods for evaluating complex social programmes; a two-day meeting of stakeholders for critical discussion and debate of the guidelines’ content and wording; and commentary on sequential versions of the guidelines from an expert consultant group. Finally, the authors consider the major differences between SQUIRE and the initial draft guidelines; limitations of and unresolved questions about SQUIRE; ancillary supporting documents and alternative versions that are under development; and plans for dissemination, testing and further development of SQUIRE. PMID:18836063

Clinical Practice Guidelines for Diagnosis and Treatment of Chronic Lymphocytic Leukemia (CLL) in The Netherlands.

PubMed

Kersting, Sabina; Neppelenbroek, Suzanne I M; Visser, Hein P J; van Gelder, Michel; Levin, Mark-David; Mous, Rogier; Posthuma, Ward; van der Straaten, Hanneke M; Kater, Arnon P

2018-01-01

In recent years, considerable progress has been made in the treatment of patients with chronic lymphocytic leukemia (CLL), and new potent drugs have become available. Therefore, the CLL working party revised the Dutch guidelines. Not only efficacy but also quality of life and socio-economic impact were taken into account in the formulation of treatment recommendations. The working party discussed a set of questions regarding diagnostic tests and treatment and wrote the draft guideline. This was evidence-based whenever possible, but in cases of low evidence, an expert-based recommendation was formulated with input of the entire working party. The draft guideline was sent to all hematologists in the Netherlands for comment and was subsequently approved. Recommendations were formulated on diagnostic tests and work-up before treatment. Also, recommendations were made for treatment with fludarabine-cyclophosphamide-rituximab, bendamustine-rituximab, chlorambucil with anti-CD20 antibody, ibrutinib, idelalisib-rituximab, venetoclax, and allogeneic stem cell transplantation. In the revised Dutch CLL guidelines, chemo-immunotherapy is still the cornerstone of CLL treatment with novel targeted drugs for specific risk groups. Copyright © 2017 Elsevier Inc. All rights reserved.

76 FR 11506 - Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind Energy...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-02

...] RIN 1018-AX45 Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind... Register on February 18, 2011, announcing the availability for public comment of draft Land-Based Wind... Guidelines are intended to supersede the Service's 2003 voluntary, interim guidelines for land-based wind...

76 FR 67439 - External Peer Review Meeting for Draft Microbial Risk Assessment Guideline: Pathogenic...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-01

... Draft Microbial Risk Assessment Guideline: Pathogenic Microorganisms With Focus on Food and Water AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The Agency is announcing that Eastern Research... Water. EPA previously announced the release of the draft guidance for a 60 day comment period (76 FR...

Findings from a novel approach to publication guideline revision: user road testing of a draft version of SQUIRE 2.0.

PubMed

Davies, Louise; Donnelly, Kyla Z; Goodman, Daisy J; Ogrinc, Greg

2016-04-01

The Standards for Quality Improvement Reporting Excellence (SQUIRE) Guideline was published in 2008 (SQUIRE 1.0) and was the first publication guideline specifically designed to advance the science of healthcare improvement. Advances in the discipline of improvement prompted us to revise it. We adopted a novel approach to the revision by asking end-users to 'road test' a draft version of SQUIRE 2.0. The aim was to determine whether they understood and implemented the guidelines as intended by the developers. Forty-four participants were assigned a manuscript section (ie, introduction, methods, results, discussion) and asked to use the draft Guidelines to guide their writing process. They indicated the text that corresponded to each SQUIRE item used and submitted it along with a confidential survey. The survey examined usability of the Guidelines using Likert-scaled questions and participants' interpretation of key concepts in SQUIRE using open-ended questions. On the submitted text, we evaluated concordance between participants' item usage/interpretation and the developers' intended application. For the survey, the Likert-scaled responses were summarised using descriptive statistics and the open-ended questions were analysed by content analysis. Consistent with the SQUIRE Guidelines' recommendation that not every item be included, less than one-third (n=14) of participants applied every item in their section in full. Of the 85 instances when an item was partially used or was omitted, only 7 (8.2%) of these instances were due to participants not understanding the item. Usage of Guideline items was highest for items most similar to standard scientific reporting (ie, 'Specific aim of the improvement' (introduction), 'Description of the improvement' (methods) and 'Implications for further studies' (discussion)) and lowest (<20% of the time) for those unique to healthcare improvement (ie, 'Assessment methods for context factors that contributed to success or failure' and 'Costs and strategic trade-offs'). Items unique to healthcare improvement, specifically 'Evolution of the improvement', 'Context elements that influenced the improvement', 'The logic on which the improvement was based', 'Process and outcome measures', demonstrated poor concordance between participants' interpretation and developers' intended application. User testing of a draft version of SQUIRE 2.0 revealed which items have poor concordance between developer intent and author usage, which will inform final editing of the Guideline and development of supporting supplementary materials. It also identified the items that require special attention when teaching about scholarly writing in healthcare improvement. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

77 FR 5057 - Draft Guidelines for Coroner/Medical Examiner Media Relations

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-01

... for Medicolegal Death Investigation will make available to the general public a draft document entitled, ``Guidelines for Media Relations: Dissemination of Public Information in Medicolegal Death...

75 FR 5633 - Notice of Extension of Comment Period for NUREG-1921, EPRI/NRC-RES Fire Human Reliability...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-03

..., EPRI/NRC- RES Fire Human Reliability Analysis Guidelines, Draft Report for Comment AGENCY: Nuclear... Human Reliability Analysis Guidelines, Draft Report for Comment'' (December 11, 2009; 74 FR 65810). This... Human Reliability Analysis Guidelines'' is available electronically under ADAMS Accession Number...

Draft Guidelines for State and Areawide Water Quality Management Program Development.

ERIC Educational Resources Information Center

Environmental Protection Agency, Washington, DC.

This document discusses the draft guidelines formulated by the Environmental Protection Agency (EPA) to assist the states in establishing a management program to integrate water quality and other resource management decisions. These guidelines are pfovided so that the long range goals of the Federal Water Pollution Control Act Amendments of 1972…

Publication Guidelines for Quality Improvement Studies in Health Care: Evolution of the SQUIRE Project

PubMed Central

Batalden, Paul; Stevens, David; Ogrinc, Greg; Mooney, Susan

2008-01-01

In 2005 we published draft guidelines for reporting studies of quality improvement interventions as the initial step in a consensus process for development of a more definitive version. The current article contains the revised version, which we refer to as SQUIRE (Standards for QUality Improvement Reporting Excellence). We describe the consensus process, which included informal feedback, formal written commentaries, input from publication guideline developers, review of the literature on the epistemology of improvement and on methods for evaluating complex social programs, and a meeting of stakeholders for critical review of the guidelines’ content and wording, followed by commentary on sequential versions from an expert consultant group. Finally, we examine major differences between SQUIRE and the initial draft, and consider limitations of and unresolved questions about SQUIRE; we also describe ancillary supporting documents and alternative versions under development, and plans for dissemination, testing, and further development of SQUIRE. PMID:18830766

Findings from a novel approach to publication guideline revision: user road testing of a draft version of SQUIRE 2.0

PubMed Central

Davies, Louise; Donnelly, Kyla Z; Goodman, Daisy J; Ogrinc, Greg

2016-01-01

Background The Standards for Quality Improvement Reporting Excellence (SQUIRE) Guideline was published in 2008 (SQUIRE 1.0) and was the first publication guideline specifically designed to advance the science of healthcare improvement. Advances in the discipline of improvement prompted us to revise it. We adopted a novel approach to the revision by asking end-users to ‘road test’ a draft version of SQUIRE 2.0. The aim was to determine whether they understood and implemented the guidelines as intended by the developers. Methods Forty-four participants were assigned a manuscript section (ie, introduction, methods, results, discussion) and asked to use the draft Guidelines to guide their writing process. They indicated the text that corresponded to each SQUIRE item used and submitted it along with a confidential survey. The survey examined usability of the Guidelines using Likert-scaled questions and participants’ interpretation of key concepts in SQUIRE using open-ended questions. On the submitted text, we evaluated concordance between participants’ item usage/interpretation and the developers’ intended application. For the survey, the Likert-scaled responses were summarised using descriptive statistics and the open-ended questions were analysed by content analysis. Results Consistent with the SQUIRE Guidelines’ recommendation that not every item be included, less than one-third (n=14) of participants applied every item in their section in full. Of the 85 instances when an item was partially used or was omitted, only 7 (8.2%) of these instances were due to participants not understanding the item. Usage of Guideline items was highest for items most similar to standard scientific reporting (ie, ‘Specific aim of the improvement’ (introduction), ‘Description of the improvement’ (methods) and ‘Implications for further studies’ (discussion)) and lowest (<20% of the time) for those unique to healthcare improvement (ie, ‘Assessment methods for context factors that contributed to success or failure’ and ‘Costs and strategic trade-offs’). Items unique to healthcare improvement, specifically ‘Evolution of the improvement’, ‘Context elements that influenced the improvement’, ‘The logic on which the improvement was based’, ‘Process and outcome measures’, demonstrated poor concordance between participants’ interpretation and developers’ intended application. Conclusions User testing of a draft version of SQUIRE 2.0 revealed which items have poor concordance between developer intent and author usage, which will inform final editing of the Guideline and development of supporting supplementary materials. It also identified the items that require special attention when teaching about scholarly writing in healthcare improvement. PMID:26263916

Safety and fitness electronic records system (SAFER) : draft master test plan

DOT National Transportation Integrated Search

1995-12-31

The purpose of this plan is to establish a formal set of guidelines and activities to be : adhered to and performed by JHU/APL and the developer to ensure that the SAFER System has been tested successfully and is fully compliant with the SAFER System...

The "National Medium- and Long-Term Educational Reform and Development Guideline (2010-20)": Expectations, Strategies, and Significance

ERIC Educational Resources Information Center

Xiaobing, Sun

2012-01-01

This paper starts out by describing the research and drafting processes of the "National Medium- and Long-Term Educational Reform and Development Guideline" (2010-20) (hereafter abbreviated as the "Guideline") and analyzes a series of core concepts that ran through the entire process of researching and drafting the…

Guiding the process of health technology disinvestment.

PubMed

Ibargoyen-Roteta, Nora; Gutiérrez-Ibarluzea, Iñaki; Asua, José

2010-12-01

To develop a guideline for health technology disinvestment. The Nominal Group Technique was used to determine relevant aspects of disinvestment decision-making. Ideas reaching consensus and previous Spanish guidelines on the acquisition of new health technologies (GANT) and new genetic tests (GEN) structures were used to develop the domains and contents of GuNFT (Guideline for Not Funding Health Technologies). The draft was peer reviewed by local and international experts and their suggestions were incorporated to the first GuNFT version. Thirty-five ideas reached consensus. The most relevant ones referred to the reasons for disinvesting in a technology and the key aspects that would facilitate disinvestment acceptance. Considering both consensus ideas and GANT and GEN guidelines, the first GuNFT draft was elaborated. After the review process, section numbers and contents were changed. The resulting GuNFT guideline was finally divided into six domains related to: (1) general preliminary recommendations, (2) completing the application form, (3) checking and prioritising applications, (4) assessment, (5) final decision and (6) action plan design. A software was also developed to facilitate GuNFT implementation. Disinvestment should be a guided process. Accordingly, we present the first guideline for that purpose. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Rich Prize, Restrictive Guidelines: Criteria Would Set High Bar for "Race to the Top" Eligibility

ERIC Educational Resources Information Center

McNeil, Michele

2009-01-01

The U.S. Department of Education's proposed guidelines for awarding $4 billion in Race to the Top Fund money send a strong message that any state hoping to land a competitive grant should expect to allow student test scores to be used in decisions about teacher compensation and evaluation. The draft plans outlined by department officials last…

Guidance for Reviewing OCSPP 850.2100 Avian Oral Toxicity Studies Conducted with Passerine Birds

EPA Pesticide Factsheets

Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.

Guidance for Use When Regurgitation is Observed in Avian Acute Toxicity Studies with Passerine Species

EPA Pesticide Factsheets

Guidance based on comparison of results from the TG223 validation studies to results from avian acute oral studies previously submitted to EPA for two test chemicals following EPA's 850.2100 (public draft) guidelines.

Textual analysis of sugar industry influence on the World Health Organization's 2015 sugars intake guideline.

PubMed

Stuckler, David; Reeves, Aaron; Loopstra, Rachel; McKee, Martin

2016-08-01

To determine whether sugar industry-related organizations influenced textual changes between the draft and final versions of the World Health Organization's (WHO's) 2015 guideline Sugars intake for adults and children. Stakeholder consultation submissions on the draft guideline from seven sugar industry-related and 10 public health organizations were assessed using the Wordscores program. Document scores were rescaled using the Martin-Vanberg transformation to improve comparability. Draft and final guidelines were compared to identify changes influenced by the sugar industry and public health organizations. There was a small shift in transformed Wordscores score between the draft and final guidelines, from 0.25 to 0.24, towards the industry position. The change was linked to increased use of the word "low" to describe the quality of the evidence, consistent with industry arguments. There was also a shift from use of the word "consumption" to "intake", irrespective of policy position. Scores for World Sugar Research Organisation and Sugar Nutrition UK submissions ( 0.11 and 0.18, respectively) represented strong pro-industry positions and scores for European Public Health Alliance and Wemos submissions (1.00 and 0.88, respectively) represented the strongest public health positions. Industry tactics included challenging the quality of the evidence, distinguishing between different types of sugar and advocating harm reduction. There was little change between draft and final versions of the WHO sugars intake guideline 2015, following industry consultation. The main change was linked to emphasizing the low quality of the evidence on sugar's adverse effects. Guideline development appeared relatively resistant to industry influence at the stakeholder consultation stage.

Consensus and controversies in best practices for molecular genetic testing of spinocerebellar ataxias

PubMed Central

Sequeiros, Jorge; Seneca, Sara; Martindale, Joanne

2010-01-01

Many laboratories worldwide are offering molecular genetic testing for spinocerebellar ataxias (SCAs). This is essential for differential diagnosis and adequate genetic counselling. The European Molecular Genetics Quality Network (EMQN) started an SCA external quality assessment scheme in 2004. There was a clear need for updated laboratory guidelines. EMQN and EuroGentest organized a Best Practice (BP) meeting to discuss current practices and achieve consensus. A pre-meeting survey showed that 36 laboratories (20 countries) conducted nearly 18 000 SCA tests the year before, and identified issues to discuss. Draft guidelines were produced immediately after the meeting and discussed online for several months. The final version was endorsed by EMQN, and harmonized with guidelines from other oligonucleotide repeat disorders. We present the procedures taken to organize the survey, BP meeting, as well as drafting and approval of BP guidelines. We emphasize the most important recommendations on (1) pre-test requirements, (2) appropriate methodologies and (3) interpretation and reporting, and focus on the discussion of controversial issues not included in the final document. In addition, after an extensive review of scientific literature, and responding to recommendations made, we now produce information that we hope will facilitate the activities of diagnostic laboratories and foster quality SCA testing. For the main loci, this includes (1) a list of repeat sequences, as originally published; (2) primers in use; and (3) an evidence-based description of the normal and pathogenic repeat-size ranges, including those of reduced penetrance and those in which there is still some uncertainty. This information will be maintained and updated in http://www.scabase.eu. PMID:20179748

A fall prevention guideline for older adults living in long-term care facilities.

PubMed

Jung, D; Shin, S; Kim, H

2014-12-01

Falls are among the most frequent critical health problems for older adults over 65 years of age and often result in consequential injuries. This study developed a guideline covering risk factors and interventions for falls in order to prevent them from occurring in long-term care facilities. This study was grounded in the methodological approach of the Scottish Intercollegiate Guideline Network for establishing evidence-based guidelines: (1) establishment of the target population and scope of the guideline, (2) systematic literature review and critical analysis, (3) determination of the recommendation grade, (4) development of a draft nursing intervention guideline and algorithm, (5) expert evaluation of the draft nursing intervention guideline, and (6) confirmation of the final intervention guideline and completion of the algorithm. The resulting evidence-based fall prevention guideline consists of a three-step factor assessment and a three-step intervention approach. The resulting guideline was based on the literature and clinical experts. Further research is required to test the guideline's feasibility in across long term care facilities. This guideline can be used by nurses to screen patients who are at a high risk of falling to provide patient interventions to help prevent falls. Considering the high rate of falls at long-term care facilities and the absence of evidence-based guidelines to prevent them, additional studies on falls at long-term care facilities are necessary. Meanwhile, given prior research that indicates the importance of human resources in the application of such guidelines, continuous investigations are needed as to whether the research outcomes are actually conveyed to nurses. © 2014 International Council of Nurses.

75 FR 9878 - Draft Principles and Standards Sections of the “Economic and Environmental Principles and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-04

... COUNCIL ON ENVIRONMENTAL QUALITY Draft Principles and Standards Sections of the ``Economic and Environmental Principles and Guidelines for Water and Related Land Resources Implementation Studies... the ``Economic and Environmental Principles and Guidelines for Water and Related Land Resources...

ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis.

PubMed

Cavero, Icilio; Crumb, William

2005-05-01

The International Conference on Harmonization (ICH) stems from the initiative of three major world partners (Japan, USA, European Community) who composed a mutually accepted body of regulations concerning the safety, quality and efficacy requirements that new medicines have to meet in order to receive market approval. Documents on non-clinical safety pharmacology already composed by this organisation include two guidelines: the S7A adopted in 2000 and, its companion, the S7B guideline, in a draft form since 2001. The S7A guideline deals with general principles and recommendations on safety pharmacology studies designed to protect healthy volunteers and patients from potential drug-induced adverse reactions. The S7B recommends a general non-clinical testing strategy for determining the propensity of non-cardiovascular pharmaceuticals to delay ventricular repolarisation, an effect that at times progresses into life-threatening ventricular arrhythmia. In the most recent version of this document (June 2004), the strategy proposes experimental assays and a critical examination of other pertinent information for applying an 'evidence of risk' label to a compound. Regrettably, the guideline fails to deal satisfactorily with a number of crucial issues such as scoring the evidence of risk and the clinical consequences of such scoring. However, in the latter case, the S7B relies on the new ICH guideline E14 which is currently in preparation. E14 is the clinical counterpart of the S7B guideline which states that non-clinical data are a poor predictor of drug-induced repolarisation delay in humans. The present contribution summarises and assesses salient aspects of the S7A guideline as its founding principles are also applicable to the S7B guideline. The differences in strategies proposed by the various existing drafts of the latter document are critically examined together with some unresolved, crucial problems. The need for extending the objective of the S7B document to characterise the full electrophysiological profile of new pharmaceuticals is argued as this approach would more extensively assess the non-clinical cardiac safety of a drug. Finally, in order to overcome present difficulties in arriving at the definitive version of the S7B guideline, the Expert Working Group could reflect on the introduction of the S7B guideline recommendations in the S7A document, as originally intended, or on postponing the adoption of an harmonized text until the availability of novel scientific data allows solving presently contentious aspects of this and the E14 guidelines.

Textual analysis of sugar industry influence on the World Health Organization’s 2015 sugars intake guideline

PubMed Central

Reeves, Aaron; Loopstra, Rachel; McKee, Martin

2016-01-01

Abstract Objective To determine whether sugar industry-related organizations influenced textual changes between the draft and final versions of the World Health Organization’s (WHO’s) 2015 guideline Sugars intake for adults and children. Methods Stakeholder consultation submissions on the draft guideline from seven sugar industry-related and 10 public health organizations were assessed using the Wordscores program. Document scores were rescaled using the Martin–Vanberg transformation to improve comparability. Draft and final guidelines were compared to identify changes influenced by the sugar industry and public health organizations. Findings There was a small shift in transformed Wordscores score between the draft and final guidelines, from 0.25 to 0.24, towards the industry position. The change was linked to increased use of the word “low” to describe the quality of the evidence, consistent with industry arguments. There was also a shift from use of the word “consumption” to “intake”, irrespective of policy position. Scores for World Sugar Research Organisation and Sugar Nutrition UK submissions ( 0.11 and 0.18, respectively) represented strong pro-industry positions and scores for European Public Health Alliance and Wemos submissions (1.00 and 0.88, respectively) represented the strongest public health positions. Industry tactics included challenging the quality of the evidence, distinguishing between different types of sugar and advocating harm reduction. Conclusion There was little change between draft and final versions of the WHO sugars intake guideline 2015, following industry consultation. The main change was linked to emphasizing the low quality of the evidence on sugar’s adverse effects. Guideline development appeared relatively resistant to industry influence at the stakeholder consultation stage. PMID:27516634

Vinblastine and diethylstilboestrol tested in the in vitro mammalian cell micronucleus test (MNvit) at Swansea University UK in support of OECD draft Test Guideline 487.

PubMed

Johnson, George E; Jenkins, Gareth J; Thomas, Adam D; Doak, Shareen H

2010-10-29

The known aneugens vinblastine and diethylstilboestrol (DES) were tested in the in vitro micronucleus assay, with and without cytokinesis block in Chinese hamster CHO cells, at the laboratories of Swansea University, Swansea, UK. These experiments were carried out to determine the suitability of the cell death and cytostasis measures used in the assay, as recommended in the draft OECD Test Guideline 487, 2007. Both compounds were positive in the assay without cytokinesis block at concentrations giving approximately 50% or less cell death and cytostasis, using relative population doublings and relative increase in cell counts. Moreover, both compounds were positive in the assay with cytokinesis block at concentrations giving approximately 50% cell death and cytostasis, using replicative index. Vinblastine was also positive for mitotic slippage, causing micronuclei in mononucleate cells with cytokinesis block. Relative population doublings and relative increase in cell counts were appropriate measures of cell death and cytostasis for the non-cytokinesis block in vitro micronucleus assay. In the cytokinesis blocked micronucleus assay, replicative index and cytokinesis block proliferation index were suitable cell death and cytostasis measures. Copyright © 2009 Elsevier B.V. All rights reserved.

Retrospective performance assessment of the draft test guideline 426 on developmental neurotoxicity.

EPA Science Inventory

This document was created by an international panel under the auspices of the International Programme on Chemical Safety of the World Health Programme. The purpose and intent of this retrospective performance assessment document is to review the history of the developmen...

Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence-Based Laboratory Medicine Committee of the American Association for Clinical Chemistry jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A(1c) (HbA(1c)) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of HbA(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended.

Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence Based Laboratory Medicine Committee of the AACC jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A(1c) (Hb A(1c)) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of Hb A(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended.

78 FR 63964 - Request for Comments on Draft NIST Interagency Report (NISTIR) 7628 Rev. 1, Guidelines for Smart...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-25

... Grid Cyber Security AGENCY: National Institute of Standards and Technology (NIST), Department of... and Technology (NIST) seeks comments on draft NISTIR 7628 Rev. 1, Guidelines for Smart Grid Cyber... (formerly the Cyber Security Working Group) of the Smart Grid Interoperability Panel. The document has been...

An International Approach to Enhancing a National Guideline on Driving and Dementia.

PubMed

Rapoport, Mark J; Chee, Justin N; Carr, David B; Molnar, Frank; Naglie, Gary; Dow, Jamie; Marottoli, Richard; Mitchell, Sara; Tant, Mark; Herrmann, Nathan; Lanctôt, Krista L; Taylor, John-Paul; Donaghy, Paul C; Classen, Sherrilene; O'Neill, Desmond

2018-03-12

The purpose of this study was to update a national guideline on assessing drivers with dementia, addressing limitations of previous versions which included a lack of developmental rigor and stakeholder involvement. An international multidisciplinary team reviewed 104 different recommendations from 12 previous guidelines on assessing drivers with dementia in light of a recent review of the literature. Revised guideline recommendations were drafted by consensus. A preliminary draft was sent to specialist physician and occupational therapy groups for feedback, using an a priori definition of 90% agreement as consensus. The research team drafted 23 guideline recommendations, and responses were received from 145 stakeholders. No recommendation was endorsed by less than 80% of respondents, and 14 (61%) of the recommendations were endorsed by more than 90%.The recommendations are presented in the manuscript. The revised guideline incorporates the perspectives of consensus of an expert group as well as front-line clinicians who regularly assess drivers with dementia. The majority of the recommendations were based on evidence at the level of expert opinion, revealing gaps in the evidence and future directions for research.

78 FR 1879 - Endangered and Threatened Wildlife and Plants; Draft Revised Indiana Bat Summer Survey Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-09

... Service, Interior. ACTION: Notice of availability; request for comments. SUMMARY: We, the U.S. Fish and Wildlife Service (USFWS), announce the availability of our draft revised summer survey guidelines for the... representatives of the U.S. Department of Agriculture's Forest Service, U.S. Department of Defense's Army Corps of...

Reading, readability, and legibility research: implications for notification letters.

PubMed

Zimmerman, D E

1993-01-01

This article defines communication science and then briefly describes three research areas relevant to worker notifications: (1) receiving of notification messages, (2) reading and understanding of notification messages, and (3) influences or effects of notification messages on workers. Next, the article focuses on the reading and legibility research relevant to worker notifications and then provides 16 guidelines for drafting worker notifications. Finally, the article suggests evaluating draft notifications by using one or more of the following: skilled editorial reviews, readability scoring, Cloze techniques, signal stopping techniques, in-depth personal interviews, focus groups, and usability testing.

Techniques for cytologic sampling of pancreatic and bile duct lesions: The Papanicolaou Society of Cytopathology Guidelines.

PubMed

Brugge, William R; De Witt, John; Klapman, Jason B; Ashfaq, Raheela; Shidham, Vinod; Chhieng, David; Kwon, Richard; Baloch, Zubair; Zarka, Matthew; Staerkel, Gregg

2014-01-01

The Papanicolaou Society of Cytopathology has developed a set of guidelines for pancreatobiliary cytology, including indications for endoscopic ultrasound guided fine-needle aspiration biopsy, techniques of the endoscopic retrograde cholangiopancreatography, terminology and nomenclature of pancreatobiliary disease, ancillary testing, and postbiopsy management. All documents are based on the expertise of the authors, a review of literature, discussions of the draft document at several national and international meetings over an 18 month period and synthesis of online comments of the draft document on the Papanicolaou Society of Cytopathology website [www.papsociety.org]. This document presents the results of these discussions regarding the use of sampling techniques in the cytological diagnosis of biliary and pancreatic lesions. This document summarizes the current state of the art for techniques in acquiring cytology specimens from the biliary tree as well as solid and cystic lesions of the pancreas.

78 FR 2421 - Endangered and Threatened Wildlife and Plants; Draft Revised Indiana Bat Summer Survey Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

... DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R5-ES-2012-N195: FXES11130300000-134-FF03E00000] Endangered and Threatened Wildlife and Plants; Draft Revised Indiana Bat Summer Survey Guidelines Correction In notice document 2013-00213, appearing on pages 1879-1880 in the issue of Wednesday, January 9...

Integrating Clinical Practice Guidelines into Daily Practice: Impact of an Interactive Workshop on Drafting of a Written Action Plan for Asthma Patients

ERIC Educational Resources Information Center

Labelle, Martin; Beaulieu, Michele; Renzi, Paolo; Rahme, Elham; Thivierge, Robert L.

2004-01-01

Introduction: Written action plans (WAPs) are instructions that enable asthmatics to manage their condition appropriately and are recommended by current asthma clinical practice guidelines (CPGs). However, general practitioners (GPs) rarely draft WAPs for their patients. An interactive, case-based workshop for asthma, combined with an objective…

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

PubMed Central

Arnold, Mark; Bakris, George L.; Bruns, David E.; Horvath, Andrea Rita; Kirkman, M. Sue; Lernmark, Ake; Metzger, Boyd E.; Nathan, David M.

2011-01-01

BACKGROUND Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence-Based Laboratory Medicine Committee of the American Association for Clinical Chemistry jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. CONTENT In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A1c (HbA1c) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended. PMID:21617108

[Draft guideline regarding appropriate use of 131I-MIBG radiotherapy for neuroendocrine tumors Drafting Committee for Guideline of Radiotherapy with 131I-MIBG, Committee for Nuclear Oncology and Immunology, The Japanese Society of Nuclear Medicine].

PubMed

Kinuya, Seigo; Yoshinaga, Keiichiro; Higuchi, Tetsuya; Jinguji, Megumi; Kawamoto, Hiroshi; Kurihara, Hiroaki

2015-02-01

131I-MIBG radiotherapy has been used for unresectable nueroendocrine tumors including malignant pheochromocytomas and neuroblastomas in foreign countries since the '80s when clinical therapeutic trials were initiated. In Japan, 131I-MIBG radiotherapy has not been approved by Ministry of Health, Labor and Welfare, however, personally imported 131I-MIBG is now available in limited institutions for therapeutic purpose. This updated guideline draft aims to provide useful information concerning 131I-MIBG radiotherapy, to prevent side effects, and to protect physicians, nurses, other health care professionals, patients and their families from radiation exposure. The committee also provides appendices including practical guidance for attending physicians, patient management and referring physicians for their conveniences.

76 FR 9590 - Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind Energy...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-18

..., wildlife and their habitats resulting from construction, operation and maintenance of land-based, wind... these draft Guidelines for all wind turbines, including community scale operations. All comments we...] RIN 1018-AX45 Fisheries and Habitat Conservation and Migratory Birds Programs; Draft Land-Based Wind...

77 FR 16990 - Notification of Submission to the Secretary of Agriculture of Two Draft Regulatory Documents...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... and Applicability; Clarification and Availability of Test Guideline''; and the second is entitled... Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4...) 305-5805. FOR FURTHER INFORMATION CONTACT: Rose Kyprianou, Field and External Affairs Division (7506P...

Guidelines for research on drugged driving

PubMed Central

Walsh, J. Michael; Verstraete, Alain G.; Huestis, Marilyn A.; Mørland, Jørg

2009-01-01

Aim A major problem in assessing the true public health impact of drug-use on driving and overall traffic safety is that the variables being measured across studies vary significantly. In studies reported in a growing global literature, basic parameters assessed, analytical techniques and drugs tested are simply not comparable due to lack of standardization in the field. These shortcomings severely limit the value of this research to add knowledge to the field. A set of standards to harmonize research findings is sorely needed. This project was initiated by several international organizations to develop guidelines for research on drugged driving. Methods A September 2006 meeting of international experts discussed the harmonization of protocols for future research on drugged driving. The principal objective of the meeting was to develop a consensus report setting guidelines, standards, core data variables and other controls that would form the basis for future international research. A modified Delphi method was utilized to develop draft guidelines. Subsequently, these draft guidelines were posted on the internet for global review, and comments received were integrated into the final document. Results The Guidelines Document is divided into three major sections, each focusing upon different aspects of drugged driving research (e.g. roadside surveys, prevalence studies, hospital studies, fatality and crash investigations, etc.) within the critical issue areas of ‘behavior’, ‘epidemiology’ and ‘toxicology’. The behavioral section contains 32 specific recommendations; (2) epidemiology 40 recommendations; and (3) toxicology 64 recommendations. Conclusions It is anticipated that these guidelines will improve significantly the overall quality of drugged driving research and facilitate future cross-study comparisons nationally and globally. PMID:18855814

Physiotherapy in hip and knee osteoarthritis: development of a practice guideline concerning initial assessment, treatment and evaluation.

PubMed

Peter, W F; Jansen, M J; Hurkmans, E J; Bloo, H; Dekker, J; Dilling, R G; Hilberdink, W; Kersten-Smit, C; de Rooij, M; Veenhof, C; Vermeulen, H M; de Vos, R J; Schoones, J W; Vliet Vlieland, T P

2011-01-01

An update of a Dutch physiotherapy practice guideline in Hip and Knee Osteoarthritis (HKOA) was made, based on current evidence and best practice. A guideline steering committee, comprising 10 expert physiotherapists, selected topics concerning the guideline chapters: initial assessment, treatment and evaluation. With respect to treatment a systematic literature search was performed using various databases, and the evidence was graded (1-4). For the initial assessment and evaluation mainly review papers and textbooks were used. Based on evidence and expert opinion, recommendations were formulated. A first draft of the guideline was reviewed by 17 experts from different professional backgrounds. A second draft was field-tested by 45 physiotherapists. In total 11 topics were selected. For the initial assessment, three recommendations were formulated, pertaining to history taking, red flags, and formulating treatment goals. Concerning treatment, 7 recommendations were formulated; (supervised) exercise therapy, education and self management interventions, a combination of exercise and manual therapy, postoperative exercise therapy and taping of the patella were recommended. Balneotherapy and hydrotherapy in HKOA, and thermotherapy, TENS, and Continuous Passive Motion in knee OA were neither recommended nor discouraged. Massage therapy, ultrasound, electrotherapy, electromagnetic field, Low Level Laser Therapy, preoperative physiotherapy and education could not be recommended. For the evaluation of treatment goals the following measurement instruments were recommended: Lequesne index, Western Ontario and McMaster Universities osteoarthritis index, Hip disability and Osteoarthritis Outcome Score and Knee injury and Osteoarthritis Outcome Score, 6-minute walktest, Timed Up and Go test, Patient Specific Complaint list, Visual Analoge Scale for pain, Intermittent and Constant OsteoArthritis Pain Questionnaire, goniometry, Medical Research Council for strength, handheld dynamometer. This update of a Dutch physiotherapy practice guideline on HKOA included 11 recommendations on the initial assessment, treatment and evaluation. The implementation of the guideline in clinical practice needs further evaluation.

Etoposide; colchicine; mitomycin C and cyclophosphamide tested in the in vitro mammalian cell micronucleus test (MNvit) in Chinese hamster lung (CHL) cells at Covance laboratories; Harrogate UK in support of OECD draft Test Guideline 487.

PubMed

Fowler, Paul; Whitwell, James; Jeffrey, Laura; Young, Jamie; Smith, Katie; Kirkland, David

2010-10-29

The following genotoxic chemicals were tested in the in vitro micronucleus assay, at Covance Laboratories, Harrogate, UK in the Chinese hamster lung cell line CHL. Etoposide (a topoisomerase inhibitor), colchicine (an aneugen), mitomycin C (a DNA cross linking agent) and cyclophosphamide (an alkylating agent requiring metabolic activation) were treated with and without cytokinesis block (by addition of cytochalasin B). This work formed part of a collaborative evaluation of the toxicity measures recommended in the draft OECD Test Guideline 487 for the in vitro micronucleus test. The toxicity measures used, detecting both cytostasis and cell death, were relative population doubling, relative increase in cell counts and relative cell counts for treatments in the absence of cytokinesis block, and replication index or cytokinesis blocked proliferation index in the presence of cytokinesis block. All of the chemicals tested gave significant increases in the percentage of micronucleated cells with and without cytokinesis block at concentrations giving approximately 60% toxicity (cytostasis and cell death) or less by all of the toxicity measures used. The outcomes from this series of tests support the use of relative increase in cell counts and relative population doubling, as well as relative cell counts, as appropriate measures of cytotoxicity for the non-cytokinesis blocked in vitro micronucleus assay. Copyright © 2010 Elsevier B.V. All rights reserved.

Cadmium chloride, benzo[a]pyrene and cyclophosphamide tested in the in vitro mammalian cell micronucleus test (MNvit) in the human lymphoblastoid cell line TK6 at Covance laboratories, Harrogate UK in support of OECD draft Test Guideline 487.

PubMed

Fowler, Paul; Whitwell, James; Jeffrey, Laura; Young, Jamie; Smith, Katie; Kirkland, David

2010-10-29

The following genotoxic chemicals were tested in the in vitro micronucleus assay, at Covance Laboratories, Harrogate, UK in the human lymphoblastoid cell line TK6. Cadmium chloride (an inorganic carcinogen), benzo[a]pyrene (a polycyclic aromatic hydrocarbon requiring metabolic activation) and cyclophosphamide (an alkylating agent requiring metabolic activation) were treated with and without cytokinesis block (by addition of cytochalasin B). This work formed part of a collaborative evaluation of the toxicity measures recommended in the draft OECD Test Guideline 487 for the in vitro micronucleus test. The toxicity measures used, capable of detecting both cytostasis and cell death, were relative population doubling, relative increase in cell counts and relative cell counts for treatments in the absence of cytokinesis block, and replication index or cytokinesis blocked proliferation index in the presence of cytokinesis block. All of the chemicals tested gave significant increases in the percentage of micronucleated cells with and without cytokinesis block at concentrations giving approximately 60% toxicity (cytostasis and cell death) or less by all of the toxicity measures used. The outcomes from this series of tests support the use of relative increase in cell counts and relative population doubling, as well as relative cell counts, as appropriate measures of cytotoxicity for the non-cytokinesis blocked in the in vitro micronucleus assay. Copyright © 2010 Elsevier B.V. All rights reserved.

Development of the First Guideline for Professional Conduct in Medical Practice in Iran.

PubMed

Saeedi Tehrani, Saeedeh; Nayeri, Fatemeh; Parsapoor, Alireza; Jafarian, Ali; Labaf, Ali; Mirzazadeh, Azim; Emadi Kouchak, Hamid; Shahi, Farhad; Ghasemzadeh, Nazafarin; Asghari, Fariba

2017-01-01

Professional behavior is first learned at the university. One of the necessary considerations in maintaining the professional environment of the university is establishing a set of codes for the behavior of physicians and medical students. This paper describes the process of developing the professional code of conduct in Tehran University of Medical Sciences, Tehran, Iran. A review of Iranian and international literature was performed to develop the first draft of the guideline. In sessions of group discussion by the authors, the articles of the draft were evaluated for relevancy, clarity, and lack of repetition. The draft was sent for evaluation to all participants, including the medical faculty members, residents, and medical students, four times and necessary corrections were made according to the comments received. The final guideline included 76 behavior codes in 6 categories, including altruism, honor and integrity, responsibility, respect, justice, and excellence. The codes of the guideline cover the physicians' commitments in the physician-patient, physician-colleague, and instructor-student relationships in order to improve the quality of the services. The Islamic and Iranian culture were taken into consideration in developing the guideline. Accordance with the administrative and educational conditions of the universities was ensured in developing the guideline and its acceptance was ensured through extensive surveys. Thus, it is expected that this guideline will be very effective in enhancing professional commitment in medical universities.

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

PubMed

Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory acceptance of 3R testing approaches, including a process for collection of real-life data (safe harbour). Pathways for regulatory acceptance of 3R testing approaches are depicted and a new procedure for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches is described.

Repeated 28-day oral toxicity study of vinclozolin in rats based on the draft protocol for the "Enhanced OECD Test Guideline No. 407" to detect endocrine effects.

PubMed

Shin, Jae-Ho; Moon, Hyun Ju; Kim, Tae Sung; Kang, Il Hyun; Ki, Ho Yeon; Choi, Kwang Sik; Han, Soon Young

2006-09-01

We performed a 28-day repeated-dose toxicity study of vinclozolin, a widely used fungicide, based on the draft protocol of the "Enhanced OECD Test Guideline 407" (Enhanced TG407) to investigate whether vinclozolin has endocrine-mediated properties according to this assay. Seven-week-old SD rats were administered with vinclozolin daily by oral gavage at dose rates of 0, 3.125, 12.5, 50 and 200 mg/kg/day for at least 28 days. The vinclozolin-treated male rats showed a reduction of epididymis and accessory sex organ weights and an alteration of hormonal patterns. A slight prolongation of the estrous cycle and changes in the estrogen/testosterone ratio and luteinizing hormone level were observed in vinclozolin-treated female rats. Thyroxin concentrations were decreased and thyroid-stimulating hormone concentrations were increased in both sexes; however, there were no compound-related microscopic lesions in the thyroid gland or changes in the thyroid weight. The endocrine-related effects of vinclozolin could be detected by the parameters examined in the present study based on the OECD protocol, suggesting the Enhanced TG407 protocol should be a suitable screening test for the detection of endocrine-mediated effects of chemicals.

Development of an Official Guideline for the Economic Evaluation of Drugs/Medical Devices in Japan.

PubMed

Shiroiwa, Takeru; Fukuda, Takashi; Ikeda, Shunya; Takura, Tomoyuki; Moriwaki, Kensuke

2017-03-01

In Japan, cost-effectiveness evaluation was implemented on a trial basis from fiscal year 2016. The results will be applied to the future repricing of drugs and medical devices. On the basis of a request from the Central Social Insurance Medical Council (Chuikyo), our research team drafted the official methodological guideline for trial implementation. Here, we report the process of developing and the contents of the official guideline for cost-effectiveness evaluation. The guideline reflects discussions at the Chuikyo subcommittee (e.g., the role of quality-adjusted life-year) and incorporates our academic perspective. Team members generated research questions for each section of the guideline and discussions on these questions were carried out. A draft guideline was prepared and submitted to the Ministry of Health, Labour and Welfare (MHLW), and then to the subcommittee. The draft guideline was revised on the basis of the discussions at the subcommitte, if appropriate. Although the "public health care payer's perspective" is standard in this guideline, other perspectives can be applied as necessary depending on the objective of analysis. On the basis of the discussions at the subcommittee, quality-adjusted life-year will be used as the basic outcome. A discount rate of 2% per annum for costs and outcomes is recommended. The final guideline was officially approved by the Chuikyo general assembly in February 2016. This is the first officially approved guideline for the economic evaluation of drugs and medical devices in Japan. The guideline is expected to improve the quality and comparability of submitted cost-effectiveness data for decision making. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

A new impetus for guideline development and implementation: construction and evaluation of a toolbox.

PubMed

Hilbink, Mirrian A H W; Ouwens, Marielle M T J; Burgers, Jako S; Kool, Rudolf B

2014-03-19

In the last decade, guideline organizations faced a number of problems, including a lack of standardization in guideline development methods and suboptimal guideline implementation. To contribute to the solution of these problems, we produced a toolbox for guideline development, implementation, revision, and evaluation. All relevant guideline organizations in the Netherlands were approached to prioritize the topics. We sent out a questionnaire and discussed the results at an invitational conference. Based on consensus, twelve topics were selected for the development of new tools. Subsequently, working groups were composed for the development of the tools. After development of the tools, their draft versions were pilot tested in 40 guideline projects. Based on the results of the pilot tests, the tools were refined and their final versions were presented. The vast majority of organizations involved in pilot testing of the tools reported satisfaction with using the tools. Guideline experts involved in pilot testing of the tools proposed a variety of suggestions for the implementation of the tools. The tools are available in Dutch and in English at a web-based platform on guideline development and implementation (http://www.ha-ring.nl). A collaborative approach was used for the development and evaluation of a toolbox for development, implementation, revision, and evaluation of guidelines. This approach yielded a potentially powerful toolbox for improving the quality and implementation of Dutch clinical guidelines. Collaboration between guideline organizations within this project led to stronger linkages, which is useful for enhancing coordination of guideline development and implementation and preventing duplication of efforts. Use of the toolbox could improve quality standards in the Netherlands, and might facilitate the development of high-quality guidelines in other countries as well.

76 FR 20006 - Wind Turbine Guidelines Advisory Committee; Teleconference Line Available for Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-11

...] Wind Turbine Guidelines Advisory Committee; Teleconference Line Available for Public Meeting AGENCY... Wildlife Service (Service), will host a Wind Turbine Guidelines Advisory Committee (Committee) meeting on... Service's Draft Land-Based Wind Energy Guidelines. DATES: The meeting will take place on April 27, 2011...

76 FR 38677 - Wind Turbine Guidelines Advisory Committee; Announcement of Public Meeting and Webcast

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

...] Wind Turbine Guidelines Advisory Committee; Announcement of Public Meeting and Webcast AGENCY: Fish and... Wildlife Service (Service), will host a Wind Turbine Guidelines Advisory Committee (Committee) meeting in... presentation and discussion of the Service's Draft Land-Based Wind Energy Guidelines. DATES: The meeting and...

On Guidelines for College English Teaching and Challenges for College English Teachers

ERIC Educational Resources Information Center

Li, Huiyin

2016-01-01

This article performs an exploratory study of the newly formulated "Guidelines" for College English Teaching ("Draft Exposure")("2015")("Guidelines"), aiming at exploring how different the latest Guidelines is from the previous ones, what challenges it brings to teachers and how these challenges can be…

76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-06

...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.

Cytosine arabinoside, vinblastine, 5-fluorouracil and 2-aminoanthracene testing in the in vitro micronucleus assay with L5178Y mouse lymphoma cells at Sanofi Aventis, with different cytotoxicity measurements, in support of the draft OECD Test Guideline on In Vitro Mammalian Cell Micronucleus Test.

PubMed

Cariou, Olivier; Laroche-Prigent, Nathalie; Ledieu, Sandrine; Guizon, Isabelle; Paillard, Françoise; Thybaud, Véronique

2010-10-29

Cytosine arabinoside (a nucleoside analogue that inhibits the gap-filling step of excision repair), vinblastine (an aneugen that inhibits tubulin polymerisation), 5-fluorouracil (a nucleoside analogue with a steep response profile), and 2-aminoanthracene (a metabolism-dependent reference genotoxin) were tested in the in vitro micronucleus assay with L5178Y mouse lymphoma cells, without cytokinesis block. The four chemicals were independently evaluated in two Sanofi Aventis laboratories, one of which used an image analyser to score micronuclei, while the other scored micronucleated cells manually. Very similar results were obtained in the two laboratories, highlighting the robustness of the assay. The four test chemicals induced significant increases in the incidence of micronucleated cells at concentrations that produced no more than a 55±5% reduction in survival growth, as measured with the three parameters recommended in the draft OECD Test Guideline on In Vitro Mammalian Cell Micronucleus Test (MNvit) for chemical testing, namely the relative increase in cell counts, relative population doubling, and the relative cell count. These results support the premise that the relative increase in cell counts and relative population doubling, that take into account both cell death and cytostasis, are appropriate measures of survival growth reduction in the in vitro micronucleus test conducted in the absence of cytokinesis block, as recommended in MNvit. Copyright © 2010 Elsevier B.V. All rights reserved.

Summary of the Chronic Obstructive Pulmonary Disease Clinical Practice Guideline Revised in 2014 by the Korean Academy of Tuberculosis and Respiratory Disease

PubMed Central

Yoon, Hyoung Kyu; Park, Yong-Bum; Rhee, Chin Kook; Lee, Jin Hwa

2017-01-01

Chronic obstructive pulmonary disease (COPD) results in high morbidity and mortality among patients both domestically and globally. The Korean clinical practice guideline for COPD was revised in 2014. It was drafted by the members of the Korean Academy of Tuberculosis and Respiratory Diseases, as well as participating members of the Health Insurance Review and Assessment Service, Korean Physicians' Association, and Korea Respiration Trouble Association. This revised guideline covers a wide range of topics, including the epidemiology, diagnosis, assessment, monitoring, management, exacerbation, and comorbidities of COPD in Korea. We drafted a guideline on COPD management by performing systematic reviews on the topic of management with the help of a meta-analysis expert. We expect this guideline will be helpful medical doctors treating patients with respiratory conditions, other health care professionals, and government personnel in South Korea. PMID:28747955

Techniques for cytologic sampling of pancreatic and bile duct lesions.

PubMed

Brugge, William; Dewitt, John; Klapman, Jason B; Ashfaq, Raheela; Shidham, Vinod; Chhieng, David; Kwon, Richard; Baloch, Zubair; Zarka, Matthew; Staerkel, Gregg

2014-04-01

The Papanicolaou Society of Cytopathology has developed a set of guidelines for pancreatobiliary cytology including indications for endoscopic ultrasound guided fine-needle aspiration biopsy, techniques of the endoscopic retrograde cholangiopancreatography, terminology and nomenclature of pancreatobiliary disease, ancillary testing, and postbiopsy management. All documents are based on the expertise of the authors, a review of the literature, discussions of the draft document at several national and international meetings over an 18-month period and synthesis of online comments of the draft document on the Papanicolaou Society of Cytopathology website [www.papsociety.org]. This document presents the results of these discussions regarding the use of ancillary testing in the cytological diagnosis of biliary and pancreatic lesions. This document summarizes the current state of the art for techniques in acquiring cytology specimens from the biliary tree as well as solid and cystic lesions of the pancreas. Copyright © 2014 Wiley Periodicals, Inc.

Smoking prevention and cessation in the Africa and Middle East region: a consensus draft guideline for healthcare providers--executive summary.

PubMed

Ali, Ahmed Yousif M; Safwat, Tarek; Onyemelukwe, Geoffrey; Otaibi, Moh'd Amin Al; Amir, Ashraf A; Nawas, Yousef N; Aouina, Hichem; Afif, Moulay Hicham; Bolliger, Chris T

2012-01-01

Despite the abundance of scientific evidence confirming the health consequences of smoking and other forms of tobacco use, the tobacco epidemic remains an important public health problem and by 2030 it is predicted that more than 80% of tobacco deaths will be in developing countries. In Africa and the Middle East, many local factors contribute to the initiation and maintenance of tobacco use. Although efforts to reduce the mortality and morbidity associated with smoking and tobacco dependence are underway, there is a need for guidance on how to utilize appropriate tobacco control policies and psychology- and pharmacology-based therapies to counter tobacco dependence as recommended by the Framework Convention on Tobacco Control (FCTC). A group of tobacco cessation experts from public health services and/or academic institutions in Africa and the Middle East participated in a series of four meetings held in Cairo, Cape Town, and Dubai between May 2008 and February 2011 to develop a draft guideline tailored to their region. This article provides the background to the development of this draft smoking cessation guideline and discusses how the recommendations can be implemented and progress monitored to promote both primary prevention and cessation of tobacco use within our countries. The draft guideline for Africa and the Middle East provides an important resource in combating the devastating effects of tobacco use in these regions which can be further localized through engagement with local stakeholders in the countries of the region. Copyright © 2012 S. Karger AG, Basel.

Basins 4.0 Climate Assessment Tool (Cat): Supporting Documentation and User Manual (External Review Draft)

EPA Science Inventory

EPA has released of the draft document solely for the purpose of pre-dissemination peer review under applicable Information Quality Guidelines (IQGs). This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agenc...

Climate Change Vulnerability Assessments: Four Case Studies of Water Utility Practices (External Review Draft)

EPA Science Inventory

EPA has released this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy ...

5-Fluorouracil, colchicine, benzo[a]pyrene and cytosine arabinoside tested in the in vitro mammalian cell micronucleus test (MNvit) in Chinese hamster V79 cells at Covance Laboratories, Harrogate, UK in support of OECD draft Test Guideline 487.

PubMed

Whitwell, James; Fowler, Paul; Allars, Sarah; Jenner, Karen; Lloyd, Melvyn; Wood, Debbie; Smith, Katie; Young, Jamie; Jeffrey, Laura; Kirkland, David

2010-10-29

The reference genotoxic agents 5-fluorouracil (a nucleoside analogue, characterised by a steep dose response profile), colchicine (an aneugen that inhibits tubulin polymerisation), benzo[a]pyrene (a polycyclic aromatic hydrocarbon requiring metabolic activation) and cytosine arabinoside (a nucleoside analogue that inhibits the gap-filling step of excision repair) were tested in the in vitro micronucleus assay using the Chinese hamster V79 cell line at Covance Laboratories, Harrogate, UK. All chemicals were treated in the absence and presence of cytokinesis block (via addition of cytochalasin B) with this work forming part of a collaborative evaluation of the toxicity measures recommended in the draft OECD Test Guideline 487 on the In Vitro Mammalian Cell Micronucleus Test (MNvit). The toxicity measures used, detecting a possible combination of both cytostasis and cell death (though not cell death directly), were relative population doubling, relative increase in cell counts and relative cell counts for treatments in the absence of cytokinesis block, and replication index in the presence of cytokinesis block. All of the chemicals tested either gave marked increases in the percentage of micronucleated cells with and without cytokinesis block, or did not induce micronuclei at concentrations giving approximately 50-60% toxicity (cytostasis and cell death) or less by all of the toxicity measures used. The outcome from this series of tests supports the use of relative increase in cell counts and relative population doubling, as well as relative cell counts, as appropriate measures of cytotoxicity for the non-cytokinesis blocked in vitro micronucleus assay. Copyright © 2010 Elsevier B.V. All rights reserved.

Monitoring Well Development Guidelines for Superfund Project Managers

EPA Pesticide Factsheets

This document provides well development guidelines and recommended additional sources of information. It was developed by the Supertund Ground Water Forum and draws upon U.S. Army Corps of Engineersand draft RCRA SW-846 field protocols. Comments..

The development of a guideline implementability tool (GUIDE-IT): a qualitative study of family physician perspectives

PubMed Central

2014-01-01

Background The potential of clinical practice guidelines has not been realized due to inconsistent adoption in clinical practice. Optimising intrinsic characteristics of guidelines (e.g., its wording and format) that are associated with uptake (as perceived by their end users) may have potential. Using findings from a realist review on guideline uptake and consultation with experts in guideline development, we designed a conceptual version of a future tool called Guideline Implementability Tool (GUIDE-IT). The tool will aim to involve family physicians in the guideline development process by providing a process to assess draft guideline recommendations. This feedback will then be given back to developers to consider when finalizing the recommendations. As guideline characteristics are best assessed by end-users, the objectives of the current study were to explore how family physicians perceive guideline implementability, and to determine what components should comprise the final GUIDE-IT prototype. Methods We conducted a qualitative study with family physicians inToronto, Ontario. Two experienced investigators conducted one-hour interviews with family physicians using a semi-structured interview guide to 1) elicit feedback on perceptions on guideline implementability; 2) to generate a discussion in response to three draft recommendations; and 3) to provide feedback on the conceptual GUIDE-IT. Sessions were audio taped and transcribed verbatim. Data collection and analysis were guided by content analyses. Results 20 family physicians participated. They perceived guideline uptake according to facilitators and barriers across 6 categories of guideline implementability (format, content, language, usability, development, and the practice environment). Participants’ feedback on 3 draft guideline recommendations were grouped according to guideline perception, cognition, and agreement. When asked to comment on GUIDE-IT, most respondents believed that the tool would be useful, but urged to involve “regular” or community family physicians in the process, and suggested that an online system would be the most efficient way to deliver it. Conclusions Our study identified facilitators and barriers of guideline implementability from the perspective of community and academic family physicians that will be used to build our GUIDE-IT prototype. Our findings build on current knowledge by showing that family physicians perceive guideline uptake mostly according to factors that are in the control of guideline developers. PMID:24476491

Development and validation of an OECD reproductive toxicity test guideline with the pond snail Lymnaea stagnalis (Mollusca, Gastropoda).

PubMed

Ducrot, Virginie; Askem, Clare; Azam, Didier; Brettschneider, Denise; Brown, Rebecca; Charles, Sandrine; Coke, Maïra; Collinet, Marc; Delignette-Muller, Marie-Laure; Forfait-Dubuc, Carole; Holbech, Henrik; Hutchinson, Thomas; Jach, Arne; Kinnberg, Karin L; Lacoste, Cédric; Le Page, Gareth; Matthiessen, Peter; Oehlmann, Jörg; Rice, Lynsey; Roberts, Edward; Ruppert, Katharina; Davis, Jessica Elphinstone; Veauvy, Clemence; Weltje, Lennart; Wortham, Ruth; Lagadic, Laurent

2014-12-01

The OECD test guideline development program has been extended in 2011 to establish a partial life-cycle protocol for assessing the reproductive toxicity of chemicals to several mollusk species, including the great pond snail Lymnaea stagnalis. In this paper, we summarize the standard draft protocol for a reproduction test with this species, and present inter-comparison results obtained in a 56-day prevalidation ring-test using this protocol. Seven European laboratories performed semi-static tests with cultured snails of the strain Renilys® exposed to nominal concentrations of cadmium chloride (from 53 to 608μgCdL(-1)). Cd concentrations in test solutions were analytically determined to confirm accuracy in the metal exposure concentrations in all laboratories. Physico-chemical and biological validity criteria (namely dissolved oxygen content >60% ASV, water temperature 20±1°C, control snail survival >80% and control snail fecundity >8 egg-masses per snail over the test period) were met in all laboratories which consistently demonstrated the reproductive toxicity of Cd in snails using the proposed draft protocol. Effect concentrations for fecundity after 56days were reproducible between laboratories (68

Tobacco industry's ITGA fights FCTC implementation in the Uruguay negotiations.

PubMed

Assunta, Mary

2012-11-01

To illustrate how the tobacco industry' front group, the International Tobacco Growers Association (ITGA), mobilised tobacco farmers to influence the fourth session of the Conference of the Parties (COP4) negotiations and defeat the adoption of Framework Convention on Tobacco Control Articles 9 and 10 Guidelines and Articles 17 and 18 progress report. A review of COP4 documents on Articles 9, 10, 17 and 18 was triangulated with relevant information from tobacco industry reports, websites of British American Tobacco, Philip Morris International and ITGA, presentations by tobacco industry executives and internal industry documents from the Legacy Tobacco Documents Library website. Philip Morris International and British American Tobacco rejected Articles 9 and 10 draft Guidelines claiming that banning ingredients in cigarettes will render burley leaf less commercially viable making tobacco growers in many countries suffer economic consequences. They claimed the terms 'attractiveness' and 'palatability' are not appropriate regulatory standards. The ITGA launched a global campaign to mobilise farmers to reject the draft Guidelines at COP4 in Uruguay. Tobacco producers, Brazil, Philippines, Tanzania, Zambia, Malawi and Zimbabwe, sent large delegations to COP4 and participated actively in the negotiation on the draft Guidelines. Partial Guidelines on Articles 9 and 10 on product regulation and disclosure were adopted. COP4's work on Article 17 provides guidance on viable alternatives, but the ITGA is opposed to this and continues fight crop substitution. Despite ITGA's international campaign to thwart the Guidelines on Articles 9 and 10 and a strong representation from tobacco-growing countries at COP4, the outcome after intense negotiations was the adoption of Partial Guidelines and work on Articles 17 and 18 to proceed.

76 FR 53424 - Intent To Prepare a Draft Supplemental Environmental Impact Statement for the Larose to Golden...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-26

... post-Katrina Hurricane and Storm Damage Risk Reduction System (HSDRRS) Design Guidelines, are in...-Hurricane Katrina hydrology and hydraulics design guidelines; (2) modify the 1965 design to complete the... adjustments) using the current HSDRRS Design Guidelines to include the Post-Hurricane Katrina surge models; (3...

Guidelines for Making Web Content Accessible to All Users

ERIC Educational Resources Information Center

Thompson, Terrill; Primlani, Saroj; Fiedor, Lisa

2009-01-01

The main goal of accessibility standards and guidelines is to design websites everyone can use. The "IT Accessibility Constituent Group" developed this set of draft guidelines to help EQ authors, reviewers, and staff and the larger EDUCAUSE community ensure that web content is accessible to all users, including those with disabilities. This…

Guidelines for the standardization of preanalytic variables for blood-based biomarker studies in Alzheimer’s disease research

PubMed Central

Gupta, Veer; Henriksen, Kim; Edwards, Melissa; Jeromin, Andreas; Lista, Simone; Bazenet, Chantal; Soares, Holly; Lovestone, Simon; Hampel, Harald; Montine, Thomas; Blennow, Kaj; Foroud, Tatiana; Carrillo, Maria; Graff-Radford, Neill; Laske, Christoph; Breteler, Monique; Shaw, Leslie; Trojanowski, John Q.; Schupf, Nicole; Rissman, Robert A.; Fagan, Anne M.; Oberoi, Pankaj; Umek, Robert; Weiner, Michael W.; Grammas, Paula; Posner, Holly; Martins, Ralph

2015-01-01

The lack of readily available biomarkers is a significant hindrance towards progressing to effective therapeutic and preventative strategies for Alzheimer’s disease (AD). Blood-based biomarkers have potential to overcome access and cost barriers and greatly facilitate advanced neuroimaging and cerebrospinal fluid biomarker approaches. Despite the fact that preanalytical processing is the largest source of variability in laboratory testing, there are no currently available standardized preanalytical guidelines. The current international working group provides the initial starting point for such guidelines for standardized operating procedures (SOPs). It is anticipated that these guidelines will be updated as additional research findings become available. The statement provides (1) a synopsis of selected preanalytical methods utilized in many international AD cohort studies, (2) initial draft guidelines/SOPs for preanalytical methods, and (3) a list of required methodological information and protocols to be made available for publications in the field in order to foster cross-validation across cohorts and laboratories. PMID:25282381

Guideline series: Control of volatile organic compound emissions from wood furniture manufacturing operations. Draft report

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

NONE

1995-08-01

This draft Control Techniques Guidelines (CTG) provides necessary guidance for development of regulations to limit emissions of volatile organic compounds (VOC`s) from wood furniture finishing and cleaning operations. This guidance includes emission limits for specific wood furniture finishing steps and work pratices to reduce waste and evaporation through pollution prevention methods; these represent reasonably available control technology for wood furniture finishing and cleaning operations. This document is intended to provide State and local air pollution authorities with an information base for proceeding with their own analyses of RACT to meet statutory requirements.

Field evaluation of the efficacy of proprietary repellent formulations with IR3535 and picaridin against Aedes aegypti.

PubMed

Naucke, T J; Kröpke, R; Benner, G; Schulz, J; Wittern, K P; Rose, A; Kröckel, U; Grünewald, H W

2007-06-01

Seven proprietary repellent formulations (3 hydro-alcoholic spray solutions and 4 skin lotions) with active ingredient IR3,535 (ethyl butylacetylaminopropionate, EBAAP) or Picaridin (hydroxyethyl isobutyl piperidine carboxylate, KBR 3,023, Bayrepel) were tested in a field study on 10 test persons over a period of 10 h for their efficacy at preventing bites. The tests were conducted in Belo Horizonte, Brazil on field populations of the yellow fever mosquito Aedes aegypti. The concentration of the active substances ranged from 10% to 20%. All the tested samples provided lasting protection (time to first bite) over several hours: ranging from 5 h 20 min to 6 h 50 min with a mean of approximately 6 h. The longest protection until the second bite (=first confirmation bite) was approximately 7 h 40 min, whereas the shortest protection was 6 h 50 min. The longest protection until the third bite (=second confirmation bite) was 8 h 35 min, whereas the shortest protection was 7 h 40 min. In the control tests in which none of the samples were applied, the mean times until the first, second and third bites were 26, 46 and 59 min, respectively. The basis for this field study was provided by two American guidelines, which have the greatest international acceptance. The first is a draft guideline from the Environmental Protection Agency (EPA (United States Environmental Protection Agency), Product performance test guidelines. OPPTS 810.3700. Insect repellents for human skin and outdoor premises. Public Draft, 1999) and the second is a standard from the American Society for Testing and Materials (ASTM (American Society for Testing and Materials International), E 939-94 (reapproved 2,000): standard test method of field testing topical applications of compounds as repellents for medically important and pest arthropods (including insects, ticks, and mites): I. Mosquitoes, 2,000). Both guidelines recommend measuring the duration of protection until the first and second bites and also determining the relative protection efficacy in terms of a 95% protection level. The ASTM standard permits different repellents to be applied, whereas the EPA guidelines only permit the use of a single repellent (in different concentrations) on the extremities (forearms or lower leg). In the study presented here, to exclude any possibility of different repellents or concentrations of a single repellent having a reciprocal effect on each other, each test person had repellent samples applied to only one of their forearms. The other forearm was used as a control for making comparative checks every hour and for determining the biting pressure. There was no significant difference in protection times between the two active substances.

Industrial Arts Curriculum Guide in Basic Technical Drafting. Bulletin No. 1686.

ERIC Educational Resources Information Center

Louisiana State Dept. of Education, Baton Rouge. Div. of Vocational Education.

This curriculum guide contains operational guidelines to help local administrators, teacher educators, and industrial arts teachers in the State of Louisiana determine the extent to which their technical drafting courses are meeting the needs of the youth they serve. It consists of a discussion of course prerequisites, goals, content, and…

75 FR 13457 - Americans With Disabilities Act (ADA) Accessibility Guidelines for Buildings and Facilities...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

... the draft, and information on benefits and costs. After reviewing the comments received in response to... comments on the quantitative and qualitative benefits and costs associated with the changes proposed in the draft; the Board also asks commenters to provide information on the benefits and costs of alternative...

Preparing Students for Computer Aided Drafting (CAD). A Conceptual Approach.

ERIC Educational Resources Information Center

Putnam, A. R.; Duelm, Brian

This presentation outlines guidelines for developing and implementing an introductory course in computer-aided drafting (CAD) that is geared toward secondary-level students. The first section of the paper, which deals with content identification and selection, includes lists of mechanical drawing and CAD competencies and a list of rationales for…

Guidelines for Preparing Economic Analysis (2010, revised 2014)

EPA Pesticide Factsheets

The Guidelines for Preparing Economic Analyses: External Review Draft have been prepared for review by the EPA Science Advisory Board and are part of a continuing effort by the U.S. EPA to develop improved economic guidance to support decision making.

Guidelines for port authorities and governments on the privatization of port facilities

DOT National Transportation Integrated Search

1998-09-23

Definitions of privatization as there are port practitioners and experts. In these circumstances, drafting "Guidelines for Port Authorities and Governments on the privatization of port facilities" is a challenge. The ten-step approach presented in th...

Collection Assessment. SPEC Kit 41.

ERIC Educational Resources Information Center

Association of Research Libraries, Washington, DC. Office of Management Studies.

This Association of Research Libraries (ARL) kit on collection assessment contains the following documents: (1) "Guidelines for the Evaluation of Library Collections--Draft Copy" (Collection Development Committee, Resource Section, Resources and Technical Services Division, American Library Association); (2) "Guidelines for Collection Assessment"…

New federal guidelines for physician-pharmaceutical industry relations: the politics of policy formation.

PubMed

Chimonas, Susan; Rothman, David J

2005-01-01

In October 2002 the federal government issued a draft "Compliance Program Guidance for Pharmaceutical Manufacturers." The draft Guidance questioned the legality of many arrangements heretofore left to the discretion of physicians and drug companies, including industry-funded educational and research grants, consultantcies, and gifts. Medical organizations and drug manufacturers proposed major revisions to the draft, arguing that current practices were in everyone's best interest. To evaluate the impact of their responses, we compare the draft, the changes requested by industry and organized medicine, and the final Guidance document (issued in April 2003). We also explore the implications--some intended, others unanticipated--of the final document.

Refining a taxonomy for guideline implementation: results of an exercise in abstract classification

PubMed Central

2013-01-01

Background To better understand the efficacy of various implementation strategies, improved methods for describing and classifying the nature of these strategies are urgently required. The aim of this study was to develop and pilot the feasibility of a taxonomy to classify the nature and content of implementation strategies. Methods A draft implementation taxonomy was developed based on the Cochrane Effective Practice and Organisation of Care (EPOC) data collection checklist. The draft taxonomy had four domains (professional, financial, organisational and regulatory) covering 49 distinct strategies. We piloted the draft taxonomy by using it to classify the implementation strategies described in the conference abstracts of the implementation stream of the 2010 Guideline International Network Conference. Five authors classified the strategies in each abstract individually. Final categorisation was then carried out in a face-to-face consensus meeting involving three authors. Results The implementation strategies described in 71 conference abstracts were classified. Approximately 15.5% of abstracts utilised strategies that could not be categorised using the draft taxonomy. Of those strategies that could be categorised, the majority were professionally focused (57%). A total of 41% of projects used only one implementation strategy, with 29% using two and 31% three or more. The three most commonly used strategies were changes in quality assurance, quality improvement and/or performance measurement systems, changes in information and communication technology, and distribution of guideline materials (via hard-copy, audio-visual and/or electronic means). Conclusions Further refinement of the draft taxonomy is required to provide hierarchical dimensions and granularity, particularly in the areas of patient-focused interventions, those concerned with audit and feedback and quality improvement, and electronic forms of implementation, including electronic decision support. PMID:23497520

Refining a taxonomy for guideline implementation: results of an exercise in abstract classification.

PubMed

Mazza, Danielle; Bairstow, Phillip; Buchan, Heather; Chakraborty, Samantha Paubrey; Van Hecke, Oliver; Grech, Cathy; Kunnamo, Ilkka

2013-03-15

To better understand the efficacy of various implementation strategies, improved methods for describing and classifying the nature of these strategies are urgently required. The aim of this study was to develop and pilot the feasibility of a taxonomy to classify the nature and content of implementation strategies. A draft implementation taxonomy was developed based on the Cochrane Effective Practice and Organisation of Care (EPOC) data collection checklist. The draft taxonomy had four domains (professional, financial, organisational and regulatory) covering 49 distinct strategies. We piloted the draft taxonomy by using it to classify the implementation strategies described in the conference abstracts of the implementation stream of the 2010 Guideline International Network Conference. Five authors classified the strategies in each abstract individually. Final categorisation was then carried out in a face-to-face consensus meeting involving three authors. The implementation strategies described in 71 conference abstracts were classified. Approximately 15.5% of abstracts utilised strategies that could not be categorised using the draft taxonomy. Of those strategies that could be categorised, the majority were professionally focused (57%). A total of 41% of projects used only one implementation strategy, with 29% using two and 31% three or more. The three most commonly used strategies were changes in quality assurance, quality improvement and/or performance measurement systems, changes in information and communication technology, and distribution of guideline materials (via hard-copy, audio-visual and/or electronic means). Further refinement of the draft taxonomy is required to provide hierarchical dimensions and granularity, particularly in the areas of patient-focused interventions, those concerned with audit and feedback and quality improvement, and electronic forms of implementation, including electronic decision support.

The CARE guidelines: consensus-based clinical case reporting guideline development

PubMed Central

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2013-01-01

A case report is a narrative that describes, for medical, scientific or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) premeeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines and (3) postmeeting feedback, review and pilot testing, followed by finalisation of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist—a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. PMID:24155002

Draft position paper on knowledge management in space activities

NASA Technical Reports Server (NTRS)

Holm, Jeanne; Moura, Denis

2003-01-01

As other fields of industry, space activities are facing the challenge of Knowledge Management and the International Academy of Astronautics decided to settle in 2002 a Study Group to analyse the problem and issue general guidelines. This communication presents the draft position paper of this group in view to be discussed during the 2003 IAF Congress.

Problem Formulation for Human Health Risk Assessments of Pathogens in Land-Applied Biosolids (External Review Draft)

EPA Science Inventory

This is a draft document and as such has not been formally disseminated by the U.S. EPA; it does not represent - and should not be construed to represent - any U.S. EPA policy or determination. Under applicable information quality guidelines, the document is being released for a...

Measuring the benefits of protected areas: a critical perspective on the IUCN guidelines

Treesearch

Dick Stanley; Luc Perron

1998-01-01

The International Union for the Conservation of Nature has drafted guidelines to help managers of protected natural areas to develop economic arguments in defense of those areas. The guidelines identify a series of benefits which protected areas might produce and which all have real markets in the outside world, and recommend that managers focus their arguments on...

Measure Guideline: Combustion Safety for Natural Draft Appliances Using Indoor Air

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

Brand, L.

2014-04-01

This measure guideline covers how to assess and carry out the combustion safety procedures for appliances and heating equipment that uses indoor air for combustion in low-rise residential buildings. Only appliances installed in the living space, or in an area freely communicating with the living space, vented alone or in tandem with another appliance are considered here. A separate measure guideline addresses combustion appliances located either within the living space in enclosed closets or side rooms or outside the living space in an adjacent area like an attic or garage that use outdoor air for combustion. This document is formore » inspectors, auditors, and technicians working in homes where energy upgrades are being conducted whether or not air infiltration control is included in the package of measures being applied. In the indoor combustion air case, guidelines summarized here are based on language provided in several of the codes to establish minimum requirements for the space using simplified prescriptive measures. In addition, building performance testing procedures are provided by testing agencies. The codes in combination with the test procedures offer comprehensive combustion safety coverage to address safety concerns, allowing inexperienced residential energy retrofit inspectors to effectively address combustion safety issues and allow energy retrofits to proceed.« less

77 FR 45378 - Guidelines for Cases Requiring On-Scene Death Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-31

... Requiring On-Scene Death Investigation AGENCY: National Institute of Justice, Justice. ACTION: Notice and... for Medicolegal Death Investigation will make available to the general public a draft document entitled, ``Guidelines for Cases Requiring On-Scene Death Investigation''. The opportunity to provide...

The wound/burn guidelines - 2: Guidelines for the diagnosis and treatment for pressure ulcers.

PubMed

Tachibana, Takao; Imafuku, Shinichi; Irisawa, Ryokichi; Ohtsuka, Masaki; Kadono, Takafumi; Fujiwara, Hiroshi; Asano, Yoshihide; Abe, Masatoshi; Ishii, Takayuki; Isei, Taiki; Ito, Takaaki; Inoue, Yuji; Ohtsuka, Mikio; Ogawa, Fumihide; Kodera, Masanari; Kawakami, Tamihiro; Kawaguchi, Masakazu; Kukino, Ryuichi; Kono, Takeshi; Sakai, Keisuke; Takahara, Masakazu; Tanioka, Miki; Nakanishi, Takeshi; Nakamura, Yasuhiro; Hashimoto, Akira; Hasegawa, Minoru; Hayashi, Masahiro; Fujimoto, Manabu; Maekawa, Takeo; Matsuo, Koma; Madokoro, Naoki; Yamasaki, Osamu; Yoshino, Yuichiro; Le Pavoux, Andres; Ihn, Hironobu

2016-05-01

The Wound/Burn Guidelines Committee consists of members commissioned by the Board of Directors of the Japanese Dermatological Association (JDA). It held several meetings and evaluations in writing since October 2008, and drafted five guidelines for the diagnosis and treatment including commentaries on wounds in general and the Guidelines for the Diagnosis and Treatment for Pressure Ulcers by taking opinions of the Scientific Committee and Board of Directors of JDA into consideration. © 2016 Japanese Dermatological Association.

Seismic design guidelines for highway bridges

NASA Astrophysics Data System (ADS)

Mayes, R. L.; Sharpe, R. L.

1981-10-01

Guidelines for the seismic design of highway bridges are given. The guidelines are the recommendations of a team of nationally recognized experts which included consulting engineers, academicians, State highway, and Federal agency representatives from throughout the United States. The guidelines are comprehensive in nature and they embody several new concepts which are significant departures from existing design provisions. An extensive commentary documenting the basis for the guidelines and an example demonstrating their use are included. A draft of the guidelines was used to seismically redesign twenty-one bridges. A summary of the redesigns is included.

A Screening Assessment of the Potential Impacts of Climate Change on Combined Sewer Overflow (Cso) Mitigation in the Great Lakes and New England Regions (External Review Draft)

EPA Science Inventory

EPA has released this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy ...

2004 GUIDELINES FOR WATER REUSE

EPA Science Inventory

The Guidelines for Water Reuse is an update of a similar document developed jointly by EPA and Camp, Dresser & McKee, Inc. in 1992. As with the earlier version, a committee of national and international experts in the field of water reclamation was established to draft new text a...

A collaborative approach to adopting/adapting guidelines - The Australian 24-Hour Movement Guidelines for the early years (Birth to 5 years): an integration of physical activity, sedentary behavior, and sleep.

PubMed

Okely, Anthony D; Ghersi, Davina; Hesketh, Kylie D; Santos, Rute; Loughran, Sarah P; Cliff, Dylan P; Shilton, Trevor; Grant, David; Jones, Rachel A; Stanley, Rebecca M; Sherring, Julie; Hinkley, Trina; Trost, Stewart G; McHugh, Clare; Eckermann, Simon; Thorpe, Karen; Waters, Karen; Olds, Timothy S; Mackey, Tracy; Livingstone, Rhonda; Christian, Hayley; Carr, Harriette; Verrender, Adam; Pereira, João R; Zhang, Zhiguang; Downing, Katherine L; Tremblay, Mark S

2017-11-20

In 2017, the Australian Government funded the update of the National Physical Activity Recommendations for Children 0-5 years, with the intention that they be an integration of movement behaviours across the 24-h period. The benefit for Australia was that it could leverage research in Canada in the development of their 24-h guidelines for the early years. Concurrently, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group published a model to produce guidelines based on adoption, adaption and/or de novo development using the GRADE evidence-to-decision framework. Referred to as the GRADE-ADOLOPMENT approach, it allows guideline developers to follow a structured and transparent process in a more efficient manner, potentially avoiding the need to unnecessarily repeat costly tasks such as conducting systematic reviews. The purpose of this paper is to outline the process and outcomes for adapting the Canadian 24-Hour Movement Guidelines for the Early Years to develop the Australian 24-Hour Movement Guidelines for the Early Years guided by the GRADE-ADOLOPMENT framework. The development process was guided by the GRADE-ADOLOPMENT approach. A Leadership Group and Consensus Panel were formed and existing credible guidelines identified. The draft Canadian 24-h integrated movement guidelines for the early years best met the criteria established by the Panel. These were evaluated based on the evidence in the GRADE tables, summaries of findings tables and draft recommendations from the Canadian Draft Guidelines. Updates to each of the Canadian systematic reviews were conducted and the Consensus Panel reviewed the evidence for each behaviour separately and made a decision to adopt or adapt the Canadian recommendations for each behaviour or create de novo recommendations. An online survey was then conducted (n = 302) along with five focus groups (n = 30) and five key informant interviews (n = 5) to obtain feedback from stakeholders on the draft guidelines. Based on the evidence from the Canadian systematic reviews and the updated systematic reviews in Australia, the Consensus Panel agreed to adopt the Canadian recommendations and, apart from some minor changes to the wording of good practice statements, keep the wording of the guidelines, preamble and title of the Canadian Guidelines. The Australian Guidelines provide evidence-informed recommendations for a healthy day (24-h), integrating physical activity, sedentary behaviour (including limits to screen time), and sleep for infants (<1 year), toddlers (1-2 years) and preschoolers (3-5 years). To our knowledge, this is only the second time the GRADE-ADOLOPMENT approach has been used. Following this approach, the judgments of the Australian Consensus Panel did not differ sufficiently to change the directions and strength of the recommendations and as such, the Canadian recommendations were adopted with very minor alterations. This allowed the Guidelines to be developed much faster and at lower cost. As such, we would recommend the GRADE-ADOLOPMENT approach, especially if a credible set of guidelines, with all supporting materials and developed using a transparent process, is available. Other countries may consider using this approach when developing and/or revising national movement guidelines.

Clinical guidelines for the treatment of depressive disorders. II. Principles of management.

PubMed

Reesal, R T; Lam, R W

2001-06-01

The Canadian Psychiatric Association and the Canadian Network for Mood and Anxiety Treatments partnered to produce clinical guidelines for psychiatrists for the treatment of depressive disorders. A standard guidelines development process was followed. Relevant literature was identified using a computerized Medline search supplemented by review of bibliographies. Operational criteria were used to rate the quality of scientific evidence, and the line of treatment recommendations included consensus clinical opinion. This section on "Principles of Management" is 1 of 7 articles drafted and reviewed by clinicians. Revised drafts underwent national and international expert peer review. The principles and goals of psychiatric management with psychotherapy and pharmacotherapy are reviewed. Two phases of treatment, acute and maintenance, are identified. Special topics, including inpatient management, suicide management, and medical-legal issues are also discussed. These principles of psychiatric management provide a framework for the use of specific treatments for depressive disorders.

Advocacy Groups Deliver Guidelines for Schools Facing Sexual-Orientation Issues

ERIC Educational Resources Information Center

Curriculum Review, 2006

2006-01-01

Groups that often find themselves on opposing sides of the cultural war over gay rights have bridged their divide to draft consensus guidelines designed to help public schools address sexual-orientation issues with sensitivity and respect. Representatives from the Christian Educators Association International and the Gay, Lesbian and Straight…

77 FR 64834 - Computational Fluid Dynamics Best Practice Guidelines for Dry Cask Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-23

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0250] Computational Fluid Dynamics Best Practice... public comments on draft NUREG-2152, ``Computational Fluid Dynamics Best Practice Guidelines for Dry Cask... System (ADAMS): You may access publicly-available documents online in the NRC Library at http://www.nrc...

78 FR 36698 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

... specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In... regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three...

Guidelines for dynamic data acquisition and analysis

NASA Technical Reports Server (NTRS)

Piersol, Allan G.

1992-01-01

The recommendations concerning pyroshock data presented in the final draft of a proposed military handbook on Guidelines for Dynamic Data Acquisition and Analysis are reviewed. The structural responses produced by pyroshocks are considered to be one of the most difficult types of dynamic data to accurately measure and analyze.

Proposed Performance Measures and Strategies for Implementation of the Fatigue Risk Management Guidelines for Emergency Medical Services.

PubMed

Martin-Gill, Christian; Higgins, J Stephen; Van Dongen, Hans P A; Buysse, Daniel J; Thackery, Ronald W; Kupas, Douglas F; Becker, David S; Dean, Bradley E; Lindbeck, George H; Guyette, Francis X; Penner, Josef H; Violanti, John M; Lang, Eddy S; Patterson, P Daniel

2018-02-15

Performance measures are a key component of implementation, dissemination, and evaluation of evidence-based guidelines (EBGs). We developed performance measures for Emergency Medical Services (EMS) stakeholders to enable the implementation of guidelines for fatigue risk management in the EMS setting. Panelists associated with the Fatigue in EMS Project, which was supported by the National Highway Traffic Safety Administration (NHTSA), used an iterative process to develop a draft set of performance measures linked to 5 recommendations for fatigue risk management in EMS. We used a cross-sectional survey design and the Content Validity Index (CVI) to quantify agreement among panelists on the wording and content of draft measures. An anonymous web-based tool was used to solicit the panelists' perceptions of clarity and relevance of draft measures. Panelists rated the clarity and relevance separately for each draft measure on a 4-point scale. CVI scores ≥0.78 for clarity and relevance were specified a priori to signify agreement and completion of measurement development. Panelists judged 5 performance measures for fatigue risk management as clear and relevant. These measures address use of fatigue and/or sleepiness survey instruments, optimal duration of shifts, access to caffeine as a fatigue countermeasure, use of napping during shift work, and the delivery of education and training on fatigue risk management for EMS personnel. Panelists complemented performance measures with suggestions for implementation by EMS agencies. Performance measures for fatigue risk management in the EMS setting will facilitate the implementation and evaluation of the EBG for Fatigue in EMS.

78 FR 23289 - Public Review of Draft National Shoreline Data Content Standard

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-18

...The Federal Geographic Data Committee (FGDC) is conducting a public review of the draft National Shoreline Data Content Standard. The FGDC has developed a draft National Shoreline Data Content Standard that provides a framework for shoreline data development, sharing of data, and shoreline data transformation and fusion. The FGDC Coastal and Marine Spatial Data Subcommittee, chaired by the National Oceanic and Atmospheric Administration (NOAA), sponsored development of the draft standard. The FGDC Coordination Group, comprised of representatives of Federal agencies, has approved releasing this draft standard for public review and comment. The draft National Shoreline Data Content Standard defines attributes or elements that are common for shoreline data development and provides suggested domains for the elements. The functional scope includes definition of data models, schemas, entities, relationships, definitions, and crosswalks to related standards. The draft National Shoreline Data Content Standard is intended to enhance the shoreline framework by providing technical guidance on shoreline semantics, data structures and their relationships to builders and users of shoreline data. The geographical scope of the draft standard comprises all shorelines of navigable waters within the United States and its territories. The primary intended users of the National Shoreline Data Content Standard are the mapping, shoreline engineering, coastal zone management, flood insurance, and natural resource management communities. The FGDC invites all stakeholders to comment on this draft standard to ensure that it meets their needs. The draft National Shoreline Data Content Standard may be downloaded from https://www.fgdc.gov/standards/projects/FGDC-standards- projects/shoreline-data-content/ revisedDraftNationalShorelineDataContentStandard. Comments shall be submitted using the content template at http://www.fgdc.gov/standards/ process/standards-directives/template.doc. Instructions for completing the comment template are found in FGDC Standards Directive 2d, Standards Working Group Review Guidelines: Review Comment Template, http://www.fgdc.gov/standards/process/standards-directives/directive- 2d-standards-working-group-review-guidelines-review-comment-template. Comments that concern specific issues/changes/additions may result in revisions to the National Shoreline Data Content Standard. Reviewers may obtain information about how comments were addressed upon request. After formal endorsement of the standard by the FGDC, the National Shoreline Data Content Standard and a summary analysis of the changes will be made available to the public on the FGDC Web site, www.fgdc.gov.

2-Aminoanthracene, 5-fluorouracil, colchicine, benzo[a]pyrene, cadmium chloride and cytosine arabinoside tested in the in vitro mammalian cell micronucleus test (MNvit) in Chinese hamster ovary (CHO) cells at Covance Laboratories, Harrogate UK in support of OECD draft Test Guideline 487.

PubMed

Whitwell, James; Fowler, Paul; Allars, Sarah; Jenner, Karen; Lloyd, Melvyn; Wood, Debbie; Smith, Katie; Young, Jamie; Jeffrey, Laura; Kirkland, David

2010-10-29

The reference genotoxic agents 2-aminoanthracene (a metabolism dependent weak clastogen), 5-fluorouracil (a nucleoside analogue, characterised by a steep dose response profile), colchicine (an aneugen that inhibits tubulin polymerisation), benzo[a]pyrene (a polycyclic aromatic hydrocarbon requiring metabolic activation), cadmium chloride (an inorganic carcinogen), and cytosine arabinoside (a nucleoside analogue that inhibits the gap-filling step of excision repair) were tested in the in vitro micronucleus assay using the Chinese hamster ovary (CHO) cell line at Covance Laboratories, Harrogate, UK. All chemicals were treated in the absence and presence of cytokinesis block (via addition of cytochalasin B) with this work forming part of a collaborative evaluation of the toxicity measures recommended in the draft OECD Test Guideline 487 on the In vitro Mammalian Cell Micronucleus Test (MNvit). The toxicity measures used, detecting a possible combination of both cytostasis and cell death (though not cell death directly), were relative population doubling, relative increase in cell counts and relative cell counts for treatments in the absence of cytokinesis block, and replication index in the presence of cytokinesis block. All of the chemicals tested either gave marked positive increases in the percentage of micronucleated cells with and without cytokinesis block, or did not induce micronuclei at concentrations giving approximately 50-60% toxicity (cytostasis and cell death) or less by all of the toxicity measures used. The outcome from this series of tests supports the use of relative increase in cell counts and relative population doubling, as well as relative cell counts, as appropriate measures of cytotoxicity for the non-cytokinesis blocked in vitro micronucleus assay. Copyright © 2010 Elsevier B.V. All rights reserved.

Multidisciplinary guidelines in Dutch mental health care: plans, bottlenecks and possible solutions.

PubMed

Hutschemaekers, Giel J M

2003-12-10

This article describes the Dutch 'Multidisciplinary Guidelines in Mental Health Care' project and its first products (multidisciplinary guidelines on depressive and anxiety disorders). In the early 1990s, disciplines in Dutch mental health care formulated their first monodisciplinary guidelines, which disagreed on essential features. In 1998, the Dutch government invited representatives of the five core disciplines in mental health care (psychiatrists, general practitioners, psychotherapists (clinical), psychologists and psychiatric nurses) to start a joint project aimed at the development of new integrated multidisciplinary guidelines. The vision document, presented in 2000 by the five core disciplines, describes the directions for the development of new guidelines. The guidelines on depressive and anxiety disorders will appear in 2004. The first draft guidelines were presented in May 2003, in line with the vision document (2000). However, it is still not certain whether they will be authorised by all professional groups. Some disciplines do not recognise themselves in these guidelines. It is argued that these problems can be attributed at least in part to the evidence-based method that was used in drafting the guidelines. Interventions are compared on the basis of their 'level of evidence', the consequence of which is that cognitive behavioural therapy and drug treatment are almost always seen as the only appropriate interventions. Other interventions are excluded because of their lower level of evidence. The conclusion is that guidelines cannot be based on empirical evidence alone. It is argued that the collective sense of professions involved should also be integrated into the guideline, for example in relation to goal differentiation. It is finally argued that multidisciplinary guidelines must also offer a hierarchy between those goals, i.e. a vision of the appropriate type of care and the order in which the various care components should be administered.

Guidelines for reporting embedded recruitment trials.

PubMed

Madurasinghe, Vichithranie W

2016-01-14

Recruitment to clinical trials is difficult with many trials failing to recruit to target and within time. Embedding trials of recruitment interventions within host trials may provide a successful way to improve this. There are no guidelines for reporting such embedded methodology trials. As part of the Medical Research Council funded Systematic Techniques for Assisting Recruitment to Trials (MRC START) programme designed to test interventions to improve recruitment to trials, we developed guidelines for reporting embedded trials. We followed a three-phase guideline development process: (1) pre-meeting literature review to generate items for the reporting guidelines; (2) face-to-face consensus meetings to draft the reporting guidelines; and (3) post-meeting feedback review, and pilot testing, followed by finalisation of the reporting guidelines. We developed a reporting checklist based on the Consolidated Standards for Reporting Trials (CONSORT) statement 2010. Embedded trials evaluating recruitment interventions should follow the CONSORT statement 2010 and report all items listed as essential. We used a number of examples to illustrate key issues that arise in embedded trials and how best to report them, including (a) how to deal with description of the host trial; (b) the importance of describing items that may differ in the host and embedded trials (such as the setting and the eligible population); and (c) the importance of identifying clearly the point at which the recruitment interventions were embedded in the host trial. Implementation of these guidelines will improve the quality of reports of embedded recruitment trials while advancing the science, design and conduct of embedded trials as a whole.

Optimizing the design of a reproduction toxicity test with the pond snail Lymnaea stagnalis.

PubMed

Charles, Sandrine; Ducrot, Virginie; Azam, Didier; Benstead, Rachel; Brettschneider, Denise; De Schamphelaere, Karel; Filipe Goncalves, Sandra; Green, John W; Holbech, Henrik; Hutchinson, Thomas H; Faber, Daniel; Laranjeiro, Filipe; Matthiessen, Peter; Norrgren, Leif; Oehlmann, Jörg; Reategui-Zirena, Evelyn; Seeland-Fremer, Anne; Teigeler, Matthias; Thome, Jean-Pierre; Tobor Kaplon, Marysia; Weltje, Lennart; Lagadic, Laurent

2016-11-01

This paper presents the results from two ring-tests addressing the feasibility, robustness and reproducibility of a reproduction toxicity test with the freshwater gastropod Lymnaea stagnalis (RENILYS strain). Sixteen laboratories (from inexperienced to expert laboratories in mollusc testing) from nine countries participated in these ring-tests. Survival and reproduction were evaluated in L. stagnalis exposed to cadmium, tributyltin, prochloraz and trenbolone according to an OECD draft Test Guideline. In total, 49 datasets were analysed to assess the practicability of the proposed experimental protocol, and to estimate the between-laboratory reproducibility of toxicity endpoint values. The statistical analysis of count data (number of clutches or eggs per individual-day) leading to ECx estimation was specifically developed and automated through a free web-interface. Based on a complementary statistical analysis, the optimal test duration was established and the most sensitive and cost-effective reproduction toxicity endpoint was identified, to be used as the core endpoint. This validation process and the resulting optimized protocol were used to consolidate the OECD Test Guideline for the evaluation of reproductive effects of chemicals in L. stagnalis. Copyright © 2016 Elsevier Inc. All rights reserved.

Guidelines for Public Libraries in the 21st Century.

ERIC Educational Resources Information Center

Gill, Philip

This paper highlights some of the issues that arose during the drafting of a revised version of the IFLA (International Federation of Library Associations and Institutions) Guidelines for Public Libraries. The sections of the new document are outlined as follows: (1) The Role and Purpose of the Public Library; (2) The Legal and Financial…

78 FR 39310 - Voluntary Guidelines to Prevent the Introduction and Spread of Aquatic Invasive Species...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-01

... the Introduction and Spread of Aquatic Invasive Species: Water Gardening These voluntary guidelines... spread of aquatic invasive species by water gardening. The goal of the two committees was to develop... to address the potential spread of aquatic invasive species by water gardening. The product, a draft...

A Screening Assessment of the Potential Impacts of Climate Change on the Costs of Implementing Water Quality-Based Effluent Limits at Publicly-Owned Treatment Works (Potws) in the Great Lakes Region (External Review Draft)

EPA Science Inventory

EPA has released this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy ...

Testing REACH draft technical guidance notes for conducting chemical safety assessments-the experience of a downstream user of a preparation.

PubMed

Gade, Anne Lill; Ovrebø, Steinar; Hylland, Ketil

2008-07-01

The goal of REACH is the safe use of chemicals. This study examines the efficiency and usefulness of two draft technical guidance notes in the REACH Interim Project 3.2-2 for the development of the chemical safety report and exposure scenarios. A case study was carried out for a paint system for protection of structural steel. The focuses of the study were risk assessment of preparations based on Derived No Effect Level (DNEL) and Predicted No Effect Concentrations (PNEC) and on effective and accurate communication in the supply chain. Exposure scenarios and generic descriptions of uses, risk management measures, and exposure determinants were developed. The study showed that communication formats, software tools, and guidelines for chemical risk assessment need further adjustment to preparations and real-life situations. Web platforms may simplify such communication. The downstream formulator needs basic substance data from the substance manufacturer during the pre-registration phase to develop exposure scenarios for preparations. Default values need to be communicated in the supply chain because these were critical for the derivation of applicable risk management demands. The current guidelines which rely on the available toxicological knowledge are insufficient to advise downstream users on how to develop exposure scenarios for preparations.

ASCCP Colposcopy Standards: Colposcopy Quality Improvement Recommendations for the United States.

PubMed

Mayeaux, Edward J; Novetsky, Akiva P; Chelmow, David; Garcia, Francisco; Choma, Kim; Liu, Angela H; Papasozomenos, Theognosia; Einstein, Mark H; Massad, L Stewart; Wentzensen, Nicolas; Waxman, Alan G; Conageski, Christine; Khan, Michelle J; Huh, Warner K

2017-10-01

The American Society for Colposcopy and Cervical Pathology (ASCCP) Colposcopy Standards recommendations address the role of and approach to colposcopy and biopsy for cervical cancer prevention in the United States. The recommendations were developed by an expert working group appointed by ASCCP's Board of Directors. The ASCCP Quality Improvement Working Group developed evidence-based guidelines to promote best practices and reduce errors in colposcopy and recommended indicators to measure colposcopy quality. The working group performed a systematic review of existing major society and national guidelines and quality indicators. An initial list of potential quality indicators was developed and refined through successive iterative discussions, and draft quality indicators were proposed. The draft recommendations were then reviewed and commented on by the entire Colposcopy Standards Committee, posted online for public comment, and presented at the International Federation for Cervical Pathology and Colposcopy 2017 World Congress for further comment. All comments were considered, additional adjustments made, and the final recommendations approved by the entire Task Force. Eleven quality indicators were selected spanning documentation, biopsy protocols, and time intervals between index screening tests and completion of diagnostic evaluation. The proposed quality indicators are intended to serve as a starting point for quality improvement in colposcopy at a time when colposcopy volume is decreasing and individual procedures are becoming technically more difficult to perform.

Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape.

PubMed

Benda, Norbert; Brandt, Andreas

2018-01-01

Recently, new draft guidelines on multiplicity issues in clinical trials have been issued by European Medicine Agency (EMA) and Food and Drug Administration (FDA), respectively. Multiplicity is an issue in clinical trials, if the probability of a false-positive decision is increased by insufficiently accounting for testing multiple hypotheses. We outline the regulatory principles related to multiplicity issues in confirmatory clinical trials intended to support a marketing authorization application in the EU, describe the reasons for an increasing complexity regarding multiple hypotheses testing and discuss the specific multiplicity issues emerging within the regulatory context and being relevant for drug approval.

How to Create Social Media Guidelines for Your School

ERIC Educational Resources Information Center

Anderson, Steven

2012-01-01

Social media is fast becoming as ubiquitous as the air we breathe. In recent months, many schools and districts around the country have taken steps to create social media policies and guidelines for their students and staff. In the author's work with several districts to draft these documents, he has seen many approaches that work well, and some…

Teacher-Board Relations in Connecticut: A Summary of the Law Regarding Scope of Negotiations, Good Faith Bargaining, and Unfair Labor Practices. Preliminary Draft.

ERIC Educational Resources Information Center

Zirkel, Perry A.

This document is a discussion draft intended to lead to the formulation of a set of guidelines by the state board of education concerning three areas of teacher negotiations: scope, good faith bargaining, and prohibited practices. It has been prepared in the form of an organized data base that focuses on summarizing the present state of the law…

Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.

PubMed

Cardot, J-M; Garcia Arieta, A; Paixao, P; Tasevska, I; Davit, B

2016-07-01

The US-FDA recently posted a draft guideline for industry recommending procedures necessary to obtain a biowaiver for immediate-release oral dosage forms based on the Biopharmaceutics Classification System (BCS). This review compares the present FDA BCS biowaiver approach, with the existing European Medicines Agency (EMA) approach, with an emphasis on similarities, difficulties, and shared challenges. Some specifics of the current EMA BCS guideline are compared with those in the recently published draft US-FDA BCS guideline. In particular, similarities and differences in the EMA versus US-FDA approaches to establishing drug solubility, permeability, dissolution, and formulation suitability for BCS biowaiver are critically reviewed. Several case studies are presented to illustrate the (i) challenges of applying for BCS biowaivers for global registration in the face of differences in the EMA and US-FDA BCS biowaiver criteria, as well as (ii) challenges inherent in applying for BCS class I or III designation and common to both jurisdictions.

The CARE guidelines: consensus-based clinical case report guideline development.

PubMed

Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2014-01-01

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.

[Guideline draft of appropriate use of 131I-MIBG for internal radiotherapy of neuroendocrine tumors].

PubMed

Nakajo, Masayuki; Yoshinaga, Keiichiro; Oriuchi, Noboru; Kinuya, Seigo; Yokoyama, Kunihiko; Yamaguchi, Toshiro

2008-02-01

I3I-MIBG has been used for therapy of unresectable neuroendocrine tumors including malignant pheochromocytomas and neuroblastomas in foreign countries since the '80s when its clinical therapeutic trials were initiated. In Japan, 131I-MIBG for therapy has not been approved by Health and Labor Ministry, however, personally imported 131I-MIBG is now available in limited institutions for therapeutic purpose. This guideline draft was made to provide the information about 131I-MIBG radiotherapy including related side effects for doctors, nurses, patients and their families, to prevent the adverse effects of this therapy and to protect radiation injuries from this tracer. The appendices were also attached concerning practical guidance for attending physicians, patient management and referring physicians for their conveniences.

Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors

PubMed Central

Lindeman, Neal I.; Cagle, Philip T.; Beasley, Mary Beth; Chitale, Dhananjay Arun; Dacic, Sanja; Giaccone, Giuseppe; Jenkins, Robert Brian; Kwiatkowski, David J.; Saldivar, Juan-Sebastian; Squire, Jeremy; Thunnissen, Erik; Ladanyi, Marc

2014-01-01

Objective To establish evidence-based recommendations for the molecular analysis of lung cancers that are required to guide EGFR- and ALK-directed therapies, addressing which patients and samples should be tested, and when and how testing should be performed. Participants Three cochairs without conflicts of interest were selected, one from each of the 3 sponsoring professional societies: College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Writing and advisory panels were constituted from additional experts from these societies. Evidence Three unbiased literature searches of electronic databases were performed to capture articles published from January 2004 through February 2012, yielding 1533 articles whose abstracts were screened to identify 521 pertinent articles that were then reviewed in detail for their relevance to the recommendations. Evidence was formally graded for each recommendation. Consensus Process Initial recommendations were formulated by the cochairs and panel members at a public meeting. Each guideline section was assigned to at least 2 panelists. Drafts were circulated to the writing panel (version 1), advisory panel (version 2), and the public (version 3) before submission (version 4). Conclusions The 37 guideline items address 14 subjects, including 15 recommendations (evidence grade A/B). The major recommendations are to use testing for EGFR mutations and ALK fusions to guide patient selection for therapy with an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) inhibitor, respectively, in all patients with advanced-stage adenocarcinoma, regardless of sex, race, smoking history, or other clinical risk factors, and to prioritize EGFR and ALK testing over other molecular predictive tests. As scientific discoveries and clinical practice outpace the completion of randomized clinical trials, evidence-based guidelines developed by expert practitioners are vital for communicating emerging clinical standards. Already, new treatments targeting genetic alterations in other, less common driver oncogenes are being evaluated in lung cancer, and testing for these may be addressed in future versions of these guidelines. PMID:23551194

Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors

PubMed Central

Lindeman, Neal I.; Cagle, Philip T.; Beasley, Mary Beth; Chitale, Dhananjay Arun; Dacic, Sanja; Giaccone, Giuseppe; Jenkins, Robert Brian; Kwiatkowski, David J.; Saldivar, Juan-Sebastian; Squire, Jeremy; Thunnissen, Erik; Ladanyi, Marc

2014-01-01

Objective To establish evidence-based recommendations for the molecular analysis of lung cancers that are that are required to guide EGFR- and ALK-directed therapies, addressing which patients and samples should be tested, and when and how testing should be performed. Participants Three cochairs without conflicts of interest were selected, one from each of the 3 sponsoring professional societies: College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Writing and advisory panels were constituted from additional experts from these societies. Evidence Three unbiased literature searches of electronic databases were performed to capture articles published published from January 2004 through February 2012, yielding 1533 articles whose abstracts were screened to identify 521 pertinent articles that were then reviewed in detail for their relevance to the recommendations. Evidence was formally graded for each recommendation. Consensus Process Initial recommendations were formulated by the cochairs and panel members at a public meeting. Each guideline section was assigned to at least 2 panelists. Drafts were circulated to the writing panel (version 1), advisory panel (version 2), and the public (version 3) before submission (version 4). Conclusions The 37 guideline items address 14 subjects, including 15 recommendations (evidence grade A/B). The major recommendations are to use testing for EGFR mutations and ALK fusions to guide patient selection for therapy with an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) inhibitor, respectively, in all patients with advanced-stage adenocarcinoma, regardless of sex, race, smoking history, or other clinical risk factors, and to prioritize EGFR and ALK testing over other molecular predictive tests. As scientific discoveries and clinical practice outpace the completion of randomized clinical trials, evidence-based guidelines developed by expert practitioners are vital for communicating emerging clinical standards. Already, new treatments targeting genetic alterations in other, less common driver oncogenes are being evaluated in lung cancer, and testing for these may be addressed in future versions of these guidelines. PMID:23552377

Proposed military handbook for dynamic data acquisition and analysis - An invitation to review

NASA Technical Reports Server (NTRS)

Himelblau, Harry; Wise, James H.; Piersol, Allan G.; Grundvig, Max R.

1990-01-01

A draft Military Handbook prepared under the sponsorship of the USAF Space Division is presently being distributed throughout the U.S. for review by the aerospace community. This comprehensive document provides recommended guidelines for the acquisition and analysis of structural dynamics and aeroacoustic data, and is intended to reduce the errors and variability commonly found in flight, ground and laboratory dynamic test measurements. In addition to the usual variety of measurement problems encountered in the definition of dynamic loads, the development of design and test criteria, and the analysis of failures, special emphasis is given to certain state-of-the-art topics, such as pyroshock data acquisition and nonstationary random data analysis.

Towards a new surface and internal charging design guideline for the 21st century

NASA Technical Reports Server (NTRS)

Garrett, Henry B.; Whittlesey, Albert C.

2005-01-01

This paper will describe the status of those on-going efforts to combine and update the two guidelines with emphasis on the proposed contents and on the differences and similarities between surface and internal charging mitigation techniques. It is planned to have a draft revision ready for review by the spacecraft charging community by the fall of 2005, with 2006 dedicated to implementing reviewers' comments and additions leading to a new, officially approved NASA guideline by the fall of 2006.

75 FR 14418 - Codex Alimentarius Commission: Meeting of the Codex Committee on Food Labeling

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-25

...) Proposed Draft Criteria and Principles for Legibility and Readability of Nutrition Labels (d) Discussion..., Physical Activity, and Health Guidelines for the Production, Processing, Labeling and Marketing of...

2016 United Kingdom national guideline on the sexual health care of men who have sex with men.

PubMed

Clutterbuck, Dan; Asboe, David; Barber, Tristan; Emerson, Carol; Field, Nigel; Gibson, Stuart; Hughes, Gwenda; Jones, Rachael; Murchie, Martin; Nori, Achyuta V; Rayment, Michael; Sullivan, Ann

2018-01-01

This guideline is intended for use in UK Genitourinary medicine clinics and sexual health services but is likely to be of relevance in all sexual health settings, including general practice and Contraception and Sexual Health (CASH) services, where men who have sex with men (MSM) seek sexual health care or where addressing the sexual health needs of MSM may have public health benefits. For the purposes of this document, MSM includes all gay, bisexual and all other males who have sex with other males and both cis and trans men. This document does not provide guidance on the treatment of particular conditions where this is covered in other British Association for Sexual Health and HIV (BASHH) Guidelines but outlines best practice in multiple aspects of the sexual health care of MSM. Where prevention of sexually transmitted infections including HIV can be addressed as an integral part of clinical care, this is consistent with the concept of combination prevention and is included. The document is designed primarily to provide guidance on the direct clinical care of MSM but also makes reference to the design and delivery of services with the aim of supporting clinicians and commissioners in providing effective services. Methodology This document was produced in accordance with the guidance set out in the BASHH CEG's document 'Framework for guideline development and assessment' published in 2010 at http://www.bashh.org/guidelines and with reference to the Agree II instrument. Following the production of the updated framework in April 2015, the GRADE system for assessing evidence was adopted and the draft recommendations were regraded. Search strategy (see also Appendix 1) Ovid Medline 1946 to December 2014, Medline daily update, Embase 1974 to December 2014, Pubmed NeLH Guidelines Database, Cochrane library from 2000 to December 2014. Search language English only. The search for Section 3 was conducted on PubMed to December 2014. Priority was given to peer-reviewed papers published in scientific journals, although for many issues evidence includes conference abstracts listed on the Embase database. In addition, for 'Identification of problematic recreational drug and alcohol use' section and 'Sexual problems and dysfunctions in MSM' section, searches included PsycINFO. Methods Article titles and abstracts were reviewed and if relevant the full text article was obtained. Priority was given to randomised controlled trial and systematic review evidence, and recommendations made and graded on the basis of best available evidence. Piloting and feedback The first draft of the guideline was circulated to the writing group and to a small group of relevant experts, third sector partners and patient representatives who were invited to comment on the whole document and specifically on particular sections. The revised draft was reviewed by the CEG and then reviewed by the BASHH patient/public panel and posted on the BASHH website for public consultation. The final draft was piloted before publication. Guideline update The guidelines will be reviewed and revised in five years' time, 2022.

Achieving 90% Adoption of Clinical Practice Guidelines Using the Delphi Consensus Method in a Large Orthopedic Group.

PubMed

Bini, Stefano A; Mahajan, John

2016-11-01

Little is known about the implementation rate of clinical practice guidelines (CPGs). Our purpose was to report on the adoption rate of CPGs created and implemented by a large orthopedic group using the Delphi consensus method. The draft CPGs were created before the group's annual meeting by 5 teams each assigned a subset of topics. The draft guidelines included a statement and a summary of the available evidence. Each guideline was debated in both small-group and plenary sessions. Voting was anonymous and a 75% supermajority was required for passage. A Likert scale was used to survey the patient's experience with the process at 1 week, and the Kirkpatrick evaluation model was used to gauge the efficacy of the process over a 6-month time frame. Eighty-five orthopedic surgeons attended the meeting. Fifteen guidelines grouped into 5 topics were created. All passed. Eighty-six percent of attendees found the process effective and 84% felt that participating in the process made it more likely that they would adopt the guidelines. At 1 week, an average of 62% of attendees stated they were practicing the guideline as written (range: 35%-72%), and at 6 months, 96% stated they were practicing them (range: 82%-100%). We have demonstrated that a modified Delphi method for reaching consensus can be very effective in both creating CPGs and leading to their adoption. Further we have shown that the process is well received by participants and that an inclusionary approach can be highly successful. Copyright © 2016 Elsevier Inc. All rights reserved.

New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment.

PubMed

Cowie, Martin R; Filippatos, Gerasimos S; Alonso Garcia, Maria de Los Angeles; Anker, Stefan D; Baczynska, Anna; Bloomfield, Daniel M; Borentain, Maria; Bruins Slot, Karsten; Cronin, Maureen; Doevendans, Pieter A; El-Gazayerly, Amany; Gimpelewicz, Claudio; Honarpour, Narimon; Janmohamed, Salim; Janssen, Heidi; Kim, Albert M; Lautsch, Dominik; Laws, Ian; Lefkowitz, Martin; Lopez-Sendon, Jose; Lyon, Alexander R; Malik, Fady I; McMurray, John J V; Metra, Marco; Figueroa Perez, Santiago; Pfeffer, Marc A; Pocock, Stuart J; Ponikowski, Piotr; Prasad, Krishna; Richard-Lordereau, Isabelle; Roessig, Lothar; Rosano, Giuseppe M C; Sherman, Warren; Stough, Wendy Gattis; Swedberg, Karl; Tyl, Benoit; Zannad, Faiez; Boulton, Caroline; De Graeff, Pieter

2017-06-01

Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

The application of an occupational health guideline reduces sedentary behaviour and increases fruit intake at work: results from an RCT.

PubMed

Verweij, Lisanne M; Proper, Karin I; Weel, Andre N H; Hulshof, Carel T J; van Mechelen, Willem

2012-07-01

To evaluate the effectiveness of a draft occupational health practice guideline aimed at preventing weight gain on employees' physical activity, sedentary behaviour and dietary behaviour and on body weight-related outcomes. A randomised controlled trial was performed comparing guideline-based care to usual care among 16 occupational physicians and 523 employees in the Netherlands between 2009 and 2011. Occupational physicians in the intervention group followed the draft guideline by providing advice to employers on how to assess and intervene on the obesogenic work environment and conducted five face-to-face behavioural change counselling sessions with employees to improve their lifestyle. Data of employees were collected by questionnaire and physical measurements at baseline and 6-months follow-up. Linear and logistic regression analyses were performed to determine effects. The intervention showed significant effects on sedentary behaviour at work (β -28 min/day, 95% CI -2 to -54) and on fruit intake (β 2.1 pieces/week; 95% CI 0.6 to 3.6). No significant intervention effects were found for physical activity, sedentary behaviour in leisure time or during weekend days, snack intake and body weight-related outcomes. Guideline-based care resulted in a more favourable sedentary behaviour at work and increased fruit intake but did not improve employees' physical activity, snack intake or body weight-related outcomes. Trial registration number ISRCTN/73545254 and NTR/1190.

Testing the price and affordability of healthy and current (unhealthy) diets and the potential impacts of policy change in Australia.

PubMed

Lee, Amanda J; Kane, Sarah; Ramsey, Rebecca; Good, Elizabeth; Dick, Mathew

2016-04-12

Price and affordability of foods are important determinants of health. Targeted food pricing policies may help improve population diets. However, methods producing comparable data to inform relevant policy decisions are lacking in Australia and globally. The objective was to develop and pilot standardised methods to assess the price, relative price and affordability of healthy (recommended) and current (unhealthy) diets and test impacts of a potential policy change. Methods followed the optimal approach proposed by INFORMAS using recent Australian dietary intake data and guidelines. Draft healthy and current (unhealthy) diet baskets were developed for five household structures. Food prices were collected in stores in a high and low SES location in Brisbane, Australia. Diet prices were calculated and compared with household incomes, and with potential changes to the Australian Taxation System. Wilcoxen-signed rank tests were used to compare differences in price. The draft tools and protocols were deemed acceptable at household level, but methods could be refined. All households spend more on current (unhealthy) diets than required to purchase healthy (recommended) diets, with the majority (53-64 %) of the food budget being spent on 'discretionary' choices, including take-away foods and alcohol. A healthy diet presently costs between 20-31 % of disposable income of low income households, but would become unaffordable for these families under proposed changes to expand the GST to apply to all foods in Australia. Results confirmed that diet pricing methods providing meaningful, comparable data to inform potential fiscal and health policy actions can be developed, but draft tools should be refined. Results suggest that healthy diets can be more affordable than current (unhealthy) diets in Australia, but other factors may be as important as price in determining food choices.

Development of a South African integrated syndromic respiratory disease guideline for primary care.

PubMed

English, René G; Bateman, Eric D; Zwarenstein, Merrick F; Fairall, Lara R; Bheekie, Angeni; Bachmann, Max O; Majara, Bosielo; Ottmani, Salah-Eddine; Scherpbier, Robert W

2008-09-01

The Practical Approach to Lung Health in South Africa (PALSA) initiative aimed to develop an integrated symptom- and sign-based (syndromic) respiratory disease guideline for nurse care practitioners working in primary care in a developing country. A multidisciplinary team developed the guideline after reviewing local barriers to respiratory health care provision, relevant health care policies, existing respiratory guidelines, and literature. Guideline drafts were evaluated by means of focus group discussions. Existing evidence-based guideline development methodologies were tailored for development of the guideline. A locally-applicable guideline based on syndromic diagnostic algorithms was developed for the management of patients 15 years and older who presented to primary care facilities with cough or difficulty breathing. PALSA has developed a guideline that integrates and presents diagnostic and management recommendations for priority respiratory diseases in adults using a symptom- and sign-based algorithmic guideline for nurses in developing countries.

Physiotherapy in rheumatoid arthritis: development of a practice guideline.

PubMed

Hurkmans, E J; van der Giesen, F J; Bloo, H; Boonman, D C; van der Esch, M; Fluit, M; Hilberdink, W K; Peter, W F; van der Stegen, H P; Veerman, E A; Verhoef, J; Vermeulen, H M; Hendriks, H M; Schoones, J W; Vliet Vlieland, T P

2011-01-01

To improve the quality of the physiotherapy management in patients with rheumatoid arthritis (RA) a Dutch practice guideline, based on current scientific evidence and best practice, was developed. This guideline comprised all elements of a structured approach (assessment, treatment and evaluation) and was based on the Internatio-nal Classification of Functioning, disability and Health (ICF) and the ICF core sets for RA. A guideline steering committee, comprising 10 expert physiotherapists, selected topics concerning the guideline chapters initial assessment, treatment and evaluation. With respect to treatment a systematic literature search was performed using various databases, and the evidence was graded (1-4). For the initial assessment and evaluation mainly review papers and textbooks were used. Based on evidence and expert opinion, recommendations were formulated. A first draft of the guideline was reviewed by 10 experts from different professional backgrounds resulting in the final guideline. In total 7 topics were selected. For the initial assessment, three recommendations were made. Based on the ICF core sets for RA a list of health problems relevant for the physiotherapist was made and completed with red flags and points of attention. Concerning treatment, three recommendations were formulated; both exercise therapy and education on physiotherapy were recommended, whereas passive interventions (delivery of heat or cold, mechanical, electric and electromagnetic energy, massage, passive mobilization/manipulation and balneotherapy) were neither recommended nor discouraged. For treatment evaluation at the level of activities and participation, the Health Assessment Questionnaire was recommended. For evaluating specific body structures and functions the handheld dynamometer, 6-minute walk test or Ästrand bicycle test (including Borg-scale for rating the perceived exertion), Escola Paulista de Medicina Range of Motion Scale and a Visual Analog Scale for pain and morning stiffness were recommended. This physiotherapy practice guideline for RA included seven recommendations on the initial assessment, treatment and evaluation, which were all based on the ICF and the ICF Core Set for RA. The implementation of the guideline in clinical practice needs further evaluation.

[Methodological guideline for the efficacy and safety assessment of new pharmaceuticals: implementation of EUnetHTA's recommendations].

PubMed

Ubago Pérez, Ruth; Castillo Muñoz, María Auxiliadora; Banqueri, Mercedes Galván; García Estepa, Raúl; Alfaro Lara, Eva Rocío; Vega Coca, María Dolores; Beltrán Calvo, Carmen; Molina López, Teresa

The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model ® , has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016-2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS). AETSA contributes by drafting "Evidence synthesis reports: pharmaceuticals" in which a rapid comparative efficacy and safety assessment is performed for drugs for which a TPR will be created. To create this type of report, AETSA follows its own methodological guideline based on EUnetHTA guidelines and the HTA Core Model ® . In this paper, the methodology that AETSA has developed to create the guideline for "Evidence synthesis reports: pharmaceuticals" is described. The structure of the report itself is also presented. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

Draft guidelines for measurement and assessment of low-level ambient noise

DOT National Transportation Integrated Search

1998-03-31

This document describes an ambient noise measurement protocol, a detailed methodology for characterizing ambient noise in low-level environments such as the National Parks. It presents definitions of terminology useful for understanding the mea...

10 CFR 960.3-2-2-4 - The environmental assessment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-4 The environmental assessment...; and an assessment of the regional and local impacts of locating a repository at the site. The draft...

Consent process for US-based family reference DNA samples.

PubMed

Katsanis, Sara H; Snyder, Lindsey; Arnholt, Kelly; Mundorff, Amy Z

2018-01-01

DNA collection from family members of the missing is a tenet for missing persons' and mass fatality investigations. Procedures for consenting family members are disparate, depending on the context supporting the reason for sample collection. While guidelines and best practices have been developed for handling mass fatalities and for identification of the missing, these guidelines do not address standard consent practices for living family members of potential victims. We examined the relevant U.S. laws, international guidelines and best practices, sampled consent forms currently used for DNA collection of family members, and drafted model language for a consent form to communicate the required and recommended information. We modeled the consent form on biobank consenting practices and tested the consent language among students and the general population for constructive feedback and readability. We also asked respondents to consider the options for DNA collection and either hypothetically agree or disagree. The model language presented here highlights information important to relay in consent processes and can serve as a foundation for future consent practices in mass fatalities and missing persons' investigations. Copyright © 2017 Elsevier B.V. All rights reserved.

Expert Consensus Contouring Guidelines for Intensity Modulated Radiation Therapy in Esophageal and Gastroesophageal Junction Cancer.

PubMed

Wu, Abraham J; Bosch, Walter R; Chang, Daniel T; Hong, Theodore S; Jabbour, Salma K; Kleinberg, Lawrence R; Mamon, Harvey J; Thomas, Charles R; Goodman, Karyn A

2015-07-15

Current guidelines for esophageal cancer contouring are derived from traditional 2-dimensional fields based on bony landmarks, and they do not provide sufficient anatomic detail to ensure consistent contouring for more conformal radiation therapy techniques such as intensity modulated radiation therapy (IMRT). Therefore, we convened an expert panel with the specific aim to derive contouring guidelines and generate an atlas for the clinical target volume (CTV) in esophageal or gastroesophageal junction (GEJ) cancer. Eight expert academically based gastrointestinal radiation oncologists participated. Three sample cases were chosen: a GEJ cancer, a distal esophageal cancer, and a mid-upper esophageal cancer. Uniform computed tomographic (CT) simulation datasets and accompanying diagnostic positron emission tomographic/CT images were distributed to each expert, and the expert was instructed to generate gross tumor volume (GTV) and CTV contours for each case. All contours were aggregated and subjected to quantitative analysis to assess the degree of concordance between experts and to generate draft consensus contours. The panel then refined these contours to generate the contouring atlas. The κ statistics indicated substantial agreement between panelists for each of the 3 test cases. A consensus CTV atlas was generated for the 3 test cases, each representing common anatomic presentations of esophageal cancer. The panel agreed on guidelines and principles to facilitate the generalizability of the atlas to individual cases. This expert panel successfully reached agreement on contouring guidelines for esophageal and GEJ IMRT and generated a reference CTV atlas. This atlas will serve as a reference for IMRT contours for clinical practice and prospective trial design. Subsequent patterns of failure analyses of clinical datasets using these guidelines may require modification in the future. Copyright © 2015 Elsevier Inc. All rights reserved.

Expert consensus contouring guidelines for IMRT in esophageal and gastroesophageal junction cancer

PubMed Central

Wu, Abraham J.; Bosch, Walter R.; Chang, Daniel T.; Hong, Theodore S.; Jabbour, Salma K.; Kleinberg, Lawrence R.; Mamon, Harvey J.; Thomas, Charles R.; Goodman, Karyn A.

2015-01-01

Purpose/Objective(s) Current guidelines for esophageal cancer contouring are derived from traditional two-dimensional fields based on bony landmarks, and do not provide sufficient anatomical detail to ensure consistent contouring for more conformal radiotherapy techniques such as intensity-modulated radiation therapy (IMRT). Therefore, we convened an expert panel with the specific aim to derive contouring guidelines and generate an atlas for the clinical target volume (CTV) in esophageal or gastroesophageal junction (GEJ) cancer. Methods and Materials Eight expert academically-based gastrointestinal radiation oncologists participated. Three sample cases were chosen: a GEJ cancer, a distal esophageal cancer, and a mid-upper esophageal cancer. Uniform CT simulation datasets and an accompanying diagnostic PET-CT were distributed to each expert, and he/she was instructed to generate gross tumor volume (GTV) and CTV contours for each case. All contours were aggregated and subjected to quantitative analysis to assess the degree of concordance between experts and generate draft consensus contours. The panel then refined these contours to generate the contouring atlas. Results Kappa statistics indicated substantial agreement between panelists for each of the three test cases. A consensus CTV atlas was generated for the three test cases, each representing common anatomic presentations of esophageal cancer. The panel agreed on guidelines and principles to facilitate the generalizability of the atlas to individual cases. Conclusions This expert panel successfully reached agreement on contouring guidelines for esophageal and GEJ IMRT and generated a reference CTV atlas. This atlas will serve as a reference for IMRT contours for clinical practice and prospective trial design. Subsequent patterns of failure analyses of clinical datasets utilizing these guidelines may require modification in the future. PMID:26104943

Expert Consensus Contouring Guidelines for Intensity Modulated Radiation Therapy in Esophageal and Gastroesophageal Junction Cancer

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

Wu, Abraham J., E-mail: wua@mskcc.org; Bosch, Walter R.; Chang, Daniel T.

Purpose/Objective(s): Current guidelines for esophageal cancer contouring are derived from traditional 2-dimensional fields based on bony landmarks, and they do not provide sufficient anatomic detail to ensure consistent contouring for more conformal radiation therapy techniques such as intensity modulated radiation therapy (IMRT). Therefore, we convened an expert panel with the specific aim to derive contouring guidelines and generate an atlas for the clinical target volume (CTV) in esophageal or gastroesophageal junction (GEJ) cancer. Methods and Materials: Eight expert academically based gastrointestinal radiation oncologists participated. Three sample cases were chosen: a GEJ cancer, a distal esophageal cancer, and a mid-upper esophagealmore » cancer. Uniform computed tomographic (CT) simulation datasets and accompanying diagnostic positron emission tomographic/CT images were distributed to each expert, and the expert was instructed to generate gross tumor volume (GTV) and CTV contours for each case. All contours were aggregated and subjected to quantitative analysis to assess the degree of concordance between experts and to generate draft consensus contours. The panel then refined these contours to generate the contouring atlas. Results: The κ statistics indicated substantial agreement between panelists for each of the 3 test cases. A consensus CTV atlas was generated for the 3 test cases, each representing common anatomic presentations of esophageal cancer. The panel agreed on guidelines and principles to facilitate the generalizability of the atlas to individual cases. Conclusions: This expert panel successfully reached agreement on contouring guidelines for esophageal and GEJ IMRT and generated a reference CTV atlas. This atlas will serve as a reference for IMRT contours for clinical practice and prospective trial design. Subsequent patterns of failure analyses of clinical datasets using these guidelines may require modification in the future.« less

RECOVER evidence and knowledge gap analysis on veterinary CPR. Part 1: Evidence analysis and consensus process: collaborative path toward small animal CPR guidelines.

PubMed

Boller, Manuel; Fletcher, Daniel J

2012-06-01

To describe the methodology used by the Reassessment Campaign on Veterinary Resuscitation (RECOVER) to evaluate the scientific evidence relevant to small animal CPR and to compose consensus-based clinical CPR guidelines for dogs and cats. This report is part of a series of 7 articles on the RECOVER evidence and knowledge gap analysis and consensus-based small animal CPR guidelines. It describes the organizational structure of RECOVER, the evaluation process employed, consisting of standardized literature searches, the analysis of relevant articles according to study design, species and predefined quality markers, and the drafting of clinical CPR guidelines based on these data. Therefore, this article serves as the methodology section for the subsequent 6 RECOVER articles. Academia, referral practice. RECOVER is a collaborative initiative that systematically evaluated the evidence on 74 topics relevant to small animal CPR and generated 101 clinical CPR guidelines from this analysis. All primary contributors were veterinary specialists, approximately evenly split between academic institutions and private referral practices. The evidence evaluation and guideline drafting processes were conducted according to a predefined sequence of steps designed to reduce bias and increase the repeatability of the findings, including multiple levels of review, culminating in a consensus process. Many knowledge gaps were identified that will allow prioritization of research efforts in veterinary CPR. Collaborative systematic evidence review is organizationally challenging but feasible and effective in veterinary medicine. More experience is needed to refine the process. © Veterinary Emergency and Critical Care Society 2012.

A study of the effect of ADA accessibility on Kansas roundabouts.

DOT National Transportation Integrated Search

2008-11-01

The Access Board, with authority to enforce provisions of the American Disabilities Act (ADA), initially determined : that roundabouts are not accessible by blind pedestrians and drafted proposed guidelines to require pedestrian : signals at all roun...

The National Football League (NFL) combine: does normalized data better predict performance in the NFL draft?

PubMed

Robbins, Daniel W

2010-11-01

The objective of this study was to investigate the predictive ability of National Football League (NFL) combine physical test data to predict draft order over the years 2005-2009. The NFL combine provides a setting in which NFL personnel can evaluate top draft prospects. The predictive ability of combine data in its raw form and when normalized in both a ratio and allometric manner was examined for 17 positions. Data from 8 combine physical performance tests were correlated with draft order to determine the direction and strength of relationship between the various combine measures and draft order. Players invited to the combine and subsequently drafted in the same year (n = 1,155) were included in the study. The primary finding was that performance in the combine physical test battery, whether normalized or not, has little association with draft success. In terms of predicting draft order from outcomes of the 8 tests making up the combine battery, normalized data provided no advantage over raw data. Of the 8 performance measures investigated, straight sprint time and jumping ability seem to hold the most weight with NFL personnel responsible for draft decisions. The NFL should consider revising the combine test battery to reflect the physical characteristics it deems important. It may be that NFL teams are more interested in attributes other than the purely physical traits reflected in the combine test battery. Players with aspirations of entering the NFL may be well advised to develop mental and technical skills in addition to developing the physical characteristics necessary to optimize performance.

Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline.

PubMed

Lenders, Jacques W M; Duh, Quan-Yang; Eisenhofer, Graeme; Gimenez-Roqueplo, Anne-Paule; Grebe, Stefan K G; Murad, Mohammad Hassan; Naruse, Mitsuhide; Pacak, Karel; Young, William F

2014-06-01

The aim was to formulate clinical practice guidelines for pheochromocytoma and paraganglioma (PPGL). The Task Force included a chair selected by the Endocrine Society Clinical Guidelines Subcommittee (CGS), seven experts in the field, and a methodologist. The authors received no corporate funding or remuneration. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. The Task Force reviewed primary evidence and commissioned two additional systematic reviews. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, European Society of Endocrinology, and Americal Association for Clinical Chemistry reviewed drafts of the guidelines. The Task Force recommends that initial biochemical testing for PPGLs should include measurements of plasma free or urinary fractionated metanephrines. Consideration should be given to preanalytical factors leading to false-positive or false-negative results. All positive results require follow-up. Computed tomography is suggested for initial imaging, but magnetic resonance is a better option in patients with metastatic disease or when radiation exposure must be limited. (123)I-metaiodobenzylguanidine scintigraphy is a useful imaging modality for metastatic PPGLs. We recommend consideration of genetic testing in all patients, with testing by accredited laboratories. Patients with paraganglioma should be tested for SDHx mutations, and those with metastatic disease for SDHB mutations. All patients with functional PPGLs should undergo preoperative blockade to prevent perioperative complications. Preparation should include a high-sodium diet and fluid intake to prevent postoperative hypotension. We recommend minimally invasive adrenalectomy for most pheochromocytomas with open resection for most paragangliomas. Partial adrenalectomy is an option for selected patients. Lifelong follow-up is suggested to detect recurrent or metastatic disease. We suggest personalized management with evaluation and treatment by multidisciplinary teams with appropriate expertise to ensure favorable outcomes.

The Production of Polyclonal Antibodies in Laboratory Animals. The Report and Recommendations of ECVAM Workshop 35.

PubMed

Leenaars, P P; Hendriksen, C F; de Leeuw, W A; Carat, F; Delahaut, P; Fischer, R; Halder, M; Hanly, W C; Hartinger, J; Hau, J; Lindblad, E B; Nicklas, W; Outschoorn, I M; Stewart-Tull, D E

1999-01-01

This is the report of the thirty-fifth of a series of workshops organised by the European Centre for the Validation of Alternative Methods (ECVAM). ECVAM's main goal, as defined in 1993 by its Scientific Advisory Committee, is to promote the scientific and regulatory acceptance of alternative methods which are of importance to the biosciences and which reduce, refine or replace the use of laboratory animals. One of the first priorities set by ECVAM was the implementation of procedures which would enable it to become well informed about the state-of-the-art of non-animal test development and validation, and the potential for the possible incorporation of alternative tests into regulatory procedures. It was decided that this would be best achieved by the organisation of ECVAM workshops on specific topics, at which small groups of invited experts would review the current status of various types of in vitro tests and their potential uses, and make recommendations about the best ways forward (1). This joint ECVAM/FELASA (Federation of European Laboratory Animal Science Associations) workshop on The Immunisation of Laboratory Animals for the Production of Polyclonal Antibodies was held in Utrecht (The Netherlands), on 20-22 March 1998, under the co-chairmanship of Coenraad Hendriksen (RIVM, Bilthoven, The Netherlands) and Wim de Leeuw (Inspectorate for Health Protection, The Netherlands). The participants, all experts in the fields of immunology, laboratory animal science, or regulation, came from universities, industry and regulatory bodies. The aims of the workshop were: a) to discuss and evaluate current immunisation procedures for the production of polyclonal antibodies (including route of injection, animal species and adjuvant ); and b) to draft recommendations and guidelines to improve the immunisation procedures, with regard both to animal welfare and to the optimisation of immunisation protocols. This report summarises the outcome of the discussions and includes a number of recommendations and a set of draft guidelines (included in Appendix 1). 1999 FRAME.

An international road map to improve pain assessment in people with impaired cognition: the development of the Pain Assessment in Impaired Cognition (PAIC) meta-tool.

PubMed

Corbett, Anne; Achterberg, Wilco; Husebo, Bettina; Lobbezoo, Frank; de Vet, Henrica; Kunz, Miriam; Strand, Liv; Constantinou, Marios; Tudose, Catalina; Kappesser, Judith; de Waal, Margot; Lautenbacher, Stefan

2014-12-10

Pain is common in people with dementia, yet identification is challenging. A number of pain assessment tools exist, utilizing observation of pain-related behaviours, vocalizations and facial expressions. Whilst they have been developed robustly, these often lack sufficient evidence of psychometric properties, like reliability, face and construct validity, responsiveness and usability, and are not internationally implemented. The EU-COST initiative "Pain in impaired cognition, especially dementia" aims to combine the expertise of clinicians and researchers to address this important issue by building on previous research in the area, identifying existing pain assessment tools for dementia, and developing consensus for items for a new universal meta-tool for use in research and clinical settings. This paper reports on the initial phase of this collaboration task. All existing observational pain behaviour tools were identified and elements categorised using a three-step reduction process. Selection and refinement of items for the draft Pain Assessment in Impaired Cognition (PAIC) meta-tool was achieved through scrutiny of the evidence, consensus of expert opinion, frequency of use and alignment with the American Geriatric Society guidelines. The main aim of this process was to identify key items with potential empirical, rather than theoretical value to take forward for testing. 12 eligible assessment tools were identified, and pain items categorised according to behaviour, facial expression and vocalisation according to the AGS guidelines (Domains 1 - 3). This has been refined to create the PAIC meta-tool for validation and further refinement. A decision was made to create a supporting comprehensive toolkit to support the core assessment tool to provide additional resources for the assessment of overlapping symptoms in dementia, including AGS domains four to six, identification of specific types of pain and assessment of duration and location of pain. This multidisciplinary, cross-cultural initiative has created a draft meta-tool for capturing pain behaviour to be used across languages and culture, based on the most promising items used in existing tools. The draft PAIC meta-tool will now be taken forward for evaluation according to COSMIN guidelines and the EU-COST protocol in order to exclude invalid items, refine included items and optimise the meta-tool.

Drafting guidelines for occupational exposure to chemicals: the Dutch experience with the assessment of reproductive risks.

PubMed

Stijkel, A; van Eijndhoven, J C; Bal, R

1996-12-01

The Dutch procedure for standard setting for occupational exposure to chemicals, just like the European Union (EU) procedure, is characterized by an organizational separation between considerations of health on the one side, and of technology, economics, and policy on the other side. Health considerations form the basis for numerical guidelines. These guidelines are next combined with technical-economical considerations. Standards are then proposed, and are finally set by the Ministry of Social Affairs and Employment. An analysis of this procedure might be of relevance to the US, where other procedures are used and criticized. In this article we focus on the first stage of the standard-setting procedure. In this stage, the Dutch Expert Committee on Occupational Standards (DECOS) drafts a criteria document in which a health-based guideline is proposed. The drafting is based on a set of starting points for assessing toxicity. We raise the questions, "Does DECOS limit itself only to health considerations? And if not, what are the consequences of such a situation?" We discuss DECOS' starting points and analyze the relationships between those starting points, and then explore eight criteria documents where DECOS was considering reproductive risks as a possible critical effect. For various reasons, it will be concluded that the starting points leave much interpretative space, and that this space is widened further by the manner in which DECOS utilizes it. This is especially true in situations involving sex-specific risks and uncertainties in knowledge. Consequently, even at the first stage, where health considerations alone are intended to play a role, there is much room for other than health-related factors to influence decision making, although it is unavoidable that some interpretative space will remain. We argue that separating the various types of consideration should not be abandoned. Rather, through adjustments in the starting points and aspects of the procedure, clarity should be guaranteed about the way the interpretative space is being employed.

[VALIDATION OF THE HUNGARIAN UNIFIED DYSKINESIA RATING SCALE].

PubMed

Horváth, Krisztina; Aschermann, Zsuzsanna; Ács, Péter; Bosnyák, Edit; Deli, Gabriella; Pál, Endre; Késmárki, Ildiko; Horvath, Réka; Takacs, Katalin; Balázs, Eva; Komoly, Sámuel; Bokor, Magdolna; Rigó, Eszter; Lajtos, Júlia; Takáts, Annamária; Tóth, Adrián; Klivényi, Péter; Dibó, György; Vecsei, László; Hidasi, Eszter; Nagy, Ferenc; Herceg, Mihály; Imre, Piroska; Kovács, Norbert

2015-05-30

The Unified Dyskinesia Rating Scale (UDysRS) was published in 2008. It was designed to be simultaneous valid, reliable and sensitive to therapeutic changes. The Movement Disorder Society organizing team developed guidelines for the development of official non-English translations consisting of four steps: translation/back-translation, cognitive pretesting, large field testing, and clinimetric analysis. The aim of this paper was to introduce the new UDysRS and its validation process into Hungarian. After the translation of UDysRS into Hungarian and back-translated into English, it was reviewed by the UDysRS translation administration team. Subsequent cognitive pretesting was conducted with ten patients. For the large field testing phase, the Hungarian official working draft version of UDysRS was tested with 256 patients with Parkinson's disease having dyskinesia. Confirmatory factor analyses (CFA) determined whether the factor structure for the valid Spanish UDysRS could be confirmed in data collected using the Hungarian Official Draft Version. To become an official translation, the Comparative Fit Index (CFI) had to be ≥ 0.90 compared to the Spanish-language version. For the Hungarian UDysRS the CFI was 0.98. The overall factor structure of the Hungarian version was consistent with that of the Spanish version based on the high CFIs for the UDysRS in the CFA; therefore, this version was designated as the Official Hungarian Version Of The UDysRS.

Protocol standards and implementation within the digital engineering laboratory computer network (DELNET) using the universal network interface device (UNID). Part 2

NASA Astrophysics Data System (ADS)

Phister, P. W., Jr.

1983-12-01

Development of the Air Force Institute of Technology's Digital Engineering Laboratory Network (DELNET) was continued with the development of an initial draft of a protocol standard for all seven layers as specified by the International Standards Organization's (ISO) Reference Model for Open Systems Interconnections. This effort centered on the restructuring of the Network Layer to perform Datagram routing and to conform to the developed protocol standards and actual software module development of the upper four protocol layers residing within the DELNET Monitor (Zilog MCZ 1/25 Computer System). Within the guidelines of the ISO Reference Model the Transport Layer was developed utilizing the Internet Header Format (IHF) combined with the Transport Control Protocol (TCP) to create a 128-byte Datagram. Also a limited Application Layer was created to pass the Gettysburg Address through the DELNET. This study formulated a first draft for the DELNET Protocol Standard and designed, implemented, and tested the Network, Transport, and Application Layers to conform to these protocol standards.

Infectious Diseases Society of America (IDSA) POSITION STATEMENT: Why IDSA Did Not Endorse the Surviving Sepsis Campaign Guidelines.

PubMed

2018-05-02

IDSA did not endorse the 2016 Surviving Sepsis Campaign Guidelines despite being represented in the working group that drafted the guidelines document. Leadership from the IDSA, the Surviving Sepsis Campaign Guidelines, and the Society of Critical Care Medicine had numerous amicable discussions primarily regarding the bolded, rated guidelines recommendations. Our societies had different perspectives, however, regarding the interpretation of the major studies that informed the guidelines' recommendations, thus leading us to different conclusions and different perspectives on the recommendations. IDSA consequently elected not to endorse the guidelines. IDSA nonetheless hopes to be able to continue collaborating with the Surviving Sepsis Campaign and the Society of Critical Care Medicine to resolve our differences and to develop further strategies together to prevent sepsis and septic shock as well as reduce death and disability from these conditions both nationally and globally.

COS-STAR: a reporting guideline for studies developing core outcome sets (protocol).

PubMed

Kirkham, Jamie J; Gorst, Sarah; Altman, Douglas G; Blazeby, Jane; Clarke, Mike; Devane, Declan; Gargon, Elizabeth; Williamson, Paula R

2015-08-22

Core outcome sets can increase the efficiency and value of research and, as a result, there are an increasing number of studies looking to develop core outcome sets (COS). However, the credibility of a COS depends on both the use of sound methodology in its development and clear and transparent reporting of the processes adopted. To date there is no reporting guideline for reporting COS studies. The aim of this programme of research is to develop a reporting guideline for studies developing COS and to highlight some of the important methodological considerations in the process. The study will include a reporting guideline item generation stage which will then be used in a Delphi study. The Delphi study is anticipated to include two rounds. The first round will ask stakeholders to score the items listed and to add any new items they think are relevant. In the second round of the process, participants will be shown the distribution of scores for all stakeholder groups separately and asked to re-score. A final consensus meeting will be held with an expert panel and stakeholder representatives to review the guideline item list. Following the consensus meeting, a reporting guideline will be drafted and review and testing will be undertaken until the guideline is finalised. The final outcome will be the COS-STAR (Core Outcome Set-STAndards for Reporting) guideline for studies developing COS and a supporting explanatory document. To assess the credibility and usefulness of a COS, readers of a COS development report need complete, clear and transparent information on its methodology and proposed core set of outcomes. The COS-STAR guideline will potentially benefit all stakeholders in COS development: COS developers, COS users, e.g. trialists and systematic reviewers, journal editors, policy-makers and patient groups.

Best Practice Guidelines for Computer Technology in the Montessori Early Childhood Classroom.

ERIC Educational Resources Information Center

Montminy, Peter

1999-01-01

Presents a draft for a principle-centered position statement of a Montessori early childhood program in central Pennsylvania, on the pros and cons of computer use in a Montessori 3-6 classroom. Includes computer software rating form. (Author/KB)

Ancillary Care in South African HIV Vaccine Trials: Addressing Needs, Drafting Protocols, and Engaging Community

PubMed Central

Slack, Catherine M.

2014-01-01

There has been debate about sponsor-investigator ethical responsibilities to address participants’ medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for “moral negotiation” recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns. PMID:24572086

Ancillary care in South African HIV vaccine trials: addressing needs, drafting protocols, and engaging community.

PubMed

Slack, Catherine M

2014-02-01

There has been debate about sponsor-investigator ethical responsibilities to address participants' medical needs in trials in resource-constrained contexts. Certain ethical guidelines make detailed recommendations. This study explored whether ethical guideline recommendations for care in HIV vaccine trials were being met, and whether stakeholders were facing difficulties addressed by guidelines. It sampled key stakeholders involved in two trials across five sites in South Africa, and reviewed relevant documentation. It concluded that sites were largely meeting guideline recommendations for addressing needs, with some exceeding these. Recommendations for writing protocols were only partially achieved. Recommendations for engaging participating community were mostly met, except for "moral negotiation" recommendations. Suggestions are made to strengthen practices, and to improve guidelines so they address empirical concerns.

Draft-camp predictors of subsequent career success in the Australian Football League.

PubMed

Burgess, Darren; Naughton, Geraldine; Hopkins, Will

2012-11-01

The National Draft Camp results are generally considered to be important for informing talent scouts about the physical performance capacities of talented young Australian Rules Football (AFL) players. The purpose of this project was to determine magnitude of associations between five year career success in the AFL and physical draft camp tests, final draft selection order and previous match physical performance. Physical testing data of 99 players from the National Under 18 (U 18) competition were retrospectively analysed across 2002 and 2003 National Draft Camps. Physical match data was collected on these players and links with subsequent early career success (AFL games played) were explored. TrakPerformance Software was used to quantify the movement of 92 players during competitive games of the National U 18 Championships. Linear modelling using results from draft camp data involving 95 U 18 players, along with final draft selection order, was used to predict five year career success in senior AFL. Multiple U 18 match variables demonstrated large associations (sprints/min=43% more games, % sprint=43% more games) with five year career success in AFL. Final draft order and single variable predictors had moderate associations with career success. Neither U 18 matches nor draft camp testing was predictive of injuries incurring over the five years. Variability in senior AFL career success had a large association with a combination of match physical variables and draft test results. The objective data available should be considered in the selection of prospective player success. Copyright © 2012 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Canadian guideline for safe and effective use of opioids for chronic noncancer pain

PubMed Central

Kahan, Meldon; Mailis-Gagnon, Angela; Wilson, Lynn; Srivastava, Anita

2011-01-01

Abstract Objective To provide family physicians with a practical clinical summary of the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, developed by the National Opioid Use Guideline Group. Quality of evidence Researchers for the guideline conducted a systematic review of the literature on the effectiveness and safety of opioids for chronic noncancer pain, and drafted a series of recommendations. A panel of 49 clinicians from across Canada reviewed the draft and achieved consensus on 24 recommendations. Main message Screening for addiction risk is recommended before prescribing opioids. Weak opioids (codeine and tramadol) are recommended for mild to moderate pain that has not responded to first-line treatments. Oxycodone, hydromorphone, and morphine can be tried in patients who have not responded to weaker opioids. A low initial dose and slow upward titration is recommended, with patient education and close monitoring. Physicians should watch for the development of complications such as sleep apnea. The optimal dose is one which improves function or decreases pain ratings by at least 30%. For by far most patients, the optimal dose will be well below a 200-mg morphine equivalent dose per day. Tapering is recommended for patients who have not responded to an adequate opioid trial. Conclusion Opioids play an important role in the management of chronic noncancer pain, but careful prescribing is needed to limit potential harms. The new Canadian guideline provides much-needed guidance to help physicians achieve a balance between optimal pain control and safety. PMID:22084455

Canadian guideline for safe and effective use of opioids for chronic noncancer pain: clinical summary for family physicians. Part 1: general population.

PubMed

Kahan, Meldon; Mailis-Gagnon, Angela; Wilson, Lynn; Srivastava, Anita

2011-11-01

To provide family physicians with a practical clinical summary of the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, developed by the National Opioid Use Guideline Group. Researchers for the guideline conducted a systematic review of the literature on the effectiveness and safety of opioids for chronic noncancer pain, and drafted a series of recommendations. A panel of 49 clinicians from across Canada reviewed the draft and achieved consensus on 24 recommendations. Screening for addiction risk is recommended before prescribing opioids. Weak opioids (codeine and tramadol) are recommended for mild to moderate pain that has not responded to first-line treatments. Oxycodone, hydromorphone, and morphine can be tried in patients who have not responded to weaker opioids. A low initial dose and slow upward titration is recommended, with patient education and close monitoring. Physicians should watch for the development of complications such as sleep apnea. The optimal dose is one which improves function or decreases pain ratings by at least 30%. For by far most patients, the optimal dose will be well below a 200-mg morphine equivalent dose per day. Tapering is recommended for patients who have not responded to an adequate opioid trial. Opioids play an important role in the management of chronic noncancer pain, but careful prescribing is needed to limit potential harms. The new Canadian guideline provides much-needed guidance to help physicians achieve a balance between optimal pain control and safety.

Effect of Ethanol Blends and Batching Operations on SCC of Carbon Steel

DOT National Transportation Integrated Search

2011-02-08

This is the draft final report of the project on blending and batching (WP#325) of the Consolidated Program on Development of Guidelines for Safe and Reliable Pipeline Transportation of Ethanol Blends. The other two aspects of the consolidated progra...

Social Marketing. A Guide. First Draft.

ERIC Educational Resources Information Center

Rosenau, Fred S.

This introductory guide to nonprofit social marketing provides marketing techniques and guidelines in seven chapters. Topics covered include a general discussion of social marketing, with several definitions; market research, including factors to be considered in planning a marketing strategy, forces for and against educational changes, cluster…

Introduction to Production/Manufacturing Drafting. Drafting Module 8. Instructor's Guide.

ERIC Educational Resources Information Center

Missouri Univ., Columbia. Instructional Materials Lab.

This module, 1 of 10 in the Drafting curriculum guide developed in Missouri, contains 3 units of study that include some or all of the following components: performance objectives, lesson plans, information sheets, transparency masters, handouts, assignment sheets, job sheets, a unit test, and answers to the unit test. Special instructions on…

[The use of systematic review to develop a self-management program for CKD].

PubMed

Lee, Yu-Chin; Wu, Shu-Fang Vivienne; Lee, Mei-Chen; Chen, Fu-An; Yao, Yen-Hong; Wang, Chin-Ling

2014-12-01

Chronic kidney disease (CKD) has become a public health issue of international concern due to its high prevalence. The concept of self-management has been comprehensively applied in education programs that address chronic diseases. In recent years, many studies have used self-management programs in CKD interventions and have investigated the pre- and post-intervention physiological and psychological effectiveness of this approach. However, a complete clinical application program in the self-management model has yet to be developed for use in clinical renal care settings. A systematic review is used to develop a self-management program for CKD. Three implementation steps were used in this study. These steps include: (1) A systematic literature search and review using databases including CEPS (Chinese Electronic Periodical Services) of Airiti, National Digital Library of Theses and Dissertations in Taiwan, CINAHL, Pubmed, Medline, Cochrane Library, and Joanna Briggs Institute. A total of 22 studies were identified as valid and submitted to rigorous analysis. Of these, 4 were systematic literature reviews, 10 were randomized experimental studies, and 8 were non-randomized experimental studies. (2) Empirical evidence then was used to draft relevant guidelines on clinical application. (3) Finally, expert panels tested the validity of the draft to ensure the final version was valid for application in practice. This study designed a self-management program for CKD based on the findings of empirical studies. The content of this program included: design principles, categories, elements, and the intervention measures used in the self-management program. This program and then was assessed using the content validity index (CVI) and a four-point Liker's scale. The content validity score was .98. The guideline of self-management program to CKD was thus developed. This study developed a self-management program applicable to local care of CKD. It is hoped that the guidelines developed in this study offer a reference for clinical caregivers to improve their healthcare practices.

An Examination of the Perceived Importance of Technical Competence in Acquisition Project Management

DTIC Science & Technology

1991-09-01

Develop (First Draft) Instructions Critique (Revision) Answerability Pilot Test (Second Draft) Analysis Response Mode Revision Useability Preparation...appropriate questionnaire items. Initially, the set of questions developed for the study reflected a few shortcomings. A pilot test of the first draft among...resulted. First, feedback from the pilot test indicated a need to reduce the completion time. Because the multiple choice format required several

Position Statement Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

PubMed Central

Arnold, Mark; Bakris, George L.; Bruns, David E.; Horvath, Andrea Rita; Kirkman, M. Sue; Lernmark, Ake; Metzger, Boyd E.; Nathan, David M.

2011-01-01

BACKGROUND Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. APPROACH An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. CONTENT In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A1c (HbA1c) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA1c. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. SUMMARY The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended. PMID:21617111

Position statement executive summary: guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus.

PubMed

Sacks, David B; Arnold, Mark; Bakris, George L; Bruns, David E; Horvath, Andrea Rita; Kirkman, M Sue; Lernmark, Ake; Metzger, Boyd E; Nathan, David M

2011-06-01

Multiple laboratory tests are used in the diagnosis and management of patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these assays varies substantially. An expert committee compiled evidence-based recommendations for the use of laboratory analysis in patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. A draft of the guidelines was posted on the Internet, and the document was modified in response to comments. The guidelines were reviewed by the joint Evidence-Based Laboratory Medicine Committee of the AACC and the National Academy of Clinical Biochemistry and were accepted after revisions by the Professional Practice Committee and subsequent approval by the Executive Committee of the American Diabetes Association. In addition to the long-standing criteria based on measurement of venous plasma glucose, diabetes can be diagnosed by demonstrating increased hemoglobin A(1c) (HbA(1c)) concentrations in the blood. Monitoring of glycemic control is performed by the patients measuring their own plasma or blood glucose with meters and by laboratory analysis of HbA(1c). The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. The guidelines provide specific recommendations based on published data or derived from expert consensus. Several analytes are found to have minimal clinical value at the present time, and measurement of them is not recommended.

American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline.

PubMed

Runowicz, Carolyn D; Leach, Corinne R; Henry, N Lynn; Henry, Karen S; Mackey, Heather T; Cowens-Alvarado, Rebecca L; Cannady, Rachel S; Pratt-Chapman, Mandi L; Edge, Stephen B; Jacobs, Linda A; Hurria, Arti; Marks, Lawrence B; LaMonte, Samuel J; Warner, Ellen; Lyman, Gary H; Ganz, Patricia A

2016-01-01

Answer questions and earn CME/CNE The purpose of the American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline is to provide recommendations to assist primary care and other clinicians in the care of female adult survivors of breast cancer. A systematic review of the literature was conducted using PubMed through April 2015. A multidisciplinary expert workgroup with expertise in primary care, gynecology, surgical oncology, medical oncology, radiation oncology, and nursing was formed and tasked with drafting the Breast Cancer Survivorship Care Guideline. A total of 1073 articles met inclusion criteria; and, after full text review, 237 were included as the evidence base. Patients should undergo regular surveillance for breast cancer recurrence, including evaluation with a cancer-related history and physical examination, and should be screened for new primary breast cancer. Data do not support performing routine laboratory tests or imaging tests in asymptomatic patients to evaluate for breast cancer recurrence. Primary care clinicians should counsel patients about the importance of maintaining a healthy lifestyle, monitor for post-treatment symptoms that can adversely affect quality of life, and monitor for adherence to endocrine therapy. Recommendations provided in this guideline are based on current evidence in the literature and expert consensus opinion. Most of the evidence is not sufficient to warrant a strong evidence-based recommendation. Recommendations on surveillance for breast cancer recurrence, screening for second primary cancers, assessment and management of physical and psychosocial long-term and late effects of breast cancer and its treatment, health promotion, and care coordination/practice implications are made. © 2015 American Cancer Society.

School Crisis Management Manual: Guidelines for Administrators.

ERIC Educational Resources Information Center

Smith, Judie

A disturbing escalation in campus emergencies compels school districts to draft effective crisis-management action plans. Effective plans can be devised that relieve burdens on principals and other school personnel, by diminishing chaos and panic, disseminating accurate information, attending to emotional strain on staff and students, and…

59 FR- Draft Guideline for Isolation Precautions in Hospitals: Part I. ``Evolution of Isolation...

Federal Register 2010, 2011, 2012, 2013, 2014

1994-11-07

... in pediatric populations (e.g., invasive Haemophilus influenza, Neisseria meningitides meningitis and... Precautions in Hospitals,'' and was prepared by the Hospital Infection Control Practices Advisory Committee..., DHHS; the Director, CDC; and the Director, NCID, regarding the practice of hospital infection control...

76 FR 65753 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0212] Monitoring the Effectiveness of Maintenance at...) re-issued Draft Regulatory Guide, DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear... Revision 4A to Nuclear Management and Resources Council (NUMARC) 93-01, ``Industry Guideline for Monitoring...

IRIS Toxicological Review of Dichlorobenzenes (2004 External Review Draft)

EPA Science Inventory

The goal of this assessment is to evaluate both carcinogenic and non-cancer toxicity based on the proposed July 1999 Cancer Guidelines and other relevant guidance. This approach will provide a better understanding of the toxicity and will aid in making informed risk-based decisio...

Government Regulation of the Pursuit of Knowledge: The Recombinant DNA Controversy.

ERIC Educational Resources Information Center

Berger, Richard G.

1978-01-01

Government regulation of recombinant DNA research is addressed. Issues discussed include the potential of such research; National Institutes of Health guidelines; federal, state, and local regulation; the controversy over self-regulation; first amendment protection for scientific research; and problems in drafting legislation. (JMD)

76 FR 65166 - International Sanitary and Phytosanitary Standard-Setting Activities

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

..., formerly known as the Office International des Epizooties) regarding animal health and welfare, and... bulletins on global disease status, and provides animal disease control guidelines to Members. Various OIE commissions and working groups undertake the development and preparation of draft standards, which are then...

An Exploratory Study: Assessment of Modeled Dioxin ...

EPA Pesticide Factsheets

EPA has released an external review draft entitled, An Exploratory Study: Assessment of Modeled Dioxin Exposure in Ceramic Art Studios(External Review Draft). The public comment period and the external peer-review workshop are separate processes that provide opportunities for all interested parties to comment on the document. In addition to consideration by EPA, all public comments submitted in accordance with this notice will also be forwarded to EPA’s contractor for the external peer-review panel prior to the workshop. EPA has realeased this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. The purpose of this report is to describe an exploratory investigation of potential dioxin exposures to artists/hobbyists who use ball clay to make pottery and related products.

Environmental assessment: Reference repository location, Hanford site, Washington

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

none,

1986-05-01

In February 1983, the US Department of Energy (DOE) identified a reference repository location at the Hanford Site in Washington as one of the nine potentially acceptable sites for a mined geologic repository for spent nuclear fuel and high-level radioactive waste. The site is in the Columbia Plateau, which is one of five distinct geohydrologic settings considered for the first repository. To determine their suitability, the Hanford Site and the eight other potentially acceptable sites have been evaluated in accordance with the DOE's General Guidelines for the Recommendation of Sites for the Nuclear Waste Repositories. These evaluations were reported inmore » draft environmental assessments (EAs), which were issued for public review and comment. After considering the comments received on the draft EAs, the DOE prepared the final EAs. On the basis of the evaluations reported in this EA, the DOE has found that the Hanford site is not disqualified under the guidelines. The DOE has also found that it is suitable for site characterization because the evidence does not support a conclusion that the site will not be able to meet each of the qualifying conditions specified in the guidelines. On the basis of these findings, the DOE is nominating the Hanford site as one of five sites suitable for characterization.« less

Environmental assessment: Yucca Mountain site, Nevada research and development area, Nevada; Volume 1

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

NONE

1986-05-01

In February 1983, the US Department of Energy (DOE) identified the Yucca Mountain site in Nevada as one of nine potentially acceptable sites for a mined geologic repository for spent nuclear fuel and high- level radioactive waste. The site is in the Great Basin, which is one of five distinct geohydrologic settings considered for the first repository. To determine their suitability, the Yucca Mountain site and the eight other potentially acceptable sites have been evaluated in accordance with the DOE`s General Guideline for the Recommendation of Sites for the Nuclear Waste Repositories. These evaluations were reported in draft environmental assessmentsmore » (EA), which were issued for public review and comment. After considering the comments received on the draft EAs, the DOE prepared the final EAs. On the basis of the evaluations reported in this EA, the DOE found that the Yucca Mountain site is not disqualified under the guidelines. The DOE has also found that it is suitable for site characterization because the evidence does not support a conclusion that the site will not be able to meet each of the qualifying conditions specified in the guidelines. On the basis of these findings, the DOE is nominating the Yucca Mountain site as of five sites suitable for characterization.« less

Environmental assessment: Yucca Mountain site, Nevada research and development area, Nevada; Volume 3

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

NONE

1986-05-01

In February 1983, the US Department of Energy (DOE) identified the Yucca Mountain site in Nevada as one of nine potentially acceptable sites for a mined geologic repository for spent nuclear fuel and high-level radioactive waste. The site is in the Great Basin, which is one of five distinct geohydrologic settings considered for the first repository. To determine their suitability, the Yucca Mountain site and the eight other potentially acceptable sites have been evaluated in accordance with the DOE`s General Guidelines for the Recommendation of Sites for the Nuclear Waste Repositories. These evaluations were reported in draft environmental assessments (EAs),more » which were issued for public review and comment. After considering the comments received on the draft EAs, the DOE prepared the final EAs. On the basis of the evaluations reported in this EA, the DOE has found that the Yucca Mountain site is not disqualified under the guidelines. The DOE has also found that it is suitable for site characterization because the evidence does not support a conclusion that the site will not be able to meet each of the qualifying conditions specified in the guidelines. On the basis of these findings, the DOE is nominating the Yucca Mountain site as one of five sites suitable for characterization.« less

Mars Sample Handling Protocol Workshop Series: Workshop 4

NASA Technical Reports Server (NTRS)

Race Margaret S. (Editor); DeVincenzi, Donald L. (Editor); Rummel, John D. (Editor); Acevedo, Sara E. (Editor)

2001-01-01

In preparation for missions to Mars that will involve the return of samples to Earth, it will be necessary to prepare for the receiving, handling, testing, distributing, and archiving of martian materials here on Earth. Previous groups and committees have studied selected aspects of sample return activities, but specific detailed protocols for the handling and testing of returned samples must still be developed. To further refine the requirements for sample hazard testing and to develop the criteria for subsequent release of sample materials from quarantine, the NASA Planetary Protection Officer convened a series of workshops in 2000-2001. The overall objective of the Workshop Series was to produce a Draft Protocol by which returned martian sample materials can be assessed for biological hazards and examined for evidence of life (extant or extinct) while safeguarding the purity of the samples from possible terrestrial contamination. This report also provides a record of the proceedings of Workshop 4, the final Workshop of the Series, which was held in Arlington, Virginia, June 5-7, 2001. During Workshop 4, the sub-groups were provided with a draft of the protocol compiled in May 2001 from the work done at prior Workshops in the Series. Then eight sub-groups were formed to discuss the following assigned topics: Review and Assess the Draft Protocol for Physical/Chemical Testing Review and Assess the Draft Protocol for Life Detection Testing Review and Assess the Draft Protocol for Biohazard Testing Environmental and Health/Monitoring and Safety Issues Requirements of the Draft Protocol for Facilities and Equipment Contingency Planning for Different Outcomes of the Draft Protocol Personnel Management Considerations in Implementation of the Draft Protocol Draft Protocol Implementation Process and Update Concepts This report provides the first complete presentation of the Draft Protocol for Mars Sample Handling to meet planetary protection needs. This Draft Protocol, which was compiled from deliberations and recommendations from earlier Workshops in the Series, represents a consensus that emerged from the discussions of all the sub-groups assembled over the course of the five Workshops of the Series. These discussions converged on a conceptual approach to sample handling, as well as on specific analytical requirements. Discussions also identified important issues requiring attention, as well as research and development needed for protocol implementation.

Simplified lipid guidelines: Prevention and management of cardiovascular disease in primary care.

PubMed

Allan, G Michael; Lindblad, Adrienne J; Comeau, Ann; Coppola, John; Hudson, Brianne; Mannarino, Marco; McMinis, Cindy; Padwal, Raj; Schelstraete, Christine; Zarnke, Kelly; Garrison, Scott; Cotton, Candra; Korownyk, Christina; McCormack, James; Nickel, Sharon; Kolber, Michael R

2015-10-01

To develop clinical practice guidelines for a simplified approach to primary prevention of cardiovascular disease (CVD), concentrating on CVD risk estimation and lipid management for primary care clinicians and their teams; we sought increased contribution from primary care professionals with little or no conflict of interest and focused on the highest level of evidence available. Nine health professionals (4 family physicians, 2 internal medicine specialists, 1 nurse practitioner, 1 registered nurse, and 1 pharmacist) and 1 nonvoting member (pharmacist project manager) comprised the overarching Lipid Pathway Committee (LPC). Member selection was based on profession, practice setting, and location, and members disclosed any actual or potential conflicts of interest. The guideline process was iterative through online posting, detailed evidence review, and telephone and online meetings. The LPC identified 12 priority questions to be addressed. The Evidence Review Group answered these questions. After review of the answers, key recommendations were derived through consensus of the LPC. The guidelines were drafted, refined, and distributed to a group of clinicians (family physicians, other specialists, pharmacists, nurses, and nurse practitioners) and patients for feedback, then refined again and finalized by the LPC. Recommendations are provided on screening and testing, risk assessments, interventions, follow-up, and the role of acetylsalicylic acid in primary prevention. These simplified lipid guidelines provide practical recommendations for prevention and treatment of CVD for primary care practitioners. All recommendations are intended to assist with, not dictate, decision making in conjunction with patients. Copyright© the College of Family Physicians of Canada.

Simplified lipid guidelines

PubMed Central

Allan, G. Michael; Lindblad, Adrienne J.; Comeau, Ann; Coppola, John; Hudson, Brianne; Mannarino, Marco; McMinis, Cindy; Padwal, Raj; Schelstraete, Christine; Zarnke, Kelly; Garrison, Scott; Cotton, Candra; Korownyk, Christina; McCormack, James; Nickel, Sharon; Kolber, Michael R.

2015-01-01

Abstract Objective To develop clinical practice guidelines for a simplified approach to primary prevention of cardiovascular disease (CVD), concentrating on CVD risk estimation and lipid management for primary care clinicians and their teams; we sought increased contribution from primary care professionals with little or no conflict of interest and focused on the highest level of evidence available. Methods Nine health professionals (4 family physicians, 2 internal medicine specialists, 1 nurse practitioner, 1 registered nurse, and 1 pharmacist) and 1 nonvoting member (pharmacist project manager) comprised the overarching Lipid Pathway Committee (LPC). Member selection was based on profession, practice setting, and location, and members disclosed any actual or potential conflicts of interest. The guideline process was iterative through online posting, detailed evidence review, and telephone and online meetings. The LPC identified 12 priority questions to be addressed. The Evidence Review Group answered these questions. After review of the answers, key recommendations were derived through consensus of the LPC. The guidelines were drafted, refined, and distributed to a group of clinicians (family physicians, other specialists, pharmacists, nurses, and nurse practitioners) and patients for feedback, then refined again and finalized by the LPC. Recommendations Recommendations are provided on screening and testing, risk assessments, interventions, follow-up, and the role of acetylsalicylic acid in primary prevention. Conclusion These simplified lipid guidelines provide practical recommendations for prevention and treatment of CVD for primary care practitioners. All recommendations are intended to assist with, not dictate, decision making in conjunction with patients. PMID:26472792

Evaluating Technical Communication Faculty: Some Empirically-Based Criteria and Guidelines. Draft.

ERIC Educational Resources Information Center

Stevenson, Dwight W.

As technical communication is a young academic discipline, evaluating technical communication faculty for promotion, tenure, and merit purposes requires special awareness and care. To determine reasonable expectations of faculty achievement, a study documented the range, types, and frequency of activities of 12 professors and 12 associate…

COMPARISON OF CANCER SLOPE FACTORS FOR USING DIFFERENT STATISTICAL APPROACHES

EPA Science Inventory

In the past, the cancer slope factor has been calculated as the upper 95% confidence limit on the coefficient (q1*) of the linear term of the multistage model for the extra cancer risk over background. The U.S. EPA's draft final cancer guidelines, released in 2003, however, pres...

76 FR 66286 - Notice of Final 2010 Effluent Guidelines Program Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

... Coalbed Methane Extraction (CBM) industry and will develop pretreatments requirements for discharges of...) industry. EPA is also issuing the detailed study report for the Coalbed Methane Extraction and the... Methane Point Source Category: Detailed Study Report, EPA-820-R-10-022, DCN 09999; Draft Guidance Document...

75 FR 21571 - Marine Mammal Protection Act; Deterrence Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

...: Fish and Wildlife Service, Interior. ACTION: Proposed rule; availability of draft environmental... bear-proof garbage containers to exclude polar bear access and limit food-conditioning and habituation... able to detect sounds down to 125 Hertz (Hz) (Bowles et al. 2008) and high- frequency sounds up to 22.5...

A Systematic Approach to Proposal Writing.

ERIC Educational Resources Information Center

Alvir, Howard P.

This document contains two research exercises entitled: "Revising Rough Drafts into Short and Simple Texts" and "Developing Vote Curriculum Criteria Based upon Federal Guidelines." The first exercise can be used by educators wishing to conduct a proposal writing workshop centered around the development and writing of acceptable goals, objectives,…

Guidelines for the management of hepatitis C in general practice: a semi-qualitative interview survey of GPs' views regarding content and implementation.

PubMed

Cullen, W; O'Leary, M; Langton, D; Stanley, J; Kelly, Y; Bury, G

2005-01-01

Hepatitis C is a common infection among people who attend GPs for methadone maintenance treatment. To determine the views of GPs towards clinical guidelines for the management of hepatitis C among current or former injecting drug users in advance of their implementation. A purposive sample of 14 GPs (10% of the total prescribing methadone at the time the guidelines were developed) was invited to review a pre-publication draft of the guidelines and interviewed regarding content, presentation, perceived barriers to implementation and suggested interventions to facilitate effective implementation of the guidelines. GPs indicated the guidelines were useful but suggested aspects of presentation should be clarified. Organisational issues were identified as the principal barriers to effective implementation, with the provision of additional nursing support the principal intervention suggested to facilitate implementation. Interviewing intended recipients may be an important step in ensuring clinical practice guidelines are effectively implemented.

Acromegaly: an endocrine society clinical practice guideline.

PubMed

Katznelson, Laurence; Laws, Edward R; Melmed, Shlomo; Molitch, Mark E; Murad, Mohammad Hassan; Utz, Andrea; Wass, John A H

2014-11-01

The aim was to formulate clinical practice guidelines for acromegaly. The Task Force included a chair selected by the Endocrine Society Clinical Guidelines Subcommittee (CGS), five experts in the field, and a methodologist. The authors received no corporate funding or remuneration. This guideline is cosponsored by the European Society of Endocrinology. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. The Task Force reviewed primary evidence and commissioned two additional systematic reviews. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society and the European Society of Endocrinology reviewed drafts of the guidelines. Using an evidence-based approach, this acromegaly guideline addresses important clinical issues regarding the evaluation and management of acromegaly, including the appropriate biochemical assessment, a therapeutic algorithm, including use of medical monotherapy or combination therapy, and management during pregnancy.

Relationship between concussion history and neurocognitive test performance in National Football League draft picks.

PubMed

Solomon, Gary S; Kuhn, Andrew

2014-04-01

There are limited empirical data available regarding the relationship between concussion history and neurocognitive functioning in active National Football League (NFL) players in general and NFL draft picks in particular. Potential NFL draft picks undergo 2 neurocognitive tests at the National Invitational Camp (Scouting Combine) every year: the Wonderlic and, since 2011, the Immediate Post-concussion Assessment and Cognitive Testing (ImPACT). After conclusion of the combine and before the draft, NFL teams invite potential draft picks to their headquarters for individual visits where further assessment may occur. To examine the relationship between concussion history and neurocognitive performance (ImPACT and Wonderlic) in a sample of elite NFL draft picks. Cohort study; Level of evidence, 3. Over 7 years, 226 potential draft picks were invited to visit a specific NFL team's headquarters after the combine. The athletes were divided into 3 groups based on self-reported concussion history: no prior concussions, 1 prior concussion, and 2 or more prior concussions. Neurocognitive measures of interest included Wonderlic scores (provided by the NFL team) and ImPACT composite scores (administered either at the combine or during a visit to the team headquarters). The relationship between concussion history and neurocognitive scores was assessed, as were the relationships among the 2 neurocognitive tests. Concussion history had no relationship to neurocognitive performance on either the Wonderlic or ImPACT. Concussion history did not affect performance on either neurocognitive test, suggesting that for this cohort, a history of concussion may not have adverse effects on neurocognitive functioning as measured by these 2 tests. This study reveals no correlation between concussion history and neurocognitive test scores (ImPACT, Wonderlic) in soon-to-be active NFL athletes.

Studies on the exercise physiology of draft horses performed in Japan during the 1950s and 1960s.

PubMed

Hiraga, Atsushi; Sugano, Shigeru

2017-01-01

Although the total number of horses raised in Japan dramatically decreased after World War II, because draft horses were still used for farm work in paddy fields and on farms during the period of the 1950s and 1960s, a performance test for selecting better draft horses was needed. In order to determine the most suitable size of draft horses for Japanese farm conditions, the working power of horses weighing from 185 to 622 kg was evaluated by performing an endurance test, several kinds of working power tests, and maximum pulling power tests. Oxygen consumption during draft exercise was measured by the Douglas bag method in order to evaluate effects of draft workload under the conditions of different types of work (14- and 18-cm plow depths, cultivator, and tillage), traction methods (shoulder traction, shoulder-trunk traction, and chest-trunk traction), walking speeds (40, 60, 80, 100, and 120 m/min), and depths of water (0, 18, 36, and 54 cm) on energy expenditure. The relationship between energy consumption and pulse rate during exercise was also evaluated. A study of a performance test for draft horses was conducted to establish a new approach for evaluating draft horse performance using heart rate as an index. For this study, a beat meter for measuring heart rate was developed, and experimental protocols were used to evaluate the relationship between heart rate and workload. Although the research results obtained from these studies do not have particular relevance in the current day, these studies are valuable for understanding the history of equine exercise physiology in Japan.

Studies on the exercise physiology of draft horses performed in Japan during the 1950s and 1960s

PubMed Central

HIRAGA, Atsushi; SUGANO, Shigeru

2017-01-01

ABSTRACT Although the total number of horses raised in Japan dramatically decreased after World War II, because draft horses were still used for farm work in paddy fields and on farms during the period of the 1950s and 1960s, a performance test for selecting better draft horses was needed. In order to determine the most suitable size of draft horses for Japanese farm conditions, the working power of horses weighing from 185 to 622 kg was evaluated by performing an endurance test, several kinds of working power tests, and maximum pulling power tests. Oxygen consumption during draft exercise was measured by the Douglas bag method in order to evaluate effects of draft workload under the conditions of different types of work (14- and 18-cm plow depths, cultivator, and tillage), traction methods (shoulder traction, shoulder-trunk traction, and chest-trunk traction), walking speeds (40, 60, 80, 100, and 120 m/min), and depths of water (0, 18, 36, and 54 cm) on energy expenditure. The relationship between energy consumption and pulse rate during exercise was also evaluated. A study of a performance test for draft horses was conducted to establish a new approach for evaluating draft horse performance using heart rate as an index. For this study, a beat meter for measuring heart rate was developed, and experimental protocols were used to evaluate the relationship between heart rate and workload. Although the research results obtained from these studies do not have particular relevance in the current day, these studies are valuable for understanding the history of equine exercise physiology in Japan. PMID:28400701

Diagnosis of Cystic Fibrosis in Screened Populations.

PubMed

Farrell, Philip M; White, Terry B; Howenstine, Michelle S; Munck, Anne; Parad, Richard B; Rosenfeld, Margaret; Sommerburg, Olaf; Accurso, Frank J; Davies, Jane C; Rock, Michael J; Sanders, Don B; Wilschanski, Michael; Sermet-Gaudelus, Isabelle; Blau, Hannah; Gartner, Silvia; McColley, Susanna A

2017-02-01

Cystic fibrosis (CF) can be difficult to diagnose, even when newborn screening (NBS) tests yield positive results. This challenge is exacerbated by the multitude of NBS protocols, misunderstandings about screening vs diagnostic tests, and the lack of guidelines for presumptive diagnoses. There is also confusion regarding the designation of age at diagnosis. To improve diagnosis and achieve standardization in definitions worldwide, the CF Foundation convened a committee of 32 experts with a mission to develop clear and actionable consensus guidelines on diagnosis of CF with an emphasis on screened populations, especially the newborn population. A comprehensive literature review was performed with emphasis on relevant articles published during the past decade. After reviewing the common screening protocols and outcome scenarios, 14 of 27 consensus statements were drafted that apply to screened populations. These were approved by 80% or more of the participants. It is recommended that all diagnoses be established by demonstrating dysfunction of the CF transmembrane conductance regulator (CFTR) channel, initially with a sweat chloride test and, when needed, potentially with newer methods assessing membrane transport directly, such as intestinal current measurements. Even in babies with 2 CF-causing mutations detected via NBS, diagnosis must be confirmed by demonstrating CFTR dysfunction. The committee also recommends that the latest classifications identified in the Clinical and Functional Translation of CFTR project [http://www.cftr2.org/index.php] should be used to aid with CF diagnosis. Finally, to avoid delays in treatment, we provide guidelines for presumptive diagnoses and recommend how to determine the age of diagnosis. Copyright © 2016. Published by Elsevier Inc.

Clinical evaluation of the FreeStyle Precision Pro system.

PubMed

Brazg, Ronald; Hughes, Kristen; Martin, Pamela; Coard, Julie; Toffaletti, John; McDonnell, Elizabeth; Taylor, Elizabeth; Farrell, Lausanne; Patel, Mona; Ward, Jeanne; Chen, Ting; Alva, Shridhara; Ng, Ronald

2013-06-05

A new version of international standard (ISO 15197) and CLSI Guideline (POCT12) with more stringent accuracy criteria are near publication. We evaluated the glucose test performance of the FreeStyle Precision Pro system, a new blood glucose monitoring system (BGMS) designed to enhance accuracy for point-of-care testing (POCT). Precision, interference and system accuracy with 503 blood samples from capillary, venous and arterial sources were evaluated in a multicenter study. Study results were analyzed and presented in accordance with the specifications and recommendations of the final draft ISO 15197 and the new POCT12. The FreeStyle Precision Pro system demonstrated acceptable precision (CV <5%), no interference across a hematocrit range of 15-65%, and, except for xylose, no interference from 24 of 25 potentially interfering substances. It also met all accuracy criteria specified in the final draft ISO 15197 and POCT12, with 97.3-98.9% of the individual results of various blood sample types agreeing within ±12 mg/dl of the laboratory analyzer values at glucose concentrations <100mg/dl and within ±12.5% of the laboratory analyzer values at glucose concentrations ≥100 mg/dl. The FreeStyle Precision Pro system met the tighter accuracy requirements, providing a means for enhancing accuracy for point-of-care blood glucose monitoring. Copyright © 2013 Elsevier B.V. All rights reserved.

Guidelines for Preparation of a Scientific Paper

PubMed Central

Kosiba, Margaret M.

1988-01-01

Even the experienced scientific writer may have difficulty transferring research results to clear, concise, publishable words. To assist the beginning scientific writer, guidelines are proposed that will provide direction for determining a topic, developing protocols, collecting data, using computers for analysis and word processing, incorporating copyediting notations, consulting scientific writing manuals, and developing sound writing habits. Guidelines for writing each section of a research paper are described to help the writer prepare the title page, introduction, materials and methods, results, and discussion sections of the paper, as well as the acknowledgments and references. Procedures for writing the first draft and subsequent revisions include a checklist of structural and stylistic problems and common errors in English usage. PMID:3339646

A national database for essential drugs in South Africa.

PubMed

Zweygarth, M; Summers, R S

2000-06-01

In the process of drafting standard treatment guidelines for adults and children at hospital level, the Secretariat of the National Essential Drugs List Committee made use of a database designed with technical support from the School of Pharmacy, MEDUNSA. The database links the current 697 drugs on the Essential Drugs List with Standard Treatment Guidelines for over 400 conditions. It served to streamline the inclusion of different drugs and dosage forms in the various guidelines, and provided concise, updated information to other departments involved in drug procurement. From information on drug prices and morbidity, it can also be used to calculate drug consumption and cost estimates and compare them with actual figures.

Latin-American guidelines for cancer pain management.

PubMed

Lara-Solares, Argelia; Ahumada Olea, Marisol; Basantes Pinos, Amparito de Los Ángeles; Bistre Cohén, Sara; Bonilla Sierra, Patricia; Duarte Juárez, Eva Rossina; Símon Escudero, Omar A; Santacruz Escudero, Juan Guillermo; Flores Cantisani, José Alberto

2017-07-01

Cancer is a major public health issue. Poor pain management has devastating consequences that seriously affect quality of life, diminish functionality and place a huge emotional burden on patients and their relatives. A group of Latin American opinion leaders were invited to participate in a meeting to discuss areas associated with cancer pain. The expert panel reviewed the latest literature to draft region-specific guidelines for effective pain management. The guidelines make recommendations on tailoring treatment to the specific type of pain and provide local physicians with the state-of-the art findings in the field. Management should be with pharmacological approaches (nonopioid, adjuvant and opioid analgesics, as well as oncologic therapies and interventional procedures) and nonpharmacological approaches.

Guidelines for lighting of plants in controlled environments

NASA Technical Reports Server (NTRS)

Dietzer, Gerald; Langhans, Robert; Sager, John; Spomer, Art; Tibbitts, Ted

1994-01-01

These guidelines for lighting of plants, established by the organizing committee, provided a focus for the discussions at the workshop. The guidelines served as a basis for discussion amongst the workshop attendees and led to a number of recommendations that were recorded by the session chairpersons. The organizing committee indicated they would incorporate the recommendations and suggestions into a revised set of guidelines for additional discussion. It was understood that these guidelines will not be standards and will require upgrading and modifications as lamps and equipment become available and as new insights are obtained on plants' response to light. Revised draft guidelines are included as Tables 1 and 2 that have been developed by the organizing committee following the suggestions obtained at the workshop. The guidelines for growth chambers are in Table 1 and guideines for greenhouses are given in Table 2. These have been distributed to the participants who indicated a willingness to review proposals that were developed. It is hoped that these proposals will lead to the development of guidelines that will have general acceptance by plant scientists.

Guidelines for lighting of plants in controlled environments

NASA Astrophysics Data System (ADS)

Dietzer, Gerald; Langhans, Robert; Sager, John; Spomer, Art; Tibbitts, Ted

1994-03-01

These guidelines for lighting of plants, established by the organizing committee, provided a focus for the discussions at the workshop. The guidelines served as a basis for discussion amongst the workshop attendees and led to a number of recommendations that were recorded by the session chairpersons. The organizing committee indicated they would incorporate the recommendations and suggestions into a revised set of guidelines for additional discussion. It was understood that these guidelines will not be standards and will require upgrading and modifications as lamps and equipment become available and as new insights are obtained on plants' response to light. Revised draft guidelines are included as Tables 1 and 2 that have been developed by the organizing committee following the suggestions obtained at the workshop. The guidelines for growth chambers are in Table 1 and guideines for greenhouses are given in Table 2. These have been distributed to the participants who indicated a willingness to review proposals that were developed. It is hoped that these proposals will lead to the development of guidelines that will have general acceptance by plant scientists.

A Heuristic Approach to Creating Technological Fair Use Guidelines in Higher Education

ERIC Educational Resources Information Center

Roper, Jerry

2017-01-01

Higher education has experienced challenges defining and implementing copyright compliance. Confusion among faculty and staff appears to be common regarding copyright and fair use. The original copyright doctrine was drafted over 200 years ago, which predates practically all technological advances that have and will continue to occur. Change is…

Environmental Science Conference for State Supervisors of Science (Portland State University, Portland, Oregon, May 1-5, 1970).

ERIC Educational Resources Information Center

Portland State Univ., OR.

The Conference report reviewed the status of man's environment and drafted guidelines for state education agencies to use for developing state programs related to environmental education. The six featured speakers and topics were: Kessler Cannon--"Report of the Governor's Committee on Natural Resources;" Dr. Harry…

78 FR 70938 - Draft Guidelines; Product Environmental Performance Standards and Ecolabels for Voluntary Use in...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-27

...-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to... existing mandates and government standards and ecolabels. [For illustration purposes, ``product category x...

76 FR 44586 - Notice of Availability of the External Review Draft of the Microbial Risk Assessment Guideline...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-26

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0532; FRL-9443-9] Notice of Availability of the... Food and in Water AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of document availability for public comment. SUMMARY: The U.S. Environmental Protection Agency (EPA) is announcing a 60-day...

77 FR 27055 - National and Governmental Advisory Committees to the U.S. Representative to the Commission for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-08

... authorized under Articles 17 and 18 of the North American Agreement on Environmental Cooperation (NAAEC... strategic, scientific, technological, regulatory, and economic issues related to implementation and further... addressing the draft Guidelines for Submissions on Enforcement Matters under Articles 14 and 15 of the NAAEC...

Machine Shop. Criterion-Referenced Test (CRT) Item Bank.

ERIC Educational Resources Information Center

Davis, Diane, Ed.

This drafting criterion-referenced test item bank is keyed to the machine shop competency profile developed by industry and education professionals in Missouri. The 16 references used for drafting the test items are listed. Test items are arranged under these categories: orientation to machine shop; performing mathematical calculations; performing…

How to Write Your First Research Paper

PubMed Central

Kallestinova, Elena D.

2011-01-01

Writing a research manuscript is an intimidating process for many novice writers in the sciences. One of the stumbling blocks is the beginning of the process and creating the first draft. This paper presents guidelines on how to initiate the writing process and draft each section of a research manuscript. The paper discusses seven rules that allow the writer to prepare a well-structured and comprehensive manuscript for a publication submission. In addition, the author lists different strategies for successful revision. Each of those strategies represents a step in the revision process and should help the writer improve the quality of the manuscript. The paper could be considered a brief manual for publication. PMID:21966034

How to write your first research paper.

PubMed

Kallestinova, Elena D

2011-09-01

Writing a research manuscript is an intimidating process for many novice writers in the sciences. One of the stumbling blocks is the beginning of the process and creating the first draft. This paper presents guidelines on how to initiate the writing process and draft each section of a research manuscript. The paper discusses seven rules that allow the writer to prepare a well-structured and comprehensive manuscript for a publication submission. In addition, the author lists different strategies for successful revision. Each of those strategies represents a step in the revision process and should help the writer improve the quality of the manuscript. The paper could be considered a brief manual for publication. Copyright © 2011.

76 FR 32878 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-07

...-0129] Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1253, ``Preoperational Testing of Emergency Core Cooling Systems for Pressurized-Water Reactors''. FOR FURTHER INFORMATION CONTACT: Mekonen M...

[Chronic pancreatitis. Evidence based management guidelines of the Hungarian Pancreatic Study Group].

PubMed

Takács, Tamás; Czakó, László; Dubravcsik, Zsolt; Farkas, Gyula; Hegyi, Péter; Hritz, István; Kelemen, Dezső; Lásztity, Natália; Morvay, Zita; Oláh, Attila; Pap, Ákos; Párniczky, Andrea; Patai, Árpád; Sahin-Tóth, Miklós; Szentkereszti, Zsolt; Szmola, Richárd; Tiszlavicz, László; Szücs, Ákos

2015-02-15

Chronic pancreatitis is an inflammatory disease associated with structural and functional damage of the pancreas. In most cases pain, maldigestion and weight loss are the leading symptoms, which significantly worsen the quality of life. Correct diagnosis and differential diagnosis of chronic pancreatitis and treatment of these patients requires up-to-date and evidence based treatment guidelines. The Hungarian Pancreatic Study Group proposed to prepare an evidence based guideline based on the available international guidelines and evidence. The preparatory and consultation task force appointed by the Hungarian Pancreatic Study Group translated and complemented and/or modified the international guidelines if it was necessary. 123 relevant clinical questions in 11 topics were defined. Evidence was classified according to the UpToDate® grading system. The draft of the guidelines were presented and discussed at the consensus meeting in September 12, 2014. All clinical questions were accepted with total or strong agreement. The present guideline is the first evidence based guideline for chronic pancreatitis in Hungary. This guideline provides very important and helpful data for tuition, everyday practice and proper financing of chronic pancreatitis. Therefore, the authors believe that these guidelines will widely become a basic reference in Hungary.

[Autoimmune pancreatitis. Evidence based management guidelines of the Hungarian Pancreatic Study Group].

PubMed

Dubravcsik, Zsolt; Farkas, Gyula; Hegyi, Péter; Hritz, István; Kelemen, Dezső; Lásztity, Natália; Morvay, Zita; Oláh, Attila; Pap, Ákos; Párniczky, Andrea; Sahin-Tóth, Miklós; Szentkereszti, Zsolt; Szmola, Richárd; Takács, Tamás; Tiszlavicz, László; Szücs, Ákos; Czakó, László

2015-02-22

Autoimmune pancreatitis is a rare disease which can even mimic pancreatic tumor, however, unlike the latter, it requires not surgical but conservative management. Correct diagnosis and differential diagnosis of autoimmune pancreatitis and treatment of these patients requires up-to-date and evidence based management guidelines. The Hungarian Pancreatic Study Group proposed to prepare an evidence based guideline based on the available international guidelines and evidences. The preparatory and consultation task force appointed by the Hungarian Pancreatic Study Group translated and complemented and/or modified the international guidelines if it was necessary. 29 relevant clinical questions in 4 topics were defined (Basics; Diagnosis; Differential diagnostics; Therapy). Evidence was classified according to the UpToDate(®) grading system. The draft of the guidelines was presented and discussed at the consensus meeting on September 12, 2014. All clinial questions were accepted with almost total (more than 95%) agreement. The present guideline is the first evidence based autoimmune pancreatitis guideline in Hungary. The guideline may provide very important and helpful data for tuition of autoimmune pancreatitis, for everyday practice and for establishing proper finance. Therefore, the authors believe that these guidelines will widely become a basic reference in Hungary.

Analysis of the Kaplan turbine draft tube effect

NASA Astrophysics Data System (ADS)

Motycak, L.; Skotak, A.; Obrovsky, J.

2010-08-01

The aim of this paper is to present information about possible problems and errors which can appear during numerical analyses of low head Kaplan turbines with a view to the runner - draft tube interaction. The setting of numerical model, grid size, used boundary conditions are the interface definition between runner and draft tube are discussed. There are available data from physical model tests which gives a great opportunity to compare CFD and experiment results and on the basis of this comparison to determine the approach to the CFD flow modeling. The main purpose for the Kaplan turbine model measurement was to gather the information about real flow field. The model tests were carried out in new hydraulic laboratory of CKD Blansko Engineering. The model tests were focused on the detailed velocity measurements downstream of the runner by differential pressure probe and on the velocity measurement downstream of the draft tube elbow by Particle Image Velocimetry method (PIV). The data from CFD simulation were compared to the velocity measurement results. In the paper also the design of the original draft tube modification due to flow improvement is discussed in the case of the Kaplan turbine uprating project. The results of the draft tube modification were confirmed by model tests in the hydraulic laboratory as well.

One map policy (OMP) implementation strategy to accelerate mapping of regional spatial planing (RTRW) in Indonesia

NASA Astrophysics Data System (ADS)

Hasyim, Fuad; Subagio, Habib; Darmawan, Mulyanto

2016-06-01

A preparation of spatial planning documents require basic geospatial information and thematic accuracies. Recently these issues become important because spatial planning maps are impartial attachment of the regional act draft on spatial planning (PERDA). The needs of geospatial information in the preparation of spatial planning maps preparation can be divided into two major groups: (i). basic geospatial information (IGD), consist of of Indonesia Topographic maps (RBI), coastal and marine environmental maps (LPI), and geodetic control network and (ii). Thematic Geospatial Information (IGT). Currently, mostly local goverment in Indonesia have not finished their regulation draft on spatial planning due to some constrain including technical aspect. Some constrain in mapping of spatial planning are as follows: the availability of large scale ofbasic geospatial information, the availability of mapping guidelines, and human resources. Ideal conditions to be achieved for spatial planning maps are: (i) the availability of updated geospatial information in accordance with the scale needed for spatial planning maps, (ii) the guideline of mapping for spatial planning to support local government in completion their PERDA, and (iii) capacity building of local goverment human resources to completed spatial planning maps. The OMP strategies formulated to achieve these conditions are: (i) accelerating of IGD at scale of 1:50,000, 1: 25,000 and 1: 5,000, (ii) to accelerate mapping and integration of Thematic Geospatial Information (IGT) through stocktaking availability and mapping guidelines, (iii) the development of mapping guidelines and dissemination of spatial utilization and (iv) training of human resource on mapping technology.

Clinical Guidelines for Management of Bone Health in Rett Syndrome Based on Expert Consensus and Available Evidence.

PubMed

Jefferson, Amanda; Leonard, Helen; Siafarikas, Aris; Woodhead, Helen; Fyfe, Sue; Ward, Leanne M; Munns, Craig; Motil, Kathleen; Tarquinio, Daniel; Shapiro, Jay R; Brismar, Torkel; Ben-Zeev, Bruria; Bisgaard, Anne-Marie; Coppola, Giangennaro; Ellaway, Carolyn; Freilinger, Michael; Geerts, Suzanne; Humphreys, Peter; Jones, Mary; Lane, Jane; Larsson, Gunilla; Lotan, Meir; Percy, Alan; Pineda, Mercedes; Skinner, Steven; Syhler, Birgit; Thompson, Sue; Weiss, Batia; Witt Engerström, Ingegerd; Downs, Jenny

2016-01-01

We developed clinical guidelines for the management of bone health in Rett syndrome through evidence review and the consensus of an expert panel of clinicians. An initial guidelines draft was created which included statements based upon literature review and 11 open-ended questions where literature was lacking. The international expert panel reviewed the draft online using a 2-stage Delphi process to reach consensus agreement. Items describe the clinical assessment of bone health, bone mineral density assessment and technique, and pharmacological and non-pharmacological interventions. Agreement was reached on 39 statements which were formulated from 41 statements and 11 questions. When assessing bone health in Rett syndrome a comprehensive assessment of fracture history, mutation type, prescribed medication, pubertal development, mobility level, dietary intake and biochemical bone markers is recommended. A baseline densitometry assessment should be performed with accommodations made for size, with the frequency of surveillance determined according to individual risk. Lateral spine x-rays are also suggested. Increasing physical activity and initiating calcium and vitamin D supplementation when low are the first approaches to optimizing bone health in Rett syndrome. If individuals with Rett syndrome meet the ISCD criterion for osteoporosis in children, the use of bisphosphonates is recommended. A clinically significant history of fracture in combination with low bone densitometry findings is necessary for a diagnosis of osteoporosis. These evidence and consensus-based guidelines have the potential to improve bone health in those with Rett syndrome, reduce the frequency of fractures, and stimulate further research that aims to ameliorate the impacts of this serious comorbidity.

Quality measures for the diagnosis and non-operative management of carpal tunnel syndrome in occupational settings.

PubMed

Nuckols, Teryl; Harber, Philip; Sandin, Karl; Benner, Douglas; Weng, Haoling; Shaw, Rebecca; Griffin, Anne; Asch, Steven

2011-03-01

Providing higher quality medical care to workers with occupationally associated carpal tunnel syndrome (CTS) may reduce disability, facilitate return to work, and lower the associated costs. Although many workers' compensation systems have adopted treatment guidelines to reduce the overuse of unnecessary care, limited attention has been paid to ensuring that the care workers do receive is high quality. Further, guidelines are not designed to enable objective assessments of quality of care. This study sought to develop quality measures for the diagnostic evaluation and non-operative management of CTS, including managing occupational activities and functional limitations. Using a variation of the well-established RAND/UCLA Appropriateness Method, we developed draft quality measures using guidelines and literature reviews. Next, in a two-round modified-Delphi process, a multidisciplinary panel of 11 U.S. experts in CTS rated the measures on validity and feasibility. Of 40 draft measures, experts rated 31 (78%) valid and feasible. Nine measures pertained to diagnostic evaluation, such as assessing symptoms, signs, and risk factors. Eleven pertain to non-operative treatments, such as the use of splints, steroid injections, and medications. Eleven others address assessing the association between symptoms and work, managing occupational activities, and accommodating functional limitations. These measures will complement existing treatment guidelines by enabling providers, payers, policymakers, and researchers to assess quality of care for CTS in an objective, structured manner. Given the characteristics of previous measures developed with these methods, greater adherence to these measures will probably lead to improved patient outcomes at a population level.

Standardized terminology and nomenclature for pancreatobiliary cytology: The Papanicolaou Society of Cytopathology Guidelines.

PubMed

Pitman, Martha B; Centeno, Barbara A; Ali, Syed Z; Genevay, Muriel; Stelow, Ed; Mino-Kenudson, Mari; Castillo, Carlos Fernandez-Del; Schmidt, C Max; Brugge, William R; Layfield, Lester J

2014-01-01

The Papanicolaou Society of Cytopathology has developed a set of guidelines for pancreatobiliary cytology including indications for endoscopic ultrasound (EUS) guided fine-needle aspiration (FNA) biopsy, techniques of EUS-FNA, terminology and nomenclature of pancreatobiliary disease, ancillary testing and post-biopsy treatment and management. All documents are based on the expertise of the authors, a review of the literature, discussion of the draft document at several national and international meetings over an 18 month period and synthesis of online comments of the draft document on the Papanicolaou Society of Cytopathology web site [www.papsociety.org]. This document selectively presents the results of these discussions and focuses on a proposed standardized terminology scheme for pancreatobiliary specimens that correlate cytological diagnosis with biological behavior and increasingly conservative patient management of surveillance only. The proposed terminology scheme recommends a six-tiered system: Non-diagnostic, negative, atypical, neoplastic [benign or other], suspicious and positive. Unique to this scheme is the "neoplastic" category separated into "benign" (serous cystadenoma) or "other" (premalignant mucinous cysts, neuroendocrine tumors and solid-pseudopapillary neoplasms (SPNs)). The positive or malignant category is reserved for high-grade, aggressive malignancies including ductal adenocarcinoma, acinar cell carcinoma, poorly differentiated neuroendocrine carcinomas, pancreatoblastoma, lymphoma and metastases. Interpretation categories do not have to be used. Some pathology laboratory information systems require an interpretation category, which places the cytological diagnosis into a general category. This proposed scheme provides terminology that standardizes the category of the various diseases of the pancreas, some of which are difficult to diagnose specifically by cytology. In addition, this terminology scheme attempts to provide maximum flexibility for patient management, which has become increasingly conservative for some neoplasms.

Standardized terminology and nomenclature for pancreatobiliary cytology: the Papanicolaou Society of Cytopathology guidelines.

PubMed

Pitman, Martha B; Centeno, Barbara A; Ali, Syed Z; Genevay, Muriel; Stelow, Ed; Mino-Kenudson, Mari; Fernandez-del Castillo, Carlos; Max Schmidt, C; Brugge, William; Layfield, Lester

2014-04-01

The Papanicolaou Society of Cytopathology has developed a set of guidelines for pancreatobiliary cytology including indications for endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) biopsy, techniques of EUS-FNA, terminology and nomenclature of pancreatobiliary disease, ancillary testing, and postbiopsy treatment and management. All documents are based on the expertise of the authors, a review of the literature, discussions of the draft document at several national and international meetings over an 18-month period and synthesis of online comments of the draft document on the Papanicolaou Society of Cytopathology web site (www.papsociety.org). This document selectively presents the results of these discussions and focuses on a proposed standardized terminology scheme for pancreatobiliary specimens that correlate cytological diagnosis with biological behavior and increasingly conservative patient management of surveillance only. The proposed terminology scheme recommends a six-tiered system: Nondiagnostic, Negative, Atypical, Neoplastic (benign or other), Suspicious and Positive. Unique to this scheme is the "Neoplastic" category separated into "benign" (serous cystadenoma), or "Other" (premalignant mucinous cysts, neuroendocrine tumors, and solid-pseudopapillary neoplasms). The positive or malignant category is reserved for high-grade, aggressive malignancies including ductal adenocarcinoma, acinar cell carcinoma, poorly differentiated neuroendocrine carcinomas, pancreatoblastoma, lymphoma, and metastases. Interpretation categories do not have to be used. Some pathology laboratory information systems require an interpretation category, which places the cytological diagnosis into a general category. This proposed scheme provides terminology that standardizes the category of the various diseases of the pancreas, some of which are difficult to diagnose specifically by cytology. In addition, this terminology scheme attempts to provide maximum flexibility for patient management, which has become increasingly conservative for some neoplasms. Copyright © 2014 Wiley Periodicals, Inc.

46 CFR 97.15-5 - Drafts and load line markings.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 4 2014-10-01 2014-10-01 false Drafts and load line markings. 97.15-5 Section 97.15-5... OPERATIONS Tests, Drills, and Inspections § 97.15-5 Drafts and load line markings. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and...

46 CFR 97.15-5 - Drafts and load line markings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 4 2010-10-01 2010-10-01 false Drafts and load line markings. 97.15-5 Section 97.15-5... OPERATIONS Tests, Drills, and Inspections § 97.15-5 Drafts and load line markings. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and...

46 CFR 97.15-5 - Drafts and load line markings.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 4 2011-10-01 2011-10-01 false Drafts and load line markings. 97.15-5 Section 97.15-5... OPERATIONS Tests, Drills, and Inspections § 97.15-5 Drafts and load line markings. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and...

46 CFR 97.15-5 - Drafts and load line markings.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 4 2012-10-01 2012-10-01 false Drafts and load line markings. 97.15-5 Section 97.15-5... OPERATIONS Tests, Drills, and Inspections § 97.15-5 Drafts and load line markings. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and...

46 CFR 97.15-5 - Drafts and load line markings.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 4 2013-10-01 2013-10-01 false Drafts and load line markings. 97.15-5 Section 97.15-5... OPERATIONS Tests, Drills, and Inspections § 97.15-5 Drafts and load line markings. (a) The master of every vessel on an ocean, coastwise, or Great Lakes voyage shall enter the drafts of the vessel, forward and...

Draft environmental assessment: Davis Canyon site, Utah. Nuclear Waste Policy Act (Section 112). [Contains glossary

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

Not Available

1984-12-01

In February 1983, the US Department of Energy (DOE) identified the Davis Canyon site in Utah, as one of nine potentially acceptable sites for a mined geologic repository for spent nuclear fuel and high-level radioactive waste. To determine their suitability, the Davis Canyon site and the eight other potentially acceptable sites have been evaluated in accordance with the DOE's General Guidelines for the Recommendation of Sites for Nuclear Waste Repositories. These evaluations are reported in this draft environmental assessment (EA), which is being issued for public review and comment. The DOE findings and determinations that are based on these evaluationsmore » are preliminary and subject to public review and comment. A final EA will be prepared after considering the comments received. On the basis of the evaluations reported in this draft EA, the DOE has found that the Davis Canyon site is not disqualified under the guidelines. The site is in the Paradox Basin, which is one of five distinct geohydrologic settings considered for the first repository. This setting contains one other potentially acceptable site - the Lavender Canyon site. Although the Lavender Canyon site appears to be suitable for site characterization, the DOE has concluded that the Davis Canyon site is the preferred site in the Paradox Basin. Furthermore, the DOE finds that the site is suitable for site characterization because the evidence does not support a conclusion that the site will not be able to meet each of the qualifying conditions specified in the guidelines. On the basis of these findings, the DOE is proposing to nominate the Davis Canyon site as one of five sites suitable for characterization. Having compared the Davis Canyon site with the other four sites proposed for nomination, the DOE has determined that the Davis Canyon site is not one of the three preferred sites for recommendation to the President as candidates for characterization.« less

Guidelines for economic analysis of pharmaceutical products: a draft document for Ontario and Canada.

PubMed

Detsky, A S

1993-05-01

In Canada, provincial formulary review committees consider the effectiveness, safety, and cost of products when they derive advice for each Minister of Health. This article offers a draft set of guidelines for pharmaceutical manufacturers making submissions which include economic information, moving beyond a simple presentation of the unit price of the pharmaceutical product (e.g. price per day or course of therapy) and comparison to similar prices for alternative products. A full economic analysis compares all relevant costs and clinical outcomes of the new product with alternate therapeutic strategies for treating patients with a particular condition. The perspective of the decision maker must be clearly identified. The quality of the evidence supporting estimates of the variables incorporated in the analysis should be evaluated. Sensitivity analyses are used to assess the robustness of the qualitative conclusions. Reviewers will examine the answers to a set of 19 questions. Manufacturers can use these questions as a worksheet for preparation of an economic analysis to be incorporated in a submission. These guidelines are intended to be a starting point for further refinement, and discussion with health economists in industry and academia. Considerable flexibility will be used in reviewing documentation supporting economic analysis. Those preparing submissions should be encouraged to experiment with various approaches as part of the general development of this field and to engage provincial review committees in ongoing discussions.

The methodology for defining the European Standards for the certification of Haemophilia Centres in Europe

PubMed Central

Candura, Fabio; Menichini, Ivana; Calizzani, Gabriele; Giangrande, Paul; Mannucci, Pier Mannuccio; Makris, Michael

2014-01-01

Introduction Work Package 4 Development of the standardisation criteria of the European Haemophilia Network project has the main objective of implementing a common and shared European strategy for a certification system for two levels of Haemophilia Centres: European Haemophilia Treatment Centres and European Haemophilia Comprehensive Care Centres in the Member States of the European Union. Materials and methods An inclusive and participatory process for developing shared standards and criteria for the management of patients with inherited bleeding disorders has been carried out. The process has been implemented through four different consultation events involving the entire European community of stakeholders that significantly contributed in the drafting of the European Guidelines for the certification of Haemophilia Centres. Results The Guidelines set the standards for the designation of centres that provide specialised and multidisciplinary care (Haemophilia Comprehensive Care Centres) as well as local routine care (Haemophilia Treatment Centres). Standards cover several issues such as: general requirements; patient care; advisory services; laboratory; networking of clinical and specialised services. Conclusions The drafting of the European Guidelines for the certification of Haemophilia Centres was performed adopting a rigorous methodological approach. In order to build the widest possible consensus to the quality standards, the main institutional and scientific stakeholders have been involved. The resulting document will significantly contribute in promoting standardisation in the quality of diagnosis and treatment in European Haemophilia Centres. PMID:24922292

DRAFT METHODOLOGY FOR DERIVATION OF WATER ...

EPA Pesticide Factsheets

Development and body functions of many organisms are directed by the endocrine system. Endocrine Disrupting Chemicals (EDCs), are those exogenous (and endogenous) compounds that may interfere with this regulatory function because they may either mimic or suppress the action of the body’s natural hormones. Because these chemicals are increasingly present in the environment as a result of human activities and they only require tiny amounts to disrupt endocrine functions, EDCs may have major impacts on ecology and particularly aquatic life as evidenced by the abundance of field observations verified by both laboratory and controlled in situ experiments. The Clean Water Act § 304(a)(1) authorizes the Administrator to develop and publish criteria for water quality that are protective of aquatic life. Traditionally, ambient water quality criteria for the protection of aquatic life have been derived using the 1985 Guidelines (Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Life and Their Uses). These guidelines have comprehensive data requirements for toxicity tests using a variety of aquatic taxa, thus ensuring protection of the existing aquatic assemblage, and helping to ensure a goal of protecting and restoring “ecological integrity”. Some “Pharmaceuticals and Personal Care Products” (PPCPs), particularly those exhibiting endocrine disrupting activity, have two unique features, which distinguish them from

Curriculum guidelines and standards for dental laser education

NASA Astrophysics Data System (ADS)

White, Joel M.; et al.

1993-07-01

The curriculum guidelines for dental laser education were developed through a consensus process with members from dental academia, industry and private practice. This document was developed at a workshop on the development of standards for dental laser education and laser instructor certification held at the University of California, San Francisco on July 25 and 26, 1992. A working draft is currently being circulated among dental laser educators, researchers, practitioners, organized dentistry and members of industry. After further discussion, modification and review, the final document will be widely distributed and updated annually. Any questions concerning the guidelines may be addressed to the authors of this document in care of the organizer. Suggestions for the improvement of this standard and endorsement of this document are invited.

SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised Publication Guidelines from a Detailed Consensus Process

PubMed Central

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2015-01-01

Since the publication of Standards for Quality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015, using 1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group; 2) two face-to-face consensus meetings to develop interim drafts; and 3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). PMID:26517437

SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): Revised Publication Guidelines from a Detailed Consensus Process.

PubMed

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2015-01-01

Since the publication of Standards for Quality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015, using 1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group; 2) two face-to-face consensus meetings to develop interim drafts; and 3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org).

78 FR 34423 - Aviation Rulemaking Advisory Committee (ARAC) Airman Testing Standards and Training Working Group...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-07

... private pilot certificate and the instrument rating. These documents are available for public review... Airman Testing Standards and Training (2) Draft PRIVATE PILOT--AIRPLANE Airman Certification Standards; (3) Draft Change Tracking Matrix referenced to FAA-S-8081-14B, Private Pilot Practical Test Standards...

46 CFR 61.35-3 - Required tests and checks.

Code of Federal Regulations, 2010 CFR

2010-10-01

... heaters without water level controls) must be tested by interrupting the feed water supply. Manual reset... alarm and visible indicator must be verified. The shutdown times must be verified. (3) Fuel supply... draft loss interlock switch must be tested to ensure proper operation. The draft limit control must...

77 FR 58999 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-25

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... their complexity, the FDA is considering standardizing stability testing policies by adopting...

Space shuttle propulsion systems on-board checkout and monitoring system development study

NASA Technical Reports Server (NTRS)

1971-01-01

Investigations on the fundamental space shuttle propulsion systems program are reported, with emphasis on in-depth reviews of preliminary drafts of the guidelines. The guidelines will be used to incorporate the onboard checkout and monitoring function into the basic design of the propulsion systems and associated interfacing systems. The analysis of checkout and monitoring requirements of the Titan 3 L expandable booster propulsion systems was completed, and the techniques for accomplishing the checkout and monitoring functions were determined. Updating results of the basic study of propulsion system checkout and monitoring is continuing.

Correspondence standards

NASA Technical Reports Server (NTRS)

1992-01-01

This revised handbook covers the drafting, preparation, and review of NASA letters, memorandums, informal communications, electronic communications, envelopes and mailing, and classified correspondence. The appendices address specific guidelines for administrator's correspondence, White House and Congressional correspondance, Privacy Act correspondence, and foreign correspondence. Also incorporated as appendices are quick references for forms of address, compound words, and capitalization of words frequently used at NASA.

Applying Learner-Centered Principles and Strategies: From Face to Face Instruction to a Hybrid Course Learning Format

ERIC Educational Resources Information Center

McDonough, Darlene

2012-01-01

This paper discusses the transition from traditional face to face instruction to a hybrid format using the newly drafted 8 Standards of the Educational Leadership Constituents Council (2010) as guidelines for the curriculum, the 14 Learner Centered Principles (1997) from the American Psychological Association as elements for instructional…

10 CFR 960.3-2-2-4 - The environmental assessment.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; and an assessment of the regional and local impacts of locating a repository at the site. The draft... 10 Energy 4 2012-01-01 2012-01-01 false The environmental assessment. 960.3-2-2-4 Section 960.3-2... FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-4 The environmental assessment...

10 CFR 960.3-2-2-4 - The environmental assessment.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; and an assessment of the regional and local impacts of locating a repository at the site. The draft... 10 Energy 4 2014-01-01 2014-01-01 false The environmental assessment. 960.3-2-2-4 Section 960.3-2... FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-4 The environmental assessment...

10 CFR 960.3-2-2-4 - The environmental assessment.

Code of Federal Regulations, 2013 CFR

2013-01-01

...; and an assessment of the regional and local impacts of locating a repository at the site. The draft... 10 Energy 4 2013-01-01 2013-01-01 false The environmental assessment. 960.3-2-2-4 Section 960.3-2... FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-4 The environmental assessment...

75 FR 18781 - Americans With Disabilities Act (ADA) Accessibility Guidelines for Buildings and Facilities...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-13

..., check-in or check-out, seat selection, boarding passes, or ordering food in restaurants and cafeterias... machines used for ticketing, check-in or check- out, seat selection, boarding passes, or ordering food in restaurants and cafeterias. 75 FR 13457 (March 22, 2010). The Board has released for public comment a draft of...

Fixing Broken Doors: Strategies for Drafting Privacy Policies Young People Can Understand

ERIC Educational Resources Information Center

Micheti, Anca; Burkell, Jacquelyn; Steeves, Valerie

2010-01-01

The goal of this project is to identify guidelines for privacy policies that children and teens can accurately interpret with relative ease. A three-pronged strategy was used to achieve this goal. First, an analysis of the relevant literature on reading was undertaken to identify the document features that affect comprehension. Second, focus…

78 FR 9409 - Endangered and Threatened Wildlife and Plants; Draft Revised Indiana Bat Summer Survey Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R3-ES-2013-N033; FXES11130300000-134... AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability; extension of comment period. SUMMARY: We, the U.S. Fish and Wildlife Service (USFWS), are extending the public comment period on...

199 Development of a National Guideline on Skin Testing and Immunotherapy

PubMed Central

Linnemann, Désirée Larenas; Ortega Martell, José Antonio; del Rio, Blanca; Rodriguez-Perez, Noel; Arias-Cruz, Alfredo; Estrada, Alan

2012-01-01

Background Several international guidelines exist on allergen immunotherapy (AIT) –eg American, European, British, Spanish, Italian- but local conditions that reign in each country limit their applicability. We present the steps we followed to develop a National Guideline on AIT, taking into account local legislation, extracts available, costs and patient preference. Methods Firstly a Nation-wide survey on the practice of skin testing and AIT was undertaken among all members of Mexican Allergist Societies. Secondly, based on the replies obtained with the survey clinical questions were formulated on critical points and issues susceptible for improvement, as diagnosed by the survey. Thirdly, all 6 Regional Allergist Societies were visited to obtain the opinion of their members on the clinical questions concerning how immunotherapy could best be practiced under local Mexican conditions. This led to the Consensed experience. Fourthly, 6 experts looked for the replies to the clinical questions reviewing the literature and assigning quality of evidence to the articles on the specific issues treated by each clinical question. Results To develop the final document the GRADE approach was used. For each clinical question both, knowledge from the local consensed experience and the evidence-based replies were taken into account, as well as cost, patient preference and safety to make a set of recommendations and suggestions on the most crucial aspects of skin testing and AIT. Forming centers of allergists in Mexico corrected the final draft. The final document came out as the January issue of Revista Mexicana Alergia and was presented by the authors in a National Course on Immunotherapy (May 2011), with—apart from the lectures—a more workshop-like part to allow for practical exercising and discussion. The updated questions on allergen immunotherapy for the final board exam are based on the Guideline. Allergy-residents developed a slide-show. In 2012 Regional Allergist Societies shall be visited again. Conclusions We present a democratic way of how a National Guideline can be developed, supported by evidence-based medicine and local experience in a country where little is legislated on this respect and quality improvement has to be stimulated by the professional community. We show how implementation can be enhanced.

Managing challenging interactions with family caregivers in the cancer setting: Guidelines for clinicians (TRIO Guidelines-2).

PubMed

Laidsaar-Powell, Rebekah; Butow, Phyllis; Boyle, Frances; Juraskova, Ilona

2018-06-01

Family caregivers can, at times, add complexity to clinical encounters. Difficult family caregivers and dynamics may: derail consultation communication, reduce patient autonomy, and compromise effective clinical care. A paucity of practical strategies guiding effective clinician-family communication exists. This study aimed to develop and evaluate the first comprehensive, evidence-based guidelines (the TRIO guidelines) for oncology physicians and nurses to better manage several complex/challenging situations involving family members. TRIO Guidelines were based on a comprehensive review of literature, relevant guidelines, and feedback from an expert advisory group (n = 10). Draft guidelines underwent two rounds of evaluation via an online Delphi consensus process involving international experts (n = 35). Guidelines incorporate topic areas, strategies, and sub-strategies on managing challenging family involvement (7 topics). Example wording, behaviours and level of evidence are provided. Challenging triadic interactions require skillful navigation, and the TRIO Guidelines provide clear, specific, and evidence-based strategies for clinicians to utilise in these potentially stressful encounters. Training based on these guidelines may improve both patient care and clinician confidence. Implementation of these guidelines into medical/nursing curricula and as a component of continuing professional development programs will likely be highly beneficial. Copyright © 2018 Elsevier B.V. All rights reserved.

Utilization of Ancillary Studies in the Cytologic Diagnosis of Biliary and Pancreatic Lesions

PubMed Central

Layfield, Lester J.; Ehya, Hormoz; Filie, Armando C.; Hruban, Ralph H.; Jhala, Nirag; Joseph, Loren; Vielh, Philippe; Pitman, Martha B.

2015-01-01

The Papanicolaou Society of Cytopathology has developed a set of guidelines for pancreatobiliary cytology including indications for endoscopic ultrasound-guided fine-needle aspiration, terminology and nomenclature of pancreatobiliary disease, ancillary testing, and post-biopsy management. All documents are based on the expertise of the authors, a review of the literature, discussions of the draft document at several national and international meetings, and synthesis of selected online comments of the draft document. This document presents the results of these discussions regarding the use of ancillary testing in the cytologic diagnosis of biliary and pancreatic lesions. Currently, fluorescence in situ hybridization (FISH) appears to be the most clinically relevant ancillary technique for cytology of bile duct strictures. The addition of FISH analysis to routine cytologic evaluation appears to yield the highest sensitivity without loss in specificity. Loss of immunohistochemical staining for the protein product of the SMAD4 gene and positive staining for mesothelin support a diagnosis of ductal adenocarcinoma. Immunohistochemical markers for endocrine and exocrine differentiation are sufficient for a diagnosis of endocrine and acinar tumors. Nuclear staining for beta-catenin supports a diagnosis of solid-pseudopapilary neoplasm. Cyst fluid analysis for amylase and carcinoembryonic antigen aids in the preoperative classification of pancreatic cysts. Many gene mutations (KRAS, GNAS, VHL, RNF43, and CTNNB1) may be of aid in the diagnosis of cystic neoplasms. Other ancillary techniques do not appear to improve diagnostic sensitivity sufficiently to justify their increased costs. PMID:24639398

ISO WD 1856. Guideline for radiation exposure of nonmetallic materials. Present status

NASA Astrophysics Data System (ADS)

Briskman, B. A.

In the framework of the International Organization for Standardization (ISO) activity we started development of international standard series for space environment simulation at on-ground tests of materials. The proposal was submitted to ISO Technical Committee 20 (Aircraft and Space Vehicles), Subcommittee 14 (Space Systems and Operations) and was approved as Working Draft 15856 at the Los-Angeles meeting (1997). A draft of the first international standard "Space Environment Simulation for Radiation Tests of Materials" (1st version) was presented at the 7th International Symposium on Materials in Space Environment (Briskman et al, 1997). The 2nd version of the standard was limited to nonmetallic materials and presented at the 20th Space Simulation Conference (Briskman and Borson, 1998). It covers the testing of nonmetallic materials embracing also polymer composite materials including metal components (metal matrix composites) to simulated space radiation. The standard does not cover semiconductor materials. The types of simulated radiation include charged particles (electrons and protons), solar ultraviolet radiation, and soft X-radiation of solar flares. Synergistic interactions of the radiation environment are covered only for these natural and some induced environmental effects. This standard outlines the recommended methodology and practices for the simulation of space radiation on materials. Simulation methods are used to reproduce the effects of the space radiation environment on materials that are located on surfaces of space vehicles and behind shielding. It was discovered that the problem of radiation environment simulation is very complex and the approaches of different specialists and countries to the problem are sometimes quite opposite. To the present moment we developed seven versions of the standard. The last version is a compromise between these approaches. It was approved at the last ISO TC20/SC14/WG4 meeting in Houston, October 2002. At a splinter meeting of Int. Conference on Materials in a Space Environment, Noordwijk, Netherlands, ESA, June 2003, the experts from ESA, USA, France, Russia and Japan discussed the last version of the draft and approved it with a number of notes. A revised version of the standard will be presented this May at ISO TC20/SC14 meeting in Russia.

EPA Releases Draft Policy to Reduce Animal Testing for Skin Sensitization

EPA Pesticide Factsheets

The document, Draft Interim Science Policy: Use of Alternative Approaches for Skin Sensitization as a Replacement for Laboratory Animal Testing, describes the science behind the non-animal alternatives that can now be used to identify skin sensitization.

Skin cancer screening: recommendations for data-driven screening guidelines and a review of the US Preventive Services Task Force controversy

PubMed Central

Johnson, Mariah M; Leachman, Sancy A; Aspinwall, Lisa G; Cranmer, Lee D; Curiel-Lewandrowski, Clara; Sondak, Vernon K; Stemwedel, Clara E; Swetter, Susan M; Vetto, John; Bowles, Tawnya; Dellavalle, Robert P; Geskin, Larisa J; Grossman, Douglas; Grossmann, Kenneth F; Hawkes, Jason E; Jeter, Joanne M; Kim, Caroline C; Kirkwood, John M; Mangold, Aaron R; Meyskens, Frank; Ming, Michael E; Nelson, Kelly C; Piepkorn, Michael; Pollack, Brian P; Robinson, June K; Sober, Arthur J; Trotter, Shannon; Venna, Suraj S; Agarwala, Sanjiv; Alani, Rhoda; Averbook, Bruce; Bar, Anna; Becevic, Mirna; Box, Neil; E Carson, William; Cassidy, Pamela B; Chen, Suephy C; Chu, Emily Y; Ellis, Darrel L; Ferris, Laura K; Fisher, David E; Kendra, Kari; Lawson, David H; Leming, Philip D; Margolin, Kim A; Markovic, Svetomir; Martini, Mary C; Miller, Debbie; Sahni, Debjani; Sharfman, William H; Stein, Jennifer; Stratigos, Alexander J; Tarhini, Ahmad; Taylor, Matthew H; Wisco, Oliver J; Wong, Michael K

2017-01-01

Melanoma is usually apparent on the skin and readily detected by trained medical providers using a routine total body skin examination, yet this malignancy is responsible for the majority of skin cancer-related deaths. Currently, there is no national consensus on skin cancer screening in the USA, but dermatologists and primary care providers are routinely confronted with making the decision about when to recommend total body skin examinations and at what interval. The objectives of this paper are: to propose rational, risk-based, data-driven guidelines commensurate with the US Preventive Services Task Force screening guidelines for other disorders; to compare our proposed guidelines to recommendations made by other national and international organizations; and to review the US Preventive Services Task Force's 2016 Draft Recommendation Statement on skin cancer screening. PMID:28758010

Development and Application of a Message Metric for NOAA NWS Tsunami Warnings and Recommended Guidelines for the NWS TsunamiReady Program

NASA Astrophysics Data System (ADS)

Gregg, C. E.; Johnston, D. M.; Ricthie, L.; Meinhold, S.; Johnson, V.; Scott, C.; Farnham, C.; Houghton, B. F.; Horan, J.; Gill, D.

2012-12-01

Improving the quality and effectiveness of tsunami warning messages and the TsunamiReady community preparedness program of the US National Oceanic and Atmospheric Administration, National Weather Service's (NWS), Tsunami Program are two key objectives of a three year project (Award NA10NWS4670015) to help integrate social science into the NWS' Tsunami Program and improve the preparedness of member states and territories of the National Tsunami Hazard Mitigation Program (NTHMP). Research was conducted in collaboration with state and local emergency managers. Based on findings from focus group meetings with a purposive sample of local, state and Federal stakeholders and emergency managers in six states (AK, WA, OR, CA, HI and NC) and two US Territories (US Virgin Islands and American Samoa), and upon review of research literature on behavioral response to warnings, we developed a warning message metric to help guide revisions to tsunami warning messages issued by the NWS' West Coast/Alaska Tsunami Warning Center, Alaska and Pacific Tsunami Warning Center, Hawaii. The metric incorporates factors that predict response to warning information, which are divided into categories of Message Content, Style, Order and Formatting and Receiver Characteristics. A message is evaluated by cross-referencing the message with the meaning of metric factors and assigning a maximum score of one point per factor. Findings are then used to guide revisions of the message until the characteristics of each factor are met. From focus groups that gathered information on the usefulness and achievability of tsunami preparedness actions, we developed recommendations for revisions to the proposed draft guidelines of the TsunamiReady Improvement Program. Proposed key revisions include the incorporation of community vulnerability to distant (far-field) versus local (near-field) tsunamis as a primary determinant of mandatory actions, rather than community population. Our team continues to work with NWS personnel, including a NWS Tsunami Warning Improvement Team, and the focus group participants to finalize and pilot test prototype warning products and the draft TsunamiReady guidelines.

Systematic Review of International Colposcopy Quality Improvement Guidelines.

PubMed

Mayeaux, Edward J; Novetsky, Akiva P; Chelmow, David; Choma, Kim; Garcia, Francisco; Liu, Angela H; Papasozomenos, Theognosia; Einstein, Mark H

2017-10-01

The American Society for Colposcopy and Cervical Pathology Colposcopy Standards Committee organized multiple working groups to draft colposcopy standards for the United States. As part of this project, international quality assurance and improvement measures were examined. The quality improvement working group performed a systematic review of the literature to collate international guidelines related to quality improvement. Source guidelines were collected using searches in Medline, Google Scholar, the International Federation of Cervical Pathology and Colposcopy Web site, other regional colposcopy group's Web sites, and communications with International Federation of Cervical Pathology and Colposcopy board of directors' members and other expert members of various national groups. Once identified, the sources were reviewed by multiple workgroup members for potential guideline materials. Fifty-six unique documents were identified, of which 18 met inclusion criteria and contributed data to the analysis. Information was abstracted and grouped by related subject. Wide variation exists in colposcopy guidance and quality indicators from regional and national colposcopy societies. Abstracted international guidelines are presented.

Korean clinical practice guideline for benign prostatic hyperplasia

PubMed Central

Yeo, Jeong Kyun; Choi, Hun; Bae, Jae Hyun; Kim, Jae Heon; Yang, Seong Ok; Oh, Chul Young; Cho, Young Sam; Kim, Kyoung Woo

2016-01-01

In 2014, the Korean Urological Association organized the Benign Prostatic Hyperplasia Guideline Developing Committee composed of experts in the field of benign prostatic hyperplasia (BPH) with the participation of the Korean Academy of Family Medicine and the Korean Continence Society to develop a Korean clinical practice guideline for BPH. The purpose of this clinical practice guideline is to provide current and comprehensive recommendations for the evaluation and treatment of BPH. The committee developed the guideline mainly by adapting existing guidelines and partially by using the de novo method. A comprehensive literature review was carried out primarily from 2009 to 2013 by using medical search engines including data from Korea. Based on the published evidence, recommendations were synthesized, and the level of evidence of the recommendations was determined by using methods adapted from the 2011 Oxford Centre for Evidence-Based Medicine. Meta-analysis was done for one key question and four recommendations. A draft guideline was reviewed by expert peer reviewers and discussed at an expert consensus meeting until final agreement was achieved. This evidence-based guideline for BPH provides recommendations to primary practitioners and urologists for the diagnosis and treatment of BPH in men older than 40 years. PMID:26966724

75 FR 48997 - NUREG-1946, “Inservice Testing of Pumps and Valves, and Inservice Examination and Testing of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-12

..., and Inservice Examination and Testing of Dynamic Restraints (Snubbers) at Nuclear Power Plants, Draft... Dynamic Restraints (Snubbers) at Nuclear Power Plants, Draft Report for Comment.'' DATES: Please submit... System (ADAMS): Publicly available documents created or received at the NRC are available electronically...

78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... components, including Source Plasma. The guidance announced in this notice replaces the draft guidance... before it begins work on the final version of the guidance, submit either electronic or written comments... the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit...

76 FR 38680 - Notice of Availability of the Draft Environmental Impact Statement for the West Chocolate...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

... solar, wind and geothermal testing and development in a renewable energy evaluation area located near... pending geothermal lease application within the renewable energy evaluation area. This CDCA Draft Plan... Availability of the Draft Environmental Impact Statement for the West Chocolate Mountains Renewable Energy...

46 CFR 131.510 - Draft and loadline markings.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 4 2012-10-01 2012-10-01 false Draft and loadline markings. 131.510 Section 131.510 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS OPERATIONS Tests, Drills, and Inspections § 131.510 Draft and loadline markings. (a) The master of each vessel on an ocean...

46 CFR 131.510 - Draft and loadline markings.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 4 2014-10-01 2014-10-01 false Draft and loadline markings. 131.510 Section 131.510 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS OPERATIONS Tests, Drills, and Inspections § 131.510 Draft and loadline markings. (a) The master of each vessel on an ocean...

Clinical Guidelines for Management of Bone Health in Rett Syndrome Based on Expert Consensus and Available Evidence

PubMed Central

Jefferson, Amanda; Leonard, Helen; Siafarikas, Aris; Woodhead, Helen; Fyfe, Sue; Ward, Leanne M.; Munns, Craig; Motil, Kathleen; Tarquinio, Daniel; Shapiro, Jay R.; Brismar, Torkel; Ben-Zeev, Bruria; Bisgaard, Anne-Marie; Coppola, Giangennaro; Ellaway, Carolyn; Freilinger, Michael; Geerts, Suzanne; Humphreys, Peter; Jones, Mary; Lane, Jane; Larsson, Gunilla; Lotan, Meir; Percy, Alan; Pineda, Mercedes; Skinner, Steven; Syhler, Birgit; Thompson, Sue; Weiss, Batia; Witt Engerström, Ingegerd; Downs, Jenny

2016-01-01

Objectives We developed clinical guidelines for the management of bone health in Rett syndrome through evidence review and the consensus of an expert panel of clinicians. Methods An initial guidelines draft was created which included statements based upon literature review and 11 open-ended questions where literature was lacking. The international expert panel reviewed the draft online using a 2-stage Delphi process to reach consensus agreement. Items describe the clinical assessment of bone health, bone mineral density assessment and technique, and pharmacological and non-pharmacological interventions. Results Agreement was reached on 39 statements which were formulated from 41 statements and 11 questions. When assessing bone health in Rett syndrome a comprehensive assessment of fracture history, mutation type, prescribed medication, pubertal development, mobility level, dietary intake and biochemical bone markers is recommended. A baseline densitometry assessment should be performed with accommodations made for size, with the frequency of surveillance determined according to individual risk. Lateral spine x-rays are also suggested. Increasing physical activity and initiating calcium and vitamin D supplementation when low are the first approaches to optimizing bone health in Rett syndrome. If individuals with Rett syndrome meet the ISCD criterion for osteoporosis in children, the use of bisphosphonates is recommended. Conclusion A clinically significant history of fracture in combination with low bone densitometry findings is necessary for a diagnosis of osteoporosis. These evidence and consensus-based guidelines have the potential to improve bone health in those with Rett syndrome, reduce the frequency of fractures, and stimulate further research that aims to ameliorate the impacts of this serious comorbidity. PMID:26849438

The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline.

PubMed

Funder, John W; Carey, Robert M; Mantero, Franco; Murad, M Hassan; Reincke, Martin; Shibata, Hirotaka; Stowasser, Michael; Young, William F

2016-05-01

To develop clinical practice guidelines for the management of patients with primary aldosteronism. The Task Force included a chair, selected by the Clinical Guidelines Subcommittee of the Endocrine Society, six additional experts, a methodologist, and a medical writer. The guideline was cosponsored by American Heart Association, American Association of Endocrine Surgeons, European Society of Endocrinology, European Society of Hypertension, International Association of Endocrine Surgeons, International Society of Endocrinology, International Society of Hypertension, Japan Endocrine Society, and The Japanese Society of Hypertension. The Task Force received no corporate funding or remuneration. We searched for systematic reviews and primary studies to formulate the key treatment and prevention recommendations. We used the Grading of Recommendations, Assessment, Development, and Evaluation group criteria to describe both the quality of evidence and the strength of recommendations. We used "recommend" for strong recommendations and "suggest" for weak recommendations. We achieved consensus by collecting the best available evidence and conducting one group meeting, several conference calls, and multiple e-mail communications. With the help of a medical writer, the Endocrine Society's Clinical Guidelines Subcommittee, Clinical Affairs Core Committee, and Council successfully reviewed the drafts prepared by the Task Force. We placed the version approved by the Clinical Guidelines Subcommittee and Clinical Affairs Core Committee on the Endocrine Society's website for comments by members. At each stage of review, the Task Force received written comments and incorporated necessary changes. For high-risk groups of hypertensive patients and those with hypokalemia, we recommend case detection of primary aldosteronism by determining the aldosterone-renin ratio under standard conditions and recommend that a commonly used confirmatory test should confirm/exclude the condition. We recommend that all patients with primary aldosteronism undergo adrenal computed tomography as the initial study in subtype testing and to exclude adrenocortical carcinoma. We recommend that an experienced radiologist should establish/exclude unilateral primary aldosteronism using bilateral adrenal venous sampling, and if confirmed, this should optimally be treated by laparoscopic adrenalectomy. We recommend that patients with bilateral adrenal hyperplasia or those unsuitable for surgery should be treated primarily with a mineralocorticoid receptor antagonist.

European guidelines for the accreditation of Sleep Medicine Centres.

PubMed

Pevernagie, Dirk

2006-06-01

This document describes guidelines for accreditation of Sleep Medicine Centres in Europe. These guidelines are the result of a consensus procedure, in which representatives of the European Sleep Research Society (ESRS) and representatives of different European National Sleep Societies (ENSS) were involved. The information obtained during different rounds of consultation was gathered and processed by the members of the Steering Committee of the ESRS. The scope of the guidelines is to define the characteristics of multidisciplinary Sleep Medicine Centres (SMCs), in terms of requirements regarding staff, operational procedures and logistic facilities. Accreditation of SMCs is proposed to be the responsibility of the individual ENSS. The Accreditation Guidelines may thus be considered an instrument for the national societies to develop new or standardize existing accreditation questionnaires, as well as procedures for visiting the site, drafting the accreditation report, and finally, granting the accreditation. The Accreditation Guidelines are meant to be a line of action, that ideally should be followed as close as possible, but that may be subject to certain exceptions, depending on local customs or regulations.

The EpiOcular™ Eye Irritation Test is the Method of Choice for the In Vitro Eye Irritation Testing of Agrochemical Formulations: Correlation Analysis of EpiOcular Eye Irritation Test and BCOP Test Data According to the UN GHS, US EPA and Brazil ANVISA Classification Schemes.

PubMed

Kolle, Susanne N; Rey Moreno, Maria Cecilia; Mayer, Winfried; van Cott, Andrew; van Ravenzwaay, Bennard; Landsiedel, Robert

2015-07-01

The Bovine Corneal Opacity and Permeability (BCOP) test is commonly used for the identification of severe ocular irritants (GHS Category 1), but it is not recommended for the identification of ocular irritants (GHS Category 2). The incorporation of human reconstructed tissue model-based tests into a tiered test strategy to identify ocular non-irritants and replace the Draize rabbit eye irritation test has been suggested (OECD TG 405). The value of the EpiOcular™ Eye Irritation Test (EIT) for the prediction of ocular non-irritants (GHS No Category) has been demonstrated, and an OECD Test Guideline (TG) was drafted in 2014. The purpose of this study was to evaluate whether the BCOP test, in conjunction with corneal histopathology (as suggested for the evaluation of the depth of the injury( and/or the EpiOcular-EIT, could be used to predict the eye irritation potential of agrochemical formulations according to the UN GHS, US EPA and Brazil ANVISA classification schemes. We have assessed opacity, permeability and histopathology in the BCOP assay, and relative tissue viability in the EpiOcular-EIT, for 97 agrochemical formulations with available in vivo eye irritation data. By using the OECD TG 437 protocol for liquids, the BCOP test did not result in sufficient correct predictions of severe ocular irritants for any of the three classification schemes. The lack of sensitivity could be improved somewhat by the inclusion of corneal histopathology, but the relative viability in the EpiOcular-EIT clearly outperformed the BCOP test for all three classification schemes. The predictive capacity of the EpiOcular-EIT for ocular non-irritants (UN GHS No Category) for the 97 agrochemical formulations tested (91% sensitivity, 72% specificity and 82% accuracy for UN GHS classification) was comparable to that obtained in the formal validation exercise underlying the OECD draft TG. We therefore conclude that the EpiOcular-EIT is currently the best in vitro method for the prediction of the eye irritation potential of liquid agrochemical formulations. 2015 FRAME.

JANNAF "Test and Evaluation Guidelines for Liquid Rocket Engines": Status and Application

NASA Technical Reports Server (NTRS)

Parkinson, Douglas; VanLerberghe, Wayne M.; Rahman, Shamim A.

2017-01-01

For many decades, the U.S. rocket propulsion industrial base has performed remarkably in developing complex liquid rocket engines that can propel critical payloads into service for the nation, as well as transport people and hardware for missions that open the frontiers of space exploration for humanity. This has been possible only at considerable expense given the lack of detailed guidance that captures the essence of successful practices and knowledge accumulated over five decades of liquid rocket engine development. In an effort to provide benchmarks and guidance for the next generation of rocket engineers, the Joint Army Navy NASA Air Force (JANNAF) Interagency Propulsion Committee published a liquid rocket engine (LRE) test and evaluation (T&E) guideline document in 2012 focusing on the development challenges and test verification considerations for liquid rocket engine systems. This document has been well received and applied by many current LRE developers as a benchmark and guidance tool, both for government-driven applications as well as for fully commercial ventures. The USAF Space and Missile Systems Center (SMC) has taken an additional near-term step and is directing activity to adapt and augment the content from the JANNAF LRE T&E guideline into a standard for potential application to future USAF requests for proposals for LRE development initiatives and launch vehicles for national security missions. A draft of this standard was already sent out for review and comment, and is intended to be formally approved and released towards the end of 2017. The acceptance and use of the LRE T&E guideline is possible through broad government and industry participation in the JANNAF liquid propulsion committee and associated panels. The sponsoring JANNAF community is expanding upon this initial baseline version and delving into further critical development aspects of liquid rocket propulsion testing at the integrated stage level as well as engine component level, in order to advance the state of the practice. The full participation of the entire U.S. rocket propulsion industrial base is invited and expected at this opportune moment in the continuing advancement of spaceflight technology.

European Society of Gastrointestinal Endoscopy (ESGE): recommendations (2009) on clinical use of video capsule endoscopy to investigate small-bowel, esophageal and colonic diseases.

PubMed

Ladas, S D; Triantafyllou, K; Spada, C; Riccioni, M E; Rey, J-F; Niv, Y; Delvaux, M; de Franchis, R; Costamagna, G

2010-03-01

These recommendations on video capsule endoscopy, an emerging technology with an impact on the practice of endoscopy, were developed by the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines Committee. The first draft of each section was prepared by one or two members of the writing team, who were selected as experts on the content of that section on the basis of their published work. They used evidence-based methodology, performing MEDLINE and PubMed literature searches to identify relevant clinical studies. Abstracts from scientific meetings were included only if there was no published full paper on a particular topic. If there was disagreement, the first author of the Guideline made the final decision. Recommendations were graded according to the strength of the supporting evidence. The draft guideline was critically reviewed by all authors and submitted to the ESGE councillors for their critical review before approval of the final document. The ESGE Guidelines Committee acknowledges that this document is based on a critical review of the data available at the time of preparation and that further studies may be needed to clarify some aspects. Moreover, this Guideline may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. This document should be regarded as supplying recommendations only to gastroenterologists in providing care to their patients. It is not a set of rules and should not be construed as establishing a legal standard of care, or as encouraging, advocating, requiring, or discouraging any particular treatment. These recommendations must be interpreted according to the clinician's knowledge, expertise, and clinical judgment in the management of individual patients and, if necessary, a course of action that varies from recommendations must be undertaken. Georg Thieme Verlag KG Stuttgart. New York.

The essence of the Japan Radiological Society/Japanese College of Radiology Imaging Guideline.

PubMed

Yamashita, Yasuyuki; Murayama, Sadayuki; Okada, Masahiro; Watanabe, Yoshiyuki; Kataoka, Masako; Kaji, Yasushi; Imamura, Keiko; Takehara, Yasuo; Hayashi, Hiromitsu; Ohno, Kazuko; Awai, Kazuo; Hirai, Toshinori; Kojima, Kazuyuki; Sakai, Shuji; Matsunaga, Naofumi; Murakami, Takamichi; Yoshimitsu, Kengo; Gabata, Toshifumi; Matsuzaki, Kenji; Tohno, Eriko; Kawahara, Yasuhiro; Nakayama, Takeo; Monzawa, Shuichi; Takahashi, Satoru

2016-01-01

Diagnostic imaging is undoubtedly important in modern medicine, and final clinical decisions are often made based on it. Fortunately, Japan has the highest numbers of diagnostic imaging instruments, such as CT and MRI devices, and boasts easy access to them as well as a high level of diagnostic accuracy. In consequence, a very large number of imaging examinations are performed, but diagnostic instruments are installed in so many medical facilities that expert management of these examinations tends to be insufficient. Particularly, in order to avoid risks, clinicians have recently become indifferent to indications of imaging modalities and tend to rely on CT or MRI resulting in increasing the number of imaging examinations in Japan. This is a serious problem from the viewpoints of avoidance of unnecessary exposure and medical economy. Under these circumstances, the Japan Radiological Society and Japanese College of Radiology jointly initiated the preparation of new guidelines for diagnostic imaging. However, the field of diagnostic imaging is extremely wide, and it is impossible to cover all diseases. Therefore, in drafting the guidelines, we selected important diseases and focused on "showing evidence and suggestions in the form of clinical questions (CQs)" concerning clinically encountered questions and "describing routine imaging techniques presently considered to be standards to guarantee the quality of imaging examinations". In so doing, we adhered to the basic principles of assuming the readers to be "radiologists specializing in diagnostic imaging", "simultaneously respecting the global standards and attending to the situation in Japan", and "making the guidelines consistent with those of other scientific societies related to imaging". As a result, the guidelines became the largest ever, consisting of 152 CQs, nine areas of imaging techniques, and seven reviews, but no other guidelines in the world summarize problems concerning diagnostic imaging in the form of CQs. In this sense, the guidelines are considered to reflect the abilities of diagnostic radiologists in Japan. The contents of the guidelines are essential knowledge for radiologists, but we believe that they are also of use to general clinicians and clinical radiological technicians. While the number and contents of CQs are still insufficient, and while chapters such as those on imaging in children and emergency imaging need to be supplemented, the guidelines will be serially improved through future revisions. Lastly, we would like to extend our sincere thanks to the 153 members of the drafting committee who authored the guidelines, 12 committee chairpersons who coordinated their efforts, six members of the secretariat, and affiliates of related scientific societies who performed external evaluation.

21 CFR 1311.08 - Incorporation by reference.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., (301) 975-6478 or TTY (301) 975-8295, [email protected]nist.gov, and are available at http://csrc.nist.gov...); incorporation by reference approved for §§ 1311.120(b), 1311.205(b), and 1311.210(c). (6) Draft NIST Special Publication 800-63-1, Electronic Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. et al...

21 CFR 1311.08 - Incorporation by reference.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., (301) 975-6478 or TTY (301) 975-8295, [email protected]nist.gov, and are available at http://csrc.nist.gov...); incorporation by reference approved for §§ 1311.120(b), 1311.205(b), and 1311.210(c). (6) Draft NIST Special Publication 800-63-1, Electronic Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. et al...

21 CFR 1311.08 - Incorporation by reference.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., (301) 975-6478 or TTY (301) 975-8295, [email protected]nist.gov, and are available at http://csrc.nist.gov...); incorporation by reference approved for §§ 1311.120(b), 1311.205(b), and 1311.210(c). (6) Draft NIST Special Publication 800-63-1, Electronic Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. et al...

Performance testing of radiobioassay laboratories: In vivo measurements, Final Report

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

MacLellan, J.A.; Traub, R.J.; Olsen, P.C.

1990-04-01

A study of two rounds of in vivo laboratory performance testing was undertaken by Pacific Northwest Laboratory (PNL) to determine the appropriateness of the in vivo performance criteria of draft American National Standards Institute (ANSI) standard ANSI N13.3, Performance Criteria for Bioassay.'' The draft standard provides guidance to in vivo counting facilities regarding the sensitivity, precision, and accuracy of measurements for certain categories of commonly assayed radionuclides and critical regions of the body. This report concludes the testing program by presenting the results of the Round Two testing. Testing involved two types of measurements: chest counting for radionuclide detection inmore » the lung, and whole body counting for detection of uniformly distributed material. Each type of measurement was further divided into radionuclide categories as defined in the draft standard. The appropriateness of the draft standard criteria by measuring a laboratory's ability to attain them were judged by the results of both round One and Round Two testing. The testing determined that performance criteria are set at attainable levels, and the majority of in vivo monitoring facilities passed the criteria when complete results were submitted. 18 refs., 18 figs., 15 tabs.« less

Environmental assessment: Davis Canyon site, Utah

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

none,

1986-05-01

In February 1983, the US Department of Energy (DOE) identified the Davis Canyon site in Utah as one of the nine potentially acceptable sites for a mined geologic repository for spent nuclear fuel and high-level radioactive waste. To determine their suitability, the Davis Canyon site and the eight other potentially acceptable sites have been evaluated in accordance with the DOE's General Guidelines for the Recommendation of Sites for the Nuclear Waste Repositories. These evaluations were reported in draft environmental assessments (EAs), which were issued for public review and comment. After considering the comments received on the draft EAs, the DOEmore » prepared the final EA. The Davis Canyon site is in the Paradox Basin, which is one of five distinct geohydrologic settings considering for the first repository. This setting contains one other potentially acceptable site -- the Lavender Canyon site. Although the Lavender Canyon site is suitable for site characterization, the DOE has concluded that the Davis Canyon site is the preferred site in the Paradox Basin. On the basis of the evaluations reported in this EA, the DOE has found that the Davis Canyon site is not disqualified under the guidelines. Furthermore, the DOE has found that the site is suitable for site characterization because the evidence does not support a conclusion that the site will not be able to meet each of the qualifying conditions specified in the guidelines. On the basis of these findings, the DOE is nominating the Davis Canyon site as one of five sites suitable for characterization.« less

Learning to Read and Write the Drafting Way. Field Test Copy.

ERIC Educational Resources Information Center

California State Dept. of Education, Sacramento. Div. of Vocational Education.

This volume comprises instructional techniques that are designed for use with drafting students who demonstrate a need for additional instruction in the areas of reading, writing, math, and verbal and visual communication. Included in the guide are the following teacher-developed instructional techniques: a drafting crossword puzzle, tool bingo, a…

MIRO: guidelines for minimum information for the reporting of an ontology.

PubMed

Matentzoglu, Nicolas; Malone, James; Mungall, Chris; Stevens, Robert

2018-01-18

Creation and use of ontologies has become a mainstream activity in many disciplines, in particular, the biomedical domain. Ontology developers often disseminate information about these ontologies in peer-reviewed ontology description reports. There appears to be, however, a high degree of variability in the content of these reports. Often, important details are omitted such that it is difficult to gain a sufficient understanding of the ontology, its content and method of creation. We propose the Minimum Information for Reporting an Ontology (MIRO) guidelines as a means to facilitate a higher degree of completeness and consistency between ontology documentation, including published papers, and ultimately a higher standard of report quality. A draft of the MIRO guidelines was circulated for public comment in the form of a questionnaire, and we subsequently collected 110 responses from ontology authors, developers, users and reviewers. We report on the feedback of this consultation, including comments on each guideline, and present our analysis on the relative importance of each MIRO information item. These results were used to update the MIRO guidelines, mainly by providing more detailed operational definitions of the individual items and assigning degrees of importance. Based on our revised version of MIRO, we conducted a review of 15 recently published ontology description reports from three important journals in the Semantic Web and Biomedical domain and analysed them for compliance with the MIRO guidelines. We found that only 41.38% of the information items were covered by the majority of the papers (and deemed important by the survey respondents) and a large number of important items are not covered at all, like those related to testing and versioning policies. We believe that the community-reviewed MIRO guidelines can contribute to improving significantly the quality of ontology description reports and other documentation, in particular by increasing consistent reporting of important ontology features that are otherwise often neglected.

MO-F-16A-01: Implementation of MPPG TPS Verification Tests On Various Accelerators

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

Smilowitz, J; Bredfeldt, J; Geurts, M

2014-06-15

Purpose: To demonstrate the implementation of the Medical Physics Practice Guideline (MPPG) for dose calculation and beam parameters verification of treatment planning systems (TPS). Methods: We implemented the draft TPS MPPG for three linacs: Varian Trilogy, TomoHDA and Elekta Infinity. Static and modulated test plans were created. The static fields are different than used in commissioning. Data was collected using ion chambers and diodes in a scanning water tank, Delta4 phantom and a custom phantom. MatLab and Microsoft Excel were used to create analysis tools to compare reference DICOM dose with scan data. This custom code allowed for the interpolation,more » registration and gamma analysis of arbitrary dose profiles. It will be provided as open source code. IMRT fields were validated with Delta4 registration and comparison tools. The time for each task was recorded. Results: The tests confirmed the strengths, and revealed some limitations, of our TPS. The agreement between calculated and measured dose was reported for all beams. For static fields, percent depth dose and profiles were analyzed with criteria in the draft MPPG. The results reveal areas of slight mismatch with the model (MLC leaf penumbra, buildup region.) For TomoTherapy, the IMRT plan 2%/2 mm gamma analysis revealed poorest agreement in the low dose regions. For one static test plan for all 10MV Trilogy photon beams, the plan generation, scan queue creation, data collection, data analysis and report took 2 hours, excluding tank setup. Conclusions: We have demonstrated the implementation feasibility of the TPS MPPG. This exercise generated an open source tool for dose comparisons between scan data and DICOM dose data. An easily reproducible and efficient infrastructure with streamlined data collection was created for repeatable robust testing of the TPS. The tests revealed minor discrepancies in our models and areas for improvement that are being investigated.« less

GRADE equity guidelines 4: considering health equity in GRADE guideline development: evidence to decision process.

PubMed

Pottie, Kevin; Welch, Vivian; Morton, Rachael; Akl, Elie A; Eslava-Schmalbach, Javier H; Katikireddi, Vittal; Singh, Jasvinder; Moja, Lorenzo; Lang, Eddy; Magrini, Nicola; Thabane, Lehana; Stanev, Roger; Matovinovic, Elizabeth; Snellman, Alexandra; Briel, Matthias; Shea, Beverly; Tugwell, Peter; Schunemann, Holger; Guyatt, Gordon; Alonso-Coello, Pablo

2017-10-01

The aim of this paper is to provide detailed guidance on how to incorporate health equity within the GRADE (Grading Recommendations Assessment and Development Evidence) evidence to decision process. We developed this guidance based on the GRADE evidence to decision framework, iteratively reviewing and modifying draft documents, in person discussion of project group members and input from other GRADE members. Considering the impact on health equity may be required, both in general guidelines and guidelines that focus on disadvantaged populations. We suggest two approaches to incorporate equity considerations: (1) assessing the potential impact of interventions on equity and (2) incorporating equity considerations when judging or weighing each of the evidence to decision criteria. We provide guidance and include illustrative examples. Guideline panels should consider the impact of recommendations on health equity with attention to remote and underserviced settings and disadvantaged populations. Guideline panels may wish to incorporate equity judgments across the evidence to decision framework. This is the fourth and final paper in a series about considering equity in the GRADE guideline development process. This series is coming from the GRADE equity subgroup. Copyright © 2017 Elsevier Inc. All rights reserved.

76 FR 16425 - Draft Guidance for Industry: Testing for Salmonella

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

... draft guidance does not apply to egg producers and other persons who are covered by FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The... eggs) and direct-human-contact animal foods, and the interpretation of test results, when the presence...

More Declassified Evidence Implicates CIA Physicians in Unethical Research.

PubMed

Llanusa-Cestero, Renée

2017-01-01

In 2010, in an article in this journal, I argued that declassified documents implicated Central Intelligence Agency (CIA) physicians in the conduct of unethical research on enhanced interrogation using detainee subjects. The focus, then as now, is upon physicians at the Office of Medical Services (OMS). The 2010 article highlighted the heavily redacted "Draft OMS Guidelines on Medical and Psychological Support to Detainee Interrogations" (the Draft). This commentary focuses upon the recently declassified final version of that document revealing further culpable evidence of unethical human subject research. The commentary locates that unethical research in historical context and the development of the Nuremberg Code. The commentary also locates enhanced interrogation in contemporary political context and considers how to hold OMS physicians accountable for the conduct of unethical human research using detainee subjects.

A Computer Model of Drafting Effects on Collective Behavior in Elite 10,000-m Runners.

PubMed

Trenchard, Hugh; Renfree, Andrew; Peters, Derek M

2017-03-01

Drafting in cycling influences collective behavior of pelotons. Although evidence for collective behavior in competitive running events exists, it is not clear if this results from energetic savings conferred by drafting. This study modeled the effects of drafting on behavior in elite 10,000-m runners. Using performance data from a men's elite 10,000-m track running event, computer simulations were constructed using Netlogo 5.1 to test the effects of 3 different drafting quantities on collective behavior: no drafting, drafting to 3 m behind with up to ~8% energy savings (a realistic running draft), and drafting up to 3 m behind with up to 38% energy savings (a realistic cycling draft). Three measures of collective behavior were analyzed in each condition: mean speed, mean group stretch (distance between first- and last-placed runner), and runner-convergence ratio (RCR), which represents the degree of drafting benefit obtained by the follower in a pair of coupled runners. Mean speeds were 6.32 ± 0.28, 5.57 ± 0.18, and 5.51 ± 0.13 m/s in the cycling-draft, runner-draft, and no-draft conditions, respectively (all P < .001). RCR was lower in the cycling-draft condition but did not differ between the other 2. Mean stretch did not differ between conditions. Collective behaviors observed in running events cannot be fully explained through energetic savings conferred by realistic drafting benefits. They may therefore result from other, possibly psychological, processes. The benefits or otherwise of engaging in such behavior are as yet unclear.

Reinstating nursing administration graduate study in federal nurse traineeships.

PubMed

Kersbergen, A L

1994-01-01

In 1992, the federal guidelines for funding nurse traineeships were amended to exclude nurses who pursue advanced degrees in nursing administration. This legislation expires soon, and final drafting of new legislation will be completed during the summer of 1994. The author presents information to use in advocating for reinstatement of nursing administration students as potential recipients of federal nurse traineeship dollars for advanced education.

The transfer of analytical procedures.

PubMed

Ermer, J; Limberger, M; Lis, K; Wätzig, H

2013-11-01

Analytical method transfers are certainly among the most discussed topics in the GMP regulated sector. However, they are surprisingly little regulated in detail. General information is provided by USP, WHO, and ISPE in particular. Most recently, the EU emphasized the importance of analytical transfer by including it in their draft of the revised GMP Guideline. In this article, an overview and comparison of these guidelines is provided. The key to success for method transfers is the excellent communication between sending and receiving unit. In order to facilitate this communication, procedures, flow charts and checklists for responsibilities, success factors, transfer categories, the transfer plan and report, strategies in case of failed transfers, tables with acceptance limits are provided here, together with a comprehensive glossary. Potential pitfalls are described such that they can be avoided. In order to assure an efficient and sustainable transfer of analytical procedures, a practically relevant and scientifically sound evaluation with corresponding acceptance criteria is crucial. Various strategies and statistical tools such as significance tests, absolute acceptance criteria, and equivalence tests are thoroughly descibed and compared in detail giving examples. Significance tests should be avoided. The success criterion is not statistical significance, but rather analytical relevance. Depending on a risk assessment of the analytical procedure in question, statistical equivalence tests are recommended, because they include both, a practically relevant acceptance limit and a direct control of the statistical risks. However, for lower risk procedures, a simple comparison of the transfer performance parameters to absolute limits is also regarded as sufficient. Copyright © 2013 Elsevier B.V. All rights reserved.

78 FR 66366 - Draft Guidance for Industry: Use of Donor Screening Tests To Test Donors of Human Cells, Tissues...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-05

...The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.

The Development of Statistics Textbook Supported with ICT and Portfolio-Based Assessment

NASA Astrophysics Data System (ADS)

Hendikawati, Putriaji; Yuni Arini, Florentina

2016-02-01

This research was development research that aimed to develop and produce a Statistics textbook model that supported with information and communication technology (ICT) and Portfolio-Based Assessment. This book was designed for students of mathematics at the college to improve students’ ability in mathematical connection and communication. There were three stages in this research i.e. define, design, and develop. The textbooks consisted of 10 chapters which each chapter contains introduction, core materials and include examples and exercises. The textbook developed phase begins with the early stages of designed the book (draft 1) which then validated by experts. Revision of draft 1 produced draft 2 which then limited test for readability test book. Furthermore, revision of draft 2 produced textbook draft 3 which simulated on a small sample to produce a valid model textbook. The data were analysed with descriptive statistics. The analysis showed that the Statistics textbook model that supported with ICT and Portfolio-Based Assessment valid and fill up the criteria of practicality.

Reflections on the United States National Institutes of Health draft guidelines for research involving human pluripotent stem cells--theological perspective.

PubMed

Sotis, J J

2000-01-01

Since the human embryonic stem cell research involves destruction of human embryos and, therefore, hinges on the fundamental question of the status of the embryo, it is essential to examine this status carefully in order to establish fitting guidelines for research. The US National Institutes of Health has proposed its own guidelines on the matter recently (1999). The document, rooted in current pluralistic perspectives in moral philosophy (or bioethics), is criticised in this paper as morally inadequate. The argumentation of the criticism stems from the theological perspective on human personhood, which focuses on a continuity of personal identity from embryos to adult human beings. An additional concern for the author is the moral complicity in which the research dependent upon the destruction of human embryonic life is sanctioned.

78 FR 52931 - Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0938] Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances... Products, Questions and Answers.'' Because of increases in the number and complexity of ANDAs and FDA's...

Standards for QUality Improvement Reporting Excellence 2.0: revised publication guidelines from a detailed consensus process.

PubMed

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2016-02-01

Since the publication of Standards for QUality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this article, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) two face-to-face consensus meetings to develop interim drafts, and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes the reporting of three key components of systematic efforts to improve the quality, value, and safety of health care: the use of formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Scenario drafting to anticipate future developments in technology assessment.

PubMed

Retèl, Valesca P; Joore, Manuela A; Linn, Sabine C; Rutgers, Emiel J T; van Harten, Wim H

2012-08-16

Health Technology Assessment (HTA) information, and in particular cost-effectiveness data is needed to guide decisions, preferably already in early stages of technological development. However, at that moment there is usually a high degree of uncertainty, because evidence is limited and different development paths are still possible. We developed a multi-parameter framework to assess dynamic aspects of a technology -still in development-, by means of scenario drafting to determine the effects, costs and cost-effectiveness of possible future diffusion patterns. Secondly, we explored the value of this method on the case of the clinical implementation of the 70-gene signature for breast cancer, a gene expression profile for selecting patients who will benefit most from chemotherapy. To incorporate process-uncertainty, ten possible scenarios regarding the introduction of the 70-gene signature were drafted with European experts. Out of 5 most likely scenarios, 3 drivers of diffusion (non-compliance, technical failure, and uptake) were quantitatively integrated in a decision-analytical model. For these scenarios, the cost-effectiveness of the 70-gene signature expressed in Incremental Cost-Effectiveness Ratios (ICERs) was compared to clinical guidelines, calculated from the past (2005) until the future (2020). In 2005 the ICER was €1,9 million/quality-adjusted-life-year (QALY), meaning that the 70-gene signature was not yet cost-effective compared to the current clinical guideline. The ICER for the 70-gene signature improved over time with a range of €1,9 million to €26,145 in 2010 and €1,9 million to €11,123/QALY in 2020 depending on the separate scenario used. From 2010, the 70-gene signature should be cost-effective, based on the combined scenario. The uptake-scenario had strongest influence on the cost-effectiveness. When optimal diffusion of a technology is sought, incorporating process-uncertainty by means of scenario drafting into a decision model may reveal unanticipated developments and can demonstrate a range of possible cost-effectiveness outcomes. The effect of scenarios give additional information on the speed with cost effectiveness might be reached and thus provide a more realistic picture for policy makers, opinion leaders and manufacturers.

Scenario drafting to anticipate future developments in technology assessment

PubMed Central

2012-01-01

Background Health Technology Assessment (HTA) information, and in particular cost-effectiveness data is needed to guide decisions, preferably already in early stages of technological development. However, at that moment there is usually a high degree of uncertainty, because evidence is limited and different development paths are still possible. We developed a multi-parameter framework to assess dynamic aspects of a technology -still in development-, by means of scenario drafting to determine the effects, costs and cost-effectiveness of possible future diffusion patterns. Secondly, we explored the value of this method on the case of the clinical implementation of the 70-gene signature for breast cancer, a gene expression profile for selecting patients who will benefit most from chemotherapy. Methods To incorporate process-uncertainty, ten possible scenarios regarding the introduction of the 70-gene signature were drafted with European experts. Out of 5 most likely scenarios, 3 drivers of diffusion (non-compliance, technical failure, and uptake) were quantitatively integrated in a decision-analytical model. For these scenarios, the cost-effectiveness of the 70-gene signature expressed in Incremental Cost-Effectiveness Ratios (ICERs) was compared to clinical guidelines, calculated from the past (2005) until the future (2020). Results In 2005 the ICER was €1,9 million/quality-adjusted-life-year (QALY), meaning that the 70-gene signature was not yet cost-effective compared to the current clinical guideline. The ICER for the 70-gene signature improved over time with a range of €1,9 million to €26,145 in 2010 and €1,9 million to €11,123/QALY in 2020 depending on the separate scenario used. From 2010, the 70-gene signature should be cost-effective, based on the combined scenario. The uptake-scenario had strongest influence on the cost-effectiveness. Conclusions When optimal diffusion of a technology is sought, incorporating process-uncertainty by means of scenario drafting into a decision model may reveal unanticipated developments and can demonstrate a range of possible cost-effectiveness outcomes. The effect of scenarios give additional information on the speed with cost effectiveness might be reached and thus provide a more realistic picture for policy makers, opinion leaders and manufacturers. PMID:22894140

Human milk banking guidelines.

PubMed

Bharadva, Ketan; Tiwari, Satish; Mishra, Sudhir; Mukhopadhyay, Kanya; Yadav, Balraj; Agarwal, R K; Kumar, Vishesh

2014-06-01

WHO and UNICEF state that the use of human milk from other sources should be the first alternative when it is not possible for the mother to breastfeed. Human milk banks should be made available in appropriate situations. The IYCF Chapter is actively concerned about the compelling use of formula feeds in the infants because of the non availability of human breast milk banks. A National Consultative Meet for framing guidelines was summoned by the IYCF Chapter and the Ministry of Health and Family Welfare, Government of India on 30th June, 2013, with representations from various stakeholders. The guidelines were drafted after an extensive literature review and discussions. Though these guidelines are based on the experiences and guidelines from other countries, changes have been made to suit the Indian setup, culture and needs, without compromising scientific evidence. To ensure quality of donated breast milk as a safe end product. Human Milk Banking Association should be constituted, and human milk banks should be established across the country. National coordination mechanism should be developed with a secretariat and technical support to follow-up on action in States. Budgetary provisions should be made available for the activities.

Assessment of chemical dispersant effectiveness in a wave tank under regular non-breaking and breaking wave conditions.

PubMed

Li, Zhengkai; Lee, Kenneth; King, Thomas; Boufadel, Michel C; Venosa, Albert D

2008-05-01

Current chemical dispersant effectiveness tests for product selection are commonly performed with bench-scale testing apparatus. However, for the assessment of oil dispersant effectiveness under real sea state conditions, test protocols are required to have hydrodynamic conditions closer to the natural environment, including transport and dilution effects. To achieve this goal, Fisheries and Oceans Canada and the US Environmental Protection Agency (EPA) designed and constructed a wave tank system to study chemical dispersant effectiveness under controlled mixing energy conditions (regular non-breaking, spilling breaking, and plunging breaking waves). Quantification of oil dispersant effectiveness was based on observed changes in dispersed oil concentrations and oil-droplet size distribution. The study results quantitatively demonstrated that total dispersed oil concentration and breakup kinetics of oil droplets in the water column were strongly dependent on the presence of chemical dispersants and the influence of breaking waves. These data on the effectiveness of dispersants as a function of sea state will have significant implications in the drafting of future operational guidelines for dispersant use at sea.

Hormonal Replacement in Hypopituitarism in Adults: An Endocrine Society Clinical Practice Guideline.

PubMed

Fleseriu, Maria; Hashim, Ibrahim A; Karavitaki, Niki; Melmed, Shlomo; Murad, M Hassan; Salvatori, Roberto; Samuels, Mary H

2016-11-01

To formulate clinical practice guidelines for hormonal replacement in hypopituitarism in adults. The participants include an Endocrine Society-appointed Task Force of six experts, a methodologist, and a medical writer. The American Association for Clinical Chemistry, the Pituitary Society, and the European Society of Endocrinology co-sponsored this guideline. The Task Force developed this evidence-based guideline using the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, the American Association for Clinical Chemistry, the Pituitary Society, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Using an evidence-based approach, this guideline addresses important clinical issues regarding the evaluation and management of hypopituitarism in adults, including appropriate biochemical assessments, specific therapeutic decisions to decrease the risk of co-morbidities due to hormonal over-replacement or under-replacement, and managing hypopituitarism during pregnancy, pituitary surgery, and other types of surgeries.

Japanese guideline for the management of hyperuricemia and gout: second edition.

PubMed

Yamanaka, Hisashi

2011-12-01

Gout is a urate deposition disease caused by persistent hyperuricemia. Because gout patients present with a variety of clinical symptoms, it is necessary to have a guideline for the standard management and care of gout and hyperuricemia. The Japanese Society of Gout and Nucleic Acid Metabolism, a scientific society committed to study nucleic acid metabolism and related diseases, established the first edition of the "Guideline for the Management of Hyperuricemia and Gout" in 2002, and published the revised version in January 2010. This second edition is not only evidence based on a search of systemic literature, but also includes consensus levels by a Delphi exercise to determine the strength of the recommendations. A draft version of this guideline was reviewed by internal and external reviewers as well as a patient. In this guideline, key messages from each chapter are listed as statements together with the evidence level, consensus level, and strength of the recommendation. In this proceeding, several selected chapters on the clinical management of gout and hyperuricemia are described. We hope this guideline is appropriately used for the standard management and care of patients with hyperuricemia and gout in daily practice.

Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association.

PubMed

Hemphill, J Claude; Greenberg, Steven M; Anderson, Craig S; Becker, Kyra; Bendok, Bernard R; Cushman, Mary; Fung, Gordon L; Goldstein, Joshua N; Macdonald, R Loch; Mitchell, Pamela H; Scott, Phillip A; Selim, Magdy H; Woo, Daniel

2015-07-01

The aim of this guideline is to present current and comprehensive recommendations for the diagnosis and treatment of spontaneous intracerebral hemorrhage. A formal literature search of PubMed was performed through the end of August 2013. The writing committee met by teleconference to discuss narrative text and recommendations. Recommendations follow the American Heart Association/American Stroke Association methods of classifying the level of certainty of the treatment effect and the class of evidence. Prerelease review of the draft guideline was performed by 6 expert peer reviewers and by the members of the Stroke Council Scientific Oversight Committee and Stroke Council Leadership Committee. Evidence-based guidelines are presented for the care of patients with acute intracerebral hemorrhage. Topics focused on diagnosis, management of coagulopathy and blood pressure, prevention and control of secondary brain injury and intracranial pressure, the role of surgery, outcome prediction, rehabilitation, secondary prevention, and future considerations. Results of new phase 3 trials were incorporated. Intracerebral hemorrhage remains a serious condition for which early aggressive care is warranted. These guidelines provide a framework for goal-directed treatment of the patient with intracerebral hemorrhage. © 2015 American Heart Association, Inc.

Diagnosis and Management of Gaucher Disease in India - Consensus Guidelines of the Gaucher Disease Task Force of the Society for Indian Academy of Medical Genetics and the Indian Academy of Pediatrics.

PubMed

Puri, Ratna Dua; Kapoor, Seema; Kishnani, Priya S; Dalal, Ashwin; Gupta, Neerja; Muranjan, Mamta; Phadke, Shubha R; Sachdeva, Anupam; Verma, Ishwar C; Mistry, Pramod K

2018-02-15

Gaucher disease (GD) is amongst the most frequently occurring lysosomal storage disorder in all ethnicities. The clinical manifestations and natural history of GD is highly heterogeneous with extreme geographic and ethnic variations. The literature on GD has paucity of information and optimal management guidelines for Indian patients. Gaucher Disease Task Force was formed under the auspices of the Society for Indian Academy of Medical Genetics. Invited experts from various specialties formulated guidelines for the management of patients with GD. A writing committee was formed and the draft guidelines were circulated by email to all members for comments and inputs. The guidelines were finalized in December 2016 at the annual meeting of the Indian Academy of Medical Genetics. These guidelines are intended to serve as a standard framework for treating physicians and the health care systems for optimal management of Gaucher disease in India and to define unique needs of this patient population. Manifestations of GD are protean and a high index of suspicion is essential for timely diagnosis. Patients frequently experience diagnostic delays during which severe irreversible complications occur. Leucocyte acid b-glucosidase activity is mandatory for establishing the diagnosis of Gaucher disease; molecular testing can help identify patients at risk of neuronopathic disease. Enzyme replacement therapy for type 1 and type 3 Gaucher disease is the standard of care. Best outcomes are achieved by early initiation of therapy before onset of irreversible complications. However, in setting of progressive neurological symptoms such as seizures and or/ neuroregression, ERT is not recommended, as it cannot cross the blood brain barrier. The recommendations herein are for diagnosis, for initiation of therapy, therapeutic goals, monitoring and follow up of patients. We highlight that prevention of recurrence of the disease through genetic counseling and prenatal diagnosis is essential in India, due to uniformly severe phenotypes encountered in our population.

Environmental assessment: Davis Canyon site, Utah

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

none,

1986-05-01

In February 1983, the US Department of Energy (DOE) identified the Davis Canyon site in Utah as one of the nine potentially acceptable sites for a mined geologic repository for spent nuclear fuel and high-level radioactive waste. To determine their suitability, the Davis Canyon site and the eight other potentially acceptable sites have been evaluated in accordance with the DOE's General Guidelines for the Recommendation of Sites for the Nuclear Waste Repositories. These evaluations were reported in draft environmental assessments (EAs), which were issued for public review and comment. After considering the comments received on the draft EAs, the DOEmore » prepared the final EA. The Davis Canyon site is in the Paradox Basin, which is one of five distinct geohydrologic settings considered for the first repository. This setting contains one other potentially acceptable site -- the Lavender Canyon site. Although the Lavender Canyon site is suitable for site characterization, the DOE has concluded that the Davis Canyon site is the preferred site in the Paradox Basin. On the basis of the evaluations reported in this EA, the DOE has found that the Davis Canyon site is not disqualified under the guidelines. Furthermore, the DOE has fond that the site is suitable for site characterization because the evidence does not support a conclusion that the site will not be able to meet each of the qualifying conditions specified in the guidelines. On the basis of these findings, the DOE is nominating the Davis Canyon site as one of five sites suitable for characterization. 181 figs., 175 tabs.« less

Environmental assessment: Davis Canyon site, Utah

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

none,

1986-05-01

In February 1983, the US Department of Energy (DOE) identified the Davis Canyon site in Utah as one of the nine potentially acceptable sites for a mined geologic repository for spent nuclear fuel and high- level radioactive waste. To determine their suitability, the Davis Canyon site and the eight other potentially acceptable sites have been evaluated in accordance with the DOE's General Guidelines for the Recommendation of Sites for the Nuclear Waste Repositories. These evaluations were reported in draft environmental assessments (EAs), which were issued for public review and comment. After considering the comments received on the draft EAs, themore » DOE prepared the final EA. The Davis Canyon site is in the Paradox Basin, which is one of five distinct geohydrologic settings considered for the first repository. This setting contains one other potentially acceptable site -- the Lavender Canyon site. Although the Lavender Canyon site is suitable for site characterization, the DOE has concluded that the Davis Canyon site is the preferred site in the Paradox Basin. On the basis of the evaluations reported in this EA, the DOE has found that the Davis Canyon site is not disqualified under the guidelines. Furthermore, the DOE has found that the site is suitable for site characterization because the evidence does not support a conclusion that the site will not be able to meet each of the qualifying conditions specified in the guidelines. On the basis of these findings, the DOE is nominating the Davis Canyon site as one of the five sites suitable for characterization.« less

Surgery for Aortic Dilatation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

PubMed

Hiratzka, Loren F; Creager, Mark A; Isselbacher, Eric M; Svensson, Lars G; Nishimura, Rick A; Bonow, Robert O; Guyton, Robert A; Sundt, Thoralf M; Halperin, Jonathan L; Levine, Glenn N; Anderson, Jeffrey L; Albert, Nancy M; Al-Khatib, Sana M; Birtcher, Kim K; Bozkurt, Biykem; Brindis, Ralph G; Cigarroa, Joaquin E; Curtis, Lesley H; Fleisher, Lee A; Gentile, Federico; Gidding, Samuel; Hlatky, Mark A; Ikonomidis, John; Joglar, José; Kovacs, Richard J; Ohman, E Magnus; Pressler, Susan J; Sellke, Frank W; Shen, Win-Kuang; Wijeysundera, Duminda N

2016-02-16

Two guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and collaborating societies address the risk of aortic dissection in patients with bicuspid aortic valves and severe aortic enlargement: the "2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease" (Circulation. 2010;121:e266-e369) and the "2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease" (Circulation. 2014;129:e521-e643). However, the 2 guidelines differ with regard to the recommended threshold of aortic root or ascending aortic dilatation that would justify surgical intervention in patients with bicuspid aortic valves. The ACC and AHA therefore convened a subcommittee representing members of the 2 guideline writing committees to review the evidence, reach consensus, and draft a statement of clarification for both guidelines. This statement of clarification uses the ACC/AHA revised structure for delineating the Class of Recommendation and Level of Evidence to provide recommendations that replace those contained in Section 9.2.2.1 of the thoracic aortic disease guideline and Section 5.1.3 of the valvular heart disease guideline. © 2015 American College of Cardiology Foundation and American Heart Association, Inc.

Creating a multidisciplinary low back pain guideline: anatomy of a guideline adaptation process.

PubMed

Harstall, Christa; Taenzer, Paul; Angus, Donna K; Moga, Carmen; Schuller, Tara; Scott, N Ann

2011-08-01

A collaborative, multidisciplinary guideline adaptation process was developed to construct a single overarching, evidence-based clinical practice guideline (CPG) for all primary care practitioners responsible for the management of low back pain (LBP) to curb the use of ineffective treatments and improve patient outcomes. The adaptation strategy, which involved multiple committees and partnerships, leveraged existing knowledge transfer connections to recruit guideline development group (GDG) members and ensure that all stakeholders had a voice in the guideline development process. Videoconferencing was used to coordinate the large, geographically dispersed GDG. Information services and health technology assessment experts were used throughout the process to lighten the GDG's workload. The GDG reviewed seven seed guidelines and drafted an Alberta-specific guideline during 10 half-day meetings over a 12-month period. The use of ad hoc subcommittees to resolve uncertainties or disagreements regarding evidence interpretation expedited the process. Challenges were encountered in dealing with subjectivity, guideline appraisal tools, evidence source limitations and inconsistencies, and the lack of sophisticated evidence analysis inherent in guideline adaptation. Strategies for overcoming these difficulties are discussed. Guideline adaptation is useful when resources are limited and good-quality seed CPGs exist. The Ambassador Program successfully utilized existing stakeholder interest to create an overarching guideline that aligned guidance for LBP management across multiple primary care disciplines. Unforeseen challenges in guideline adaptation can be overcome with credible seed guidelines, a consistently applied and transparent methodology, and clear documentation of the subjective contextualization process. Multidisciplinary stakeholder input and an open, trusting relationship among all contributors will ensure that the end product is clinically meaningful. © 2010 Blackwell Publishing Ltd.

Guidelines for integrating population education into primary education and literacy programmes.

PubMed

1989-01-01

In recent seminars and workshops in the Asia and Pacific region the integration of population education into primary schools and literacy programs were the main topics. In most of the countries in this area separate courses in population education appear to be unfeasible for primary and secondary schools. In the nonformal area experience has indicated that population education acquires more meaning and relevance if it is integrated into an ongoing development program. The integration approach requires knowledge of the contents of the accommodating subjects or programs and knowledge of the contents of the accommodating subjects or programs and knowledge of the contents of population education. Guidelines suggested include the following steps in developing an integrated curriculum and instructional materials. First determine the needs, characteristics and other background information needed on the target group. Next prioritize the problems and needs of the target group, and formulate educational objectives from the identified needs and problems. Next determine and sequence the curriculum contents and then determine specific population education objectives and contents for integration, and what specific materials have to be developed. Then identify the specific type of format of materials to be developed, and write the first draft of the material. Also prepare illustrations and other art and graphic materials. Then the draft material should be reviewed and translated into the language of the target audience if needed. The materials should then be pretested, or field tested, using a sample of the intended users. To make sure the materials are reaching the target groups and being used effectively, a user's guide should be prepared and teachers and facilitators, as well as supervisors, should be prepared on the use of the material. In addition, a distribution and utilization plan should be prepared. Nonformal education materials can be distributed through libraries, reading center, residences of village leaders, neighborhood stores, and direct mail. The material distribution and utilization should be monitored and evaluated.

Development of STEADI: a fall prevention resource for health care providers.

PubMed

Stevens, Judy A; Phelan, Elizabeth A

2013-09-01

Falls among people aged ≥65 years are the leading cause of both injury deaths and emergency department visits for trauma. Research shows that many falls are preventable. In the clinical setting, an effective fall intervention involves assessing and addressing an individual's fall risk factors. This individualized approach is recommended in the American and British Geriatrics Societies' (AGS/BGS) practice guideline. This article describes the development of STEADI (Stopping Elderly Accidents, Deaths, and Injuries), a fall prevention tool kit that contains an array of health care provider resources for assessing and addressing fall risk in clinical settings. As researchers at the Centers for Disease Control and Prevention's Injury Center, we reviewed relevant literature and conducted in-depth interviews with health care providers to determine current knowledge and practices related to older adult fall prevention. We developed draft resources based on the AGS/BGS guideline, incorporated provider input, and addressed identified knowledge and practice gaps. Draft resources were reviewed by six focus groups of health care providers and revised. The completed STEADI tool kit, Preventing Falls in Older Patients-A Provider Tool Kit, is designed to help health care providers incorporate fall risk assessment and individualized fall interventions into routine clinical practice and to link clinical care with community-based fall prevention programs.

Progress on the HUPO Draft Human Proteome: 2017 Metrics of the Human Proteome Project.

PubMed

Omenn, Gilbert S; Lane, Lydie; Lundberg, Emma K; Overall, Christopher M; Deutsch, Eric W

2017-12-01

The Human Proteome Organization (HUPO) Human Proteome Project (HPP) continues to make progress on its two overall goals: (1) completing the protein parts list, with an annual update of the HUPO draft human proteome, and (2) making proteomics an integrated complement to genomics and transcriptomics throughout biomedical and life sciences research. neXtProt version 2017-01-23 has 17 008 confident protein identifications (Protein Existence [PE] level 1) that are compliant with the HPP Guidelines v2.1 ( https://hupo.org/Guidelines ), up from 13 664 in 2012-12 and 16 518 in 2016-04. Remaining to be found by mass spectrometry and other methods are 2579 "missing proteins" (PE2+3+4), down from 2949 in 2016. PeptideAtlas 2017-01 has 15 173 canonical proteins, accounting for nearly all of the 15 290 PE1 proteins based on MS data. These resources have extensive data on PTMs, single amino acid variants, and splice isoforms. The Human Protein Atlas v16 has 10 492 highly curated protein entries with tissue and subcellular spatial localization of proteins and transcript expression. Organ-specific popular protein lists have been generated for broad use in quantitative targeted proteomics using SRM-MS or DIA-SWATH-MS studies of biology and disease.

Development of STEADI: A Fall Prevention Resource for Health Care Providers

PubMed Central

Stevens, Judy A.; Phelan, Elizabeth A.

2015-01-01

Falls among people aged ≥65 years are the leading cause of both injury deaths and emergency department visits for trauma. Research shows that many falls are preventable. In the clinical setting, an effective fall intervention involves assessing and addressing an individual’s fall risk factors. This individualized approach is recommended in the American and British Geriatrics Societies’ (AGS/BGS) practice guideline. This article describes the development of STEADI (Stopping Elderly Accidents, Deaths, and Injuries), a fall prevention tool kit that contains an array of health care provider resources for assessing and addressing fall risk in clinical settings. As researchers at the Centers for Disease Control and Prevention’s Injury Center, we reviewed relevant literature and conducted in-depth interviews with health care providers to determine current knowledge and practices related to older adult fall prevention. We developed draft resources based on the AGS/BGS guideline, incorporated provider input, and addressed identified knowledge and practice gaps. Draft resources were reviewed by six focus groups of health care providers and revised. The completed STEADI tool kit, Preventing Falls in Older Patients—A Provider Tool Kit, is designed to help health care providers incorporate fall risk assessment and individualized fall interventions into routine clinical practice and to link clinical care with community-based fall prevention programs. PMID:23159993

Environmental assessment: Richton Dome Site, Mississippi

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

none,

1986-05-01

In February 1983, the US Department of Energy (DOE) identified the Richton Dome site in Mississippi as one of the nine potentially acceptable sites for a mined geologic repository for spent nuclear fuel and high-level radioactive waste. To determine their suitability, the Richton Dome site and the eight other potentially acceptable sites have been evaluated in accordance with the DOE's General Guidelines for the Recommendation of Sites for the Nuclear Waste Repositories. These evaluations were reported in draft environmental assessments (EAs), which were issued for public review and comment. After considering the comments received on the draft EAs, the DOEmore » prepared the final EAs. The site is in the Gulf interior region, which is one of five distinct geohydrologic settings considered for the first repository. This setting contains two other potentially acceptable sites--the Cypress Creek Dome site in Mississippi and the Vacherie Dome site in Louisiana. Although the Cypress Creek Dome and the Vacherie Dome sites are suitable for site characterization, the DOE has concluded that the Richton Dome site is the preferred site in the Gulf interior region. On the basis of the evaluations reported in this EA, the DOE has found that the Richton Dome site is not disqualified under the guidelines.« less

Reform of general education and vocational training in the U.S.S.R

NASA Technical Reports Server (NTRS)

Spearman, M. L.

1985-01-01

School reform in the Soviet Union is now being carried out in accordance with programmatic directives of the June 1983 plenary session of the CPSU Central Committee. The draft reform was under study and discussion for several months by various groups within the Soviet Union with the participation of about 120 million people. Following the discussion of the draft reform, the basic guidelines for reform were approved by the plenary session of the CPSU Central Committee on April 10, 1984, and by the U.S.S.R. Supreme Soviet on April 12, 1984. The essence of the reform is to improve the quality of instruction (including an added year of compulsory education-from 10 to 11) and to teach young people a profession in addition to the required volume of knowledge and work skills.

Flow characteristics of an inclined air-curtain range hood in a draft

PubMed Central

CHEN, Jia-Kun

2015-01-01

The inclined air-curtain technology was applied to build an inclined air-curtain range hood. A draft generator was applied to affect the inclined air-curtain range hood in three directions: lateral (θ=0°), oblique (θ=45°), and front (θ=90°). The three suction flow rates provided by the inclined air-curtain range hood were 10.1, 10.9, and 12.6 m3/min. The laser-assisted flow visualization technique and the tracer-gas test method were used to investigate the performance of the range hood under the influence of a draft. The results show that the inclined air-curtain range hood has a strong ability to resist the negative effect of a front draft until the draft velocity is greater than 0.5 m/s. The oblique draft affected the containment ability of the inclined air-curtain range hood when the draft velocity was larger than 0.3 m/s. When the lateral draft effect was applied, the capture efficiency of the inclined air-curtain range hood decreased quickly in the draft velocity from 0.2 m/s to 0.3 m/s. However, the capture efficiencies of the inclined air-curtain range hood under the influence of the front draft were higher than those under the influence of the oblique draft from 0.3 m/s to 0.5 m/s. PMID:25810445

Flow characteristics of an inclined air-curtain range hood in a draft.

PubMed

Chen, Jia-Kun

2015-01-01

The inclined air-curtain technology was applied to build an inclined air-curtain range hood. A draft generator was applied to affect the inclined air-curtain range hood in three directions: lateral (θ=0°), oblique (θ=45°), and front (θ=90°). The three suction flow rates provided by the inclined air-curtain range hood were 10.1, 10.9, and 12.6 m(3)/min. The laser-assisted flow visualization technique and the tracer-gas test method were used to investigate the performance of the range hood under the influence of a draft. The results show that the inclined air-curtain range hood has a strong ability to resist the negative effect of a front draft until the draft velocity is greater than 0.5 m/s. The oblique draft affected the containment ability of the inclined air-curtain range hood when the draft velocity was larger than 0.3 m/s. When the lateral draft effect was applied, the capture efficiency of the inclined air-curtain range hood decreased quickly in the draft velocity from 0.2 m/s to 0.3 m/s. However, the capture efficiencies of the inclined air-curtain range hood under the influence of the front draft were higher than those under the influence of the oblique draft from 0.3 m/s to 0.5 m/s.

Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry.

PubMed

Kadian, Naveen; Raju, Kanumuri Siva Rama; Rashid, Mamunur; Malik, Mohd Yaseen; Taneja, Isha; Wahajuddin, Muhammad

2016-07-15

The concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. United States Food and Drug Administration (USFDA) guidelines issued in 2001 have been referred for every guideline released ever since; may it be European Medical Agency (EMA) Europe, National Health Surveillance Agency (ANVISA) Brazil, Ministry of Health and Labour Welfare (MHLW) Japan or any other guideline in reference to bioanalytical method validation. After 12 years, USFDA released its new draft guideline for comments in 2013, which covers the latest parameters or topics encountered in bioanalytical method validation and approached towards the harmonization of bioanalytical method validation across the globe. Even though the regulatory agencies have general agreement, significant variations exist in acceptance criteria and methodology. The present review highlights the variations, similarities and comparison between bioanalytical method validation guidelines issued by major regulatory authorities worldwide. Additionally, other evaluation parameters such as matrix effect, incurred sample reanalysis including other stability aspects have been discussed to provide an ease of access for designing a bioanalytical method and its validation complying with the majority of drug authority guidelines. Copyright © 2016. Published by Elsevier B.V.

Health system guidance appraisal--concept evaluation and usability testing.

PubMed

Ako-Arrey, Denis E; Brouwers, Melissa C; Lavis, John N; Giacomini, Mita K

2016-01-05

Health system guidance (HSG) provides recommendations aimed to address health system challenges. However, there is a paucity of methods to direct, appraise, and report HSG. Earlier research identified 30 candidate criteria (concepts) that can be used to evaluate the quality of HSG and guide development and reporting requirements. The objective of this paper was to describe two studies aimed at evaluating the importance of these 30 criteria, design a draft HSG appraisal tool, and test its usability. This study involved a two-step survey process. In step 1, respondents rated the 30 concepts for appropriateness to, relevance to, and priority for health system decisions and HSG. This led to a draft tool. In step 2, respondents reviewed HSG documents, appraised them using the tool, and answered a series of questions. Descriptive analyses were computed. Fifty participants were invited in step 1, and we had a response rate of 82 %. The mean response rates for each concept within each survey question were universally favorable. There was also an overall agreement about the need for a high-quality tool to systematically direct the development, appraisal, and reporting of HSG. Qualitative feedback and a consensus process by the team led to refinements to some of the concepts and the creation of a beta (draft) version of the HSG tool. In step 2, 35 participants were invited and we had a response rate of 74 %. Exploratory analyses showed that the quality of the HSGs reviewed varied as a function of the HSG item and the specific document assessed. A favorable consensus was reached with participants agreeing that the HSG items were easy to understand and easy to apply. Moreover, the overall agreement was high for the usability of the tool to systematically direct the development (85 %), appraisal (92 %), and reporting (81 %) of HSG. From this process, version 1.0 of the HSG appraisal tool was generated complete with 32 items (and their descriptions) and 4 domains. The final tool, named the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS) (version 1), defines expectations of HSG and facilitates informed decisions among policymakers on health system delivery, financial, and governance arrangements.

National Health Guidelines in I.R of Iran, an Innovative Approach for Developing Countries

PubMed Central

Esmaeil Akbari, Mohammad; Mohammadi, Gohar; Vosoogh-Moghaddam, Abbas; Rabanikhah, Fahimeh; Javadi, Hamideh; Rostami-Gooran, Narges; Safaei, Asal; Akbari, Atieh

2015-01-01

Background Guidelines have produced and used in complex environment of health care system with its ethical, economical, legal and other aspects; that should be taken into account in any country. Modifying the format and content of guidelines might facilitate their usage and lead to improved quality of care and cost containment. We have produced this tool for explained above purpose. Methods A coordinating national team has settled at the office of minster of health and medical education, supported by a guideline review committee. An innovative and appropriate approach for adapting national health guidelines has consisted of eight steps, have defined For preparing the draft of each guideline a technical team which, including main author, her/his co-workers have nominated. The authors of each topic have systematically searched databases of the proposed Twenty-two International Sites, and then have selected at least five sources of them that were more relevant. The final recommendations have proposed by agreement of technical team and Guideline Review Committee. Results In less than 5 months, more than 500 authors in whole country have selected to prepare guidelines and, approximately 150 guidelines have provided in three volumes of the published and distributed book. Each guideline had a national ID number, constant forever; all topics should be reviewed every 3-5 years. Conclusion National health guideline(s) would be essential means for policy making in health system and increased the cost containment and quality of care. Ministry of Health and Medical Education should provide and distribute the guidelines based on its accountability to legal responsibility. PMID:25960845

National health guidelines in I.R of iran, an innovative approach for developing countries.

PubMed

Esmaeil Akbari, Mohammad; Mohammadi, Gohar; Vosoogh-Moghaddam, Abbas; Rabanikhah, Fahimeh; Javadi, Hamideh; Rostami-Gooran, Narges; Safaei, Asal; Akbari, Atieh

2015-01-01

Guidelines have produced and used in complex environment of health care system with its ethical, economical, legal and other aspects; that should be taken into account in any country. Modifying the format and content of guidelines might facilitate their usage and lead to improved quality of care and cost containment. We have produced this tool for explained above purpose. A coordinating national team has settled at the office of minster of health and medical education, supported by a guideline review committee. An innovative and appropriate approach for adapting national health guidelines has consisted of eight steps, have defined For preparing the draft of each guideline a technical team which, including main author, her/his co-workers have nominated. The authors of each topic have systematically searched databases of the proposed Twenty-two International Sites, and then have selected at least five sources of them that were more relevant. The final recommendations have proposed by agreement of technical team and Guideline Review Committee. In less than 5 months, more than 500 authors in whole country have selected to prepare guidelines and, approximately 150 guidelines have provided in three volumes of the published and distributed book. Each guideline had a national ID number, constant forever; all topics should be reviewed every 3-5 years. National health guideline(s) would be essential means for policy making in health system and increased the cost containment and quality of care. Ministry of Health and Medical Education should provide and distribute the guidelines based on its accountability to legal responsibility.

Middle East Respiratory Syndrome Infection Control and Prevention Guideline for Healthcare Facilities

PubMed Central

Kim, Jin Yong; Song, Joon Young; Yoon, Young Kyung; Choi, Seong-Ho; Song, Young Goo; Kim, Sung-Ran; Son, Hee-Jung; Jeong, Sun-Young; Choi, Jung-Hwa; Kim, Kyung Mi; Yoon, Hee Jung; Choi, Jun Yong; Kim, Tae Hyong; Choi, Young Hwa; Kim, Hong Bin; Yoon, Ji Hyun; Lee, Jacob; Eom, Joong Sik; Lee, Sang-Oh; Oh, Won Sup; Choi, Jung-Hyun; Yoo, Jin-Hong; Kim, Woo Joo

2015-01-01

Middle East Respiratory Syndrome (MERS) is an acute viral respiratory illness with high mortality caused by a new strain of betacoronavirus (MERS-CoV). Since the report of the first patient in Saudi Arabia in 2012, large-scale outbreaks through hospital-acquired infection and inter-hospital transmission have been reported. Most of the patients reported in South Korea were also infected in hospital settings. Therefore, to eliminate the spread of MERS-CoV, infection prevention and control measures should be implemented with rigor. The present guideline has been drafted on the basis of the experiences of infection control in the South Korean hospitals involved in the recent MERS outbreak and on domestic and international infection prevention and control guidelines. To ensure efficient MERS-CoV infection prevention and control, care should be taken to provide comprehensive infection control measures including contact control, hand hygiene, personal protective equipment, disinfection, and environmental cleaning. PMID:26788414

Middle East Respiratory Syndrome Infection Control and Prevention Guideline for Healthcare Facilities.

PubMed

Kim, Jin Yong; Song, Joon Young; Yoon, Young Kyung; Choi, Seong-Ho; Song, Young Goo; Kim, Sung-Ran; Son, Hee-Jung; Jeong, Sun-Young; Choi, Jung-Hwa; Kim, Kyung Mi; Yoon, Hee Jung; Choi, Jun Yong; Kim, Tae Hyong; Choi, Young Hwa; Kim, Hong Bin; Yoon, Ji Hyun; Lee, Jacob; Eom, Joong Sik; Lee, Sang-Oh; Oh, Won Sup; Choi, Jung-Hyun; Yoo, Jin-Hong; Kim, Woo Joo; Cheong, Hee Jin

2015-12-01

Middle East Respiratory Syndrome (MERS) is an acute viral respiratory illness with high mortality caused by a new strain of betacoronavirus (MERS-CoV). Since the report of the first patient in Saudi Arabia in 2012, large-scale outbreaks through hospital-acquired infection and inter-hospital transmission have been reported. Most of the patients reported in South Korea were also infected in hospital settings. Therefore, to eliminate the spread of MERS-CoV, infection prevention and control measures should be implemented with rigor. The present guideline has been drafted on the basis of the experiences of infection control in the South Korean hospitals involved in the recent MERS outbreak and on domestic and international infection prevention and control guidelines. To ensure efficient MERS-CoV infection prevention and control, care should be taken to provide comprehensive infection control measures including contact control, hand hygiene, personal protective equipment, disinfection, and environmental cleaning.

Acute and sub-chronic toxicity of four cytostatic drugs in zebrafish.

PubMed

Kovács, Róbert; Bakos, Katalin; Urbányi, Béla; Kövesi, Judit; Gazsi, Gyöngyi; Csepeli, Andrea; Appl, Ádám János; Bencsik, Dóra; Csenki, Zsolt; Horváth, Ákos

2016-08-01

The acute and sub-chronic effects of four cytostatic drugs-5-fluorouracil (5-FU), cisplatin (CisPt), etoposide (ET) and imatinib mesylate (IM)-on zebrafish (Danio rerio) were investigated. Acute tests were carried out in a static system in accordance with the OECD guideline 203 for adult fish and the draft guideline for fish embryos (FET test) in order to find the LC50 values of the four cytostatic drugs. Early-life stage toxicity test on zebrafish was conducted according the OECD guideline 210 using the cytostatic drugs 5-FU and IM in a semistatic system with the objective of investigating the sub-chronic effects of the cytostatic drugs on fish. In adult fish, the cytostatic drugs 5-FU and ET did not pass the limit test, thus, are considered non-toxic. In case of cisplatin, LC50 was calculated at 64.5 mg L(-1), whereas in case of IM, LC50 was at 70.8 mg L(-1). In the FET test, LC50 of 5-FU at 72-h post fertilization (hpf) was 2441.6 mg L(-1). In case of CisPt, LC50 was 349.9 mg L(-1) at 48 hpf and it progressively decreased to 81.3 mg L(-1) at 120 hpf. In addition, CisPt caused a significant delay in the hatch of larvae. In case of ET, LC50 values were not calculable as they were higher than 300 mg L(-1) at which concentration the substance crystallized in the solution. LC50 values of IM were 48 hpf; 158.3 mg L(-1) , 72 hpf; 141.6 mg L(-1), 96 hpf; 118.0 mg L(-1), and 120 hpf; 65.9 mg L(-1). In the Early-life Stage Test with 5-FU, embryonic deformities were not detected during the tests. Regarding mortalities, the 10 mg L(-1) concentration can be considered as LOEC, as statistically significant difference in mortalities was detected in this group alone. Concerning dry body weight and standard length, 1 mg L(-1) is the LOEC. In case of IM, the highest tested concentration (10 mg L(-1)) can be considered LOEC for mortalities, however, the treatment did not have an effect on the other investigated parameters (dry and wet weight, standard length). All four cytostatic drugs were characterized by low toxicity in zebrafish in acute and sub-chronic tests.

Evaluation of a multi-endpoint assay in rats, combining the bone-marrow micronucleus test, the Comet assay and the flow-cytometric peripheral blood micronucleus test.

PubMed

Bowen, Damian E; Whitwell, James H; Lillford, Lucinda; Henderson, Debbie; Kidd, Darren; Mc Garry, Sarah; Pearce, Gareth; Beevers, Carol; Kirkland, David J

2011-05-18

With the publication of revised draft ICH guidelines (Draft ICH S2), there is scope and potential to establish a combined multi-end point in vivo assay to alleviate the need for multiple in vivo assays, thereby reducing time, cost and use of animals. Presented here are the results of an evaluation trial in which the bone-marrow and peripheral blood (via MicroFlow(®) flow cytometry) micronucleus tests (looking at potential chromosome breakage and whole chromosome loss) in developing erythrocytes or young reticulocytes were combined with the Comet assay (measuring DNA strand-breakage), in stomach, liver and blood lymphocytes. This allowed a variety of potential target tissues (site of contact, site of metabolism and peripheral distribution) to be assessed for DNA damage. This combination approach was performed with minimal changes to the standard and regulatory recommended sampling times for the stand-alone assays. A series of eight in vivo genotoxins (2-acetylaminofluorene, benzo[a]pyrene, carbendazim, cyclophosphamide, dimethylnitrosamine, ethyl methanesulfonate, ethyl nitrosourea and mitomycin C), which are known to act via different modes of action (direct- and indirect-acting clastogens, alkylating agents, gene mutagens, cross-linking and aneugenic compounds) were tested. Male rats were dosed at 0, 24 and 45 h, and bone marrow and peripheral blood (micronucleus endpoint), liver, whole blood and stomach (Comet endpoint) were sampled at three hours after the last dose. Comet and micronucleus responses were as expected based on available data for conventional (acute) stand-alone assays. All compounds were detected as genotoxic in at least one of the endpoints. The importance of evaluating both endpoints was highlighted by the uniquely positive responses for certain chemicals (benzo[a]pyrene and 2-acetylaminofluorene) with the Comet endpoint and certain other chemicals (carbendazim and mitomycin C) with the micronucleus endpoint. The data generated from these investigations demonstrate the suitability of the multi-endpoint design. 2011 Elsevier B.V. All rights reserved.

The relationship among neurocognitive performances and biopsychosocial characteristics of elite National Football League draft picks: an exploratory investigation.

PubMed

Solomon, Gary S; Haase, Richard F; Kuhn, Andrew

2013-02-01

Sports neuropsychology has emerged as a specialty area within the field of clinical neuropsychology. The role of the sports neuropsychologist, rooted in baseline and post-concussion testing, has evolved to include other clinical domains, including the clinical assessment of potential draft picks. There is no published information on the neurocognitive characteristics of these draft picks. We sought to determine whether elite NFL draft picks differed from NFL roster athletes on neurocognitive (ImPACT) and biopsychosocial characteristics, and given that no published data exists for this population, adopted null hypotheses. Null hypotheses were rejected for two of the four ImPACT scores, as elite draft picks scored higher on measures of visual motor speed and reaction time than roster NFL athletes. Subtle but distinct neurocognitive differences are noted when comparing elite NFL draft picks with norms from a cumulative roster of a single NFL team.

The National Football League Combine: performance differences between drafted and nondrafted players entering the 2004 and 2005 drafts.

PubMed

Sierer, S Patrick; Battaglini, Claudio L; Mihalik, Jason P; Shields, Edgar W; Tomasini, Nathan T

2008-01-01

The purpose of this study was to examine performance differences between drafted and nondrafted athletes (N = 321) during the 2004 and 2005 National Football League (NFL) Combines. We categorized players into one of 3 groups: Skill, Big skill, and Linemen. Skill players (SP) consisted of wide receivers, cornerbacks, free safeties, strong safeties, and running backs. Big skill players (BSP) included fullbacks, linebackers, tight ends, and defensive ends. Linemen (LM) consisted of centers, offensive guards, offensive tackles, and defensive tackles. We analyzed player height and mass, as well as performance on the following combine drills: 40-yard dash, 225-lb bench press test, vertical jump, broad jump, pro-agility shuttle, and the 3-cone drill. Student t-tests compared performance on each of these measures between drafted and nondrafted players. Statistical significance was found between drafted and nondrafted SP for the 40-yard dash (P < 0.001), vertical jump (P = 0.003), pro-agility shuttle (P < 0.001), and 3-cone drill (P < 0.001). Drafted and nondrafted BSP performed differently on the 40-yard dash (P = 0.002) and 3-cone drill (P = 0.005). Finally, drafted LM performed significantly better than nondrafted LM on the 40-yard dash (P = 0.016), 225-lb bench press (P = 0.003), and 3-cone drill (P = 0.005). Certified strength and conditioning specialists will be able to utilize the significant findings to help better prepare athletes as they ready themselves for the NFL Combine.

The Diagnosis and Management of Lipodystrophy Syndromes: A Multi-Society Practice Guideline

PubMed Central

Araujo-Vilar, David; Cheung, Pik To; Dunger, David; Garg, Abhimanyu; Jack, Michelle; Mungai, Lucy; Oral, Elif A.; Patni, Nivedita; Rother, Kristina I.; von Schnurbein, Julia; Sorkina, Ekaterina; Stanley, Takara; Vigouroux, Corinne; Wabitsch, Martin; Williams, Rachel; Yorifuji, Tohru

2016-01-01

Objective: Lipodystrophy syndromes are extremely rare disorders of deficient body fat associated with potentially serious metabolic complications, including diabetes, hypertriglyceridemia, and steatohepatitis. Due to their rarity, most clinicians are not familiar with their diagnosis and management. This practice guideline summarizes the diagnosis and management of lipodystrophy syndromes not associated with HIV or injectable drugs. Participants: Seventeen participants were nominated by worldwide endocrine societies or selected by the committee as content experts. Funding was via an unrestricted educational grant from Astra Zeneca to the Pediatric Endocrine Society. Meetings were not open to the general public. Evidence: A literature review was conducted by the committee. Recommendations of the committee were graded using the system of the American Heart Association. Expert opinion was used when published data were unavailable or scarce. Consensus Process: The guideline was drafted by committee members and reviewed, revised, and approved by the entire committee during group meetings. Contributing societies reviewed the document and provided approval. Conclusions: Lipodystrophy syndromes are heterogeneous and are diagnosed by clinical phenotype, supplemented by genetic testing in certain forms. Patients with most lipodystrophy syndromes should be screened for diabetes, dyslipidemia, and liver, kidney, and heart disease annually. Diet is essential for the management of metabolic complications of lipodystrophy. Metreleptin therapy is effective for metabolic complications in hypoleptinemic patients with generalized lipodystrophy and selected patients with partial lipodystrophy. Other treatments not specific for lipodystrophy may be helpful as well (eg, metformin for diabetes, and statins or fibrates for hyperlipidemia). Oral estrogens are contraindicated. PMID:27710244

Choosing Wisely: The Top-5 Recommendations from the Italian Panel of the National Guidelines for the Management of Acute Pharyngitis in Children.

PubMed

Chiappini, Elena; Bortone, Barbara; Di Mauro, Giuseppe; Esposito, Susanna; Galli, Luisa; Landi, Massimo; Novelli, Andrea; Marchisio, Paola; Marseglia, Gian Luigi; Principi, Nicola; de Martino, Maurizio

2017-03-01

With the aim to reduce waste in the health care system and avoid risks associated with unnecessary treatment, the Italian Panel of the National Guidelines for the Management of Acute Pharyngitis in Children joined the Choosing Wisely initiative. An ad hoc Choosing Wisely task force was selected to develop a candidate list of items for the top-5 list on pharyngitis medicine. Through a process of literature review and consensus, the final list of 5 items was chosen. Drafted recommendations were formulated and then reviewed by the task force members until a final consensus was reached. The 5 recommendations approved are: blood exams should not be performed; antibiotics should not be administrated unless microbiologic confirmation of streptococcal infection has been carried out; if a throat culture is performed, susceptibility tests on isolates should not be executed; antibiotic course should not be shortened; because penicillin V is not available in Italy, amoxicillin (50 mg/kg/d in 2-3 doses orally) for 10 days is the first choice treatment; and steroids should not be administered for the risk of masking possible underlying severe condition. This top-5 list can be a novel tool to spread the key messages of guidelines and to avoid unnecessary diagnostic procedures, and to promote a rational use of antibiotics in children. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Mycobacterium tuberculosis transmission rates in a sanatorium: implications for new preventive guidelines.

PubMed

Jernigan, J A; Adal, K A; Anglim, A M; Byers, K E; Farr, B M

1994-12-01

In 1990, the Centers for Disease Control and Prevention recommended substituting dust-mist particulate respirators for simple isolation masks in acid-fast bacillus isolation rooms, reasoning that air leaks around the simple masks could result in a higher rate of purified protein derivative skin-test conversion. In 1993, a Centers for Disease Control and Prevention draft guideline proposed that high-efficiency particulate air filter respirators be used instead of dust-mist particulate respirators. Epidemiologic data were not available to assess the importance of these changes or their cost-effectiveness. The University of Virginia was affiliated with a tuberculosis hospital from 1979 until 1987. We surveyed physicians who had served as residents in internal medicine during this period regarding purified protein derivative skin-test history. duration of work at the tuberculosis sanatorium, and any history of unprotected exposures to patients with active pulmonary or laryngeal tuberculosis. Patients with active tuberculosis at the sanatorium were isolated in negative-pressure rooms with UV lights. Physicians wore simple isolation masks in these rooms. Responses were received from 83 former resident physicians. Fifty-two physicians had worked on the tuberculosis wards for a total of 420 weeks, with no subsequent skin-test conversions (95% CI 0 to 1 conversion/8 physician-years). These data document a low risk of occupational transmission of Mycobacterium tuberculosis to physicians who wear simple isolation masks in negative-pressure ventilation rooms with UV lights. This low rate predicts that the additional protective efficacy and cost-effectiveness of the more expensive high-efficiency particulate air filter respirators and the respiratory protection program will be low.

National Football League Skilled and Unskilled Positions Vary in Opportunity and Yield in Return to Play After an Anterior Cruciate Ligament Injury

PubMed Central

Yang, JaeWon; Hodax, Jonathan D.; Machan, Jason T.; Secrist, Eric S.; Durand, Wesley M.; Owens, Brett D.; Eltorai, Adam E.M.; Dodson, Christopher C.

2017-01-01

Background: Anterior cruciate ligament (ACL) injuries pose a significant risk to the careers of players in the National Football League (NFL). The relationships between draft round and position on return to play (RTP) among NFL players are not well understood, and the ability to return to preinjury performance levels remains unknown for most positions. Purpose: To test for differences in RTP rates and changes in performance after an ACL injury by position and draft round. We hypothesized that skilled positions would return at a lower rate compared to unskilled positions. We further hypothesized that early draft-round status would relate to a greater rate of RTP and that skilled positions and a lower draft round would correlate with decreased performance for players who return to sport. Study Design: Case-control study; Level of evidence, 3. Methods: Utilizing a previously established database of publicly available information regarding ACL tears among NFL players, athletes with ACL tears occurring between the 2010 and 2013 seasons were identified. Generalized linear models and Kaplan-Meier time-to-event models were used to test the study hypotheses. Results: The overall RTP rate was 61.7%, with skilled players and unskilled players returning at rates of 64.1% and 60.4%, respectively (P = .74). Early draft-round players and unskilled late draft-round players had greater rates of RTP compared to skilled late draft-round players and both unskilled and skilled undrafted free agents (UDFAs). Skilled early draft-round players constituted the only cohort that played significantly fewer games after an injury. Unskilled UDFAs constituted the only cohort to show a significant increase in the number of games started and ratio of games started to games played, starting more games in which they played, after an injury. Conclusion: Early draft-round and unskilled players were more likely to return compared to their later draft-round and skilled peers. Skilled early draft-round players, who displayed relatively high rates of RTP, constituted the only cohort to show a decline in performance. Unskilled UDFAs, who exhibited relatively low rates of RTP, constituted the only cohort to show an increase in performance. The significant effect of draft round and position type on RTP may be caused by a combination of differences in talent levels and in opportunities given to returning to play. PMID:28975136

A Clinician-Centered Evaluation of the Usability of AHLTA and Automated Clinical Practice Guidelines at TAMC

DTIC Science & Technology

2009-10-01

gathering has been rescheduled to November 14, 2009, in San Francisco, at the AMIA Conference location. August 14, 2009, SOADEX provided a draft system...Bethesda. MD, USA d Core Unit for Medical Statistics and Informatics, Medical University of Vienna, Austria • Department of Nursing . lnha University...scheduled. Insook Cho, PhD, RN Associate Professor, Maternity Nursing & Nursing Informat- ics, lnha University, Younghyun-dong, Nam-gu, Jncheon, South

Domestic and foreign trends in the prevalence of heart failure and the necessity of next-generation artificial hearts: a survey by the Working Group on Establishment of Assessment Guidelines for Next-Generation Artificial Heart Systems.

PubMed

Tatsumi, Eisuke; Nakatani, Takeshi; Imachi, Kou; Umezu, Mitsuo; Kyo, Shun-Ei; Sase, Kazuhiro; Takatani, Setsuo; Matsuda, Hikaru

2007-01-01

A series of guidelines for development and assessment of next-generation medical devices has been drafted under an interagency collaborative project by the Ministry of Health, Labor and Welfare and the Ministry of Economy, Trade and Industry. The working group for assessment guidelines of next-generation artificial hearts reviewed the trend in the prevalence of heart failure and examined the potential usefulness of such devices in Japan and in other countries as a fundamental part of the process of establishing appropriate guidelines. At present, more than 23 million people suffer from heart failure in developed countries, including Japan. Although Japan currently has the lowest mortality from heart failure among those countries, the number of patients is gradually increasing as our lifestyle becomes more Westernized; the associated medical expenses are rapidly growing. The number of heart transplantations, however, is limited due to the overwhelming shortage of donor hearts, not only in Japan but worldwide. Meanwhile, clinical studies and surveys have revealed that the major causes of death in patients undergoing long-term use of ventricular assist devices (VADs) were infection, thrombosis, and mechanical failure, all of which are typical of VADs. It is therefore of urgent and universal necessity to develop next-generation artificial hearts that have excellent durability to provide at least 2 years of event-free operation with a superior quality of life and that can be used for destination therapy to save patients with irreversible heart failure. It is also very important to ensure that an environment that facilitates the development, testing, and approval evaluation processes of next-generation artificial hearts be established as soon as possible.

Establishing Obstetric Anesthesiology Practice Guidelines in the Republic of Armenia: A Global Health Collaboration.

PubMed

Yuill, Gordon; Amroyan, Ashot; Millar, Simon; Vardapetyan, Emil; Habib, Ashraf S; Owen, Medge D

2017-08-01

Disparity exists in anesthesia practices between high- and low-to-middle income countries, and awareness has been raised within the global health community to improve the standards of anesthesia care and patient safety. The establishment of international collaborations and appropriate practice guidelines may help address clinical care deficiencies. This report's aim was to assess the impact of a multiyear collaboration on obstetric anesthesia practices in the Republic of Armenia. An invited multinational team of physicians conducted six visits to Armenia between 2006 and 2015 to observe current practice and establish standards of obstetric anesthesia care. The Armenian Society of Anaesthesiologists and Intensive Care specialists collected data on the numbers of vaginal delivery, cesarean delivery, and neuraxial anesthesia use in maternity units during the period. Data were analyzed with the Fisher exact or chi-square test, as appropriate. Neuraxial anesthesia use for cesarean delivery increased significantly (P < 0.0001) in all 10 maternity hospitals within the capital city of Yerevan. For epidural labor analgesia, there was sustained or increased use in only two hospitals. For hospitals located outside the capital city, there was a similar increase in the use of neuraxial anesthesia for cesarean delivery that was greater in hospitals that were visited by an external team (P < 0.0001); however, use of epidural labor analgesia was not increased significantly. Over the course of the collaboration, guidelines for obstetric anesthesia were drafted and approved by the Armenian Ministry of Health. Collaboration between Armenian anesthesiologists and dedicated visiting physicians to update and standardize obstetric anesthesia practices led to national practice guidelines and sustained improvements in clinical care in the Republic of Armenia.

Martins Creek S. E. S. 800-MW Units 3 and 4: design and operating experience with axial-flow FD and ID fans

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

Curley, C.C.; Overas, A.J.

1976-01-01

The design and performance of the variable-pitch axial-flow forced-draft and induced-draft fans used in two 820MW generating units at the Martins Creek Power Plant are described. Information is included on fan design; silencers; mechanical and metallurgical testing; insulation; performance testing; start-up and shutdown procedures; and maintenance. (LCL)

Don't Forget the Distributor! the Importance of Field Testing Draft Educational Materials with Key Gatekeepers before Production and Dissemination

ERIC Educational Resources Information Center

Flores, Alina L.; Prue, Christine E.; Panissidi, Paula

2010-01-01

Objective: This article presents the results of testing draft folic acid educational materials with key gatekeepers, leading to the development of a Spanish-language print advertisement, poster, and radio public service announcement (PSA) aimed at promoting folic acid consumption among 18- to 25-year-old young Latina adults, as well as a…

Flow characteristics and spillage mechanisms of wall-mounted and jet-isolated range hoods subject to influence from cross draft.

PubMed

Chen, Jia-Kun; Huang, Rong Fung; Peng, Kuan-Lin

2012-01-01

The effects of draft on the flow and spillage characteristics of wall-mounted and jet-isolated range hoods were investigated. A specially designed draft generator that could supply low-swirl air current was used to provide "cross draft" from three directions, lateral (θ = 0(o)), oblique (θ = 45(o)), and front (θ = 90(o)), with respect to the center point of the range hoods. Flow characteristics of oil mist were inspected through visualization of smoke flows with light scattering (laser light sheet-assisted visualization of smoke flow). The leakage mechanisms, which were closely related to the flow features, were studied by examining both movies and still pictures showing smoke-flow evolution. The sulfur hexafluoride tracer gas concentration detection method was employed to measure the capture indices. The results showed that the lateral draft pushed the pollutants generated under the hood in the opposite direction and induced serious spillage. The oblique draft pushed the pollutants toward both the rear wall and opposite side and induced more serious spillage than did the lateral draft. The frontal draft forced the pollutants to bifurcate into streams moving toward the left and the right, and induced the most serious pollutant spillage among the three tested drafts. Pollutant spillage became critically significant as the cross draft velocity was increased to greater than 0.2 m/sec. Spillage of pollutants increased as the velocity of the cross draft was increased. Increasing the suction flow rate of the range hood may increase resistance to the draft, but the benefits were limited at draft velocities greater than 0.2 m/sec. Both range hoods had a similarly low capture index under the influence of the lateral draft. For the oblique and frontal drafts, the jet-isolated range hood demonstrated a higher capture index than did the wall-mounted range hood.

The development of a multidisciplinary, evidence-based guideline for "HIV and employment".

PubMed

Wagener, Marlies N; Roelofs, Pepijin; Miedema, Harold S; Brandjes, Dees P M; Dahmen, Rutger; van Gorp, Eric C M

2015-01-01

The objective of this study was to develop a multidisciplinary guideline that supports the care and vocational rehabilitation of HIV-infected people with employment-related problems. The guideline was developed according to the "evidence-based guideline development" method developed by the Dutch Institute for Health Care Improvement. This method consists of the following steps: forming a multidisciplinary core group and an expert panel, formulating key questions, searching and appraising the available literature, formulating considerations and recommendations, peer reviewing the draft guideline, and authorizing the final guideline. All relevant professional associations were represented in the core group that was assembled to develop the guideline, i.e., HIV doctors, HIV nurses, general practitioners, occupational health physicians, psychologists, social workers, occupational health nurses, vocational experts, and insurance physicians. Five key questions for the guideline were formulated with the following themes: determinants of employment, disclosure and stigma, self-management, interventions, and the organization of care. In the literature review on these topics, 45 studies met the inclusion criteria. The methodological quality of the included articles was poor. Factors such as patient preferences and medical/ethical issues were considered. The recommendations in the guideline are a weighting of the scientific evidence and the considerations of the core group. The guideline, as well as its summary for daily practice, clarifies the most important barriers and facilitators to people with HIV either staying at work or returning to work, and it constitutes a clinical, easy-to-use guideline for health-care providers and how they can support people with HIV who want to work.

Surgery for aortic dilatation in patients with bicuspid aortic valves: A statement of clarification from the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

PubMed

Hiratzka, Loren F; Creager, Mark A; Isselbacher, Eric M; Svensson, Lars G; Nishimura, Rick A; Bonow, Robert O; Guyton, Robert A; Sundt, Thoralf M

2016-04-01

Two guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and collaborating societies address the risk of aortic dissection in patients with bicuspid aortic valves and severe aortic enlargement: The "2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease" (J Am Coll Cardiol. 2010;55:e27-130) and the "2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease" (J Am Coll Cardiol. 2014;63:e57-185). However, the 2 guidelines differ with regard to the recommended threshold of aortic root or ascending aortic dilatation that would justify surgical intervention in patients with bicuspid aortic valves. The ACC and AHA therefore convened a subcommittee representing members of the 2 guideline writing committees to review the evidence, reach consensus, and draft a statement of clarification for both guidelines. This statement of clarification uses the ACC/AHA revised structure for delineating the Class of Recommendation and Level of Evidence to provide recommendations that replace those contained in Section 9.2.2.1 of the thoracic aortic disease guideline and Section 5.1.3 of the valvular heart disease guideline. Copyright © 2016 American College of Cardiology Foundation and American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.

Surgery for Aortic Dilatation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.

PubMed

Hiratzka, Loren F; Creager, Mark A; Isselbacher, Eric M; Svensson, Lars G; Nishimura, Rick A; Bonow, Robert O; Guyton, Robert A; Sundt, Thoralf M

2016-02-16

Two guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and collaborating societies address the risk of aortic dissection in patients with bicuspid aortic valves and severe aortic enlargement: the "2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease" (J Am Coll Cardiol 2010;55:e27-130) and the "2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease" (J Am Coll Cardiol 2014;63:e57-185). However, the 2 guidelines differ with regard to the recommended threshold of aortic root or ascending aortic dilatation that would justify surgical intervention in patients with bicuspid aortic valves. The ACC and AHA therefore convened a subcommittee representing members of the 2 guideline writing committees to review the evidence, reach consensus, and draft a statement of clarification for both guidelines. This statement of clarification uses the ACC/AHA revised structure for delineating the Class of Recommendation and Level of Evidence to provide recommendations that replace those contained in Section 9.2.2.1 of the thoracic aortic disease guideline and Section 5.1.3 of the valvular heart disease guideline. Copyright © 2016 American College of Cardiology Foundation and American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.

Optimizing the Design of Preprinted Orders for Ambulatory Chemotherapy: Combining Oncology, Human Factors, and Graphic Design

PubMed Central

Jeon, Jennifer; White, Rachel E.; Hunt, Richard G.; Cassano-Piché, Andrea L.; Easty, Anthony C.

2012-01-01

Purpose: To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. Methods: Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. Results: The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. Conclusion: Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards. PMID:23077436

Optimizing the design of preprinted orders for ambulatory chemotherapy: combining oncology, human factors, and graphic design.

PubMed

Jeon, Jennifer; White, Rachel E; Hunt, Richard G; Cassano-Piché, Andrea L; Easty, Anthony C

2012-03-01

To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards.

Korean clinical practice guidelines: otitis media in children.

PubMed

Lee, Hyo-Jeong; Park, Su-Kyoung; Choi, Kyu Young; Park, Su Eun; Chun, Young Myung; Kim, Kyu-Sung; Park, Shi-Nae; Cho, Yang-Sun; Kim, Young-Jae; Kim, Hyung-Jong; Korean Otologic Society

2012-08-01

Acute otitis media (AOM) and otitis media with effusion (OME) are common infections in children, and their diagnosis and treatment have significant impacts on the health of children and the costs of providing national medical care. In 2009, the Korean Otologic Society organized a committee composed of experts in the field of otolaryngology, pediatrics, and family medicine to develop Korean clinical practice guidelines (CPG) for otitis media in children with the goal of meeting regional medical and social needs in Korea. For this purpose, the committee adapted existing guidelines. A comprehensive literature review was carried out primarily from 2004 to 2009 using medical search engines including data from Korea. A draft was written after a national questionnaire survey and several public audits, and it was editorially supervised by senior advisors before publication of the final report. These evidence-based guidelines for the management of otitis media in children provide recommendations to primary practitioners for the diagnosis and treatment of children younger than 15 yr old with uncomplicated AOM and OME. The guidelines include recommendations regarding diagnosis, treatment options, prevention and parent education, medical records, referral, and complementary/alternative medicine for treating pediatric otitis media.

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

Savy, J.

New design and evaluation guidelines for department of energy facilities subjected to natural phenomena hazard, are being finalized. Although still in draft form at this time, the document describing those guidelines should be considered to be an update of previously available guidelines. The recommendations in the guidelines document mentioned above, and simply referred to as the guidelines'' thereafter, are based on the best information at the time of its development. In particular, the seismic hazard model for the Princeton site was based on a study performed in 1981 for Lawrence Livermore National Laboratory (LLNL), which relied heavily on the resultsmore » of the NRC's Systematic Evaluation Program and was based on a methodology and data sets developed in 1977 and 1978. Considerable advances have been made in the last ten years in the domain of seismic hazard modeling. Thus, it is recommended to update the estimate of the seismic hazard at the DOE sites whenever possible. The major differences between previous estimates and the ones proposed in this study for the PPPL are in the modeling of the strong ground motion at the site, and the treatment of the total uncertainty in the estimates to include knowledge uncertainty, random uncertainty, and expert opinion diversity as well. 28 refs.« less

Teaching Pharmacology Graduate Students how to Write an NIH Grant Application

PubMed Central

O’Donnell, Lauren A.; Surratt, Christopher K.

2015-01-01

Objective. To fill the gap in grant writing training in pharmacology graduate education using an active-learning strategy. Design. Graduate students wrote subsections of a grant according to NIH guidelines. Students revised their applications based on multiple rounds of critiques from professors and peers throughout a semester-long scientific writing course. Assessment. Prerevision and postrevision grant drafts were graded. Students were provided with questionnaires assessing their perception of the process. To determine the impact of feedback on the proposals, the quality of the pre/postrevision drafts was assessed by professors who were blinded and unaffiliated with the course. Conclusion. Student grades improved significantly upon resubmission. Perceptions of the proposals by blinded faculty members favored revised submissions based on multiple criteria. Survey feedback indicated an increase in student confidence in grant writing ability. The results of 3 independent measures demonstrate that intensive feedback on scientific writing improved the quality of student proposals. PMID:28435165

Teaching Pharmacology Graduate Students how to Write an NIH Grant Application.

PubMed

Leak, Rehana K; O'Donnell, Lauren A; Surratt, Christopher K

2015-11-25

Objective. To fill the gap in grant writing training in pharmacology graduate education using an active-learning strategy. Design. Graduate students wrote subsections of a grant according to NIH guidelines. Students revised their applications based on multiple rounds of critiques from professors and peers throughout a semester-long scientific writing course. Assessment. Prerevision and postrevision grant drafts were graded. Students were provided with questionnaires assessing their perception of the process. To determine the impact of feedback on the proposals, the quality of the pre/postrevision drafts was assessed by professors who were blinded and unaffiliated with the course. Conclusion. Student grades improved significantly upon resubmission. Perceptions of the proposals by blinded faculty members favored revised submissions based on multiple criteria. Survey feedback indicated an increase in student confidence in grant writing ability. The results of 3 independent measures demonstrate that intensive feedback on scientific writing improved the quality of student proposals.

Managing the nation`s nuclear waste. Site descriptions: Cypress Creek, Davis Canyon, Deaf Smith, Hanford Reference, Lavender Canyon, Richton Dome, Swisher, Vacherie Dome, and Yucca Mountain

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

NONE

1985-12-31

In 1982, the Congress enacted the Nuclear Waste Policy Act (Public Law 97-425), which established a comprehensive national program directed toward siting, constructing, and operating geologic repositories for the permanent disposal of high-level radioactive waste. In February 1983, the United States Department of Energy (DOE) identified the nine referenced repository locations as potentially acceptable sites for a mined geologic repository. These sites have been evaluated in accordance with the DOE`s General Guidelines for the Recommendation of Sites for Nuclear Waste Repositories. The DOE findings and determinations are based on the evaluations contained in the draft Environmental Assessments (EA). A finalmore » EA will be prepared after considering the comments received on the draft EA. The purpose of this document is to provide the public with specific site information on each potential repository location.« less

Draft Plan to Develop Non-Intrusive Load Monitoring Test Protocols

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

Mayhorn, Ebony T.; Sullivan, Greg P.; Petersen, Joseph M.

2015-09-29

This document presents a Draft Plan proposed to develop a common test protocol that can be used to evaluate the performance requirements of Non-Intrusive Load Monitoring. Development on the test protocol will be focused on providing a consistent method that can be used to quantify and compare the performance characteristics of NILM products. Elements of the protocols include specifications for appliances to be used, metrics, instrumentation, and a procedure to simulate appliance behavior during tests. In addition, three priority use cases for NILM will be identified and their performance requirements will specified.

The World Health Organization's safe abortion guidance document.

PubMed

Van Look, Paul F A; Cottingham, Jane

2013-04-01

We discuss the history of the World Health Organization's (WHO's) development of guidelines for governments on providing safe abortion services, which WHO published as Safe Abortion: Technical and Policy Guidance for Health Systems in 2003 and updated in 2012. We show how the recognition of the devastating impact of unsafe abortion on women's health and survival, the impetus of the International Conference on Population and Development and its five-year follow-up, and WHO's progressive leadership at the end of the century enabled the organization to elaborate guidance on providing safe abortion services. Guideline formulation involved extensive review of published evidence, an international technical expert meeting to review the draft document, and a protracted in-house review by senior WHO management.

Guidelines of the First International Consensus Conference on Endovenous Thermal Ablation for Varicose Vein Disease--ETAV Consensus Meeting 2012.

PubMed

Pavlović, Miloš D; Schuller-Petrović, Sanja; Pichot, Olivier; Rabe, Eberhard; Maurins, Uldis; Morrison, Nick; Pannier, Felizitas

2015-05-01

Endovenous thermal ablation (ETA) procedures are catheter-directed, ultrasound (US)-guided thermal methods for treatment in varicose veins disease. Radiofrequency, laser or steam energy thermally denatures vein wall collagen, leading first to vein wall inflammation, then fibrosis and finally to occlusion. The aim of this guideline is to give evidence-based recommendations for ETA procedures. These guidelines were drafted during a consensus meeting of a group of experts in the field of ETA in June 2012 (Hvar, Croatia) under the auspices of the International Union of Phlebology (IUP). These guidelines review the present state of knowledge as reflected in peer-reviewed published medical literature. The recommendations of these guidelines are graded according to the American College of Chest Physicians Task Force recommendations on Grading Strength of Recommendations and Quality of Evidence in Clinical Guidelines. Recommendations on the use of ETA procedures were made based on the quality of evidence for efficacy, safety, tolerability, cosmetic outcome, patient satisfaction/preference and, where appropriate, on the experts' opinion. Health economics were not considered, since differences in national health systems and pricing make it difficult to form general conclusions that are relevant at an international level. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Relationship of physical fitness test results and hockey playing potential in elite-level ice hockey players.

PubMed

Burr, Jaime F; Jamnik, Roni K; Baker, Joseph; Macpherson, Alison; Gledhill, Norman; McGuire, E J

2008-09-01

The primary purpose of this study was to determine the fitness variables with the highest capability for predicting hockey playing potential at the elite level as determined by entry draft selection order. We also examined the differences associated with the predictive abilities of the test components among playing positions. The secondary purpose of this study was to update the physiological profile of contemporary hockey players including positional differences. Fitness test results conducted by our laboratory at the National Hockey League Entry Draft combine were compared with draft selection order on a total of 853 players. Regression models revealed peak anaerobic power output to be important for higher draft round selection in all positions; however, the degree of importance of this measurement varied with playing position. The body index, which is a composite score of height, lean mass, and muscular development, was similarly important in all models, with differing influence by position. Removal of the goalies' data increased predictive capacity, suggesting that talent identification using physical fitness testing of this sort may be more appropriate for skating players. Standing long jump was identified as a significant predictor variable for forwards and defense and could be a useful surrogate for assessing overall hockey potential. Significant differences exist between the physiological profiles of current players based on playing position. There are also positional differences in the relative importance of anthropometric and fitness measures of off-ice hockey tests in relation to draft order. Physical fitness measures and anthropometric data are valuable in helping predict hockey playing potential. Emphasis on anthropometry should be used when comparing elite-level forwards, whereas peak anaerobic power and fatigue rate are more useful for differentiating between defense.

Congenital rubella syndrome surveillance in Honduras.

PubMed

Molina, Ida Berenice; Mendoza, Lourdes Otilia; Palma, María Aparicia

2011-09-01

Congenital rubella syndrome (CRS) surveillance was established in Honduras to determine the scope of the problem and assess the impact of vaccination. Implementation of the surveillance system required the drafting of national CRS epidemiological surveillance guidelines, the development of a laboratory diagnostic method, and training of physicians, nurses, and microbiologists in the Honduran hospital network and social security system on CRS surveillance guidelines. Honduras' experience with the surveillance of other vaccine-preventable diseases facilitated the implementation of hospital-based CRS surveillance. The surveillance system operates in 23 of the 25 public hospitals that offer services to children and at 2 social security hospitals; the private sector has not been integrated into this system. Clinical and technical staff, including representatives from various disciplines such as pediatrics, neonatology, general medicine, epidemiology, nursing, and microbiology, participate in the hospital network, as well as follow up on cases in accordance with the standardized guidelines, depending on their areas of expertise. Implementation of the CRS surveillance system requires technical guidelines, laboratory diagnostic capacity, and trained multidisciplinary human resources for its systematization and operation.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

Experimental investigation of the local wave speed in a draft tube with cavitation vortex rope

NASA Astrophysics Data System (ADS)

Landry, C.; Favrel, A.; Müller, A.; Nicolet, C.; Yamamoto, K.; Avellan, F.

2014-03-01

Hydraulic machines operating in a wider range are subjected to cavitation developments inducing undesirable pressure pulsations which could lead to potential instability of the power plant. The occurrence of pulsating cavitation volumes in the runner and the draft tube is considered as a mass source of the system and is depending on the cavitation compliance. This dynamic parameter represents the cavitation volume variation with the respect to a variation of pressure and defines implicitly the local wave speed in the draft tube. This parameter is also decisive for an accurate prediction of system eigen frequencies. Therefore, the local wave speed in the draft tube is intrinsically linked to the eigen frequencies of the hydraulic system. Thus, if the natural frequency of a hydraulic system can be determined experimentally, it also becomes possible to estimate a local wave speed in the draft tube with a numerical model. In the present study, the reduced scale model of a Francis turbine (v=0.29) was investigated at off-design conditions. In order to measure the first eigenmode of the hydraulic test rig, an additional discharge was injected at the inlet of the hydraulic turbine at a variable frequency and amplitude to excite the system. Thus, with different pressure sensors installed on the test rig, the first eigenmode was determined. Then, a hydro-acoustic test rig model was developed with the In-house EPFL SIMSEN software and the local wave speed in the draft tube was adjusted to obtain the same first eigen frequency as that measured experimentally. Finally, this method was applied for different Thoma and Froude numbers at part load conditions.

International Society for Analytical Cytology biosafety standard for sorting of unfixed cells.

PubMed

Schmid, Ingrid; Lambert, Claude; Ambrozak, David; Marti, Gerald E; Moss, Delynn M; Perfetto, Stephen P

2007-06-01

Cell sorting of viable biological specimens has become very prevalent in laboratories involved in basic and clinical research. As these samples can contain infectious agents, precautions to protect instrument operators and the environment from hazards arising from the use of sorters are paramount. To this end the International Society of Analytical Cytology (ISAC) took a lead in establishing biosafety guidelines for sorting of unfixed cells (Schmid et al., Cytometry 1997;28:99-117). During the time period these recommendations have been available, they have become recognized worldwide as the standard practices and safety precautions for laboratories performing viable cell sorting experiments. However, the field of cytometry has progressed since 1997, and the document requires an update. Initially, suggestions about the document format and content were discussed among members of the ISAC Biosafety Committee and were incorporated into a draft version that was sent to all committee members for review. Comments were collected, carefully considered, and incorporated as appropriate into a draft document that was posted on the ISAC web site to invite comments from the flow cytometry community at large. The revised document was then submitted to ISAC Council for review. Simultaneously, further comments were sought from newly-appointed ISAC Biosafety committee members. This safety standard for performing viable cell sorting experiments was recently generated. The document contains background information on the biohazard potential of sorting and the hazard classification of infectious agents as well as recommendations on (1) sample handling, (2) operator training and personal protection, (3) laboratory design, (4) cell sorter set-up, maintenance, and decontamination, and (5) testing the instrument for the efficiency of aerosol containment. This standard constitutes an updated and expanded revision of the 1997 biosafety guideline document. It is intended to provide laboratories involved in cell sorting with safety practices that take into account the enhanced hazard potential of high-speed sorting. Most importantly, it states that droplet-based sorting of infectious or hazardous biological material requires a higher level of containment than the one recommended for the risk group classification of the pathogen. The document also provides information on safety features of novel instrumentation, new options for personal protective equipment, and recently developed methods for testing the efficiency of aerosol containment.

Canadian 24-Hour Movement Guidelines for Children and Youth: An Integration of Physical Activity, Sedentary Behaviour, and Sleep.

PubMed

Tremblay, Mark S; Carson, Valerie; Chaput, Jean-Philippe; Connor Gorber, Sarah; Dinh, Thy; Duggan, Mary; Faulkner, Guy; Gray, Casey E; Gruber, Reut; Janson, Katherine; Janssen, Ian; Katzmarzyk, Peter T; Kho, Michelle E; Latimer-Cheung, Amy E; LeBlanc, Claire; Okely, Anthony D; Olds, Timothy; Pate, Russell R; Phillips, Andrea; Poitras, Veronica J; Rodenburg, Sophie; Sampson, Margaret; Saunders, Travis J; Stone, James A; Stratton, Gareth; Weiss, Shelly K; Zehr, Lori

2016-06-01

Leaders from the Canadian Society for Exercise Physiology convened representatives of national organizations, content experts, methodologists, stakeholders, and end-users who followed rigorous and transparent guideline development procedures to create the Canadian 24-Hour Movement Guidelines for Children and Youth: An Integration of Physical Activity, Sedentary Behaviour, and Sleep. These novel guidelines for children and youth aged 5-17 years respect the natural and intuitive integration of movement behaviours across the whole day (24-h period). The development process was guided by the Appraisal of Guidelines for Research Evaluation (AGREE) II instrument and systematic reviews of evidence informing the guidelines were assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Four systematic reviews (physical activity, sedentary behaviour, sleep, integrated behaviours) examining the relationships between and among movement behaviours and several health indicators were completed and interpreted by expert consensus. Complementary compositional analyses were performed using Canadian Health Measures Survey data to examine the relationships between movement behaviours and health indicators. A stakeholder survey was employed (n = 590) and 28 focus groups/stakeholder interviews (n = 104) were completed to gather feedback on draft guidelines. Following an introductory preamble, the guidelines provide evidence-informed recommendations for a healthy day (24 h), comprising a combination of sleep, sedentary behaviours, light-, moderate-, and vigorous-intensity physical activity. Proactive dissemination, promotion, implementation, and evaluation plans have been prepared in an effort to optimize uptake and activation of the new guidelines. Future research should consider the integrated relationships among movement behaviours, and similar integrated guidelines for other age groups should be developed.

SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process.

PubMed

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2016-12-01

Since the publication of Standards for QUality Improvement Reporting Excellence (SQUIRE 1.0) guidelines in 2008, the science of the field has advanced considerably. In this manuscript, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) semistructured interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) two face-to-face consensus meetings to develop interim drafts and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasises the reporting of three key components of systematic efforts to improve the quality, value and safety of healthcare: the use of formal and informal theory in planning, implementing and evaluating improvement work; the context in which the work is done and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve healthcare, recognising that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (http://www.squire-statement.org). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Special Inspector General for Afghanistan Reconstruction Quarterly Report to the United States Congress

DTIC Science & Technology

2011-04-30

U.S. Justice Sector Support Program Operating under INL, the Justice Sector Support Program ( JSSP ) aims to develop the capacity of the Afghan criminal...investigators graduated from JSSP legal training programs.252 The JSSP also added to the number of U.S. and local Afghan lawyers on its staff, growing...drafting guidelines for an extension of the JSSP based on experiences in the preceding year. Anticipated changes include moving some functions into the

PROJECT KAIZEN. Review of the Oversight by Congress of DoD Acquisition Programs with the Aim of Continuous Improvement

DTIC Science & Technology

1994-06-01

legitimate firms from being competitive in a global market and selling to DoD. CONCLUSION While there are some improvements in the way DoD purchases...and a final report . RDT&E BUDGET EXHIBITS DRAFT RDT&E BUDGET EXHIBITS HANDBOOK PREPARATION/REVIEW GUIDELINES Craig A . Farr Dennis L. Ryan, CAPT, USN... A -1 Chapter 5. Financial Management Regulation LIST OF FIGURES Figure 1I- RDT&E Exhibits Timeline

The use and interpretation of in vitro data in regulatory toxicology: cosmetics, toiletries and household products.

PubMed

Indans, Ian

2002-02-28

There is currently a drive to eliminate animal testing for cosmetics, toiletries and household products; indeed, the European Union Cosmetics Directive aims to prohibit the use of experimental animals for the testing of finished cosmetic products after 2002. At present, national prohibitions are in place in the UK, Germany, Austria and the Netherlands, for the testing of finished cosmetic products and cosmetic ingredients. In the USA animal testing for certain types of finished products is mandatory. Against this background, the currently available regulatory in vitro tests comprise methods for eye irritation, skin corrosivity, genotoxicity, dermal penetration and photoirritation. The draft updates to the Organisation for Economic Co-operation and Development guidelines for eye and skin irritation advocate the use of in vitro or ex vivo methods prior to the commencement of animal studies. At present, testing for these endpoints cannot be completed in vitro, but potentially corrosive substances and products can be classified without the need for animal studies. Regulatory genotoxicity testing can be completed using only in vitro methods, provided that a clear negative outcome is obtained for each test. Data from dermal penetration studies may be used to refine risk assessments. Current developments in areas such as skin sensitisation and skin irritation promise that in the reasonably near future such information may be generated without the use of animals.

RAPADAPTE for rapid guideline development: high-quality clinical guidelines can be rapidly developed with limited resources.

PubMed

Alper, Brian S; Tristan, Mario; Ramirez-Morera, Anggie; Vreugdenhil, Maria M T; Van Zuuren, Esther J; Fedorowicz, Zbys

2016-06-01

Guideline development is challenging, expensive and labor-intensive. A high-quality guideline with 90 recommendations for breast cancer treatment was developed within 6 months with limited resources in Costa Rica. We describe the experience and propose a process others can use and adapt.The ADAPTE method (using existing guidelines to minimize repeating work that has been done) was used but existing guidelines were not current. The method was extended to use databases that systematically identify, appraise and synthesize evidence for clinical application (DynaMed, EBM Guidelines) to provide current evidence searches and critical appraisal of evidence. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to rate the quality of evidence and the strength of recommendations. Draft recommendations with supporting evidence were provided to panel members for facilitated voting to target panel discussion to areas necessary for reaching consensus.Training panelists in guideline development methodology facilitated rapid consensus development. Extending 'guideline adaptation' to 'evidence database adaptation' was highly effective and efficient. Methods were created to simplify mapping DynaMed evidence ratings to GRADE ratings. Twelve steps are presented to facilitate rapid guideline development and enable further adaptation by others.This is a case report and the RAPADAPTE method was retrospectively derived. Prospective replication and validation will support advances for the guideline development community. If guideline development can be accelerated without compromising validity and relevance of the resulting recommendations this would greatly improve our ability to impact clinical care. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

It's Time to Develop a New "Draft Test Protocol" for a Mars Sample Return Mission (or Two…).

PubMed

Rummel, John D; Kminek, Gerhard

2018-04-01

The last time NASA envisioned a sample return mission from Mars, the development of a protocol to support the analysis of the samples in a containment facility resulted in a "Draft Test Protocol" that outlined required preparations "for the safe receiving, handling, testing, distributing, and archiving of martian materials here on Earth" (Rummel et al., 2002 ). This document comprised a specific protocol to be used to conduct a biohazard test for a returned martian sample, following the recommendations of the Space Studies Board of the US National Academy of Sciences. Given the planned launch of a sample-collecting and sample-caching rover (Mars 2020) in 2 years' time, and with a sample return planned for the end of the next decade, it is time to revisit the Draft Test Protocol to develop a sample analysis and biohazard test plan to meet the needs of these future missions. Key Words: Biohazard detection-Mars sample analysis-Sample receiving facility-Protocol-New analytical techniques-Robotic sample handling. Astrobiology 18, 377-380.

Predicted percentage dissatisfied with ankle draft.

PubMed

Liu, S; Schiavon, S; Kabanshi, A; Nazaroff, W W

2017-07-01

Draft is unwanted local convective cooling. The draft risk model of Fanger et al. (Energy and Buildings 12, 21-39, 1988) estimates the percentage of people dissatisfied with air movement due to overcooling at the neck. There is no model for predicting draft at ankles, which is more relevant to stratified air distribution systems such as underfloor air distribution (UFAD) and displacement ventilation (DV). We developed a model for predicted percentage dissatisfied with ankle draft (PPD AD ) based on laboratory experiments with 110 college students. We assessed the effect on ankle draft of various combinations of air speed (nominal range: 0.1-0.6 m/s), temperature (nominal range: 16.5-22.5°C), turbulence intensity (at ankles), sex, and clothing insulation (<0.7 clo; lower legs uncovered and covered). The results show that whole-body thermal sensation and air speed at ankles are the dominant parameters affecting draft. The seated subjects accepted a vertical temperature difference of up to 8°C between ankles (0.1 m) and head (1.1 m) at neutral whole-body thermal sensation, 5°C more than the maximum difference recommended in existing standards. The developed ankle draft model can be implemented in thermal comfort and air diffuser testing standards. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Ulcerative colitis outpatient management: development and evaluation of tools to support primary care practitioners.

PubMed

Bennett, A L; Buckton, S; Lawrance, I; Leong, R W; Moore, G; Andrews, J M

2015-12-01

Current models of care for ulcerative colitis (UC) across healthcare systems are inconsistent with a paucity of existing guidelines or supportive tools for outpatient management. This study aimed to produce and evaluate evidence-based outpatient management tools for UC to guide primary care practitioners and patients in clinical decision-making. Three tools were developed after identifying current gaps in the provision of healthcare services for patients with UC at a Clinical Insights Meeting in 2013. Draft designs were further refined through consultation and consolidation of feedback by the steering committee. Final drafts were developed following feasibility testing in three key stakeholder groups (gastroenterologists, general practitioners and patients) by questionnaire. The tools were officially launched into mainstream use in Australia in 2014. Three quarters of all respondents liked the layout and content of each tool. Minimal safety concerns were aired and those, along with pieces of information that were felt to be omitted, that were reviewed by the steering committee and incorporated into the final documents. The majority (over 80%) of respondents felt that the tools would be useful and would improve outpatient management of UC. Evidence-based outpatient clinical management tools for UC can be developed. The concept and end-product have been well received by all stakeholder groups. These tools should support non-specialist clinicians to optimise UC management and empower patients by facilitating them to safely self-manage and identify when medical support is needed. © 2015 Royal Australasian College of Physicians.

Methodology: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement.

PubMed

Ornelas, Joe; Dichter, Jeffrey R; Devereaux, Asha V; Kissoon, Niranjan; Livinski, Alicia; Christian, Michael D

2014-10-01

Natural disasters, industrial accidents, terrorism attacks, and pandemics all have the capacity to result in large numbers of critically ill or injured patients. This supplement provides suggestions for all those involved in a disaster or pandemic with multiple critically ill patients, including front-line clinicians, hospital administrators, professional societies, and public health or government officials. The field of disaster medicine does not have the required body of evidence needed to undergo a traditional guideline development process. In result, consensus statement-development methodology was used to capture the highest-caliber expert opinion in a structured, scientific approach. Task Force Executive Committee members identified core topic areas regarding the provision of care to critically ill or injured patients from pandemics or disasters and subsequently assembled an international panel for each identified area. International disaster medicine experts were brought together to identify key questions (in a population, intervention, comparator, outcome [PICO]-based format) within each of the core topic areas. Comprehensive literature searches were then conducted to identify studies upon which evidence-based recommendations could be made. No studies of sufficient quality were identified. Therefore, the panel developed expert opinion-based suggestions that are presented in this supplement using a modified Delphi process. A total of 315 suggestions were drafted across all topic groups. After two rounds of a Delphi consensus-development process, 267 suggestions were chosen by the panel to include in the document and published in a total of 12 manuscripts composing the core chapters of this supplement. Draft manuscripts were prepared by the topic editor and members of the working groups for each of the topics, producing a total of 11 papers. Once the preliminary drafts were received, the Executive Committee (Writing Committee) then met to review, edit, and promote alignment of all of the primary drafts of the manuscripts prepared by the topic editors and their groups. The topic editors then revised their manuscripts based on the Executive Committee's edits and comments. The Writing Committee subsequently reviewed the updated drafts and prepared the final manuscripts for submission to the Guidelines Oversight Committee (GOC). The manuscripts subsequently underwent review by the GOC, including external review as well as peer review for the journal publication. The Writing Committee received the feedback from the reviewers and modified the manuscripts as required. Based on a robust and transparent process, this project used rigorous methodology to produce clinically relevant, trustworthy consensus statements, with the aim to provide needed guidance on treatment and procedures for practitioners, hospital administrators, and public health and government officials when addressing the care of critically ill or injured patients in disasters or pandemics.

2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association.

PubMed

Powers, William J; Rabinstein, Alejandro A; Ackerson, Teri; Adeoye, Opeolu M; Bambakidis, Nicholas C; Becker, Kyra; Biller, José; Brown, Michael; Demaerschalk, Bart M; Hoh, Brian; Jauch, Edward C; Kidwell, Chelsea S; Leslie-Mazwi, Thabele M; Ovbiagele, Bruce; Scott, Phillip A; Sheth, Kevin N; Southerland, Andrew M; Summers, Deborah V; Tirschwell, David L

2018-03-01

The purpose of these guidelines is to provide an up-to-date comprehensive set of recommendations for clinicians caring for adult patients with acute arterial ischemic stroke in a single document. The intended audiences are prehospital care providers, physicians, allied health professionals, and hospital administrators. These guidelines supersede the 2013 guidelines and subsequent updates. Members of the writing group were appointed by the American Heart Association Stroke Council's Scientific Statements Oversight Committee, representing various areas of medical expertise. Strict adherence to the American Heart Association conflict of interest policy was maintained. Members were not allowed to participate in discussions or to vote on topics relevant to their relations with industry. The members of the writing group unanimously approved all recommendations except when relations with industry precluded members voting. Prerelease review of the draft guideline was performed by 4 expert peer reviewers and by the members of the Stroke Council's Scientific Statements Oversight Committee and Stroke Council Leadership Committee. These guidelines use the American College of Cardiology/American Heart Association 2015 Class of Recommendations and Levels of Evidence and the new American Heart Association guidelines format. These guidelines detail prehospital care, urgent and emergency evaluation and treatment with intravenous and intra-arterial therapies, and in-hospital management, including secondary prevention measures that are appropriately instituted within the first 2 weeks. The guidelines support the overarching concept of stroke systems of care in both the prehospital and hospital settings. These guidelines are based on the best evidence currently available. In many instances, however, only limited data exist demonstrating the urgent need for continued research on treatment of acute ischemic stroke. © 2018 American Heart Association, Inc.

Developing guidelines for postgraduate dental educators in the UK.

PubMed

Bullock, A D; Firmstone, V R; Falcon, H C

2010-01-09

Commissioned by the UK Committee of Postgraduate Dental Deans and Directors (COPDEND), the purpose of this work was to establish UK guidelines for dental educators. The final document comprises 79 statements, in eight domains. Each domain has four zones related to what dental educators (1) know, (2) do with members of the dental team as learners, (3) do with other dental educators as learners and (4) lead on. Launched in November 2008, the document provides a framework of good practice for use in the employment, development and management of dental educators in the UK. The guidelines are readily available from the COPDEND website. A key purpose of this paper is to report on the process of development and a central part of that was the integration of feedback and consultation on early drafts. These processes elicited a total of 102 responses. Issues raised in consultation included: (1) how the zones interrelate; (2) differentiation between domains; (3) measurability; and (4) implementation challenges. This paper includes our responses to these issues.

ASEAN GMP and pharmaceutical industries in Indonesia.

PubMed

Soesilo, S; Sitorus, U

1995-01-01

Indonesia was appointed by the ASEAN Technical Cooperation in Pharmaceutical as a focal point and to coordinate the development of practical guidelines for the implementation of GMP. The ASEAN GMP Guidelines were endorsed by the ASEAN Technical Cooperation in Pharmaceutical in 1988, which among others required separation of Beta-Lactam dedicated facilities and three degrees of cleanliness for production areas. As it was realised that drug manufacturers in developing countries need more detailed guidelines to be able to implement the GMP, an Operational Manual for GMP was also prepared for providing examples of SOPs lay-outs, documentation etc. It was agreed by the technical cooperation group to leave the implementation of GMP to each member country. However, the ASEAN Manual for Inspection of GMP was drafted and endorsed by the group and training of ASEAN Drug Inspectors was organized to support the implementation. The ASEAN GMP is being implemented in Indonesia through a five-year, stepwise implementation plan, starting in 1989.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2005-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, this report discusses the monographs on antiretrovirals proposed for inclusion in The International Pharmacopoeia and specifications for radiopharmaceuticals, quality specifications for antituberculosis drugs and the revision of the monograph on artemisinin derivatives, as well as quality control of reference materials, good manufacturing practices (GMP), inspection, distribution and trade and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including an amendment to good manufacturing practices: main principles regarding the requirement for the sampling of starting materials, guidelines on good manufacturing practices regarding water for pharmaceutical use, guidelines on the sampling of pharmaceutical products and related materials and draft guidelines for registration of fixed-dose combination medicinal products.

Updated Draft Protocol for the Evaluation of Bactericidal Activity of Hard, Non-porous Copper Containing Surface Products

EPA Pesticide Factsheets

This document describes the updated draft testing protocol recommended by the EPA to support the registration of copper-containing surface products (such as door knobs, or other items that are not intended for food contact) that bear sanitizer claims.

78 FR 65302 - Notice of Public Meetings for the Draft Environmental Impact Statement/Overseas Environmental...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... of Guam, Leon Guerrero School of Business and Public Administration Building, Anthony Leon Guerrero... DEPARTMENT OF DEFENSE Department of the Navy Notice of Public Meetings for the Draft Environmental... Islands Training and Testing Study Area; Correction and Public Comment Period Extension AGENCY: Department...

Sequencing and De novo Draft Assemblies of the Fathead Minnow (Pimphales promelas)Reference Genome

EPA Science Inventory

This study was undertaken to develop genome-scale resources for the fathead minnow (Pimphales promelas) an important model organism widely used in both aquatic ecotoxicology research and in regulatory toxicity testing. We report on the first sequencing and two draft assemblies fo...

78 FR 69693 - Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

...] Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic... ``Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid... submitters and FDA reviewers in preparing and reviewing 510(k) submissions for nucleic acid-based HLA test...

Arizona watershed framework in the Verde River watershed

Treesearch

Ren Northrup

2000-01-01

The Arizona Department of Environmental Quality, Water Quality Division drafted a six-step approach to guide its staff and local participants in developing and implementing watershed management plans. From January 1999 through June 2000, the draft Arizona Statewide Watershed Framework will be tested in Arizona's Verde River watershed. This concept proofing...

78 FR 31943 - Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-28

... documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0558] Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements...

Payload crew activity planning integration. Task 2: Inflight operations and training for payloads

NASA Technical Reports Server (NTRS)

Hitz, F. R.

1976-01-01

The primary objectives of the Payload Crew Activity Planning Integration task were to: (1) Determine feasible, cost-effective payload crew activity planning integration methods. (2) Develop an implementation plan and guidelines for payload crew activity plan (CAP) integration between the JSC Orbiter planners and the Payload Centers. Subtask objectives and study activities were defined as: (1) Determine Crew Activity Planning Interfaces. (2) Determine Crew Activity Plan Type and Content. (3) Evaluate Automated Scheduling Tools. (4) Develop a draft Implementation Plan for Crew Activity Planning Integration. The basic guidelines were to develop a plan applicable to the Shuttle operations timeframe, utilize existing center resources and expertise as much as possible, and minimize unnecessary data exchange not directly productive in the development of the end-product timelines.

The World Health Organization’s Safe Abortion Guidance Document

PubMed Central

Van Look, Paul F. A.; Cottingham, Jane

2013-01-01

We discuss the history of the World Health Organization’s (WHO’s) development of guidelines for governments on providing safe abortion services, which WHO published as Safe Abortion: Technical and Policy Guidance for Health Systems in 2003 and updated in 2012. We show how the recognition of the devastating impact of unsafe abortion on women’s health and survival, the impetus of the International Conference on Population and Development and its five-year follow-up, and WHO’s progressive leadership at the end of the century enabled the organization to elaborate guidance on providing safe abortion services. Guideline formulation involved extensive review of published evidence, an international technical expert meeting to review the draft document, and a protracted in-house review by senior WHO management. PMID:23409886

Investigation of the status quo of massive blood transfusion in China and a synopsis of the proposed guidelines for massive blood transfusion

PubMed Central

Yang, Jiang-Cun; Wang, Qiu-Shi; Dang, Qian-Li; Sun, Yang; Xu, Cui-Xiang; Jin, Zhan-Kui; Ma, Ting; Liu, Jing

2017-01-01

Abstract The aim of this study was to provide an overview of massive transfusion in Chinese hospitals, identify the important indications for massive transfusion and corrective therapies based on clinical evidence and supporting experimental studies, and propose guidelines for the management of massive transfusion. This multiregion, multicenter retrospective study involved a Massive Blood Transfusion Coordination Group composed of 50 clinical experts specializing in blood transfusion, cardiac surgery, anesthesiology, obstetrics, general surgery, and medical statistics from 20 tertiary general hospitals across 5 regions in China. Data were collected for all patients who received ≥10 U red blood cell transfusion within 24 hours in the participating hospitals from January 1 2009 to December 31 2010, including patient demographics, pre-, peri-, and post-operative clinical characteristics, laboratory test results before, during, and after transfusion, and patient mortality at post-transfusion and discharge. We also designed an in vitro hemodilution model to investigate the changes of blood coagulation indices during massive transfusion and the correction of coagulopathy through supplement blood components under different hemodilutions. The experimental data in combination with the clinical evidence were used to determine the optimal proportion and timing for blood component supplementation during massive transfusion. Based on the findings from the present study, together with an extensive review of domestic and international transfusion-related literature and consensus feedback from the 50 experts, we drafted the guidelines on massive blood transfusion that will help Chinese hospitals to develop standardized protocols for massive blood transfusion. PMID:28767599

Threading needles in the dark: the effect of the physical work environment on nursing practice.

PubMed

Simmons, Debora; Graves, Krisanne; Flynn, Elizabeth A

2009-01-01

Frequently, the most critical calculations, considerations, and preparations for patient care and medication administration are made in noisy, dimly lit, and chaotic areas of the nursing unit. Healthcare has begun to recognize the impact of the physical work environment plays in the ability of humans to perform reliably and safely. This article reviews the draft guidelines recently released by the United States Pharmacopeia for public comment for the physical environment to promote safe medication administration.

A FRAME response to the Draft Report on Alternative (Non-animal) Methods for Cosmetics Testing: Current Status and Future Prospects--2010.

PubMed

Balls, Michael; Clothier, Richard

2010-10-01

This response on behalf of FRAME to the European Commission's consultation on the five chapters of the Draft Report on Alternative (Non-animal) Methods for Cosmetics Testing: Current Status and Future Prospects--2010, is via a Comment in ATLA, rather than via the template supplied by the Commission. This is principally so that a number of general points about cosmetic ingredient testing can be made. It is concluded that the five draft chapters do not provide a credible basis for the Commission's forthcoming report to the European Parliament and the European Council on the five cosmetic ingredient safety issues for which the 7th Amendment to the Cosmetic Directive's ban on animal testing was postponed until 2013. This is mainly because there is insufficient focus in the draft chapters on the specific nature of cosmetic ingredients, their uses, their local effects and metabolism at their sites of application, and, in particular, on whether their possible absorption into the body would be likely to lead to their accumulation in target sites at levels approaching Thresholds of Toxicological Concern. Meanwhile, there continues to be uncertainty about how the provisions of the Cosmetics Directive should be applied, given the requirements of the REACH system and directives concerned with the safety of other chemicals and products. © 2010 FRAME.

Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline.

PubMed

Peters, Anne L; Ahmann, Andrew J; Battelino, Tadej; Evert, Alison; Hirsch, Irl B; Murad, M Hassan; Winter, William E; Wolpert, Howard

2016-11-01

To formulate clinical practice guidelines for the use of continuous glucose monitoring and continuous subcutaneous insulin infusion in adults with diabetes. The participants include an Endocrine Society-appointed Task Force of seven experts, a methodologist, and a medical writer. The American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology co-sponsored this guideline. The Task Force developed this evidence-based guideline using the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned one systematic review and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Committees and members of the Endocrine Society, the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Continuous subcutaneous insulin infusion and continuous glucose monitoring have an important role in the treatment of diabetes. Data from randomized controlled trials are limited on the use of medical devices, but existing studies support the use of diabetes technology for a wide variety of indications. This guideline presents a review of the literature and practice recommendations for appropriate device use.

The Nuremberg Code–A critique

PubMed Central

Ghooi, Ravindra B.

2011-01-01

The Nuremberg Code drafted at the end of the Doctor’s trial in Nuremberg 1947 has been hailed as a landmark document in medical and research ethics. Close examination of this code reveals that it was based on the Guidelines for Human Experimentation of 1931. The resemblance between these documents is uncanny. It is unfortunate that the authors of the Nuremberg Code passed it off as their original work. There is evidence that the defendants at the trial did request that their actions be judged on the basis of the 1931 Guidelines, in force in Germany. The prosecutors, however, ignored the request and tried the defendants for crimes against humanity, and the judges included the Nuremberg Code as a part of the judgment. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. There is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki, it is not regularly reviewed and updated. The regular updating of some ethics codes is evidence of the evolving nature of human ethics. PMID:21731859

The Nuremberg Code-A critique.

PubMed

Ghooi, Ravindra B

2011-04-01

The Nuremberg Code drafted at the end of the Doctor's trial in Nuremberg 1947 has been hailed as a landmark document in medical and research ethics. Close examination of this code reveals that it was based on the Guidelines for Human Experimentation of 1931. The resemblance between these documents is uncanny. It is unfortunate that the authors of the Nuremberg Code passed it off as their original work. There is evidence that the defendants at the trial did request that their actions be judged on the basis of the 1931 Guidelines, in force in Germany. The prosecutors, however, ignored the request and tried the defendants for crimes against humanity, and the judges included the Nuremberg Code as a part of the judgment. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. There is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki, it is not regularly reviewed and updated. The regular updating of some ethics codes is evidence of the evolving nature of human ethics.

Estimation of Direct Melanoma-related Costs by Disease Stage and by Phase of Diagnosis and Treatment According to Clinical Guidelines.

PubMed

Buja, Alessandra; Sartor, Gino; Scioni, Manuela; Vecchiato, Antonella; Bolzan, Mario; Rebba, Vincenzo; Sileni, Vanna Chiarion; Palozzo, Angelo Claudio; Montesco, Maria; Del Fiore, Paolo; Baldo, Vincenzo; Rossi, Carlo Riccardo

2018-02-07

Cutaneous melanoma is a major concern in terms of healthcare systems and economics. The aim of this study was to estimate the direct costs of melanoma by disease stage, phase of diagnosis, and treatment according to the pre-set clinical guidelines drafted by the AIOM (Italian Medical Oncological Association). Based on the AIOM guidelines for malignant cutaneous melanoma, a highly detailed decision-making model was developed describing the patient's pathway from diagnosis through the subsequent phases of disease staging, surgical and medical treatment, and follow-up. The model associates each phase potentially involving medical procedures with a likelihood measure and a cost, thus enabling an estimation of the expected costs by disease stage and clinical phase of melanoma diagnosis and treatment according to the clinical guidelines. The mean per-patient cost of the whole melanoma pathway (including one year of follow-up) ranged from €149 for stage 0 disease to €66,950 for stage IV disease. The costs relating to each phase of the disease's diagnosis and treatment depended on disease stage. It is essential to calculate the direct costs of managing malignant cutaneous melanoma according to clinical guidelines in order to estimate the economic burden of this disease and to enable policy-makers to allocate appropriate resources.

Management of severe perioperative bleeding: guidelines from the European Society of Anaesthesiology: First update 2016.

PubMed

Kozek-Langenecker, Sibylle A; Ahmed, Aamer B; Afshari, Arash; Albaladejo, Pierre; Aldecoa, Cesar; Barauskas, Guidrius; De Robertis, Edoardo; Faraoni, David; Filipescu, Daniela C; Fries, Dietmar; Haas, Thorsten; Jacob, Matthias; Lancé, Marcus D; Pitarch, Juan V L; Mallett, Susan; Meier, Jens; Molnar, Zsolt L; Rahe-Meyer, Niels; Samama, Charles M; Stensballe, Jakob; Van der Linden, Philippe J F; Wikkelsø, Anne J; Wouters, Patrick; Wyffels, Piet; Zacharowski, Kai

2017-06-01

: The management of perioperative bleeding involves multiple assessments and strategies to ensure appropriate patient care. Initially, it is important to identify those patients with an increased risk of perioperative bleeding. Next, strategies should be employed to correct preoperative anaemia and to stabilise macrocirculation and microcirculation to optimise the patient's tolerance to bleeding. Finally, targeted interventions should be used to reduce intraoperative and postoperative bleeding, and so prevent subsequent morbidity and mortality. The objective of these updated guidelines is to provide healthcare professionals with an overview of the most recent evidence to help ensure improved clinical management of patients. For this update, electronic databases were searched without language restrictions from 2011 or 2012 (depending on the search) until 2015. These searches produced 18 334 articles. All articles were assessed and the existing 2013 guidelines were revised to take account of new evidence. This update includes revisions to existing recommendations with respect to the wording, or changes in the grade of recommendation, and also the addition of new recommendations. The final draft guideline was posted on the European Society of Anaesthesiology website for four weeks for review. All comments were collated and the guidelines were amended as appropriate. This publication reflects the output of this work.

Functional Hypothalamic Amenorrhea: An Endocrine Society Clinical Practice Guideline.

PubMed

Gordon, Catherine M; Ackerman, Kathryn E; Berga, Sarah L; Kaplan, Jay R; Mastorakos, George; Misra, Madhusmita; Murad, M Hassan; Santoro, Nanette F; Warren, Michelle P

2017-05-01

The American Society for Reproductive Medicine, the European Society of Endocrinology, and the Pediatric Endocrine Society. This guideline was funded by the Endocrine Society. To formulate clinical practice guidelines for the diagnosis and treatment of functional hypothalamic amenorrhea (FHA). The participants include an Endocrine Society-appointed task force of eight experts, a methodologist, and a medical writer. This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation approach to describe the strength of recommendations and the quality of evidence. The task force commissioned two systematic reviews and used the best available evidence from other published systematic reviews and individual studies. One group meeting, several conference calls, and e-mail communications enabled consensus. Endocrine Society committees and members and cosponsoring organizations reviewed and commented on preliminary drafts of this guideline. FHA is a form of chronic anovulation, not due to identifiable organic causes, but often associated with stress, weight loss, excessive exercise, or a combination thereof. Investigations should include assessment of systemic and endocrinologic etiologies, as FHA is a diagnosis of exclusion. A multidisciplinary treatment approach is necessary, including medical, dietary, and mental health support. Medical complications include, among others, bone loss and infertility, and appropriate therapies are under debate and investigation. Copyright © 2017 Endocrine Society

[Consumer involvement in the Disease Management Guideline for Asthma--a background report].

PubMed

Senger, Sylvia; Lelgemann, Monika; Kopp, Ina

2006-01-01

In the past clinical guidelines were mainly developed by experts and in everyday clinical practice almost exclusively used by clinical experts, while issues that were relevant from the patients' (consumers') point of view tended to be neglected. But then, the majority of patient information has not been perceptibly connected to clinical guidelines. Connecting the development of clinical guidelines with the development of patient information publications would make good sense for both products, though. On the one hand, evidence-based treatment guidelines could be made available to the actual target group of the clinical care process--i.e. the patients or consumers--and on the other hand, patient experiences and competencies (social evidence) might inform the production of guidelines. Such a procedure demands the cooperation of clinical experts and patients. So far there are no generally accepted methods in Germany for the practical implementation of consumer involvement on both the organizational and content level with the aim of involving patients in the development process of guidelines as well as the production of the respective patient information versions. Such a methodology shall be established as part of the National Program for Disease Management Guidelines. For the first time in this program, patient involvement is being exercised within the scope of the National Disease Management Guideline for Asthma (NDM Asthma). Here, patients are involved in the NDM development process by providing the opportunity to comment on the consented guideline draft and to participate in the translation of the NDM Asthma into a patient version. The present paper is a background report describing the current state of work and indicating consequences for some future developments.

Provider Services Network Project. Draft Final Report.

ERIC Educational Resources Information Center

Urban and Rural Systems Associates, San Francisco, CA.

This draft report on the development and testing of a child care Provider Services Network (PSN) model in Santa Clara County, California, includes a handbook (Manual to Optimize a PSN) designed to provide the State Department of Education and regional or local child care coordinating agencies with information needed to develop PSN optimization…

76 FR 34999 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

... human specimens or bacterial growth detected by continuous monitoring blood culture systems. This draft... versus SA in either human specimens or bacterial growth detected by continuous monitoring blood culture... devices that detect MRSA by growth in culture media or those devices that test for the protein, penicillin...

Unions Assail Teacher Ideas in NCLB Draft

ERIC Educational Resources Information Center

Klein, Alyson; Hoff, David J.

2007-01-01

This article reports on two national teachers' unions that have mounted a vigorous lobbying campaign to rewrite language linking teacher bonuses to student test scores and other incentive-pay provisions contained in a draft bill for reauthorizing the No Child Left Behind Act. Members of the National Education Association circulated in the halls of…

Design of a Kaplan turbine for a wide range of operating head -Curved draft tube design and model test verification-

NASA Astrophysics Data System (ADS)

KO, Pohan; MATSUMOTO, Kiyoshi; OHTAKE, Norio; DING, Hua

2016-11-01

As for turbomachine off-design performance improvement is challenging but critical for maximising the performing area. In this paper, a curved draft tube for a medium head Kaplan type hydro turbine is introduced and discussed for its significant effect on expanding operating head range. Without adding any extra structure and working fluid for swirl destruction and damping, a carefully designed outline shape of draft tube with the selected placement of center-piers successfully supresses the growth of turbulence eddy and the transport of the swirl to the outlet. Also, more kinetic energy is recovered and the head lost is improved. Finally, the model test results are also presented. The obvious performance improvement was found in the lower net head area, where the maximum efficiency improvement was measured up to 20% without compromising the best efficiency point. Additionally, this design results in a new draft tube more compact in size and so leads to better construction and manufacturing cost performance for prototype. The draft tube geometry parameter designing process was concerning the best efficiency point together with the off-design points covering various water net heads and discharges. The hydraulic performance and flow behavior was numerically previewed and visualized by solving Reynolds-Averaged Navier-Stokes equations with Shear Stress Transport turbulence model. The simulation was under the assumption of steady-state incompressible turbulence flow inside the flow passage, and the inlet boundary condition was the carefully simulated flow pattern from the runner outlet. For confirmation, the corresponding turbine efficiency performance of the entire operating area was verified by model test.

Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association.

PubMed

Jauch, Edward C; Saver, Jeffrey L; Adams, Harold P; Bruno, Askiel; Connors, J J Buddy; Demaerschalk, Bart M; Khatri, Pooja; McMullan, Paul W; Qureshi, Adnan I; Rosenfield, Kenneth; Scott, Phillip A; Summers, Debbie R; Wang, David Z; Wintermark, Max; Yonas, Howard

2013-03-01

The authors present an overview of the current evidence and management recommendations for evaluation and treatment of adults with acute ischemic stroke. The intended audiences are prehospital care providers, physicians, allied health professionals, and hospital administrators responsible for the care of acute ischemic stroke patients within the first 48 hours from stroke onset. These guidelines supersede the prior 2007 guidelines and 2009 updates. Members of the writing committee were appointed by the American Stroke Association Stroke Council's Scientific Statement Oversight Committee, representing various areas of medical expertise. Strict adherence to the American Heart Association conflict of interest policy was maintained throughout the consensus process. Panel members were assigned topics relevant to their areas of expertise, reviewed the stroke literature with emphasis on publications since the prior guidelines, and drafted recommendations in accordance with the American Heart Association Stroke Council's Level of Evidence grading algorithm. The goal of these guidelines is to limit the morbidity and mortality associated with stroke. The guidelines support the overarching concept of stroke systems of care and detail aspects of stroke care from patient recognition; emergency medical services activation, transport, and triage; through the initial hours in the emergency department and stroke unit. The guideline discusses early stroke evaluation and general medical care, as well as ischemic stroke, specific interventions such as reperfusion strategies, and general physiological optimization for cerebral resuscitation. Because many of the recommendations are based on limited data, additional research on treatment of acute ischemic stroke remains urgently needed.

Development of practice guidelines for psychological interventions in the rehabilitation of patients with oncological disease (breast, prostate, or colorectal cancer): Methods and results.

PubMed

Reese, Christina; Weis, Joachim; Schmucker, Dieter; Mittag, Oskar

2017-10-01

The goal of this project was to develop evidence- and consensus-based practice guidelines for psychological interventions in the rehabilitation of patients with oncological disease (breast, prostate, or colorectal cancer). First of all, we conducted a literature search and survey of all oncological rehabilitation centers in Germany (N = 145) to obtain a thorough perspective of the recent evidence, guidelines, the structural framework, and practice of psychological services in oncological rehabilitation. Next, an expert workshop was held with national experts from scientific departments, clinicians from rehabilitation centers, and patients. In this workshop, we drafted and agreed upon an initial version of the practice guidelines. Afterwards, the practice guidelines were sent to all head physicians and senior psychologists at oncological rehabilitation centers in Germany for approval (N = 280 questionnaires). In addition, key recommendations were discussed with a group of rehabilitation patients. Finally, the practice guidelines were revised by the expert panel and made available online to the public. The practice guidelines have been widely accepted by both the expert panel and the surveyed clinicians and patients. They include recommendations for psycho-oncological interventions that should be offered to all rehabilitation patients with breast, prostate, or colorectal cancer. They also comprise recommendations for specific problem areas concerning psychological functions, body functions, and environmental and personal factors. The practice guidelines provide detailed recommendations for high-quality psychosocial care in an oncological rehabilitation context. It is their aim to guide the multidisciplinary team, especially psychologists and physicians, in their daily practice. Copyright © 2016 John Wiley & Sons, Ltd.

Framework for continuous palliative sedation therapy in Canada.

PubMed

Dean, Mervyn M; Cellarius, Victor; Henry, Blair; Oneschuk, Doreen; Librach Canadian Society Of Palliative Care Physicians Taskforce, S Lawrence

2012-08-01

Canada does not have a standardized ethical and practice framework for continuous palliative sedation therapy (CPST). Although a number of institutional and regional guidelines exist, Canadian practice varies. Given the lack of international and national consensus on CPST, the Canadian Society for Palliative Care Physicians (CSPCP) formed a special task force to develop a consensus-based framework for CPST. Through a preliminary review of sedation practices nationally and internationally, it was determined that although considerable consensus was emerging on this topic, there remained both areas of contention and a lack of credible scientific evidence to support a definitive clinical practice guideline. This led to the creation of a framework to help guide policy, practice, and research. This framework was developed through the following steps: 1) literature review; 2) identification of issues; 3) preparation of a draft framework; 4) expert consultation and revision; 5) presentation at conferences and further revision; and 6) further revision and national consensus building. A thorough literature review, including gray literature, of sedation therapy at the end of life was conducted from which an initial framework was drafted. This document was reviewed by 30 multidisciplinary experts in Canada and internationally, revised several times, and then submitted to CSPCP members for review. Consensus was high on most parts of the framework. The framework for CPST will provide a basis for the development of safe, effective, and ethical use of CPST for patients in palliative care and at the end of life.

Study on longitudinal force simulation of heavy-haul train

NASA Astrophysics Data System (ADS)

Chang, Chongyi; Guo, Gang; Wang, Junbiao; Ma, Yingming

2017-04-01

The longitudinal dynamics model of heavy-haul trains and air brake model used in the longitudinal train dynamics (LTDs) are established. The dry friction damping hysteretic characteristic of steel friction draft gears is simulated by the equation which describes the suspension forces in truck leaf springs. The model of draft gears introduces dynamic loading force, viscous friction of steel friction and the damping force. Consequently, the numerical model of the draft gears is brought forward. The equation of LTDs is strongly non-linear. In order to solve the response of the strongly non-linear system, the high-precision and equilibrium iteration method based on the Newmark-β method is presented and numerical analysis is made. Longitudinal dynamic forces of the 20,000 tonnes heavy-haul train are tested, and models and solution method provided are verified by the test results.

Turbine-99 unsteady simulations - Validation

NASA Astrophysics Data System (ADS)

Cervantes, M. J.; Andersson, U.; Lövgren, H. M.

2010-08-01

The Turbine-99 test case, a Kaplan draft tube model, aimed to determine the state of the art within draft tube simulation. Three workshops were organized on the matter in 1999, 2001 and 2005 where the geometry and experimental data were provided as boundary conditions to the participants. Since the last workshop, computational power and flow modelling have been developed and the available data completed with unsteady pressure measurements and phase resolved velocity measurements in the cone. Such new set of data together with the corresponding phase resolved velocity boundary conditions offer new possibilities to validate unsteady numerical simulations in Kaplan draft tube. The present work presents simulation of the Turbine-99 test case with time dependent angular resolved inlet velocity boundary conditions. Different grids and time steps are investigated. The results are compared to experimental time dependent pressure and velocity measurements.

Burn disaster response planning: an urban region's approach.

PubMed

Yurt, Roger W; Lazar, Eliot J; Leahy, Nicole E; Cagliuso, Nicholas V; Rabbitts, Angela C; Akkapeddi, Vijay; Cooper, Arthur; Dajer, Antonio; Delaney, Jack; Mineo, Frank P; Silber, Steven H; Soloff, Lewis; Magbitang, Kevin; Mozingo, David W

2008-01-01

The objective of this study was to describe a draft response plan for the tiered triage, treatment, or transportation of 400 adult and pediatric victims (50/million population) of a burn disaster for the first 3 to 5 days after injury using regional resources. Review of meeting minutes and the 11 deliverables of the draft response plan was performed. The draft burn disaster response plan developed for NYC recommended: 1) City hospitals or regional burn centers within a 60-mile distance be designated as tiered Burn Disaster Receiving Hospitals (BDRH); 2) these hospitals be divided into a four-tier system, based on clinical resources; and 3) burn care supplies be provided to Tier 3 nonburn centers. Existing burn center referral guidelines were modified into a hierarchical BDRH matrix, which would vector certain patients to local or regional burn centers for initial care until capacity is reached; the remainder would be cared for in nonburn center facilities for up to 3 to 5 days until a city, regional, or national burn bed becomes available. Interfacility triage would be coordinated by a central team. Although recommendations for patient transportation, educational initiatives for prehospital and hospital providers, city-wide, interfacility or interagency communication strategies and coordination at the State or Federal levels were outlined, future initiatives will expound on these issues. An incident resulting in critically injured burn victims exceeding the capacity of local and regional burn center beds may be a reality within any community and warrants a planned response. To address this possibility within New York City, an initial draft of a burn disaster response has been created. A scaleable plan using local, state, regional, or federal health care and governmental institutions was developed.

Outlining and dictating scientific manuscripts is a useful method for health researchers: A focus group interview.

PubMed

Andresen, Kristoffer; Laursen, Jannie; Rosenberg, Jacob

2018-01-01

Young researchers may experience difficulties when writing scientific articles for publication in biomedical journals. Various methods may facilitate the writing process including outlining the paper before the actual writing and using dictation instead of writing the first draft. The aim of this study was to investigate the experiences and difficulties for young, experienced researchers when writing articles using a detailed outline and dictation of the first draft. We used qualitative focus group interviews and the study was reported according to the COnsolidated criteria for REporting Qualitative research guideline. Participants were sampled from a group of researchers participating in a writing retreat/course. The interviews were recorded on a digital recorder and transcribed. The text was analyzed according to content analysis and coded and condensed into themes and subthemes. Groups of participants were added until data saturation was reached. A total of 14 researchers participated (9 women and 5 men). Their clinical experience was median (range) of 6 (1-11) years since graduation from medical school. Two themes arose during the analyses of the data: "Process guidance with the outline as the map" and "arrival at dictation." The outline was used in the preparation phase leading up to the day of dictation and was used in collaboration with co-authors and supervisors. The participants found it to be a useful tool for preparing the manuscript and dictating their initial first full draft. Experienced young researchers found beneficial effects of using a structured outline to prepare for dictation of scientific articles. The outline was a tool that would develop in close collaboration with co-authors and mentors. With dictation, a full first draft of a manuscript can be produced in a few hours. Participants positively evaluated this structured and reproducible way of producing scientific articles.

An integrated draft gear model with the consideration of wagon body structural characteristics

NASA Astrophysics Data System (ADS)

Chang, Gao; Liangliang, Yang; Weihua, Ma; Min, Zhang; Shihui, Luo

2018-03-01

With the increase of railway wagon axle load and the growth of marshalling quantity, the problem caused by impact and vibration of vehicles is increasingly serious, which leads to the damage of vehicle structures and the components. In order to improve the reliability of longitudinal connection model for vehicle impact tests, a new railway wagon longitudinal connection model was developed to simulate and analyse vehicle impact tests. The new model is based on characteristics of longitudinal force transmission for vehicles and parts. In this model, carbodies and bogies were simplified to a particle system that can vibrate in the longitudinal direction, which corresponded to a stiffness-damping vibration system. The model consists of three sub-models, that is, coupler and draft gear sub-model, centre plate sub-model and carbody structure sub-model. Compared with conventional draft gear models, the new model was proposed with geometrical and mechanical relations of friction draft gears considered and with behaviours of sticking, sliding and impact between centre plate and centre bowl added. Besides, virtual springs between discrete carbodies were built to describe the structural deformation of carbody. A computation program for longitudinal dynamics based on vehicle impact tests was accomplished to simulate. Comparisons and analyses regarding the train dynamics outputs and vehicle impact tests were conducted. Simulation results indicate that the new wagon longitudinal connection model can provide a practical application environment for wagons, and the outputs of vehicle impact tests agree with those of field tests. The new model can also be used to study on longitudinal vibrations of different vehicles, of carbody and bogie, and of carbody itself.

Comparison of Western and Asian Guidelines Concerning the Management of Colon Cancer.

PubMed

Pellino, Gianluca; Warren, Oliver; Mills, Sarah; Rasheed, Shahnawaz; Tekkis, Paris P; Kontovounisios, Christos

2018-02-01

Guidelines are important to standardize treatments and optimize outcomes. Several societies have published authoritative guidelines for patients with colon cancer, and a certain degree of variation can be predicted. This study aims to compare Western and Asian guidelines for the management of colon cancer. A literature review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines for studies published between 2010 and 2017 by the online resources from the official Web sites of the societies/panels. Sources included guidelines by European Society of Medical Oncology, the Japanese Society for Cancer of the Colon and Rectum, and the National Comprehensive Cancer Network. Only full-text studies and the latest guidelines dealing with colon cancer were included. Studies and guidelines were separately assessed by 2 authors, who independently identified discrepancies and areas for further research. These were discussed and agreed with by all the authors. The recommendations of the guidelines of each society were compared, seeking discrepancies and potential areas for improvement. Endoscopic techniques for the management of early colon cancer are discussed in detail in the Asian guidelines. Asian guidelines advocate extended (D3) lymphadenectomy on a routine basis in T3/T4 and in selected T2 patients, whereas such an approach is still under investigation in Western countries. Only US guidelines describe neoadjuvant chemotherapy and radiotherapy. All the guidelines recommend adjuvant treatment in selected stage II patients, but agreement exists that this is performed without solid evidence, because better outcomes are hypothesized based on studies including stage III or stage II/III patients. The role of cytoreductive surgery with intra-abdominal chemotherapy is dubious, and European guidelines only recommend it in the setting of trials. Asian guidelines endorse an aggressive surgical approach to peritoneal disease. Only US guidelines include a patient advocate in the drafting panel. Bias may have arisen from country-specific socioeconomic and cultural issues, and from the latest available updates. Surgical approaches to colon cancer differ significantly among Western and Asian guidelines, reflecting different concepts of treatment. The role of adjuvant treatment in node-negative disease and quality-of-life assessment need further research.

United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU).

PubMed

Löhr, J Matthias; Dominguez-Munoz, Enrique; Rosendahl, Jonas; Besselink, Marc; Mayerle, Julia; Lerch, Markus M; Haas, Stephan; Akisik, Fatih; Kartalis, Nikolaos; Iglesias-Garcia, Julio; Keller, Jutta; Boermeester, Marja; Werner, Jens; Dumonceau, Jean-Marc; Fockens, Paul; Drewes, Asbjorn; Ceyhan, Gürlap; Lindkvist, Björn; Drenth, Joost; Ewald, Nils; Hardt, Philip; de Madaria, Enrique; Witt, Heiko; Schneider, Alexander; Manfredi, Riccardo; Brøndum, Frøkjer J; Rudolf, Sasa; Bollen, Thomas; Bruno, Marco

2017-03-01

There have been substantial improvements in the management of chronic pancreatitis, leading to the publication of several national guidelines during recent years. In collaboration with United European Gastroenterology, the working group on 'Harmonizing diagnosis and treatment of chronic pancreatitis across Europe' (HaPanEU) developed these European guidelines using an evidence-based approach. Twelve multidisciplinary review groups performed systematic literature reviews to answer 101 predefined clinical questions. Recommendations were graded using the Grading of Recommendations Assessment, Development and Evaluation system and the answers were assessed by the entire group in a Delphi process online. The review groups presented their recommendations during the 2015 annual meeting of United European Gastroenterology. At this one-day, interactive conference, relevant remarks were voiced and overall agreement on each recommendation was quantified using plenary voting (Test and Evaluation Directorate). After a final round of adjustments based on these comments, a draft version was sent out to external reviewers. The 101 recommendations covered 12 topics related to the clinical management of chronic pancreatitis: aetiology (working party (WP)1), diagnosis of chronic pancreatitis with imaging (WP2 and WP3), diagnosis of pancreatic exocrine insufficiency (WP4), surgery in chronic pancreatitis (WP5), medical therapy (WP6), endoscopic therapy (WP7), treatment of pancreatic pseudocysts (WP8), pancreatic pain (WP9), nutrition and malnutrition (WP10), diabetes mellitus (WP11) and the natural course of the disease and quality of life (WP12). Using the Grading of Recommendations Assessment, Development and Evaluation system, 70 of the 101 (70%) recommendations were rated as 'strong' and plenary voting revealed 'strong agreement' for 99 (98%) recommendations. The 2016 HaPanEU/United European Gastroenterology guidelines provide evidence-based recommendations concerning key aspects of the medical and surgical management of chronic pancreatitis based on current available evidence. These recommendations should serve as a reference standard for existing management of the disease and as a guide for future clinical research.

Predicting higher selection in elite junior Australian Rules football: The influence of physical performance and anthropometric attributes.

PubMed

Robertson, Sam; Woods, Carl; Gastin, Paul

2015-09-01

To develop a physiological performance and anthropometric attribute model to predict Australian Football League draft selection. Cross-sectional observational. Data was obtained (n=4902) from three Under-18 Australian football competitions between 2010 and 2013. Players were allocated into one of the three groups, based on their highest level of selection in their final year of junior football (Australian Football League Drafted, n=292; National Championship, n=293; State-level club, n=4317). Physiological performance (vertical jumps, agility, speed and running endurance) and anthropometric (body mass and height) data were obtained. Hedge's effect sizes were calculated to assess the influence of selection-level and competition on these physical attributes, with logistic regression models constructed to discriminate Australian Football League Drafted and National Championship players. Rule induction analysis was undertaken to determine a set of rules for discriminating selection-level. Effect size comparisons revealed a range of small to moderate differences between State-level club players and both other groups for all attributes, with trivial to small differences between Australian Football League Drafted and National Championship players noted. Logistic regression models showed multistage fitness test, height and 20 m sprint time as the most important attributes in predicting Draft success. Rule induction analysis showed that players displaying multistage fitness test scores of >14.01 and/or 20 m sprint times of <2.99 s were most likely to be recruited. High levels of performance in aerobic and/or speed tests increase the likelihood of elite junior Australian football players being recruited to the highest level of the sport. Copyright © 2014 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Proposal for defining the relevance of drug accumulation derived from single dose study data for modified release dosage forms

PubMed Central

Scheerans, Christian; Heinig, Roland; Mueck, Wolfgang

2015-01-01

Recently, the European Medicines Agency (EMA) published the new draft guideline on the pharmacokinetic and clinical evaluation of modified release (MR) formulations. The draft guideline contains the new requirement of performing multiple dose (MD) bioequivalence studies, in the case when the MR formulation is expected to show ‘relevant’ drug accumulation at steady state (SS). This new requirement reveals three fundamental issues, which are discussed in the current work: first, measurement for the extent of drug accumulation (MEDA) predicted from single dose (SD) study data; second, its relationship with the percentage residual area under the plasma concentration–time curve (AUC) outside the dosing interval (τ) after SD administration, %AUC(τ-∞)SD; and third, the rationale for a threshold of %AUC(τ-∞)SD that predicts ‘relevant’ drug accumulation at SS. This work revealed that the accumulation ratio RA,AUC, derived from the ratio of the time-averaged plasma concentrations during τ at SS and after SD administration, respectively, is the ‘preferred’ MEDA for MR formulations. A causal relationship was derived between %AUC(τ-∞)SD and RA,AUC, which is valid for any drug (product) that shows (dose- and time-) linear pharmacokinetics regardless of the shape of the plasma concentration–time curve. Considering AUC thresholds from other guidelines together with the causal relationship between %AUC(τ-∞)SD and RA,AUC indicates that values of %AUC(τ-∞)SD ≤ 20%, resulting in RA,AUC ≤ 1.25, can be considered as leading to non-relevant drug accumulation. Hence, the authors suggest that 20% for %AUC(τ-∞)SD is a reasonable threshold and selection criterion between SD or MD study designs for bioequivalence studies of new MR formulations. © 2014 The Authors Biopharmaceutics & Drug Disposition Published by John Wiley & Sons Ltd. PMID:25327367

A Screening Assessment of the Potential Impacts of Climate ...

EPA Pesticide Factsheets

EPA has released this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. EPA will consider any public comments submitted in accordance with this notice when revising the document. The report is a screening level analysis intended to determine the scope and magnitude of global change impacts rather than a detailed assessment of specific impacts and adaptation measures.

Another Look at the Draft Mil-Std-1540E Unit Random Vibration Test Requirements

NASA Astrophysics Data System (ADS)

Perl, E.; Peterson, A. J..; Davis, D.

2012-07-01

The draft Mil-Std-1540E has been updated to reflect lessons learned since its publication as an SMC Standard in 2008, [1], and an earlier Aerospace Corporation Technical Report released in 2006, [2]. This paper discusses the technical rationale supporting some of the unit random vibration test requirements to provide better insight into their derivation and application to programs. It is intended that these requirements be tailored for each program to reflect the customer risk profile. Several tailoring options are provided and a two phase test strategy is discussed to highlight its applicability to utilizing heritage hardware in new applications.

Field Testing of Alternative Cookstove Performance in a Rural Setting of Western India

PubMed Central

Muralidharan, Veena; Sussan, Thomas E.; Limaye, Sneha; Koehler, Kirsten; Williams, D’Ann L.; Rule, Ana M.; Juvekar, Sanjay; Breysse, Patrick N.; Salvi, Sundeep; Biswal, Shyam

2015-01-01

Nearly three billion people use solid fuels for cooking and heating, which leads to extremely high levels of household air pollution and is a major cause of morbidity and mortality. Many stove manufacturers have developed alternative cookstoves (ACSs) that are aimed at reducing emissions and fuel consumption. Here, we tested a traditional clay chulha cookstove (TCS) and five commercially available ACSs, including both natural draft (Greenway Smart Stove, Envirofit PCS-1) and forced draft stoves (BioLite HomeStove, Philips Woodstove HD4012, and Eco-Chulha XXL), in a test kitchen in a rural village of western India. Compared to the TCS, the ACSs produced significant reductions in particulate matter less than 2.5 µm (PM2.5) and CO concentrations (Envirofit: 22%/16%, Greenway: 24%/42%, BioLite: 40%/35%, Philips: 66%/55% and Eco-Chulha: 61%/42%), which persisted after normalization for fuel consumption or useful energy. PM2.5 and CO concentrations were lower for forced draft stoves than natural draft stoves. Furthermore, the Philips and Eco-Chulha units exhibited higher cooking efficiency than the TCS. Despite significant reductions in concentrations, all ACSs failed to achieve PM2.5 levels that are considered safe by the World Health Organization (ACSs: 277–714 μg/m3 or 11–28 fold higher than the WHO recommendation of 25 μg/m3;). PMID:25654775

A novel test cage with an air ventilation system as an alternative to conventional cages for the efficacy testing of mosquito repellents.

PubMed

Obermayr, U; Rose, A; Geier, M

2010-11-01

We have developed a novel test cage and improved method for the evaluation of mosquito repellents. The method is compatible with the United States Environmental Protection Agency, 2000 draft OPPTS 810.3700 Product Performance Test Guidelines for Testing of Insect Repellents. The Biogents cages (BG-cages) require fewer test mosquitoes than conventional cages and are more comfortable for the human volunteers. The novel cage allows a section of treated forearm from a volunteer to be exposed to mosquito probing through a window. This design minimizes residual contamination of cage surfaces with repellent. In addition, an air ventilation system supplies conditioned air to the cages after each single test, to flush out and prevent any accumulation of test substances. During biting activity tests, the untreated skin surface does not receive bites because of a screen placed 150 mm above the skin. Compared with the OPPTS 810.3700 method, the BG-cage is smaller (27 liters, compared with 56 liters) and contains 30 rather than hundreds of blood-hungry female mosquitoes. We compared the performance of a proprietary repellent formulation containing 20% KBR3023 with four volunteers on Aedes aegypti (L.) (Diptera: Culicidae) in BG- and conventional cages. Repellent protection time was shorter in tests conducted with conventional cages. The average 95% protection time was 4.5 +/- 0.4 h in conventional cages and 7.5 +/- 0.6 h in the novel BG-cages. The protection times measured in BG-cages were more similar to the protection times determined with these repellents in field tests.

Martins Creek SES 800 MW-Units 3 and 4: design and operating experience with axial flow FD and ID fans

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

Curley, C.C.; Olesen, P.

1976-09-01

The Martins Creek SES units 3 and 4 are 820 MW crude oil- or residual oil-fired power units. The forced draft and induced draft fans used in the plants are variable pitch axial flow units. The design, operation, maintenance, and field testing of these fans are discussed. (LCL)

Recommendations for the follow-up care of female breast cancer survivors: a guideline of the Spanish Society of Medical Oncology (SEOM), Spanish Society of General Medicine (SEMERGEN), Spanish Society for Family and Community Medicine (SEMFYC), Spanish Society for General and Family Physicians (SEMG), Spanish Society of Obstetrics and Gynecology (SEGO), Spanish Society of Radiation Oncology (SEOR), Spanish Society of Senology and Breast Pathology (SESPM), and Spanish Society of Cardiology (SEC).

PubMed

Barnadas, A; Algara, M; Cordoba, O; Casas, A; Gonzalez, M; Marzo, M; Montero, A; Muñoz, M; Ruiz, A; Santolaya, F; Fernandez, T

2018-06-01

The increased incidence and decreased mortality of breast cancer have produced an increased number of breast cancer survivors. The type of sequelae and comorbidities that these patients present call for a collaborative follow-up by hospital-based specialized care and primary care. In this document, we present a guideline drafted and agreed among scientific societies whose members care for breast cancer survivors. The purpose of this guideline is to achieve the shared and coordinated follow-up of these patients by specialized care and primary care professionals. In it, we review the health issues derived from the treatments performed, with recommendations about the therapeutic approach to each of them, as well as a proposal for joint follow-up by primary and specialized care.

Developing an Inpatient Group Psychotherapy Program: Challenges and Lessons Learnt

PubMed Central

Razaghi, Emran Mohammad; Tabatabaee, Maryam; Pourramzani, Ali; Shirali Mohammadpour, Reza; Mousazade Moghaddam, Arezou; Yahyavi, Seyyed Taha

2015-01-01

In Iran, inpatient group psychotherapy has been limited to transient practices for research purposes or fulfilling personal interest of therapists. The goal of this paper is to share and explain the experience of developing an inpatient group psychotherapy program in Roozbeh Psychiatric Hospital, Tehran, Iran. After theoretical delineation and preparation of a draft of the program guideline, two pilot sessions were held. Based on this initial experience a final treatment guideline was prepared. Afterwards, the program was continued for more than 1 year in a female ward at Roozbeh Psychiatric Hospital. The output of this exercise was a guideline that covers important topics in development of inpatient group psychotherapy. It is concluded that inpatient group psychotherapy has its unique challenges. Of the most important challenges that can be mentioned in this regard are the participation of patients with significant differences in levels of psychopathology and psychiatric signs and symptoms, and high comorbidity with specific personality traits or disorders. Other challenges relevant to the structure of the group include items such as very limited time for working through and inevitable out-of-group contacts. PMID:26576176

Using a wiki platform to promote guidelines internationally and maintain their currency: evidence-based guidelines for the nutritional management of adult patients with head and neck cancer.

PubMed

Brown, T; Findlay, M; von Dincklage, J; Davidson, W; Hill, J; Isenring, E; Talwar, B; Bell, K; Kiss, N; Kurmis, R; Loeliger, J; Sandison, A; Taylor, K; Bauer, J

2013-04-01

The present study describes the development of evidence-based practice guidelines for the nutritional management of adult patients with head and neck cancer using a wiki platform to enable wide international stakeholder consultation and maintain currency. A dietitian steering committee and a multidisciplinary steering committee were established for consultation. Traditional methods of evidence-based guideline development were utilised to perform the literature review, assess the evidence and produce a draft document. This was transferred to a wiki platform for stakeholder consultation and international endorsement processes in Australia, New Zealand and the UK. Data were collected on website traffic utilising Google Analytics. In addition to broad stakeholder consultation through the steering committees, an additional twenty comments were received via the wiki by twelve individuals covering six different professions from three different countries, compared to four comments by e-mail. The guidelines were subsequently endorsed by the dietetic associations of Australia, New Zealand and the UK. During a 4-month period monitoring the use of the guidelines, there were 2303 page views to the landing page from 33 countries. The average number of pages accessed per visit was five and the duration of time spent on the website was approximately 6 min. Using a wiki platform for guideline development and dissemination is a successful method for producing high-quality resources that can undergo wide international stakeholder review and include open public consultation. This can replace conventional methods whereby guidelines can quickly become outdated. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

Clinical practice guidelines for support of the family in the patient-centered intensive care unit: American College of Critical Care Medicine Task Force 2004-2005.

PubMed

Davidson, Judy E; Powers, Karen; Hedayat, Kamyar M; Tieszen, Mark; Kon, Alexander A; Shepard, Eric; Spuhler, Vicki; Todres, I David; Levy, Mitchell; Barr, Juliana; Ghandi, Raj; Hirsch, Gregory; Armstrong, Deborah

2007-02-01

To develop clinical practice guidelines for the support of the patient and family in the adult, pediatric, or neonatal patient-centered ICU. A multidisciplinary task force of experts in critical care practice was convened from the membership of the American College of Critical Care Medicine (ACCM) and the Society of Critical Care Medicine (SCCM) to include representation from adult, pediatric, and neonatal intensive care units. The task force members reviewed the published literature. The Cochrane library, Cinahl, and MedLine were queried for articles published between 1980 and 2003. Studies were scored according to Cochrane methodology. Where evidence did not exist or was of a low level, consensus was derived from expert opinion. The topic was divided into subheadings: decision making, family coping, staff stress related to family interactions, cultural support, spiritual/religious support, family visitation, family presence on rounds, family presence at resuscitation, family environment of care, and palliative care. Each section was led by one task force member. Each section draft was reviewed by the group and debated until consensus was achieved. The draft document was reviewed by a committee of the Board of Regents of the ACCM. After steering committee approval, the draft was approved by the SCCM Council and was again subjected to peer review by this journal. More than 300 related studies were reviewed. However, the level of evidence in most cases is at Cochrane level 4 or 5, indicating the need for further research. Forty-three recommendations are presented that include, but are not limited to, endorsement of a shared decision-making model, early and repeated care conferencing to reduce family stress and improve consistency in communication, honoring culturally appropriate requests for truth-telling and informed refusal, spiritual support, staff education and debriefing to minimize the impact of family interactions on staff health, family presence at both rounds and resuscitation, open flexible visitation, way-finding and family-friendly signage, and family support before, during, and after a death.

Canadian 24-Hour Movement Guidelines for the Early Years (0-4 years): An Integration of Physical Activity, Sedentary Behaviour, and Sleep.

PubMed

Tremblay, Mark S; Chaput, Jean-Philippe; Adamo, Kristi B; Aubert, Salomé; Barnes, Joel D; Choquette, Louise; Duggan, Mary; Faulkner, Guy; Goldfield, Gary S; Gray, Casey E; Gruber, Reut; Janson, Katherine; Janssen, Ian; Janssen, Xanne; Jaramillo Garcia, Alejandra; Kuzik, Nicholas; LeBlanc, Claire; MacLean, Joanna; Okely, Anthony D; Poitras, Veronica J; Rayner, Mary-Ellen; Reilly, John J; Sampson, Margaret; Spence, John C; Timmons, Brian W; Carson, Valerie

2017-11-20

The Canadian Society for Exercise Physiology convened representatives of national organizations, research experts, methodologists, stakeholders, and end-users who followed rigorous and transparent guideline development procedures to create the Canadian 24-Hour Movement Guidelines for the Early Years (0-4 years): An Integration of Physical Activity, Sedentary Behaviour, and Sleep. These novel guidelines for children of the early years embrace the natural and intuitive integration of movement behaviours across the whole day (24-h period). The development process was guided by the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. Four systematic reviews (physical activity, sedentary behaviour, sleep, combined behaviours) examining the relationships within and among movement behaviours and several health indicators were completed and interpreted by a Guideline Development Panel. The systematic reviews that were conducted to inform the development of the guidelines, and the framework that was applied to develop the recommendations, followed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology. Complementary compositional analyses were performed using data from the Canadian Health Measures Survey to examine the relationships between movement behaviours and indicators of adiposity. A review of the evidence on the cost effectiveness and resource use associated with the implementation of the proposed guidelines was also undertaken. A stakeholder survey (n = 546), 10 key informant interviews, and 14 focus groups (n = 92 participants) were completed to gather feedback on draft guidelines and their dissemination. The guidelines provide evidence-informed recommendations as to the combinations of light-, moderate- and vigorous-intensity physical activity, sedentary behaviours, and sleep that infants (<1 year), toddlers (1-2 years) and preschoolers (3-4 years) should achieve for a healthy day (24 h). Proactive dissemination, promotion, implementation, and evaluation plans were prepared to optimize uptake and activation of the new guidelines. These guidelines represent a sensible evolution of public health guidelines whereby optimal health is framed within the balance of movement behaviours across the whole day, while respecting preferences of end-users. Future research should consider the integrated relationships among movement behaviours, and similar integrated guidelines for other age groups should be developed.

Strategies for an effective tobacco harm reduction policy in Indonesia

PubMed Central

Nurwidya, Fariz; Takahashi, Fumiyuki; Baskoro, Hario; Hidayat, Moulid; Yunus, Faisal; Takahashi, Kazuhisa

2014-01-01

Tobacco consumption is a major causative agent for various deadly diseases such as coronary artery disease and cancer. It is the largest avoidable health risk in the world, causing more problems than alcohol, drug use, high blood pressure, excess body weight or high cholesterol. As countries like Indonesia prepare to develop national policy guidelines for tobacco harm reduction, the scientific community can help by providing continuous ideas and a forum for sharing and distributing information, drafting guidelines, reviewing best practices, raising funds, and establishing partnerships. We propose several strategies for reducing tobacco consumption, including advertisement interference, cigarette pricing policy, adolescent smoking prevention policy, support for smoking cessation therapy, special informed consent for smokers, smoking prohibition in public spaces, career incentives, economic incentives, and advertisement incentives. We hope that these strategies would assist people to avoid starting smoking or in smoking cessation. PMID:25518881

Feeding in the first year of life - emerging benefits of introducing complementary solids from 4 months.

PubMed

Symon, Brian; Bammann, Michael

2012-04-01

Current World Health Organization guidelines recommend exclusive breastfeeding for the first 6 months of life. Breastfeeding conveys clear benefits to both mother and child. These benefits are likely to be amplified by prolonged feeding. This article outlines the emerging evidence that suggests possible benefits from introducing complementary solids from 4 months of age in developed countries. The human gut may have a critical early window during which it has an opportunity to develop immunological tolerance. Introducing complementary solids from 4 months of age may decrease the risk of food allergy and coeliac disease - immunological illnesses that have become a public health priority. The new draft National Health and Medical Research Council guidelines recommend introducing solids at around 6 months (22-26 weeks). However, given recent evidence, it may be appropriate to recommend the introduction of solids from 4 months of age in the Australian context.

The clinical development process for a novel preventive vaccine: An overview.

PubMed

Singh, K; Mehta, S

2016-01-01

Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.

Radiated Emissions Test Approach

DOT National Transportation Integrated Search

2015-10-02

1. Draft Department of Transportation (DOT) Test Plan to Develop : Interference Tolerance Masks for GNSS Receivers in the L1 : Radiofrequency Band (1559 1610 MHz) provides high level : overview of radiated emissions test setup : 2. Presenta...

Guideline on cochlear implants.

PubMed

Manrique, Manuel; Ramos, Ángel; de Paula Vernetta, Carlos; Gil-Carcedo, Elisa; Lassaleta, Luis; Sanchez-Cuadrado, Isabel; Espinosa, Juan Manuel; Batuecas, Ángel; Cenjor, Carlos; Lavilla, María José; Núñez, Faustino; Cavalle, Laura; Huarte, Alicia

2018-03-26

In the last decade numerous hospitals have started to work with patients who are candidates for a cochlear implant (CI) and there have been numerous and relevant advances in the treatment of sensorineural hearing loss that extended the indications for cochlear implants. To provide a guideline on cochlear implants to specialists in otorhinolaryngology, other medical specialities, health authorities and society in general. The Scientific Committees of Otology, Otoneurology and Audiology from the Spanish Society of Otolaryngology and Head and Neck Surgery (SEORL-CCC), in a coordinated and agreed way, performed a review of the current state of CI based on the existing regulations and in the scientific publications referenced in the bibliography of the document drafted. The clinical guideline on cochlear implants provides information on: a) Definition and description of Cochlear Implant; b) Indications for cochlear implants; c) Organizational requirements for a cochlear implant programme. A clinical guideline on cochlear implants has been developed by a Committee of Experts of the SEORL-CCC, to help and guide all the health professionals involved in this field of CI in decision-making to treathearing impairment. Copyright © 2018 Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. Publicado por Elsevier España, S.L.U. All rights reserved.

Spanish Guidelines on Treatment of Bronchiectasis in Adults.

PubMed

Martínez-García, Miguel Ángel; Máiz, Luis; Olveira, Casilda; Girón, Rosa Maria; de la Rosa, David; Blanco, Marina; Cantón, Rafael; Vendrell, Montserrat; Polverino, Eva; de Gracia, Javier; Prados, Concepción

2018-02-01

In 2008, the Spanish Society of Pulmonology (SEPAR) published the first guidelines in the world on the diagnosis and treatment of bronchiectasis. Almost 10 years later, considerable scientific advances have been made in both the treatment and the evaluation and diagnosis of this disease, and the original guidelines have been updated to include the latest therapies available for bronchiectasis. These new recommendations have been drafted following a strict methodological process designed to ensure quality of content, and are linked to a large amount of online information that includes a wealth of references. The guidelines are focused on the treatment of bronchiectasis from both a multidisciplinary perspective, including specialty areas and the different healthcare levels involved, and a multidimensional perspective, including a comprehensive overview of the specific aspects of the disease. A series of recommendations have been drawn up, based on an in-depth review of the evidence for treatment of the underlying etiology, the bronchial infection in its different forms of presentation using existing therapies, bronchial inflammation, and airflow obstruction. Nutritional aspects, management of secretions, muscle training, management of complications and comorbidities, infection prophylaxis, patient education, home care, surgery, exacerbations, and patient follow-up are addressed. Copyright © 2017 SEPAR. Publicado por Elsevier España, S.L.U. All rights reserved.

Treatment of Cushing's Syndrome: An Endocrine Society Clinical Practice Guideline

PubMed Central

Nieman, Lynnette K.; Biller, Beverly M. K.; Findling, James W.; Murad, M. Hassan; Newell-Price, John; Savage, Martin O.; Tabarin, Antoine

2015-01-01

Objective: The objective is to formulate clinical practice guidelines for treating Cushing's syndrome. Participants: Participants include an Endocrine Society-appointed Task Force of experts, a methodologist, and a medical writer. The European Society for Endocrinology co-sponsored the guideline. Evidence: The Task Force used the Grading of Recommendations, Assessment, Development, and Evaluation system to describe the strength of recommendations and the quality of evidence. The Task Force commissioned three systematic reviews and used the best available evidence from other published systematic reviews and individual studies. Consensus Process: The Task Force achieved consensus through one group meeting, several conference calls, and numerous e-mail communications. Committees and members of The Endocrine Society and the European Society of Endocrinology reviewed and commented on preliminary drafts of these guidelines. Conclusions: Treatment of Cushing's syndrome is essential to reduce mortality and associated comorbidities. Effective treatment includes the normalization of cortisol levels or action. It also includes the normalization of comorbidities via directly treating the cause of Cushing's syndrome and by adjunctive treatments (eg, antihypertensives). Surgical resection of the causal lesion(s) is generally the first-line approach. The choice of second-line treatments, including medication, bilateral adrenalectomy, and radiation therapy (for corticotrope tumors), must be individualized to each patient. PMID:26222757

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

Petruccelli, Umberto, E-mail: umberto.petruccelli@unibas.it

Many studies about the external costs generated by the transport system have been developed in the last twenty years. To standardize methodologies and assessment procedures to be used in the evaluation of the projects, some European countries recently have adopted specific guidelines that differ from each other in some aspects even sensibly. This paper presents a critical analysis of the British, Italian and German guidelines and is aimed at cataloguing the external cost types regarded and the assessment methods indicated as well as to highlight the differences of the results, in terms of applicability and reliability. The goal is tomore » contribute to a European standardization process that would lead to the drafting of guidelines suited for all EU countries. - Highlights: • The analyzed guidelines agree on the methods to evaluate costs from air pollution, greenhouse gases and accidents. • They recommend respectively: dose-resp. approach; costs to reduce/permit emissions; whole direct, indirect and social costs. • For noise, DE guide indicates defensive expenditure or SP methods; IT guide, SP method; UK guide, the hedonic prices one. • For on territory impact, DE guide regards only the barrier effect; the IT one, also the soil consumption and system effects. • British guide proposes a qualitative methodology to estimate the impact on various landscapes and environments.« less

Processes to manage analyses and publications in a phase III multicenter randomized clinical trial

PubMed Central

2014-01-01

Background The timely publication of findings in peer-reviewed journals is a primary goal of clinical research. In clinical trials, the processes leading to publication can be complex from choice and prioritization of analytic topics through to journal submission and revisions. As little literature exists on the publication process for multicenter trials, we describe the development, implementation, and effectiveness of such a process in a multicenter trial. Methods The Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial included a data coordinating center (DCC) and clinical centers that recruited and followed more than 1,000 patients. Publication guidelines were approved by the steering committee, and the publications committee monitored the publication process from selection of topics to publication. Results A total of 73 manuscripts were published in 23 peer-reviewed journals. When manuscripts were closely tracked, the median time for analyses and drafting of manuscripts was 8 months. The median time for data analyses was 5 months and the median time for manuscript drafting was 3 months. The median time for publications committee review, submission, and journal acceptance was 7 months, and the median time from analytic start to journal acceptance was 18 months. Conclusions Effective publication guidelines must be comprehensive, implemented early in a trial, and require active management by study investigators. Successful collaboration, such as in the HALT-C trial, can serve as a model for others involved in multidisciplinary and multicenter research programs. Trial registration The HALT-C Trial was registered with clinicaltrials.gov (NCT00006164). PMID:24886378

Management of neonatal cholestasis: consensus statement of the Pediatric Gastroenterology Chapter of Indian Academy of Pediatrics.

PubMed

Bhatia, Vidyut; Bavdekar, Ashish; Matthai, John; Waikar, Yogesh; Sibal, Anupam

2014-03-01

Neonatal cholestasis is an important cause of chronic liver disease in young children. Late referral and lack of precise etiological diagnosis are reasons for poor outcome in substantial number of cases in India. There is a need to create better awareness among the pediatricians, obstetricians and primary care physicians on early recognition, prompt evaluation and referral to regional centers. Eminent national faculty members were invited to participate in the process of forming a consensus statement. Selected members were requested to prepare guidelines on specific issues, which were reviewed by two other members. These guidelines were then incorporated into a draft statement, which was circulated to all members. A round table conference was organized; presentations, ensuing discussions, and opinions expressed by the participants were incorporated into the final draft. To review available published data on the subject from India and the West, to discuss current diagnostic and management practices in major centers in India, and to identify various problems in effective diagnosis and ways to improve the overall outcome. Current problems faced in different areas were discussed and possible remedial measures were identified. The ultimate aim would be to achieve results comparable to the West. Early recognition, prompt evaluation and algorithm-based management will improve outcome in neonatal cholestasis. Inclusion of stool/urine color charts in well baby cards and sensitizing pediatricians about differentiating conjugated from the more common unconjugated hyperbilirubinemia are possible effective steps. Considering the need for specific expertise and the poor outcome in sub- optimally managed cases, referral to regional centers is warranted.

Practice guidelines for evaluating new fever in critically ill adult patients. Task Force of the Society of Critical Care Medicine and the Infectious Diseases Society of America.

PubMed

O'Grady, N P; Barie, P S; Bartlett, J G; Bleck, T; Garvey, G; Jacobi, J; Linden, P; Maki, D G; Nam, M; Pasculle, W; Pasquale, M D; Tribett, D L; Masur, H

1998-05-01

The development of practice guidelines for evaluating adult patients who develop new fever in the intensive care unit (ICU) for the purpose of guiding clinical practice. A task force of 13 experts in disciplines related to critical care medicine, infectious diseases, and surgery was convened from the membership of the Society of Critical Care Medicine and the Infectious Disease Society of America. The task force members provided personal experience and determined the published literature (articles retrieved with use of MEDLINE or textbooks) from which consensus would be sought. The published literature was reviewed and classified into one of four categories, according to study design and scientific value. The task force met several times in person and twice monthly by teleconference over a 1-year period to identify the pertinent literature and arrive at consensus recommendations. Consideration was given to the relationship between the weight of scientific evidence and the experts' opinions. Draft documents were composed and debated by the task force until consensus was reached by nominal group process. The panel concluded that because fever can have many infectious and noninfectious etiologies, a new fever in an adult patient in the ICU should trigger a careful clinical assessment rather than automatic orders for laboratory and radiological tests. A cost-conscious approach to obtaining diagnostic studies should be undertaken if they are indicated after a clinical evaluation. The goal of such an approach is to determine, in a directed manner, whether infection is present so that additional testing can be avoided and therapeutic options can be identified.

Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors.

PubMed

Checketts, Jake X; Sims, Matthew Thomas; Vassar, Matt

2017-12-01

It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10 000, and 18 accepted more than $50 000. Financial payments amounted to a mean of $157 177 per author. The total reimbursement among the 49 authors from 2013 to 2015 was $7 701 681. Of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. Authors received payments from companies with products directly related to the guideline topic. Violations to the Administrative Regulations were found. Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments. The American Academy of Dermatology policies may benefit from stricter enforcement or the adoption of new standards.

index

Science.gov Websites

) Control panel layout and wiring diagram. (Rev. 6, 12/14/06). 2. SUMMARY AND TEST INFORMATION Barrel Movement Test (*.pdf) Summary of data collected during barrel movement test in June, 2005 (DRAFT, 6/27/05

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

Wohlgemuth, John; Silverman, Timothy; Miller, David C.

This paper describes an effort to inspect and evaluate PV modules in order to determine what failure or degradation modes are occurring in field installations. This paper will report on the results of six site visits, including the Sacramento Municipal Utility District (SMUD) Hedge Array, Tucson Electric Power (TEP) Springerville, Central Florida Utility, Florida Solar Energy Center (FSEC), the TEP Solar Test Yard, and University of Toledo installations. The effort here makes use of a recently developed field inspection data collection protocol, and the results were input into a corresponding database. The results of this work have also been usedmore » to develop a draft of the IEC standard for climate and application specific accelerated stress testing beyond module qualification. TEP Solar Test Yard, and University of Toledo installations. The effort here makes use of a recently developed field inspection data collection protocol, and the results were input into a corresponding database. The results of this work have also been used to develop a draft of the IEC standard for climate and application specific accelerated stress testing beyond module qualification. TEP Solar Test Yard, and University of Toledo installations. The effort here makes use of a recently developed field inspection data collection protocol, and the results were input into a corresponding database. The results of this work have also been used to develop a draft of the IEC standard for climate and application specific accelerated stress testing beyond module qualification.« less

Achievement Test Program.

ERIC Educational Resources Information Center

Ohio State Dept. of Education, Columbus. Trade and Industrial Education Service.

The Ohio Trade and Industrial Education Achievement Test battery is comprised of seven basic achievement tests: Machine Trades, Automotive Mechanics, Basic Electricity, Basic Electronics, Mechanical Drafting, Printing, and Sheet Metal. The tests were developed by subject matter committees and specialists in testing and research. The Ohio Trade and…

The growth and gaps of genetic data sharing policies in the United States

PubMed Central

Arias, Jalayne J.; Pham-Kanter, Genevieve; Campbell, Eric G.

2014-01-01

The 1996 Bermuda Principles launched a new era in data sharing, reflecting a growing belief that the rapid public dissemination of research data was crucial to scientific progress in genetics. A historical review of data sharing policies in the field of genetics and genomics reflects changing scientific norms and evolving views of genomic data, particularly related to human subjects’ protections and privacy concerns. The 2013 NIH Draft Genomic Data Sharing (GDS) Policy incorporates the most significant protections and guidelines to date. The GDS Policy, however, will face difficult challenges ahead as geneticists seek to balance the very real concerns of research participants and the scientific norms that propel research forward. This article provides a novel evaluation of genetic and GDS policies’ treatment of human subjects’ protections. The article examines not only the policies, but also some of the most pertinent scientific, legal, and regulatory developments that occurred alongside data sharing policies. This historical perspective highlights the challenges that future data sharing policies, including the recently disseminated NIH GDS Draft Policy, will encounter. PMID:27774180

Australasian Gastrointestinal Trials Group (AGITG) Contouring Atlas and Planning Guidelines for Intensity-Modulated Radiotherapy in Anal Cancer

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

Ng, Michael, E-mail: mng@radoncvic.com.au; Leong, Trevor; University of Melbourne

2012-08-01

Purpose: To develop a high-resolution target volume atlas with intensity-modulated radiotherapy (IMRT) planning guidelines for the conformal treatment of anal cancer. Methods and Materials: A draft contouring atlas and planning guidelines for anal cancer IMRT were prepared at the Australasian Gastrointestinal Trials Group (AGITG) annual meeting in September 2010. An expert panel of radiation oncologists contoured an anal cancer case to generate discussion on recommendations regarding target definition for gross disease, elective nodal volumes, and organs at risk (OARs). Clinical target volume (CTV) and planning target volume (PTV) margins, dose fractionation, and other IMRT-specific issues were also addressed. A steeringmore » committee produced the final consensus guidelines. Results: Detailed contouring and planning guidelines and a high-resolution atlas are provided. Gross tumor and elective target volumes are described and pictorially depicted. All elective regions should be routinely contoured for all disease stages, with the possible exception of the inguinal and high pelvic nodes for select, early-stage T1N0. A 20-mm CTV margin for the primary, 10- to 20-mm CTV margin for involved nodes and a 7-mm CTV margin for the elective pelvic nodal groups are recommended, while respecting anatomical boundaries. A 5- to 10-mm PTV margin is suggested. When using a simultaneous integrated boost technique, a dose of 54 Gy in 30 fractions to gross disease and 45 Gy to elective nodes with chemotherapy is appropriate. Guidelines are provided for OAR delineation. Conclusion: These consensus planning guidelines and high-resolution atlas complement the existing Radiation Therapy Oncology Group (RTOG) elective nodal ano-rectal atlas and provide additional anatomic, clinical, and technical instructions to guide radiation oncologists in the planning and delivery of IMRT for anal cancer.« less

2015 American Heart Association/American Stroke Association Focused Update of the 2013 Guidelines for the Early Management of Patients With Acute Ischemic Stroke Regarding Endovascular Treatment: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association.

PubMed

Powers, William J; Derdeyn, Colin P; Biller, José; Coffey, Christopher S; Hoh, Brian L; Jauch, Edward C; Johnston, Karen C; Johnston, S Claiborne; Khalessi, Alexander A; Kidwell, Chelsea S; Meschia, James F; Ovbiagele, Bruce; Yavagal, Dileep R

2015-10-01

The aim of this guideline is to provide a focused update of the current recommendations for the endovascular treatment of acute ischemic stroke. When there is overlap, the recommendations made here supersede those of previous guidelines. This focused update analyzes results from 8 randomized, clinical trials of endovascular treatment and other relevant data published since 2013. It is not intended to be a complete literature review from the date of the previous guideline publication but rather to include pivotal new evidence that justifies changes in current recommendations. Members of the writing committee were appointed by the American Heart Association/American Stroke Association Stroke Council's Scientific Statement Oversight Committee and the American Heart Association/American Stroke Association Manuscript Oversight Committee. Strict adherence to the American Heart Association conflict of interest policy was maintained throughout the consensus process. Recommendations follow the American Heart Association/American Stroke Association methods of classifying the level of certainty of the treatment effect and the class of evidence. Prerelease review of the draft guideline was performed by 6 expert peer reviewers and by the members of the Stroke Council Scientific Statement Oversight Committee and Stroke Council Leadership Committee. Evidence-based guidelines are presented for the selection of patients with acute ischemic stroke for endovascular treatment, for the endovascular procedure, and for systems of care to facilitate endovascular treatment. Certain endovascular procedures have been demonstrated to provide clinical benefit in selected patients with acute ischemic stroke. Systems of care should be organized to facilitate the delivery of this care. © 2015 American Heart Association, Inc.

Methodology for senior-proof guidelines: A practice example from the Netherlands.

PubMed

van Munster, Barbara C; Portielje, Johanna E A; Maier, Andrea B; Arends, Arend J; de Beer, Johannes J A

2018-02-01

Evidence-based guidelines constitute a foundation for medical decision making. It is often unclear whether recommendations in general guidelines also apply to older people. This study aimed to develop a methodology to increase the focus on older people in the development of guidelines. The methodology distinguishes 4 groups of older people: (1) relatively healthy older people; (2) older people with 1 additional specific (interfering) comorbid condition; (3) older people with multimorbidity; and (4) vulnerable older people. The level of focus on older people required may be determined by the prevalence of the disease or condition, level of suffering, social relevance, and the expectation that a guideline may improve the quality of care. A specialist in geriatric medicine may be involved in the guideline process via participation, provision of feedback on drafts, or involvement in the analysis of problem areas. Regarding the patient perspective, it is advised to involve organisations for older people or informal carers in the inventory of problem areas, and additionally to perform literature research of patient values on the subject. If the guideline focuses on older people, then the relative importance of the various outcome measures for this target group needs to be explicitly stated. Search strategies for all the 4 groups are suggested. For clinical studies that focus on the treatment of diseases that frequently occur in older people, a check should be made regarding whether these studies produce the required evidence. This can be achieved by verifying if there is sufficient representation of older people in the studies and determining if there is a separate reporting of results applying to this age group. © 2017 John Wiley & Sons, Ltd.

Developing Guidelines for Assessing Visual Analytics Environments

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

Scholtz, Jean

2011-07-01

In this paper, we develop guidelines for evaluating visual analytic environments based on a synthesis of reviews for the entries to the 2009 Visual Analytics Science and Technology (VAST) Symposium Challenge and from a user study with professional intelligence analysts. By analyzing the 2009 VAST Challenge reviews we gained a better understanding of what is important to our reviewers, both visualization researchers and professional analysts. We also report on a small user study with professional analysts to determine the important factors that they use in evaluating visual analysis systems. We then looked at guidelines developed by researchers in various domainsmore » and synthesized these into an initial set for use by others in the community. In a second part of the user study, we looked at guidelines for a new aspect of visual analytic systems – the generation of reports. Future visual analytic systems have been challenged to help analysts generate their reports. In our study we worked with analysts to understand the criteria they used to evaluate the quality of analytic reports. We propose that this knowledge will be useful as researchers look at systems to automate some of the report generation.1 Based on these efforts, we produced some initial guidelines for evaluating visual analytic environment and for evaluation of analytic reports. It is important to understand that these guidelines are initial drafts and are limited in scope because of the type of tasks for which the visual analytic systems used in the studies in this paper were designed. More research and refinement is needed by the Visual Analytics Community to provide additional evaluation guidelines for different types of visual analytic environments.« less

Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.

PubMed

Siegfried, Elaine C; Jaworski, Jennifer C; Eichenfield, Lawrence F; Paller, Amy; Hebert, Adelaide A; Simpson, Eric L; Altman, Emily; Arena, Charles; Blauvelt, Andrew; Block, Julie; Boguniewicz, Mark; Chen, Suephy; Cordoro, Kelly; Hanna, Diane; Horii, Kimberly; Hultsch, Thomas; Lee, James; Leung, Donald Y; Lio, Peter; Milner, Joshua; Omachi, Theodore; Schneider, Christine; Schneider, Lynda; Sidbury, Robert; Smith, Timothy; Sugarman, Jeffrey; Taha, Sharif; Tofte, Susan; Tollefson, Megha; Tom, Wynnis L; West, Dennis P; Whitney, Lucinda; Zane, Lee

2018-05-01

Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices). © 2018 Wiley Periodicals, Inc.

7 CFR 28.958 - Payment of fees.

Code of Federal Regulations, 2013 CFR

2013-01-01

..., TESTING, AND STANDARDS Cotton Fiber and Processing Tests Fiber and Processing Tests § 28.958 Payment of... earlier date. Payment shall be by check or by draft or post office or express money order, payable to the...

7 CFR 28.958 - Payment of fees.

Code of Federal Regulations, 2011 CFR

2011-01-01

..., TESTING, AND STANDARDS Cotton Fiber and Processing Tests Fiber and Processing Tests § 28.958 Payment of... earlier date. Payment shall be by check or by draft or post office or express money order, payable to the...

Space transfer concepts and analysis for exploration missions. Implementation plan and element description document (draft final). Volume 4: Solar electric propulsion vehicle

NASA Technical Reports Server (NTRS)

1991-01-01

This document presents the solar electric propulsion (SEP) concept design developed as part of the Space Transfer Concepts and Analysis for Exploration Missions (STCAEM) study. The evolution of the SEP concept is described along with the requirements, guidelines and assumptions for the design. Operating modes and options are defined and a systems description of the vehicle is presented. Artificial gravity configuration options and space and ground support systems are discussed. Finally, an implementation plan is presented which addresses technology needs, schedules, facilities, and costs.

Status report of wind energy programs in the Philippines

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

Benavidez, P.J.

1996-12-31

This paper discusses the wind resource assessment activities being undertaken by the National Power Corporation at the extreme northern part of Luzon island. Preliminary results from the 10-month wind data are presented. This will give prospective wind developers all idea oil tile vast resources of wind energy available in the northern part of the country. This paper will also discuss briefly the stand-alone 10 kW wind turbine system that was commissioned early this year and the guidelines being drafted for the entry of new and renewable energy sources in the country`s energy generation mix. 4 figs., 1 tab.

Educational approaches for discouraging plagiarism.

PubMed

Fischer, Beth A; Zigmond, Michael J

2011-01-01

Suggested approaches to reduce the occurrence of plagiarism in academia, particularly among trainees. These include (1) educating individuals as to the definition of plagiarism and its consequences through written guidelines, active discussions, and practice in identifying proper and improper citation practices; (2) distributing checklists that break the writing task into more manageable steps, (3) requiring the submission of an outline and then a first draft prior to the deadline for a paper; (4) making assignments relevant to individual interests; and (5) providing trainees with access to software programs that detect plagiarism. Copyright © 2011 Elsevier Inc. All rights reserved.

In Brief: Climate Change Science Program comment period; Ocean Commission comment period; Fine-tuning particulate matter research

NASA Astrophysics Data System (ADS)

Showstack, Randy

2004-04-01

Public comments on the draft guidelines for the synthesis and assessment products being prepared by the U.S. Climate Change Science Program are being accepted through 7 May; The long-anticipated preliminary report of the U.S. Commission on Ocean Policy is being released on 20 April. The comment period extends through 21 May; Determining the most hazardous chemical components and other characteristics of aerosol particulate matter should be a focus of research by the U.S. Environmental Protection Agency, according to a 24 March report by the National Academies' National Research Council.

Space transfer concepts and analysis for exploration missions. Implementation plan and element description document (draft final). Volume 2: Cryo/aerobrake vehicle

NASA Technical Reports Server (NTRS)

1991-01-01

The cryogenic/aerobrake (CAB) and the cryogenic all-propulsive (CAP) concept designs developed in support of the Space Transfer Concepts and Analysis for Exploration Missions (STCAEM) study are presented. The evolution of the CAB and CAP concepts is described along with the requirements, guidelines and assumptions for the designs. Operating modes and options are defined and systems descriptions of the vehicles are presented. Artificial gravity configuration options and space and ground support systems are discussed. Finally, an implementation plan is presented which addresses technology needs, schedules, facilities, and costs.

Space transfer concepts and analysis for exploration missions. Implementation plan and element description document (draft final). Volume 5: Nuclear electric propulsion vehicle

NASA Technical Reports Server (NTRS)

1991-01-01

The nuclear electric propulsion (NEP) concept design developed in support of the Space Transfer Concepts and Analysis for Exploration Missions (STCAEM) study is presented. The evolution of the NEP concept is described along with the requirements, guidelines, and assumptions for the design. Operating modes and options are defined and a systems description of the vehicle is presented. Artificial gravity configuration options and space and ground support systems are discussed. Finally, an implementation plan is presented which addresses technology needs, schedules, facilities and costs.

Space transfer concepts and analysis for exploration missions. Implementation plan and element description document (draft final). Volume 3: Nuclear thermal rocket vehicle

NASA Technical Reports Server (NTRS)

1991-01-01

This document presents the nuclear thermal rocket (NTR) concept design developed in support of the Space Transfer Concepts and Analysis for Exploration Missions (STCAEM) study. The evolution of the NTR concept is described along with the requirements, guidelines and assumptions for the design. Operating modes and options are defined and a systems description of the vehicle is presented. Artificial gravity configuration options and space and ground support systems are discussed. Finally, an implementation plan is presented which addresses technology needs, schedules, facilities and costs.

Data Citation Standard: A Means to Support Data Sharing, Attribution, and Traceability

NASA Astrophysics Data System (ADS)

McCallum, I.; Plag, H. P.; Fritz, S.

2012-04-01

Geo-referenced data are crucial for addressing many of the burning societal problems and to support related interdisciplinary research. Data sharing is hampered by the lack of a widely accepted method for giving credit to those who make their data freely available and for tracking the use of data throughout it's life-cycle. Particularly in the scientific community, recognition and renown are important currencies. Providing means for data citation would be a strong incentive for data sharing. Recently, a number of organizations and projects have started to address the concept of data citation (e.g., PANGAEA, NASA DAACS, USGS, NOAA National Data Centers, ESIP, US National Academy of Sciences, and EGIDA). A number of proposals for data citation guidelines have emerged and a better understanding of the many issues at hand is evolving, but to date, no standard has been accepted. This is not surprising, as data citation is far more complicated than citation of scientific publication. Data sets differ in many aspects from standard scientific publications. For example, data sets generally are not locatable and attributable in the same way as scientific publications. Data sets often are not static (introducing versioning), and they are mostly not peer-reviewed (requiring quality control). There is a consensus that the implementation of a standard would reveal new issues that are not obvious today. With the Global Earth Observation System of Systems (GEOSS), the Group on Earth Observations (GEO) is in a unique position to provide the testbed for the implementation of a draft standard. The GEO Plenary supports the implementation of a draft standard developed by the Science and Technology Committee (STC) of GEO with support of the EGIDA Project. This draft is based on guidelines developed by international groups. Currently, users of the GEO-Portal are not obliged or encouraged to cite data accessed through GEOSS - if at all, citation requirements come from the individual data providers. This naturally leads to a at-best non-standard form of data citation or, in the worst case, no data citation at all. The testbed implementation will rectify this situation and help to identify issues not covered by the standard. The process of implementing and iteratively improving the draft is led by the GEO Work Plan Task ID-03 under the Institutions and Development Board; coordinated with the GEO working groups in charge of developing the GEOSS Common Infrastructure (e.g., the Architecture Board, SIF, DSTF, GCI-CT; with other groups within GEO, such as the Data Sharing Task Force, who have initiated similar activities, and with organizations outside of GEO developing the internationally emerging specifications. Metadata for GEOSS data and products may have to be extended to support data citation. It is expected that the availability of a draft citation standard will increase the attractiveness of GEO and GEOSS for scientists by fostering acknowledgment of their contributions when others use them. The testbed implementation will provide valuable insight into issues that need to be addressed and this will be infused into the international discussion on data citation.

Scandinavian guidelines for initial management of minor and moderate head trauma in children.

PubMed

Astrand, Ramona; Rosenlund, Christina; Undén, Johan

2016-02-18

The management of minor and moderate head trauma in children differs widely between countries. Presently, there are no existing guidelines for management of these children in Scandinavia. The purpose of this study was to produce new evidence-based guidelines for the initial management of head trauma in the paediatric population in Scandinavia. The primary aim was to detect all children in need of neurosurgical intervention. Detection of any traumatic intracranial injury on CT scan was an important secondary aim. General methodology according to the Appraisal of Guidelines for Research and Evaluation (AGREE) II and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system was used. Systematic evidence-based review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology and based upon relevant clinical questions with respect to patient-important outcomes. Quality ratings of the included studies were performed using Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 and Centre of Evidence Based Medicine (CEBM)-2 tools. Based upon the results, GRADE recommendations, a guideline, discharge instructions and in-hospital observation instructions were drafted. For elements with low evidence, a modified Delphi process was used for consensus, which included relevant clinical stakeholders. The guidelines include criteria for selecting children for CT scans, in-hospital observation or early discharge, and suggestions for monitoring routines and discharge advice for children and guardians. The guidelines separate mild head trauma patients into high-, medium- and low-risk categories, favouring observation for mild, low-risk patients as an attempt to reduce CT scans in children. We present new evidence and consensus based Scandinavian Neurotrauma Committee guidelines for initial management of minor and moderate head trauma in children. These guidelines should be validated before extensive clinical use and updated within four years due to rapid development of new diagnostic tools within paediatric neurotrauma.

Proposal of Polish guidelines for conducting financial analysis and their comparison to existing guidance on budget impact in other countries.

PubMed

Orlewska, Ewa; Mierzejewski, Piotr

2004-01-01

Financial analysis (budget impact analysis, BIA) is increasingly required by decision-makers to ascertain the macroeconomic consequences of new product reimbursement in addition to proof of cost-effectiveness. Poland is in the process of drafting country-specific guidelines for BIA, positioned as complementary to economic evaluation in decision-making The aim of this article is to present the Polish project and compare it with currently available guidance. A checklist was developed that focuses on issues that are unique to BIA. An analysis of the differences between different national guidelines and their Polish counterparts was subsequently undertaken. The Polish project of BIA guidelines is composed of two sections. The first section presents the objective, the use of BIA, the responsibility for the preparation, and the target audience. The second section presents important methodological aspects that researchers should keep in mind when carrying out BIA. In comparison to existing guidance the Polish project appears to be more detailed. It includes more precise recommendations on perspective, time horizon, and reliability of data sources; reporting of results; rates of adoption of new therapies; and the probability of redeploying resources. Although there is an increased demand for BIA, there is only limited guidance on how such studies should be undertaken. It is hoped that the Polish guidelines can contribute to the development of such analyses and deliver benefit for Polish health-care decision-makers and beyond.

ASCCP Colposcopy Standards: How Do We Perform Colposcopy? Implications for Establishing Standards.

PubMed

Waxman, Alan G; Conageski, Christine; Silver, Michelle I; Tedeschi, Candice; Stier, Elizabeth A; Apgar, Barbara; Huh, Warner K; Wentzensen, Nicolas; Massad, L Stewart; Khan, Michelle J; Mayeaux, Edward J; Einstein, Mark H; Schiffman, Mark H; Guido, Richard S

2017-10-01

The American Society for Colposcopy and Cervical Pathology (ASCCP) Colposcopy Standards recommendations address the role of and approach to colposcopy and biopsy for cervical cancer prevention in the United States. The recommendations were developed by an expert working group appointed by ASCCP's Board of Directors. Working group 3 defined colposcopy procedure guidelines for minimum and comprehensive colposcopy practice and evaluated the use of colposcopy adjuncts. The working group performed a systematic literature review to identify best practices in colposcopy methodology and to evaluate the use of available colposcopy adjuncts. The literature provided little evidence to support specific elements of the procedure. The working group, therefore, implemented a national survey of current and recent ASCCP members to evaluate common elements of the colposcopy examination. The findings of this survey were modified by expert consensus from the ASCCP Colposcopy Standards Committee members to create guidelines for performing colposcopy. The draft recommendations were posted online for public comment and presented at an open session of the International Federation for Cervical Pathology and Colposcopy 2017 World Congress for further comment. All comments were considered in the development of final recommendations. Minimum and comprehensive colposcopy practice guidelines were developed. These guidelines represent recommended practice in all parts of the examination including the following: precolposcopy evaluation, performing the procedure, documentation of findings, biopsy practice, and postprocedure follow-up. These guidelines are intended to serve as a guide to standardize colposcopy across the United States.

Nonmedical interventions for children with ASD: recommended guidelines and further research needs.

PubMed

Maglione, Margaret A; Gans, Daphna; Das, Lopamudra; Timbie, Justin; Kasari, Connie

2012-11-01

To use the findings of a systematic review of scientific evidence to develop consensus guidelines on nonmedical interventions that address cognitive function and core deficits in children with autism spectrum disorders (ASDs) and to recommend priorities for future research. The guidelines were developed by a Technical Expert Panel (TEP) consisting of practitioners, researchers, and parents. A systematic overview of research findings was presented to the TEP; guideline statements were drafted, discussed, debated, edited, reassessed, and presented for formal voting. The strength of evidence of efficacy varied by intervention type from insufficient to moderate. There was some evidence that greater intensity of treatment (hours per week) and greater duration (in months) led to better outcomes. The TEP agreed that children with ASD should have access to at least 25 hours per week of comprehensive intervention to address social communication, language, play skills, and maladaptive behavior. They agreed that applied behavioral analysis, integrated behavioral/developmental programs, the Picture Exchange Communication System, and various social skills interventions have shown efficacy. Based on identified gaps, they recommend that future research focus on assessment and monitoring of outcomes, addressing the needs of pre/nonverbal children and adolescents, and identifying the most effective strategies, dose, and duration to improve specific core deficits. The creation of treatment guidelines and recommendations for future research represents an effort by leading experts to improve access to services for children with ASDs while acknowledging that the research evidence has many gaps.

Guidelines for seizure management in palliative care: Proposal for an updated clinical practice model based on a systematic literature review.

PubMed

León Ruiz, M; Rodríguez Sarasa, M L; Sanjuán Rodríguez, L; Pérez Nieves, M T; Ibáñez Estéllez, F; Arce Arce, S; García-Albea Ristol, E; Benito-León, J

2017-02-27

Very little has been written on seizure management in palliative care (PC). Given this situation, and considering the forthcoming setting up of the Palliative Care Unit at our neurorehabilitation centre, the Clínica San Vicente, we decided to establish a series of guidelines on the use of antiepileptic drugs (AEDs) for handling seizures in PC. We conducted a literature search in PubMed to identify articles, recent manuals, and clinical practice guidelines on seizure management in PC published by the most relevant scientific societies. Clinical practice guidelines are essential to identify patients eligible for PC, manage seizures adequately, and avoid unnecessary distress to these patients and their families. Given the profile of these patients, we recommend choosing AEDs with a low interaction potential and which can be administered by the parenteral route, preferably intravenously. Diazepam and midazolam appear to be the most suitable AEDs during the acute phase whereas levetiracetam, valproic acid, and lacosamide are recommended for refractory cases and long-term treatment. These guidelines provide general recommendations that must be adapted to each particular clinical case. Nevertheless, we will require further well-designed randomised controlled clinical trials including large samples of patients eligible for PC to draft a consensus document recommending adequate, rational, and effective use of AEDs, based on a high level of evidence, in this highly complex area of medical care. Copyright © 2017 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.

Treatment of maladaptive aggression in youth: CERT guidelines II. Treatments and ongoing management.

PubMed

Scotto Rosato, Nancy; Correll, Christoph U; Pappadopulos, Elizabeth; Chait, Alanna; Crystal, Stephen; Jensen, Peter S

2012-06-01

To develop guidelines for management and treatment of maladaptive aggression in youth in the areas of psychosocial interventions, medication treatments, and side-effect management. Evidence was assembled and evaluated in a multistep process, including systematic reviews of published literature; an expert survey of recommended practices; a consensus conference of researchers, policymakers, clinicians, and family advocates; and review by the steering committee of successive drafts of the recommendations. The Center for Education and Research on Mental Health Therapeutics Treatment of Maladaptive Aggression in Youth guidelines reflect a synthesis of the available evidence, based on this multistep process. This article describes the content, rationale, and evidence for 11 recommendations. Key treatment principles include considering psychosocial interventions, such as evidence-based parent and child skills training as the first line of treatment; targeting the underlying disorder first following evidence-based guidelines; considering individual psychosocial and medical factors, including cardiovascular risk in the selection of agents if medication treatment (ideally with the best evidence base) is initiated; avoiding the use of multiple psychotropic medications simultaneously; and careful monitoring of treatment response, by using structured rating scales, as well as close medical monitoring for side effects, including metabolic changes. Treatment of children with maladaptive aggression is a "moving target" requiring ongoing assimilation of new evidence as it emerges. Based on the existing evidence, the Treatment of Maladaptive Aggression in Youth guidelines provide a framework for management of maladaptive aggression in youth, appropriate for use by primary care clinicians and mental health providers.

[The federal participation law : New requirements for needs assessment with special emphasis on medical rehabilitation services].

PubMed

Schubert, Michael; Schian, Marcus; Viehmeier, Sarah

2016-09-01

The federal participation law (Bundesteilhabegesetz - BTHG) is one of the largest efforts in the last 15 years to reform the legal participation rights of people with disabilities. In particular, a number of enhancements are planned in the overall benefits law in Part 1 of Book IX in the Social Code (Sozialgesetzbuch - SGB), which applies to all rehabilitation carriers including general provisions and standards for needs assessment. This paper deals with the implications of these provisions and interacting standards, based on the draft bill of April 2016.The discussion takes place against the background of the regulatory objectives formulated in the ministerial draft itself, jurisprudential expertise on the effects of the current legal norms of the SGB IX as well as relevant professional political developments and statements by various stakeholders.The analysis shows a clear political commitment to increase the requirements for needs assessment in the overall law of the SGB IX and to express these more effectively. The draft bill seeks not only to modify procedures subsequent to the application for rehabilitation benefits, but also to precisely set out provisions on instruments for needs assessment in a new § 13. Common principles for these instruments of needs assessment should increase the cooperation, coordination and convergence among rehabilitation carriers.Nevertheless, with regard to the proposed regulatory texts, there is doubt that the objectives set by the draft bill itself will be achieved. For example, the required common principles for needs assessment are to be agreed upon based on the existing special legislation for the different rehabilitation carriers, without the SGB IX setting its own binding standards or framework principles. In addition, it lacks clear legal guidelines for the professional practice to make use of the bio-psycho-social model of the WHO and the ICF in the process of needs assessment. As a consequence the ICF cannot serve as a legally standardized reference point.

78 FR 68360 - Unmanned Aircraft System Test Site Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-14

...-0061] Unmanned Aircraft System Test Site Program AGENCY: Federal Aviation Administration (FAA), DOT...'') test site program; response to comments. SUMMARY: On February 22, 2013 the FAA published and requested public comment on the proposed privacy requirements (the ``Draft Privacy Requirements'') for UAS test...

Privacy and Biobanking in China: A Case of Policy in Transition.

PubMed

Chen, Haidan; Chan, Benny; Joly, Yann

2015-01-01

Disease-based biobanks have operated in hospitals and research institutes in China for decades, and China has recently embarked on a plan to establish further biobank networks with the aim of promoting data sharing among the existing biobanks. Although the Chinese Constitution has only recently begun to recognize individual privacy as a distinct and independent constitutional right, biobanking in China has been loosely regulated under a patchwork of sometimes overlapping laws (such as the Interim Measures for the Administration of Human Genetic Resources) and regulatory instruments, as well as and the policies of individual biobanks and networks of biobanks (such as the Shanghai Biobank Network Guidelines). A Draft Ordinance on Human Genetics Resources is currently being developed that will deal in more detail than previous laws with issues such as management measures, legal liability, and punishment for violations. International data sharing will be tightly regulated under this new law, and individual biobanks' policies such as the Shanghai Guidelines may choose to regulate such sharing even more. In contrast with national regulatory instruments, the Shanghai Guidelines also contain detailed de-identification policies, and explicitly endorse broad consent. © 2015 American Society of Law, Medicine & Ethics, Inc.

[National guidelines for the management of patients with chronic lymphocytic leukemia. Sociedad Espan˜ola de Hematologı´a y Hemoterapia and Grupo Espan˜ol de Leucemia Linfocı´tica Cro´ nica].

PubMed

García Marco, José A; Giraldo Castellano, Pilar; López Jiménez, Javier; Ríos Herranz, Eduardo; Sastre Moral, José Luis; Terol Casterá, M José; Bosch Albareda, Francesc

2013-08-17

Chronic lymphocytic leukemia is the most common chronic lymphoproliferative disorder in Spain. The clinical management of this entity varies widely. Currently, in Spain, there are no national consensus guidelines, such as those published in other countries, to guide the diagnosis and treatment of this malignancy and the use of prognostic scores. This article reviews the current scientific literature and addresses issues on the diagnosis of chronic lymphocytic leukemia, the spread of the disease, the presence of comorbidities, the classification of prognostic scores, the common treatment regimens stratified by risk factors, and the management of complications associated with both the disease and its treatment, as well as the various controversies related to this entity. This document was drafted with the collaboration of national experts and aims to establish practical guidelines with their corresponding levels of evidence and grades of recommendation to guide the diagnosis, treatment and follow-up of patients with chronic lymphocytic leukemia. Copyright © 2013 Elsevier España, S.L. All rights reserved.

Pharmacologic Therapy for Pulmonary Arterial Hypertension in Adults

PubMed Central

Taichman, Darren B.; Chung, Lorinda; Klinger, James R.; Lewis, Sandra; Mandel, Jess; Palevsky, Harold I.; Rich, Stuart; Sood, Namita; Rosenzweig, Erika B.; Trow, Terence K.; Yung, Rex; Elliott, C. Gregory; Badesch, David B.

2014-01-01

OBJECTIVE: Choices of pharmacologic therapies for pulmonary arterial hypertension (PAH) are ideally guided by high-level evidence. The objective of this guideline is to provide clinicians advice regarding pharmacologic therapy for adult patients with PAH as informed by available evidence. METHODS: This guideline was based on systematic reviews of English language evidence published between 1990 and November 2013, identified using the MEDLINE and Cochrane Library databases. The strength of available evidence was graded using the Grades of Recommendations, Assessment, Development, and Evaluation methodology. Guideline recommendations, or consensus statements when available evidence was insufficient to support recommendations, were developed using a modified Delphi technique to achieve consensus. RESULTS: Available evidence is limited in its ability to support high-level recommendations. Therefore, we drafted consensus statements to address many clinical questions regarding pharmacotherapy for patients with PAH. A total of 79 recommendations or consensus statements were adopted and graded. CONCLUSIONS: Clinical decisions regarding pharmacotherapy for PAH should be guided by high-level recommendations when sufficient evidence is available. Absent higher level evidence, consensus statements based upon available information must be used. Further studies are needed to address the gaps in available knowledge regarding optimal pharmacotherapy for PAH. PMID:24937180

SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process.

PubMed

Ogrinc, Greg; Davies, Louise; Goodman, Daisy; Batalden, Paul; Davidoff, Frank; Stevens, David

2015-01-01

In the past several years, the science of health care improvement has advanced considerably. In this article, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) face-to-face consensus meetings to develop interim drafts, and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes 3 key components of systematic efforts to improve the quality, value, and safety of health care: formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org). © The Author(s) 2015.

NDE Techniques Used in PARENT Open Round Robin Testing

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

Meyer, Ryan M.

2014-11-05

This is a draft technical letter report for NRC client describing the NDE techniques used in the open testing portion of the Program to Assess the Reliability of Emerging Nondestructive Techniques (PARENT).

76 FR 4113 - Independent Scientific Peer Review Panel Meeting on an In Vitro

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-24

... Vitro Estrogen Receptor Transcriptional Activation Test Method for Endocrine Disruptor Chemical... Vitro Estrogen Receptor Transcriptional Activation Test Method for Endocrine Disruptor Chemical... the information included in the BRD supports ICCVAM's draft test method recommendations. NICEATM...

Personal hygiene among military personnel: developing and testing a self-administered scale.

PubMed

Saffari, Mohsen; Koenig, Harold G; Pakpour, Amir H; Sanaeinasab, Hormoz; Jahan, Hojat Rshidi; Sehlo, Mohammad Gamal

2014-03-01

Good personal hygiene (PH) behavior is recommended to prevent contagious diseases, and members of military forces may be at high risk for contracting contagious diseases. The aim of this study was to develop and test a new questionnaire on PH for soldiers. Participants were all male and from different military settings throughout Iran. Using a five-stage guideline, a panel of experts in the Persian language (Farsi) developed a 21-item self-administered questionnaire. Face and content validity of the first-draft items were assessed. The questionnaire was then translated and subsequently back-translated into English, and both the Farsi and English versions were tested in pilot studies. The consistency and stability of the questionnaire were tested using Cronbach's alpha and the test-retest strategy. The final scale was administered to a sample of 502 military personnel. Explanatory and confirmatory factor analyses evaluated the structure of the scale. Both the convergent and discriminative validity of the scale were also determined. Cronbach's alpha coefficients were >0.85. Principal component analysis demonstrated a uni-dimensional structure that explained 59 % of the variance in PH behaviors. Confirmatory factor analysis indicated a good fit (goodness-of-fit index = 0.902; comparative fitness index = 0.923; root mean square error of approximation = 0.0085). The results show that this new PH scale has solid psychometric properties for testing PH behaviors among an Iranian sample of military personnel. We conclude that this scale can be a useful tool for assessing PH behaviors in military personnel. Further research is needed to determine the scale's value in other countries and cultures.

Combining usability evaluations to highlight the chain that leads from usability flaws to usage problems and then negative outcomes.

PubMed

Watbled, Ludivine; Marcilly, Romaric; Guerlinger, Sandra; Bastien, J-M Christian; Beuscart-Zéphir, Marie-Catherine; Beuscart, Régis

2018-02-01

Poor usability of health technology is thought to diminish work system performance, increase error rates and, potentially, harm patients. The present study (i) used a combination of usability evaluation methods to highlight the chain that leads from usability flaws to usage problems experienced by users and, ultimately, to negative patient outcomes, and (ii) validated this approach by studying two different discharge summary production systems. To comply with quality guidelines, the process of drafting and sending discharge summaries is increasingly being automated. However, the usability of these systems may modify their impact (or the absence thereof) in terms of production times and quality, and must therefore be evaluated. Here, we applied three successive techniques for usability evaluation (heuristic evaluation, user testing and field observation) to two discharge summary production systems (underpinned by different technologies). The systems' main usability flaws led respectively to an increase in the time need to produce a discharge summary and the risk of patient misidentification. Our results are discussed with regard to the possibility of linking the usability flaws, usage problems and the negative outcomes by successively applying three methods for evaluating usability (heuristic evaluation, user testing and in situ observations) throughout the system development life cycle. Copyright © 2018 Elsevier Inc. All rights reserved.

Patient-reported outcome measure for neuromyelitis optica: pretesting of preliminary instrument and protocol for further development in accordance with international guidelines.

PubMed

Moore, P; Jackson, C; Mutch, K; Methley, A; Pollard, C; Hamid, S; Jacob, A

2016-09-30

This study outlines the development of a patient-reported outcome measure (PROM), an instrument to obtain self-reported health status for neuromyeltis optica (NMO), a disabling neurological condition. Development was conducted in accordance with international guidance for PROMs including systematic review of existing literature, item generation guided by qualitative interviews, health-related quality of life conceptual framework and clinical expert panel and cognitive interviews with NMO patients. Participants were identified through a national NMO clinic in a tertiary NHS neurosciences service. 15 individuals with NMO participated in cognitive interviews requiring review and ranking of proposed PROM items and qualitative feedback on content, layout and response options. Participants endorsed the draft instrument as reflecting their experience of the condition and as being easy to understand. Rating and ranking of item relevance and importance reduced the draft instrument from 106 to 48 items. Participant feedback on overlapping items eliminated a further 2 items and resulted in a preliminary instrument of 46 items. As a direct result of participant feedback ordering of the 10 domains was revised, a 4 option Likert scale was employed and a 4-week recall period for impact of symptoms was selected. A 46-item instrument developed in accordance with international PROM development guidelines through literature review, developed by subject matter experts and refined through pretesting examining content validity provides a preliminary measure for assessing patient-report of health status in NMO. Further evaluation is proposed including sensitivity to clinical change, and international contributions to evaluating the measure are encouraged. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Guidelines for the diagnosis, prevention and management of osteoporosis.

PubMed

Rossini, M; Adami, S; Bertoldo, F; Diacinti, D; Gatti, D; Giannini, S; Giusti, A; Malavolta, N; Minisola, S; Osella, G; Pedrazzoni, M; Sinigaglia, L; Viapiana, O; Isaia, G C

2016-06-23

Osteoporosis poses a significant public health issue. National Societies have developed Guidelines for the diagnosis and treatment of this disorder with an effort of adapting specific tools for risk assessment on the peculiar characteristics of a given population. The Italian Society for Osteoporosis, Mineral Metabolism and Bone Diseases (SIOMMMS) has recently revised the previously published Guidelines on the diagnosis, riskassessment, prevention and management of primary and secondary osteoporosis. The guidelines were first drafted by a working group and then approved by the board of SIOMMMS. Subsequently they received also the endorsement of other major Scientific Societies that deal with bone metabolic disease. These recommendations are based on systematic reviews of the best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on leading experts' experience and opinion, and on good clinical practice. The osteoporosis prevention should be based on the elimination of specific risk factors. The use of drugs registered for the treatment of osteoporosis are recommended when the benefits overcome the risk, and this is the case only when the risk of fracture is rather high as measured with variables susceptible to pharmacological effect. DeFRA (FRAX® derived fracture risk assessment) is recognized as a useful tool for easily estimate the long-term fracture risk. Several secondary forms of osteoporosis require a specific diagnostic and therapeutic management.

Creating the Action Model for High Risk Infant Follow Up Program in Iran.

PubMed

Heidarzadeh, Mohammad; Jodiery, Behzad; Mirnia, Kayvan; Akrami, Forouzan; Hosseini, Mohammad Bagher; Heidarabadi, Seifollah; HabibeLahi, Abbas

2013-11-01

Intervention in early childhood development as one of the social determinants of health, is important for reducing social gap and inequity. In spite of increasingly developing intensive neonatal care wards and decreasing neonatal mortality rate, there is no follow up program in Iran. This study was carreid out to design high risk infants follow up care program with the practical aim of creating an model action for whole country, in 2012. This qualitative study has been done by the Neonatal Department of the Deputy of Public Health in cooperation with Pediatrics Health Research Center of Tabriz University of Medical Sciences, Iran. After study of international documents, consensus agreement about adapted program for Iran has been accomplished by focus group discussion and attended Delphi agreement technique. After compiling primary draft included evidence based guidelines and executive plan, 14 sessions including expert panels were hold to finalize the program. After finalizing the program, high risk infants follow up care service package has been designed in 3 chapters: Evidence based clinical guidelines; eighteen main clinical guidelines and thirteen subsidiaries clinical guidelines, executive plan; 6 general, 6 following up and 5 backup processes. Education program including general and especial courses for care givers and follow up team, and family education processes. We designed and finalized high risk infants follow up care service package. It seems to open a way to extend it to whole country.

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

Lim, Karen; Small, William; Portelance, Lorraine

Purpose: Accurate target definition is vitally important for definitive treatment of cervix cancer with intensity-modulated radiotherapy (IMRT), yet a definition of clinical target volume (CTV) remains variable within the literature. The aim of this study was to develop a consensus CTV definition in preparation for a Phase 2 clinical trial being planned by the Radiation Therapy Oncology Group. Methods and Materials: A guidelines consensus working group meeting was convened in June 2008 for the purposes of developing target definition guidelines for IMRT for the intact cervix. A draft document of recommendations for CTV definition was created and used to aidmore » in contouring a clinical case. The clinical case was then analyzed for consistency and clarity of target delineation using an expectation maximization algorithm for simultaneous truth and performance level estimation (STAPLE), with kappa statistics as a measure of agreement between participants. Results: Nineteen experts in gynecological radiation oncology generated contours on axial magnetic resonance images of the pelvis. Substantial STAPLE agreement sensitivity and specificity values were seen for gross tumor volume (GTV) delineation (0.84 and 0.96, respectively) with a kappa statistic of 0.68 (p < 0.0001). Agreement for delineation of cervix, uterus, vagina, and parametria was moderate. Conclusions: This report provides guidelines for CTV definition in the definitive cervix cancer setting for the purposes of IMRT, building on previously published guidelines for IMRT in the postoperative setting.« less

Experimentally Identify the Effective Plume Chimney over a Natural Draft Chimney Model

NASA Astrophysics Data System (ADS)

Rahman, M. M.; Chu, C. M.; Tahir, A. M.; Ismail, M. A. bin; Misran, M. S. bin; Ling, L. S.

2017-07-01

The demands of energy are in increasing order due to rapid industrialization and urbanization. The researchers and scientists are working hard to improve the performance of the industry so that the energy consumption can be reduced significantly. Industries like power plant, timber processing plant, oil refinery, etc. performance mainly depend on the cooling tower chimney’s performance, either natural draft or forced draft. Chimney is used to create sufficient draft, so that air can flow through it. Cold inflow or flow reversal at chimney exit is one of the main identified problems that may alter the overall plant performance. The presence Effective Plume Chimney (EPC) is an indication of cold inflow free operation of natural draft chimney. Different mathematical model equations are used to estimate the EPC height over the heat exchanger or hot surface. In this paper, it is aim to identify the EPC experimentally. In order to do that, horizontal temperature profiling is done at the exit of the chimneys of face area 0.56m2, 1.00m2 and 2.25m2. A wire mesh screen is installed at chimneys exit to ensure cold inflow chimney operation. It is found that EPC exists in all modified chimney models and the heights of EPC varied from 1 cm to 9 cm. The mathematical models indicate that the estimated heights of EPC varied from 1 cm to 2.3 cm. Smoke test is also conducted to ensure the existence of EPC and cold inflow free option of chimney. Smoke test results confirmed the presence of EPC and cold inflow free operation of chimney. The performance of the cold inflow free chimney is increased by 50% to 90% than normal chimney.

[Guidelines on psychological intervention in cardiac rehabilitation- methodological process].

PubMed

Sommaruga, Marinella; Tramarin, Roberto; Angelino, Elisabetta; Bettinardi, Ornella; Cauteruccio, Maria Antonella; Miglioretti, Massimo; Monti, Marco; Pierobon, Antonia; Sguazzin, Cinzia

2003-03-01

The development and the role of cardiac rehabilitation in healthcare programs related to cardiovascular diseases has led to the growth of knowledge, experience and specific technical, scientific, organizational and cultural skills on the part of the different health professionals engaged with the cardiologist in the management of rehabilitation programs. The need to define the characteristics of the psychological intervention in cardiac rehabilitation programs on the basis of scientific evidence encouraged the Board of the Italian Group of Cardiac Rehabilitation and Prevention [Gruppo Italiano di Cardiologia Riabilitativa e Preventiva (GICR)] to set up a working group (WG), composed of psychologists chosen on the basis of their proven specific experience in clinical research, with the task of defining the state-of-the-art of the psychological intervention in cardiac rehabilitation on the basis of documented efficacy, as a first step to formulating Guidelines on Psychological Intervention in Cardiac Rehabilitation. The methodology adopted by the WG was in line with the recommendations of the National Guidelines Program of the Italian Ministry of Health; the WG chose, in addition, to exploit a detailed critical review of clinical psychology practice in order to provide systematic evidence for recommendations and clinical approaches at present supported only by expert opinion. The document, which represents the basis upon which the Guidelines on the psychological activity in cardiac rehabilitation will be drawn up, is subdivided into three parts: an introduction, the main body of the text, and some appendices. In the introduction, the theme and context of the Guidelines are defined, preceded by a series of notes and user instructions; also defined in this section are the intended audience. The main body of the document is structured on the basis of the steps that characterize the interactions between the patient suffering from heart disease and the psychologist, through a qualitative analysis of the intervention offered by the psychologist. The phases of this process have been schematized as follows: selection, entry, evaluation, intervention, follow-up. For each of these phases, the evidence is given in support of the evaluative and therapeutic tools at the psychologist's disposition in the context of cardiac rehabilitation. The appendices to the document contain syntheses of the scientific information, some tables, a glossary and a section providing more in-depth information on specific topics. The recommendations contained in the document elaborated by the WG were formulated on the basis of a systematic review of the evidence available in the Italian and international literature, codified according to the National Guidelines Program. Also included is a series of recommendations or working instructions based on the shared clinical experience of the members of the WG. The state of progress of the work of formulating the Guidelines, the objectives, the methodological premises and the deadlines set for the phases of development, diffusion and implementation were presented at the VI National Congress of the GICR which was held in Cosenza, 3-5 October 2002. The base-draft of the document was submitted to the Scientific Committee of Reviewers. In October 2002 the Executive Committee of the GICR announced to the National Guidelines Program of the Ministry of Health, in the persons of the Presidents of the Advanced Institute of Health and of the Regional Health Services Agency, the planning and the timetable for the formulation of the Guidelines. In the course of the first 4 months of 2003 the document produced will be discussed and reviewed jointly by the WG, the Cardiologic Scientific Board instituted by the GICR enlarged to include a delegate of the patient and volunteer no-profit worker associations. The following phases will include the publication by mid 2003 of a position-paper. The final draft of the Guidelines on Psychological Intervention in Cardiac Rehabilitation will be submitted to the Commission of the National Guidelines Program.

Canadian guidelines for acute bacterial rhinosinusitis

PubMed Central

Kaplan, Alan

2014-01-01

Objective To provide a clinical summary of the Canadian clinical practice guidelines for acute bacterial rhinosinusitis (ABRS) that includes relevant considerations for family physicians. Quality of evidence Guideline authors performed a systematic literature search and drafted recommendations. Recommendations received both strength of evidence and strength of recommendation ratings. Input from external content experts was sought, as was endorsement from Canadian medical societies (Association of Medical Microbiology and Infectious Disease Canada, Canadian Society of Allergy and Clinical Immunology, Canadian Society of Otolaryngology—Head and Neck Surgery, Canadian Association of Emergency Physicians, and the Family Physicians Airways Group of Canada). Main message Diagnosis of ABRS is based on the presence of specific symptoms and their duration; imaging or culture are not needed in uncomplicated cases. Treatment is dependent on symptom severity, with intranasal corticosteroids (INCSs) recommended as monotherapy for mild and moderate cases, although the benefit might be modest. Use of INCSs plus antibiotics is reserved for patients who fail to respond to INCSs after 72 hours, and for initial treatment of patients with severe symptoms. Antibiotic selection must account for the suspected pathogen, the risk of resistance, comorbid conditions, and local antimicrobial resistance trends. Adjunct therapies such as nasal saline irrigation are recommended. Failure to respond to treatment, recurrent episodes, and signs of complications should prompt referral to an otolaryngologist. The guidelines address situations unique to the Canadian health care environment, including actions to take during prolonged wait periods for specialist referral or imaging. Conclusion The Canadian guidelines provide up-to-date recommendations for diagnosis and treatment of ABRS that reflect an evolving understanding of the disease. In addition, the guidelines offer useful tools to help clinicians discern viral from bacterial episodes, as well as optimally manage their patients with ABRS. PMID:24627376

CAR: contig assembly of prokaryotic draft genomes using rearrangements.

PubMed

Lu, Chin Lung; Chen, Kun-Tze; Huang, Shih-Yuan; Chiu, Hsien-Tai

2014-11-28

Next generation sequencing technology has allowed efficient production of draft genomes for many organisms of interest. However, most draft genomes are just collections of independent contigs, whose relative positions and orientations along the genome being sequenced are unknown. Although several tools have been developed to order and orient the contigs of draft genomes, more accurate tools are still needed. In this study, we present a novel reference-based contig assembly (or scaffolding) tool, named as CAR, that can efficiently and more accurately order and orient the contigs of a prokaryotic draft genome based on a reference genome of a related organism. Given a set of contigs in multi-FASTA format and a reference genome in FASTA format, CAR can output a list of scaffolds, each of which is a set of ordered and oriented contigs. For validation, we have tested CAR on a real dataset composed of several prokaryotic genomes and also compared its performance with several other reference-based contig assembly tools. Consequently, our experimental results have shown that CAR indeed performs better than all these other reference-based contig assembly tools in terms of sensitivity, precision and genome coverage. CAR serves as an efficient tool that can more accurately order and orient the contigs of a prokaryotic draft genome based on a reference genome. The web server of CAR is freely available at http://genome.cs.nthu.edu.tw/CAR/ and its stand-alone program can also be downloaded from the same website.

The diagnosis of male infertility: an analysis of the evidence to support the development of global WHO guidance-challenges and future research opportunities.

PubMed

Barratt, Christopher L R; Björndahl, Lars; De Jonge, Christopher J; Lamb, Dolores J; Osorio Martini, Francisco; McLachlan, Robert; Oates, Robert D; van der Poel, Sheryl; St John, Bianca; Sigman, Mark; Sokol, Rebecca; Tournaye, Herman

2017-11-01

Herein, we describe the consensus guideline methodology, summarize the evidence-based recommendations we provided to the World Health Organization (WHO) for their consideration in the development of global guidance and present a narrative review of the diagnosis of male infertility as related to the eight prioritized (problem or population (P), intervention (I), comparison (C) and outcome(s) (O) (PICO)) questions. Additionally, we discuss the challenges and research gaps identified during the synthesis of this evidence. The aim of this paper is to present an evidence-based approach for the diagnosis of male infertility as related to the eight prioritized PICO questions. Collating the evidence to support providing recommendations involved a collaborative process as developed by WHO, namely: identification of priority questions and critical outcomes; retrieval of up-to-date evidence and existing guidelines; assessment and synthesis of the evidence; and the formulation of draft recommendations to be used for reaching consensus with a wide range of global stakeholders. For each draft recommendation the quality of the supporting evidence was then graded and assessed for consideration during a WHO consensus. Evidence was synthesized and recommendations were drafted to address the diagnosis of male infertility specifically encompassing the following: What is the prevalence of male infertility and what proportion of infertility is attributable to the male? Is it necessary for all infertile men to undergo a thorough evaluation? What is the clinical (ART/non ART) value of traditional semen parameters? What key male lifestyle factors impact on fertility (focusing on obesity, heat and tobacco smoking)? Do supplementary oral antioxidants or herbal therapies significantly influence fertility outcomes for infertile men? What are the evidence-based criteria for genetic screening of infertile men? How does a history of neoplasia and related treatments in the male impact on (his and his partner's) reproductive health and fertility options? And lastly, what is the impact of varicocele on male fertility and does correction of varicocele improve semen parameters and/or fertility? This evidence synthesis analysis has been conducted in a manner to be considered for global applicability for the diagnosis of male infertility. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology.

The diagnosis of male infertility: an analysis of the evidence to support the development of global WHO guidance—challenges and future research opportunities

PubMed Central

Barratt, Christopher L R; Björndahl, Lars; De Jonge, Christopher J; Lamb, Dolores J; Osorio Martini, Francisco; McLachlan, Robert; Oates, Robert D; van der Poel, Sheryl; St John, Bianca; Sigman, Mark; Sokol, Rebecca; Tournaye, Herman

2017-01-01

Abstract BACKGROUND Herein, we describe the consensus guideline methodology, summarize the evidence-based recommendations we provided to the World Health Organization (WHO) for their consideration in the development of global guidance and present a narrative review of the diagnosis of male infertility as related to the eight prioritized (problem or population (P), intervention (I), comparison (C) and outcome(s) (O) (PICO)) questions. Additionally, we discuss the challenges and research gaps identified during the synthesis of this evidence. OBJECTIVE AND RATIONALE The aim of this paper is to present an evidence-based approach for the diagnosis of male infertility as related to the eight prioritized PICO questions. SEARCH METHODS Collating the evidence to support providing recommendations involved a collaborative process as developed by WHO, namely: identification of priority questions and critical outcomes; retrieval of up-to-date evidence and existing guidelines; assessment and synthesis of the evidence; and the formulation of draft recommendations to be used for reaching consensus with a wide range of global stakeholders. For each draft recommendation the quality of the supporting evidence was then graded and assessed for consideration during a WHO consensus. OUTCOMES Evidence was synthesized and recommendations were drafted to address the diagnosis of male infertility specifically encompassing the following: What is the prevalence of male infertility and what proportion of infertility is attributable to the male? Is it necessary for all infertile men to undergo a thorough evaluation? What is the clinical (ART/non ART) value of traditional semen parameters? What key male lifestyle factors impact on fertility (focusing on obesity, heat and tobacco smoking)? Do supplementary oral antioxidants or herbal therapies significantly influence fertility outcomes for infertile men? What are the evidence-based criteria for genetic screening of infertile men? How does a history of neoplasia and related treatments in the male impact on (his and his partner's) reproductive health and fertility options? And lastly, what is the impact of varicocele on male fertility and does correction of varicocele improve semen parameters and/or fertility? WIDER IMPLICATIONS This evidence synthesis analysis has been conducted in a manner to be considered for global applicability for the diagnosis of male infertility. PMID:28981651

77 FR 50720 - Test Documentation for Digital Computer Software Used in Safety Systems of Nuclear Power Plants

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0195] Test Documentation for Digital Computer Software...) is issuing for public comment draft regulatory guide (DG), DG-1207, ``Test Documentation for Digital... practices for test documentation for software and computer systems as described in the Institute of...

77 FR 36014 - Initial Test Program of Emergency Core Cooling Systems for Boiling-Water Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0134] Initial Test Program of Emergency Core Cooling... for public comment draft regulatory guide (DG), DG-1277, ``Initial Test Program of Emergency Core... acceptable to implement with regard to initial testing features of emergency core cooling systems (ECCSs) for...

16 CFR 1610.5 - Test apparatus and materials.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Test apparatus and materials. 1610.5 Section... STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES The Standard § 1610.5 Test apparatus and materials. (a) Flammability apparatus. The flammability test apparatus consists of a draft-proof ventilated chamber enclosing...

16 CFR 1610.5 - Test apparatus and materials.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Test apparatus and materials. 1610.5 Section... STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES The Standard § 1610.5 Test apparatus and materials. (a) Flammability apparatus. The flammability test apparatus consists of a draft-proof ventilated chamber enclosing...

Tests Screening Reading Difficulty in Malayalam among Upper Primary School Boys

ERIC Educational Resources Information Center

Gafoor, K. Abdul

2014-01-01

Design of a screening test for identifying reading difficult students in Malayalam and validation thereof among boys is made to help schools proactively intervene with such students. A battery of tests developed based on extant literature on screening tests, reviewed difficulties in reading Malayalam, and discrimination power of the draft tests is…

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016).

PubMed

Nishida, Osamu; Ogura, Hiroshi; Egi, Moritoki; Fujishima, Seitaro; Hayashi, Yoshiro; Iba, Toshiaki; Imaizumi, Hitoshi; Inoue, Shigeaki; Kakihana, Yasuyuki; Kotani, Joji; Kushimoto, Shigeki; Masuda, Yoshiki; Matsuda, Naoyuki; Matsushima, Asako; Nakada, Taka-Aki; Nakagawa, Satoshi; Nunomiya, Shin; Sadahiro, Tomohito; Shime, Nobuaki; Yatabe, Tomoaki; Hara, Yoshitaka; Hayashida, Kei; Kondo, Yutaka; Sumi, Yuka; Yasuda, Hideto; Aoyama, Kazuyoshi; Azuhata, Takeo; Doi, Kent; Doi, Matsuyuki; Fujimura, Naoyuki; Fuke, Ryota; Fukuda, Tatsuma; Goto, Koji; Hasegawa, Ryuichi; Hashimoto, Satoru; Hatakeyama, Junji; Hayakawa, Mineji; Hifumi, Toru; Higashibeppu, Naoki; Hirai, Katsuki; Hirose, Tomoya; Ide, Kentaro; Kaizuka, Yasuo; Kan'o, Tomomichi; Kawasaki, Tatsuya; Kuroda, Hiromitsu; Matsuda, Akihisa; Matsumoto, Shotaro; Nagae, Masaharu; Onodera, Mutsuo; Ohnuma, Tetsu; Oshima, Kiyohiro; Saito, Nobuyuki; Sakamoto, So; Sakuraya, Masaaki; Sasano, Mikio; Sato, Norio; Sawamura, Atsushi; Shimizu, Kentaro; Shirai, Kunihiro; Takei, Tetsuhiro; Takeuchi, Muneyuki; Takimoto, Kohei; Taniguchi, Takumi; Tatsumi, Hiroomi; Tsuruta, Ryosuke; Yama, Naoya; Yamakawa, Kazuma; Yamashita, Chizuru; Yamashita, Kazuto; Yoshida, Takeshi; Tanaka, Hiroshi; Oda, Shigeto

2018-01-01

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J-SSCG 2016), a Japanese-specific set of clinical practice guidelines for sepsis and septic shock created jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in February 2017 in Japanese. An English-language version of these guidelines was created based on the contents of the original Japanese-language version. Members of the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine were selected and organized into 19 committee members and 52 working group members. The guidelines were prepared in accordance with the Medical Information Network Distribution Service (Minds) creation procedures. The Academic Guidelines Promotion Team was organized to oversee and provide academic support to the respective activities allocated to each Guideline Creation Team. To improve quality assurance and workflow transparency, a mutual peer review system was established, and discussions within each team were open to the public. Public comments were collected once after the initial formulation of a clinical question (CQ), and twice during the review of the final draft. Recommendations were determined to have been adopted after obtaining support from a two-thirds (>66.6%) majority vote of each of the 19 committee members. A total of 87 CQs were selected among 19 clinical areas, including pediatric topics and several other important areas not covered in the first edition of the Japanese guidelines (J-SSCG 2012). The approval rate obtained through committee voting, in addition to ratings of the strengths of the recommendation and its supporting evidence were also added to each recommendation statement. We conducted meta-analyses for 29 CQs. Thirty seven CQs contained recommendations in the form of an expert consensus due to insufficient evidence. No recommendations were provided for 5 CQs. Based on the evidence gathered, we were able to formulate Japanese-specific clinical practice guidelines that are tailored to the Japanese context in a highly transparent manner. These guidelines can easily be used not only by specialists, but also by non-specialists, general clinicians, nurses, pharmacists, clinical engineers, and other healthcare professionals.

Development of the Canadian Physiotherapy Assessment of Clinical Performance: A New Tool to Assess Physiotherapy Students' Performance in Clinical Education.

PubMed

Mori, Brenda; Brooks, Dina; Norman, Kathleen E; Herold, Jodi; Beaton, Dorcas E

2015-08-01

To develop the first draft of a Canadian tool to assess physiotherapy (PT) students' performance in clinical education (CE). Phase 1: to gain consensus on the items within the new tool, the number and placement of the comment boxes, and the rating scale; Phase 2: to explore the face and content validity of the draft tool. Phase 1 used the Delphi method; Phase 2 used cognitive interviewing methods with recent graduates and clinical instructors (CIs) and detailed interviews with clinical education and measurement experts. Consensus was reached on the first draft of the new tool by round 3 of the Delphi process, which was completed by 21 participants. Interviews were completed with 13 CIs, 6 recent graduates, and 7 experts. Recent graduates and CIs were able to interpret the tool accurately, felt they could apply it to a recent CE experience, and provided suggestions to improve the draft. Experts provided salient advice. The first draft of a new tool to assess PT students in CE, the Canadian Physiotherapy Assessment of Clinical Performance (ACP), was developed and will undergo further development and testing, including national consultation with stakeholders. Data from Phase 2 will contribute to developing an online education module for CIs and students.

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of adult isthmic spondylolisthesis.

PubMed

Kreiner, D Scott; Baisden, Jamie; Mazanec, Daniel J; Patel, Rakesh D; Bess, Robert S; Burton, Douglas; Chutkan, Norman B; Cohen, Bernard A; Crawford, Charles H; Ghiselli, Gary; Hanna, Amgad S; Hwang, Steven W; Kilincer, Cumhur; Myers, Mark E; Park, Paul; Rosolowski, Karie A; Sharma, Anil K; Taleghani, Christopher K; Trammell, Terry R; Vo, Andrew N; Williams, Keith D

2016-12-01

The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Adult Isthmic Spondylolisthesis features evidence-based recommendations for diagnosing and treating adult patients with isthmic spondylolisthesis. The guideline is intended to reflect contemporary treatment concepts for symptomatic isthmic spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of June 2013. NASS' guideline on this topic is the only guideline on adult isthmic spondylolisthesis accepted in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse. The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with isthmic spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. This is a guideline summary review. This guideline is the product of the Adult Isthmic Spondylolisthesis Work Group of NASS' Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questionsto address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Adult Isthmic Spondylolisthesis guideline was accepted into the National Guideline Clearinghouse and will be updated approximately every 5 years. Thirty-one clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with isthmic spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

PubMed Central

Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

2016-01-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-05

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

Recommendations for liver transplantation for hepatocellular carcinoma: an international consensus conference report

PubMed Central

Clavien, Pierre-Alain; Lesurtel, Mickael; Bossuyt, Patrick M M; Gores, Gregory J; Langer, Bernard; Perrier, Arnaud

2012-01-01

Although liver transplantation is a widely accepted treatment for hepatocellular carcinoma (HCC), much controversy remains and there is no generally accepted set of guidelines. An international consensus conference was held on Dec 2–4, 2010, in Zurich, Switzerland, with the aim of reviewing current practice regarding liver transplantation in patients with HCC and to develop internationally accepted statements and guidelines. The format of the conference was based on the Danish model. 19 working groups of experts prepared evidence-based reviews according to the Oxford classification, and drafted recommendations answering 19 specific questions. An independent jury of nine members was appointed to review these submissions and make final recommendations, after debates with the experts and audience at the conference. This report presents the final 37 statements and recommendations, covering assessment of candidates for liver transplantation, criteria for listing in cirrhotic and non-cirrhotic patients, role of tumour downstaging, management of patients on the waiting list, role of living donation, and post-transplant management. PMID:22047762

Self-regulation of recombinant DNA technology in Japan in the 1970s.

PubMed

Nagai, Hiroyuki; Nukaga, Yoshio; Saeki, Koji; Akabayashi, Akira

2009-07-01

Recombinant DNA technology was developed in the United States in the early 1970s. Leading scientists held an international Asilomar Conference in 1975 to examine the self regulation of recombinant DNA technology, followed by the U.S. National Institutes of Health drafting the Recombinant DNA Research Guidelines in 1976. The result of this conference significantly affected many nations, including Japan. However, there have been few historical studies on the self-regulation of recombinant technologies conducted by scientists and government officials in Japan. The purpose of this paper is to analyze how the Science Council of Japan, the Ministry of Education, Science adn Culture, and the Science and Technology Agency developed self-regulation policies for recombinant DNA technology in Japan in the 1970s. Groups of molecular biologist and geneticists played a key role in establishing guidelines in cooperation with government officials. Our findings suggest that self-regulation policies on recombinant DNA technology have influenced safety management for the life sciences and establishment of institutions for review in Japan.

Future Research Opportunities in Peri-Prosthetic Joint Infection Prevention.

PubMed

Berbari, Elie; Segreti, John; Parvizi, Javad; Berríos-Torres, Sandra I

Peri-prosthetic joint infection (PJI) is a serious complication of prosthetic joint arthroplasty. A better understanding and reversal of modifiable risk factors may lead to a reduction in the incidence of incisional (superficial and deep) and organ/space (e.g., PJI) surgical site infections (SSI). Recently, the Centers for Disease Control and Prevention (CDC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC) published the Guideline for Prevention of Surgical Site Infection. This targeted update applies evidence-based methodology in drafting recommendations for potential strategies to reduce the risk of SSI both across surgical procedures and specifically in prosthetic joint arthroplasty. A panel of PJI content experts identified nine PJI prevention research opportunities based on both evidence gaps identified through the guideline development process (transfusion, immunosuppressive therapy, anticoagulation, orthopedic space suit, and biofilm) and expert opinion (anesthesia, operative room environment, glycemic control, and Staphylococcus aureus nasal screening and decolonization. This article offers a road map for PJI prevention research.

Assembly and features of secondary metabolite biosynthetic gene clusters in Streptomyces ansochromogenes.

PubMed

Zhong, Xingyu; Tian, Yuqing; Niu, Guoqing; Tan, Huarong

2013-07-01

A draft genome sequence of Streptomyces ansochromogenes 7100 was generated using 454 sequencing technology. In combination with local BLAST searches and gap filling techniques, a comprehensive antiSMASH-based method was adopted to assemble the secondary metabolite biosynthetic gene clusters in the draft genome of S. ansochromogenes. A total of at least 35 putative gene clusters were identified and assembled. Transcriptional analysis showed that 20 of the 35 gene clusters were expressed in either or all of the three different media tested, whereas the other 15 gene clusters were silent in all three different media. This study provides a comprehensive method to identify and assemble secondary metabolite biosynthetic gene clusters in draft genomes of Streptomyces, and will significantly promote functional studies of these secondary metabolite biosynthetic gene clusters.

ETV-DRAFT TEST REPORT OF MOBILE SOURCE EMISSIONS CONTROL DEVICES DONALDSON COMPANY,INC. SERIES 6100 DIESEL OXIDATION CATALYST MUFFLER

EPA Science Inventory

This report reflects verification testing of a catalytic muffler for diesel trucks. Produced by Donaldson Corp., it was tested on low sulfur and ultra low sulfur fuel, and shown to have reduced emissions.

An overview of spray drift reduction testing of spray nozzles

USDA-ARS?s Scientific Manuscript database

The importance of the development and testing of drift reduction technologies (DRTs) is increasing. Common spray drift reduction technologies include spray nozzles and spray adjuvants. Following draft procedures developed for a DRT program, three spray nozzles were tested under high air speed cond...

Evaluation of a low-temperature steam and formaldehyde sterilizer.

PubMed

Kanemitsu, K; Kunishima, H; Imasaka, T; Ishikawa, S; Harigae, H; Yamato, S; Hirayama, Y; Kaku, M

2003-09-01

We evaluated a low-temperature steam and formaldehyde (LTSF) sterilizer based on the draft European Standard prEN 14180. Microbiological tests were conducted on small and full loads using process challenge devices in five programs (P1-P5). With small loads all tests showed no growth of Bacillus stearothermophilus (ATCC7953) spores. However, positive cultures were observed with full-load tests using P5 (sterilization temperature, 50 degrees C). Our data indicated that the load influenced the efficacy of the LTSF sterilizer. Desorption tests were conducted to determine residual formaldehyde in indicator strips. The mean concentrations of formaldehyde in P1-P5 were 31.9, 56.3, 54.9, 82.2 and 180.6 microg, respectively, which are below the limits allowed by the draft Standard. Our results indicate that the LTSF sterilizer is useful for sterilization because of its excellent efficacy, short handling time, and safety.

An education and motivation intervention to change clinical management of the third stage of labor - the GIRMMAHP Initiative.

PubMed

Figueras, Albert; Narváez, Edgar; Valsecia, Mabel; Vásquez, Susana; Rojas, Germán; Camilo, Angiolina; del Valle, José-María; Aguilera, Cristina

2008-12-01

Hemorrhage and hypertensive disorders are major contributors to death after delivery in developing countries. The GIRMMAHP Initiative was designed to describe the actual delivery care in five Latin American countries and to educate and motivate clinical staff at 17 hospitals with the purpose of implementing their own clinical practice guidelines to prevent postpartum hemorrhage. A multicountry education intervention was developed in four consecutive stages, using two analyses: (a) an observational study of the clinical records in eight teaching and nine nonteaching hospitals and (b) a study of the long-term changes measured 12 months after completion of an education intervention and writing a local clinical guideline. Data from 2,247 pregnant women showed that only 23.3 percent had an active management of the third stage of labor and that 22.7 percent received no prenatal care visit. These data were used to prepare local clinical practice guidelines in each participant hospital. The proportion of active management increased to 72.6 percent of deliveries at 3 months and 58.7 percent 1 year later. Use of oxytocin during the third stage of labor increased to 85.9 percent of included deliveries. The proportion of women who had postpartum hemorrhage decreased from 12.7 percent at baseline to 5 percent at 1 year after the intervention. An education intervention and discussion of actual clinical practice problems with health professionals and their involvement in drafting clinical guidelines helped improve health care quality and practitioners' adherence to these guidelines.