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

PubMed

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

2015-02-15

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

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

PubMed

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

2015-02-22

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

Incentives for Organ Donation: Proposed Standards for an Internationally Acceptable System

PubMed Central

2012-01-01

Incentives for organ donation, currently prohibited in most countries, may increase donation and save lives. Discussion of incentives has focused on two areas: (1) whether or not there are ethical principles that justify the current prohibition and (2) whether incentives would do more good than harm. We herein address the second concern and propose for discussion standards and guidelines for an acceptable system of incentives for donation. We believe that if systems based on these guidelines were developed, harms would be no greater than those to today’s conventional donors. Ultimately, until there are trials of incentives, the question of benefits and harms cannot be satisfactorily answered. PMID:22176925

Guidelines for infertility counselling in different countries: is there an emerging trend?

PubMed

Blyth, Eric

2012-07-01

It is widely accepted that infertility and involuntary childlessness, and the decision to engage with assisted reproduction technology (ART) services as a patient, donor or surrogate can entail wide-ranging psychosocial issues. Psychosocial counselling has, therefore, become valued as an integral element of ART services. The objective of this study was to begin to map out what exists globally by the way of guidelines for infertility counselling. Data were analysed from formal guidelines produced by seven national infertility counselling bodies, onetransnational infertility counselling organization, reports of the American Society for Reproductive Medicine Ethics Committee and Practice Committee and the ESHRE Task Force on Ethics and Law. Additional sources of data were the International Infertility Counseling Organization and counselling colleagues internationally. Four broad areas concerning contemporary practice in infertility counselling are identified: (i) the legal mandate for counselling; (ii) eligibility credentials for individuals carrying out professional counselling activities; (iii) different forms of counselling and (iv) counselling practice in relation to specific elements of assisted reproduction treatment. Internationally, the development of infertility guidelines is best described as a 'work in progress', although key trends are evident.

Review of achievements of the OECD Working Party on Manufactured Nanomaterials' Testing and Assessment Programme. From exploratory testing to test guidelines.

PubMed

Rasmussen, Kirsten; González, Mar; Kearns, Peter; Sintes, Juan Riego; Rossi, François; Sayre, Phil

2016-02-01

This paper charts the almost ten years of history of OECD's work on nanosafety, during which the programme of the OECD on the Testing and Assessment of Manufactured Nanomaterials covered the testing of eleven nanomaterials for about 59 end-points addressing physical-chemical properties, mammalian and environmental toxicity, environmental fate and material safety. An overview of the materials tested, the test methods applied and the discussions regarding the applicability of the OECD test guidelines, which are recognised methods for regulatory testing of chemicals, are given. The results indicate that many existing OECD test guidelines are suitable for nanomaterials and consequently, hazard data collected using such guidelines will fall under OECD's system of Mutual Acceptance of Data (MAD) which is a legally binding instrument to facilitate the international acceptance of information for the regulatory safety assessment of chemicals. At the same time, some OECD test guidelines and guidance documents need to be adapted to address nanomaterials while new test guidelines and guidance documents may be needed to address endpoints that are more relevant to nanomaterials. This paper presents examples of areas where test guidelines or guidance for nanomaterials are under development. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Measure Guideline: Internal Insulation of Masonry Walls

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

Straube, J. F.; Ueno, K.; Schumacher, C. J.

2012-07-01

This measure guideline provides recommendations for interior insulation assemblies that control interstitial condensation and durability risks; recommendations for acceptable thermal performance are also provided. An illustrated guide of high-risk exterior details (which concentrate bulk water), and recommended remediation details is provided. This is followed by a recommended methodology for risk assessment of a masonry interior insulation project: a series of steps are suggested to assess the risks associated with this retrofit, with greater certainty with added steps.

Measure Guideline. Internal Insulation of Masonry Walls

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

Straube, J. F.; Ueno, K.; Schumacher, C. J.

2012-07-01

This measure guideline provides recommendations for interior insulation assemblies that control interstitial condensation and durability risks; recommendations for acceptable thermal performance are also provided. An illustrated guide of high-risk exterior details (which concentrate bulk water), and recommended remediation details is provided. This is followed by a recommended methodology for risk assessment of a masonry interior insulation project: a series of steps are suggested to assess the risks associated with this retrofit, with greater certainty with added steps.

An overview of coefficient alpha and a reliability matrix for estimating adequacy of internal consistency coefficients with psychological research measures.

PubMed

Ponterotto, Joseph G; Ruckdeschel, Daniel E

2007-12-01

The present article addresses issues in reliability assessment that are often neglected in psychological research such as acceptable levels of internal consistency for research purposes, factors affecting the magnitude of coefficient alpha (alpha), and considerations for interpreting alpha within the research context. A new reliability matrix anchored in classical test theory is introduced to help researchers judge adequacy of internal consistency coefficients with research measures. Guidelines and cautions in applying the matrix are provided.

Setting Housing Standards to Improve Global Health

PubMed Central

Howden-Chapman, Philippa; Roebbel, Nathalie

2017-01-01

Developing World Health Organization international guidelines is a highly formal process. Yet the resulting guidelines, which Member States are encouraged, but not required to adopt, are a powerful way of developing rigorous policy and fostering implementation. Using the example of the housing and health guidelines, which are currently being finalised, this paper outlines the process for developing WHO guidelines. This includes: forming a Guidelines Review Group that represents all regions of the world, and ensures gender balance and technical expertise; identifying key health outcomes of interest; commissioning systematic reviews of the evidence; assessing the evidence; and formulating recommendations. The strength of each recommendation is assessed based on the quality of the evidence, along with consideration of issues such as equity, acceptability, and feasibility of the implementation of the recommendation. The proposed housing guidelines will address: cold and hot indoor temperatures, home injuries, household crowding, accessibility and access to active travel infrastructure. PMID:29232827

Frameworks for Teaching and Learning Business Ethics within the Global Context: Background of Ethical Theories

ERIC Educational Resources Information Center

White, Judith; Taft, Susan

2004-01-01

In this article, we provide a summary of several major traditional and contemporary philosophical and psychological perspectives on ethical conduct for businesses, along with five different sets of internationally accepted ethical guidelines for corporations operating anywhere in the world. We include examples of corporate codes of conduct from…

A Reporting Tool for Practice Guidelines in Health Care: The RIGHT Statement.

PubMed

Chen, Yaolong; Yang, Kehu; Marušic, Ana; Qaseem, Amir; Meerpohl, Joerg J; Flottorp, Signe; Akl, Elie A; Schünemann, Holger J; Chan, Edwin S Y; Falck-Ytter, Yngve; Ahmed, Faruque; Barber, Sarah; Chen, Chiehfeng; Zhang, Mingming; Xu, Bin; Tian, Jinhui; Song, Fujian; Shang, Hongcai; Tang, Kun; Wang, Qi; Norris, Susan L

2017-01-17

The quality of reporting practice guidelines is often poor, and there is no widely accepted guidance or standards for such reporting in health care. The international RIGHT (Reporting Items for practice Guidelines in HealThcare) Working Group was established to address this gap. The group followed an existing framework for developing guidelines for health research reporting and the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach. It developed a checklist and an explanation and elaboration statement. The RIGHT checklist includes 22 items that are considered essential for good reporting of practice guidelines: basic information (items 1 to 4), background (items 5 to 9), evidence (items 10 to 12), recommendations (items 13 to 15), review and quality assurance (items 16 and 17), funding and declaration and management of interests (items 18 and 19), and other information (items 20 to 22). The RIGHT checklist can assist developers in reporting guidelines, support journal editors and peer reviewers when considering guideline reports, and help health care practitioners understand and implement a guideline.

Radiotherapy for non-malignant disorders: state of the art and update of the evidence-based practice guidelines

PubMed Central

Micke, O; Muecke, R

2015-01-01

Every year in Germany about 50,000 patients are referred and treated by radiotherapy (RT) for “non-malignant disorders”. This highly successful treatment is applied only for specific indications such as preservation or recovery of the quality of life by means of pain reduction or resolution and/or an improvement of formerly impaired physical body function owing to specific disease-related symptoms. Since 1995, German radiation oncologists have treated non-malignant disorders according to national consensus guidelines; these guidelines were updated and further developed over 3 years by implementation of a systematic consensus process to achieve national upgraded and accepted S2e clinical practice guidelines. Throughout this process, international standards of evaluation were implemented. This review summarizes most of the generally accepted indications for the application of RT for non-malignant diseases and presents the special treatment concepts. The following disease groups are addressed: painful degenerative skeletal disorders, hyperproliferative disorders and symptomatic functional disorders. These state of the art guidelines may serve as a platform for daily clinical work; they provide a new starting point for quality assessment, future clinical research, including the design of prospective clinical trials, and outcome research in the underrepresented and less appreciated field of RT for non-malignant disorders. PMID:25955230

[Essential competencies in training in obstetrics].

PubMed

Duarte, Sebastião Junior Henrique; Machado, Richardson Miranda

2016-11-01

Analyze international reports related to training in obstetrics and present guidelines to help leading educational institutions to develop curriculum guidelines for the teaching of obstetrics and advanced nursing practice in this specialty. A narrative review was conducted of documents from the World Health Organization and the International Confederation of Midwives. The search used the descriptors midwifery and education. All official reports that guide midwife education policies, published from 2009 to 2015 in English and Spanish, and available online, were included. Reports that did not specifically refer to training were excluded. Five reports were selected. Analysis and synthesis of their respective objectives and contents were based on three themes: requirements for professional qualification, continuing education, and guidelines for skilled training in obstetrics, taking into account accepted core competencies for this specialty. Analysis of reports related to training in obstetrics identified that key tasks are being implemented for both educators and midwives. The reports represent a solid basis to develop educational policies that can contribute to universal access and coverage in health and to reducing maternal and neonatal mortality, and potentially can be used to guide international policies.

Guidelines for Standardized Testing of Broadband Seismometers and Accelerometers

USGS Publications Warehouse

Hutt, Charles R.; Evans, John R.; Followill, Fred; Nigbor, Robert L.; Wielandt, Erhard

2010-01-01

Testing and specification of seismic and earthquake-engineering sensors and recorders has been marked by significant variations in procedures and selected parameters. These variations cause difficulty in comparing such specifications and test results. In July 1989, and again in May 2005, the U.S. Geological Survey hosted international pub-lic/private workshops with the goal of defining widely accepted guidelines for the testing of seismological inertial sensors, seismometers, and accelerometers. The Proceedings of the 2005 workshop have been published and include as appendix 6 the report of the 1989 workshop. This document represents a collation and rationalization of a single set of formal guidelines for testing and specifying broadband seismometers and accelerometers.

Update of Standard Practices for New Method Validation in Forensic Toxicology.

PubMed

Wille, Sarah M R; Coucke, Wim; De Baere, Thierry; Peters, Frank T

2017-01-01

International agreement concerning validation guidelines is important to obtain quality forensic bioanalytical research and routine applications as it all starts with the reporting of reliable analytical data. Standards for fundamental validation parameters are provided in guidelines as those from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the German speaking Gesellschaft fur Toxikologie und Forensische Chemie (GTFCH) and the Scientific Working Group of Forensic Toxicology (SWGTOX). These validation parameters include selectivity, matrix effects, method limits, calibration, accuracy and stability, as well as other parameters such as carryover, dilution integrity and incurred sample reanalysis. It is, however, not easy for laboratories to implement these guidelines into practice as these international guidelines remain nonbinding protocols, that depend on the applied analytical technique, and that need to be updated according the analyst's method requirements and the application type. In this manuscript, a review of the current guidelines and literature concerning bioanalytical validation parameters in a forensic context is given and discussed. In addition, suggestions for the experimental set-up, the pros and cons of statistical approaches and adequate acceptance criteria for the validation of bioanalytical applications are given. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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

PubMed

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

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

The Relationship between the Training Function and ISO-9000 Registration.

ERIC Educational Resources Information Center

Maxwell, Randy C.; Jost, Karen L.

ISO 9000 is one of a series of international standards providing guidelines and governing quality of products and services. The ISO 9000 certification demonstrates the capability of a supplier to control the processes that determine the acceptability of the product or service being supplied. This paper focuses on the training aspects of ISO 9000…

A Lesson Plan for the Enhancement of Training and Research in Academia by the Adaptation and Adoption of Good Laboratory Practice Guidelines

ERIC Educational Resources Information Center

Sitaraman, Ramakrishnan

2010-01-01

The implementation of good laboratory practices (GLPs) is recognized by the biotechnology and pharmaceutical industries as being critical for ensuring the international acceptability of products. However, as universities and colleges (and research organizations) do not necessarily work under similar constraints, actual laboratory practices vary…

Online advertising and marketing claims by providers of proton beam therapy: are they guideline-based?

PubMed

Corkum, Mark T; Liu, Wei; Palma, David A; Bauman, Glenn S; Dinniwell, Robert E; Warner, Andrew; Mishra, Mark V; Louie, Alexander V

2018-03-15

Cancer patients frequently search the Internet for treatment options, and hospital websites are seen as reliable sources of knowledge. Guidelines support the use of proton radiotherapy in specific disease sites or on clinical trials. This study aims to evaluate direct-to-consumer advertising content and claims made by proton therapy centre (PTC) websites worldwide. Operational PTC websites in English were identified through the Particle Therapy Co-Operative Group website. Data abstraction of website content was performed independently by two investigators. Eight international guidelines were consulted to determine guideline-based indications for proton radiotherapy. Univariate and multivariate logistic regression models were used to determine the characteristics of PTC websites that indicated proton radiotherapy offered greater disease control or cure rates. Forty-eight PTCs with 46 English websites were identified. 60·9% of PTC websites claimed proton therapy provided improved disease control or cure. U.S. websites listed more indications than international websites (15·5 ± 5·4 vs. 10·4 ± 5·8, p = 0·004). The most common disease sites advertised were prostate (87·0%), head and neck (87·0%) and pediatrics (82·6%), all of which were indicated in least one international guideline. Several disease sites advertised were not present in any consensus guidelines, including pancreatobiliary (52·2%), breast (50·0%), and esophageal (43·5%) cancers. Multivariate analysis found increasing number of disease sites and claiming their centre was a local or regional leader in proton radiotherapy was associated with indicating proton radiotherapy offers greater disease control or cure. Information from PTC websites often differs from recommendations found in international consensus guidelines. As online marketing information may have significant influence on patient decision-making, alignment of such information with accepted guidelines and consensus opinion should be adopted by PTC providers.

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.

Report from AmSECT's International Consortium for Evidence-Based Perfusion: American Society of Extracorporeal Technology Standards and Guidelines for Perfusion Practice: 2013.

PubMed

Baker, Robert A; Bronson, Shahna L; Dickinson, Timothy A; Fitzgerald, David C; Likosky, Donald S; Mellas, Nicholas B; Shann, Kenneth G

2013-09-01

One of the roles of a professional society is to develop standards and guidelines of practice as an instrument to guide safe and effective patient care. The American Society of Extracorporeal Technology (AmSECT) first published its Essentials for Perfusion Practice, Clinical Function: Conduct of Extracorporeal Circulation in 1993. The International Consortium for Evidence-Based Perfusion (ICEBP), a committee within AmSECT, was tasked with updating this document in 2010. The aim of this report is to describe the method of development and content of AmSECT's new professional standards and guidelines. The ICEBP committee independently evaluated and provided input regarding the current "Essentials and Guidelines." Structural changes were made to the entire document, and a draft document was developed, presented, and circulated to the AmSECT Board of Directors and broader membership for comment. Informed by these reviews, a revised document was then presented to the Society for a membership vote. The final document consists of 15 areas of practice covered by 50 Standards and 38 Guidelines (see Appendix 1) with the first standard focusing on the development of institutional protocols to support their implementation and use. A majority of the membership voted to accept the document (81.2% of the voting membership accepting, 18.8% rejecting). After an audit of the balloting process by AmSECT's Ethics Committee, the results were reported to the membership and the document was officially adopted on July 24, 2013. The Standards and Guidelines will serve as a useful guide for cardiac surgical teams that wish to develop institution-specific standards and guidelines to improve the reliability, safety, and effectiveness of adult cardiopulmonary bypass. The ICEBP recognizes that the development of a Standards and Guidelines statement alone will not change care. Safe, reliable, and effective care will be best served through the development and implementation of institutional protocols based on these standards. AmSECT's Standards and Guidelines for Perfusion Practice reflect the changing landscape of our profession as we work toward a safer and optimal provision of cardiopulmonary bypass for all our patients as well as a work environment that is supportive of delivering this care. standards, guidelines, cardiopulmonary bypass, perfusion, cardiac surgery.

Occupational therapy and physiotherapy for the patient with burns: principles and management guidelines.

PubMed

Simons, M; King, S; Edgar, D

2003-01-01

Clinical practice guidelines are a tool to assist with clinical decision making. They provide information about the care for a condition and make recommendations based on research evidence, which can be adapted locally. A focus group within the Allied Health Interest Group of the Australian and New Zealand Burn Association has compiled the "Occupational Therapy and Physiotherapy for the Patient with Burns--Principles and Management Guidelines." These guidelines are designed as a practical guide to the relevant clinical knowledge and therapy intervention techniques required for effective patient management. Content areas include respiratory management, edema management, splinting and positioning, physical function (mobility, function, exercise), scar management, and psychosocial and mutual elements. The document has undergone extensive review by members of the Australian and New Zealand Burn Association to ensure clarity, internal consistency, and acceptability. The guidelines have been endorsed by the Australian and New Zealand Burn Association. An abridged version of the guidelines is included in this article, with the full document available from www.anzba.org.au.

[A reporting tool for practice guidelines in health care: the RIGHT statement].

PubMed

Chen, Yaolong; Yang, Kehu; Marušić, Ana; Qaseem, Amir; Meerpohl, Joerg J; Flottorp, Signe; Akl, Elie A; Schünemann, Holger J; Chan, Edwin S Y; Falck-Ytter, Yngve; Ahmed, Faruque; Barber, Sarah; Chen, Chiehfeng; Zhang, Mingming; Xu, Bin; Tian, Jinhui; Song, Fujian; Shang, Hongcai; Tang, Kun; Wang, Qi; Norris, Susan L; Labonté, Valérie C; Möhler, Ralph; Kopp, Ina; Nothacker, Monika; Meerpohl, Joerg J

2017-11-01

The quality of reporting practice guidelines is often poor, and there is no widely accepted guidance or standards for such reporting in health care. The international RIGHT (Reporting Items for practice Guidelines in HealThcare) Working Group was established to address this gap. The group followed an existing framework for developing guidelines for health research reporting and the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network approach. A checklist and an explanation and elaboration statement were developed. The RIGHT checklist includes 22 items that are considered essential for good reporting of practice guidelines: basic information (items 1 to 4), background (items 5 to 9), evidence (items 10 to 12), recommendations (items 13 to 15), review and quality assurance (items 16 and 17), funding and declaration and management of interests (items 18 and 19), and other information (items 20 to 22). The RIGHT checklist can assist developers in reporting guidelines, support journal editors and peer reviewers when considering guideline reports, and help health care practitioners understand and implement a guideline. Copyright © 2017. Published by Elsevier GmbH.

Marginal lung donors: A diminishing margin of safety?

PubMed

Botha, Phil; Fisher, Andrew J; Dark, John H

2006-11-27

Lung donor shortages have resulted in the critical appraisal of cadaveric donor acceptability criteria and the gradual relaxation of once strict guidelines. Many centers have reported their results with these "extended criteria" donors and an increasing number of multicenter registry studies have also been published. The results have been contradictory and leave many questions unanswered. Important new data has however come to light since the last review of the subject by the International Society for Heart and Lung Transplantation Pulmonary Council. We review the current literature focusing on recent developments in the pursuit of an expanded lung donor pool with acceptable outcomes.

A method for developing standardised interactive education for complex clinical guidelines

PubMed Central

2012-01-01

Background Although systematic use of the Perinatal Society of Australia and New Zealand internationally endorsed Clinical Practice Guideline for Perinatal Mortality (PSANZ-CPG) improves health outcomes, implementation is inadequate. Its complexity is a feature known to be associated with non-compliance. Interactive education is effective as a guideline implementation strategy, but lacks an agreed definition. SCORPIO is an educational framework containing interactive and didactic teaching, but has not previously been used to implement guidelines. Our aim was to transform the PSANZ-CPG into an education workshop to develop quality standardised interactive education acceptable to participants for learning skills in collaborative interprofessional care. Methods The workshop was developed using the construct of an educational framework (SCORPIO), the PSANZ-CPG, a transformation process and tutor training. After a pilot workshop with key target and stakeholder groups, modifications were made to this and subsequent workshops based on multisource written observations from interprofessional participants, tutors and an independent educator. This participatory action research process was used to monitor acceptability and educational standards. Standardised interactive education was defined as the attainment of content and teaching standards. Quantitative analysis of positive expressed as a percentage of total feedback was used to derive a total quality score. Results Eight workshops were held with 181 participants and 15 different tutors. Five versions resulted from the action research methodology. Thematic analysis of multisource observations identified eight recurring education themes or quality domains used for standardisation. The two content domains were curriculum and alignment with the guideline and the six teaching domains; overload, timing, didacticism, relevance, reproducibility and participant engagement. Engagement was the most challenging theme to resolve. Tutors identified all themes for revision whilst participants identified a number of teaching but no content themes. From version 1 to 5, a significant increasing trend in total quality score was obtained; participants: 55%, p=0.0001; educator: 42%, p=0.0004; tutor peers: 57%, p=0.0001. Conclusions Complex clinical guidelines can be developed into a workshop acceptable to interprofessional participants. Eight quality domains provide a framework to standardise interactive teaching for complex clinical guidelines. Tutor peer review is important for content validity. This methodology may be useful for other guideline implementation. PMID:23131137

A method for developing standardised interactive education for complex clinical guidelines.

PubMed

Vaughan, Janet I; Jeffery, Heather E; Raynes-Greenow, Camille; Gordon, Adrienne; Hirst, Jane; Hill, David A; Arbuckle, Susan

2012-11-06

Although systematic use of the Perinatal Society of Australia and New Zealand internationally endorsed Clinical Practice Guideline for Perinatal Mortality (PSANZ-CPG) improves health outcomes, implementation is inadequate. Its complexity is a feature known to be associated with non-compliance. Interactive education is effective as a guideline implementation strategy, but lacks an agreed definition. SCORPIO is an educational framework containing interactive and didactic teaching, but has not previously been used to implement guidelines. Our aim was to transform the PSANZ-CPG into an education workshop to develop quality standardised interactive education acceptable to participants for learning skills in collaborative interprofessional care. The workshop was developed using the construct of an educational framework (SCORPIO), the PSANZ-CPG, a transformation process and tutor training. After a pilot workshop with key target and stakeholder groups, modifications were made to this and subsequent workshops based on multisource written observations from interprofessional participants, tutors and an independent educator. This participatory action research process was used to monitor acceptability and educational standards. Standardised interactive education was defined as the attainment of content and teaching standards. Quantitative analysis of positive expressed as a percentage of total feedback was used to derive a total quality score. Eight workshops were held with 181 participants and 15 different tutors. Five versions resulted from the action research methodology. Thematic analysis of multisource observations identified eight recurring education themes or quality domains used for standardisation. The two content domains were curriculum and alignment with the guideline and the six teaching domains; overload, timing, didacticism, relevance, reproducibility and participant engagement. Engagement was the most challenging theme to resolve. Tutors identified all themes for revision whilst participants identified a number of teaching but no content themes. From version 1 to 5, a significant increasing trend in total quality score was obtained; participants: 55%, p=0.0001; educator: 42%, p=0.0004; tutor peers: 57%, p=0.0001. Complex clinical guidelines can be developed into a workshop acceptable to interprofessional participants. Eight quality domains provide a framework to standardise interactive teaching for complex clinical guidelines. Tutor peer review is important for content validity. This methodology may be useful for other guideline implementation.

Customized Clinical Practice Guidelines for Management of Adult Cataract in Iran

PubMed Central

Rajavi, Zhaleh; Javadi, Mohammad Ali; Daftarian, Narsis; Safi, Sare; Nejat, Farhad; Shirvani, Armin; Ahmadieh, Hamid; Shahraz, Saeid; Ziaei, Hossein; Moein, Hamidreza; Motlagh, Behzad Fallahi; Feizi, Sepehr; Foroutan, Alireza; Hashemi, Hassan; Hashemian, Seyed Javad; Jabbarvand, Mahmoud; Jafarinasab, Mohammad Reza; Karimian, Farid; Mohammad-Rabei, Hossein; Mohammadpour, Mehrdad; Nassiri, Nader; Panahi-Bazaz, Mahmoodreza; Rohani, Mohammad Reza; Sedaghat, Mohammad Reza; Sheibani, Kourosh

2015-01-01

Purpose: To customize clinical practice guidelines (CPGs) for cataract management in the Iranian population. Methods: First, four CPGs (American Academy of Ophthalmology 2006 and 2011, Royal College of Ophthalmologists 2010, and Canadian Ophthalmological Society 2008) were selected from a number of available CPGs in the literature for cataract management. All recommendations of these guidelines, together with their references, were studied. Each recommendation was summarized in 4 tables. The first table showed the recommendation itself in clinical question components format along with its level of evidence. The second table contained structured abstracts of supporting articles related to the clinical question with their levels of evidence. The third table included the customized recommendation of the internal group respecting its clinical advantage, cost, and complications. In the fourth table, the internal group their recommendations from 1 to 9 based on the customizing capability of the recommendation (applicability, acceptability, external validity). Finally, customized recommendations were sent one month prior to a consensus session to faculty members of all universities across the country asking for their comments on recommendations. Results: The agreed recommendations were accepted as conclusive while those with no agreement were discussed at the consensus session. Finally, all customized recommendations were codified as 80 recommendations along with their sources and levels of evidence for the Iranian population. Conclusion: Customization of CPGs for management of adult cataract for the Iranian population seems to be useful for standardization of referral, diagnosis and treatment of patients. PMID:27051491

A new framing approach in guideline development to manage different sources of knowledge.

PubMed

Lukersmith, Sue; Hopman, Katherine; Vine, Kristina; Krahe, Lee; McColl, Alexander

2017-02-01

Contemporary guideline methodology struggles to consider context and information from different sources of knowledge besides quantitative research. Return to work programmes involve multiple components and stakeholders. If the guideline is to be relevant and practical for a complex intervention such as return to work, it is essential to use broad sources of knowledge. This paper reports on a new method in guideline development to manage different sources of knowledge. The method used framing for the return-to-work guidance within the Clinical Practice Guidelines for the Management of Rotator Cuff Syndrome in the Workplace. The development involved was a multi-disciplinary working party of experts including consumers. The researchers considered a broad range of research, expert (practice and experience) knowledge, the individual's and workplace contexts, and used framing with the International Classification of Functioning, Disability and Health. Following a systematic database search on four clinical questions, there were seven stages of knowledge management to extract, unpack, map and pack information to the ICF domains framework. Companion graded recommendations were developed. The results include practical examples, user and consumer guides, flow charts and six graded or consensus recommendations on best practice for return to work intervention. Our findings suggest using framing in guideline methodology with internationally accepted frames such as the ICF is a reliable and transparent framework to manage different sources of knowledge. Future research might examine other examples and methods for managing complexity and using different sources of knowledge in guideline development. © 2016 John Wiley & Sons, Ltd.

[Indication and Evidence of Internationally Developed Online Coaches as Intervention for Mental Illness - a Meta-Review].

PubMed

Stein, Janine; Röhr, Susanne; Luck, Tobias; Löbner, Margrit; Riedel-Heller, Steffi G

2018-01-01

The aim of the study was to investigate the current state of research concerning internationally developed Online Coaches for treatment support and prevention of mental disorders. Evidence and effectiveness of the Online Coaches ought to be explored. A systematic literature search was performed in international databases in order to provide a meta-review of existing Online Coaches for mental disorders. The assessment of the methodological quality and evidence of the studies was based on the established guidelines of the Scottish Intercollegiate Guideline Network. 52 studies (24 meta-analyses, 16 systematic reviews, 2 health-technology assessment reports, and 10 RCT studies) were identified. The efficacy was demonstrated for a variety of Online Coaches for mental disorders, especially for anxiety and depressive disorders, insomnia, and post-traumatic stress disorders, with predominantly acceptable and high quality. The present work provides an overview of internationally developed Online Coaches in the field of mental health care. Online Coaches can serve as a useful supplement to the treatment and prevention of mental disorders. © Georg Thieme Verlag KG Stuttgart · New York.

The use of forensic DNA analysis in humanitarian forensic action: The development of a set of international standards.

PubMed

Goodwin, William H

2017-09-01

DNA analysis was first applied to the identification of victims of armed conflicts and other situations of violence (ACOSV) in the mid-1990s, starting in South America and the Balkans. Argentina was the first country to establish a genetic database specifically developed to identify disappeared children. Following on from these programs the early 2000s marked major programs, using a largely DNA-led approach, identifying missing persons in the Balkans and following the attack on the World Trade Center in New York. These two identification programs significantly expanded the magnitude of events to which DNA analysis was used to help provide the identity of missing persons. Guidelines developed by Interpol (2014) [1] related to best practice for identification of human remains following DVI type scenarios have been widely disseminated around the forensic community; in numerous cases these guidelines have been adopted or incorporated into national guidelines/standards/practice. However, given the complexity of many humanitarian contexts in which forensic science is employed there is a lack of internationally accepted guidelines, related to these contexts, for authorities to reference. In response the Argentine government's Human Rights Division in the Ministry of Foreign Affairs and Worship (MREC) proposed that the United Nations (UN) should promote best practice in the use of forensic genetics in humanitarian forensic action: this was adopted by the UN in Resolutions A/HRC/RES/10/26 and A/HRC/RES/15/5. Following on from the adoption of the resolutions MREC has coordinated, with the support of the International Committee of the Red Cross (ICRC), the drafting of a set of guidelines (MREC, ICRC, 2014) [2], with input from national and international agencies. To date the guidelines have been presented to South America's MERCOSUR and the UN and have been disseminated to interested parties. Copyright © 2017 Elsevier B.V. All rights reserved.

Guidelines for project-level traffic forecasting for Hawaii Department of Transportation.

DOT National Transportation Integrated Search

2015-12-01

These guidelines describe both best practice and acceptable practice for performing project-level traffic : forecasts for the State of Hawaii. The guidelines describe a number of techniques and options that are all : acceptable within their intended ...

Surrogate outcomes: experiences at the Common Drug Review

PubMed Central

2013-01-01

Background Surrogate outcomes are a significant challenge in drug evaluation for health technology assessment (HTA) agencies. The research objectives were to: identify factors associated with surrogate use and acceptability in Canada’s Common Drug Review (CDR) recommendations, and compare the CDR with other HTA or regulatory agencies regarding surrogate concerns. Methods Final recommendations were identified from CDR inception (September 2003) to December 31, 2010. Recommendations were classified by type of outcome (surrogate, final, other) and acceptability of surrogates (determined by the presence/absence of statements of concern regarding surrogates). Descriptive and statistical analyses examined factors related to surrogate use and acceptability. For thirteen surrogate-based submissions, recommendations from international HTA and regulatory agencies were reviewed for statements about surrogate acceptability. Results Of 156 final recommendations, 68 (44%) involved surrogates. The overall ‘do not list’ (DNL) rate was 48%; the DNL rate for surrogates was 41% (p = 0.175). The DNL rate was 64% for non-accepted surrogates (n = 28) versus 25% for accepted surrogates (odds ratio 5.4, p = 0.002). Clinical uncertainty, use of economic evidence over price alone, and a premium price were significantly associated with non-accepted surrogates. Surrogates were used most commonly for HIV, diabetes, rare diseases, cardiovascular disease and cancer. For the subset of drugs studied, other HTA agencies did not express concerns for most recommendations, while regulatory agencies frequently stated surrogate acceptance. Conclusions The majority of surrogates were accepted at the CDR. Non-accepted surrogates were significantly associated with clinical uncertainty and a DNL recommendation. There was inconsistency of surrogate acceptability across several international agencies. Stakeholders should consider collaboratively establishing guidelines on the use, validation, and acceptability of surrogates. PMID:24341379

The Good Clinical Practice guideline and its interpretation - perceptions of clinical trial teams in sub-Saharan Africa.

PubMed

Vischer, N; Pfeiffer, C; Joller, A; Klingmann, I; Ka, A; Kpormegbe, S K; Burri, C

2016-08-01

To explore the advantages and challenges of working with the Good Clinical Practice (GCP)-International Conference of Harmonization (ICH) E6 guideline and its interpretation from the perspective of clinical trial teams based in sub-Saharan Africa. We conducted 60 key informant interviews with clinical trial staff at different levels in clinical research centres in Kenya, Ghana, Burkina Faso and Senegal and thematically analysed the responses. Clinical trial teams perceived working with ICH-GCP as highly advantageous and regarded ICH-GCP as applicable to their setting and efficiently applied. Only for informed consent did some clinical trial staff (one-third) perceive the guideline as insufficiently applicable. Specific challenges included meeting the requirements for written and individual consent, conditions for impartial witnesses for illiterates or legally acceptable representatives for children, guaranteeing voluntary participation and ensuring full understanding of the consent given. It was deemed important to have ICH-GCP compliance monitored by relevant ethics committees and regulatory authorities, without having guidelines applied overcautiously. Clinical trial teams in sub-Saharan Africa perceived GCP as a helpful guideline, despite having been developed by northern organisations and despite the high administrative burden of implementing it. To mitigate consent challenges, we suggest adapting GCP and making use of the flexibility it offers. © 2016 The Authors. Tropical Medicine & International Health Published by John Wiley & Sons Ltd.

Evidence-based practice guidelines in OHS: are they agree-able?

PubMed

Hulshof, Carel; Hoenen, John

2007-01-01

The purpose of this study was to evaluate the acceptance, validity, reliability and feasibility of the AGREE (Appraisal of Guidelines and REsearch and Evaluation) instrument to assess the quality of evidence-based practice guidelines for occupational physicians. In total, 6 practice guidelines of the Netherlands Society of Occupational Medicine (NVAB) were appraised by 20 occupational health professionals and experts in guideline development or implementation. Although appraisers often disagreed on individual item scores, the internal consistency and interrater reliability for most domains was sufficient. The AGREE criteria were in general considered relevant and no major suggestions for additional items for use in the context of occupational health were brought up. The domain scores for the individual guidelines show a wide variety: 'applicability' had on average the lowest mean score (53%) while 'scope and purpose' had the highest one (87%). Low scores indicate where improvements are possible and necessary, e.g. by providing more information about the development. Key experts in occupational health report that AGREE is a relevant and easy to use instrument to evaluate quality aspects and the included criteria provide a good framework to develop or update evidence-based practice guidelines in the field of occupational health.

Acceptable Reimbursable Costs Guidelines in Determining Community Services Fees.

ERIC Educational Resources Information Center

Petersen, Allan; And Others

Guidelines for California's community colleges are proposed with respect to acceptable reimbursable costs in determining community services fees. These guidelines are offered in the aftermath of the 1984 passage of an amendment to the Education Code, section 78305, which prohibits expenditures of State General Fund monies to establish and maintain…

Tailoring International Pressure Ulcer Prevention Guidelines for Nigeria: A Knowledge Translation Study Protocol.

PubMed

Ilesanmi, Rose Ekama; Gillespie, Brigid M; Adejumo, Prisca Olabisi; Chaboyer, Wendy

2015-07-28

The 2014 International Pressure Ulcer Prevention (PUP) Clinical Practice Guidelines (CPG) provides the most current evidence based strategies to prevent Pressure Ulcer (PU). The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable. To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. Guided by the Knowledge to Action (KTA) framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle. A PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care. Using KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources.

Guidelines for cytopathologic diagnosis of epithelioid and mixed type malignant mesothelioma. Complementary statement from the International Mesothelioma Interest Group, also endorsed by the International Academy of Cytology and the Papanicolaou Society of Cytopathology

PubMed Central

Hjerpe, Anders; Ascoli, Valeria; Bedrossian, Carlos; Boon, Mathilde; Creaney, Jenette; Davidson, Ben; Dejmek, Annika; Dobra, Katalin; Fassina, Ambrogio; Field, Andrew; Firat, Pinar; Kamei, Toshiaki; Kobayashi, Tadao; Michael, Claire W.; Önder, Sevgen; Segal, Amanda; Vielh, Philippe

2015-01-01

To provide practical guidelines for the cytopathologic diagnosis of malignant mesothelioma (MM). Cytopathologists involved in the International Mesothelioma Interest Group (IMIG) and the International Academy of Cytology (IAC), who have an interest in the field contributed to this update. Reference material includes peer-reviewed publications and textbooks. This article is the result of discussions during and after the IMIG 2012 conference in Boston, followed by thorough discussions during the 2013 IAC meeting in Paris. Additional contributions have been obtained from cytopathologists and scientists, who could not attend these meetings, with final discussions and input during the IMIG 2014 conference in cape town. During the previous IMIG biennial meetings, thorough discussions have resulted in published guidelines for the pathologic diagnosis of MM. However, previous recommendations have stated that the diagnosis of MM should be based on histological material only.[12] Accumulating evidence now indicates that the cytological diagnosis of MM supported by ancillary techniques is as reliable as that based on histopathology, although the sensitivity with cytology may be somewhat lower.[345] Recognizing that noninvasive diagnostic modalities benefit both the patient and the health system, future recommendations should include cytology as an accepted method for the diagnosis of this malignancy.[67] The article describes the consensus of opinions of the authors on how cytology together with ancillary testing can be used to establish a reliable diagnosis of MM. PMID:26681974

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.

Mono-disciplinary or multidisciplinary back pain guidelines? How can we achieve a common message in primary care?

PubMed

Breen, Alan C; van Tulder, Maurits W; Koes, Bart W; Jensen, Irene; Reardon, Rhoda; Bronfort, Gert

2006-05-01

Description of a workshop entitled "Sharing Guidelines for Low Back Pain Between Primary Health Care Providers: Toward a Common Message in Primary Care" that was held at the Fifth International Forum on Low Back Pain in Primary Care in Canada in May 2002. Despite a considerable degree of acceptance of current evidence-based guidelines, in practice, primary health care providers still do not share a common message. The objective of the workshop was to describe the outcomes of a workshop on the sharing of guidelines in primary care. The Fifth International Forum on Low Back Pain Research in Primary Care focused on relations between stakeholders in the primary care management of back pain. Participants in this workshop contributed to an open discussion on "how and why" evidence-based guidelines about back pain do or do not work in practice. Ways to minimise the factors that inhibit implementation were discussed in the light of whether guidelines are mono-disciplinary or multidisciplinary. Examples of potential issues for debate were contained in introductory presentations. The prospects for improving implementation and reducing barriers, and the priorities for future research, were then considered by an international group of researchers. This paper summarises the conclusions of three researcher subgroups that focused on the sharing of guidelines under the headings of: (1) the content, (2) the development process, and (3) implementation. How to share the evidence and make it meaningful to practice stakeholders is the main challenge of guideline implementation. There is a need to consider the balance between the strength of evidence in multidisciplinary guidelines and the utility/feasibility of mono-disciplinary guidelines. The usefulness of both mono-disciplinary and multidisciplinary guidelines was agreed on. However, in order to achieve consistent messages, mono-disciplinary guidelines should have a multidisciplinary parent. In other words, guidelines should be developed and monitored by a multidisciplinary team, but may be transferred to practice by mono-disciplinary messengers. Despite general agreement that multi-faceted interventions are most effective for implementing guidelines, the feasibility of doing this in busy clinical settings is questioned. Research is needed from local implementation pilots and quality monitoring studies to understand how to develop and deliver the contextual understanding required. This relates to processes of care as well as outcomes, and to social factors and policymaking as well as health care interventions. We commend these considerations to all who are interested in the challenges of achieving better-integrated, evidence-based care for people with back pain.

A Retrospective Performance Assessment of the Developmental Neurotoxicity Study in Support of OECD Test Guideline 426

PubMed Central

Makris, Susan L.; Raffaele, Kathleen; Allen, Sandra; Bowers, Wayne J.; Hass, Ulla; Alleva, Enrico; Calamandrei, Gemma; Sheets, Larry; Amcoff, Patric; Delrue, Nathalie; Crofton, Kevin M.

2009-01-01

Objective We conducted a review of the history and performance of developmental neurotoxicity (DNT) testing in support of the finalization and implementation of Organisation of Economic Co-operation and Development (OECD) DNT test guideline 426 (TG 426). Information sources and analysis In this review we summarize extensive scientific efforts that form the foundation for this testing paradigm, including basic neurotoxicology research, interlaboratory collaborative studies, expert workshops, and validation studies, and we address the relevance, applicability, and use of the DNT study in risk assessment. Conclusions The OECD DNT guideline represents the best available science for assessing the potential for DNT in human health risk assessment, and data generated with this protocol are relevant and reliable for the assessment of these end points. The test methods used have been subjected to an extensive history of international validation, peer review, and evaluation, which is contained in the public record. The reproducibility, reliability, and sensitivity of these methods have been demonstrated, using a wide variety of test substances, in accordance with OECD guidance on the validation and international acceptance of new or updated test methods for hazard characterization. Multiple independent, expert scientific peer reviews affirm these conclusions. PMID:19165382

Alleviating gender role strain in adult men with traumatic brain injury: an evaluation of a set of guidelines for occupational therapy.

PubMed

Gutman, S A

1999-01-01

A set of guidelines to assist men with traumatic brain injury (TBI) to alleviate gender role strain was assessed to determine its effectiveness and acceptability to participants. Four adult male participants with TBI received the intervention (the set of guidelines) for 4 months. The intervention consisted of rebuilding self-identified gendered social roles and activities. Focused interviews and participant observation were used to determine whether gender role strain changed after intervention. The participants reported that the intervention enabled them to (a) enhance their gender role satisfaction through newly rebuilt roles and activities, (b) attain certain long-held personal goals, (c) feel more like members of society, (d) perceive a greater congruency between their internal self-images and external postinjury roles, (e) learn more about personal skills and values as men, (f) feel more comfortable using help-seeking behaviors, (g) feel a sense of shared experience and affinity, (h) feel more understood and accepted, and (i) contribute to others through community member roles. The set of guidelines for alleviating gender role strain was effective in assisting these participants to enhance their gender role satisfaction through rebuilding desired male-gendered social roles and activities. Dating, courtship, extended family member, community member, friend, and mentor-protege roles, lost as a result of TBI, were rebuilt through gender-neutral activities that facilitated a sense of volitional control, competency, and normalcy. Nonetheless, the men continued to lack desired rites of passage leading from male adolescence to adulthood.

Stakeholders' perceptions of rehabilitation services for individuals living with disability: a survey study.

PubMed

Darzi, Andrea J; Officer, Alana; Abualghaib, Ola; Akl, Elie A

2016-01-08

The World Health Organization (WHO) was tasked with developing health system guidelines for the implementation of rehabilitation services. Stakeholders' perceptions are an essential factor to take into account in the guideline development process. The aim of this study was to assess stakeholders' perceived feasibility and acceptability of eighteen rehabilitation services and the values they attach to ten rehabilitation outcomes. We disseminated an online self-administered questionnaire through a number of international and regional organizations from the different WHO regions. Eligible individuals included persons with disability, caregivers of persons with disability, health professionals, administrators and policy makers. The answer options consisted of a 9-point Likert scale. Two hundred fifty three stakeholders participated. The majority of participants were health professional (64 %). In terms of outcomes, 'Increasing access' and 'Optimizing utilization' were the top service outcomes rated as critical (i.e., 7, 8 or 9 on the Likert scale) by >70 % of respondents. 'Fewer hospital admissions', 'Decreased burden of care' and 'Increasing longevity' were the services rated as least critical (57 %, 63 % and 58 % respectively). In terms of services, 'Community based rehabilitation' and 'Home based rehabilitation' were found to be both definitely feasible and acceptable (75 % and 74 % respectively). 'Integrated and decentralized rehabilitation services' was found to be less feasible than acceptable according to stakeholders (61 % and 71 % respectively). As for 'Task shifting', most stakeholders did not appear to find task shifting as either definitely feasible or definitely acceptable (63 % and 64 % respectively). The majority of stakeholder's perceived 'Increasing access' and 'Optimizing utilization' as most critical amongst rehabilitation outcomes. The feasibility of the 'Integrated and decentralized rehabilitation services' was perceived to be less than their acceptability. The majority of stakeholders found 'Task shifting' as neither feasible nor acceptable.

Abnormal uterine bleeding in reproductive-aged women.

PubMed

Matthews, Michelle L

2015-03-01

Abnormal uterine bleeding is a common medical condition with several causes. The International Federation of Gynecology and Obstetrics published guidelines in 2011 to develop universally accepted nomenclature and a classification system. In addition, the American College of Obstetrics and Gynecology recently updated recommendations on evaluation of abnormal uterine bleeding and indications for endometrial biopsies. This article reviews both medical and surgical treatments, including meta-analysis reviews of the most effective treatment options. Copyright © 2015 Elsevier Inc. All rights reserved.

Technical developments in international satellite business services

NASA Astrophysics Data System (ADS)

Tan, P. P.

At the conception of International Satellite Business Services (ISBS), it was a primary objective to provide flexibility for accommodating a variety of service requirements which might be established by mutual agreement between users. The design guidelines are to ensure that the space segment is efficiently utilized, while other satellite services are protected from interference. Other considerations are related to an acceptable earth segment cost, maximum connectivity in worldwide services, the capability of growth and a reasonably smooth transition into future systems, and the maintenance of high performance objectives. Attention is given to a system overview, the characteristics of satellites for ISBS, and technological developments with some application possibilities for ISBS.

Driving and diabetics on insulin therapy.

PubMed

Distiller, L A; Kramer, B D

1996-08-01

Patients with diabetes mellitus who require insulin therapy have always been thought to be at high risk of motor vehicle accidents, primarily because of the possibility of hypoglycaemic events while driving. There are, however, no specific guidelines in South Africa that allow for a rational decision as to when a diabetic is medically fit to drive. The Road Traffic Ordinance simply states that 'Patients with uncontrolled diabetes should be forbidden to drive'. No guidelines are given as to what constitutes 'uncontrolled diabetes'. The situation is not much clearer internationally, where various countries have different laws in this regard. Diabetics on insulin therapy are not restricted from driving private vehicles in any country, but the laws regarding commercial vehicle driving by diabetics on insulin are widely disparate. The actual increased risk of motor vehicle accidents incurred by diabetic drivers on insulin is also uncertain, there being wide variations in the risk rate in different publications. Literature review does suggest, however, that diabetics are probably at a slightly increased risk of traffic violations and accidents compared with the general population, but that this increased overall risk is slight and probably acceptable. There are, however, no known actual statistics for South Africa and any rational guidelines on driving for diabetics on insulin in this country will need to be based on international experience, mostly gleaned from the USA and Western Europe. The decision as to whether a diabetic on insulin should be allowed to drive (either a private vehicle or, more often, a commercial vehicle) is frequently left to the attending doctor. Appropriate guidelines, based on international experience, are suggested.

Mycological Research: instructions and guidelines for authors.

PubMed

Hawksworth, David L

2007-01-01

Instructions and guidelines for authors submitting papers to Mycological Research are provided. The journal is international and covers all fields of mycology, both fundamental and applied. It publishes news items, reviews, original papers, and book reviews. Contributions should be of interest to a wide spectrum of mycologists or make significant novel contributions. Papers with particularly exciting results are fast-tracked and prioritized for publication. Submission must be made online via the Elsevier Editorial System (ees.elsevier.com/mycres); hard copy submissions are no longer accepted. Information is provided on: scope and timeliness; submission of articles; manuscript preparation; tables; illustrations; spellings, numbers, chemical symbols, and abbreviations; voucher material; molecular data; taxonomic data; references; the decision-making process; copyright; author's copies; proofs; and further questions.

IPEM guidelines on dosimeter systems for use as transfer instruments between the UK primary dosimetry standards laboratory (NPL) and radiotherapy centres1

NASA Astrophysics Data System (ADS)

Morgan, A. M.; Aird, E. G. A.; Aukett, R. J.; Duane, S.; Jenkins, N. H.; Mayles, W. P. M.; Moretti, C.; Thwaites, D. I.

2000-09-01

United Kingdom dosimetry codes of practice have traditionally specified one electrometer for use as a secondary standard, namely the Nuclear Enterprises (NE) 2560 NPL secondary standard therapy level exposure meter. The NE2560 will become obsolete in the foreseeable future. This report provides guidelines to assist physicists following the United Kingdom dosimetry codes of practice in the selection of an electrometer to replace the NE2560 when necessary. Using an internationally accepted standard (BS EN 60731:1997) as a basis, estimated error analyses demonstrate that the uncertainty (one standard deviation) in a charge measurement associated with the NE2560 alone is approximately 0.3% under specified conditions. Following a review of manufacturers' literature, it is considered that modern electrometers should be capable of equalling this performance. Additional constructural and operational requirements not specified in the international standard but considered essential in a modern electrometer to be used as a secondary standard are presented.

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of adult isthmic spondylolisthesis.

PubMed

Kreiner, D Scott; Baisden, Jamie; Mazanec, Daniel J; Patel, Rakesh D; Bess, Robert S; Burton, Douglas; Chutkan, Norman B; Cohen, Bernard A; Crawford, Charles H; Ghiselli, Gary; Hanna, Amgad S; Hwang, Steven W; Kilincer, Cumhur; Myers, Mark E; Park, Paul; Rosolowski, Karie A; Sharma, Anil K; Taleghani, Christopher K; Trammell, Terry R; Vo, Andrew N; Williams, Keith D

2016-12-01

The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Adult Isthmic Spondylolisthesis features evidence-based recommendations for diagnosing and treating adult patients with isthmic spondylolisthesis. The guideline is intended to reflect contemporary treatment concepts for symptomatic isthmic spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of June 2013. NASS' guideline on this topic is the only guideline on adult isthmic spondylolisthesis accepted in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse. The purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with isthmic spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. This is a guideline summary review. This guideline is the product of the Adult Isthmic Spondylolisthesis Work Group of NASS' Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questionsto address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Adult Isthmic Spondylolisthesis guideline was accepted into the National Guideline Clearinghouse and will be updated approximately every 5 years. Thirty-one clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature. The evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with isthmic spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

Validation in Support of Internationally Harmonised OECD Test Guidelines for Assessing the Safety of Chemicals.

PubMed

Gourmelon, Anne; Delrue, Nathalie

Ten years elapsed since the OECD published the Guidance document on the validation and international regulatory acceptance of test methods for hazard assessment. Much experience has been gained since then in validation centres, in countries and at the OECD on a variety of test methods that were subjected to validation studies. This chapter reviews validation principles and highlights common features that appear to be important for further regulatory acceptance across studies. Existing OECD-agreed validation principles will most likely generally remain relevant and applicable to address challenges associated with the validation of future test methods. Some adaptations may be needed to take into account the level of technique introduced in test systems, but demonstration of relevance and reliability will continue to play a central role as pre-requisite for the regulatory acceptance. Demonstration of relevance will become more challenging for test methods that form part of a set of predictive tools and methods, and that do not stand alone. OECD is keen on ensuring that while these concepts evolve, countries can continue to rely on valid methods and harmonised approaches for an efficient testing and assessment of chemicals.

Commandant’s International Technical Series. Volume 7. Regulations and Guidelines for Inert Gas Systems

DTIC Science & Technology

1980-04-01

problems might arise that would not occur in the absence of the system. Such problems include generation of static charges and pyrophoric iron ...gas isolating valves should take into account the temperature ofogas at the offtake. Cast iron is acceptable for temperatures below C20 0. Valves... sulfide , *Each U.S.-flag tankship that is certified to carry Grades A, B, C, D, and some E liquids. i1 2 which can ignite spontaneously or emit sparks when

[Detailed methodological recommendations for the treatment of Clostridium difficile-associated diarrhea with faecal transplantation].

PubMed

Nagy, Gergely György; Várvölgyi, Csaba; Balogh, Zoltán; Orosi, Piroska; Paragh, György

2013-01-06

The incidence of Clostridium difficile associated enteral disease shows dramatic increase worldwide, with appallingly high treatment costs, mortality figures, recurrence rates and treatment refractoriness. It is not surprising, that there is significant interest in the development and introduction of alternative therapeutic strategies. Among these only stool transplantation (or faecal bacteriotherapy) is gaining international acceptance due to its excellent cure rate (≈92%), low recurrence rate (≈6%), safety and cost-effectiveness. Unfortunately faecal transplantation is not available for most patients, although based on promising international results, its introduction into the routine clinical practice is well justified and widely expected. The authors would like to facilitate this process, by presenting a detailed faecal transplantation protocol prepared in their Institution based on the available literature and clinical rationality. Officially accepted national methodological guidelines will need to be issued in the future, founded on the expert opinion of relevant professional societies and upcoming advances in this field.

Handheld solar light use, durability, and retention among women and girls in internally displaced persons camps in Haiti — 2013–2014

PubMed Central

Dynes, Michelle; Rosenthal, Mariana; Hulland, Erin; Hardy, Colleen; Torre, Lisandro; Tomczyk, Barbara

2016-01-01

During conflict and disasters, women and girls are at increased risk of gender based violence. International humanitarian guidelines call for the distribution of individual lighting to meet women and girls’ basic needs and to reduce risk of violence; however, little evidence exists to support these guidelines. This paper presents an evaluation of handheld solar light use, retention, and durability among women and girls living in two internally displaced persons camps in Port-au-Prince, Haiti. Data was gathered prospectively via five household surveys from August 2013 to April 2014; a total of 754 females participated in the study. Women reported going outside at night more frequently at the end of the study than at the beginning. The handheld solar lights were the most common source of lighting at endline, whereas candle and gas lamp use declined significantly over time. Results from a Life-Table survival analysis estimated that households had an 83% probability of still owning a functioning light after seven months. Given the frequent use, acceptable durability, and retention of the lights, donors and humanitarian organizations should consider supporting light distribution to women and girls in internally displaced persons camps to help meet their basic needs. PMID:27482509

Handheld solar light use, durability, and retention among women and girls in internally displaced persons camps in Haiti - 2013-2014.

PubMed

Dynes, Michelle; Rosenthal, Mariana; Hulland, Erin; Hardy, Colleen; Torre, Lisandro; Tomczyk, Barbara

2016-09-01

During conflict and disasters, women and girls are at increased risk of gender based violence. International humanitarian guidelines call for the distribution of individual lighting to meet women and girls' basic needs and to reduce risk of violence; however, little evidence exists to support these guidelines. This paper presents an evaluation of handheld solar light use, retention, and durability among women and girls living in two internally displaced persons camps in Port-au-Prince, Haiti. Data was gathered prospectively via five household surveys from August 2013 to April 2014; a total of 754 females participated in the study. Women reported going outside at night more frequently at the end of the study than at the beginning. The handheld solar lights were the most common source of lighting at endline, whereas candle and gas lamp use declined significantly over time. Results from a Life-Table survival analysis estimated that households had an 83% probability of still owning a functioning light after seven months. Given the frequent use, acceptable durability, and retention of the lights, donors and humanitarian organizations should consider supporting light distribution to women and girls in internally displaced persons camps to help meet their basic needs.

Guideline group composition and group processes: article 3 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

PubMed

Kunz, Regina; Fretheim, Atle; Cluzeau, Françoise; Wilt, Timothy J; Qaseem, Amir; Lelgemann, Monika; Kelson, Marcia; Guyatt, Gordon; Schünemann, Holger J

2012-12-01

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the third of a series of 14 articles that were prepared to advise guideline developers in respiratory and other diseases on considerations for group compositions and group processes in guideline development, and how this can be effectively integrated in the context of respiratory disease guidelines on a national and international level. We updated a review of the literature addressing group composition and group process, focusing on the following questions: 1. How to compose a functioning and representative guideline group; Who should be included in a guideline panel?; How to select organizations, groups, and individuals; What expertise is needed?; Consultation with non-included groups. 2. How to assure a functioning group process; How to make the process constructive; Balancing participation and finding agreement; Administrative support; What constitutes sufficient resources? Our conclusions are based on available evidence from published literature, experience from guideline developers, and workshop discussions. Formal studies addressing optimal processes in developing guidelines are limited, and experience from guideline organizations supplement the formal studies. When resources are available, guideline development groups should aim for multidisciplinary groups, including patients. Prerequisites for a multidisciplinary group include: a strong chair experienced in group facilitation with broad acceptance in the group, training the group in guideline methodology, and professional technical support. Formal consensus developing methods have proved effective in reaching agreement on the final recommendations.

Surgery for malignant pleural mesothelioma: an international guidelines review

PubMed Central

Cardillo, Giuseppe; Zirafa, Carmelina Cristina; Carleo, Francesco; Facciolo, Francesco; Fontanini, Gabriella; Mutti, Luciano; Melfi, Franca

2018-01-01

Currently there is no universally accepted surgical therapy for malignant pleural mesothelioma (MPM). The goal of surgery in this dismal disease is a macroscopic complete resection (MCR) and there are two types of intervention with a curative intent. At one side, there is the extrapleural pneumonectomy (EPP) which consists in an en-bloc resection of the lung, pleura, pericardium and diaphragm and at the other side, there is pleurectomy/decortication (P/D) a lung-sparing surgery. Initially, EPP was considered the only surgical option with a curative aim, but during the decades P/D have acquired a role of increasing importance in MPM therapy. Several randomized prospective trials are required to establish the best strategy in the treatment of pleural mesothelioma. Although which is the best surgical option remains unclear, the International Mesothelioma Interest Group (IMIG), recently have stated that the type of surgery depends on clinical factors and on individual surgical judgment and expertise. Moreover, according to the current evidence, the surgery should be performed in high-volume centres within multimodality protocols. The aim of this study is to examine the currently available international guidelines in the surgical diagnosis and treatment of MPM. PMID:29507797

Interventions for maintaining nasogastric feeding after stroke: An integrative review of effectiveness and acceptability.

PubMed

Mahoney, Catherine; Veitch, Linda

2018-02-01

To investigate the effectiveness and acceptability of interventions for maintaining nasogastric tubes in adult stroke patients. Internationally, incidence of cerebral vascular disease continues to increase and stroke is the largest cause of complex disability in adults. Dysphagia is common following a stroke which necessitates feeding via a nasogastric tube. Nasogastric tubes are not well tolerated by stroke patients and may be frequently dislodged. Hence, interventions such as tape, the nasal bridle/loop or hand mittens may be used to maintain nasogastric tube position. However, evidence around the effectiveness and acceptability of these interventions has not been reviewed and synthesised. Integrative literature review. Database searches in MEDLINE, PubMed, CINAHL, Scopus, Cochrane and EMBASE; manual reference list searches. Seven studies met the eligibility criteria and were included in the review. Evidence for the effectiveness of nasal bridle/loop and hand mittens to maintain nasogastric tube position in patients after a stroke is spare and methodologically poor, and especially limited around hand mittens use. There is insufficient evidence about the acceptability of both nasal bridle/loop and hand mittens among stroke patients. Current clinical practice is underpinned by assumptions around the acceptability of nasal bridle/loop and hand mittens to secure nasogastric tubes. This results in reliance on consensual judgement between professional, patients and their families to guide their use among individuals with dysphagia after stroke. Further research is required to assess the effectiveness of hand mittens and acceptability of both nasal bridle/loop and hand mittens among stroke patients to inform guideline development. Given the lack of evidence on the acceptability of hand mittens and nasal bridle/loop among stroke patients to inform evidence-based guidelines and protocols, healthcare professionals should reach consensus on their use by exercising clinical judgement and through consultation with patients (if possible) and their families. © 2017 John Wiley & Sons Ltd.

Preserving the Near-Earth Space Environment with Green Engineering and Operations

NASA Technical Reports Server (NTRS)

Johnson, Nicholas L.

2009-01-01

Green engineering and operations are essential to preserving the near-Earth space environment for future generations. The U.S. and the international aerospace community have been proactive in addressing the threat of the increasing orbital debris population and the risks to people and property from reentering debris. NASA has led this activity first by devoting resources to thoroughly understand the technical issues and then by developing effective and acceptable policies and guidelines. NASA also worked closely with the international community to ensure that the US aerospace industry was not placed at an economic disadvantage. In the long term, the removal of large orbital debris will be essential to the sustainability of space operations.

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

PubMed

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

2017-01-01

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

Barriers to pediatricians' adherence to American Academy of Pediatrics oral health referral guidelines: North Carolina general dentists' opinions.

PubMed

Long, C Marshall; Quinonez, Rocio B; Rozier, R Gary; Kranz, Ashley M; Lee, Jessica Y

2014-01-01

The purposes of this study were to: (1) assess knowledge, attitudes, and behaviors of North Carolina general dentists (GDs) regarding American Academy of Pediatrics (AAP) dental referral guidelines; and (2) determine factors that influence pediatricians' ability to comply with AAP guidelines. One thousand GDs were surveyed to determine barriers toward acceptance of physician referrals of infants and toddlers. The primary outcome using ordered logistic regression was GDs' acceptance of children described in five case scenarios, with different levels of risk and oral health status. GDs believed pediatricians should refer patients at risk for caries to a dentist. While 61 to 75 percent of GDs were willing to accept low caries risk referrals of infants and toddlers, only 35 percent would accept referrals when caries was present. Predictors of referral acceptance were correct knowledge about AAP guidelines (OR=2.0, 95%CI=1.2-3.3), confidence in providing preventive care to infants and toddlers (OR=2.6, 95%CI=1.3-4.9), and agreement that parents see importance in dental referrals (OR=2.1, 95% CI=1.2-3.6). This study identified factors influencing acceptance of pediatrician referrals for the age one dental visit among North Carolina GDs and highlighted challenges pediatricians face in referring young children for dental care.

Ethical Guidelines for Structural Interventions to Small-Scale Historic Stone Masonry Buildings.

PubMed

Hurol, Yonca; Yüceer, Hülya; Başarır, Hacer

2015-12-01

Structural interventions to historic stone masonry buildings require that both structural and heritage values be considered simultaneously. The absence of one of these value systems in implementation can be regarded as an unethical professional action. The research objective of this article is to prepare a guideline for ensuring ethical structural interventions to small-scale stone historic masonry buildings in the conservation areas of Northern Cyprus. The methodology covers an analysis of internationally accepted conservation documents and national laws related to the conservation of historic buildings, an analysis of building codes, especially Turkish building codes, which have been used in Northern Cyprus, and an analysis of the structural interventions introduced to a significant historic building in a semi-intact state in the walled city of Famagusta. This guideline covers issues related to whether buildings are intact or ruined, the presence of earthquake risk, the types of structural decisions in an architectural conservation project, and the values to consider during the decision making phase.

Chinese Guideline on allergen immunotherapy for allergic rhinitis

PubMed Central

Bao, Yixiao; Chen, Jianjun; Cheng, Lei; Guo, Yinshi; Hong, Suling; Kong, Weijia; Lai, He; Li, Houyong; Li, Huabin; Li, Jing; Li, Tianying; Lin, Xiaoping; Liu, Shixi; Liu, Zheng; Lou, Hongfei; Meng, Juan; Qiu, Qianhui; Shen, Kunling; Tang, Wei; Tao, Zezhang; Wang, Chengshuo; Wang, Xiangdong; Wei, Qingyu; Xiang, Li; Xie, Hua; Xu, Yu; Zhang, Gehua; Zhang, Yuan; Zheng, Yiwu; Zhi, Yuxiang; Chen, Dehua; Hong, Haiyu; Li, Quansheng; Liu, Lin; Meng, Yifan; Wang, Nan; Wang, Yihui; Zhou, Yue

2017-01-01

The present document is based on a consensus reached by a panel of experts from Chinese Society of Allergy (CSA) and Chinese Allergic Rhinitis Collaborative Research Group (C2AR2G). Allergen immunotherapy (AIT), has increasingly been used as a treatment for allergic rhinitis (AR) globally, as it has been shown to provide a long-term effect in improving nasal and ocular symptoms, reducing medication need, and improving quality of life. AIT is currently the only curative intervention that can potentially modify the immune system in individuals suffering from AR and prevent the development of new sensitization and the progression of disease from AR to asthma. Although the use of AIT is becoming more acceptable in China, to date no AR immunotherapy guideline from China is available for use by the international community. This document has thus been produced and covers the main aspects of AIT undertaken in China; including selection of patients for AIT, the allergen extracts available on the Chinese market, schedules and doses of allergen employed in different routes of AIT, assessment of effect and safety, patients’ administration and follow-up, and management of adverse reactions. The Chinese guideline for AR immunotherapy will thus serve as a reference point by doctors, healthcare professionals and organizations involved in the AIT of AR in China. Moreover, this guideline will serve as a source of information for the international community on AIT treatment strategies employed in China. PMID:29268533

Suborbital Safety Technical Committee- Summary of Proposed Standards & Guidelines

NASA Astrophysics Data System (ADS)

Quinn, Andy; Atencia Yepez, Amaya; Klicker, Michael; Howard, Diane; Verstraeten, Joram; Other Suborbital Safety TC Members

2013-09-01

There are currently no international safety standards and guidelines to assist designers, operators and authorities in the suborbital domain. There is a launch licensing regime in the United States (US) to assist the forerunners of the suborbital domain however this does not provide a safety approval for the vehicle against set standards or does not have an acceptable level of safety to achieve in terms of design or operation. In Europe a certification framework may be implemented however this (or any regulatory framework) is not in place as yet. This paper summarises the 5 tasks thus far completed by the International Association for the Advancement of Space Safety (IAASS) Suborbital Safety Technical Committee (SS TC) in terms of deriving standards and guidelines for the suborbital domain. The SS TC comprises members from the suborbital industry (US and European vehicle designers), safety experts, legal experts, medical/training experts, prospective spaceport operators and members from the US and European authorities (though these members cannot directly steer the standards and guidelines - they can merely review them for interest and comment on non-policy aspects). The SS TC has been divided into three working groups (WG): Regulatory WG, Technical WG and Operations WG. The 5 tasks that are summarised in this paper include: Regulatory WG - (Task 1) Clarify and promote regulatory framework for suborbital flights (including discussions on Space Law 'v' Air Law for suborbital domain); Technical WG - (Task 1) Defining & Alignment (globally) of Safety Criteria for Suborbital domain using industry best practices, (Task 2) Software/complex hardware certification for suborbital flights; Operations WG - (Task 1) Flight Crew and Spaceflight Participant Medical and Training Standards & Guidelines for suborbital flight, (Task 2) Spaceport Safety Management System. This paper also details the next set of standards and guidelines that will be derived by the SS TC. The paper concludes that these and future IAASS suborbital safety standards and guidelines are needed now and should beconsidered by the industry players before the first commercial flights expected late 2013/early 2014.

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).

The acceptance and feasibility of replacement feeding at 6 months as an HIV prevention method in Lilongwe, Malawi: Results from the BAN Study

PubMed Central

Parker, Megan E.; Bentley, Margaret E.; Chasela, Charles; Adair, Linda; Piwoz, Ellen G.; Jamieson, Denise J.; Ellington, Sascha; Kayira, Dumbani; Soko, Alice; Mkhomawanthu, Chimwemwe; Tembo, Martin; Martinson, Francis; van der Horst, Charles M.

2011-01-01

International guidelines recommend exclusive breastfeeding to 6 months among HIV-infected mothers choosing to breastfeed and cessation thereafter if replacement feeding is acceptable, feasible, affordable, sustainable and safe. When mothers wean they are challenged to provide an adequate replacement diet. This study investigates the use and acceptability of a lipid-based nutrient supplement (LNS) as a breastmilk substitute when provided to infants (6-12mo) of HIV-positive mothers, as part of the Breastfeeding, Antiretroviral, and Nutrition (BAN) Study. A sub-sample of mothers (n=45) participated in interviews that explored exclusive breastfeeding, weaning, and strategies to feed LNS. Mothers reported several weaning strategies, including gradual reduction of breastfeeding, expressing breastmilk into a cup, and separation of mother and child. LNS, a peanut-based micronutrient fortified paste, was highly accepted and incorporated into the traditional diet. Weaning is a feasible HIV prevention method among this population in Malawi when supported by the provision of LNS as a breastmilk substitute. PMID:21696245

A perspective on the selection of unrelated donors and cord blood units for transplantation

PubMed Central

Spellman, Stephen R.; Eapen, Mary; Logan, Brent R.; Mueller, Carlheinz; Rubinstein, Pablo; Setterholm, Michelle I.; Woolfrey, Ann E.; Confer, Dennis L.; Hurley, Carolyn K.

2012-01-01

Selection of a suitable graft for allogeneic hematopoietic stem cell transplantation involves consideration of both donor and recipient characteristics. Of primary importance is sufficient donor-recipient HLA matching to ensure engraftment and acceptable rates of GVHD. In this Perspective, the National Marrow Donor Program and the Center for International Blood and Marrow Transplant Research provide guidelines, based on large studies correlating graft characteristics with clinical transplantation outcomes, on appropriate typing strategies and matching criteria for unrelated adult donor and cord blood graft selection. PMID:22596257

Clinical trials and the new good clinical practice guideline in Japan. An economic perspective.

PubMed

Ono, S; Kodama, Y

2000-08-01

Japanese clinical trials have been drastically changing in response to the implementation of the International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guideline in 1997. The most important aim of the new guideline is to standardise the quality of clinical trials in the US, European Union and Japan, but it inevitably imposes substantial costs on investigators, sponsors and even patients in Japan. The study environment in Japan differs from that in the US in several ways: (i) historical lack of a formal requirement for informed consent; (ii) patients' attitudes to clinical trials in terms of expectation of positive outcomes; (iii) the implications of universal health insurance for trial participation; (iv) the historical absence of on-site monitoring by the sponsor, with the attendant effects on study quality; and (v) the lack of adequate financial and personnel support for the conduct of trials. Implementation of the new GCP guideline will improve the ethical and scientific quality of trials conducted in Japan. It may also lead to an improved relationship between medical professionals and patients if the requirement for explicit informed consent in clinical trials leads to the provision of a similar level of patient information in routine care and changes the traditional paternalistic attitude of physicians to patients. The initial response of the Japanese 'market' for clinical trials to the implementation of the ICH-GCP guideline has been clinical trial price increases and a decrease in the number of study contracts. These changes can be explained by applying a simple demand-supply scheme. Whether clinical trials undertaken in Japan become more or less attractive to the industry in the long term will depend on other factors such as international regulations on the acceptability of foreign clinical trials and the reform of domestic healthcare policies.

Impacts of iron and steelmaking facilities on soil quality.

PubMed

Strezov, Vladimir; Chaudhary, Chandrakant

2017-12-01

Iron and steel are highly important materials used in a wide range of products with important contribution to the economic development. The processes for making iron and steel are energy intensive and known to contribute to local pollution. Deposition of the metals may also have adverse impacts on soil quality, which requires detailed assessment. The aim of this study was to investigate the impacts of iron and steelmaking facilities on the local soil quality. Soil samples were collected in the vicinity of two steelmaking sites in Australia, one based on blast furnace steelmaking operation, while the second site was based on electric arc furnace steel recycling. The soil samples were compared to a background site where no industrial impact is expected. The soil collected near industrial facilities contained larger toxic metal contents, however this concentration for all priority metals was within the Australian National Environmental Protection Measure guidelines for the acceptable recreational soil quality. When compared to the international soil quality guidelines, some of the soils collected near the industrial sites, particularly near the blast furnace operated steelmaking, exceeded the arsenic, iron and manganese (according to United States Environmental Protection Agency guidelines) and chromium, copper and nickel concentrations (according to the Canadian guidelines). The work further provided a novel environmental assessment model taking into consideration the environmental and health impacts of each element. The environmental assessment revealed most significant contribution of manganese, followed by titanium, zinc, chromium and lead. Titanium was the second most important contributor to the soil quality, however this metal is currently not included in any of the international soil quality guidelines. Copyright © 2017 Elsevier Ltd. All rights reserved.

Appraising the methodological quality of the clinical practice guideline for diabetes mellitus using the AGREE II instrument: a methodological evaluation.

PubMed

Radwan, Mahmoud; Akbari Sari, Ali; Rashidian, Arash; Takian, Amirhossein; Abou-Dagga, Sanaa; Elsous, Aymen

2017-02-01

To evaluate the methodological quality of the Palestinian Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological evaluation. A cross-cultural adaptation framework was followed to translate and develop a standardised Translated Arabic Version of the AGREE II. Palestinian Primary Healthcare Centres. Sixteen appraisers independently evaluated the Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological quality of diabetic guideline. The Translated Arabic Version of the AGREE II showed an acceptable reliability and validity. Internal consistency ranged between 0.67 and 0.88 (Cronbach's α). Intra-class coefficient among appraisers ranged between 0.56 and 0.88. The quality of this guideline is low. Both domains 'Scope and Purpose' and 'Clarity of Presentation' had the highest quality scores (66.7% and 61.5%, respectively), whereas the scores for 'Applicability', 'Stakeholder Involvement', 'Rigour of Development' and 'Editorial Independence' were the lowest (27%, 35%, 36.5%, and 40%, respectively). The findings suggest that the quality of this Clinical Practice Guideline is disappointingly low. To improve the quality of current and future guidelines, the AGREE II instrument is extremely recommended to be incorporated as a gold standard for developing, evaluating or updating the Palestinian Clinical Practice Guidelines. Future guidelines can be improved by setting specific strategies to overcome implementation barriers with respect to economic considerations, engaging of all relevant end-users and patients, ensuring a rigorous methodology for searching, selecting and synthesising the evidences and recommendations, and addressing potential conflict of interests within the development group.

Hematology journals do not sufficiently adhere to reporting guidelines: a systematic review.

PubMed

Wayant, C; Smith, C; Sims, M; Vassar, M

2017-04-01

Essentials Reporting guidelines and trial/review registration aim to limit bias in research. We systematically reviewed hematology journals to examine the use of these policies. Forty-eight percent of journals made no use of these policies. Improving the use of reporting guidelines will improve research for all stakeholders. Background Reporting guidelines and trial/review registration policies have been instituted in order to minimize bias and improve research practices. Objective The objective of this study was to investigate the policies of hematology journals concerning reporting guideline adoption and trial/review registration. Methods We performed a web-based data abstraction from the Instructions for Authors of 67 hematology journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports to identify whether each journal required, recommended or made no mention of the following reporting guidelines: EQUATOR, ICMJE, CONSORT, MOOSE, QUOROM, PRISMA, STARD, STROBE, ARRIVE and CARE. We also extracted whether journals required or recommended trial or systematic review registration. We e-mailed editors three times to determine which types of studies their journal accepts. Results Forty-eight per cent (32/67) of hematology journals do not adhere to any reporting guidelines. For responding journals, the QUOROM statement, MOOSE, CARE and PROSPERO were the least often mentioned, whereas the ICMJE guidelines, CONSORT statement and general trial registration were most often mentioned. Discussion Reporting guidelines are infrequently required or recommended by hematology journals. Furthermore, few require clinical trial or systematic review database registration. A higher rate of adherence to reporting guidelines can prevent bias from entering the literature. Participation from all stakeholders, including authors and journal editors, to improve reporting guideline and policy practices is required. © 2017 International Society on Thrombosis and Haemostasis.

Epidemiological evidence for a health risk from mobile phone base stations.

PubMed

Khurana, Vini G; Hardell, Lennart; Everaert, Joris; Bortkiewicz, Alicja; Carlberg, Michael; Ahonen, Mikko

2010-01-01

Human populations are increasingly exposed to microwave/radiofrequency (RF) emissions from wireless communication technology, including mobile phones and their base stations. By searching PubMed, we identified a total of 10 epidemiological studies that assessed for putative health effects of mobile phone base stations. Seven of these studies explored the association between base station proximity and neurobehavioral effects and three investigated cancer. We found that eight of the 10 studies reported increased prevalence of adverse neurobehavioral symptoms or cancer in populations living at distances < 500 meters from base stations. None of the studies reported exposure above accepted international guidelines, suggesting that current guidelines may be inadequate in protecting the health of human populations. We believe that comprehensive epidemiological studies of long-term mobile phone base station exposure are urgently required to more definitively understand its health impact.

The pharmaceutical death-ride of dihydroartemisinin

PubMed Central

2010-01-01

In the 2010 second edition of WHO's guidelines for the treatment of malaria, the relatively new fixed dose combination dihydroartemisinin-piperaquine is included as one of the recommended artemisinin combination therapies. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements. At a time when many efforts aim to ban counterfeit and substandard drugs from the malaria market, the obvious question rises how WHO and public-private partnerships, such as Medicine for Malaria venture (MMV), can support the production and marketing of anti-malarial drugs that do not even meet the International Pharmacopoeia requirements? PMID:20649950

Nuclear energy acceptance and potential role to meet future energy demand. Which technical/scientific achievements are needed?

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

Schenkel, Roland

25 years after Chernobyl, the Fukushima disaster has changed the perspectives of nuclear power. The disaster has shed a negative light on the independence, reliability and rigor of the national nuclear regulator and plant operator and the usefulness of the international IAEA guidelines on nuclear safety. It has become clear that, in the light of the most severe earthquake in the history of Japan, the plants at Fukushima Daiichi were not adequately protected against tsunamis. Nuclear acceptance has suffered enormously and has changed the perspectives of nuclear energy dramatically in countries that have a very risk-sensitive population, Germany is anmore » example. The paper analyses the reactions in major countries and the expected impact on future deployment of reactors and on R and D activities. On the positive side, the disaster has demonstrated a remarkable robustness of most of the 14 reactors closest to the epicentre of the Tohoku Seaquake although not designed to an event of level 9.0. Public acceptance can only be regained with a rigorous and worldwide approach towards inherent reactor safety and design objectives that limit the impact of severe accidents to the plant itself (like many of the new Gen III reactors). A widespread release of radioactivity and the evacuation (temporary or permanent) of the population up to 30 km around a facility are simply not acceptable. Several countries have announced to request more stringent international standards for reactor safety. The IAEA should take this move forward and intensify and strengthen the different peer review mission schemes. The safety guidelines and peer reviews should in fact become legally binding for IAEA members. The paper gives examples of the new safety features developed over the last 20 years and which yield much safer reactors with lesser burden to the environment under severe accident conditions. The compatibility of these safety systems with the current concepts for fusion-fission hybrids, which have recently been proposed for energy production, is critically reviewed. There are major challenges remaining that are shortly outlined. Scientific/technical achievements that are required in the light of the Fukushima accident are highlighted.« less

Nuclear energy acceptance and potential role to meet future energy demand. Which technical/scientific achievements are needed?

NASA Astrophysics Data System (ADS)

Schenkel, Roland

2012-06-01

25 years after Chernobyl, the Fukushima disaster has changed the perspectives of nuclear power. The disaster has shed a negative light on the independence, reliability and rigor of the national nuclear regulator and plant operator and the usefulness of the international IAEA guidelines on nuclear safety. It has become clear that, in the light of the most severe earthquake in the history of Japan, the plants at Fukushima Daiichi were not adequately protected against tsunamis. Nuclear acceptance has suffered enormously and has changed the perspectives of nuclear energy dramatically in countries that have a very risk-sensitive population, Germany is an example. The paper analyses the reactions in major countries and the expected impact on future deployment of reactors and on R&D activities. On the positive side, the disaster has demonstrated a remarkable robustness of most of the 14 reactors closest to the epicentre of the Tohoku Seaquake although not designed to an event of level 9.0. Public acceptance can only be regained with a rigorous and worldwide approach towards inherent reactor safety and design objectives that limit the impact of severe accidents to the plant itself (like many of the new Gen III reactors). A widespread release of radioactivity and the evacuation (temporary or permanent) of the population up to 30 km around a facility are simply not acceptable. Several countries have announced to request more stringent international standards for reactor safety. The IAEA should take this move forward and intensify and strengthen the different peer review mission schemes. The safety guidelines and peer reviews should in fact become legally binding for IAEA members. The paper gives examples of the new safety features developed over the last 20 years and which yield much safer reactors with lesser burden to the environment under severe accident conditions. The compatibility of these safety systems with the current concepts for fusion-fission hybrids, which have recently been proposed for energy production, is critically reviewed. There are major challenges remaining that are shortly outlined. Scientific/technical achievements that are required in the light of the Fukushima accident are highlighted.

An audit of best evidence topic reviews in the International Journal of Surgery.

PubMed

Mabvuure, Nigel Tapiwa; Klimach, Stefan; Eisner, Mark; Rodrigues, Jeremy Neil

2015-05-01

IJS launched best evidence topic reviews (BETs) in 2011, when the guidelines for conducting and reporting these reviews were published in the journal. (1) Audit the adherence of all published BETs in IJS to these guidelines. (2) Assess the reach and impact of BETs published in IJS. BETs published between 2011 and February 2014 were identified from http://www.journal-surgery.net/. Standards audited included: completeness of description of study attrition, and independent verification of searches. Other extracted data included: relevant subspecialty, duration between searches and publication, and between acceptance and publication. Each BET's number of citations (http://scholar.google.co.uk/), number of tweets (http://www.altmetric.com/) and number of Researchgate views (https://www.researchgate.net/) were recorded. Thirty-four BETs were identified: the majority, 19 (56%), relating to upper gastrointestinal surgery and none to cardiothoracic, orthopaedic or paediatric surgery. Twenty-nine BETs (82%) fully described study attrition. Twenty-one (62%) had independently verified search results. The mean times from literature searching to publication and acceptance to publication were 38.5 weeks and 13 days respectively. There were a mean 40 (range 0-89) Researchgate views/article, mean 2 (range 0-7) citations/article and mean 0.36 (range 0-2) tweets/article. Adherence to BET guidelines has been variable. Authors are encouraged to adhere to journal guidelines and reviewers and editors to enforce them. BETs have received similar citation levels to other IJS articles. Means of increasing the visibility of published BETs such as social media sharing, conference presentation and deposition of abstracts in public repositories should be explored. More work is required to encourage more submissions from other surgical subspecialties other than gastrointestinal specialties. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Guidelines for planting along Virginia's roadways.

DOT National Transportation Integrated Search

1986-01-01

This Guideline for Planting along Virginia Roadways provides broad policy : statements for highway landscaping. The guideline's purpose is to ensure quality : and consistency that conform with accepted landscape architectural principles : and practic...

Diabetes in Pregnancy: Glycemia control guidelines and rationale

PubMed Central

Karakash, Scarlett D.; Einstein, Francine H.

2011-01-01

Purpose of review Little consensus exists on the definition of gestational diabetes (GDM), how the condition should diagnosed, and if interventions for mild maternal hyperglycemia are of any benefit to the mother or fetus. Today, after several large multi-center clinical trials, we are closer than ever to a national and international consensus. Recent findings Glucose tolerance in pregnancy is a continuum, which has a fundamental link to fetal growth. The relationship between maternal glycemia and adverse outcomes is continuous, with no distinct inflection point for increased risk. As a result, any cutoff for the diagnosis of GDM is somewhat arbitrary. Treatment for GDM, even mild cases, significantly reduces the rate of certain adverse perinatal and maternal outcomes, warranting intervention. Summary Clinical guidelines for the diagnosis of GDM are expected to change in the near future provided that recommendations from the International Association of Diabetes and Pregnancy Study Group (IADPSG) are accepted by professional organizations. The criteria for the diagnosis will likely be based on a single 75g, 2-hour oral glucose tolerance test with at least one abnormal value. The proposed threshold values are based on an international consensus regarding risk of adverse pregnancy outcomes. The public health implications for these changes are anticipated to be significant. PMID:21330917

International Guidelines on Computer-Based and Internet-Delivered Testing

ERIC Educational Resources Information Center

International Journal of Testing, 2006

2006-01-01

Developed by the International Test Commission, the International Guidelines on Computer-Based and Internet-Delivered Testing are a set of guidelines specifically developed to highlight good practice issues in relation to computer/Internet tests and testing. These guidelines have been developed from an international perspective and are directed at…

Translation and cross-cultural adaptation of the International Hip Outcome Tool (iHOT) into Portuguese

PubMed Central

Polesello, Giancarlo Cavalli; Godoy, Guilherme Finardi; Trindade, Christiano Augusto de Castro; de Queiroz, Marcelo Cavalheiro; Honda, Emerson; Ono, Nelson Keiske

2012-01-01

Objective iHOT12/33 is an outcome tool designed for young patients with hip problems. The objective of this study is to translate and establish a cross-cultural adaptation of this questionnaire to Portuguese. Method The Guillemin guidelines were followed for the translation and cross-cultural adaptation consisting on: translation, back-translation, prefinal version, administration of the Questionnaire, and editing of the final version. Results The prefinal version was applied to 30 young patients with hip problems. Some difficulties in understanding some of the words and expressions were noted, and these were replaced with simpler ones, achieving the patient's full acceptability in the final version of the Questionnaire. Conclusion The creation of the Brazilian version of the International Hip Outocome Tool (iHOT) 12/33 enables this questionnaire to be used in the evaluation of patients with hip problems in Brazil, and was clearly understood, with good acceptance by the patients tested. Level of evidence II - Development of diagnostic criteria on consecutive patients (with universally applied reference "gold" standard). PMID:24453587

EAACI/GA(2)LEN/EDF/WAO guideline: definition, classification and diagnosis of urticaria.

PubMed

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

2009-10-01

This guideline, together with its sister guideline on the management 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: Management of urticaria. Allergy, 2009; 64:1427-1443] is the result of a consensus reached during a panel discussion at the 3rd 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). Urticaria is a frequent disease. The life-time prevalence for any subtype of urticaria is approximately 20%. Chronic spontaneous urticaria and other chronic forms of urticaria do not only cause a decrease in quality of life, but also affect performance at work and school and, as such, are members of the group of severe allergic diseases. This guideline covers the definition and classification of urticaria, taking into account the recent progress in identifying its causes, eliciting factors, and pathomechanisms. In addition, it outlines evidence-based diagnostic approaches for different subtypes of urticaria. The correct management of urticaria, which is of paramount importance for patients, is very complex and is consequently covered in a separate guideline developed during the same consensus meeting. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS).

International CPR guidelines - perspectives in CPR.

PubMed

Nolan, Jerry P

2013-09-01

The International Liaison Committee on Resuscitation (ILCOR) co-ordinates regular reviews of cardiopulmonary resuscitation (CPR) science and publishes consensus on science statements and treatment recommendations. These outputs are used by international resuscitation organisations to generate clinical guidelines. This review will outline the history behind the development of international CPR guidelines and will provide a detailed description of the current guideline generating process. A perspective is provided on the future of this process and the prospects for completely unified international CPR guidelines. Copyright © 2013 Elsevier Ltd. All rights reserved.

Ethics of xenotransplantation: animal issues, consent, and likely transformation of transplant ethics.

PubMed

Daar, A S

1997-01-01

The shortage of organs, breakthroughs in research, involvement of biotechnology companies, absence of ethically more acceptable alternatives, and a vaguely perceived "time to put man on the moon" feeling have contributed to the current reawakening of interest in xenotransplantation. The focus of ethical attention has changed from the moral correctness of using animals for research/therapy to an increasingly appreciated danger of the establishment and spread of xenozoonoses in recipients, their contacts, and the general public. The United Kingdom has established an embargo on clinical trials and has set up a national regulatory authority to oversee and coordinate the development of research, establish guidelines, and decide on when trials can proceed. In the United States, on the other hand, the overall attitude is to "proceed with caution," and the Food and Drug Administration has approved a number of xenotransplant studies. The Public Health Service guidelines on reducing infection risk are still evolving and are likely to end up being more cautions than they are currently. There are a number of reasons for not using subhuman primates for xenotransplantation, including their closeness to humans, the likelihood of passing on infections, their depletability (gorillas, chimpanzees), their slow breeding, and the expense of breeding them under specified-pathogen free conditions. The pig, although domesticated and familiar, is too distant to evoke the same feelings we have for primates, has the correct-size organs, is probably less likely to pass on infections, breeds rapidly, and is not endangered; moreover, millions of them are eaten every year. Although drawing ethical conclusions is difficult, at this stage of knowledge and debate it seems acceptable to manipulate pigs genetically and to proceed to using their organs for xenotransplantation trials when infection control measures and the scientific base justify it. The question of informed consent is likely to be a vexing one. It might end up more of a binding legal contract than consent as we understand it now. Xenotransplantation is also unlikely to cost less than, or significantly alleviate the shortage of, cadaveric organs in the short term. The international dimension of the risk of infection is becoming obvious, but there has so far been no effort to convene an international forum to agree on universally acceptable guidelines.

10 CFR 960.3-1-4-1 - Site identification as potentially acceptable.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Site identification as potentially acceptable. 960.3-1-4-1 Section 960.3-1-4-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-1-4-1 Site identification...

10 CFR 960.3-2-2-1 - Evaluation of all potentially acceptable sites.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Evaluation of all potentially acceptable sites. 960.3-2-2-1 Section 960.3-2-2-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-1 Evaluation...

[Spirometry interpretation feasibility among pre-school children according to the European Respiratory Society and American Thoracic Society Guidelines].

PubMed

Donaire, Roberto M; González, Scarlett A; Moya, Ana I; Fierro, Laura T; Brockmann, Pablo V; Caussade, Solange L

2015-01-01

Spirometry is the most used test to evaluate pulmonary function. Guidelines that defined acceptability and repeatability criteria for its implementation and interpretation among preschoolers were published in 2007. Our objective was to quantify the actual compliance with these criteria among pre-school patients. A review was performed on the baseline spirometry measured in patients aged 2 to 5 years in the Pediatric Respiratory Laboratory of the Pontificia Universidad Católica de Chile, who were admitted due to recurrent or persistent coughing or wheezing. Only those results obtained in patients who took the test for the first time were considered. They were analyzed by international standards. A total of 93 spirometry results (mean age 57.4 ± 8.6 months, 48 males) were obtained, of which 44 (47%) met all acceptable criteria, 87 (93%) obtained expiratory time of ≥ 0.5seconds, and 67 (72%) of the patients had an end-expiratory flow of ≤10% from peak flow. The variation in the measurement of forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) was very low (intraclass correlation coefficient > 0.9). It was possible to meet the acceptability and repeatability criteria for spirometry among pre-school children in our Center, which was similar to previous reports. As in older children, this test is fully recommended for pre-school children who require lung function studies. Copyright © 2015. Publicado por Elsevier España, S.L.U.

76 FR 63565 - Event Reporting Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-13

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

Consensus guidelines on plasma cell myeloma minimal residual disease analysis and reporting.

PubMed

Arroz, Maria; Came, Neil; Lin, Pei; Chen, Weina; Yuan, Constance; Lagoo, Anand; Monreal, Mariela; de Tute, Ruth; Vergilio, Jo-Anne; Rawstron, Andy C; Paiva, Bruno

2016-01-01

Major heterogeneity between laboratories in flow cytometry (FC) minimal residual disease (MRD) testing in multiple myeloma (MM) must be overcome. Cytometry societies such as the International Clinical Cytometry Society and the European Society for Clinical Cell Analysis recognize a strong need to establish minimally acceptable requirements and recommendations to perform such complex testing. A group of 11 flow cytometrists currently performing FC testing in MM using different instrumentation, panel designs (≥ 6-color) and analysis software compared the procedures between their respective laboratories and reviewed the literature to propose a consensus guideline on flow-MRD analysis and reporting in MM. Consensus guidelines support i) the use of minimum of five initial gating parameters (CD38, CD138, CD45, forward, and sideward light scatter) within the same aliquot for accurate identification of the total plasma cell compartment; ii) the analysis of potentially aberrant phenotypic markers and to report the antigen expression pattern on neoplastic plasma cells as being reduced, normal or increased, when compared to a normal reference plasma cell immunophenotype (obtained using the same instrument and parameters); and iii) the percentage of total bone marrow plasma cells plus the percentages of both normal and neoplastic plasma cells within the total bone marrow plasma cell compartment, and over total bone marrow cells. Consensus guidelines on minimal current and future MRD analyses should target a lower limit of detection of 0.001%, and ideally a limit of quantification of 0.001%, which requires at least 3 × 10(6) and 5 × 10(6) bone marrow cells to be measured, respectively. © 2015 International Clinical Cytometry Society.

Implementation and evaluation of a tele-education system for the diagnosis of ophthalmic disease by international trainees

PubMed Central

Campbell, J. Peter; Swan, Ryan; Jonas, Karyn; Ostmo, Susan; Ventura, Camila V.; Martinez-Castellanos, Maria A.; Anzures, Rachelle Go Ang Sam; Chiang, Michael F.; Chan, R.V. Paul

2015-01-01

Tele-education systems are increasingly being utilized in medical education worldwide. Due to limited human resources in healthcare in low and middle-income countries, developing online systems that are accessible to medical trainees in underserved areas potentially represents a highly efficient and effective method of improving the quantity and quality of the health care workforce. We developed, implemented, and evaluated an interactive web-based tele-education system (based on internationally accepted, image-based guidelines) for the diagnosis of retinopathy of prematurity among ophthalmologists-in-training in Brazil, Mexico, and the Philippines. We demonstrate that participation in this tele-education program improved diagnostic accuracy and reliability, and was preferred to standard pedagogical methods. This system may be employed not only in training, but also in international certification programs, and the process may be generalizable to other image-based specialties, such as dermatology and radiology. PMID:26958168

Implementation and evaluation of a tele-education system for the diagnosis of ophthalmic disease by international trainees.

PubMed

Campbell, J Peter; Swan, Ryan; Jonas, Karyn; Ostmo, Susan; Ventura, Camila V; Martinez-Castellanos, Maria A; Anzures, Rachelle Go Ang Sam; Chiang, Michael F; Chan, R V Paul

Tele-education systems are increasingly being utilized in medical education worldwide. Due to limited human resources in healthcare in low and middle-income countries, developing online systems that are accessible to medical trainees in underserved areas potentially represents a highly efficient and effective method of improving the quantity and quality of the health care workforce. We developed, implemented, and evaluated an interactive web-based tele-education system (based on internationally accepted, image-based guidelines) for the diagnosis of retinopathy of prematurity among ophthalmologists-in-training in Brazil, Mexico, and the Philippines. We demonstrate that participation in this tele-education program improved diagnostic accuracy and reliability, and was preferred to standard pedagogical methods. This system may be employed not only in training, but also in international certification programs, and the process may be generalizable to other image-based specialties, such as dermatology and radiology.

Improving the quality of health care: using international collaboration to inform guideline programmes by founding the Guidelines International Network (G-I-N)*

PubMed Central

Ollenschlager, G; Marshall, C; Qureshi, S; Rosenbrand, K; Burgers, J; Makela, M; Slutsky, J; t for

2004-01-01



 Clinical practice guidelines are regarded as powerful tools to achieve effective health care. Although many countries have built up experience in the development, appraisal, and implementation of guidelines, until recently there has been no established forum for collaboration at an international level. As a result, in different countries seeking similar goals and using similar strategies, efforts have been unnecessarily duplicated and opportunities for harmonisation lost because of the lack of a supporting organisational framework. This triggered a proposal in 2001 for an international guidelines network built on existing partnerships. A baseline survey confirmed a strong demand for such an entity. A multinational group of guideline experts initiated the development of a non-profit organisation aimed at promotion of systematic guideline development and implementation. The Guidelines International Network (G-I-N) was founded in November 2002. One year later the Network released the International Guideline Library, a searchable database which now contains more than 2000 guideline resources including published guidelines, guidelines under development, "guidelines for guidelines", training materials, and patient information tools. By June 2004, 52 organisations from 27 countries had joined the network including institutions from Oceania, North America, and Europe, and WHO. This paper describes the process that led to the foundation of the G-I-N, its characteristics, prime activities, and ideas on future projects and collaboration. PMID:15576708

Subarachnoid haemorrhage guidelines and clinical practice: a cross-sectional study of emergency department consultants' and neurospecialists' views and risk tolerances.

PubMed

Lansley, J; Selai, C; Krishnan, A S; Lobotesis, K; Jäger, H R

2016-09-15

To establish if emergency medicine and neuroscience specialist consultants have different risk tolerances for investigation of suspected spontaneous subarachnoid haemorrhage (SAH), and to establish if their risk-benefit appraisals concur with current guidelines. 4 major neuroscience centres in London. 58 consultants in emergency medicine and neuroscience specialities (neurology, neurosurgery and neuroradiology) participated in an anonymous survey. The primary outcome measure was the highest stated acceptable risk of missing SAH in the neurologically intact patient presenting with sudden onset headache. Secondary outcome measures included agreement with guideline recommendations, risk/benefit appraisal and required performance of diagnostic tests, including lumbar puncture. Emergency department clinicians accepted almost 3 times the risk of a missed SAH diagnosis compared with the neuroscience specialists (2.8% vs 1.1%; p=0.02), were more likely to accept a higher risk of missed diagnosis for the benefit of a non-invasive test (p=0.04) and were more likely to disagree with current published guidelines stipulating the need for LP in all CT-negative cases (p=0.001). Divergence from recognised procedures for SAH investigation is often criticised and attributed to a lack of knowledge of guidelines. This study indicates that divergence from guidelines may be explained by alternative risk-benefit appraisals made by doctors with their patients. Guideline recommendations may gain wider acceptance if they accommodate the requirements of the doctors and patients using them. Further study of clinical risk tolerance may help explain patterns of diagnostic test use and other variations in healthcare delivery. 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/

Pesticides, Neurodevelopmental Disagreement, and Bradford Hill's Guidelines.

PubMed

Shrader-Frechette, Kristin; ChoGlueck, Christopher

2016-06-27

Neurodevelopmental disorders such as autism affect one-eighth of all U.S. newborns. Yet scientists, accessing the same data and using Bradford-Hill guidelines, draw different conclusions about the causes of these disorders. They disagree about the pesticide-harm hypothesis, that typical United States prenatal pesticide exposure can cause neurodevelopmental damage. This article aims to discover whether apparent scientific disagreement about this hypothesis might be partly attributable to questionable interpretations of the Bradford-Hill causal guidelines. Key scientists, who claim to employ Bradford-Hill causal guidelines, yet fail to accept the pesticide-harm hypothesis, fall into errors of trimming the guidelines, requiring statistically-significant data, and ignoring semi-experimental evidence. However, the main scientists who accept the hypothesis appear to commit none of these errors. Although settling disagreement over the pesticide-harm hypothesis requires extensive analysis, this article suggests that at least some conflicts may arise because of questionable interpretations of the guidelines.

Topical Treatment of Degenerative Knee Osteoarthritis.

PubMed

Meng, Zengdong; Huang, Rongzhong

2018-01-01

This article reviews topical management strategies for degenerative osteoarthritis (OA) of the knee. A search of Pubmed, Embase and the Cochrane library using MeSH terms including "topical," "treatment," "knee" and "osteoarthritis" was carried out. Original research and review articles on the effectiveness and safety, recommendations from international published guidelines and acceptability studies of topical preparations were included. Current topical treatments included for the management of knee OA include topical nonsteroidal anti-inflammatory drugs, capsaicin, salicylates and physical treatments such as hot or cold therapy. Current treatment guidelines recommend topical nonsteroidal anti-inflammatory drugs as an alternative and even first-line therapy for OA management, especially among elderly patients. Guidelines on other topical treatments vary, from recommendations against their use, to in favor as alternative or simultaneous therapy, especially for patients with contraindications to other analgesics. Although often well-tolerated and preferred by many patients, clinical care still lags in the adoption of topical treatments. Aspects of efficacy, safety and patient quality of life data require further research. Copyright © 2018 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.

[Dissection of differences and similarities of botanical drugs in European Union, US and Canada].

PubMed

He, Yi; Zhao, Libin; Ye, Zhengliang; Guo, Zhixin; Sun, He

2011-10-01

Because of the unique nature and treatment concept of traditional Chinese medicines (TCMs), TCMs have been respected again since 70s of last century. The regulatory agencies of some developed countries (the FDA, EMA and Health Canada etc) have published new guidance/guidelines/directives in recent years, such as the botanical drug product guidance of the FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products/ traditional herbal medicinal products of the EMA etc. All of the regulatory agencies are willing to scientifically evaluate the herbal medicines and accept it as therapeutic product. This paper analyzed the history of herbal medicine regulation and the similarities and differences of the regulatory requirements of the European Union, the United States and Canada, proposed possible future direction of the international development of Chinese medicine from the perspective of global regulatory affairs.

Characteriation of clinical data packages using foreign data in new drug applications in Japan.

PubMed

Tanaka, M; Nagata, T

2008-09-01

The objective of this research was to characterize clinical data packages (CDPs) of new drug applications (NDAs) using foreign data based on the International Conference on Harmonization (ICH) E5 guideline. Official review reports of NDAs approved in Japan between January 1999 and April 2005 were examined. Those NDAs considered by the official reviewers to be approved based on the ICH E5 guideline (E5-NDAs) were identified and classified into six categories of approval requirements in Japan. The details of pivotal clinical efficacy studies in the CDPs were examined. Forty-one NDAs were identified as E5-NDAs. Pivotal clinical studies conducted in Japan were required by the E5-NDAs, except for nine of those in which the foreign clinical studies reduced Japanese clinical studies in the CDPs. Given the differences in approval requirements among regions, the acceptability of foreign clinical data to Japanese approval is limited.

[Accreditation of medical laboratories].

PubMed

Horváth, Andrea Rita; Ring, Rózsa; Fehér, Miklós; Mikó, Tivadar

2003-07-27

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the official acceptance of ISO 15189 the clauses of this harmonized guideline fulfill the requirements of the new international standard as well. Accreditation of medical laboratories in Hungary may not only facilitate quality improvement of laboratory services, but also the development of a quality-based purchasing and reimbursement policy of the health insurance fund.

Critical factors influencing physicians' intention to use computerized clinical practice guidelines: an integrative model of activity theory and the technology acceptance model.

PubMed

Hsiao, Ju-Ling; Chen, Rai-Fu

2016-01-16

With the widespread use of information communication technologies, computerized clinical practice guidelines are developed and considered as effective decision supporting tools in assisting the processes of clinical activities. However, the development of computerized clinical practice guidelines in Taiwan is still at the early stage and acceptance level among major users (physicians) of computerized clinical practice guidelines is not satisfactory. This study aims to investigate critical factors influencing physicians' intention to computerized clinical practice guideline use through an integrative model of activity theory and the technology acceptance model. The survey methodology was employed to collect data from physicians of the investigated hospitals that have implemented computerized clinical practice guidelines. A total of 505 questionnaires were sent out, with 238 completed copies returned, indicating a valid response rate of 47.1 %. The collected data was then analyzed by structural equation modeling technique. The results showed that attitudes toward using computerized clinical practice guidelines (γ = 0.451, p < 0.001), organizational support (γ = 0.285, p < 0.001), perceived usefulness of computerized clinical practice guidelines (γ = 0.219, p < 0.05), and social influence (γ = 0.213, p < 0.05) were critical factors influencing physicians' intention to use computerized clinical practice guidelines, and these factors can explain 68.6 % of the variance in intention to use computerized clinical practice guidelines. This study confirmed that some subject (human) factors, environment (organization) factors, tool (technology) factors mentioned in the activity theory should be carefully considered when introducing computerized clinical practice guidelines. Managers should pay much attention on those identified factors and provide adequate resources and incentives to help the promotion and use of computerized clinical practice guidelines. Through the appropriate use of computerized clinical practice guidelines, the clinical benefits, particularly in improving quality of care and facilitating the clinical processes, will be realized.

Teaching authorship and publication practices in the biomedical and life sciences.

PubMed

Macrina, Francis L

2011-06-01

Examination of a limited number of publisher's Instructions for Authors, guidelines from two scientific societies, and the widely accepted policy document of the International Committee of Medical Journal Editors (ICMJE) provided useful information on authorship practices. Three of five journals examined (Nature, Science, and the Proceedings of the National Academy of Sciences) publish papers across a variety of disciplines. One is broadly focused on topics in medical research (New England Journal of Medicine) and one publishes research reports in a single discipline (Journal of Bacteriology). Similar elements of publication policy and accepted practices were found across the policies of these journals articulated in their Instructions for Authors. A number of these same elements were found in the professional society guidelines of the Society for Neuroscience and the American Chemical Society, as well as the ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Taken together, these sources provide the basis for articulating best practices in authorship in scientific research. Emerging from this material is a definition of authorship, as well as policy statements on duplicative publication, conflict of interest disclosure, electronic access, data sharing, digital image integrity, and research requiring subjects' protection, including prior registration of clinical trials. These common elements provide a foundation for teaching about scientific authorship and publication practices across biomedical and life sciences disciplines.

Breast screen new South wales generally demonstrates good radiologic viewing conditions.

PubMed

Soh, BaoLin Pauline; Lee, Warwick; Diffey, Jennifer L; McEntee, Mark F; Kench, Peter L; Reed, Warren M; Brennan, Patrick C

2013-08-01

This study measured reading workstation monitors and the viewing environment currently available within BreastScreen New South Wales (BSNSW) centres to determine levels of adherence to national and international guidelines. Thirteen workstations from four BSNSW service centres were assessed using the American Association of Physicists in Medicine Task Group 18 Quality Control test pattern. Reading workstation monitor performance and ambient light levels when interpreting screening mammographic images were assessed using spectroradiometer CS-2000 and chroma meter CL-200. Overall, radiologic monitors within BSNSW were operating at good acceptable levels. Some non-adherence to published guidelines included the percentage difference in maximum luminance between pairs of primary monitors at individual workstations (61.5 % or 30.8 % of workstations depending on specific guidelines), maximum luminance (23.1 % of workstations), luminance non-uniformity (11.5 % of workstations) and minimum luminance (3.8 % of workstations). A number of ambient light measurements did not comply with the only available evidence-based guideline relevant to the methodology used in this study. Larger ambient light variations across sites are shown when monitors were switched off, suggesting that differences in ambient lighting between sites can be masked when a standard mammogram is displayed for photometric measurements. Overall, BSNSW demonstrated good adherence to available guidelines, although some non-compliance has been shown. Recently updated United Kingdom and Australian guidelines should help reduce confusion generated by the plethora and sometimes dated nature of currently available recommendations.

Developing Guidelines for IRM: A Grassroots Process in a Decentralized Environment.

ERIC Educational Resources Information Center

Balkan, Lore; Sheldon, Philip

1990-01-01

The offices of Information Resource Management and Institutional Research at Virginia Tech developed a set of guidelines for information management. This article describes the historical evolution, the forces that motivated the development of the guidelines, and the consensus-building activities that led to the acceptance of the guidelines.…

The EAACI/GA²LEN/EDF/WAO Guideline for the Definition, Classification, Diagnosis and Management of Urticaria. The 2017 Revision and Update.

PubMed

Zuberbier, T; Aberer, W; Asero, R; Abdul Latiff, A H; Baker, D; Ballmer-Weber, B; Bernstein, J A; Bindslev-Jensen, C; Brzoza, Z; Buense Bedrikow, R; Canonica, G W; Church, M K; Craig, T; Danilycheva, I V; Dressler, C; Ensina, L F; Giménez-Arnau, A; Godse, K; Gonçalo, M; Grattan, C; Hebert, J; Hide, M; Kaplan, A; Kapp, A; Katelaris, C H; Kocatürk, E; Kulthanan, K; Larenas-Linnemann, D; Leslie, T A; Magerl, M; Mathelier-Fusade, P; Meshkova, R Y; Metz, M; Nast, A; Nettis, E; Oude-Elberink, H; Rosumeck, S; Saini, S S; Sánchez-Borges, M; Schmid-Grendelmeier, P; Staubach, P; Sussman, G; Toubi, E; Vena, G A; Vestergaard, C; Wedi, B; Werner, R N; Zhao, Z; Maurer, M

2018-01-15

This evidence and consensus-based guideline was developed following the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group. The conference was held on December 1st, 2016. It is a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the EU-founded network of excellence, the Global Allergy and Asthma European Network (GA²LEN), the European Dermatology Forum (EDF), and the World Allergy Organization (WAO) with the participation of 48 delegates of 42 national and international societies. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). Urticaria is a frequent, mast cell-driven disease, presenting with wheals, angioedema, or both. The lifetime prevalence for acute urticaria is approximately 20%. Chronic spontaneous urticaria and other chronic forms of urticaria are disabling, impair quality of life, and affect performance at work and school. This guideline covers the definition and classification of urticaria, taking into account the recent progress in identifying its causes, eliciting factors and pathomechanisms. In addition, it outlines evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

[Consolidation of international guidelines for the management of canine populations in urban areas and proposal of performance indicators].

PubMed

Garcia, Rita de Cassia Maria; Calderón, Néstor; Ferreira, Fernando

2012-08-01

The objective of this study is to propose a generic program for the management of urban canine populations with suggestion of performance indicators. The following international guidelines on canine population management were revised and consolidated: World Health Organization, World Organisation for Animal Health, World Society for the Protection of Animals, International Companion Animal Management Coalition, and the Food and Agriculture Organization. Management programs should cover: situation diagnosis, including estimates of population size; social participation with involvement of various sectors in the planning and execution of strategies; educational actions to promote humane values, animal welfare, community health, and responsible ownership (through purchase or adoption); environmental and waste management to eliminate sources of food and shelter; registration and identification of animals; animal health care, reproductive control; prevention and control of zoonoses; control of animal commerce; management of animal behavior and adequate solutions for abandoned animals; and laws regulating responsible ownership, prevention of abandonment and zoonoses. To monitor these actions, four groups of indicators are suggested: animal population indicators, human/animal interaction indicators, public service indicators, and zoonosis indicators. The management of stray canine populations requires political, sanitary, ethologic, ecologic, and humanitarian strategies that are socially acceptable and environmentally sustainable. Such measures must also include the control of zoonoses such as rabies and leishmaniasis, considering the concept of "one health," which benefits both the animals and people in the community.

International Consensus On (ICON) Pediatric Asthma

PubMed Central

Papadopoulos, N. G.; Arakawa, H.; Carlsen, K.-H.; Custovic, A.; Gern, J.; Lemanske, R.; Le Souef, P.; Makela, M.; Roberts, G.; Wong, G.; Zar, H.; Akdis, C. A.; Bacharier, L. B.; Baraldi, E.; van Bever, H. P.; de Blic, J.; Boner, A.; Burks, W.; Casale, T. B.; Castro-Rodriguez, J. A.; Chen, Y. Z.; El-Gamal, Y. M.; Everard, M. L.; Frischer, T.; Geller, M.; Gereda, J.; Goh, D. Y.; Guilbert, T. W.; Hedlin, G.; Heymann, P. W.; Hong, S. J.; Hossny, E. M.; Huang, J. L.; Jackson, D. J.; de Jongste, J. C.; Kalayci, O.; Khaled, N.; Kling, S.; Kuna, P.; Lau, S.; Ledford, D. K.; Lee, S. I.; Liu, A. H.; Lockey, R. F.; Lodrup-Carlsen, K.; Lotvall, J.; Morikawa, A.; Nieto, A.; Paramesh, H.; Pawankar, R.; Pohunek, P.; Pongracic, J.; Price, D.; Robertson, C.; Rosario, N.; Rossenwasser, L. J.; Sly, P. D.; Stein, R.; Stick, S.; Szefler, S.; Taussig, L. M.; Valovirta, E.; Vichyanond, P.; Wallace, D.; Weinberg, E.; Wennergren, G.; Wildhaber, J.; Zeiger, R. S.

2015-01-01

Asthma is the most common chronic lower respiratory disease in childhood throughout the world. Several guidelines and/or consensus documents are available to support medical decisions on pediatric asthma. Although there is no doubt that the use of common systematic approaches for management can considerably improve outcomes, dissemination and implementation of these are still major challenges. Consequently, the International Collaboration in Asthma, Allergy and Immunology (iCAALL), recently formed by the EAACI, AAAAI, ACAAI and WAO, has decided to propose an International Consensus on (ICON) Pediatric Asthma. The purpose of this document is to highlight the key messages that are common to many of the existing guidelines, while critically reviewing and commenting on any differences, thus providing a concise reference. The principles of pediatric asthma management are generally accepted. Overall, the treatment goal is disease control. In order to achieve this, patients and their parents should be educated to optimally manage the disease, in collaboration with health care professionals. Identification and avoidance of triggers is also of significant importance. Assessment and monitoring should be performed regularly to re-evaluate and fine-tune treatment. Pharmacotherapy is the cornerstone of treatment. The optimal use of medication can, in most cases, help patients control symptoms and reduce the risk for future morbidity. The management of exacerbations is a major consideration, independent from chronic treatment. There is a trend towards considering phenotype specific treatment choices; however this goal has not yet been achieved. PMID:22702533

Sweat test and cystic fibrosis: overview of test performance at public and private centers in the state of São Paulo, Brazil

PubMed Central

Servidoni, Maria Fátima; Gomez, Carla Cristina Souza; Marson, Fernando Augusto Lima; Toro, Adyléia Aparecida Dalbo Contrera; Ribeiro, Maria Ângela Gonçalves de Oliveira; Ribeiro, José Dirceu; Ribeiro, Antônio Fernando

2017-01-01

ABSTRACT Objective: The sweat test (ST) measures chloride levels in sweat and is considered the gold standard for the diagnosis of cystic fibrosis (CF). However, the reliability of a ST depends on their being performed by experienced technicians and in accordance with strict guidelines. Our aim was to evaluate how sweat stimulation, sweat collection, and chloride measurement are performed at 14 centers (9 public centers and 5 private centers) that routinely perform STs in the state of São Paulo, which has the highest frequency of CF in Brazil. Methods: This was a cross-sectional cohort study, using a standardized questionnaire administered in loco to the staff responsible for conducting STs. Results: No uniformity regarding the procedures was found among the centers. Most centers were noncompliant with the international guidelines, especially regarding the collection of sweat (the samples were insufficient in 10-50% of the subjects tested); availability of stimulation equipment (which was limited at 2 centers); modernity and certification of stimulation equipment (most of the equipment having been used for 3-23 years); and written protocols (which were lacking at 12 centers). Knowledge of ST guidelines was evaluated at only 1 center. Conclusions: Our results show that STs largely deviate from internationally accepted guidelines at the participating centers. Therefore, there is an urgent need for standardization of STs, training of qualified personnel, and acquisition/certification of suitable equipment. These are essential conditions for a reliable diagnosis of CF, especially with the increasing demand due to newborn screening nationwide, and for the assessment of a possible clinical benefit from the use of modulator drugs. PMID:28538779

12 CFR 621.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... accepted accounting principles means that body of conventions, rules, and procedures necessary to define accepted accounting practices at a particular time, as promulgated by the Financial Accounting Standards... profession in the United States. Generally accepted accounting principles include not only broad guidelines...

Working towards accreditation by the International Standards Organization 15189 Standard: how to validate an in-house developed method an example of lead determination in whole blood by electrothermal atomic absorption spectrometry.

PubMed

Garcia Hejl, Carine; Ramirez, Jose Manuel; Vest, Philippe; Chianea, Denis; Renard, Christophe

2014-09-01

Laboratories working towards accreditation by the International Standards Organization (ISO) 15189 standard are required to demonstrate the validity of their analytical methods. The different guidelines set by various accreditation organizations make it difficult to provide objective evidence that an in-house method is fit for the intended purpose. Besides, the required performance characteristics tests and acceptance criteria are not always detailed. The laboratory must choose the most suitable validation protocol and set the acceptance criteria. Therefore, we propose a validation protocol to evaluate the performance of an in-house method. As an example, we validated the process for the detection and quantification of lead in whole blood by electrothermal absorption spectrometry. The fundamental parameters tested were, selectivity, calibration model, precision, accuracy (and uncertainty of measurement), contamination, stability of the sample, reference interval, and analytical interference. We have developed a protocol that has been applied successfully to quantify lead in whole blood by electrothermal atomic absorption spectrometry (ETAAS). In particular, our method is selective, linear, accurate, and precise, making it suitable for use in routine diagnostics.

Standard development at the Human Variome Project.

PubMed

Smith, Timothy D; Vihinen, Mauno

2015-01-01

The Human Variome Project (HVP) is a world organization working towards facilitating the collection, curation, interpretation and free and open sharing of genetic variation information. A key component of HVP activities is the development of standards and guidelines. HVP Standards are systems, procedures and technologies that the HVP Consortium has determined must be used by HVP-affiliated data sharing infrastructure and should be used by the broader community. HVP guidelines are considered to be beneficial for HVP affiliated data sharing infrastructure and the broader community to adopt. The HVP also maintains a process for assessing systems, processes and tools that implement HVP Standards and Guidelines. Recommended System Status is an accreditation process designed to encourage the adoption of HVP Standards and Guidelines. Here, we describe the HVP standards development process and discuss the accepted standards, guidelines and recommended systems as well as those under acceptance. Certain HVP Standards and Guidelines are already widely adopted by the community and there are committed users for the others. © The Author(s) 2015. Published by Oxford University Press.

Standard development at the Human Variome Project

PubMed Central

Smith, Timothy D.; Vihinen, Mauno

2015-01-01

The Human Variome Project (HVP) is a world organization working towards facilitating the collection, curation, interpretation and free and open sharing of genetic variation information. A key component of HVP activities is the development of standards and guidelines. HVP Standards are systems, procedures and technologies that the HVP Consortium has determined must be used by HVP-affiliated data sharing infrastructure and should be used by the broader community. HVP guidelines are considered to be beneficial for HVP affiliated data sharing infrastructure and the broader community to adopt. The HVP also maintains a process for assessing systems, processes and tools that implement HVP Standards and Guidelines. Recommended System Status is an accreditation process designed to encourage the adoption of HVP Standards and Guidelines. Here, we describe the HVP standards development process and discuss the accepted standards, guidelines and recommended systems as well as those under acceptance. Certain HVP Standards and Guidelines are already widely adopted by the community and there are committed users for the others. PMID:25818894

Nephrology nurses' perspectives on difficult ethical issues and practice guideline for shared decision making.

PubMed

Rabetoy, Christy Price; Bair, Bradley C

2007-01-01

Nephrologists and nephrology nurses have struggled with the technological, financial, and ethical concerns surrounding the life sustaining treatment of hemodialysis for as long as this treatment as been available. One of the overriding issues for the nephrology community has been appropriate utilization of this technology and the appropriate restraint for prescribing dialysis. Since the inception of dialysis, there has been discussion of guidelines for deciding who should receive and who should not receive this therapy. In 2000, a clinical guideline was developed to assist in directing the care of patients. The knowledge and acceptance of this guideline by nephrologists has been researched in the past. However, there is no data of knowledge and acceptance of the guideline by nephrology clinical nurses or nephrology nurse practitioners. A survey was conducted to begin to ascertain this information in order to better understand the perspectives of nephrology nurses.

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

5 CFR 2601.204 - Conditions for acceptance.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Conditions for acceptance. 2601.204 Section 2601.204 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and...

Guideline for the utilization of commercial grade items in nuclear safety related applications: Final report. [Contains Glossary

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

Tulay, M.P.; Yurich, F.J.; Schremser, F.M. Jr.

1988-06-01

This guideline provides direction for the procurement and use of Commercial Grade Items (CGI)in safety-related applications. It is divided into five major sections. A glossary of terms and definitions, an acronym listing, and seven appendices have been included. The glossary defines terms used in this guideline. In certain instances, the definitions may be unique to this guideline. Identification of acronyms utilized in this guideline is also provided. Section 1 provides a background of the commercial grade item issues facing the nuclear industry. It provides a historical perspective of commercial grade item issues. Section 2 discusses the generic process for themore » acceptance of a commercial grade item for safety-related use. Section 3 defines the four distinct methods used to accept commercial grade items for safety-related applications. Section 4 lists specific references that are identified in this guideline. Section 5 is a bibliography of documents that were considered in developed this guideline, but were not directly referenced in the document.« less

Tall Buildings Initiative

Science.gov Websites

Design Task 7 - Guidelines on Modeling and Acceptance Values Task 8 - Input Ground Motions for Tall - Performance-Based Seismic Design Guidelines for Tall Buildings Task 12 - Quantification of seismic performance published Report No. 2017/06 titled: "Guidelines for Performance-Based Seismic Design of Tall Buildings

Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors.

PubMed

Checketts, Jake X; Sims, Matthew Thomas; Vassar, Matt

2017-12-01

It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10 000, and 18 accepted more than $50 000. Financial payments amounted to a mean of $157 177 per author. The total reimbursement among the 49 authors from 2013 to 2015 was $7 701 681. Of the 40 authors receiving payments, 22 did not accurately disclose industry relationships. Authors received payments from companies with products directly related to the guideline topic. Violations to the Administrative Regulations were found. Dermatology clinical practice guideline authors received sizable industry payments and did not completely disclose these payments. The American Academy of Dermatology policies may benefit from stricter enforcement or the adoption of new standards.

Prospective systematic review registration: perspective from the Guidelines International Network (G-I-N).

PubMed

Van der Wees, Philip; Qaseem, Amir; Kaila, Minna; Ollenschlaeger, Guenter; Rosenfeld, Richard

2012-02-09

Clinical practice and public health guidelines are important tools for translating research findings into practice with the aim of assisting health practitioners as well as patients and consumers in health behavior and healthcare decision-making. Numerous programs for guideline development exist around the world, with growing international collaboration to improve their quality. One of the key features in developing trustworthy guidelines is that recommendations should be based on high-quality systematic reviews of the best available evidence. The review process used by guideline developers to identify and grade relevant evidence for developing recommendations should be systematic, transparent and unbiased. In this paper, we provide an overview of current international developments in the field of practice guidelines and methods to develop guidelines, with a specific focus on the role of systematic reviews. The Guidelines International Network (G-I-N) aims to stimulate collaboration between guideline developers and systematic reviewers to optimize the use of available evidence in guideline development and to increase efficiency in the guideline development process. Considering the significant benefit of systematic reviews for the guideline community, the G-I-N Board of Trustees supports the international prospective register of systematic reviews (PROSPERO) initiative. G-I-N also recently launched a Data Extraction Resource (GINDER) to present and share data extracted from individual studies in a standardized template. PROSPERO and GINDER are complementary tools to enhance collaboration between guideline developers and systematic reviewers to allow for alignment of activities and a reduction in duplication of effort.

Solid-State Thermionic Power Generators: An Analytical Analysis in the Nonlinear Regime

NASA Astrophysics Data System (ADS)

Zebarjadi, M.

2017-07-01

Solid-state thermionic power generators are an alternative to thermoelectric modules. In this paper, we develop an analytical model to investigate the performance of these generators in the nonlinear regime. We identify dimensionless parameters determining their performance and provide measures to estimate an acceptable range of thermal and electrical resistances of thermionic generators. We find the relation between the optimum load resistance and the internal resistance and suggest guidelines for the design of thermionic power generators. Finally, we show that in the nonlinear regime, thermionic power generators can have efficiency values higher than the state-of-the-art thermoelectric modules.

Guidelines for international collaborative research.

PubMed

Rosser, W W; Culpepper, L; Lam, C L; Parkerson, G; Poon, V; Weel, C V

1997-08-01

As the global village becomes a reality, there is an increasing need to conduct international collaborative studies in family practice. A workshop at the WONCA meeting in Hong Kong used international attendees to produce a set of guidelines for international research. At the workshop four completed international projects, each using a different strategy, were presented so that common themes might become apparent. The themes were then discussed and guidelines emerged from the process. Seven guidelines emerged for consideration before embarking on an international collaborative research project in family medicine. The guidelines deal with the characteristics of the research question and the importance of communication. The need for simple, brief methods of data collection, funding and pilot testing were identified. The question must be relevant to all participants to maintain interest and measurement tools must be validated to understand the impact of cultural differences in understanding.

Maelstrom Research guidelines for rigorous retrospective data harmonization

PubMed Central

Fortier, Isabel; Raina, Parminder; Van den Heuvel, Edwin R; Griffith, Lauren E; Craig, Camille; Saliba, Matilda; Doiron, Dany; Stolk, Ronald P; Knoppers, Bartha M; Ferretti, Vincent; Granda, Peter; Burton, Paul

2017-01-01

Abstract Background: It is widely accepted and acknowledged that data harmonization is crucial: in its absence, the co-analysis of major tranches of high quality extant data is liable to inefficiency or error. However, despite its widespread practice, no formalized/systematic guidelines exist to ensure high quality retrospective data harmonization. Methods: To better understand real-world harmonization practices and facilitate development of formal guidelines, three interrelated initiatives were undertaken between 2006 and 2015. They included a phone survey with 34 major international research initiatives, a series of workshops with experts, and case studies applying the proposed guidelines. Results: A wide range of projects use retrospective harmonization to support their research activities but even when appropriate approaches are used, the terminologies, procedures, technologies and methods adopted vary markedly. The generic guidelines outlined in this article delineate the essentials required and describe an interdependent step-by-step approach to harmonization: 0) define the research question, objectives and protocol; 1) assemble pre-existing knowledge and select studies; 2) define targeted variables and evaluate harmonization potential; 3) process data; 4) estimate quality of the harmonized dataset(s) generated; and 5) disseminate and preserve final harmonization products. Conclusions: This manuscript provides guidelines aiming to encourage rigorous and effective approaches to harmonization which are comprehensively and transparently documented and straightforward to interpret and implement. This can be seen as a key step towards implementing guiding principles analogous to those that are well recognised as being essential in securing the foundational underpinning of systematic reviews and the meta-analysis of clinical trials. PMID:27272186

Text recycling: acceptable or misconduct?

PubMed

Harriman, Stephanie; Patel, Jigisha

2014-08-16

Text recycling, also referred to as self-plagiarism, is the reproduction of an author's own text from a previous publication in a new publication. Opinions on the acceptability of this practice vary, with some viewing it as acceptable and efficient, and others as misleading and unacceptable. In light of the lack of consensus, journal editors often have difficulty deciding how to act upon the discovery of text recycling. In response to these difficulties, we have created a set of guidelines for journal editors on how to deal with text recycling. In this editorial, we discuss some of the challenges of developing these guidelines, and how authors can avoid undisclosed text recycling.

Life-time risk of mortality due to different levels of alcohol consumption in seven European countries: implications for low-risk drinking guidelines.

PubMed

Shield, Kevin D; Gmel, Gerrit; Gmel, Gerhard; Mäkelä, Pia; Probst, Charlotte; Room, Robin; Rehm, Jürgen

2017-09-01

Low-risk alcohol drinking guidelines require a scientific basis that extends beyond individual or group judgements of risk. Life-time mortality risks, judged against established thresholds for acceptable risk, may provide such a basis for guidelines. Therefore, the aim of this study was to estimate alcohol mortality risks for seven European countries based on different average daily alcohol consumption amounts. The maximum acceptable voluntary premature mortality risk was determined to be one in 1000, with sensitivity analyses of one in 100. Life-time mortality risks for different alcohol consumption levels were estimated by combining disease-specific relative risk and mortality data for seven European countries with different drinking patterns (Estonia, Finland, Germany, Hungary, Ireland, Italy and Poland). Alcohol consumption data were obtained from the Global Information System on Alcohol and Health, relative risk data from meta-analyses and mortality information from the World Health Organization. The variation in the life-time mortality risk at drinking levels relevant for setting guidelines was less than that observed at high drinking levels. In Europe, the percentage of adults consuming above a risk threshold of one in 1000 ranged from 20.6 to 32.9% for women and from 35.4 to 54.0% for men. Life-time risk of premature mortality under current guideline maximums ranged from 2.5 to 44.8 deaths per 1000 women in Finland and Estonia, respectively, and from 2.9 to 35.8 deaths per 1000 men in Finland and Estonia, respectively. If based upon an acceptable risk of one in 1000, guideline maximums for Europe should be 8-10 g/day for women and 15-20 g/day for men. If low-risk alcohol guidelines were based on an acceptable risk of one in 1000 premature deaths, then maximums for Europe should be 8-10 g/day for women and 15-20 g/day for men, and some of the current European guidelines would require downward revision. © 2017 Society for the Study of Addiction.

Prevalence and socio-demographic correlates of the compliance with the physical activity guidelines in children and adolescents in Germany.

PubMed

Jekauc, Darko; Reimers, Anne K; Wagner, Matthias O; Woll, Alexander

2012-08-30

Regular physical activity (PA) is a prerequisite for normal growth and maturation, health, and fitness of children and adolescents. Because of the growing evidence of the health benefits of regular PA, several national and international public health organisations have established PA guidelines. The purpose of this study was to assess the percentage of children and adolescents in Germany who meet the PA guideline of 60 minutes of moderate-to-vigorous PA each day and to evaluate socio-demographic correlates of compliance with the PA guideline. The sample consists of 4,529 children and adolescents aged between 4 and 17 years who lived and were registered in the Federal Republic of Germany between 2003 and 2006. The compliance with the PA guideline was assessed using a widely accepted screening measure. Socioeconomic status, immigration background and residential area were assessed using a parent questionnaire. Overall, 13.1% of girls and 17.4% of boys complied with the national guideline of 60 minutes of moderate-to-vigorous PA daily. While compliance was significantly lower in older participants of both gender groups, the steepest decrease in compliance was observed for age groups around the transition time from primary to secondary school. Logistic regression revealed that socioeconomic status and a migration background were significant predictors for compliance in girls and residential area for compliance in boys. Programs and policy action addressing the problem of decreasing compliance with PA guideline with increasing age are warranted. The transition from primary school to secondary school seems to be a critical stage in life with respect to PA behaviour. Therefore, specific interventions should aim at restructuring and reorganising their daily and physical activities during this transition.

Consensus-based guidelines for Video EEG monitoring in the pre-surgical evaluation of children with epilepsy in the UK.

PubMed

Pressler, Ronit M; Seri, Stefano; Kane, Nick; Martland, Tim; Goyal, Sushma; Iyer, Anand; Warren, Elliott; Notghi, Lesley; Bill, Peter; Thornton, Rachel; Appleton, Richard; Doyle, Sarah; Rushton, Sarah; Worley, Alan; Boyd, Stewart G

2017-08-01

Paediatric Epilepsy surgery in the UK has recently been centralised in order to improve expertise and quality of service available to children. Video EEG monitoring or telemetry is a highly specialised and a crucial component of the pre-surgical evaluation. Although many Epilepsy Monitoring Units work to certain standards, there is no national or international guideline for paediatric video telemetry. Due to lack of evidence we used a modified Delphi process utilizing the clinical and academic expertise of the clinical neurophysiology sub-specialty group of Children's Epilepsy Surgical Service (CESS) centres in England and Wales. This process consisted of the following stages I: Identification of the consensus working group, II: Identification of key areas for guidelines, III: Consensus practice points and IV: Final review. Statements that gained consensus (median score of either 4 or 5 using a five-point Likerttype scale) were included in the guideline. Two rounds of feedback and amendments were undertaken. The consensus guidelines includes the following topics: referral pathways, neurophysiological equipment standards, standards of recording techniques, with specific emphasis on safety of video EEG monitoring both with and without drug withdrawal, a protocol for testing patient's behaviours, data storage and guidelines for writing factual reports and conclusions. All statements developed received a median score of 5 and were adopted by the group. Using a modified Delphi process we were able to develop universally-accepted video EEG guidelines for the UK CESS. Although these recommendations have been specifically developed for the pre-surgical evaluation of children with epilepsy, it is assumed that most components are transferable to any paediatric video EEG monitoring setting. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Improved access to life insurance after genetic diagnosis of familial hypercholesterolaemia: cross-sectional postal questionnaire study

PubMed Central

Huijgen, Roeland; Homsma, Sietske JM; Hutten, Barbara A; Kindt, Iris; Vissers, Maud N; Kastelein, John JP; van Rijckevorsel, Jan LA

2012-01-01

A decade ago, in the initial stage of genetic testing for familial hypercholesterolaemia (FH) in The Netherlands, it was reported that such screening decreased access to affordable life insurance for mutation carriers. In 2003, in order to improve access to insurance for FH mutation carriers, insurers agreed to underwrite according to a set of guidelines. In this cross-sectional study, we assessed whether access to insurance has improved since the advent of these guidelines. We approached 2825 subjects that had participated in the genetic testing for FH between 1998 and 2003. We compared unconditional acceptance rates before and after FH diagnosis and before and after the guidelines were issued by means of logistic regression analysis. Our study outcome pertains to 414 FH patients who applied for life insurance. Unconditional acceptance of a policy before DNA diagnosis and before the issue of guidelines occurred in 182 out of 255 (71%) cases, versus 27 out of 35 (77%) cases after DNA diagnosis, but before the issue of guidelines. De facto, 107 out of 124 (86%) patients received unconditional acceptance after DNA diagnosis and after the issue of guidelines (P for trend=0.002). Access to life insurance improved for FH patients after molecular diagnosis and it improved even further after the guidelines were issued. Therefore, we argue that limited access to life insurance on the basis of ‘DNA discrimination' is no longer a valid argument against genetic cascade testing for FH, at least not in our country. PMID:22293687

Epilepsy and vaccinations: Italian guidelines.

PubMed

Pruna, Dario; Balestri, Paolo; Zamponi, Nelia; Grosso, Salvatore; Gobbi, Giuseppe; Romeo, Antonino; Franzoni, Emilio; Osti, Maria; Capovilla, Giuseppe; Longhi, Riccardo; Verrotti, Alberto

2013-10-01

Reports of childhood epilepsies in temporal association with vaccination have had a great impact on the acceptance of vaccination programs by health care providers, but little is known about this possible temporal association and about the types of seizures following vaccinations. For these reasons the Italian League Against Epilepsy (LICE), in collaboration with other Italian scientific societies, has decided to generate Guidelines on Vaccinations and Epilepsy. The aim of Guidelines on Vaccinations and Epilepsy is to present recent unequivocal evidence from published reports on the possible relationship between vaccines and epilepsy in order to provide information about contraindications and risks of vaccinations in patients with epilepsy. The following main issues have been addressed: (1) whether contraindications to vaccinations exist in patients with febrile convulsions, epilepsy, and/or epileptic encephalopathies; and (2) whether any vaccinations can cause febrile seizures, epilepsy, and/or epileptic encephalopathies. Diphtheria-tetanus-pertussis (DTP) vaccination and measles, mumps, and rubella vaccination (MMR) increase significantly the risk of febrile seizures. Recent observations and data about the relationships between vaccination and epileptic encephalopathy show that some cases of apparent vaccine-induced encephalopathy could in fact be caused by an inherent genetic defect with no causal relationship with vaccination. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

Pulmonary thromboembolic disease. Clinical management of acute and chronic disease.

PubMed

Torbicki, Adam

2010-07-01

Pulmonary thromboembolism falls between the areas of pulmonology and cardiology, internal medicine and intensive care, radiology and nuclear medicine, and hematology and cardiothoracic surgery. Depending on their clinical background, physicians faced with a patient with a pulmonary thromboembolism may speak different languages and adopt different treatment approaches. Now, however, there is an opportunity to end the Tower of Babel surrounding pulmonary thromboembolism. There is a growing acknowledgement that the key clinical problems in both acute pulmonary embolism and chronic thromboembolic pulmonary hypertension are linked to right ventricular pressure overload and right ventricular failure. As a result, cardiologists and cardiac intensive care specialists are taking an increasing interest in understanding and combating these conditions. The European Society of Cardiology was the first to elaborate comprehensive clinical practice guidelines for pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension. The task forces involved in producing these guidelines included radiologists, pulmonologists, hematologists, intensive care physicians and surgeons, which ensured that the final document was universally acceptable. The aim of this article was to provide an overview of the epidemiology, risk factors, diagnosis, treatment, prognosis and prevention of acute pulmonary thromboembolism and chronic thromboembolic pulmonary hypertension, while taking into account European Society of Cardiology guidelines and incorporating new evidence where necessary.

[Globalization in medical research].

PubMed

Ehni, H-J; Wiesing, U

2018-03-01

The globalization of clinical research is gaining momentum. In particular, emerging countries, such as Brazil, India, Russia and South Africa show a significant increase in clinical trials. This trend is generating various ethical problems, which are examined in the present article. Sometimes, generally accepted ethical rules, such as the evaluation of clinical trials by ethics commissions are not respected and sometimes conflicts are generated which are difficult to resolve. For instance, it is controversial which standard of care researchers and sponsors have to provide in an international study. These conflicts are exacerbated by a fundamental dilemma: more research on diseases prevalent in developing and emerging countries is necessary. At the same time, the protection of study participants in those countries creates particular challenges. In recent years, international commissions and guidelines have achieved significant progress in solving these conflicts; however, the further development has to be analyzed very carefully. Incentives for better research on neglected diseases have to be created. Undesirable developments and abuse have to be prevented by appropriate international ethical standards.

1st International consensus guidelines for advanced breast cancer (ABC 1).

PubMed

Cardoso, F; Costa, A; Norton, L; Cameron, D; Cufer, T; Fallowfield, L; Francis, P; Gligorov, J; Kyriakides, S; Lin, N; Pagani, O; Senkus, E; Thomssen, C; Aapro, M; Bergh, J; Di Leo, A; El Saghir, N; Ganz, P A; Gelmon, K; Goldhirsch, A; Harbeck, N; Houssami, N; Hudis, C; Kaufman, B; Leadbeater, M; Mayer, M; Rodger, A; Rugo, H; Sacchini, V; Sledge, G; van't Veer, L; Viale, G; Krop, I; Winer, E

2012-06-01

The 1st international Consensus Conference for Advanced Breast Cancer (ABC 1) took place on November 2011, in Lisbon. Consensus guidelines for the management of this disease were developed. This manuscript summarizes these international consensus guidelines. Copyright © 2012 Elsevier Ltd. All rights reserved.

COOP+ project: Promoting the cooperation of international Research Infrastructures to address global environmental challenges.

NASA Astrophysics Data System (ADS)

Bonet-García, F.; Järvi, L.; Asmi, A.; Suárez-Muñoz, M.

2016-12-01

Humanity must face enormous environmental challenges including biodiversity decline, climate change, ocean acidification, sea level rise and overpopulation. The research infrastructures (RIs) created in the last decades worldwide cover a wide range of spatial and thematic scales and collect information about the functioning of Earth ecosystems. However, we need to go one step forward: understand and simulate the functioning of the Earth as a complex system in a global change scenario. Cooperation among international RIs as well as multidisciplinary work are mandatory to achieve this challenging objective. COOP+ (EU Horizon 2020 project) aims to strengthen the links and coordination of European environmental RIs with their international counterparts. COOP+ will create cooperation threads among international research infrastructures using environmental Global Challenges (GCs) as thematic guidelines. These GCs are polyhedral and sometimes wicked problems that threaten the sustainability of our modern societies from a social and environmental perspective. This contribution describes how COOP+ uses GCs as guidelines to foster cooperation among RIs. First we have created an open survey to collect ideas about GCs within the different scientific communities. We present the structure of this survey as well as the preliminary information that it contains. The survey will be accepting responses during the project life (September 2018). We also describe the structure of a template that will be used to collaboratively characterize some selected GCs under the point of view of RIs. The main idea is to assess how RIs can be useful to address global environmental problems. We encourage all scientists related to RIs communities to participate in this process.

Commercial grade item (CGI) dedication of generators for nuclear safety related applications

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

Das, R.K.; Hajos, L.G.

1993-03-01

The number of nuclear safety related equipment suppliers and the availability of spare and replacement parts designed specifically for nuclear safety related application are shrinking rapidly. These have made it necessary for utilities to apply commercial grade spare and replacement parts in nuclear safety related applications after implementing proper acceptance and dedication process to verify that such items conform with the requirements of their use in nuclear safety related application. The general guidelines for the commercial grade item (CGI) acceptance and dedication are provided in US Nuclear Regulatory Commission (NRC) Generic Letters and Electric Power Research Institute (EPRI) Report NP-5652,more » Guideline for the Utilization of Commercial Grade Items in Nuclear Safety Related Applications. This paper presents an application of these generic guidelines for procurement, acceptance, and dedication of a commercial grade generator for use as a standby generator at Salem Generating Station Units 1 and 2. The paper identifies the critical characteristics of the generator which once verified, will provide reasonable assurance that the generator will perform its intended safety function. The paper also delineates the method of verification of the critical characteristics through tests and provide acceptance criteria for the test results. The methodology presented in this paper may be used as specific guidelines for reliable and cost effective procurement and dedication of commercial grade generators for use as standby generators at nuclear power plants.« less

Cross-cultural translation, validity, and reliability of the French version of the Neurophysiology of Pain Questionnaire.

PubMed

Demoulin, Christophe; Brasseur, Pauline; Roussel, Nathalie; Brereton, Clara; Humblet, Fabienne; Flynn, Daniel; Van Beveren, Julien; Osinsky, Thomas; Donneau, Anne-Françoise; Crielaard, Jean-Michel; Vanderthommen, Marc; Bruyère, Olivier

2017-11-01

Pain physiology education is an important component in the management of patients with chronic musculoskeletal pain. The Neurophysiology of Pain Questionnaire (NPQ) was developed in English to assess pain physiology knowledge in patients. This study aimed to translate the NPQ into French (NPQ-Fr) and to investigate the main psychometric properties of the NPQ-Fr. The translation was performed using the best practice translation guidelines. One hundred and one French-speaking patients with chronic non-specific spinal pain completed the NPQ-Fr to assess its acceptability and presence of floor/ceiling effects and test its dimensionality. The construct validity was tested by comparing the patients' NPQ-Fr scores to those of 17 physiotherapists and investigating its correlation with subscales of the Short Form-36 questionnaire. The reliability (i.e., internal consistency and test-retest reliability) was also investigated. To test the test-retest reliability, 70 patients were asked to complete the NPQ-Fr twice with one week in between. Regarding the NPQ-Fr psychometric properties: 1) acceptability was good; 2) internal consistency reached a Cronbach α-coefficient of 0.44; 3) no floor and ceiling effects were observed in patients; 4) a principal factor analysis generated three major factors; 5) construct validity was good; and 6) reliability was acceptable (intraclass correlation coefficient = 0.644; standard error of measurement = 1.5). The NPQ-Fr has satisfactory basic psychometric properties in patients with chronic spinal pain.

Potential of DNA barcoding for detecting quarantine fungi.

PubMed

Gao, Ruifang; Zhang, Guiming

2013-11-01

The detection of live quarantine pathogenic fungi plays an important role in guaranteeing regional biological safety. DNA barcoding, an emerging species identification technology, holds promise for the reliable, quick, and accurate detection of quarantine fungi. International standards for phytosanitary guidelines are urgently needed. The varieties of quarantine fungi listed for seven countries/regions, the currently applied detection methods, and the status of DNA barcoding for detecting quarantine fungi are summarized in this study. Two approaches have been proposed to apply DNA barcoding to fungal quarantine procedures: (i) to verify the reliability of known internal transcribed spacer (ITS)/cytochrome c oxidase subunit I (COI) data for use as barcodes, and (ii) to determine other barcodes for species that cannot be identified by ITS/COI. As a unique, standardizable, and universal species identification tool, DNA barcoding offers great potential for integrating detection methods used in various countries/regions and establishing international detection standards based on accepted DNA barcodes. Through international collaboration, interstate disputes can be eased and many problems related to routine quarantine detection methods can be solved for global trade.

Current status of laparoscopic and robotic ventral mesh rectopexy for external and internal rectal prolapse.

PubMed

van Iersel, Jan J; Paulides, Tim J C; Verheijen, Paul M; Lumley, John W; Broeders, Ivo A M J; Consten, Esther C J

2016-06-07

External and internal rectal prolapse with their affiliated rectocele and enterocele, are associated with debilitating symptoms such as obstructed defecation, pelvic pain and faecal incontinence. Since perineal procedures are associated with a higher recurrence rate, an abdominal approach is commonly preferred. Despite the description of greater than three hundred different procedures, thus far no clear superiority of one surgical technique has been demonstrated. Ventral mesh rectopexy (VMR) is a relatively new and promising technique to correct rectal prolapse. In contrast to the abdominal procedures of past decades, VMR avoids posterolateral rectal mobilisation and thereby minimizes the risk of postoperative constipation. Because of a perceived acceptable recurrence rate, good functional results and low mesh-related morbidity in the short to medium term, VMR has been popularized in the past decade. Laparoscopic or robotic-assisted VMR is now being progressively performed internationally and several articles and guidelines propose the procedure as the treatment of choice for rectal prolapse. In this article, an outline of the current status of laparoscopic and robotic ventral mesh rectopexy for the treatment of internal and external rectal prolapse is presented.

Human Papillomavirus Vaccine Uptake in Adolescent Boys: An Evidence Review.

PubMed

Voss, Danielle S; Wofford, Linda G

2016-10-01

Despite evidence-based guidelines recommending routine vaccination against human papillomavirus (HPV) for adolescent boys, ages 11-12 years, vaccine uptake among this population remains low. To examine reasons for low HPV quadrivalent vaccine uptake and methods available to increase vaccine uptake among adolescent males, ages 11-12 years. Of 341 identified studies, 30 were included from three databases. The 30 studies were grouped into six categories: population-specific, problem-specific, educational interventions, theory-specific, political implications, and foundational guidelines and Websites. Among eight studies, low vaccine uptake was attributed to lack of parental, adolescent, and physician knowledge of HPV4 vaccine availability and recommendations. HPV4 vaccine educational interventions for parents and adolescents were the most effective for promoting vaccine uptake. Theory applications and gain-framed messages were shown to be effective for assessing HPV vaccine attitudes and perceptions. Political implication studies reveal the need for political and financial measures to encourage HPV vaccine acceptability among the population. To promote HPV vaccine uptake among adolescent males, providers must remain current with HPV vaccine recommendations and offer parental and adolescent HPV education focusing on benefits of vaccine acceptance and risks of vaccine refusal. The results of this review inform our understanding of effective educational strategies to positively impact HPV vaccine uptake in adolescent males. Based on this review, clinicians can employ several evidence-based educational strategies to facilitate HPV vaccine uptake. © 2016 Sigma Theta Tau International.

The Empirically Supported Status of Acceptance and Commitment Therapy: An Update

ERIC Educational Resources Information Center

Smout, Matthew F.; Hayes, Louise; Atkins, Paul W. B.; Klausen, Jessica; Duguid, James E.

2012-01-01

Acceptance and commitment therapy (ACT) is a transdiagnostic cognitive behavioural therapy that predominantly teaches clients acceptance and mindfulness skills, as well as values clarification and enactment skills. Australian treatment guideline providers have been cautious in recognising ACT as empirically supported. This article reviews evidence…

Canadian 24-Hour Movement Guidelines for Children and Youth: Exploring the perceptions of stakeholders regarding their acceptability, barriers to uptake, and dissemination.

PubMed

Faulkner, Guy; White, Lauren; Riazi, Negin; Latimer-Cheung, Amy E; Tremblay, Mark S

2016-06-01

Engaging stakeholders in the development of guidelines and plans for implementation is vital. The purpose of this study was to examine stakeholders' (parents, teachers, exercise professionals, paediatricians, and youth) perceptions of the Canadian 24-Hour Movement Behaviour Guidelines for Children and Youth ("Movement Guidelines"). Stakeholders (n = 104) engaged in semi-structured focus groups or interviews to discuss the perceived acceptability of the guidelines, potential barriers to implementation, and preferred methods and messengers of dissemination. A thematic analysis was conducted. Overall, there was consistent support across all stakeholder groups, with the exception of youth participants, for the Movement Guidelines. Stakeholders identified a range of barriers to the uptake of the guidelines including concerns with accurately defining key terms such as "recreational" screen time; everyday challenges such as financial and time constraints; and the possibility of the Movement Guidelines becoming just another source of stress and guilt for already busy and overwhelmed parents. Participants identified a range of recommended methods and messengers for future dissemination. School and medical settings were the most commonly recommended settings through which dissemination efforts should be delivered. Overall, participants representing a range of stakeholder groups were receptive to the new Movement Guidelines and endorsed their value. In complementing the Movement Guidelines, messaging and resources will need to be developed that address common concerns participants had regarding their dissemination and implementation.

Light pollution and protection of optical telescope sites

NASA Astrophysics Data System (ADS)

Tan, Huisong; Cen, Xuefen

2002-03-01

There is now great investment in astronomy as a science in China and other countries. We are currently looking forward to the fruits of the astronomical instruments. Unfortunately the light pollution influences optical/infrared observations on the contrast and the signal-to-noise ratio. Astronomy has been retreated to mountains, deserts and into space. The only way is human being aiming for good lighting environments and protecting the telescope sites. The Commission Internationale d'Eclairage, the International Dark-sky Association, the IAU Commission 21 (The Light of the Night Sky) and 50 (Protection of Existing and Potential Observatory Sites) have done many efforts in this field to control light pollution. Some countries (Japan, Chile) or local (Tucson, USA; Canarias, Spain) governments have issued guidelines for light pollution to keep dark sky for observatories. These guidelines could be used as references in China. If we do not solve the question of light pollution, the merely a few acceptable observatories in China have to be retreated.

International Consensus Statement on the Clinical and Therapeutic Management of Leber Hereditary Optic Neuropathy.

PubMed

Carelli, Valerio; Carbonelli, Michele; de Coo, Irenaeus F; Kawasaki, Aki; Klopstock, Thomas; Lagrèze, Wolf A; La Morgia, Chiara; Newman, Nancy J; Orssaud, Christophe; Pott, Jan Willem R; Sadun, Alfredo A; van Everdingen, Judith; Vignal-Clermont, Catherine; Votruba, Marcela; Yu-Wai-Man, Patrick; Barboni, Piero

2017-12-01

Leber hereditary optic neuropathy (LHON) is currently estimated as the most frequent mitochondrial disease (1 in 27,000-45,000). Its molecular pathogenesis and natural history is now fairly well understood. LHON also is the first mitochondrial disease for which a treatment has been approved (idebenone-Raxone, Santhera Pharmaceuticals) by the European Medicine Agency, under exceptional circumstances because of the rarity and severity of the disease. However, what remains unclear includes the optimal target population, timing, dose, and frequency of administration of idebenone in LHON due to lack of accepted definitions, criteria, and general guidelines for the clinical management of LHON. To address these issues, a consensus conference with a panel of experts from Europe and North America was held in Milan, Italy, in 2016. The intent was to provide expert consensus statements for the clinical and therapeutic management of LHON based on the currently available evidence. We report the conclusions of this conference, providing the guidelines for clinical and therapeutic management of LHON.

HIV/AIDS research conducted in the developing world and sponsored by the developed world: reporting of research ethics committee review in two countries.

PubMed

Chin, Lisa Judy; Rifai-Bashjawish, Hoda; Kleinert, Kelly; Saltman, Alexandra; Leu, Cheng-Shiun; Klitzman, Robert

2011-09-01

We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.

78 FR 40507 - Appendix B Guidelines for Reviewing Applications for Compensation and Reimbursement of Expenses...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-05

... AGENCY: Executive Office for United States Trustees, Justice. ACTION: Notice of internal procedural... DEPARTMENT OF JUSTICE Appendix B Guidelines for Reviewing Applications for Compensation and... internal procedural guidelines in the Federal Register of June 17, 2013, concerning guidelines for...

10 CFR 960.3-2-2-1 - Evaluation of all potentially acceptable sites.

Code of Federal Regulations, 2013 CFR

2013-01-01

...-1 Section 960.3-2-2-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-1 Evaluation... technical guidelines of subparts C and D, in accordance with the application requirements set forth in...

10 CFR 960.3-2-2-1 - Evaluation of all potentially acceptable sites.

Code of Federal Regulations, 2012 CFR

2012-01-01

...-1 Section 960.3-2-2-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-1 Evaluation... technical guidelines of subparts C and D, in accordance with the application requirements set forth in...

10 CFR 960.3-2-2-1 - Evaluation of all potentially acceptable sites.

Code of Federal Regulations, 2011 CFR

2011-01-01

...-1 Section 960.3-2-2-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-1 Evaluation... technical guidelines of subparts C and D, in accordance with the application requirements set forth in...

10 CFR 960.3-2-1 - Site screening for potentially acceptable sites.

Code of Federal Regulations, 2014 CFR

2014-01-01

... Section 960.3-2-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-1 Site screening for... technical guidelines can exist in the same land unit, the DOE shall seek to evaluate the composite...

10 CFR 960.3-2-1 - Site screening for potentially acceptable sites.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Section 960.3-2-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-1 Site screening for... technical guidelines can exist in the same land unit, the DOE shall seek to evaluate the composite...

10 CFR 960.3-2-1 - Site screening for potentially acceptable sites.

Code of Federal Regulations, 2012 CFR

2012-01-01

... Section 960.3-2-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-1 Site screening for... technical guidelines can exist in the same land unit, the DOE shall seek to evaluate the composite...

10 CFR 960.3-2-2-1 - Evaluation of all potentially acceptable sites.

Code of Federal Regulations, 2014 CFR

2014-01-01

...-1 Section 960.3-2-2-1 Energy DEPARTMENT OF ENERGY GENERAL GUIDELINES FOR THE PRELIMINARY SCREENING OF POTENTIAL SITES FOR A NUCLEAR WASTE REPOSITORY Implementation Guidelines § 960.3-2-2-1 Evaluation... technical guidelines of subparts C and D, in accordance with the application requirements set forth in...

Ethical and Legal Considerations in Dental Caries Research Using Human Subjects: Conference Summary.

ERIC Educational Resources Information Center

Jenny, Joanna

1980-01-01

Guidelines of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research are discussed. It is concluded that dentistry must not uncritically accept guidelines meant for a broader class of research, that guidelines can be misapplied, and that researchers must educate themselves on the Commission…

12 CFR 412.11 - Payment guidelines.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Payment guidelines. 412.11 Section 412.11 Banks and Banking EXPORT-IMPORT BANK OF THE UNITED STATES ACCEPTANCE OF PAYMENT FROM A NON-FEDERAL SOURCE FOR TRAVEL EXPENSES § 412.11 Payment guidelines. (a) Payments from a non-Federal source, other than...

Ethics in international health research: a perspective from the developing world.

PubMed Central

Bhutta, Zulfiqar Ahmed

2002-01-01

Health research plays a pivotal role in addressing inequities in health and human development, but to achieve these objectives the research must be based on sound scientific and ethical principles. Although it is accepted that ethics play a central role in health research in developing countries, much of the recent debate has focused on controversies surrounding internationally sponsored research and has taken place largely without adequate participation of the developing countries. The relationship between ethical guidelines and regulations, and indigenously sponsored and public health research has not been adequately explored. For example, while the fundamental principles of ethical health research, such as community participation, informed consent, and shared benefits and burdens, remain sacrosanct other issues, such as standards of care and prior agreements, merit greater public debate within developing countries. In particular, the relationship of existing ethical guidelines to epidemiological and public health research merits further exploration. In order to support health research in developing countries that is both relevant and meaningful, the focus must be on developing health research that promotes equity and on developing local capacity in bioethics. Only through such proactive measures can we address the emerging ethical dilemmas and challenges that globalization and the genomics revolution will bring in their wake. PMID:11953789

Validation of Omron RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010.

PubMed

Takahashi, Hakuo; Yoshika, Masamichi; Yokoi, Toyohiko

2013-01-01

Allowing patients to measure their blood pressure at home is recognized as being of clinical value. However, it is not known how often these measurements are taken correctly. Blood pressure monitors for home use fall into two types based on the position of the cuff, ie, at the upper arm or the wrist. The latter is particularly convenient, as measurements can be taken fully clothed. This study aimed to evaluate the performance of the wrist-type blood pressure monitors Omron RS8 (HEM-6310F-E), Omron RS6 (HEM-6221-E), and Omron RS3 (HEM-6130-E). A team of three trained doctors validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. All the devices met the validation requirements of the European Society of Hypertension International Protocol revision 2010. The difference in blood pressure readings between the tested device and the standard mercury sphygmomanometer was within 3 mmHg, which is acceptable according to the European Society of Hypertension guidelines. All the home devices tested were found to be suitable for measuring blood pressure at home because their performance fulfilled the requirement of the guidelines.

Searching the optimal PTH target range in children undergoing peritoneal dialysis: new insights from international cohort studies.

PubMed

Haffner, Dieter; Schaefer, Franz

2013-04-01

The treatment of the mineral and bone disorder associated with chronic kidney disease (CKD-MBD) remains a major challenge in pediatric patients. The principal aims of therapeutic measures are not only to prevent the debilitating skeletal complications and to achieve normal growth but also to preserve long-term cardiovascular health. Serum parathyroid hormone (PTH) levels are used as a surrogate parameter of bone turnover. Whereas it is generally accepted that serum calcium and phosphate levels should be kept within the range for age, current pediatric consensus guidelines differ markedly with respect to the optimal PTH target range and operate on a limited evidence base. Recently, the International Pediatric Dialysis Network (IPPN) established a global registry collecting detailed clinical and biochemical information, including data relevant to CKD-MBD in children on chronic peritoneal dialysis (PD). This review highlights the current evidence basis regarding the optimal PTH target range in pediatric CKD patients, and re-assesses the current guidelines in view of the outcome data collected by the IPPN registry. Based on a comprehensive evaluation of CKD-MBD outcome measures in this global patient cohort, a PTH target range of 1.7-3 times the upper limit of normal (i.e. 100-200 pg/ml) appears reasonable in children undergoing chronic PD.

Applicability of the World Commission on Dams' recommendations for public financial institutions: a case for Japanese yen loan assistance

NASA Astrophysics Data System (ADS)

Fujikura, Ryo; Nakayama, Mikiyasu; Mori, Katsuhiko

2003-10-01

The World Commission on Dams (WCD) published Dams and Development as its only and final report in November 2000. Identifying core values and strategic priorities, the report proposed internationally acceptable criteria and standards. Despite the fact that the WCD itself did not intend that the report be used as a blueprint, many non-governmental organizations strongly support the report and the criteria and guidelines recommended in the report, and demand that they be adopted in their current form by funding organizations. The WCD criteria and guidelines were found to have several methodological problems, and it appears impossible to apply the recommended criteria and guidelines as they stand. This study examines the applicability of the WCD criteria and guidelines for public financing institutes involved in overseas development assistance and proposes necessary measures to increase their applicability in order to realize core values and strategic priorities. The character of and relationships among key decision points, strategic priorities, criteria, and guidelines should be clarified. Then, this study examines the applicability of the WCD recommendations for Japanese public financial institutions, as Japan has nearly become the sole bilateral donor providing financial assistance (loans) for large dam construction projects. The public financial institution can only be mandated to check the legal status of the decisions made regarding Stages 1 and 2 which are the first two of the five successive stages from the planning to the operation of the dam project. Needs assessment and alternative selection are expected to be conducted at Stage 1 and 2 respectively. The Japan Bank for International Cooperation (JBIC), which deals with the Japanese concessional yen loan, and the Japan International Cooperation Agency (JICA), which is in charge of technical assistance, are featured in this study. As for the Japanese concessional yen loan assistance, there are other inherent problems for adopting the recommendations. First, it is not clear which government agency officially and substantially carries the decision-making responsibility. Second, JBIC may be involved only when Stage 2 has been completed, and it should be decided and clarified to what extent the Japanese government, as well as JIBC and JICA, should be involved in Stages 1 and 2 (2A: intensive studies on alternatives) of a project for which funding is requested. These issues need to be solved if the Japanese government wishes to adopt the recommendations. Copyright

Pediatric Psycho-oncology Care: Standards, Guidelines and Consensus Reports

PubMed Central

Wiener, Lori; Viola, Adrienne; Koretski, Julia; Perper, Emily Diana; Patenaude, Andrea Farkas

2014-01-01

Objective To identify existing guidelines, standards, or consensus-based reports for psychosocial care of children with cancer and their families. Purpose Psychosocial standards of care for children with cancer can systematize the approach to care and create a replicable model that can be utilized in pediatric hospitals around the world. Determining gaps in existing standards in pediatric psycho-oncology can guide development of useful evidence- and consensus-based standards. Methods The MEDLINE and PubMed databases were searched by investigators at two major pediatric oncology centers for existing guidelines, consensus-based reports, or standards for psychosocial care of pediatric cancer patients and their families published in peer-reviewed journals in English between 1980 and 2013. Results We located 27 articles about psychosocial care that met inclusion criteria: 5 set forth standards, 19 guidelines and 3 were consensus-based reports. None were sufficiently up-to-date, significantly evidence-based, comprehensive and specific enough to serve as a current standard for psychosocial care for children with cancer and their families. Conclusion Despite calls by a number of international pediatric oncology and psycho-oncology professional organizations about the urgency of addressing the psychosocial needs of the child with cancer in order to reduce suffering, there remains a need for development of a widely acceptable, evidence- and consensus-based, comprehensive standard of care to guide provision of essential psychosocial services to all pediatric cancer patients. PMID:24906202

The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update.

PubMed

Zuberbier, T; Aberer, W; Asero, R; Bindslev-Jensen, C; Brzoza, Z; Canonica, G W; Church, M K; Ensina, L F; Giménez-Arnau, A; Godse, K; Gonçalo, M; Grattan, C; Hebert, J; Hide, M; Kaplan, A; Kapp, A; Abdul Latiff, A H; Mathelier-Fusade, P; Metz, M; Nast, A; Saini, S S; Sánchez-Borges, M; Schmid-Grendelmeier, P; Simons, F E R; Staubach, P; Sussman, G; Toubi, E; Vena, G A; Wedi, B; Zhu, X J; Maurer, M

2014-07-01

This guideline is the result of a systematic literature review using the 'Grading of Recommendations Assessment, Development and Evaluation' (GRADE) methodology and a structured consensus conference held on 28 and 29 November 2012, in Berlin. It is a joint initiative of the Dermatology Section of the European Academy of Allergy 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) with the participation of delegates of 21 national and international societies. Urticaria is a frequent, mast cell-driven disease, presenting with wheals, angioedema, or both. The life-time prevalence for acute urticaria is approximately 20%. Chronic spontaneous urticaria and other chronic forms of urticaria do not only cause a decrease in quality of life, but also affect performance at work and school and, as such, are members of the group of severe allergic diseases. This guideline covers the definition and classification of urticaria, taking into account the recent progress in identifying its causes, eliciting factors and pathomechanisms. In addition, it outlines evidence-based diagnostic and therapeutic approaches for the different subtypes of urticaria. This guideline was acknowledged and accepted by the European Union of Medical Specialists (UEMS). © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

76 FR 2917 - Notice of Cancellation of Public Meeting on the International Maritime Organization Guidelines...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... Public Meeting on the International Maritime Organization Guidelines for Exhaust Gas Cleaning Systems for... that a public meeting on the International Maritime Organization guidelines for exhaust gas cleaning..., 2011. F.J. Strum, Acting Director of Commercial Regulations and Standards. [FR Doc. 2011-1024 Filed 1...

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

DTIC Science & Technology

1979-08-21

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

10 CFR 1050.204 - Advance approval for acceptance of gifts or decorations.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Advance approval for acceptance of gifts or decorations. 1050.204 Section 1050.204 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) FOREIGN GIFTS AND DECORATIONS Guidelines for Acceptance of Foreign Gifts or Decorations § 1050.204 Advance approval for...

DNA Commission of the International Society for Forensic Genetics: revised and extended guidelines for mitochondrial DNA typing.

PubMed

Parson, W; Gusmão, L; Hares, D R; Irwin, J A; Mayr, W R; Morling, N; Pokorak, E; Prinz, M; Salas, A; Schneider, P M; Parsons, T J

2014-11-01

The DNA Commission of the International Society of Forensic Genetics (ISFG) regularly publishes guidelines and recommendations concerning the application of DNA polymorphisms to the question of human identification. Previous recommendations published in 2000 addressed the analysis and interpretation of mitochondrial DNA (mtDNA) in forensic casework. While the foundations set forth in the earlier recommendations still apply, new approaches to the quality control, alignment and nomenclature of mitochondrial sequences, as well as the establishment of mtDNA reference population databases, have been developed. Here, we describe these developments and discuss their application to both mtDNA casework and mtDNA reference population databasing applications. While the generation of mtDNA for forensic casework has always been guided by specific standards, it is now well-established that data of the same quality are required for the mtDNA reference population data used to assess the statistical weight of the evidence. As a result, we introduce guidelines regarding sequence generation, as well as quality control measures based on the known worldwide mtDNA phylogeny, that can be applied to ensure the highest quality population data possible. For both casework and reference population databasing applications, the alignment and nomenclature of haplotypes is revised here and the phylogenetic alignment proffered as acceptable standard. In addition, the interpretation of heteroplasmy in the forensic context is updated, and the utility of alignment-free database searches for unbiased probability estimates is highlighted. Finally, we discuss statistical issues and define minimal standards for mtDNA database searches. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Evaluation of pediatric cochlear implant care throughout Europe: Is European pediatric cochlear implant care performed according to guidelines?

PubMed

Bruijnzeel, Hanneke; Bezdjian, Aren; Lesinski-Schiedat, Anke; Illg, Angelika; Tzifa, Konstance; Monteiro, Luisa; Volpe, Antonio Della; Grolman, Wilko; Topsakal, Vedat

2017-11-01

International guidelines indicate that children with profound hearing loss should receive a cochlear implant (CI) soon after diagnosis in order to optimize speech and language rehabilitation. Although prompt rehabilitation is encouraged by current guidelines, delays in cochlear implantation are still present. This study investigated whether European countries establish timely pediatric CI care based on epidemiological, commercial, and clinical data. An estimation of the number of pediatric CI candidates in European countries was performed and compared to epidemiological (Euro-CIU), commercial (Cochlear ® ), and clinical (institutional) age-at-implantation data. The ages at implantation of pediatric patients in eight countries (the Netherlands, Belgium, Germany, the United Kingdom, France, Turkey, Portugal, and Italy) between 2005 and 2015 were evaluated. From 2010 onwards, over 30% of the pediatric CI candidates were implanted before 24 months of age. Northern European institutions implanted children on average around 12 months of age, whereas southern European institutions implanted children after 18 months of age. The Netherlands and Germany implanted earliest (between 6 and 11 months). Implemented newborn hearing screening programs and reimbursement rates of CIs vary greatly within Europe due to local, social, financial, and political differences. However, internationally accepted recommendations are applicable to this heterogeneous European CI practice. Although consensus on early pediatric cochlear implantation exists, this study identified marked delays in European care. Regardless of the great heterogeneity in European practice, reasons for latency should be identified on a national level and possibilities to prevent avoidable future implantation delays should be explored to provide national recommendations.

Surrogate outcomes in health technology assessment: an international comparison.

PubMed

Velasco Garrido, Marcial; Mangiapane, Sandra

2009-07-01

Our aim was to review the recommendations given by health technology assessment (HTA) institutions in their methodological guidelines concerning the use of surrogate outcomes in their assessments. In a second step, we aimed at quantifying the role surrogate parameters take in assessment reports. We analyzed methodological papers and guidelines from HTA agencies with International Network of Agencies for Health Technology Assessment membership as well as from institutions related to pharmaceutical regulation (i.e., reimbursement, pricing). We analyzed the use of surrogate outcomes in a sample of HTA reports randomly drawn from the HTA database. We checked methods, results (including evidence tables), and conclusions sections and extracted the outcomes reported. We report descriptive statistics on the presence of surrogate outcomes in the reports. We identified thirty-four methodological guidelines, twenty of them addressing the issue of outcome parameter choice and the problematic of surrogate outcomes. Overall HTA agencies call on caution regarding the reliance on surrogate outcomes. None of the agencies has provided a list or catalog of acceptable and validated surrogate outcomes. We extracted the outcome parameter of 140 HTA reports. Only around half of the reports determined the outcomes for the assessment prospectively. Surrogate outcomes had been used in 62 percent of the reports. However, only 3.6 percent were based upon surrogate outcomes exclusively. All of them assessed diagnostic or screening technologies and the surrogate outcomes were predominantly test characteristics. HTA institutions seem to agree on a cautious approach to the use of surrogate outcomes in technology assessment. Thorough assessment of health technologies should not rely exclusively on surrogate outcomes.

[Hospital Doctors Should Receive Lecture for Sedation According to Joint Commission International].

PubMed

Ueshima, Hironobu; Komasawa, Nobuyasu; Kitamura, Akira

2015-08-01

At our hospital, intending to obtaining an approval from the Joint Commission International (JCI), we conducted a workshop on sedation for all staff physicians. A sedation instructor authorized by the Japanese Association for Medical Simulation gave a lecture using the "practice guidelines for sedation and administration of analgesics for non-anesthesiologists", revised in 2002 by the American Society of Anesthesiologists, following which, a test using 10 true-false questions was conducted, while before and after the lecture a questionnaire survey on the sedation lecture was carried out Among 191 physicians attending the lecture, except for one person, 7 or more questions were answered correctly. From the questionnaires, the sedation lectures were also generally accepted favourably. In the test of understanding, the mistakes were mostly in the sections on "sedation evaluation" "intraoperative monitoring" "pharmaceutical knowledge" and "airway management methods". The sedation lecture in the hospital was effective.

A core syllabus for the teaching of embryology and teratology to medical students.

PubMed

Fakoya, Francis A; Emmanouil-Nikoloussi, Elpida; Sharma, Deepak; Moxham, Bernard J

2017-03-01

Clinical relevance in the teaching of biomedical sciences within health care courses presupposes that there is internationally agreed core material within the curricula. However, with the exception of a syllabus for neuroanatomy and gross anatomy of the head and neck for medical students, core syllabuses within many of the specialized anatomical sciences have yet to be developed. The International Federation of Associations of Anatomists aims to formulate internationally accepted core syllabuses for all anatomical sciences disciplines initially using Delphi Panels that comprise anatomists, scientists, and clinicians who evaluate syllabus content. Here, the suggestions of a Delphi Panel for embryology and teratology are presented prior to their publication on the website of the International Federation of Associations of Anatomists. Hence, to obtain a more definitive syllabus, it is required that anatomical and embryological/teratological societies, as well as individual anatomists, embryologists and clinicians, freely comment upon, elaborate and amend, this draft syllabus. The goal is to set internationally recognized standards and thereby provide guidelines concerning embryological and teratological knowledge when involved with course development. Clin. Anat. 30:159-167, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Adapting clinical guidelines in low‐resources countries: a study on the guideline on the management and prevention of type 2 diabetes mellitus in Indonesia

PubMed Central

Wangge, Grace; van der Graaf, Yolanda; van der Heijden, Geert J. M. G.

2016-01-01

Abstract Rationale, aims and objectives Most of the clinical guidelines in low‐resource countries are adaptations from preexisting international guidelines. This adaptation can be problematic when those international guidelines are not based on current evidence or original evidence‐based international guidelines are not followed. This study aims to evaluate the quality of an Indonesian type 2 diabetes mellitus guideline adapted from selected international guidelines. Methods The “Consensus on the Management and Prevention of type 2 Diabetes in Indonesia 2011” is a guideline by the Indonesian Society of Endocrinology (Perkeni). Four parent guidelines identified from its list of references were from the International Diabetes Federation (IDF), American Association of Clinical Endocrinologist (AACE), American Diabetes Association (ADA), and one jointly released by ADA and European Association for the Study of Diabetes (EASD). Two reviewers independently assessed its quality using the Appraisal of Guidelines, Research and Evaluation Collaboration (AGREE II) instrument. Six recommendations were compared: (1) screening for diabetes; (2) diagnosis; (3) control of hyperglycemia; (4) target blood glucose; (5) target blood pressure; and (6) treatment of dyslipidemia. Results Perkeni's guideline satisfied 55% of the AGREE II items, while its parent guidelines satisfied 59% to 74%. Perkeni's shows low score on “rigor of development” and “applicability” and the lowest score in the “scope and purpose” domain. Differences were found in 4 recommendations: the screening of diabetes, control of hyperglycemia, target blood glucose, and treatment of dyslipidemia. In 3 of 4, Perkeni followed the ADA's recommendation. Conclusion Derivation of recommendations from parent guidelines and their adaptation to the context of Indonesian health care lacks transparency. When guidelines are either derived from other guidelines or adapted for use in different context, evidence‐based practice principles should be followed and adhered to. PMID:27592587

Adapting clinical guidelines in low-resources countries: a study on the guideline on the management and prevention of type 2 diabetes mellitus in Indonesia.

PubMed

Widyahening, Indah S; Wangge, Grace; van der Graaf, Yolanda; van der Heijden, Geert J M G

2017-02-01

Most of the clinical guidelines in low-resource countries are adaptations from preexisting international guidelines. This adaptation can be problematic when those international guidelines are not based on current evidence or original evidence-based international guidelines are not followed. This study aims to evaluate the quality of an Indonesian type 2 diabetes mellitus guideline adapted from selected international guidelines. The "Consensus on the Management and Prevention of type 2 Diabetes in Indonesia 2011" is a guideline by the Indonesian Society of Endocrinology (Perkeni). Four parent guidelines identified from its list of references were from the International Diabetes Federation (IDF), American Association of Clinical Endocrinologist (AACE), American Diabetes Association (ADA), and one jointly released by ADA and European Association for the Study of Diabetes (EASD). Two reviewers independently assessed its quality using the Appraisal of Guidelines, Research and Evaluation Collaboration (AGREE II) instrument. Six recommendations were compared: (1) screening for diabetes; (2) diagnosis; (3) control of hyperglycemia; (4) target blood glucose; (5) target blood pressure; and (6) treatment of dyslipidemia. Perkeni's guideline satisfied 55% of the AGREE II items, while its parent guidelines satisfied 59% to 74%. Perkeni's shows low score on "rigor of development" and "applicability" and the lowest score in the "scope and purpose" domain. Differences were found in 4 recommendations: the screening of diabetes, control of hyperglycemia, target blood glucose, and treatment of dyslipidemia. In 3 of 4, Perkeni followed the ADA's recommendation. Derivation of recommendations from parent guidelines and their adaptation to the context of Indonesian health care lacks transparency. When guidelines are either derived from other guidelines or adapted for use in different context, evidence-based practice principles should be followed and adhered to. © 2016 The Authors Journal of Evaluation in Clinical Practice Published by John Wiley & Sons Ltd.

Multi-faceted implementation strategy to increase use of a clinical guideline for the diagnosis of deep venous thrombosis in primary care.

PubMed

Kingma, Anna E C; van Stel, Henk F; Oudega, Ruud; Moons, Karel G M; Geersing, Geert-Jan

2017-08-01

A clinical decision rule (CDR), combined with a negative D-dimer test, can safely rule out deep venous thrombosis (DVT) in primary care. This strategy is recommended by guidelines, yet uptake by GPs is low. To evaluate a multi-faceted implementation strategy aimed at increased use of the guideline recommended CDR plus D-dimer test in primary care patients with suspected DVT. This multi-faceted implementation strategy consisted of educational outreach visits, financial reimbursements and periodical newsletters. 217 Dutch GPs (implementation group) received this strategy and included patients. Effectiveness was measured through the following patient-level outcomes: (i) proportion of non-referred patients, (ii) proportion of missed DVT cases within this group and (iii) the proportion of patients in whom the guideline was applied incorrectly. Implementation outcomes ('acceptability', 'feasibility', 'fidelity' and 'sustainability') were assessed with an online questionnaire. Patient-level outcomes were compared with those of patients included by 450 GPs, uninformed about the study's purposes providing information about usual care. 336 (54%) of 619 analyzable implementation group patients were not referred, missing 6 [1.8% (95% confidence interval 0.7% to 3.9%)] DVT cases. Incorrect guideline use was observed in 199 patients (32%). Self-reported acceptability, feasibility and expected sustainability were high. Guideline use increased from 42% to an expected continuation of use of 91%. Only 32 usual care GPs included 62 patients, making formal comparison unreliable. This multi-faceted implementation strategy safely reduced patient referral to secondary care, despite frequently incorrect application of the guideline and resulted in high acceptability, feasibility and expected sustainability. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

EURONET: Guidelines for Cooperation between Data Base Suppliers and Host Organizations.

ERIC Educational Resources Information Center

Commission des Communautes Europeennes (Luxembourg). Bureau de Terminologie.

The purpose of the guidelines is to focus on the mutual benefits which arise from close cooperation between Data Base Suppliers (DBS) and Hosts, and to identify some of the individual responsibilities. The guidelines have been assembled from accepted policies and procedures in information supply activities to assist EURONET Hosts and DBS to work…

[History of the development of screening tests for cervical cancer].

PubMed

Herrera, Yelda A; Piña-Sánchez, Patricia

2015-01-01

Cervical cancer (CC) is one of the best known malignancies. Currently, it is accepted that the etiological factor is persistent infection with high-risk human papillomavirus (HPV). Even before the identification of its etiological factors, methods such as Pap cytology and colposcopy were developed as tools for early diagnosis on CC and its precursor lesions. At the time when such tests were being developed, they were not fully accepted by the scientific community of the time; however, as time went by, the dissemination of knowledge, and more extensive application, these tests were finally included within the international guidelines. The implementation of programs with adequate coverage and quality allowed a significant reduction in the incidence and mortality of CC. However this did not occur widely, and CC is still a public health problem in developing countries. From the epidemiological and molecular viewpoint, knowledge on HPVs laid the foundations for the development of new prevention strategies based on vaccination and molecular detection of the causal agent, currently accepted as strategies for primary and secondary prevention. It is expected that the implementation of these strategies will have a greater impact on the control on CC and other malignancies associated with HPV infection.

Radiofrequency ablation of hepatocellular carcinoma: pros and cons.

PubMed

Rhim, Hyunchul; Lim, Hyo K

2010-09-01

Among locoregional treatments for hepatocellular carcinoma (HCC), radiofrequency ablation (RFA) has been accepted as the most popular alternative to curative transplantation or resection, and it shows an excellent local tumor control rate and acceptable morbidity. The benefits of RFA have been universally validated by the practice guidelines of international societies of hepatology. The main advantages of RFA include 1) it is minimally invasive with acceptable morbidity, 2) it enables excellent local tumor control, 3) it has promising long-term survival, and 4) it is a multimodal approach. Based on these pros, RFA will play an important role in managing the patient with early HCC (smaller than 3 cm with fewer than four tumors). The main limitations of current RFA technology in hepatic ablation include 1) limitation of ablation volume, 2) technically infeasible in some tumors due to conspicuity and dangerous location, and 3) the heat-sink effect. Many technical approaches have been introduced to overcome those limitations, including a novel guiding modality, use of artificial fluid or air, and combined treatment strategies. RFA will continue to play a role as a representative ablative modality in the management of HCC, even in the era of targeted agents.

Radiofrequency Ablation of Hepatocellular Carcinoma: Pros and Cons

PubMed Central

Lim, Hyo K.

2010-01-01

Among locoregional treatments for hepatocellular carcinoma (HCC), radiofrequency ablation (RFA) has been accepted as the most popular alternative to curative transplantation or resection, and it shows an excellent local tumor control rate and acceptable morbidity. The benefits of RFA have been universally validated by the practice guidelines of international societies of hepatology. The main advantages of RFA include 1) it is minimally invasive with acceptable morbidity, 2) it enables excellent local tumor control, 3) it has promising long-term survival, and 4) it is a multimodal approach. Based on these pros, RFA will play an important role in managing the patient with early HCC (smaller than 3 cm with fewer than four tumors). The main limitations of current RFA technology in hepatic ablation include 1) limitation of ablation volume, 2) technically infeasible in some tumors due to conspicuity and dangerous location, and 3) the heat-sink effect. Many technical approaches have been introduced to overcome those limitations, including a novel guiding modality, use of artificial fluid or air, and combined treatment strategies. RFA will continue to play a role as a representative ablative modality in the management of HCC, even in the era of targeted agents. PMID:21103289

Tablet splitting: a review of the clinical and economic outcomes and patient acceptance. Second of a 2-part series. Part 1 was published in May 2012 (Consult Pharm 2012;27:239-53).

PubMed

Freeman, Maisha Kelly; White, Whitney; Iranikhah, Maryam

2012-06-01

To describe the clinical outcomes, patient acceptance, and economic effect associated with tablet splitting. PubMed (1966-June 2011) and International Pharmaceutical Abstract (1975-June 2011) searches were conducted using tablet splitting as the search terms. All studies that evaluated the clinical outcome (n = 4), patient acceptance (n = 5), and economic effects (n = 8) of tablet splitting were included. The American Pharmacists Association guidelines, recommendations from the Food and Drug Administration, and clinical trial data were evaluated. The majority of trials conducted evaluating clinical outcomes associated with tablet splitting were evaluated in patients receiving statins and antihypertensives. Clinical outcomes associated with risperidone were assessed. No adverse clinical outcomes were observed with therapy. Most studies evaluating the economic effects of tablet splitting have revealed a cost savings associated with this process; however, many studies were subject to limitations. The first part of this two-part series reviewed the weight and content uniformity in tablet splitting. Tablet splitting does not seem to significantly affect clinical outcomes related to management of hypertension, cholesterol, or psychiatric disorders, nor influence overall patient adherence.

Systematic Review of International Colposcopy Quality Improvement Guidelines.

PubMed

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

2017-10-01

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

Impact of external haematology proficiency testing programme on quality of laboratories.

PubMed

Saxena, Renu; Katoch, S C; Srinivas, Upendra; Rao, Seema; Anand, Hema

2007-11-01

A reliable and reproducible report from a laboratory needs internal quality control within the laboratory and participation in external proficiency testing programmes (EPTP). This study conducted at the Department of Haematology, All India Institute of Medical Sciences (AIIMS), New Delhi, which has been conducting an EPTP since 1992, was undertaken to assess the efficacy of this programme in improving the performance of participating laboratories in reporting test samples sent for Hb, total leucocyte count (TLC), reticulocyte count and assessment of peripheral blood smear (PBS). The samples were prepared in our laboratory according to the International Standards Organization (ISO) guidelines. The performance of individual laboratories was assessed using robust Z score, which is an indicator of acceptability of the test result. An improvement in the overall percentage of laboratories with acceptable reports was seen during the study period. It has increased from 38,40,40 per cent in 1992 to 85, 90,94.7 per cent in 2006 for Hb, TLC, reticulocyte count, respectively. However, the results for peripheral smear assessment improved only marginally. The external haematology proficiency testing programme run by our department for Hb, TLC, reticulocyte count, and peripheral blood smear assessment, has helped in improving the reporting standards of these parameters in Indian laboratories.

An international comparison of occupational health guidelines for the management of mental disorders and stress-related psychological symptoms.

PubMed

Joosen, Margot C W; Brouwers, Evelien P M; van Beurden, Karlijn M; Terluin, Berend; Ruotsalainen, Jani H; Woo, Jong-Min; Choi, Kyeong-Sook; Eguchi, Hisashi; Moriguchi, Jiro; van der Klink, Jac J L; van Weeghel, Jaap

2015-05-01

We compared available guidelines on the management of mental disorders and stress-related psychological symptoms in an occupational healthcare setting and determined their development and reporting quality. To identify eligible guidelines, we systematically searched National Guideline Clearinghouse, Guidelines International Network Library and PubMed. Members of the International Commission on Occupational Health (ICOH), were also consulted. Guidelines recommendations were compared and reporting quality was assessed using the AGREE II instrument. Of 2126 titles retrieved, 14 guidelines were included: 1 Japanese, 2 Finnish, 2 Korean, 2 British and 7 Dutch. Four guidelines were of high-reporting quality. Best described was the Scope and Purpose, and the poorest described were competing interests (Editorial independence) and barriers and facilitators for implementation (Applicability). Key recommendations were often difficult to identify. Most guidelines recommend employing an inventory of symptoms, diagnostic classification, performance problems and workplace factors. All guidelines recommend specific return-to-work interventions, and most agreed on psychological treatment and communication between involved stakeholders. Practice guidelines to address work disability due to mental disorders and stress-related symptoms are available in various countries around the world, however, these guidelines are difficult to find. To promote sharing, national guidelines should be accessible via established international databases. The quality of the guideline's developmental process varied considerably. To increase quality and applicability, guideline developers should adopt a common structure for the development and reporting of their guidelines, for example Appraisal of Guidelines for Research and Evaluation (AGREE) criteria. Owing to differences in social systems, developers can learn from each other through reviews of this kind. 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.

The updating of clinical practice guidelines: insights from an international survey

PubMed Central

2011-01-01

Background Clinical practice guidelines (CPGs) have become increasingly popular, and the methodology to develop guidelines has evolved enormously. However, little attention has been given to the updating process, in contrast to the appraisal of the available literature. We conducted an international survey to identify current practices in CPG updating and explored the need to standardize and improve the methods. Methods We developed a questionnaire (28 items) based on a review of the existing literature about guideline updating and expert comments. We carried out the survey between March and July 2009, and it was sent by email to 106 institutions: 69 members of the Guidelines International Network who declared that they developed CPGs; 30 institutions included in the U.S. National Guideline Clearinghouse database that published more than 20 CPGs; and 7 institutions selected by an expert committee. Results Forty-four institutions answered the questionnaire (42% response rate). In the final analysis, 39 completed questionnaires were included. Thirty-six institutions (92%) reported that they update their guidelines. Thirty-one institutions (86%) have a formal procedure for updating their guidelines, and 19 (53%) have a formal procedure for deciding when a guideline becomes out of date. Institutions describe the process as moderately rigorous (36%) or acknowledge that it could certainly be more rigorous (36%). Twenty-two institutions (61%) alert guideline users on their website when a guideline is older than three to five years or when there is a risk of being outdated. Twenty-five institutions (64%) support the concept of "living guidelines," which are continuously monitored and updated. Eighteen institutions (46%) have plans to design a protocol to improve their guideline-updating process, and 21 (54%) are willing to share resources with other organizations. Conclusions Our study is the first to describe the process of updating CPGs among prominent guideline institutions across the world, providing a comprehensive picture of guideline updating. There is an urgent need to develop rigorous international standards for this process and to minimize duplication of effort internationally. PMID:21914177

10 CFR 300.12 - Acceptance of reports and registration of entity emission reductions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 3 2012-01-01 2012-01-01 false Acceptance of reports and registration of entity emission reductions. 300.12 Section 300.12 Energy DEPARTMENT OF ENERGY CLIMATE CHANGE VOLUNTARY GREENHOUSE GAS REPORTING PROGRAM: GENERAL GUIDELINES § 300.12 Acceptance of reports and registration of entity emission...

10 CFR 300.12 - Acceptance of reports and registration of entity emission reductions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 3 2014-01-01 2014-01-01 false Acceptance of reports and registration of entity emission reductions. 300.12 Section 300.12 Energy DEPARTMENT OF ENERGY CLIMATE CHANGE VOLUNTARY GREENHOUSE GAS REPORTING PROGRAM: GENERAL GUIDELINES § 300.12 Acceptance of reports and registration of entity emission...

10 CFR 300.12 - Acceptance of reports and registration of entity emission reductions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 3 2013-01-01 2013-01-01 false Acceptance of reports and registration of entity emission reductions. 300.12 Section 300.12 Energy DEPARTMENT OF ENERGY CLIMATE CHANGE VOLUNTARY GREENHOUSE GAS REPORTING PROGRAM: GENERAL GUIDELINES § 300.12 Acceptance of reports and registration of entity emission...

10 CFR 300.12 - Acceptance of reports and registration of entity emission reductions.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 3 2011-01-01 2011-01-01 false Acceptance of reports and registration of entity emission reductions. 300.12 Section 300.12 Energy DEPARTMENT OF ENERGY CLIMATE CHANGE VOLUNTARY GREENHOUSE GAS REPORTING PROGRAM: GENERAL GUIDELINES § 300.12 Acceptance of reports and registration of entity emission...

10 CFR 300.12 - Acceptance of reports and registration of entity emission reductions.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 3 2010-01-01 2010-01-01 false Acceptance of reports and registration of entity emission reductions. 300.12 Section 300.12 Energy DEPARTMENT OF ENERGY CLIMATE CHANGE VOLUNTARY GREENHOUSE GAS REPORTING PROGRAM: GENERAL GUIDELINES § 300.12 Acceptance of reports and registration of entity emission...

Meeting the requirements of importing countries: practice and policy for on-farm approaches to food safety.

PubMed

Dagg, P J; Butler, R J; Murray, J G; Biddle, R R

2006-08-01

In light of the increasing consumer demand for safe, high-quality food and recent public health concerns about food-borne illness, governments and agricultural industries are under pressure to provide comprehensive food safety policies and programmes consistent with international best practice. Countries that export food commodities derived from livestock must meet both the requirements of the importing country and domestic standards. It is internationally accepted that end-product quality control, and similar methods aimed at ensuring food safety, cannot adequately ensure the safety of the final product. To achieve an acceptable level of food safety, governments and the agricultural industry must work collaboratively to provide quality assurance systems, based on sound risk management principles, throughout the food supply chain. Quality assurance systems on livestock farms, as in other parts of the food supply chain, should address food safety using hazard analysis critical control point principles. These systems should target areas including biosecurity, disease monitoring and reporting, feedstuff safety, the safe use of agricultural and veterinary chemicals, the control of potential food-borne pathogens and traceability. They should also be supported by accredited training programmes, which award certification on completion, and auditing programmes to ensure that both local and internationally recognised guidelines and standards continue to be met. This paper discusses the development of policies for on-farm food safety measures and their practical implementation in the context of quality assurance programmes, using the Australian beef industry as a case study.

Tell a Good Story Well: Writing Tips

ERIC Educational Resources Information Center

Smith, Randolph A.

2013-01-01

This chapter gives reasons why writing is important, summarizes general writing guidelines common to many academic disciplines, and provides specific writing guidelines that authors should use to make their manuscripts stronger and more likely to be acceptable to editors.

To adopt, to adapt, or to contextualise? The big question in clinical practice guideline development.

PubMed

Dizon, Janine Margarita; Machingaidze, Shingai; Grimmer, Karen

2016-09-13

Developing new clinical practice guidelines (CPGs) can be time-consuming and expensive. A more efficient approach could be to adopt, adapt or contextualise recommendations from existing good quality CPGs so that the resultant guidance is tailored to the local context. The first steps are to search for international CPGs that have a similar purpose, end-users and patients to your situation. The second step is to critically appraise the methodological quality of the CPGs to ensure that your guidance is based on credible evidence. Then the decisions begin. Can you simply 'adopt' this (parent) clinical practice guidelines, and implement the recommendations in their entirety, without any changes, in your setting? If so, then no further work is required. However this situation is rare. What is more likely, is that even if recommendations from the parent clinical practice guidelines can be adopted, how they are implemented needs to address local issues. Thus you may need to 'contextualise' the guidance, by addressing implementation issues such as local workforce, training, health systems, equipment and/or access to services. Generally this means that additional information is required (Practice/Context Points) to support effective implementation of the clinical practice guidelines recommendations. In some cases, you may need to 'adapt' the guidance, where you will make changes to the recommendations so that care is relevant to your local environments. This may involve additional work to search for local research, or obtain local consensus, regarding how best to adapt recommendations. For example, adaptation might reflect substituting one drug for another (drugs have similar effects, but the alternative drug to the recommended one may be cheaper, more easily obtained or more culturally acceptable). There is lack of standardisation of clinical practice guidelines terminology, leading clinical practice guideline activities often being poorly conceptualised or reported. We provide an approach that would help improve efficiency and standardisation of clinical practice guidelines activities.

A low-fat vegan diet elicits greater macronutrient changes, but is comparable in adherence and acceptability, compared with a more conventional diabetes diet among individuals with type 2 diabetes.

PubMed

Barnard, Neal D; Gloede, Lise; Cohen, Joshua; Jenkins, David J A; Turner-McGrievy, Gabrielle; Green, Amber A; Ferdowsian, Hope

2009-02-01

Although therapeutic diets are critical to diabetes management, their acceptability to patients is largely unstudied. To quantify adherence and acceptability for two types of diets for diabetes. Controlled trial conducted between 2004 and 2006. Individuals with type 2 diabetes (n=99) at a community-based research facility. Participants were randomly assigned to a diet following 2003 American Diabetes Association guidelines or a low-fat, vegan diet for 74 weeks. Attrition, adherence, dietary behavior, diet acceptability, and cravings. For nutrient intake and questionnaire scores, t tests determined between-group differences. For diet-acceptability measures, the related samples Wilcoxon sum rank test assessed within-group changes; the independent samples Mann-Whitney U test compared the diet groups. Changes in reported symptoms among the groups was compared using chi(2) for independent samples. All participants completed the initial 22 weeks; 90% (45/50) of American Diabetes Association guidelines diet group and 86% (42/49) of the vegan diet group participants completed 74 weeks. Fat and cholesterol intake fell more and carbohydrate and fiber intake increased more in the vegan group. At 22 weeks, group-specific diet adherence criteria were met by 44% (22/50) of members of the American Diabetes Association diet group and 67% (33/49) of vegan-group participants (P=0.019); the American Diabetes Association guidelines diet group reported a greater increase in dietary restraint; this difference was not significant at 74 weeks. Both groups reported reduced hunger and reduced disinhibition. Questionnaire responses rated both diets as satisfactory, with no significant differences between groups, except for ease of preparation, for which the 22-week ratings marginally favored the American Diabetes Association guideline group. Cravings for fatty foods diminished more in the vegan group at 22 weeks, with no significant difference at 74 weeks. Despite its greater influence on macronutrient intake, a low-fat, vegan diet has an acceptability similar to that of a more conventional diabetes diet. Acceptability appears to be no barrier to its use in medical nutrition therapy.

[ARIA Mexico 2014. Adaptation of the Clinical Practice Guide ARIA 2010 for Mexico. Methodology ADAPTE].

PubMed

Larenas-Linnemann, Désirée; Mayorga-Butrón, José Luis; Sánchez-González, Andrés; Ramírez-García, Arturo; Medina-Ávalos, Miguel; Figueroa-Morales, Marco Antonio; Montaño-Velázquez, B Beatriz; Montes-Narváez, Gabriel; Romero-Tapia, Sergio; Stone-Aguilar, Héctor; Xochihua-Díaz, Luis; Salas-Hernández, Jorge; Hernán-Ruiz, Héctor; Betancourt-Suárez, Miguel A; Cano-Salas, María Carmen; Curiel-Aceves, Lorenzo; Dibildox-Martínez, Javier; Fernández-Vega, Margarita; García-Bolaños, Carlos; Iduñate-Palacios, Fernando; Jiménez-Chobillon, M Alejandro; López-Lizárraga, Doris N; Matta-Campos, Juan José; Olvera-Salinas, Jorge; Rivera-Gómez, María Antonia; Virgen-Ortega, César; Sienra-Monge, Juan José; Del Río-Navarro, Blanca; Arias-Cruz, Alfredo; Sacre-Hazouri, Antonio; Aguilar-Aranda, Ambrocio; Vásquez Del Mercado-Cordero, Rodrigo; Barnica, Raúl Humberto; Velasco-Hidalgo, Liliana; Solís-Galicia, Cecilia

2014-01-01

The global prevalence of allergic rhinitis is high. International Study of Asthma and Allergies in Childhood (ISAAC) Phase III reports a total estimated prevalence of 4.6% in Mexico. There is evidence based on allergic rhinitis Clinical Practice Guidelines (CPG), but its promotion, acceptance and application is not optimal or adequate in Mexico. To generate a guideline for the treatment of allergic rhinitis and its impact on asthma by adaptating the 2010 ARIA Guideline to Mexican reality, through a transculturation process applying the ADAPTE methodology. Using the ADAPTE Methodology, the original 2010 ARIA CPG recommendations were evaluated by the guideline development group (GDG) into which multiple medical specialities managing patients with allergic rhinitis were incoorporated. The GDG valorated the quality of 2010 ARIA, checked and translated key clinical questions. Moreover, the GDG adjusted recommendations, patient preferences and included comments in the context of the Mexican reality (safety, costs and cultural issues). To accomplish this, we ran Delphi panels with as many rounds as necessary to reach agreement. One extra question, not included in the original 2010 ARIA, on the use of Nasal Lavages for AR was created sustained by a systematic literature review. A total of 45 questions from the original 2010 ARIA were included and divided into six groups covering prevention, medical treatment, immunotherapy and alternative medicine to treat patients with allergic rhinitis with or without asthma. Most of the questions reached agreement in one or two rounds; one question required three rounds. An easy-to-use, adaptated, up-to-date and applicable allergic rhinitis guideline for Mexico is now available.

Ethics in clinical research: the Indian perspective.

PubMed

Sanmukhani, J; Tripathi, C B

2011-03-01

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

International Group Work Research: Guidelines in Cultural Contexts

ERIC Educational Resources Information Center

Guth, Lorraine J.; Asner-Self, Kimberly K.

2017-01-01

This article offers 10 guidelines for conducting international group work research. These guidelines include the importance of establishing relationships, conducting a needs assessment, co-constructing the research questions/design, determining the approach, choosing culturally relevant instruments, choosing culturally responsive group…

Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry.

PubMed

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

2016-07-15

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

Review of the International Society for Heart and Lung Transplantation Practice guidelines for management of heart failure in children.

PubMed

Colan, Steven D

2015-08-01

In 2004, practice guidelines for the management of heart failure in children by Rosenthal and colleagues were published in conjunction with the International Society for Heart and Lung Transplantation. These guidelines have not been updated or reviewed since that time. In general, there has been considerable controversy as to the utility and purpose of clinical practice guidelines, but there is general recognition that the relentless progress of medicine leads to the progressive irrelevance of clinical practice guidelines that do not undergo periodic review and updating. Paediatrics and paediatric cardiology, in particular, have had comparatively minimal participation in the clinical practice guidelines realm. As a result, most clinical practice guidelines either specifically exclude paediatrics from consideration, as has been the case for the guidelines related to cardiac failure in adults, or else involve clinical practice guidelines committees that include one or two paediatric cardiologists and produce guidelines that cannot reasonably be considered a consensus paediatric opinion. These circumstances raise a legitimate question as to whether the International Society for Heart and Lung Transplantation paediatric heart failure guidelines should be re-reviewed. The time, effort, and expense involved in producing clinical practice guidelines should be considered before recommending an update to the International Society for Heart and Lung Transplantation Paediatric Heart Failure guidelines. There are specific areas of rapid change in the evaluation and management of heart failure in children that are undoubtedly worthy of updating. These domains include areas such as use of serum and imaging biomarkers, wearable and implantable monitoring devices, and acute heart failure management and mechanical circulatory support. At the time the International Society for Heart and Lung Transplantation guidelines were published, echocardiographic tissue Doppler, 3 dimensional imaging, and strain and strain rate were either novel or non-existent and have now moved into the main stream. Cardiac magnetic resonance imaging (MRI) had very limited availability, and since that time imaging and assessment of myocardial iron content, delayed gadolinium enhancement, and extracellular volume have moved into the mainstream. The only devices discussed in the International Society for Heart and Lung Transplantation guidelines were extracorporeal membrane oxygenators, pacemakers, and defibrillators. Since that time, ventricular assist devices have become mainstream. Despite the relative lack of randomised controlled trials in paediatric heart failure, advances continue to occur. These advances warrant implementation of an update and review process, something that is best done under the auspices of the national and international cardiology societies. A joint activity that includes the International Society for Heart and Lung Transplantation, American College of Cardiology/American Heart Association, the Association for European Paediatric and Congenital Cardiology (AEPC), European Society of Cardiology, Canadian Cardiovascular Society, and others will have more credibility than independent efforts by any of these organisations.

Guidelines for the assessment and acceptance of potential brain-dead organ donors

PubMed Central

Westphal, Glauco Adrieno; Garcia, Valter Duro; de Souza, Rafael Lisboa; Franke, Cristiano Augusto; Vieira, Kalinca Daberkow; Birckholz, Viviane Renata Zaclikevis; Machado, Miriam Cristine; de Almeida, Eliana Régia Barbosa; Machado, Fernando Osni; Sardinha, Luiz Antônio da Costa; Wanzuita, Raquel; Silvado, Carlos Eduardo Soares; Costa, Gerson; Braatz, Vera; Caldeira Filho, Milton; Furtado, Rodrigo; Tannous, Luana Alves; de Albuquerque, André Gustavo Neves; Abdala, Edson; Gonçalves, Anderson Ricardo Roman; Pacheco-Moreira, Lúcio Filgueiras; Dias, Fernando Suparregui; Fernandes, Rogério; Giovanni, Frederico Di; de Carvalho, Frederico Bruzzi; Fiorelli, Alfredo; Teixeira, Cassiano; Feijó, Cristiano; Camargo, Spencer Marcantonio; de Oliveira, Neymar Elias; David, André Ibrahim; Prinz, Rafael Augusto Dantas; Herranz, Laura Brasil; de Andrade, Joel

2016-01-01

Organ transplantation is the only alternative for many patients with terminal diseases. The increasing disproportion between the high demand for organ transplants and the low rate of transplants actually performed is worrisome. Some of the causes of this disproportion are errors in the identification of potential organ donors and in the determination of contraindications by the attending staff. Therefore, the aim of the present document is to provide guidelines for intensive care multi-professional staffs for the recognition, assessment and acceptance of potential organ donors. PMID:27737418

Guidelines for the acceptance of peroxide-containing oral hygiene products. American Dental Association Council on Dental Therapeutics.

PubMed

1994-08-01

Safety and efficacy criteria are defined for oral products containing various forms of peroxides. The guidelines ask for safety and efficacy studies plus observation criteria that include long-term follow-up.

Validation of a Spanish version of the psychological inflexibility in pain scale (PIPS) and an evaluation of its relation with acceptance of pain and mindfulness in sample of persons with fibromyalgia

PubMed Central

2013-01-01

Background Psychological flexibility has been suggested as a fundamental process in health. The Psychological Inflexibility in Pain Scale (PIPS) is one of the scales employed for assessing psychological inflexibility in pain patients. The aim of this study was to validate the Spanish version of the PIPS and secondly, to compare it to two other psychological constructs, the acceptance of pain and mindfulness scales. Methods The PIPS was translated into Spanish by two bilingual linguistic experts, and then, back-translated into English to assess for equivalence. The final Spanish version was administered along with the Pain Visual Analogue Scale, Fibromyalgia Impact Questionnaire, Hospital Anxiety Depression Scale, Pain Catastrophizing Scale, Chronic Pain Acceptance Questionnaire and the Mindful Attention Awareness Scale, to 250 Spanish patients with fibromyalgia. Face validity, construct validity, reliability (internal consistency and test-retest) and convergent validity were tested. Also a multiple regression analysis was carried out.The usual guidelines have been followed for cross-cultural adaptations. Results Data were very similar to the ones obtained in the original PIPS version. The construct validity confirmed the original two-components solution which explained 61.6% of the variance. The Spanish PIPS had good test-retest reliability (intraclass correlation coefficient 0.97) and internal consistency reliability (Cronbach’s alpha: 0.90). The Spanish PIPS’ score correlated significantly with worse global functioning (r = 0.55), anxiety (r = 0.54), depression (r = 0.66), pain catastrophizing (r = 0.62), pain acceptance (r = −0.72) and mindfulness (r = −0.47), as well as correlating modestly with pain intensity (r = 0.12). The multiple regression analyses showed that psychological inflexibility, acceptance and mindfulness are not overlapped. Conclusions The Spanish PIPS scale appears to be a valid and reliable instrument for the evaluation of psychological inflexibility among a sample of fibromyalgia patients. These results ensure the use of this scale in research as well as in clinical practice. Psychological inflexibility measures processes different from other related components such as acceptance and mindfulness. PMID:23594367

Recommendations and consensus on the treatment of peritoneal metastases of colorectal origin: a systematic review of national and international guidelines.

PubMed

Klaver, C E L; Groenen, H; Morton, D G; Laurberg, S; Bemelman, W A; Tanis, P J

2017-03-01

This systematic review aimed to provide an overview of (inter)national guidelines on the treatment of peritoneal metastases of colorectal cancer origin (PMCRC) and to determine the degree of consensus and available evidence with identification of topics for future research. A systematic search of MEDLINE, Embase, PubMed as well as Tripdatabase, National Guideline Clearinghouse, BMJ Best Practice and Guidelines International Network was performed to identify (inter)national guidelines and consensus statements from oncological or surgical societies on PMCRC. The quality of guidelines was assessed using the AGREE-II score. Topics followed by recommendations were extracted from the guidelines. The recommendations, highest level of supporting evidence and the degree of consensus were determined for each topic. Twenty-one guidelines were included, in most (15) of which cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) was recommended in selected patients based on level 1b evidence. Substantial consensus was also reached on the benefit of multidisciplinary team discussion and the achievability of a (near) complete cytoreduction (CC0-1) without supporting evidence. Both evidence and consensus were lacking regarding other aspects including preoperative positron emission tomography/CT, second look surgery in high risk patients, the optimal patient selection for CRS/HIPEC, procedural aspects of HIPEC and (perioperative) systemic therapy. In currently available guidelines, evidence and consensus on the treatment strategy for PMCRC are lacking. Updates of guidelines are ongoing and future (randomized) clinical trials should contribute to multidisciplinary and international consensus on treatment strategies for PMCRC. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

Comparison of International Guidelines of Dermal Absorption Tests Used in Pesticides Exposure Assessment for Operators

PubMed Central

So, Jaehwan; Ahn, Junyoung; Lee, Tae-Hee; Park, Kyung-Hun; Paik, Min-Kyoung; Jeong, Mihye; Cho, Myung-Haing

2014-01-01

The number of farmers who have suffered from non-fatal acute pesticide poisoning has been reported to vary from 5.7% to 86.7% in South Korea since 1975. Absorption through the skin is the main route of exposure to pesticides for farmers who operate with them. Several in vitro tests using the skins of humans or animal and in vivo tests using laboratory animals are introduced for the assessment of human dermal absorption level of pesticides. The objective of this study is to evaluate and compare international guidelines and strategies of dermal absorption assessments and to propose unique approaches for applications into pesticide registration process in our situation. Until present in our situation, pesticide exposure level to operator is determined just using default value of 10 as for skin absorption ratio because of data shortage. Dermal absorption tests are requested to get exposure level of pesticides and to ultimately know the safety of pesticides for operators through the comparison with the value of AOEL. When the exposure level is higher than AOEL, the pesticide cannot be approved. We reviewed the skin absorption test guidelines recommended by OECD, EFSA and EPA. The EPA recommends assessment of skin absorption of pesticides for humans through the TPA which includes all the results of in vitro human and animal and animal in vivo skin absorption studies. OECD and EFSA, employ a tiered approach, which the requirement of further study depends on the results of the former stage study. OECD guidelines accept the analysis of pesticide level absorbed through skin without radioisotope when the recovery using the non-labeled method is within 80~120%. Various factors are reviewed in this study, including the origin of skin (gender, animal species and sites of skin), thickness, temperature and, etc., which can influence the integrity of results. PMID:25584144

Following the giant's paces-governance issues and bioethical reflections in China.

PubMed

Wang, Zhaochen; Zhang, Di; Ng, Vincent H; Lie, Reidar; Zhai, Xiaomei

2014-10-31

China has become a global player in the field of biosamples research and analysis of genetic data. The Beijing Genomics Institute is a genetics factory where enormous amounts of biosamples/data from all over the world are being analyzed. Most of the global bioethics discussions focused on research conducted by scientists from industrialized countries with subjects from poorer countries. Today, however, samples from industrialized nations are being analyzed in China on an unprecedented scale. This means that one should not just focus on bioethics developments in western countries, but also should pay attention to the situation in China. Under this era of rapid advancement in genomics, reassessing the conventionally accepted bioethical principles is strongly needed. In this paper, we will analyze the case of BGI in the context of the Chinese regulatory system in order to identify methods to regulate genetic research more effectively and to strengthen BGI's role in international collaborative research projects. Three main issues concerning sample collection and samples/data management are addressed. Firstly, an ambiguous definition of research, which does not specifically include biosamples/data, when applied to genetic research, may cause confusion and leave loopholes in governance. Secondly, the current regulations do not provide sufficient guidelines on the details of what information to present to prospective subjects, and how to combine informed consent with strategies of re-consent, withdrawal and feedback from research. Finally, the existing regulations do not adequately address issues of genetic privacy and data protection. Bioethical issues related to genetic research in China may be partially due to the nature of genetic research and partially stems from the strategy of simply adopting general international guidelines into the Chinese context without detailed considerations of the local needs. However, there are no perfect readymade ethical solutions for everyone; every country faces different open questions and challenges behind what appears to be unified guidelines. Given the importance of China in international genetic research, other countries ought to be concerned about the bioethical developments in China. China should also have a substantive discussion with the international community on bioethics issues.

PIAAC Technical Standards and Guidelines

ERIC Educational Resources Information Center

OECD Publishing, 2014

2014-01-01

The Programme for International Assessment of Adult Competencies (PIAAC) will establish technical standards and guidelines to ensure that the survey design and implementation processes of PIAAC yield high-quality and internationally comparable data. This document provides a revised version of the technical standards and guidelines originally…

Technological Diffusion within Educational Institutions: Applying the Technology Acceptance Model.

ERIC Educational Resources Information Center

Wolski, Stacy; Jackson, Sally

Expectancy models of behavior such as the Theory of Reasoned Action (TRA) and the Technology Acceptance Model (TAM) offer guidelines that aid efforts to facilitate use of new technology. These models remind us that both acceptance of and resistance to technology use are grounded in beliefs and norms regarding the technology. Although TAM is widely…

19 CFR 10.593 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... other good or material; (e) Generally Accepted Accounting Principles. “Generally Accepted Accounting Principles” means the recognized consensus or substantial authoritative support in the territory of a Party... information, and the preparation of financial statements. These principles may encompass broad guidelines of...

Establishing a Distance Learning Plan for International Space Station (ISS) Interactive Video Education Events (IVEE)

NASA Technical Reports Server (NTRS)

Wallington, Clint

1999-01-01

Educational outreach is an integral part of the International Space Station (ISS) mandate. In a few scant years, the International Space Station has already established a tradition of successful, general outreach activities. However, as the number of outreach events increased and began to reach school classrooms, those events came under greater scrutiny by the education community. Some of the ISS electronic field trips, while informative and helpful, did not meet the generally accepted criteria for education events, especially within the context of the classroom. To make classroom outreach events more acceptable to educators, the ISS outreach program must differentiate between communication events (meant to disseminate information to the general public) and education events (designed to facilitate student learning). In contrast to communication events, education events: are directed toward a relatively homogeneous audience who are gathered together for the purpose of learning, have specific performance objectives which the students are expected to master, include a method of assessing student performance, and include a series of structured activities that will help the students to master the desired skill(s). The core of the ISS education events is an interactive videoconference between students and ISS representatives. This interactive videoconference is to be preceded by and followed by classroom activities which help the students aftain the specified learning objectives. Using the interactive videoconference as the centerpiece of the education event lends a special excitement and allows students to ask questions about what they are learning and about the International Space Station and NASA. Whenever possible, the ISS outreach education events should be congruent with national guidelines for student achievement. ISS outreach staff should recognize that there are a number of different groups that will review the events, and that each group has different criteria for acceptance. For example, school administrators are more likely to be concerned about an event meeting national standards and the cost of the event. In contrast, a teacher's acceptance of an education event may be directly related to the amount of extra work the event imposes upon that teacher. ISS education events must be marketed differently to the different groups of educators, and must never increase the workload of the average teacher.

New International School Library Guidelines

ERIC Educational Resources Information Center

Oberg, Dianne

2018-01-01

The publication in 2015 of new international school library guidelines was the culmination of a two-year process involving a wide network of contributors. The process was guided by the Joint Committee of the International Federation of Library Associations (IFLA) School Libraries Section and the International Association of School Librarianship…

Research ethics for a globalised world: the revised CIOMS international guidelines.

PubMed

Ehni, Hans-Jöerg; Wiesing, Urban

2017-01-01

On December 6, 2016, the Council of International Organisations of Medical Sciences published a new version of its guidelines with the title "International Ethical Guidelines for Health-related Research Involving Humans." In this article we briefly describe the revision process and the structure and content of these guidelines. We outline some of its main guidelines such as the ones on social value, post-trial access, and risk-benefit ratio. In our overall evaluation we come to the conclusion that the CIOMS guidelines manage to strike a balance between the protection of human participants in health-related research and the promotion of such research activities in an exemplary way. The guidelines combine key principles with a guide to their application based on the state of the art in research ethics. Thus they represent a timely and indispensable orientation for researchers, ethics committees, and other stakeholders in health-related research.

The historical development and basis of human factors guidelines for automated systems in aeronautical operations

NASA Technical Reports Server (NTRS)

Ciciora, J. A.; Leonard, S. D.; Johnson, N.; Amell, J.

1984-01-01

In order to derive general design guidelines for automated systems a study was conducted on the utilization and acceptance of existing automated systems as currently employed in several commercial fields. Four principal study area were investigated by means of structured interviews, and in some cases questionnaires. The study areas were aviation, a both scheduled airline and general commercial aviation; process control and factory applications; office automation; and automation in the power industry. The results of over eighty structured interviews were analyzed and responses categoried as various human factors issues for use by both designers and users of automated equipment. These guidelines address such items as general physical features of automated equipment; personnel orientation, acceptance, and training; and both personnel and system reliability.

Use of Linear Programming to Develop Cost-Minimized Nutritionally Adequate Health Promoting Food Baskets.

PubMed

Parlesak, Alexandr; Tetens, Inge; Dejgård Jensen, Jørgen; Smed, Sinne; Gabrijelčič Blenkuš, Mojca; Rayner, Mike; Darmon, Nicole; Robertson, Aileen

2016-01-01

Food-Based Dietary Guidelines (FBDGs) are developed to promote healthier eating patterns, but increasing food prices may make healthy eating less affordable. The aim of this study was to design a range of cost-minimized nutritionally adequate health-promoting food baskets (FBs) that help prevent both micronutrient inadequacy and diet-related non-communicable diseases at lowest cost. Average prices for 312 foods were collected within the Greater Copenhagen area. The cost and nutrient content of five different cost-minimized FBs for a family of four were calculated per day using linear programming. The FBs were defined using five different constraints: cultural acceptability (CA), or dietary guidelines (DG), or nutrient recommendations (N), or cultural acceptability and nutrient recommendations (CAN), or dietary guidelines and nutrient recommendations (DGN). The variety and number of foods in each of the resulting five baskets was increased through limiting the relative share of individual foods. The one-day version of N contained only 12 foods at the minimum cost of DKK 27 (€ 3.6). The CA, DG, and DGN were about twice of this and the CAN cost ~DKK 81 (€ 10.8). The baskets with the greater variety of foods contained from 70 (CAN) to 134 (DGN) foods and cost between DKK 60 (€ 8.1, N) and DKK 125 (€ 16.8, DGN). Ensuring that the food baskets cover both dietary guidelines and nutrient recommendations doubled the cost while cultural acceptability (CAN) tripled it. Use of linear programming facilitates the generation of low-cost food baskets that are nutritionally adequate, health promoting, and culturally acceptable.

Current status of laparoscopic and robotic ventral mesh rectopexy for external and internal rectal prolapse

PubMed Central

van Iersel, Jan J; Paulides, Tim J C; Verheijen, Paul M; Lumley, John W; Broeders, Ivo A M J; Consten, Esther C J

2016-01-01

External and internal rectal prolapse with their affiliated rectocele and enterocele, are associated with debilitating symptoms such as obstructed defecation, pelvic pain and faecal incontinence. Since perineal procedures are associated with a higher recurrence rate, an abdominal approach is commonly preferred. Despite the description of greater than three hundred different procedures, thus far no clear superiority of one surgical technique has been demonstrated. Ventral mesh rectopexy (VMR) is a relatively new and promising technique to correct rectal prolapse. In contrast to the abdominal procedures of past decades, VMR avoids posterolateral rectal mobilisation and thereby minimizes the risk of postoperative constipation. Because of a perceived acceptable recurrence rate, good functional results and low mesh-related morbidity in the short to medium term, VMR has been popularized in the past decade. Laparoscopic or robotic-assisted VMR is now being progressively performed internationally and several articles and guidelines propose the procedure as the treatment of choice for rectal prolapse. In this article, an outline of the current status of laparoscopic and robotic ventral mesh rectopexy for the treatment of internal and external rectal prolapse is presented. PMID:27275090

Aircraft disinsection.

PubMed

Rayman, Russell B

2006-07-01

Aircraft disinsection has been an international practice since the 1920s, the purpose of which is to protect public health, the environment, agriculture, and livestock by the eradication of disease vectors. Although most nations of the world have discontinued this practice, about 20 continue with this requirement. Aircraft disinsection is sanctioned by international law with the World Health Organization (WHO) publishing general procedural guidelines in the International Health Regulations (IHR). There are currently four acceptable procedures: blocks away, top of descent, on arrival, and residual. A 2% pyrethrum solution, a naturally occurring substance found in the chrysanthemum flower, or several synthetic pyrethroids, are the recommended agents because they are extremely effective insecticides which pose minimal health risks. Although the use of insecticides for aircraft disinsection is controversial, national policies compelling this requirement must be respected. This paper will explore the background of aircraft disinsection, the procedures, the types of agents, and the toxicity. If aircraft disinsection is regulatory policy, it should be done in accordance with WHO procedures. Residual application is probably the most efficacious method. The use of air curtains or plastic strips should be explored as an alternative to the use of chemicals.

International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences.

PubMed

Davit, Barbara; Braddy, April C; Conner, Dale P; Yu, Lawrence X

2013-10-01

The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. We focused on the 13 jurisdictions and organizations participating in the International Generic Drug Regulators Pilot. These are Australia, Brazil, Canada, China, Chinese Taipei, the European Medicines Association, Japan, Mexico, Singapore, South Korea, Switzerland, the USA, and the World Health Organization. We began with a comparison of how the various jurisdictions and organizations define a generic product and its corresponding reference product. We then compared the following bioequivalence approaches: recommended bioequivalence study designs, method of pharmacokinetic calculations and bioequivalence acceptance limits, recommendations for modifying bioequivalence study designs and limits for highly variable drugs and narrow therapeutic index drugs, provisions for waiving bioequivalence study requirements (granting biowaivers), and implementation of the Biopharmaceutics Classification System. We observed that, overall, there are more similarities than differences in bioequivalence approaches among the regulatory authorities surveyed.

[Telecardiology: Tasks and duties of telemedicine].

PubMed

Borbás, János; Forczek, Erzsébet; Sepp, Róbert; Bari, Ferenc

2017-11-01

Telemedicine is a young science that integrates innovations of information-technology and telecommunications into medical science. A successful telemedicine procedure should guarantee reduced workload of the healthcare system with well secured and cost-effective processes. Our goal was to collect the development phases of telemedicine projects through existing telecardiology solutions. Subsequent to reviewing international publications we analyzed the past and present situation of blood pressure monitoring, remote diagnostics of electrocardiography, implantable cardioverter defibrillator monitoring and pocket ultrasound devices. In case of new solutions (a) several internationally accepted, confidently reproducible "good practices" are needed for creating (b) guidelines and recommendations of international medical associations. They have to ensure (c) cost-effective work, with well-designed sustainability and (d) patient confidentiality. Improving (e) education for professionals and patients is essential. We recommend to telemedicine developers to use our standards in order to introduce their products more effectively into clinical practice. It is encouraging that current possibilities of telecardiology partly or fully meet the aforementioned criteria. Further development of the topic can contribute to financial sustainability of our healthcare and might be able to resolve limitations of human resources. Orv Hetil. 2017; 158(44): 1741-1746.

An immunohistochemical and fluorescence in situ hybridization-based comparison between the Oracle HER2 Bond Immunohistochemical System, Dako HercepTest, and Vysis PathVysion HER2 FISH using both commercially validated and modified ASCO/CAP and United Kingdom HER2 IHC scoring guidelines.

PubMed

O'Grady, Anthony; Allen, David; Happerfield, Lisa; Johnson, Nicola; Provenzano, Elena; Pinder, Sarah E; Tee, Lilian; Gu, Mai; Kay, Elaine W

2010-12-01

Immunohistochemistry (IHC) is used as the frontline assay to determine HER2 status in invasive breast cancer patients. The aim of the study was to compare the performance of the Leica Oracle HER2 Bond IHC System (Oracle) with the current most readily accepted Dako HercepTest (HercepTest), using both commercially validated and modified ASCO/CAP and UK HER2 IHC scoring guidelines. A total of 445 breast cancer samples from 3 international clinical HER2 referral centers were stained with the 2 test systems and scored in a blinded fashion by experienced pathologists. The overall agreement between the 2 tests in a 3×3 (negative, equivocal and positive) analysis shows a concordance of 86.7% and 86.3%, respectively when analyzed using commercially validated and modified ASCO/CAP and UK HER2 IHC scoring guidelines. There is a good concordance between the Oracle and the HercepTest. The advantages of a complete fully automated test such as the Oracle include standardization of key analytical factors and improved turn around time. The implementation of the modified ASCO/CAP and UK HER2 IHC scoring guidelines has minimal effect on either assay interpretation, showing that Oracle can be used as a methodology for accurately determining HER2 IHC status in formalin fixed, paraffin-embedded breast cancer tissue.

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 3 2014-01-01 2014-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 3 2011-01-01 2011-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 3 2013-01-01 2013-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.202 - Procedure.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Procedure. 2601.202 Section 2601.202 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

5 CFR 2601.201 - Delegation.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 3 2012-01-01 2012-01-01 false Delegation. 2601.201 Section 2601.201 Administrative Personnel OFFICE OF GOVERNMENT ETHICS ORGANIZATION AND PROCEDURES IMPLEMENTATION OF OFFICE OF GOVERNMENT ETHICS STATUTORY GIFT ACCEPTANCE AUTHORITY Guidelines for Solicitation and Acceptance of Gifts...

Debris Mitigation as a Component of Space Traffic Management

NASA Astrophysics Data System (ADS)

Kemper Force, M.

2012-01-01

The necessity of a traffic management in space is a consequence of our "free use" of it over the past fifty years, during which certain orbits have accumulated a significant amount of debris that may, in the future, threaten the feasibility of their use. This paper encapsulates the primary issues involved in the concept of space traffic management through basic questions, using as a case study the recent alarm caused by two close-misses of the ISS in one week, in order to guide the reader to an understanding of the current need for a space traffic management regime. The paper will describe the fundamental elements of space traffic management, including the tracking of objects, conjunction assessment, collision avoidance and orbital mechanics to understand why Earth-bound systems cannot be extrapolated to space. The paper will then focus on the primary concern of space debris, the acceptance and use of current guidelines in light of the existing corpus juris spatialis and international law, positing that the guidelines may soon develop into a customary norm. The paper will conclude that the latest close calls with the ISS demonstrate we cannot count on the mere vastness of space to reduce the probability of collisions with space objects. Despite the significant political, technical and economic challenges recognized by the International Space University Final Report of 2007, the International Academy of Astronautics' Cosmic Study of 2006 and the IAASS An ICAO for Space?, there is a need for a system to obviate the looming peril before governments and investors will sign on to a comprehensive program which limits their "free" use of space.

78 FR 72979 - Bovine Spongiform Encephalopathy; Importation of Bovines and Bovine Products

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-04

...We are amending the regulations that govern the importation of animals and animal products to revise the conditions for the importation of live bovines and products derived from bovines with regard to bovine spongiform encephalopathy (BSE). We are basing importation conditions on the inherent risk of BSE infectivity in specified commodities, as well as on the BSE risk status of the region in which the commodities originate. We are establishing a system for classifying regions as to BSE risk that is consistent with the system employed by the World Organization for Animal Health (OIE), the international standard-setting organization for guidelines related to animal health. The conditions we are adopting for the importation of specified commodities are based on internationally accepted scientific literature, and are, in general, consistent with guidelines set out in the OIE's Terrestrial Animal Health Code. We are also classifying certain specified countries as to BSE risk and are removing BSE restrictions on the importation of cervids and camelids and products derived from such animals. We are making these amendments after conducting a thorough review of relevant scientific literature and a comprehensive evaluation of the issues and concluding that the changes to the regulations will continue to guard against the introduction of BSE into the United States, while allowing the importation of additional animals and animal products into this country.

Gender Differences in the Determinants of the Willingness to Accept an International Assignment

ERIC Educational Resources Information Center

van der Velde, Mandy E. G.; Bossink, Carin J. H.; Jansen, Paul G. W.

2005-01-01

Multinational organisations experience difficulties in finding managers willing to accept international assignments. This study has therefore focused on factors that can predict males' and females' willingness to accept international assignments, or to follow their partners on international assignments. Hypotheses were formulated based on the…

1999 World Health Organization-International Society of Hypertension Guidelines for the management of hypertension. Guidelines sub-committee of the World Health Organization.

PubMed

Chalmers, J; MacMahon, S; Mancia, G; Whitworth, J; Beilin, L; Hansson, L; Neal, B; Rodgers, A; Ni Mhurchu, C; Clark, T

1999-01-01

The present Guidelines were prepared by the Guidelines Sub-Committee of the World Health Organization-International Society of Hypertension (WHO-ISH) Mild Hypertension Liaison Committee, the members of which are listed at the end of the text. These guidelines represent the fourth revision of the WHO-ISH Guidelines and were finalised after presentation and discussion at the 7th WHO-ISH Meeting on Hypertension, Fukuoka, Japan, 29th Sept-1st Oct, 1998. Previous versions of the Guidelines were published in Bull WHO 1993, 71:503-517 and J Hypertens 1993, 11:905-918.

Intermittent auscultation of fetal heart rate during labour - a widely accepted technique for low risk pregnancies: but are the current national guidelines robust and practical?

PubMed

Sholapurkar, S L

2010-01-01

Intermittent auscultation of fetal heart rate is an accepted practice in low risk labours in many countries. National guidelines on intrapartum fetal monitoring were critically reviewed regarding timing and frequency of intermittent auscultation. Hypothetical but plausible examples are presented to illustrate that it may be possible to miss significant fetal distress with strict adherence to current guidelines. Opinion is forwarded that intermittent auscultation should be performed for 60 seconds before and after three contractions over about 10 min every half an hour in the first stage of labour. Reasons are put forward to show how this could be more practical and patient friendly and at the same time could improve detection of fetal distress. The current recommendation of intermittent auscultation every 15 min in the first stage is associated with poor compliance and leads to unnecessary burden, stress and medicolegal liability for birth attendants. Modification of current national guidelines would be desirable.

[Systemic validation of clinical practice guidelines: the AGREE network].

PubMed

Hannes, K; Van Royen, P; Aertgeerts, B; Buntinx, F; Ramaekers, D; Chevalier, P

2005-12-01

Over recent decades, the number of available clinical practice guidelines has enormously grown. Guidelines should meet specific quality criteria to ensure good quality. There is a growing need for the developement of a set of criteria to ensure that potential biases inherent in guideline development have been properly addressed and that the recommendations for practice are valid and reliable. The AGREE-collaboration is an international network that developed an instrument to critically appraise the methodological quality of guidelines. AGREE promotes a clear strategy to produce, disseminate and evaluate guidelines of high quality. In the first phase of the international project the AGREE-instrument was tested in 11 different countries. Based on this experience the instrument was refined and optimised. In the second phase it was disseminated, promoted and evaluated in 18 participating countries. Belgium was one of them. The Belgian partner in the AGREE-project developed 3 workshops and established 13 validation committees to validate guidelines from Belgian developer groups. We collected 33 questionnaires from participants of the workshops and the validation committees, in which we asked for primary experiences and information on the usefulness and applicability of the instrument. We were also interested in the shortcomings of the instrument and potential strategies to bridge them. More efforts should be made to train methodological experts to gain certain skills for a critical appraisal of clinical practice guidelines. Promoting the AGREE-instrument will lead to a broader knowledge and use of quality criteria in guideline development and appraisal. The development and dissemination of an international list of criteria to appraise the quality of guidelines will stimulate the development of methodologically sound guidelines. International comparisons between existing guidelines will lead to a better collaboration between guideline developers throughout the world.

32 CFR 2004.11 - Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)].

Code of Federal Regulations, 2014 CFR

2014-07-01

..., or Guidelines [102(b)(3)]. 2004.11 Section 2004.11 National Defense Other Regulations Relating to... NATIONAL INDUSTRIAL SECURITY PROGRAM DIRECTIVE NO. 1 Implementation and Oversight § 2004.11 Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)]. (a) Reviews and Updates. All implementing...

32 CFR 2004.11 - Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)].

Code of Federal Regulations, 2012 CFR

2012-07-01

..., or Guidelines [102(b)(3)]. 2004.11 Section 2004.11 National Defense Other Regulations Relating to... NATIONAL INDUSTRIAL SECURITY PROGRAM DIRECTIVE NO. 1 Implementation and Oversight § 2004.11 Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)]. (a) Reviews and Updates. All implementing...

32 CFR 2004.11 - Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)].

Code of Federal Regulations, 2013 CFR

2013-07-01

..., or Guidelines [102(b)(3)]. 2004.11 Section 2004.11 National Defense Other Regulations Relating to... NATIONAL INDUSTRIAL SECURITY PROGRAM DIRECTIVE NO. 1 Implementation and Oversight § 2004.11 Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)]. (a) Reviews and Updates. All implementing...

32 CFR 2004.11 - Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)].

Code of Federal Regulations, 2011 CFR

2011-07-01

..., or Guidelines [102(b)(3)]. 2004.11 Section 2004.11 National Defense Other Regulations Relating to... NATIONAL INDUSTRIAL SECURITY PROGRAM DIRECTIVE NO. 1 Implementation and Oversight § 2004.11 Agency Implementing Regulations, Internal Rules, or Guidelines [102(b)(3)]. (a) Reviews and Updates. All implementing...

Effects of an electronic reminder system on guideline-concordant treatment of psychotic disorders : Results from a pilot feasibility trial.

PubMed

Franke, Irina; Thier, Sarah; Riecher-Rössler, Anita

2016-12-01

Adherence to evidence-based guidelines is essential for the treatment outcome of psychotic disorders. Previous studies showed that IT-supported pathways are able to increase guideline adherence in psychiatric care. This paper describes a pilot study on the development of an electronic recall-reminder-system (RRS) for supporting guideline-adherent treatment in outpatient care of patients with chronic psychotic disorders and analyses its feasibility. Guidelines were integrated in the RRS software M.E.M.O.R.E.S. Software training for the staff was provided. We compared the number of conducted vs. guideline-recommended interventions 6 months before and after implementation. Subsequently both the caregivers' and the patients' satisfaction with the RRS was evaluated. Guideline adherence in general was low and the RRS was barely used. After its implementation a significant increase was observed in chemogram-check-ups and diagnostics regarding cardiovascular risks (esp. ECG). Both patients and professionals described problems with integrating the RRS in their daily routine and questioned the usefulness of the guidelines for chronically ill, although they basically approved its importance and usefulness. Participants appreciated the idea of supporting guideline adherence with an IT-system, but there seemed to be major obstacles to implementation: caregivers appear to be concerned of being exposed or questioned, technical difficulties might lead to avoidance, and there seems to be a lack of knowledge and awareness about the health risks for individuals with psychotic disorders. Possibly guidelines adapted for the chronically ill would find more acceptance. Technical simplifications and better information should be considered prior to further attempts to implement IT-supported guidelines in order to increase acceptance.

Consumer acceptance of an extruded soy-based high-protein breakfast cereal.

PubMed

Yeu, K; Lee, Y; Lee, S-Y

2008-01-01

Studies have shown the beneficial effects of soy and high-protein diets on weight loss. The objective of this study was to determine consumer acceptance of a soy-based high-protein breakfast cereal developed to be utilized for weight loss and control. Four formulations with soy flour content of 41%, 47%, 54%, and 60% (w/w) were processed by extrusion. The formulations met the Food and Drug Administration (FDA) guidelines to claim the role of soy protein in reducing the risk of cardiovascular diseases and guidelines for high-protein and high-fiber foods. The effects of soy flour level, addition of cinnamon flavor, and evaluation with or without milk on acceptance were investigated. Overall acceptance of 3 of 8 cereal products was also compared to the acceptance of 5 commercial products in the "healthy" cereal category. Addition of up to 54% (w/w) soy flour resulted in comparable acceptance ratings to products with lower soy flour content. Addition of milk improved aroma and texture acceptance scores and addition of cinnamon flavor improved overall, aroma, and taste acceptance scores. Acceptance of the developed cereal products was not as high as the commercial products; however, it significantly increased when nutritional and cost information was presented. The results of this study demonstrated that with modification of the formulations, an acceptable high-protein soy-based cereal can be developed to increase protein consumption during breakfast meals, which can consequently aid in weight loss and control.

Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelines.

PubMed

Tangwa, G B

2004-02-01

In this paper, the author attempts to explore some of the problems connected with the formulation and application of international biomedical ethical guidelines, with particular reference to Africa. Recent attempts at revising and updating some international medical ethical guidelines have been bedevilled by intractable controversies and wrangling regarding both the content and formulation. From the vantage position of relative familiarity with both African and Western contexts, and the privilege of having been involved in the revision and updating of one of the international ethical guidelines, the author reflects broadly on these issues and attempts prescribing an approach from both the theoretical and practical angles liable to mitigate, if not completely eliminate, some of the problems and difficulties.

[EBM, guidelines, protocols: knowledge, attitudes and utilization in the era of law on professional responsibility and safety of health care.

PubMed

Minozzi, Silvia; Ruggiero, Francesca; Capobussi, Matteo; González-Lorenzo, Marien; La Regina, Micaela; Squizzato, Alessandro; Moja, Lorenzo; Orlandini, Francesco

2018-05-01

The knowledge of principles and methods of Evidence Based Medicine (EBM) and the use of Clinical Practice Guidelines to inform clinical decisions are recognised as key instruments to improve the quality of care. In Italy the Parliament has revised the legal system that rules the responsibilities of health professionals and health care safety, prescribing health professionals to adhere to guidelines and good practice recommendations. The objective of the study was to evaluate guidelines and clinical pathways developed at local level and to assess knowledge and attitudes of healthcare workers toward EBM and guidelines. At the l'ASL 5 Liguria La Spezia we performed a census of all the documents registered as "guidelines" or "clinical pathways" at the Direzione Generale by the end of May 2016. We assessed their methodological quality by the "Recognition Card for Clinical Pathways Production and Revision Activity" prepared by the Ligurian Region. We conducted semi-structured interviews to assess attitudes and knowledge of healthcare workers. We found 17 clinical pathways, 41% contained organizational/management recommendations, and 59% contained mainly clinical recommendations. 41% was produced by assimilating already existing guidelines. 29% did not describe the method of production. Only one document linked directly each recommendation with scientific evidence. 10 healthcare workers out of 32 invited actually accepted to conduct the interview. Respondents showed a positive attitude toward the EBM and guidelines but a poor knowledge of the methodology of production and the instruments and principles for critical appraising of scientific literature. Nobody knew the GRADE approach. The most relevant barriers identified were: lack of time, poor knowledge of English and statistical methods, poor applicability of the international guidelines to local setting and real patients encountered in clinical practice. Despite the initiatives of the legislator toward civil responsibility and safety of care that should increase the use of guidelines, we found an overall poor knowledge of the concepts of EBM and method of guidelines production. Though the attitudes of responders to the interview were positive, barriers to use seemed to be predominant and considered more as obstacles than as a stimulus. In peripheral settings or in hospitals of medium/small size, clinical guidelines could remain confined to a merely juridical role, with weak impact on professional practice.

Clinical imaging guidelines part 4: challenges in identifying, engaging and collaborating with stakeholders.

PubMed

Bettmann, Michael A; Oikarinen, Helja; Rehani, Madan; Holmberg, Ola; del Rosario Perez, Maria; Naidoo, Anusha; Do, Kyung-Hyun; Dreyer, Keith; Ebdon-Jackson, Steve

2015-04-01

The effective development and use of clinical imaging guidelines requires an understanding of who the stakeholders are, what their interests in the process are, and what roles they should play. If the appropriate stakeholders are not engaged in the right roles, it is unlikely that clinical imaging guidelines will be successfully developed, relied on, and actually used. Some stakeholders are obvious: for the development of clinical imaging guidelines, both imagers and those who request examinations, such as general practitioners, internists, and medical specialists, must be involved. To gain acceptance, other relevant groups are stakeholders, including medical societies, other health care professionals, insurers, health IT experts and vendors, and patients. The role of stakeholders must be dictated by their specific interest. For some, involvement in the creation of guidelines is the right role. For others, such as regulators or insurers, reviews or invitations to comment are required, and for others, such as medical educators, it is probably sufficient to provide information and create awareness. Only through a careful consideration of who the stakeholders are and what are their interests are the successful development, acceptance, and use of clinical imaging guidelines likely to occur. Future efforts must focus on collaboration, particularly among groups that create clinical imaging guidelines and those that can support their use, and on regulatory roles and mandates. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Effect of residential air-to-air heat and moisture exchangers on indoor humidity

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

Barringer, C.G.; McGugan, C.A.

1989-01-01

A project was undertaken to develop guidelines for the selection of residential heat and moisture recovery ventilation systems (HRVs) in order to maintain an acceptable indoor humidity for various climatic conditions. These guidelines were developed from reviews on ventilation requirements, HRV performance specifications, and from computer modeling. Space conditions within three house/occupancy models for several types of HRV were simulated for three climatic conditions (Lake Charles, LA; Seattle, WA; and Winnipeg, MB) in order to determine the impact of the HRVs on indoor relative humidity and space-conditioning loads. Results show that when reduction of cooling cost is the main consideration,more » exchangers with moisture recovery are preferable to sensible HRVs. For reduction of heating costs, moisture recovery should be done for ventilation rates greater than about 15 L/s and average winter temperatures less than about (minus) 10{degrees}C if internal moisture generation rates are low. For houses with higher ventilation rates and colder average winter temperatures, exchangers with moisture recovery should be used.« less

Radioactive waste management treatments: A selection for the Italian scenario

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

Locatelli, G.; Mancini, M.; Sardini, M.

2012-07-01

The increased attention for radioactive waste management is one of the most peculiar aspects of the nuclear sector considering both reactors and not power sources. The aim of this paper is to present the state-of-art of treatments for radioactive waste management all over the world in order to derive guidelines for the radioactive waste management in the Italian scenario. Starting with an overview on the international situation, it analyses the different sources, amounts, treatments, social and economic impacts looking at countries with different industrial backgrounds, energetic policies, geography and population. It lists all these treatments and selects the most reasonablemore » according to technical, economic and social criteria. In particular, a double scenario is discussed (to be considered in case of few quantities of nuclear waste): the use of regional, centralized, off site processing facilities, which accept waste from many nuclear plants, and the use of mobile systems, which can be transported among multiple nuclear sites for processing campaigns. At the end the treatments suitable for the Italian scenario are presented providing simplified work-flows and guidelines. (authors)« less

Exploration of ethyl anthranilate-loaded monolithic matrix-type prophylactic polymeric patch.

PubMed

Islam, Johirul; Zaman, Kamaruz; Chakrabarti, Srijita; Bora, Nilutpal Sharma; Pathak, Manash Pratim; Mandal, Santa; Junejo, Julfikar Ali; Chattopadhyay, Pronobesh

2017-10-01

Compromised stability of pharmaceutical formulations loaded with volatiles is a serious problem associated with devices designed to deliver volatile compounds. The present study has been focused to evaluate the stability potential of matrix-type polymeric patches composed of volatile ethyl anthranilate for prophylaxis against vector-borne diseases. Ethyl anthranilate-loaded matrix-type polymeric patches were fabricated by solvent evaporation method on an impermeable backing membrane and attached to temporary release liners. Stability testing of the polymeric patches was performed as per the International Conference on Harmonization (ICH) guidelines for 6 months under accelerated conditions. In addition, the quantification of residual solvents was also performed as per the ICH guidelines. After conducting the stability studies for 6 months, the optimized patches showed the best possible results with respect to uniformity of drug content, physical appearance, and other analytical parameters. Furthermore, the amount of residual solvent was found well below the accepted limit. Thus, the present report outlined the analytical parameters to be evaluated to ensure the stability of a certain devices consisting of volatile compounds. Copyright © 2016. Published by Elsevier B.V.

Use of risk stratification to guide ambulatory management of neutropenic fever. Australian Consensus Guidelines 2011 Steering Committee.

PubMed

Worth, L J; Lingaratnam, S; Taylor, A; Hayward, A M; Morrissey, S; Cooney, J; Bastick, P A; Eek, R W; Wei, A; Thursky, K A

2011-01-01

Utilization of risk-stratification tools in the setting of neutropenic fever is currently limited by inadequate knowledge and lack of awareness. Within this context, the approach to management of low-risk patients with neutropenic fever is inconsistent with the available evidence across many Australian treating centres. These clinical guidelines define and clarify an accepted standard of care for this patient group given the current evidence base. The Multinational Association for Supportive Care in Cancer risk index is presented as the preferred risk assessment tool for determining patient risk. Suitability of ambulatory care within specific patient populations is discussed, with defined eligibility criteria provided to guide clinical decision-making. Detailed recommendations for implementing appropriate ambulatory strategies, such as early discharge and outpatient antibiotic therapy, are also provided. Due consideration is given to infrastructural requirements and other supportive measures at a resourcing and operational level. An analysis of the relevant health economics is also presented. © 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

The Mediterranean diet among British older adults: Its understanding, acceptability and the feasibility of a randomised brief intervention with two levels of dietary advice.

PubMed

Lara, Jose; Turbett, Edel; Mckevic, Agata; Rudgard, Kate; Hearth, Henrietta; Mathers, John C

2015-12-01

To assess (i) understanding, acceptability and preference for two graphical displays of the Mediterranean diet (MD); and (ii) feasibility of a brief MD intervention and cost of adherence to this diet among British older adults. Two studies undertaken at the Human Nutrition Research Centre, Newcastle University are reported. In study-1, preference and understanding of the MD guidelines and two graphical displays, a plate and a pyramid, were evaluated in an educational group session (EGS). In study-2, we evaluated the feasibility of a three-week brief MD intervention with two levels of dietary advice: Group-1 (level 1) attended an EGS on the MD, and Group-2 (level 2) attended an EGS and received additional support. MD adherence using a 9-point score, and the cost of food intake during intervention, were assessed. RESULTS STUDY-1: No differences in preference for a MD plate or pyramid were observed. Both graphic displays were rated as acceptable and conveyed clearly these guidelines. STUDY-2: The intervention was rated as acceptable. No significant differences were observed between groups 1 and 2. Analysis of the combined sample showed significant increases from baseline in fish intake (P=0.01) and MD score (P=0.05). The cost of food intake during intervention was not significantly different from baseline. British older adults rated a MD as an acceptable model of healthy eating, and a plate and a pyramid as comprehensible graphic displays of these guidelines. A brief dietary intervention was also acceptable and revealed that greater adherence to the MD could be achieved without incurring significantly greater costs. Copyright © 2015. Published by Elsevier Ireland Ltd.

Comparison of international guideline programs to evaluate and update the Dutch program for clinical guideline development in physical therapy

PubMed Central

Van der Wees, Philip J; Hendriks, Erik JM; Custers, Jan WH; Burgers, Jako S; Dekker, Joost; de Bie, Rob A

2007-01-01

Background Clinical guidelines are considered important instruments to improve quality in health care. Since 1998 the Royal Dutch Society for Physical Therapy (KNGF) produced evidence-based clinical guidelines, based on a standardized program. New developments in the field of guideline research raised the need to evaluate and update the KNGF guideline program. Purpose of this study is to compare different guideline development programs and review the KNGF guideline program for physical therapy in the Netherlands, in order to update the program. Method Six international guideline development programs were selected, and the 23 criteria of the AGREE Instrument were used to evaluate the guideline programs. Information about the programs was retrieved from published handbooks of the organizations. Also, the Dutch program for guideline development in physical therapy was evaluated using the AGREE criteria. Further comparison the six guideline programs was carried out using the following elements of the guideline development processes: Structure and organization; Preparation and initiation; Development; Validation; Dissemination and implementation; Evaluation and update. Results Compliance with the AGREE criteria of the guideline programs was high. Four programs addressed 22 AGREE criteria, and two programs addressed 20 AGREE criteria. The previous Dutch program for guideline development in physical therapy lacked in compliance with the AGREE criteria, meeting only 13 criteria. Further comparison showed that all guideline programs perform systematic literature searches to identify the available evidence. Recommendations are formulated and graded, based on evidence and other relevant factors. It is not clear how decisions in the development process are made. In particular, the process of translating evidence into practice recommendations can be improved. Conclusion As a result of international developments and consensus, the described processes for developing clinical practice guidelines have much in common. The AGREE criteria are common basis for the development of guidelines, although it is not clear how final decisions are made. Detailed comparison of the different guideline programs was used for updating the Dutch program. As a result the updated KNGF program complied with 22 AGREE criteria. International discussion is continuing and will be used for further improvement of the program. PMID:18036215

Comparison of international guideline programs to evaluate and update the Dutch program for clinical guideline development in physical therapy.

PubMed

Van der Wees, Philip J; Hendriks, Erik J M; Custers, Jan W H; Burgers, Jako S; Dekker, Joost; de Bie, Rob A

2007-11-23

Clinical guidelines are considered important instruments to improve quality in health care. Since 1998 the Royal Dutch Society for Physical Therapy (KNGF) produced evidence-based clinical guidelines, based on a standardized program. New developments in the field of guideline research raised the need to evaluate and update the KNGF guideline program. Purpose of this study is to compare different guideline development programs and review the KNGF guideline program for physical therapy in the Netherlands, in order to update the program. Six international guideline development programs were selected, and the 23 criteria of the AGREE Instrument were used to evaluate the guideline programs. Information about the programs was retrieved from published handbooks of the organizations. Also, the Dutch program for guideline development in physical therapy was evaluated using the AGREE criteria. Further comparison the six guideline programs was carried out using the following elements of the guideline development processes: Structure and organization; Preparation and initiation; Development; Validation; Dissemination and implementation; Evaluation and update. Compliance with the AGREE criteria of the guideline programs was high. Four programs addressed 22 AGREE criteria, and two programs addressed 20 AGREE criteria. The previous Dutch program for guideline development in physical therapy lacked in compliance with the AGREE criteria, meeting only 13 criteria. Further comparison showed that all guideline programs perform systematic literature searches to identify the available evidence. Recommendations are formulated and graded, based on evidence and other relevant factors. It is not clear how decisions in the development process are made. In particular, the process of translating evidence into practice recommendations can be improved. As a result of international developments and consensus, the described processes for developing clinical practice guidelines have much in common. The AGREE criteria are common basis for the development of guidelines, although it is not clear how final decisions are made. Detailed comparison of the different guideline programs was used for updating the Dutch program. As a result the updated KNGF program complied with 22 AGREE criteria. International discussion is continuing and will be used for further improvement of the program.

Quality and reporting of guidelines on the diagnosis and management of dystonia.

PubMed

Tamás, G; Abrantes, C; Valadas, A; Radics, P; Albanese, A; Tijssen, M A J; Ferreira, J J

2018-02-01

The quality of clinical practice guidelines on dystonia has not yet been assessed. Our aim was to appraise the methodological quality of guidelines worldwide and to analyze the consistency of their recommendations. We searched for clinical practice guidelines on dystonia diagnosis/treatment in the National Guideline Clearinghouse, PubMed, National Institute for Health and Care Excellence, Guidelines International Network and Web of Science databases. We also searched for guidelines on homepages of international neurological societies. We asked for guidelines from every Management Committee member of the BM1101 Action of the Cooperation between Science and Technology European framework and every member of the International Parkinson and Movement Disorders Society with special interest in dystonia. Fifteen guidelines were evaluated. Among guidelines on treatment, only one from the American Academy of Neurology could be considered as high quality. Among guidelines on diagnosis and therapy, the guideline from the European Federation of Neurological Societies was recommended by the appraisers. Clinical applicability and reports of editorial independence were the greatest shortcomings. The rigor of development was poor and stakeholder involvement was also incomplete in most guidelines. Discrepancies among recommendations may result from the weight given to consensus statements and expert opinions due to the lack of evidence, as well as inaccuracy of disease classification. The quality of appraised guidelines was low. It is necessary to improve the quality of guidelines on dystonia, and the applied terminology of dystonia also needs to be standardized. © 2017 EAN.

International Variation in Asthma and Bronchiolitis Guidelines.

PubMed

Bakel, Leigh Anne; Hamid, Jemila; Ewusie, Joycelyne; Liu, Kai; Mussa, Joseph; Straus, Sharon; Parkin, Patricia; Cohen, Eyal

2017-11-01

Guideline recommendations for the same clinical condition may vary. The purpose of this study was to determine the degree of agreement among comparable asthma and bronchiolitis treatment recommendations from guidelines. National and international guidelines were searched by using guideline databases (eg, National Guidelines Clearinghouse: December 16-17, 2014, and January 9, 2015). Guideline recommendations were categorized as (1) recommend, (2) optionally recommend, (3) abstain from recommending, (4) recommend against a treatment, and (5) not addressed by the guideline. The degree of agreement between recommendations was evaluated by using an unweighted and weighted κ score. Pairwise comparisons of the guidelines were evaluated similarly. There were 7 guidelines for asthma and 4 guidelines for bronchiolitis. For asthma, there were 166 recommendation topics, with 69 recommendation topics given in ≥2 guidelines. For bronchiolitis, there were 46 recommendation topics, with 21 recommendation topics provided in ≥2 guidelines. The overall κ for asthma was 0.03, both unweighted (95% confidence interval [CI]: -0.01 to 0.07) and weighted (95% CI: -0.01 to 0.10); for bronchiolitis, it was 0.32 unweighted (95% CI: 0.16 to 0.52) and 0.15 weighted (95% CI: -0.01 to 0.5). Less agreement was found in national and international guidelines for asthma than for bronchiolitis. Additional studies are needed to determine if differences are based on patient preferences and values and economic considerations or if other recommendation-level, guideline-level, and condition-level factors are driving these differences. Copyright © 2017 by the American Academy of Pediatrics.

The Disposal of Spacecraft and Launch Vehicle Stages in Low Earth Orbit

NASA Technical Reports Server (NTRS)

Johnson, Nicholas L.

2007-01-01

Spacecraft and launch vehicle stages abandoned in Earth orbit have historically been a primary source of debris from accidental explosions. In the future, such satellites will become the principal cause of orbital debris via inadvertent collisions. To curtail both the near-term and far-term risks posed by derelict spacecraft and launch vehicle stages to operational space systems, numerous national and international orbital debris mitigation guidelines specifically recommend actions which could prevent or limit such future debris generation. Although considerable progress has been made in implementing these recommendations, some changes to existing vehicle designs can be difficult. Moreover, the nature of some missions also can present technological and budgetary challenges to be compliant with widely accepted orbital debris mitigation measures.

Venous thromboembolism management in Northeast Melbourne: how does it compare to international guidelines and data?

PubMed

Lim, Hui Y; Chua, Chong C; Tacey, Mark; Sleeman, Matthew; Donnan, Geoffrey; Nandurkar, Harshal; Ho, Prahlad

2017-09-01

Venous thromboembolism (VTE) is a major cause of morbidity and mortality with significant heterogeneity in its management, both within our local practice and in international guidelines. To provide a holistic evaluation of 'real-world' Australian experience in the warfarin era, including how we compare to international guidelines. Retrospective evaluation of VTE from July 2011 to December 2012 at two major hospitals in Melbourne, Australia. These results were compared to recommendations in the international guidelines. A total of 752 episodes involving 742 patients was identified. Contrary to international guidelines, an unwarranted heritable thrombophilia screen was performed in 22.0% of patients, amounting to a cost of AU$29 000. The duration of anticoagulation was longer compared to international recommendations, although the overall recurrence (3.2/100 person-years) and clinically significant bleeding rates (2.4/100 person-years) were comparable to 'real-world' data. Unprovoked VTE (hazard ratio 2.06; P = 0.01) was a risk factor for recurrence, and there was no difference in recurrence between major VTE (proximal deep vein thrombosis (DVT) and/or pulmonary embolism) and isolated distal DVT (3.02 vs 3.94/100 person-years; P = 0.25). Fourteen patients were subsequently diagnosed with malignancy, and patients with recurrent VTE had increased risk of prospective cancer diagnosis (relative risk 6.68; P < 0.001). While our 'real-world' VTE experience during the warfarin era largely correlates with international guidelines, there remains heterogeneity in the management strategies, including excessive thrombophilia screening and longer duration of anticoagulation. This audit highlights the need for national VTE guidelines, as well as prospective auditing of VTE management, in the direct oral anticoagulant era for future comparison. © 2017 Royal Australasian College of Physicians.

The guideline implementability research and application network (GIRAnet): an international collaborative to support knowledge exchange: study protocol.

PubMed

Gagliardi, Anna R; Brouwers, Melissa C; Bhattacharyya, Onil K

2012-04-02

Modifying the format and content of guidelines may facilitate their use and lead to improved quality of care. We reviewed the medical literature to identify features desired by different users and associated with guideline use to develop a framework of implementability and found that most guidelines do not contain these elements. Further research is needed to develop and evaluate implementability tools. We are launching the Guideline Implementability Research and Application Network (GIRAnet) to enable the development and testing of implementability tools in three domains: Resource Implications, Implementation, and Evaluation. Partners include the Guidelines International Network (G-I-N) and its member guideline developers, implementers, and researchers. In phase one, international guidelines will be examined to identify and describe exemplar tools. Indication-specific and generic tools will populate a searchable repository. In phase two, qualitative analysis of cognitive interviews will be used to understand how developers can best integrate implementability tools in guidelines and how health professionals use them for interpreting and applying guidelines. In phase three, a small-scale pilot test will assess the impact of implementability tools based on quantitative analysis of chart-based behavioural outcomes and qualitative analysis of interviews with participants. The findings will be used to plan a more comprehensive future evaluation of implementability tools. Infrastructure funding to establish GIRAnet will be leveraged with the in-kind contributions of collaborating national and international guideline developers to advance our knowledge of implementation practice and science. Needs assessment and evaluation of GIRAnet will provide a greater understanding of how to develop and sustain such knowledge-exchange networks. Ultimately, by facilitating use of guidelines, this research may lead to improved delivery and outcomes of patient care.

A Review of Established Guidelines and Standards for International Education Travel and Exchange Programs for Students. Report of the Department of Education to the Governor and the General Assembly of Virgina. House Document No. 25.

ERIC Educational Resources Information Center

Virginia State General Assembly, Richmond. House.

This study of existing guidelines and standards for international travel by students in local school divisions is the result of a Virginia Department of Education team effort over four months. The interdisciplinary team reviewed guidelines and standards for international travel and student exchange programs from major organizations and developed…

Modeling the value for money of changing clinical practice change: a stochastic application in diabetes care.

PubMed

Hoomans, Ties; Abrams, Keith R; Ament, Andre J H A; Evers, Silvia M A A; Severens, Johan L

2009-10-01

Decision making about resource allocation for guideline implementation to change clinical practice is inevitably undertaken in a context of uncertainty surrounding the cost-effectiveness of both clinical guidelines and implementation strategies. Adopting a total net benefit approach, a model was recently developed to overcome problems with the use of combined ratio statistics when analyzing decision uncertainty. To demonstrate the stochastic application of the model for informing decision making about the adoption of an audit and feedback strategy for implementing a guideline recommending intensive blood glucose control in type 2 diabetes in primary care in the Netherlands. An integrated Bayesian approach to decision modeling and evidence synthesis is adopted, using Markov Chain Monte Carlo simulation in WinBUGs. Data on model parameters is gathered from various sources, with effectiveness of implementation being estimated using pooled, random-effects meta-analysis. Decision uncertainty is illustrated using cost-effectiveness acceptability curves and frontier. Decisions about whether to adopt intensified glycemic control and whether to adopt audit and feedback alter for the maximum values that decision makers are willing to pay for health gain. Through simultaneously incorporating uncertain economic evidence on both guidance and implementation strategy, the cost-effectiveness acceptability curves and cost-effectiveness acceptability frontier show an increase in decision uncertainty concerning guideline implementation. The stochastic application in diabetes care demonstrates that the model provides a simple and useful tool for quantifying and exploring the (combined) uncertainty associated with decision making about adopting guidelines and implementation strategies and, therefore, for informing decisions about efficient resource allocation to change clinical practice.

75 FR 82040 - Notice of Public Meeting on the International Maritime Organization Guidelines for Exhaust Gas...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-29

... on the International Maritime Organization Guidelines for Exhaust Gas Cleaning Systems for Marine... Organization guidelines for exhaust gas cleaning systems for marine engines in Washington, DC. The purpose of... exhaust gas cleaning systems for marine engines to remove sulphur oxide emissions in order to comply with...

Developing guidelines for return to play: consensus and evidence-based approaches.

PubMed

Echemendia, Ruben J; Giza, Christopher C; Kutcher, Jeffrey S

2015-01-01

Sports-related concussions are commonplace at all levels of play and across all age groups. The dynamic, evolving nature of this injury coupled with a lack of objective biomarkers creates a challenging management issue for the sports medicine team. Athletes who return to play following a concussion are known to be at higher risk for an additional brain injury, which necessitates a careful, informed return to play (RTP) process. The goal of this paper is to outline historical attempts at developing RTP guidelines and trace their evolution over time, culminating in a discussion of the process and outcomes of the most recent consensus statements/guidelines published by the international Concussion In Sport Group (CISG), the American Academy of Neurology (AAN), the National Athletic Trainers' Association, and the 2013 Team Physician Consensus Statement Update. An evaluation of the pros and cons of these guidelines is presented along with suggestions for future directions. In addition, the Institute of Medicine recently conducted a comprehensive report outlining the current state of evidence regarding youth concussions, which provides specific recommendations for future research. The different methodologies utilized in the development of consensus statements have distinct advantages and disadvantages, and both approaches add value to the everyday management of sports concussions. Importantly, the overall approach for management of sports concussion is remarkably similar using either consensus-based or formal evidence-based methods, which adds confidence to the current guidelines and allows practitioners to focus on accepted standards of clinical care. Moving forward, careful study designs need to be utilized to avoid bias in selection of research subjects, collection of data, and interpretation of results. Although useful, clinicians must venture beyond consensus statements to examine reviews of the literature that are published in much greater frequency than consensus statements.

Inherited mutations in BRCA1 and BRCA2 in an unselected multiethnic cohort of Asian patients with breast cancer and healthy controls from Malaysia

PubMed Central

Wen, Wei Xiong; Allen, Jamie; Lai, Kah Nyin; Mariapun, Shivaani; Hasan, Siti Norhidayu; Ng, Pei Sze; Lee, Daphne Shin-Chi; Lee, Sheau Yee; Yoon, Sook-Yee; Lim, Joanna; Lau, Shao Yan; Decker, Brennan; Pooley, Karen; Dorling, Leila; Luccarini, Craig; Baynes, Caroline; Conroy, Don M; Harrington, Patricia; Simard, Jacques; Yip, Cheng Har; Mohd Taib, Nur Aishah; Ho, Weang Kee; Antoniou, Antonis C; Dunning, Alison M; Easton, Douglas F

2018-01-01

Background Genetic testing for BRCA1 and BRCA2 is offered typically to selected women based on age of onset and family history of cancer. However, current internationally accepted genetic testing referral guidelines are built mostly on data from cancer genetics clinics in women of European descent. To evaluate the appropriateness of such guidelines in Asians, we have determined the prevalence of germ line variants in an unselected cohort of Asian patients with breast cancer and healthy controls. Methods Germ line DNA from a hospital-based study of 2575 unselected patients with breast cancer and 2809 healthy controls were subjected to amplicon-based targeted sequencing of exonic and proximal splice site junction regions of BRCA1 and BRCA2 using the Fluidigm Access Array system, with sequencing conducted on a Illumina HiSeq2500 platform. Variant calling was performed with GATK UnifiedGenotyper and were validated by Sanger sequencing. Results Fifty-five (2.1%) BRCA1 and 66 (2.6%) BRCA2 deleterious mutations were identified among patients with breast cancer and five (0.18%) BRCA1 and six (0.21%) BRCA2 mutations among controls. One thousand one hundred and eighty-six (46%) patients and 97 (80%) carriers fulfilled the National Comprehensive Cancer Network guidelines for genetic testing. Conclusion Five per cent of unselected Asian patients with breast cancer carry deleterious variants in BRCA1 or BRCA2. While current referral guidelines identified the majority of carriers, one in two patients would be referred for genetic services. Given that such services are largely unavailable in majority of low-resource settings in Asia, our study highlights the need for more efficient guidelines to identify at-risk individuals in Asia. PMID:28993434

Evaluation of conformity of a first prescription of lipid-based formulation of amphotericin B in a university-teaching pediatric hospital.

PubMed

Agogué, Claire; Bussières, Jean-François; Dehaut, Catherine; Lebel, Denis; Brochet, Marie-Sophie

2006-04-01

Invasive fungal infections are an important cause of morbidity and mortality in immunodeficient children. Amphotericin B is an important therapeutic agent for the treatment of invasive fungal infections but is associated with significant toxicities and high acquisition costs. The purpose of this study was to evaluate physician adherence to a local guideline for the use of lipid-based amphotericin B. The study was approved through Pharmacology & Therapeutics (P&T) committee activities. A retrospective drug utilization review (DUR) was conducted. All orders written between January 1, 2003, and December 31, 2004, were reviewed. Demographic and descriptive clinical data were collected as well as variables related to the drug order process. Conformity rates were calculated for the primary objective criteria (authorized prescribers - infectious disease members; recommended drug of choice-Abelcet; accepted indications; and presence of underlying conditions). A total of 109 orders for 70 patients were reviewed by a single research assistant for a 2-year period. Global conformity rate for all four criteria was calculated at 7.3%. Non-conformity was mostly associated with the absence of underlying conditions (e.g., prerenal insufficiency or presence of nephrotoxicity due to amphotericin B desoxycholate) in 84.5% of the cases. Infusionrelated adverse drug reactions partly explained a switch to a non-formulary lipid-based amphotericin B product. External factors (newly published results since the adoption of the guideline and continuous marketing practices) and internal factors (availability of non-formulary process, inefficient DUR process) could have contributed to non-adherence to a local guideline. This study shows low adherence to P&T committee drug guidelines on lipid-based amphotericin B. Continuous and efficient DUR processes should be in place to monitor drug guideline adherence.

Using a knowledge translation framework to implement asthma clinical practice guidelines in primary care.

PubMed

Licskai, Christopher; Sands, Todd; Ong, Michael; Paolatto, Lisa; Nicoletti, Ivan

2012-10-01

Quality problem International guidelines establish evidence-based standards for asthma care; however, recommendations are often not implemented and many patients do not meet control targets. Initial assessment Regional pilot data demonstrated a knowledge-to-practice gap. Choice of solutions We engineered health system change in a multi-step approach described by the Canadian Institutes of Health Research knowledge translation framework. Implementation Knowledge translation occurred at multiple levels: patient, practice and local health system. A regional administrative infrastructure and inter-disciplinary care teams were developed. The key project deliverable was a guideline-based interdisciplinary asthma management program. Six community organizations, 33 primary care physicians and 519 patients participated. The program operating cost was $290/patient. Evaluation Six guideline-based care elements were implemented, including spirometry measurement, asthma controller therapy, a written self-management action plan and general asthma education, including the inhaler device technique, role of medications and environmental control strategies in 93, 95, 86, 100, 97 and 87% of patients, respectively. Of the total patients 66% were adults, 61% were female, the mean age was 35.7 (SD = ± 24.2) years. At baseline 42% had two or more symptoms beyond acceptable limits vs. 17% (P< 0.001) post-intervention; 71% reported urgent/emergent healthcare visits at baseline (2.94 visits/year) vs. 45% (1.45 visits/year) (P< 0.001); 39% reported absenteeism (5.0 days/year) vs. 19% (3.0 days/year) (P< 0.001). The mean follow-up interval was 22 (SD = ± 7) months. Lessons learned A knowledge-translation framework can guide multi-level organizational change, facilitate asthma guideline implementation, and improve health outcomes in community primary care practices. Program costs are similar to those of diabetes programs. Program savings offset costs in a ratio of 2.1:1.

Using a knowledge translation framework to implement asthma clinical practice guidelines in primary care

PubMed Central

Licskai, Christopher; Sands, Todd; Ong, Michael; Paolatto, Lisa; Nicoletti, Ivan

2012-01-01

Quality problem International guidelines establish evidence-based standards for asthma care; however, recommendations are often not implemented and many patients do not meet control targets. Initial assessment Regional pilot data demonstrated a knowledge-to-practice gap. Choice of solutions We engineered health system change in a multi-step approach described by the Canadian Institutes of Health Research knowledge translation framework. Implementation Knowledge translation occurred at multiple levels: patient, practice and local health system. A regional administrative infrastructure and inter-disciplinary care teams were developed. The key project deliverable was a guideline-based interdisciplinary asthma management program. Six community organizations, 33 primary care physicians and 519 patients participated. The program operating cost was $290/patient. Evaluation Six guideline-based care elements were implemented, including spirometry measurement, asthma controller therapy, a written self-management action plan and general asthma education, including the inhaler device technique, role of medications and environmental control strategies in 93, 95, 86, 100, 97 and 87% of patients, respectively. Of the total patients 66% were adults, 61% were female, the mean age was 35.7 (SD = ±24.2) years. At baseline 42% had two or more symptoms beyond acceptable limits vs. 17% (P< 0.001) post-intervention; 71% reported urgent/emergent healthcare visits at baseline (2.94 visits/year) vs. 45% (1.45 visits/year) (P< 0.001); 39% reported absenteeism (5.0 days/year) vs. 19% (3.0 days/year) (P< 0.001). The mean follow-up interval was 22 (SD = ±7) months. Lessons learned A knowledge-translation framework can guide multi-level organizational change, facilitate asthma guideline implementation, and improve health outcomes in community primary care practices. Program costs are similar to those of diabetes programs. Program savings offset costs in a ratio of 2.1:1 PMID:22893665

40 CFR 240.200 - Solid wastes accepted.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 24 2010-07-01 2010-07-01 false Solid wastes accepted. 240.200 Section 240.200 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.200 Solid...

40 CFR 240.200 - Solid wastes accepted.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 25 2011-07-01 2011-07-01 false Solid wastes accepted. 240.200 Section 240.200 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.200 Solid...

Development of the International Guidelines for Home Health Nursing.

PubMed

Narayan, Mary; Farris, Cindy; Harris, Marilyn D; Hiong, Fong Yoke

2017-10-01

Throughout the world, healthcare is increasingly being provided in home and community-based settings. There is a growing awareness that the most effective, least costly, patient-preferred setting is patients' home. Thus, home healthcare nursing is a growing nursing specialty, requiring a unique set of nursing knowledge and skills. Unlike many other nursing specialties, home healthcare nursing has few professional organizations to develop or support its practice. This article describes how an international network of home healthcare nurses developed international guidelines for home healthcare nurses throughout the world. It outlines how the guidelines for home healthcare nursing practice were developed, how an international panel of reviewers was recruited, and the process they used for reaching a consensus. It also describes the plan for nurses to contribute to future updates to the guidelines.

Between universalism and relativism: a conceptual exploration of problems in formulating and applying international biomedical ethical guidelines

PubMed Central

Tangwa, G

2004-01-01

In this paper, the author attempts to explore some of the problems connected with the formulation and application of international biomedical ethical guidelines, with particular reference to Africa. Recent attempts at revising and updating some international medical ethical guidelines have been bedevilled by intractable controversies and wrangling regarding both the content and formulation. From the vantage position of relative familiarity with both African and Western contexts, and the privilege of having been involved in the revision and updating of one of the international ethical guidelines, the author reflects broadly on these issues and attempts prescribing an approach from both the theoretical and practical angles liable to mitigate, if not completely eliminate, some of the problems and difficulties. PMID:14872078

The developmental processes for NANDA International Nursing Diagnoses.

PubMed

Scroggins, Leann M

2008-01-01

This study aims to provide a step-by-step procedural guideline for the development of a nursing diagnosis that meets the necessary criteria for inclusion in the NANDA International and NNN classification systems. The guideline is based on the processes developed by the Diagnosis Development Committee of NANDA International and includes the necessary processes for development of Actual, Wellness, Health Promotion, and Risk nursing diagnoses. Definitions of Actual, Wellness, Health Promotion, and Risk nursing diagnoses along with inclusion criteria and taxonomy rules have been incorporated into the guideline to streamline the development and review processes for submitted diagnoses. A step-by-step procedural guideline will assist the submitter to move efficiently and effectively through the submission process, resulting in increased submissions and enhancement of the NANDA International and NNN classification systems.

Could accreditation bodies facilitate the implementation of medical guidelines in laboratories?

PubMed

Aakre, Kristin M; Oosterhuis, Wytze P; Misra, Shivani; Langlois, Michel R; Joseph, Watine; Twomey, Patrick J; Barth, Julian H

2017-05-01

Several studies have shown that recommendations related to how laboratory testing should be performed and results interpreted are limited in medical guidelines and that the uptake and implementation of the recommendations that are available need improvement. The EFLM/UEMS Working Group on Guidelines conducted a survey amongst the national societies for clinical chemistry in Europe regarding development of laboratory-related guidelines. The results showed that most countries have guidelines that are specifically related to laboratory testing; however, not all countries have a formal procedure for accepting such guidelines and few countries have guideline committees. Based on this, the EFLM/UEMS Working Group on Guidelines conclude that there is still room for improvement regarding these processes in Europe and raise the question if the accreditation bodies could be a facilitator for an improvement.

46 CFR 403.100 - Applicability of system of accounts and reports.

Code of Federal Regulations, 2010 CFR

2010-10-01

... accordance with the guidelines of the Generally Accepted Accounting Principles (GAAP) issued by the Financial Accounting Standards Board. These guidelines are available by writing to the Director, Great Lakes Pilotage... PILOTAGE UNIFORM ACCOUNTING SYSTEM General § 403.100 Applicability of system of accounts and reports. Each...

75 FR 4635 - Risk-Based Capital Guidelines; Capital Adequacy Guidelines; Capital Maintenance: Regulatory...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-28

... phase-in would unfairly penalize banking organizations given their already established businesses..., will aid banking organizations with capital planning as they implement FAS 166 and FAS 167 and adjust... assets a banking organization consolidates as a result of changes to U.S. generally accepted accounting...

Irrigation and Fertilization Type, Rate, and Frequency of Application

Treesearch

Thomas E. Starkey

2002-01-01

There is no "cookbook" formula for growing longleaf pine (Pinus palustris Mill.). However, some very definite minimum guidelines must be followed to successfully produce an acceptable crop of trees. Irrigation and fertilization are the two most important management practices in the growth of the seedlings. Specific guidelines and...

Use of Linear Programming to Develop Cost-Minimized Nutritionally Adequate Health Promoting Food Baskets

PubMed Central

Tetens, Inge; Dejgård Jensen, Jørgen; Smed, Sinne; Gabrijelčič Blenkuš, Mojca; Rayner, Mike; Darmon, Nicole; Robertson, Aileen

2016-01-01

Background Food-Based Dietary Guidelines (FBDGs) are developed to promote healthier eating patterns, but increasing food prices may make healthy eating less affordable. The aim of this study was to design a range of cost-minimized nutritionally adequate health-promoting food baskets (FBs) that help prevent both micronutrient inadequacy and diet-related non-communicable diseases at lowest cost. Methods Average prices for 312 foods were collected within the Greater Copenhagen area. The cost and nutrient content of five different cost-minimized FBs for a family of four were calculated per day using linear programming. The FBs were defined using five different constraints: cultural acceptability (CA), or dietary guidelines (DG), or nutrient recommendations (N), or cultural acceptability and nutrient recommendations (CAN), or dietary guidelines and nutrient recommendations (DGN). The variety and number of foods in each of the resulting five baskets was increased through limiting the relative share of individual foods. Results The one-day version of N contained only 12 foods at the minimum cost of DKK 27 (€ 3.6). The CA, DG, and DGN were about twice of this and the CAN cost ~DKK 81 (€ 10.8). The baskets with the greater variety of foods contained from 70 (CAN) to 134 (DGN) foods and cost between DKK 60 (€ 8.1, N) and DKK 125 (€ 16.8, DGN). Ensuring that the food baskets cover both dietary guidelines and nutrient recommendations doubled the cost while cultural acceptability (CAN) tripled it. Conclusion Use of linear programming facilitates the generation of low-cost food baskets that are nutritionally adequate, health promoting, and culturally acceptable. PMID:27760131

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2003-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. Of particular relevance to drug regulatory authorities and pharmaceutical manufacturers, the report discusses activities related to the development of The International Pharmacopoeia and basic tests for pharmaceutical substances and dosage forms, as well as quality control of reference materials, good manufacturing practices (GMP), stability studies, inspection, hazard analysis, procurement, storage and other aspects of quality assurance of pharmaceuticals, and regulatory issues. The report is complemented by a number of annexes, including recommendations on the risk of transmitting animal spongiform encephalopathy agents via medicinal products, guidelines on GMP for pharmaceutical products, a model certificate for GMP and guidance on a GMP inspection report. The final annexes provide guidance on the application of Hazard Analysis and Critical Control Point (HACCP) method to pharmaceuticals, good storage practices and a procedure for assessing acceptability of pharmaceutical products for purchase by United Nations agencies.

Diagnostic criteria, severity classification and guidelines of localized scleroderma.

PubMed

Asano, Yoshihide; Fujimoto, Manabu; Ishikawa, Osamu; Sato, Shinichi; Jinnin, Masatoshi; Takehara, Kazuhiko; Hasegawa, Minoru; Yamamoto, Toshiyuki; Ihn, Hironobu

2018-04-23

We established diagnostic criteria and severity classification of localized scleroderma because there is no established diagnostic criteria or widely accepted severity classification of the disease. Also, there has been no clinical guideline for localized scleroderma, so we established its clinical guideline ahead of all over the world. In particular, the clinical guideline was established by clinical questions based on evidence-based medicine according to the New Minds Clinical Practice Guideline Creation Manual (version 1.0). We aimed to make the guideline easy to use and reliable based on the newest evidence, and to present guidance as specific as possible for various clinical problems in treatment of localized scleroderma. © 2018 Japanese Dermatological Association.

Review and evaluation of the methodological quality of the existing guidelines and recommendations for inherited neurometabolic disorders.

PubMed

Cassis, Linda; Cortès-Saladelafont, Elisenda; Molero-Luis, Marta; Yubero, Delia; González, Maria Julieta; Ormazábal, Aida; Fons, Carme; Jou, Cristina; Sierra, Cristina; Castejon Ponce, Esperanza; Ramos, Federico; Armstrong, Judith; O'Callaghan, M Mar; Casado, Mercedes; Montero, Raquel; Meavilla-Olivas, Silvia; Artuch, Rafael; Barić, Ivo; Bartoloni, Franco; Bellettato, Cinzia Maria; Bonifazi, Fedele; Ceci, Adriana; Cvitanović-Šojat, Ljerka; Dali, Christine I; D'Avanzo, Francesca; Fumic, Ksenija; Giannuzzi, Viviana; Lampe, Christina; Scarpa, Maurizio; Garcia-Cazorla, Ángels

2015-12-30

Inherited neurometabolic disorders (iNMDs) represent a group of almost seven hundred rare diseases whose common manifestations are clinical neurologic or cognitive symptoms that can appear at any time, in the first months/years of age or even later in adulthood. Early diagnosis and timely treatments are often pivotal for the favorable course of the disease. Thus, the elaboration of new evidence-based recommendations for iNMD diagnosis and management is increasingly requested by health care professionals and patients, even though the methodological quality of existing guidelines is largely unclear. InNerMeD-I-Network is the first European network on iNMDs that was created with the aim of sharing and increasing validated information about diagnosis and management of neurometabolic disorders. One of the goals of the project was to determine the number and the methodological quality of existing guidelines and recommendations for iNMDs. We performed a systematic search on PubMed, the National Guideline Clearinghouse (NGC), the Guidelines International Network (G-I-N), the Scottish Intercollegiate Guideline Network (SIGN) and the National Institute for Health and Care Excellence (NICE) to identify all the published guidelines and recommendations for iNMDs from January 2000 to June 2015. The methodological quality of the selected documents was determined using the AGREE II instrument, an appraisal tool composed of 6 domains covering 23 key items. A total of 55 records met the inclusion criteria, 11 % were about groups of disorders, whereas the majority encompassed only one disorder. Lysosomal disorders, and in particular Fabry, Gaucher disease and mucopolysaccharidoses where the most studied. The overall methodological quality of the recommendation was acceptable and increased over time, with 25 % of the identified guidelines strongly recommended by the appraisers, 64 % recommended, and 11 % not recommended. However, heterogeneity in the obtained scores for each domain was observed among documents covering different groups of disorders and some domains like 'stakeholder involvement' and 'applicability' were generally scarcely addressed. Greater efforts should be devoted to improve the methodological quality of guidelines and recommendations for iNMDs and AGREE II instrument seems advisable for new guideline development. The elaboration of new guidelines encompassing still uncovered disorders is badly needed.

Review of national research ethics regulations and guidelines in Middle Eastern Arab countries

PubMed Central

2012-01-01

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. PMID:23234422

A Comparison of Current Guidelines of Five International Societies on Clostridium difficile Infection Management.

PubMed

Fehér, Csaba; Mensa, Josep

2016-09-01

Clostridium difficile infection (CDI) is increasingly recognized as an emerging healthcare problem of elevated importance. Prevention and treatment strategies are constantly evolving along with the apperance of new scientific evidence and novel treatment methods, which is well-reflected in the differences among consecutive international guidelines. In this article, we summarize and compare current guidelines of five international medical societies on CDI management, and discuss some of the controversial and currently unresolved aspects which should be addressed by future research.

Law, ethics and pandemic preparedness: the importance of cross-jurisdictional and cross-cultural perspectives.

PubMed

Bennett, Belinda; Carney, Terry

2010-04-01

To explore social equity, health planning, regulatory and ethical dilemmas in responding to a pandemic influenza (H5N1) outbreak, and the adequacy of protocols and standards such as the International Health Regulations (2005). This paper analyses the role of legal and ethical considerations for pandemic preparedness, including an exploration of the relevance of cross-jurisdictional and cross-cultural perspectives in assessing the validity of goals for harmonisation of laws and policies both within and between nations. Australian and international experience is reviewed in various areas, including distribution of vaccines during a pandemic, the distribution of authority between national and local levels of government, and global and regional equity issues for poorer countries. This paper finds that questions such as those of distributional justice (resource allocation) and regulatory frameworks raise important issues about the cultural and ethical acceptability of planning measures. Serious doubt is cast on a 'one size fits all' approach to international planning for managing a pandemic. It is concluded that a more nuanced approach than that contained in international guidelines may be required if an effective response is to be constructed internationally. The paper commends the wisdom of reliance on 'soft law', international guidance that leaves plenty of room for each nation to construct its response in conformity with its own cultural and value requirements. © 2010 The Authors. Journal Compilation © 2010 Public Health Association of Australia.

Coping with Anger--Yours, Your Child's.

ERIC Educational Resources Information Center

Caruso, Saf Lerman

1989-01-01

Children's feelings of anger, jealousy, and even hatred need to be acknowledged and accepted by parents. This article suggests methods for teaching acceptable ways to express strong feelings. Because parents are role models for children, guidelines are also provided for parents on coping with their own anger. (IAH)

Knowledge-Based Personal Health System to empower outpatients of diabetes mellitus by means of P4 Medicine.

PubMed

Bresó, Adrián; Sáez, Carlos; Vicente, Javier; Larrinaga, Félix; Robles, Montserrat; García-Gómez, Juan Miguel

2015-01-01

Diabetes Mellitus (DM) affects hundreds of millions of people worldwide and it imposes a large economic burden on healthcare systems. We present a web patient empowering system (PHSP4) that ensures continuous monitoring and assessment of the health state of patients with DM (type I and II). PHSP4 is a Knowledge-Based Personal Health System (PHS) which follows the trend of P4 Medicine (Personalized, Predictive, Preventive, and Participative). It provides messages to outpatients and clinicians about the achievement of objectives, follow-up, and treatments adjusted to the patient condition. Additionally, it calculates a four-component risk vector of the associated pathologies with DM: Nephropathy, Diabetic retinopathy, Diabetic foot, and Cardiovascular event. The core of the system is a Rule-Based System which Knowledge Base is composed by a set of rules implementing the recommendations of the American Diabetes Association (ADA) (American Diabetes Association: http://www.diabetes.org/ ) clinical guideline. The PHSP4 is designed to be standardized and to facilitate its interoperability by means of terminologies (SNOMED-CT [The International Health Terminology Standards Development Organization: http://www.ihtsdo.org/snomed-ct/ ] and UCUM [The Unified Code for Units of Measure: http://unitsofmeasure.org/ ]), standardized clinical documents (HL7 CDA R2 [Health Level Seven International: http://www.hl7.org/index.cfm ]) for managing Electronic Health Record (EHR). We have evaluated the functionality of the system and its users' acceptance of the system using simulated and real data, and a questionnaire based in the Technology Acceptance Model methodology (TAM). Finally results show the reliability of the system and the high acceptance of clinicians.

49 CFR Appendix B to Part 180 - Acceptable Internal Self-closing Stop Valve Leakage Tests for Cargo Tanks Transporting Liquefied...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 3 2011-10-01 2011-10-01 false Acceptable Internal Self-closing Stop Valve... Pt. 180, App. B Appendix B to Part 180—Acceptable Internal Self-closing Stop Valve Leakage Tests for Cargo Tanks Transporting Liquefied Compressed Gases For internal self-closing stop valve leakage testing...

[Effects of a mandatory guideline that prohibit hospital doctors from accepting any form of benefits in any form from the pharmaceutical industry].

PubMed

Gundermann, C; Meier-Hellmann, A; Bauer, M; Hartmann, M

2010-05-01

Several hospitals have issued their own guidelines that regulate the conduct of staff members toward the pharmaceutical industry. The effect of theses guidelines on the attitude of the doctors toward the pharmaceutical industry in Germany has so far been unknown. This study investigated whether hospital doctors with guidelines and those without guidelines differ in their attitude toward the pharmaceutical industry. A retrospective analysis was undertaken to determine the influence of hospital guidelines on the attitude of doctors toward the pharmaceutical industry. In May 2008 all doctors in intensive care of a hospital with and one without guidelines were asked anonymously by a questionnaire about their dealings with the pharmaceutical industry. The response rate was 64.9 % (37/57) and 55.1 % (59/107) respectively. The cooperation rate in both groups was 100 %. In the hospital with guidelines every doctor was on average carrying 0.56 +/- 0.64 pharmaceutical advertising gifts with a company logo, while the average in the institution without guidelines was 1.2 +/- 0.61 advertising gifts (p = 0.026). Whereas 49 % of doctors with guidelines considered the acceptance of advertising gifts as not questionable, 81 % without guidelines did (p = 0.001; RRR = 0.65; 95 % CI = 0.48-0.91). Furthermore, 70 % of doctors in the institution with guidelines compared with 92 % of those doctors in the hospital without guidelines believed that the advertising practices of the pharmaceutical industry had no influence on their prescribing behaviour (p = 0.010; RRR = 3.6; 95 % CI = 1.36-9.52). Both groups of doctors are convinced that other doctors are more influenced by the pharmaceutical industry than they are themselves (51 % with and 37 % without guidelines, p = 0.207). 70 % and 90 %, respectively of all participants considered hospital guidelines setting standards of conduct toward the pharmaceutical industry and those not sponsored by industry to have a positive effect. Every other doctor additionally stated the advice by the pharmaceutical industry was not helpful for his work. Hospital guidelines on relations with the pharmaceutical industry appear to further a critical attitude by physicians regarding the pharmaceutical industry. Georg Thieme Verlag KG Stuttgart. New York.

Antimicrobial stewardship: a qualitative study of the development of national guidelines for antibiotic use in hospitals.

PubMed

Feiring, Eli; Walter, Anne Berit

2017-11-21

As effective antibiotics are becoming a scarce resource, governmental regulation is needed to promote responsible use. Implementation of antibiotic stewardship and practice guidelines in health care facilities seems to be crucial to this effort. Empirical studies suggest, however, that guidelines have limited influence on health professionals' behavior and practice. Barriers and facilitators to guideline implementability are much studied, but little attention has been given to health professionals' perceptions of normative acceptability of guidelines as a condition for compliance. The aim of the present study was first, to examine if and how aspects potentially promoting acceptability and compliance among clinical target users were addressed during development of Norwegian national guidelines for antibiotic use in hospitals and second, to identify procedural characteristics of the development process that were perceived by target users to yield legitimate guidelines. Qualitative deductive thematic analysis was used. A theoretical framework inspired by the AGREE II Instrument and the Accountability for reasonableness framework assisted data gathering and interpretation. Archival data was collected and used to detail the guideline development process. Semi-structured, in-depth interviews with eight clinicians with extensive knowledge of the guidelines were carried out. Guideline development was characterized by i) broad agreement about scope and purpose, ii) broad involvement of stakeholders in the development process, iii) use of systematic methods to search for and apply evidence, iv) easily identifiable and specific recommendations, v) provision of tools on how to put recommendations into practice, and vi) editorial independence. Several procedural characteristics were perceived by the interviewees as promoting guideline legitimacy; i) diverse perspectives systematically involved in the process, ii) accessibility and transparency of the rationales for decision making, iii) opportunities for appeals and reconsiderations, and iv) regulative authority. This study provides insights as to how guidelines that are intended to promote responsible use of antibiotics in hospitals can be carefully developed to facilitate perceptions of relevance, transparency, and authority by health professionals.

[Impact of conflicts of interest on guideline recommendations : Empirical study within the second update of the German interdisciplinary S3 guidelines on fibromyalgia syndrome].

PubMed

Häuser, W; Petzke, F; Kopp, I; Nothacker, M

2017-06-01

The impact of conflicts of interest (COI) in general and of academic COI in particular on guideline recommendations in pain medicine has not yet been studied. Whether the inclusion of patients and of representatives of all relevant healthcare professions into a guidelines group is protective against a systematic bias of decisions of a guidelines group is currently unknown. All members of the guidelines group declared their COI before the consensus conferences by a standard form according to the rules and standards of the Association of the German Medical and Scientific Societies. The acceptance or rejection and the strength of consensus of recommendations of the second update of the interdisciplinary guidelines on fibromyalgia syndrome was analyzed twice by first including and then excluding the votes of the guideline group members with COI related to a recommendation from the results of anonymous voting via an internet platform. A total of 42 persons from different healthcare professions and patients participated in the online voting on recommendations. Of the participants 29% had no COI according to the predefined criteria, 53% met the criteria of academic and 33% the criteria of financial COI. In the case of exclusion of participants with a COI related to a specific recommendation, 2 out of 23 recommendations (homeopathy, tramadol) were not accepted. In all votes, there were more participants without COI than with COI. Academic COI were more frequent than financial COI in the second update of the German interdisciplinary guidelines group on fibromyalgia syndrome. The impact of COI on guideline recommendations was low. The inclusion of patients and of all relevant healthcare professionals into a guidelines group is a protective factor against the influence of COI on guideline recommendations.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2014-01-01

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, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia--updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

First Update of the Criteria for Certification of Chest Pain Units in Germany: Facelift or New Model?

PubMed

Breuckmann, Frank; Rassaf, Tienush

2016-03-01

In an effort to provide a systematic and specific standard-of-care for patients with acute chest pain, the German Cardiac Society introduced criteria for certification of specialized chest pain units (CPUs) in 2008, which have been replaced by a recent update published in 2015. We reviewed the development of CPU establishment in Germany during the past 7 years and compared and commented the current update of the certification criteria. As of October 2015, 228 CPUs in Germany have been successfully certified by the German Cardiac Society; 300 CPUs are needed for full coverage closing gaps in rural regions. Current changes of the criteria mainly affect guideline-adherent adaptions of diagnostic work-ups, therapeutic strategies, risk stratification, in-hospital timing and education, and quality measures, whereas the overall structure remained unchanged. Benchmarking by participation within the German CPU registry is encouraged. Even though the history is short, the concept of certified CPUs in Germany is accepted and successful underlined by its recent implementation in national and international guidelines. First registry data demonstrated a high standard of quality-of-care. The current update provides rational adaptions to new guidelines and developments without raising the level for successful certifications. A periodic release of fast-track updates with shorter time frames and an increase of minimum requirements should be considered.

Quality by design approach: application of artificial intelligence techniques of tablets manufactured by direct compression.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Ozer, Ozgen; Güneri, Tamer; York, Peter

2012-12-01

The publication of the International Conference of Harmonization (ICH) Q8, Q9, and Q10 guidelines paved the way for the standardization of quality after the Food and Drug Administration issued current Good Manufacturing Practices guidelines in 2003. "Quality by Design", mentioned in the ICH Q8 guideline, offers a better scientific understanding of critical process and product qualities using knowledge obtained during the life cycle of a product. In this scope, the "knowledge space" is a summary of all process knowledge obtained during product development, and the "design space" is the area in which a product can be manufactured within acceptable limits. To create the spaces, artificial neural networks (ANNs) can be used to emphasize the multidimensional interactions of input variables and to closely bind these variables to a design space. This helps guide the experimental design process to include interactions among the input variables, along with modeling and optimization of pharmaceutical formulations. The objective of this study was to develop an integrated multivariate approach to obtain a quality product based on an understanding of the cause-effect relationships between formulation ingredients and product properties with ANNs and genetic programming on the ramipril tablets prepared by the direct compression method. In this study, the data are generated through the systematic application of the design of experiments (DoE) principles and optimization studies using artificial neural networks and neurofuzzy logic programs.

[After seven years of National Disease Management Guidelines: quo vadis?].

PubMed

Weinbrenner, Susanne; Conrad, Susann; Weikert, Beate; Kopp, Ina

2010-01-01

After seven years the National Disease Management Guidelines Programme (German DM-CPG Programme) that was established under the auspices of the German Medical Association, the National Association of Statutory Health Insurance Physicians and the Association of the Scientific Medical Societies in Germany has been widely accepted by both health care professionals and patients. DM-CPGs are available as tools for knowledge and quality management for widespread chronic diseases showing need for improvement in treatment pathways and coordination between health care providers. The main objective of the German DM-CPG Programme is to establish consensus among the medical professions on evidence-based key recommendations covering all sectors of health care provision and facilitating the coordination of care for the individual patient over time and across interfaces. German DM-CPGs provide a conceptual basis for disease management and integrative care aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation, chronic care and management aspects for high priority health care topics. Thus, representatives of all disciplines, professions and patients concerned with the topic of an individual German DM-CPG are involved in the development process. The methodology of guideline development is in accordance with international standards. However, the improvement of strategies for effective implementation and continuous update remain challenging. Future work will also focus on content-related aspects such as co-morbidity, gender and migration background. Copyright © 2010. Published by Elsevier GmbH.

78 FR 24817 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

...The National Highway Traffic Safety Administration (NHTSA) is concerned about the effects of distraction on motor vehicle safety due to drivers' use of electronic devices. Consequently, NHTSA is issuing nonbinding, voluntary Driver Distraction Guidelines (NHTSA Guidelines) to promote safety by discouraging the introduction of excessively distracting devices in vehicles. This notice announces the issuance of the final version of the first phase of the NHTSA Guidelines. This first phase applies to original equipment (OE) in-vehicle electronic devices used by the driver to perform secondary tasks (communications, entertainment, information gathering, navigation tasks, etc. are considered secondary tasks) through visual-manual means (i.e., the driver looks at a device, manipulates a device-related control with his or her hand, and/or watches for visual feedback). The NHTSA Guidelines list certain secondary tasks believed by the agency to interfere inherently with a driver's ability to safely control the vehicle. The NHTSA Guidelines recommend that in-vehicle devices be designed so that they cannot be used by the driver to perform these inherently distracting secondary tasks while driving. For all other visual-manual secondary tasks, the NHTSA Guidelines specify a test method for measuring eye glance behavior during those tasks. Eye glance metrics are compared to acceptance criteria to evaluate whether a task interferes too much with driver attention, rendering it unsuitable for a driver to perform while driving. If a task does not meet the acceptance criteria, the NHTSA Guidelines recommend that the task be made inaccessible for performance by the driver while driving. In addition, the NHTSA Guidelines contain several recommendations to limit and reduce the potential for distraction associated with the use of OE in-vehicle electronic devices.

Successful hazard analysis critical control point implementation in the United Kingdom: understanding the barriers through the use of a behavioral adherence model.

PubMed

Gilling, S J; Taylor, E A; Kane, K; Taylor, J Z

2001-05-01

Hazard analysis critical control point (HACCP), a system of risk management designed to control food safety, has emerged over the last decade as the primary approach to securing the safety of the food supply. It is thus an important tool in combatting the worldwide escalation of foodborne disease. Yet despite wide dissemination and scientific support of its principles, successful HACCP implementation has been limited. This report takes a psychological approach to this problem by examining processes and factors that could impede adherence to the internationally accepted HACCP Guidelines and subsequent successful implementation of HACCP. Utilizing knowledge of medical clinical guideline adherence models and practical experience of HACCP implementation problems, the potential advantages of applying a behavioral model to food safety management are highlighted. The models' applicability was investigated using telephone interviews from over 200 businesses in the United Kingdom. Eleven key barriers to HACCP guideline adherence were identified. In-depth narrative interviews with food business proprietors then confirmed these findings and demonstrated the subsequent negative effect(s) on HACCP implementation. A resultant HACCP awareness to adherence model is proposed that demonstrates the complex range of potential knowledge, attitude, and behavior-related barriers involved in failures of HACCP guideline adherence. The model's specificity and detail provide a tool whereby problems can be identified and located and in this way facilitate tailored and constructive intervention. It is suggested that further investigation into the barriers involved and how to overcome them would be of substantial benefit to successful HACCP implementation and thereby contribute to an overall improvement in public health.

[Classifying Mexican adolescents' high blood pressure, associated factors and importance].

PubMed

Salcedo-Rocha, Ana L; de Alba, Javier E García; Contreras-Marmolejo, Margarita

2010-08-01

Determining characteristics regarding risk and high blood pressure (HBP) frequency in a group of 12 to 16 year-old students from the city of León, Mexico, according to two types of classification: the 7th Joint National Committee (JNC-7) and 4th report of the working group for diagnosis, evaluation and treatment of HBP in children and adolescents. This was an observational, descriptive cross-sectional study of 458 male students. HBP was determined according to international standards after parents and students' informed consent had been obtained and they answered a questionnaire for recording clinical-epidemiological data. Blood pressure levels were classified as being normal, pre-HBP and hyper-HBP in accordance with the guidelines issued by the 7th National Joint Committee for detecting, evaluating and treating HBP (JNC-7) and the 4th report of the working group for diagnosis, evaluation and treatment of HBP in children and adolescents. 61.3 % and 68.7 % were found to have normal blood pressure, 34.9 % and 20.7 % were pre-HBP and 3.7 % and 10.4 % hyper-HBP according to JNC-7 and 4th report guidelines, respectively, whilst 71 % and 66 % had a family background of diabetes and HBP, 22 % were overweight and obese and 24 % had a background of alcohol consumption. It is suggested that 4th report guidelines should be adopted in clinical practice whilst JNC-7 guidelines should be used for epidemiological studies. Accepting the pre-HBP concept and its early detection for preventing HBP will facilitate effective health promotion regarding changes in lifestyle.

Standardization in dimensional nanometrology: development of a calibration guideline for Scanning Probe Microscopy

NASA Astrophysics Data System (ADS)

Dziomba, Thorsten; Koenders, Ludger; Wilkening, Günter

2005-10-01

The continuing miniaturization in many technologies - among them the optical systems - demands high-resolution measurements with uncertainties in the nanometre-range or even well below. A brief introduction of measurement methods used at the micro- & nanometre scale is therefore given as introduction. While a wide range of these methods are well established for the determination of various physical properties down to the nanometric scale, it is Scanning Probe Microscopy (SPM) that provides a unique direct access to topographic surface features in the size range from atomic diameters to some ten or hundred micrometres. With the increasing use of SPMs as quantitative measurement instruments, the demand for standardized calibration routines also for this type of instruments rises. However, except for a few specially designed set-ups mainly at National Metrology Institutes (e. g. PTB in Germany), measurements made with SPMs usually lack traceability to the metre definition. A number of physical transfer standards have therefore been developed and are already available commercially. While detailed knowledge of the standards' properties is a prerequisite for their practical applicability, the calibration procedure itself deserves careful consideration as well. As there is, up to now, no generally accepted concept how to perform SPM calibrations, guidelines are now being developed on various national and international levels, e. g. VDI/VDE-GMA in Germany and ISO. This papers discusses the draft of an SPM calibration guideline by focusing on several critical practical aspects of SPM calibration. The paper intends to invite the readers to take active part in guideline discussions.

77 FR 12907 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-02

... impact of task performance while driving on driving safety and time-based acceptance criteria for... feedback). The proposed NHTSA Guidelines list certain secondary, non-driving related tasks that, based on... cannot be used by the driver to perform such tasks while the driver is driving. For all other secondary...

78 FR 3883 - The Bon-Ton Stores, Inc., Provisional Acceptance of a Settlement Agreement and Order

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-17

...) 504-7602. SUPPLEMENTARY INFORMATION: The text of the Agreement and Order appears below. Dated... strangling or entangling on neck and waist drawstrings. The Guidelines state that drawstrings can cause, and... cribs. In the Guidelines, staff recommends that there be no hood and neck drawstrings in children's...

76 FR 10339 - Ms. Bubbles, Inc., Provisional Acceptance of a Settlement Agreement and Order

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

... 20814-4408; telephone (301) 504-7587. SUPPLEMENTARY INFORMATION: The text of the Agreement and Order... entangling on neck and waist drawstrings. The Guidelines state that drawstrings can cause, and have caused... Guidelines, the Staff recommends that there be no hood and neck drawstrings in children's upper outerwear...

17 CFR Appendix B to Part 36 - Guidance on, and Acceptable Practices in, Compliance With Core Principles

Code of Federal Regulations, 2010 CFR

2010-04-01

... decision-making process and the reasons for using its emergency action authority. Information on steps... have clear procedures and guidelines for decision-making regarding emergency intervention in the market, including procedures and guidelines to avoid conflicts of interest while carrying out such decision-making...

Development of Techniques and Data for Evaluating Ride Quality, Volume III : Guidelines for Development of Ride-Quality Models and Their Applications

DOT National Transportation Integrated Search

1978-02-01

Ride-quality models for city buses and intercity trains are presented and discussed in terms of their ability to predict passenger comfort and ride acceptability. The report, the last of three volumes, contains procedural guidelines to be employed by...

International Rules for Pre-College Science Research: Guidelines for Science and Engineering Fairs, 2010-2011

ERIC Educational Resources Information Center

Society for Science & the Public, 2011

2011-01-01

This paper presents the rules and guidelines of the Intel International Science and Engineering Fair 2011 to be held in Los Angeles, California in May 8-13, 2011. In addition to providing the rules of competition, these rules and guidelines for conducting research were developed to facilitate the following: (1) protect the rights and welfare of…

Medicare depreciation; useful life guidelines--HCFA. Proposed rule.

PubMed

1982-09-30

We are proposing to amend Medicare regulations to clarify which useful life guidelines providers of health care services may use to determine the useful life of a depreciable asset for Medicare reimbursement purposes. Current regulations state that providers must utilize HHS useful life guidelines or, if none have been published by HHS, the American Hospital Association (AHA) useful life guidelines of 1973 or IRS guidelines. We are proposing to eliminate the reference to IRS guidelines because those previously acceptable for Medicare purposes are outdated and have been made obsolete by the IRS or by statutory change. We would also delete the specific reference to the 1973 AHA guidelines. In addition, we intend this amendment to clarify that certain tax legislation on accelerated depreciation, recently passed by Congress, does not apply to the Medicare program.

EBMPracticeNet: A Bilingual National Electronic Point-Of-Care Project for Retrieval of Evidence-Based Clinical Guideline Information and Decision Support

PubMed Central

2013-01-01

Background In Belgium, the construction of a national electronic point-of-care information service, EBMPracticeNet, was initiated in 2011 to optimize quality of care by promoting evidence-based decision-making. The collaboration of the government, health care providers, evidence-based medicine (EBM) partners, and vendors of electronic health records (EHR) is unique to this project. All Belgian health care professionals get free access to an up-to-date database of validated Belgian and nearly 1000 international guidelines, incorporated in a portal that also provides EBM information from other sources than guidelines, including computerized clinical decision support that is integrated in the EHRs. Objective The objective of this paper was to describe the development strategy, the overall content, and the management of EBMPracticeNet which may be of relevance to other health organizations creating national or regional electronic point-of-care information services. Methods Several candidate providers of comprehensive guideline solutions were evaluated and one database was selected. Translation of the guidelines to Dutch and French was done with translation software, post-editing by translators and medical proofreading. A strategy is determined to adapt the guideline content to the Belgian context. Acceptance of the computerized clinical decision support tool has been tested and a randomized controlled trial is planned to evaluate the effect on process and patient outcomes. Results Currently, EBMPracticeNet is in "work in progress" state. Reference is made to the results of a pilot study and to further planned research including a randomized controlled trial. Conclusions The collaboration of government, health care providers, EBM partners, and vendors of EHRs is unique. The potential value of the project is great. The link between all the EHRs from different vendors and a national database held on a single platform that is controlled by all EBM organizations in Belgium are the strengths of EBMPracticeNet. PMID:23842038

ESPEN guideline on ethical aspects of artificial nutrition and hydration.

PubMed

Druml, Christiane; Ballmer, Peter E; Druml, Wilfred; Oehmichen, Frank; Shenkin, Alan; Singer, Pierre; Soeters, Peter; Weimann, Arved; Bischoff, Stephan C

2016-06-01

The worldwide debate over the use of artificial nutrition and hydration remains controversial although the scientific and medical facts are unequivocal. Artificial nutrition and hydration are a medical intervention, requiring an indication, a therapeutic goal and the will (consent) of the competent patient. The guideline was developed by an international multidisciplinary working group based on the main aspects of the Guideline on "Ethical and Legal Aspects of Artificial Nutrition" published 2013 by the German Society for Nutritional Medicine (DGEM) after conducting a review of specific current literature. The text was extended and introduced a broader view in particular on the impact of culture and religion. The results were discussed at the ESPEN Congress in Lisbon 2015 and accepted in an online survey among ESPEN members. The ESPEN Guideline on Ethical Aspects of Artificial Nutrition and Hydration is focused on the adult patient and provides a critical summary for physicians and caregivers. Special consideration is given to end of life issues and palliative medicine; to dementia and to specific situations like nursing care or the intensive care unit. The respect for autonomy is an important focus of the guideline as well as the careful wording to be used in the communication with patients and families. The other principles of Bioethics like beneficence, non-maleficence and justice are presented in the context of artificial nutrition and hydration. In this respect the withholding and withdrawing of artificial nutrition and/or hydration is discussed. Due to increasingly multicultural societies and the need for awareness of different values and beliefs an elaborated chapter is dedicated to cultural and religious issues and nutrition. Last but not least topics like voluntary refusal of nutrition and fluids, and forced feeding of competent persons (persons on hunger strike) is included in the guideline. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Gestational diabetes mellitus: Confusion among medical doctors caused by multiple international criteria.

PubMed

Agarwal, Mukesh M; Shah, Syed M; Al Kaabi, Juma; Saquib, Shabnam; Othman, Yusra

2015-06-01

The aim of this study was to appraise the current regional practices of screening, diagnosis and follow-up of gestational diabetes mellitus (GDM) because the approach to GDM is frequently inconsistent. A 21-item questionnaire was distributed to physicians taking care of pregnant women in seven hospitals in the United Arab Emirates and one hospital in Oman. Besides assessing their attitudes towards testing for GDM, the questionnaire assessed familiarity with the Hyperglycemia and Pregnancy Outcome study and the International Association of Diabetes in Pregnancy Study Groups GDM guidelines. One hundred and forty-eight (93%) of the 159 questionnaires distributed to the medical doctors (106 [72%] obstetricians and 42 [28%] internists) were returned. For GDM screening, six hospitals used five different tests; two hospitals utilized one single test. For GDM diagnosis, six hospitals employed the 2-h, 75-g oral glucose tolerance test (OGTT) (four different criteria) while two hospitals used the 3-h, 100-g OGTT (single criteria). For post-delivery follow-up, the 2-h, 75-g OGTT and fasting plasma glucose were accepted by 103 (70%) and 38 (26%) of the 148 medical doctors, respectively. Ninety-eight (69%) of 143 responding physicians were aware of the Hyperglycemia and Pregnancy Outcome study, while 85 (61%) of 140 responders were familiar with the guidelines of the International Association of Diabetes in Pregnancy Study Groups; this knowledge was independent of specialty, seniority, academia, years in practice or country trained. Although this study is parochial, its implications are global; that is, further education of caregivers would make the discordant approach to GDM (within and between hospitals) more harmonious and improve the obstetric care of pregnant women. © 2014 The Authors. Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology.

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

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

Ekechukwu, A

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

What Next? Translating AGI's 2015 Guidelines for Ethical Professional Conduct into Practice

NASA Astrophysics Data System (ADS)

Boland, M. A.; Keane, C.

2016-12-01

In 2015, the American Geosciences Institute (AGI) published a revised version of the 1999 Guidelines for Ethical Professional Conduct, an aspirational document outlining ethical principles that should inform the professional behavior of all geoscientists. The revised Guidelines reflect a consensus of opinion among AGI's 51 member societies and show an evolution in thinking about geoscience ethics. The Guidelines also represent a foundational document to support the expansion of ethical guidelines by individual societies and organizations. Publishing the Guidelines was a significant milestone but aspirations need to be matched by action. We examine several developments that implement aspects of the Guidelines, including the development of a consensus statement regarding access and inclusion of individuals living with disabilities in the geosciences, a Joint AGI/Geological Society of America Societies meeting on professional conduct, geoethics training initiatives, and efforts to foster international cooperation in recognizing and implementing ethical practice in the geosciences. In addition, we examine the level of success in using these Guidelines as philosophical cornerstones for a number of international projects, such as Resourcing Future Generations and the International Raw Materials Observatory, that bring geoscience directly into contact with large societal issues.

Protocol-developing meta-ethnography reporting guidelines (eMERGe).

PubMed

France, E F; Ring, N; Noyes, J; Maxwell, M; Jepson, R; Duncan, E; Turley, R; Jones, D; Uny, I

2015-11-25

Designing and implementing high-quality health care services and interventions requires robustly synthesised evidence. Syntheses of qualitative research studies can provide evidence of patients' experiences of health conditions; intervention feasibility, appropriateness and acceptability to patients; and advance understanding of health care issues. The unique, interpretive, theory-based meta-ethnography synthesis approach is suited to conveying patients' views and developing theory to inform service design and delivery. However, meta-ethnography reporting is often poor quality, which discourages trust in, and use of, meta-ethnography findings. Users of evidence syntheses require reports that clearly articulate analytical processes and findings. Tailored research reporting guidelines can raise reporting standards but none exists for meta-ethnography. This study aims to create an evidence-based meta-ethnography reporting guideline articulating the methodological standards and depth of reporting required to improve reporting quality. The mixed-methods design of this National Institute of Health Research-funded study (http://www.stir.ac.uk/emerge/) follows good practice in research reporting guideline development comprising: (1) a methodological systematic review (PROSPERO registration: CRD42015024709) to identify recommendations and guidance in conducting/reporting meta-ethnography; (2) a review and audit of published meta-ethnographies to identify good practice principles and develop standards in conduct/reporting; (3) an online workshop and Delphi studies to agree guideline content with 45 international qualitative synthesis experts and 45 other stakeholders including patients; (4) development and wide dissemination of the guideline and its accompanying detailed explanatory document, a report template for National Institute of Health Research commissioned meta-ethnographies, and training materials on guideline use. Meta-ethnography, devised in the field of education, is now used widely in other disciplines. Methodological advances relevant to meta-ethnography conduct exist. The extent of discipline-specific adaptations of meta-ethnography and the fit of any adaptions with the underpinning philosophy of meta-ethnography require investigation. Well-reported meta-ethnography findings could inform clinical decision-making. A bespoke meta-ethnography reporting guideline is needed to improve reporting quality, but to be effective potential users must know it exists, trust it and use it. Therefore, a rigorous study has been designed to develop and promote a guideline. By raising reporting quality, the guideline will maximise the likelihood that high-quality meta-ethnographies will contribute robust evidence to improve health care and patient outcomes.

Using AGREE II to Evaluate the Quality of Traditional Medicine Clinical Practice Guidelines in China.

PubMed

Deng, Wei; Li, Le; Wang, Zixia; Chang, Xiaonan; Li, Rui; Fang, Ziye; Wei, Dang; Yao, Liang; Wang, Xiaoqin; Wang, Qi; An, Guanghui

2016-03-15

To evaluate/assess the quality of the Clinical Practice Guidelines (CPGs) of traditional medicine in China. We systematically searched the literature databases WanFang Data, VIP, CNKI and CBM for studies published between 1978 and 2012 to identify and select CPGs of traditional medicine. We used the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument to evaluate these guidelines. A total of 75 guidelines were included, of which 46 guidelines (62%) were on Traditional Chinese Medicine, 19 (25%) on Chinese Integrated Medicine, and 10 (13%) on Uyghur Medicine. Most traditional medicine CPGs published in domestic journals scored <20% (range: 0-63%). Eleven (14%) CPGs were developed following the methodology of evidence-based medicine. In each domain of AGREE II, traditional Medicine CPGs performed clearly better than international CPGs. The same trend was seen in guidelines of Modern Medicine. An increasing amount of CPGs are being published, but their quality is low. Referring to the key points of international guidelines development, supervision through AGREE II, cooperating with international groups and exploring the strategy of guideline development could improve the quality of CPGs on traditional medicine. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

What do international ethics guidelines say in terms of the scope of medical research ethics?

PubMed

Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; van Delden, Johannes J M

2016-04-26

In research ethics, the most basic question would always be, "which is an ethical issue, which is not?" Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that. We extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative. We found that there is no consensus on the majority of the imperatives and that in only 8.2% of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least. There was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences.

The quality of reports of medical and public health research from Palestinian institutions: a systematic review

PubMed Central

Abu-Rmeileh, Niveen ME; Elessi, Khamis; Obeidallah, Mohammad; Bjertness, Espen; Chalmers, Iain

2017-01-01

Objective Over the past decade, there has been an increase in reports of health research from Palestine, but no assessment of their quality. We have assessed the quality of reports of Palestinian health research and factors associated with it. Design This is a systematic review. Inclusion criteria We searched Medline and Scopus for reports of original research relevant to human health or healthcare authored by researchers affiliated with Palestinian institutions and published between January 2000 and August 2015 inclusive. Outcomes We used international guidelines to assess report quality, classifying as adequate those with ≥50% of items completely addressed. Results Of 2383 reports identified, 497 met our inclusion criteria. Just over half (264; 55%) of these were published after 2010. 354 (71%) of first authors were affiliated with Palestinian institutions; 261 (53%) reports had coauthors from outside Palestine. The majority of the reports in our study were inadequately reported (342; 69%), and none had adequately reported all items. Of 439 observational studies, 11 (2.5%) reports provided adequate descriptions of eligibility criteria and selection procedures; 35 (8%) reported efforts to address potential sources of bias; 50 (11.4%) reported the basis for the study sample size; and funding sources were mentioned in 74 reports (17%). Higher reporting quality was associated with international affiliation of the first author (prevalence ratio (PR) 1.6 (95% CI 1.2 to 2.1)), international collaboration (PR 2.9 (95% CI 1.7 to 5.0)), international funding (PR 1.9 (95% CI1.5 to 2.5)), publication after 2005 (PR 3.9 (95% CI 1.8 to 8.5)) and four or more coauthors (PR 1.5 (95% CI 1.1 to 2.1)). Conclusion Although the quality of reports of Palestinian research has improved in recent years, it remains well below an acceptable standard. International reporting guidelines should be used to guide research design and improve the quality of reports of research. Trial registration number The systematic review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) registery (registration number: CRD42015027553). PMID:28601839

Global standard for the composition of infant formula: recommendations of an ESPGHAN coordinated international expert group.

PubMed

Koletzko, Berthold; Baker, Susan; Cleghorn, Geoff; Neto, Ulysses Fagundes; Gopalan, Sarath; Hernell, Olle; Hock, Quak Seng; Jirapinyo, Pipop; Lonnerdal, Bo; Pencharz, Paul; Pzyrembel, Hildegard; Ramirez-Mayans, Jaime; Shamir, Raanan; Turck, Dominique; Yamashiro, Yuichiro; Zong-Yi, Ding

2005-11-01

The Codex Alimentarius Commission of the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) develops food standards, guidelines and related texts for protecting consumer health and ensuring fair trade practices globally. The major part of the world's population lives in more than 160 countries that are members of the Codex Alimentarius. The Codex Standard on Infant Formula was adopted in 1981 based on scientific knowledge available in the 1970s and is currently being revised. As part of this process, the Codex Committee on Nutrition and Foods for Special Dietary Uses asked the ESPGHAN Committee on Nutrition to initiate a consultation process with the international scientific community to provide a proposal on nutrient levels in infant formulae, based on scientific analysis and taking into account existing scientific reports on the subject. ESPGHAN accepted the request and, in collaboration with its sister societies in the Federation of International Societies on Pediatric Gastroenterology, Hepatology and Nutrition, invited highly qualified experts in the area of infant nutrition to form an International Expert Group (IEG) to review the issues raised. The group arrived at recommendations on the compositional requirements for a global infant formula standard which are reported here.

A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care.

PubMed

Quanbeck, Andrew; Brown, Randall T; Zgierska, Aleksandra E; Jacobson, Nora; Robinson, James M; Johnson, Roberta A; Deyo, Brienna M; Madden, Lynn; Tuan, Wen-Jan; Alagoz, Esra

2018-01-25

This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

[Legal relevance of guidelines : Contextualization exemplified by international recommendations for treatment of inguinal hernia in adults].

PubMed

Weyhe, D; Uslar, V N; Mählmeyer, C; Oehlers, H

2018-06-21

Guidelines aim to standardize treatment concepts based on evidence from the literature and may thus be viewed as collegial support; however, there is a lack of clarity about the legal relevance and legal validity of international guidelines compared to the Association of the Scientific Medical Societies in Germany (AWMF) recommendations. A literature search was conducted on German AWMF guidelines and on international guidelines for inguinal hernia in adults. Differences in the structure of the guidelines were analyzed and legal terms, such as the medical standard, the Patients' Rights Act and the current legal literature are defined and commented on with respect to guideline-compliant treatment. Since 2003 a total of 15 guidelines and recommendations for the treatment of inguinal hernia have been published. There are no AWMF guidelines on one of the procedures most frequently performed in Germany. Among the relevant judgments and laws passed from 1994 onwards, § 630 of the German Civil Code (BGB) passed in 2013 seems to be particularly significant, since it standardizes the term "medical standard" and explicitly allows values falling short of the standard after clarification. From a legal point of view, the basic prerequisites for medical treatment are patient consent and intervention education. In principle, a non-guideline-compliant treatment procedure can be agreed. The patient must be informed about the treatment options that are relevant to the medical standard, the procedure must be indicated according to the medical standard and the operation must be performed in accordance with the national medical specialist standard. Thus, international guidelines cannot a priori claim to be followed unobserved and are therefore not legally comparable to the German S3 guidelines of the AWMF. It is strongly advised to expressly point out and explicitly explain anything falling short of the standard, individual healing attempts and so-called outsider methods.

Barriers to Implementation of Recommendations for Transport of Children in Ground Ambulances.

PubMed

Woods, Rashida H; Shah, Manish; Doughty, Cara; Gilchrest, Anthony

2017-10-16

The National Highway Traffic Safety Administration (NHTSA) released draft recommendations in 2010 on the safe transport of children in ground ambulances. The purpose of this study was to assess awareness of these guidelines among emergency medical service (EMS) agencies and to identify implementation barriers. We conducted a cross-sectional, anonymous online survey of 911-responding, ground transport EMS agencies in Texas. Demographics, modes of transport based on case scenarios, and barriers to implementation were assessed. Of 62 eligible EMS agencies that took the survey, 35.7% were aware of the NHTSA guidelines, 62.5% agreed they would improve safety, and 41.1% planned to implement them. Seventy-five percent of EMS agencies used the ideal or acceptable alternative to transport children requiring continuous monitoring, and 69.5% chose ideal or acceptable alternatives for children requiring spinal immobilization. The ideal or acceptable alternative was not chosen for children who were not injured or ill (93.2%), ill or injured but not requiring continuous monitoring (53.3%), and situations when multiple patients required transport (57.6%). The main requirements for implementation were provider education, ambulance interior modifications, new guidelines in the EMS agency, and purchase of new equipment. Few EMS agencies are aware of the NHTSA guidelines on safe transport of children in ground ambulances. Although most agencies appropriately transport children who require monitoring, interventions, or spinal immobilization, they use inappropriate means to transport children in situations with multiple patients, lack of injury or illness, or lack of need for monitoring.

A Survey of Restraint Methods for the Safe Transport of Children in Ground Ambulances.

PubMed

Woods, Rashida H; Shah, Manish; Doughty, Cara; Gilchrest, Anthony

2018-03-01

The National Highway Traffic Safety Administration (NHTSA) released draft recommendations in 2010 on the safe transport of children in ground ambulances. The purpose of this study was to assess awareness of these guidelines among emergency medical service (EMS) agencies and to identify implementation barriers. We conducted a cross-sectional, anonymous online survey of 911-responding, ground transport EMS agencies in Texas. Demographics, modes of transport based on case scenarios, and barriers to implementation were assessed. Of 62 eligible EMS agencies that took the survey, 35.7% were aware of the NHTSA guidelines, 62.5% agreed they would improve safety, and 41.1% planned to implement them. Seventy-five percent of EMS agencies used the ideal or acceptable alternative to transport children requiring continuous monitoring, and 69.5% chose ideal or acceptable alternatives for children requiring spinal immobilization. The ideal or acceptable alternative was not chosen for children who were not injured or ill (93.2%), ill or injured but not requiring continuous monitoring (53.3%), and situations when multiple patients required transport (57.6%). The main requirements for implementation were provider education, ambulance interior modifications, new guidelines in the EMS agency, and purchase of new equipment. Few EMS agencies are aware of the NHTSA guidelines on safe transport of children in ground ambulances. Although most agencies appropriately transport children who require monitoring, interventions, or spinal immobilization, they use inappropriate means to transport children in situations with multiple patients, lack of injury or illness, or lack of need for monitoring.

The baby killers are still at large.

PubMed

Power, J

1994-08-12

This newspaper editorial reports that the UN Children's Fund's (UNICEF) executive director and recent US Presidential Medal of Freedom recipient believes that 1.5 million infants would survive annually if breast feeding declines worldwide were reversed. UNICEF adopted the International Code of Marketing of Breast Milk Substitutes in the World Health Assembly in 1981. The code restricts direct advertising, inadequate labels, saleswomen dressed as nurses, and promotion of free samples. The Baby Food Action Network is reported to have released a report which states that baby food companies are still donating free supplies of infant formula to hospitals. The UNICEF position is that provision of free supplies is the most important disincentive to breast feeding. 81 governments adopted the guidelines, but 41 countries have hospitals which accept free samples. 28 of these 41 countries adopted the ban. The Nestle Company, which was cited 20 years age for this practice, won the legal battle and today defies the guidelines in 22 countries, including China, Zimbabwe, and Bangladesh. A US company, Mead Johnson, uses advertising on its label that shows Beatrice Potter's Peter Rabbit being bottle fed. The International Code restricts idealization of bottle feeding. Nutrician, a large conglomerate ownership of US and European infant formula companies, brazenly advertises in the Peruvian daily newspapers with photos of baby milk boxes being donated to hospitals. Dr. Derek Jelliffe, an infant nutritionist, is credited with being the first to publicize the dangers of commercialized malnutrition 21 years ago.

External branch of the superior laryngeal nerve monitoring during thyroid and parathyroid surgery: International Neural Monitoring Study Group standards guideline statement.

PubMed

Barczyński, Marcin; Randolph, Gregory W; Cernea, Claudio R; Dralle, Henning; Dionigi, Gianlorenzo; Alesina, Piero F; Mihai, Radu; Finck, Camille; Lombardi, Davide; Hartl, Dana M; Miyauchi, Akira; Serpell, Jonathan; Snyder, Samuel; Volpi, Erivelto; Woodson, Gayle; Kraimps, Jean Louis; Hisham, Abdullah N

2013-09-01

Intraoperative neural monitoring (IONM) during thyroid surgery has gained widespread acceptance as an adjunct to the gold standard of visual identification of the recurrent laryngeal nerve (RLN). Contrary to routine dissection of the RLN, most surgeons tend to avoid rather than routinely expose and identify the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy or parathyroidectomy. IONM has the potential to be utilized for identification of the EBSLN and functional assessment of its integrity; therefore, IONM might contribute to voice preservation following thyroidectomy or parathyroidectomy. We reviewed the literature and the cumulative experience of the multidisciplinary International Neural Monitoring Study Group (INMSG) with IONM of the EBSLN. A systematic search of the MEDLINE database (from 1950 to the present) with predefined search terms (EBSLN, superior laryngeal nerve, stimulation, neuromonitoring, identification) was undertaken and supplemented by personal communication between members of the INMSG to identify relevant publications in the field. The hypothesis explored in this review is that the use of a standardized approach to the functional preservation of the EBSLN can be facilitated by application of IONM resulting in improved preservation of voice following thyroidectomy or parathyroidectomy. These guidelines are intended to improve the practice of neural monitoring of the EBSLN during thyroidectomy or parathyroidectomy and to optimize clinical utility of this technique based on available evidence and consensus of experts. 5 Copyright © 2013 The American Laryngological, Rhinological and Otological Society, Inc.

Consensus guidelines for the diagnosis and management of patients with classic hairy cell leukemia.

PubMed

Grever, Michael R; Abdel-Wahab, Omar; Andritsos, Leslie A; Banerji, Versha; Barrientos, Jacqueline; Blachly, James S; Call, Timothy G; Catovsky, Daniel; Dearden, Claire; Demeter, Judit; Else, Monica; Forconi, Francesco; Gozzetti, Alessandro; Ho, Anthony D; Johnston, James B; Jones, Jeffrey; Juliusson, Gunnar; Kraut, Eric; Kreitman, Robert J; Larratt, Loree; Lauria, Francesco; Lozanski, Gerard; Montserrat, Emili; Parikh, Sameer A; Park, Jae H; Polliack, Aaron; Quest, Graeme R; Rai, Kanti R; Ravandi, Farhad; Robak, Tadeusz; Saven, Alan; Seymour, John F; Tadmor, Tamar; Tallman, Martin S; Tam, Constantine; Tiacci, Enrico; Troussard, Xavier; Zent, Clive S; Zenz, Thorsten; Zinzani, Pier Luigi; Falini, Brunangelo

2017-02-02

Hairy cell leukemia is an uncommon hematologic malignancy characterized by pancytopenia and marked susceptibility to infection. Tremendous progress in the management of patients with this disease has resulted in high response rates and improved survival, yet relapse and an appropriate approach to re-treatment present continuing areas for research. The disease and its effective treatment are associated with immunosuppression. Because more patients are being treated with alternative programs, comparison of results will require general agreement on definitions of response, relapse, and methods of determining minimal residual disease. The development of internationally accepted, reproducible criteria is of paramount importance in evaluating and comparing clinical trials to provide optimal care. Despite the success achieved in managing these patients, continued participation in available clinical trials in the first-line and particularly in the relapse setting is highly recommended. The Hairy Cell Leukemia Foundation convened an international conference to provide common definitions and structure to guide current management. There is substantial opportunity for continued research in this disease. In addition to the importance of optimizing the prevention and management of the serious risk of infection, organized evaluations of minimal residual disease and treatment at relapse offer ample opportunities for clinical research. Finally, a scholarly evaluation of quality of life in the increasing number of survivors of this now manageable chronic illness merits further study. The development of consensus guidelines for this disease offers a framework for continued enhancement of the outcome for patients.

Consensus guidelines for the diagnosis and management of patients with classic hairy cell leukemia

PubMed Central

Abdel-Wahab, Omar; Andritsos, Leslie A.; Banerji, Versha; Barrientos, Jacqueline; Blachly, James S.; Call, Timothy G.; Catovsky, Daniel; Dearden, Claire; Demeter, Judit; Else, Monica; Forconi, Francesco; Gozzetti, Alessandro; Ho, Anthony D.; Johnston, James B.; Jones, Jeffrey; Juliusson, Gunnar; Kraut, Eric; Kreitman, Robert J.; Larratt, Loree; Lauria, Francesco; Lozanski, Gerard; Montserrat, Emili; Parikh, Sameer A.; Park, Jae H.; Polliack, Aaron; Quest, Graeme R.; Rai, Kanti R.; Ravandi, Farhad; Robak, Tadeusz; Saven, Alan; Seymour, John F.; Tadmor, Tamar; Tallman, Martin S.; Tam, Constantine; Tiacci, Enrico; Troussard, Xavier; Zent, Clive S.; Zenz, Thorsten; Zinzani, Pier Luigi; Falini, Brunangelo

2017-01-01

Hairy cell leukemia is an uncommon hematologic malignancy characterized by pancytopenia and marked susceptibility to infection. Tremendous progress in the management of patients with this disease has resulted in high response rates and improved survival, yet relapse and an appropriate approach to re-treatment present continuing areas for research. The disease and its effective treatment are associated with immunosuppression. Because more patients are being treated with alternative programs, comparison of results will require general agreement on definitions of response, relapse, and methods of determining minimal residual disease. The development of internationally accepted, reproducible criteria is of paramount importance in evaluating and comparing clinical trials to provide optimal care. Despite the success achieved in managing these patients, continued participation in available clinical trials in the first-line and particularly in the relapse setting is highly recommended. The Hairy Cell Leukemia Foundation convened an international conference to provide common definitions and structure to guide current management. There is substantial opportunity for continued research in this disease. In addition to the importance of optimizing the prevention and management of the serious risk of infection, organized evaluations of minimal residual disease and treatment at relapse offer ample opportunities for clinical research. Finally, a scholarly evaluation of quality of life in the increasing number of survivors of this now manageable chronic illness merits further study. The development of consensus guidelines for this disease offers a framework for continued enhancement of the outcome for patients. PMID:27903528

Chiropractic quality assurance: standards and guidelines

PubMed Central

Gatterman, Meridel I; Dobson, Thomas P; LeFevbre, Ron

2001-01-01

Chiropractic quality assurance involves development of both clinical guidelines and standards. Confusion generated by poor differentiation of guidelines from standards contributes to mistrust of the guideline development process. Guidelines are considered to be recommendations that allow for flexibility and individual patient differences. Standards are more binding and require a high level of supporting evidence. While guidelines serve as educational tools to improve the quality of practice, standards that outline minimum competency are used more as administrative tools on which to base policy. Barriers to development of clinical guidelines and standards include fear that they will create prescriptive “cookbook” practice, and the distrust that guidelines are developed primarily for cost containment. Clinicians also criticize guidelines developed by academics that don't relate to practice, and those based on evidence that lacks clinical relevance. Conflicting guidelines perceived to be based on strong bias or conflict of interest are also suspect. To reduce barriers to acceptance and implementation, guidelines should be inclusive, patient-centered, and based on a variety of evidence and clinical experience.

Developing Practice Guidelines for Psychoanalysis

PubMed Central

GRAY, SHEILA HAFTER

1996-01-01

Consensus-based practice guidelines codify clinical intelligence and the rich oral tradition in medicine. Because they reflect actual practice, they are readily accepted by clinicians as a basis for external review. This article illustrates the development of guidelines for a psychoanalytic approach to the large pool of patients who present with a depression. It suggests an integrated biopsychosocial approach to these individuals that is useful in current practice, and it offers propositions that may be tested in future research undertakings. Eventually, practice guidelines such as these may form the basis of economical systems of health care that avoid arbitrary, clinically untenable limitations on services. PMID:22700290

Guidelines in preparing computer-generated plots for NASA technical reports with the LaRC graphics output system

NASA Technical Reports Server (NTRS)

Taylor, N. L.

1983-01-01

To response to a need for improved computer-generated plots that are acceptable to the Langley publication process, the LaRC Graphics Output System has been modified to encompass the publication requirements, and a guideline has been established. This guideline deals only with the publication requirements of computer-generated plots. This report explains the capability that authors of NASA technical reports can use to obtain publication--quality computer-generated plots or the Langley publication process. The rules applied in developing this guideline and examples illustrating the rules are included.

Guidelines and Suggestions for Balloon Gondola Design

NASA Technical Reports Server (NTRS)

Franco, Hugo

2017-01-01

This paper discusses the current gondola design requirements for the Columbia Scientific Balloon Facility (CSBF). The CSBF is responsible for launching and supporting balloon borne scientific instruments and has some current updated guidelines that will be discussed in this presentation. As the sophistication of Payload systems have increased in size and complexity new guidelines have been implemented in order to make these instruments stay within the acceptable launch risks. Additionally, there is a requirement to submit a proper stress analysis report that states the flight design requirements have been met. Suggestions are discussed in this presentation that establish the proper guidelines to submit these.

Ethics in practice: the state of the debate on promoting the social value of global health research in resource poor settings particularly Africa.

PubMed

Lairumbi, Geoffrey M; Michael, Parker; Fitzpatrick, Raymond; English, Michael C

2011-11-15

Promoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide. We reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services. Access to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries. Although in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. © 2011 Lairumbi et al; licensee BioMed Central Ltd.

Implementing international sexual counselling guidelines in hospital cardiac rehabilitation: development of the CHARMS intervention using the Behaviour Change Wheel.

PubMed

Mc Sharry, J; Murphy, P J; Byrne, M

2016-10-10

Decreased sexual activity and sexual problems are common among people with cardiovascular disease, negatively impacting relationship satisfaction and quality of life. International guidelines recommend routine delivery of sexual counselling to cardiac patients. The Cardiac Health and Relationship Management and Sexuality (CHARMS) baseline study in Ireland found, similar to international findings, limited implementation of sexual counselling guidelines in practice. The aim of the current study was to develop the CHARMS multi-level intervention to increase delivery of sexual counselling by healthcare professionals. We describe the methods used to develop the CHARMS intervention following the three phases of the Behaviour Change Wheel approach: understand the behaviour, identify intervention options, and identify content and implementation options. Survey (n = 60) and focus group (n = 14) data from two previous studies exploring why sexual counselling is not currently being delivered were coded by two members of the research team to understand staff's capability, opportunity, and motivation to engage in the behaviour. All potentially relevant intervention functions to change behaviour were identified and the APEASE (affordability, practicability, effectiveness, acceptability, side effects and equity) criteria were used to select the most appropriate. The APEASE criteria were then used to choose between all behaviour change techniques (BCTs) potentially relevant to the identified functions, and these BCTs were translated into intervention content. The Template for Intervention Description and Replication (TIDieR) checklist was used to specify details of the intervention including the who, what, how and where of proposed intervention delivery. Providing sexual counselling group sessions by cardiac rehabilitation staff to patients during phase III cardiac rehabilitation was identified as the target behaviour. Education, enablement, modelling, persuasion and training were selected as appropriate intervention functions. Twelve BCTs, linked to intervention functions, were identified for inclusion and translated into CHARMS intervention content. This paper details the use of Behaviour Change Wheel approach to develop an implementation intervention in an under-researched area of healthcare provision. The systematic and transparent development of the CHARMS intervention will facilitate the evaluation of intervention effectiveness and future replication and contribute to the advancement of a cumulative science of implementation intervention design.

The Breast Health Global Initiative: clinical practice guidelines for management of breast cancer in low- and middle-income countries.

PubMed

Yip, Cheng Har; Anderson, Benjamin O

2007-08-01

Breast cancer is an increasingly urgent problem in low- and mid-level resource countries of the world. Despite knowing the optimal management strategy based on guidelines developed in wealthy countries, clinicians are forced to provide less-than-optimal care to patients when diagnostic and/or treatment resources are lacking. For this reason, it is important to identify which resources commonly applied in resource-abundant countries most effectively fill the healthcare needs in limited-resource regions, where patients commonly present with more advanced disease at diagnosis, and to provide guidance on how new resource allocations should be made in order to maximize improvement in outcome. Established in 2002, the Breast Health Global Initiative (BHGI) created an international health alliance to develop evidence-based guidelines for countries with limited resources (low- and middle-income countries) to improve breast health outcomes. The BHGI serves as a program for international guideline development and as a hub for linkage among clinicians, governmental health agencies and advocacy groups to translate guidelines into policy and practice. The BHGI collaborated with 12 national and international health organizations, cancer societies and nongovernmental organizations to host two BHGI international summits. The evidence-based BHGI Guidelines, developed at the 2002 Global Summit, were published in 2003 as a theoretical treatise on international breast healthcare. These guidelines were then updated and expanded at the 2005 Global Summit into a fully comprehensive and flexible framework to permit incremental improvements in healthcare delivery, based upon outcomes, cost, cost-effectiveness and use of healthcare services.

Impediments to global surveillance of infectious diseases: consequences of open reporting in a global economy.

PubMed Central

Cash, R. A.; Narasimhan, V.

2000-01-01

Globalization has led to an increase in the spread of emerging and re-emerging infectious diseases. International efforts are being launched to control their dissemination through global surveillance, a major hindrance to which is the failure of some countries to report outbreaks. Current guidelines and regulations on emerging and re-emerging infectious diseases do not sufficiently take into account the fact that when developing countries report outbreaks they often derive few benefits and suffer disproportionately heavy social and economic consequences. In order to facilitate full participation in global surveillance by developing countries there should be: better and more affordable diagnostic capabilities to allow for timely and accurate information to be delivered in an open and transparent fashion; accurate, less sensationalist news reporting of outbreaks of diseases; adherence by countries to international regulations, including those of the World Trade Organization and the International Health Regulations; financial support for countries that are economically damaged by the diseases in question. The article presents two cases--plague in India and cholera in Peru--that illuminate some of the limitations of current practices. Recommendations are made on measures that could be taken by WHO and the world community to make global surveillance acceptable. PMID:11143197

International experts' practice in the antibiotic therapy of infective endocarditis is not following the guidelines.

PubMed

Tissot-Dupont, H; Casalta, J P; Gouriet, F; Hubert, S; Salaun, E; Habib, G; Fernandez-Gerlinger, M P; Mainardi, J L; Tattevin, P; Revest, M; Lucht, F; Botelho-Nevers, E; Gagneux-Brunon, A; Snygg-Martin, U; Chan, K L; Bishara, J; Vilacosta, I; Olmos, C; San Román, J A; López, J; Tornos, P; Fernández-Hidalgo, N; Durante-Mangoni, E; Utili, R; Paul, M; Baddour, L M; DeSimone, D C; Sohail, M R; Steckelberg, J M; Wilson, W R; Raoult, D

2017-10-01

The management of infective endocarditis (IE) may differ from international guidelines, even in reference centres. This is probably because most recommendations are not based on hard evidence, so the consensus obtained for the guidelines does not represent actual practices. For this reason, we aimed to evaluate this question in the particular field of antibiotic therapy. Thirteen international centres specialized in the management of IE were selected, according to their reputation, clinical results, original research publications and quotations. They were asked to detail their actual practice in terms of IE antibiotic treatment in various bacteriological and clinical situations. They were also asked to declare their IE-related in-hospital mortality for the year 2015. The global compliance with guidelines concerning antibiotic therapy was 58%, revealing the differences between theoretical 'consensus', local recommendations and actual practice. Some conflicts of interest were also probably expressed. The adherence to guidelines was 100% when the protocol was simple, and decreased with the seriousness of the situation (Staphylococus spp. 54%-62%) or in blood-culture-negative endocarditis (0%-15%) that requires adaptation to clinical and epidemiological data. Worldwide experts in IE management, although the majority of them were involved and co-signed the guidelines, do not follow international consensus guidelines on the particular point of the use of antibiotics. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Characterizing synthetic gypsum for wallboard manufacture

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

Henkels, P.J.; Gynor, J.C.

1996-12-31

United States Gypsum Company (USGC) has developed specifications and guidelines covering the chemical and physical aspects of synthetic gypsum to help predict end use acceptability in wallboard manufacture. These guidelines are based in part on past experiences with natural and synthetic gypsum. Similarly, most wallboard manufacturers in North America have developed their own guidelines based in part on its unique history and particular experiences with synthetic gypsum. While there are similarities between manufacturers` guidelines, differences do exist. This paper discusses the importance of selected parameters contained in the FGD gypsum guidelines. In most cases, the parameters are equally relevant tomore » other synthetic gypsums and the naturally occurring gypsum mineral as well.« less

Syllabus in Medical Assisting: Health Occupations Education Program.

ERIC Educational Resources Information Center

New York State Education Dept., Albany. Bureau of Occupational and Career Curriculum Development.

The document presents a syllabus which would serve as a guideline for health occupations educators in establishing a course of study for training medical assistants which would meet New York State requirements and be acceptable for State credit. The syllabus is arranged in three columns: (1) minimum acceptable content of study which requires 80…

Needed: Guidelines for defining acceptable advance regeneration

Treesearch

Dennis E. Ferguson

1984-01-01

Advance regeneration is an important component in many stands scheduled for harvesting. Properly managed, such regeneration can contribute to a healthy, new stand, but too often trees do not quickly respond to the new environment or take too long to adjust. Definitions of acceptable advance regeneration are needed for pre- and postharvest inventories. The author...

48 CFR 352.234-3 - Full earned value management system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Federal Agency (CFA) as being compliant with the guidelines in ANSI/EIA Standard-748 (current version at... and accepted by the CFA at the time of award, see paragraph (b) of this clause. The Contractor shall..., the Contractor's EVM system has not been validated and accepted by the CFA as complying with EVMS...

Sibling Family Practices: Guidelines for Healthy Boundaries

ERIC Educational Resources Information Center

Johnson, Toni Cavanagh; Huang, Bevan Emma; Simpson, Pippa M.

2009-01-01

A questionnaire was given to 500 mental health and child welfare professionals asking for maximum acceptable ages for siblings to engage jointly in certain family practices related to hygiene, affection, and privacy. A large proportion of respondents felt it was never acceptable for siblings to take showers together (40%), kiss on the mouth (37%),…

Adapting a large database of point of care summarized guidelines: a process description.

PubMed

Delvaux, Nicolas; Van de Velde, Stijn; Aertgeerts, Bert; Goossens, Martine; Fauquert, Benjamin; Kunnamo, Ilka; Van Royen, Paul

2017-02-01

Questions posed at the point of care (POC) can be answered using POC summarized guidelines. To implement a national POC information resource, we subscribed to a large database of POC summarized guidelines to complement locally available guidelines. Our challenge was in developing a sustainable strategy for adapting almost 1000 summarized guidelines. The aim of this paper was to describe our process for adapting a database of POC summarized guidelines. An adaptation process based on the ADAPTE framework was tailored to be used by a heterogeneous group of participants. Guidelines were assessed on content and on applicability to the Belgian context. To improve efficiency, we chose to first aim our efforts towards those guidelines most important to primary care doctors. Over a period of 3 years, we screened about 80% of 1000 international summarized guidelines. For those guidelines identified as most important for primary care doctors, we noted that in about half of the cases, remarks were made concerning content. On the other hand, at least two-thirds of all screened guidelines required no changes when evaluating their local usability. Adapting a large body of POC summarized guidelines using a formal adaptation process is possible, even when faced with limited resources. This can be done by creating an efficient and collaborative effort and ensuring user-friendly procedures. Our experiences show that even though in most cases guidelines can be adopted without adaptations, careful review of guidelines developed in a different context remains necessary. Streamlining international efforts in adapting international POC information resources and adopting similar adaptation processes may lessen duplication efforts and prove more cost-effective. © 2015 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

Management Approaches for Enterocutaneous Fistulas.

PubMed

Heimroth, Jamie; Chen, Eric; Sutton, Erica

2018-03-01

There are very few clinical studies that highlight a definitive and comprehensive guideline for the management of enterocutaneous fistulas. Most accepted guidelines are found in textbooks and are taken from expert advice and case reports. The goal of this review is to highlight advancements relevant to the management of enterocutaneous fistulas from the recent two to three years. Although strong evidence-based guidelines are lacking, the consensus is that a multidisciplinary team working with a clear treatment plan targeting multiple aspects of management can maximize patient outcomes.

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

PubMed

Cavero, Icilio; Crumb, William

2005-05-01

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

Implementation of Out-of-Office Blood Pressure Monitoring in the Netherlands: From Clinical Guidelines to Patients' Adoption of Innovation.

PubMed

Carrera, Pricivel M; Lambooij, Mattijs S

2015-10-01

Out-of-office blood pressure monitoring is promoted by various clinical guidelines toward properly diagnosing and effectively managing hypertension and engaging the patient in their care process. In the Netherlands, however, the Dutch cardiovascular risk management (CVRM) guidelines do not explicitly prescribe 24-hour ambulatory blood pressure measurement (ABPM) and home BP measurement (HBPM). The aim of this descriptive study was to develop an understanding of patients' and physicians' acceptance and use of out-of-office BP monitoring in the Netherlands given the CVRM recommendations.Three small focus group discussions (FGDs) with patients and 1 FGD with physicians were conducted to explore the mechanisms behind the acceptance and use of out-of-office BP monitoring and reveal real-world challenges that limit the implementation of out-of-office BP monitoring methods. To facilitate the FGDs, an analytical framework based on the technology acceptance model (TAM), the theory of planned behavior and the model of personal computing utilization was developed to guide the FGDs and analysis of the transcriptions of each FGD.ABPM was the out-of-office BP monitoring method prescribed by physicians and used by patients. HBPM was not offered to patients even with patients' feedback of poor tolerance of ABPM. Even as there was little awareness about HBPM among patients, there were a few patients who owned and used sphygmomanometers. Patients professed and seemed to exhibit self-efficacy, whereas physicians had reservations about (all of their) patients' self-efficacy in properly using ABPM. Since negative experience with ABPM impacted patients' acceptance of ABPM, the interaction of factors that determined acceptance and use was found to be dynamic among patients but not for physicians.In reference to the CVRM guidelines, physicians implemented out-of-office BP monitoring but showed a strong preference for ABPM even where there is poor tolerance of the method. We found that physicians' positive attitude to ABPM enabled the use of the method by patients which, in turn, impeded the diffusion of HBPM. For patients, the acceptance process of HBPM can only begin after the physician has adopted the innovation. Physicians are in a position to encourage as well as hinder out-of-office BP monitoring and self-management.

Children's Acceptance of Safety Guidelines after Exposure to Televised Dramas Depicting Accidents.

ERIC Educational Resources Information Center

Cantor, Joanne; Omdahl, Becky L.

1999-01-01

Presents a study where grade-school children were exposed to a scene from a movie involving one of two activities (either fire- or water-related activities) and involving one of two outcomes (fatal accidents or neutral events). Finds that watching the dramatized accidents increased students' estimated importance of adopting safety guidelines and…

WE-E-204-02: Journal of Medical Physics and JACMP

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

Williamson, J.

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given dozens of competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose of this symposium ismore » to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Radiology, Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. Senior members of the editorial board for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; open access policies, the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. Other journals will be discussed as well. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the quality and impact of the paper and the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase quality, impact and chances of acceptance To help decipher which journal is appropriate for a given work A. Karellas, Research collaboration with Koning, Corporation.« less

WE-E-204-00: Where to Send My Manuscript

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

NONE

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given dozens of competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose of this symposium ismore » to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Radiology, Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. Senior members of the editorial board for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; open access policies, the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. Other journals will be discussed as well. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the quality and impact of the paper and the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase quality, impact and chances of acceptance To help decipher which journal is appropriate for a given work A. Karellas, Research collaboration with Koning, Corporation.« less

WE-E-204-01: ASTRO Based Journals

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

Klein, E.

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given dozens of competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose of this symposium ismore » to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Radiology, Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. Senior members of the editorial board for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; open access policies, the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. Other journals will be discussed as well. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the quality and impact of the paper and the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase quality, impact and chances of acceptance To help decipher which journal is appropriate for a given work A. Karellas, Research collaboration with Koning, Corporation.« less

TU-B-16A-01: To Which Journal Should I Submit My Paper

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

Williamson, J; Mills, M; Klein, E

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given the large number (about 100) competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose ofmore » this symposium is to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. The senior editors for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase chances of acceptance To help decipher which journal is appropriate for a given work.« less

WE-E-204-03: Radiology and Other Imaging Journals

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

Karellas, A.

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given dozens of competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose of this symposium ismore » to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Radiology, Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. Senior members of the editorial board for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; open access policies, the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. Other journals will be discussed as well. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the quality and impact of the paper and the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase quality, impact and chances of acceptance To help decipher which journal is appropriate for a given work A. Karellas, Research collaboration with Koning, Corporation.« less

Crafting practice guidelines in the world of evidence-based medicine.

PubMed

Chung, Kevin C; Shauver, Melissa J

2009-10-01

In the era of exponential increase in the medical literature, physicians and health policy-makers are relying on well-constructed, evidence-based practice guidelines to help ensure that the care given to patients is based on valid, scientific data. The construction of practice guidelines, however, may not always adhere to accepted research protocol. In this article, the authors detail the steps required to produce effective, evidence-based practice guidelines. The seven essential steps in crafting a practice guideline are presented: (1) defining a topic, (2) selecting a work group, (3) performing a literature review, (4) writing the guideline, (5) peer review, (6) making plans for review and revision, and (7) dissemination. Given the importance of practice guidelines in supporting everyday practice, this article strives to provide a practical guide in the development of this key component of evidence-based medicine.

Standard Operating Procedures, ethical and legal regulations in BTB (Brain/Tissue/Bio) banking: what is still missing?

PubMed

Ravid, Rivka

2008-09-01

The use of human biological specimens in scientific research is the focus of current international public and professional concern and a major issue in bioethics in general. Brain/Tissue/Bio banks (BTB-banks) are a rapid developing sector; each of these banks acts locally as a steering unit for the establishment of the local Standard Operating Procedures (SOPs) and the legal regulations and ethical guidelines to be followed in the procurement and dissemination of research specimens. An appropriat Code of Conduct is crucial to a successful operation of the banks and the research application they handle. What are we still missing ? (1) Adequate funding for research BTB-banks. (2) Standard evaluation protocls for audit of BTB-bank performance. (3) Internationally accepted SOP's which will facilitate exchange and sharing of specimens and data with the scientific community. (4) Internationally accepted Code of Conduct. In the present paper we review the most pressing organizational, methodological, medico-legal and ethical issues involved in BTB-banking; funding, auditing, procurement, management/handling, dissemination and sharing of specimens, confidentiality and data protection, genetic testing, "financial gain" and safety measures. Taking into consideration the huge variety of the specimens stored in different repositories and the enormous differences in medico-legal systems and ethics regulations in different countries it is strongly recommend that the health-care systems and institutions who host BTB-Banks will put more efforts in getting adequate funding for the infrastructure and daily activities. The BTB-banks should define evaluation protocols, SOPs and their Code of Conduct. This in turn will enable the banks to share the collected specimens and data with the largest possible number of researchers and aim at a maximal scientific spin-off and advance in public health research.

Evidence-Based Management Guidelines on Peyronie's Disease.

PubMed

Chung, Eric; Ralph, David; Kagioglu, Ates; Garaffa, Guilio; Shamsodini, Ahmed; Bivalacqua, Trinity; Glina, Sidney; Hakim, Lawrence; Sadeghi-Nejad, Hossein; Broderick, Gregory

2016-06-01

Despite recent advances in our knowledge and treatment strategies in Peyronie's Disease (PD), much remained unknown about this disease. To provide a clinical framework and key guideline statements to assist clinicians in an evidence-based management of PD. A systematic literature search was conducted to identify published literature relevant to PD. The search included all relevant articles published up to June 2015, including preclinical studies and published guidelines. References used in the text were assessed according to their level of evidence, and guideline recommendations were graded based on the Oxford Centre for Evidence-Based Medicine Levels of Evidence. Owing to the paucity of larger series and randomized placebo-controlled trials with regard to surgical intervention, guideline statements are provided as clinical principle or expert opinion. This literature was discussed at a panel meeting, and selected articles with the highest evidence available were used to create consensus guideline statements for the Fourth International Consultation on Sexual Medicine guidelines on PD. In addition to existing Third International Consultation on Sexual Medicine guidelines on PD, seven new summary recommendations were created. A greater understanding of the scientific basis of PD is greatly needed to address our understanding of the pathophysiology, clinical epidemiology, psychosocial, and diagnostic assessment as well as treatment strategies. Copyright © 2016 International Society for Sexual Medicine. All rights reserved.

Guideline summary review: An evidence-based clinical guideline for the diagnosis and treatment of degenerative lumbar spondylolisthesis.

PubMed

Matz, Paul G; Meagher, R J; Lamer, Tim; Tontz, William L; Annaswamy, Thiru M; Cassidy, R Carter; Cho, Charles H; Dougherty, Paul; Easa, John E; Enix, Dennis E; Gunnoe, Bryan A; Jallo, Jack; Julien, Terrence D; Maserati, Matthew B; Nucci, Robert C; O'Toole, John E; Rosolowski, Karie; Sembrano, Jonathan N; Villavicencio, Alan T; Witt, Jens-Peter

2016-03-01

The North American Spine Society's (NASS) Evidence-Based Clinical Guideline for the Diagnosis and Treatment of Degenerative Lumbar Spondylolisthesis features evidence-based recommendations for diagnosing and treating degenerative lumbar spondylolisthesis. The guideline updates the 2008 guideline on this topic and is intended to reflect contemporary treatment concepts for symptomatic degenerative lumbar spondylolisthesis as reflected in the highest quality clinical literature available on this subject as of May 2013. The NASS guideline on this topic is the only guideline on degenerative lumbar spondylolisthesis included in the Agency for Healthcare Research and Quality's National Guideline Clearinghouse (NGC). The purpose of this guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for patients with degenerative lumbar spondylolisthesis. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition. A systematic review of clinical studies relevant to degenerative spondylolisthesis was carried out. This NASS spondyolisthesis guideline is the product of the Degenerative Lumbar Spondylolisthesis Work Group of NASS' Evidence-Based Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members used the NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guidelines were submitted to an internal peer review process and ultimately approved by the NASS Board of Directors. Upon publication, the Degenerative Lumbar Spondylolisthesis guideline was accepted into the NGC and will be updated approximately every 5 years. Twenty-seven clinical questions were addressed in this guideline update, including 15 clinical questions from the original guideline and 12 new clinical questions. The respective recommendations were graded by strength of the supporting literature, which was stratified by levels of evidence. Twenty-one new or updated recommendations or consensus statements were issued and 13 recommendations or consensus statements were maintained from the original guideline. The clinical guideline was created using the techniques of evidence-based medicine and best available evidence to aid practitioners in the care of patients with degenerative lumbar spondylolisthesis. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flow chart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/Pages/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx and will remain updated on a timely schedule. Copyright © 2016 Elsevier Inc. All rights reserved.

Uncovering Professional Attitudes Toward Treatment of Rare Carcinomas of the Breast: An International Practice e-Survey Involving 32 Countries.

PubMed

Saghatchian, Mahasti; Fadoukhair, Zouhour; Hofert, Kathrin; Lanoy, Emilie; Mathieu, Marie-Christine; Mazouni, Chafika; Delaloge, Suzette

2016-01-01

World Health Organization classification has identified a dozen rare subtypes accounting for less than 10% of all breast cancers (BC), generally not taken into account in treatment guidelines. We evaluated professionals' attitudes toward decision-making regarding rare BC and consensus guidelines needs. In this international e-survey, 236 BC experts from all specialties were contacted through email to fill an online questionnaire about their practices. Eighty-six experts from 32 countries participated (36%); 50% medical oncologists, 21% surgeons, 17% pathologists, and 12% radiation oncologists. General BC care decisions were based on consensus guidelines in 77% of expert, whereas routine individual treatment decisions for BC were made by multi-disciplinary boards in 76%. Only 10% strongly considered rare BC should be treated following existing standard guidelines. Interestingly, 50-80% described individualizing treatment for rare BC according to pathologic subtype. More than 90% of experts would welcome international recommendations for rare BC. This large scale international multi-disciplinary survey revealed overarching concerns centered on several key themes: the lack of resources and data to address these less common BC; the heterogeneous management of rare BC depending on geographical location and specialist training; the demand for international consensus guidelines regarding their diagnosis and treatment. © 2015 Wiley Periodicals, Inc.

Legal and ethical issues in research.

PubMed

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-09-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

[Barriers to evidence-based medicine encountered among GPs - an issue based on misunderstanding? A qualitative study in the general practice setting].

PubMed

Bölter, Regine; Kühlein, Thomas; Ose, Dominik; Götz, Katja; Freund, Tobias; Szecsenyi, Joachim; Miksch, Antje

2010-01-01

The Chronic Care Model (CCM) is a framework for the structured care of patients with chronic conditions. It requires access of both physicians and patients to scientific evidence in order to facilitate shared treatment decision-making on the basis of the patient's individual needs and the best available external evidence. The aim of this study was to find out whether general practitioners (GP) actually make use of evidence-based information and guidelines and whether and how they communicate this information to their patients. We interviewed 14 general practitioners and conducted a content analysis. The majority of these GPs take a sceptical view towards evidence-based guidelines. Their main point of criticism is that guidelines disregard the individual patient's reality and life style. Instead, GPs emphasize the relevance of their own knowledge of the personal and medical history of and the continual care for their patients. Since GPs themselves often do not accept guidelines, they seldom impart their content to their patients. According to the GPs' experience there are contradictions between guideline-conformant therapy and individual treatment. The integrative character of evidence-based medicine is not recognized. The reason is that evidence-based medicine is equated with guidelines and trial results by the majority of the GPs interviewed. To facilitate guideline implementation in everyday practice GPs need to be provided with adequate access to scientific evidence and an understanding of the intentions of guidelines. If the doctors themselves do not accept guidelines, they will not share them with their patients. It must be made clear that guidelines are not intended as normative demands for a specific therapy for every patient, but are rather meant to assist the physician with his struggle for the best therapy for individual patients. Copyright © 2010. Published by Elsevier GmbH.

Psychological abuse, mental health, and acceptance of dating violence among adolescents

PubMed Central

Temple, Jeff R.; Choi, Hye Jeong; Elmquist, JoAnna; Hecht, Michael; Miller-Day, Michelle; Stuart, Gregory L.; Brem, Meagan; Wolford-Clevenger, Caitlin

2016-01-01

Purpose Existing literature indicates that acceptance of dating violence is a significant and robust risk factor for psychological dating abuse perpetration. Past work also indicates a significant relationship between psychological dating abuse perpetration and poor mental health. However, no known research has examined the relationship between acceptance of dating violence, perpetration of dating abuse, and mental health. In addition to exploring this complex relationship, the current study examines whether psychological abuse perpetration mediates the relationship between acceptance of dating violence and mental health (i.e., internalizing symptoms of depression, anxiety, and hostility). Methods Three waves of longitudinal data were obtained from 1,042 ethnically diverse high school students in Texas. Participants completed assessments of psychological dating abuse perpetration, acceptance of dating violence, and internalizing symptoms (hostility, and symptoms of anxiety and depression). Results As predicted, results indicated that perpetration of psychological abuse was significantly associated with acceptance of dating violence and all internalizing symptoms. Furthermore, psychological abuse mediated the relationship between acceptance of dating violence and internalizing symptoms. Conclusions Findings from the current study suggest that acceptance of dating violence is an important target for the prevention of dating violence and related emotional distress. Implications and Contribution Study findings indicate that perpetration of psychological abuse is significantly associated with acceptance of dating violence and select mental health variables (i.e., anxiety, depression, hostility). Moreover, psychological abuse perpetration mediated the relationship between acceptance of dating violence and internalizing symptoms. To be effective in preventing mental health problems, interventions may benefit from targeting acceptance and perpetration of dating violence. PMID:27238840

Fatigue Risk Management: A Maritime Framework

PubMed Central

Grech, Michelle Rita

2016-01-01

It is evident that despite efforts directed at mitigating the risk of fatigue through the adoption of hours of work and rest regulations and development of codes and guidelines, fatigue still remains a concern in shipping. Lack of fatigue management has been identified as a contributory factor in a number of recent accidents. This is further substantiated through research reports with shortfalls highlighted in current fatigue management approaches. These approaches mainly focus on prescriptive hours of work and rest and include an individualistic approach to managing fatigue. The expectation is that seafarers are responsible to manage and tolerate fatigue as part of their working life at sea. This attitude is an accepted part of a seafarer’s role. Poor compliance is one manifest of this problem with shipboard demands making it hard for seafarers to follow hours of work and rest regulations, forcing them into this “poor compliance” trap. This makes current fatigue management approaches ineffective. This paper proposes a risk based approach and way forward for the implementation of a fatigue risk management framework for shipping, aiming to support the hours of work and rest requirements. This forms part of the work currently underway to review and update the International Maritime Organization, Guidelines on Fatigue. PMID:26840326

Ecological restoration of farmland: progress and prospects.

PubMed

Wade, Mark R; Gurr, Geoff M; Wratten, Steve D

2008-02-27

Sustainable agricultural practices in conjunction with ecological restoration methods can reduce the detrimental effects of agriculture. The Society for Ecological Restoration International has produced generic guidelines for conceiving, organizing, conducting and assessing ecological restoration projects. Additionally, there are now good conceptual frameworks, guidelines and practical methods for developing ecological restoration programmes that are based on sound ecological principles and supported by empirical evidence and modelling approaches. Restoration methods must also be technically achievable and socially acceptable and spread over a range of locations. It is important to reconcile differences between methods that favour conservation and those that favour economic returns, to ensure that conservation efforts are beneficial for both landowners and biodiversity. One option for this type of mutual benefit is the use of agri-environmental schemes to provide financial incentives to landholders in exchange for providing conservation services and other benefits. However, further work is required to define and measure the effectiveness of agri-environmental schemes. The broader potential for ecological restoration to improve the sustainability of agricultural production while conserving biodiversity in farmscapes and reducing external costs is high, but there is still much to learn, particularly for the most efficient use of agri-environmental schemes to change land use practice.

Improving secondary prevention screening in clinical encounters using mhealth among prelicensure master's entry clinical nursing students.

PubMed

FitzGerald, Leah Z; Rorie, Anne; Salem, Benissa E

2015-04-01

To determine the feasibility and acceptability of a mHealth application among nursing students for health promotion and secondary prevention health recommendations for hospitalized adult patients. A pretest-posttest design with a convenience sample of 169 prelicensure master's entry clinical nursing students in a large urban public university. Survey questions assessed intention to use, perceived usefulness, perceived ease of use, subjective norm, voluntariness, clinical area relevance, output quality, and result demonstrability of the United States Preventive Services Task Force (USPSTF) evidence-based practice guidelines via the mHealth application. Descriptive statistics and frequencies were used to explore sociodemographics; paired t-tests were used to evaluate pre- and posttest differences. Pre- and posttest significant differences (p < .01) were found between intention to use, perceived usefulness, subjective norm, voluntariness, image, clinical relevance, result demonstrability, and output quality (p < .02). Ease use of a mHealth application was not significantly different. These findings highlight the need to integrate evidence-based practice tools using mHealth technology among prelicensure master's entry clinical nursing students in order to engage and foster translational learning and improve dissemination of secondary prevention screening guidelines among hospitalized patients. © 2015 Sigma Theta Tau International.

Bariatric surgery: an IDF statement for obese Type 2 diabetes

PubMed Central

Dixon, J B; Zimmet, P; Alberti, K G; Rubino, F

2011-01-01

The International Diabetes Federation Taskforce on Epidemiology and Prevention of Diabetes convened a consensus working group of diabetologists, endocrinologists, surgeons and public health experts to review the appropriate role of surgery and other gastrointestinal interventions in the treatment and prevention of Type 2 diabetes. The specific goals were: to develop practical recommendations for clinicians on patient selection; to identify barriers to surgical access and suggest interventions for health policy changes that ensure equitable access to surgery when indicated; and to identify priorities for research. Bariatric surgery can significantly improve glycaemic control in severely obese patients with Type 2 diabetes. It is an effective, safe and cost-effective therapy for obese Type 2 diabetes. Surgery can be considered an appropriate treatment for people with Type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies, especially in the presence of other major co-morbidities. The procedures must be performed within accepted guidelines and require appropriate multidisciplinary assessment for the procedure, comprehensive patient education and ongoing care, as well as safe and standardized surgical procedures. National guidelines for bariatric surgery need to be developed for people with Type 2 diabetes and a BMI of 35 kg/m2 or more. PMID:21480973

Dietary Sodium and Blood Pressure: How Low Should We Go?

PubMed

Van Horn, Linda

2015-01-01

Sodium intake in the United States exceeds recommended amounts across all age, gender and ethnic groups. National dietary guidelines advocate reduced intake by at least 1,000mg per day or more, but whether there is population-wide benefit from further reductions to levels of 1500mg per day remains controversial. A brief review of current evidence-based dietary guidelines is provided and key prospective, randomized studies that report dietary and urinary sodium data are summarized. Dietary sources of sodium and eating patterns that offer nutritiously sound approaches to nutrient dense, reduced sodium intake are compared. No studies suggest that high sodium intake at the levels of the population's current diet is optimal. On the contrary, national and international evidence and systematic reviews consistently recommend reducing sodium intake overall, generally by 1000mg/day. Recommendations to reduce intakes to 2400mg/d are generally accepted as beneficial. Whether further reductions to 1500mg/d are useful, feasible and safe among specific subgroups in the population who are at increased risk of hypertension or stroke remains controversial and requires individualized consideration by patients and their health care providers. Copyright © 2015 Elsevier Inc. All rights reserved.

Fatigue Risk Management: A Maritime Framework.

PubMed

Grech, Michelle Rita

2016-01-29

It is evident that despite efforts directed at mitigating the risk of fatigue through the adoption of hours of work and rest regulations and development of codes and guidelines, fatigue still remains a concern in shipping. Lack of fatigue management has been identified as a contributory factor in a number of recent accidents. This is further substantiated through research reports with shortfalls highlighted in current fatigue management approaches. These approaches mainly focus on prescriptive hours of work and rest and include an individualistic approach to managing fatigue. The expectation is that seafarers are responsible to manage and tolerate fatigue as part of their working life at sea. This attitude is an accepted part of a seafarer's role. Poor compliance is one manifest of this problem with shipboard demands making it hard for seafarers to follow hours of work and rest regulations, forcing them into this "poor compliance" trap. This makes current fatigue management approaches ineffective. This paper proposes a risk based approach and way forward for the implementation of a fatigue risk management framework for shipping, aiming to support the hours of work and rest requirements. This forms part of the work currently underway to review and update the International Maritime Organization, Guidelines on Fatigue.

A rapid and sensitive LC-MS/MS assay for the determination of saxagliptin and its active metabolite 5-hydroxy saxagliptin in human plasma and its application to a pharmacokinetic study.

PubMed

Batta, N; Pilli, N R; Derangula, V R; Vurimindi, H B; Damaramadugu, R; Yejella, R P

2015-03-01

The authors proposed a simple, rapid and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method for the simultaneous determination of saxagliptin and its active metabolite 5-hydroxy saxagliptin in human plasma. The developed method was fully validated as per the US FDA guidelines. The method utilized stable labeled isotopes saxagliptin-15 N d2 (IS1) and 5-hydroxy saxagliptin-15 N-d2 (IS2) as internal standards for the quantification of saxagliptin and 5-hydroxy saxagliptin, respectively. Analytes and the internal standards were extracted from human plasma by a single step solid-phase extraction technique without drying, evaporation and reconstitution steps. The optimized mobile phase was composed of 0.1% acetic acid in 5 mM ammonium acetate and acetonitrile (30:70, v/v) and delivered at a flow rate of 0.85 mL/min. The method exhibits the linear calibration range of 0.05-100 ng/mL for both the analytes. The precision and accuracy results for both the analytes were well within the acceptance limits. The different stability experiments conducted in aqueous samples and in matrix samples are meeting the acceptance criteria. The chromatographic run time was set at 1.8 min; hence more than 400 samples can be analyzed in a single day. © Georg Thieme Verlag KG Stuttgart · New York.

Exploring podcasting in heredity and evolution teaching.

PubMed

Almeida-Aguiar, Cristina; Carvalho, Ana Amélia

2016-09-10

Podcasts are digital files very popular in several and very distinct areas. In higher education, they have been explored in a multitude of ways mainly to support teaching and learning processes. The study here described focuses the integration of podcasts in Heredity and Evolution, a course from the Biology and Geology Degree Program at University of Minho, Portugal. It aimed to introduce podcasts in the teaching/learning context, to empirically study different dimensions of podcasting, and to evaluate students' acceptance and receptiveness to the pedagogical use of this technology. Five informative podcasts and three with feedback were produced and delivered. All the students listened to the audio files and considered the episodes audible and clear, their preference going to episodes of short or moderate length and containing summaries, study guidelines or syllabus contents. Students judged extremely valuable the integration of this technology in learning and showed receptiveness to podcasting in other courses. Curiously, in spite of owning mobile devices, students clearly favored the use of personal computers to listen to the podcasts. This student acceptance and openness to podcasting has been encouraging its pedagogical application in other teaching courses. The episodes produced often maintain the characteristics identified as the best by the students of this study but the pedagogical approach has been moving to a more student-centered learning situation, with students as podcasts producers. © 2016 by The International Union of Biochemistry and Molecular Biology, 44(5):429-432, 2016. © 2016 The International Union of Biochemistry and Molecular Biology.

Do guidelines on first impression make sense? Implementation of a chest pain guideline in primary care: a systematic evaluation of acceptance and feasibility.

PubMed

Kramer, Lena; Rabanizada, Nagela; Haasenritter, Jörg; Bösner, Stefan; Baum, Erika; Donner-Banzhoff, Norbert

2011-11-21

Most guidelines concentrate on investigations, treatment, and monitoring instead of patient history and clinical examination. We developed a guideline that dealt with the different aetiologies of chest pain by emphasizing the patient's history and physical signs. The objective of this study was to evaluate the guideline's acceptance and feasibility in the context of a practice test. The evaluation study was nested in a diagnostic cross-sectional study with 56 General Practitioners (GPs) and 862 consecutively recruited patients with chest pain. The evaluation of the guideline was conducted in a mixed method design on a sub-sample of 17 GPs and 282 patients. Physicians' evaluation of the guideline was assessed via standardized questionnaires and case record forms. Additionally, practice nursing staff and selected patients were asked for their evaluation of specific guideline modules. Quantitative data was analyzed descriptively for frequencies, means, and standard deviations. In addition, two focus groups with a total of 10 GPs were held to gain further insights in the guideline implementation process. The data analysis and interpretation followed the standards of the qualitative content analysis. The overall evaluation of the GPs participating in the evaluation study regarding the recommendations made in the chest pain guideline was positive. A total of 14 GPs were convinced that there was a need for this kind of guideline and perceived the guideline recommendations as useful. While the long version was partially criticized for a perceived lack of clarity, the short version of the chest pain guideline and the heart score were especially appreciated by the GPs. However, change of clinical behaviour as consequence of the guideline was inconsistent. While on a concrete patient related level, GPs indicated to have behaved as the guideline recommended, the feedback on a more general level was heterogeneous. Several suggestions to improve guideline implementation were made by participating physicians. Due to the small number of practice nursing staff evaluating the flowchart and patients remembering the patient leaflet, no valid results regarding the flowchart and patient leaflet modules could be reported. Overall, the participating GPs perceived the guideline recommendations as useful to increase awareness and to reflect on diagnostic issues. Although behaviour change in consequence of the guideline was not reported on a general level, guidelines on history taking and the clinical examination may serve an important conservative and practical function in a technology driven environment. Further research to increase the implementation success of the guideline should be undertaken.

[Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise].

PubMed

Morgano, Gian Paolo; Davoli, Marina; Moja, Lorenzo; Amato, Laura; Ferroni, Eliana; Tirani, Marcello

2015-06-01

Guideline developers worldwide are struggling with the lack of guidance for the practical steps in the guideline enterprise. Our objective was to systematically compile a comprehensive checklist of items linked to relevant resources and tools that guideline developers would consider for development and support of implementation. Data sources included manuals of international guideline developers, literature on guidelines for guidelines with a focus on international and national guideline agencies, professional societies, and recent systematic guidance articles. We reviewed these sources in duplicate, extracted items using a sensitive approach and developed overarching topics that are relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions. We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers (http://cebgrade.mcmaster.ca/guidecheck.html). The topics and items included cover all stages of the guideline enterprise, from planning to formulating recommendations, to dissemination and evaluation. The final itemized guideline development checklist (GDC) includes links to training material and resources for methodology. The GDC will serve as a resource for those involved in guideline development and we will use crowdsourcing to keep the checklist up to date and enhance it.

The Council for International Organizations and Medical Sciences (CIOMS) guidelines on ethics of clinical trials.

PubMed

Macrae, Duncan J

2007-05-01

Numerous bodies from many countries, including governments, government regulatory departments, research organizations, medical professional bodies, and health care providers, have issued guidance or legislation on the ethical conduct of clinical trials. It is possible to trace the development of current guidelines back to the post-World War II Nuremburg war crimes trials, more specifically the "Doctors' Trial." From that trial emerged the Nuremburg Code, which set out basic principles to be observed when conducting research involving human subjects and which subsequently formed the basis for comprehensive international guidelines on medical research, such as the Declaration of Helsinki. Most recently, the Council for International Organizations and Medical Sciences (CIOMS) produced detailed guidelines (originally published in 1993 and updated in 2002) on the implementation of the principles outlined in the Declaration of Helsinki. The CIOMS guidelines set in an appropriate context the challenges of present-day clinical research, by addressing complex issues including HIV/AIDS research, availability of study treatments after a study ends, women as research subjects, safeguarding confidentiality, compensation for adverse events, as well guidelines on consent.

Antimicrobial Use Guidelines for Treatment of Urinary Tract Disease in Dogs and Cats: Antimicrobial Guidelines Working Group of the International Society for Companion Animal Infectious Diseases

PubMed Central

Weese, J. Scott; Blondeau, Joseph M.; Boothe, Dawn; Breitschwerdt, Edward B.; Guardabassi, Luca; Hillier, Andrew; Lloyd, David H.; Papich, Mark G.; Rankin, Shelley C.; Turnidge, John D.; Sykes, Jane E.

2011-01-01

Urinary tract disease is a common reason for use (and likely misuse, improper use, and overuse) of antimicrobials in dogs and cats. There is a lack of comprehensive treatment guidelines such as those that are available for human medicine. Accordingly, guidelines for diagnosis and management of urinary tract infections were created by a Working Group of the International Society for Companion Animal Infectious Diseases. While objective data are currently limited, these guidelines provide information to assist in the diagnosis and management of upper and lower urinary tract infections in dogs and cats. PMID:21776346

RESIDENT IMPLEMENTATION OF THE 2007 ACC/AHA GUIDELINES ON PREOPERATIVE CARDIAC EVALUATION IN NON-CARDIAC SURGERY PATIENTS: IS CLINICAL EXPERIENCE ENOUGH?

PubMed

Amhaz, Hassan H; Kuo, Ruth; Chidiac, Elie J; Pallekonda, Vinay; Fuleihan, Samir F; McKelvey, George; Kaddoum, Romeo N

2015-06-01

Preoperative evaluation of surgical patients is important, as perioperative complications are associated with increased mortality. Specialties including anesthesiology, internal medicine, cardiology, and surgery are involved in the evaluation and management of these patients. This institutional study investigated the residents' knowledge of the 2007 American College of Cardiology/American Heart Association (ACC/AHA) guidelines on perioperative evaluation of patients undergoing non-cardiac surgery. This pilot study used a web-based survey questionnaire to assess resident's knowledge of the 2007 ACC/AHA guidelines through individual steps and corresponding branch point(s) in twelve clinical scenarios. Additionally, residents were asked if they were aware of, or if they had received lectures on ACC/AHA guidelines. Staff anesthesiologists with training in cardiac and intensive care medicine validated the scenarios. A total of 104 resident participants were surveyed including 35 anesthesiology residents, 41 internal medicine residents, 20 surgery residents, and 8 cardiology fellows. Awareness of the 2007 ACC/AHA guidelines by specialty was: anesthesiology (85%), internal medicine (97.6%), cardiology (100%), and surgery (70%). Only 54.3% of anesthesiology, 31.7% of internal medicine, 100% of cardiology, and 10% of surgery residents stated they received lectures. The overall mean score achieved on the eleven scenarios was 50.4% for anesthesiology, 47.0% for internal medicine, 55.7% for cardiology, and 42.3% for surgery. Although the majority of residents were aware of the 2007 ACC/AHA guidelines, fewer received lectures and regardless of specialty, implementation of these guidelines was poor. There exists significant room for improvement in the understanding of preoperative assessment of non-cardiac surgery patients.

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

PubMed

Assunta, Mary

2012-11-01

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

Singapore Cancer Network (SCAN) Guidelines for Systemic Therapy of Pancreatic Adenocarcinoma.

PubMed

2015-10-01

The SCAN pancreatic cancer workgroup aimed to develop Singapore Cancer Network (SCAN) clinical practice guidelines for systemic therapy for pancreatic adenocarcinoma in Singapore. The workgroup utilised a modified ADAPTE process to calibrate high quality international evidence-based clinical practice guidelines to our local setting. Five international guidelines were evaluated- those developed by the National Cancer Comprehensive Network (2014), the European Society of Medical Oncology (2012), Cancer Care Ontario (2013), the Japan Pancreas Society (2013) and the British Society of Gastroenterology, Pancreatic Society of Great Britain and Ireland, and the Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland (2005). Recommendations on the management of resected, borderline resectable, locally advanced and metastatic pancreatic adenocarcinoma were developed. These adapted guidelines form the SCAN Guidelines for systemic therapy for pancreatic adenocarcinoma in Singapore.

Aquatic Animal Models – Not Just for Ecotox Anymore

EPA Science Inventory

A wide range of internationally harmonized toxicity test guidelines employing aquatic animal models have been established for regulatory use. For fish alone, there are over a dozen internationally harmonized toxicity test guidelines that have been, or are being, validated. To dat...

48 CFR 352.234-4 - Partial earned value management system.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Cognizant Federal Agency (CFA) as being compliant with the schedule-related guidelines in ANSI/EIA Standard... has not been validated and accepted by the CFA at the time of award, see paragraph (b) of this clause..., at the time of award, the Contractor's EVM system has not been validated and accepted by the CFA as...

SPAN security policies and guidelines

NASA Technical Reports Server (NTRS)

Sisson, Patricia L.; Green, James L.

1989-01-01

A guide is provided to system security with emphasis on requirements and guidelines that are necessary to maintain an acceptable level of security on the network. To have security for the network, each node on the network must be secure. Therefore, each system manager, must strictly adhere to the requirements and must consider implementing the guidelines discussed. There are areas of vulnerability within the operating system that may not be addressed. However, when a requirement or guideline is discussed, implementation techniques are included. Information related to computer and data security is discussed to provide information on implementation options. The information is presented as it relates to a VAX computer environment.

Clinical guidelines: proliferation and medicolegal significance.

PubMed Central

Hurwitz, B

1994-01-01

Guidelines seeking to influence and regulate clinical activity are currently gaining a new cultural ascendancy on both sides of the Atlantic. Statutory agencies may be charged with developing clinical guidelines, and civil courts, in deciding actions in negligence, could be influenced by standards of care expressed in guideline statements. Clinical guidelines are not accorded unchallengeable status: they have been subject to careful scrutiny by British and American courts to establish their authenticity and relevance. In the United States, compliance with clinical guidelines cannot be used as a defence against liability if a physician's conduct is held to have been negligent, and third party organisations can be held liable if their clinical guidelines are found to be a contributory cause of patient harm. Guidelines have not usurped the role of the expert witness in court. The importance the law attaches to customary practice means that atypical or bizarre guidelines are unlikely to be accepted as embodying a legally required standard of clinical care. PMID:10136259

Singapore Cancer Network (SCAN) Guidelines for Adjuvant Chemotherapy in Resected Non-Small Cell Lung Cancer.

PubMed

2015-10-01

The SCAN lung cancer workgroup aimed to develop Singapore Cancer Network (SCAN) clinical practice guidelines for the use of adjuvant systemic therapy for non-small cell lung cancer in Singapore. The workgroup utilised a modified ADAPTE process to calibrate high quality international evidence-based clinical practice guidelines to our local setting. Five international guidelines were evaluated- those developed by the National Comprehensive Cancer Network (2014), European Society of Medical Oncology (2014), National Institute of Clinical Excellence (2012), Scottish Intercollegiate Guidelines Network (2014), and the Cancer Care Council Australia (2012). Recommendations on the selection of patients, chemotherapy regimen, treatment for stage I disease, treatment for positive margins and treatment options for pN2 disease with negative margins were produced. These adapted guidelines form the SCAN Guidelines 2015 for adjuvant systemic therapy of non-small cell lung cancer.

Singapore Cancer Network (SCAN) Guidelines for Referral for Genetic Evaluation of Common Hereditary Cancer Syndromes.

PubMed

2015-10-01

The SCAN cancer genetics workgroup aimed to develop Singapore Cancer Network (SCAN) clinical practice guidelines for referral for genetic evaluation of common hereditary cancer syndromes. The workgroup utilised a modified ADAPTE process to calibrate high quality international evidence-based clinical practice guidelines to our local setting. To formulate referral guidelines for the 3 most commonly encountered hereditary cancer syndromes to guide healthcare providers in Singapore who care for cancer patients and/or their family members, 7, 5, and 3 sets of international guidelines respectively for hereditary breast and ovarian cancer (HBOC) syndrome, Lynch syndrome (LS), and familial adenomatous polyposis (FAP) were evaluated. For each syndrome, the most applicable one was selected, with modifications made such that they would be appropriate to the local context. These adapted guidelines form the SCAN Guidelines 2015 for referral for genetic evaluation of common hereditary cancer syndromes.

International Continence Society guidelines on urodynamic equipment performance.

PubMed

Gammie, Andrew; Clarkson, Becky; Constantinou, Chris; Damaser, Margot; Drinnan, Michael; Geleijnse, Geert; Griffiths, Derek; Rosier, Peter; Schäfer, Werner; Van Mastrigt, Ron

2014-04-01

These guidelines provide benchmarks for the performance of urodynamic equipment, and have been developed by the International Continence Society to assist purchasing decisions, design requirements, and performance checks. The guidelines suggest ranges of specification for uroflowmetry, volume, pressure, and EMG measurement, along with recommendations for user interfaces and performance tests. Factors affecting measurement relating to the different technologies used are also described. Summary tables of essential and desirable features are included for ease of reference. It is emphasized that these guidelines can only contribute to good urodynamics if equipment is used properly, in accordance with good practice. © 2014 Wiley Periodicals, Inc.

WHO expert committee on specifications for pharmaceutical preparations.

PubMed

2013-01-01

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: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products.

AGREEing on Canadian cardiovascular clinical practice guidelines.

PubMed

Stone, James A; Austford, Leslie; Parker, John H; Gledhill, Norm; Tremblay, Guy; Arthur, Heather M

2008-10-01

The use of clinical practice guidelines (CPGs), particularly the routine implementation of evidence-based cardiovascular health maintenance and disease management recommendations, affords both expert and nonexpert practitioners the opportunity to achieve better, and at least theoretically similar, patient outcomes. However, health care practitioners are often stymied in their efforts to follow even well-researched and well-written CPGs as a consequence of contradictory information. The purposeful integration and harmonization of Canadian cardiovascular CPGs, regardless of their specific risk factor or clinical management focus, is critical to their widespread acceptance and implementation. This level of cooperation and coordination among CPG groups and organizations would help to ensure that their clinical practice roadmaps (ie, best practice recommendations) contain clear, concise and complementary, rather than contradictory, patient care information. Similarly, the application of specific tools intended to improve the quality of CPGs, such as the Appraisal of Guidelines for Research and Evaluation (AGREE) assessment tool, may also lead to improvements in CPG quality and potentially enhance their acceptance and implementation.

A "good practice" approach to the quality and consistency of morphological examination of the internal head structures of the term rabbit fetus.

PubMed

French, Julian M

2014-07-01

Variation in the interpretation of the regulatory guidelines has resulted in a diversity of techniques employed to examine the internal structures of the foetal rabbit head. Examination of the foetal rabbit brain, using a single transverse section as the sole technique, is considered not to be sufficiently thorough to be regarded as an adequate examination method. It is not compliant with published EPA and OECD guidelines covering required examination of the internal head structures, nor is it considered to conform to the spirit of the safety assessment required by the ICH guideline. Fixation of approximately half of the heads in each litter to allow the examination of multiple transverse sections enables the major structures within the head to be assessed effectively. This method is compliant with current guidelines, represents "good practice" and should be consistently adopted for the examination of the internal head structures of the term rabbit foetus. Copyright © 2014 Elsevier Inc. All rights reserved.

Hanford Site Solid Waste Acceptance Criteria

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

Not Available

1993-11-17

This manual defines the Hanford Site radioactive, hazardous, and sanitary solid waste acceptance criteria. Criteria in the manual represent a guide for meeting state and federal regulations; DOE Orders; Hanford Site requirements; and other rules, regulations, guidelines, and standards as they apply to acceptance of radioactive and hazardous solid waste at the Hanford Site. It is not the intent of this manual to be all inclusive of the regulations; rather, it is intended that the manual provide the waste generator with only the requirements that waste must meet in order to be accepted at Hanford Site TSD facilities.

Companies' opinions and acceptance of global food safety initiative benchmarks after implementation.

PubMed

Crandall, Phil; Van Loo, Ellen J; O'Bryan, Corliss A; Mauromoustakos, Andy; Yiannas, Frank; Dyenson, Natalie; Berdnik, Irina

2012-09-01

International attention has been focused on minimizing costs that may unnecessarily raise food prices. One important aspect to consider is the redundant and overlapping costs of food safety audits. The Global Food Safety Initiative (GFSI) has devised benchmarked schemes based on existing international food safety standards for use as a unifying standard accepted by many retailers. The present study was conducted to evaluate the impact of the decision made by Walmart Stores (Bentonville, AR) to require their suppliers to become GFSI compliant. An online survey of 174 retail suppliers was conducted to assess food suppliers' opinions of this requirement and the benefits suppliers realized when they transitioned from their previous food safety systems. The most common reason for becoming GFSI compliant was to meet customers' requirements; thus, supplier implementation of the GFSI standards was not entirely voluntary. Other reasons given for compliance were enhancing food safety and remaining competitive. About 54 % of food processing plants using GFSI benchmarked schemes followed the guidelines of Safe Quality Food 2000 and 37 % followed those of the British Retail Consortium. At the supplier level, 58 % followed Safe Quality Food 2000 and 31 % followed the British Retail Consortium. Respondents reported that the certification process took about 10 months. The most common reason for selecting a certain GFSI benchmarked scheme was because it was widely accepted by customers (retailers). Four other common reasons were (i) the standard has a good reputation in the industry, (ii) the standard was recommended by others, (iii) the standard is most often used in the industry, and (iv) the standard was required by one of their customers. Most suppliers agreed that increased safety of their products was required to comply with GFSI benchmarked schemes. They also agreed that the GFSI required a more carefully documented food safety management system, which often required improved company food safety practices and increased employee training. Adoption of a GFSI benchmarked scheme resulted in fewer audits, i.e., one less per year. An educational opportunity exists to acquaint retailers and suppliers worldwide with the benefits of having an internationally recognized certification program such as that recognized by the GFSI.

[Brazilian guidelines for marketing baby food: history, limitations and perspectives].

PubMed

Monteiro, Renata

2006-05-01

The objective of this paper is to present and discuss Brazilian policy concerning actions to protect breastfeeding, especially the history, international and national background, limitations, and perspectives of the Brazilian Guidelines for the Marketing of Baby Food, Pacifiers and Bottles. The Brazilian Guidelines, which play a crucial role in protecting breastfeeding against industry marketing strategies, were based on the International Code of Marketing of Breastmilk Substitutes, proposed by the World Health Organization in 1981. The first version of the Brazilian Guidelines was released in 1988, and there were subsequent revisions in 1992 and 2001/2002. In 2006, the Guidelines became national law. However, the strides made over this period in terms of regulation have been few because the law is not always observed. Thus, it is essential that all actors involved, including government officials, manufacturers and sellers of baby food and other baby products, teaching and health professionals and their associations, international bodies, and non-governmental organizations make a commitment to enforce the current law.

Systematic review of return to work after mild traumatic brain injury: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

PubMed

Cancelliere, Carol; Kristman, Vicki L; Cassidy, J David; Hincapié, Cesar A; Côté, Pierre; Boyle, Eleanor; Carroll, Linda J; Stålnacke, Britt-Marie; Nygren-de Boussard, Catharina; Borg, Jörgen

2014-03-01

To synthesize the best available evidence on return to work (RTW) after mild traumatic brain injury (MTBI). MEDLINE and other databases were searched (2001-2012) with terms including "craniocerebral trauma" and "employment." Reference lists of eligible articles were also searched. Controlled trials and cohort and case-control studies were selected according to predefined criteria. Studies had to assess RTW or employment outcomes in at least 30 MTBI cases. Eligible studies were critically appraised using a modification of the Scottish Intercollegiate Guidelines Network criteria. Two reviewers independently reviewed and extracted data from accepted studies into evidence tables. Evidence was synthesized qualitatively according to modified Scottish Intercollegiate Guidelines Network criteria and prioritized according to design as exploratory or confirmatory. After 77,914 records were screened, 299 articles were found eligible and reviewed; 101 (34%) of these with a low risk of bias were accepted as scientifically admissible, and 4 of these had RTW or employment outcomes. This evidence is preliminary and suggests that most workers RTW within 3 to 6 months after MTBI; MTBI is not a significant risk factor for long-term work disability; and predictors of delayed RTW include a lower level of education (<11y of formal education), nausea or vomiting on hospital admission, extracranial injuries, severe head/bodily pain early after injury, and limited job independence and decision-making latitude. Our findings are based on preliminary evidence with varied patient characteristics and MTBI definitions, thus limiting firm conclusions. More well-designed studies are required to understand RTW and sustained employment after MTBI in the longer term (≥2y post-MTBI). Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Systematic review of prognosis and return to play after sport concussion: results of the International Collaboration on Mild Traumatic Brain Injury Prognosis.

PubMed

Cancelliere, Carol; Hincapié, Cesar A; Keightley, Michelle; Godbolt, Alison K; Côté, Pierre; Kristman, Vicki L; Stålnacke, Britt-Marie; Carroll, Linda J; Hung, Ryan; Borg, Jörgen; Nygren-de Boussard, Catharina; Coronado, Victor G; Donovan, James; Cassidy, J David

2014-03-01

To synthesize the best available evidence on prognosis after sport concussion. MEDLINE and other databases were searched (2001-2012) with terms including "craniocerebral trauma" and "sports." Reference lists of eligible articles were also searched. Randomized controlled trials and cohort and case-control studies were selected according to predefined criteria. Studies had to have a minimum of 30 concussion cases. Eligible studies were critically appraised using a modification of the Scottish Intercollegiate Guidelines Network (SIGN) criteria. Two reviewers independently reviewed and extracted data from accepted studies into evidence tables. Evidence was synthesized qualitatively according to modified SIGN criteria, and studies were categorized as exploratory or confirmatory based on the strength of their design and evidence. After 77,914 records were screened, 52 articles were eligible for this review, and 24 articles (representing 19 studies) with a low risk of bias were accepted. Our findings are based on exploratory studies of predominantly male football players at the high school, collegiate, and professional levels. Most athletes recover within days to a few weeks, and American and Australian professional football players return to play quickly after mild traumatic brain injury. Delayed recovery appears more likely in high school athletes, in those with a history of previous concussion, and in those with a higher number and duration of postconcussion symptoms. The evidence concerning sports concussion course and prognosis is very preliminary, and there is no evidence on the effect of return-to-play guidelines on prognosis. Our findings have implications for further research. Well-designed, confirmatory studies are urgently needed to understand the consequences of sport concussion, including recurrent concussion, across different athletic populations and sports. Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Comprehensive Auditing in Nuclear Medicine Through the International Atomic Energy Agency Quality Management Audits in Nuclear Medicine (QUANUM) Program. Part 1: the QUANUM Program and Methodology.

PubMed

Dondi, Maurizio; Torres, Leonel; Marengo, Mario; Massardo, Teresa; Mishani, Eyal; Van Zyl Ellmann, Annare; Solanki, Kishor; Bischof Delaloye, Angelika; Lobato, Enrique Estrada; Miller, Rodolfo Nunez; Paez, Diana; Pascual, Thomas

2017-11-01

An effective management system that integrates quality management is essential for a modern nuclear medicine practice. The Nuclear Medicine and Diagnostic Imaging Section of the International Atomic Energy Agency (IAEA) has the mission of supporting nuclear medicine practice in low- and middle-income countries and of helping them introduce it in their health-care system, when not yet present. The experience gathered over several years has shown diversified levels of development and varying degrees of quality of practice, among others because of limited professional networking and limited or no opportunities for exchange of experiences. Those findings triggered the development of a program named Quality Management Audits in Nuclear Medicine (QUANUM), aimed at improving the standards of NM practice in low- and middle-income countries to internationally accepted standards through the introduction of a culture of quality management and systematic auditing programs. QUANUM takes into account the diversity of nuclear medicine services around the world and multidisciplinary contributions to the practice. Those contributions include clinical, technical, radiopharmaceutical, and medical physics procedures. Aspects of radiation safety and patient protection are also integral to the process. Such an approach ensures consistency in providing safe services of superior quality to patients. The level of conformance is assessed using standards based on publications of the IAEA and the International Commission on Radiological Protection, and guidelines from scientific societies such as Society of Nuclear Medicine and Molecular Imaging (SNMMI) and European Association of Nuclear Medicine (EANM). Following QUANUM guidelines and by means of a specific assessment tool developed by the IAEA, auditors, both internal and external, will be able to evaluate the level of conformance. Nonconformances will then be prioritized and recommendations will be provided during an exit briefing. The same tool could then be applied to assess any improvement after corrective actions are taken. This is the first comprehensive audit program in nuclear medicine that helps evaluate managerial aspects, safety of patients and workers, clinical practice, and radiopharmacy, and, above all, keeps them under control all together, with the intention of continuous improvement. Copyright © 2017. Published by Elsevier Inc.

Special report on taxation. IRS issues stricter guidelines for audits of tax-exempt hospitals.

PubMed

Solomon, J E

1992-07-01

The new audit guidelines serve as yet another reminder to tax-exempt hospitals that great care must be taken in structuring and documenting business arrangements with physicians and executives so as to withstand scrutiny by the IRS with regard to exempt status. Since increased census and utilization, and enhancement of the hospital's financial position, are no longer acceptable justifications for such activities as physician recruitment incentives (being suggestive of payment for referrals), it is important that hospitals make an effort to ensure that board minutes, recruitment policies, internal memoranda, and other documentation set forth the reasons--other than the benefits to the institution's bottom line--for having entered into such transactions. Hospitals must establish and document a community need for each physician recruited. Hospitals that actively recruit should be armed with studies evaluating recruiting needs in each clinical area, based on objective criteria, taking into consideration managed care contracting needs and the provision of services to the poor and needy. Finally, hospitals should re-examine all joint ventures and other business relationships with physicians to determine whether such arrangements resulted from arm's length negotiation, involve fair market value for goods and services, and conform, insofar as possible, with the Medicare fraud and abuse safe harbor regulations. Under GCM 39862 and the new guidelines, "aggressive" arrangements may not only create exposure under fraud and abuse laws, but could jeopardize the provider's tax-exempt status as well.

Interest and limits of the six sigma methodology in medical laboratory.

PubMed

Scherrer, Florian; Bouilloux, Jean-Pierre; Calendini, Ors'Anton; Chamard, Didier; Cornu, François

2017-02-01

The mandatory accreditation of clinical laboratories in France provides an incentive to develop real tools to measure performance management methods and to optimize the management of internal quality controls. Six sigma methodology is an approach commonly applied to software quality management and discussed in numerous publications. This paper discusses the primary factors that influence the sigma index (the choice of the total allowable error, the approach used to address bias) and compares the performance of different analyzers on the basis of the sigma index. Six sigma strategy can be applied to the policy management of internal quality control in a laboratory and demonstrates through a comparison of four analyzers that there is no single superior analyzer in clinical chemistry. Similar sigma results are obtained using approaches toward bias based on the EQAS or the IQC. The main difficulty in using the six sigma methodology lies in the absence of official guidelines for the definition of the total error acceptable. Despite this drawback, our comparison study suggests that difficulties with defined analytes do not vary with the analyzer used.

Foods Served in Child Care Facilities Participating in the Child and Adult Care Food Program: Menu Match and Agreement with the New Meal Patterns and Best Practices.

PubMed

Dave, Jayna M; Cullen, Karen W

2018-06-01

To assess the agreement of posted menus with foods served to 3- to 5-year-old children attending federal Child and Adult Care Food Program (CACFP)-enrolled facilities, and the degree to which the facilities met the new meal patterns and best practices. On-site observations and menu coding. Nine early care and education centers. Agreement of posted menus with foods served, and comparison of foods served and consumed with the new CACFP meal guidelines and best practices. Data were compiled for each meal (breakfast, lunch, and snacks). Frequencies and percentages of agreement with the posted menu (coded matches, substitutions, additions, and omissions) were calculated for each food component in the CACFP menu guidelines. Menu total match was created by summing the menu match plus acceptable substitutions. Menus were compared with the new CACFP meal guidelines and best practices. The match between the posted menus and foods actually served to children at breakfast, lunch, and snack was high when the acceptable menu substitutions were considered (approximately 94% to 100% total match). Comparing the menus with the new meal guidelines and best practices, the 1 guideline that was fully implemented was serving only unflavored, low-fat, or 1% milk; fruit and vegetable guidelines were partially met; fruit juice was not served often, nor were legumes; the guideline for 1 whole grain-rich serving/d was not met; and regular beef and full-fat cheese products were commonly served. Early care and education centers enrolled in CACFP provided meals that met the current CACFP guidelines. Some menu improvements are needed for the centers to meet the new guidelines and best practices. Copyright © 2018 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

PRINTQUAL - a measure for assessing the quality of newspaper reporting of suicide.

PubMed

John, Ann; Hawton, Keith; Lloyd, Keith; Luce, Ann; Platt, Stephen; Scourfield, Jonathan; Marchant, Amanda L; Jones, Phil A; Dennis, Mick S

2014-01-01

Many studies have demonstrated a relationship between newspaper reporting of actual or fictional suicides and subsequent suicidal behaviors. Previous measures of the quality of reporting lack consistency concerning which specific elements should be included and how they should be weighted. To develop an instrument, PRINTQUAL, comprising two scales of the quality (poor and good) of newspaper reporting of suicide that can be used in future studies of reporting. A first draft of the PRINTQUAL instrument was compiled, comprising items indicative of poor- and good-quality newspaper reporting based on guidelines and key sources of evidence. This was refined by team members and then circulated to a group of international experts in the field for further opinion and weighting of individual items. The final instrument comprised 19 items in the poor-quality scale and four in the good-quality scale. Following training, agreement between raters was acceptably high for most items (κ ≥ .75) except for three items for which agreement was still acceptable (κ ≥ .60). The PRINTQUAL instrument for assessing the quality of newspaper reporting of suicide appears appropriate for use in research and monitoring in future studies.

Successful validation of in vitro methods in toxicology by ZEBET, the National Centre for Alternatives in Germany at the BfR (Federal Institute for Risk Assessment).

PubMed

Spielmann, Horst; Grune, Barbara; Liebsch, Manfred; Seiler, Andrea; Vogel, Richard

2008-06-01

A short description of the history of the 3Rs concept is given, which was developed as the scientific concept to refine, reduce and replace animal experiments by Russel and Burch more than 40 years ago. In addition, the legal framework in Europe for developing alternatives to animal experiments is given and the current status of in vitro systems in pharmacology and toxicology is described including an update on metabolising systems. The decrease in experimental animal numbers during the past decade in Europe is illustrated by the situation in Germany and the contribution of international harmonisation of test guidelines on reducing animal numbers in regulatory testing is described. A review of the development of the principles of experimental validation is given and the 3T3 NRU in vitro phototoxicity test is used as an example for a successful validation study, which led to the acceptance of the first in vitro toxicity test for regulatory purposes by the OECD. Finally, the currently accepted alternative methods for standardisation and safety testing of drugs, biologicals and medical devices are summarised.

Feasibility, acceptability, and potential effectiveness of dignity therapy for people with motor neurone disease.

PubMed

Bentley, Brenda; O'Connor, Moira; Kane, Robert; Breen, Lauren J

2014-01-01

Motor neurone disease (MND) practice guidelines suggest developing interventions that will promote hope, meaning, and dignity to alleviate psychological distress, but very little research has been done. This study begins to address this need by exploring the use of dignity therapy with people with MND. Dignity therapy is a brief psychotherapy that promotes hope, meaning and dignity, and enhances the end of life for people with advanced cancer. The aims of this study are to assess the feasibility, acceptability, and potential effectiveness of dignity therapy for people with MND. This cross-sectional feasibility study used a one-group pre-test post-test design with 29 people diagnosed with MND. Study participants completed the following self-report questionnaires: Herth Hope Index, FACIT-sp, Patient Dignity Inventory, ALS Assessment Questionnaire, ALS Cognitive Behavioural Screen, and a demographic and health history questionnaire. Acceptability was measured with a 25-item feedback questionnaire. Feasibility was assessed by examining the length of time taken to complete dignity therapy and how symptoms common in MND affected the intervention. Generalised linear mixed models and reliable change scores were used to analyse the data. There were no significant pre-test post-test changes for hopefulness, spirituality or dignity on the group level, but there were changes in hopefulness on the individual level. The results of the feedback questionnaire indicates dignity therapy is highly acceptable to people with MND, who report benefits similar to those in the international randomised controlled trial on dignity therapy, a population who primarily had end-stage cancer. Benefits include better family relationships, improved sense of self and greater acceptance. Dignity therapy with people with MND is feasible if the therapist can overcome time and communication difficulties. Dignity therapy for people with MND is feasible and acceptable. Further research is warranted to explore its ability to diminish distress. www.anzctr.org.au ACTRN12611000410954.

Feasibility, Acceptability, and Potential Effectiveness of Dignity Therapy for People with Motor Neurone Disease

PubMed Central

Bentley, Brenda; O'Connor, Moira; Kane, Robert; Breen, Lauren J.

2014-01-01

Background Motor neurone disease (MND) practice guidelines suggest developing interventions that will promote hope, meaning, and dignity to alleviate psychological distress, but very little research has been done. This study begins to address this need by exploring the use of dignity therapy with people with MND. Dignity therapy is a brief psychotherapy that promotes hope, meaning and dignity, and enhances the end of life for people with advanced cancer. The aims of this study are to assess the feasibility, acceptability, and potential effectiveness of dignity therapy for people with MND. Methods/design This cross-sectional feasibility study used a one-group pre-test post-test design with 29 people diagnosed with MND. Study participants completed the following self-report questionnaires: Herth Hope Index, FACIT-sp, Patient Dignity Inventory, ALS Assessment Questionnaire, ALS Cognitive Behavioural Screen, and a demographic and health history questionnaire. Acceptability was measured with a 25-item feedback questionnaire. Feasibility was assessed by examining the length of time taken to complete dignity therapy and how symptoms common in MND affected the intervention. Generalised linear mixed models and reliable change scores were used to analyse the data. Results There were no significant pre-test post-test changes for hopefulness, spirituality or dignity on the group level, but there were changes in hopefulness on the individual level. The results of the feedback questionnaire indicates dignity therapy is highly acceptable to people with MND, who report benefits similar to those in the international randomised controlled trial on dignity therapy, a population who primarily had end-stage cancer. Benefits include better family relationships, improved sense of self and greater acceptance. Dignity therapy with people with MND is feasible if the therapist can overcome time and communication difficulties. Conclusions Dignity therapy for people with MND is feasible and acceptable. Further research is warranted to explore its ability to diminish distress. Trial Registration www.anzctr.org.au ACTRN12611000410954 PMID:24816742

Using a wiki platform to promote guidelines internationally and maintain their currency: evidence-based guidelines for the nutritional management of adult patients with head and neck cancer.

PubMed

Brown, T; Findlay, M; von Dincklage, J; Davidson, W; Hill, J; Isenring, E; Talwar, B; Bell, K; Kiss, N; Kurmis, R; Loeliger, J; Sandison, A; Taylor, K; Bauer, J

2013-04-01

The present study describes the development of evidence-based practice guidelines for the nutritional management of adult patients with head and neck cancer using a wiki platform to enable wide international stakeholder consultation and maintain currency. A dietitian steering committee and a multidisciplinary steering committee were established for consultation. Traditional methods of evidence-based guideline development were utilised to perform the literature review, assess the evidence and produce a draft document. This was transferred to a wiki platform for stakeholder consultation and international endorsement processes in Australia, New Zealand and the UK. Data were collected on website traffic utilising Google Analytics. In addition to broad stakeholder consultation through the steering committees, an additional twenty comments were received via the wiki by twelve individuals covering six different professions from three different countries, compared to four comments by e-mail. The guidelines were subsequently endorsed by the dietetic associations of Australia, New Zealand and the UK. During a 4-month period monitoring the use of the guidelines, there were 2303 page views to the landing page from 33 countries. The average number of pages accessed per visit was five and the duration of time spent on the website was approximately 6 min. Using a wiki platform for guideline development and dissemination is a successful method for producing high-quality resources that can undergo wide international stakeholder review and include open public consultation. This can replace conventional methods whereby guidelines can quickly become outdated. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

Measuring Alcohol Consumption in Population Surveys: A Review of International Guidelines and Comparison with Surveys in England

PubMed Central

Nugawela, Manjula D.; Langley, Tessa; Szatkowski, Lisa; Lewis, Sarah

2016-01-01

Aims To review the international guidelines and recommendations on survey instruments for measurement of alcohol consumption in population surveys and to examine how national surveys in England meet the core recommendations. Methods A systematic search for international guidelines for measuring alcohol consumption in population surveys was undertaken. The common core recommendations for alcohol consumption measures and survey instruments were identified. Alcohol consumption questions in national surveys in England were compared with these recommendations for specific years and over time since 2000. Results Four sets of international guidelines and three core alcohol consumption measures (alcohol consumption status, average volume of consumption, frequency and volume of heavy episodic drinking) with another optional measure (drinking context) were identified. English national surveys have been inconsistent over time in including questions that provide information on average volume of consumption but have not included questions on another essential alcohol consumption measure, frequency of heavy episodic drinking. Instead, they have used questions that focus only on maximum volume of alcohol consumed on any day in the previous week. Conclusions International guidelines provide consistent recommendations for measuring alcohol consumption in population surveys. These recommendations have not been consistently applied in English national surveys, and this has contributed to the inadequacy of survey measurements for monitoring vital aspects of alcohol consumption in England over recent years. PMID:26115987

48 CFR 915.404-4-70-8 - Weighted guidelines application considerations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Weighted guidelines....404-4-70-8 Weighted guidelines application considerations. The Department has developed internal procedures to aid the contracting officer in the application of weighted guidelines and to assure a...

Toward Evidence-Based Chinese Medicine: Status Quo, Opportunities and Challenges.

PubMed

Chen, Yao-Long; Zhao, Chen; Zhang, Li; Li, Bo; Wu, Chuan-Hong; Mu, Wei; Wang, Jia-Ying; Yang, Ke-Hu; Li, You-Ping; Chen, Chiehfeng; Wang, Yong-Yan; Wang, Chen; Bian, Zhao-Xiang; Shang, Hong-Cai

2018-03-01

How to test the treatments of Chinese medicine (CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM. For centuries, various approaches have been used to identify and measure the efficacy and safety of CM. However, the high-quality evidence related to CM that produced in China is still rare. Over the recent years, evidence-based medicine (EBM) has been increasingly applied to CM, strengthening its theoretical basis. This paper reviews the past and present state of CM, analyzes the status quo, challenges and opportunities of basic research, clinical trials, systematic reviews, clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China, pointing out how EBM can help to make CM more widely used and recognized worldwide.

Definition of spacecraft standard interfaces by the NASA Space Assembly and Servicing Working Group (SASWG)

NASA Technical Reports Server (NTRS)

Radtke, Robert; Woolley, Charles; Arnold, Lana

1993-01-01

The purpose of the NASA Space Assembly and Servicing Working Group (SASWG) is to study enabling technologies for on-orbit spacecraft maintenance and servicing. One key technology required for effective space logistics activity is the development of standard spacecraft interfaces, including the 'Basic Set' defined by NASA, the U.S. Space Command, and industry panelists to be the following: (1) navigation aids; (2) grasping, berthing, and docking; and (3) utility connections for power, data, and fluids. Draft standards have been prepared and referred to professional standards organizations, including the AIAA, EIA, and SAE space standards committee. The objective of the SASWG is to support these committees with the technical expertise required to prepare standards, guidelines, and recommended practices which will be accepted by the ANSI and international standards organizations, including the ISO, IEC, and PASC.

Lack of international consensus in low-risk drinking guidelines.

PubMed

Furtwaengler, Nina A F F; de Visser, Richard O

2013-01-01

To encourage moderate alcohol consumption, many governments have developed guidelines for alcohol intake, guidelines for alcohol consumption during pregnancy and legislation relating to blood alcohol limits when driving. The aim of this study was to determine the degree of international consensus within such guidelines. Official definitions of standard drinks and consumption guidelines were searched for on government websites, including all 27 European Union Member States and countries from all global geographic regions. There was a remarkable lack of agreement about what constitutes harmful or excessive alcohol consumption on a daily basis, a weekly basis and when driving, with no consensus about the ratios of consumption guidelines for men and women. International consensus in low-risk drinking guidelines is an important--and achievable--goal. Such agreement would facilitate consistent labelling of packaged products and could help to promote moderate alcohol consumption. However, there are some paradoxes related to alcohol content labelling and people's use of such information: although clearer information could increase people's capacity to monitor and regulate their alcohol consumption, not all drinkers are motivated to drink moderately or sensibly, and drinkers who intend to get drunk may use alcohol content labelling to select more alcoholic products. © 2012 Australasian Professional Society on Alcohol and other Drugs.

Evaluation of the theory-based Quality Improvement in Physical Therapy (QUIP) programme: a one-group, pre-test post-test pilot study.

PubMed

Rutten, Geert M; Harting, Janneke; Bartholomew, L Kay; Schlief, Angelique; Oostendorp, Rob A B; de Vries, Nanne K

2013-05-25

Guideline adherence in physical therapy is far from optimal, which has consequences for the effectiveness and efficiency of physical therapy care. Programmes to enhance guideline adherence have, so far, been relatively ineffective. We systematically developed a theory-based Quality Improvement in Physical Therapy (QUIP) programme aimed at the individual performance level (practicing physiotherapists; PTs) and the practice organization level (practice quality manager; PQM). The aim of the study was to pilot test the multilevel QUIP programme's effectiveness and the fidelity, acceptability and feasibility of its implementation. A one-group, pre-test, post-test pilot study (N = 8 practices; N = 32 PTs, 8 of whom were also PQMs) done between September and December 2009. Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines' main recommendations. Determinants of adherence were measured using quantitative methods (questionnaires). Delivery of the programme and management changes were assessed using qualitative methods (observations, group interviews, and document analyses). Changes in adherence and determinants were tested in the paired samples T-tests and expressed in effect sizes (Cohen's d). Overall adherence did not change (3.1%; p = .138). Adherence to three quality indicators improved (8%, 24%, 43%; .000 ≤ p ≤ .023). Adherence to one quality indicator decreased (-15.7%; p = .004). Scores on various determinants of individual performance improved and favourable changes at practice organizational level were observed. Improvements were associated with the programme's multilevel approach, collective goal setting, and the application of self-regulation; unfavourable findings with programme deficits. The one-group pre-test post-test design limits the internal validity of the study, the self-selected sample its external validity. The QUIP programme has the potential to change physical therapy practice but needs considerable revision to induce the ongoing quality improvement process that is required to optimize overall guideline adherence. To assess its value, the programme needs to be tested in a randomized controlled trial.

Inherited mutations in BRCA1 and BRCA2 in an unselected multiethnic cohort of Asian patients with breast cancer and healthy controls from Malaysia.

PubMed

Wen, Wei Xiong; Allen, Jamie; Lai, Kah Nyin; Mariapun, Shivaani; Hasan, Siti Norhidayu; Ng, Pei Sze; Lee, Daphne Shin-Chi; Lee, Sheau Yee; Yoon, Sook-Yee; Lim, Joanna; Lau, Shao Yan; Decker, Brennan; Pooley, Karen; Dorling, Leila; Luccarini, Craig; Baynes, Caroline; Conroy, Don M; Harrington, Patricia; Simard, Jacques; Yip, Cheng Har; Mohd Taib, Nur Aishah; Ho, Weang Kee; Antoniou, Antonis C; Dunning, Alison M; Easton, Douglas F; Teo, Soo Hwang

2018-02-01

Genetic testing for BRCA1 and BRCA2 is offered typically to selected women based on age of onset and family history of cancer. However, current internationally accepted genetic testing referral guidelines are built mostly on data from cancer genetics clinics in women of European descent. To evaluate the appropriateness of such guidelines in Asians, we have determined the prevalence of germ line variants in an unselected cohort of Asian patients with breast cancer and healthy controls. Germ line DNA from a hospital-based study of 2575 unselected patients with breast cancer and 2809 healthy controls were subjected to amplicon-based targeted sequencing of exonic and proximal splice site junction regions of BRCA1 and BRCA2 using the Fluidigm Access Array system, with sequencing conducted on a Illumina HiSeq2500 platform. Variant calling was performed with GATK UnifiedGenotyper and were validated by Sanger sequencing. Fifty-five (2.1%) BRCA1 and 66 (2.6%) BRCA2 deleterious mutations were identified among patients with breast cancer and five (0.18%) BRCA1 and six (0.21%) BRCA2 mutations among controls. One thousand one hundred and eighty-six (46%) patients and 97 (80%) carriers fulfilled the National Comprehensive Cancer Network guidelines for genetic testing. Five per cent of unselected Asian patients with breast cancer carry deleterious variants in BRCA1 or BRCA2 . While current referral guidelines identified the majority of carriers, one in two patients would be referred for genetic services. Given that such services are largely unavailable in majority of low-resource settings in Asia, our study highlights the need for more efficient guidelines to identify at-risk individuals in Asia. © 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.

Rules and guidelines in clinical practice: a qualitative study in operating theatres of doctors' and nurses' views

PubMed Central

McDonald, R; Waring, J; Harrison, S; Walshe, K; Boaden, R

2005-01-01

Background: The current orthodoxy within patient safety research and policy is characterised by a faith in rules based systems which limit the capacity for individual discretion, and hence fallibility. However, guidelines have been seen as stifling innovation and eroding trust. Our objectives were to explore the attitudes towards guidelines of doctors and nurses working together in surgical teams and to examine the extent to which trusting relationships are maintained in a context governed by explicit rules. Methods: Fourteen consultant grade surgeons of mixed specialty, 12 consultant anaesthetists, and 15 nurses were selected to reflect a range of roles. Participant observation was combined with semi-structured interviews. Results: Doctors' views about the contribution of guidelines to safety and to clinical practice differed from those of nurses. Doctors rejected written rules, instead adhering to the unwritten rules of what constitutes acceptable behaviour for members of the medical profession. In contrast, nurses viewed guideline adherence as synonymous with professionalism and criticised doctors for failing to comply with guidelines. Conclusions: While the creation of a "safety culture" requires a shared set of beliefs, attitudes and norms in relation to what is seen as safe clinical practice, differences of opinion on these issues exist which cannot be easily reconciled since they reflect deeply ingrained beliefs about what constitutes professional conduct. While advocates of standardisation (such as nurses) view doctors as rule breakers, doctors may not necessarily regard guidelines as legitimate or identify with the rules written for them by members of other social groups. Future safety research and policy should attempt to understand the unwritten rules which govern clinical behaviour and examine the ways in which such rules are produced, maintained, and accepted as legitimate. PMID:16076795

77 FR 11199 - Visual-Manual NHTSA Driver Distraction Guidelines for In-Vehicle Electronic Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

...The National Highway Traffic Safety Administration (NHTSA) is concerned about the effects of distraction due to drivers' use of electronic devices on motor vehicle safety. Consequently, NHTSA is issuing nonbinding, voluntary NHTSA Driver Distraction Guidelines (NHTSA Guidelines) to promote safety by discouraging the introduction of excessively distracting devices in vehicles. This notice details the contents of the first phase of the NHTSA Driver Distraction Guidelines. These NHTSA Guidelines cover original equipment in-vehicle device secondary tasks (communications, entertainment, information gathering, and navigation tasks not required to drive are considered secondary tasks) performed by the driver through visual-manual means (meaning the driver looking at a device, manipulating a device-related control with the driver's hand, and watching for visual feedback). The proposed NHTSA Guidelines list certain secondary, non-driving related tasks that, based on NHTSA's research, are believed by the agency to interfere inherently with a driver's ability to safely control the vehicle. The Guidelines recommend that those in-vehicle devices be designed so that they cannot be used by the driver to perform such tasks while the driver is driving. For all other secondary, non-driving-related visual-manual tasks, the NHTSA Guidelines specify a test method for measuring the impact of task performance on driving safety while driving and time-based acceptance criteria for assessing whether a task interferes too much with driver attention to be suitable to perform while driving. If a task does not meet the acceptance criteria, the NHTSA Guidelines recommend that in- vehicle devices be designed so that the task cannot be performed by the driver while driving. In addition to identifying inherently distracting tasks and providing a means for measuring and evaluating the level of distraction associated with other non-driving-related tasks, the NHTSA Guidelines contain several design recommendations for in-vehicle devices in order to minimize their potential for distraction. NHTSA seeks comments on these NHTSA Guidelines and any suggestions for how to improve them so as to better enhance motor vehicle safety.

Legal and ethical issues in research

PubMed Central

Yip, Camille; Han, Nian-Lin Reena; Sng, Ban Leong

2016-01-01

Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees. PMID:27729698

Use of the ‘Accountability for Reasonableness’ Approach to Improve Fairness in Accessing Dialysis in a Middle-Income Country

PubMed Central

Maree, Jonathan David; Chirehwa, Maxwell T.; Benatar, Solomon R.

2016-01-01

Universal access to renal replacement therapy is beyond the economic capability of most low and middle-income countries due to large patient numbers and the high recurrent cost of treating end stage kidney disease. In countries where limited access is available, no systems exist that allow for optimal use of the scarce dialysis facilities. We previously reported that using national guidelines to select patients for renal replacement therapy resulted in biased allocation. We reengineered selection guidelines using the ‘Accountability for Reasonableness’ (procedural fairness) framework in collaboration with relevant stakeholders, applying these in a novel way to categorize and prioritize patients in a unique hierarchical fashion. The guidelines were primarily premised on patients being transplantable. We examined whether the revised guidelines enhanced fairness of dialysis resource allocation. This is a descriptive study of 1101 end stage kidney failure patients presenting to a tertiary renal unit in a middle-income country, evaluated for dialysis treatment over a seven-year period. The Assessment Committee used the accountability for reasonableness-based guidelines to allocate patients to one of three assessment groups. Category 1 patients were guaranteed renal replacement therapy, Category 3 patients were palliated, and Category 2 were offered treatment if resources allowed. Only 25.2% of all end stage kidney disease patients assessed were accepted for renal replacement treatment. The majority of patients (48%) were allocated to Category 2. Of 134 Category 1 patients, 98% were accepted for treatment while 438 (99.5%) Category 3 patients were excluded. Compared with those palliated, patients accepted for dialysis treatment were almost 10 years younger, employed, married with children and not diabetic. Compared with our previous selection process our current method of priority setting based on procedural fairness arguably resulted in more equitable allocation of treatment but, more importantly, it is a model that is morally, legally and ethically more defensible. PMID:27701466

Probability of Failure Analysis Standards and Guidelines for Expendable Launch Vehicles

NASA Astrophysics Data System (ADS)

Wilde, Paul D.; Morse, Elisabeth L.; Rosati, Paul; Cather, Corey

2013-09-01

Recognizing the central importance of probability of failure estimates to ensuring public safety for launches, the Federal Aviation Administration (FAA), Office of Commercial Space Transportation (AST), the National Aeronautics and Space Administration (NASA), and U.S. Air Force (USAF), through the Common Standards Working Group (CSWG), developed a guide for conducting valid probability of failure (POF) analyses for expendable launch vehicles (ELV), with an emphasis on POF analysis for new ELVs. A probability of failure analysis for an ELV produces estimates of the likelihood of occurrence of potentially hazardous events, which are critical inputs to launch risk analysis of debris, toxic, or explosive hazards. This guide is intended to document a framework for POF analyses commonly accepted in the US, and should be useful to anyone who performs or evaluates launch risk analyses for new ELVs. The CSWG guidelines provide performance standards and definitions of key terms, and are being revised to address allocation to flight times and vehicle response modes. The POF performance standard allows a launch operator to employ alternative, potentially innovative methodologies so long as the results satisfy the performance standard. Current POF analysis practice at US ranges includes multiple methodologies described in the guidelines as accepted methods, but not necessarily the only methods available to demonstrate compliance with the performance standard. The guidelines include illustrative examples for each POF analysis method, which are intended to illustrate an acceptable level of fidelity for ELV POF analyses used to ensure public safety. The focus is on providing guiding principles rather than "recipe lists." Independent reviews of these guidelines were performed to assess their logic, completeness, accuracy, self- consistency, consistency with risk analysis practices, use of available information, and ease of applicability. The independent reviews confirmed the general validity of the performance standard approach and suggested potential updates to improve the accuracy each of the example methods, especially to address reliability growth.

Opioid substitution treatment in pretrial prison detention: a case study from Geneva, Switzerland.

PubMed

Favrod-Coune, Thierry; Baroudi, Mariem; Casillas, Alejandra; Rieder, Jean-Pierre; Gétaz, Laurent; Barro, Javier; Gaspoz, Jean-Michel; Broers, Barbara; Wolff, Hans

2013-11-01

Opioid substitution treatment (OST) is not uniformly provided in all prisons as recommended by international guidelines. The Swiss prison of Champ-Dollon in Geneva is an exception, where OST has been available for the last 20 years. The aims of this study were to describe the OST programme in this pretrial prison setting, and the patients involved. We reviewed health records of 2566 detainees entering Switzerland's largest pretrial prison in 2007. Sociodemographic characteristics, substance use diagnosis and history, OST history and prison course, medical complications, and evidence of OST side effects were assessed by questionnaire. The mean age was 29.6 years (SD 7.1) and 95.4% of prisoners were male. Among 233 opioid users (9.1%) at baseline, 221 (94.8%) used other substances, and 39.9% had used drugs intravenously. Opioid dependence was confirmed in 71.2% of opioid users. OST was offered to all dependent users, and all patients accepted treatment. Methadone was the treatment of preference, with a prescribed mean dose of 41.7 mg (standard deviation 29.1) upon departure. No serious side effects or death by overdose occurred. There was postrelease OST continuity-of-care for 49.7% of OST patients. Prescription of OST for opioid dependent detainees by trained physicians is feasible and safe in a pretrial setting. The methadone dose was lower when compared with general OST treatment recommendations. Nevertheless, treatment was available in accordance with national and international guidelines. In-prison OST offers access to a much needed and safe healthcare service for this vulnerable population.

Management of postoperative pseudomeningoceles: an international survey study.

PubMed

Tu, Albert; Tamburrini, Gianpiero; Steinbok, Paul

2014-11-01

Pseudomeningoceles are common complications after posterior fossa and intradural spinal surgery and are often asymptomatic. Management guidelines are lacking, and anecdotally, we have encountered radically different suggested treatments varying from observation to immediate surgical intervention. The goal of this study was to determine the prevailing opinions among neurosurgeons on the management of this condition. Neurosurgeons from around the world were invited via an International Society for Pediatric Neurosurgery (ISPN) and Neurosurgery ListServ e-blast to participate in a 33-question survey on the management of pseudomeningoceles, presented as simulated scenarios after posterior fossa and spinal intradural surgery. Two hundred forty-one responses were obtained. Pseudomeningoceles after posterior fossa tumor resection, in the absence of hydrocephalus, were typically managed nonoperatively for 7 to 14 days before re-exploration. Only 0.5 % of the surgeons would offer upfront repair of the pseudomeningocele. In the presence of hydrocephalus, 48 % of the neurosurgeons intervene initially with cerebrospinal fluid (CSF) diversion and would change therapy if the lesion did not resolve in 2 to 4 days. Ninety percent of the surgeons manage spinal pseudomeningoceles nonoperatively for 7-14 days before re-exploration is considered. The most common steps taken to prevent pseudomeningoceles are watertight closure, tissue glues, and duroplasty. The present zeitgeist suggests that, in the absence of hydrocephalus, initial observation is appropriate for cranial and spinal pseudomeningoceles. Operative revision should be reserved for failure of conservative treatment. If hydrocephalus is present, consideration should be made for CSF diversion. This study may serve as a guideline regarding acceptable management.

An international consensus algorithm for management of chronic postoperative inguinal pain.

PubMed

Lange, J F M; Kaufmann, R; Wijsmuller, A R; Pierie, J P E N; Ploeg, R J; Chen, D C; Amid, P K

2015-02-01

Tension-free mesh repair of inguinal hernia has led to uniformly low recurrence rates. Morbidity associated with this operation is mainly related to chronic pain. No consensus guidelines exist for the management of this condition. The goal of this study is to design an expert-based algorithm for diagnostic and therapeutic management of chronic inguinal postoperative pain (CPIP). A group of surgeons considered experts on inguinal hernia surgery was solicited to develop the algorithm. Consensus regarding each step of an algorithm proposed by the authors was sought by means of the Delphi method leading to a revised expert-based algorithm. With the input of 28 international experts, an algorithm for a stepwise approach for management of CPIP was created. 26 participants accepted the final algorithm as a consensus model. One participant could not agree with the final concept. One expert did not respond during the final phase. There is a need for guidelines with regard to management of CPIP. This algorithm can serve as a guide with regard to the diagnosis, management, and treatment of these patients and improve clinical outcomes. If an expectative phase of a few months has passed without any amelioration of CPIP, a multidisciplinary approach is indicated and a pain management team should be consulted. Pharmacologic, behavioral, and interventional modalities including nerve blocks are essential. If conservative measures fail and surgery is considered, triple neurectomy, correction for recurrence with or without neurectomy, and meshoma removal if indicated should be performed. Surgeons less experienced with remedial operations for CPIP should not hesitate to refer their patients to dedicated hernia surgeons.

The International Confederation of Midwives: Global Standards for Midwifery Education (2010) with companion guidelines.

PubMed

Thompson, Joyce B; Fullerton, Judith T; Sawyer, Angela J

2011-08-01

a 2-year study was conducted to develop Global Standards for Midwifery Education in keeping with core documents of the International Confederation of Midwives. Elements of the standards were based on evidence available in the published and unpublished literature. Companion Guidelines to assist in implementing the standards were also developed. a modified Delphi survey process was conducted in two rounds following item validation by a panel of midwifery education experts. a global survey conducted in 88 countries. midwifery educators and clinicians associated with midwifery education located in any of the ICM member association countries. Additional participants included an Expert Midwifery Resource Group, other Key Stakeholders, midwifery regulators and policy makers. A total of 241 individuals from 46 ICM member association countries and ten non-member countries responded to one or both of the survey rounds. survey respondents expressed an opinion on whether to retain or to delete any of the proposed components of the standards. Version one had 109 proposed components and version two had 111 items for consideration. a majority consensus of .80 was required to accept an item without further deliberation. The Education Standards Task Force (expert panel) made final decisions in the four instances where this level of consensus was not reached, retaining all four items. The panel also amended the wording of selected items or added new items based on feedback received from survey respondents. The final document contains 10 Preface items, 35 glossary terms, and 37 discrete standards with 27 sub-sections. Copyright © 2011 Elsevier Ltd. All rights reserved.

ESPEN guidelines on nutrition in dementia.

PubMed

Volkert, Dorothee; Chourdakis, Michael; Faxen-Irving, Gerd; Frühwald, Thomas; Landi, Francesco; Suominen, Merja H; Vandewoude, Maurits; Wirth, Rainer; Schneider, Stéphane M

2015-12-01

Older people suffering from dementia are at increased risk of malnutrition due to various nutritional problems, and the question arises which interventions are effective in maintaining adequate nutritional intake and nutritional status in the course of the disease. It is of further interest whether supplementation of energy and/or specific nutrients is able to prevent further cognitive decline or even correct cognitive impairment, and in which situations artificial nutritional support is justified. It is the purpose of these guidelines to cover these issues with evidence-based recommendations. The guidelines were developed by an international multidisciplinary working group in accordance with officially accepted standards. The GRADE system was used for assigning strength of evidence. Recommendations were discussed, submitted to Delphi rounds and accepted in an online survey among ESPEN members. 26 recommendations for nutritional care of older persons with dementia are given. In every person with dementia, screening for malnutrition and close monitoring of body weight are recommended. In all stages of the disease, oral nutrition may be supported by provision of adequate, attractive food in a pleasant environment, by adequate nursing support and elimination of potential causes of malnutrition. Supplementation of single nutrients is not recommended unless there is a sign of deficiency. Oral nutritional supplements are recommended to improve nutritional status but not to correct cognitive impairment or prevent cognitive decline. Artificial nutrition is suggested in patients with mild or moderate dementia for a limited period of time to overcome a crisis situation with markedly insufficient oral intake, if low nutritional intake is predominantly caused by a potentially reversible condition, but not in patients with severe dementia or in the terminal phase of life. Nutritional care and support should be an integral part of dementia management. In all stages of the disease, the decision for or against nutritional interventions should be made on an individual basis after carefully balancing expected benefit and potential burden, taking the (assumed) patient will and general prognosis into account. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

The development of a core syllabus for the teaching of oral anatomy, histology, and embryology to dental students via an international 'Delphi Panel'.

PubMed

Moxham, Bernard John; McHanwell, Stephen; Berkovitz, Barry

2018-03-01

The formulation of core syllabuses for the biomedical sciences within medical and dental courses is partially driven by the need to cope with decreased time allocations for these subjects as a result of major curricular changes taking place worldwide. There is also a requirement to deal with the request for increased clinical relevance. In response to such demands, the International Federation of Associations of Anatomists (IFAA) is devising core syllabuses for the anatomical sciences relating to the education and training of both scientific and clinical professions. The process initially involves using Delphi Panels consisting of a team of anatomists, scientists, and clinicians who evaluate syllabus content in detail and accord each element/topic 'essential,' 'important,' 'acceptable,' or 'not required' status. Their conjectures, published on the IFAA website, provide merely a framework to enable other stakeholders to comment. The approach is international in scope, is conceptually 'democratic,' and is developmentally fluid in being readily available for amendment. The aim is to set internationally recognized standards and thus to provide guidelines concerning anatomical knowledge when engaged in course development. This article presents the deliberations of an IFAA Delphi Panel into a core syllabus for oral anatomy, histology, and embryology within the dental curriculum. Clin. Anat. 31:231-249, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Venous thromboembolism: the prevailing approach to diagnosis, prevention and treatment among Internal Medicine practitioners.

PubMed

Markel, Arie; Gavish, Israel; Kfir, Hila; Rimbrot, Sofia

2017-02-01

Venous thromboembolism (VTE) is the third most common cause of death and the leading cause of sudden death in hospitalized medical patients. Despite the existence of guidelines for prevention and treatment of this disorder, their implementation in everyday life is not always accomplished. We performed a survey among directors of Internal Medicine departments in our country in order to evaluate their attitude and approach to this issue. A questionnaire with pertinent questions regarding prevention and treatment of VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE) was sent to each one of the directors of Internal Medicine Departments around the country. Sixty-nine out of 97 (71%) of the Internal Medicine departments directors responded the questionnaire. We found that several of the current guidelines were followed in a reasonable way. On the other hand, heterogeneity of responses was also present and the performance of current guidelines was imperfectly followed, and showed to be deficient in several aspects. An effort should be done in order to reemphasize and put in effect current guidelines for the prevention and treatment of VTE among hospitalists and Internal Medicine practitioners.

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

NASA Technical Reports Server (NTRS)

Garrett, Henry B.; Whittlesey, Albert C.

2005-01-01

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

COMP report: CPQR technical quality control guidelines for low-dose-rate permanent seed brachytherapy.

PubMed

Beaulieu, Luc; Radford, Dee-Ann; Eduardo Villarreal-Barajas, J

2018-03-14

The Canadian Organization of Medical Physicists (COMP), in close partnership with the Canadian Partnership for Quality Radiotherapy (CPQR) has developed a series of Technical Quality Control (TQC) guidelines for radiation treatment equipment. These guidelines outline the performance objectives that equipment should meet in order to ensure an acceptable level of radiation treatment quality. The TQC guidelines have been rigorously reviewed and field tested in a variety of Canadian radiation treatment facilities. The development process enables rapid review and update to keep the guidelines current with changes in technology. This article contains detailed performance objectives and safety criteria for low-dose-rate (LDR) permanent seed brachytherapy. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Consensus Among International Ethical Guidelines for the Provision of Videoconferencing-Based Mental Health Treatments.

PubMed

Sansom-Daly, Ursula M; Wakefield, Claire E; McGill, Brittany C; Wilson, Helen L; Patterson, Pandora

2016-05-18

Online technologies may reduce barriers to evidence-based mental health care, yet they also create numerous ethical challenges. Recently, numerous professional organizations and expert groups have produced best-practice guidelines to assist mental health professionals in delivering online interventions in an ethically and clinically sound manner. However, there has been little critical examination of these international best-practice guidelines regarding appropriate electronic mental health (e-mental health) service delivery via technologies such as videoconferencing (including Skype), particularly for specific, vulnerable populations. Further, the extent to which concordance exists between these guidelines remains unclear. Synthesizing this literature to provide clear guidance to both mental health professionals and researchers is critical to ensure continued progress in the field of e-mental health. This study aims to review all currently available ethical and best-practice guidelines relating to videoconferencing-delivered mental health treatments in order to ascertain the recommendations for which international consensus could be found. Additionally, this review examines the extent to which each set of guidance addresses several key special populations, including children and young people, and populations living with illness. This systematic review examined guidelines using a two-armed search strategy, examining (1) professional organizations' published guidance; and (2) MEDLINE, PsycINFO, and EMBASE for the past ten years. In order to determine consensus for best-practice, a recommendation was considered "firm" if 50% or more of the reviewed guidelines endorsed it and "tentative" if recommended by fewer guidelines than these. The professional guidelines were also scored by two raters using the Appraisal of Guidelines for Research and Evaluation II (AGREE-II) criteria. In the study, 19 guidelines were included, yielding 11 specific "firm" and a further 123 "tentative-level" recommendations regarding the appropriateness of e-mental health, competence, legal and regulatory issues, confidentiality, consent, professional boundaries, and crisis management. International consensus yielded firm guidance across almost all areas except professional boundaries and some aspects of determining the appropriateness of e-mental health. Few guidelines specifically addressed special populations. Overall guideline quality varied; however, 42% (8/19) of the guidelines scored at least 5 out of 7. This synthesis of guidelines provides a foundation for clinicians and researchers utilizing e-mental health worldwide. The lack of specific guidance relating to special populations is an area warranting further attention in order to strengthen mental health professionals' and researchers' capacity to ethically and effectively tailor e-mental health interventions to these groups.

The current state of epilepsy guidelines: A systematic review.

PubMed

Sauro, Khara M; Wiebe, Samuel; Dunkley, Colin; Janszky, Jozsef; Kumlien, Eva; Moshé, Solomon; Nakasato, Nobukazu; Pedley, Timothy A; Perucca, Emilio; Senties, Horacio; Thomas, Sanjeev V; Wang, Yuping; Wilmshurst, Jo; Jetté, Nathalie

2016-01-01

The International League Against Epilepsy (ILAE) Epilepsy Guidelines Task Force, composed of 14 international members, was established in 2011 to identify, using systematic review methodology, international epilepsy clinical care guidelines, assess their quality, and determine gaps in areas of need of development. A systematic review of the literature (1985-2014) was performed in six electronic databases (e.g. Medline, Embase) using a broad search strategy without initial limits to language or study design. Six gray literature databases (e.g., American Academy of Neurology [AAN], ILAE) were also searched to minimize publication bias. Two independent reviewers screened abstracts, reviewed full text articles, and performed data abstraction. Descriptive statistics and a meta-analysis were generated. The search identified 10,926 abstracts. Of the 410 articles selected for full text review, 63 met our eligibility criteria for a guideline. Of those included, 54 were in English and 9 were in other languages (French, Spanish, and Italian). Of all guidelines, 29% did not specify the target age groups, 27% were focused on adults, 22% included only children, and 6% specifically addressed issues related to women with epilepsy. Guidelines included in the review were most often aimed at guiding clinical practice for status epilepticus (n = 7), first seizure (n = 6), drug-resistant epilepsy (n = 5), and febrile seizures (n = 4), among others. Most of the guidelines were therapeutic (n = 35) or diagnostic (n = 16) in nature. The quality of the guidelines using a 1-7 point scale (7 = highest) varied and was moderate overall (mean = 4.99 ± 1.05 [SD]). We identified substantial gaps in topics (e.g., epilepsy in the elderly) and there was considerable heterogeneity in methodologic quality. The findings should offer a valuable resource for health professionals caring for people with epilepsy, since they will help guide the prioritization, development, and dissemination of future epilepsy-related guidelines. Wiley Periodicals, Inc. © 2015 International League Against Epilepsy.

Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise.

PubMed

Schünemann, Holger J; Wiercioch, Wojtek; Etxeandia, Itziar; Falavigna, Maicon; Santesso, Nancy; Mustafa, Reem; Ventresca, Matthew; Brignardello-Petersen, Romina; Laisaar, Kaja-Triin; Kowalski, Sérgio; Baldeh, Tejan; Zhang, Yuan; Raid, Ulla; Neumann, Ignacio; Norris, Susan L; Thornton, Judith; Harbour, Robin; Treweek, Shaun; Guyatt, Gordon; Alonso-Coello, Pablo; Reinap, Marge; Brozek, Jan; Oxman, Andrew; Akl, Elie A

2014-02-18

Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a comprehensive checklist of items linked to relevant resources and tools that guideline developers could consider, without the expectation that every guideline would address each item. We searched data sources, including manuals of international guideline developers, literature on guidelines for guidelines (with a focus on methodology reports from international and national agencies, and professional societies) and recent articles providing systematic guidance. We reviewed these sources in duplicate, extracted items for the checklist using a sensitive approach and developed overarching topics relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions and suggestions for items to be added. We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers. The topics and included items cover all stages of the guideline enterprise, from the planning and formulation of guidelines, to their implementation and evaluation. The final checklist includes links to training materials as well as resources with suggested methodology for applying the items. The checklist will serve as a resource for guideline developers. Consideration of items on the checklist will support the development, implementation and evaluation of guidelines. We will use crowdsourcing to revise the checklist and keep it up to date.

Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise

PubMed Central

Schünemann, Holger J.; Wiercioch, Wojtek; Etxeandia, Itziar; Falavigna, Maicon; Santesso, Nancy; Mustafa, Reem; Ventresca, Matthew; Brignardello-Petersen, Romina; Laisaar, Kaja-Triin; Kowalski, Sérgio; Baldeh, Tejan; Zhang, Yuan; Raid, Ulla; Neumann, Ignacio; Norris, Susan L.; Thornton, Judith; Harbour, Robin; Treweek, Shaun; Guyatt, Gordon; Alonso-Coello, Pablo; Reinap, Marge; Brožek, Jan; Oxman, Andrew; Akl, Elie A.

2014-01-01

Background: Although several tools to evaluate the credibility of health care guidelines exist, guidance on practical steps for developing guidelines is lacking. We systematically compiled a comprehensive checklist of items linked to relevant resources and tools that guideline developers could consider, without the expectation that every guideline would address each item. Methods: We searched data sources, including manuals of international guideline developers, literature on guidelines for guidelines (with a focus on methodology reports from international and national agencies, and professional societies) and recent articles providing systematic guidance. We reviewed these sources in duplicate, extracted items for the checklist using a sensitive approach and developed overarching topics relevant to guidelines. In an iterative process, we reviewed items for duplication and omissions and involved experts in guideline development for revisions and suggestions for items to be added. Results: We developed a checklist with 18 topics and 146 items and a webpage to facilitate its use by guideline developers. The topics and included items cover all stages of the guideline enterprise, from the planning and formulation of guidelines, to their implementation and evaluation. The final checklist includes links to training materials as well as resources with suggested methodology for applying the items. Interpretation: The checklist will serve as a resource for guideline developers. Consideration of items on the checklist will support the development, implementation and evaluation of guidelines. We will use crowdsourcing to revise the checklist and keep it up to date. PMID:24344144

Modern radiation therapy for primary cutaneous lymphomas: field and dose guidelines from the International Lymphoma Radiation Oncology Group.

PubMed

Specht, Lena; Dabaja, Bouthaina; Illidge, Tim; Wilson, Lynn D; Hoppe, Richard T

2015-05-01

Primary cutaneous lymphomas are a heterogeneous group of diseases. They often remain localized, and they generally have a more indolent course and a better prognosis than lymphomas in other locations. They are highly radiosensitive, and radiation therapy is an important part of the treatment, either as the sole treatment or as part of a multimodality approach. Radiation therapy of primary cutaneous lymphomas requires the use of special techniques that form the focus of these guidelines. The International Lymphoma Radiation Oncology Group has developed these guidelines after multinational meetings and analysis of available evidence. The guidelines represent an agreed consensus view of the International Lymphoma Radiation Oncology Group steering committee on the use of radiation therapy in primary cutaneous lymphomas in the modern era. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Psychological Abuse, Mental Health, and Acceptance of Dating Violence Among Adolescents.

PubMed

Temple, Jeff R; Choi, Hye Jeong; Elmquist, JoAnna; Hecht, Michael; Miller-Day, Michelle; Stuart, Gregory L; Brem, Meagan; Wolford-Clevenger, Caitlin

2016-08-01

Existing literature indicates that acceptance of dating violence is a significant and robust risk factor for psychological dating abuse perpetration. Past work also indicates a significant relationship between psychological dating abuse perpetration and poor mental health. However, no known research has examined the relationship between acceptance of dating violence, perpetration of dating abuse, and mental health. In addition to exploring this complex relationship, the present study examines whether psychological abuse perpetration mediates the relationship between acceptance of dating violence and mental health (i.e., internalizing symptoms of depression, anxiety, and hostility). Three waves of longitudinal data were obtained from 1,042 ethnically diverse high school students in Texas. Participants completed assessments of psychological dating abuse perpetration, acceptance of dating violence, and internalizing symptoms (hostility and symptoms of anxiety and depression). As predicted, results indicated that perpetration of psychological abuse was significantly associated with acceptance of dating violence and all internalizing symptoms. Furthermore, psychological abuse mediated the relationship between acceptance of dating violence and internalizing symptoms. Findings from the present study suggest that acceptance of dating violence is an important target for the prevention of dating violence and related emotional distress. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Evaluation of the International Consensus Guidelines for the Surgical Resection of Intraductal Papillary Mucinous Neoplasms.

PubMed

Tsukagoshi, Mariko; Araki, Kenichiro; Saito, Fumiyoshi; Kubo, Norio; Watanabe, Akira; Igarashi, Takamichi; Ishii, Norihiro; Yamanaka, Takahiro; Shirabe, Ken; Kuwano, Hiroyuki

2018-04-01

International consensus guidelines for intraductal papillary mucinous neoplasms (IPMNs) were revised in 2012. We aimed to evaluate the clinical utility of each predictor in the 2006 and 2012 guidelines and validate the diagnostic value and surgical indications. Forty-two patients with surgically resected IPMNs were included. Each predictor was applied to evaluate its diagnostic value. The 2012 guidelines had greater accuracy for invasive carcinoma than the 2006 guidelines (64.3 vs. 31.0%). Moreover, the accuracy for high-grade dysplasia was also increased (48.6 vs. 77.1%). When the main pancreatic duct (MPD) size ≥8 mm was substituted for MPD size ≥10 mm in the 2012 guidelines, the accuracy for high-grade dysplasia was 80.0%. The 2012 guidelines exhibited increased diagnostic accuracy for invasive IPMN. It is important to consider surgical resection prior to invasive carcinoma, and high-risk stigmata might be a useful diagnostic criterion. Furthermore, MPD size ≥8 mm may be predictive of high-grade dysplasia.

[The management of osteoarthritis by general practitioners in Germany: comparison of self-reported behaviour with international guidelines].

PubMed

Rosemann, T; Joos, S; Szecsenyi, J

2008-01-01

In most countries, guidelines for the treatment of osteoarthritis (OA) are available. However, in Germany, no guideline for the primary care sector is available. The care provider of most patients is the general practitioner (GP). The aim of the study was to investigate the approaches in diagnosing and treating OA of German GPs and to assess adherence to international guidelines. Cross-sectional study using a structured questionnaire with a random sample of 144 GPs. Regarding diagnosis, the importance of X-rays was overestimated. Regarding treatment approaches, exercising and weight reduction were regarded as primary treatment targets. Pharmacological treatment approaches were somewhat guideline oriented, but conservative approaches such as physical therapy were overestimated as invasive treatments such as intra-articular injections were underestimated in its benefit. Establishing a guideline specifically for primary care and increasing guideline adherence could help to prevent the present overuse of X-rays and the high amount of referrals to orthopaedics, save costs and reduce inadequate treatments.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine].

PubMed

Han, Xue-Jie; Liu, Meng-Yu; Lian, Zhi-Hua; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Jun

2017-09-01

To evaluate the applicability and clinical applications of Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine, so as to provide the basis for the revision of the guidelines. This study was completed by the research and promotion base for traditional Chinese medicine(TCM) standard. The methods of applicability evaluation and application evaluation were used in the study. The questionnaires were filled out to evaluate applicability of the guideline, including doctor's familiarity with the guideline,the quality of the guideline, applicable conditions and clinical applications. The prospective case study analysis method was used to evaluate application of the guideline, including evaluation of clinical application compliance and application results(such as clinical effects, safety and economy). There were two parts in the guideline, which were TCM guideline and Western medicine guideline. The results of applicability evaluation showed that there were no obvious differences between TCM guideline and Western medicine guideline in doctor's familiarity with guideline(85.43%, 84.57%) and the use of the guideline(52.10%, 54.47%); the guidelines with good quality, and higher scores in the scope of application and the use of the term rationality(91.94%, 93.35%); the rationality scores of relevant contents in syndrome differentiation and treatment were more than 75%; the applicable conditions were better, and the safety score was the the highest. The comprehensive applicability evaluation showed that the proportion of the application of TCM guideline and Western medicine guideline were 77.73%, 75.46%, respectively. The results of application evaluation showed that there was high degree coincidence between the guideline with its clinical application; except for "other treatment" and "recuperation and prevention" in TCM, other items got high scores which were more than 90%; in the evaluation of application effects, safety of the guideline was best, economy of the guideline was better, and clincal effect was good. The comprehensive application evaluation showed that 75%~80% doctors were satisfied with the guideline. The Guidelines for Diagnosis and Treatment of Internal Diseases in Traditional Chinese Medicine has been widely used in clinical practice, which is of high quality, high degree of clinical application,good safety and economy. But there were some disadvantages of the guideline such as lack of evidence-based medicine and innovation, which is need to be improved constantly in the guideline revision. Copyright© by the Chinese Pharmaceutical Association.

40 CFR 240.205-3 - Recommended procedures: Operations.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended... excessive emissions, appropriate adjustments should be made to lower the emission to acceptable levels. ...

ISPOR Code of Ethics 2017 (4th Edition).

PubMed

Santos, Jessica; Palumbo, Francis; Molsen-David, Elizabeth; Willke, Richard J; Binder, Louise; Drummond, Michael; Ho, Anita; Marder, William D; Parmenter, Louise; Sandhu, Gurmit; Shafie, Asrul A; Thompson, David

2017-12-01

As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 - Introduction; 2 - Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 - Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 - Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 - Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 - Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 - Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 - Publication and Dissemination; and 9 - Conclusion and Limitations. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Understanding and avoiding potential problems in implementing automation

NASA Astrophysics Data System (ADS)

Rouse, W. B.; Morris, N. M.

1985-11-01

Technology-driven efforts to implement automation often encounter problems due to lack of acceptance or begrudging acceptance by the personnel involved. It is argued in this paper that the level of automation perceived by an individual heavily influences whether or not the automation is accepted by that individual. The factors that appear to affect perceived level of automation are discussed. Issues considered include the impact of automation on the system and the individual, correlates of acceptance, problems and risks of automation, and factors influencing alienation. Based on an understanding of these issues, a set of eight guidelines is proposed as a possible means of avoiding problems in implementing automation.

Understanding and avoiding potential problems in implementing automation

NASA Technical Reports Server (NTRS)

Rouse, W. B.; Morris, N. M.

1985-01-01

Technology-driven efforts to implement automation often encounter problems due to lack of acceptance or begrudging acceptance by the personnel involved. It is argued in this paper that the level of automation perceived by an individual heavily influences whether or not the automation is accepted by that individual. The factors that appear to affect perceived level of automation are discussed. Issues considered include the impact of automation on the system and the individual, correlates of acceptance, problems and risks of automation, and factors influencing alienation. Based on an understanding of these issues, a set of eight guidelines is proposed as a possible means of avoiding problems in implementing automation.

Longitudinal Relations Between Adolescent and Parental Behaviors, Parental Knowledge, and Internalizing Behaviors Among Urban Adolescents

PubMed Central

Garthe, Rachel C.; Sullivan, Terri; Kliewer, Wendy

2018-01-01

High prevalence rates of depression and anxiety among adolescents underscore the importance of identifying parental and adolescent behaviors that may lessen the risk for these outcomes. Previous research has shown that parental acceptance, parental knowledge, and child disclosure are negatively associated with internalizing behaviors. It is also important to explore the impact of internalizing behaviors on these parental and child constructs. The current study examined longitudinal relationships between parental acceptance, parental knowledge, child disclosure, and internalizing symptoms across a one-year time period. Participants were 358 adolescents (54 % female) and their primary caregivers, who were primarily African American (92 %). Parents and adolescents provided data through face-to-face interviews. Results showed that parental knowledge and parental acceptance predicted child disclosure, and child disclosure predicted parental knowledge one year later. Higher levels of parental acceptance predicted lower levels of adolescent-reported depressive symptoms, while higher levels of parental report of adolescents’ internalizing symptoms predicted lower levels of parental knowledge. No differences in the strength of these relationships were found across grade or gender. These findings highlight the role of the adolescent’s perceived acceptance by parents in promoting children’s disclosure, and the benefits of parental acceptance in decreasing depressive symptoms over time. Overall, these results show the impact that both adolescent and parental behaviors and internalizing behaviors have on each other across time. PMID:24609843

Evaluation of the acceptability, feasibility and effectiveness of two methods of involving patients with disability in developing clinical guidelines: study protocol of a randomized pragmatic pilot trial.

PubMed

Lamontagne, Marie-Eve; Perreault, Kadija; Gagnon, Marie-Pierre

2014-04-10

Despite growing interest in the importance of, and challenges associated with the involvement of patient and population (IPP) in the process of developing and adapting clinical practice guidelines (CPGs), there is a lack of knowledge about the best method to use. This is especially problematic in the field of rehabilitation, where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process. The goal of this pilot trial is to document the acceptability, feasibility and effectiveness of two methods of involving patients with a disability (traumatic brain injury) in CPG development. A single-blind, randomized, crossover pragmatic trial will be performed with 20 patients with traumatic brain injury (TBI). They will be randomized into two groups, and each will try two alternative methods of producing recommendations; a discussion group (control intervention) and a Wiki, a webpage that can be modified by those who have access to it (experimental intervention). The participants will rate the acceptability of the two methods, and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods, and the number of support interventions required. Twenty experts, blinded to the method of producing the recommendations, will independently rate the recommendations produced by the participants for clarity, accuracy, appropriateness and usefulness. Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI. Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings. Clinical trial KT Canada 87776.

ISRIA statement: ten-point guidelines for an effective process of research impact assessment.

PubMed

Adam, Paula; Ovseiko, Pavel V; Grant, Jonathan; Graham, Kathryn E A; Boukhris, Omar F; Dowd, Anne-Maree; Balling, Gert V; Christensen, Rikke N; Pollitt, Alexandra; Taylor, Mark; Sued, Omar; Hinrichs-Krapels, Saba; Solans-Domènech, Maite; Chorzempa, Heidi

2018-02-08

As governments, funding agencies and research organisations worldwide seek to maximise both the financial and non-financial returns on investment in research, the way the research process is organised and funded is becoming increasingly under scrutiny. There are growing demands and aspirations to measure research impact (beyond academic publications), to understand how science works, and to optimise its societal and economic impact. In response, a multidisciplinary practice called research impact assessment is rapidly developing. Given that the practice is still in its formative stage, systematised recommendations or accepted standards for practitioners (such as funders and those responsible for managing research projects) across countries or disciplines to guide research impact assessment are not yet available.In this statement, we propose initial guidelines for a rigorous and effective process of research impact assessment applicable to all research disciplines and oriented towards practice. This statement systematises expert knowledge and practitioner experience from designing and delivering the International School on Research Impact Assessment (ISRIA). It brings together insights from over 450 experts and practitioners from 34 countries, who participated in the school during its 5-year run (from 2013 to 2017) and shares a set of core values from the school's learning programme. These insights are distilled into ten-point guidelines, which relate to (1) context, (2) purpose, (3) stakeholders' needs, (4) stakeholder engagement, (5) conceptual frameworks, (6) methods and data sources, (7) indicators and metrics, (8) ethics and conflicts of interest, (9) communication, and (10) community of practice.The guidelines can help practitioners improve and standardise the process of research impact assessment, but they are by no means exhaustive and require evaluation and continuous improvement. The prima facie effectiveness of the guidelines is based on the systematised expert and practitioner knowledge of the school's faculty and participants derived from their practical experience and research evidence. The current knowledge base has gaps in terms of the geographical and scientific discipline as well as stakeholder coverage and representation. The guidelines can be further strengthened through evaluation and continuous improvement by the global research impact assessment community.

FAO/INFOODS Guidelines for Checking Food Composition Data Prior to the Publication of a User Table/Database, Version 1.0

USDA-ARS?s Scientific Manuscript database

Food composition data play an essential role in many sectors, including nutrition, health, agriculture, environment, food labeling and trade. Over the last 25 years, International Network of Food Data Systems (INFOODS) has developed many international standards, guidelines and tools to obtain harmo...

International Rules for Precollege Science Research: Guidelines for Science and Engineering Fairs, 2007-2008

ERIC Educational Resources Information Center

Science Service, 2007

2007-01-01

This publication presents changes and modifications for 2007-2008 to the "International Rules for Precollege Science Research: Guidelines for Science and Engineering Fairs." It is written to guide fair directors, teachers, scientists, parents, and adult volunteers as they pursue their work of encouraging students to explore and investigate their…

International Rules for Precollege Science Research: Guidelines for Science and Engineering Fairs, 2006-2007

ERIC Educational Resources Information Center

Science Service, 2006

2006-01-01

This publication presents changes and modifications for 2006-2007 to the "International Rules for Precollege Science Research: Guidelines for Science and Engineering Fairs." It is written to guide fair directors, teachers, scientists, parents, and adult volunteers as they pursue their work of encouraging students to explore and investigate their…

[Primary immune thrombocytopenia in adults in Mexico: national characteristics and the relation to international literature].

PubMed

Meillón-García, Luis Antonio; García-Chávez, Jaime; Gómez-Almaguer, David; Gutiérrez-Espíndola, Guillermo R; Martínez-Murillo, Carlos

2014-01-01

In order to identify the clinical approach of a sample of Mexican hematologists for primary immune thrombocytopenia (ITP) in adults in Mexico, we applied an electronic survey via the internet to identify common practices for the diagnosis and treatment of ITP and draw a comparison between the information from these hematologists with international guidelines or the international literature. The results were analyzed using measures of central tendency. The sample was 21 medical hematologists, predominantly from Mexico City (average age: 51.4 years). A total of 66.7% of the surveyed physicians use international guidelines to make therapeutic decisions, and 43% defined ITP including the numerical concept (< 100 x 10(9)/l). We found some differences between requested clinical exams and tests indicated by the guidelines. In first-line treatment (except emergency), 91% of the participants start with prednisone and 24% use dexamethasone. Danazol is used in persistent ITP by most (41%) of the specialists. In second-line treatment, 67% would indicate splenectomy. Some differences were found between clinical practice of the hematologists in Mexico versus guidelines recommendations.

Standardization of search methods for guideline development: an international survey of evidence-based guideline development groups.

PubMed

Deurenberg, Rikie; Vlayen, Joan; Guillo, Sylvie; Oliver, Thomas K; Fervers, Beatrice; Burgers, Jako

2008-03-01

Effective literature searching is particularly important for clinical practice guideline development. Sophisticated searching and filtering mechanisms are needed to help ensure that all relevant research is reviewed. To assess the methods used for the selection of evidence for guideline development by evidence-based guideline development organizations. A semistructured questionnaire assessing the databases, search filters and evaluation methods used for literature retrieval was distributed to eight major organizations involved in evidence-based guideline development. All of the organizations used search filters as part of guideline development. The medline database was the primary source accessed for literature retrieval. The OVID or SilverPlatter interfaces were used in preference to the freely accessed PubMed interface. The Cochrane Library, embase, cinahl and psycinfo databases were also frequently used by the organizations. All organizations reported the intention to improve and validate their filters for finding literature specifically relevant for guidelines. In the first international survey of its kind, eight major guideline development organizations indicated a strong interest in identifying, improving and standardizing search filters to improve guideline development. It is to be hoped that this will result in the standardization of, and open access to, search filters, an improvement in literature searching outcomes and greater collaboration among guideline development organizations.

New Approaches in International Guidelines for Genetic Toxicology Assays: Latest Updates on OECD Guidelines

EPA Science Inventory

In March 2010, the 22nd meeting of the Working Group of National Coordinators of the OECD Test Guidelines Programme (WNT) approved a project for updating the Test Guidelines on genotoxicity, with Canada, the Netherlands, France and the USA identified as lead countries for this wo...

WHO Expert Committee on Specifications for Pharmaceutical Preparations. Forty-ninth report.

PubMed

2015-01-01

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. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities.

Design and construction guidelines for strengthening bridges using fiber reinforced polymers (FRP).

DOT National Transportation Integrated Search

2014-09-01

This research concerns the development of guidelines : for the design and use of externally-bonded FRP : strengthening systems on bridges in Michigan. Si : x representative international FRP-related guidelines : were analyzed and compared for applica...

Pancreatic-duct-lavage cytology in candidates for surgical resection of branch-duct intraductal papillary mucinous neoplasm of the pancreas: should the International Consensus Guidelines be revised?

PubMed

Sai, Jin Kan; Suyama, Masafumi; Kubokawa, Yoshihiro; Watanabe, Sumio; Maehara, Tadayuki

2009-03-01

The International Consensus Guidelines are helpful for the management of branch-duct intraductal papillary mucinous neoplasms (IPMNs), because they allow us to exclude malignancy. However, it is not possible to predict malignancy with certainty, and further preoperative differentiation between benign and malignant IPMNs is required to avoid the false-positive results. To examine the usefulness of pancreatic-duct-lavage cytology by using an originally designed double-lumen catheter for discriminating benign and malignant IPMNs of the branch-duct type in candidates for surgical resection based on the International Consensus Guidelines. Pancreatic-duct-lavage cytology was investigated in 24 patients with branch-duct IPMNs who underwent surgical resection based on the International Consensus Guidelines, namely, they either had intramural nodules or the ectatic branch duct was >30 mm in diameter. Single-center retrospective study. Academic medical center. The sensitivity and specificity of pancreatic-duct-lavage cytology for discriminating benign from malignant IPMNs. More than 30 mL of pancreatic-duct-lavage fluid was obtained from each patient, and there were no patients with noninformative results. The sensitivity, specificity, positive predictive value, and negative predictive value of the cytologic diagnosis were 78%, 93%, 88%, and 88%, respectively. Single-center and small number of patients. Pancreatic-duct-lavage cytology can improve differentiation between benign and malignant IPMNs of the branch-duct type in candidates for surgical resection based on the International Consensus Guidelines.

Usefulness of vegetarian and vegan diets for treating type 2 diabetes.

PubMed

Trapp, Caroline B; Barnard, Neal D

2010-04-01

Significant benefits for diabetes prevention and management have been observed with vegetarian and especially vegan diets. This article reviews observational studies and intervention trials on such diets, and discusses their efficacy, nutritional adequacy, acceptability, and sustainability. Research to date has demonstrated that a low-fat, plant-based nutritional approach improves control of weight, glycemia, and cardiovascular risk. These studies have also shown that carefully planned vegan diets can be more nutritious than diets based on more conventional diet guidelines, with an acceptability that is comparable with that of other therapeutic regimens. Current intervention guidelines from professional organizations offer support for this approach. Vegetarian and vegan diets present potential advantages in managing type 2 diabetes that merit the attention of individuals with diabetes and their caregivers.

The quality of reports of medical and public health research from Palestinian institutions: a systematic review.

PubMed

Albarqouni, Loai; Abu-Rmeileh, Niveen Me; Elessi, Khamis; Obeidallah, Mohammad; Bjertness, Espen; Chalmers, Iain

2017-06-09

Over the past decade, there has been an increase in reports of health research from Palestine, but no assessment of their quality. We have assessed the quality of reports of Palestinian health research and factors associated with it. This is a systematic review. We searched Medline and Scopus for reports of original research relevant to human health or healthcare authored by researchers affiliated with Palestinian institutions and published between January 2000 and August 2015 inclusive. We used international guidelines to assess report quality, classifying as adequate those with ≥50% of items completely addressed. Of 2383 reports identified, 497 met our inclusion criteria. Just over half (264; 55%) of these were published after 2010. 354 (71%) of first authors were affiliated with Palestinian institutions; 261 (53%) reports had coauthors from outside Palestine. The majority of the reports in our study were inadequately reported (342; 69%), and none had adequately reported all items. Of 439 observational studies, 11 (2.5%) reports provided adequate descriptions of eligibility criteria and selection procedures; 35 (8%) reported efforts to address potential sources of bias; 50 (11.4%) reported the basis for the study sample size; and funding sources were mentioned in 74 reports (17%). Higher reporting quality was associated with international affiliation of the first author (prevalence ratio (PR) 1.6 (95% CI 1.2 to 2.1)), international collaboration (PR 2.9 (95% CI 1.7 to 5.0)), international funding (PR 1.9 (95% CI1.5 to 2.5)), publication after 2005 (PR 3.9 (95% CI 1.8 to 8.5)) and four or more coauthors (PR 1.5 (95% CI 1.1 to 2.1)). Although the quality of reports of Palestinian research has improved in recent years, it remains well below an acceptable standard. International reporting guidelines should be used to guide research design and improve the quality of reports of research. The systematic review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) registery (registration number: CRD42015027553). © 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.

Challenges in the research ethics review of cluster randomized trials: international survey of investigators.

PubMed

Chaudhry, Shazia H; Brehaut, Jamie C; Grimshaw, Jeremy M; Weijer, Charles; Boruch, Robert; Donner, Allan; Eccles, Martin P; McRae, Andrew D; Saginur, Raphael; Skea, Zoë C; Zwarenstein, Merrick; Taljaard, Monica

2013-04-01

Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or strongly agreed that there is a need to develop ethics guidelines for CRTs, and (70%; 95% CI: 63%-77%) that ethics committees could be better informed about distinct ethical issues surrounding CRTs. Thirty-six percent of authors did not respond to the survey. Due to the absence of comparable results from a representative sample of authors of individually randomized trials, it is unclear to what extent the reported challenges result from the CRT design. CRT investigators are experiencing challenges in the research ethics review of their trials, including excessive delays, variability in process and outcome, and imposed requirements that can have negative consequences for study conduct. Investigators identified a clear need for ethics guidelines for CRTs and education of research ethics committees about distinct ethical issues in CRTs.

Guidelines and algorithms for managing the difficult airway.

PubMed

Gómez-Ríos, M A; Gaitini, L; Matter, I; Somri, M

2018-01-01

The difficult airway constitutes a continuous challenge for anesthesiologists. Guidelines and algorithms are key to preserving patient safety, by recommending specific plans and strategies that address predicted or unexpected difficult airway. However, there are currently no "gold standard" algorithms or universally accepted standards. The aim of this article is to present a synthesis of the recommendations of the main guidelines and difficult airway algorithms. Copyright © 2017 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

[Perioperative coagulation management in microsurgery: report of the consensus workshops in the course of the 31st and 32nd Annual Meeting of the German-language Working Group for microsurgery of the peripheral nerves and vessels (DAM) November 2009 in Erlangen and November 2010 in Basel].

PubMed

Schmitz, M; Riss, R; Kneser, U; Jokuszies, A; Harder, Y; Beier, J P; Schäfer, D J; Vogt, P M; Fansa, H; Andree, C; Pierer, G; Horch, R E

2011-12-01

Microsurgery is a very relevant component of reconstructive surgery. In this context anticoagulation plays an increasing role. At the moment there are no unanimously accepted prospective studies or generally accepted regimes available that could serve as evidence-based guidelines for the prevention of thrombosis in microsurgery. With regard to this problem the aim of a series of workshops during the annual meetings of the German-speaking group for microsurgery in 2009 and 2010 was to establish a first possible consensus. This article reflects the main aspects of the ongoing development of a generally acceptable guideline for anticoagulation in microsurgery as interim report of these consensus workshops. Basically there are 3 main agents in thromboprophylaxis available: antiplatelet drugs, dextran and heparin. In the course of the workshops no general use of aspirin or dextran for anticoagulation in microsurgery was recommended. The use of heparin as anticoagulation agent is advisable for different indications. Low molecular heparins (LMH) have certain advantages in comparison to unfractionated heparins (UFH) and are therefore preferred by most participants. Indications for UFH are still complex microsurgical revisions, renal failure and some specific constellations in patients undergoing reconstruction of the lower extremity, where the continuous administration of heparin is recommended. At the moment of clamp release a single-shot of UFH is still given by many microsurgeons, despite a lack of scientific evidence. Future prospective clinical trials and the establishment of a generally accepted evidence-based guideline regarding anticoagulation treatment in microsurgery are deemed necessary. © Georg Thieme Verlag KG Stuttgart · New York.

Disintegration of highly soluble immediate release tablets: a surrogate for dissolution.

PubMed

Gupta, Abhay; Hunt, Robert L; Shah, Rakhi B; Sayeed, Vilayat A; Khan, Mansoor A

2009-01-01

The purpose of the work was to investigate correlation between disintegration and dissolution for immediate release tablets containing a high solubility drug and to identify formulations where disintegration test, instead of the dissolution test, may be used as the acceptance criteria based on International Conference on Harmonization Q6A guidelines. A statistical design of experiments was used to study the effect of filler, binder, disintegrating agent, and tablet hardness on the disintegration and dissolution of verapamil hydrochloride tablets. All formulation variables, i.e., filler, binder, and disintegrating agent, were found to influence tablet dissolution and disintegration, with the filler and disintegrating agent exerting the most significant influence. Slower dissolution was observed with increasing disintegration time when either the filler or the disintegrating agent was kept constant. However, no direct corelationship was observed between the disintegration and dissolution across all formulations due to the interactions between different formulation components. Although all tablets containing sodium carboxymethyl cellulose as the disintegrating agent, disintegrated in less than 3 min, half of them failed to meet the US Pharmacopeia 30 dissolution criteria for the verapamil hydrochloride tablets highlighting the dependence of dissolution process on the formulation components other than the disintegrating agent. The results identified only one formulation as suitable for using the disintegration test, instead of the dissolution test, as drug product acceptance criteria and highlight the need for systematic studies before using the disintegration test, instead of the dissolution test as the drug acceptance criteria.

Contact lens disinfecting solutions antibacterial efficacy: comparison between clinical isolates and the standard ISO ATCC strains of Pseudomonas aeruginosa and Staphylococcus aureus.

PubMed

Mohammadinia, M; Rahmani, S; Eslami, G; Ghassemi-Broumand, M; Aghazadh Amiri, M; Aghaie, Gh; Tabatabaee, S M; Taheri, S; Behgozin, A

2012-02-01

To evaluate the disinfectant properties of the three multipurpose contact lens disinfecting solutions available in Iran, against clinical isolates and the standard ISO ATCC strains of Pseudomonas aeruginosa and Staphylococcus aureus, based on the international organization for standardization (ISO) 14729 guidelines. Three multipurpose solutions that were tested were ReNu Multiplus, Solo Care Aqua and All-Clean Soft. The test solutions were challenged with clinical isolates and the standard strains of P. aeruginosa(ATCC 9027) and S. aureus(ATCC 6538), based on the ISO Stand-alone procedure for disinfecting products. Solutions were sampled for surviving microorganisms at manufacturer's minimum recommended disinfection time. The number of viable organisms was determined and log reductions calculated. All of the three test solutions in this study provided a reduction greater than the required mean 3.0 logarithmic reduction against the recommended standard ATCC strains of P. aeruginosa and S. aureus. Antibacterial effectiveness of Solo Care Aqua and All-Clean Soft against clinical isolates of P. aeruginosa and S. aureus were acceptable based on ISO 14729 Stand-alone test. ReNu MultiPlus showed a minimum acceptable efficacy against the clinical isolate of S. aureus, but did not reduce the clinical isolate by the same amount. Although the contact lens disinfecting solutions meet/exceed the ISO 14729 Stand-alone primary acceptance criteria for standard strains of P. aeruginosa and S. aureus, their efficacy may be insufficient against clinical isolates of these organisms.

Contact lens disinfecting solutions antibacterial efficacy: comparison between clinical isolates and the standard ISO ATCC strains of Pseudomonas aeruginosa and Staphylococcus aureus

PubMed Central

Mohammadinia, M; Rahmani, S; Eslami, G; Ghassemi-Broumand, M; Aghazadh Amiri, M; Aghaie, Gh; Tabatabaee, S M; Taheri, S; Behgozin, A

2012-01-01

Purpose To evaluate the disinfectant properties of the three multipurpose contact lens disinfecting solutions available in Iran, against clinical isolates and the standard ISO ATCC strains of Pseudomonas aeruginosaand Staphylococcus aureus, based on the international organization for standardization (ISO) 14729 guidelines. Methods Three multipurpose solutions that were tested were ReNu Multiplus, Solo Care Aqua and All-Clean Soft. The test solutions were challenged with clinical isolates and the standard strains of P. aeruginosa(ATCC 9027) and S. aureus(ATCC 6538), based on the ISO Stand-alone procedure for disinfecting products. Solutions were sampled for surviving microorganisms at manufacturer's minimum recommended disinfection time. The number of viable organisms was determined and log reductions calculated. Results All of the three test solutions in this study provided a reduction greater than the required mean 3.0 logarithmic reduction against the recommended standard ATCC strains of P. aeruginosaand S. aureus. Antibacterial effectiveness of Solo Care Aqua and All-Clean Soft against clinical isolates of P. aeruginosaand S. aureuswere acceptable based on ISO 14729 Stand-alone test. ReNu MultiPlus showed a minimum acceptable efficacy against the clinical isolate of S. aureus, but did not reduce the clinical isolate by the same amount. Conclusions Although the contact lens disinfecting solutions meet/exceed the ISO 14729 Stand-alone primary acceptance criteria for standard strains of P. aeruginosaand S. aureus, their efficacy may be insufficient against clinical isolates of these organisms. PMID:22094301

Evaluation of the reliability and validity of the Persian version of Patient-Rated Elbow Evaluation questionnaire.

PubMed

Farazdaghi, Mohammad Reza; Mansoori, Ali; Vosoughi, Omid; Kordi Yoosefinejad, Amin

2017-05-01

Elbow joint pathologies are highly prevalent in Persian-speaking countries. A reliable low-cost method like an appropriate questionnaire is mandatory for the early diagnosis of elbow joint disorders. Among designed questionnaires, Patient-Rated Elbow Evaluation (PREE) is an accepted commonly used scale evaluating pain and dysfunction of the patients. The aims of the study were to cross-culturally adapt and also to identify the psychometric properties of the Persian PREE. The original version of the PREE was translated and cross-culturally adapted to Persian according to the guidelines by Beaton et al. Seventy-three patients and thirty-nine healthy people were enrolled in the study. Test-retest reliability and internal consistency were evaluated using ICC, Cronbach's alpha, and item-total correlation, respectively. Construct validity was investigated using Disability of Arm, Shoulder, and Hand (DASH) questionnaire and physical component scale of SF-36 (PCS). To determine a cutoff point for discriminating patients from non-patients, receiver operating characteristic curve was plotted. The Persian PREE displayed high internal consistency (Cronbach's alpha = 0.91) and had acceptable ICC values in the subscales and total score (ICC > 0.90). A positive moderate correlation with DASH (r = 0.66, P < 0.001) and a negative moderate correlation with PCS of SF-36 (r = -0.44, P < 0.001) were observed. The cutoff point equal to 13.16 was determined for Persian PREE. The Persian PREE exhibited promising validity and reliability. The findings supported its applicability in clinical situations that were consistent with the original version.

MANUAL: GUIDELINES FOR WATER REUSE

EPA Science Inventory

Water reclamation for nonpotable reuse has been adopted in the United States and elsewhere without the benefit of national or international guidelines or standards. However, in recent years, many states in the U.S. have adopted standards or guidelines, and the World Health Organi...

U.S. EPA’S GUIDELINES FOR WATER REUSE

EPA Science Inventory

In August 2004, the U.S. Environmental Protection Agency and the U.S. Agency for International Development published “Guidelines for Water Reuse”, updating their 1992 guidelines document. Because communities around the world are reaching, or have reached, the limits o...

Multicultural Communities: Guidelines for Library Services. Third Edition

ERIC Educational Resources Information Center

International Federation of Library Associations and Institutions (NJ1), 2009

2009-01-01

These Guidelines constitute the third edition of the International Federation of Library Associations (IFLA) "Multicultural Communities: "Guidelines for Library Services." This revision follows the IFLA Section of Library Services to Multicultural Populations' "2006-2010 Strategic Plans": to review and revise the…

Is being mindful associated with reduced risk for internally-motivated drinking and alcohol use among undergraduates?

PubMed

Reynolds, Ashley; Keough, Matthew T; O'Connor, Roisin M

2015-03-01

Mindfulness encompasses four core skills: observing, describing, acting with awareness, and accepting without judgment; which aim to increase one's awareness, tolerance, and acceptance of internal experiences (Baer et al., 2004). Despite promising clinical results that mindfulness reduces alcohol craving and relapse, complementary etiological research is underdeveloped. Theory suggests that those who are motivated to drink to change internal states (reduce negative/increase positive affect) are at risk for elevated alcohol use. The ability to accept one's affective state should preclude internally-motivated drinking, and thus, elevated alcohol use. The purpose of this study was to parse out which mindfulness skills are central to alcohol use. We hypothesized that accepting without judgment would be a unique negative predictor of internally-motivated drinking (drinking for coping and enhancement motives) and alcohol use. Students (N=76) completed self-report measures of past month alcohol use and four motives for drinking: to cope, for enhancement, to conform, and for social reasons. Partially supporting our hypotheses, accepting without judgment was negatively associated with drinking for coping motives, but was unassociated with drinking for enhancement motives. Interestingly, acceptance without judgment was negatively associated with drinking for conformity motives (to reduce social rejection). Unexpectedly, acting with awareness, but not accepting without judgment, was a negative predictor of alcohol use. Our findings suggest that interventions aimed at reducing coping- and conformity-motivated drinking and alcohol use by young adults may benefit from incorporating mindfulness skills training (i.e., accepting without judgment; acting with awareness). Copyright © 2014 Elsevier Ltd. All rights reserved.

Development of the Parkland-UT Southwestern Colonoscopy Reporting System (CoRS) for evidence-based colon cancer surveillance recommendations

PubMed Central

Gupta, Samir; Halm, Ethan A; Wright, Shaun; McCallister, Katharine; Bishop, Wendy; Santini, Noel; Mayorga, Christian; Agrawal, Deepak; Moran, Brett; Sanders, Joanne M; Singal, Amit G

2016-01-01

Objective Through colonoscopy, polyps can be identified and removed to reduce colorectal cancer incidence and mortality. Appropriate use of surveillance colonoscopy, post polypectomy, is a focus of healthcare reform. Materials and Methods The authors developed and implemented the first electronic medical record–based colonoscopy reporting system (CoRS) that matches endoscopic findings with guideline-consistent surveillance recommendations and generates tailored results and recommendation letters for patients and providers. Results In its first year, CoRS was used in 98.6% of indicated cases. Via a survey, colonoscopists agreed/strongly agreed it is easy to use (83%), provides guideline-based recommendations (89%), improves quality of Spanish letters (94%), they would recommend it for other institutions (78%), and it made their work easier (61%), and led to improved practice (56%). Discussion CoRS’ widespread adoption and acceptance likely resulted from stakeholder engagement throughout the development and implementation process. Conclusion CoRS is well-accepted by clinicians and provides guideline-based recommendations and results communications to patients and providers. PMID:26254481

Global Initiatives for Early Childhood Care and Education: Global Guidelines and Global Guidelines Assessment

ERIC Educational Resources Information Center

Trube, Mary Barbara

2015-01-01

This report focuses on the Association for Childhood Education International's (ACEI) Global Guidelines (GG) and Global Guidelines Assessment (GGA), which were developed in response to and in keeping with the prominence that the issue of quality early childhood care, development, and education has reached globally. Further, the paper positions the…

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.

IFLA General Conference, 1985. Division on Libraries Serving the General Public. Section on Public Libraries. Papers.

ERIC Educational Resources Information Center

International Federation of Library Associations, The Hague (Netherlands).

This document includes papers on public libraries which were presented at the 1985 International Federation of Library Associations (IFLA) conference. The first paper, "International Guidelines for Public Libraries," is the report of an IFLA working group and it includes guidelines in six areas: public library services; media of…

Psychosocial issues in evidence-based guidelines on inflammatory bowel diseases: A review

PubMed Central

Häuser, Winfried; Moser, Gabriele; Klose, Petra; Mikocka-Walus, Antonina

2014-01-01

AIM: To study statements and recommendations on psychosocial issues as presented in international evidence-based guidelines on the management of inflammatory bowel diseases (IBD). METHODS: MEDLINE, guidelines International Network, National Guideline Clearing House and National Institute for Health and Care Excellence were searched from January 2006 to June 30, 2013 for evidence-based guidelines on the management of IBD. RESULTS: The search yielded 364 hits. Thirteen guidelines were included in the review, of which three were prepared in Asia, eight in Europe and two in the United States. Eleven guidelines made statements and recommendations on psychosocial issues. The guidelines were concordant in that mental health disorders and stress do not contribute to the aetiology of IBD, but that they can influence its course. It was recommended that IBD-patients should be screened for psychological distress. If indicated, psychotherapy and/or psychopharmacological therapy should be recommended. IBD-centres should collaborate with mental health care specialists. Tobacco smoking patients with Crohn’s disease should be advised to quit. CONCLUSION: Patients and mental health specialists should be able to participate in future guideline groups to contribute to establishing recommendations on psychosocial issues in IBD. Future guidelines should acknowledge the presence of psychosocial problems in IBD-patients and encourage screening for psychological distress. PMID:24707152

Analyzing international clinical education practices for Canadian rehabilitation students.

PubMed

Ahluwalia, Puja; Cameron, Debra; Cockburn, Lynn; Ellwood, Lynn; Mori, Brenda; Nixon, Stephanie A

2014-09-09

Clinical training in low-income countries has become increasingly popular among pre-licensure trainees from high-income countries. The Working Group on Ethics Guidelines for Global Health Training ("WEIGHT Guidelines") were designed to identify and inform the complex and contentious field of international clinical education. The purpose of this study was to use the WEIGHT Guidelines to evaluate an international clinical internship programme for Master's-level rehabilitation students at a Canadian university. In-depth, semi-structured interviews were conducted with eight Canadian rehabilitation researchers, educations and/or clinicians responsible for administering international internships across three clinical training programmes. Interview questions were informed by the WEIGHT Guidelines. Directed content analysis was used to identify priorities for policy, practice and research. Five themes relating to strengthening international clinical education were identified: (1) from one-time internships to long-term partnerships, (2) starting a discussion about "costs", (3) a more informed approach to student selection, (4) expanding and harmonizing pre-departure training across disciplines, and (5) investing in post-internship debriefing. International clinical education is fraught with ethical, pedagogical and logistical issues that require recognition and ongoing management. This is the first study to use the WEIGHT Guidelines as a qualitative research tool for assessing an existing global health education programme. Results highlight new priorities for action at the Canadian "sending institution", including more explicit attention to the costs (broadly defined) borne by all parties. A crucial next step is deepened engagement with educational partners at the "receiving organizations" based in low-income countries to nurture dialogue regarding reciprocity, trust and sustainability of the partnership. Education research is also needed that evaluates models of pre-departure training and post-internship debriefing for trainees.

Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice.

PubMed

Cohen, A D; Wu, J J; Puig, L; Chimenti, S; Vender, R; Rajagopalan, M; Romiti, R; de la Cruz, C; Skov, L; Zachariae, C; Young, H S; Foley, P; van der Walt, J M; Naldi, L; Prens, E P; Blauvelt, A

2017-12-01

The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of 'big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies. © 2017 British Association of Dermatologists.

Discrepancy among acute guideline levels for emergency response.

PubMed

Oberg, Mattias; Palmen, Nicole; Johanson, Gunnar

2010-12-15

Acute guidance values are tools for public health risk assessment and management during planning, preparedness and response related to sudden airborne release of hazardous chemicals. The two most frequently used values, i.e. Acute Exposure Guidance Levels (AEGL) and Emergency Response Planning Guideline (ERPG), were compared in qualitative and quantitative terms. There was no significant difference between the general level of AEGL and ERPG values, suggesting the two systems are equally precautious. However, the guidance values diverged by a factor of 3 or more for almost 40% of the substances, including many of high production volume. These deviations could be explained by differences in selection of critical effect or critical study and in a few cases differences in interpretation of the same critical study. Diverging guidance values may hamper proper risk communication and risk management. Key factors for broad international acceptance of harmonized values include transparency of the decision process, agreement on definition of toxicological tiers, and a target population including sensitive groups of the general population. In addition, development of purely health based values is encouraged. Risk management issues, such as land use and emergency response planning should be treated separately, as these rely on national legislation and considerations. Copyright © 2010 Elsevier B.V. All rights reserved.

2014 Consensus conference on viscoelastic test-based transfusion guidelines for early trauma resuscitation: Report of the panel.

PubMed

Inaba, Kenji; Rizoli, Sandro; Veigas, Precilla V; Callum, Jeannie; Davenport, Ross; Hess, John; Maegele, Marc

2015-06-01

There has been an increased interest in the use of viscoelastic testing to guide blood product replacement during the acute resuscitation of the injured patient. Currently, no uniformly accepted guidelines exist for how this technology should be integrated into clinical care. In September 2014, an international multidisciplinary group of leaders in the field of trauma coagulopathy and resuscitation was assembled for a 2-day consensus conference in Philadelphia, Pennsylvania. This panel included trauma surgeons, hematologists, blood bank specialists, anesthesiologists, and the lay public.Nine questions regarding the impact of viscoelastic testing in the early resuscitation of trauma patients were developed before the conference by panel consensus. Early use was defined as baseline viscoelastic test result thresholds obtained within the first minutes of hospital arrival-when conventional laboratory results are not available. The available data for each question were then reviewed in person using standardized presentations by the expert panel. A consensus summary document was then developed and reviewed by the panel in an open forum. Finally, a two-round Delphi poll was administered to the panel of experts regarding viscoelastic thresholds for triggering the initiation of specific treatments including fibrinogen, platelets, plasma, and prothrombin complex concentrates. This report summarizes the findings and recommendations of this consensus conference.

Moral agency, moral worth and the question of double standards in medical research in developing countries.

PubMed

Tangwa, G B

2001-11-01

International regulations governing medical research, healthcare and medical practice, are, obviously, meant to be guidelines and not detailed procedural rules of thumb that can be applied unreflectively without any danger of doing moral wrong. Moreover, such regulations are meant to apply internationally, and no set of straight-jacketed rules of thumb can conceivably apply to all societies and communities of the world, extremely diverse and differently situated as they are. The mark of a good international guideline or regulation, in my view, is that it should provide a clear principle of action that applies equally to all global communities and societies without seeking to foist the particular or momentary moral dilemmas, quandaries, obsessions and preoccupations of some on all. In this paper, I propose to argue that, because moral obligations are obligations only from the point of view of a particular moral agent, we should avoid making the peculiar problems of any particular moral agent(s) the obsessive concern of all moral agents, and that we need, in particular, to make appropriate distinctions between the ethics of developed world research in the developing world, collaborative or cooperative research between the developed and developing worlds, developed world research in the developed world and developing world research in the developing world. A consequence of looking at things this way is that, while it should be clear that there are ethical concerns, imperatives and obligations at all levels, different standards may and, in fact, cannot but be applied in different contexts at different levels, without resorting to the use of double standards, which can never be morally justified. Finally, I venture to propose a formula for a solemn pledge of moral integrity and noble intent, from the perspective of the agent, that is to say, the investigator, sponsor and funder of any research, to complement and balance the widely accepted informed consent requirement, from the perspective of the patient, the subject of any biomedical research.

Current challenges in adherence to clinical guidelines for antibiotic prophylaxis in surgery.

PubMed

Khan, Sohail Ahmad; Rodrigues, Gabrial; Kumar, Pramod; Rao, Padma G M

2006-06-01

To study the impact of guidelines on surgical antibiotic prophylaxis in clinical practice, barriers involved in adherence to guidelines and how to overcome the same. Literature pertaining to prophylactic antibiotic usage was searched. Medscape, Medline, Cochrane, Surgical Infection Prevention (SIP) project databases were reviewed. Recent articles from relevant journals, texts, and standard guidelines were also studied. Local guidelines seem more likely to be accepted and followed than those developed nationally. Major barriers involved in adherence to guidelines include lack of awareness about the guidelines, general perception of guideline as a bureaucratic rather than educational tool. Some practitioners perceive guidelines as "cookbook medicine" that does not permit them to make their own medical decisions. Other barriers are complex, multi-step systems that create confusion, decrease accountability. Methods for guideline adherence include surveillance and data analysis, new systems to facilitate documentation and improving workflow, education regarding current evidence-based guidelines and promoting the development of local guidelines or protocol, development and implementation of reminders to facilitate adherence to the local guidelines. A multidisciplinary steering team of surgeons, infectious disease specialists, pharmacists, anesthesiologists, microbiologists and nurses should develop local guidelines suitable to their institution and methods for adherence to prevent the surgical site infections. The gap between evidence-based guidelines and practice must be addressed in order to achieve optimal practice in this domain.

40 CFR 240.204-3 - Recommended procedures: Operations.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended... acceptable levels. (b) In the event of an accidental spill, the local regulatory agency should be notified...

Airborne Contaminants in the TE Lab: How to Reduce Your Exposure.

ERIC Educational Resources Information Center

Zeimet, Denis E.; Merrell, Wayne L.

1995-01-01

Details the dangers from airborne contaminants in technology education laboratories and ways to protect students from them, including ventilation, acceptable limits, and guidelines for using respirators. (SK)

U.S. EPA’S GUIDELINES FOR WATER REUSE

EPA Science Inventory

In August 2004, the U.S. Environmental Protection Agency and the U.S. Agency for International Development published “Guidelines for Water Reuse”, updating their 1992 guidelines document. Because communities around the world are reaching, or have reached, the limits of available...

Guidelines for lighting of plants in controlled environments

NASA Technical Reports Server (NTRS)

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

1994-01-01

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

Guidelines for lighting of plants in controlled environments

NASA Astrophysics Data System (ADS)

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

1994-03-01

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

A General Methodology for the Translation of Behavioral Terms into Vernacular Languages.

PubMed

Virues-Ortega, Javier; Martin, Neil; Schnerch, Gabriel; García, Jesús Ángel Miguel; Mellichamp, Fae

2015-05-01

As the field of behavior analysis expands internationally, the need for comprehensive and systematic glossaries of behavioral terms in the vernacular languages of professionals and clients becomes crucial. We created a Spanish-language glossary of behavior-analytic terms by developing and employing a systematic set of decision-making rules for the inclusion of terms. We then submitted the preliminary translation to a multi-national advisory committee to evaluate the transnational acceptability of the glossary. This method led to a translated corpus of over 1200 behavioral terms. The end products of this work included the following: (a) a Spanish-language glossary of behavior analytic terms that are publicly available over the Internet through the Behavior Analyst Certification Board and (b) a set of translation guidelines summarized here that may be useful for the development of glossaries of behavioral terms into other vernacular languages.

Biofeedback for pain management in traumatised refugees.

PubMed

Muller, Julia; Karl, Anke; Denke, Claudia; Mathier, Fabienne; Dittmann, Jennifer; Rohleder, Nicolas; Knaevelsrud, Christine

2009-01-01

Chronic pain (CP) and posttraumatic stress disorder (PTSD) are both frequent and often comorbid in refugees. To date, few controlled trials have studied the efficacy of treatments targeting this comorbidity; no treatment guidelines yet exist. The authors examined the feasibility and efficacy of short-term cognitive behavioural biofeedback (BF) addressing CP in traumatised refugees. The sample comprised 11 severely traumatised refugees with CP and PTSD (mean age = 36 years, SD = 6), who underwent assessment with the Mini International Neuropsychiatric Interview, Posttraumatic Diagnostic Scale, Pain Disability Index, and Visual Rating Scale. Additionally, coping with pain and psychotherapy tolerance were assessed. Acceptance of BF was high. Pre-post effects were small to medium for increased pain management and associated heart rate reactivity but large for coping with pain. The results encourage further research to confirm whether BF is indicated as a treatment component, but not a stand-alone treatment, for traumatised refugees with comorbid CP and PTSD.

Topical negative pressure wound therapy: a review of its role and guidelines for its use in the management of acute wounds.

PubMed

Bovill, Estas; Banwell, Paul E; Teot, Luc; Eriksson, Elof; Song, Colin; Mahoney, Jim; Gustafsson, Ronny; Horch, Raymund; Deva, Anand; Whitworth, Ian

2008-10-01

Over the past two decades, topical negative pressure (TNP) wound therapy has gained wide acceptance as a genuine strategy in the treatment algorithm for a wide variety of acute and chronic wounds. Although extensive experimental and clinical evidence exists to support its use and despite the recent emergence of randomised control trials, its role and indications have yet to be fully determined. This article provides a qualitative overview of the published literature appertaining to the use of TNP therapy in the management of acute wounds by an international panel of experts using standard methods of appraisal. Particular focus is applied to the use of TNP for the open abdomen, sternal wounds, lower limb trauma, burns and tissue coverage with grafts and dermal substitutes. We provide evidence-based recommendations for indications and techniques in TNP wound therapy and, where studies are insufficient, consensus on best practice.

Collaborative trial validation study of two methods, one based on high performance liquid chromatography-tandem mass spectrometry and on gas chromatography-mass spectrometry for the determination of acrylamide in bakery and potato products.

PubMed

Wenzl, Thomas; Karasek, Lubomir; Rosen, Johan; Hellenaes, Karl-Erik; Crews, Colin; Castle, Laurence; Anklam, Elke

2006-11-03

A European inter-laboratory study was conducted to validate two analytical procedures for the determination of acrylamide in bakery ware (crispbreads, biscuits) and potato products (chips), within a concentration range from about 20 microg/kg to about 9000 microgg/kg. The methods are based on gas chromatography-mass spectrometry (GC-MS) of the derivatised analyte and on high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) of native acrylamide. Isotope dilution with isotopically labelled acrylamide was an integral part of both methods. The study was evaluated according to internationally accepted guidelines. The performance of the HPLC-MS/MS method was found to be superior to that of the GC-MS method and to be fit-for-the-purpose.

A new year, a new Journal.

PubMed

Fokkens, W J

2018-03-01

Let us start this first editorial of 2018 with wishing you all a marvelous year where most of your dreams come true. In the last years, the editors of Rhinology felt often very unhappy when again we had to refuse papers send to us for Rhinology. Unfortunately, every year we can only accept around 15% of the papers we receive. With pain in our hearts, we often have to refuse papers of good quality but just not innovative enough or with slight methodological imperfections. The editorial board of Rhinology recognized this feeling and we decided to start a new journal: Rhinology Online to have space for all those papers that are good but just do not make the cut for Rhinology. Rhinology Online is a journal of the European Rhinologic Society, and will provide a platform for the dissemination of rhinologic research and reviews, as well as position papers, task force reports and guidelines, amongst an international scientific audience.

Emergence of new norovirus variants on spring cruise ships and prediction of winter epidemics.

PubMed

Verhoef, Linda; Depoortere, Evelyn; Boxman, Ingeborg; Duizer, Erwin; van Duynhoven, Yvonne; Harris, John; Johnsen, Christina; Kroneman, Annelies; Le Guyader, Soizick; Lim, Wilina; Maunula, Leena; Meldal, Hege; Ratcliff, Rod; Reuter, Gábor; Schreier, Eckart; Siebenga, Joukje; Vainio, Kirsti; Varela, Carmen; Vennema, Harry; Koopmans, Marion

2008-02-01

In June 2006, reported outbreaks of norovirus on cruise ships suddenly increased; 43 outbreaks occurred on 13 vessels. All outbreaks investigated manifested person-to-person transmission. Detection of a point source was impossible because of limited investigation of initial outbreaks and data sharing. The most probable explanation for these outbreaks is increased norovirus activity in the community, which coincided with the emergence of 2 new GGII.4 variant strains in Europe and the Pacific. As in 2002, a new GGII.4 variant detected in the spring and summer corresponded with high norovirus activity in the subsequent winter. Because outbreaks on cruise ships are likely to occur when new variants circulate, an active reporting system could function as an early warning system. Internationally accepted guidelines are needed for reporting, investigating, and controlling norovirus illness on cruise ships in Europe.

Emergence of New Norovirus Variants on Spring Cruise Ships and Prediction of Winter Epidemics

PubMed Central

Depoortere, Evelyn; Boxman, Ingeborg; Duizer, Erwin; van Duynhoven, Yvonne; Harris, John; Johnsen, Christina; Kroneman, Annelies; Le Guyader, Soizick; Lim, Wilina; Maunula, Leena; Meldal, Hege; Ratcliff, Rod; Reuter, Gábor; Schreier, Eckart; Siebenga, Joukje; Vainio, Kirsti; Varela, Carmen; Vennema, Harry; Koopmans, Marion

2008-01-01

In June 2006, reported outbreaks of norovirus on cruise ships suddenly increased; 43 outbreaks occurred on 13 vessels. All outbreaks investigated manifested person-to-person transmission. Detection of a point source was impossible because of limited investigation of initial outbreaks and data sharing. The most probable explanation for these outbreaks is increased norovirus activity in the community, which coincided with the emergence of 2 new GGII.4 variant strains in Europe and the Pacific. As in 2002, a new GGII.4 variant detected in the spring and summer corresponded with high norovirus activity in the subsequent winter. Because outbreaks on cruise ships are likely to occur when new variants circulate, an active reporting system could function as an early warning system. Internationally accepted guidelines are needed for reporting, investigating, and controlling norovirus illness on cruise ships in Europe. PMID:18258116

Cost-effectiveness of cognitive-behavioural therapy for mental disorders: implications for public health care funding policy in Canada.

PubMed

Myhr, Gail; Payne, Krista

2006-09-01

Publicly funded cognitive-behavioural therapy (CBT) for mental disorders is scarce in Canada, despite proven efficacy and guidelines recommending its use. This paper reviews published data on the economic impact of CBT to inform recommendations for current Canadian mental health care funding policy. We searched the literature for economic analyses of CBT in the treatment of mental disorders. We identified 22 health economic studies involving CBT for mood, anxiety, psychotic, and somatoform disorders. Across health care settings and patient populations, CBT alone or in combination with pharmacotherapy represented acceptable value for health dollars spent, with CBT costs offset by reduced health care use. International evidence suggests CBT is cost-effective. Greater access to CBT would likely improve outcomes and result in cost savings. Future research is warranted to evaluate the economic impact of CBT in Canada.

Contracting in vivo research: what are the issues?

PubMed

Underwood, Wendy J

2007-07-01

As a result of increasing internal and external pressures, research institutions are using contract research organizations for the conduct of in vivo research. Many issues arise when contracting animal research, including concern regarding animal health and welfare. Each sponsor institution should develop a program for outsourced in vivo research that evaluates and ensures appropriate care and use of research animals. Each sponsoring institution should consider establishing a policy and procedure for how outsourced in vivo studies will be approved, conducted, and monitored. An approved list of contract facilities can be established on the basis of accepted standards for animal care and use. Written contracts should include confidentiality agreements, the delineation of animal ownership, and the expectation to comply with all applicable regulations and guidelines for research animal care and use. Finally, a process for communication of adverse study or animal welfare events should be established. Thorough evaluation of contract organizations will help ensure appropriate research animal care and use.

"More bang for the buck": exploring optimal approaches for guideline implementation through interviews with international developers.

PubMed

Gagliardi, Anna R

2012-11-15

Population based studies show that guidelines are underused. Surveys of international guideline developers found that many do not implement their guidelines. The purpose of this research was to interview guideline developers about implementation approaches and resources. Semi-structured telephone interviews were conducted with representatives of guideline development agencies identified in the National Guideline Clearinghouse and sampled by country, type of developer, and guideline clinical indication. Participants were asked to comment on the benefits and resource implications of three approaches for guideline implementation that varied by responsibility: developers, intermediaries, or users. Thirty individuals from seven countries were interviewed, representing government (n = 12) and professional (n = 18) organizations that produced guidelines for a variety of clinical indications. Organizations with an implementation mandate featured widely inconsistent funding and staffing models, variable approaches for choosing promotional strategies, and an array of dissemination activities. When asked to choose a preferred approach, most participants selected the option of including information within guidelines that would help users to implement them. Given variable mandate and resources for implementation, it was considered the most feasible approach, and therefore most likely to have impact due to potentially broad use. While implementation approaches and strategies need not be standardized across organizations, the findings may be used by health care policy makers and managers, and guideline developers to generate strategic and operational plans that optimize implementation capacity. Further research is needed to examine how to optimize implementation capacity by guideline developers, intermediaries and users.

Delphi Rating on the Internet

PubMed Central

Deshpande, Aniruddha M.; Shiffman, Richard N.

2003-01-01

We designed an application to allow respondents to rate components of clinical guidelines on the Internet. Twenty-three invited experts completed the rating followed by a satisfaction survey using a 5-level Likert scale. The experts felt that Web data entry was convenient, acceptable and easily accessible. We conclude that Web-based Delphi rating for consensus development is a convenient and acceptable alternative to the traditional paper-based method. PMID:14728333

41 CFR 304-6.9 - Does acceptance by OGE of the Standard Form (SF) 326 constitute a determination by OGE that the...

Code of Federal Regulations, 2010 CFR

2010-07-01

... or a concurrence by OGE in the agency's conflict of interest analysis? 304-6.9 Section 304-6.9 Public...-FEDERAL SOURCE AGENCY REQUIREMENTS 6-PAYMENT GUIDELINES Valuation § 304-6.9 Does acceptance by OGE of the... concurrence by OGE in the agency's conflict of interest analysis? No. OGE is responsible for making the...

Benefits, Harms, and Costs of Osteoporosis Screening in Male Veterans

DTIC Science & Technology

2015-10-01

K Lyles, J LaFleur, C VanHoutven, C Pieper – accepted to American Geriatrics Society Annual Meeting, May 2016 Background: Practice guidelines...Veterans. Rasheeda K. Hall, Richard Sloane, Carl Pieper, Cathleen Colón-Emeric. – accepted to American Geriatrics Society Annual Meeting, May 2016...who had no prior diagnoses of fracture or osteoporosis therapy . Estimated glomerular filtration rate (eGFR) was estimated using baseline creatinine

Thermophysical Properties of Selected Aerospace Materials. Part 1. Thermal Radiative Properties

DTIC Science & Technology

1976-01-01

discusses the available data and information, the theoretical guidelines and other factors on which the critical evaluation, analysis, and synthesis of...text and a specification table. The former reviews and discusses the available data and information, the theoretical guidelines and other factors on...conditions 6’ Zenith angle for viewing conditions A6 Half angle of acceptance of optical system K Loss value factor X Wavelength p Reflectance p

Cervical cancer screening and updated Pap guidelines.

PubMed

Warren, Johanna B; Gullett, Heidi; King, Valerie J

2009-03-01

Cervical cancer and its dysplasia precursors account for significant morbidity and mortality in women worldwide. Human papillomavirus infection is common, preventable, and now widely accepted as the causative agent with oncogenic potential in the development of cervical cancer. Screening via Papanicolaou testing is critical, and interpretation of test results with knowledge of patient risk factors is imperative. Many evidence-based guidelines for screening, interpretation, and management have been developed and are widely available for use.

Recommended approach to sofware development

NASA Technical Reports Server (NTRS)

Mcgarry, F. E.; Page, J.; Eslinger, S.; Church, V.; Merwarth, P.

1983-01-01

A set of guideline for an organized, disciplined approach to software development, based on data collected and studied for 46 flight dynamics software development projects. Methods and practices for each phase of a software development life cycle that starts with requirements analysis and ends with acceptance testing are described; maintenance and operation is not addressed. For each defined life cycle phase, guidelines for the development process and its management, and the products produced and their reviews are presented.

Recommended approach to software development, revision 3

NASA Technical Reports Server (NTRS)

Landis, Linda; Waligora, Sharon; Mcgarry, Frank; Pajerski, Rose; Stark, Mike; Johnson, Kevin Orlin; Cover, Donna

1992-01-01

Guidelines for an organized, disciplined approach to software development that is based on studies conducted by the Software Engineering Laboratory (SEL) since 1976 are presented. It describes methods and practices for each phase of a software development life cycle that starts with requirements definition and ends with acceptance testing. For each defined life cycle phase, guidelines for the development process and its management, and for the products produced and their reviews are presented.

Quality Assessment of Clinical Practice Guidelines Developed by Professional Societies in Turkey.

PubMed

Yaşar, Ilknur; Kahveci, Rabia; Baydar Artantaş, Aylin; Ayhan Başer, Duygu; Gökşin Cihan, Fatma; Şencan, Irfan; Koç, Esra Meltem; Özkara, Adem

2016-01-01

Clinical practice guidelines (CPGs) are systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances. There is a limited number of studies on guidelines in Turkey. The quality of Ministry of Health guidelines have formerly been assessed whereas there is no information on the other guidelines developed in the country. This study aims to assess the quality of CPGs that are developed by professional societies that work for the health sector in Turkey, and compare the findings with international guidelines. Professional societies that work for the health sector were determined by using the data obtained from the Ministry of Internal Affairs. Inclusion and exclusion criteria were defined for selecting the CPGs. Guidelines containing recommendations about disease management to the doctors, accessible online, developed within the past 5 years, citing references for recommendations, about the diseases over 1% prevalence according to the "Statistical Yearbook of Turkey 2012" were included in the study. The quality of CPGs were assessed with the AGREE II instrument, which is an internationally recognized tool for this purpose. Four independent reviewers, who did not participate in the development of the selected guidelines and were trained in CPG appraisal, used the AGREE instrument for assessment of the selected guidelines. 47 professional societies were defined which provided access to CPGs in their websites; 3 of them were only open to members so these could not be reached. 8 CPGs from 7 societies were selected from a total of 401 CPGs from 44 societies. The mean scores of the domains of the guidelines which were assessed by the AGREE II tool were; 64%, stakeholder involvement: 37.9%, rigour of development: 35.3%, clarity and presentation: 77.9%, applicability: 49.0% and editorial independence: 46.0%. This is the first study in Turkey regarding quality appraisal of guidelines developed by the local professional societies. It adds to the limited amount of information in the literature that comes from Turkey as well as other developing countries.

Labor Dystocia: Uses of Related Nomenclature.

PubMed

Neal, Jeremy L; Ryan, Sharon L; Lowe, Nancy K; Schorn, Mavis N; Buxton, Margaret; Holley, Sharon L; Wilson-Liverman, Angela M

2015-01-01

Labor dystocia (slow or difficult labor or birth) is the most commonly diagnosed aberration of labor and the most frequently documented indication for primary cesarean birth. Yet, dystocia remains a poorly specified diagnostic category, with determinations often varying widely among clinicians. The primary aims of this review are to 1) summarize definitions of active labor and dystocia, as put forth by leading professional obstetric and midwifery organizations in world regions wherein English is the majority language and 2) describe the use of dystocia and related terms in contemporary research studies. Major national midwifery and obstetric organizations from qualifying United Nations-member sovereign nations and international organizations were searched to identify guidelines providing definitions of active labor and dystocia or related terms. Research studies (2000-2013) were systematically identified via PubMed, MEDLINE, and CINAHL searches to describe the use of dystocia and related terms in contemporary scientific publications. Only 6 organizational guidelines defined dystocia or related terms. Few research teams (n = 25 publications) defined dystocia-related terms with nonambiguous clinical parameters that can be applied prospectively. There is heterogeneity in the nomenclature used to describe dystocia, and when a similar term is shared between guidelines or research publications, the underlying definition of that term is sometimes inconsistent between documents. Failure to define dystocia in evidence-based, well-described, clinically meaningful terms that are widely acceptable to and reproducible among clinicians and researchers is concerning at both national and global levels. This failure is particularly problematic in light of the major contribution of this diagnosis to primary cesarean birth rates. © 2015 by the American College of Nurse-Midwives.

What do international pharmacoeconomic guidelines say about economic data transferability?

PubMed

Barbieri, Marco; Drummond, Michael; Rutten, Frans; Cook, John; Glick, Henry A; Lis, Joanna; Reed, Shelby D; Sculpher, Mark; Severens, Johan L

2010-12-01

The objectives of this article were to assess the positions of the various national pharmacoeconomic guidelines on the transferability (or lack of transferability) of clinical and economic data and to review the methods suggested in the guidelines for addressing issues of transferability. A review of existing national pharmacoeconomic guidelines was conducted to assess recommendations on the transferability of clinical and economic data, whether there are important differences between countries, and whether common methodologies have been suggested to address key transferability issues. Pharmacoeconomic guidelines were initially identified through the ISPOR Web site. In addition, those national guidelines not included in the ISPOR Web site, but known to us, were also considered. Across 27 sets of guidelines, baseline risk and unit costs were uniformly considered to be of low transferability, while treatment effect was classified as highly transferable. Results were more variable for resource use and utilities, which were considered to have low transferability in 63% and 45% of cases, respectively. There were some differences between older and more recent guidelines in the treatment of transferability issues. A growing number of jurisdictions are using guidelines for the economic evaluation of pharmaceuticals. The recommendations in existing guidelines regarding the transferability of clinical and economic data are quite diverse. There is a case for standardization in dealing with transferability issues. One important step would be to update guidelines more frequently. © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Do current national and international guidelines have specific recommendations for older adults with bipolar disorder? A brief report.

PubMed

Dols, Annemiek; Kessing, Lars Vedel; Strejilevich, Sergio A; Rej, Soham; Tsai, Shang-Ying; Gildengers, Ariel G; Almeida, Osvaldo P; Shulman, Kenneth I; Sajatovic, Martha

2016-12-01

Older adults with bipolar disorder (OABD) are a growing segment of patients with bipolar disorder (BD) for which specific guidelines are warranted. Although, OABD are frequently excluded from randomized controlled trials due to their age or somatic comorbidity, more treatment data from a variety of sources have become available in recent years. It is expected that at least some of this emerging information on OABD would be incorporated into treatment guidelines available to clinicians around the world. The International Society of Bipolar Disorders OABD task force compiled and compared recommendations from current national and international guidelines that specifically address geriatric or older individuals with BD (from year 2005 onwards). There were 34 guidelines, representing six continents and 19 countries. The majority of guidelines had no separate section on OABD. General principles for treating OABD with medication are recommended to be similar to those for younger adults, with special caution for side effects due to somatic comorbidity and concomitant medications. Therapeutic lithium serum levels are suggested to be lower but recommendations are very general and mostly not informed by specific research evidence. There is a lack of emphasis of OABD-specific issues in existing guidelines. Given the substantial clinical heterogeneity in BD across the life span, along with the rapidly expanding population of older individuals worldwide, and limited mental health workforce with geriatric expertise, it is critical that additional effort and resources be devoted to studying treatment interventions specific to OABD and that treatment guidelines reflect research findings. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.

PubMed

2006-01-01

This report presents the recommendations of an international group of experts convened by the World Health Organization to consider matters concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. The report is complemented by a number of annexes. These include: a list of available International Chemical Reference Substances and International Infrared Spectra; supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; updated supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines; supplementary guidelines on good manufacturing practices for validation; good distribution practices for pharmaceutical products; a model quality assurance system for procurement agencies (recommendations for quality assurance systems focusing on prequalification of products and manufacturers, purchasing, storage and distribution of pharmaceutical products); multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability; a proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; and additional guidance for organizations performing in vivo bioequivalence studies.

40 CFR 240.200-3 - Recommended procedures: Operations.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.200-3 Recommended procedures: Operations. (a) Storage areas for special wastes should be... acceptance of Special Wastes. ...

40 CFR 240.200-3 - Recommended procedures: Operations.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) SOLID WASTES GUIDELINES FOR THE THERMAL PROCESSING OF SOLID WASTES Requirements and Recommended Procedures § 240.200-3 Recommended procedures: Operations. (a) Storage areas for special wastes should be... acceptance of Special Wastes. ...

76 FR 27925 - Requirements for Maintenance of Inspections, Tests, Analyses, and Acceptance Criteria

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-13

... State Compatibility IX. Voluntary Consensus Standards X. Environmental Impact--Categorical Exclusion XI... endorsed guidance developed by the Nuclear Energy Institute (NEI) in NEI 08-01, ``Industry Guideline for...

Global perspectives on ensuring the safety of pharmaceutical products in the distribution process
.

PubMed

Jeong, Sohyun; Ji, Eunhee

2018-01-01

The distribution of counterfeit or falsified drugs is increasing worldwide. This can contribute to the high burden of disease and cost to society and is of global concern with the worldwide circulation of pharmaceuticals. The preparation and implementation of good distribution practice should be one of the most important aspects of ensuring safe drug circulation and administration. This research aimed to compare and analyze good distribution practice guidelines from advanced countries and international organizations, and to evaluate the status of the current good distribution practice guidelines in the world. Advanced pharmaceutical countries and international organizations, such as the World Health Organization, European Union, Pharmaceutical Inspection Co-operation Scheme, United States of America, Canada, and Australia, which have stable good distribution practice guidelines and public confidence, were included in the analysis. The World Health Organization and European Union guidelines are models for standardized good distribution practice for nations worldwide. The United States of America has a combination of four different series of distribution practices which have a unique structure and detailed content compared to those of other countries. The Canadian guidelines focus on temperature control during storage and transportation. The Australian guidelines apply to both classes of medicinal products and medical devices and need separate standardization. Transparent information about the Internet chain, international cooperation regarding counterfeiting, a high-standard qualification of sellers and customers, and technology to track and trace the whole life cycle of drugs should be the main focus of future good distribution practice guidelines worldwide.
.

Environmental assessment: Davis Canyon site, Utah

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

none,

1986-05-01

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

An automated tool for an analysis of compliance to evidence-based clinical guidelines.

PubMed

Metfessel, B A

2001-01-01

Evidence-based clinical guidelines have been developed in an attempt to decrease practice variation and improve patient outcomes. Although a number of studies and a few commercial products have attempted to measure guideline compliance, there still exists a strong need for an automated product that can take as input large amounts of data and create systematic and detailed profiles of compliance to evidence-based guidelines. The Guideline Compliance Assessment Tool is a product presently under development in our group that will accept as input medical and pharmacy claims data and create a guideline compliance profile that assesses provider practice patterns as compared to evidence-based standards. The system components include an episode of care grouper to standardize classifications of illnesses, an evidence-based guideline knowledge base that potentially contains information on several hundred distinct conditions, a guideline compliance scoring system that emphasizes systematic guideline variance rather than random variances, and an advanced data warehouse that would allow drilling into specific areas of interest. As provider profiling begins to shift away from a primary emphasis on cost to an emphasis on quality, automated methods for measuring guideline compliance will become important in measuring provider performance and increasing guideline usage, consequently improving the standard of care and the potential for better patient outcomes.

A review of guidance on fish consumption in pregnancy: is it fit for purpose?

PubMed

Taylor, Caroline M; Emmett, Pauline M; Emond, Alan M; Golding, Jean

2018-03-26

Public health messages to reduce Hg exposure for pregnant women have focused exclusively on advice on fish consumption to limit Hg exposure, with little account being taken of the positive contribution of fish to nutritional quality. The aim of the present review was to compare and contrast the content and presentation of national guidelines on fish consumption in pregnancy, and comment on their evidence base and impact on consumption. We searched for national and international guidelines on fish consumption in pregnancy using Internet search strategies. The detailed content and style of presentation of the guidelines were compared. The evidence base for the guidelines, and evidence for the impact of the guidelines on fish consumption levels, were assessed. We identified nineteen national guidelines and three international guidelines. There was great variation in the content, complexity and presentation style. The guidelines were based largely on the Hg content of fish with far less consideration being given to the positive beneficial effects of nutrients provided by fish. The complexity of the guidelines may lead to pregnant women reducing their fish intake, or not eating fish at all. Guidelines on fish consumption in pregnancy should take the beneficial effects of fish into account. Guidelines need to be clear and memorable, and appropriately disseminated, to achieve impact. Guidelines could include visual rather than narrative content. Use of technology, for example apps, could enable women to record their fish consumption in real time and log compliance with guidance over a week or other time period.