Consensus on best practice standards for Fracture Liaison Service in the Asia-Pacific region.

PubMed

Chan, Ding-Cheng Derrick; Chang, Lo-Yu; Akesson, Kristina E; Mitchell, Paul; Chen, Chung-Hwan; Michael Lewiecki, E; Lee, Joon Kiong; Lau, Tang Ching; Songpatanasilp, Thawee; Lee, Kin Bong; Kim, Kwang Joon; Chen, Jung-Fu; Huang, Ko-En; Gau, Yih-Lan; Chang, Yin-Fan; Ebeling, Peter; Xia, Weibo; Yu, Wei; Suzuki, Atsushi; Hew, Fen Lee; Mercado-Asis, Leilani B; Chung, Yoon-Sok; Tsai, Keh-Sung; Lin, Gau-Tyan; Yang, Rong-Sen; Wu, Chih-Hsing

2018-05-12

The Fracture Liaison Service (FLS) Consensus Meeting endorsed by the International Osteoporosis Foundation (IOF), Asian Federation of Osteoporosis Societies (AFOS), and Asia Pacific Osteoporosis Foundation (APOF) was hosted by the Taiwanese Osteoporosis Association on October 14, 2017. International and domestic experts reviewed the 13 Best Practice Framework (BPF) standards and concluded that all standards were generally applicable in the Asia-Pacific region and needed only minor modifications to fit the healthcare settings in the region. To review and generate consensus on best practices of fracture liaison service (FLS) in the Asia-Pacific (AP) region. In October 2017, the Taiwanese Osteoporosis Association (TOA) invited experts from the AP region (n = 23), the Capture the Fracture Steering Committee (n = 2), and the USA (n = 1) to join the AP region FLS Consensus Meeting in Taipei. After two rounds of consensus generation, the recommendations on the 13 Best Practice Framework (BPF) standards were reported and reviewed by the attendees. Experts unable to attend the on-site meeting reviewed the draft, made suggestions, and approved the final version. Because the number of FLSs in the region is rapidly increasing, experts agreed that it was timely to establish consensus on benchmark quality standards for FLSs in the region. They also agreed that the 13 BPF standards and the 3 levels of standards were generally applicable, but that some clarifications were necessary. They suggested, for example, that patient and family education be incorporated into the current standards and that communication with the public to promote FLSs be increased. The consensus on the 13 BPF standards reviewed in this meeting was that they were generally applicable and required only a few advanced clarifications to increase the quality of FLSs in the region.

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.

ACVIM consensus update on Lyme borreliosis in dogs and cats

PubMed Central

Gerber, Bernhard; Goldstein, Richard E.; Labato, Mary Anna; Lappin, Michael R.; Moore, George E.

2018-01-01

An update of the 2006 American College of Veterinary Internal Medicine (ACVIM) Small Animal Consensus Statement on Lyme Disease in Dogs: Diagnosis, Treatment, and Prevention was presented at the 2016 ACVIM Forum in Denver, CO, followed by panel and audience discussion and a drafted consensus statement distributed online to diplomates for comment. The updated consensus statement is presented below. The consensus statement aims to provide guidance on the diagnosis, treatment, and prevention of Lyme borreliosis in dogs and cats. PMID:29566442

Consensus Reached in the Role of EMS in Injury Prevention

DOT National Transportation Integrated Search

1996-06-01

The intent of this statement is to represent the consensus of the EMS community on essential and desirable activities for EMS in primary injury prevention. After reviewing the literature, the project steering committee drafted the statement. Then the...

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.

Development of Taiwan's strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations.

PubMed

Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

2014-01-01

Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan's regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan.

Development of Taiwan’s strategies for regulating nanotechnology-based pharmaceuticals harmonized with international considerations

PubMed Central

Guo, Jiun-Wen; Lee, Yu-Hsuan; Huang, Hsiau-Wen; Tzou, Mei-Chyun; Wang, Ying-Jan; Tsai, Jui-Chen

2014-01-01

Nanotechnology offers potential in pharmaceuticals and biomedical developments for improving drug delivery systems, medical imaging, diagnosis, cancer therapy, and regenerative medicine. Although there is no international regulation or legislation specifically for nanomedicine, it is agreed worldwide that considerably more attention should be paid to the quality, safety, and efficacy of nanotechnology-based drugs. The US Food and Drug Administration and the European Medicines Agency have provided several draft regulatory guidance and reflection papers to assist the development of nanomedicines. To cope with the impact of nanotechnology and to foster its pharmaceutical applications and development in Taiwan, this article reviews the trends of regulating nanotechnology-based pharmaceuticals in the international community and proposes strategies for Taiwan’s regulation harmonized with international considerations. The draft regulatory measures include a chemistry, manufacturing, and controls (CMC) review checklist and guidance for CMC review of liposomal products. These have been submitted for discussion among an expert committee, with membership comprised of multidisciplinary academia, research institutions, the pharmaceutical industry, and regulators, and are currently approaching final consensus. Once a consensus is reached, these mechanisms will be recommended to the Taiwan Food and Drug Administration for jurisdiction and may be initiated as the starting point for regulating nanotechnology-based pharmaceuticals in Taiwan. PMID:25342901

The Japan Lung Cancer Society–Japanese Society for Radiation Oncology consensus-based computed tomographic atlas for defining regional lymph node stations in radiotherapy for lung cancer

PubMed Central

Itazawa, Tomoko; Tamaki, Yukihisa; Komiyama, Takafumi; Nishimura, Yasumasa; Nakayama, Yuko; Ito, Hiroyuki; Ohde, Yasuhisa; Kusumoto, Masahiko; Sakai, Shuji; Suzuki, Kenji; Watanabe, Hirokazu; Asamura, Hisao

2017-01-01

The purpose of this study was to develop a consensus-based computed tomographic (CT) atlas that defines lymph node stations in radiotherapy for lung cancer based on the lymph node map of the International Association for the Study of Lung Cancer (IASLC). A project group in the Japanese Radiation Oncology Study Group (JROSG) initially prepared a draft of the atlas in which lymph node Stations 1–11 were illustrated on axial CT images. Subsequently, a joint committee of the Japan Lung Cancer Society (JLCS) and the Japanese Society for Radiation Oncology (JASTRO) was formulated to revise this draft. The committee consisted of four radiation oncologists, four thoracic surgeons and three thoracic radiologists. The draft prepared by the JROSG project group was intensively reviewed and discussed at four meetings of the committee over several months. Finally, we proposed definitions for the regional lymph node stations and the consensus-based CT atlas. This atlas was approved by the Board of Directors of JLCS and JASTRO. This resulted in the first official CT atlas for defining regional lymph node stations in radiotherapy for lung cancer authorized by the JLCS and JASTRO. In conclusion, the JLCS–JASTRO consensus-based CT atlas, which conforms to the IASLC lymph node map, was established. PMID:27609192

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.

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 1: risk assessment.

PubMed

Park, Dong Il; Hisamatsu, Tadakazu; Chen, Minhu; Ng, Siew Chien; Ooi, Choon Jin; Wei, Shu Chen; Banerjee, Rupa; Hilmi, Ida Normiha; Jeen, Yoon Tae; Han, Dong Soo; Kim, Hyo Jong; Ran, Zhihua; Wu, Kaichun; Qian, Jiaming; Hu, Pin-Jin; Matsuoka, Katsuyoshi; Andoh, Akira; Suzuki, Yasuo; Sugano, Kentaro; Watanabe, Mamoru; Hibi, Toshifumi; Puri, Amarender S; Yang, Suk-Kyun

2018-01-01

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 1 of the statements comprised 2 parts: risk of TB infection Recommendaduring anti-TNF therapy, and screening for TB infection prior to commencing anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 2: management.

PubMed

Park, Dong Il; Hisamatsu, Tadakazu; Chen, Minhu; Ng, Siew Chien; Ooi, Choon Jin; Wei, Shu Chen; Banerjee, Rupa; Hilmi, Ida Normiha; Jeen, Yoon Tae; Han, Dong Soo; Kim, Hyo Jong; Ran, Zhihua; Wu, Kaichun; Qian, Jiaming; Hu, Pin-Jin; Matsuoka, Katsuyoshi; Andoh, Akira; Suzuki, Yasuo; Sugano, Kentaro; Watanabe, Mamoru; Hibi, Toshifumi; Puri, Amarender S; Yang, Suk-Kyun

2018-01-01

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 2 of the statements comprised 3 parts: management of latent TB in preparation for anti-TNF therapy, monitoring during anti-TNF therapy, and management of an active TB infection after anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 1: risk assessment

PubMed Central

Park, Dong Il; Hisamatsu, Tadakazu; Chen, Minhu; Ng, Siew Chien; Ooi, Choon Jin; Wei, Shu Chen; Banerjee, Rupa; Hilmi, Ida Normiha; Jeen, Yoon Tae; Han, Dong Soo; Kim, Hyo Jong; Ran, Zhihua; Wu, Kaichun; Qian, Jiaming; Hu, Pin-Jin; Matsuoka, Katsuyoshi; Andoh, Akira; Suzuki, Yasuo; Sugano, Kentaro; Watanabe, Mamoru; Hibi, Toshifumi; Puri, Amarender S.

2018-01-01

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 1 of the statements comprised 2 parts: risk of TB infection Recommendaduring anti-TNF therapy, and screening for TB infection prior to commencing anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment. PMID:29422793

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.

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.

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.

The Japan Lung Cancer Society-Japanese Society for Radiation Oncology consensus-based computed tomographic atlas for defining regional lymph node stations in radiotherapy for lung cancer.

PubMed

Itazawa, Tomoko; Tamaki, Yukihisa; Komiyama, Takafumi; Nishimura, Yasumasa; Nakayama, Yuko; Ito, Hiroyuki; Ohde, Yasuhisa; Kusumoto, Masahiko; Sakai, Shuji; Suzuki, Kenji; Watanabe, Hirokazu; Asamura, Hisao

2017-01-01

The purpose of this study was to develop a consensus-based computed tomographic (CT) atlas that defines lymph node stations in radiotherapy for lung cancer based on the lymph node map of the International Association for the Study of Lung Cancer (IASLC). A project group in the Japanese Radiation Oncology Study Group (JROSG) initially prepared a draft of the atlas in which lymph node Stations 1-11 were illustrated on axial CT images. Subsequently, a joint committee of the Japan Lung Cancer Society (JLCS) and the Japanese Society for Radiation Oncology (JASTRO) was formulated to revise this draft. The committee consisted of four radiation oncologists, four thoracic surgeons and three thoracic radiologists. The draft prepared by the JROSG project group was intensively reviewed and discussed at four meetings of the committee over several months. Finally, we proposed definitions for the regional lymph node stations and the consensus-based CT atlas. This atlas was approved by the Board of Directors of JLCS and JASTRO. This resulted in the first official CT atlas for defining regional lymph node stations in radiotherapy for lung cancer authorized by the JLCS and JASTRO. In conclusion, the JLCS-JASTRO consensus-based CT atlas, which conforms to the IASLC lymph node map, was established. © The Author 2016. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.

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.

77 FR 42988 - Updating OSHA Construction Standards Based on National Consensus Standards; Head Protection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-23

.... OSHA-2011-0184] RIN 1218-AC65 Updating OSHA Construction Standards Based on National Consensus... Administration (OSHA), Department of Labor. ACTION: Direct final rule; correction. SUMMARY: OSHA is correcting a... confusion resulting from a drafting error. OSHA published the DFR on June 22, 2012 (77 FR 37587). OSHA also...

Development of a Consensus Taxonomy of Sedentary Behaviors (SIT): Report of Delphi Round 1

PubMed Central

Chastin, Sebastien Francois Martin; Schwarz, Ulf; Skelton, Dawn Ann

2013-01-01

Background Over the last decade, sedentary behaviors have emerged as a distinctive behavioral paradigm with deleterious effects on health independent of physical activity. The next phase of research is to establish dose response between sedentary behaviors and health outcomes and improve understanding of context and determinants of these behaviors. Establishing a common taxonomy of these behaviors is a necessary step in this process. Aim The Sedentary behavior International Taxonomy project was developed to establish a classification of sedentary behaviors by use of a formal consensus process. Methods The study follows a Delphi process in three Rounds. A preparatory stage informed the development of terms of reference documents. In Round 1, experts were asked to make statements about the taxonomy; 1) its purpose and use ; 2) the domains, categories or facets that should be consider and include; 3) the structure/architecture to arrange and link these domains and facets. In Round 2 experts will be presented with a draft taxonomy emerging from Round 1 and invited to comment and propose alterations. The taxonomy will then be finalised at the outset of this stage. Results Results of Round 1 are reported here. There is a general consensus that a taxonomy will help advances in research by facilitating systematic and standardised: 1) investigation and analysis; 2) reporting and communication; 3) data pooling, comparison and meta-analysis; 4) development of measurement tools; 4) data descriptions, leading to higher quality in data querying and facilitate discoveries. There is also a consensus that such a taxonomy should be flexible to accommodate diverse purposes of use, and future advances in the field and yet provide a cross-disciplinary common language. A consensual taxonomy structure emerged with nine primary facets (Purpose, Environment, Posture, Social, Measurement, Associated behavior, Status, Time, Type) and the draft structure presented here for Round 2. PMID:24312653

[Critical evaluation of the first draft of DSM-V].

PubMed

Frances, A

2011-02-16

Critical evaluation of DSM-V first draft This is an evaluation of the first DSM-V (Diagnostic and Statistical Manual of Mental Disorders-V) draft from the DSM-IV chairman. First, a brief history of DSM is reported. Then, major reasons for present controversies and the threat they raise to APA leadership in the field are discussed. Third point is careful recollection of the several conflicting aspects of the DSM-V draft, paying attention to drawbacks and their implications for future clinical practice, research and forensic activity. Comment is finally provided about APA (American Psychiatric Association) decisions aimed at reaching more consensus about this basic instrument of American psychiatry.

Society for Neuroscience in Anesthesiology and Critical Care Expert consensus statement: anesthetic management of endovascular treatment for acute ischemic stroke*: endorsed by the Society of NeuroInterventional Surgery and the Neurocritical Care Society.

PubMed

Talke, Pekka O; Sharma, Deepak; Heyer, Eric J; Bergese, Sergio D; Blackham, Kristine A; Stevens, Robert D

2014-04-01

Literature on the anesthetic management of endovascular treatment of acute ischemic stroke (AIS) is limited. Anesthetic management during these procedures is still mostly dependent on individual or institutional preferences. Thus, the Society of Neuroscience in Anesthesiology and Critical Care (SNACC) created a task force to provide expert consensus recommendations on anesthetic management of endovascular treatment of AIS. The task force conducted a systematic literature review (up to August 2012). Because of the limited number of research articles relating to this subject, the task force solicited opinions from experts in this area. The task force created a draft consensus statement based on the available data. Classes of recommendations and levels of evidence were assigned to articles specifically addressing anesthetic management during endovascular treatment of stroke using the standard American Heart Association evidence rating scheme. The draft consensus statement was reviewed by the Task Force, SNACC Executive Committee and representatives of Society of NeuroInterventional Surgery (SNIS) and Neurocritical Care Society (NCS) reaching consensus on the final document. For this consensus statement the anesthetic management of endovascular treatment of AIS was subdivided into 12 topics. Each topic includes a summary of available data followed by recommendations. This consensus statement is intended for use by individuals involved in the care of patients with acute ischemic stroke, such as anesthesiologists, interventional neuroradiologists, neurologists, neurointensivists, and neurosurgeons.

Republished: Society for Neuroscience in Anesthesiology and Critical Care expert consensus statement: Anesthetic management of endovascular treatment for acute ischemic stroke.

PubMed

Talke, Pekka O; Sharma, Deepak; Heyer, Eric J; Bergese, Sergio D; Blackham, Kristine A; Stevens, Robert D

2014-08-01

Literature on the anesthetic management of endovascular treatment of acute ischemic stroke (AIS) is limited. Anesthetic management during these procedures is still mostly dependent on individual or institutional preferences. Thus, the Society of Neuroscience in Anesthesiology and Critical Care (SNACC) created a task force to provide expert consensus recommendations on anesthetic management of endovascular treatment of AIS. The task force conducted a systematic literature review (up to August 2012). Because of the limited number of research articles relating to this subject, the task force solicited opinions from experts in this area. The task force created a draft consensus statement based on the available data. Classes of recommendations and levels of evidence were assigned to articles specifically addressing anesthetic management during endovascular treatment of stroke using the standard American Heart Association evidence rating scheme. The draft consensus statement was reviewed by the Task Force, SNACC Executive Committee and representatives of Society of NeuroInterventional Surgery (SNIS) and Neurocritical Care Society (NCS) reaching consensus on the final document. For this consensus statement the anesthetic management of endovascular treatment of AIS was subdivided into 12 topics. Each topic includes a summary of available data followed by recommendations. This consensus statement is intended for use by individuals involved in the care of patients with acute ischemic stroke, such as anesthesiologists, interventional neuroradiologists, neurologists, neurointensivists and neurosurgeons. © 2014 American Heart Association, Inc.

Asian Organization for Crohn's and Colitis and Asian Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 1: Risk assessment.

PubMed

Park, Dong Ii; Hisamatsu, Tadakazu; Chen, Minhu; Ng, Siew Chien; Ooi, Choon Jin; Wei, Shu Chen; Banerjee, Rupa; Hilmi, Ida Normiha; Jeen, Yoon Tae; Han, Dong Soo; Kim, Hyo Jong; Ran, Zhihua; Wu, Kaichun; Qian, Jiaming; Hu, Pin-Jin; Matsuoka, Katsuyoshi; Andoh, Akira; Suzuki, Yasuo; Sugano, Kentaro; Watanabe, Mamoru; Hibi, Toshifumi; Puri, Amarender S; Yang, Suk-Kyun

2018-01-01

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asian Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection, and prevention of latent TB infection and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from nine Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 1 of the statements comprised two parts: (i) risk of TB infection during anti-TNF therapy and (ii) screening for TB infection prior to commencing anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 2: Management.

PubMed

Park, Dong Il; Hisamatsu, Tadakazu; Chen, Minhu; Ng, Siew Chien; Ooi, Choon Jin; Wei, Shu Chen; Banerjee, Rupa; Hilmi, Ida Normiha; Jeen, Yoon Tae; Han, Dong Soo; Kim, Hyo Jong; Ran, Zhihua; Wu, Kaichun; Qian, Jiaming; Hu, Pin-Jin; Matsuoka, Katsuyoshi; Andoh, Akira; Suzuki, Yasuo; Sugano, Kentaro; Watanabe, Mamoru; Hibi, Toshifumi; Puri, Amarender S; Yang, Suk-Kyun

2018-01-01

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from nine Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 2 of the statements comprised three parts: (3) management of latent TB in preparation for anti-TNF therapy, (4) monitoring during anti-TNF therapy, and (5) management of an active TB infection after anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment. © 2017 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Consensus on the clinical management, screening-to-treat, and surveillance of Helicobacter pylori infection to improve gastric cancer control on a nationwide scale.

PubMed

Sheu, Bor-Shyang; Wu, Ming-Shiang; Chiu, Cheng-Tang; Lo, Jing-Chuan; Wu, Deng-Chyang; Liou, Jyh-Ming; Wu, Chun-Ying; Cheng, Hsiu-Chi; Lee, Yi-Chia; Hsu, Ping-I; Chang, Chun-Chao; Chang, Wei-Lun; Lin, Jaw-Town

2017-06-01

Previous international consensus statements provided general policies for the management of Helicobacter pylori infection. However, there are geographic differences in the prevalence and antimicrobial resistance of H. pylori, and in the availability of medications and endoscopy. Thus, nationwide or regional consensus statements are needed to improve control of H. pylori infection and gastric cancer. This consensus statement for management of H. pylori in Taiwan has three major sections: (1) optimal diagnosis and indications; (2) current treatment strategies; and (3) screening-to-treat and surveillance for control of gastric cancer. The literature review emphasized recent data for development of draft statements and determination of levels of evidence. Twenty-five Taiwan experts conducted a consensus conference, by a modified Delphi process, to modify the draft statements. Consensus, defined as an agreement of least 80% of the experts, and recommendation grade were determined by anonymous voting. There were 24 consensus statements. Section 1 has seven statements on recommendations for the diagnosis and indications for treatment of H. pylori infection. Section 2 has 10 statements that provide an updated treatment algorithm for first-line, second-line, and third-line regimens. Section 3 has seven statements regarding H. pylori eradication for reducing the risk of gastric cancer, with a cost-benefit analysis. After H. pylori eradication, the consensus highlights the use of endoscopic surveillance and/or chemoprevention to further reduce the burden of gastric cancer. This consensus statement has updated recommendations for improving the clinical management of H. pylori infection in areas such as Taiwan, which have high prevalence of H. pylori infection and gastric cancer. © 2017 The Authors. Helicobacter Published by John Wiley & Sons Ltd.

A High Quality Draft Consensus Sequence of the Genome of a Heterozygous Grapevine Variety

PubMed Central

Cartwright, Dustin A.; Cestaro, Alessandro; Pruss, Dmitry; Pindo, Massimo; FitzGerald, Lisa M.; Vezzulli, Silvia; Reid, Julia; Malacarne, Giulia; Iliev, Diana; Coppola, Giuseppina; Wardell, Bryan; Micheletti, Diego; Macalma, Teresita; Facci, Marco; Mitchell, Jeff T.; Perazzolli, Michele; Eldredge, Glenn; Gatto, Pamela; Oyzerski, Rozan; Moretto, Marco; Gutin, Natalia; Stefanini, Marco; Chen, Yang; Segala, Cinzia; Davenport, Christine; Demattè, Lorenzo; Mraz, Amy; Battilana, Juri; Stormo, Keith; Costa, Fabrizio; Tao, Quanzhou; Si-Ammour, Azeddine; Harkins, Tim; Lackey, Angie; Perbost, Clotilde; Taillon, Bruce; Stella, Alessandra; Solovyev, Victor; Fawcett, Jeffrey A.; Sterck, Lieven; Vandepoele, Klaas; Grando, Stella M.; Toppo, Stefano; Moser, Claudio; Lanchbury, Jerry; Bogden, Robert; Skolnick, Mark; Sgaramella, Vittorio; Bhatnagar, Satish K.; Fontana, Paolo; Gutin, Alexander; Van de Peer, Yves; Salamini, Francesco; Viola, Roberto

2007-01-01

Background Worldwide, grapes and their derived products have a large market. The cultivated grape species Vitis vinifera has potential to become a model for fruit trees genetics. Like many plant species, it is highly heterozygous, which is an additional challenge to modern whole genome shotgun sequencing. In this paper a high quality draft genome sequence of a cultivated clone of V. vinifera Pinot Noir is presented. Principal Findings We estimate the genome size of V. vinifera to be 504.6 Mb. Genomic sequences corresponding to 477.1 Mb were assembled in 2,093 metacontigs and 435.1 Mb were anchored to the 19 linkage groups (LGs). The number of predicted genes is 29,585, of which 96.1% were assigned to LGs. This assembly of the grape genome provides candidate genes implicated in traits relevant to grapevine cultivation, such as those influencing wine quality, via secondary metabolites, and those connected with the extreme susceptibility of grape to pathogens. Single nucleotide polymorphism (SNP) distribution was consistent with a diffuse haplotype structure across the genome. Of around 2,000,000 SNPs, 1,751,176 were mapped to chromosomes and one or more of them were identified in 86.7% of anchored genes. The relative age of grape duplicated genes was estimated and this made possible to reveal a relatively recent Vitis-specific large scale duplication event concerning at least 10 chromosomes (duplication not reported before). Conclusions Sanger shotgun sequencing and highly efficient sequencing by synthesis (SBS), together with dedicated assembly programs, resolved a complex heterozygous genome. A consensus sequence of the genome and a set of mapped marker loci were generated. Homologous chromosomes of Pinot Noir differ by 11.2% of their DNA (hemizygous DNA plus chromosomal gaps). SNP markers are offered as a tool with the potential of introducing a new era in the molecular breeding of grape. PMID:18094749

EULAR/PReS standards and recommendations for the transitional care of young people with juvenile-onset rheumatic diseases.

PubMed

Foster, Helen E; Minden, Kirsten; Clemente, Daniel; Leon, Leticia; McDonagh, Janet E; Kamphuis, Sylvia; Berggren, Karin; van Pelt, Philomine; Wouters, Carine; Waite-Jones, Jennifer; Tattersall, Rachel; Wyllie, Ruth; Stones, Simon R; Martini, Alberto; Constantin, Tamas; Schalm, Susanne; Fidanci, Berna; Erer, Burak; Demirkaya, Erkan; Ozen, Seza; Carmona, Loreto

2017-04-01

To develop standards and recommendations for transitional care for young people (YP) with juvenile-onset rheumatic and musculoskeletal diseases (jRMD). The consensus process involved the following: (1) establishing an international expert panel to include patients and representatives from multidisciplinary teams in adult and paediatric rheumatology; (2) a systematic review of published models of transitional care in jRMDs, potential standards and recommendations, strategies for implementation and tools to evaluate services and outcomes; (3) setting the framework, developing the process map and generating a first draft of standards and recommendations; (4) further iteration of recommendations; (5) establishing consensus recommendations with Delphi methodology and (6) establishing standards and quality indicators. The final consensus derived 12 specific recommendations for YP with jRMD focused on transitional care. These included: high-quality, multidisciplinary care starting in early adolescence; the integral role of a transition co-ordinator; transition policies and protocols; efficient communications; transfer documentation; an open electronic-based platform to access resources; appropriate training for paediatric and adult healthcare teams; secure funding to continue treatments and services into adult rheumatology and the need for increased evidence to inform best practice. These consensus-based recommendations inform strategies to reach optimal outcomes in transitional care for YP with jRMD based on available evidence and expert opinion. They need to be implemented in the context of individual countries, healthcare systems and regulatory frameworks. 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/.

Groin Pain Syndrome Italian Consensus Conference on terminology, clinical evaluation and imaging assessment in groin pain in athlete

PubMed Central

Bisciotti, G N; Volpi, P; Zini, R; Auci, A; Aprato, A; Belli, A; Bellistri, G; Benelli, P; Bona, S; Bonaiuti, D; Carimati, G; Canata, G L; Cassaghi, G; Cerulli, S; Delle Rose, G; Di Benedetto, P; Di Marzo, F; Di Pietto, F; Felicioni, L; Ferrario, L; Foglia, A; Galli, M; Gervasi, E; Gia, L; Giammattei, C; Guglielmi, A; Marioni, A; Moretti, B; Niccolai, R; Orgiani, N; Pantalone, A; Parra, F; Quaglia, A; Respizzi, F; Ricciotti, L; Pereira Ruiz, M T; Russo, A; Sebastiani, E; Tancredi, G; Tosi, F; Vuckovic, Z

2016-01-01

The nomenclature and the lack of consensus of clinical evaluation and imaging assessment in groin pain generate significant confusion in this field. The Groin Pain Syndrome Italian Consensus Conference has been organised in order to prepare a consensus document regarding taxonomy, clinical evaluation and imaging assessment for groin pain. A 1-day Consensus Conference was organised on 5 February 2016, in Milan (Italy). 41 Italian experts with different backgrounds participated in the discussion. A consensus document previously drafted was discussed, eventually modified, and finally approved by all members of the Consensus Conference. Unanimous consensus was reached concerning: (1) taxonomy (2) clinical evaluation and (3) imaging assessment. The synthesis of these 3 points is included in this paper. The Groin Pain Syndrome Italian Consensus Conference reached a consensus on three main points concerning the groin pain syndrome assessment, in an attempt to clarify this challenging medical problem. PMID:28890800

Study of business ethics in occupational medicine.

PubMed Central

Philipp, R; Goodman, G; Harling, K; Beattie, B

1997-01-01

OBJECTIVE: To investigate the views of specialists in occupational medicine about business ethics in occupational medicine. METHOD: A qualitative study with face to face focus groups and successive reviews of the draft consensus was undertaken of all accredited specialists in occupational medicine who were members of the south Wales and west of England group of the Society of Occupational Medicine, and of all regional specialty advisers and deputies from the Faculty of Occupational Medicine. RESULTS: There was widespread agreement for the need of a code of business ethics. In all, during the four draft stages of preparing a consensus, 72% (28/39) of members of the south Wales and west of England group of the Society of Occupational Medicine, and 31% (20/64) of regional specialty advisers and deputies provided detailed comment for inclusion in it. CONCLUSIONS: Consensus of their views was reached among study participants for issues of business ethics involving advertising, competence, qualifications, fees, commitment, changes in provider contracts, regulation, and supervision of trainees. It provides a basis for further debate. PMID:9196458

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/.

Involving patients in a multidisciplinary European consensus process and in the development of a 'patient summary of the consensus document for colon and rectal cancer care'.

PubMed

Boelens, Petra G; Taylor, Claire; Henning, Geoffrey; Marang-van de Mheen, Perla J; Espin, Eloy; Wiggers, Theo; Gore-Booth, Jola; Moss, Barbara; Valentini, Vincenzo; van de Velde, Cornelis J H

2014-01-01

High-quality cancer care should be accessible for patients and healthcare professionals. Involvement of patients as partners in guideline formation and consensus processes is still rarely found. EURECCA, short for European Registration of Cancer Care, is the platform to improve outcomes of cancer care by reducing variation in the diagnostic and treatment process. EURECCA acknowledges the important role of patients in implementation of consensus information in clinical practice. The aim of this article is to describe the process of involving patients in the consensus process and in developing the patient summary of the consensus for colon and rectal cancer care. The Delphi method for achieving consensus was used. Three online voting rounds and one tele-voting round were offered to an expert panel of oncology professionals and patient representatives. At four different stages, patients and/or patient representatives were involved in the process: (1) during the consensus process, (2) lecturing about the role of the patient, (3) development of the patient summary, and (4) testing the patient summary. Representatives were invited to the voting and commenting rounds of this process and given an equal vote. Although patients were not consulted during the planning stages of this process, patient involvement increased following the panel's discussion of the implementation of the consensus among the patient population. After the consensus meeting, the patient summary was written by patient representatives, oncologists and nurses. A selection of proactive patients reviewed the draft patient summary; responses were positive and several patient-reported outcomes were added. Questionnaires to evaluate the use and implementation of the patient summary in daily practice are currently being developed and tested. Patient consultation will be needed in future planning for selection of topics. The present study may function as a model for future consensus processes to involve patients at different stages and to implement both patient and healthcare professional versions in daily practice.

SIAMOC position paper on gait analysis in clinical practice: General requirements, methods and appropriateness. Results of an Italian consensus conference.

PubMed

Benedetti, Maria Grazia; Beghi, Ettore; De Tanti, Antonio; Cappozzo, Aurelio; Basaglia, Nino; Cutti, Andrea Giovanni; Cereatti, Andrea; Stagni, Rita; Verdini, Federica; Manca, Mario; Fantozzi, Silvia; Mazzà, Claudia; Camomilla, Valentina; Campanini, Isabella; Castagna, Anna; Cavazzuti, Lorenzo; Del Maestro, Martina; Croce, Ugo Della; Gasperi, Marco; Leo, Tommaso; Marchi, Pia; Petrarca, Maurizio; Piccinini, Luigi; Rabuffetti, Marco; Ravaschio, Andrea; Sawacha, Zimi; Spolaor, Fabiola; Tesio, Luigi; Vannozzi, Giuseppe; Visintin, Isabella; Ferrarin, Maurizio

2017-10-01

Gait analysis is recognized as a useful assessment tool in the field of human movement research. However, doubts remain on its real effectiveness as a clinical tool, i.e. on its capability to change the diagnostic-therapeutic practice. In particular, the conditions in which evidence of a favorable cost-benefit ratio is found and the methodology for properly conducting and interpreting the exam are not identified clearly. To provide guidelines for the use of Gait Analysis in the context of rehabilitation medicine, SIAMOC (the Italian Society of Clinical Movement Analysis) promoted a National Consensus Conference which was held in Bologna on September 14th, 2013. The resulting recommendations were the result of a three-stage process entailing i) the preparation of working documents on specific open issues, ii) the holding of the consensus meeting, and iii) the drafting of consensus statements by an external Jury. The statements were formulated based on scientific evidence or experts' opinion, when the quality/quantity of the relevant literature was deemed insufficient. The aim of this work is to disseminate the consensus statements. These are divided into 13 questions grouped in three areas of interest: 1) General requirements and management, 2) Methodological and instrumental issues, and 3) Scientific evidence and clinical appropriateness. SIAMOC hopes that this document will contribute to improve clinical practice and help promoting further research in the field. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Surviving critical illness: what is next? An expert consensus statement on physical rehabilitation after hospital discharge.

PubMed

Major, M E; Kwakman, R; Kho, M E; Connolly, B; McWilliams, D; Denehy, L; Hanekom, S; Patman, S; Gosselink, R; Jones, C; Nollet, F; Needham, D M; Engelbert, R H H; van der Schaaf, M

2016-10-29

The study objective was to obtain consensus on physical therapy (PT) in the rehabilitation of critical illness survivors after hospital discharge. Research questions were: what are PT goals, what are recommended measurement tools, and what constitutes an optimal PT intervention for survivors of critical illness? A Delphi consensus study was conducted. Panelists were included based on relevant fields of expertise, years of clinical experience, and publication record. A literature review determined five themes, forming the basis for Delphi round one, which was aimed at generating ideas. Statements were drafted and ranked on a 5-point Likert scale in two additional rounds with the objective to reach consensus. Results were expressed as median and semi-interquartile range, with the consensus threshold set at ≤0.5. Ten internationally established researchers and clinicians participated in this Delphi panel, with a response rate of 80 %, 100 %, and 100 % across three rounds. Consensus was reached on 88.5 % of the statements, resulting in a framework for PT after hospital discharge. Essential handover information should include information on 15 parameters. A core set of outcomes should test exercise capacity, skeletal muscle strength, function in activities of daily living, mobility, quality of life, and pain. PT interventions should include functional exercises, circuit and endurance training, strengthening exercises for limb and respiratory muscles, education on recovery, and a nutritional component. Screening tools to identify impairments in other health domains and referral to specialists are proposed. A consensus-based framework for optimal PT after hospital discharge is proposed. Future research should focus on feasibility testing of this framework, developing risk stratification tools and validating core outcome measures for ICU survivors.

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

Draft versus finished sequence data for DNA and protein diagnostic signature development

PubMed Central

Gardner, Shea N.; Lam, Marisa W.; Smith, Jason R.; Torres, Clinton L.; Slezak, Tom R.

2005-01-01

Sequencing pathogen genomes is costly, demanding careful allocation of limited sequencing resources. We built a computational Sequencing Analysis Pipeline (SAP) to guide decisions regarding the amount of genomic sequencing necessary to develop high-quality diagnostic DNA and protein signatures. SAP uses simulations to estimate the number of target genomes and close phylogenetic relatives (near neighbors or NNs) to sequence. We use SAP to assess whether draft data are sufficient or finished sequencing is required using Marburg and variola virus sequences. Simulations indicate that intermediate to high-quality draft with error rates of 10−3–10−5 (∼8× coverage) of target organisms is suitable for DNA signature prediction. Low-quality draft with error rates of ∼1% (3× to 6× coverage) of target isolates is inadequate for DNA signature prediction, although low-quality draft of NNs is sufficient, as long as the target genomes are of high quality. For protein signature prediction, sequencing errors in target genomes substantially reduce the detection of amino acid sequence conservation, even if the draft is of high quality. In summary, high-quality draft of target and low-quality draft of NNs appears to be a cost-effective investment for DNA signature prediction, but may lead to underestimation of predicted protein signatures. PMID:16243783

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.

75 FR 16459 - Draft Document Related to the Review of the National Ambient Air Quality Standards for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-01

... Review of the National Ambient Air Quality Standards for Particulate Matter AGENCY: Environmental... Review of the Particulate Matter National Ambient Air Quality Standards--First External Review Draft (75... Particulate Matter National Ambient Air Quality Standards--First External Review Draft (March 2010), please...

[Expert consensus post-marketing evaluation scheme to detect immunotoxicity of Chinese medicine in clinical populations (draft version for comments)].

PubMed

Xie, Yan-Ming; Zhao, Yu-Bin; Jiang, Jun-Jie; Chang, Yan-Peng; Zhang, Wen; Shen, Hao; Lu, Peng-Fei

2013-09-01

Through consensus, establish a post-marketing scheme and the technical processes to evaluate Chinese medicine's immunotoxicity on a population, as well as its beneficial influences on the immune system. Provide regulations on the collection, storage and transportation of serum samples. This article applies to the post-marketing scientific evaluation of the immunotoxicity of parenterally administered, and for other ways of taking Chinese medicine.

Augmenting Chinese hamster genome assembly by identifying regions of high confidence.

PubMed

Vishwanathan, Nandita; Bandyopadhyay, Arpan A; Fu, Hsu-Yuan; Sharma, Mohit; Johnson, Kathryn C; Mudge, Joann; Ramaraj, Thiruvarangan; Onsongo, Getiria; Silverstein, Kevin A T; Jacob, Nitya M; Le, Huong; Karypis, George; Hu, Wei-Shou

2016-09-01

Chinese hamster Ovary (CHO) cell lines are the dominant industrial workhorses for therapeutic recombinant protein production. The availability of genome sequence of Chinese hamster and CHO cells will spur further genome and RNA sequencing of producing cell lines. However, the mammalian genomes assembled using shot-gun sequencing data still contain regions of uncertain quality due to assembly errors. Identifying high confidence regions in the assembled genome will facilitate its use for cell engineering and genome engineering. We assembled two independent drafts of Chinese hamster genome by de novo assembly from shotgun sequencing reads and by re-scaffolding and gap-filling the draft genome from NCBI for improved scaffold lengths and gap fractions. We then used the two independent assemblies to identify high confidence regions using two different approaches. First, the two independent assemblies were compared at the sequence level to identify their consensus regions as "high confidence regions" which accounts for at least 78 % of the assembled genome. Further, a genome wide comparison of the Chinese hamster scaffolds with mouse chromosomes revealed scaffolds with large blocks of collinearity, which were also compiled as high-quality scaffolds. Genome scale collinearity was complemented with EST based synteny which also revealed conserved gene order compared to mouse. As cell line sequencing becomes more commonly practiced, the approaches reported here are useful for assessing the quality of assembly and potentially facilitate the engineering of cell lines. Copyright © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

75 FR 8045 - National Environmental Policy Act (NEPA) Draft Guidance, Establishing, Applying, and Revising...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

... COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance...: Council on Environmental Quality. ACTION: Notice of Availability, Draft Guidance, ``Establishing, Applying... February 18, 2010, the Council on Environmental Quality (CEQ) announced four steps to modernize...

Australian recommendations for the integration of emergency care for older people: Consensus Statement.

PubMed

Lowthian, Judy A; Arendts, Glenn; Strivens, Edward

2018-05-07

Management of older patients during acute illness or injury does not occur in isolation in emergency departments. We aimed to develop a collaborative Consensus Statement to enunciate principles of integrated emergency care. Briefing notes, informed by research and evidence reviews, were developed and evaluated by a Consensus Working Party comprising cross-specialty representation from clinical experts, service providers, consumers and policymakers. The Consensus Working Party then convened to discuss and develop the statement's content. A subcommittee produced a draft, which was reviewed and edited by the Consensus Working Party. Consensus was reached after three rounds of discussion, with 12 principles and six recommendations for how to follow these principles, including an integrated care framework for action. Dissemination will encourage stakeholders and associated policy bodies to embrace the principles and priorities for action, potentially leading to collaborative work practices and improvement of care during and after acute illness or injury. © 2018 AJA Inc.

Genome sequencing of bacteria: sequencing, de novo assembly and rapid analysis using open source tools.

PubMed

Kisand, Veljo; Lettieri, Teresa

2013-04-01

De novo genome sequencing of previously uncharacterized microorganisms has the potential to open up new frontiers in microbial genomics by providing insight into both functional capabilities and biodiversity. Until recently, Roche 454 pyrosequencing was the NGS method of choice for de novo assembly because it generates hundreds of thousands of long reads (<450 bps), which are presumed to aid in the analysis of uncharacterized genomes. The array of tools for processing NGS data are increasingly free and open source and are often adopted for both their high quality and role in promoting academic freedom. The error rate of pyrosequencing the Alcanivorax borkumensis genome was such that thousands of insertions and deletions were artificially introduced into the finished genome. Despite a high coverage (~30 fold), it did not allow the reference genome to be fully mapped. Reads from regions with errors had low quality, low coverage, or were missing. The main defect of the reference mapping was the introduction of artificial indels into contigs through lower than 100% consensus and distracting gene calling due to artificial stop codons. No assembler was able to perform de novo assembly comparable to reference mapping. Automated annotation tools performed similarly on reference mapped and de novo draft genomes, and annotated most CDSs in the de novo assembled draft genomes. Free and open source software (FOSS) tools for assembly and annotation of NGS data are being developed rapidly to provide accurate results with less computational effort. Usability is not high priority and these tools currently do not allow the data to be processed without manual intervention. Despite this, genome assemblers now readily assemble medium short reads into long contigs (>97-98% genome coverage). A notable gap in pyrosequencing technology is the quality of base pair calling and conflicting base pairs between single reads at the same nucleotide position. Regardless, using draft whole genomes that are not finished and remain fragmented into tens of contigs allows one to characterize unknown bacteria with modest effort.

75 FR 8046 - National Environmental Policy Act (NEPA) Draft Guidance, “NEPA Mitigation and Monitoring.”

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

... COUNCIL ON ENVIRONMENTAL QUALITY National Environmental Policy Act (NEPA) Draft Guidance, ``NEPA Mitigation and Monitoring.'' AGENCY: Council On Environmental Quality. ACTION: Notice of Availability, Draft... Quality (CEQ) announced four steps to modernize, reinvigorate, and ease the use and increase 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.

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

Development of quality indicators for physiotherapy for patients with PAOD in the Netherlands: a Delphi study.

PubMed

Gijsbers, H J H; Lauret, G J; van Hofwegen, A; van Dockum, T A; Teijink, J A W; Hendriks, H J M

2016-06-01

The aim of the study was to develop quality indicators (QIs) for physiotherapy management of patients with intermittent claudication (IC) in the Netherlands. As part of an international six-step method to develop QIs, an online survey Delphi-procedure was completed. After two Delphi-rounds a validation round was performed. Twenty-six experts were recruited to participate in this study. Twenty-four experts completed two Delphi-rounds. A third round was conducted inviting 1200 qualified and registered physiotherapists of the Dutch integrated care network 'Claudicationet' to validate a draft set of quality indicators. Out of 83 potential QIs in the Dutch physiotherapy guideline on 'Intermittent claudication', consensus among the experts selected nine indicators. All nine quality indicators were validated by 300 physiotherapists. A final set of nine indicators was derived from (1) a Dutch evidence-based physiotherapy guideline, (2) an expert Delphi procedure and (3) a validation by 300 physiotherapists. This set of indicators should be validated in clinical practice. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Development of a Draft Core Set of Domains for Measuring Shared Decision Making in Osteoarthritis: An OMERACT Working Group on Shared Decision Making.

PubMed

Toupin-April, Karine; Barton, Jennifer; Fraenkel, Liana; Li, Linda; Grandpierre, Viviane; Guillemin, Francis; Rader, Tamara; Stacey, Dawn; Légaré, France; Jull, Janet; Petkovic, Jennifer; Scholte-Voshaar, Marieke; Welch, Vivian; Lyddiatt, Anne; Hofstetter, Cathie; De Wit, Maarten; March, Lyn; Meade, Tanya; Christensen, Robin; Gaujoux-Viala, Cécile; Suarez-Almazor, Maria E; Boonen, Annelies; Pohl, Christoph; Martin, Richard; Tugwell, Peter S

2015-12-01

Despite the importance of shared decision making for delivering patient-centered care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this Outcome Measures in Rheumatology (OMERACT) working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspectives of patients, health professionals, and researchers. We followed the OMERACT Filter 2.0 method to develop a draft core domain set by (1) forming an OMERACT working group; (2) conducting a review of domains of shared decision making; and (3) obtaining opinions of all those involved using a modified nominal group process held at a session activity at the OMERACT 12 meeting. In all, 26 people from Europe, North America, and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the draft core set: (1) identifying the decision, (2) exchanging information, (3) clarifying views, (4) deliberating, (5) making the decision, (6) putting the decision into practice, and (7) assessing the effect of the decision. Contextual factors were also suggested. We proposed a draft core set of shared decision-making domains for OA intervention research studies. Next steps include a workshop at OMERACT 13 to reach consensus on these proposed domains in the wider OMERACT group, as well as to detail subdomains and assess instruments to develop a core outcome measurement set.

Development of a Draft Core Set of Domains for Measuring Shared Decision Making in Osteoarthritis: An OMERACT Working Group on Shared Decision Making

PubMed Central

Toupin April, Karine; Barton, Jennifer; Fraenkel, Liana; Li, Linda; Grandpierre, Viviane; Guillemin, Francis; Rader, Tamara; Stacey, Dawn; Légaré, France; Jull, Janet; Petkovic, Jennifer; Scholte Voshaar, Marieke; Welch, Vivian; Lyddiatt, Anne; Hofstetter, Cathie; De Wit, Maarten; March, Lyn; Meade, Tanya; Christensen, Robin; Gaujoux-Viala, Cécile; Suarez-Almazor, Maria E.; Boonen, Annelies; Pohl, Christoph; Martin, Richard; Tugwell, Peter

2015-01-01

Objective Despite the importance of shared decision making for delivering patient-centred care in rheumatology, there is no consensus on how to measure its process and outcomes. The aim of this OMERACT working group is to determine the core set of domains for measuring shared decision making in intervention studies in adults with osteoarthritis (OA), from the perspective of patients, health professionals and researchers. Methods We followed the OMERACT Filter 2.0 to develop a draft core domain set, which consisted of: (i) forming an OMERACT working group; (ii) conducting a review of domains of shared decision making; and (iii) obtaining the opinions of stakeholders using a modified nominal group process held at a session activity at the OMERACT 2014 meeting. Results 26 stakeholders from Europe, North America and Australia, including 5 patient research partners, participated in the session activity. Participants identified the following domains for measuring shared decision making to be included as part of the Draft Core Set: 1) Identifying the decision; 2) Exchanging Information; 3) Clarifying views; 4) Deliberating; 5) Making the decision; 6) Putting the decision into practice; and 7) Assessing the impact of the decision. Contextual factors were also suggested. Conclusion We propose a Draft Core Set of shared decision making domains for OA intervention research studies. Next steps include a workshop at OMERACT 2016 to reach consensus on these proposed domains in the wider OMERACT group, as well as detail sub-domains and assess instruments to develop a Core Outcome Measurement Set. PMID:25877502

Assessment and management of nutrition and growth in Rett syndrome

PubMed Central

Leonard, Helen; Ravikumara, Madhur; Baikie, Gordon; Naseem, Nusrat; Ellaway, Carolyn; Percy, Alan; Abraham, Suzanne; Geerts, Suzanne; Lane, Jane; Jones, Mary; Bathgate, Katherine; Downs, Jenny

2014-01-01

Objectives We developed recommendations for the clinical management of poor growth and weight gain in Rett syndrome through evidence review and the consensus of an expert panel of clinicians. Methods Initial draft recommendations were created based upon literature review and 34 open-ended questions where the literature was lacking. Statements and questions were made available to an international, multi-disciplinary panel of clinicians in an online format and a Microsoft Word formatted version of the draft via email. Input was sought using a 2-stage modified Delphi process to reach consensus agreement. Items included clinical assessment of growth, anthropometry, feeding difficulties and management to increase caloric intake, decrease feeding difficulties and consideration of gastrostomy. Results Agreement was achieved on 101/112 statements. A comprehensive approach to the management of poor growth in Rett syndrome is recommended that takes into account factors such as feeding difficulties and nutritional needs. A BMI of approximately the 25th centile can be considered as a reasonable target in clinical practice. Gastrostomy is indicated for very poor growth, if there is risk of aspiration and if feeding times are prolonged. Conclusions These evidence- and consensus-based recommendations have the potential to improve care of nutrition and growth in a rare condition and stimulate research to improve the current limited evidence base. PMID:24084372

Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist.

PubMed

Sepucha, Karen R; Abhyankar, Purva; Hoffman, Aubri S; Bekker, Hilary L; LeBlanc, Annie; Levin, Carrie A; Ropka, Mary; Shaffer, Victoria A; Sheridan, Stacey L; Stacey, Dawn; Stalmeier, Peep; Vo, Ha; Wills, Celia E; Thomson, Richard

2018-05-01

Patient decision aids (PDAs) are evidence-based tools designed to help patients make specific and deliberated choices among healthcare options. The International Patient Decision Aid Standards (IPDAS) Collaboration review papers and Cochrane systematic review of PDAs have found significant gaps in the reporting of evaluations of PDAs, including poor or limited reporting of PDA content, development methods and delivery. This study sought to develop and reach consensus on reporting guidelines to improve the quality of publications evaluating PDAs. An international workgroup, consisting of members from IPDAS Collaboration, followed established methods to develop reporting guidelines for PDA evaluation studies. This paper describes the results from three completed phases: (1) planning, (2) drafting and (3) consensus, which included a modified, two-stage, online international Delphi process. The work was conducted over 2 years with bimonthly conference calls and three in-person meetings. The workgroup used input from these phases to produce a final set of recommended items in the form of a checklist. The SUNDAE Checklist (Standards for UNiversal reporting of patient Decision Aid Evaluations) includes 26 items recommended for studies reporting evaluations of PDAs. In the two-stage Delphi process, 117/143 (82%) experts from 14 countries completed round 1 and 96/117 (82%) completed round 2. Respondents reached a high level of consensus on the importance of the items and indicated strong willingness to use the items when reporting PDA studies. The SUNDAE Checklist will help ensure that reports of PDA evaluation studies are understandable, transparent and of high quality. A separate Explanation and Elaboration publication provides additional details to support use of the checklist. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

76 FR 79176 - Notice of Availability of Draft Recreational Water Quality Criteria and Request for Scientific Views

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-21

... ENVIRONMENTAL PROTECTION AGENCY [EPA-OW-2011-0466; FRL-9609-3] Notice of Availability of Draft Recreational Water Quality Criteria and Request for Scientific Views AGENCY: Environmental Protection Agency... Environmental Protection Agency (EPA) is announcing the availability of the draft document Recreational Water...

78 FR 3420 - Office of Environmental Information; Announcement of Availability and Comment Period for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-16

...) Organizations and two associated draft QA Handbooks; 1) draft Handbook for Preparing Quality Management Plans... Availability and Comment Period for the Draft Quality Standard for Environmental Data Collection, Production, and Use by Non-EPA (External) Organizations and Two Associated QA Handbooks; Correction AGENCY...

77 FR 22282 - Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

...] Draft Guidelines on Biologics Quality Monitoring: Testing for the Detection of Mycoplasma Contamination... Detection of Mycoplasma Contamination.'' This draft guideline identifies stages of manufacture where... contamination. Because the guidelines apply to final product and master seed/cell testing in veterinary vaccines...

76 FR 35216 - Science Advisory Board Staff Office Notification of a Public Teleconference of the Chartered...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-16

...The EPA Science Advisory Board (SAB) Staff Office announces a public teleconference of the chartered SAB on July 5, 2011 to conduct a quality review of a draft SAB report, Review of EPA's Draft Hydraulic Fracturing Study Plan (Quality Review Draft).

75 FR 71694 - Science Advisory Board Staff Office; Notification of Two Public Quality Review Teleconferences of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

... review of EPA's ``Toxicological Review of Trichloroethylene'' on December 15, 2010 and (b) a quality... of Trichloroethylene'' (October 2009), and (2) a draft report peer reviewing EPA's draft document... draft assessment entitled ``Toxicological Review of Trichloroethylene'' (October 2009). EPA's Office of...

Use of low-coverage, large-insert, short-read data for rapid and accurate generation of enhanced-quality draft Pseudomonas genome sequences.

PubMed

O'Brien, Heath E; Gong, Yunchen; Fung, Pauline; Wang, Pauline W; Guttman, David S

2011-01-01

Next-generation genomic technology has both greatly accelerated the pace of genome research as well as increased our reliance on draft genome sequences. While groups such as the Genomics Standards Consortium have made strong efforts to promote genome standards there is a still a general lack of uniformity among published draft genomes, leading to challenges for downstream comparative analyses. This lack of uniformity is a particular problem when using standard draft genomes that frequently have large numbers of low-quality sequencing tracts. Here we present a proposal for an "enhanced-quality draft" genome that identifies at least 95% of the coding sequences, thereby effectively providing a full accounting of the genic component of the genome. Enhanced-quality draft genomes are easily attainable through a combination of small- and large-insert next-generation, paired-end sequencing. We illustrate the generation of an enhanced-quality draft genome by re-sequencing the plant pathogenic bacterium Pseudomonas syringae pv. phaseolicola 1448A (Pph 1448A), which has a published, closed genome sequence of 5.93 Mbp. We use a combination of Illumina paired-end and mate-pair sequencing, and surprisingly find that de novo assemblies with 100x paired-end coverage and mate-pair sequencing with as low as low as 2-5x coverage are substantially better than assemblies based on higher coverage. The rapid and low-cost generation of large numbers of enhanced-quality draft genome sequences will be of particular value for microbial diagnostics and biosecurity, which rely on precise discrimination of potentially dangerous clones from closely related benign strains.

Developing 21st century accreditation standards for teaching hospitals: the Taiwan experience.

PubMed

Huang, Chung-I; Wung, Cathy; Yang, Che-Ming

2009-12-15

The purpose of this study is to establish teaching hospital accreditation standards anew with the hope that Taiwan's teaching hospitals can live up to the expectations of our society and ensure quality teaching. The development process lasted two years, 2005-2006, and was separated into three stages. The first stage centered on leadership meetings and consensus building, the second on drafting the new standards with expert focus groups, and the third on a pilot study and subsequent revision. Our new teaching hospital accreditation standards have six categories and 95 standards as follows: educational resources (20 items), teaching and training plans and outcomes (42 items), research and results (9 items), development of clinical faculty and continuing education (8 items), academic exchanges and community education (8 items), and administration (8 items). The new standards have proven feasible and posed reasonable challenges in the pilot study. We hope the new standards will strengthen teaching and research, and improve the quality of hospital services at the same time.

75 FR 47595 - Science Advisory Board Staff Office; Notification of a Public Teleconference of the Clean Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... Air Quality Standards--Second External Review Draft (June 2010). DATES: The teleconference will be... Standards--Second External Review Draft (June 2010). Background information on previous meetings and... Quality Standards--Second External Review Draft (June 2010) should be directed to Ms. Beth Hassett-Sipple...

75 FR 9206 - Science Advisory Board Staff Office; Notification of a Clean Air Scientific Advisory Committee...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-01

...: Second External Review Draft and EPA's Policy Assessment for the Review of the Carbon Monoxide National Ambient Air Quality Standards: External Review Draft. The chartered CASAC will subsequently hold a public... National Ambient Air Quality Standards: Second External Review Draft and the Policy Assessment for the...

75 FR 4067 - Release of Draft Documents Related to the Review of the National Ambient Air Quality Standards...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-26

... for public comment a second draft assessment document titled, Quantitative Health Risk Assessment for... quantitative analyses that are being conducted as part of the review of the national ambient air quality...-Focused Visibility Assessment--Second External Review Draft and Quantitative Health Risk Assessment for...

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.

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…

From Crisis to Consensus. Setting Standards in Chicago.

ERIC Educational Resources Information Center

Barth, Patte

1994-01-01

In 1993 the Council for Basic Education assisted in the drafting of academic standards for the students of the Chicago (Illinois) Public Schools. The results of this project, the Chicago Learning Outcomes, are now the official basis for designing new curricula, citywide assessments, and professional development throughout the district. The Chicago…

Towards Consensus on the Nature of Outdoor Education. Editorial.

ERIC Educational Resources Information Center

Higgins, Peter; Loynes, Chris

1997-01-01

At a European conference in Finland, various outdoor education organizations drafted a statement of intent for the newly created European Institute for Outdoor Adventure Education. Their common view of outdoor education is that it strives to stimulate personal and social development experientially through some experience of the outdoors. Discusses…

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.

Applied Swarm-based medicine: collecting decision trees for patterns of algorithms analysis.

PubMed

Panje, Cédric M; Glatzer, Markus; von Rappard, Joscha; Rothermundt, Christian; Hundsberger, Thomas; Zumstein, Valentin; Plasswilm, Ludwig; Putora, Paul Martin

2017-08-16

The objective consensus methodology has recently been applied in consensus finding in several studies on medical decision-making among clinical experts or guidelines. The main advantages of this method are an automated analysis and comparison of treatment algorithms of the participating centers which can be performed anonymously. Based on the experience from completed consensus analyses, the main steps for the successful implementation of the objective consensus methodology were identified and discussed among the main investigators. The following steps for the successful collection and conversion of decision trees were identified and defined in detail: problem definition, population selection, draft input collection, tree conversion, criteria adaptation, problem re-evaluation, results distribution and refinement, tree finalisation, and analysis. This manuscript provides information on the main steps for successful collection of decision trees and summarizes important aspects at each point of the analysis.

Pharmacologic management of chronic neuropathic pain: Review of the Canadian Pain Society consensus statement.

PubMed

Mu, Alex; Weinberg, Erica; Moulin, Dwight E; Clarke, Hance

2017-11-01

To provide family physicians with a practical clinical summary of the Canadian Pain Society (CPS) revised consensus statement on the pharmacologic management of neuropathic pain. A multidisciplinary interest group within the CPS conducted a systematic review of the literature on the current treatments of neuropathic pain in drafting the revised consensus statement. Gabapentinoids, tricyclic antidepressants, and serotonin-norepinephrine reuptake inhibitors are the first-line agents for treating neuropathic pain. Tramadol and other opioids are recommended as second-line agents, while cannabinoids are newly recommended as third-line agents. Other anticonvulsants, methadone, tapentadol, topical lidocaine, and botulinum toxin are recommended as fourth-line agents. Many pharmacologic analgesics exist for the treatment of neuropathic pain. Through evidence-based recommendations, the CPS revised consensus statement helps guide family physicians in the management of patients with neuropathic pain. Copyright© the College of Family Physicians of Canada.

75 FR 65480 - Science Advisory Board Staff Office; Notification of Two Public Teleconferences of the Clean Air...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-25

... Quality Standards for NOX and SOX: Second External Review Draft (September 2010) and a teleconference for... the Secondary National Ambient Air Quality Standards for NO X and SO X : Second External Review Draft... External Review Draft (September 2010) should be directed to Dr. Byran Hubbell, OAR, at (919) 541-0621 or...

Consensus standards for introductory e-learning courses in human participants research ethics

PubMed Central

Williams, John R; Sprumont, Dominique; Hirtle, Marie; Adebamowo, Clement; Braunschweiger, Paul; Bull, Susan; Burri, Christian; Czarkowski, Marek; Te Fan, Chien; Franck, Caroline; Gefenas, Eugenjius; Geissbuhler, Antoine; Klingmann, Ingrid; Kouyaté, Bocar; Kraehenbhul, Jean-Pierre; Kruger, Mariana; Moodley, Keymanthri; Ntoumi, Francine; Nyirenda, Thomas; Pym, Alexander; Silverman, Henry; Tenorio, Sara

2015-01-01

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders. PMID:23959838

Procedural considerations for CPV outdoor power ratings per IEC 62670

NASA Astrophysics Data System (ADS)

Muller, Matthew; Kurtz, Sarah; Rodriguez, Jose

2013-09-01

The IEC Working Group 7 (WG7) is in the process of developing a draft procedure for an outdoor concentrating photovoltaic (CPV) module power rating at Concentrator Standard Operating Conditions (CSOC). WG7 recently achieved some consensus that using component reference cells to monitor/limit spectral variation is the preferred path for the outdoor power rating. To build on this consensus, the community must quantify these spectral limits and select a procedure for calculating and reporting a power rating. This work focuses on statistically comparing several procedures the community is considering in context with monitoring/limiting spectral variation.

Comparison of Conventional and Computer-Aided Drafting Methods from the View of Time and Drafting Quality

ERIC Educational Resources Information Center

Ozkan, Aysen; Yildirim, Kemal

2016-01-01

Problem Statement: Drafting course is essential for students in the design disciplines for becoming more organized and for complying with standards in the educational system. Drafting knowledge is crucial, both for comprehension of the issues and for the implementation phase. In any design project, drafting performance and success are as important…

First High-Quality Draft Genome Sequence of Pasteurella multocida Sequence Type 128 Isolated from Infected Bone.

PubMed

Kavousi, Niloofar; Eng, Wilhelm Wei Han; Lee, Yin Peng; Tan, Lian Huat; Thuraisingham, Ravindran; Yule, Catherine M; Gan, Han Ming

2016-03-03

We report here the first high-quality draft genome sequence of Pasteurella multocida sequence type 128, which was isolated from the infected finger bone of an adult female who was bitten by a domestic dog. The draft genome will be a valuable addition to the scarce genomic resources available for P. multocida. Copyright © 2016 Kavousi et al.

Socioeconomic Representativeness and the Draft

DTIC Science & Technology

1980-06-01

l that the quality of recruits who enter the services ( especiall the Army) is of lover caliber than historically experienced. Proponents of...the "quality" of recruits who enter the services ( especially the Army) is of lower caliber than historically experienced. Proponents of conscription...draft, especially when considering peacetime conscrip- tion. The strength of the argument for the draft was held to be that all eligible men would serve

76 FR 10892 - Aquatic Ecosystems, Water Quality, and Global Change: Challenges of Conducting Multi-Stressor...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-28

... Ecosystems, Water Quality, and Global Change: Challenges of Conducting Multi-Stressor Vulnerability...: EPA is announcing the release of the draft report titled, ``Aquatic Ecosystems, Water Quality, and... for Environmental Assessment within EPA's Office of Research and Development. This draft report...

Asia-Pacific consensus on the management of gastro-oesophageal reflux disease: an update focusing on refractory reflux disease and Barrett's oesophagus.

PubMed

Fock, Kwong Ming; Talley, Nicholas; Goh, Khean Lee; Sugano, Kentaro; Katelaris, Peter; Holtmann, Gerald; Pandolfino, John E; Sharma, Prateek; Ang, Tiing Leong; Hongo, Michio; Wu, Justin; Chen, Minhu; Choi, Myung-Gyu; Law, Ngai Moh; Sheu, Bor-Shyang; Zhang, Jun; Ho, Khek Yu; Sollano, Jose; Rani, Abdul Aziz; Kositchaiwat, Chomsri; Bhatia, Shobna

2016-09-01

Since the publication of the Asia-Pacific consensus on gastro-oesophageal reflux disease in 2008, there has been further scientific advancement in this field. This updated consensus focuses on proton pump inhibitor-refractory reflux disease and Barrett's oesophagus. A steering committee identified three areas to address: (1) burden of disease and diagnosis of reflux disease; (2) proton pump inhibitor-refractory reflux disease; (3) Barrett's oesophagus. Three working groups formulated draft statements with supporting evidence. Discussions were done via email before a final face-to-face discussion. We used a Delphi consensus process, with a 70% agreement threshold, using Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria to categorise the quality of evidence and strength of recommendations. A total of 32 statements were proposed and 31 were accepted by consensus. A rise in the prevalence rates of gastro-oesophageal reflux disease in Asia was noted, with the majority being non-erosive reflux disease. Overweight and obesity contributed to the rise. Proton pump inhibitor-refractory reflux disease was recognised to be common. A distinction was made between refractory symptoms and refractory reflux disease, with clarification of the roles of endoscopy and functional testing summarised in two algorithms. The definition of Barrett's oesophagus was revised such that a minimum length of 1 cm was required and the presence of intestinal metaplasia no longer necessary. We recommended the use of standardised endoscopic reporting and advocated endoscopic therapy for confirmed dysplasia and early cancer. These guidelines standardise the management of patients with refractory gastro-oesophageal reflux disease and Barrett's oesophagus in the Asia-Pacific region. 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/

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.

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 clinical introduction of genetic testing for Alzheimer disease. An ethical perspective.

PubMed

Post, S G; Whitehouse, P J; Binstock, R H; Bird, T D; Eckert, S K; Farrer, L A; Fleck, L M; Gaines, A D; Juengst, E T; Karlinsky, H; Miles, S; Murray, T H; Quaid, K A; Relkin, N R; Roses, A D; St George-Hyslop, P H; Sachs, G A; Steinbock, B; Truschke, E F; Zinn, A B

1997-03-12

Primary caregivers should be aware of recent progress in the genetics of Alzheimer disease (AD) and of the clinical and ethical considerations raised regarding the introduction of genetic testing for purposes of disease prediction and susceptibility (risk) analysis in asymptomatic individuals and diagnosis in patients who present clinically with dementia. This statement addresses arguments for and against clinical genetic testing. The 20 participants were selected by the investigators (S.G.P., T.H.M., A.B.Z., and P.J.W.) to achieve balance in the areas of genetics, counseling, ethics, and public policy, and to include leadership from related consensus projects. The consensus group met twice in closed meetings and carried on extensive correspondence over 2 years (1995-1997). The project was supported by the National Human Genome Research Institute of the National Institutes of Health. All 4 involved chromosomes were discussed in group meetings against a background of information from several focus group sessions with AD-affected families. The focus groups comprised volunteers identified by the Cleveland Area Chapter of the Alzheimer's Disease and Related Disorders Association and represented a variety of ethnic populations. The first draft was written in April 1996 by the principal investigator (S.G.P.) after the consensus group had met twice. The draft was mailed to all consensus group members 3 times over 6 months for extensive response and redrafting by the principal investigator until all members were satisfied. Except for autosomal dominant early-onset families, genetic testing in asymptomatic individuals is unwarranted. Use of APOE genetic testing as a diagnostic adjunct in patients already presenting with dementia may prove useful but it remains under investigation. The premature introduction of genetic testing and possible adverse consequences are to be avoided.

Defining consensus norms for palliative care of people with intellectual disabilities in Europe, using Delphi methods: A White Paper from the European Association of Palliative Care

PubMed Central

Tuffrey-Wijne, Irene; McLaughlin, Dorry; Curfs, Leopold; Dusart, Anne; Hoenger, Catherine; McEnhill, Linda; Read, Sue; Ryan, Karen; Satgé, Daniel; Straßer, Benjamin; Westergård, Britt-Evy; Oliver, David

2015-01-01

Background: People with intellectual disabilities often present with unique challenges that make it more difficult to meet their palliative care needs. Aim: To define consensus norms for palliative care of people with intellectual disabilities in Europe. Design: Delphi study in four rounds: (1) a taskforce of 12 experts from seven European countries drafted the norms, based on available empirical knowledge and regional/national guidelines; (2) using an online survey, 34 experts from 18 European countries evaluated the draft norms, provided feedback and distributed the survey within their professional networks. Criteria for consensus were clearly defined; (3) modifications and recommendations were made by the taskforce; and (4) the European Association for Palliative Care reviewed and approved the final version. Setting and participants: Taskforce members: identified through international networking strategies. Expert panel: a purposive sample identified through taskforce members’ networks. Results: A total of 80 experts from 15 European countries evaluated 52 items within the following 13 norms: equity of access, communication, recognising the need for palliative care, assessment of total needs, symptom management, end-of-life decision making, involving those who matter, collaboration, support for family/carers, preparing for death, bereavement support, education/training and developing/managing services. None of the items scored less than 86% agreement, making a further round unnecessary. In light of respondents’ comments, several items were modified and one item was deleted. Conclusion: This White Paper presents the first guidance for clinical practice, policy and research related to palliative care for people with intellectual disabilities based on evidence and European consensus, setting a benchmark for changes in policy and practice. PMID:26346181

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.

Seeking worldwide professional consensus on the principles of end-of-life care for the critically ill. The Consensus for Worldwide End-of-Life Practice for Patients in Intensive Care Units (WELPICUS) study.

PubMed

Sprung, Charles L; Truog, Robert D; Curtis, J Randall; Joynt, Gavin M; Baras, Mario; Michalsen, Andrej; Briegel, Josef; Kesecioglu, Jozef; Efferen, Linda; De Robertis, Edoardo; Bulpa, Pierre; Metnitz, Philipp; Patil, Namrata; Hawryluck, Laura; Manthous, Constantine; Moreno, Rui; Leonard, Sara; Hill, Nicholas S; Wennberg, Elisabet; McDermid, Robert C; Mikstacki, Adam; Mularski, Richard A; Hartog, Christiane S; Avidan, Alexander

2014-10-15

Great differences in end-of-life practices in treating the critically ill around the world warrant agreement regarding the major ethical principles. This analysis determines the extent of worldwide consensus for end-of-life practices, delineates where there is and is not consensus, and analyzes reasons for lack of consensus. Critical care societies worldwide were invited to participate. Country coordinators were identified and draft statements were developed for major end-of-life issues and translated into six languages. Multidisciplinary responses using a web-based survey assessed agreement or disagreement with definitions and statements linked to anonymous demographic information. Consensus was prospectively defined as >80% agreement. Definitions and statements not obtaining consensus were revised based on comments of respondents, and then translated and redistributed. Of the initial 1,283 responses from 32 countries, consensus was found for 66 (81%) of the 81 definitions and statements; 26 (32%) had >90% agreement. With 83 additional responses to the original questionnaire (1,366 total) and 604 responses to the revised statements, consensus could be obtained for another 11 of the 15 statements. Consensus was obtained for informed consent, withholding and withdrawing life-sustaining treatment, legal requirements, intensive care unit therapies, cardiopulmonary resuscitation, shared decision making, medical and nursing consensus, brain death, and palliative care. Consensus was obtained for 77 of 81 (95%) statements. Worldwide consensus could be developed for the majority of definitions and statements about end-of-life practices. Statements achieving consensus provide standards of practice for end-of-life care; statements without consensus identify important areas for future research.

78 FR 14538 - Notification of a Public Teleconference of the Clean Air Scientific Advisory Committee

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-06

... Assessment for Lead (Third External Review Draft--November 2012) and EPA's Policy Assessment for the Review of the Lead National Ambient Air Quality Standards (First External Review Draft--January 2013). DATES... CASAC will hold a public teleconference review its draft letters on EPA's third external review draft of...

Development and Validation of the Role Profile of the Nurse Continence Specialist: A Project of the International Continence Society.

PubMed

Paterson, Janice; Ostaszkiewicz, Joan; Suyasa, I Gede Putu Darma; Skelly, Jennifer; Bellefeuille, Lesley

Although nurses have specialized in the management of incontinence, bladder, bowel, and pelvic floor dysfunction for more than 30 years, there is a lack of awareness and underutilization of their role. This article describes a 6-year project to define, characterize, and validate a role profile of the Nurse Continence Specialist. Data collection used a 2-phase, mixed-methods design. Phase 1 of the project resulted in a draft Nurse Continence Specialist role profile and Phase 2 led to validation of the draft profile. The result was a broad consensus about what constitutes the specific skill set for Nurse Continence Specialist specialization within nursing.

Consensus Statement National Consensus Workshop on Management of SAM Children through Medical Nutrition Therapy.

PubMed

Sachdev, H P S; Kapil, Umesh; Vir, Sheila

2010-08-01

Severe acute malnutrition (SAM) is an important preventable and treatable cause of morbidity and mortality in children below five years of age in India. The concerned stakeholders are not in agreement about the role of product based medical nutrition therapy in the management of this condition. In November 2009, a National Consensus Workshop was organized by the Department of Human Nutrition, All India Institute of Medical Sciences, New Delhi in collaboration with the Department of Pediatrics and Clinical Epidemiology, Sitaram Bhartia Institute of Science and Research, New Delhi, and the Sub-specialty Chapter on Nutrition, Indian Academy of Pediatrics. Presentations by eminent national and international scientists, the ensuing discussions, and opinions expressed by the participants provided the basic framework for drafting the consensus statement. The draft of the consensus statement was circulated to all the participants; it underwent two revisions after consideration of their comments. (i) Critically appraise the current global evidence on the utility of Medical Nutrition Therapy (MNT) for the management of SAM in under five children; (ii) Formulate a consensus amongst stakeholders regarding the need to introduce product based MNT for the management of SAM in under five children in India; (iii) Identify research priorities for MNT for the management of SAM in under five children in India; and (iv)Ascertain potential challenges for introducing product based MNT in India, if consensus opinion identifies such a need. Guidelines related to the role of MNT in management of children suffering from SAM are presented. Global and regional data document the effectiveness of MNT using ready-to-use therapeutic foods (RUTF) and locally formulated products. Adequate caution should be exercised to ensure that MNT for SAM does not interfere with measures for the holistic prevention of childhood undernutrition. Indian manufacture of RUTF is feasible, and can be scaled up. Product-based nutrition therapy including RUTF can be introduced on a pilot basis when a delivery design and plan of action is developed and is in place as a part of the larger system to deal with childhood undernutrition. RUTF should be used only as therapeutic and not supplementary feeding, above six months of age, and for a limited time period (4-8 weeks) until the child recovers from SAM, which should be defined in explicit treatment protocols. An urgent research issue is comparison of RUTF with home-based and locally-formulated products.

Care of girls and women with Turner syndrome: a guideline of the Turner Syndrome Study Group.

PubMed

Bondy, Carolyn A

2007-01-01

The objective of this work is to provide updated guidelines for the evaluation and treatment of girls and women with Turner syndrome (TS). The Turner Syndrome Consensus Study Group is a multidisciplinary panel of experts with relevant clinical and research experience with TS that met in Bethesda, Maryland, April 2006. The meeting was supported by the National Institute of Child Health and unrestricted educational grants from pharmaceutical companies. The study group used peer-reviewed published information to form its principal recommendations. Expert opinion was used where good evidence was lacking. The study group met for 3 d to discuss key issues. Breakout groups focused on genetic, cardiological, auxological, psychological, gynecological, and general medical concerns and drafted recommendations for presentation to the whole group. Draft reports were available for additional comment on the meeting web site. Synthesis of the section reports and final revisions were reviewed by e-mail and approved by whole-group consensus. We suggest that parents receiving a prenatal diagnosis of TS be advised of the broad phenotypic spectrum and the good quality of life observed in TS in recent years. We recommend that magnetic resonance angiography be used in addition to echocardiography to evaluate the cardiovascular system and suggest that patients with defined cardiovascular defects be cautioned in regard to pregnancy and certain types of exercise. We recommend that puberty should not be delayed to promote statural growth. We suggest a comprehensive educational evaluation in early childhood to identify potential attention-deficit or nonverbal learning disorders. We suggest that caregivers address the prospect of premature ovarian failure in an open and sensitive manner and emphasize the critical importance of estrogen treatment for feminization and for bone health during the adult years. All individuals with TS require continued monitoring of hearing and thyroid function throughout the lifespan. We suggest that adults with TS be monitored for aortic enlargement, hypertension, diabetes, and dyslipidemia.

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

Recommendations on disease management for patients with advanced human epidermal growth factor receptor 2-positive breast cancer and brain metastases: American Society of Clinical Oncology clinical practice guideline.

PubMed

Ramakrishna, Naren; Temin, Sarah; Chandarlapaty, Sarat; Crews, Jennie R; Davidson, Nancy E; Esteva, Francisco J; Giordano, Sharon H; Gonzalez-Angulo, Ana M; Kirshner, Jeffrey J; Krop, Ian; Levinson, Jennifer; Modi, Shanu; Patt, Debra A; Perez, Edith A; Perlmutter, Jane; Winer, Eric P; Lin, Nancy U

2014-07-01

To provide formal expert consensus-based recommendations to practicing oncologists and others on the management of brain metastases for patients with human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. The American Society of Clinical Oncology (ASCO) convened a panel of medical oncology, radiation oncology, guideline implementation, and advocacy experts and conducted a systematic review of the literature. When that failed to yield sufficiently strong quality evidence, the Expert Panel undertook a formal expert consensus-based process to produce these recommendations. ASCO used a modified Delphi process. The panel members drafted recommendations, and a group of other experts joined them for two rounds of formal ratings of the recommendations. No studies or existing guidelines met the systematic review criteria; therefore, ASCO conducted a formal expert consensus-based process. Patients with brain metastases should receive appropriate local therapy and systemic therapy, if indicated. Local therapies include surgery, whole-brain radiotherapy, and stereotactic radiosurgery. Treatments depend on factors such as patient prognosis, presence of symptoms, resectability, number and size of metastases, prior therapy, and whether metastases are diffuse. Other options include systemic therapy, best supportive care, enrollment onto a clinical trial, and/or palliative care. Clinicians should not perform routine magnetic resonance imaging (MRI) to screen for brain metastases, but rather should have a low threshold for MRI of the brain because of the high incidence of brain metastases among patients with HER2-positive advanced breast cancer. © 2014 by American Society of Clinical Oncology.

77 FR 15052 - National Ocean Council-National Ocean Policy Draft Implementation Plan

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-14

... COUNCIL ON ENVIRONMENTAL QUALITY National Ocean Council--National Ocean Policy Draft Implementation Plan AGENCY: Council on Environmental Quality. ACTION: Extension of comment period. SUMMARY: On July 19, 2010, President Obama signed Executive Order 13547 establishing a National Policy for the...

Developing a pressure ulcer risk factor minimum data set and risk assessment framework.

PubMed

Coleman, Susanne; Nelson, E Andrea; Keen, Justin; Wilson, Lyn; McGinnis, Elizabeth; Dealey, Carol; Stubbs, Nikki; Muir, Delia; Farrin, Amanda; Dowding, Dawn; Schols, Jos M G A; Cuddigan, Janet; Berlowitz, Dan; Jude, Edward; Vowden, Peter; Bader, Dan L; Gefen, Amit; Oomens, Cees W J; Schoonhoven, Lisette; Nixon, Jane

2014-10-01

To agree a draft pressure ulcer risk factor Minimum Data Set to underpin the development of a new evidenced-based Risk Assessment Framework. A recent systematic review identified the need for a pressure ulcer risk factor Minimum Data Set and development and validation of an evidenced-based pressure ulcer Risk Assessment Framework. This was undertaken through the Pressure UlceR Programme Of reSEarch (RP-PG-0407-10056), funded by the National Institute for Health Research and incorporates five phases. This article reports phase two, a consensus study. Consensus study. A modified nominal group technique based on the Research and Development/University of California at Los Angeles appropriateness method. This incorporated an expert group, review of the evidence and the views of a Patient and Public Involvement service user group. Data were collected December 2010-December 2011. The risk factors and assessment items of the Minimum Data Set (including immobility, pressure ulcer and skin status, perfusion, diabetes, skin moisture, sensory perception and nutrition) were agreed. In addition, a draft Risk Assessment Framework incorporating all Minimum Data Set items was developed, comprising a two stage assessment process (screening and detailed full assessment) and decision pathways. The draft Risk Assessment Framework will undergo further design and pre-testing with clinical nurses to assess and improve its usability. It will then be evaluated in clinical practice to assess its validity and reliability. The Minimum Data Set could be used in future for large scale risk factor studies informing refinement of the Risk Assessment Framework. © 2014 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

2017 Draft Aquatic Life Criteria for Aluminum in Freshwater

EPA Pesticide Factsheets

EPA has released draft updated aluminum aquatic life ambient water quality criteria for freshwater under Section 304(a)(1) of the Clean Water Act. EPA will accept public comments on the draft criteria for 60 days upon publication in the Federal Register.

Lead us not into tanktation: a simulation modelling approach to gain insights into incentives for sporting teams to tank.

PubMed

Tuck, Geoffrey N; Whitten, Athol R

2013-01-01

Annual draft systems are the principal method used by teams in major sporting leagues to recruit amateur players. These draft systems frequently take one of three forms: a lottery style draft, a weighted draft, or a reverse-order draft. Reverse-order drafts can create incentives for teams to deliberately under-perform, or tank, due to the perceived gain from obtaining quality players at higher draft picks. This paper uses a dynamic simulation model that captures the key components of a win-maximising sporting league, including the amateur player draft, draft choice error, player productivity, and between-team competition, to explore how competitive balance and incentives to under-perform vary according to league characteristics. We find reverse-order drafts can lead to some teams cycling between success and failure and to other teams being stuck in mid-ranking positions for extended periods of time. We also find that an incentive for teams to tank exists, but that this incentive decreases (i) as uncertainty in the ability to determine quality players in the draft increases, (ii) as the number of teams in the league reduces, (iii) as team size decreases, and (iv) as the number of teams adopting a tanking strategy increases. Simulation models can be used to explore complex stochastic dynamic systems such as sports leagues, where managers face difficult decisions regarding the structure of their league and the desire to maintain competitive balance.

Lead Us Not into Tanktation: A Simulation Modelling Approach to Gain Insights into Incentives for Sporting Teams to Tank

PubMed Central

Tuck, Geoffrey N.; Whitten, Athol R.

2013-01-01

Annual draft systems are the principal method used by teams in major sporting leagues to recruit amateur players. These draft systems frequently take one of three forms: a lottery style draft, a weighted draft, or a reverse-order draft. Reverse-order drafts can create incentives for teams to deliberately under-perform, or tank, due to the perceived gain from obtaining quality players at higher draft picks. This paper uses a dynamic simulation model that captures the key components of a win-maximising sporting league, including the amateur player draft, draft choice error, player productivity, and between-team competition, to explore how competitive balance and incentives to under-perform vary according to league characteristics. We find reverse-order drafts can lead to some teams cycling between success and failure and to other teams being stuck in mid-ranking positions for extended periods of time. We also find that an incentive for teams to tank exists, but that this incentive decreases (i) as uncertainty in the ability to determine quality players in the draft increases, (ii) as the number of teams in the league reduces, (iii) as team size decreases, and (iv) as the number of teams adopting a tanking strategy increases. Simulation models can be used to explore complex stochastic dynamic systems such as sports leagues, where managers face difficult decisions regarding the structure of their league and the desire to maintain competitive balance. PMID:24312243

Report of the American Psychiatric Association Task Force on Treatment of Gender Identity Disorder.

PubMed

Byne, William; Bradley, Susan J; Coleman, Eli; Eyler, A Evan; Green, Richard; Menvielle, Edgardo J; Meyer-Bahlburg, Heino F L; Pleak, Richard R; Tompkins, D Andrew

2012-08-01

Both the diagnosis and treatment of Gender Identity Disorder (GID) are controversial. Although linked, they are separate issues and the DSM does not evaluate treatments. The Board of Trustees (BOT) of the American Psychiatric Association (APA), therefore, formed a Task Force charged to perform a critical review of the literature on the treatment of GID at different ages, to assess the quality of evidence pertaining to treatment, and to prepare a report that included an opinion as to whether or not sufficient credible literature exists for development of treatment recommendations by the APA. The literature on treatment of gender dysphoria in individuals with disorders of sex development was also assessed. The completed report was accepted by the BOT on September 11, 2011. The quality of evidence pertaining to most aspects of treatment in all subgroups was determined to be low; however, areas of broad clinical consensus were identified and were deemed sufficient to support recommendations for treatment in all subgroups. With subjective improvement as the primary outcome measure, current evidence was judged sufficient to support recommendations for adults in the form of an evidence-based APA Practice Guideline with gaps in the empirical data supplemented by clinical consensus. The report recommends that the APA take steps beyond drafting treatment recommendations. These include issuing position statements to clarify the APA's position regarding the medical necessity of treatments for GID, the ethical bounds of treatments of gender variant minors, and the rights of persons of any age who are gender variant, transgender or transsexual.

[A model for shared decision-making with frail older patients: consensus reached using Delphi technique].

PubMed

van de Pol, M H J; Fluit, C R M G; Lagro, J; Lagro-Janssen, A L M; Olde Rikkert, M G M

2017-01-01

To develop a model for shared decision-making with frail older patients. Online Delphi forum. We used a three-round Delphi technique to reach consensus on the structure of a model for shared decision-making with older patients. The expert panel consisted of 16 patients (round 1), and 59 professionals (rounds 1-3). In round 1, the panel of experts was asked about important steps in the process of shared decision-making and the draft model was introduced. Rounds 2 and 3 were used to adapt the model and test it for 'importance' and 'feasibility'. Consensus for the dynamic shared decision-making model as a whole was achieved for both importance (91% panel agreement) and feasibility (76% panel agreement). Shared decision-making with older patients is a dynamic process. It requires a continuous supportive dialogue between health care professional and patient.

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

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

Air Quality Criteria for Ozone and Related Photochemical Oxidants (First External Review Draft)

EPA Science Inventory

This first external review draft of the Air Quality Criteria for Ozone and Related Photochemical Oxidants (Ozone Criteria Document) is being released in January 2005 for public comment and for review by EPA's Clean A...

Air Quality Criteria for Ozone and Related Photochemical Oxidants (Second External Review Draft)

EPA Science Inventory

This second external review draft of the Air Quality Criteria for Ozone and Related Photochemical Oxidants, Volumes I-III (Ozone Criteria Document) is being released for public comment and for review by EPA's Clean Air Scientific Advisory Committee (CASAC) r...

Aquatic Ecosystems, Water Quality, and Global Change: Challenges of conducting Multi-Stressor Vulnerability Assessments (External Review Draft)

EPA Science Inventory

This draft report investigates the issues and challenges associated with identifying, calculating, and mapping indicators of the relative vulnerability of water quality and aquatic ecosystems, across the United States, to the potential impacts of global change. Using a large set...

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...

Bias in dissemination of clinical research findings: structured OPEN framework of what, who and why, based on literature review and expert consensus.

PubMed

Bassler, Dirk; Mueller, Katharina F; Briel, Matthias; Kleijnen, Jos; Marusic, Ana; Wager, Elizabeth; Antes, Gerd; von Elm, Erik; Altman, Douglas G; Meerpohl, Joerg J

2016-01-21

The aim of this study is to review highly cited articles that focus on non-publication of studies, and to develop a consistent and comprehensive approach to defining (non-) dissemination of research findings. We performed a scoping review of definitions of the term 'publication bias' in highly cited publications. Ideas and experiences of a core group of authors were collected in a draft document, which was complemented by the findings from our literature search. The draft document including findings from the literature search was circulated to an international group of experts and revised until no additional ideas emerged and consensus was reached. We propose a new approach to the comprehensive conceptualisation of (non-) dissemination of research. Our 'What, Who and Why?' approach includes issues that need to be considered when disseminating research findings (What?), the different players who should assume responsibility during the various stages of conducting a clinical trial and disseminating clinical trial documents (Who?), and motivations that might lead the various players to disseminate findings selectively, thereby introducing bias in the dissemination process (Why?). Our comprehensive framework of (non-) dissemination of research findings, based on the results of a scoping literature search and expert consensus will facilitate the development of future policies and guidelines regarding the multifaceted issue of selective publication, historically referred to as 'publication bias'. 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/

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.

77 FR 42495 - Release of Draft Documents Related to the Review of the National Ambient Air Quality Standards...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-19

... Review Draft. These two draft assessment documents describe the quantitative analyses the EPA is... NAAQS,\\3\\ the Agency is conducting quantitative assessments characterizing the: (1) Health risks... present the initial key results, observations, and related uncertainties associated with the quantitative...

High-Quality Draft Genome Sequence of Candida apicola NRRL Y-50540

PubMed Central

Vega-Alvarado, Leticia; Gómez-Angulo, Jorge; Escalante-García, Zazil; Grande, Ricardo; Gschaedler-Mathis, Anne; Amaya-Delgado, Lorena

2015-01-01

Candida apicola, a highly osmotolerant ascomycetes yeast, produces sophorolipids (biosurfactants), membrane fatty acids, and enzymes of biotechnological interest. The genome obtained has a high-quality draft for this species and can be used as a reference to perform further analyses, such as differential gene expression in yeast from Candida genera. PMID:26067948

High-Quality Draft Genome Sequence of Babesia divergens, the Etiological Agent of Cattle and Human Babesiosis

PubMed Central

Cuesta, Isabel; González, Luis M.; Estrada, Karel; Grande, Ricardo; Zaballos, Ángel; Lobo, Cheryl A.; Barrera, Jorge

2014-01-01

Babesia divergens causes significant morbidity and mortality in cattle and splenectomized or immunocompromised individuals. Here, we present a 10.7-Mb high-quality draft genome of this parasite close to chromosome resolution that will enable comparative genome analyses and synteny studies among related parasites. PMID:25395649

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…

Methodological Quality of Consensus Guidelines in Implant Dentistry.

PubMed

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions.

Methodological Quality of Consensus Guidelines in Implant Dentistry

PubMed Central

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Background Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. Objective To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. Methods The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Results Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Conclusions Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions. PMID:28107405

76 FR 67437 - Draft Aquatic Life Ambient Water Quality Criteria for Carbaryl-2011

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-01

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2011-0787; FRL-9483-8] Draft Aquatic Life Ambient Water... criteria for the protection of aquatic life from effects of carbaryl (EPA-820-D-11-001). The draft criteria document incorporates the latest scientific knowledge on the toxicity of carbaryl to aquatic life. The...

Obesity services planning framework for interprofessional primary care organizations.

PubMed

Brauer, Paula; Royall, Dawna; Dwyer, John; Edwards, A Michelle; Hussey, Tracy; Kates, Nick; Smith, Heidi; Kirkconnell, Ross

2017-03-01

Aim We report on a formative project to develop an organization-level planning framework for obesity prevention and management services. It is common when developing new services to first develop a logic model outlining expected outcomes and key processes. This can be onerous for single primary care organizations, especially for complex conditions like obesity. The initial draft was developed by the research team, based on results from provider and patient focus groups in one large Family Health Team (FHT) in Ontario. This draft was reviewed and activities prioritized by 20 FHTs using a moderated electronic consensus process. A national panel then reviewed the draft. Findings Providers identified five main target groups: pregnancy to 2, 3-12, 13-18, 18+ years at health risk, and 18+ with complex care needs. Desired outcomes were identified and activities were prioritized under categories: raising awareness (eg, providing information and resources on weight-health), identification and initial management (eg, wellness care), follow-up management (eg, group programs), expanded services (eg, availability of team services), and practice initiatives (eg, interprofessional education). Overall, there was strong support for raising awareness by providing information on the weight-health connection and on community services. There was also strong support for growth assessment in pediatric care. In adults, there was strong support for wellness care/health check visits and episodic care to identify people for interventions, for group programs, and for additional provider education. Joint development by different teams proved useful for consensus on outcomes and for ensuring relevancy across practices. While priorities will vary depending on local context, the basic descriptions of care processes were endorsed by reviewers. Key next steps are to trial the use of the framework and for further implementation studies to find optimally effective approaches for obesity prevention and management across the lifespan.

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.

Consensus standards for introductory e-learning courses in human participants research ethics.

PubMed

Williams, John R; Sprumont, Dominique; Hirtle, Marie; Adebamowo, Clement; Braunschweiger, Paul; Bull, Susan; Burri, Christian; Czarkowski, Marek; Fan, Chien Te; Franck, Caroline; Gefenas, Eugenjius; Geissbuhler, Antoine; Klingmann, Ingrid; Kouyaté, Bocar; Kraehenbhul, Jean-Pierre; Kruger, Mariana; Moodley, Keymanthri; Ntoumi, Francine; Nyirenda, Thomas; Pym, Alexander; Silverman, Henry; Tenorio, Sara

2014-06-01

This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

[Episodic breathlessness: translation and consenting of the international definition using the Delphi method].

PubMed

Simon, S T; Weingärtner, V; Voltz, R; Bausewein, C

2014-10-01

Similar to pain, refractory breathlessness can occur episodically. Episodic Breathlessness is a distressing symptom in patients with advanced life-limiting disease. The lack of a universal definition impedes symptom understanding in clinical practice and effective management, respectively. The aim of the study was to formally consent a German translation of the English definition and terminology of episodic breathlessness. A web-based Delphi survey was conducted with German breathlessness experts (breathlessness working group of Germany's National Guideline (S3) for Palliative Care). Drafts of German-language definitions und terminology were assessed using structured questionnaires by binary rating or rankings, respectively. Optional comments were analysed by content analysis. Consensus was defined by ≥ 70% agreement among participants. In two resulting Delphi-rounds 8/16 (50%) und 11/16 (69%) experts, 30-59 years of age, 50%/55% female, participated. After the second round, consensus was reached for the symptom's description "Atemnotattacke" (73%) and a German-language definition (90%). The terms "vorhersehbar" vs. "unvorhersehbar" were directly consented for the categorization (88%). The formally consented German definition and terminology of episodic breathlessness enable clearer symptom understanding and provide a precise basis for education and research on the symptom and its management also in Germany. Effective management options are warranted to improve quality of life of suffering patients and their relatives. © Georg Thieme Verlag KG Stuttgart · New York.

The EPTN consensus-based atlas for CT- and MR-based contouring in neuro-oncology.

PubMed

Eekers, Daniëlle Bp; In 't Ven, Lieke; Roelofs, Erik; Postma, Alida; Alapetite, Claire; Burnet, Neil G; Calugaru, Valentin; Compter, Inge; Coremans, Ida E M; Høyer, Morton; Lambrecht, Maarten; Nyström, Petra Witt; Romero, Alejandra Méndez; Paulsen, Frank; Perpar, Ana; de Ruysscher, Dirk; Renard, Laurette; Timmermann, Beate; Vitek, Pavel; Weber, Damien C; van der Weide, Hiske L; Whitfield, Gillian A; Wiggenraad, Ruud; Troost, Esther G C

2018-03-13

To create a digital, online atlas for organs at risk (OAR) delineation in neuro-oncology based on high-quality computed tomography (CT) and magnetic resonance (MR) imaging. CT and 3 Tesla (3T) MR images (slice thickness 1 mm with intravenous contrast agent) were obtained from the same patient and subsequently fused. In addition, a 7T MR without intravenous contrast agent was obtained from a healthy volunteer. Based on discussion between experienced radiation oncologists, the clinically relevant organs at risk (OARs) to be included in the atlas for neuro-oncology were determined, excluding typical head and neck OARs previously published. The draft atlas was delineated by a senior radiation oncologist, 2 residents in radiation oncology, and a senior neuro-radiologist incorporating relevant available literature. The proposed atlas was then critically reviewed and discussed by European radiation oncologists until consensus was reached. The online atlas includes one CT-scan at two different window settings and one MR scan (3T) showing the OARs in axial, coronal and sagittal view. This manuscript presents the three-dimensional descriptions of the fifteen consensus OARs for neuro-oncology. Among these is a new OAR relevant for neuro-cognition, the posterior cerebellum (illustrated on 7T MR images). In order to decrease inter- and intra-observer variability in delineating OARs relevant for neuro-oncology and thus derive consistent dosimetric data, we propose this atlas to be used in photon and particle therapy. The atlas is available online at www.cancerdata.org and will be updated whenever required. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Management of Helicobacter pylori infection in Latin America: A Delphi technique-based consensus

PubMed Central

Rollan, Antonio; Arab, Juan Pablo; Camargo, M Constanza; Candia, Roberto; Harris, Paul; Ferreccio, Catterina; Rabkin, Charles S; Gana, Juan Cristóbal; Cortés, Pablo; Herrero, Rolando; Durán, Luisa; García, Apolinaria; Toledo, Claudio; Espino, Alberto; Lustig, Nicole; Sarfatis, Alberto; Figueroa, Catalina; Torres, Javier; Riquelme, Arnoldo

2014-01-01

AIM: To optimize diagnosis and treatment guidelines for this geographic region, a panel of gastroenterologists, epidemiologists, and basic scientists carried out a structured evaluation of available literature. METHODS: Relevant questions were distributed among the experts, who generated draft statements for consideration by the entire panel. A modified three-round Delphi technique method was used to reach consensus. Critical input was also obtained from representatives of the concerned medical community. The quality of the evidence and level of recommendation supporting each statement was graded according to United States Preventive Services Task Force criteria. RESULTS: A group of ten experts was established. The survey included 15 open-ended questions that were distributed among the experts, who assessed the articles associated with each question. The levels of agreement achieved by the panel were 50% in the first round, 73.3% in the second round and 100% in the third round. Main consensus recommendations included: (1) when available, urea breath and stool antigen test (HpSA) should be used for non-invasive diagnosis; (2) detect and eradicate Helicobacter pylori (H. pylori) in all gastroscopy patients to decrease risk of peptic ulcer disease, prevent o retard progression in patients with preneoplastic lesions, and to prevent recurrence in patients treated for gastric cancer; (3) further investigate implementation issues and health outcomes of H. pylori eradication for primary prevention of gastric cancer in high-risk populations; (4) prescribe standard 14-d triple therapy or sequential therapy for first-line treatment; (5) routinely assess eradication success post-treatment in clinical settings; and (6) select second- and third-line therapies according to antibiotic susceptibility testing. CONCLUSION: These achievable steps toward better region-specific management can be expected to improve clinical health outcomes. PMID:25152601

75 FR 63519 - Notice of Availability of Draft Environmental Assessment and Draft Finding of No Significant...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-15

... significantly affect the quality of the human environment and that a finding of no significant impact should...). Ecology SMALL SMALL SMALL to MODERATE. Noise SMALL SMALL SMALL to MODERATE. Historic & Cultural SMALL..., Tennessee to continue for a period of 40 years would not significantly affect the quality of the human...

Workshop to Obtain Input on Draft Materials for the Integrated Science Assessment (ISA) for Sulfur Oxides (SOx): Health Criteria

EPA Science Inventory

As part of the review of the air quality criteria for sulfur oxides (SO_X) and primary (health-based) National Ambient Air Quality Standards (NAAQS) for sulfur dioxide (SO₂), EPA is announcing a teleconference workshop to evaluate preliminary draft materials ...

High-quality permanent draft genome sequence of Bradyrhizobium sp. Th.b2, a microsymbiont of Amphicarpaea bracteata collected in Johnson City, New York

DOE PAGES

Tian, Rui; Parker, Matthew; Seshadri, Rekha; ...

2015-05-16

Bradyrhizobium sp. Th.b2 is an aerobic, motile, Gram-negative, non-spore-forming rod that was isolated from an effective nitrogen-fixing root nodule of Amphicarpaea bracteata collected in Johnson City, New York. Here we describe the features of Bradyrhizobium sp. Th.b2, together with high-quality permanent draft genome sequence information and annotation. The 10,118,060 high-quality draft genome is arranged in 266 scaffolds of 274 contigs, contains 9,809 protein-coding genes and 108 RNA-only encoding genes. In conclusion, this rhizobial genome was sequenced as part of the DOE Joint Genome Institute 2010 Genomic Encyclopedia for Bacteria and Archaea-Root Nodule Bacteria (GEBA-RNB) project.

High-quality permanent draft genome sequence of Bradyrhizobium sp. Th.b2, a microsymbiont of Amphicarpaea bracteata collected in Johnson City, New York

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

Tian, Rui; Parker, Matthew; Seshadri, Rekha

Bradyrhizobium sp. Th.b2 is an aerobic, motile, Gram-negative, non-spore-forming rod that was isolated from an effective nitrogen-fixing root nodule of Amphicarpaea bracteata collected in Johnson City, New York. Here we describe the features of Bradyrhizobium sp. Th.b2, together with high-quality permanent draft genome sequence information and annotation. The 10,118,060 high-quality draft genome is arranged in 266 scaffolds of 274 contigs, contains 9,809 protein-coding genes and 108 RNA-only encoding genes. In conclusion, this rhizobial genome was sequenced as part of the DOE Joint Genome Institute 2010 Genomic Encyclopedia for Bacteria and Archaea-Root Nodule Bacteria (GEBA-RNB) project.

Development of a nationwide consensus syllabus of palliative medicine for undergraduate medical education in Japan: a modified Delphi method.

PubMed

Kizawa, Yoshiyuki; Tsuneto, Satoru; Tamba, Kaichiro; Takamiya, Yusuke; Morita, Tatsuya; Bito, Seiji; Otaki, Junji

2012-07-01

There is currently no consensus syllabus of palliative medicine for undergraduate medical education in Japan, although the Cancer Control Act proposed in 2007 covers the dissemination of palliative care. To develop a nationwide consensus syllabus of palliative medicine for undergraduate medical education in Japan using a modified Delphi method. We adopted the following three-step method: (1) a workshop to produce the draft syllabus; (2) a survey-based provisional syllabus; (3) Delphi rounds and a panel meeting (modified Delphi method) to produce the working syllabus. Educators in charge of palliative medicine from 63% of the medical schools in Japan collaborated to develop a survey-based provisional syllabus before the Delphi rounds. A panel of 32 people was then formed for the modified Delphi rounds comprising 28 educators and experts in palliative medicine, one cancer survivor, one bereaved family member, and two medical students. The final consensus syllabus consists of 115 learning objectives across seven sections as follows: basic principles; disease process and comprehensive assessment; symptom management; psychosocial care; cultural, religious, and spiritual issues; ethical issues; and legal frameworks. Learning objectives were categorized as essential or desirable (essential: 66; desirable: 49). A consensus syllabus of palliative medicine for undergraduate medical education was developed using a clear and innovative methodology. The final consensus syllabus will be made available for further dissemination of palliative care education throughout the country.

Consensus guidelines on management of childhood convulsive status epilepticus.

PubMed

Mishra, Devendra; Sharma, Suvasini; Sankhyan, Naveen; Konanki, Ramesh; Kamate, Mahesh; Kanhere, Sujata; Aneja, Satinder

2014-12-01

Status epilepticus has a wide etiological spectrum, and significant morbidity and mortality. Management using a pre-determined uniform protocol leads to better outcomes. Multiple protocols for management of childhood status epilepticus are available, without much consensus. A 'Multi-disciplinary Consensus Development Workshop on Management of Status Epilepticus in Children in India' was organized. The invited experts included Pediatricians, Pediatric neurologists, Neurologists, Epileptologists, and Pediatric intensive care specialists from India, with experience in the relevant field. Experts had previously been divided into focus groups and had interacted on telephone and e-mail regarding their group recommendations, and developed consensus on the topic. During the meeting, each group presented their recommendations, which were deliberated upon by the house and a consensus was reached on various issues; the document was finalized after incorporating suggestions of experts on the draft document. To provide consensus guidelines on evaluation and management of convulsive status epilepticus in children in India (excluding neonatal and super-refractory status epilepticus). Each institution should use a pre-determined protocol for management of status epilepticus; pre-hospital management and early stabilization is the key to a satisfactory outcome of status epilepticus. Pharmacotherapy should not be delayed for any investigations; the initial management should consist of a parenteral benzodiazepine by any route feasible. Subsequent management has been detailed. The group also felt the need for more epidemiological research on status epilepticus from India, and identified certain research areas for the purpose.

Scientific principles for the identification of endocrine-disrupting chemicals: a consensus statement.

PubMed

Solecki, Roland; Kortenkamp, Andreas; Bergman, Åke; Chahoud, Ibrahim; Degen, Gisela H; Dietrich, Daniel; Greim, Helmut; Håkansson, Helen; Hass, Ulla; Husoy, Trine; Jacobs, Miriam; Jobling, Susan; Mantovani, Alberto; Marx-Stoelting, Philip; Piersma, Aldert; Ritz, Vera; Slama, Remy; Stahlmann, Ralf; van den Berg, Martin; Zoeller, R Thomas; Boobis, Alan R

2017-02-01

Endocrine disruption is a specific form of toxicity, where natural and/or anthropogenic chemicals, known as "endocrine disruptors" (EDs), trigger adverse health effects by disrupting the endogenous hormone system. There is need to harmonize guidance on the regulation of EDs, but this has been hampered by what appeared as a lack of consensus among scientists. This publication provides summary information about a consensus reached by a group of world-leading scientists that can serve as the basis for the development of ED criteria in relevant EU legislation. Twenty-three international scientists from different disciplines discussed principles and open questions on ED identification as outlined in a draft consensus paper at an expert meeting hosted by the German Federal Institute for Risk Assessment (BfR) in Berlin, Germany on 11-12 April 2016. Participants reached a consensus regarding scientific principles for the identification of EDs. The paper discusses the consensus reached on background, definition of an ED and related concepts, sources of uncertainty, scientific principles important for ED identification, and research needs. It highlights the difficulty in retrospectively reconstructing ED exposure, insufficient range of validated test systems for EDs, and some issues impacting on the evaluation of the risk from EDs, such as non-monotonic dose-response and thresholds, modes of action, and exposure assessment. This report provides the consensus statement on EDs agreed among all participating scientists. The meeting facilitated a productive debate and reduced a number of differences in views. It is expected that the consensus reached will serve as an important basis for the development of regulatory ED criteria.

Latin American Consensus for Pediatric Cardiopulmonary Resuscitation 2017: Latin American Pediatric Critical Care Society Pediatric Cardiopulmonary Resuscitation Committee.

PubMed

López-Herce, Jesús; Almonte, Enma; Alvarado, Manuel; Bogado, Norma Beatriz; Cyunel, Mariana; Escalante, Raffo; Finardi, Christiane; Guzmán, Gustavo; Jaramillo-Bustamante, Juan C; Madrid, Claudia C; Matamoros, Martha; Moya, Luis Augusto; Obando, Grania; Reboredo, Gaspar; López, Lissette R; Scheu, Christian; Valenzuela, Alejandro; Yerovi, Rocío; Yock-Corrales, Adriana

2018-03-01

To develop a Latin American Consensus about Pediatric Cardiopulmonary Resuscitation. To clarify, reinforce, and adapt some specific recommendations for pediatric patients and to stimulate the implementation of these recommendations in clinical practice. Expert consensus recommendations with Delphi methodology. Latin American countries. Experts in pediatric cardiopulmonary resuscitation from 19 Latin American countries. Delphi methodology for expert consensus. The goal was to reach consensus with all the participating experts for every recommendation. An agreement of at least 80% of the participating experts had to exist in order to deliver a recommendation. Two Delphi voting rounds were sent out electronically. The experts were asked to score between 1 and 9 their level of agreement for each recommendation. The score was then classified into three groups: strong agreement (score 7-9), moderate agreement (score 4-6), and disagreement (score 1-3). Nineteen experts from 19 countries participated in both voting rounds and in the whole process of drafting the recommendations. Sixteen recommendations about organization of cardiopulmonary resuscitation, prevention, basic resuscitation, advanced resuscitation, and postresuscitation measures were approved. Ten of them had a consensus of 100%. Four of them were agreed by all the participants except one (94.7% consensus). One recommendation was agreed by all except two experts (89.4%), and finally, one was agreed by all except three experts (84.2%). All the recommendations reached a level of agreement. This consensus adapts 16 international recommendations to Latin America in order to improve the practice of cardiopulmonary resuscitation in children. Studies should be conducted to analyze the effectiveness of the implementation of these recommendations.

Developing a clinical pathway for the identification and management of anxiety and depression in adult cancer patients: an online Delphi consensus process.

PubMed

Shaw, Joanne M; Price, Melanie A; Clayton, Josephine M; Grimison, Peter; Shaw, Tim; Rankin, Nicole; Butow, Phyllis N

2016-01-01

People with cancer and their families experience high levels of psychological morbidity. However, many cancer services do not routinely screen patients for anxiety and depression, and there are no standardized clinical referral pathways. This study aimed to establish consensus on elements of a draft clinical pathway tailored to the Australian context. A two-round Delphi study was conducted to gain consensus among Australian oncology and psycho-oncology clinicians about the validity of 39 items that form the basis of a clinical pathway that includes screening, assessment, referral and stepped care management of anxiety and depression in the context of cancer. The expert panel comprised 87 multidisciplinary clinician members of the Australian Psycho-oncology Co-operative Research Group (PoCoG). Respondents rated their level of agreement with each statement on a 5-point Likert scale. Consensus was defined as >80% of respondents scoring within 2 points on the Likert scale. Consensus was reached for 21 of 39 items, and a further 15 items approached consensus except for specific contextual factors, after two Delphi rounds. Formal screening for anxiety and depression, a stepped care model of management and recommendations for inclusion of length of treatment and time to review were endorsed. Consensus was not reached on items related to roles and responsibilities, particularly those not applicable across cancer settings. This study identified a core set of evidence- and consensus-based principles considered essential to a stepped care model of care incorporating identification, referral and management of anxiety and depression in adult cancer patients.

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.

77 FR 39959 - Draft Guidance To Implement Requirements for the Treatment of Air Quality Monitoring Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... of the revised draft High Winds Guidance document, the EPA identifies example technical analyses that... identified analyses and any additional technical analyses that air agencies could use to demonstrate that the... Web site at http://www.epa.gov/ttn/analysis/exevents.htm for additional details on the draft non...

Adult Bronchoscopy Training

PubMed Central

Wahidi, Momen M.; Read, Charles A.; Buckley, John D.; Addrizzo-Harris, Doreen J.; Shah, Pallav L.; Herth, Felix J. F.; de Hoyos Parra, Alberto; Ornelas, Joseph; Yarmus, Lonny; Silvestri, Gerard A.

2015-01-01

BACKGROUND: The determination of competency of trainees in programs performing bronchoscopy is quite variable. Some programs provide didactic lectures with hands-on supervision, other programs incorporate advanced simulation centers, whereas others have a checklist approach. Although no single method has been proven best, the variability alone suggests that outcomes are variable. Program directors and certifying bodies need guidance to create standards for training programs. Little well-developed literature on the topic exists. METHODS: To provide credible and trustworthy guidance, rigorous methodology has been applied to create this bronchoscopy consensus training statement. All panelists were vetted and approved by the CHEST Guidelines Oversight Committee. Each topic group drafted questions in a PICO (population, intervention, comparator, outcome) format. MEDLINE data through PubMed and the Cochrane Library were systematically searched. Manual searches also supplemented the searches. All gathered references were screened for consideration based on inclusion criteria, and all statements were designated as an Ungraded Consensus-Based Statement. RESULTS: We suggest that professional societies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. Bronchoscopy training programs should incorporate multiple tools, including simulation. We suggest that ongoing quality and process improvement systems be introduced and that certifying agencies move from a volume-based certification system to skill acquisition and knowledge-based competency assessment for trainees. We also suggest that assessment of skill maintenance and improvement in practice be evaluated regularly with ongoing quality and process improvement systems after initial skill acquisition. CONCLUSIONS: The current methods used for bronchoscopy competency in training programs are variable. We suggest that professional societies and certifying agencies move from a volume- based certification system to a standardized skill acquisition and knowledge-based competency assessment for pulmonary and thoracic surgery trainees. PMID:25674901

How to evaluate the microcirculation: report of a round table conference

PubMed Central

De Backer, Daniel; Hollenberg, Steven; Boerma, Christiaan; Goedhart, Peter; Büchele, Gustavo; Ospina-Tascon, Gustavo; Dobbe, Iwan; Ince, Can

2007-01-01

Introduction Microvascular alterations may play an important role in the development of organ failure in critically ill patients and especially in sepsis. Recent advances in technology have allowed visualization of the microcirculation, but several scoring systems have been used so it is sometimes difficult to compare studies. This paper reports the results of a round table conference that was organized in Amsterdam in November 2006 in order to achieve consensus on image acquisition and analysis. Methods The participants convened to discuss the various aspects of image acquisition and the different scores, and a consensus statement was drafted using the Delphi methodology. Results The participants identified the following five key points for optimal image acquisition: five sites per organ, avoidance of pressure artifacts, elimination of secretions, adequate focus and contrast adjustment, and recording quality. The scores that can be used to describe numerically the microcirculatory images consist of the following: a measure of vessel density (total and perfused vessel density; two indices of perfusion of the vessels (proportion of perfused vessels and microcirculatory flow index); and a heterogeneity index. In addition, this information should be provided for all vessels and for small vessels (mostly capillaries) identified as smaller than 20 μm. Venular perfusion should be reported as a quality control index, because venules should always be perfused in the absence of pressure artifact. It is anticipated that although this information is currently obtained manually, it is likely that image analysis software will ease analysis in the future. Conclusion We proposed that scoring of the microcirculation should include an index of vascular density, assessment of capillary perfusion and a heterogeneity index. PMID:17845716

Towards an International Classification for Patient Safety: a Delphi survey.

PubMed

Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

2009-02-01

Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. International web-based survey of expert opinion. Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur.

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

Lapidus, Alla L.

From the date its role in heredity was discovered, DNA has been generating interest among scientists from different fields of knowledge: physicists have studied the three dimensional structure of the DNA molecule, biologists tried to decode the secrets of life hidden within these long molecules, and technologists invent and improve methods of DNA analysis. The analysis of the nucleotide sequence of DNA occupies a special place among the methods developed. Thanks to the variety of sequencing technologies available, the process of decoding the sequence of genomic DNA (or whole genome sequencing) has become robust and inexpensive. Meanwhile the assembly ofmore » whole genome sequences remains a challenging task. In addition to the need to assemble millions of DNA fragments of different length (from 35 bp (Solexa) to 800 bp (Sanger)), great interest in analysis of microbial communities (metagenomes) of different complexities raises new problems and pushes some new requirements for sequence assembly tools to the forefront. The genome assembly process can be divided into two steps: draft assembly and assembly improvement (finishing). Despite the fact that automatically performed assembly (or draft assembly) is capable of covering up to 98% of the genome, in most cases, it still contains incorrectly assembled reads. The error rate of the consensus sequence produced at this stage is about 1/2000 bp. A finished genome represents the genome assembly of much higher accuracy (with no gaps or incorrectly assembled areas) and quality ({approx}1 error/10,000 bp), validated through a number of computer and laboratory experiments.« less

Towards an International Classification for Patient Safety: a Delphi survey

PubMed Central

Thomson, Richard; Lewalle, Pierre; Sherman, Heather; Hibbert, Peter; Runciman, William; Castro, Gerard

2009-01-01

Objective Interpretation and comparison of patient safety information have been compromised by the lack of a common understanding of the concepts involved. The World Alliance set out to develop an International Classification for Patient Safety (ICPS) to address this, and to test the relevance and acceptability of the draft ICPS and progressively refine it prior to field testing. Design Two-stage Delphi survey. Quantitative and qualitative analyses informed the review of the ICPS. Setting International web-based survey of expert opinion. Participants Experts in the fields of patient safety, health policy, reporting systems, safety and quality control, classification theory and development, health informatics, consumer advocacy, law and medicine; 253 responded to the first round survey, 30% of whom responded to the second round. Results In the first round, 14% felt that the conceptual framework was missing at least one class, although it was apparent that most respondents were actually referring to concepts they felt should be included within the classes rather than the classes themselves. There was a need for clarification of several components of the classification, particularly its purpose, structure and depth. After revision and feedback, round 2 results were more positive, but further significant changes were made to the conceptual framework and to the major classes in response to concerns about terminology and relationships between classes. Conclusions The Delphi approach proved invaluable, as both a consensus-building exercise and consultation process, in engaging stakeholders to support completion of the final draft version of the ICPS. Further refinement will occur. PMID:19147596

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.

Translations on Environmental Quality No. 124.

DTIC Science & Technology

1976-11-01

pollution is being drawn up, the Dewan Rakyat was told today. The programme consists of preventive and restorative measures and would be aimed against all...ENVIRONMENTAL QUALITY No. 124 CONTENTS PAGE ASIA MALAYSIA Malaysia Drafting Antipollution Program (NEW STRAITS TIMES, 17 Jul 76)... 1 EASTERN EUROPE...French, Swiss Experience and Projects Opponents of Nuclear Power Plants Appeal to Bonn Government MALAYSIA MALAYSIA DRAFTING ANTIPOLLUTION

Permanent Improved High-Quality Draft Genome Sequence of Nocardia casuarinae Strain BMG51109, an Endophyte of Actinorhizal Root Nodules of Casuarina glauca

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

Ghodhbane-Gtari, Faten; Beauchemin, Nicholas; Louati, Moussa

Here, we report the first genome sequence of a Nocardia plant endophyte, N. casuarinae strain BMG51109, isolated from Casuarina glauca root nodules. The improved high-quality draft genome sequence contains 8,787,999 bp with a 68.90% GC content and 7,307 predicted protein-coding genes.

Air Quality Criteria for Particulate Matter (Fourth External Review Draft) [revised Drafts of Chapters 7 and 8, December 2003

EPA Science Inventory

EPA is in the process of updating and revising, where appropriate, its Air Quality Criteria for Particulate Matter as issued in 1996 (usually referred to as the Criteria Document). Sections 108 and 109 of the Clean Air Act require that EPA carry out a periodic review an...

Permanent Improved High-Quality Draft Genome Sequence of Nocardia casuarinae Strain BMG51109, an Endophyte of Actinorhizal Root Nodules of Casuarina glauca

DOE PAGES

Ghodhbane-Gtari, Faten; Beauchemin, Nicholas; Louati, Moussa; ...

2016-08-04

Here, we report the first genome sequence of a Nocardia plant endophyte, N. casuarinae strain BMG51109, isolated from Casuarina glauca root nodules. The improved high-quality draft genome sequence contains 8,787,999 bp with a 68.90% GC content and 7,307 predicted protein-coding genes.

Parameters of care for craniosynostosis.

PubMed

McCarthy, Joseph G; Warren, Stephen M; Bernstein, Joseph; Burnett, Whitney; Cunningham, Michael L; Edmond, Jane C; Figueroa, Alvaro A; Kapp-Simon, Kathleen A; Labow, Brian I; Peterson-Falzone, Sally J; Proctor, Mark R; Rubin, Marcie S; Sze, Raymond W; Yemen, Terrance A

2012-01-01

A multidisciplinary meeting was held from March 4 to 6, 2010, in Atlanta, Georgia, entitled "Craniosynostosis: Developing Parameters for Diagnosis, Treatment, and Management." The goal of this meeting was to create parameters of care for individuals with craniosynostosis. Fifty-two conference attendees represented a broad range of expertise, including anesthesiology, craniofacial surgery, dentistry, genetics, hand surgery, neurosurgery, nursing, ophthalmology, oral and maxillofacial surgery, orthodontics, otolaryngology, pediatrics, psychology, public health, radiology, and speech-language pathology. These attendees also represented 16 professional societies and peer-reviewed journals. The current state of knowledge related to each discipline was reviewed. Based on areas of expertise, four breakout groups were created to reach a consensus and draft specialty-specific parameters of care based on the literature or, in the absence of literature, broad clinical experience. In an iterative manner, the specialty-specific draft recommendations were presented to all conference attendees. Participants discussed the recommendations in multidisciplinary groups to facilitate exchange and consensus across disciplines. After the conference, a pediatric intensivist and social worker reviewed the recommendations. Consensus was reached among the 52 conference attendees and two post hoc reviewers. Longitudinal parameters of care were developed for the diagnosis, treatment, and management of craniosynostosis in each of the 18 specialty areas of care from prenatal evaluation to adulthood. To our knowledge, this is the first multidisciplinary effort to develop parameters of care for craniosynostosis. These parameters were designed to help facilitate the development of educational programs for the patient, families, and health-care professionals; stimulate the creation of a national database and registry to promote research, especially in the area of outcome studies; improve credentialing of interdisciplinary craniofacial clinical teams; and improve the availability of health insurance coverage for all individuals with craniosynostosis.

Quality Metrics in Neonatal and Pediatric Critical Care Transport: A National Delphi Project.

PubMed

Schwartz, Hamilton P; Bigham, Michael T; Schoettker, Pamela J; Meyer, Keith; Trautman, Michael S; Insoft, Robert M

2015-10-01

The transport of neonatal and pediatric patients to tertiary care facilities for specialized care demands monitoring the quality of care delivered during transport and its impact on patient outcomes. In 2011, pediatric transport teams in Ohio met to identify quality indicators permitting comparisons among programs. However, no set of national consensus quality metrics exists for benchmarking transport teams. The aim of this project was to achieve national consensus on appropriate neonatal and pediatric transport quality metrics. Modified Delphi technique. The first round of consensus determination was via electronic mail survey, followed by rounds of consensus determination in-person at the American Academy of Pediatrics Section on Transport Medicine's 2012 Quality Metrics Summit. All attendees of the American Academy of Pediatrics Section on Transport Medicine Quality Metrics Summit, conducted on October 21-23, 2012, in New Orleans, LA, were eligible to participate. Candidate quality metrics were identified through literature review and those metrics currently tracked by participating programs. Participants were asked in a series of rounds to identify "very important" quality metrics for transport. It was determined a priori that consensus on a metric's importance was achieved when at least 70% of respondents were in agreement. This is consistent with other Delphi studies. Eighty-two candidate metrics were considered initially. Ultimately, 12 metrics achieved consensus as "very important" to transport. These include metrics related to airway management, team mobilization time, patient and crew injuries, and adverse patient care events. Definitions were assigned to the 12 metrics to facilitate uniform data tracking among programs. The authors succeeded in achieving consensus among a diverse group of national transport experts on 12 core neonatal and pediatric transport quality metrics. We propose that transport teams across the country use these metrics to benchmark and guide their quality improvement activities.

Radiofrequency ablation for hepatic hemangiomas: A consensus from a Chinese panel of experts

PubMed Central

Gao, Jun; Fan, Rui-Fang; Yang, Jia-Yin; Cui, Yan; Ji, Jian-Song; Ma, Kuan-Sheng; Li, Xiao-Long; Zhang, Long; Xu, Chong-Liang; Kong, Xin-Liang; Ke, Shan; Ding, Xue-Mei; Wang, Shao-Hong; Yang, Meng-Meng; Song, Jin-Jin; Zhai, Bo; Nin, Chun-Ming; Guo, Shi-Gang; Xin, Zong-Hai; Lu, Jun; Dong, Yong-Hong; Zhu, Hua-Qiang; Sun, Wen-Bing

2017-01-01

Recent studies have shown that radiofrequency (RF) ablation therapy is a safe, feasible, and effective procedure for hepatic hemangiomas, even huge hepatic hemangiomas. RF ablation has the following advantages in the treatment of hepatic hemangiomas: minimal invasiveness, definite efficacy, high safety, fast recovery, relatively simple operation, and wide applicability. It is necessary to formulate a widely accepted consensus among the experts in China who have extensive expertise and experience in the treatment of hepatic hemangiomas using RF ablation, which is important to standardize the application of RF ablation for the management of hepatic hemangiomas, regarding the selection of patients with suitable indications to receive RF ablation treatment, the technical details of the techniques, therapeutic effect evaluations, management of complications, etc. A final consensus by a Chinese panel of experts who have the expertise of using RF ablation to treat hepatic hemangiomas was reached by means of literature review, comprehensive discussion, and draft approval. PMID:29093616

Assessment, Diagnosis, and Treatment of HIV-Associated Neurocognitive Disorder: A Consensus Report of the Mind Exchange Program

PubMed Central

Antinori, Andrea; Arendt, Gabriele; Grant, Igor; Letendre, Scott; Chair; Muñoz-Moreno, Jose A.; Eggers, Christian; Brew, Bruce; Brouillette, Marie-Josée; Bernal-Cano, Francisco; Carvalhal, Adriana; Christo, Paulo Pereira; Cinque, Paola; Cysique, Lucette; Ellis, Ronald; Everall, Ian; Gasnault, Jacques; Husstedt, Ingo; Korten, Volkan; Machala, Ladislav; Obermann, Mark; Ouakinin, Silvia; Podzamczer, Daniel; Portegies, Peter; Rackstraw, Simon; Rourke, Sean; Sherr, Lorraine; Streinu-Cercel, Adrian; Winston, Alan; Wojna, Valerie; Yazdanpannah, Yazdan; Arbess, Gordon; Baril, Jean-Guy; Begovac, Josip; Bergin, Colm; Bonfanti, Paolo; Bonora, Stefano; Brinkman, Kees; Canestri, Ana; Cholewińska-Szymańska, Graźyna; Chowers, Michal; Cooney, John; Corti, Marcelo; Doherty, Colin; Elbirt, Daniel; Esser, Stefan; Florence, Eric; Force, Gilles; Gill, John; Goffard, Jean-Christophe; Harrer, Thomas; Li, Patrick; de Kerckhove, Linos Van; Knecht, Gaby; Matsushita, Shuzo; Matulionyte, Raimonda; McConkey, Sam; Mouglignier, Antoine; Oka, Shinichi; Penalva, Augusto; Riesenberg, Klaris; Sambatakou, Helen; Tozzi, Valerio; Vassallo, Matteo; Wetterberg, Peter; Drapato, Alicia Wiercińska

2013-01-01

Many practical clinical questions regarding the management of human immunodeficiency virus (HIV)–associated neurocognitive disorder (HAND) remain unanswered. We sought to identify and develop practical answers to key clinical questions in HAND management. Sixty-six specialists from 30 countries provided input into the program, which was overseen by a steering committee. Fourteen questions were rated as being of greatest clinical importance. Answers were drafted by an expert group based on a comprehensive literature review. Sixty-three experts convened to determine consensus and level of evidence for the answers. Consensus was reached on all answers. For instance, good practice suggests that all HIV patients should be screened for HAND early in disease using standardized tools. Follow-up frequency depends on whether HAND is already present or whether clinical data suggest risk for developing HAND. Worsening neurocognitive impairment may trigger consideration of antiretroviral modification when other causes have been excluded. The Mind Exchange program provides practical guidance in the diagnosis, monitoring, and treatment of HAND. PMID:23175555

Consensus and clinical recommendations for nutritional intervention for head and neck cancer patients undergoing chemoradiotherapy in Taiwan.

PubMed

Lin, Mei-Chun; Shueng, Pei-Wei; Chang, Wei-Kuo; Mu-Hsin Chang, Peter; Feng, Hsin-Chun; Yang, Muh-Hwa; Lou, Pei-Jen

2018-06-01

Because of the anatomical location, patients with head and neck cancer (HNC) frequently experience dysphagia and malnutrition at the time of diagnosis and these conditions are often exacerbated after chemoradiotherapy. There is an emerging medical need to establish a consensus on nutritional intervention for these patients. A panel of 30 senior physicians and experts from multidisciplinary teams drafted clinical recommendations to improve the management of nutritional interventions in Taiwan and to provide updated treatment strategy recommendations in hope of improving the nutritional status of patients with HNC. This clinical review describes the resulting consensus document, including the impact of malnutrition on clinical outcomes, the role of prophylactic tube feeding, the choice of tube feeding, and the benefit of oral nutritional supplements in patients with HNC undergoing chemoradiotherapy. The outcomes of this review will support clinicians in their efforts to improve the nutritional status of patients with HNC. Copyright © 2018 Elsevier Ltd. All rights reserved.

High-quality permanent draft genome sequence of Bradyrhizobium sp. Tv2a.2, a microsymbiont of Tachigali versicolor discovered in Barro Colorado Island of Panama

DOE PAGES

Tian, Rui; Parker, Matthew; Seshadri, Rekha; ...

2015-05-17

Bradyrhizobiumsp. Tv2a.2 is an aerobic, motile, Gram-negative, non-spore-forming rod that was isolated from an effective nitrogen-fixing root nodule of Tachigali versicolor collected in Barro Colorado Island of Panama. Here we describe the features of Bradyrhizobiumsp. Tv2a.2, together with high-quality permanent draft genome sequence information and annotation. The 8,496,279 bp high-quality draft genome is arranged in 87 scaffolds of 87 contigs, contains 8,109 protein-coding genes and 72 RNA-only encoding genes. In conclusion, this rhizobial genome was sequenced as part of the DOE Joint Genome Institute 2010 Genomic Encyclopedia for Bacteria and Archaea-Root Nodule Bacteria (GEBA-RNB) project.

Draft Genome Sequences of Two Novel Salmonella enterica subsp. enterica Strains Isolated from Low-Moisture Foods with Applications in Food Safety Research.

PubMed

Radford, Devon R; Leon-Velarde, Carlos G; Chen, Shu; Hamidi Oskouei, Amir M; Balamurugan, Sampathkumar

2018-03-29

The genomes of two strains of Salmonella enterica subsp. enterica serovar Cubana and serovar Muenchen, isolated from dry hazelnuts and chia seeds, respectively, were sequenced using the Illumina MiSeq platform, assembled de novo using the overlap-layout-consensus method, and aligned to their respective most identical sequence genome scaffolds using MUMMER and BLAST searches. Copyright © 2018 Radford et al.

NIH consensus development conference statement: Lactose intolerance and health.

PubMed

Suchy, Frederick J; Brannon, Patsy M; Carpenter, Thomas O; Fernandez, Jose R; Gilsanz, Vicente; Gould, Jeffrey B; Hall, Karen; Hui, Siu L; Lupton, Joanne; Mennella, Julie; Miller, Natalie J; Osganian, Stavroula Kalis; Sellmeyer, Deborah E; Wolf, Marshall A

2010-02-24

To provide health care providers, patients, and the general public with a responsible assessment of currently available data on lactose intolerance and health. A non-DHHS, nonadvocate 14-member panel representing the fields of internal medicine, pediatrics, pediatric and adult endocrinology, gastroenterology, hepatology, neonatology and perinatology, geriatrics, racial/ethnic disparities, radiology, maternal and fetal nutrition, vitamin and mineral metabolism, nutritional sciences, bone health, preventive medicine, biopsychology, biostatistics, statistical genetics, epidemiology, and a public representative. In addition, 22 experts from pertinent fields presented data to the panel and conference audience. Presentations by experts and a systematic review of the literature prepared by the University of Minnesota Evidence-based Practice Center, through the Agency for Healthcare Research and Quality. Scientific evidence was given precedence over anecdotal experience. The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was presented on the final day of the conference and circulated to the audience for comment. The panel released a revised statement later that day at http://consensus.nih.gov. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. • Lactose intolerance is a real and important clinical syndrome, but its true prevalence is not known. • The majority of people with lactose malabsorption do not have clinical lactose intolerance. Many individuals who think they are lactose intolerant are not lactose malabsorbers. • Many individuals with real or perceived lactose intolerance avoid dairy and ingest inadequate amounts of calcium and vitamin D, which may predispose them to decreased bone accrual, osteoporosis, and other adverse health outcomes. In most cases, individuals do not need to eliminate dairy consumption completely. • Evidence-based dietary approaches with and without dairy foods and supplementation strategies are needed to ensure appropriate consumption of calcium and other nutrients in lactose-intolerant individuals. • Educational programs and behavioral approaches for individuals and their healthcare providers should be developed and validated to improve the nutrition and symptoms of individuals with lactose intolerance and dairy avoidance.

Formal consensus to identify clinically important changes in management resulting from the use of cardiovascular magnetic resonance (CMR) in patients who activate the primary percutaneous coronary intervention (PPCI) pathway.

PubMed

Pufulete, Maria; Brierley, Rachel C; Bucciarelli-Ducci, Chiara; Greenwood, John P; Dorman, Stephen; Anderson, Richard A; Harris, Jessica; McAlindon, Elisa; Rogers, Chris A; Reeves, Barnaby C

2017-06-22

To define important changes in management arising from the use of cardiovascular magnetic resonance (CMR) in patients who activate the primary percutaneous coronary intervention (PPCI) pathway. Formal consensus study using literature review and cardiologist expert opinion to formulate consensus statements and setting up a consensus panel to review the statements (by completing a web-based survey, attending a face-to-face meeting to discuss survey results and modify the survey to reflect group discussion and completing the modified survey to determine which statements were in consensus). Formulation of consensus statements: four cardiologists (two CMR and two interventional) and six non-clinical researchers. Formal consensus: seven cardiologists (two CMR and three interventional, one echocardiography and one heart failure). Forty-nine additional cardiologists completed the modified survey. Thirty-seven draft statements describing changes in management following CMR were generated; these were condensed into 12 statements and reviewed through the formal consensus process. Three of 12 statements were classified in consensus in the first survey; these related to the role of CMR in identifying the cause of out-of-hospital cardiac arrest, providing a definitive diagnosis in patients found to have unobstructed arteries on angiography and identifying patients with left ventricular thrombus. Two additional statements were in consensus in the modified survey, relating to the ability of CMR to identify patients who have a poor prognosis after PPCI and assess ischaemia and viability in patients with multivessel disease. There was consensus that CMR leads to clinically important changes in management in five subgroups of patients who activate the PPCI pathway. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

Kyoto global consensus report on Helicobacter pylori gastritis

PubMed Central

Sugano, Kentaro; Tack, Jan; Kuipers, Ernst J; Graham, David Y; El-Omar, Emad M; Miura, Soichiro; Haruma, Ken; Asaka, Masahiro; Uemura, Naomi; Malfertheiner, Peter

2015-01-01

Objective To present results of the Kyoto Global Consensus Meeting, which was convened to develop global consensus on (1) classification of chronic gastritis and duodenitis, (2) clinical distinction of dyspepsia caused by Helicobacter pylori from functional dyspepsia, (3) appropriate diagnostic assessment of gastritis and (4) when, whom and how to treat H. pylori gastritis. Design Twenty-three clinical questions addressing the above-mentioned four domains were drafted for which expert panels were asked to formulate relevant statements. A Delphi method using an anonymous electronic system was adopted to develop the consensus, the level of which was predefined as ≥80%. Final modifications of clinical questions and consensus were achieved at the face-to-face meeting in Kyoto. Results All 24 statements for 22 clinical questions after extensive modifications and omission of one clinical question were achieved with a consensus level of >80%. To better organise classification of gastritis and duodenitis based on aetiology, a new classification of gastritis and duodenitis is recommended for the 11th international classification. A new category of H. pylori-associated dyspepsia together with a diagnostic algorithm was proposed. The adoption of grading systems for gastric cancer risk stratification, and modern image-enhancing endoscopy for the diagnosis of gastritis, were recommended. Treatment to eradicate H. pylori infection before preneoplastic changes develop, if feasible, was recommended to minimise the risk of more serious complications of the infection. Conclusions A global consensus for gastritis was developed for the first time, which will be the basis for an international classification system and for further research on the subject. PMID:26187502

Executive Summary, Hydraulic Fracturing Study - Draft Assessment 2015

EPA Pesticide Factsheets

In this Executive Summary of the HF Draft report, EPA highlights the reviews of scientific literature to assess the potential for hydraulic fracturing for oil and gas to change the quality or quantity of drinking water resources.

Consensus statement on injury definitions and data collection procedures for studies of injuries in rugby union

PubMed Central

Fuller, Colin W; Molloy, Michael G; Bagate, Christian; Bahr, Roald; Brooks, John H M; Donson, Hilton; Kemp, Simon P T; McCrory, Paul; McIntosh, Andrew S; Meeuwisse, Willem H; Quarrie, Kenneth L; Raftery, Martin; Wiley, Preston

2007-01-01

Wide variations in the definitions and methodologies used for studies of injuries in rugby union have created inconsistencies in reported data and made interstudy comparisons of results difficult. The International Rugby Board established a Rugby Injury Consensus Group (RICG) to reach an agreement on the appropriate definitions and methodologies to standardise the recording of injuries and reporting of studies in rugby union. The RICG reviewed the consensus definitions and methodologies previously published for football (soccer) at a meeting in Dublin in order to assess their suitability for and application to rugby union. Following this meeting, iterative draft statements were prepared and circulated to members of the RICG for comment; a follow‐up meeting was arranged in Dublin, at which time all definitions and procedures were finalised. At this stage, all authors confirmed their agreement with the consensus statement. The agreed document was presented to and approved by the International Rugby Board Council. Agreement was reached on definitions for injury, recurrent injury, non‐fatal catastrophic injury, and training and match exposures, together with criteria for classifying injuries in terms of severity, location, type, diagnosis and causation. The definitions and methodology presented in this consensus statement for rugby union are similar to those proposed for football. Adoption of the proposals presented in this consensus statement should ensure that more consistent and comparable results will be obtained from studies of injuries within rugby union. PMID:17452684

High-Quality Draft Genome Sequences of Four Lignocellulose-Degrading Bacteria Isolated from Puerto Rican Forest Soil: Gordonia sp., Paenibacillus sp., Variovorax sp., and Vogesella sp.

DOE PAGES

Woo, Hannah L.; DeAngelis, Kristen M.; Teshima, Hazuki; ...

2017-05-04

In this paper, we report the high-quality draft genome sequences of four phylogenetically diverse lignocellulose-degrading bacteria isolated from tropical soil ( Gordonia sp., Paenibacillus sp., Variovorax sp., and Vogesella sp.) to elucidate the genetic basis of their ability to degrade lignocellulose. These isolates may provide novel enzymes for biofuel production.

High-Quality Draft Genome Sequences of Four Lignocellulose-Degrading Bacteria Isolated from Puerto Rican Forest Soil: Gordonia sp., Paenibacillus sp., Variovorax sp., and Vogesella sp.

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

Woo, Hannah L.; DeAngelis, Kristen M.; Teshima, Hazuki

In this paper, we report the high-quality draft genome sequences of four phylogenetically diverse lignocellulose-degrading bacteria isolated from tropical soil ( Gordonia sp., Paenibacillus sp., Variovorax sp., and Vogesella sp.) to elucidate the genetic basis of their ability to degrade lignocellulose. These isolates may provide novel enzymes for biofuel production.

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 ...

Exploring emerging learning needs: a UK-wide consultation on environmental sustainability learning objectives for medical education.

PubMed

Walpole, Sarah C; Mortimer, Frances; Inman, Alice; Braithwaite, Isobel; Thompson, Trevor

2015-12-24

This study aimed to engage wide-ranging stakeholders and develop consensus learning objectives for undergraduate and postgraduate medical education. A UK-wide consultation garnered opinions of healthcare students, healthcare educators and other key stakeholders about environmental sustainability in medical education. The policy Delphi approach informed this study. Draft learning objectives were revised iteratively during three rounds of consultation: online questionnaire or telephone interview, face-to-face seminar and email consultation. Twelve draft learning objectives were developed based on review of relevant literature. In round one, 64 participants' median ratings of the learning objectives were 3.5 for relevance and 3.0 for feasibility on a Likert scale of one to four. Revisions were proposed, e.g. to highlight relevance to public health and professionalism. Thirty three participants attended round two. Conflicting opinions were explored. Added content areas included health benefits of sustainable behaviours. To enhance usability, restructuring provided three overarching learning objectives, each with subsidiary points. All participants from rounds one and two were contacted in round three, and no further edits were required. This is the first attempt to define consensus learning objectives for medical students about environmental sustainability. Allowing a wide range of stakeholders to comment on multiple iterations of the document stimulated their engagement with the issues raised and ownership of the resulting learning objectives.

A process for developing standards to promote quality in general practice.

PubMed

Khoury, Julie; Krejany, Catherine J; Versteeg, Roald W; Lodewyckx, Michaela A; Pike, Simone R; Civil, Michael S; Jiwa, Moyez

2018-06-02

Since 1991, the Royal Australian College of General Practitioners' (RACGP) Standards for General Practices (the Standards) have provided a framework for quality care, risk management and best practice in the operation of Australian general practices. The Standards are also linked to incentives for general practice remuneration. These Standards were revised in 2017. The objective of this study is to describe the process undertaken to develop the fifth edition Standards published in 2017 to inform future standards development both nationally and internationally. A modified Delphi process was deployed to develop the fifth edition Standards. Development was directed by the RACGP and led by an expert panel of GPs and representatives of stakeholder groups who were assisted and facilitated by a team from RACGP. Each draft was released for stakeholder feedback and tested twice before the final version was submitted for approval by the RACGP board. Four rounds of consultation and two rounds of piloting were carried out over 32 months. The Standards were redrafted after each round. One hundred and fifty-two individuals and 225 stakeholder groups participated in the development of the Standards. Twenty-three new indicators were recommended and grouped into three sections in a new modular structure that was different from the previous edition. The Standards represent the consensus view of national stakeholders on the indicators of quality and safety in Australian general practice and primary care.

A review of the FDA draft guidance document for software validation: guidance for industry.

PubMed

Keatley, K L

1999-01-01

A Draft Guidance Document (Version 1.1) was issued by the United States Food and Drug Administration (FDA) to address the software validation requirement of the Quality System Regulation, 21 CFR Part 820, effective June 1, 1997. The guidance document outlines validation considerations that the FDA regards as applicable to both medical device software and software used to "design, develop or manufacture" medical devices. The Draft Guidance is available at the FDA web site http:@www.fda.gov/cdrh/comps/swareval++ +.html. Presented here is a review of the main features of the FDA document for Quality System Regulation (QSR), and some guidance for its implementation in industry.

A Comprehensive Definition for Integrative Oncology.

PubMed

Witt, Claudia M; Balneaves, Lynda G; Cardoso, Maria J; Cohen, Lorenzo; Greenlee, Heather; Johnstone, Peter; Kücük, Ömer; Mailman, Josh; Mao, Jun J

2017-11-01

Integrative oncology, which is generally understood to refer to the use of a combination of complementary medicine therapies in conjunction with conventional cancer treatments, has been defined in different ways, but there is no widely accepted definition. We sought to develop and establish a consensus for a comprehensive definition of the field of integrative oncology. We used a mixed-methods approach that included a literature analysis and a consensus procedure, including an interdisciplinary expert panel and surveys, to develop a comprehensive and acceptable definition for the term "integrative oncology." The themes identified in the literature and from the expert discussion were condensed into a two-sentence definition. Survey respondents had very positive views on the draft definition, and their comments helped to shape the final version. The final definition for integrative oncology is: "Integrative oncology is a patient-centered, evidence-informed field of cancer care that utilizes mind and body practices, natural products, and/or lifestyle modifications from different traditions alongside conventional cancer treatments. Integrative oncology aims to optimize health, quality of life, and clinical outcomes across the cancer care continuum and to empower people to prevent cancer and become active participants before,during, and beyond cancer treatment." This short and comprehensive definition for the term integrative oncology will facilitate a better understanding and communication of this emerging field. This definition will also drive focused and cohesive effort to advance the field of integrative oncology. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

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.

75 FR 2107 - Notice of Availability of the Draft Environmental Assessment (Draft EA) for the Urban Stream...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-14

... discloses any potential significant impacts to the quality of the human environment that may arise from the... augmentation. The Urban Stream Research Center will propagate and augment the population densities and increase...

Meeting Summary, Credit Trading Work Group

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

Kevin Bryan

2000-12-07

OAK-B135 Credit Trading Work Group Meeting Summary. The purpose of the meeting is to: (1) Provide an opportunity for NWCC Work Group Members, NWCC Members, and invited expert participants to hear an overview of the draft NWCC Credit Trading Report and to critically review and discuss the report's recommendations and principles. (2) Hear presentations from several perspectives of other experts on credit trading which provide: (a) a brief summary of credit trading activities they are involved in, and (b) critical responses to the NWCC draft report. (3) Identify how the report can be improved at the big picture level. Attemptmore » to resolve issues or concerns if necessary. (4) Discuss the recommendations and credit trading principles in detail and attempt to reach consensus on these sections for presentation to the NWCC. (5) Discuss if any of the outreach and communication recommendations in the report should be conducted by the NWCC.« less

A reply from earth? - A proposed approach to developing a message from humankind to extraterrestrial intelligence after we detect them

NASA Technical Reports Server (NTRS)

Michaud, Michael; Billingham, John; Tarter, Jill

1990-01-01

The question of the formulation of a proper response to the detection of an extraterrestrial civilization is considered. It is proposed that an international agreement or declaration of principles establishing procedures enabling international participation in the making of such decisions be developed and that the SETI Committee of the International Academy of Aeronautics, in cooperation with other interested bodies, draft an agreement or declaration of principles that would set up these procedures; and that the draft be presented to the United Nations for consideration through the Committee on Peaceful Uses of Outer Space. A suggested outline of the agreement or declaration is presented and proposes that a response to the detection of extraterrestrial intelligence should be on behalf of all humankind; that this decision should be made by an appropriately representative international body; and that the content of the reply should reflect an international consensus.

No. 347-Obstetric Management at Borderline Viability.

PubMed

Ladhani, Noor Niyar N; Chari, Radha S; Dunn, Michael S; Jones, Griffith; Shah, Prakesh; Barrett, Jon F R

2017-09-01

The primary objective of this guideline was to develop consensus statements to guide clinical practice and recommendations for obstetric management of a pregnancy at borderline viability, currently defined as prior to 25+6 weeks. Clinicians involved in the obstetric management of women whose fetus is at the borderline of viability. Women presenting for possible birth at borderline viability. This document presents a summary of the literature and a general consensus on the management of pregnancies at borderline viability, including maternal transfer and consultation, administration of antenatal corticosteroids and magnesium sulfate, fetal heart rate monitoring, and considerations in mode of delivery. Medline, EMBASE, and Cochrane databases were searched using the following keywords: extreme prematurity, borderline viability, preterm, pregnancy, antenatal corticosteroids, mode of delivery. The results were then studied, and relevant articles were reviewed. The references of the reviewed studies were also searched, as were documents citing pertinent studies. The evidence was then presented at a consensus meeting, and statements were developed. The content and recommendations were developed by the consensus group from the fields of Maternal-Fetal Medicine, Neonatology, Perinatal Nursing, Patient Advocacy, and Ethics. The quality of evidence was rated using criteria described in the Grading of Recommendations Assessment, Development and Evaluation methodology framework (reference 1). The Board of the Society of Obstetricians and Gynaecologists of Canada approved the final draft for publication. The quality of evidence was rated using the criteria described in the Grading of Recommendations, Assessment, Development, and Evaluation methodology framework. The interpretation of strong and weak recommendations is described later. The Summary of Findings is available upon request. A multidisciplinary approach should be used in counselling women and families at borderline viability. The impact of obstetric interventions in the improvement of neonatal outcomes is suggested in the literature, and if active resuscitation is intended, then active obstetric interventions should be considered. Evidence will be reviewed 5 years after publication to decide whether all or part of the guideline should be updated. However, if important new evidence is published prior to the 5-year cycle, the review process may be accelerated for a more rapid update of some recommendations. This guideline was developed with resources funded by the Society of Obstetricians and Gynaecologists of Canada and the Women and Babies Program at Sunnybrook Health Sciences Centre. Copyright © 2017 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.

EAACI/GA(2)LEN/EDF/WAO guideline: management of urticaria.

PubMed

Zuberbier, T; Asero, R; Bindslev-Jensen, C; Walter Canonica, G; Church, M K; Giménez-Arnau, A M; Grattan, C E H; Kapp, A; Maurer, M; Merk, H F; Rogala, B; Saini, S; Sánchez-Borges, M; Schmid-Grendelmeier, P; Schünemann, H; Staubach, P; Vena, G A; Wedi, B

2009-10-01

This guideline, together with its sister guideline on the classification of urticaria (Zuberbier T, Asero R, Bindslev-Jensen C, Canonica GW, Church MK, Giménez-Arnau AM et al. EAACI/GA(2)LEN/EDF/WAO Guideline: definition, classification and diagnosis of urticaria. Allergy 2009;64: 1417-1426), is the result of a consensus reached during a panel discussion at the Third International Consensus Meeting on Urticaria, Urticaria 2008, a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the EU-funded network of excellence, the Global Allergy and Asthma European Network (GA(2)LEN), the European Dermatology Forum (EDF) and the World Allergy Organization (WAO). As members of the panel, the authors had prepared their suggestions regarding management of urticaria before the meeting. The draft of the guideline took into account all available evidence in the literature (including Medline and Embase searches and hand searches of abstracts at international allergy congresses in 2004-2008) and was based on the existing consensus reports of the first and the second symposia in 2000 and 2004. These suggestions were then discussed in detail among the panel members and with the over 200 international specialists of the meeting to achieve a consensus using a simple voting system where appropriate. Urticaria has a profound impact on the quality of life and effective treatment is, therefore, required. The recommended first line treatment is new generation, nonsedating H(1)-antihistamines. If standard dosing is not effective, increasing the dosage up to four-fold is recommended. For patients who do not respond to a four-fold increase in dosage of nonsedating H(1)-antihistamines, it is recommended that second-line therapies should be added to the antihistamine treatment. In the choice of second-line treatment, both their costs and risk/benefit profiles are most important to consider. Corticosteroids are not recommended for long-term treatment due to their unavoidable severe adverse effects. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS).

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

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

Fast and accurate de novo genome assembly from long uncorrected reads

PubMed Central

Vaser, Robert; Sović, Ivan; Nagarajan, Niranjan

2017-01-01

The assembly of long reads from Pacific Biosciences and Oxford Nanopore Technologies typically requires resource-intensive error-correction and consensus-generation steps to obtain high-quality assemblies. We show that the error-correction step can be omitted and that high-quality consensus sequences can be generated efficiently with a SIMD-accelerated, partial-order alignment–based, stand-alone consensus module called Racon. Based on tests with PacBio and Oxford Nanopore data sets, we show that Racon coupled with miniasm enables consensus genomes with similar or better quality than state-of-the-art methods while being an order of magnitude faster. PMID:28100585

Responding to the World Health Organization Global Disability Action Plan in Egypt: A Technical Consultancy to develop a National Disability, Health and Rehabilitation Plan.

PubMed

Gutenbrunner, Christoph; Nugraha, Boya

2018-04-18

A technical consultation to develop a National Disability, Health and Rehabilitation Plan (NDHRP) for Egypt was carried out in 2015. Its overall goal was to improve health, functioning, well-being, quality of life, and participation of persons with disability in Egypt by supporting the Ministry of Health and Population and other stakeholders to improve access to health services and strengthen health-related rehabilitation services for all persons in need. The methodological steps of the technical consultation were as follows: collecting and reviewing accessible documents and data; site visits to state institutions, health and rehabilitation services; discussions with relevant stakeholders in rehabilitation, including persons with disability; drafting recommendations based on the principles of the World Report on Disability and the World Health Organization Global Disability Action Plan and the information collected; discussion with stakeholders in a workshop; and preparation of a final report. The development of a NDHRP was successful and led to recommendations with a good level of consensus among stakeholders in Egypt. The authors hope that the NDHRP will lead to improved rehabilitation service provision, and health and quality of life of persons with disability and chronic health conditions living in Egypt.

Kyoto global consensus report on Helicobacter pylori gastritis.

PubMed

Sugano, Kentaro; Tack, Jan; Kuipers, Ernst J; Graham, David Y; El-Omar, Emad M; Miura, Soichiro; Haruma, Ken; Asaka, Masahiro; Uemura, Naomi; Malfertheiner, Peter

2015-09-01

To present results of the Kyoto Global Consensus Meeting, which was convened to develop global consensus on (1) classification of chronic gastritis and duodenitis, (2) clinical distinction of dyspepsia caused by Helicobacter pylori from functional dyspepsia, (3) appropriate diagnostic assessment of gastritis and (4) when, whom and how to treat H. pylori gastritis. Twenty-three clinical questions addressing the above-mentioned four domains were drafted for which expert panels were asked to formulate relevant statements. A Delphi method using an anonymous electronic system was adopted to develop the consensus, the level of which was predefined as ≥80%. Final modifications of clinical questions and consensus were achieved at the face-to-face meeting in Kyoto. All 24 statements for 22 clinical questions after extensive modifications and omission of one clinical question were achieved with a consensus level of >80%. To better organise classification of gastritis and duodenitis based on aetiology, a new classification of gastritis and duodenitis is recommended for the 11th international classification. A new category of H. pylori-associated dyspepsia together with a diagnostic algorithm was proposed. The adoption of grading systems for gastric cancer risk stratification, and modern image-enhancing endoscopy for the diagnosis of gastritis, were recommended. Treatment to eradicate H. pylori infection before preneoplastic changes develop, if feasible, was recommended to minimise the risk of more serious complications of the infection. A global consensus for gastritis was developed for the first time, which will be the basis for an international classification system and for further research on the subject. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Improved High-Quality Draft Genome Sequence and Annotation of Burkholderia contaminans LMG 23361T.

PubMed

Jung, Ji Young; Ahn, Youngbeom; Kweon, Ohgew; LiPuma, John J; Hussong, David; Marasa, Bernard S; Cerniglia, Carl E

2017-04-20

Burkholderia contaminans LMG 23361 is the type strain of the species isolated from the milk of a dairy sheep with mastitis. Some pharmaceutical products contain disinfectants such as benzalkonium chloride (BZK) and previously we reported that B. contaminans LMG 23361 T possesses the ability to inactivate BZK with high biodegradation rates. Here, we report an improved high-quality draft genome sequence of this strain. Copyright © 2017 Jung et al.

Programmatic Agreements for Project-Level Air Quality Analyses : NCHRP 25-25 Task 78

DOT National Transportation Integrated Search

2015-09-01

The research performed under Task 78 was divided into two phases. The first phase involved development of a draft Programmatic Agreement (PA) template and a draft Technical Support Document (TSD) template for project-level carbon monoxide (CO) hot-sp...

Venturia carpophila draft genome sequence

USDA-ARS?s Scientific Manuscript database

Venturia carpophila causes peach scab, a disease that renders peach fruit unmarketable. We report a high-quality draft genome sequence (36.9 Mb) of V. carpophila from an isolate collected from a peach tree in central Georgia in the United States. The genome sequence described will be a useful resour...

77 FR 3545 - Notice of Availability of the Draft Program Environmental Impact Report (PEIR): Southern...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-24

... transportation and urban form strategies that encourage compact growth, increased jobs/housing balance and... DEPARTMENT OF TRANSPORTATION Federal Highway Administration Notice of Availability of the Draft... California Environmental Quality Act for the 2012-2035 Regional Transportation Plan and Sustainable...

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...

International standardisation work on the measurement of radon in air and water.

PubMed

Calmet, D; Ameon, R; Beck, T; Bombard, A; Bourquin, M N; Brun, S; De Jong, P; Forte, M; Fournier, M; Herranz, M; Jerome, S; Klett, A; Kwakman, P; Llaurado, M; Loyen, J; Michel, R; Nardoux, P; Richards, T; Schuler, C; Tokonami, S; Woods, M

2011-05-01

Radon is considered to be the main source of human exposure to natural radiation. As stated by the World Health Organization, the exposure due to the inhalation of indoor radon is much greater than the one via the ingestion of water as radon degasses from water during handling. In response to these concerns about the universal presence of radon, environmental assessment studies are regularly commissioned to assess the radon exposure of public and workers. The credibility of such studies relies on the quality and reliability of radon analysis as well as on the sample representativeness of the radiological situation. The standard-setting approach, based on consensus, seemed to lend itself to a settlement of technical aspects of potential comparison. At present, two Working Groups of the International Standardization Organization are focussing on drafting standards on radon and its decay products measurement in air and water. These standards, which aim for a set of rigorous metrology practices, will be useful for persons in charge of the initial characterisation of a site with respect to natural radioactivity as well as to those performing the routine surveillance of specific sites.

76 FR 72919 - Draft Integrated Science Assessment for Ozone and Related Photochemical Oxidants

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... Science Assessment for Ozone and Related Photochemical Oxidants AGENCY: Environmental Protection Agency... Draft Integrated Science Assessment for Ozone and Related Photochemical Oxidants'' (EPA/600/R-10/076B... national ambient air quality standards (NAAQS) for ozone. DATES: The public comment period began on...

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

EPA Science Inventory

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

EPA Science Inventory

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AIR QUALITY CRITERIA FOR PARTICULATE MATTER DOCUMENT

EPA Science Inventory

A Planning Document was produced by NCEA/RTP and reviewed by the Clean Air Scientific Advisory Committee (CASAC) (62 FR 55201, October 23, 1997). In FY99, a workshop draft of the PM AQCD was completed, a peer input workshop held, and an External Review Draft released for public ...

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Draft Plan for Development of the Integrated Science Assessment for Nitrogen Oxides - Health Criteria

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EPA has announced a draft development plan for the next Integrated Science Assessment (ISA) for the health effects of nitrogen oxides (NOX) which will serve as the scientific basis for review of the primary (health-based) National Ambient Air Quality Standard for nitrogen dioxide...

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Maintaining success, reducing treatment burden, focusing on survivorship: highlights from the third European consensus conference on diagnosis and treatment of germ-cell cancer.

PubMed

Beyer, J; Albers, P; Altena, R; Aparicio, J; Bokemeyer, C; Busch, J; Cathomas, R; Cavallin-Stahl, E; Clarke, N W; Claßen, J; Cohn-Cedermark, G; Dahl, A A; Daugaard, G; De Giorgi, U; De Santis, M; De Wit, M; De Wit, R; Dieckmann, K P; Fenner, M; Fizazi, K; Flechon, A; Fossa, S D; Germá Lluch, J R; Gietema, J A; Gillessen, S; Giwercman, A; Hartmann, J T; Heidenreich, A; Hentrich, M; Honecker, F; Horwich, A; Huddart, R A; Kliesch, S; Kollmannsberger, C; Krege, S; Laguna, M P; Looijenga, L H J; Lorch, A; Lotz, J P; Mayer, F; Necchi, A; Nicolai, N; Nuver, J; Oechsle, K; Oldenburg, J; Oosterhuis, J W; Powles, T; Rajpert-De Meyts, E; Rick, O; Rosti, G; Salvioni, R; Schrader, M; Schweyer, S; Sedlmayer, F; Sohaib, A; Souchon, R; Tandstad, T; Winter, C; Wittekind, C

2013-04-01

In November 2011, the Third European Consensus Conference on Diagnosis and Treatment of Germ-Cell Cancer (GCC) was held in Berlin, Germany. This third conference followed similar meetings in 2003 (Essen, Germany) and 2006 (Amsterdam, The Netherlands) [Schmoll H-J, Souchon R, Krege S et al. European consensus on diagnosis and treatment of germ-cell cancer: a report of the European Germ-Cell Cancer Consensus Group (EGCCCG). Ann Oncol 2004; 15: 1377-1399; Krege S, Beyer J, Souchon R et al. European consensus conference on diagnosis and treatment of germ-cell cancer: a report of the second meeting of the European Germ-Cell Cancer Consensus group (EGCCCG): part I. Eur Urol 2008; 53: 478-496; Krege S, Beyer J, Souchon R et al. European consensus conference on diagnosis and treatment of germ-cell cancer: a report of the second meeting of the European Germ-Cell Cancer Consensus group (EGCCCG): part II. Eur Urol 2008; 53: 497-513]. A panel of 56 of 60 invited GCC experts from all across Europe discussed all aspects on diagnosis and treatment of GCC, with a particular focus on acute and late toxic effects as well as on survivorship issues. The panel consisted of oncologists, urologic surgeons, radiooncologists, pathologists and basic scientists, who are all actively involved in care of GCC patients. Panelists were chosen based on the publication activity in recent years. Before the meeting, panelists were asked to review the literature published since 2006 in 20 major areas concerning all aspects of diagnosis, treatment and follow-up of GCC patients, and to prepare an updated version of the previous recommendations to be discussed at the conference. In addition, ∼50 E-vote questions were drafted and presented at the conference to address the most controversial areas for a poll of expert opinions. Here, we present the main recommendations and controversies of this meeting. The votes of the panelists are added as online supplements.

Towards the development of skills-based health promotion competencies: the Canadian experience.

PubMed

Hyndman, Brian

2009-06-01

The health promotion competencies presented in the Galway Consensus Conference Statement build on an emerging international literature that includes a proposed set of Canadian competencies developed for health promotion practitioners. In Canada, the creation of draft health promotion competencies by Health Promotion Ontario (HPO) was fueled by increased concerns about the potential marginalization of health promotion as well as a national public health renewal process that placed increased emphasis on competency development as a means of strengthening the public health workforce. This commentary presents the proposed Canadian competencies and provides an overview of the process utilized to develop them. Key similarities and differences between the proposed Canadian competencies and the competencies outlined in the Consensus Statement are also explored. The Canadian experience illustrates the way in which national health promotion competencies can be shaped by cultural and political factors unique to a specific jurisdiction.

College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference on good laboratory practices in gynecologic cytology: background, rationale, and organization.

PubMed

Tworek, Joseph A; Henry, Michael R; Blond, Barbara; Jones, Bruce Allen

2013-02-01

Gynecologic cytopathology is a heavily regulated field, with Clinical Laboratory Improvement Amendments of 1988 mandating the collection of many quality metrics. There is a lack of consensus regarding methods to collect, monitor, and benchmark these data and how these data should be used in a quality assurance program. Furthermore, the introduction of human papilloma virus testing and proficiency testing has provided more data to monitor. To determine good laboratory practices in quality assurance of gynecologic cytopathology. Data were collected through a written survey consisting of 98 questions submitted to 1245 Clinical Laboratory Improvement Amendments-licensed or Department of Defense laboratories. There were 541 usable responses. Additional input was sought through a Web posting of results and questions on the College of American Pathologists Web site. Four senior authors who authored the survey and 28 cytopathologists and cytotechnologists were assigned to 5 working groups to analyze data and present statements on good laboratory practices in gynecologic cytopathology at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference. Ninety-eight attendees at the College of American Pathologists Gynecologic Cytopathology Quality Consensus Conference discussed and voted on good laboratory practice statements to obtain consensus. This paper describes the rationale, background, process, and strengths and limitations of a series of papers that summarize good laboratory practice statements in quality assurance in gynecologic cytopathology.

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.

QUALITY CONTROLS FOR PCR

EPA Science Inventory

The purpose of this presentation is to present an overview of the quality control (QC) sections of a draft EPA document entitled, "Quality Assurance/Quality Control Guidance for Laboratories Performing PCR Analyses on Environmental Samples." This document has been prepared by th...

Complete genome sequence of the phenanthrene-degrading soil bacterium Delftia acidovorans Cs1-4

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

Shetty, Ameesha R.; de Gannes, Vidya; Obi, Chioma C.

Polycyclic aromatic hydrocarbons (PAH) are ubiquitous environmental pollutants and microbial biodegradation is an important means of remediation of PAH-contaminated soil. Delftia acidovorans Cs1-4 (formerly Delftia sp. Cs1-4) was isolated by using phenanthrene as the sole carbon source from PAH contaminated soil in Wisconsin. Its full genome sequence was determined to gain insights into a mechanisms underlying biodegradation of PAH. Three genomic libraries were constructed and sequenced: an Illumina GAii shotgun library (916,416,493 reads), a 454 Titanium standard library (770,171 reads) and one paired-end 454 library (average insert size of 8 kb, 508,092 reads). The initial assembly contained 40 contigs inmore » two scaffolds. The 454 Titanium standard data and the 454 paired end data were assembled together and the consensus sequences were computationally shredded into 2 kb overlapping shreds. Illumina sequencing data was assembled, and the consensus sequence was computationally shredded into 1.5 kb overlapping shreds. Gaps between contigs were closed by editing in Consed, by PCR and by Bubble PCR primer walks. A total of 182 additional reactions were needed to close gaps and to raise the quality of the finished sequence. The final assembly is based on 253.3 Mb of 454 draft data (averaging 38.4 X coverage) and 590.2 Mb of Illumina draft data (averaging 89.4 X coverage). The genome of strain Cs1-4 consists of a single circular chromosome of 6,685,842 bp (66.7 %G+C) containing 6,028 predicted genes; 5,931 of these genes were protein-encoding and 4,425 gene products were assigned to a putative function. Genes encoding phenanthrene degradation were localized to a 232 kb genomic island (termed the phn island), which contained near its 3’ end a bacteriophage P4-like integrase, an enzyme often associated with chromosomal integration of mobile genetic elements. Other biodegradation pathways reconstructed from the genome sequence included: benzoate (by the acetyl-CoA pathway), styrene, nicotinic acid (by the maleamate pathway) and the pesticides Dicamba and Fenitrothion. Lastly, determination of the complete genome sequence of D. acidovorans Cs1-4 has provided new insights the microbial mechanisms of PAH biodegradation that may shape the process in the environment.« less

Complete genome sequence of the phenanthrene-degrading soil bacterium Delftia acidovorans Cs1-4

DOE PAGES

Shetty, Ameesha R.; de Gannes, Vidya; Obi, Chioma C.; ...

2015-08-15

Polycyclic aromatic hydrocarbons (PAH) are ubiquitous environmental pollutants and microbial biodegradation is an important means of remediation of PAH-contaminated soil. Delftia acidovorans Cs1-4 (formerly Delftia sp. Cs1-4) was isolated by using phenanthrene as the sole carbon source from PAH contaminated soil in Wisconsin. Its full genome sequence was determined to gain insights into a mechanisms underlying biodegradation of PAH. Three genomic libraries were constructed and sequenced: an Illumina GAii shotgun library (916,416,493 reads), a 454 Titanium standard library (770,171 reads) and one paired-end 454 library (average insert size of 8 kb, 508,092 reads). The initial assembly contained 40 contigs inmore » two scaffolds. The 454 Titanium standard data and the 454 paired end data were assembled together and the consensus sequences were computationally shredded into 2 kb overlapping shreds. Illumina sequencing data was assembled, and the consensus sequence was computationally shredded into 1.5 kb overlapping shreds. Gaps between contigs were closed by editing in Consed, by PCR and by Bubble PCR primer walks. A total of 182 additional reactions were needed to close gaps and to raise the quality of the finished sequence. The final assembly is based on 253.3 Mb of 454 draft data (averaging 38.4 X coverage) and 590.2 Mb of Illumina draft data (averaging 89.4 X coverage). The genome of strain Cs1-4 consists of a single circular chromosome of 6,685,842 bp (66.7 %G+C) containing 6,028 predicted genes; 5,931 of these genes were protein-encoding and 4,425 gene products were assigned to a putative function. Genes encoding phenanthrene degradation were localized to a 232 kb genomic island (termed the phn island), which contained near its 3’ end a bacteriophage P4-like integrase, an enzyme often associated with chromosomal integration of mobile genetic elements. Other biodegradation pathways reconstructed from the genome sequence included: benzoate (by the acetyl-CoA pathway), styrene, nicotinic acid (by the maleamate pathway) and the pesticides Dicamba and Fenitrothion. Lastly, determination of the complete genome sequence of D. acidovorans Cs1-4 has provided new insights the microbial mechanisms of PAH biodegradation that may shape the process in the environment.« less

Resequencing of the common marmoset genome improves genome assemblies and gene-coding sequence analysis.

PubMed

Sato, Kengo; Kuroki, Yoko; Kumita, Wakako; Fujiyama, Asao; Toyoda, Atsushi; Kawai, Jun; Iriki, Atsushi; Sasaki, Erika; Okano, Hideyuki; Sakakibara, Yasubumi

2015-11-20

The first draft of the common marmoset (Callithrix jacchus) genome was published by the Marmoset Genome Sequencing and Analysis Consortium. The draft was based on whole-genome shotgun sequencing, and the current assembly version is Callithrix_jacches-3.2.1, but there still exist 187,214 undetermined gap regions and supercontigs and relatively short contigs that are unmapped to chromosomes in the draft genome. We performed resequencing and assembly of the genome of common marmoset by deep sequencing with high-throughput sequencing technology. Several different sequence runs using Illumina sequencing platforms were executed, and 181 Gbp of high-quality bases including mate-pairs with long insert lengths of 3, 8, 20, and 40 Kbp were obtained, that is, approximately 60× coverage. The resequencing significantly improved the MGSAC draft genome sequence. The N50 of the contigs, which is a statistical measure used to evaluate assembly quality, doubled. As a result, 51% of the contigs (total length: 299 Mbp) that were unmapped to chromosomes in the MGSAC draft were merged with chromosomal contigs, and the improved genome sequence helped to detect 5,288 new genes that are homologous to human cDNAs and the gaps in 5,187 transcripts of the Ensembl gene annotations were completely filled.

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.

European Society for Paediatric Endocrinology Consensus Guidelines on Screening, Diagnosis, and Management of Congenital Hypothyroidism

PubMed Central

Léger, Juliane; Olivieri, Antonella; Donaldson, Malcolm; Torresani, Toni; Krude, Heiko; van Vliet, Guy; Polak, Michel

2014-01-01

Objective: The aim was to formulate practice guidelines for the diagnosis and management of congenital hypothyroidism (CH). Evidence: A systematic literature search was conducted to identify key articles relating to the screening, diagnosis, and management of CH. The evidence-based guidelines were developed with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system, describing both the strength of recommendations and the quality of evidence. In the absence of sufficient evidence, conclusions were based on expert opinion. Consensus Process: Thirty-two participants drawn from the European Society for Paediatric Endocrinology and five other major scientific societies in the field of pediatric endocrinology were allocated to working groups with assigned topics and specific questions. Each group searched the literature, evaluated the evidence, and developed a draft document. These papers were debated and finalized by each group before presentation to the full assembly for further discussion and agreement. Recommendations: The recommendations include: worldwide neonatal screening, approaches to assess the cause (including genotyping) and the severity of the disorder, the immediate initiation of appropriate L-T4 supplementation and frequent monitoring to ensure dose adjustments to keep thyroid hormone levels in the target ranges, a trial of treatment in patients suspected of transient CH, regular assessments of developmental and neurosensory functions, consulting health professionals as appropriate, and education about CH. The harmonization of diagnosis, management, and routine health surveillance would not only optimize patient outcomes, but should also facilitate epidemiological studies of the disorder. Individuals with CH require monitoring throughout their lives, particularly during early childhood and pregnancy. PMID:24446653

Draft genome sequence of Venturia carpophila, the causal agent of peach scab

USDA-ARS?s Scientific Manuscript database

Venturia carpophila causes peach scab, a disease that renders peach fruit unmarketable. We report a high-quality draft genome sequence (36.9 Mb) of V. carpophila from an isolate collected from a peach tree in central Georgia in the United States. The genome sequence described will be a useful resour...

77 FR 12853 - Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for...

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2012-03-02

... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver... the review of 351(k) applications and general scientific principles in conducting comparative analyses... specific, on the scientific considerations, Q&A, and quality considerations draft guidances. For example...

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2010-02-23

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... a Public Teleconference of the Clean Air Scientific Advisory Committee (CASAC) Lead Review Panel... (CASAC) Lead Review Panel to provide consultative advice on EPA's draft Integrated Review Plan for the National Ambient Air Quality Standards for Lead (draft IRP). DATES: The public teleconference will be held...

Memoranda Associated with the Second External Review Draft of Health Risk and Exposure Assessments from the Current Review of Ozone NAAQS

EPA Pesticide Factsheets

EPA's Health and Environmental Impacts Division had to make corrections to some of the risk results included in earlier drafts of the Health Risk and Exposure Assessment from the current review of ozone national ambient air quality standards (NAAQS).

75 FR 59716 - Draft Toxicological Review of Urea: In Support of Summary Information on the Integrated Risk...

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2010-09-28

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Draft Genome sequence of Frankia sp. Strain QA3, a nitrogen-fixing actinobacterium isolated from the root nodule of Alnus nitida

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

Sen, Arnab; Beauchemin, Nicholas; Bruce, David

Members of actinomycete genus Frankia form a nitrogen-fixing symbiosis with 8 different families of actinorhizal plants. We report a high-quality draft genome sequence for Frankia sp. stain QA3, a nitrogen-fixing actinobacterium isolated from root nodules of Alnus nitida.

76 FR 60825 - Draft Toxicological Review of Vanadium Pentoxide: In Support of Summary Information on the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-30

...) within the EPA Office of Research and Development (ORD). EPA is releasing this draft assessment solely... quantitative and qualitative risk information on effects that may result from exposure to chemical substances found in the environment. Through the IRIS Program, EPA provides the highest quality science- based...

The Diabetes Surgery Summit consensus conference: recommendations for the evaluation and use of gastrointestinal surgery to treat type 2 diabetes mellitus.

PubMed

Rubino, Francesco; Kaplan, Lee M; Schauer, Philip R; Cummings, David E

2010-03-01

To develop guidelines for the use of gastrointestinal surgery to treat type 2 diabetes and to craft an agenda for further research. Increasing evidence demonstrates that bariatric surgery can dramatically ameliorate type 2 diabetes. Not surprisingly, gastrointestinal operations are now being used throughout the world to treat diabetes in association with obesity, and increasingly, for diabetes alone. However, the role for surgery in diabetes treatment is not clearly defined and there are neither clear guidelines for these practices nor sufficient plans for clinical trials to evaluate the risks and benefits of such "diabetes surgery." A multidisciplinary group of 50 voting delegates from around the world gathered in Rome, Italy for the first International Conference on Gastrointestinal Surgery to Treat Type 2 Diabetes--(the "Diabetes Surgery Summit"). During the meeting, available scientific evidence was examined and critiqued by the entire group to assess the strength of evidence and to draft consensus statements. Through an iterative process, draft statements were then serially discussed, debated, edited, reassessed, and finally presented for formal voting. After the Rome meeting, statements that achieved consensus were summarized and distributed to all voting delegates for further input and final approval. These statements were then formally critiqued by representatives of several sientific societies at the 1st World Congress on Interventional Therapies for T2DM (New York, Sept 2008). Input from this discussion was used to generate the current position statement. A Diabetes Surgery Summit (DSS) Position Statement consists of recommendations for clinical and research issues, as well as general concepts and definitions in diabetes surgery. The DSS recognizes the legitimacy of surgical approaches to treat diabetes in carefully selected patients. For example, gastric bypass was deemed a reasonable treatment option for patients with poorly controlled diabetes and a body mass index > or =30 kg/m. Clinical trials to investigate the exact role of surgery in patients with less severe obesity and diabetes are considered a priority. Furthermore, investigations on the mechanisms of surgical control of diabetes are strongly encouraged, as they may help advance the understanding of diabetes pathophysiology. The DSS consensus document embodies the foundations of "diabetes surgery," and represents a timely attempt by leading scholars to improve access to surgical options supported by sound evidence, while also preventing harm from inappropriate use of unproven procedures.

Causal Evaluation of Acute Recurrent and Chronic Pancreatitis in Children: Consensus From the INSPPIRE Group.

PubMed

Gariepy, Cheryl E; Heyman, Melvin B; Lowe, Mark E; Pohl, John F; Werlin, Steven L; Wilschanski, Michael; Barth, Bradley; Fishman, Douglas S; Freedman, Steven D; Giefer, Matthew J; Gonska, Tanja; Himes, Ryan; Husain, Sohail Z; Morinville, Veronique D; Ooi, Chee Y; Schwarzenberg, Sarah J; Troendle, David M; Yen, Elizabeth; Uc, Aliye

2017-01-01

Acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) have been diagnosed in children at increasing rates during the past decade. As pediatric ARP and CP are still relatively rare conditions, little quality evidence is available on which to base the diagnosis and determination of etiology. The aim of the study was to review the current state of the literature regarding the etiology of these disorders and to developed a consensus among a panel of clinically active specialists caring for children with these disorders to help guide the diagnostic evaluation and identify areas most in need of future research. A systematic review of the literature was performed and scored for quality, followed by consensus statements developed and scored by each individual in the group for level of agreement and strength of the supporting data using a modified Delphi method. Scores were analyzed for the level of consensus achieved by the group. The panel reached consensus on 27 statements covering the definitions of pediatric ARP and CP, evaluation for potential etiologies of these disorders, and long-term monitoring. Statements for which the group reached consensus to make no recommendation or could not reach consensus are discussed. This consensus helps define the minimal diagnostic evaluation and monitoring of children with ARP and CP. Even in areas in which we reached consensus, the quality of the evidence is weak, highlighting the need for further research. Improved understanding of the underlying cause will facilitate treatment development and targeting.

The Causal Evaluation of Acute Recurrent and Chronic Pancreatitis in Children: Consensus From the INSPPIRE Group

PubMed Central

Gariepy, Cheryl E.; Heyman, Melvin B.; Lowe, Mark E.; Pohl, John F.; Werlin, Steven L.; Wilschanski, Michael; Barth, Bradley; Fishman, Douglas S.; Freedman, Steven D.; Giefer, Matthew J.; Gonska, Tanja; Himes, Ryan; Husain, Sohail Z.; Morinville, Veronique D.; Ooi, Chee Y.; Schwarzenberg, Sarah Jane; Troendle, David M.; Yen, Elizabeth; Uc, Aliye

2016-01-01

Acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP) have been diagnosed in children at increasing rates over the past decade. However, as pediatric ARP and CP are still relatively rare conditions, little quality evidence is available on which to base the diagnosis and determination of etiology. Objectives: To review the current state of the literature regarding the etiology of these disorders and to developed a consensus among a panel of clinically active specialists caring for children with these disorders to help guide the diagnostic evaluation and identify areas most in need of future research. Methods: A systematic review of the literature was performed and scored for quality, then consensus statements developed and scored by each individual in the group for level of agreement and strength of the supporting data using a modified Delphi method. Scores were analyzed for the level of consensus achieved by the group. Results: The panel reached consensus on 27 statements covering the definitions of pediatric ARP and CP, evaluation for potential etiologies of these disorders, and long-term monitoring. Statements for which the group reached consensus to make no recommendation or could not reach consensus are discussed. Conclusion: This consensus helps define the minimal diagnostic evaluation and monitoring of children with ARP and CP. Even in areas in which we reached consensus, the quality of the evidence is weak, highlighting the need for further research. Improved understanding of the underlying cause will facilitate treatment development and targeting. PMID:27782962

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.

Sedentary Behavior Research Network (SBRN) - Terminology Consensus Project process and outcome.

PubMed

Tremblay, Mark S; Aubert, Salomé; Barnes, Joel D; Saunders, Travis J; Carson, Valerie; Latimer-Cheung, Amy E; Chastin, Sebastien F M; Altenburg, Teatske M; Chinapaw, Mai J M

2017-06-10

The prominence of sedentary behavior research in health science has grown rapidly. With this growth there is increasing urgency for clear, common and accepted terminology and definitions. Such standardization is difficult to achieve, especially across multi-disciplinary researchers, practitioners, and industries. The Sedentary Behavior Research Network (SBRN) undertook a Terminology Consensus Project to address this need. First, a literature review was completed to identify key terms in sedentary behavior research. These key terms were then reviewed and modified by a Steering Committee formed by SBRN. Next, SBRN members were invited to contribute to this project and interested participants reviewed and provided feedback on the proposed list of terms and draft definitions through an online survey. Finally, a conceptual model and consensus definitions (including caveats and examples for all age groups and functional abilities) were finalized based on the feedback received from the 87 SBRN member participants who responded to the original invitation and survey. Consensus definitions for the terms physical inactivity, stationary behavior, sedentary behavior, standing, screen time, non-screen-based sedentary time, sitting, reclining, lying, sedentary behavior pattern, as well as how the terms bouts, breaks, and interruptions should be used in this context are provided. It is hoped that the definitions resulting from this comprehensive, transparent, and broad-based participatory process will result in standardized terminology that is widely supported and adopted, thereby advancing future research, interventions, policies, and practices related to sedentary behaviors.

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.

[Identification of sentinel events in primary care].

PubMed

Olivera Cañadas, G; Cañada Dorado, A; Drake Canela, M; Fernández-Martínez, B; Ordóñez León, G; Cimas Ballesteros, M

To identify and describe a list of sentinel events (SEs) for Primary Care (PC). A structured experts' consensus was obtained by using two online questionnaires. The participants were selected because of their expertise in PC and patient safety. The first questionnaire assessed the suitability of the hospital SEs established in the National Quality Forum 2006 for use in PC via responses of "yes", "no", or "yes but with modification". In the latter case, a re-wording of the SE was requested. Additionally, inclusion of new SEs was also allowed. The second questionnaire included those SEs with positive responses ("yes", "yes with modification"), so that the experts could choose between the original and alternative drafts, and evaluate the newly described SEs. The questionnaires were completed by 44 out of a total of the 47 experts asked to participate, and a total of 17 SEs were identified as suitable for PC. For the first questionnaire, 12 of the 28 hospital SEs were considered adaptable to PC, of which 11 were re-drafts. Thirty-seven experts proposed new SEs. These mainly concerned problems with medication and vaccines, delay, or lack of assistance, diagnostic delays, and problems with diagnostic tests, and were finally summarised in 5 SEs. In the second questionnaire, ≥65% of the experts chose the alternative wording against the original cases for the 11 SEs suitable for PC. The 5 newly included SEs were considered adequate with a positive response of 70-85%. Having a list of SEs available in PC will help to improve the management of health care risks. Copyright © 2017 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application.

PubMed

Lance, Philip T; Greenaway, Ruth V; Edwards, Brian

2018-01-01

The US Food and Drug Administration (FDA) put out a call for comments on new draft guidance for industry "Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA." This call for comments elicited 7 submissions from various organizations in the field of health care products. This article reports on a review conducted on these 7 submissions. The purpose of this review was to identify any commonalities across the different submissions and determine if there was consensus on any point or aspect of the draft guidance. To identify any commonalities, a heat map plotting the lines of the draft guidance that had raised a comment/suggestion was produced. Also, a thematic analysis was conducted on the comments/suggestions. In total the 7 submissions produced 137 suggestions. The heat map revealed that these suggestions did not focus on any single part of the guidance but were spread throughout the guidance. The thematic analysis conducted on the suggestions found a number of distinct trends. These trends were grouped into 10 primary themes, each with a number of subthemes. It was concluded that guidance from the FDA on this matter is warranted and would be appreciated. However, it was also concluded that based on the distinct trends identified in the suggestions, there are issues that the FDA may wish to consider before publishing their final guidance.

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.

ASDS Cosmetic Dermatologic Surgery Fellowship Milestones.

PubMed

Waldman, Abigail; Arndt, Kenneth A; Avram, Mathew M; Brown, Mariah R; Dover, Jeffrey S; Fabi, Sabrina G; Friedmann, Daniel P; Geronemus, Roy G; Goldberg, David J; Goldman, Mitchel P; Green, Jeremy B; Ibrahimi, Omar A; Jones, Derek H; Kilmer, Suzanne L; McDaniel, David H; Obagi, Suzan; Ortiz, Arisa E; Rohrer, Thomas E; Taylor, Mark B; Torres, Abel; Weinkle, Susan H; Weiss, Margaret A; Weiss, Eduardo T; Weiss, Robert A; Poon, Emily; Alam, Murad

2016-10-01

The American Council of Graduate Medical Education, which oversees much of postgraduate medical education in the United States, has championed the concept of "milestones," standard levels of achievement keyed to particular time points, to assess trainee performance during residency. To develop a milestones document for the American Society for Dermatologic Surgery (ASDS) Cosmetic Dermatologic Surgery (CDS) fellowship program. An ad hoc milestone drafting committee was convened that included members of the ASDS Accreditation Work Group and program directors of ASDS-approved Cosmetic Dermatologic Surgery (CDC) fellowship training programs. Draft milestones were circulated through email in multiple rounds until consensus was achieved. Thirteen milestones were developed in the 6 Accreditation Council for Graduate Medical Education (ACGME) competency areas, with 8 of these being patient-care milestones. Additional instructions for milestone administration more specific to the CDS fellowship than general ACGME instructions were also approved. Implementation of semiannual milestones was scheduled for the fellowship class entering in July 2018. Milestones are now available for CDS fellowship directors to implement in combination with other tools for fellow evaluation.

Evaluation of tuberculosis diagnostics in children: 1. Proposed clinical case definitions for classification of intrathoracic tuberculosis disease. Consensus from an expert panel.

PubMed

Graham, Stephen M; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E; Gale, Marianne; Gie, Robert P; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J; McNeeley, David F; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R; Swaminathan, Soumya; Wingfield, Claire

2012-05-15

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis.

78 FR 22269 - International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

...The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The draft guidance is intended to provide guidance for new drug substances and new drug products during their clinical development and subsequent applications for marketing.

Consensus statement for standard of care in spinal muscular atrophy.

PubMed

Wang, Ching H; Finkel, Richard S; Bertini, Enrico S; Schroth, Mary; Simonds, Anita; Wong, Brenda; Aloysius, Annie; Morrison, Leslie; Main, Marion; Crawford, Thomas O; Trela, Anthony

2007-08-01

Spinal muscular atrophy is a neurodegenerative disease that requires multidisciplinary medical care. Recent progress in the understanding of molecular pathogenesis of spinal muscular atrophy and advances in medical technology have not been matched by similar developments in the care for spinal muscular atrophy patients. Variations in medical practice coupled with differences in family resources and values have resulted in variable clinical outcomes that are likely to compromise valid measure of treatment effects during clinical trials. The International Standard of Care Committee for Spinal Muscular Atrophy was formed in 2005, with a goal of establishing practice guidelines for clinical care of these patients. The 12 core committee members worked with more than 60 spinal muscular atrophy experts in the field through conference calls, e-mail communications, a Delphi survey, and 2 in-person meetings to achieve consensus on 5 care areas: diagnostic/new interventions, pulmonary, gastrointestinal/nutrition, orthopedics/rehabilitation, and palliative care. Consensus was achieved on several topics related to common medical problems in spinal muscular atrophy, diagnostic strategies, recommendations for assessment and monitoring, and therapeutic interventions in each care area. A consensus statement was drafted to address the 5 care areas according to 3 functional levels of the patients: nonsitter, sitter, and walker. The committee also identified several medical practices lacking consensus and warranting further investigation. It is the authors' intention that this document be used as a guideline, not as a practice standard for their care. A practice standard for spinal muscular atrophy is urgently needed to help with the multidisciplinary care of these patients.

Diagnosis and management of Neuromyelitis Optica Spectrum Disorder (NMOSD) in Iran: A consensus guideline and recommendations.

PubMed

Sahraian, Mohammad Ali; Moghadasi, Abdorreza Naser; Azimi, Amir Reza; Asgari, Nasrin; H Akhoundi, Fahimeh; Abolfazli, Roya; Alaie, Shekoofeh; Ashtari, Fereshteh; Ayromlou, Hormoz; Baghbanian, Seyed Mohammad; Moghadam, Nahid Beladi; Fatehi, Farzad; Foroughipour, Mohsen; Langroodi, Hamidreza Ghalyanchi; Majdinasab, Nastaran; Nickseresht, Alireza; Nourian, Abbas; Shaygannejad, Vahid; Torabi, Hamid Reza

2017-11-01

Neuromyelitis Optica Spectrum Disorder (NMOSD) is a relapsing neuro inflammatory disease of the central nervous system that typically presents with optic neuritis or myelitis and may cause severe disability. The diagnostic criteria have been updated and several immunosuppressive agents have been demonstrated to prevent acute exacerbations. As the disease rarely develops in a progressive course, management of acute attacks and proper prevention of exacerbations may change the long term out-come and prevent future disability. Consensus recommendations and guidelines will help the physicians to improve their practice and unify the treatment approaches in different communities. In order to develop a national consensus and recommendations for the diagnosis and management of NMOSD in Iran, a group of neurologists with long term experience in management of NMOSD were gathered to develop this consensus based on available national and international data. The primary draft was prepared and discussed to suggest the most appropriate treatment for these patients. We propose strategies for early diagnosis and treatment for prevention of relapses and minimizing consequences of attacks as a primary therapeutic goal. Attacks are currently treated with intravenous corticosteroids and, in refractory cases, with plasma exchange. All participants agreed on preventive treatment with currently available immunosuppressive agents such as azothioprin, rituximab and mycofenolate mofetil based on previous positive data in NMOSD in order to reduce attack frequency. The current consensus reviews the previous data and provides the clinicians with practical recommendations and advices for the diagnosis and management of NMOSD based on scientific data and clinical experience. Copyright © 2017 Elsevier B.V. All rights reserved.

78 FR 2394 - Release of Draft Document Related to the Review of the National Ambient Air Quality Standards for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

... technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your... docket number and other identifying information (subject heading, Federal Register date and page number... information presented in the third draft Integrated Science Assessment for Lead \\2\\ and health and ecological...

77 FR 12579 - Notification of a Public Meeting of the Chartered Science Advisory Board

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... the Chartered SAB to conduct quality reviews of a draft report on the President's requested FY 2013 budget for EPA research and a draft report on science integration at EPA; to plan for a joint meeting of... receive a briefing on ORD and sustainability science; and to discuss the scientific and technical bases...

76 FR 54227 - Draft Toxicological Review of n-Butanol: In Support of Summary Information on the Integrated Risk...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

... found in the environment. Through the IRIS Program, EPA provides the highest quality science-based human... for the external review draft human health assessment titled, ``Toxicological Review of n-Butanol: In... will need audio-visual equipment (e.g., laptop computer and slide projector). In general, each...

76 FR 62087 - Draft Conservation Plan and Draft Environmental Assessment; Dunes Sagebrush Lizard, Texas

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-06

... known as the sand dune lizard, and the lesser prairie-chicken, among the Service, the Bureau of Land... southeastern New Mexico and west Texas. The species only occurs in sand dune complexes associated with shinnery... direct, indirect, and cumulative impacts of the TCP on the quality of the human environment and other...

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...

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

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015 Treatment Recommendations for Psoriatic Arthritis.

PubMed

Coates, Laura C; Kavanaugh, Arthur; Mease, Philip J; Soriano, Enrique R; Laura Acosta-Felquer, Maria; Armstrong, April W; Bautista-Molano, Wilson; Boehncke, Wolf-Henning; Campbell, Willemina; Cauli, Alberto; Espinoza, Luis R; FitzGerald, Oliver; Gladman, Dafna D; Gottlieb, Alice; Helliwell, Philip S; Husni, M Elaine; Love, Thorvardur J; Lubrano, Ennio; McHugh, Neil; Nash, Peter; Ogdie, Alexis; Orbai, Ana-Maria; Parkinson, Andrew; O'Sullivan, Denis; Rosen, Cheryl F; Schwartzman, Sergio; Siegel, Evan L; Toloza, Sergio; Tuong, William; Ritchlin, Christopher T

2016-05-01

To update the 2009 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations for the spectrum of manifestations affecting patients with psoriatic arthritis (PsA). GRAPPA rheumatologists, dermatologists, and PsA patients drafted overarching principles for the management of PsA, based on consensus achieved at face-to-face meetings and via online surveys. We conducted literature reviews regarding treatment for the key domains of PsA (arthritis, spondylitis, enthesitis, dactylitis, skin disease, and nail disease) and convened a new group to identify pertinent comorbidities and their effect on treatment. Finally, we drafted treatment recommendations for each of the clinical manifestations and assessed the level of agreement for the overarching principles and treatment recommendations among GRAPPA members, using an online questionnaire. Six overarching principles had ≥80% agreement among both health care professionals (n = 135) and patient research partners (n = 10). We developed treatment recommendations and a schema incorporating these principles for arthritis, spondylitis, enthesitis, dactylitis, skin disease, nail disease, and comorbidities in the setting of PsA, using the Grading of Recommendations, Assessment, Development and Evaluation process. Agreement of >80% was reached for approval of the individual recommendations and the overall schema. We present overarching principles and updated treatment recommendations for the key manifestations of PsA, including related comorbidities, based on a literature review and consensus of GRAPPA members (rheumatologists, dermatologists, other health care providers, and patient research partners). Further updates are anticipated as the therapeutic landscape in PsA evolves. © 2016, American College of Rheumatology.

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.

The Canadian Rheumatology Association/ Spondyloarthritis Research Consortium of Canada treatment recommendations for the management of spondyloarthritis: a national multidisciplinary stakeholder project.

PubMed

Maksymowych, Walter P; Gladman, Dafna; Rahman, Proton; Boonen, Annelies; Bykerk, Vivien; Choquette, Denis; Dimond, Sherry; Fortin, Paul; Karsh, Jacob; Klinkhoff, Alice V; Mosher, Dianne; Mulholland, Ken; Olszynski, Wojciech P; Russell, Anthony S; Savage, Laurie; Shanner, Laura; Shojania, Kam; Starr, Michael; Thomson, Glen; Zummer, Michel; Inman, Robert

2007-11-01

Development of treatment recommendations for arthritis has traditionally relied on the compilation of evidence-based data by experts in the field despite recommendations by various bodies for broad stakeholder input. Our objectives were: (1) To develop evidence-based treatment recommendations for the management of spondyloarthritis (SpA) in Canada that also incorporate the perspective of multiple stakeholders. (2) To generate a procedural template for the multidisciplinary development of treatment recommendations. The process was directed by a steering committee comprising the SPARCC Executive, rheumatologists from academic and community-based practice, patient consumers, and a representative from the John Dossetor Health Ethics Centre. Guidelines established by EULAR and stipulated in the AGREE instrument were followed. First, a working document was drafted that included a referenced summary of the evidence-based data and the 12 national arthritis care standards developed by the Alliance for the Canadian Arthritis Program. Second, a Web-based survey was conducted among patient consumers to address the relevance to patients of 2 primary outcome instruments that assess the effectiveness of treatment. Third, a list of questions was generated for drafting propositions by the ethics consultant. A Delphi consensus exercise was then conducted. Consensus was generated on a final list of 38 treatment recommendations categorized under the subject headings of general management principles, ethical considerations, target groups, definition of target disease, disease monitoring, and specific management recommendations. Using broad stakeholder input, we provide treatment recommendations to guide clinical practice and access to care for patients with SpA in Canada.

UK quantitative WB-DWI technical workgroup: consensus meeting recommendations on optimisation, quality control, processing and analysis of quantitative whole-body diffusion-weighted imaging for cancer.

PubMed

Barnes, Anna; Alonzi, Roberto; Blackledge, Matthew; Charles-Edwards, Geoff; Collins, David J; Cook, Gary; Coutts, Glynn; Goh, Vicky; Graves, Martin; Kelly, Charles; Koh, Dow-Mu; McCallum, Hazel; Miquel, Marc E; O'Connor, James; Padhani, Anwar; Pearson, Rachel; Priest, Andrew; Rockall, Andrea; Stirling, James; Taylor, Stuart; Tunariu, Nina; van der Meulen, Jan; Walls, Darren; Winfield, Jessica; Punwani, Shonit

2018-01-01

Application of whole body diffusion-weighted MRI (WB-DWI) for oncology are rapidly increasing within both research and routine clinical domains. However, WB-DWI as a quantitative imaging biomarker (QIB) has significantly slower adoption. To date, challenges relating to accuracy and reproducibility, essential criteria for a good QIB, have limited widespread clinical translation. In recognition, a UK workgroup was established in 2016 to provide technical consensus guidelines (to maximise accuracy and reproducibility of WB-MRI QIBs) and accelerate the clinical translation of quantitative WB-DWI applications for oncology. A panel of experts convened from cancer centres around the UK with subspecialty expertise in quantitative imaging and/or the use of WB-MRI with DWI. A formal consensus method was used to obtain consensus agreement regarding best practice. Questions were asked about the appropriateness or otherwise on scanner hardware and software, sequence optimisation, acquisition protocols, reporting, and ongoing quality control programs to monitor precision and accuracy and agreement on quality control. The consensus panel was able to reach consensus on 73% (255/351) items and based on consensus areas made recommendations to maximise accuracy and reproducibly of quantitative WB-DWI studies performed at 1.5T. The panel were unable to reach consensus on the majority of items related to quantitative WB-DWI performed at 3T. This UK Quantitative WB-DWI Technical Workgroup consensus provides guidance on maximising accuracy and reproducibly of quantitative WB-DWI for oncology. The consensus guidance can be used by researchers and clinicians to harmonise WB-DWI protocols which will accelerate clinical translation of WB-DWI-derived QIBs.

[How to establish a good acupuncture-moxibustion standard?].

PubMed

Wu, Xiao-dong; Xiao, Hui

2014-10-01

At the beginning of a standard item, the standardized objects and involved contents should be demonstrated thoroughly, which is the precondition of establishing a good standard. After the proposal of this standard, a high-level drafting group should be built, led by top specialists who also draft the standard, which is essential to guarantee the quality of the standard. Before drafting the standard, literature regarding this standard should be searched completely, and Directives for Standardization should be learned to understand the basic requirements of establishing a standard; in the meanwhile, selections on standardized contents and quantitative boundaries of technical indices should be comprehensively and deeply studied. At the stage of consultation, focus should be paid on the scope of the consultation departments, level and personnel quality. As for standard review, it should be precise and truth-seeking. At the stage of submitting and authorization, it is necessary to have timely communication. Only by full cooperations of all parties, and by strictly following the procedure, method and rule of standard establishment, can a high-quality acupuncture-moxibustion standard be established.

Association of Postoperative Readmissions With Surgical Quality Using a Delphi Consensus Process to Identify Relevant Diagnosis Codes.

PubMed

Mull, Hillary J; Graham, Laura A; Morris, Melanie S; Rosen, Amy K; Richman, Joshua S; Whittle, Jeffery; Burns, Edith; Wagner, Todd H; Copeland, Laurel A; Wahl, Tyler; Jones, Caroline; Hollis, Robert H; Itani, Kamal M F; Hawn, Mary T

2018-04-18

Postoperative readmission data are used to measure hospital performance, yet the extent to which these readmissions reflect surgical quality is unknown. To establish expert consensus on whether reasons for postoperative readmission are associated with the quality of surgery in the index admission. In a modified Delphi process, a panel of 14 experts in medical and surgical readmissions comprising physicians and nonphysicians from Veterans Affairs (VA) and private-sector institutions reviewed 30-day postoperative readmissions from fiscal years 2008 through 2014 associated with inpatient surgical procedures performed at a VA medical center between October 1, 2007, and September 30, 2014. The consensus process was conducted from January through May 2017. Reasons for readmission were grouped into categories based on International Classification of Diseases, Ninth Revision (ICD-9) diagnosis codes. Panelists were given the proportion of readmissions coded by each reason and median (interquartile range) days to readmission. They answered the question, "Does the readmission reason reflect possible surgical quality of care problems in the index admission?" on a scale of 1 (never related) to 5 (directly related) in 3 rounds of consensus building. The consensus process was completed in May 2017 and data were analyzed in June 2017. Consensus on proportion of ICD-9-coded readmission reasons that reflected quality of surgical procedure. In 3 Delphi rounds, the 14 panelists achieved consensus on 50 reasons for readmission; 12 panelists also completed group telephone calls between rounds 1 and 2. Readmissions with diagnoses of infection, sepsis, pneumonia, hemorrhage/hematoma, anemia, ostomy complications, acute renal failure, fluid/electrolyte disorders, or venous thromboembolism were considered associated with surgical quality and accounted for 25 521 of 39 664 readmissions (64% of readmissions; 7.5% of 340 858 index surgical procedures). The proportion of readmissions considered to be not associated with surgical quality varied by procedure, ranging from to 21% (613 of 2331) of readmissions after lower-extremity amputations to 47% (745 of 1598) of readmissions after cholecystectomy. One-third of postoperative readmissions are unlikely to reflect problems with surgical quality. Future studies should test whether restricting readmissions to those with specific ICD-9 codes might yield a more useful quality measure.

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.

Pesticide applicators questionnaire content validation: A fuzzy delphi method.

PubMed

Manakandan, S K; Rosnah, I; Mohd Ridhuan, J; Priya, R

2017-08-01

The most crucial step in forming a set of survey questionnaire is deciding the appropriate items in a construct. Retaining irrelevant items and removing important items will certainly mislead the direction of a particular study. This article demonstrates Fuzzy Delphi method as one of the scientific analysis technique to consolidate consensus agreement within a panel of experts pertaining to each item's appropriateness. This method reduces the ambiguity, diversity, and discrepancy of the opinions among the experts hence enhances the quality of the selected items. The main purpose of this study was to obtain experts' consensus on the suitability of the preselected items on the questionnaire. The panel consists of sixteen experts from the Occupational and Environmental Health Unit of Ministry of Health, Vector-borne Disease Control Unit of Ministry of Health and Occupational and Safety Health Unit of both public and private universities. A set of questionnaires related to noise and chemical exposure were compiled based on the literature search. There was a total of six constructs with 60 items in which three constructs for knowledge, attitude, and practice of noise exposure and three constructs for knowledge, attitude, and practice of chemical exposure. The validation process replicated recent Fuzzy Delphi method that using a concept of Triangular Fuzzy Numbers and Defuzzification process. A 100% response rate was obtained from all the sixteen experts with an average Likert scoring of four to five. Post FDM analysis, the first prerequisite was fulfilled with a threshold value (d) ≤ 0.2, hence all the six constructs were accepted. For the second prerequisite, three items (21%) from noise-attitude construct and four items (40%) from chemical-practice construct had expert consensus lesser than 75%, which giving rise to about 12% from the total items in the questionnaire. The third prerequisite was used to rank the items within the constructs by calculating the average fuzzy numbers. The seven items which did not fulfill the second prerequisite similarly had lower ranks during the analysis, therefore those items were discarded from the final draft. Post FDM analysis, the experts' consensus on the suitability of the pre-selected items on the questionnaire set were obtained, hence it is now ready for further construct validation process.

NIH state-of-the-science conference statement: Enhancing use and quality of colorectal cancer screening.

PubMed

Steinwachs, Donald; Allen, Jennifer Dacey; Barlow, William Eric; Duncan, R Paul; Egede, Leonard E; Friedman, Lawrence S; Keating, Nancy L; Kim, Paula; Lave, Judith R; LaVeist, Thomas A; Ness, Roberta B; Optican, Robert J; Virnig, Beth A

2010-02-04

To provide health care providers, patients, and the general public with a responsible assessment of currently available data on enhancing use and quality of colorectal cancer screening. A non-DHHS, nonadvocate 13-member panel representing the fields of cancer surveillance, health services research, community-based research, informed decision-making, access to care, health care policy, health communication, health economics, health disparities, epidemiology, statistics, thoracic radiology, internal medicine, gastroenterology, public health, end-of-life care, and a public representative. In addition, 20 experts from pertinent fields presented data to the panel and conference audience. Presentations by experts and a systematic review of the literature prepared by the RTI International-University of North Carolina Evidence-based Practice Center, through the Agency for Healthcare Research and Quality. Scientific evidence was given precedence over anecdotal experience. The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was presented on the final day of the conference and circulated to the audience for comment. The panel released a revised statement later that day at http://consensus.nih.gov. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government. The panel found that despite substantial progress toward higher colorectal cancer screening rates nationally, screening rates fall short of desirable levels. Targeted initiatives to improve screening rates and reduce disparities in underscreened communities and population subgroups could further reduce colorectal cancer morbidity and mortality. This could be achieved by utilizing the full range of screening options and evidence-based interventions for increasing screening rates. With additional investments in quality monitoring, Americans could be assured that all screening achieves high rates of cancer prevention and early detection. To close the gap in screening, this report identifies the following priority areas for implementation and research to enhance the use and quality of colorectal cancer screening: • Eliminate financial barriers to colorectal cancer screening and appropriate follow up. • Widely implement interventions that have proven effective at increasing colorectal cancer screening, including patient reminder systems and one-on-one interactions with providers, educators, or navigators. • Conduct research to assess the effectiveness of tailoring programs to match the characteristics and preferences of target population groups to increase colorectal cancer screening. • Implement systems to ensure appropriate follow-up of positive colorectal cancer screening results. • Develop systems to assure high quality of colorectal cancer screening programs. • Conduct studies to determine the comparative effectiveness of the various colorectal cancer screening methods in usual practice settings.

High-quality permanent draft genome sequence of the Parapiptadenia rigida-nodulating Cupriavidus sp. strain UYPR2.512

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

De Meyer, Sofie E.; Fabiano, Elena; Tian, Rui

Cupriavidus sp. strain UYPR2.512 is an aerobic, motile, Gram-negative, non-spore-forming rod that was isolated from a root nodule of Parapiptadenia rigida grown in soils from a native forest of Uruguay. Here we describe the features of Cupriavidus sp. strain UYPR2.512, together with sequence and annotation. We find the 7,858,949 bp high-quality permanent draft genome is arranged in 365 scaffolds of 369 contigs, contains 7,411 protein-coding genes and 76 RNA-only encoding genes, and is part of the GEBA-RNB project proposal.

High-quality permanent draft genome sequence of the Parapiptadenia rigida-nodulating Cupriavidus sp. strain UYPR2.512

DOE PAGES

De Meyer, Sofie E.; Fabiano, Elena; Tian, Rui; ...

2015-04-11

Cupriavidus sp. strain UYPR2.512 is an aerobic, motile, Gram-negative, non-spore-forming rod that was isolated from a root nodule of Parapiptadenia rigida grown in soils from a native forest of Uruguay. Here we describe the features of Cupriavidus sp. strain UYPR2.512, together with sequence and annotation. We find the 7,858,949 bp high-quality permanent draft genome is arranged in 365 scaffolds of 369 contigs, contains 7,411 protein-coding genes and 76 RNA-only encoding genes, and is part of the GEBA-RNB project proposal.

The draft genome of whitefly Bemisia tabaci MEAM1, a global crop pest, provides novel insights into virus transmission, host adaptation, and insecticide resistance

USDA-ARS?s Scientific Manuscript database

Whiteflies are among the most important agricultural pests. They have a broad range of host plants and exceptional ability to transmit a large number of plant viruses, and can rapidly evolve insecticide resistance. Here we present a high-quality draft genome of the whitefly, Bemisia tabaci. Comparat...

76 FR 57751 - Notice of Availability of a Draft Programmatic Environmental Impact Statement for Northern Border...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-16

... particular place. Because this effort is programmatic in nature, the Draft PEIS does not define effects for a... the purposes of the PEIS, the Northern Border is defined as the area between the United States and... environmental quality and the government's role in protecting it. The essence of NEPA is the requirement that...

76 FR 30149 - Science Advisory Board Staff Office Notification of a Public Teleconference of the Chartered...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

... of ballast water treatment systems; A Report by the EPA Science Advisory Board (May 2011 Draft... Board can be found on the EPA Web site at http://www.epa.gov/sab . SUPPLEMENTARY INFORMATION: The SAB... quality review of a draft report entitled Efficacy of ballast water treatment systems; a report by the EPA...

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 ...

Concept of Draft International Standard for a Unified Approach to Space Program Quality Assurance

NASA Astrophysics Data System (ADS)

Stryzhak, Y.; Vasilina, V.; Kurbatov, V.

2002-01-01

For want of the unified approach to guaranteed space project and product quality assurance, implementation of many international space programs has become a challenge. Globalization of aerospace industry and participation of various international ventures with diverse quality assurance requirements in big international space programs requires for urgent generation of unified international standards related to this field. To ensure successful fulfillment of space missions, aerospace companies should design and process reliable and safe products with properties complying or bettering User's (or Customer's) requirements. Quality of the products designed or processed by subcontractors (or other suppliers) should also be in compliance with the main user (customer)'s requirements. Implementation of this involved set of unified requirements will be made possible by creating and approving a system (series) of international standards under a generic title Space Product Quality Assurance based on a system consensus principle. Conceptual features of the baseline standard in this system (series) should comprise: - Procedures for ISO 9000, CEN and ECSS requirements adaptation and introduction into space product creation, design, manufacture, testing and operation; - Procedures for quality assurance at initial (design) phases of space programs, with a decision on the end product made based on the principle of independence; - Procedures to arrange incoming inspection of products delivered by subcontractors (including testing, audit of supplier's procedures, review of supplier's documentation), and space product certification; - Procedures to identify materials and primary products applied; - Procedures for quality system audit at the component part, primary product and materials supplier facilities; - Unified procedures to form a list of basic performances to be under configuration management; - Unified procedures to form a list of critical space product components, and unified procedures to define risks related to the specific component application and evaluate safety for the entire program implementation. In the eyes of the authors, those features together with a number of other conceptual proposals should constitute a unified standard-technical basis for implementing international space programs.

77 FR 1913 - Notice of Meeting of the Agricultural Air Quality Task Force

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-12

... Conservation Service Notice of Meeting of the Agricultural Air Quality Task Force AGENCY: Natural Resources...), Agricultural Air Quality Task Force (AAQTF) will meet to continue discussions on critical air quality issues... relationship between agricultural production and air quality. The meeting is open to the public, and a draft...

Canadian Association of Gastroenterology consensus guidelines on safety and quality indicators in endoscopy

PubMed Central

Armstrong, David; Barkun, Alan; Bridges, Ron; Carter, Rose; de Gara, Chris; Dubé, Catherine; Enns, Robert; Hollingworth, Roger; MacIntosh, Donald; Borgaonkar, Mark; Forget, Sylviane; Leontiadis, Grigorios; Meddings, Jonathan; Cotton, Peter; Kuipers, Ernst J; Valori, Roland

2012-01-01

BACKGROUND: Increasing use of gastrointestinal endoscopy, particularly for colorectal cancer screening, and increasing emphasis on health care quality, highlight the need for clearly defined, evidence-based processes to support quality improvement in endoscopy. OBJECTIVE: To identify processes and indicators of quality and safety relevant to high-quality endoscopy service delivery. METHODS: A multidisciplinary group of 35 voting participants developed recommendation statements and performance indicators. Systematic literature searches generated 50 initial statements that were revised iteratively following a modified Delphi approach using a web-based evaluation and voting tool. Statement development and evidence evaluation followed the AGREE (Appraisal of Guidelines, REsearch and Evaluation) and GRADE (Grading of Recommendations, Assessment, Development and Evaluation) guidelines. At the consensus conference, participants voted anonymously on all statements using a 6-point scale. Subsequent web-based voting evaluated recommendations for specific, individual quality indicators, safety indicators and mandatory endoscopy reporting fields. Consensus was defined a priori as agreement by 80% of participants. RESULTS: Consensus was reached on 23 recommendation statements addressing the following: ethics (statement 1: agreement 100%), facility standards and policies (statements 2 to 9: 90% to 100%), quality assurance (statements 10 to 13: 94% to 100%), training, education, competency and privileges (statements 14 to 19: 97% to 100%), endoscopy reporting standards (statements 20 and 21: 97% to 100%) and patient perceptions (statements 22 and 23: 100%). Additionally, 18 quality indicators (agreement 83% to 100%), 20 safety indicators (agreement 77% to 100%) and 23 recommended endoscopy-reporting elements (agreement 91% to 100%) were identified. DISCUSSION: The consensus process identified a clear need for high-quality clinical and outcomes research to support quality improvement in the delivery of endoscopy services. CONCLUSIONS: The guidelines support quality improvement in endoscopy by providing explicit recommendations on systematic monitoring, assessment and modification of endoscopy service delivery to yield benefits for all patients affected by the practice of gastrointestinal endoscopy. PMID:22308578

AIR QUALITY CRITERIA CARBON MONOXIDE, EXTERNAL REVIEW DRAFT

EPA Science Inventory

The U.S. Environmental Protection Agency (EPA) promulgates the National Ambient Air Quality Standards (NAAQS) on the basis of scientific information contained in criteria documents. The last air quality criteria document for carbon monoxide (CO) was completed by EPA in 1991. This...

Hemorrhagic fever viruses as biological weapons: medical and public health management.

PubMed

Borio, Luciana; Inglesby, Thomas; Peters, C J; Schmaljohn, Alan L; Hughes, James M; Jahrling, Peter B; Ksiazek, Thomas; Johnson, Karl M; Meyerhoff, Andrea; O'Toole, Tara; Ascher, Michael S; Bartlett, John; Breman, Joel G; Eitzen, Edward M; Hamburg, Margaret; Hauer, Jerry; Henderson, D A; Johnson, Richard T; Kwik, Gigi; Layton, Marci; Lillibridge, Scott; Nabel, Gary J; Osterholm, Michael T; Perl, Trish M; Russell, Philip; Tonat, Kevin

2002-05-08

To develop consensus-based recommendations for measures to be taken by medical and public health professionals if hemorrhagic fever viruses (HFVs) are used as biological weapons against a civilian population. The Working Group on Civilian Biodefense included 26 representatives from academic medical centers, public health, military services, governmental agencies, and other emergency management institutions. MEDLINE was searched from January 1966 to January 2002. Retrieved references, relevant material published prior to 1966, and additional sources identified by participants were reviewed. Three formal drafts of the statement that synthesized information obtained in the evidence-gathering process were reviewed by the working group. Each draft incorporated comments and judgments of the members. All members approved the final draft. Weapons disseminating a number of HFVs could cause an outbreak of an undifferentiated febrile illness 2 to 21 days later, associated with clinical manifestations that could include rash, hemorrhagic diathesis, and shock. The mode of transmission and clinical course would vary depending on the specific pathogen. Diagnosis may be delayed given clinicians' unfamiliarity with these diseases, heterogeneous clinical presentation within an infected cohort, and lack of widely available diagnostic tests. Initiation of ribavirin therapy in the early phases of illness may be useful in treatment of some of these viruses, although extensive experience is lacking. There are no licensed vaccines to treat the diseases caused by HFVs.

MBGD update 2015: microbial genome database for flexible ortholog analysis utilizing a diverse set of genomic data.

PubMed

Uchiyama, Ikuo; Mihara, Motohiro; Nishide, Hiroyo; Chiba, Hirokazu

2015-01-01

The microbial genome database for comparative analysis (MBGD) (available at http://mbgd.genome.ad.jp/) is a comprehensive ortholog database for flexible comparative analysis of microbial genomes, where the users are allowed to create an ortholog table among any specified set of organisms. Because of the rapid increase in microbial genome data owing to the next-generation sequencing technology, it becomes increasingly challenging to maintain high-quality orthology relationships while allowing the users to incorporate the latest genomic data available into an analysis. Because many of the recently accumulating genomic data are draft genome sequences for which some complete genome sequences of the same or closely related species are available, MBGD now stores draft genome data and allows the users to incorporate them into a user-specific ortholog database using the MyMBGD functionality. In this function, draft genome data are incorporated into an existing ortholog table created only from the complete genome data in an incremental manner to prevent low-quality draft data from affecting clustering results. In addition, to provide high-quality orthology relationships, the standard ortholog table containing all the representative genomes, which is first created by the rapid classification program DomClust, is now refined using DomRefine, a recently developed program for improving domain-level clustering using multiple sequence alignment information. © The Author(s) 2014. Published by Oxford University Press on behalf of Nucleic Acids Research.

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.

[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.

Beyond the false negative rate: development of quality indicators for sentinel lymph node biopsy in breast cancer.

PubMed

Quan, May Lynn; Wells, Bryan J; McCready, David; Wright, Frances C; Fraser, Novlette; Gagliardi, Anna R

2010-02-01

Sentinel lymph node biopsy (SNLB) has been adopted as the standard method of axillary staging for women with clinically node-negative early-stage breast cancer. The false negative rate as a quality indicator is impractical given the need for a completion axillary dissection to calculate. The objective of this study was to develop practical quality indicators for SLNB using an expert consensus method and to determine if they were feasible to measure. We used a modified Delphi consensus process to develop quality indicators for SLNB. A multidisciplinary expert panel reviewed potential indicators extracted from the medical literature to select quality indicators that were relevant and measurable. Feasibility was determined by abstracting the quality indicator variables from a retrospective chart review. The expert panel prioritized 11 quality indicators as benchmarks for assessing the quality of surgical care in SNLB. Nine of the indicators were measurable at the chart or institutional level. A systematic evidence- and consensus-based approach was used to develop measurable quality indicators that could be used by practicing surgeons and administrators to evaluate performance of SLNB in breast cancer.

Keeping granny safe on July 1: a consensus on minimum geriatrics competencies for graduating medical students.

PubMed

Leipzig, Rosanne M; Granville, Lisa; Simpson, Deborah; Anderson, M Brownell; Sauvigné, Karen; Soriano, Rainier P

2009-05-01

Competency-based education prepares trainees to perform tasks occurring within the context of practice. There are currently no geriatrics-specific, competency-based consensus performance standards for medical students.The authors present the results of a systematic, multimethod process to identify and define the minimum geriatrics-specific competencies needed by a new intern to adequately care for older adults. An alpha draft was crafted by geriatricians, identifying measurable performance subtasks associated with accepted standards of evidence-based geriatric care, patient safety, and "do no harm" within the first-year resident's expected scope of practice. The competencies were then assessed for content validity by key stakeholders and informants. Of the 315 respondents, 26% were geriatricians, 21% family physicians, 24% general internists, 6% neurology program directors, 14% surgery program directors, and 9% other. Twenty-four were decanal appointees. Faculty from almost half (44%) of U.S. medical schools and representatives of several major medical education organizations were present at the working conference.The final document consists of 26 competencies nested within eight content domains: Medication Management; Self-Care Capacity; Falls, Balance and Gait Disorders; Hospital Care for Elders; Cognitive and Behavioral Disorders; Atypical Presentation of Disease; Health Care Planning and Promotion; and Palliative Care.Setting minimum geriatric competency standards establishes the performance benchmarks for medical school graduates who as first-year residents will care for geriatric patients. Only half-facetiously, they are referred to as the "Don't Kill Granny" competencies. Achievement of these minimum competencies by medical students, grounded in evidence-based principles of quality care for older adults, will assure that, each year, older patients are in safer hands on July 1.

Diagnosis and Treatment of Polycystic Ovary Syndrome: An Endocrine Society Clinical Practice Guideline

PubMed Central

Legro, Richard S.; Arslanian, Silva A.; Ehrmann, David A.; Hoeger, Kathleen M.; Murad, M. Hassan; Pasquali, Renato; Welt, Corrine K.

2013-01-01

Objective: The aim was to formulate practice guidelines for the diagnosis and treatment of polycystic ovary syndrome (PCOS). Participants: An Endocrine Society-appointed Task Force of experts, a methodologist, and a medical writer developed the guideline. Evidence: 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. Consensus Process: 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 and commented on preliminary drafts of these guidelines. Two systematic reviews were conducted to summarize supporting evidence. Conclusions: We suggest using the Rotterdam criteria for diagnosing PCOS (presence of two of the following criteria: androgen excess, ovulatory dysfunction, or polycystic ovaries). Establishing a diagnosis of PCOS is problematic in adolescents and menopausal women. Hyperandrogenism is central to the presentation in adolescents, whereas there is no consistent phenotype in postmenopausal women. Evaluation of women with PCOS should exclude alternate androgen-excess disorders and risk factors for endometrial cancer, mood disorders, obstructive sleep apnea, diabetes, and cardiovascular disease. Hormonal contraceptives are the first-line management for menstrual abnormalities and hirsutism/acne in PCOS. Clomiphene is currently the first-line therapy for infertility; metformin is beneficial for metabolic/glycemic abnormalities and for improving menstrual irregularities, but it has limited or no benefit in treating hirsutism, acne, or infertility. Hormonal contraceptives and metformin are the treatment options in adolescents with PCOS. The role of weight loss in improving PCOS status per se is uncertain, but lifestyle intervention is beneficial in overweight/obese patients for other health benefits. Thiazolidinediones have an unfavorable risk-benefit ratio overall, and statins require further study. PMID:24151290

Family Medicine Maternity Care Call to Action: Moving Toward National Standards for Training and Competency Assessment.

PubMed

Magee, Susanna R; Eidson-Ton, W Suzanne; Leeman, Larry; Tuggy, Michael; Kim, Thomas O; Nothnagle, Melissa; Breuner, Joseph; Loafman, Mark

2017-03-01

Maternity care is an integral part of family medicine, and the quality and cost-effectiveness of maternity care provided by family physicians is well documented. Considering the population health perspective, increasing the number of family physicians competent to provide maternity care is imperative, as is working to overcome the barriers discouraging maternity care practice. A standard that clearly defines maternity care competency and a systematic set of tools to assess competency levels could help overcome these barriers. National discussions between 2012 and 2014 revealed that tools for competency assessment varied widely. These discussions resulted in the formation of a workgroup, culminating in a Family Medicine Maternity Care Summit in October 2014. This summit allowed for expert consensus to describe three scopes of maternity practice, draft procedural and competency assessment tools for each scope, and then revise the tools, guided by the Family Medicine and OB/GYN Milestones documents from the respective residency review committees. The summit group proposed that achievement of a specified number of procedures completed should not determine competency; instead, a standardized competency assessment should take place after a minimum number is performed. The traditionally held required numbers for core procedures were reassessed at the summit, and the resulting consensus opinion is proposed here. Several ways in which these evaluation tools can be disseminated and refined through the creation of a learning collaborative across residency programs is described. The summit group believed that standardization in training will more clearly define the competencies of family medicine maternity care providers and begin to reduce one of the barriers that may discourage family physicians from providing maternity care.

A decision-making tool to prescribe knee orthoses in daily practice for patients with osteoarthritis.

PubMed

Coudeyre, Emmanuel; Nguyen, Christelle; Chabaud, Aurore; Pereira, Bruno; Beaudreuil, Johann; Coudreuse, Jean-Marie; Deat, Philippe; Sailhan, Frédéric; Lorenzo, Alain; Rannou, François

2018-03-01

To develop a decision-making tool (DMT) to facilitate the prescription of knee orthoses for patients with osteoarthritis (OA) in daily practice. A steering committee gathered a multidisciplinary task force experienced in OA management/clinical research. Two members performed a literature review with qualitative analysis of the highest-quality randomized controlled trials and practice guidelines to confirm evidence concerning knee orthosis for OA. A first DMT draft was presented to the task force in a 1-day meeting in January 2016. The first version of the DMT was criticized and discussed regarding everyday practice issues. Every step was discussed and amended until consensus agreement was achieved within the task force. Then 4 successive consultation rounds occurred by electronic communication, first with primary- and secondary-care physicians, then with international experts. All corrections and suggestions by each member were shared with the rest of the task force and included to reach final consensus. The final version was validated by the steering committee. The definition and indication of several types of knee orthoses (sleeve, patello-femoral, hinged or unicompartmental offloading braces) were detailed. Orthoses may be proposed in addition to first-line non-pharmacological treatment if patient acceptance is considered good. At every step, a specific clinical assessment is needed. Based on the latest high-level evidence, practice guidelines, and an expert panel, a DMT to facilitate daily practice prescription of knee orthoses for OA patients was designed. An evaluation of DMT implementation in a wide range of health professionals is still needed. Copyright © 2018 The Author(s). Published by Elsevier Masson SAS.. All rights reserved.

[Homozygous familial hypercholesterolaemia: Spanish adaptation of the position paper from the Consensus Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society. Consensus document of the Spanish Society of Arteriosclerosis (SEA) and Familial Hypercholesterolaemia Foundation (FHF)].

PubMed

Ascaso, Juan F; Mata, Pedro; Arbona, Cristina; Civeira, Fernando; Valdivielso, Pedro; Masana, Luis

2015-01-01

Homozygous familial hypercholesterolaemia (HoFH) is a rare life-threatening disease characterized by markedly elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease (ACVD). The Consensus Panel on Familial Hypercholesterolaemia of the European Atherosclerosis Society (EAS) has recently published a clinical guide to diagnose and manage HoFH (Eur Heart J. 2014;35:2146-57). Both the Spanish Society of Atherosclerosis (SEA) and Familial Hypercholesterolaemia Foundation (FHF) consider this European Consensus document of great value and utility. However, there are particularities in our country which advise to have a Spanish adaptation of the European HoFH document in order to approximate this clinical guide to our environment. In Spain, chronic treatment with statins, ezetimibe and resins (colesevelam) has a reduced contribution in the National Health System (NHS) and is one of the few European countries where LDL apheresis is included in the Basic Service Portfolio coverage. This Spanish document also includes clinical experience in the management of these patients in our country. The Drafting Committee emphasizes the need for early identification of HoFH patients, prompt referral to specialized units, and an early and appropriate treatment. These recommendations will provide a guidance for HoFH patient management in Spain. Copyright © 2015 Sociedad Española de Arteriosclerosis. Published by Elsevier España. All rights reserved.

[Health councils, intergovernmental commissions, and interest groups in the Unified Health System

PubMed

Ribeiro

1997-01-01

Health councils have developed in Brazil in keeping with arrangements under the 1988 Constitution, and the logic of their political consensus has expanded among interest groups relevant to public policy. Collegiate bodies, such as intergovernmental commissions, represent an extension of that logic to executive relationships and also express political intermediation by expertise, following the tradition of the European Welfare State. The state technical bureaucracy has thus developed a remarkable role in policy-making and in State-level modeling of interest groups. This article argues that such collegiate bodies should be analyzed through State action and defines two models for health councils. One, the vocal political model, is characterized by a prevalence of outspoken denunciation and an overload of demands on the political agenda. The other, the consensus model, expresses self-limitation amongst interest groups in drafting demands. These models are not hierarchically fixed and are usually linked to the political platforms of interest groups participating in the collegiate bodies.

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

Consensus Conference Findings on Supragingival and Subgingival Air Polishing.

PubMed

Cobb, Charles M; Daubert, Diane M; Davis, Karen; Deming, Jodi; Flemmig, Thomas F; Pattison, Anna; Roulet, Jean-François; Stambaugh, Roger V

2017-02-01

A consensus conference was convened to evaluate and address issues of safety and efficacy when using glycine powder in an air-powder jet device for supra- and subgingival applications during dental prophylaxis and periodontal maintenance. The conference reported the following conclusions: 1) Supra- and subgingival air polishing using glycine powder is safe and effective for removal of biofilms from natural tooth structure and restorative materials; 2) there is no evidence of soft-tissue abrasion when using glycine powder in an air-polishing device; 3) in periodontal probing depths of 1 mm to 4 mm, glycine-powder air polishing, using a standard air-polishing nozzle, is more effective at removing subgingival biofilm than manual or ultrasonic instruments; and 4) at probing depths of 5 mm to 9 mm, using a subgingival nozzle, glycine powder air polishing is more effective at removing subgingival biofilm than manual or ultrasonic instrumentation. This conference statement, supported by an industry grant, was drafted by a panel of distinguished dental professionals.

High-Quality Draft Genomes from Thermus caliditerrae YIM 77777 and T. tengchongensis YIM 77401, Isolates from Tengchong, China

DOE PAGES

Mefferd, Chrisabelle C.; Zhou, En-Min; Yu, Tian-Tian; ...

2016-04-28

The draft genomes ofThermus  tengchongensisYIM 77401 andT. caliditerraeYIM 77777 are 2,562,314 and 2,218,114 bp and encode 2,726 and 2,305 predicted genes, respectively. Gene content and growth experiments demonstrate broad metabolic capacity, including starch hydrolysis, thiosulfate oxidation, arsenite oxidation, incomplete denitrification, and polysulfide reduction.

High-Quality Draft Genome Sequence of Thermocrinis jamiesonii GBS1 T Isolated from Great Boiling Spring, Nevada

DOE PAGES

Ganji, Rakesh; Murugapiran, Senthil K.; Ong, John C.; ...

2016-10-20

The draft genome of Thermocrinis jamiesonii GBS1 T is 1,315,625 bp in 10 contigs and encodes 1,463 predicted genes. The presence of sox genes and various glycoside hydrolases and the absence of uptake NiFe hydrogenases ( hyaB) are consistent with a requirement for thiosulfate and suggest the ability to use carbohydrate polymers.

Draft Genome Sequence of Telmatospirillum siberiense 26-4b1, an Acidotolerant Peatland Alphaproteobacterium Potentially Involved in Sulfur Cycling

PubMed Central

Schreck, Katharina; Herbold, Craig W.; Daims, Holger; Wagner, Michael; Loy, Alexander

2018-01-01

ABSTRACT The facultative anaerobic chemoorganoheterotrophic alphaproteobacterium Telmatospirillum siberiense 26-4b1 was isolated from a Siberian peatland. We report here a 6.20-Mbp near-complete high-quality draft genome sequence of T. siberiense that reveals expected and novel metabolic potential for the genus Telmatospirillum, including genes for sulfur oxidation. PMID:29371357

2016 Draft Estuarine/Marine Copper Aquatic Life Ambient Water Quality Criteria

EPA Pesticide Factsheets

Documents pertain to Aquatic Life Ambient Water Quality criteria for Copper (2016 Estuarine/marine). These documents contain the safe levels of Copper in water that should protect to the majority of species.

A multi-disciplinary consensus statement concerning surgical approaches to low-grade, high-grade astrocytomas and diffuse intrinsic pontine gliomas in childhood (CPN Paris 2011) using the Delphi method.

PubMed

Walker, David A; Liu, JoFen; Kieran, Mark; Jabado, Nada; Picton, Susan; Packer, Roger; St Rose, Christian

2013-04-01

Astrocytic tumors account for 42% of childhood brain tumors, arising in all anatomical regions and associated with neurofibromatosis type 1 (NF1) in 15%. Anatomical site determines the degree and risk of resectability; the more complete resection, the better the survival rates. New biological markers and modern radiotherapy techniques are altering the risk assessments of clinical decisions for tumor resection and biopsy. The increasingly distinct pediatric neuro-oncology multidisciplinary team (PNMDT) is developing a distinct evidence base. A multidisciplinary consensus conference on pediatric neurosurgery was held in February 2011, where 92 invited participants reviewed evidence for clinical management of hypothalamic chiasmatic glioma (HCLGG), diffuse intrinsic pontine glioma (DIPG), and high-grade glioma (HGG). Twenty-seven statements were drafted and subjected to online Delphi consensus voting by participants, seeking >70% agreement from >60% of respondents; where <70% consensus occurred, the statement was modified and resubmitted for voting. Twenty-seven statements meeting consensus criteria are reported. For HCLGG, statements describing overall therapeutic purpose and indications for biopsy, observation, or treatment aimed at limiting the risk of visual damage and the need for on-going clinical trials were made. Primary surgical resection was not recommended. For DIPG, biopsy was recommended to ascertain biological characteristics to enhance understanding and targeting of treatments, especially in clinical trials. For HGG, biopsy is essential, the World Health Organization classification was recommended; selection of surgical strategy to achieve gross total resection in a single or multistep process should be discussed with the PNMDT and integrated with trials based drug strategies for adjuvant therapies.

Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis

PubMed Central

Buch, Maya H; Smolen, Josef S; Betteridge, Neil; Breedveld, Ferdinand C; Burmester, Gerd; Dörner, Thomas; Ferraccioli, Gianfranco; Gottenberg, Jacques-Eric; Isaacs, John; Kvien, Tore K; Mariette, Xavier; Martin-Mola, Emilio; Pavelka, Karel; Tak, Paul P; van der Heijde, Desiree; van Vollenhoven, Ronald F; Emery, Paul

2011-01-01

Background Since initial approval for the treatment of rheumatoid arthritis (RA), rituximab has been evaluated in clinical trials involving various populations with RA. Information has also been gathered from registries. This report therefore updates the 2007 consensus document on the use of rituximab in the treatment of RA. Methods Preparation of this new document involved many international experts experienced in the treatment of RA. Following a meeting to agree upon the core agenda, a systematic literature review was undertaken to identify all relevant data. Data were then interrogated by a drafting committee, with subsequent review and discussion by a wider expert committee leading to the formulation of an updated consensus statement. These committees also included patients with RA. Results The new statement covers wide-ranging issues including the use of rituximab in earlier RA and impact on structural progression, and aspects particularly pertinent to rituximab such as co-medication, optimal dosage regimens, repeat treatment cycles and how to manage non-response. Biological therapy following rituximab usage is also addressed, and safety concerns including appropriate screening for hepatitis, immunoglobulin levels and infection risk. This consensus statement will support clinicians and inform patients when using B-cell depletion in the management of RA, providing up-to-date information and highlighting areas for further research. Conclusion New therapeutic strategies and treatment options for RA, a chronic destructive and disabling disease, have expanded over recent years. These have been summarised in general strategic suggestions and specific management recommendations, emphasising the importance of expedient disease-modifying antirheumatic drug implementation and tight disease control. This consensus statement is in line with these fundamental principles of management. PMID:21378402

QMEANclust: estimation of protein model quality by combining a composite scoring function with structural density information.

PubMed

Benkert, Pascal; Schwede, Torsten; Tosatto, Silvio Ce

2009-05-20

The selection of the most accurate protein model from a set of alternatives is a crucial step in protein structure prediction both in template-based and ab initio approaches. Scoring functions have been developed which can either return a quality estimate for a single model or derive a score from the information contained in the ensemble of models for a given sequence. Local structural features occurring more frequently in the ensemble have a greater probability of being correct. Within the context of the CASP experiment, these so called consensus methods have been shown to perform considerably better in selecting good candidate models, but tend to fail if the best models are far from the dominant structural cluster. In this paper we show that model selection can be improved if both approaches are combined by pre-filtering the models used during the calculation of the structural consensus. Our recently published QMEAN composite scoring function has been improved by including an all-atom interaction potential term. The preliminary model ranking based on the new QMEAN score is used to select a subset of reliable models against which the structural consensus score is calculated. This scoring function called QMEANclust achieves a correlation coefficient of predicted quality score and GDT_TS of 0.9 averaged over the 98 CASP7 targets and perform significantly better in selecting good models from the ensemble of server models than any other groups participating in the quality estimation category of CASP7. Both scoring functions are also benchmarked on the MOULDER test set consisting of 20 target proteins each with 300 alternatives models generated by MODELLER. QMEAN outperforms all other tested scoring functions operating on individual models, while the consensus method QMEANclust only works properly on decoy sets containing a certain fraction of near-native conformations. We also present a local version of QMEAN for the per-residue estimation of model quality (QMEANlocal) and compare it to a new local consensus-based approach. Improved model selection is obtained by using a composite scoring function operating on single models in order to enrich higher quality models which are subsequently used to calculate the structural consensus. The performance of consensus-based methods such as QMEANclust highly depends on the composition and quality of the model ensemble to be analysed. Therefore, performance estimates for consensus methods based on large meta-datasets (e.g. CASP) might overrate their applicability in more realistic modelling situations with smaller sets of models based on individual methods.

Evaluation of Tuberculosis Diagnostics in Children: 1. Proposed Clinical Case Definitions for Classification of Intrathoracic Tuberculosis Disease. Consensus From an Expert Panel

PubMed Central

Graham, Stephen M.; Ahmed, Tahmeed; Amanullah, Farhana; Browning, Renee; Cardenas, Vicky; Casenghi, Martina; Cuevas, Luis E.; Gale, Marianne; Gie, Robert P.; Grzemska, Malgosia; Handelsman, Ed; Hatherill, Mark; Hesseling, Anneke C.; Jean-Philippe, Patrick; Kampmann, Beate; Kabra, Sushil Kumar; Lienhardt, Christian; Lighter-Fisher, Jennifer; Madhi, Shabir; Makhene, Mamodikoe; Marais, Ben J.; McNeeley, David F.; Menzies, Heather; Mitchell, Charles; Modi, Surbhi; Mofenson, Lynne; Musoke, Philippa; Nachman, Sharon; Powell, Clydette; Rigaud, Mona; Rouzier, Vanessa; Starke, Jeffrey R.; Swaminathan, Soumya; Wingfield, Claire

2012-01-01

There is a critical need for improved diagnosis of tuberculosis in children, particularly in young children with intrathoracic disease as this represents the most common type of tuberculosis in children and the greatest diagnostic challenge. There is also a need for standardized clinical case definitions for the evaluation of diagnostics in prospective clinical research studies that include children in whom tuberculosis is suspected but not confirmed by culture of Mycobacterium tuberculosis. A panel representing a wide range of expertise and child tuberculosis research experience aimed to develop standardized clinical research case definitions for intrathoracic tuberculosis in children to enable harmonized evaluation of new tuberculosis diagnostic technologies in pediatric populations. Draft definitions and statements were proposed and circulated widely for feedback. An expert panel then considered each of the proposed definitions and statements relating to clinical definitions. Formal group consensus rules were established and consensus was reached for each statement. The definitions presented in this article are intended for use in clinical research to evaluate diagnostic assays and not for individual patient diagnosis or treatment decisions. A complementary article addresses methodological issues to consider for research of diagnostics in children with suspected tuberculosis. PMID:22448023

Means and ENDS - e-cigarettes, the Framework Convention on Tobacco Control, and global health diplomacy in action.

PubMed

Russell, Andrew; Wainwright, Megan; Tilson, Melodie

2018-01-01

E-cigarettes are a new and disruptive element in global health diplomacy (GHD) and policy-making. This is an ethnographic account of how e-cigarettes and other Electronic Nicotine Delivery Systems (ENDS) were tackled at the 6th Conference of the Parties to the World Health Organization's Framework Convention on Tobacco Control. It demonstrates how uncertainty about ENDS and differences of opinion are currently so great that 'agreeing to disagree' as a consensus position and 'strategic use of time' were the principles that ensured effective GHD in this case. Observers representing accredited non-governmental organisations were active in briefing and lobbying country delegates not to spend too much time debating an issue for which insufficient evidence exists, and for which countries were unlikely to reach a consensus on a specific regulatory approach or universally applicable regulatory measures. Equally, the work of Costa Rica in preparing and re-negotiating the draft decision, and the work of the relevant Committee Chair in managing the discussion, contributed to effectively reining in lengthy statements from Parties and focusing on points of consensus. As well as summarising the debate itself and analysing the issues surrounding it, this account offers an example of GHD working effectively in a situation of epistemic uncertainty.

International consensus for a definition of disease flare in lupus.

PubMed

Ruperto, N; Hanrahan, L M; Alarcón, G S; Belmont, H M; Brey, R L; Brunetta, P; Buyon, J P; Costner, M I; Cronin, M E; Dooley, M A; Filocamo, G; Fiorentino, D; Fortin, P R; Franks, A G; Gilkeson, G; Ginzler, E; Gordon, C; Grossman, J; Hahn, B; Isenberg, D A; Kalunian, K C; Petri, M; Sammaritano, L; Sánchez-Guerrero, J; Sontheimer, R D; Strand, V; Urowitz, M; von Feldt, J M; Werth, V P; Merrill, J T

2011-04-01

The Lupus Foundation of America (LFA) convened an international working group to obtain a consensus definition of disease flare in lupus. With help from the Paediatric Rheumatology International Trials Organization (PRINTO), two web-based Delphi surveys of physicians were conducted. Subsequently, the LFA held a second consensus conference followed by a third Delphi survey to reach a community-wide agreement for flare definition. Sixty-nine of the 120 (57.5%) polled physicians responded to the first survey. Fifty-nine of the responses were available to draft 12 preliminary statements, which were circulated in the second survey. Eighty-seven of 118 (74%) physicians completed the second survey, with an agreement of 70% for 9/12 (75%) statements. During the second conference, three alternative flare definitions were consolidated and sent back to the international community. One hundred and sixteen of 146 (79.5%) responded, with agreement by 71/116 (61%) for the following definition: "A flare is a measurable increase in disease activity in one or more organ systems involving new or worse clinical signs and symptoms and/or laboratory measurements. It must be considered clinically significant by the assessor and usually there would be at least consideration of a change or an increase in treatment." The LFA proposes this definition for lupus flare on the basis of its high face validity.

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

Tian, Rui; Parker, Matthew; Seshadri, Rekha

Bradyrhizobiumsp. Tv2a.2 is an aerobic, motile, Gram-negative, non-spore-forming rod that was isolated from an effective nitrogen-fixing root nodule of Tachigali versicolor collected in Barro Colorado Island of Panama. Here we describe the features of Bradyrhizobiumsp. Tv2a.2, together with high-quality permanent draft genome sequence information and annotation. The 8,496,279 bp high-quality draft genome is arranged in 87 scaffolds of 87 contigs, contains 8,109 protein-coding genes and 72 RNA-only encoding genes. In conclusion, this rhizobial genome was sequenced as part of the DOE Joint Genome Institute 2010 Genomic Encyclopedia for Bacteria and Archaea-Root Nodule Bacteria (GEBA-RNB) project.

High quality draft genome of Nakamurella lactea type strain, a rock actinobacterium, and emended description of Nakamurella lactea

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

Nouioui, Imen; Göker, Markus; Carro, Lorena

Nakamurella lactea DLS-10 T , isolated from rock in Korea, is one of the four type strains of the genus Nakamurella. In this study, we describe the high quality draft genome of N. lactea DLS-10 T and its annotation. A summary of phenotypic data collected from previously published studies was also included. The genome of strain DLS-10 T presents a size of 5.82 Mpb, 5100 protein coding genes, and a C + G content of 68.9%. Based on the genome analysis, emended description of N. lactea in terms of G + C content was also proposed.

High quality draft genome of Nakamurella lactea type strain, a rock actinobacterium, and emended description of Nakamurella lactea

DOE PAGES

Nouioui, Imen; Göker, Markus; Carro, Lorena; ...

2017-01-06

Nakamurella lactea DLS-10 T , isolated from rock in Korea, is one of the four type strains of the genus Nakamurella. In this study, we describe the high quality draft genome of N. lactea DLS-10 T and its annotation. A summary of phenotypic data collected from previously published studies was also included. The genome of strain DLS-10 T presents a size of 5.82 Mpb, 5100 protein coding genes, and a C + G content of 68.9%. Based on the genome analysis, emended description of N. lactea in terms of G + C content was also proposed.

What European gynaecologists need to master: Consensus on medical expertise outcomes of pan-European postgraduate training in obstetrics & gynaecology.

PubMed

van der Aa, Jessica E; Tancredi, Annalisa; Goverde, Angelique J; Velebil, Petr; Feyereisl, Jaroslav; Benedetto, Chiara; Teunissen, Pim W; Scheele, Fedde

2017-09-01

European harmonisation of training standards in postgraduate medical education in Obstetrics and Gynaecology is needed because of the increasing mobility of medical specialists. Harmonisation of training will provide quality assurance of training and promote high quality care throughout Europe. Pan-European training standards should describe medical expertise outcomes that are required from the European gynaecologist. This paper reports on consensus development on the medical expertise outcomes of pan-European training in Obstetrics and Gynaecology. A Delphi procedure was performed amongst European gynaecologists and trainees in Obstetrics & Gynaecology, to develop consensus on outcomes of training. The consensus procedure consisted of two questionnaire rounds, followed by a consensus meeting. To ensure reasonability and feasibility for implementation of the training standards in Europe, implications of the outcomes were considered in a working group thereafter. We invited 142 gynaecologists and trainees in Obstetrics & Gynaecology for participation representing a wide range of European countries. They were selected through the European Board & College of Obstetrics and Gynaecology and the European Network of Trainees in Obstetrics & Gynaecology. Sixty people participated in round 1 and 2 of the consensus procedure, 38 (63.3%) of whom were gynaecologists and 22 (36.7%) were trainees in Obstetrics & Gynaecology. Twenty-eight European countries were represented in this response. Round 3 of the consensus procedure was performed in a consensus meeting with six experts. Implications of the training outcomes were discussed in a working group meeting, to ensure reasonability and feasibility of the material for implementation in Europe. The entire consensus procedure resulted in a core content of training standards of 188 outcomes, categorised in ten topics. European consensus was developed regarding the medical expertise outcomes of pan-European training in Obstetrics and Gynaecology. The outcomes will be described in core trainings standards, aimed at harmonising training in Obstetrics and Gynaecology in Europe to promote high quality care. Copyright © 2017 Elsevier B.V. All rights reserved.

Tribal Air Grants Framework - Menu of Options

EPA Pesticide Factsheets

Tool to assist tribes that apply for CAA funding to draft moreeffective work plans for projects that will develop tribal knowledge of air quality issues andbuild tribal expertise to manage air quality on reservations and tribal trust land

Extensive Error in the Number of Genes Inferred from Draft Genome Assemblies

PubMed Central

Denton, James F.; Lugo-Martinez, Jose; Tucker, Abraham E.; Schrider, Daniel R.; Warren, Wesley C.; Hahn, Matthew W.

2014-01-01

Current sequencing methods produce large amounts of data, but genome assemblies based on these data are often woefully incomplete. These incomplete and error-filled assemblies result in many annotation errors, especially in the number of genes present in a genome. In this paper we investigate the magnitude of the problem, both in terms of total gene number and the number of copies of genes in specific families. To do this, we compare multiple draft assemblies against higher-quality versions of the same genomes, using several new assemblies of the chicken genome based on both traditional and next-generation sequencing technologies, as well as published draft assemblies of chimpanzee. We find that upwards of 40% of all gene families are inferred to have the wrong number of genes in draft assemblies, and that these incorrect assemblies both add and subtract genes. Using simulated genome assemblies of Drosophila melanogaster, we find that the major cause of increased gene numbers in draft genomes is the fragmentation of genes onto multiple individual contigs. Finally, we demonstrate the usefulness of RNA-Seq in improving the gene annotation of draft assemblies, largely by connecting genes that have been fragmented in the assembly process. PMID:25474019

Extensive error in the number of genes inferred from draft genome assemblies.

PubMed

Denton, James F; Lugo-Martinez, Jose; Tucker, Abraham E; Schrider, Daniel R; Warren, Wesley C; Hahn, Matthew W

2014-12-01

Current sequencing methods produce large amounts of data, but genome assemblies based on these data are often woefully incomplete. These incomplete and error-filled assemblies result in many annotation errors, especially in the number of genes present in a genome. In this paper we investigate the magnitude of the problem, both in terms of total gene number and the number of copies of genes in specific families. To do this, we compare multiple draft assemblies against higher-quality versions of the same genomes, using several new assemblies of the chicken genome based on both traditional and next-generation sequencing technologies, as well as published draft assemblies of chimpanzee. We find that upwards of 40% of all gene families are inferred to have the wrong number of genes in draft assemblies, and that these incorrect assemblies both add and subtract genes. Using simulated genome assemblies of Drosophila melanogaster, we find that the major cause of increased gene numbers in draft genomes is the fragmentation of genes onto multiple individual contigs. Finally, we demonstrate the usefulness of RNA-Seq in improving the gene annotation of draft assemblies, largely by connecting genes that have been fragmented in the assembly process.

Draft Genome Sequence of Telmatospirillum siberiense 26-4b1, an Acidotolerant Peatland Alphaproteobacterium Potentially Involved in Sulfur Cycling.

PubMed

Hausmann, Bela; Pjevac, Petra; Schreck, Katharina; Herbold, Craig W; Daims, Holger; Wagner, Michael; Loy, Alexander

2018-01-25

The facultative anaerobic chemoorganoheterotrophic alphaproteobacterium Telmatospirillum siberiense 26-4b1 was isolated from a Siberian peatland. We report here a 6.20-Mbp near-complete high-quality draft genome sequence of T. siberiense that reveals expected and novel metabolic potential for the genus Telmatospirillum , including genes for sulfur oxidation. Copyright © 2018 Hausmann et al.

Reaching consensus on reporting patient and public involvement (PPI) in research: methods and lessons learned from the development of reporting guidelines

PubMed Central

Brett, Jo; Staniszewska, Sophie; Simera, Iveta; Seers, Kate; Mockford, Carole; Goodlad, Susan; Altman, Doug; Moher, David; Barber, Rosemary; Denegri, Simon; Entwistle, Andrew Robert; Littlejohns, Peter; Suleman, Rashida; Thomas, Victoria; Tysall, Colin

2017-01-01

Introduction Patient and public involvement (PPI) is inconsistently reported in health and social care research. Improving the quality of how PPI is reported is critical in developing a higher quality evidence base to gain a better insight into the methods and impact of PPI. This paper describes the methods used to develop and gain consensus on guidelines for reporting PPI in research studies (updated version of the Guidance for Reporting Patient and Public Involvement (GRIPP2)). Methods There were three key stages in the development of GRIPP2: identification of key items for the guideline from systematic review evidence of the impact of PPI on health research and health services, a three-phase online Delphi survey with a diverse sample of experts in PPI to gain consensus on included items and a face-to-face consensus meeting to finalise and reach definitive agreement on GRIPP2. Challenges and lessons learnt during the development of the reporting guidelines are reported. Discussion The process of reaching consensus is vital within the development of guidelines and policy directions, although debate around how best to reach consensus is still needed. This paper discusses the critical stages of consensus development as applied to the development of consensus for GRIPP2 and discusses the benefits and challenges of consensus development. PMID:29061613

Positional bias in variant calls against draft reference assemblies.

PubMed

Briskine, Roman V; Shimizu, Kentaro K

2017-03-28

Whole genome resequencing projects may implement variant calling using draft reference genomes assembled de novo from short-read libraries. Despite lower quality of such assemblies, they allowed researchers to extend a wide range of population genetic and genome-wide association analyses to non-model species. As the variant calling pipelines are complex and involve many software packages, it is important to understand inherent biases and limitations at each step of the analysis. In this article, we report a positional bias present in variant calling performed against draft reference assemblies constructed from de Bruijn or string overlap graphs. We assessed how frequently variants appeared at each position counted from ends of a contig or scaffold sequence, and discovered unexpectedly high number of variants at the positions related to the length of either k-mers or reads used for the assembly. We detected the bias in both publicly available draft assemblies from Assemblathon 2 competition as well as in the assemblies we generated from our simulated short-read data. Simulations confirmed that the bias causing variants are predominantly false positives induced by reads from spatially distant repeated sequences. The bias is particularly strong in contig assemblies. Scaffolding does not eliminate the bias but tends to mitigate it because of the changes in variants' relative positions and alterations in read alignments. The bias can be effectively reduced by filtering out the variants that reside in repetitive elements. Draft genome sequences generated by several popular assemblers appear to be susceptible to the positional bias potentially affecting many resequencing projects in non-model species. The bias is inherent to the assembly algorithms and arises from their particular handling of repeated sequences. It is recommended to reduce the bias by filtering especially if higher-quality genome assembly cannot be achieved. Our findings can help other researchers to improve the quality of their variant data sets and reduce artefactual findings in downstream analyses.

Access to Quality Early Childhood Care and Education. Background Paper for the Quality Child Care Think Tank. Draft.

ERIC Educational Resources Information Center

Brandon, Richard N.; Smith, Diana

This background paper discusses the current system of child care finance in Washington State and analyzes options for improvement. It describes prominent characteristics of the early childhood care and education system, findings relating program quality to staff/child ratios and staff educational levels, characteristics of quality, parent…

Jobs and the Quality of Life in Cities: Local Government's Role in Full Employment.

ERIC Educational Resources Information Center

Newport, Eugene "Gus"

1986-01-01

"The Quality-of-Life Action" conference was held to: (1) involve more people in activities relating to economic well-being; (2) plan for responsible growth and environmental preservation; and (3) involve people in quality-of-life legislation. Included is the conference's draft of a "Proposed Berkeley Ordinance on Quality-of-Life…

Fact Sheet: Revised Draft Ambient Water Quality Criteria Document for Atrazine and Request for Scientific Views

EPA Pesticide Factsheets

Documents pertaining to Acute and Chronic Ambient Water Quality Aquatic Life Criteria for Atrazine (Freshwater and Salt Water) and revised Ecological Fate and Effects Risk Assessment for Atrazine. (Fact Sheet)

77 FR 41442 - Notice of Availability of the Draft Order of the Secretary on Oil and Gas and Potash Development...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... protection of other mineral resources, other natural resources, environmental quality, life, health, safety... sufficient thickness and quality to be mineable), the Development Areas would generally be larger...

21 CFR 26.6 - Equivalence assessment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS... draft programs for assessing the equivalence of the respective regulatory systems in terms of quality... inspection reports), joint training, and joint inspections for the purpose of assessing regulatory systems...

AN ECOEPIDEMIOLOGICAL APPROACH FOR DEVELOPING WATER QUALITY CRITERIA

EPA Science Inventory

The USEPA's Draft Framework for Developing Suspended and Bedded Sediments Water Quality Criteria is based on an ecoepidemiological approach that is potentially applicable to any chemical or non-chemical agent. An ecoepidemiological approach infers associations from the co-occurre...

Cairo consensus on the IVF laboratory environment and air quality: report of an expert meeting.

PubMed

Mortimer, D; Cohen, J; Mortimer, S T; Fawzy, M; McCulloh, D H; Morbeck, D E; Pollet-Villard, X; Mansour, R T; Brison, D R; Doshi, A; Harper, J C; Swain, J E; Gilligan, A V

2018-03-02

This proceedings report presents the outcomes from an international Expert Meeting to establish a consensus on the recommended technical and operational requirements for air quality within modern assisted reproduction technology (ART) laboratories. Topics considered included design and construction of the facility, as well as its heating, ventilation and air conditioning system; control of particulates, micro-organisms (bacteria, fungi and viruses) and volatile organic compounds (VOCs) within critical areas; safe cleaning practices; operational practices to optimize air quality while minimizing physicochemical risks to gametes and embryos (temperature control versus air flow); and appropriate infection-control practices that minimize exposure to VOC. More than 50 consensus points were established under the general headings of assessing site suitability, basic design criteria for new construction, and laboratory commissioning and ongoing VOC management. These consensus points should be considered as aspirational benchmarks for existing ART laboratories, and as guidelines for the construction of new ART laboratories. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Resident Wellness and Social Support: Development and Cognitive Validation of a Resident Social Capital Assessment Tool.

PubMed

Kaplan, Stephen J; Seabott, Heather M; Cunningham, Erika B; Helman, James D; Calderon, Alvin; Thirlby, Richard C; Schenarts, Kimberly D

The purpose of this study is to develop and generate validity evidence for an instrument to measure social capital in residents. Mixed-methods, phased approach utilizing a modified Delphi technique, focus groups, and cognitive interviews. Four residency training institutions in Washington state between February 2016 and March 2017. General surgery, anesthesia, and internal medicine residents ranging from PGY-1 to PGY-6. The initial resident-focused instrument underwent revision via Delphi process with 6 experts; 100% expert consensus was achieved after 4 cycles. Three focus groups were conducted with 19 total residents. Focus groups identified 6 of 11 instrument items with mean quality ratings ≤4.0 on a 1-5 scale. The composite instrument rating of the draft version was 4.1 ± 0.5. After refining the instrument, cognitive interviews with the final version were completed with 22 residents. All items in the final version had quality ratings >4.0; the composite instrument rating was 4.8 ± 0.1. Social capital may be an important factor in resident wellness as residents rely upon each other and external social support to withstand fatigue, burnout, and other negative sequelae of rigorous training. This instrument for assessment of social capital in residents may provide an avenue for data collection and potentially, identification of residents at-risk for wellness degradation. Copyright © 2018 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Evaluation of Agency Non-Code Layered Pressure Vessels (LPVs) . Volume 2; Appendices

NASA Technical Reports Server (NTRS)

Prosser, William H.

2014-01-01

In coordination with the Office of Safety and Mission Assurance and the respective Center Pressure System Managers (PSMs), the NASA Engineering and Safety Center (NESC) was requested to formulate a consensus draft proposal for the development of additional testing and analysis methods to establish the technical validity, and any limitation thereof, for the continued safe operation of facility non-code layered pressure vessels. The PSMs from each NASA Center were asked to participate as part of the assessment team by providing, collecting, and reviewing data regarding current operations of these vessels. This document contains the appendices to the main report.

High quality draft genome sequence of the moderately halophilic bacterium Pontibacillus yanchengensis Y32(T) and comparison among Pontibacillus genomes.

PubMed

Huang, Jing; Qiao, Zi Xu; Tang, Jing Wei; Wang, Gejiao

2015-01-01

Pontibacillus yanchengensis Y32(T) is an aerobic, motile, Gram-positive, endospore-forming, and moderately halophilic bacterium isolated from a salt field. In this study, we describe the features of P. yanchengensis strain Y32(T) together with a comparison with other four Pontibacillus genomes. The 4,281,464 bp high-quality-draft genome of strain Y32(T) is arranged into 153 contigs containing 3,965 protein-coding genes and 77 RNA encoding genes. The genome of strain Y32(T) possesses many genes related to its halophilic character, flagellar assembly and chemotaxis to support its survival in a salt-rich environment.

Early Childhood Standards of Quality for Prekindergarten through Second Grade.

ERIC Educational Resources Information Center

Michigan State Board of Education, Lansing.

Recognizing the value and need for quality early childhood education programs for children ages four through eight years, the Michigan State Board of Education appointed an ad hoc committee to develop standards of quality. Based on the draft developed by this committee, this standards guide is designed to assist administrators, teachers, and…

78 FR 29016 - Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material AGENCY: Nuclear..., ``Establishing Quality Assurance Programs for Packaging Used in Transport of Radioactive Material.'' This draft... regulations for the packaging and transportation of radioactive material in Part 71 of Title 10 of the Code of...

78 FR 53777 - Notice of Availability of the Draft Visual Resource Management and Areas of Critical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-30

... species, a unique sand dune community and habitat, the desert kangaroo rat, and for scenic quality. The... criteria: McCarty Canyon; for scenic quality and wildlife habitat; Seminoe and Pathfinder Reservoirs; for sensitive plant species, scenic quality, and wildlife habitat; Flattop Mountain; for sensitive plant species...

Rating scale for the assessment of competence in ultrasound-guided peripheral vascular access - a Delphi Consensus Study.

PubMed

Primdahl, Stine C; Todsen, Tobias; Clemmesen, Louise; Knudsen, Lars; Weile, Jesper

2016-09-21

Peripheral vascular access is vital for treatment and diagnostics of hospitalized patients. Ultrasound-guided vascular access (UGVA) is superior to the landmark technique. To ensure competence-based education, an assessment tool of UGVA competence is needed. We aimed to develop a global rating scale (RS) for assessment of UGVA competence based on opinions on the content from ultrasound experts in a modified Delphi consensus study. We included experts from anesthesiology, emergency medicine and radiology across university hospitals in Denmark. Nine elements were drafted based on existing literature and recommendations from international societies. In a multi-round survey, the experts rated the elements on a five-point Likert scale according to importance, and suggested missing elements. The final Delphi round occurred when >80% of the experts rated all elements ≥4 on the Likert scale. Sixteen experts consented to participate in the study, one withdrew consent prior to the first Delphi round, and 14 completed all three Delphi rounds. In the first Delphi round the experts excluded one element from the scale and changed the content of two elements. In the second Delphi round, the experts excluded one element from the scale. In the third Delphi round, consensus was obtained on the eight elements: preparation of utensils, ergonomics, preparation of the ultrasound device, identification of blood vessels, anatomy, hygiene, coordination of the needle, and completion of the procedure. We developed an RS for assessment of UGVA competence based on opinions of ultrasound experts through a modified Delphi consensus study.

Educator Toolkits on Second Victim Syndrome, Mindfulness and Meditation, and Positive Psychology: The 2017 Resident Wellness Consensus Summit

PubMed Central

Smart, Jon; Zdradzinski, Michael; Roth, Sarah; Gende, Alecia; Conroy, Kylie; Battaglioli, Nicole

2018-01-01

Introduction Burnout, depression, and suicidality among residents of all specialties have become a critical focus of attention for the medical education community. Methods As part of the 2017 Resident Wellness Consensus Summit in Las Vegas, Nevada, resident participants from 31 programs collaborated in the Educator Toolkit workgroup. Over a seven-month period leading up to the summit, this workgroup convened virtually in the Wellness Think Tank, an online resident community, to perform a literature review and draft curricular plans on three core wellness topics. These topics were second victim syndrome, mindfulness and meditation, and positive psychology. At the live summit event, the workgroup expanded to include residents outside the Wellness Think Tank to obtain a broader consensus of the evidence-based toolkits for these three topics. Results Three educator toolkits were developed. The second victim syndrome toolkit has four modules, each with a pre-reading material and a leader (educator) guide. In the mindfulness and meditation toolkit, there are three modules with a leader guide in addition to a longitudinal, guided meditation plan. The positive psychology toolkit has two modules, each with a leader guide and a PowerPoint slide set. These toolkits provide educators the necessary resources, reading materials, and lesson plans to implement didactic sessions in their residency curriculum. Conclusion Residents from across the world collaborated and convened to reach a consensus on high-yield—and potentially high-impact—lesson plans that programs can use to promote and improve resident wellness. These lesson plans may stand alone or be incorporated into a larger wellness curriculum. PMID:29560061

Educator Toolkits on Second Victim Syndrome, Mindfulness and Meditation, and Positive Psychology: The 2017 Resident Wellness Consensus Summit.

PubMed

Chung, Arlene S; Smart, Jon; Zdradzinski, Michael; Roth, Sarah; Gende, Alecia; Conroy, Kylie; Battaglioli, Nicole

2018-03-01

Burnout, depression, and suicidality among residents of all specialties have become a critical focus of attention for the medical education community. As part of the 2017 Resident Wellness Consensus Summit in Las Vegas, Nevada, resident participants from 31 programs collaborated in the Educator Toolkit workgroup. Over a seven-month period leading up to the summit, this workgroup convened virtually in the Wellness Think Tank, an online resident community, to perform a literature review and draft curricular plans on three core wellness topics. These topics were second victim syndrome, mindfulness and meditation, and positive psychology. At the live summit event, the workgroup expanded to include residents outside the Wellness Think Tank to obtain a broader consensus of the evidence-based toolkits for these three topics. Three educator toolkits were developed. The second victim syndrome toolkit has four modules, each with a pre-reading material and a leader (educator) guide. In the mindfulness and meditation toolkit, there are three modules with a leader guide in addition to a longitudinal, guided meditation plan. The positive psychology toolkit has two modules, each with a leader guide and a PowerPoint slide set. These toolkits provide educators the necessary resources, reading materials, and lesson plans to implement didactic sessions in their residency curriculum. Residents from across the world collaborated and convened to reach a consensus on high-yield-and potentially high-impact-lesson plans that programs can use to promote and improve resident wellness. These lesson plans may stand alone or be incorporated into a larger wellness curriculum.

US Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations for the management of non-tuberculous mycobacteria in individuals with cystic fibrosis

PubMed Central

Olivier, Kenneth N; Saiman, Lisa; Daley, Charles L; Herrmann, Jean-Louis; Nick, Jerry A; Noone, Peadar G; Bilton, Diana; Corris, Paul; Gibson, Ronald L; Hempstead, Sarah E; Koetz, Karsten; Sabadosa, Kathryn A; Sermet-Gaudelus, Isabelle; Smyth, Alan R; van Ingen, Jakko; Wallace, Richard J; Winthrop, Kevin L; Marshall, Bruce C; Haworth, Charles S

2016-01-01

Non-tuberculous mycobacteria (NTM) are ubiquitous environmental organisms that can cause chronic pulmonary infection, particularly in individuals with pre-existing inflammatory lung disease such as cystic fibrosis (CF). Pulmonary disease caused by NTM has emerged as a major threat to the health of individuals with CF but remains difficult to diagnose and problematic to treat. In response to this challenge, the US Cystic Fibrosis Foundation (CFF) and the European Cystic Fibrosis Society (ECFS) convened an expert panel of specialists to develop consensus recommendations for the screening, investigation, diagnosis and management of NTM pulmonary disease in individuals with CF. Nineteen experts were invited to participate in the recommendation development process. Population, Intervention, Comparison, Outcome (PICO) methodology and systematic literature reviews were employed to inform draft recommendations. An anonymous voting process was used by the committee to reach consensus. All committee members were asked to rate each statement on a scale of: 0, completely disagree, to 9, completely agree; with 80% or more of scores between 7 and 9 being considered ‘good’ agreement. Additionally, the committee solicited feedback from the CF communities in the USA and Europe and considered the feedback in the development of the final recommendation statements. Three rounds of voting were conducted to achieve 80% consensus for each recommendation statement. Through this process, we have generated a series of pragmatic, evidence-based recommendations for the screening, investigation, diagnosis and treatment of NTM infection in individuals with CF as an initial step in optimising management for this challenging condition. PMID:26666259

Establishing Key Performance Indicators [KPIs] and Their Importance for the Surgical Management of Inflammatory Bowel Disease-Results From a Pan-European, Delphi Consensus Study.

PubMed

Morar, Pritesh S; Hollingshead, James; Bemelman, Willem; Sevdalis, Nick; Pinkney, Thomas; Wilson, Graeme; Dunlop, Malcolm; Davies, R Justin; Guy, Richard; Fearnhead, Nicola; Brown, Steven; Warusavitarne, Janindra; Edwards, Cathryn; Faiz, Omar

2017-10-27

Key performance indicators [KPIs] exist across a range of areas in medicine. They help to monitor outcomes, reduce variation, and drive up standards across services. KPIs exist for inflammatory bowel disease [IBD] care, but none specifically cover inflammatory bowel disease [IBD] surgical service provision. This was a consensus-based study using a panel of expert IBD clinicians from across Europe. Items were developed and fed through a Delphi process to achieve consensus. Items were ranked on a Likert scale from 1 [not important] to 5 [very important]. Consensus was defined when the inter quartile range was ≤ 1, and items with a median score > 3 were considered for inclusion. A panel of 21 experts [14 surgeons and 7 gastroenterologists] was recruited. Consensus was achieved on procedure-specific KPIs for ileocaecal and perianal surgery for Crohn's disease, [N = 10] with themes relating to morbidity [N = 7], multidisciplinary input [N = 2], and quality of life [N = 1]; and for subtotal colectomy, proctocolectomy and ileoanal pouch surgery for ulcerative colitis [N = 11], with themes relating to mortality [N = 2], morbidity [N = 8], and service provision [N = 1]. Consensus was also achieved for measures of the quality of IBD surgical service provision and quality assurance in IBD surgery. This study has provided measurable KPIs for the provision of surgical services in IBD. These indicators cover IBD surgery in general, the governance and structures of the surgical services, and separate indicators for specific subareas of surgery. Monitoring of IBD services with these KPIs may reduce variation across services and improve quality. Copyright © 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com

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.

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.

Air Quality Criteria for Lead (First External Review Draft)

EPA Science Inventory

Background:

The Clean Air Act mandates periodic review of the National Ambient Air Quality Standards (NAAQS) for six common air pollutants, also referred to as criteria pollutants, including lead. Under the review process, EPA's Office of Research and Development d...

Develop nondestructive rapid pavement quality assurance/quality control evaluation test methods and supporting technology : project summary.

DOT National Transportation Integrated Search

2017-01-01

The findings from the proof of concept with mechanics-based models for flexible base suggest additional validation work should be performed, draft construction specification frameworks should be developed, and work extending the technology to stabili...

Develop nondestructive rapid pavement quality Assurance/quality control evaluation test methods and supporting technology : project summary.

DOT National Transportation Integrated Search

2017-01-01

The findings from the proof of concept with mechanics-based models for flexible base suggest additional validation work should be performed, draft construction specification frameworks should be developed, and work extending the technology to stabili...

CheckM: assessing the quality of microbial genomes recovered from isolates, single cells, and metagenomes

PubMed Central

Parks, Donovan H.; Imelfort, Michael; Skennerton, Connor T.; Hugenholtz, Philip; Tyson, Gene W.

2015-01-01

Large-scale recovery of genomes from isolates, single cells, and metagenomic data has been made possible by advances in computational methods and substantial reductions in sequencing costs. Although this increasing breadth of draft genomes is providing key information regarding the evolutionary and functional diversity of microbial life, it has become impractical to finish all available reference genomes. Making robust biological inferences from draft genomes requires accurate estimates of their completeness and contamination. Current methods for assessing genome quality are ad hoc and generally make use of a limited number of “marker” genes conserved across all bacterial or archaeal genomes. Here we introduce CheckM, an automated method for assessing the quality of a genome using a broader set of marker genes specific to the position of a genome within a reference genome tree and information about the collocation of these genes. We demonstrate the effectiveness of CheckM using synthetic data and a wide range of isolate-, single-cell-, and metagenome-derived genomes. CheckM is shown to provide accurate estimates of genome completeness and contamination and to outperform existing approaches. Using CheckM, we identify a diverse range of errors currently impacting publicly available isolate genomes and demonstrate that genomes obtained from single cells and metagenomic data vary substantially in quality. In order to facilitate the use of draft genomes, we propose an objective measure of genome quality that can be used to select genomes suitable for specific gene- and genome-centric analyses of microbial communities. PMID:25977477

CheckM: assessing the quality of microbial genomes recovered from isolates, single cells, and metagenomes.

PubMed

Parks, Donovan H; Imelfort, Michael; Skennerton, Connor T; Hugenholtz, Philip; Tyson, Gene W

2015-07-01

Large-scale recovery of genomes from isolates, single cells, and metagenomic data has been made possible by advances in computational methods and substantial reductions in sequencing costs. Although this increasing breadth of draft genomes is providing key information regarding the evolutionary and functional diversity of microbial life, it has become impractical to finish all available reference genomes. Making robust biological inferences from draft genomes requires accurate estimates of their completeness and contamination. Current methods for assessing genome quality are ad hoc and generally make use of a limited number of "marker" genes conserved across all bacterial or archaeal genomes. Here we introduce CheckM, an automated method for assessing the quality of a genome using a broader set of marker genes specific to the position of a genome within a reference genome tree and information about the collocation of these genes. We demonstrate the effectiveness of CheckM using synthetic data and a wide range of isolate-, single-cell-, and metagenome-derived genomes. CheckM is shown to provide accurate estimates of genome completeness and contamination and to outperform existing approaches. Using CheckM, we identify a diverse range of errors currently impacting publicly available isolate genomes and demonstrate that genomes obtained from single cells and metagenomic data vary substantially in quality. In order to facilitate the use of draft genomes, we propose an objective measure of genome quality that can be used to select genomes suitable for specific gene- and genome-centric analyses of microbial communities. © 2015 Parks et al.; Published by Cold Spring Harbor Laboratory Press.

The management of anovulatory infertility in women with polycystic ovary syndrome: an analysis of the evidence to support the development of global WHO guidance.

PubMed

Balen, Adam H; Morley, Lara C; Misso, Marie; Franks, Stephen; Legro, Richard S; Wijeyaratne, Chandrika N; Stener-Victorin, Elisabet; Fauser, Bart C J M; Norman, Robert J; Teede, Helena

2016-11-01

Here we describe the consensus guideline methodology, summarise the evidence-based recommendations we provided to the World Health Organisation (WHO) for their consideration in the development of global guidance and present a narrative review on the management of anovulatory infertility in women with polycystic ovary syndrome (PCOS). The aim of this paper was to present an evidence base for the management of anovulatory PCOS. The evidence to support providing recommendations involved a collaborative process for: (i) identification of priority questions and critical outcomes, (ii) retrieval of up-to-date evidence and exiting guidelines, (iii) assessment and synthesis of the evidence and (iv) the formulation of draft recommendations to be used for reaching consensus with a wide range of global stakeholders. For each draft recommendation, the methodologist evaluated the quality of the supporting evidence that was then graded as very low, low, moderate or high for consideration during consensus. Evidence was synthesized and we made recommendations across the definition of PCOS including hyperandrogenism, menstrual cycle regulation and ovarian assessment. Metabolic features and the impact of ethnicity were covered. Management includes lifestyle changes, bariatric surgery, pharmacotherapy (including clomiphene citrate (CC), aromatase inhibitors, metformin and gonadotropins), as well as laparoscopic surgery. In-vitro fertilization (IVF) was considered as were the risks of ovulation induction and of pregnancy in PCOS. Approximately 80% of women who suffer from anovulatory infertility have PCOS. Lifestyle intervention is recommended first in women who are obese largely on the basis of general health benefits. Bariatric surgery can be considered where the body mass index (BMI) is ≥35 kg/m 2 and lifestyle therapy has failed. Carefully conducted and monitored pharmacological ovulation induction can achieve good cumulative pregnancy rates and multiple pregnancy rates can be minimized with adherence to recommended protocols. CC should be first-line pharmacotherapy for ovulation induction and letrozole can also be used as first-line therapy. Metformin alone has limited benefits in improving live birth rates. Gonadotropins and laparoscopic surgery can be used as second-line treatment. There is no clear evidence for efficacy of acupuncture or herbal mixtures in women with PCOS. For women with PCOS who fail lifestyle and ovulation induction therapy or have additional infertility factors, IVF can be used with the safer gonadotropin releasing hormone (GnRH) antagonist protocol. If a GnRH-agonist protocol is used, metformin as an adjunct may reduce the risk of ovarian hyperstimulation syndrome. Patients should be informed of the potential side effects of ovulation induction agents and of IVF on the foetus, and of the risks of multiple pregnancy. Increased risks for the mother during pregnancy and for the child, including the exacerbating impact of obesity on adverse outcomes, should also be discussed. This guidance generation and evidence-synthesis analysis has been conducted in a manner to be considered for global applicability for the safe administration of ovulation induction for anovulatory women with PCOS. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Draft Genome Sequence of thermoalkaliphilic Caldalkalibacillus thermarum strain TA2.A1 Reveals Molecular Adaptations to Extreme pH and Temperature

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

Kalamorz, Falk; Keis, Stefanie; Stanton, Jo-Ann

The genes and molecular machines that allow for a thermoalkaliphilic lifestyle have not been defined. To address this goal, we report on the improved high-quality draft genome sequence of Caldalkalibacillus thermarum strain TA2.A1, an obligately aerobic bacterium that grows optimally at pH 9.5 and 65 to 70 C on a wide variety of carbon and energy sources.

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.

Top management leadership style and quality of care in nursing homes.

PubMed

Castle, Nicholas G; Decker, Frederic H

2011-10-01

The purpose of this study was to examine the association of Nursing Home Administrator (NHA) leadership style and Director of Nursing (DON) leadership style with quality of care. Leaders were categorized into 4 groups: consensus managers, consultative autocrats, shareholder managers, or autocrats. This leadership style assessment came from primary data collected from approximately 4,000 NHAs and DONs that was linked to quality information (i.e., Nursing Home Compare Quality Measures and 5-Star rating scores) and nursing home information (i.e., Online Survey, Certification, And Reporting data). A consensus manager leadership style has a strong association with better quality. Top managers using this style solicit and act upon input from their employees. For NHAs exhibiting this leadership style, the coefficients on 5 of the 7 quality indicators are statistically significant, and all 7 are significant when the DON exhibits this style. When the NHA and DON both have a consensus manager leadership style, 6 of the 7 quality indicator coefficients are significantly associated with better quality. The findings indicate that NHA and DON leadership style is associated with quality of care. Leadership strategies are amenable to change; thus, the findings of this study may be used to develop policies for promoting more effective leadership in nursing homes.

Quantitative and qualitative analysis on the legislative production relating to healthcare in passage in the National Congress in the years 2007 and 2008.

PubMed

Santos, Viviane Cristina dos; Ferraz, Marcos Bosi

2013-01-01

The Federal Constitution of 1988 allowed the National Congress to contribute towards formulation of new public policies. The objective of this study was to analyze the legislative production that dealt with health issues that was in passage in the National Congress between January 2007 and December 2008. Descriptive-exploratory cross-sectional study with quantitative and qualitative approaches, conducted in a federal university. The analysis material for the study comprised 144 draft bills that were classified and subsequently randomly evaluated by 155 professionals working within the healthcare system. The analysis showed that the Workers' Party (PT) and Brazilian Democratic Movement Party (PMDB) were the parties that presented the largest proportions of the draft bills (12.5% and 11.1%); 25.4% of the draft bills were presented by congress members with academic qualifications within healthcare and only 1.4% of the draft bills became transformed into legal regulations. In questionnaire responses, 51.5% of the evaluators did not consider the draft bills to be viable, 40.6% did not consider them to be relevant and 52.5% said that if the draft bills were not approved it would not be harmful to Brazilian society. In analyzing the data from this study, it was noted that the legislative production relating to healthcare was low and the transformation rate from draft bill to legal regulation was negligible. The results from the evaluation showed that the quality of legislative production was impaired.

A manually annotated Actinidia chinensis var. chinensis (kiwifruit) genome highlights the challenges associated with draft genomes and gene prediction in plants.

PubMed

Pilkington, Sarah M; Crowhurst, Ross; Hilario, Elena; Nardozza, Simona; Fraser, Lena; Peng, Yongyan; Gunaseelan, Kularajathevan; Simpson, Robert; Tahir, Jibran; Deroles, Simon C; Templeton, Kerry; Luo, Zhiwei; Davy, Marcus; Cheng, Canhong; McNeilage, Mark; Scaglione, Davide; Liu, Yifei; Zhang, Qiong; Datson, Paul; De Silva, Nihal; Gardiner, Susan E; Bassett, Heather; Chagné, David; McCallum, John; Dzierzon, Helge; Deng, Cecilia; Wang, Yen-Yi; Barron, Lorna; Manako, Kelvina; Bowen, Judith; Foster, Toshi M; Erridge, Zoe A; Tiffin, Heather; Waite, Chethi N; Davies, Kevin M; Grierson, Ella P; Laing, William A; Kirk, Rebecca; Chen, Xiuyin; Wood, Marion; Montefiori, Mirco; Brummell, David A; Schwinn, Kathy E; Catanach, Andrew; Fullerton, Christina; Li, Dawei; Meiyalaghan, Sathiyamoorthy; Nieuwenhuizen, Niels; Read, Nicola; Prakash, Roneel; Hunter, Don; Zhang, Huaibi; McKenzie, Marian; Knäbel, Mareike; Harris, Alastair; Allan, Andrew C; Gleave, Andrew; Chen, Angela; Janssen, Bart J; Plunkett, Blue; Ampomah-Dwamena, Charles; Voogd, Charlotte; Leif, Davin; Lafferty, Declan; Souleyre, Edwige J F; Varkonyi-Gasic, Erika; Gambi, Francesco; Hanley, Jenny; Yao, Jia-Long; Cheung, Joey; David, Karine M; Warren, Ben; Marsh, Ken; Snowden, Kimberley C; Lin-Wang, Kui; Brian, Lara; Martinez-Sanchez, Marcela; Wang, Mindy; Ileperuma, Nadeesha; Macnee, Nikolai; Campin, Robert; McAtee, Peter; Drummond, Revel S M; Espley, Richard V; Ireland, Hilary S; Wu, Rongmei; Atkinson, Ross G; Karunairetnam, Sakuntala; Bulley, Sean; Chunkath, Shayhan; Hanley, Zac; Storey, Roy; Thrimawithana, Amali H; Thomson, Susan; David, Charles; Testolin, Raffaele; Huang, Hongwen; Hellens, Roger P; Schaffer, Robert J

2018-04-16

Most published genome sequences are drafts, and most are dominated by computational gene prediction. Draft genomes typically incorporate considerable sequence data that are not assigned to chromosomes, and predicted genes without quality confidence measures. The current Actinidia chinensis (kiwifruit) 'Hongyang' draft genome has 164 Mb of sequences unassigned to pseudo-chromosomes, and omissions have been identified in the gene models. A second genome of an A. chinensis (genotype Red5) was fully sequenced. This new sequence resulted in a 554.0 Mb assembly with all but 6 Mb assigned to pseudo-chromosomes. Pseudo-chromosomal comparisons showed a considerable number of translocation events have occurred following a whole genome duplication (WGD) event some consistent with centromeric Robertsonian-like translocations. RNA sequencing data from 12 tissues and ab initio analysis informed a genome-wide manual annotation, using the WebApollo tool. In total, 33,044 gene loci represented by 33,123 isoforms were identified, named and tagged for quality of evidential support. Of these 3114 (9.4%) were identical to a protein within 'Hongyang' The Kiwifruit Information Resource (KIR v2). Some proportion of the differences will be varietal polymorphisms. However, as most computationally predicted Red5 models required manual re-annotation this proportion is expected to be small. The quality of the new gene models was tested by fully sequencing 550 cloned 'Hort16A' cDNAs and comparing with the predicted protein models for Red5 and both the original 'Hongyang' assembly and the revised annotation from KIR v2. Only 48.9% and 63.5% of the cDNAs had a match with 90% identity or better to the original and revised 'Hongyang' annotation, respectively, compared with 90.9% to the Red5 models. Our study highlights the need to take a cautious approach to draft genomes and computationally predicted genes. Our use of the manual annotation tool WebApollo facilitated manual checking and correction of gene models enabling improvement of computational prediction. This utility was especially relevant for certain types of gene families such as the EXPANSIN like genes. Finally, this high quality gene set will supply the kiwifruit and general plant community with a new tool for genomics and other comparative analysis.

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