76 FR 5289 - Income Level for Individuals Eligible for Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-31

... amendments to the Federal Poverty Guidelines as issued by the Department of Health and Human Services. DATES... Poverty Guidelines. Since 1982, the Department of Health and Human Services has been responsible for updating and issuing the Federal Poverty Guidelines. On January 26, 2011, LSC issued a notice in the...

Added value of involving patients in the first step of multidisciplinary guideline development: a qualitative interview study among infertile patients.

PubMed

den Breejen, Elvira M E; Hermens, Rosella P M G; Galama, Wienke H; Willemsen, Wim N P; Kremer, Jan A M; Nelen, Willianne L D M

2016-06-01

Patient involvement in scoping the guideline is emphasized, but published initiatives actively involving patients are generally limited to the writing and reviewing phase. To assess patients' added value to the scoping phase of a multidisciplinary guideline on infertility. Qualitative interview study. We conducted interviews among 12 infertile couples and 17 professionals. We listed and compared the couples' and professionals' key clinical issues (=care aspects that need improvement) to be addressed in the guideline according to four domains: current guidelines, professionals, patients and organization of care. Main key clinical issues suggested by more than three quarters of the infertile couples and/or at least two professionals were identified and compared. Overall, we identified 32 key clinical issues among infertile couples and 23 among professionals. Of the defined main key clinical issues, infertile couples mentioned eight issues that were not mentioned by the professionals. These main key clinical issues mainly concerned patient-centred (e.g. poor information provision and poor alignment of care) aspects of care on the professional and organizational domain. Both groups mentioned two main key clinical issues collectively that were interpreted differently: the lack of emotional support and respect for patients' values. Including patients from the first phase of the guideline development process leads to valuable additional main key clinical issues for the next step of a multidisciplinary guideline development process and broadens the scope of the guideline, particularly regarding patient-centredness and organizational issues from a patients' perspective. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Validation of QuEChERS analytical technique for organochlorines and synthetic pyrethroids in fruits and vegetables using GC-ECD.

PubMed

Dubey, J K; Patyal, S K; Sharma, Ajay

2018-03-19

In the present day scenario of increasing awareness and concern about the pesticides, it is very important to ensure the quality of data being generated in pesticide residue analysis. To impart confidence in the products, terms like quality assurance and quality control are used as an integral part of quality management. In order to ensure better quality of results in pesticide residue analysis, validation of analytical methods to be used is extremely important. Keeping in view the importance of validation of method, the validation of QuEChERS (quick, easy, cheap, effective, rugged, and safe) a multiresidue method for extraction of 13 organochlorines and seven synthetic pyrethroids in fruits and vegetables followed by GC ECD for quantification was done so as to use this method for analysis of samples received in the laboratory. The method has been validated as per the Guidelines issued by SANCO (French words Sante for Health and Consommateurs for Consumers) in accordance with their document SANCO/XXXX/2013. Various parameters analyzed, viz., linearity, specificity, repeatability, reproducibility, and ruggedness were found to have acceptable values with a per cent RSD of less than 10%. Limit of quantification (LOQ) for the organochlorines was established to be 0.01 and 0.05 mg kg -1 for the synthetic pyrethroids. The uncertainty of the measurement (MU) for all these compounds ranged between 1 and 10%. The matrix-match calibration was used to compensate the matrix effect on the quantification of the compounds. The overall recovery of the method ranged between 80 and 120%. These results demonstrate the applicability and acceptability of this method in routine estimation of pesticide residues of these 20 pesticides in the fruits and vegetables by the laboratory.

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

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).

Real-time polymerase chain reaction-based approach for quantification of the pat gene in the T25 Zea mays event.

PubMed

Weighardt, Florian; Barbati, Cristina; Paoletti, Claudia; Querci, Maddalena; Kay, Simon; De Beuckeleer, Marc; Van den Eede, Guy

2004-01-01

In Europe, a growing interest for reliable techniques for the quantification of genetically modified component(s) of food matrixes is arising from the need to comply with the European legislative framework on novel food products. Real-time polymerase chain reaction (PCR) is currently the most powerful technique for the quantification of specific nucleic acid sequences. Several real-time PCR methodologies based on different molecular principles have been developed for this purpose. The most frequently used approach in the field of genetically modified organism (GMO) quantification in food or feed samples is based on the 5'-3'-exonuclease activity of Taq DNA polymerase on specific degradation probes (TaqMan principle). A novel approach was developed for the establishment of a TaqMan quantification system assessing GMO contents around the 1% threshold stipulated under European Union (EU) legislation for the labeling of food products. The Zea mays T25 elite event was chosen as a model for the development of the novel GMO quantification approach. The most innovative aspect of the system is represented by the use of sequences cloned in plasmids as reference standards. In the field of GMO quantification, plasmids are an easy to use, cheap, and reliable alternative to Certified Reference Materials (CRMs), which are only available for a few of the GMOs authorized in Europe, have a relatively high production cost, and require further processing to be suitable for analysis. Strengths and weaknesses of the use of novel plasmid-based standards are addressed in detail. In addition, the quantification system was designed to avoid the use of a reference gene (e.g., a single copy, species-specific gene) as normalizer, i.e., to perform a GMO quantification based on an absolute instead of a relative measurement. In fact, experimental evidences show that the use of reference genes adds variability to the measurement system because a second independent real-time PCR-based measurement must be performed. Moreover, for some reference genes no sufficient information on copy number in and among genomes of different lines is available, making adequate quantification difficult. Once developed, the method was subsequently validated according to IUPAC and ISO 5725 guidelines. Thirteen laboratories from 8 EU countries participated in the trial. Eleven laboratories provided results complying with the predefined study requirements. Repeatability (RSDr) values ranged from 8.7 to 15.9%, with a mean value of 12%. Reproducibility (RSDR) values ranged from 16.3 to 25.5%, with a mean value of 21%. Following Codex Alimentarius Committee guidelines, both the limits of detection and quantitation were determined to be <0.1%.

Uncertainty Quantification and Statistical Convergence Guidelines for PIV Data

NASA Astrophysics Data System (ADS)

Stegmeir, Matthew; Kassen, Dan

2016-11-01

As Particle Image Velocimetry has continued to mature, it has developed into a robust and flexible technique for velocimetry used by expert and non-expert users. While historical estimates of PIV accuracy have typically relied heavily on "rules of thumb" and analysis of idealized synthetic images, recently increased emphasis has been placed on better quantifying real-world PIV measurement uncertainty. Multiple techniques have been developed to provide per-vector instantaneous uncertainty estimates for PIV measurements. Often real-world experimental conditions introduce complications in collecting "optimal" data, and the effect of these conditions is important to consider when planning an experimental campaign. The current work utilizes the results of PIV Uncertainty Quantification techniques to develop a framework for PIV users to utilize estimated PIV confidence intervals to compute reliable data convergence criteria for optimal sampling of flow statistics. Results are compared using experimental and synthetic data, and recommended guidelines and procedures leveraging estimated PIV confidence intervals for efficient sampling for converged statistics are provided.

Ethics guidelines, health research and Indigenous Australians.

PubMed

Anderson, Ian; Griew, Robert; McAullay, Daniel

2003-02-01

In this paper we overview the findings of a literature review that was undertaken to guide the revision of the Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (NH&MRC, 1991). The literature reviewed, in general, supported the development of specific research guidelines for Aboriginal and Torres Strait Islander contexts. The findings of this review were analysed thematically, and a number of key issues were identified for consideration in the review process. We present a summary of these key issues. In the final section of the paper we consider in more detail two of the key issues raised in the review process (the assessment of relevance or benefit of proposed research; and the process of consultation and negotiation of collective consent) in order to critically consider how these issue should be engaged in revised guidelines. On the basis of this analysis, it is our contention that specific guidelines on key issues are limited to the extent to which they can anticipate all possible research contexts. In order to address this problem, and guide researchers, guidelines should also explicitly outline the values, from an Aboriginal and Torres Islander perspective that are foundational to an ethical research process.

Monte Carlo Modeling-Based Digital Loop-Mediated Isothermal Amplification on a Spiral Chip for Absolute Quantification of Nucleic Acids.

PubMed

Xia, Yun; Yan, Shuangqian; Zhang, Xian; Ma, Peng; Du, Wei; Feng, Xiaojun; Liu, Bi-Feng

2017-03-21

Digital loop-mediated isothermal amplification (dLAMP) is an attractive approach for absolute quantification of nucleic acids with high sensitivity and selectivity. Theoretical and numerical analysis of dLAMP provides necessary guidance for the design and analysis of dLAMP devices. In this work, a mathematical model was proposed on the basis of the Monte Carlo method and the theories of Poisson statistics and chemometrics. To examine the established model, we fabricated a spiral chip with 1200 uniform and discrete reaction chambers (9.6 nL) for absolute quantification of pathogenic DNA samples by dLAMP. Under the optimized conditions, dLAMP analysis on the spiral chip realized quantification of nucleic acids spanning over 4 orders of magnitude in concentration with sensitivity as low as 8.7 × 10 -2 copies/μL in 40 min. The experimental results were consistent with the proposed mathematical model, which could provide useful guideline for future development of dLAMP devices.

Development and Optimization of a Dedicated, Hybrid Dual-Modality SPECT-CmT System for Improved Breast Lesion Diagnosis

DTIC Science & Technology

2010-01-01

throughout the entire 3D volume which made quantification of the different tissues in the breast possible. The p eaks representing glandular and fat in...coefficients. Keywords: tissue quantification , absolute attenuation coefficient, scatter correction, computed tomography, tomography... tissue types. 1-4 Accurate measurements of t he quantification and di fferentiation of numerous t issues can be useful to identify di sease from

Detection and quantification limits of the EPA Enterococcus qPCR method

EPA Science Inventory

The U.S. EPA will be recommending a quantitative polymerase chain reaction (qPCR) method targeting Enterococcus spp. as an option for monitoring recreational beach water quality in 2013 and has published preliminary proposed water quality criteria guidelines for the method. An im...

Scientific authorship. Part 2. History, recurring issues, practices, and guidelines.

PubMed

Claxton, Larry D

2005-01-01

One challenge for most scientists is avoiding and resolving issues that center around authorship and the publishing of scientific manuscripts. While trying to place the research in proper context, impart new knowledge, follow proper guidelines, and publish in the most appropriate journal, the scientist often must deal with multi-collaborator issues like authorship allocation, trust and dependence, and resolution of publication conflicts. Most guidelines regarding publications, commentaries, and editorials have evolved from the ranks of editors in an effort to diminish the issues that faced them as editors. For example, the Ingelfinger rule attempts to prevent duplicate publications of the same study. This paper provides a historical overview of commonly encountered scientific authorship issues, a comparison of opinions on these issues, and the influence of various organizations and guidelines in regards to these issues. For example, a number of organizations provide guidelines for author allocation; however, a comparison shows that these guidelines differ on who should be an author, rules for ordering authors, and the level of responsibility for coauthors. Needs that emerge from this review are (a) a need for more controlled studies on authorship issues, (b) an increased awareness and a buy-in to consensus views by non-editor groups, e.g., managers, authors, reviewers, and scientific societies, and (c) a need for editors to express a greater understanding of authors' dilemmas and to exhibit greater flexibility. Also needed are occasions (e.g., an international congress) when editors and others (managers, authors, etc.) can directly exchange views, develop consensus approaches and solutions, and seek agreement on how to resolve authorship issues. Open dialogue is healthy, and it is essential for scientific integrity to be protected so that younger scientists can confidently follow the lead of their predecessors.

12 CFR 1.130 - Type II securities; guidelines for obligations issued for university and housing purposes.

Code of Federal Regulations, 2014 CFR

2014-01-01

...; guidelines for obligations issued for university and housing purposes. (a) Investment quality. An obligation issued for housing, university, or dormitory purposes is a Type II security only if it: (1) Qualifies as... issued for university and housing purposes. 1.130 Section 1.130 Banks and Banking COMPTROLLER OF THE...

12 CFR 1.130 - Type II securities; guidelines for obligations issued for university and housing purposes.

Code of Federal Regulations, 2011 CFR

2011-01-01

...; guidelines for obligations issued for university and housing purposes. (a) Investment quality. An obligation issued for housing, university, or dormitory purposes is a Type II security only if it: (1) Qualifies as... issued for university and housing purposes. 1.130 Section 1.130 Banks and Banking COMPTROLLER OF THE...

12 CFR 1.130 - Type II securities; guidelines for obligations issued for university and housing purposes.

Code of Federal Regulations, 2012 CFR

2012-01-01

...; guidelines for obligations issued for university and housing purposes. (a) Investment quality. An obligation issued for housing, university, or dormitory purposes is a Type II security only if it: (1) Qualifies as... issued for university and housing purposes. 1.130 Section 1.130 Banks and Banking COMPTROLLER OF THE...

12 CFR 1.130 - Type II securities; guidelines for obligations issued for university and housing purposes.

Code of Federal Regulations, 2013 CFR

2013-01-01

...; guidelines for obligations issued for university and housing purposes. (a) Investment quality. An obligation issued for housing, university, or dormitory purposes is a Type II security only if it: (1) Qualifies as... issued for university and housing purposes. 1.130 Section 1.130 Banks and Banking COMPTROLLER OF THE...

Are LOD and LOQ Reliable Parameters for Sensitivity Evaluation of Spectroscopic Methods?

PubMed

Ershadi, Saba; Shayanfar, Ali

2018-03-22

The limit of detection (LOD) and the limit of quantification (LOQ) are common parameters to assess the sensitivity of analytical methods. In this study, the LOD and LOQ of previously reported terbium sensitized analysis methods were calculated by different methods, and the results were compared with sensitivity parameters [lower limit of quantification (LLOQ)] of U.S. Food and Drug Administration guidelines. The details of the calibration curve and standard deviation of blank samples of three different terbium-sensitized luminescence methods for the quantification of mycophenolic acid, enrofloxacin, and silibinin were used for the calculation of LOD and LOQ. A comparison of LOD and LOQ values calculated by various methods and LLOQ shows a considerable difference. The significant difference of the calculated LOD and LOQ with various methods and LLOQ should be considered in the sensitivity evaluation of spectroscopic methods.

7 CFR 622.5 - Guidelines.

Code of Federal Regulations, 2010 CFR

2010-01-01

... NEPA (40 CFR parts 1500-1508) issued by the Council on Environmental Quality, and in Economic and Environmental Principles and Guidelines for Water and Related Land Resources Implementation Studies issued by...

Overview of the SAE G-11 RMSL (Reliability, Maintainability, Supportability, and Logistics) Division Activities and Technical Projects

NASA Technical Reports Server (NTRS)

Singhal, Surendra N.

2003-01-01

The SAE G-11 RMSL (Reliability, Maintainability, Supportability, and Logistics) Division activities include identification and fulfillment of joint industry, government, and academia needs for development and implementation of RMSL technologies. Four Projects in the Probabilistic Methods area and two in the area of RMSL have been identified. These are: (1) Evaluation of Probabilistic Technology - progress has been made toward the selection of probabilistic application cases. Future effort will focus on assessment of multiple probabilistic softwares in solving selected engineering problems using probabilistic methods. Relevance to Industry & Government - Case studies of typical problems encountering uncertainties, results of solutions to these problems run by different codes, and recommendations on which code is applicable for what problems; (2) Probabilistic Input Preparation - progress has been made in identifying problem cases such as those with no data, little data and sufficient data. Future effort will focus on developing guidelines for preparing input for probabilistic analysis, especially with no or little data. Relevance to Industry & Government - Too often, we get bogged down thinking we need a lot of data before we can quantify uncertainties. Not True. There are ways to do credible probabilistic analysis with little data; (3) Probabilistic Reliability - probabilistic reliability literature search has been completed along with what differentiates it from statistical reliability. Work on computation of reliability based on quantification of uncertainties in primitive variables is in progress. Relevance to Industry & Government - Correct reliability computations both at the component and system level are needed so one can design an item based on its expected usage and life span; (4) Real World Applications of Probabilistic Methods (PM) - A draft of volume 1 comprising aerospace applications has been released. Volume 2, a compilation of real world applications of probabilistic methods with essential information demonstrating application type and timehost savings by the use of probabilistic methods for generic applications is in progress. Relevance to Industry & Government - Too often, we say, 'The Proof is in the Pudding'. With help from many contributors, we hope to produce such a document. Problem is - not too many people are coming forward due to proprietary nature. So, we are asking to document only minimum information including problem description, what method used, did it result in any savings, and how much?; (5) Software Reliability - software reliability concept, program, implementation, guidelines, and standards are being documented. Relevance to Industry & Government - software reliability is a complex issue that must be understood & addressed in all facets of business in industry, government, and other institutions. We address issues, concepts, ways to implement solutions, and guidelines for maximizing software reliability; (6) Maintainability Standards - maintainability/serviceability industry standard/guidelines and industry best practices and methodologies used in performing maintainability/ serviceability tasks are being documented. Relevance to Industry & Government - Any industry or government process, project, and/or tool must be maintained and serviced to realize the life and performance it was designed for. We address issues and develop guidelines for optimum performance & life.

Unreasonable Compensation: The Hidden Issue in the IRS College and University Examination Guidelines.

ERIC Educational Resources Information Center

Harding, Bertrand M., Jr.; McClellan, Edgar D.

1993-01-01

Issues in Internal Revenue Service (IRS) guidelines for financial audit of colleges and universities that relate specifically to the institution's compensation of officers, directors, and employees are discussed. Institutions are advised that the "unreasonable compensation" issue may be raised, and they should review compensation…

32 CFR 199.10 - Appeal and hearing procedures.

Code of Federal Regulations, 2011 CFR

2011-07-01

... issues shall be bound by policy manuals, instructions, procedures, and other guidelines issued by the ASD..., procedures, instructions or guidelines by the ASD(HA), or a designee, when the final decision is issued in... Department of Defense in the administration of CHAMPUS. (ii) Referral for review by ASD(HA). The Director...

Guidelines for Acoustical Measurements Inside Historical Opera Houses: Procedures and Validation

NASA Astrophysics Data System (ADS)

POMPOLI, ROBERTO; PRODI, NICOLA

2000-04-01

The acoustics of Italian historical theatres is to be regarded as a cultural heritage, which is to be preserved and studied. These actions are imperative for handing down the heritage to future generations and to avoid its loss. In this paper, the technical means for scientific quantification of the acoustical heritage are presented in the form of operative guidelines for acoustical measurements inside historical theatres. The document includes the advice of international experts and is being employed during an extended measurement campaign inside renaissance and baroque historical theatres. A relevant part of the paper deals with the experimental validation of the recommendations given in the guidelines, achieved by a dedicated test session inside the Municipal Theatre of Ferrara.

Recent advances in stable isotope labeling based techniques for proteome relative quantification.

PubMed

Zhou, Yuan; Shan, Yichu; Zhang, Lihua; Zhang, Yukui

2014-10-24

The large scale relative quantification of all proteins expressed in biological samples under different states is of great importance for discovering proteins with important biological functions, as well as screening disease related biomarkers and drug targets. Therefore, the accurate quantification of proteins at proteome level has become one of the key issues in protein science. Herein, the recent advances in stable isotope labeling based techniques for proteome relative quantification were reviewed, from the aspects of metabolic labeling, chemical labeling and enzyme-catalyzed labeling. Furthermore, the future research direction in this field was prospected. Copyright © 2014 Elsevier B.V. All rights reserved.

Quantification of Spatial Heterogeneity in Old Growth Forst of Korean Pine

Treesearch

Wang Zhengquan; Wang Qingcheng; Zhang Yandong

1997-01-01

Spatial hetergeneity is a very important issue in studying functions and processes of ecological systems at various scales. Semivariogram analysis is an effective technique to summarize spatial data, and quantification of sptail heterogeneity. In this paper, we propose some principles to use semivariograms to characterize and compare spatial heterogeneity of...

A systematic review of methodology: time series regression analysis for environmental factors and infectious diseases.

PubMed

Imai, Chisato; Hashizume, Masahiro

2015-03-01

Time series analysis is suitable for investigations of relatively direct and short-term effects of exposures on outcomes. In environmental epidemiology studies, this method has been one of the standard approaches to assess impacts of environmental factors on acute non-infectious diseases (e.g. cardiovascular deaths), with conventionally generalized linear or additive models (GLM and GAM). However, the same analysis practices are often observed with infectious diseases despite of the substantial differences from non-infectious diseases that may result in analytical challenges. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, systematic review was conducted to elucidate important issues in assessing the associations between environmental factors and infectious diseases using time series analysis with GLM and GAM. Published studies on the associations between weather factors and malaria, cholera, dengue, and influenza were targeted. Our review raised issues regarding the estimation of susceptible population and exposure lag times, the adequacy of seasonal adjustments, the presence of strong autocorrelations, and the lack of a smaller observation time unit of outcomes (i.e. daily data). These concerns may be attributable to features specific to infectious diseases, such as transmission among individuals and complicated causal mechanisms. The consequence of not taking adequate measures to address these issues is distortion of the appropriate risk quantifications of exposures factors. Future studies should pay careful attention to details and examine alternative models or methods that improve studies using time series regression analysis for environmental determinants of infectious diseases.

Rapid Development and Validation of Improved Reversed-Phase High-performance Liquid Chromatography Method for the Quantification of Mangiferin, a Polyphenol Xanthone Glycoside in Mangifera indica

PubMed Central

Naveen, P.; Lingaraju, H. B.; Prasad, K. Shyam

2017-01-01

Mangiferin, a polyphenolic xanthone glycoside from Mangifera indica, is used as traditional medicine for the treatment of numerous diseases. The present study was aimed to develop and validate a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of mangiferin from the bark extract of M. indica. RP-HPLC analysis was performed by isocratic elution with a low-pressure gradient using 0.1% formic acid: acetonitrile (87:13) as a mobile phase with a flow rate of 1.5 ml/min. The separation was done at 26°C using a Kinetex XB-C18 column as stationary phase and the detection wavelength at 256 nm. The proposed method was validated for linearity, precision, accuracy, limit of detection, limit of quantification, and robustness by the International Conference on Harmonisation guidelines. In linearity, the excellent correlation coefficient more than 0.999 indicated good fitting of the curve and also good linearity. The intra- and inter-day precision showed < 1% of relative standard deviation of peak area indicated high reliability and reproducibility of the method. The recovery values at three different levels (50%, 100%, and 150%) of spiked samples were found to be 100.47, 100.89, and 100.99, respectively, and low standard deviation value < 1% shows high accuracy of the method. In robustness, the results remain unaffected by small variation in the analytical parameters, which shows the robustness of the method. Liquid chromatography–mass spectrometry analysis confirmed the presence of mangiferin with M/Z value of 421. The assay developed by HPLC method is a simple, rapid, and reliable for the determination of mangiferin from M. indica. SUMMARY The present study was intended to develop and validate an RP-HPLC method for the quantification of mangiferin from the bark extract of M. indica. The developed method was validated for linearity, precision, accuracy, limit of detection, limit of quantification and robustness by International Conference on Harmonization guidelines. This study proved that the developed assay by HPLC method is a simple, rapid and reliable for the quantification of the mangiferin from M. indica. Abbreviations Used: M. indica: Mangifera indica, RP-HPLC: Reversed-phase high-performance liquid chromatography, M/Z: Mass to charge ratio, ICH: International conference on harmonization, % RSD: Percentage of relative standard deviation, ppm: Parts per million, LOD: Limit of detection, LOQ: Limit of quantification. PMID:28539748

Rapid Development and Validation of Improved Reversed-Phase High-performance Liquid Chromatography Method for the Quantification of Mangiferin, a Polyphenol Xanthone Glycoside in Mangifera indica.

PubMed

Naveen, P; Lingaraju, H B; Prasad, K Shyam

2017-01-01

Mangiferin, a polyphenolic xanthone glycoside from Mangifera indica , is used as traditional medicine for the treatment of numerous diseases. The present study was aimed to develop and validate a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of mangiferin from the bark extract of M. indica . RP-HPLC analysis was performed by isocratic elution with a low-pressure gradient using 0.1% formic acid: acetonitrile (87:13) as a mobile phase with a flow rate of 1.5 ml/min. The separation was done at 26°C using a Kinetex XB-C18 column as stationary phase and the detection wavelength at 256 nm. The proposed method was validated for linearity, precision, accuracy, limit of detection, limit of quantification, and robustness by the International Conference on Harmonisation guidelines. In linearity, the excellent correlation coefficient more than 0.999 indicated good fitting of the curve and also good linearity. The intra- and inter-day precision showed < 1% of relative standard deviation of peak area indicated high reliability and reproducibility of the method. The recovery values at three different levels (50%, 100%, and 150%) of spiked samples were found to be 100.47, 100.89, and 100.99, respectively, and low standard deviation value < 1% shows high accuracy of the method. In robustness, the results remain unaffected by small variation in the analytical parameters, which shows the robustness of the method. Liquid chromatography-mass spectrometry analysis confirmed the presence of mangiferin with M/Z value of 421. The assay developed by HPLC method is a simple, rapid, and reliable for the determination of mangiferin from M. indica . The present study was intended to develop and validate an RP-HPLC method for the quantification of mangiferin from the bark extract of M. indica . The developed method was validated for linearity, precision, accuracy, limit of detection, limit of quantification and robustness by International Conference on Harmonization guidelines. This study proved that the developed assay by HPLC method is a simple, rapid and reliable for the quantification of the mangiferin from M. indica . Abbreviations Used: M. indica : Mangifera indica , RP-HPLC: Reversed-phase high-performance liquid chromatography, M/Z: Mass to charge ratio, ICH: International conference on harmonization, % RSD: Percentage of relative standard deviation, ppm: Parts per million, LOD: Limit of detection, LOQ: Limit of quantification.

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

A Java program for LRE-based real-time qPCR that enables large-scale absolute quantification.

PubMed

Rutledge, Robert G

2011-03-02

Linear regression of efficiency (LRE) introduced a new paradigm for real-time qPCR that enables large-scale absolute quantification by eliminating the need for standard curves. Developed through the application of sigmoidal mathematics to SYBR Green I-based assays, target quantity is derived directly from fluorescence readings within the central region of an amplification profile. However, a major challenge of implementing LRE quantification is the labor intensive nature of the analysis. Utilizing the extensive resources that are available for developing Java-based software, the LRE Analyzer was written using the NetBeans IDE, and is built on top of the modular architecture and windowing system provided by the NetBeans Platform. This fully featured desktop application determines the number of target molecules within a sample with little or no intervention by the user, in addition to providing extensive database capabilities. MS Excel is used to import data, allowing LRE quantification to be conducted with any real-time PCR instrument that provides access to the raw fluorescence readings. An extensive help set also provides an in-depth introduction to LRE, in addition to guidelines on how to implement LRE quantification. The LRE Analyzer provides the automated analysis and data storage capabilities required by large-scale qPCR projects wanting to exploit the many advantages of absolute quantification. Foremost is the universal perspective afforded by absolute quantification, which among other attributes, provides the ability to directly compare quantitative data produced by different assays and/or instruments. Furthermore, absolute quantification has important implications for gene expression profiling in that it provides the foundation for comparing transcript quantities produced by any gene with any other gene, within and between samples.

A Java Program for LRE-Based Real-Time qPCR that Enables Large-Scale Absolute Quantification

PubMed Central

Rutledge, Robert G.

2011-01-01

Background Linear regression of efficiency (LRE) introduced a new paradigm for real-time qPCR that enables large-scale absolute quantification by eliminating the need for standard curves. Developed through the application of sigmoidal mathematics to SYBR Green I-based assays, target quantity is derived directly from fluorescence readings within the central region of an amplification profile. However, a major challenge of implementing LRE quantification is the labor intensive nature of the analysis. Findings Utilizing the extensive resources that are available for developing Java-based software, the LRE Analyzer was written using the NetBeans IDE, and is built on top of the modular architecture and windowing system provided by the NetBeans Platform. This fully featured desktop application determines the number of target molecules within a sample with little or no intervention by the user, in addition to providing extensive database capabilities. MS Excel is used to import data, allowing LRE quantification to be conducted with any real-time PCR instrument that provides access to the raw fluorescence readings. An extensive help set also provides an in-depth introduction to LRE, in addition to guidelines on how to implement LRE quantification. Conclusions The LRE Analyzer provides the automated analysis and data storage capabilities required by large-scale qPCR projects wanting to exploit the many advantages of absolute quantification. Foremost is the universal perspective afforded by absolute quantification, which among other attributes, provides the ability to directly compare quantitative data produced by different assays and/or instruments. Furthermore, absolute quantification has important implications for gene expression profiling in that it provides the foundation for comparing transcript quantities produced by any gene with any other gene, within and between samples. PMID:21407812

Cancer screening in the United States, 2018: A review of current American Cancer Society guidelines and current issues in cancer screening.

PubMed

Smith, Robert A; Andrews, Kimberly S; Brooks, Durado; Fedewa, Stacey A; Manassaram-Baptiste, Deana; Saslow, Debbie; Brawley, Otis W; Wender, Richard C

2018-05-30

Each year, the American Cancer Society publishes a summary of its guidelines for early cancer detection, data and trends in cancer screening rates from the National Health Interview Survey, and select issues related to cancer screening. In this 2018 update, we also summarize the new American Cancer Society colorectal cancer screening guideline and include a clarification in the language of the 2013 lung cancer screening guideline. CA Cancer J Clin 2018. © 2018 American Cancer Society. © 2018 American Cancer Society.

76 FR 60017 - Technical Conference on Penalty Guidelines; Notice of Technical Conference on Penalty Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

... Conference on Penalty Guidelines; Notice of Technical Conference on Penalty Guidelines The staff of the... the Penalty Guidelines, which the Commission issued on September 17, 2010.\\1\\ The conference will be... impact of the Penalty Guidelines on compliance and enforcement matters. More information on the topics to...

Guidelines for Performing Regulatory Impact Analysis (1983/1991)

EPA Pesticide Factsheets

These 1983 guidelines as modified in 1991 provide guidance for preparing EPA Regulatory Impact Analyses including benefit-cost analyses. These guidelines have been superseded by the Guidelines for Preparing Economic Analyses issued in 2000 (see EE-0568).

Quantification of shear stress in a meandering native topographic channel using a physical hydraulic model

Treesearch

Michael E. Ursic

2011-01-01

Current guidelines for predicting increases in shear stress in open-channel bends were developed from investigations that were primarily prismatic in cross section. This study provides possible increases in shear stress relative to approach flow conditions resulting from planimetric and topographic geometric features. Boundary shear stress estimates were determined by...

A Standardized System of Training Intensity Guidelines for the Sports of Track and Field and Cross Country

ERIC Educational Resources Information Center

Belcher, Christopher P.; Pemberton, Cynthia Lee A.

2012-01-01

Accurate quantification of training intensity is an essential component of a training program (Rowbottom, 2000). A training program designed to optimize athlete performance abilities cannot be practically planned or implemented without a valid and reliable indication of training intensity and its effect on the physiological mechanisms of the human…

Long-term pavement performance compliance with Department of Transportation information dissemination quality guidelines

DOT National Transportation Integrated Search

2008-11-01

This document provides information on the compliance of the LTPP program with the guidelines the Department of Transportation (DOT) issued Information Dissemination Quality Guidelines (IDQG). These guidelines were developed in response to requirement...

Clinical imaging guidelines part 2: Risks, benefits, barriers, and solutions.

PubMed

Malone, James; del Rosario-Perez, Maria; Van Bladel, Lodewijk; Jung, Seung Eun; Holmberg, Ola; Bettmann, Michael A

2015-02-01

A recent international meeting was convened by two United Nations bodies to focus on international collaboration on clinical appropriateness/referral guidelines for use in medical imaging. This paper, the second of 4 from this technical meeting, addresses barriers to the successful development/deployment of clinical imaging guidelines and means of overcoming them. It reflects the discussions of the attendees, and the issues identified are treated under 7 headings: ■ Practical Strategy for Development and Deployment of Guidelines; ■ Governance Arrangements and Concerns with Deployment of Guidelines; ■ Finance, Sustainability, Reimbursement, and Related Issues; ■ Identifying Benefits and Radiation Risks from Radiological Examinations; ■ Information Given to Patients and the Public, and Consent Issues; ■ Special Concerns Related to Pregnancy; and ■ The Research Agenda. Examples of topics identified include the observation that guideline development is a global task and there is no case for continuing it as the project of the few professional organizations that have been brave enough to make the long-term commitment required. Advocacy for guidelines should include the expectations that they will facilitate: (1) better health care delivery; (2) lower cost of that delivery; with (3) reduced radiation dose and associated health risks. Radiation protection issues should not be isolated; rather, they should be integrated with the overall health care picture. The type of dose/radiation risk information to be provided with guidelines should include the uncertainty involved and advice on application of the precautionary principle with patients. This principle may be taken as an extension of the well-established medical principle of "first do no harm." Copyright © 2015. Published by Elsevier Inc.

In vivo quantitative evaluation of vascular parameters for angiogenesis based on sparse principal component analysis and aggregated boosted trees

NASA Astrophysics Data System (ADS)

Zhao, Fengjun; Liu, Junting; Qu, Xiaochao; Xu, Xianhui; Chen, Xueli; Yang, Xiang; Cao, Feng; Liang, Jimin; Tian, Jie

2014-12-01

To solve the multicollinearity issue and unequal contribution of vascular parameters for the quantification of angiogenesis, we developed a quantification evaluation method of vascular parameters for angiogenesis based on in vivo micro-CT imaging of hindlimb ischemic model mice. Taking vascular volume as the ground truth parameter, nine vascular parameters were first assembled into sparse principal components (PCs) to reduce the multicolinearity issue. Aggregated boosted trees (ABTs) were then employed to analyze the importance of vascular parameters for the quantification of angiogenesis via the loadings of sparse PCs. The results demonstrated that vascular volume was mainly characterized by vascular area, vascular junction, connectivity density, segment number and vascular length, which indicated they were the key vascular parameters for the quantification of angiogenesis. The proposed quantitative evaluation method was compared with both the ABTs directly using the nine vascular parameters and Pearson correlation, which were consistent. In contrast to the ABTs directly using the vascular parameters, the proposed method can select all the key vascular parameters simultaneously, because all the key vascular parameters were assembled into the sparse PCs with the highest relative importance.

Primary care of adults with developmental disabilities

PubMed Central

Sullivan, William F.; Berg, Joseph M.; Bradley, Elspeth; Cheetham, Tom; Denton, Richard; Heng, John; Hennen, Brian; Joyce, David; Kelly, Maureen; Korossy, Marika; Lunsky, Yona; McMillan, Shirley

2011-01-01

Abstract Objective To update the 2006 Canadian guidelines for primary care of adults with developmental disabilities (DD) and to make practical recommendations based on current knowledge to address the particular health issues of adults with DD. Quality of evidence Knowledgeable health care providers participating in a colloquium and a subsequent working group discussed and agreed on revisions to the 2006 guidelines based on a comprehensive review of publications, feedback gained from users of the guidelines, and personal clinical experiences. Most of the available evidence in this area of care is from expert opinion or published consensus statements (level III). Main message Adults with DD have complex health issues, many of them differing from those of the general population. Good primary care identifies the particular health issues faced by adults with DD to improve their quality of life, to improve their access to health care, and to prevent suffering, morbidity, and premature death. These guidelines synthesize general, physical, behavioural, and mental health issues of adults with DD that primary care providers should be aware of, and they present recommendations for screening and management based on current knowledge that practitioners can apply. Because of interacting biologic, psychoaffective, and social factors that contribute to the health and well-being of adults with DD, these guidelines emphasize involving caregivers, adapting procedures when appropriate, and seeking input from a range of health professionals when available. Ethical care is also emphasized. The guidelines are formulated within an ethical framework that pays attention to issues such as informed consent and the assessment of health benefits in relation to risks of harm. Conclusion Implementation of the guidelines proposed here would improve the health of adults with DD and would minimize disparities in health and health care between adults with DD and those in the general population. PMID:21571716

Methods for quantification of soil-transmitted helminths in environmental media: current techniques and recent advances

PubMed Central

Collender, Philip A.; Kirby, Amy E.; Addiss, David G.; Freeman, Matthew C.; Remais, Justin V.

2015-01-01

Limiting the environmental transmission of soil-transmitted helminths (STH), which infect 1.5 billion people worldwide, will require sensitive, reliable, and cost effective methods to detect and quantify STH in the environment. We review the state of the art of STH quantification in soil, biosolids, water, produce, and vegetation with respect to four major methodological issues: environmental sampling; recovery of STH from environmental matrices; quantification of recovered STH; and viability assessment of STH ova. We conclude that methods for sampling and recovering STH require substantial advances to provide reliable measurements for STH control. Recent innovations in the use of automated image identification and developments in molecular genetic assays offer considerable promise for improving quantification and viability assessment. PMID:26440788

Sustainable design guidelines to support the Washington State ferries terminal design manual : stormwater and material issues.

DOT National Transportation Integrated Search

2011-08-01

In an effort to assist the developers of the terminal design manual in potentially addressing : sustainable design issues, the overall goal is to produce Sustainable Design Guidelines that : will specifically address the unique needs and requirements...

Evidence-based and value-based formulary guidelines.

PubMed

Neumann, Peter J

2004-01-01

Health plans and hospitals have long used drug formularies, but the processes by which formulary committees made decisions have typically lacked transparency and scientific rigor. A growing number of organizations have begun implementing formulary guidelines issued by the Academy of Managed Care Pharmacy (AMCP). These guidelines call for health plans to request formally that drug companies present a standardized "dossier" that contains detailed information not only on the drug's effectiveness and safety but also on its economic value relative to alternative therapies. This paper describes the guidelines, reviews progress to date, and analyzes several critical issues for the future.

Evidence-based review of diabetic macular edema management: Consensus statement on Indian treatment guidelines

PubMed Central

Das, Taraprasad; Aurora, Ajay; Chhablani, Jay; Giridhar, Anantharaman; Kumar, Atul; Raman, Rajiv; Nagpal, Manish; Narayanan, Raja; Natarajan, Sundaram; Ramasamay, Kim; Tyagi, Mudit; Verma, Lalit

2016-01-01

The purpose of the study was to review the current evidence and design a diabetic macular edema (DME) management guideline specific for India. The published DME guidelines from different organizations and publications were weighed against the practice trends in India. This included the recently approved drugs. DME management consisted of control of diabetes and other associated systemic conditions, such as hypertension and hyperlipidemia, and specific therapy to reduce macular edema. Quantification of macular edema is precisely made with the optical coherence tomography and treatment options include retinal laser, intravitreal anti-vascular endothelial growth factors (VEGF), and implantable dexamethasone. Specific use of these modalities depends on the presenting vision and extent of macular involvement. Invariable eyes with center-involving macular edema benefit from intravitreal anti-VEGF or dexamethasone implant therapy, and eyes with macular edema not involving the macula center benefit from retinal laser. The results are illustrated with adequate case studies and frequently asked questions. This guideline prepared on the current published evidence is meant as a guideline for the treating physicians. PMID:26953019

Bacteriophage removal efficiency as a validation and operational monitoring tool for virus reduction in wastewater reclamation: Review.

PubMed

Amarasiri, Mohan; Kitajima, Masaaki; Nguyen, Thanh H; Okabe, Satoshi; Sano, Daisuke

2017-09-15

The multiple-barrier concept is widely employed in international and domestic guidelines for wastewater reclamation and reuse for microbiological risk management, in which a wastewater reclamation system is designed to achieve guideline values of the performance target of microbe reduction. Enteric viruses are one of the pathogens for which the target reduction values are stipulated in guidelines, but frequent monitoring to validate human virus removal efficacy is challenging in a daily operation due to the cumbersome procedures for virus quantification in wastewater. Bacteriophages have been the first choice surrogate for this task, because of the well-characterized nature of strains and the presence of established protocols for quantification. Here, we performed a meta-analysis to calculate the average log 10 reduction values (LRVs) of somatic coliphages, F-specific phages, MS2 coliphage and T4 phage by membrane bioreactor, activated sludge, constructed wetlands, pond systems, microfiltration and ultrafiltration. The calculated LRVs of bacteriophages were then compared with reported human enteric virus LRVs. MS2 coliphage LRVs in MBR processes were shown to be lower than those of norovirus GII and enterovirus, suggesting it as a possible validation and operational monitoring tool. The other bacteriophages provided higher LRVs compared to human viruses. The data sets on LRVs of human viruses and bacteriophages are scarce except for MBR and conventional activated sludge processes, which highlights the necessity of investigating LRVs of human viruses and bacteriophages in multiple treatment unit processes. Copyright © 2017 Elsevier Ltd. All rights reserved.

5 CFR 724.403 - Advisory guidelines.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 2 2010-01-01 2010-01-01 false Advisory guidelines. 724.403 Section 724.403 Administrative Personnel OFFICE OF PERSONNEL MANAGEMENT (CONTINUED) CIVIL SERVICE REGULATIONS... RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

A Guideline to Family-Wide Comparative State-of-the-Art Quantitative RT-PCR Analysis Exemplified with a Brassicaceae Cross-Species Seed Germination Case Study[W][OA

PubMed Central

Graeber, Kai; Linkies, Ada; Wood, Andrew T.A.; Leubner-Metzger, Gerhard

2011-01-01

Comparative biology includes the comparison of transcriptome and quantitative real-time RT-PCR (qRT-PCR) data sets in a range of species to detect evolutionarily conserved and divergent processes. Transcript abundance analysis of target genes by qRT-PCR requires a highly accurate and robust workflow. This includes reference genes with high expression stability (i.e., low intersample transcript abundance variation) for correct target gene normalization. Cross-species qRT-PCR for proper comparative transcript quantification requires reference genes suitable for different species. We addressed this issue using tissue-specific transcriptome data sets of germinating Lepidium sativum seeds to identify new candidate reference genes. We investigated their expression stability in germinating seeds of L. sativum and Arabidopsis thaliana by qRT-PCR, combined with in silico analysis of Arabidopsis and Brassica napus microarray data sets. This revealed that reference gene expression stability is higher for a given developmental process between distinct species than for distinct developmental processes within a given single species. The identified superior cross-species reference genes may be used for family-wide comparative qRT-PCR analysis of Brassicaceae seed germination. Furthermore, using germinating seeds, we exemplify optimization of the qRT-PCR workflow for challenging tissues regarding RNA quality, transcript stability, and tissue abundance. Our work therefore can serve as a guideline for moving beyond Arabidopsis by establishing high-quality cross-species qRT-PCR. PMID:21666000

78 FR 9743 - Event Reporting Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... NUCLEAR REGULATORY COMMISSION [NRC-2011-0237] Event Reporting Guidelines AGENCY: Nuclear... Regulatory Commission (NRC) has issued NUREG- 1022, Revision 3, ``Event Reporting Guidelines: 10 CFR 50.72 and 50.73.'' [[Page 9744

Cancer screening in the United States, 2017: A review of current American Cancer Society guidelines and current issues in cancer screening.

PubMed

Smith, Robert A; Andrews, Kimberly S; Brooks, Durado; Fedewa, Stacey A; Manassaram-Baptiste, Deana; Saslow, Debbie; Brawley, Otis W; Wender, Richard C

2017-03-01

Answer questions and earn CME/CNE Each year, the American Cancer Society publishes a summary of its guidelines for early cancer detection, data and trends in cancer screening rates, and select issues related to cancer screening. In this issue of the journal, the authors summarize current American Cancer Society cancer screening guidelines, describe an update of their guideline for using human papillomavirus vaccination for cancer prevention, describe updates in US Preventive Services Task Force recommendations for breast and colorectal cancer screening, discuss interim findings from the UK Collaborative Trial on Ovarian Cancer Screening, and provide the latest data on utilization of cancer screening from the National Health Interview Survey. CA Cancer J Clin 2017;67:100-121. © 2017 American Cancer Society. © 2017 American Cancer Society.

41 CFR 101-27.102-2 - Guidelines.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Replenishment § 101-27.102-2 Guidelines. Guidelines for implementing the EOQ principle of stock replenishment are in the GSA Handbook, The Economic Order Quantity Principle and Applications, issued by the Federal...

Human factors issues in the design of user interfaces for planning and scheduling

NASA Technical Reports Server (NTRS)

Murphy, Elizabeth D.

1991-01-01

The purpose is to provide and overview of human factors issues that impact the effectiveness of user interfaces to automated scheduling tools. The following methods are employed: (1) a survey of planning and scheduling tools; (2) the identification and analysis of human factors issues; (3) the development of design guidelines based on human factors literature; and (4) the generation of display concepts to illustrate guidelines.

5 CFR 724.403 - Advisory guidelines.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 5 Administrative Personnel 2 2011-01-01 2011-01-01 false Advisory guidelines. 724.403 Section 724... (CONTINUED) IMPLEMENTATION OF TITLE II OF THE NOTIFICATION AND FEDERAL EMPLOYEE ANTIDISCRIMINATION AND RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

5 CFR 724.403 - Advisory guidelines.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 2 2013-01-01 2013-01-01 false Advisory guidelines. 724.403 Section 724... (CONTINUED) IMPLEMENTATION OF TITLE II OF THE NOTIFICATION AND FEDERAL EMPLOYEE ANTIDISCRIMINATION AND RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

5 CFR 724.403 - Advisory guidelines.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 2 2014-01-01 2014-01-01 false Advisory guidelines. 724.403 Section 724... (CONTINUED) IMPLEMENTATION OF TITLE II OF THE NOTIFICATION AND FEDERAL EMPLOYEE ANTIDISCRIMINATION AND RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

5 CFR 724.403 - Advisory guidelines.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 2 2012-01-01 2012-01-01 false Advisory guidelines. 724.403 Section 724... (CONTINUED) IMPLEMENTATION OF TITLE II OF THE NOTIFICATION AND FEDERAL EMPLOYEE ANTIDISCRIMINATION AND RETALIATION ACT OF 2002 Best Practices § 724.403 Advisory guidelines. OPM will issue advisory guidelines to...

50 CFR 253.18 - Program operating guidelines.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 50 Wildlife and Fisheries 7 2010-10-01 2010-10-01 false Program operating guidelines. 253.18 Section 253.18 Wildlife and Fisheries NATIONAL MARINE FISHERIES SERVICE, NATIONAL OCEANIC AND ATMOSPHERIC... Guarantee Program § 253.18 Program operating guidelines. The Division may issue Program operating guidelines...

Simultaneous quantification of withanolides in Withania somnifera by a validated high-performance thin-layer chromatographic method.

PubMed

Srivastava, Pooja; Tiwari, Neerja; Yadav, Akhilesh K; Kumar, Vijendra; Shanker, Karuna; Verma, Ram K; Gupta, Madan M; Gupta, Anil K; Khanuja, Suman P S

2008-01-01

This paper describes a sensitive, selective, specific, robust, and validated densitometric high-performance thin-layer chromatographic (HPTLC) method for the simultaneous determination of 3 key withanolides, namely, withaferin-A, 12-deoxywithastramonolide, and withanolide-A, in Ashwagandha (Withania somnifera) plant samples. The separation was performed on aluminum-backed silica gel 60F254 HPTLC plates using dichloromethane-methanol-acetone-diethyl ether (15 + 1 + 1 + 1, v/v/v/v) as the mobile phase. The withanolides were quantified by densitometry in the reflection/absorption mode at 230 nm. Precise and accurate quantification could be performed in the linear working concentration range of 66-330 ng/band with good correlation (r2 = 0.997, 0.999, and 0.996, respectively). The method was validated for recovery, precision, accuracy, robustness, limit of detection, limit of quantitation, and specificity according to International Conference on Harmonization guidelines. Specificity of quantification was confirmed using retention factor (Rf) values, UV-Vis spectral correlation, and electrospray ionization mass spectra of marker compounds in sample tracks.

The Aging of lignin rich papers upon exposure to light : its quantification and prediction

Treesearch

James S. Bond; Rajai H. Atalla; Agarwal Umesh P.; Chris G. Hunt

1999-01-01

A program was undertaken at the Forest Products Laboratory in conjunction with the American Society for Testing and Materials (ASTM) to develop guidelines for a credible accelerated photoaging protocol for printing and writing papers. In support of this, indepth studies of photodegredation were undertaken in sufficient detail to establish the validity of the protocol....

Uncertainty in Agricultural Impact Assessment

NASA Technical Reports Server (NTRS)

Wallach, Daniel; Mearns, Linda O.; Rivington, Michael; Antle, John M.; Ruane, Alexander C.

2014-01-01

This chapter considers issues concerning uncertainty associated with modeling and its use within agricultural impact assessments. Information about uncertainty is important for those who develop assessment methods, since that information indicates the need for, and the possibility of, improvement of the methods and databases. Such information also allows one to compare alternative methods. Information about the sources of uncertainties is an aid in prioritizing further work on the impact assessment method. Uncertainty information is also necessary for those who apply assessment methods, e.g., for projecting climate change impacts on agricultural production and for stakeholders who want to use the results as part of a decision-making process (e.g., for adaptation planning). For them, uncertainty information indicates the degree of confidence they can place in the simulated results. Quantification of uncertainty also provides stakeholders with an important guideline for making decisions that are robust across the known uncertainties. Thus, uncertainty information is important for any decision based on impact assessment. Ultimately, we are interested in knowledge about uncertainty so that information can be used to achieve positive outcomes from agricultural modeling and impact assessment.

Development and validation of a HPTLC method for simultaneous estimation of lornoxicam and thiocolchicoside in combined dosage form.

PubMed

Sahoo, Madhusmita; Syal, Pratima; Hable, Asawaree A; Raut, Rahul P; Choudhari, Vishnu P; Kuchekar, Bhanudas S

2011-07-01

To develop a simple, precise, rapid and accurate HPTLC method for the simultaneous estimation of Lornoxicam (LOR) and Thiocolchicoside (THIO) in bulk and pharmaceutical dosage forms. The separation of the active compounds from pharmaceutical dosage form was carried out using methanol:chloroform:water (9.6:0.2:0.2 v/v/v) as the mobile phase and no immiscibility issues were found. The densitometric scanning was carried out at 377 nm. The method was validated for linearity, accuracy, precision, LOD (Limit of Detection), LOQ (Limit of Quantification), robustness and specificity. The Rf values (±SD) were found to be 0.84 ± 0.05 for LOR and 0.58 ± 0.05 for THIO. Linearity was obtained in the range of 60-360 ng/band for LOR and 30-180 ng/band for THIO with correlation coefficients r(2) = 0.998 and 0.999, respectively. The percentage recovery for both the analytes was in the range of 98.7-101.2 %. The proposed method was optimized and validated as per the ICH guidelines.

Simultaneous quantification of four antiretroviral drugs in breast milk samples from HIV-positive women by an ultra-high performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method

PubMed Central

Rodríguez-Delgado, Rosa Georgina; Figueroa-Damián, Ricardo; Domínguez-Castro, Mauricio; López-Martínez, Margarita; Flores-García, Zayra

2018-01-01

The primary strategy to avoid mother-to-child transmission of human immunodeficiency virus (HIV) through breastfeeding is administration of highly active antiretroviral therapy (HAART) to HIV-positive pregnant women. Because significant changes in the pharmacokinetics of antiretroviral (ARV) drugs occur during pregnancy, quantifying HAART and the viral load in breast milk in this population is essential. Here, we developed an analytical assay for the simultaneous quantification of four ARV drugs in breast milk using ultra-performance liquid chromatography coupled to tandem mass spectrometry. We validated this method following Mexican and international guidelines. ARV drugs. We extracted the ARV drugs from 200 μL samples of breast milk and detected these drugs in a triple quadrupole mass spectrometer with positive electrospray ionization. The validated concentration ranges (ng/mL) for zidovudine, lamivudine, lopinavir, and ritonavir were 12.5–750, 50–2500, 100–5000 and 5 to 250, respectively. Additionally, the absolute recovery percentages (and matrix effects) were 91.4 (8.39), 88.78 (28.75), 91.38 (11.77) and 89.78 (12.37), respectively. We determined that ARV drugs are stable for 24 h at 8°C and 24°C for 15 days at –80°C. This methodology had the capacity for simultaneous detection; separation; and accurate, precise quantification of ARV drugs in human breast milk samples according to Mexican standard laws and United States Food and Drug Administration guidelines. PMID:29351333

Advocacy Groups Deliver Guidelines for Schools Facing Sexual-Orientation Issues

ERIC Educational Resources Information Center

Curriculum Review, 2006

2006-01-01

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

AIDS: Workplace Issues. INFO-LINE. Practical Guidelines for Training and Development Professionals. Issue 9208.

ERIC Educational Resources Information Center

American Society for Training and Development, Alexandria, VA.

Practical guidelines are presented for training and development professionals dealing with acquired immune deficiency syndrome (AIDS) in the workplace. The following topics are covered: AIDS in the workplace; AIDS basics, including information on the required corporate commitment and transmission of human immunodeficiency virus (HIV); employment…

Is There a European View on Health Economic Evaluations? Results from a Synopsis of Methodological Guidelines Used in the EUnetHTA Partner Countries.

PubMed

Heintz, Emelie; Gerber-Grote, Andreas; Ghabri, Salah; Hamers, Francoise F; Rupel, Valentina Prevolnik; Slabe-Erker, Renata; Davidson, Thomas

2016-01-01

The objectives of this study were to review current methodological guidelines for economic evaluations of all types of technologies in the 33 countries with organizations involved in the European Network for Health Technology Assessment (EUnetHTA), and to provide a general framework for economic evaluation at a European level. Methodological guidelines for health economic evaluations used by EUnetHTA partners were collected through a survey. Information from each guideline was extracted using a pre-tested extraction template. On the basis of the extracted information, a summary describing the methods used by the EUnetHTA countries was written for each methodological item. General recommendations were formulated for methodological issues where the guidelines of the EUnetHTA partners were in agreement or where the usefulness of economic evaluations may be increased by presenting the results in a specific way. At least one contact person from all 33 EUnetHTA countries (100 %) responded to the survey. In total, the review included 51 guidelines, representing 25 countries (eight countries had no methodological guideline for health economic evaluations). On the basis of the results of the extracted information from all 51 guidelines, EUnetHTA issued ten main recommendations for health economic evaluations. The presented review of methodological guidelines for health economic evaluations and the consequent recommendations will hopefully improve the comparability, transferability and overall usefulness of economic evaluations performed within EUnetHTA. Nevertheless, there are still methodological issues that need to be investigated further.

The Qiagen Investigator® Quantiplex HYres as an alternative kit for DNA quantification.

PubMed

Frégeau, Chantal J; Laurin, Nancy

2015-05-01

The Investigator® Quantiplex HYres kit was evaluated as a potential replacement for dual DNA quantification of casework samples. This kit was determined to be highly sensitive with a limit of quantification and limit of detection of 0.0049ng/μL and 0.0003ng/μL, respectively, for both human and male DNA, using full or half reaction volumes. It was also accurate in assessing the amount of male DNA present in 96 mock and actual casework male:female mixtures (various ratios) processed in this exercise. The close correlation between the male/human DNA ratios expressed in percentages derived from the Investigator® Quantiplex HYres quantification results and the male DNA proportion calculated in mixed AmpFlSTR® Profiler® Plus or AmpFlSTR® Identifiler® Plus profiles, using the Amelogenin Y peak and STR loci, allowed guidelines to be developed to facilitate decisions regarding when to submit samples to Y-STR rather than autosomal STR profiling. The internal control (IC) target was shown to be more sensitive to inhibitors compared to the human and male DNA targets included in the Investigator® Quantiplex HYres kit serving as a good quality assessor of DNA extracts. The new kit met our criteria of enhanced sensitivity, accuracy, consistency, reliability and robustness for casework DNA quantification. Crown Copyright © 2015. Published by Elsevier Ireland Ltd. All rights reserved.

5 CFR 1310.1 - Policy guidelines.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Policy guidelines. 1310.1 Section 1310.1 Administrative Personnel OFFICE OF MANAGEMENT AND BUDGET OMB DIRECTIVES OMB CIRCULARS § 1310.1 Policy guidelines. In carrying out its responsibilities, the Office of Management and Budget issues policy guidelines to...

A Systematic Review of Methodology: Time Series Regression Analysis for Environmental Factors and Infectious Diseases

PubMed Central

Imai, Chisato; Hashizume, Masahiro

2015-01-01

Background: Time series analysis is suitable for investigations of relatively direct and short-term effects of exposures on outcomes. In environmental epidemiology studies, this method has been one of the standard approaches to assess impacts of environmental factors on acute non-infectious diseases (e.g. cardiovascular deaths), with conventionally generalized linear or additive models (GLM and GAM). However, the same analysis practices are often observed with infectious diseases despite of the substantial differences from non-infectious diseases that may result in analytical challenges. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, systematic review was conducted to elucidate important issues in assessing the associations between environmental factors and infectious diseases using time series analysis with GLM and GAM. Published studies on the associations between weather factors and malaria, cholera, dengue, and influenza were targeted. Findings: Our review raised issues regarding the estimation of susceptible population and exposure lag times, the adequacy of seasonal adjustments, the presence of strong autocorrelations, and the lack of a smaller observation time unit of outcomes (i.e. daily data). These concerns may be attributable to features specific to infectious diseases, such as transmission among individuals and complicated causal mechanisms. Conclusion: The consequence of not taking adequate measures to address these issues is distortion of the appropriate risk quantifications of exposures factors. Future studies should pay careful attention to details and examine alternative models or methods that improve studies using time series regression analysis for environmental determinants of infectious diseases. PMID:25859149

Automated quantification of renal interstitial fibrosis for computer-aided diagnosis: A comprehensive tissue structure segmentation method.

PubMed

Tey, Wei Keat; Kuang, Ye Chow; Ooi, Melanie Po-Leen; Khoo, Joon Joon

2018-03-01

Interstitial fibrosis in renal biopsy samples is a scarring tissue structure that may be visually quantified by pathologists as an indicator to the presence and extent of chronic kidney disease. The standard method of quantification by visual evaluation presents reproducibility issues in the diagnoses. This study proposes an automated quantification system for measuring the amount of interstitial fibrosis in renal biopsy images as a consistent basis of comparison among pathologists. The system extracts and segments the renal tissue structures based on colour information and structural assumptions of the tissue structures. The regions in the biopsy representing the interstitial fibrosis are deduced through the elimination of non-interstitial fibrosis structures from the biopsy area and quantified as a percentage of the total area of the biopsy sample. A ground truth image dataset has been manually prepared by consulting an experienced pathologist for the validation of the segmentation algorithms. The results from experiments involving experienced pathologists have demonstrated a good correlation in quantification result between the automated system and the pathologists' visual evaluation. Experiments investigating the variability in pathologists also proved the automated quantification error rate to be on par with the average intra-observer variability in pathologists' quantification. Interstitial fibrosis in renal biopsy samples is a scarring tissue structure that may be visually quantified by pathologists as an indicator to the presence and extent of chronic kidney disease. The standard method of quantification by visual evaluation presents reproducibility issues in the diagnoses due to the uncertainties in human judgement. An automated quantification system for accurately measuring the amount of interstitial fibrosis in renal biopsy images is presented as a consistent basis of comparison among pathologists. The system identifies the renal tissue structures through knowledge-based rules employing colour space transformations and structural features extraction from the images. In particular, the renal glomerulus identification is based on a multiscale textural feature analysis and a support vector machine. The regions in the biopsy representing interstitial fibrosis are deduced through the elimination of non-interstitial fibrosis structures from the biopsy area. The experiments conducted evaluate the system in terms of quantification accuracy, intra- and inter-observer variability in visual quantification by pathologists, and the effect introduced by the automated quantification system on the pathologists' diagnosis. A 40-image ground truth dataset has been manually prepared by consulting an experienced pathologist for the validation of the segmentation algorithms. The results from experiments involving experienced pathologists have demonstrated an average error of 9 percentage points in quantification result between the automated system and the pathologists' visual evaluation. Experiments investigating the variability in pathologists involving samples from 70 kidney patients also proved the automated quantification error rate to be on par with the average intra-observer variability in pathologists' quantification. The accuracy of the proposed quantification system has been validated with the ground truth dataset and compared against the pathologists' quantification results. It has been shown that the correlation between different pathologists' estimation of interstitial fibrosis area has significantly improved, demonstrating the effectiveness of the quantification system as a diagnostic aide. Copyright © 2017 Elsevier B.V. All rights reserved.

Accounting guidelines for HMOs: issues and practices.

PubMed

Ingram, R W; Robbins, W A

1987-03-01

HMOs are fast becoming an important part of the healthcare industry today. Unfortunately, specific accounting guidelines have not yet been established for them. This concern has led the AICPA to describe and offer recommendations concerning preferred accounting techniques for HMOs. This article looks at the issues raised by the AICPA and how current HMO financial officers feel about the practices that are recommended. It is suggested that the organization, taxability, and other attributes of an HMO must be clearly understood before strict accounting guidelines are imposed.

Methods for Quantification of Soil-Transmitted Helminths in Environmental Media: Current Techniques and Recent Advances.

PubMed

Collender, Philip A; Kirby, Amy E; Addiss, David G; Freeman, Matthew C; Remais, Justin V

2015-12-01

Limiting the environmental transmission of soil-transmitted helminths (STHs), which infect 1.5 billion people worldwide, will require sensitive, reliable, and cost-effective methods to detect and quantify STHs in the environment. We review the state-of-the-art of STH quantification in soil, biosolids, water, produce, and vegetation with regard to four major methodological issues: environmental sampling; recovery of STHs from environmental matrices; quantification of recovered STHs; and viability assessment of STH ova. We conclude that methods for sampling and recovering STHs require substantial advances to provide reliable measurements for STH control. Recent innovations in the use of automated image identification and developments in molecular genetic assays offer considerable promise for improving quantification and viability assessment. Copyright © 2015 Elsevier Ltd. All rights reserved.

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…

76 FR 16724 - Child Nutrition Programs-Income Eligibility Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-25

... for Children (7 CFR part 215). These eligibility guidelines are based on the Federal income poverty... price meals were obtained by multiplying the year 2011 Federal income poverty guidelines by 1.30 and 1... only the annual Federal poverty guidelines issued by the Department of Health and Human Services...

Statistical image quantification toward optimal scan fusion and change quantification

NASA Astrophysics Data System (ADS)

Potesil, Vaclav; Zhou, Xiang Sean

2007-03-01

Recent advance of imaging technology has brought new challenges and opportunities for automatic and quantitative analysis of medical images. With broader accessibility of more imaging modalities for more patients, fusion of modalities/scans from one time point and longitudinal analysis of changes across time points have become the two most critical differentiators to support more informed, more reliable and more reproducible diagnosis and therapy decisions. Unfortunately, scan fusion and longitudinal analysis are both inherently plagued with increased levels of statistical errors. A lack of comprehensive analysis by imaging scientists and a lack of full awareness by physicians pose potential risks in clinical practice. In this paper, we discuss several key error factors affecting imaging quantification, studying their interactions, and introducing a simulation strategy to establish general error bounds for change quantification across time. We quantitatively show that image resolution, voxel anisotropy, lesion size, eccentricity, and orientation are all contributing factors to quantification error; and there is an intricate relationship between voxel anisotropy and lesion shape in affecting quantification error. Specifically, when two or more scans are to be fused at feature level, optimal linear fusion analysis reveals that scans with voxel anisotropy aligned with lesion elongation should receive a higher weight than other scans. As a result of such optimal linear fusion, we will achieve a lower variance than naïve averaging. Simulated experiments are used to validate theoretical predictions. Future work based on the proposed simulation methods may lead to general guidelines and error lower bounds for quantitative image analysis and change detection.

Issues Related to Equipment and the Dietary Guidelines for Americans.

ERIC Educational Resources Information Center

Nettles, Mary Frances

A multi-year project was initiated to examine production equipment issues related to implementation of the Dietary Guidelines for Americans (DGA). The purposes of the research project were to determine foodservice directors' opinions regarding use and appropriateness of equipment in school foodservice, to identify the number and variety of menu…

Understanding Gender Equity in the Workplace.

ERIC Educational Resources Information Center

Nunnelley State Technical Coll., Childersburg, AL.

This document discusses issues of gender equity in the workplace which are pertinent to the high school counselor. The first chapter provides guidelines for helping students to understand gender equity issues. These guidelines include asking the students if they would have the same career goals if they were of the other sex and challenging the…

76 FR 4550 - Income Level for Individuals Eligible for Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-26

... Poverty Guidelines as issued by the Department of Health and Human Services. DATES: Effective Date: This... maximum income level equivalent to one hundred and twenty-five percent (125%) of the Federal Poverty... issuing the Federal Poverty Guidelines. The figures for 2010 set out below are equivalent to 125% of the...

SCIENTIFIC AUTHORSHIP, PART I: A WINDOW INOT SCIENTIFIC FRAUD SCIENTIFIC AUTHORSHIP, PART II: HISTORY, REOCCURRING ISSUES, PRACTICES, AND GUIDELINES (SEE COMMENTS)

EPA Science Inventory

Scientific Authorship: History, Reoccurring Issues, Practices, and Guidelines
Introduction
Often, the most challenging aspect of being a scientist is dealing with the intricacies of publishing one's research and knowledge. One must do much more than just accurately record...

76 FR 67725 - Technical Conference on Penalty Guidelines; Second Notice of Technical Conference on Penalty...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-02

... Conference on Penalty Guidelines; Second Notice of Technical Conference on Penalty Guidelines On September 21... Conference on Penalty Guidelines to be held on November 17, 2011. The conference will be held from 1 p.m. to... impact of the Penalty Guidelines, which the Commission issued on September 17, 2010,\\1\\ on compliance and...

The full spectrum of ethical issues in dementia care: systematic qualitative review.

PubMed

Strech, Daniel; Mertz, Marcel; Knüppel, Hannes; Neitzke, Gerald; Schmidhuber, Martina

2013-06-01

Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.

Dietary Guidelines for the Asia Pacific Region.

PubMed

Binns, Colin W; Lee, Mi Kyung; Kagawa, Masaharu; Low, Wah Yun; Liqian, Qiu; Guldan, Georgia S; Hokama, Tomiko; Nanishi, Keiko; Oy, Sreymom; Tang, Li; Zerfas, Alfred

2017-03-01

Nutrition is a major determinant of health throughout all stages of life and together with smoking is the most important risk factor for morbidity and mortality in the Asia Pacific Region. The workshop participants examined Dietary Guidelines and Food Guides that are in use in our region, together with additional materials from the World Health Organization, UNICEF and the World Cancer Research Foundation. The resulting set of guidelines is meant as a reminder of the main issues to be covered in a general public health education program. It may also be of value in reminding public health practitioners, educators, administrators, and policy makers of current nutrition issues. It may additionally be useful as a checklist of the issues to be considered in public health programs and regulations. The main areas of nutrition that are included in the Guidelines are eating a variety of foods, including vegetables, fruits, whole grain cereals, and nuts. Choose fish, poultry, and meats grown in a sustainable way. Appropriate growth, including avoiding obesity, and physical activity are important. Breastfeeding is the basis of infant nutrition and nutrition of mothers is an important public health measure. Negative factors in the Asian diet include salt, refined sugar, alcohol and fats. The APACPH Dietary Guidelines will need to be kept under review and modified to meet regional differences in food supply. The Guidelines will be useful as a checklist of the issues to be considered in public health programs, addressing both acute and chronic diseases.

The management of scabies outbreaks in residential care facilities for the elderly in England: a review of current health protection guidelines.

PubMed

White, L C J; Lanza, S; Middleton, J; Hewitt, K; Freire-Moran, L; Edge, C; Nicholls, M; Rajan-Iyer, J; Cassell, J A

2016-11-01

Commonly thought of as a disease of poverty and overcrowding in resource-poor settings globally, scabies is also an important public health issue in residential care facilities for the elderly (RCFE) in high-income countries such as the UK. We compared and contrasted current local Health Protection Team (HPT) guidelines for the management of scabies outbreaks in RCFE throughout England. We performed content analysis on 20 guidelines, and used this to create a quantitative report of their variation in key dimensions. Although the guidelines were generally consistent on issues such as the treatment protocols for individual patients, there was substantial variation in their recommendations regarding the prophylactic treatment of contacts, infection control measures and the roles and responsibilities of individual stakeholders. Most guidelines did not adequately address the logistical challenges associated with mass treatment in this setting. We conclude that the heterogeneous nature of the guidelines reviewed is an argument in favour of national guidelines being produced.

Network Security Guideline

DTIC Science & Technology

1993-06-01

3.2.15.3 ISDN Services over the Telephone Network 3 Integrated Services Digital Network (ISDN) services are subject to the same restrictions as router...to be audited: [SYS$SYSTEM]SYS.EXE, LOGINOUT.EXE, STARTUP.COM, RIGHTSLIST.DAT [SYS$ LIBARY ] I SECURESHR.EXE [SYS$ROOT] SYSEXE.DIR, SYSLIB.DIR...quantification) of the encoded value; ASCII is normally used for asynchronous transmission. compare with digital . ASYNCHRONOUS-Data transmission that is

Proposed Guidelines for Operating Counselor Education and Supervision Training Clinics

ERIC Educational Resources Information Center

Lauka, Justin D.; McCarthy, Amanda K.

2013-01-01

The purpose of this article is to justify and present a set of guidelines for the effective and ethical administration of counselor education and supervision training clinics. Responding directly to a call for creating guidelines, the authors address core issues surrounding their development. Benefits for clear and accessible guidelines and risks…

If you drink alcoholic beverages do so in moderation: what does this mean?

PubMed

Dufour, M C

2001-02-01

The changes in content of the alcohol guideline of the various editions of the Dietary Guidelines for Americans from 1980 to 2000 are discussed. This is followed by a capsule summary of the history and evolution of the discipline of alcohol epidemiology compared with that of nutrition epidemiology. Methods of assessment are discussed, and issues surrounding the validity and reliability of self-report of alcohol consumption are then outlined. Relevant objectives from Healthy People 2010 are discussed. Surveillance of the alcohol guideline discloses that, at present, very few American drinkers follow the recommendations of the alcohol guideline. Indications for future research needs to address this issue conclude the discussion.

Species identification and quantification in meat and meat products using droplet digital PCR (ddPCR).

PubMed

Floren, C; Wiedemann, I; Brenig, B; Schütz, E; Beck, J

2015-04-15

Species fraud and product mislabelling in processed food, albeit not being a direct health issue, often results in consumer distrust. Therefore methods for quantification of undeclared species are needed. Targeting mitochondrial DNA, e.g. CYTB gene, for species quantification is unsuitable, due to a fivefold inter-tissue variation in mtDNA content per cell resulting in either an under- (-70%) or overestimation (+160%) of species DNA contents. Here, we describe a reliable two-step droplet digital PCR (ddPCR) assay targeting the nuclear F2 gene for precise quantification of cattle, horse, and pig in processed meat products. The ddPCR assay is advantageous over qPCR showing a limit of quantification (LOQ) and detection (LOD) in different meat products of 0.01% and 0.001%, respectively. The specificity was verified in 14 different species. Hence, determining F2 in food by ddPCR can be recommended for quality assurance and control in production systems. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Echocardiographic chamber quantification in a healthy Dutch population.

PubMed

van Grootel, R W J; Menting, M E; McGhie, J; Roos-Hesselink, J W; van den Bosch, A E

2017-12-01

For accurate interpretation of echocardiographic measurements normative data are required, which are provided by guidelines. For this article, the hypothesis was that these cannot be extrapolated to the Dutch population, since in Dutch clinical practice often higher values are found, which may not be pathological but physiological. Therefore this study aimed to 1) obtain and propose normative values for cardiac chamber quantification in a healthy Dutch population and 2) determine influences of baseline characteristics on these measurements. Prospectively recruited healthy subjects, aged 20-72 years (at least 28 subjects per age decade, equally distributed for gender) underwent physical examination and 2D and 3D echocardiography. Both ventricles and atria were assessed and volumes were calculated. 147 subjects were included (age 44 ± 14 years, 50% female). Overall, feasibility was good for both linear and volumetric measurements. Linear and volumetric parameters were consistently higher than current guidelines recommend, while functional parameters were in line with the guidelines. This was more so in the older population. 3D volumes were higher than 2D volumes. Gender dependency was seen in all body surface area (BSA) corrected volumes and with increasing age, ejection fractions decreased. This study provides 2D and 3D echocardiographic reference ranges for both ventricles and atria derived from a healthy Dutch population. BSA indexed volumes are gender-dependent, age did not influence ventricular volumes and a rise in blood pressure was independently associated with increased right ventricular volumes. The higher volumes found may be indicative for the Dutch population being the tallest in the world.

Developing Computer Use in Education: Guidelines, Trends and Issues.

ERIC Educational Resources Information Center

Anderson, Jonathan; And Others

Designed to provide educational policy-makers and decision-makers with a basis for the development of guidelines for the development of education programs, this report presents an overview of trends and issues in computer education within the countries of the Asia and Pacific region. The impact of computers on society is described, as well as the…

Into the Wild Country: Epistemic Issues in Professional Guidelines for Palliative Sedation in End-of-Life Care

ERIC Educational Resources Information Center

Wackers, Ger

2015-01-01

End-of-life care is an important object of governance. Using the linguistic notions of polysemy, metaphorical blending and counterfactual reasoning, this paper critically examines epistemic issues in professional guidelines for palliative sedation of the dying. As a last resort option, palliative sedation is described as the intentional,…

Taking Ownership of the ITC's Guidelines for Computer-Based and Internet-Delivered Testing: A South African Application

ERIC Educational Resources Information Center

Foxcroft, Cheryl D.; Davies, Caroline

2006-01-01

The increased use of computer-based and Internet-delivered testing has raised a number of ethical and legal issues. The International Test Commission's (this issue) Guidelines for Computer-Based and Internet-Delivered Testing represent the most recent attempt to provide test users, publishers, and developers with guidance regarding the appropriate…

Monitoring ethical, legal, and social issues in developing population genetic databases.

PubMed

Austin, Melissa A; Harding, Sarah E; McElroy, Courtney E

2003-01-01

To characterize ethical, legal, and social issues unique to population genetic database research and to determine the relevance of international recommendations and guidelines for addressing these issues in the development of "genebank" projects globally. Building on our previous description of eight international genebanks, we conducted a comprehensive electronic search and literature review of relevant publications and consulted national and international documents applicable to genebank research. We identified and characterized five categories of ethical, legal, and social issues unique to genebank development: sponsorship and benefit-sharing, neutrality and regulatory power of ethics committees, public engagement, consent, and data protection. We illustrate these issues with examples from specific genebanks. Not all of the issues are addressed in current international guidelines, many of which are nonspecific and unenforceable. The trend of genebank development promises to provide new discoveries to the field of medical science and to greatly improve public health. However, there is a growing need for more explicit, enforceable, and coordinated international guidelines relevant to the development and implementation of genebanks. By comparing ethical, legal and social issues as they arise in genebanks, researchers can better evaluate how to best use these projects to improve public health while protecting participating populations.

Fact Sheet: EPA's Guidelines for Carcinogen Risk Assessment

EPA Science Inventory

March 29, 2005

FACT SHEET: EPA's GUIDELINES FOR CARCINOGEN RISK ASSESSMENT

On March 29, 2005, EPA issued the Guidelines for Carcinogen Risk A...

NSPWG-recommended safety requirements and guidelines for SEI nuclear propulsion

NASA Technical Reports Server (NTRS)

Marshall, Albert C.; Sawyer, J. C., Jr.; Bari, Robert A.; Brown, Neil W.; Cullingford, Hatice S.; Hardy, Alva C.; Lee, James H.; Mcculloch, William H.; Niederauer, George F.; Remp, Kerry

1992-01-01

An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative (SEI) nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top-level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of safety functional requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top-level safety requirements and guidelines to address these issues. Safety requirements were developed for reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, and safeguards. Guidelines were recommended for risk/reliability, operational safety, flight trajectory and mission abort, space debris and meteoroids, and ground test safety. In this paper the specific requirements and guidelines will be discussed.

Perspective: Challenges and Controversial Issues in the Dietary Guidelines for Americans, 1980-2015.

PubMed

Nestle, Marion

2018-03-01

Since 1980, every edition of the Dietary Guidelines for Americans (DGAs) has recommended increased consumption of fruits, vegetables, and whole grains, but reduced consumption of saturated fat, sugars, and sodium and, therefore, their primary food sources. Every edition has generated controversy, mainly from producers of foods affected by "eat less" recommendations, particularly meat. Objections to the 2015 DGAs focused on environmental as well as scientific issues, but also on purported conflicts of interest among members of the Dietary Guidelines Advisory Committee. On this basis, critics induced Congress to authorize the National Academy of Medicine (NAM) to review the process of drawing up the guidelines. The NAM's 2017 reports should strengthen the process, but as long as science continues to support advice to reduce consumption of targeted foods, the guidelines will continue to elicit political controversy.

Quantification of pelvic floor muscle strength in female urinary incontinence: A systematic review and comparison of contemporary methodologies.

PubMed

Deegan, Emily G; Stothers, Lynn; Kavanagh, Alex; Macnab, Andrew J

2018-01-01

There remains no gold standard for quantification of voluntary pelvic floor muscle (PFM) strength, despite international guidelines that recommend PFM assessment in females with urinary incontinence (UI). Methods currently reported for quantification of skeletal muscle strength across disciplines are systematically reviewed and their relevance for clinical and academic use related to the pelvic floor are described. A systematic review via Medline, PubMed, CINHAL, and the Cochrane database using key terms for pelvic floor anatomy and function were cross referenced with skeletal muscle strength quantification from 1946 to 2016. Full text peer-reviewed articles in English having female subjects with incontinence were identified. Each study was analyzed for use of controls, type of methodology as direct or indirect measures, benefits, and limitations of the technique. A total of 1586 articles were identified of which 50 met the inclusion criteria. Nine methodologies of determining PFM strength were described including: digital palpation, perineometer, dynamometry, EMG, vaginal cones, ultrasonography, magnetic resonance imaging, urine stream interruption test, and the Colpexin pull test. Thirty-two percent lacked a control group. Technical refinements in both direct and indirect instrumentation for PFM strength measurement are allowing for sensitivity. However, the most common methods of quantification remain digital palpation and perineometry; techniques that pose limitations and yield subjective or indirect measures of muscular strength. Dynamometry has potential as an accurate and sensitive tool, but is limited by inability to assess PFM strength during dynamic movements. © 2017 Wiley Periodicals, Inc.

Fundamentals of Counting Statistics in Digital PCR: I Just Measured Two Target Copies-What Does It Mean?

PubMed

Tzonev, Svilen

2018-01-01

Current commercially available digital PCR (dPCR) systems and assays are capable of detecting individual target molecules with considerable reliability. As tests are developed and validated for use on clinical samples, the need to understand and develop robust statistical analysis routines increases. This chapter covers the fundamental processes and limitations of detecting and reporting on single molecule detection. We cover the basics of quantification of targets and sources of imprecision. We describe the basic test concepts: sensitivity, specificity, limit of blank, limit of detection, and limit of quantification in the context of dPCR. We provide basic guidelines how to determine those, how to choose and interpret the operating point, and what factors may influence overall test performance in practice.

Methodological aspects of multicenter studies with quantitative PET.

PubMed

Boellaard, Ronald

2011-01-01

Quantification of whole-body FDG PET studies is affected by many physiological and physical factors. Much of the variability in reported standardized uptake value (SUV) data seen in the literature results from the variability in methodology applied among these studies, i.e., due to the use of different scanners, acquisition and reconstruction settings, region of interest strategies, SUV normalization, and/or corrections methods. To date, the variability in applied methodology prohibits a proper comparison and exchange of quantitative FDG PET data. Consequently, the promising role of quantitative PET has been demonstrated in several monocentric studies, but these published results cannot be used directly as a guideline for clinical (multicenter) trials performed elsewhere. In this chapter, the main causes affecting whole-body FDG PET quantification and strategies to minimize its inter-institute variability are addressed.

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…

Blood bank on-call physician's experiences at a large university medical center.

PubMed

Bryant, Barbara J; Alperin, Jack B; Indrikovs, Alexander J

2005-01-01

The responsibilities of the blood bank on-call physician (blood bank physician from here on) encompass many aspects of transfusion medicine and physician education. This physician is available 24 hours a day to address any issues concerning the collection and transfusion of blood and blood components. The purpose of this study was to identify and categorize the issues that may confront a blood bank physician. Each call received over a 4-month period was logged and the resolution documented. The calls were grouped into five categories: donor issues, therapeutic procedure issues, patient issues, physician education issues, and requests for blood components not meeting previously defined transfusion guidelines. The blood bank physician received 224 calls during the study period. To resolve each issue, an additional 1 to 14 telephone calls were needed to gather further information. Number of calls by category were donor issues, 20 (8.9%); therapeutic procedure issues, 9 (4.0%); patient issues, 4 (1.8%); physician education issues, 33 (14.7%); and requests for blood components not meeting previously defined transfusion guidelines, 158 (70.6%). Requests for blood components were denied in 39.8 percent of the cases not meeting guidelines. Other forms of therapy were warranted in 20.9 percent of the cases. This study revealed that 85.3 percent of the calls referred to the blood bank physician related to physician education and the appropriateness of blood component orders. These results emphasize the need for ongoing education of medical staff in transfusion medicine issues.

Optimization of recombinant β-glucuronidase hydrolysis and quantification of eight urinary cannabinoids and metabolites by liquid chromatography tandem mass spectrometry.

PubMed

Sempio, Cristina; Scheidweiler, Karl B; Barnes, Allan J; Huestis, Marilyn A

2018-03-01

Prolonged urinary cannabinoid excretion in chronic frequent cannabis users confounds identification of recent cannabis intake that may be important in treatment, workplace, clinical, and forensic testing programs. In addition, differentiation of synthetic Δ9-tetrahydrocannabinol (THC) intake from cannabis plant products might be an important interpretive issue. THC, 11-hydroxy-THC (11-OH-THC) and 11-nor-9-carboxy-THC (THCCOOH) urine concentrations were evaluated during previous controlled cannabis administration studies following tandem alkaline/E. coli β-glucuronidase hydrolysis. We optimized recombinant β-glucuronidase enzymatic urinary hydrolysis before simultaneous liquid chromatography tandem mass spectrometry (LC-MS/MS) quantification of THC, 11-OH-THC, THCCOOH, cannabidiol (CBD), cannabinol (CBN), cannabigerol (CBG), tetrahydrocannabivarin (THCV) and 11-nor-9-carboxy-THCV (THCVCOOH) in urine. Enzyme amount, incubation time and temperature, buffer molarity and pH were optimized using pooled urine samples collected during a National Institute on Drug Abuse, Institutional Review Board-approved clinical study. Optimized cannabinoid hydrolysis with recombinant β-glucuronidase was achieved with 2000 IU enzyme, 2 M pH 6.8 sodium phosphate buffer, and 0.2 mL urine at 37°C for 16 h. The LC-MS/MS quantification method for hydrolyzed urinary cannabinoids was validated per the Scientific Working Group on Toxicology guidelines. Linear ranges were 1-250 μg/L for THC and CBG, 2-250 μg/L for 11-OH-THC, CBD, CBN, THCV and THCVCOOH, and 1-500 μg/L for THCCOOH. Inter-batch analytical bias was 92.4-112.4%, imprecision 4.4-9.3% CV (n = 25), extraction efficiency 44.3-97.1% and matrix effect -29.6 to 1.8% (n = 10). The method was utilized to analyze urine specimens collected during our controlled smoked, vaporized, and edible cannabis administration study to improve interpretation of urine cannabinoid test results. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

Good quantification practices of flavours and fragrances by mass spectrometry.

PubMed

Begnaud, Frédéric; Chaintreau, Alain

2016-10-28

Over the past 15 years, chromatographic techniques with mass spectrometric detection have been increasingly used to monitor the rapidly expanded list of regulated flavour and fragrance ingredients. This trend entails a need for good quantification practices suitable for complex media, especially for multi-analytes. In this article, we present experimental precautions needed to perform the analyses and ways to process the data according to the most recent approaches. This notably includes the identification of analytes during their quantification and method validation, when applied to real matrices, based on accuracy profiles. A brief survey of application studies based on such practices is given.This article is part of the themed issue 'Quantitative mass spectrometry'. © 2016 The Authors.

miR-MaGiC improves quantification accuracy for small RNA-seq.

PubMed

Russell, Pamela H; Vestal, Brian; Shi, Wen; Rudra, Pratyaydipta D; Dowell, Robin; Radcliffe, Richard; Saba, Laura; Kechris, Katerina

2018-05-15

Many tools have been developed to profile microRNA (miRNA) expression from small RNA-seq data. These tools must contend with several issues: the small size of miRNAs, the small number of unique miRNAs, the fact that similar miRNAs can be transcribed from multiple loci, and the presence of miRNA isoforms known as isomiRs. Methods failing to address these issues can return misleading information. We propose a novel quantification method designed to address these concerns. We present miR-MaGiC, a novel miRNA quantification method, implemented as a cross-platform tool in Java. miR-MaGiC performs stringent mapping to a core region of each miRNA and defines a meaningful set of target miRNA sequences by collapsing the miRNA space to "functional groups". We hypothesize that these two features, mapping stringency and collapsing, provide more optimal quantification to a more meaningful unit (i.e., miRNA family). We test miR-MaGiC and several published methods on 210 small RNA-seq libraries, evaluating each method's ability to accurately reflect global miRNA expression profiles. We define accuracy as total counts close to the total number of input reads originating from miRNAs. We find that miR-MaGiC, which incorporates both stringency and collapsing, provides the most accurate counts.

Optimizing total reflection X-ray fluorescence for direct trace element quantification in proteins I: Influence of sample homogeneity and reflector type

NASA Astrophysics Data System (ADS)

Wellenreuther, G.; Fittschen, U. E. A.; Achard, M. E. S.; Faust, A.; Kreplin, X.; Meyer-Klaucke, W.

2008-12-01

Total reflection X-ray fluorescence (TXRF) is a very promising method for the direct, quick and reliable multi-elemental quantification of trace elements in protein samples. With the introduction of an internal standard consisting of two reference elements, scandium and gallium, a wide range of proteins can be analyzed, regardless of their salt content, buffer composition, additives and amino acid composition. This strategy also enables quantification of matrix effects. Two potential issues associated with drying have been considered in this study: (1) Formation of heterogeneous residues of varying thickness and/or density; and (2) separation of the internal standard and protein during drying (which has to be prevented to allow accurate quantification). These issues were investigated by microbeam X-ray fluorescence (μXRF) with special emphasis on (I) the influence of sample support and (II) the protein / buffer system used. In the first part, a model protein was studied on well established sample supports used in TXRF, PIXE and XRF (Mylar, siliconized quartz, Plexiglas and silicon). In the second part we imaged proteins of different molecular weight, oligomerization state, bound metals and solubility. A partial separation of protein and internal standard was only observed with untreated silicon, suggesting it may not be an adequate support material. Siliconized quartz proved to be the least prone to heterogeneous drying of the sample and yielded the most reliable results.

[Systematic Review of the Methodology Quality in Lung Cancer Screening Guidelines].

PubMed

Li, Jiang; Su, Kai; Li, Fang; Tang, Wei; Huang, Yao; Wang, Le; Huang, Huiyao; Shi, Jufang; Dai, Min

2016-10-20

Lung cancer is the most common malignancy and screening can decrease the mortality. High quality screening guideline is necessary and important for effective work. Our study is to review and evaluate the basic characteristics and methodology quality of the current global lung cancer screening guidelines so as to provide useful information for domestic study in the future. Electronic searches were done in English and Chinese databases including PubMed, the Cochrane Library, Web of Science, Embase, CNKI, CBM, Wanfang, and some cancer official websites. Articles were screened according to the predefined inclusion and exclusion criteria by two researchers. The quality of guidelines was assessed by AGREE II. At last, a total of 11 guidelines with methodology were included. The guidelines were issued mainly by USA (81%). Canada and China developed one, respectively. As for quality, the average score in the "Scale and objective" of all guidelines was 80, the average score in the "Participants" was 52, the average score in the "rigorism" was 50, the average score in the "clarity" was 76, the average score in the "application" was 43 and the average score in the "independence" was 59. The highest average score was found in 2013 and 2015. Canada guideline had higher quality in six domains. 7 guidelines were evaluated as A level. The number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries with heavy burden. Multi-country contribution to one guideline was another trend. Evidence-based methodology was accepted globally in the guideline development.

Regulatory assessment of proposed accessibility guidelines for pedestrians in the public right-of-way

DOT National Transportation Integrated Search

2011-06-30

This report assesses the potential costs and benefits of proposed accessibility guidelines issued by the Access Board for pedestrian facilities in the public right-of-way. The report also analyzes the potential impacts of the proposed guidelines on s...

The Development of Human Factor Guidelines for Unmanned Aircraft System Control Stations

NASA Technical Reports Server (NTRS)

Hobbs, Alan

2014-01-01

Despite being referred to as unmanned some of the major challenges confronting unmanned aircraft systems (UAS) relate to human factors. NASA is conducting research to address the human factors relevant to UAS access to non-segregated airspace. This work covers the issues of pilot performance, interaction with ATC, and control station design. A major outcome of this research will be recommendations for human factors design guidelines for UAS control stations to support routine beyond-line-of-sight operations in the US national airspace system (NAS). To be effective, guidelines must be relevant to a wide range of systems, must not be overly prescriptive, and must not impose premature standardization on evolving technologies. In developing guidelines, we recognize that existing regulatory and guidance material may already provide adequate coverage of certain issues. In other cases suitable guidelines may be found in existing military or industry human factors standards. In cases where appropriate existing standards cannot be identified, original guidelines will be proposed.

[Guidelines on medically assisted reproduction: legal issues and professional liability].

PubMed

Molinelli, A; Motroni Gherardi, S M; Picchioni, D M; Ventura, F

2007-08-01

The authors analyze the legal and medico-legal issues deriving from the recent Law No. 40 of February 19, 2004 concerning the Medically Assisted Reproduction. In particular, they analyze the contrasting points between the dispositions of Law No. 40/2004 and those of Law No. 194/1978 on the voluntary interruption of pregnancy, and they analyze the guidelines about the procedures and the techniques of the Medically Assisted Reproduction, issued by the Ministry of Health with D.M. of July 21, 2004. The Guidelines, as well as some sentences of several courts, lead to some reflections also about the consent and the professional liability, in particular considering the various moments of the medical action, from the first interview to the carrying out of the assisted reproduction techniques.

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

A new independent authority is needed to issue National Health Care guidelines.

PubMed

Keyhani, Salomeh; Kim, Azalea; Mann, Micah; Korenstein, Deborah

2011-02-01

Health experts emphasize that getting doctors to follow clinical guidelines can save both lives and money. Less attention has been paid to how the guidelines are developed and the variability in the recommendations they include. We examined the quality and content of screening guidelines as a proxy for guidelines in general and found that the source of the guidelines affects their quality. Guidelines with inconsistent recommendations are unlikely to serve patients or physicians well. The creation of an independent organization that would work with multiple stakeholders to develop guidelines holds the potential to improve their quality.

Exploiting Temporal Constraints of Clinical Guidelines by Applying OpenEHR Archetypes.

PubMed

Cintho, Lilian Mie Mukai; Garcia, Diego; da Silva Santos, Bruno Henrique; Sacchi, Lucia; Quaglini, Silvana; Moro, Claudia Maria Cabral

2017-01-01

Studies describing Computer-Interpretable Clinical Guidelines (CIG) with temporal constrains (TC) generally have not addressed issues related to their integration into Electronic Health Record (EHR) systems. This study aimed to represent TCs contained in clinical guidelines by applying archetypes and Guideline Definition Language (GDL) to incorporate decision support into EHRs. An example of each TC class in the clinical guideline for management of Atrial Fibrillation was represented using archetypes and GDL.

Genetic Testing for Minors: Comparison between Italian and British Guidelines

PubMed Central

Tozzo, Pamela; Caenazzo, Luciana; Rodriguez, Daniele

2012-01-01

Genetic testing in children raises many important ethical, legal, and social issues. One of the main concerns is the ethically inappropriate genetic testing of minors. Various European countries established professional guidelines which reflect the different countries perspectives regarding the main ethical issues involved. In this paper, we analyze the Italian and the British guidelines by highlighting differences and similarities. We discuss presymptomatic, predictive, and carrier testing because we consider them to be the more ethically problematic types of genetic testing in minors. In our opinion, national guidelines should take into account the different needs in clinical practice. At the same time, in the case of genetic testing the national and supranational protection of minors could be strengthened by approving guidelines based on a common framework of principles and values. We suggest that the Oviedo Convention could represent an example of such a common framework or, at least, it could lead to articulate it. PMID:22567400

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.

Applying Cognitive Psychology to User Interfaces

NASA Astrophysics Data System (ADS)

Durrani, Sabeen; Durrani, Qaiser S.

This paper explores some key aspects of cognitive psychology that may be mapped onto user interfaces. Major focus in existing user interface guidelines is on consistency, simplicity, feedback, system messages, display issues, navigation, colors, graphics, visibility and error prevention [8-10]. These guidelines are effective indesigning user interfaces. However, these guidelines do not handle the issues that may arise due to the innate structure of human brain and human limitations. For example, where to place graphics on the screen so that user can easily process them and what kind of background should be given on the screen according to the limitation of human motor system. In this paper we have collected some available guidelines from the area of cognitive psychology [1, 5, 7]. In addition, we have extracted few guidelines from theories and studies of cognitive psychology [3, 11] which may be mapped to user interfaces.

Dual quantification of dapivirine and maraviroc in cervicovaginal secretions from ophthalmic tear strips and polyester-based swabs via liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis.

PubMed

Parsons, Teresa L; Emory, Joshua F; Seserko, Lauren A; Aung, Wutyi S; Marzinke, Mark A

2014-09-01

Topical microbicidal agents are being actively pursued as a modality to prevent HIV viral transmission during sexual intercourse. Quantification of antiretroviral agents in specimen sources where antiviral activity is elicited is critical, and drug measurements in cervicovaginal fluid can provide key information on local drug concentrations. Two antiretroviral drugs, dapivirine and maraviroc, have gained interest as vaginal microbicidal agents, and rugged methods are required for their quantification in cervicovaginal secretions. Cervicovaginal fluid spiked with dapivirine and maraviroc were applied to ophthalmic tear strips or polyester-based swabs to mimic collection procedures used in clinical studies. Following sample extraction and the addition of isotopically labeled internal standards, samples were subjected to liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis using a Waters BEH C8, 50mm×2.1mm, 1.7μm particle size column, on an API 4000 mass analyzer operated in selective reaction monitoring mode. The method was validated according to FDA Bioanalytical Method Validation guidelines. Due to the disparate saturation capacity of the tested collection devices, the analytical measuring ranges for dapivirine and maravirocin cervicovaginal fluid on the ophthalmic tear strip were 0.05-25ng/tear strip, and 0.025-25ng/tear strip, respectively. As for the polyester-based swab, the analytical measuring ranges were 0.25-125ng/swab for dapivirine and 0.125-125ng/swab for maraviroc. Dilutional studies were performed for both analytes to extended ranges of 25,000ng/tear strip and 11,250ng/swab. Standard curves were generated via weighted (1/x(2)) linear or quadratic regression of calibrators. Precision, accuracy, stability and matrix effects studies were all performed and deemed acceptable according to the recommendations of the FDA Bioanalytical Method Validation guidelines. A rugged LC-MS/MS method for the dual quantification of dapivirine and maraviroc in cervicovaginal fluid using two unique collection devices has been developed and validated. The described method meets the criteria to support large research trials. Copyright © 2014 Elsevier B.V. All rights reserved.

Dual Quantification of Dapivirine and Maraviroc in Cervicovaginal Secretions from Ophthalmic Tear Strips and Polyester-Based Swabs via Liquid Chromatographic-Tandem Mass Spectrometric (LC-MS/MS) Analysis

PubMed Central

Parsons, Teresa L.; Emory, Joshua F.; Seserko, Lauren A.; Aung, Wutyi S.; Marzinke, Mark A.

2014-01-01

Background Topical microbicidal agents are being actively pursued as a modality to prevent HIV viral transmission during sexual intercourse. Quantification of antiretroviral agents in specimen sources where antiviral activity is elicited is critical, and drug measurements in cervicovaginal fluid can provide key information on local drug concentrations. Two antiretroviral drugs, dapivirine and maraviroc, have gained interest as vaginal microbicidal agents, and rugged methods are required for their quantification in cervicovaginal secretions. Methods Cervicovaginal fluid spiked with dapivirine and maraviroc were applied to ophthalmic tear strips or polyester-based swabs to mimic collection procedures used in clinical studies. Following sample extraction and the addition of isotopically-labeled internal standards, samples were subjected to liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis using a Waters BEH C8, 50 × 2.1 mm, 1.7 µm particle size column, on an API 4000 mass analyzer operated in selective reaction monitoring mode. The method was validated according to FDA Bioanalytical Method Validation guidelines. Results Due to the disparate saturation capacity of the tested collection devices, the analytical measuring ranges for dapivirine and maravirocin cervicovaginal fluid on the ophthalmic tear strip were 0.05 to 25 ng/tear strip, and 0.025 to 25 ng/tear strip, respectively. As for the polyester-based swab, the analytical measuring ranges were 0.25 to 125 ng/swab for dapivirine and 0.125 to 125 ng/swab for maraviroc. Dilutional studies were performed for both analytes to extended ranges of 25,000 ng/tear strip and 11,250 ng/swab. Standard curves were generated via weighted (1/x2) linear or quadratic regression of calibrators. Precision, accuracy, stability and matrix effects studies were all performed and deemed acceptable according to the recommendations of the FDA Bioanalytical Method Validation guidelines. Conclusions A rugged LC-MS/MS method for the dual quantification of dapivirine and maraviroc in cervicovaginal fluid using two unique collection devices has been developed and validated. The described method meets the criteria to support large research trials. PMID:25005891

Selection Criteria for Mathematical Models Used in Exposure Assessments: Atmospheric Dispersion Models

EPA Science Inventory

Before the U.S. Environmental Protection Agency issued the 1988 Guidelines for Estimating Exposures, it published proposed guidelines in the Federal Register for public review and comment. he guidelines are intended to give risk analysis a basic framework and the tools they need ...

Effluent Guidelines

EPA Pesticide Factsheets

Effluent guidelines are national standards for wastewater discharges to surface waters and municipal sewage treatment plants. We issue the regulations for industrial categories based on the performance of treatment and control technologies.

Characterization of PET/CT images using texture analysis: the past, the present… any future?

PubMed

Hatt, Mathieu; Tixier, Florent; Pierce, Larry; Kinahan, Paul E; Le Rest, Catherine Cheze; Visvikis, Dimitris

2017-01-01

After seminal papers over the period 2009 - 2011, the use of texture analysis of PET/CT images for quantification of intratumour uptake heterogeneity has received increasing attention in the last 4 years. Results are difficult to compare due to the heterogeneity of studies and lack of standardization. There are also numerous challenges to address. In this review we provide critical insights into the recent development of texture analysis for quantifying the heterogeneity in PET/CT images, identify issues and challenges, and offer recommendations for the use of texture analysis in clinical research. Numerous potentially confounding issues have been identified, related to the complex workflow for the calculation of textural features, and the dependency of features on various factors such as acquisition, image reconstruction, preprocessing, functional volume segmentation, and methods of establishing and quantifying correspondences with genomic and clinical metrics of interest. A lack of understanding of what the features may represent in terms of the underlying pathophysiological processes and the variability of technical implementation practices makes comparing results in the literature challenging, if not impossible. Since progress as a field requires pooling results, there is an urgent need for standardization and recommendations/guidelines to enable the field to move forward. We provide a list of correct formulae for usual features and recommendations regarding implementation. Studies on larger cohorts with robust statistical analysis and machine learning approaches are promising directions to evaluate the potential of this approach.

Near-source mobile methane emission estimates using EPA Method33a and a novel probabilistic approach as a basis for leak quantification in urban areas

EPA Science Inventory

Methane emissions from underground pipeline leaks remain an ongoing issue in the development of accurate methane emission inventories for the natural gas supply chain. Application of mobile methods during routine street surveys would help address this issue, but there are large ...

Pure hydroxyapatite phantoms for the calibration of in vivo X-ray fluorescence systems of bone lead and strontium quantification.

PubMed

Da Silva, Eric; Kirkham, Brian; Heyd, Darrick V; Pejović-Milić, Ana

2013-10-01

Plaster of Paris [poP, CaSO4·(1)/(2) H2O] is the standard phantom material used for the calibration of in vivo X-ray fluorescence (IVXRF)-based systems of bone metal quantification (i.e bone strontium and lead). Calibration of IVXRF systems of bone metal quantification employs the use of a coherent normalization procedure which requires the application of a coherent correction factor (CCF) to the data, calculated as the ratio of the relativistic form factors of the phantom material and bone mineral. Various issues have been raised as to the suitability of poP for the calibration of IVXRF systems of bone metal quantification which include its chemical purity and its chemical difference from bone mineral (a calcium phosphate). This work describes the preparation of a chemically pure hydroxyapatite phantom material, of known composition and stoichiometry, proposed for the purpose of calibrating IVXRF systems of bone strontium and lead quantification as a replacement for poP. The issue with contamination by the analyte was resolved by preparing pure Ca(OH)2 by hydroxide precipitation, which was found to bring strontium and lead levels to <0.7 and <0.3 μg/g Ca, respectively. HAp phantoms were prepared from known quantities of chemically pure Ca(OH)2, CaHPO4·2H2O prepared from pure Ca(OH)2, the analyte, and a HPO4(2-) containing setting solution. The final crystal structure of the material was found to be similar to that of the bone mineral component of NIST SRM 1486 (bone meal), as determined by powder X-ray diffraction spectrometry.

76 FR 47353 - Final Directives for Forest Service Wind Energy Special Use Authorizations, Forest Service Manual...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... siting wind energy turbines, evaluating a variety of resource interests, and addressing issues... power guidelines produced by the Wind Energy Turbines Guidelines Advisory Committee, which consists of... recognizes that recommendations from the Wind Energy Turbines Guidelines Advisory Committee will be used to...

77 FR 4909 - Income Level for Individuals Eligible for Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-01

... Poverty Guidelines as issued by the Department of Health and Human Services. DATES: Effective Date: This... level equivalent to one hundred and twenty-five percent (125%) of the Federal Poverty Guidelines. Since... Federal Poverty Guidelines. The figures for 2012 set out below are equivalent to 125% of the current...

75 FR 47487 - Income Level for Individuals Eligible for Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... Poverty Guidelines as issued by the Department of Health and Human Services. DATES: Effective Date: This... level equivalent to one hundred and twenty-five percent (125%) of the Federal Poverty Guidelines. Since... Federal Poverty Guidelines. The figures for 2010 set out below are equivalent to 125% of the current...

Occupational safety and health aspects of corporate social responsibility (CSR) in Japanese companies listed on the Tokyo Stock Exchange (TSE) first section.

PubMed

Kawashita, Futoshi; Taniyama, Yukari; Hwi, Song You; Fujisaki, Takeshi; Kameda, Takashi; Mori, Koji

2005-11-01

Recently, corporate social responsibility (CSR) is becoming widely recognized as an issue for Japanese companies. Corporate responsibility for employees is considered important by various stakeholders, and occupational safety and health is regarded as one of these responsibilities. The present authors examined this issue from the viewpoint of corporate management by analysis of statements found in CSR-related reports. For companies listed on the First Section of the Tokyo Stock Exchange (TSE), we searched for CSR-related reports, and titles and contents, based on two established guidelines: the GRI Sustainability Reporting Guidelines 2002 as the international reference and the Environmental Reporting Guidelines of the Ministry of the Environment, Government of Japan, as the domestic reference. Corporations that published CSR reports were 26.3% (416/1,581) of the total, and large differences were recognized by type of industry. Comparing the numbers of pages for various contents, more concern was shown about the environment than about social activity, indicating the environment to be the main issue of CSR in Japan. In the items included in the guidelines, many matters about occupational accidents were mentioned, but it was found that statements regarding HIV/AIDS, which is not of such strong social concern in Japan, and statements regarding the costs of safety that are difficult to calculate were few. However, statements regarding mental health, which is of high interest socially, were many, even though this issue is not included in the two guidelines used. In revising the guidelines, these matters should be reviewed. In the future, continuance of analysis of CSR-related reports with regard to changes and comparisons with overseas reports will help improve occupational safety and health.

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine].

PubMed

Wang, Yue-Xi; Liu, Meng-Yu; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Xue-Yao; Liu, Yu-Qi; Wang, Yan-Ping; Han, Xue-Jie

2017-09-01

To assess the quality and application effect of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine(Guidelines) through the applicability and applicability evaluation respectively. The questionnaire survey was adopted to evaluate the applicability of the Guidelines, including the utilization, quality, and clinical application conditions. The results showed that the familiarity rate and utilization rate of the Guidelines were 85.37%, 48.78%, respectively. The data showed that the familiarity and the utilization rates were different in the working staff with different professional titles. The evaluation level was the lowest given by the staff with junior professional title (70.97%, 29.03%) in comparison. The assessment showed the overall quality of the Guideline was good and slightly low level for the rationality scores of the other therapeutic methods as well as for the recuperation and prevention (80.49%, 85.37%), which was in line with the clinical compliance of the Guideline. The perspective observation of clinical cases was used for the applicability evaluation, including clinical compliance of the Guideline, effect evaluation, and comprehensive assessment, et al. The results showed that the safety score was the highest, followed by the economic issue and efficacy. For the comprehensive evaluation of the applicability, complete applicability accounted for 29.27%, and the general applicability accounted for 87.80%. It was showed in the three index scores of the applicability evaluation that the accumulative score 7-9 scores were 75.65%, 73.89%, 71.12%. Through the applicability and applicability evaluation, the Guideline was satisfactory in the overall quality, high in the safety of clinical application and good in efficacy and economic issues. There are some limits on the development method and technical issues in the Guideline, which is required to be supplemented in the revision. Additionally, the strategy study on the promotion of the Guideline should be enhanced so as to expedite the recognition and utilization of the Guideline. Copyright© by the Chinese Pharmaceutical Association.

FRAMEWORK FOR DEVELOPING AMBIENT WATER ...

EPA Pesticide Factsheets

Currently, Ambient Water Quality Criteria (AWQC) for aquatic life protection are derived according to the Guidelines for Derivation of Ambient Water Quality Criteria for the Protection of Aquatic Life and Their Uses, published in 1985. To ensure that AWQC are derived from the best available science, Office of Water assessed the need to update the Guidelines and identified issues that should be addressed in the revisions. In December 2002, EPA's Science Advisory Board concurred with EPA's assessment of the need to update the Guidelines as well as with the issues EPA identified to address. Updating the Guidelines is a Priority Strategic Action included in OST's Strategy for Water Quality Standards and Criteria (Next Priority Strategic Action #1). To revise existing methodology for deriving ambient water quality criteria for the protection of aquatic life.

Is traditional Chinese medicine recommended in Western medicine clinical practice guidelines in China? A systematic analysis

PubMed Central

Ren, Jun; Li, Xun; Sun, Jin; Han, Mei; Yang, Guo-Yan; Li, Wen-Yuan; Robinson, Nicola; Lewith, George; Liu, Jian-Ping

2015-01-01

Background Evidence-based medicine promotes and relies on the use of evidence in developing clinical practice guidelines (CPGs). The Chinese healthcare system includes both traditional Chinese medicine (TCM) and Western medicine, which are expected to be equally reflected in Chinese CPGs. Objective To evaluate the inclusion of TCM-related information in Western medicine CPGs developed in China and the adoption of high level evidence. Methods All CPGs were identified from the China Guideline Clearinghouse (CGC), which is the main Chinese organisation maintaining the guidelines issued by the Ministry of Health of China, the Chinese Medical Association and the Chinese Medical Doctors’ Association. TCM-related contents were extracted from all the CPGs identified. Extracted information comprised the institution issuing the guideline, date of issue, disease, recommendations relating to TCM, evidence level of the recommended content and references supporting the recommendations. Results A total of 604 CPGs were identified, only a small number of which (74/604; 12%) recommended TCM therapy and only five guidelines (7%) had applied evidence grading. The 74 CPGs involved 13 disease systems according to the International Classification of Diseases 10th edition. TCM was mainly recommended in the treatment part of the guidelines (73/74, 99%), and more than half of the recommendations (43/74, 58%) were related to Chinese herbal medicine (single herbs or herbal treatment based on syndrome differentiation). Conclusions Few Chinese Western medicine CPGs recommend TCM therapies and very few provide evidence grading for the TCM recommendation. We suggest that future guideline development should be based on systematic searches for evidence to support CPG recommendations and involve a multidisciplinary approach including TCM expertise. PMID:26041487

Is traditional Chinese medicine recommended in Western medicine clinical practice guidelines in China? A systematic analysis.

PubMed

Ren, Jun; Li, Xun; Sun, Jin; Han, Mei; Yang, Guo-Yan; Li, Wen-Yuan; Robinson, Nicola; Lewith, George; Liu, Jian-Ping

2015-06-03

Evidence-based medicine promotes and relies on the use of evidence in developing clinical practice guidelines (CPGs). The Chinese healthcare system includes both traditional Chinese medicine (TCM) and Western medicine, which are expected to be equally reflected in Chinese CPGs. To evaluate the inclusion of TCM-related information in Western medicine CPGs developed in China and the adoption of high level evidence. All CPGs were identified from the China Guideline Clearinghouse (CGC), which is the main Chinese organisation maintaining the guidelines issued by the Ministry of Health of China, the Chinese Medical Association and the Chinese Medical Doctors' Association.TCM-related contents were extracted from all the CPGs identified. Extracted information comprised the institution issuing the guideline, date of issue, disease, recommendations relating to TCM, evidence level of the recommended content and references supporting the recommendations. A total of 604 CPGs were identified, only a small number of which (74/604; 12%) recommended TCM therapy and only five guidelines (7%) had applied evidence grading. The 74 CPGs involved 13 disease systems according to the International Classification of Diseases 10th edition. TCM was mainly recommended in the treatment part of the guidelines (73/74, 99%), and more than half of the recommendations (43/74, 58%) were related to Chinese herbal medicine (single herbs or herbal treatment based on syndrome differentiation). Few Chinese Western medicine CPGs recommend TCM therapies and very few provide evidence grading for the TCM recommendation. We suggest that future guideline development should be based on systematic searches for evidence to support CPG recommendations and involve a multidisciplinary approach including TCM expertise. 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.

A Guideline to Univariate Statistical Analysis for LC/MS-Based Untargeted Metabolomics-Derived Data

PubMed Central

Vinaixa, Maria; Samino, Sara; Saez, Isabel; Duran, Jordi; Guinovart, Joan J.; Yanes, Oscar

2012-01-01

Several metabolomic software programs provide methods for peak picking, retention time alignment and quantification of metabolite features in LC/MS-based metabolomics. Statistical analysis, however, is needed in order to discover those features significantly altered between samples. By comparing the retention time and MS/MS data of a model compound to that from the altered feature of interest in the research sample, metabolites can be then unequivocally identified. This paper reports on a comprehensive overview of a workflow for statistical analysis to rank relevant metabolite features that will be selected for further MS/MS experiments. We focus on univariate data analysis applied in parallel on all detected features. Characteristics and challenges of this analysis are discussed and illustrated using four different real LC/MS untargeted metabolomic datasets. We demonstrate the influence of considering or violating mathematical assumptions on which univariate statistical test rely, using high-dimensional LC/MS datasets. Issues in data analysis such as determination of sample size, analytical variation, assumption of normality and homocedasticity, or correction for multiple testing are discussed and illustrated in the context of our four untargeted LC/MS working examples. PMID:24957762

A Guideline to Univariate Statistical Analysis for LC/MS-Based Untargeted Metabolomics-Derived Data.

PubMed

Vinaixa, Maria; Samino, Sara; Saez, Isabel; Duran, Jordi; Guinovart, Joan J; Yanes, Oscar

2012-10-18

Several metabolomic software programs provide methods for peak picking, retention time alignment and quantification of metabolite features in LC/MS-based metabolomics. Statistical analysis, however, is needed in order to discover those features significantly altered between samples. By comparing the retention time and MS/MS data of a model compound to that from the altered feature of interest in the research sample, metabolites can be then unequivocally identified. This paper reports on a comprehensive overview of a workflow for statistical analysis to rank relevant metabolite features that will be selected for further MS/MS experiments. We focus on univariate data analysis applied in parallel on all detected features. Characteristics and challenges of this analysis are discussed and illustrated using four different real LC/MS untargeted metabolomic datasets. We demonstrate the influence of considering or violating mathematical assumptions on which univariate statistical test rely, using high-dimensional LC/MS datasets. Issues in data analysis such as determination of sample size, analytical variation, assumption of normality and homocedasticity, or correction for multiple testing are discussed and illustrated in the context of our four untargeted LC/MS working examples.

Development and validation of a HPTLC method for simultaneous estimation of lornoxicam and thiocolchicoside in combined dosage form

PubMed Central

Sahoo, Madhusmita; Syal, Pratima; Hable, Asawaree A.; Raut, Rahul P.; Choudhari, Vishnu P.; Kuchekar, Bhanudas S.

2011-01-01

Aim: To develop a simple, precise, rapid and accurate HPTLC method for the simultaneous estimation of Lornoxicam (LOR) and Thiocolchicoside (THIO) in bulk and pharmaceutical dosage forms. Materials and Methods: The separation of the active compounds from pharmaceutical dosage form was carried out using methanol:chloroform:water (9.6:0.2:0.2 v/v/v) as the mobile phase and no immiscibility issues were found. The densitometric scanning was carried out at 377 nm. The method was validated for linearity, accuracy, precision, LOD (Limit of Detection), LOQ (Limit of Quantification), robustness and specificity. Results: The Rf values (±SD) were found to be 0.84 ± 0.05 for LOR and 0.58 ± 0.05 for THIO. Linearity was obtained in the range of 60–360 ng/band for LOR and 30–180 ng/band for THIO with correlation coefficients r2 = 0.998 and 0.999, respectively. The percentage recovery for both the analytes was in the range of 98.7–101.2 %. Conclusion: The proposed method was optimized and validated as per the ICH guidelines. PMID:23781452

Canadian Primary Care Physicians' Attitudes Toward Understanding Clinical Practice Guidelines for Diabetes Screening.

PubMed

Alexander, Paul E; Li, Shelly-Anne; Tonelli, Marcello; Guyatt, Gordon

2016-12-01

The Canadian Task Force on Preventive Health Care (CTFPHC) produces guidelines for Canadian physicians regarding screening and prevention. To better appreciate the barriers to and facilitators of guideline adherence, we sought to explore physicians' views of guidelines in general and their understanding of this CTFPHC diabetes screening guideline in particular because they pertain to screening and positive treatment. We included Canadian physicians (N=10) who agreed to be interviewed regarding their use of guidelines as part of practice, focusing on the CTFPHC 2012 diabetes screening guideline. Individual semistructured interviews explored primary care physicians' experiences and perspectives on the use, relevance and feasibility of guidelines as part of practice, approaches to screening for diabetes, and suggestions for improving guidelines. Overall, physicians recognized the need for guidelines and the benefits of using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods in the guideline development process. Physicians also noted several barriers to guideline adherence, including the lack of opportunity for physicians to provide input during guideline formulation, insufficient guidance on interpreting GRADE's weak or conditional recommendations, and feasibility issues concerning using risk calculators. The predominant challenge raised by physicians was the unclear guidance for pharmacologic interventions; all respondents were unclear about the guidelines' implicit assumption that screen-positive patients would be treated with statins and aspirin (ASA). These interviews suggest the need for greater clarity in guideline recommendations, including clarification of the quality of evidence ratings and the strength of recommendation grading. Our low participation rate raises the issue of representativeness; replication in samples with greater willingness to participate would be desirable. Copyright © 2016 Canadian Diabetes Association. Published by Elsevier Inc. All rights reserved.

Canadian physicians' attitudes about and preferences regarding clinical practice guidelines.

PubMed

Hayward, R S; Guyatt, G H; Moore, K A; McKibbon, K A; Carter, A O

1997-06-15

To assess Canadian physicians' confidence in, attitudes about and preferences regarding clinical practice guidelines. Cross-sectional, self-administered mailed survey. Stratified random sample of 3000 Canadian physicians; 1878 (62.6%) responded. Canada. Physicians' use of various information sources; familiarity with and confidence in guidelines; attitudes about guidelines and their effect on medical care; rating of importance of guidelines and other sources of information in clinical decision-making; rating of importance of various considerations in deciding whether to adopt a set of guidelines; and rating of usefulness of different formats for presenting guidelines. In all, 52% of the respondents reported using guidelines at least monthly, substantially less frequently than traditional information sources. Most of the respondents expressed confidence in guidelines issued by various physician organizations, but 51% to 77% were not confident in guidelines issued by federal or provincial health ministries or by health insurance plans. The respondents were generally positive about guidelines (e.g., over 50% strongly agreed that they are a convenient source of advice and good educational tools); however, 22% to 26% had concerns about loss of autonomy, the rigidity of guidelines and decreased satisfaction with medical practice. Endorsement by respected colleagues or major organizations was identified as very important by 78% and 62% of the respondents respectively in deciding whether to adopt a set of guidelines in their practice. User friendliness of the guidelines format was thought to be very important by 62%; short pamphlets, manuals summarizing a number of guidelines, journal articles and pocket cards summarizing guidelines were the preferred formats (identified as most useful by 50% to 62% of the respondents). Canadian physicians, although generally positive about guidelines and confident in those developed by clinicians, have not yet integrated the use of guidelines into their practices to a large extent. Our results suggest that respected organizations and opinion leaders should be involved in the development of guidelines and that the acceptability of any proposed format and medium for guidelines presentation should be pretested.

Whole farm quantification of GHG emissions within smallholder farms in developing countries

NASA Astrophysics Data System (ADS)

Seebauer, Matthias

2014-03-01

The IPCC has compiled the best available scientific methods into published guidelines for estimating greenhouse gas emissions and emission removals from the land-use sector. In order to evaluate existing GHG quantification tools to comprehensively quantify GHG emissions and removals in smallholder conditions, farm scale quantification was tested with farm data from Western Kenya. After conducting a cluster analysis to identify different farm typologies GHG quantification was exercised using the VCS SALM methodology complemented with IPCC livestock emission factors and the cool farm tool. The emission profiles of four farm clusters representing the baseline conditions in the year 2009 are compared with 2011 where farmers adopted sustainable land management practices (SALM). The results demonstrate the variation in both the magnitude of the estimated GHG emissions per ha between different smallholder farm typologies and the emissions estimated by applying two different accounting tools. The farm scale quantification further shows that the adoption of SALM has a significant impact on emission reduction and removals and the mitigation benefits range between 4 and 6.5 tCO2 ha-1 yr-1 with significantly different mitigation benefits depending on typologies of the crop-livestock systems, their different agricultural practices, as well as adoption rates of improved practices. However, the inherent uncertainty related to the emission factors applied by accounting tools has substantial implications for reported agricultural emissions. With regard to uncertainty related to activity data, the assessment confirms the high variability within different farm types as well as between different parameters surveyed to comprehensively quantify GHG emissions within smallholder farms.

Development of a Protein Standard Absolute Quantification (PSAQ™) assay for the quantification of Staphylococcus aureus enterotoxin A in serum.

PubMed

Adrait, Annie; Lebert, Dorothée; Trauchessec, Mathieu; Dupuis, Alain; Louwagie, Mathilde; Masselon, Christophe; Jaquinod, Michel; Chevalier, Benoît; Vandenesch, François; Garin, Jérôme; Bruley, Christophe; Brun, Virginie

2012-06-06

Enterotoxin A (SEA) is a staphylococcal virulence factor which is suspected to worsen septic shock prognosis. However, the presence of SEA in the blood of sepsis patients has never been demonstrated. We have developed a mass spectrometry-based assay for the targeted and absolute quantification of SEA in serum. To enhance sensitivity and specificity, we combined an immunoaffinity-based sample preparation with mass spectrometry analysis in the selected reaction monitoring (SRM) mode. Absolute quantification of SEA was performed using the PSAQ™ method (Protein Standard Absolute Quantification), which uses a full-length isotope-labeled SEA as internal standard. The lower limit of detection (LLOD) and lower limit of quantification (LLOQ) were estimated at 352pg/mL and 1057pg/mL, respectively. SEA recovery after immunocapture was determined to be 7.8±1.4%. Therefore, we assumed that less than 1femtomole of each SEA proteotypic peptide was injected on the liquid chromatography column before SRM analysis. From a 6-point titration experiment, quantification accuracy was determined to be 77% and precision at LLOQ was lower than 5%. With this sensitive PSAQ-SRM assay, we expect to contribute to decipher the pathophysiological role of SEA in severe sepsis. This article is part of a Special Issue entitled: Proteomics: The clinical link. Copyright © 2011 Elsevier B.V. All rights reserved.

Guidelines for Creating, Implementing, and Evaluating Mind-Body Programs in a Military Healthcare Setting.

PubMed

Smith, Katherine; Firth, Kimberly; Smeeding, Sandra; Wolever, Ruth; Kaufman, Joanna; Delgado, Roxana; Bellanti, Dawn; Xenakis, Lea

2016-01-01

Research suggests that the development of mind-body skills can improve individual and family resilience, particularly related to the stresses of illness, trauma, and caregiving. To operationalize the research evidence that mind-body skills help with health and recovery, Samueli Institute, in partnership with experts in mind-body programming, created a set of guidelines for developing and evaluating mind-body programs for service members, veterans, and their families. The Guidelines for Creating, Implementing, and Evaluating Mind-Body Programs in a Military Healthcare Setting outline key strategies and issues to consider when developing, implementing, and evaluating a mind-body focused family empowerment approach in a military healthcare setting. Although these guidelines were developed specifically for a military setting, most of the same principles can be applied to the development of programs in the civilian setting as well. The guidelines particularly address issues unique to mind-body programs, such as choosing evidence-based modalities, licensure and credentialing, safety and contraindications, and choosing evaluation measures that capture the holistic nature of these types of programs. The guidelines are practical, practice-based guidelines, developed by experts in the fields of program development and evaluation, mind-body therapies, patient- and family-centered care, as well as, experts in military and veteran's health systems. They provide a flexible framework to create mind-body family empowerment programs and describe important issues that program developers and evaluators are encouraged to address to ensure the development of the most impactful, successful, evidence-supported programs possible. Copyright © 2016 Elsevier Inc. All rights reserved.

Ethical issues in the translation of social neuroscience: a policy analysis of current guidelines for public dialogue in human research.

PubMed

Zimmerman, Emma; Racine, Eric

2012-01-01

Social neuroscience and its potential implications create an interesting case study for examining human research ethics policies on the topic of public communication of research. We reviewed mainstream national and international human research ethics guidelines and policies on issues of public communication of research. Our analysis relied on five thematic nets to capture the interactions between research and the public: public understanding, knowledge translation, public participation, social outcomes, and dual use. Coverage of these topics is sparse and inconsistent in mainstream policies and guidelines. We identify three options to address these gaps and analyze their strengths and weaknesses.

Validation and implementation of liquid chromatographic-mass spectrometric (LC-MS) methods for the quantification of tenofovir prodrugs.

PubMed

Hummert, Pamela; Parsons, Teresa L; Ensign, Laura M; Hoang, Thuy; Marzinke, Mark A

2018-04-15

The nucleotide reverse transcriptase inhibitor tenofovir (TFV) is widely administered in a disoproxil prodrug form (tenofovir disoproxil fumarate, TDF) for HIV management and prevention. Recently, novel prodrugs tenofovir alafenamide fumarate (TAF) and hexadecyloxypropyl tenofovir (CMX157) have been pursued for HIV treatment while minimizing adverse effects associated with systemic TFV exposure. Dynamic and sensitive bioanalytical tools are required to characterize the pharmacokinetics of these prodrugs in systemic circulation. Two parallel methods have been developed, one to combinatorially quantify TAF and TFV, and a second method for CMX157 quantification, in plasma. K 2 EDTA plasma was spiked with TAF and TFV, or CMX157. Following the addition of isotopically labeled internal standards and sample extraction via solid phase extraction (TAF and TFV) or protein precipitation (CMX157), samples were subjected to liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis. For TAF and TFV, separation occurred using a Zorbax Eclipse Plus C18 Narrow Bore RR, 2.1 × 50 mm, 3.5 μm column and analytes were detected on an API5000 mass analyzer; CMX157 was separated using a Kinetex C8, 2.1 × 50 mm, 2.6 μm column and quantified using an API4500 mass spectrometer. Methods were validated according to FDA Bioanalytical Method Validation guidelines. Analytical methods: were optimized for the multiplexed monitoring of TAF and TFV, and CMX157 in plasma. The lower limits of quantification (LLOQs) for TAF, TFV, and CMX157 were 0.03, 1.0, and 0.25 ng/mL, respectively. Calibration curves were generated via weighted linear regression of standards. Intra- and inter-assay precision and accuracy studies demonstrated %CVs ≤ 14.4% and %DEVs ≤ ± 7.95%, respectively. Stability and matrix effects studies were also performed. All results were acceptable and in accordance with the recommended guidelines for bioanalytical methods. Assays were also applied to quantify in vivo concentrations of prodrugs and TFV in a preclinical study post-rectal administration. Sensitive, specific, and dynamic LC-MS/MS assays have been developed and validated for the multiplexed quantification TAF and TFV, as well as an independent assay for CMX157 quantification, in plasma. The described methods meet sufficient throughput criteria to support large research trials. Copyright © 2018 Elsevier B.V. All rights reserved.

Guidelines for Management of Incidental Pulmonary Nodules Detected on CT Images: From the Fleischner Society 2017.

PubMed

MacMahon, Heber; Naidich, David P; Goo, Jin Mo; Lee, Kyung Soo; Leung, Ann N C; Mayo, John R; Mehta, Atul C; Ohno, Yoshiharu; Powell, Charles A; Prokop, Mathias; Rubin, Geoffrey D; Schaefer-Prokop, Cornelia M; Travis, William D; Van Schil, Paul E; Bankier, Alexander A

2017-07-01

The Fleischner Society Guidelines for management of solid nodules were published in 2005, and separate guidelines for subsolid nodules were issued in 2013. Since then, new information has become available; therefore, the guidelines have been revised to reflect current thinking on nodule management. The revised guidelines incorporate several substantive changes that reflect current thinking on the management of small nodules. The minimum threshold size for routine follow-up has been increased, and recommended follow-up intervals are now given as a range rather than as a precise time period to give radiologists, clinicians, and patients greater discretion to accommodate individual risk factors and preferences. The guidelines for solid and subsolid nodules have been combined in one simplified table, and specific recommendations have been included for multiple nodules. These guidelines represent the consensus of the Fleischner Society, and as such, they incorporate the opinions of a multidisciplinary international group of thoracic radiologists, pulmonologists, surgeons, pathologists, and other specialists. Changes from the previous guidelines issued by the Fleischner Society are based on new data and accumulated experience. © RSNA, 2017 Online supplemental material is available for this article. An earlier incorrect version of this article appeared online. This article was corrected on March 13, 2017.

Guidelines for the Productive Employment of Older Adults in Child Care.

ERIC Educational Resources Information Center

Newman, Sally M.; And Others

This publication offers guidelines that policymakers, advocates of children and older adults, and child care practitioners can use to provide older adults with opportunities to work in the child care field. Guidelines that address developmental issues relating to older adults concern employers' sensitivity to older adults and staffing patterns in…

Guidelines for Curriculum Development for Undergraduate Medical Education in the Prevention of Pulmonary Diseases.

ERIC Educational Resources Information Center

National Heart, Lung, and Blood Inst. (DHHS/NIH), Bethesda, MD. Div. of Lung Diseases.

These guidelines for developing an undergraduate medical education curriculum in pulmonary disease prevention emphasize not only the most current scientific practice but also the active application of cognitive and behavioral skills related to patient education. Chapter 1 introduces the guidelines and the issues and trends in preventative…

41 CFR 102-79.90 - What criteria must Executive agencies consider when evaluating antenna siting requests?

Code of Federal Regulations, 2010 CFR

2010-07-01

... radiofrequency exposure, ET Docket No. 93-62, entitled “Guidelines for Evaluating the Environmental Effects of Radiofrequency Radiation,” issued August 1, 1996, and any other order on reconsideration relating to radiofrequency guidelines and their enforcement. These are updated guidelines for meeting health concerns that...

Drug Testing Guidelines and Practices for Juvenile Probation and Parole Agencies.

ERIC Educational Resources Information Center

American Probation and Parole Association, Lexington, KY.

This document, intended as a resource manual, provides guidelines on drug testing. These topics are covered: (1) National Institute on Drug Abuse guidelines applicability; (2) introduction to legal issues, drug testing in juvenile probation and parole, and juvenile law; (3) mission of a juvenile parole agency; (4) purpose of testing; (5) drug…

78 FR 7679 - Income Level for Individuals Eligible for Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-04

... Poverty Guidelines as issued by the Department of Health and Human Services. DATES: Effective date: This... level equivalent to one hundred and twenty-five percent (125%) of the Federal Poverty Guidelines. Since... Federal Poverty Guidelines. The figures for 2013 set out below are equivalent to 125 percent (125%) of the...

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.

• New guidelines for national airline caterers.

PubMed

1989-06-24

The Government is to issue new guidelines to prevent food poisoning from airline meals. The proposed action comes in response to recent survey evidence which found contaminated meals served up to passengers.

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest

PubMed Central

2012-01-01

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development. PMID:22762776

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest.

PubMed

Eccles, Martin P; Grimshaw, Jeremy M; Shekelle, Paul; Schünemann, Holger J; Woolf, Steven

2012-07-04

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development.

Addressing implementation challenges during guideline development - a case study of Swedish national guidelines for methods of preventing disease.

PubMed

Richter-Sundberg, Linda; Kardakis, Therese; Weinehall, Lars; Garvare, Rickard; Nyström, Monica E

2015-01-22

Many of the world's life threatening diseases (e.g. cancer, heart disease, stroke) could be prevented by eliminating life-style habits such as tobacco use, unhealthy diet, physical inactivity and excessive alcohol use. Incorporating evidence-based research on methods to change unhealthy lifestyle habits in clinical practice would be equally valuable. However gaps between guideline development and implementation are well documented, with implications for health care quality, safety and effectiveness. The development phase of guidelines has been shown to be important both for the quality in guideline content and for the success of implementation. There are, however, indications that guidelines related to general disease prevention methods encounter specific barriers compared to guidelines that are diagnosis-specific. In 2011 the Swedish National board for Health and Welfare launched guidelines with a preventive scope. The aim of this study was to investigate how implementation challenges were addressed during the development process of these disease preventive guidelines. Seven semi-structured interviews were conducted with members of the guideline development management group. Archival data detailing the guideline development process were also collected and used in the analysis. Qualitative data were analysed using content analysis as the analytical framework. The study identified several strategies and approaches that were used to address implementation challenges during guideline development. Four themes emerged from the analysis: broad agreements and consensus about scope and purpose; a formalized and structured development procedure; systematic and active involvement of stakeholders; and openness and transparency in the specific guideline development procedure. Additional factors concerning the scope of prevention and the work environment of guideline developers were perceived to influence the possibilities to address implementation issues. This case study provides examples of how guideline developers perceive and approach the issue of implementation during the development and early launch of prevention guidelines. Models for guideline development could benefit from an initial assessment of how the guideline topic, its target context and stakeholders will affect the upcoming implementation.

The UK water crisis: What actions the government and private sector need to take.

PubMed

Skelton, Emmeline

2015-01-01

The paper discusses why resilience is increasingly important for companies to measure and address, thinking about relevant issues such as climate change and extreme weather. It gives insight on how companies measure their resilience and that it is more than a business continuity issue; indeed, it is a board issue. The paper looks at the role of regulation for companies with national critical infrastructure in putting in resilience guidelines and discusses the benefits of regulation in resilience, presenting a case study of the UK Water Services Regulation Authority resilience guidelines.

Factors controlling volume errors through 2D gully erosion assessment: guidelines for optimal survey design

NASA Astrophysics Data System (ADS)

Castillo, Carlos; Pérez, Rafael

2017-04-01

The assessment of gully erosion volumes is essential for the quantification of soil losses derived from this relevant degradation process. Traditionally, 2D and 3D approaches has been applied for this purpose (Casalí et al., 2006). Although innovative 3D approaches have recently been proposed for gully volume quantification, a renewed interest can be found in literature regarding the useful information that cross-section analysis still provides in gully erosion research. Moreover, the application of methods based on 2D approaches can be the most cost-effective approach in many situations such as preliminary studies with low accuracy requirements or surveys under time or budget constraints. The main aim of this work is to examine the key factors controlling volume error variability in 2D gully assessment by means of a stochastic experiment involving a Monte Carlo analysis over synthetic gully profiles in order to 1) contribute to a better understanding of the drivers and magnitude of gully erosion 2D-surveys uncertainty and 2) provide guidelines for optimal survey designs. Owing to the stochastic properties of error generation in 2D volume assessment, a statistical approach was followed to generate a large and significant set of gully reach configurations to evaluate quantitatively the influence of the main factors controlling the uncertainty of the volume assessment. For this purpose, a simulation algorithm in Matlab® code was written, involving the following stages: - Generation of synthetic gully area profiles with different degrees of complexity (characterized by the cross-section variability) - Simulation of field measurements characterised by a survey intensity and the precision of the measurement method - Quantification of the volume error uncertainty as a function of the key factors In this communication we will present the relationships between volume error and the studied factors and propose guidelines for 2D field surveys based on the minimal survey densities required to achieve a certain accuracy given the cross-sectional variability of a gully and the measurement method applied. References Casali, J., Loizu, J., Campo, M.A., De Santisteban, L.M., Alvarez-Mozos, J., 2006. Accuracy of methods for field assessment of rill and ephemeral gully erosion. Catena 67, 128-138. doi:10.1016/j.catena.2006.03.005

Guidance for Catastrophic Emergency Situations Involving Asbestos

EPA Pesticide Factsheets

This document addresses the types of asbestos issues that may arise during catastrophic events and how EPA has addressed such issues. It replaces the Guidelines for Catastrophic Emergency Situations Involving Asbestos which was issued in 1992.

Measure Guideline. Transitioning to a Tankless Water Heater

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

Brozyna, K.; Rapport, A.

2012-09-01

This measure guideline provides information to help residential builders and retrofitters with the design, specification, selection, implementation, installation, and maintenance issues of transitioning from tank-type water heaters to tankless water heaters.

Current husbandry of red pandas (Ailurus fulgens) in zoos.

PubMed

Eriksson, P; Zidar, J; White, D; Westander, J; Andersson, M

2010-01-01

The endangered red panda (Ailurus fulgens) is held in zoos worldwide. The aim of this study was to examine how red pandas are kept and managed in captivity and to compare it with the management guidelines. Sixty-nine zoos, mainly from Europe but also from North America and Australia/New Zealand, responded to our survey. The results revealed that in general zoos follow the management guidelines for most of the investigated issues. The average enclosure is almost four times larger than the minimum size recommended by the management guidelines, although seven zoos have smaller enclosures. About half the zoos do not follow the guidelines concerning visitor access and number of nest boxes. Other issues that may compromise animal welfare include proximity of neighboring carnivore species and placement of nest boxes. © 2010 Wiley-Liss, 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.

Current Strategies for Managing Providers Infected with Bloodborne Pathogens

PubMed Central

Turkel, Sarah; Henderson, David K.

2016-01-01

Background In 1991 CDC issued guidelines to reduce risks for provider-to-patient transmission of bloodborne pathogens. These guidelines, unchanged since 1991, recommend management strategies for hepatitis B ‘e’ antigen-positive providers and for providers infected with human immunodeficiency virus (HIV); they do not address hepatitis-C-virus (HCV)-infected providers. Objective We summarize current state practices and surveyed state health departments to determine: 1) if state policies have been modified since 1991; 2), if state laws require prospective notification of patients and/or expert review panels to manage infected providers; 3) the frequency with which infected-providers issues come to the attention of state health departments; and 4) how state health departments intervene. Methods We reviewed all 50 states’ laws and guidelines to determine current practices and conducted a structured telephone survey of all state health departments. Results Whereas only 19 states require infected providers to notify patients of the providers’ bloodborne pathogen infection, these 19 states require notification under highly varied circumstances. Only ten of 50 state health department officials identified these issues as requiring significant departmental effort. No state law or guideline incorporates information about providers’ viral burdens as part of the risk assessment. Only 3/50 States have modified policies or laws since initial passage; and only 1/50 discusses the management of HCV-infected providers.. Conclusions These results identify a need for incorporating contemporary scientific information into guidelines and also suggest that infected-provider issues are not occurring commonly, are not being detected, or that they are being managed at levels below the state health department. PMID:21515972

National origin harassment in the work place: recent guideline developments from the EEOC.

PubMed

Hollon, C J; Bright, T L

1982-01-01

In December 1980 the EEOC published its revised "Guidelines on Discrimination Because of National Origin." The revised guidelines expand the definition of national origin harassment and declare it a violation of Title Vii. According to the EEOC, the guidelines reaffirm the position the Commission has taken in earlier decisions. In the following article, the authors examine the EEOC's position on national origin harassment. Using the guidelines as a frame of reference, they look at both EEOC decisions issued prior to the guidelines and court decisions that may offer employers guidance regarding impermissible conduct and liability in this area.

System Identification and Uncertainty Quantification Using Orthogonal Excitations and the Semi-span Super Sonic Transport (S4T) Model

NASA Technical Reports Server (NTRS)

Heeg, Jennifer; Wieseman, Carol D.

2012-01-01

Orthogonal harmonic multisine excitations were utilized in a wind tunnel test and in simulation of the SemiSpan Supersonic Transport model to assess aeroservoelastic characteristics. Fundamental issues associated with analyzing sinusoidal signals were examined, including spectral leakage, excitation truncation, and uncertainties on frequency response functions and mean-square coherence. Simulation allowed for evaluation of these issues relative to a truth model, while wind tunnel data introduced real-world implementation issues.

Strategies for Involvement in Wildlife Issues.

ERIC Educational Resources Information Center

Kennedy, Carolyn L.; Nye, Donna I.

1984-01-01

Highlights a workshop with children focusing on the treatment of controversial issues and guidelines typically provided by school districts or organizations. Activities designed to stimulate discussion on three issues (endangered species, acid rain, and predator control) are included. (BC)

Title VII Sexual Harassment Guidelines and Educational Employment [and] What Can Students Do About Sex Discrimination?

ERIC Educational Resources Information Center

Howard, Susan; And Others

Guidelines concerning sexual harassment of employees at educational institutions under Title VII of the Civil Rights Act of 1964 are considered. November 1980 final interpretive guidelines issued by the Equal Employment Opportunity Commission state that Title VII prohibits sexual harassment of employees, that employers are responsible for the…

48 CFR 47.403 - Guidelines for implementation of the Fly America Act.

Code of Federal Regulations, 2014 CFR

2014-10-01

... implementation of the Fly America Act. 47.403 Section 47.403 Federal Acquisition Regulations System FEDERAL... Guidelines for implementation of the Fly America Act. This section 47.403 is based on the Guidelines for Implementation of the Fly America Act (case number B-138942), issued by the Comptroller General of the United...

48 CFR 47.403 - Guidelines for implementation of the Fly America Act.

Code of Federal Regulations, 2011 CFR

2011-10-01

... implementation of the Fly America Act. 47.403 Section 47.403 Federal Acquisition Regulations System FEDERAL... Guidelines for implementation of the Fly America Act. This section 47.403 is based on the Guidelines for Implementation of the Fly America Act (case number B-138942), issued by the Comptroller General of the United...

48 CFR 47.403 - Guidelines for implementation of the Fly America Act.

Code of Federal Regulations, 2012 CFR

2012-10-01

... implementation of the Fly America Act. 47.403 Section 47.403 Federal Acquisition Regulations System FEDERAL... Guidelines for implementation of the Fly America Act. This section 47.403 is based on the Guidelines for Implementation of the Fly America Act (case number B-138942), issued by the Comptroller General of the United...

48 CFR 47.403 - Guidelines for implementation of the Fly America Act.

Code of Federal Regulations, 2013 CFR

2013-10-01

... implementation of the Fly America Act. 47.403 Section 47.403 Federal Acquisition Regulations System FEDERAL... Guidelines for implementation of the Fly America Act. This section 47.403 is based on the Guidelines for Implementation of the Fly America Act (case number B-138942), issued by the Comptroller General of the United...

Novel rapid liquid chromatography tandem masspectrometry method for vemurafenib and metabolites in human plasma, including metabolite concentrations at steady state.

PubMed

Vikingsson, Svante; Strömqvist, Malin; Svedberg, Anna; Hansson, Johan; Höiom, Veronica; Gréen, Henrik

2016-08-01

A novel, rapid and sensitive liquid chromatography tandem-mass spectrometry method for quantification of vemurafenib in human plasma, that also for the first time allows for metabolite semi-quantification, was developed and validated to support clinical trials and therapeutic drug monitoring. Vemurafenib was analysed by precipitation with methanol followed by a 1.9 min isocratic liquid chromatography tandem masspectrometry analysis using an Acquity BEH C18 column with methanol and formic acid using isotope labelled internal standards. Analytes were detected in multireaction monitoring mode on a Xevo TQ. Semi-quantification of vemurafenib metabolites was performed using the same analytical system and sample preparation with gradient elution. The vemurafenib method was successfully validated in the range 0.5-100 μg/mL according to international guidelines. The metabolite method was partially validated owing to the lack of commercially available reference materials. For the first time concentration levels at steady state for melanoma patients treated with vemurafenib is presented. The low abundance of vemurafenib metabolites suggests that they lack clinical significance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Quantification of type I error probabilities for heterogeneity LOD scores.

PubMed

Abreu, Paula C; Hodge, Susan E; Greenberg, David A

2002-02-01

Locus heterogeneity is a major confounding factor in linkage analysis. When no prior knowledge of linkage exists, and one aims to detect linkage and heterogeneity simultaneously, classical distribution theory of log-likelihood ratios does not hold. Despite some theoretical work on this problem, no generally accepted practical guidelines exist. Nor has anyone rigorously examined the combined effect of testing for linkage and heterogeneity and simultaneously maximizing over two genetic models (dominant, recessive). The effect of linkage phase represents another uninvestigated issue. Using computer simulation, we investigated type I error (P value) of the "admixture" heterogeneity LOD (HLOD) score, i.e., the LOD score maximized over both recombination fraction theta and admixture parameter alpha and we compared this with the P values when one maximizes only with respect to theta (i.e., the standard LOD score). We generated datasets of phase-known and -unknown nuclear families, sizes k = 2, 4, and 6 children, under fully penetrant autosomal dominant inheritance. We analyzed these datasets (1) assuming a single genetic model, and maximizing the HLOD over theta and alpha; and (2) maximizing the HLOD additionally over two dominance models (dominant vs. recessive), then subtracting a 0.3 correction. For both (1) and (2), P values increased with family size k; rose less for phase-unknown families than for phase-known ones, with the former approaching the latter as k increased; and did not exceed the one-sided mixture distribution xi = (1/2) chi1(2) + (1/2) chi2(2). Thus, maximizing the HLOD over theta and alpha appears to add considerably less than an additional degree of freedom to the associated chi1(2) distribution. We conclude with practical guidelines for linkage investigators. Copyright 2002 Wiley-Liss, Inc.

Targeted Quantification of Isoforms of a Thylakoid-Bound Protein: MRM Method Development.

PubMed

Bru-Martínez, Roque; Martínez-Márquez, Ascensión; Morante-Carriel, Jaime; Sellés-Marchart, Susana; Martínez-Esteso, María José; Pineda-Lucas, José Luis; Luque, Ignacio

2018-01-01

Targeted mass spectrometric methods such as selected/multiple reaction monitoring (SRM/MRM) have found intense application in protein detection and quantification which competes with classical immunoaffinity techniques. It provides a universal procedure to develop a fast, highly specific, sensitive, accurate, and cheap methodology for targeted detection and quantification of proteins based on the direct analysis of their surrogate peptides typically generated by tryptic digestion. This methodology can be advantageously applied in the field of plant proteomics and particularly for non-model species since immunoreagents are scarcely available. Here, we describe the issues to take into consideration in order to develop a MRM method to detect and quantify isoforms of the thylakoid-bound protein polyphenol oxidase from the non-model and database underrepresented species Eriobotrya japonica Lindl.

Novel HPLC-UV Method for Simultaneous Determination of Fat-soluble Vitamins and Coenzyme Q10 in Medicines and Supplements.

PubMed

Temova-Rakuša, Žane; Srečnik, Eva; Roškar, Robert

2017-09-01

A precise, accurate and rapid HPLC-UV method for simultaneous determination of fat-soluble vitamins (vitamin D3, E-acetate, K1, β-carotene, A-palmitate) and coenzyme Q10 was developed and validated according to ICH guidelines. Optimal chromatographic separation of the analytes in minimal analysis time (8 min) was achieved on a Luna C18 150 × 4.6 mm column using a mixture of acetonitrile, tetrahydrofuran and water (50:45:5, v/v/v). The described reversed phase HPLC method is the first published for quantification of these five fat-soluble vitamins and coenzyme Q10 within a single chromatographic run. The method was further applied for quantification of the analytes in selected liquid and solid dosage forms, registered as nutritional supplements and prescription medicines, which confirmed its suitability for routine analysis.

Diabetes and end of life: ethical and methodological issues in gathering evidence to guide care.

PubMed

Dunning, Trisha; Duggan, Nicole; Savage, Sally; Martin, Peter

2013-03-01

Providing palliative care for people with diabetes at the end of life is part of the chronic disease care trajectory, but end of life care is complex and the presence of diabetes further complicates management. The aim of the paper is to discuss the ethical and methodological issues encountered when undertaking research to develop guidelines for managing diabetes at the end of life and the strategies used to address the issues. The issues emerged as we developed guidelines for managing diabetes at the end of life, which included conducting individual interviews with 14 people with diabetes requiring palliative care and 10 family members. A reflexive researcher journal was maintained throughout the guideline development process. The interview transcripts and researcher's journal were analysed to determine key methodological, ethical and researcher-related issues. Key themes were vulnerability of the sampling population, methodological issues included recruiting participants and ensuring rigor, ethical issues concerned benefit and risk, justice, autonomy, privacy, professional boundaries and informed consent. Researcher-related issues were identified such as managing participant distress and their own emotional distress. People were willing to discuss end of life diabetes management preferences. Undertaking research with people at the end of life is complex because of their vulnerability and the ethical issues involved. However, the ethical principles of autonomy and justice apply and people should be given the relevant information and opportunity to decide whether to participate or not. © 2012 The Authors. Scandinavian Journal of Caring Sciences © 2012 Nordic College of Caring Science.

Canadian physicians' attitudes about and preferences regarding clinical practice guidelines

PubMed Central

Hayward, R S; Guyatt, G H; Moore, K A; McKibbon, K A; Carter, A O

1997-01-01

OBJECTIVE: To assess Canadian physicians' confidence in, attitudes about and preferences regarding clinical practice guidelines. DESIGN: Cross-sectional, self-administered mailed survey. PARTICIPANTS: Stratified random sample of 3000 Canadian physicians; 1878 (62.6%) responded. SETTING: Canada. OUTCOME MEASURES: Physicians' use of various information sources; familiarity with and confidence in guidelines; attitudes about guidelines and their effect on medical care; rating of importance of guidelines and other sources of information in clinical decision-making; rating of importance of various considerations in deciding whether to adopt a set of guidelines; and rating of usefulness of different formats for presenting guidelines. MAIN RESULTS: In all, 52% of the respondents reported using guidelines at least monthly, substantially less frequently than traditional information sources. Most of the respondents expressed confidence in guidelines issued by various physician organizations, but 51% to 77% were not confident in guidelines issued by federal or provincial health ministries or by health insurance plans. The respondents were generally positive about guidelines (e.g., over 50% strongly agreed that they are a convenient source of advice and good educational tools); however, 22% to 26% had concerns about loss of autonomy, the rigidity of guidelines and decreased satisfaction with medical practice. Endorsement by respected colleagues or major organizations was identified as very important by 78% and 62% of the respondents respectively in deciding whether to adopt a set of guidelines in their practice. User friendliness of the guidelines format was thought to be very important by 62%; short pamphlets, manuals summarizing a number of guidelines, journal articles and pocket cards summarizing guidelines were the preferred formats (identified as most useful by 50% to 62% of the respondents). CONCLUSIONS: Canadian physicians, although generally positive about guidelines and confident in those developed by clinicians, have not yet integrated the use of guidelines into their practices to a large extent. Our results suggest that respected organizations and opinion leaders should be involved in the development of guidelines and that the acceptability of any proposed format and medium for guidelines presentation should be pretested. PMID:9220923

Development and validation of an ultra high performance liquid chromatography-electrospray tandem mass spectrometry method using selective derivatisation, for the quantification of two reactive aldehydes produced by lipid peroxidation, HNE (4-hydroxy-2(E)-nonenal) and HHE (4-hydroxy-2(E)-hexenal) in faecal water.

PubMed

Chevolleau, S; Noguer-Meireles, M-H; Jouanin, I; Naud, N; Pierre, F; Gueraud, F; Debrauwer, L

2018-04-15

Red or processed meat rich diets have been shown to be associated with an elevated risk of colorectal cancer (CRC). One major hypothesis involves dietary heme iron which induces lipid peroxidation. The quantification of the resulting reactive aldehydes (e.g. HNE and HHE) in the colon lumen is therefore of great concern since these compounds are known for their cytotoxic and genotoxic properties. UHPLC-ESI-MS/MS method has been developed and validated for HNE and HHE quantification in rat faeces. Samples were derivatised using a brominated reagent (BBHA) in presence of pre-synthesized deuterated internal standards (HNE-d11/HHE-d5), extracted by solid phase extraction, and then analysed by LC-positive ESI-MS/MS (MRM) on a TSQ Vantage mass spectrometer. The use of BBHA allowed the efficient stabilisation of the unstable and reactive hydroxy-alkenals HNE and HHE. The MRM method allowed selective detection of HNE and HHE on the basis of characteristic transitions monitored from both the 79 and 81 bromine isotopic peaks. This method was validated according to the European Medicines Agency (EMEA) guidelines, by determining selectivity, sensitivity, linearity, carry-over effect, recovery, matrix effect, repeatability, trueness and intermediate precision. The performance of the method enabled the quantification of HNE and HHE in concentrations 0.10-0.15 μM in faecal water. Results are presented on the application to the quantification of HNE and HHE in different faecal waters obtained from faeces of rats fed diets with various fatty acid compositions thus corresponding to different pro-oxidative features. Copyright © 2018 Elsevier B.V. All rights reserved.

Development and validation of a bioanalytical LC-MS method for the quantification of GHRP-6 in human plasma.

PubMed

Gil, Jeovanis; Cabrales, Ania; Reyes, Osvaldo; Morera, Vivian; Betancourt, Lázaro; Sánchez, Aniel; García, Gerardo; Moya, Galina; Padrón, Gabriel; Besada, Vladimir; González, Luis Javier

2012-02-23

Growth hormone-releasing peptide 6 (GHRP-6, His-(DTrp)-Ala-Trp-(DPhe)-Lys-NH₂, MW=872.44 Da) is a potent growth hormone secretagogue that exhibits a cytoprotective effect, maintaining tissue viability during acute ischemia/reperfusion episodes in different organs like small bowel, liver and kidneys. In the present work a quantitative method to analyze GHRP-6 in human plasma was developed and fully validated following FDA guidelines. The method uses an internal standard (IS) of GHRP-6 with ¹³C-labeled Alanine for quantification. Sample processing includes a precipitation step with cold acetone to remove the most abundant plasma proteins, recovering the GHRP-6 peptide with a high yield. Quantification was achieved by LC-MS in positive full scan mode in a Q-Tof mass spectrometer. The sensitivity of the method was evaluated, establishing the lower limit of quantification at 5 ng/mL and a range for the calibration curve from 5 ng/mL to 50 ng/mL. A dilution integrity test was performed to analyze samples at higher concentration of GHRP-6. The validation process involved five calibration curves and the analysis of quality control samples to determine accuracy and precision. The calibration curves showed R² higher than 0.988. The stability of the analyte and its internal standard (IS) was demonstrated in all conditions the samples would experience in a real time analyses. This method was applied to the quantification of GHRP-6 in plasma from nine healthy volunteers participating in a phase I clinical trial. Copyright © 2011 Elsevier B.V. All rights reserved.

Simultaneous Quantification of Syringic Acid and Kaempferol in Extracts of Bergenia Species Using Validated High-Performance Thin-Layer Chromatographic-Densitometric Method.

PubMed

Srivastava, Nishi; Srivastava, Amit; Srivastava, Sharad; Rawat, Ajay Kumar Singh; Khan, Abdul Rahman

2016-03-01

A rapid, sensitive, selective and robust quantitative densitometric high-performance thin-layer chromatographic method was developed and validated for separation and quantification of syringic acid (SYA) and kaempferol (KML) in the hydrolyzed extracts of Bergenia ciliata and Bergenia stracheyi. The separation was performed on silica gel 60F254 high-performance thin-layer chromatography plates using toluene : ethyl acetate : formic acid (5 : 4: 1, v/v/v) as the mobile phase. The quantification of SYA and KML was carried out using a densitometric reflection/absorption mode at 290 nm. A dense spot of SYA and KML appeared on the developed plate at a retention factor value of 0.61 ± 0.02 and 0.70 ± 0.01. A precise and accurate quantification was performed using linear regression analysis by plotting the peak area vs concentration 100-600 ng/band (correlation coefficient: r = 0.997, regression coefficient: R(2) = 0.996) for SYA and 100-600 ng/band (correlation coefficient: r = 0.995, regression coefficient: R(2) = 0.991) for KML. The developed method was validated in terms of accuracy, recovery and inter- and intraday study as per International Conference on Harmonisation guidelines. The limit of detection and limit of quantification of SYA and KML were determined, respectively, as 91.63, 142.26 and 277.67, 431.09 ng. The statistical data analysis showed that the method is reproducible and selective for the estimation of SYA and KML in extracts of B. ciliata and B. stracheyi. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Ultra-high Performance Liquid Chromatography Tandem Mass-Spectrometry for Simple and Simultaneous Quantification of Cannabinoids

PubMed Central

Jamwal, Rohitash; Topletz, Ariel R.; Ramratnam, Bharat; Akhlaghi, Fatemeh

2017-01-01

Cannabis is used widely in the United States, both recreationally and for medical purposes. Current methods for analysis of cannabinoids in human biological specimens rely on complex extraction process and lengthy analysis time. We established a rapid and simple assay for quantification of Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), 11-hydroxy Δ9-tetrahydrocannabinol (11-OH THC) and 11-nor-9-carboxy-Δ9-tetrahydrocannbinol (THC-COOH) in human plasma by U-HPLC-MS/MS using Δ9-tetrahydrocannabinol-D3 as the internal standard. Chromatographic separation was achieved on an Acquity BEH C18 column using a gradient comprising of water (0.1% formic acid) and methanol (0.1% formic acid) over a 6 min run-time. Analytes from 200 µL plasma were extracted using acetonitrile (containing 1% formic acid and THC-D3). Mass spectrometry was performed in positive ionization mode, and total ion chromatogram was used for quantification of analytes. The assay was validated according to guidelines set forth by Food and Drug Administration of United States. An eight-point calibration curve was fitted with quadratic regression (r2>0.99) from 1.56 to 100 ng mL−1 and a lower limit of quantification (LLOQ) of 1.56 ng mL−1 was achieved. Accuracy and precision calculated from six calibration curves was between 85 to 115% while the mean extraction recovery was >90% for all the analytes. Several plasma phospholipids eluted after the analytes thus did not interfere with the assay. Bench-top, freeze-thaw, auto-sampler and short-term stability ranged from 92.7 to 106.8% of nominal values. Application of the method was evaluated by quantification of analytes in human plasma from six subjects. PMID:28192758

Guidelines for establishing and maintaining construction quality databases.

DOT National Transportation Integrated Search

2006-11-01

The main objective of this study was to develop and present guidelines for State highway agencies (SHAs) in establishing and maintaining database systems geared towards construction quality issues for asphalt and concrete paving projects. To accompli...

Investigation of user stereotypes and preferences

DOT National Transportation Integrated Search

1999-12-01

The presentation of in-vehicle information to the driver is an important issue for highway safety. A review of the guideline literature revealed that although attempts have been made to develop guidelines for in-vehicle information systems, few guide...

New EPA Guidelines for Review of Surface Coal Mining Operations in Appalachia (released in AEO2010)

EIA Publications

2010-01-01

On April 1, 2010, the Environmental Protection Agency (EPA) issued a set of new guidelines to several of its Regional offices regarding the compliance of surface coal mining operations in Appalachia with the provisions of the Clean Water Act (CWA), the National Environmental Policy Act, and the environmental justice Executive Order (E.O. 12898). The stated purpose of the guidance was to explain more fully the approach that the EPA will be following in permit reviews, and to provide additional assurance that its Regional offices use clear, consistent, and science-based standards in reviewing the permits. Although the new guidelines go into effect immediately, they will be subjected to review both by the public and by the EPA's Science Advisory Board, with a set of final guidelines to be issued no later than April 1, 2011.

Drug-disease and drug-drug interactions: systematic examination of recommendations in 12 UK national clinical guidelines.

PubMed

Dumbreck, Siobhan; Flynn, Angela; Nairn, Moray; Wilson, Martin; Treweek, Shaun; Mercer, Stewart W; Alderson, Phil; Thompson, Alex; Payne, Katherine; Guthrie, Bruce

2015-03-11

To identify the number of drug-disease and drug-drug interactions for exemplar index conditions within National Institute of Health and Care Excellence (NICE) clinical guidelines. Systematic identification, quantification, and classification of potentially serious drug-disease and drug-drug interactions for drugs recommended by NICE clinical guidelines for type 2 diabetes, heart failure, and depression in relation to 11 other common conditions and drugs recommended by NICE guidelines for those conditions. NICE clinical guidelines for type 2 diabetes, heart failure, and depression Potentially serious drug-disease and drug-drug interactions. Following recommendations for prescription in 12 national clinical guidelines would result in several potentially serious drug interactions. There were 32 potentially serious drug-disease interactions between drugs recommended in the guideline for type 2 diabetes and the 11 other conditions compared with six for drugs recommended in the guideline for depression and 10 for drugs recommended in the guideline for heart failure. Of these drug-disease interactions, 27 (84%) in the type 2 diabetes guideline and all of those in the two other guidelines were between the recommended drug and chronic kidney disease. More potentially serious drug-drug interactions were identified between drugs recommended by guidelines for each of the three index conditions and drugs recommended by the guidelines for the 11 other conditions: 133 drug-drug interactions for drugs recommended in the type 2 diabetes guideline, 89 for depression, and 111 for heart failure. Few of these drug-disease or drug-drug interactions were highlighted in the guidelines for the three index conditions. Drug-disease interactions were relatively uncommon with the exception of interactions when a patient also has chronic kidney disease. Guideline developers could consider a more systematic approach regarding the potential for drug-disease interactions, based on epidemiological knowledge of the comorbidities of people with the disease the guideline is focused on, and should particularly consider whether chronic kidney disease is common in the target population. In contrast, potentially serious drug-drug interactions between recommended drugs for different conditions were common. The extensive number of potentially serious interactions requires innovative interactive approaches to the production and dissemination of guidelines to allow clinicians and patients with multimorbidity to make informed decisions about drug selection. © Dumbreck et al 2015.

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.

[Dietary guidelines for the Brazilian population: implications for the Brazilian National Policy on Oral Health].

PubMed

Freire, Maria do Carmo Matias; Balbo, Patrícia Lima; Amador, Maiara de Andrade; Sardinha, Luciana Monteiro Vasconcelos

2012-01-01

Dietary guidelines are intended to orient dietary habits and policies for health promotion and disease prevention. This article discusses Brazil's national dietary guidelines, aiming to identify issues that can support the strategies proposed by the National Policy on Oral Health. The two currently available official guidelines produced by the Ministry of Health were reviewed: the Dietary Guidelines for Children under Two and the Population Dietary Guidelines. The guidelines recommend reduction in sugar intake, essential for caries prevention, and other measures to prevent tooth decay and oral cancer. These guidelines are thus a key part of an oral and overall health promotion strategy and should be integrated into the National Policy on Oral Health.

Educational Challenges in Toxicology.

ERIC Educational Resources Information Center

Dixon, Robert L.

1984-01-01

Issues and topics related to educational challenges in toxicology at all levels are discussed. They include public awareness and understanding, general approach to toxicology, quality structure-activity relationships, epidemiological studies, quantification of risk, and the types of toxicants studied. (JN)

High-performance liquid chromatography as a technique to determine protein adsorption onto hydrophilic/hydrophobic surfaces.

PubMed

Huang, Tongtong; Anselme, Karine; Sarrailh, Segolene; Ponche, Arnaud

2016-01-30

The purpose of this study is to evaluate the potential of simple high performance liquid chromatography (HPLC) setup for quantification of adsorbed proteins on various type of plane substrates with limited area (<3 cm(2)). Protein quantification was investigated with a liquid chromatography chain equipped with a size exclusion column or a reversed-phase column. By evaluating the validation of the method according to guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), all the results obtained by HPLC were reliable. By simple adsorption test at the contact of hydrophilic (glass) and hydrophobic (polydimethylsiloxane: PDMS) surfaces, kinetics of adsorption were determined and amounts of adsorbed bovine serum albumin, myoglobin and lysozyme were obtained: as expected for each protein, the amount adsorbed at the plateau on glass (between 0.15 μg/cm(2) and 0.4 μg/cm(2)) is lower than for hydrophobic PDMS surfaces (between 0.45 μg/cm(2) and 0.8 μg/cm(2)). These results were consistent with bicinchoninic acid protein determination. According to ICH guidelines, both Reversed Phase and Size Exclusion HPLC can be validated for quantification of adsorbed protein. However, we consider the size exclusion approach more interesting in this field because additional informations can be obtained for aggregative proteins. Indeed, monomer, dimer and oligomer of bovine serum albumin (BSA) were observed in the chromatogram. On increasing the temperature, we found a decrease of peak intensity of bovine serum albumin as well as the fraction of dimer and oligomer after contact with PDMS and glass surface. As the surface can act as a denaturation parameter, these informations can have a huge impact on the elucidation of the interfacial behavior of protein and in particular for aggregation processes in pharmaceutical applications. Copyright © 2015 Elsevier B.V. All rights reserved.

Best Practices for Mental Health in Child Welfare: Parent Support and Youth Empowerment Guidelines

ERIC Educational Resources Information Center

Romanelli, Lisa Hunter; Hoagwood, Kimberly E.; Kaplan, Sandra J.; Kemp, Susan P.; Hartman, Robert L.; Trupin, Casey; Soto, Wilfredo; Pecora, Peter J.; LaBarrie, Theresa L.; Jensen, Peter S.

2009-01-01

This paper, the second in a series of two guideline papers emerging from the 2007 Best Practices for Mental Health in Child Welfare Consensus Conference, provides an overview of the key issues related to parent support and youth empowerment in child welfare and presents consensus guidelines in these important areas. The paper also discusses some…

Developing prehospital clinical practice guidelines for resource limited settings: why re-invent the wheel?

PubMed

McCaul, Michael; de Waal, Ben; Hodkinson, Peter; Pigoga, Jennifer L; Young, Taryn; Wallis, Lee A

2018-02-05

Methods on developing new (de novo) clinical practice guidelines (CPGs) have received substantial attention. However, the volume of literature is not matched by research into alternative methods of CPG development using existing CPG documents-a specific issue for guideline development groups in low- and middle-income countries. We report on how we developed a context specific prehospital CPG using an alternative guideline development method. Difficulties experienced and lessons learnt in applying existing global guidelines' recommendations to a national context are highlighted. The project produced the first emergency care CPG for prehospital providers in Africa. It included > 270 CPGs and produced over 1000 recommendations for prehospital emergency care. We encountered various difficulties, including (1) applicability issues: few pre-hospital CPGs applicable to Africa, (2) evidence synthesis: heterogeneous levels of evidence classifications and (3) guideline quality. Learning points included (1) focusing on key CPGs and evidence mapping, (2) searching other resources for CPGs, (3) broad representation on CPG advisory boards and (4) transparency and knowledge translation. Re-inventing the wheel to produce CPGs is not always feasible. We hope this paper will encourage further projects to use existing CPGs in developing guidance to improve patient care in resource-limited settings.

Appropriate evidence sources for populating decision analytic models within health technology assessment (HTA): a systematic review of HTA manuals and health economic guidelines.

PubMed

Zechmeister-Koss, Ingrid; Schnell-Inderst, Petra; Zauner, Günther

2014-04-01

An increasing number of evidence sources are relevant for populating decision analytic models. What is needed is detailed methodological advice on which type of data is to be used for what type of model parameter. We aim to identify standards in health technology assessment manuals and economic (modeling) guidelines on appropriate evidence sources and on the role different types of data play within a model. Documents were identified via a call among members of the International Network of Agencies for Health Technology Assessment and by hand search. We included documents from Europe, the United States, Canada, Australia, and New Zealand as well as transnational guidelines written in English or German. We systematically summarized in a narrative manner information on appropriate evidence sources for model parameters, their advantages and limitations, data identification methods, and data quality issues. A large variety of evidence sources for populating models are mentioned in the 28 documents included. They comprise research- and non-research-based sources. Valid and less appropriate sources are identified for informing different types of model parameters, such as clinical effect size, natural history of disease, resource use, unit costs, and health state utility values. Guidelines do not provide structured and detailed advice on this issue. The article does not include information from guidelines in languages other than English or German, and the information is not tailored to specific modeling techniques. The usability of guidelines and manuals for modeling could be improved by addressing the issue of evidence sources in a more structured and comprehensive format.

A comparative review of the pharmacoeconomic guidelines in South Africa.

PubMed

Carapinha, João L

2017-01-01

To compare the pharmacoeconomic guidelines in South Africa (SA) with other middle- and high-income countries. A comparative review of key features of the pharmacoeconomic guidelines in SA was undertaken using the Comparative Table of Pharmacoeconomic Guidelines developed by the International Society of Pharmacoeconomics and Outcomes Research, and published country-level pharmacoeconomics guidelines. A random sample of guidelines in high- and middle-income countries were analyzed if data on all key features were available. Key features of the pharmacoeconomic guidelines in SA were compared with those in other countries, and divergent features were identified and elaborated. Five upper middle-income countries (Brazil, Colombia, Cuba, Malaysia, and Mexico), one lower middle-income country (Egypt), and six high-income countries (Germany, Ireland, Norway, Portugal, Taiwan, and the Netherlands) were analyzed. The pharmacoeconomic guidelines in SA differ in important areas when compared with other countries. In SA, the study perspective and costs are limited to private health-insurance companies, complex modelling is discouraged and models require pre-approval, equity issues are not explicitly stated, a budget impact analysis is not required, and pharmacoeconomic submissions are voluntary. Future updates to the pharmacoeconomic guidelines in SA may include a societal perspective with limitations, incentivize complex and transparent models, and integrate equity issues. The pharmacoeconomic guidelines could be improved by addressing conflicting objectives with policies on National Health Insurance, incentivize private health insurance companies to disclose reimbursement data, and require the inclusion of a budget impact analysis in all pharmacoeconomic submissions. Further research is also needed on the impact of mandatory pharmacoeconomic submissions in middle-income countries.

Analytical Validation of Quantitative Real-Time PCR Methods for Quantification of Trypanosoma cruzi DNA in Blood Samples from Chagas Disease Patients

PubMed Central

Ramírez, Juan Carlos; Cura, Carolina Inés; Moreira, Otacilio da Cruz; Lages-Silva, Eliane; Juiz, Natalia; Velázquez, Elsa; Ramírez, Juan David; Alberti, Anahí; Pavia, Paula; Flores-Chávez, María Delmans; Muñoz-Calderón, Arturo; Pérez-Morales, Deyanira; Santalla, José; Guedes, Paulo Marcos da Matta; Peneau, Julie; Marcet, Paula; Padilla, Carlos; Cruz-Robles, David; Valencia, Edward; Crisante, Gladys Elena; Greif, Gonzalo; Zulantay, Inés; Costales, Jaime Alfredo; Alvarez-Martínez, Miriam; Martínez, Norma Edith; Villarroel, Rodrigo; Villarroel, Sandro; Sánchez, Zunilda; Bisio, Margarita; Parrado, Rudy; Galvão, Lúcia Maria da Cunha; da Câmara, Antonia Cláudia Jácome; Espinoza, Bertha; de Noya, Belkisyole Alarcón; Puerta, Concepción; Riarte, Adelina; Diosque, Patricio; Sosa-Estani, Sergio; Guhl, Felipe; Ribeiro, Isabela; Aznar, Christine; Britto, Constança; Yadón, Zaida Estela; Schijman, Alejandro G.

2015-01-01

An international study was performed by 26 experienced PCR laboratories from 14 countries to assess the performance of duplex quantitative real-time PCR (qPCR) strategies on the basis of TaqMan probes for detection and quantification of parasitic loads in peripheral blood samples from Chagas disease patients. Two methods were studied: Satellite DNA (SatDNA) qPCR and kinetoplastid DNA (kDNA) qPCR. Both methods included an internal amplification control. Reportable range, analytical sensitivity, limits of detection and quantification, and precision were estimated according to international guidelines. In addition, inclusivity and exclusivity were estimated with DNA from stocks representing the different Trypanosoma cruzi discrete typing units and Trypanosoma rangeli and Leishmania spp. Both methods were challenged against 156 blood samples provided by the participant laboratories, including samples from acute and chronic patients with varied clinical findings, infected by oral route or vectorial transmission. kDNA qPCR showed better analytical sensitivity than SatDNA qPCR with limits of detection of 0.23 and 0.70 parasite equivalents/mL, respectively. Analyses of clinical samples revealed a high concordance in terms of sensitivity and parasitic loads determined by both SatDNA and kDNA qPCRs. This effort is a major step toward international validation of qPCR methods for the quantification of T. cruzi DNA in human blood samples, aiming to provide an accurate surrogate biomarker for diagnosis and treatment monitoring for patients with Chagas disease. PMID:26320872

Quantification of steroid hormones in human serum by liquid chromatography-high resolution tandem mass spectrometry.

PubMed

Matysik, Silke; Liebisch, Gerhard

2017-12-01

A limited specificity is inherent to immunoassays for steroid hormone analysis. To improve selectivity mass spectrometric analysis of steroid hormones by liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been introduced in the clinical laboratory over the past years usually with low mass resolution triple-quadrupole instruments or more recently by high resolution mass spectrometry (HR-MS). Here we introduce liquid chromatography-high resolution tandem mass spectrometry (LC-MS/HR-MS) to further increase selectivity of steroid hormone quantification. Application of HR-MS demonstrates an enhanced selectivity compared to low mass resolution. Separation of isobaric interferences reduces background noise and avoids overestimation. Samples were prepared by automated liquid-liquid extraction with MTBE. The LC-MS/HR-MS method using a quadrupole-Orbitrap analyzer includes eight steroid hormones i.e. androstenedione, corticosterone, cortisol, cortisone, 11-deoxycortisol, 17-hydroxyprogesterone, progesterone, and testosterone. It has a run-time of 5.3min and was validated according to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) guidelines. For most of the analytes coefficient of variation were 10% or lower and LOQs were determined significantly below 1ng/ml. Full product ion spectra including accurate masses substantiate compound identification by matching their masses and ratios with authentic standards. In summary, quantification of steroid hormones by LC-MS/HR-MS is applicable for clinical diagnostics and holds also promise for highly selective quantification of other small molecules. Copyright © 2017 Elsevier B.V. All rights reserved.

Localized 2D COSY sequences: Method and experimental evaluation for a whole metabolite quantification approach

NASA Astrophysics Data System (ADS)

Martel, Dimitri; Tse Ve Koon, K.; Le Fur, Yann; Ratiney, Hélène

2015-11-01

Two-dimensional spectroscopy offers the possibility to unambiguously distinguish metabolites by spreading out the multiplet structure of J-coupled spin systems into a second dimension. Quantification methods that perform parametric fitting of the 2D MRS signal have recently been proposed for resolved PRESS (JPRESS) but not explicitly for Localized Correlation Spectroscopy (LCOSY). Here, through a whole metabolite quantification approach, correlation spectroscopy quantification performances are studied. The ability to quantify metabolite relaxation constant times is studied for three localized 2D MRS sequences (LCOSY, LCTCOSY and the JPRESS) in vitro on preclinical MR systems. The issues encountered during implementation and quantification strategies are discussed with the help of the Fisher matrix formalism. The described parameterized models enable the computation of the lower bound for error variance - generally known as the Cramér Rao bounds (CRBs), a standard of precision - on the parameters estimated from these 2D MRS signal fittings. LCOSY has a theoretical net signal loss of two per unit of acquisition time compared to JPRESS. A rapid analysis could point that the relative CRBs of LCOSY compared to JPRESS (expressed as a percentage of the concentration values) should be doubled but we show that this is not necessarily true. Finally, the LCOSY quantification procedure has been applied on data acquired in vivo on a mouse brain.

Science Facilities Design Guidelines.

ERIC Educational Resources Information Center

Maryland State Dept. of Education, Baltimore.

These guidelines, presented in five chapters, propose a framework to support the planning, designing, constructing, and renovating of school science facilities. Some program issues to be considered in the articulation of a science program include environmental concerns, interdisciplinary approaches, space flexibility, and electronic…

[Proposal for a media guideline to improve medical and health journalism].

PubMed

Kojima, Masami

2012-01-01

A lot of healthcare professionals experienced annoyance with biased mass media news regarding medical and health issues. In this paper, I propose "news profiling method" and "media guideline" to improve the medical and health journalism.

Guidelines warfare over interventional techniques: is there a lack of discourse or straw man?

PubMed

Manchikanti, Laxmaiah; Benyamin, Ramsin M; Falco, Frank J E; Caraway, David L; Datta, Sukdeb; Hirsch, Joshua A

2012-01-01

Guideline development seems to have lost some of its grounding as a medical science. At their best, guidelines should be a constructive response to assist practicing physicians in applying the exponentially expanding body of medical knowledge. In fact, guideline development seems to be evolving into a cottage industry with multiple, frequently discordant guidance on the same subject. Evidence Based Medicine does not always provide for conclusive opinions. With competing interests of payers, practitioners, health policy makers, and third parties benefiting from development of the guidelines as cost saving measures, guideline preparation has been described as based on pre-possession, vagary, rationalization, or congeniality of conclusion. Beyond legitimate differences in opinions regarding the evidence that could yield different guidelines there are potentials for conflicts of interest and various other issues play a major role in guideline development. As is always the case, conflicts of interest in guideline preparation must be evaluated and considered. Following the development of American Pain Society (APS) guidelines there has been an uproar in interventional pain management communities on various issues related to not only the evidence synthesis, but conflicts of interest. A recent manuscript published by Chou et al, in addition to previous publications, appears to have limited clinician involvement in the development of APS guidelines, and demonstrates some of these challenges clearly. This manuscript illustrates the deficiencies of Chou et al's criticisms, and demonstrates their significant conflicts of interest, and use a lack of appropriate evaluations in interventional pain management as a straw man to support their argument. Further, this review will attempt to demonstrate that excessive focus on this straw man has inhibited critique of what we believe to be flaws in the approach.  

Pre-implementation guidelines for infectious disease point-of-care testing in medical institutions.

PubMed

van der Eijk, Annemiek A; Tintu, Andrei N; Hays, John P

2017-01-01

Infectious disease point-of-care test (ID-POCT) devices are becoming widely available, and in this respect, international quality standards and guidelines are available for consultation once ID-POCT has been implemented into medical institutions. However, specific guidelines for consultation during the initial pre-implementation decision-making process are currently lacking. Further, there exist pre-implementation issues specific to ID-POCT. Here we present pre-implementation guidelines for consultation when considering the implementation of ID-POCT in medical institutions.

A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - Quanti-Qualitative Appointment Timing.

PubMed

Paramasivan, Sangeetha; Strong, Sean; Wilson, Caroline; Campbell, Bruce; Blazeby, Jane M; Donovan, Jenny L

2015-03-11

Recruitment to pragmatic randomised controlled trials (RCTs) is acknowledged to be difficult, and few interventions have proved to be effective. Previous qualitative research has consistently revealed that recruiters provide imbalanced information about RCT treatments. However, qualitative research can be time-consuming to apply. Within a programme of research to optimise recruitment and informed consent in challenging RCTs, we developed a simple technique, Q-QAT (Quanti-Qualitative Appointment Timing), to systematically investigate and quantify the imbalance to help identify and address recruitment difficulties. The Q-QAT technique comprised: 1) quantification of time spent discussing the RCT and its treatments using transcripts of audio-recorded recruitment appointments, 2) targeted qualitative research to understand the obstacles to recruitment and 3) feedback to recruiters on opportunities for improvement. This was applied to two RCTs with different clinical contexts and recruitment processes. Comparisons were made across clinical centres, recruiters and specialties. In both RCTs, the Q-QAT technique first identified considerable variations in the time spent by recruiters discussing the RCT and its treatments. The patterns emerging from this initial quantification of recruitment appointments then enabled targeted qualitative research to understand the issues and make suggestions to improve recruitment. In RCT1, presentation of the treatments was balanced, but little time was devoted to describing the RCT. Qualitative research revealed patients would have considered participation, but lacked awareness of the RCT. In RCT2, the balance of treatment presentation varied by specialists and centres. Qualitative research revealed difficulties with equipoise and confidence among recruiters presenting the RCT. The quantitative and qualitative findings were well-received by recruiters and opportunities to improve information provision were discussed. A blind coding exercise across three researchers led to the development of guidelines that can be used to apply the Q-QAT technique to other difficult RCTs. The Q-QAT technique was easy to apply and rapidly identified obstacles to recruitment that could be understood through targeted qualitative research and addressed through feedback. The technique's combination of quantitative and qualitative findings enabled the presentation of a holistic picture of recruitment challenges and added credibility to the feedback process. Note: both RCTs in this manuscript asked to be anonymised, so no trial registration details are provided.

Guidelines for preparing high school psychology teachers: course-based and standards-based approaches.

PubMed

2013-01-01

Psychology is one of the most popular elective high school courses. The high school psychology course provides the foundation for students to benefit from psychological perspectives on personal and contemporary issues and learn the rules of evidence and theoretical frameworks of the discipline. The guidelines presented here constitute the second of two reports in this issue of the American Psychologist (January 2013) representing recent American Psychological Association (APA) policies that support high-quality instruction in the teaching of high school psychology. These guidelines, aligned to the standards presented in the preceding report, describe models for the preparation of preservice psychology teachers. The two reports together demonstrate the rigor and competency that should be expected in psychology instruction at the high school level.

A look at statin cost-effectiveness in view of the 2013 ACC/AHA cholesterol management guidelines.

PubMed

Deaño, Roderick C; Pandya, Ankur; Jones, Erica C; Borden, William B

2014-09-01

The 2013 cholesterol management guidelines presented a major shift in recommendations on which patients at risk of cardiovascular disease should be treated and how to treat them. Implementation of the guidelines is estimated to increase substantially the number of people who would be eligible for statin therapy. As the medical community considers the broad population impact of the new cholesterol guidelines, the issue of cost-effectiveness plays a role. This review covers the basic fundamentals of cost-effectiveness analysis and summarizes the key cost-effectiveness studies that relate to the new cholesterol guidelines.

Practical guidelines for feminist research in nursing.

PubMed

Im, Eun-Ok

2013-01-01

With increasing interests in oppressed groups, the number of feminist studies in nursing has steadily increased. Despite the increasing number of feminist studies, very few articles have been written to provide practical guidelines for feminist research in nursing. In this article, guidelines for feminist research in nursing are proposed on the basis of 3 previous feminist studies. First, characteristics of feminist research are concisely described. Then, the 3 studies that are the basis for the guidelines are described. Finally, practical guidelines for feminist nursing research are proposed on the basis of 10 idea categories related to issues/concerns from the 3 studies.

Critical analysis of the Council for International Organizations of Medical Sciences 2016 International Guidelines for health-related research involving humans.

PubMed

Kottow Lang, Miguel Hugo

2017-05-15

This paper presents a preliminary discussion of the Council for International Organizations of Medical Sciences (CIOMS), recently issued “International Ethical Guidelines for Health-related Research Involving Humans” (2016) that acknowledges the document’s declared concern of the protection of human subjects and awareness of their needs and interests in “low-resource settings”. Nevertheless, guideline recommendations present exceptional situations –vulnerability, mental incompetence- wherein voluntary and consented participation may be reduced or omitted under three concurrent conditions: compelling scientific value, the need to include persons that will not benefit directly from participation, exposure to minimal or slight risks. CIOMS 2016 extends the range of issues than need deliberation and regulation, but it does not clarify controversial issues in research ethics. The indetermination of special situations that would allow incomplete or absent informed disclosure weakens rigorous ethical norms and opens up to slippery slopes of permissiveness that may be harmful to host-nations and participants of biomedical studies.

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

A critical appraisal of clinical practice guidelines for the treatment of lower-limb osteoarthritis

PubMed Central

Pencharz, James N; Grigoriadis, Elizabeth; Jansz, Gwenderlyn F; Bombardier, Claire

2002-01-01

Clinical practice guidelines are important tools to assist clinical decision-making. Recently, several guidelines addressing the management of osteoarthritis (OA) have been published. Clinicians treating patients with OA must ensure that these guidelines are developed with consistency and methodological rigour. We undertook a qualitative summary and critical appraisal of six medical treatment guidelines for the management of lower-limb OA published in the medical literature within the past 5 years. A review of these six guidelines revealed that each possesses strengths and weakness. While most described the scope and intended patient populations, the guidelines varied considerably in the rigour of their development, coverage of implementation issues, and disclosure of conflicts of interest. PMID:11879536

A stochastic approach to uncertainty quantification in residual moveout analysis

NASA Astrophysics Data System (ADS)

Johng-Ay, T.; Landa, E.; Dossou-Gbété, S.; Bordes, L.

2015-06-01

Oil and gas exploration and production relies usually on the interpretation of a single seismic image, which is obtained from observed data. However, the statistical nature of seismic data and the various approximations and assumptions are sources of uncertainties which may corrupt the evaluation of parameters. The quantification of these uncertainties is a major issue which supposes to help in decisions that have important social and commercial implications. The residual moveout analysis, which is an important step in seismic data processing is usually performed by a deterministic approach. In this paper we discuss a Bayesian approach to the uncertainty analysis.

Foreword: Biomonitoring Equivalents special issue.

PubMed

Meek, M E; Sonawane, B; Becker, R A

2008-08-01

The challenge of interpreting results of biomonitoring for environmental chemicals in humans is highlighted in this Foreword to the Biomonitoring Equivalents (BEs) special issue of Regulatory Toxicology and Pharmacology. There is a pressing need to develop risk-based tools in order to empower scientists and health professionals to interpret and communicate the significance of human biomonitoring data. The BE approach, which integrates dosimetry and risk assessment methods, represents an important advancement on the path toward achieving this objective. The articles in this issue, developed as a result of an expert panel meeting, present guidelines for derivation of BEs, guidelines for communication using BEs and several case studies illustrating application of the BE approach for specific substances.

Pediatric Sepsis Guidelines: Summary for resource-limited countries

PubMed Central

Khilnani, Praveen; Singhi, Sunit; Lodha, Rakesh; Santhanam, Indumathi; Sachdev, Anil; Chugh, Krishan; Jaishree, M.; Ranjit, Suchitra; Ramachandran, Bala; Ali, Uma; Udani, Soonu; Uttam, Rajiv; Deopujari, Satish

2010-01-01

Justification: Pediatric sepsis is a commonly encountered global issue. Existing guidelines for sepsis seem to be applicable to the developed countries, and only few articles are published regarding application of these guidelines in the developing countries, especially in resource-limited countries such as India and Africa. Process: An expert representative panel drawn from all over India, under aegis of Intensive Care Chapter of Indian Academy of Pediatrics (IAP) met to discuss and draw guidelines for clinical practice and feasibility of delivery of care in the early hours in pediatric patient with sepsis, keeping in view unique patient population and limited availability of equipment and resources. Discussion included issues such as sepsis definitions, rapid cardiopulmonary assessment, feasibility of early aggressive fluid therapy, inotropic support, corticosteriod therapy, early endotracheal intubation and use of positive end expiratory pressure/mechanical ventilation, initial empirical antibiotic therapy, glycemic control, and role of immunoglobulin, blood, and blood products. Objective: To achieve a reasonable evidence-based consensus on the basis of published literature and expert opinion to formulating clinical practice guidelines applicable to resource-limited countries such as India. Recommendations: Pediatric sepsis guidelines are presented in text and flow chart format keeping resource limitations in mind for countries such as India and Africa. Levels of evidence are indicated wherever applicable. It is anticipated that once the guidelines are used and outcomes data evaluated, further modifications will be necessary. It is planned to periodically review and revise these guidelines every 3–5 years as new body of evidence accumulates. PMID:20606908

Management of stable angina: A commentary on the European Society of Cardiology guidelines.

PubMed

Ambrosio, Giuseppe; Mugelli, Alessandro; Lopez-Sendón, José; Tamargo, Juan; Camm, John

2016-09-01

In 2013 the European Society of Cardiology (ESC) released new guidelines on the management of stable coronary artery disease. These guidelines update and replace the previous ESC guidelines on the management of stable angina pectoris, issued in 2006. There are several new aspects in the 2013 ESC guidelines compared with the 2006 version. This opinion paper provides an in-depth interpretation of the ESC guidelines with regard to these issues, to help physicians in making evidence-based therapeutic choices in their routine clinical practice. The first new element is the definition of stable coronary artery disease itself, which has now broadened from a 'simple' symptom, angina pectoris, to a more complex disease that can even be asymptomatic. In the first-line setting, the major changes in the new guidelines are the upgrading of calcium channel blockers, the distinction between dihydropyridines and non-dihydropyridine calcium channel blockers, and the presence of important statements regarding the combination of calcium channel blockers with beta-blockers. In the second-line setting, the 2013 ESC guidelines recommend the addition of long-acting nitrates, ivabradine, nicorandil or ranolazine to first-line agents. Trimetazidine may also be considered. However, no clear distinction is made among different second-line drugs, despite different quality of evidence in favour of these agents. For example, the use of ranolazine is supported by strong and recent evidence, while data supporting the use of the traditional agents appear relatively scanty. © The European Society of Cardiology 2016.

Phototoxicity of Selected Nanomaterials

EPA Science Inventory

Quantification of exposure to nanomaterials is critical for assessing their environmental hazard and risk. This is an immediate issue for nano-TiO2 because it is one of more common nanomaterials now in commerce, and is difficult to analyze using common acid-digestion techniques. ...

Evaluation of the performance of quantitative detection of the Listeria monocytogenes prfA locus with droplet digital PCR.

PubMed

Witte, Anna Kristina; Fister, Susanne; Mester, Patrick; Schoder, Dagmar; Rossmanith, Peter

2016-11-01

Fast and reliable pathogen detection is an important issue for human health. Since conventional microbiological methods are rather slow, there is growing interest in detection and quantification using molecular methods. The droplet digital polymerase chain reaction (ddPCR) is a relatively new PCR method for absolute and accurate quantification without external standards. Using the Listeria monocytogenes specific prfA assay, we focused on the questions of whether the assay was directly transferable to ddPCR and whether ddPCR was suitable for samples derived from heterogeneous matrices, such as foodstuffs that often included inhibitors and a non-target bacterial background flora. Although the prfA assay showed suboptimal cluster formation, use of ddPCR for quantification of L. monocytogenes from pure bacterial cultures, artificially contaminated cheese, and naturally contaminated foodstuff was satisfactory over a relatively broad dynamic range. Moreover, results demonstrated the outstanding detection limit of one copy. However, while poorer DNA quality, such as resulting from longer storage, can impair ddPCR, internal amplification control (IAC) of prfA by ddPCR, that is integrated in the genome of L. monocytogenes ΔprfA, showed even slightly better quantification over a broader dynamic range. Graphical Abstract Evaluating the absolute quantification potential of ddPCR targeting Listeria monocytogenes prfA.

Ethical issues of cost effectiveness analysis and guideline setting in mental health care.

PubMed

Berghmans, R; Berg, M; van den Burg, M; ter Meulen, R

2004-04-01

This article discusses ethical issues which are raised as a result of the introduction of economic evidence in mental health care in order to rationalise clinical practice. Cost effectiveness studies and guidelines based on such studies are often seen as impartial, neutral instruments which try to reduce the influence of non-scientific factors. However, such rationalising instruments often hide normative assumptions about the goals of treatment, the selection of treatments, the role of the patient, and the just distribution of scarce resources. These issues are dealt with in the context of increased control over clinical practice by third parties. In particular, health insurers have a great interest in economic evidence in clinical care settings in order to control access to and quality of (mental) health care. The authors conclude that guideline setting and cost effectiveness analysis may be seen as important instruments for making choices in health care, including mental health care, but that such an approach should always go hand in hand with a social and political debate about the goals of medicine and (mental) health care. This article is partly based on the results of a research project on the normative aspects of guideline setting in psychiatry and cardiology which was conducted under the guidance of the Royal Dutch Medical Association.

Strategic Planning for Deepening the All-Around Structural Reform of Education: Issues of Structural Reform in the "National Medium- and Long-Term Educational Reform and Development Guideline (2010-20)"

ERIC Educational Resources Information Center

Songhua, Tan; Wang, Catherine Yan

2012-01-01

The "National Medium- and Long-Term Educational Reform and Development Guideline (2010-20)" (hereafter abbreviated as the "Guideline") posits that the development of education must be driven by reform and innovation. It devotes six chapters to mapping out the targets, tasks, and major policy measures for reforming the…

A Study of Method Development, Validation, and Forced Degradation for Simultaneous Quantification of Paracetamol and Ibuprofen in Pharmaceutical Dosage Form by RP-HPLC Method

PubMed Central

Jahan, Md. Sarowar; Islam, Md. Jahirul; Begum, Rehana; Kayesh, Ruhul; Rahman, Asma

2014-01-01

A rapid and stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous quantification of paracetamol and ibuprofen in their combined dosage form especially to get some more advantages over other methods already developed for this combination. The method was validated according to United States Pharmacopeia (USP) guideline with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity, and system suitability. Forced degradation study was validated according to International Conference on Harmonisation (ICH). For this, an isocratic condition of mobile phase comprising phosphate buffer (pH 6.8) and acetonitrile in a ratio of 65:35, v/v at a flow rate of 0.7 mL/minute over RP C18 (octadecylsilane (ODS), 150 × 4.6 mm, 5 μm, Phenomenex Inc.) column at ambient temperature was maintained. The method showed excellent linear response with correlation coefficient (R2) values of 0.999 and 1.0 for paracetamol and ibuprofen respectively, which were within the limit of correlation coefficient (R2 > 0.995). The percent recoveries for two drugs were found within the acceptance limit of (97.0–103.0%). Intra-and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) ≤ 2.0. Forced degradation of the drug product was carried out as per the ICH guidelines with a view to establishing the stability-indicating property of this method and providing useful information about the degradation pathways, degradation products, and how the quality of a drug substance and drug product changes with time under the influence of various stressing conditions. The degradation of ibuprofen was within the limit (5–20%, according to the guideline of ICH), while paracetamol showed <20% degradation in oxidation and basic condition. PMID:25452691

A Study of Method Development, Validation, and Forced Degradation for Simultaneous Quantification of Paracetamol and Ibuprofen in Pharmaceutical Dosage Form by RP-HPLC Method.

PubMed

Jahan, Md Sarowar; Islam, Md Jahirul; Begum, Rehana; Kayesh, Ruhul; Rahman, Asma

2014-01-01

A rapid and stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous quantification of paracetamol and ibuprofen in their combined dosage form especially to get some more advantages over other methods already developed for this combination. The method was validated according to United States Pharmacopeia (USP) guideline with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity, and system suitability. Forced degradation study was validated according to International Conference on Harmonisation (ICH). For this, an isocratic condition of mobile phase comprising phosphate buffer (pH 6.8) and acetonitrile in a ratio of 65:35, v/v at a flow rate of 0.7 mL/minute over RP C18 (octadecylsilane (ODS), 150 × 4.6 mm, 5 μm, Phenomenex Inc.) column at ambient temperature was maintained. The method showed excellent linear response with correlation coefficient (R (2)) values of 0.999 and 1.0 for paracetamol and ibuprofen respectively, which were within the limit of correlation coefficient (R (2) > 0.995). The percent recoveries for two drugs were found within the acceptance limit of (97.0-103.0%). Intra-and inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) ≤ 2.0. Forced degradation of the drug product was carried out as per the ICH guidelines with a view to establishing the stability-indicating property of this method and providing useful information about the degradation pathways, degradation products, and how the quality of a drug substance and drug product changes with time under the influence of various stressing conditions. The degradation of ibuprofen was within the limit (5-20%, according to the guideline of ICH), while paracetamol showed <20% degradation in oxidation and basic condition.

An interagency space nuclear propulsion safety policy for SEI - Issues and discussion

NASA Technical Reports Server (NTRS)

Marshall, A. C.; Sawyer, J. C., Jr.

1991-01-01

An interagency Nuclear Safety Policy Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative nuclear propulsion program to facilitate the implementation of mission planning and conceptual design studies. The NSPWG developed a top level policy to provide the guiding principles for the development and implementation of the nuclear propulsion safety program and the development of Safety Functional Requirements. In addition, the NSPWG reviewed safety issues for nuclear propulsion and recommended top level safety requirements and guidelines to address these issues. Safety topics include reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations. In this paper the emphasis is placed on the safety policy and the issues and considerations that are addressed by the NSPWG recommendations.

Quantification of metronidazole in human plasma using a highly sensitive and rugged LC-MS/MS method for a bioequivalence study.

PubMed

Vanol, Pravin G; Sanyal, Mallika; Shah, Priyanka A; Shrivastav, Pranav S

2018-03-23

A highly sensitive, selective and rugged method has been described for the quantification of metronidazole (MTZ) in human plasma by liquid chromatography-tandem mass spectrometry using metronidazole-d4 as the internal standard (IS). The analyte and the IS were extracted from 100 μL plasma by liquid-liquid extraction. The clear samples obtained were chromatographed on an ACE C 18 (100 × 4.6 mm, 5 μm) column using acetonitrile and 10.0 mm ammonium formate in water, pH 4.00 (80:20, v/v) as the mobile phase. A triple quadrupole mass spectrometer system equipped with turbo ion spray source and operated in multiple reaction monitoring mode was used for the detection and quantification of MTZ. The calibration range was established from 0.01 to 10.0 μg/mL. The results of validation testing for precision and accuracy, selectivity, matrix effects, recovery and stability complied with current bioanalytical guidelines. A run time of 3.0 min permitted analysis of more than 300 samples in a day. The method was applied to a bioequivalence study with 250 mg MTZ tablet formulation in 24 healthy Indian males. Copyright © 2018 John Wiley & Sons, Ltd.

Development of an on-line solid phase extraction ultra-high-performance liquid chromatography technique coupled to tandem mass spectrometry for quantification of bisphenol S and bisphenol S glucuronide: Applicability to toxicokinetic investigations.

PubMed

Grandin, Flore; Picard-Hagen, Nicole; Gayrard, Véronique; Puel, Sylvie; Viguié, Catherine; Toutain, Pierre-Louis; Debrauwer, Laurent; Lacroix, Marlène Z

2017-12-01

Regulatory measures and public concerns regarding bisphenol A (BPA) have led to its replacement by structural analogues, such as Bisphenol S (BPS), in consumer products. At present, no toxicokinetic investigations have been conducted to assess the factors determining human internal exposure to BPS for subsequent risk assessment. Toxicokinetic studies require reliable analytical methods to measure the plasma concentrations of BPS and its main conjugated metabolite, BPS-glucuronide (BPS-G). An efficient on-line SPE-UPLC-MS/MS method for the simultaneous quantification of BPS and BPS-G in ovine plasma was therefore developed and validated in accordance with the European Medicines Agency guidelines for bioanalytical method validation. This method has a limit of quantification of 3ngmL -1 for BPS and 10ngmL -1 for BPS-G, an analytical capacity of 200 samples per day, and is particularly well suited to toxicokinetic studies. Use of this method in toxicokinetic studies in sheep showed that BPS, like BPA, is efficiently metabolized into its glucuronide form. However, the clearances and distributions of BPS and BPS-G were lower than those of the corresponding unconjugated and glucuroconjugated forms of BPA. Copyright © 2017 Elsevier B.V. All rights reserved.

Ultra-sensitive LC-MS/MS method for the quantification of gemcitabine and its metabolite 2',2'-difluorodeoxyuridine in human plasma for a microdose clinical trial.

PubMed

van Nuland, M; Hillebrand, M J X; Rosing, H; Burgers, J A; Schellens, J H M; Beijnen, J H

2018-03-20

In microdose clinical trials a maximum of 100 μg of drug substance is administered to participants, in order to determine the pharmacokinetic properties of the agents. Measuring low plasma concentrations after administration of a microdose is challenging and requires the use of ulta-sensitive equipment. Novel liquid chromatography-mass spectrometry (LC-MS/MS) platforms can be used for quantification of low drug plasma levels. Here we describe the development and validation of an LC-MS/MS method for quantification of gemcitabine and its metabolite 2',2'-difluorodeoxyuridine (dFdU) in the low picogram per milliliter range to support a microdose trial. The validated assay ranges from 2.5-500 pg/mL for gemcitabine and 250-50,000 pg/mL for dFdU were linear, with a correlation coefficient (r 2 ) of 0.996 or better. Sample preparation with solid phase extraction provided a good and reproducible recovery. All results were within the acceptance criteria of the latest US FDA guidance and EMA guidelines. In addition, the method was successfully applied to measure plasma concentrations of gemcitabine in a patient after administration of a microdose of gemcitabine. Copyright © 2017 Elsevier B.V. All rights reserved.

An Improved LC-ESI-MS/MS Method to Quantify Pregabalin in Human Plasma and Dry Plasma Spot for Therapeutic Monitoring and Pharmacokinetic Applications.

PubMed

Dwivedi, Jaya; Namdev, Kuldeep K; Chilkoti, Deepak C; Verma, Surajpal; Sharma, Swapnil

2018-06-06

Therapeutic drug monitoring (TDM) of anti-epileptic drugs provides a valid clinical tool in optimization of overall therapy. However, TDM is challenging due to the high biological samples (plasma/blood) storage/shipment costs and the limited availability of laboratories providing TDM services. Sampling in the form of dry plasma spot (DPS) or dry blood spot (DBS) is a suitable alternative to overcome these issues. An improved, simple, rapid, and stability indicating method for quantification of pregabalin in human plasma and DPS has been developed and validated. Analyses were performed on liquid chromatography tandem mass spectrometer under positive ionization mode of electrospray interface. Pregabain-d4 was used as internal standard, and the chromatographic separations were performed on Poroshell 120 EC-C18 column using an isocratic mobile phase flow rate of 1 mL/min. Stability of pregabalin in DPS was evaluated under simulated real-time conditions. Extraction procedures from plasma and DPS samples were compared using statistical tests. The method was validated considering the FDA method validation guideline. The method was linear over the concentration range of 20-16000 ng/mL and 100-10000 ng/mL in plasma and DPS, respectively. DPS samples were found stable for only one week upon storage at room temperature and for at least four weeks at freezing temperature (-20 ± 5 °C). Method was applied for quantification of pregabalin in over 600 samples of a clinical study. Statistical analyses revealed that two extraction procedures in plasma and DPS samples showed statistically insignificant difference and can be used interchangeably without any bias. Proposed method involves simple and rapid steps of sample processing that do not require a pre- or post-column derivatization procedure. The method is suitable for routine pharmacokinetic analysis and therapeutic monitoring of pregabalin.

Development of a fast and simple gas chromatographic protocol based on the combined use of alkyl chloroformate and solid phase microextraction for the assay of polyamines in human urine.

PubMed

Naccarato, Attilio; Elliani, Rosangela; Cavaliere, Brunella; Sindona, Giovanni; Tagarelli, Antonio

2018-05-11

Polyamines are aliphatic amines with low molecular weight that are widely recognized as one of the most important cancer biomarkers for early diagnosis and treatment. The goal of the work herein presented is the development of a rapid and simple method for the quantification of free polyamines (i.e., putrescine, cadaverine, spermidine, spermine) and N-monoacetylated polyamines (i.e., N 1 -Acetylspermidine, N 8 -Acetylspermidine, and N 1 -Acetylspermine) in human urine. A preliminary derivatization with propyl chloroformate combined with the use of solid phase microextraction (SPME) allowed for an easy and automatable protocol involving minimal sample handling and no consumption of organic solvents. The affinity of the analytes toward five commercial SPME coatings was evaluated in univariate mode, and the best result in terms of analyte extraction was achieved using the divinylbenzene/carboxen/polydimethylsiloxane fiber. The variables affecting the performance of SPME analysis were optimized by the multivariate approach of experimental design and, in particular, using a central composite design (CCD). The optimal working conditions in terms of response values are the following: extraction temperature 40 °C, extraction time of 15 min and no addition of NaCl. Analyses were carried out by gas chromatography-triple quadrupole mass spectrometry (GC-QqQ-MS) in selected reaction monitoring (SRM) acquisition mode. The developed method was validated according to the guidelines issued by the Food and Drug Administration (FDA). The satisfactory performances reached in terms of linearity, sensitivity (LOQs between 0.01 and 0.1 μg/mL), matrix effect (68-121%), accuracy, and precision (inter-day values between -24% and +16% and in the range 3.3-28.4%, respectively) make the proposed protocol suitable to be adopted for quantification of these important biomarkers in urine samples. Copyright © 2018 Elsevier B.V. All rights reserved.

Computerization of guidelines: towards a "guideline markup language".

PubMed

Dart, T; Xu, Y; Chatellier, G; Degoulet, P

2001-01-01

Medical decision making is one of the most difficult daily tasks for physicians. Guidelines have been designed to reduce variance between physicians in daily practice, to improve patient outcomes and to control costs. In fact, few physicians use guidelines in daily practice. A way to ease the use of guidelines is to implement computerised guidelines (computer reminders). We present in this paper a method of computerising guidelines. Our objectives were: 1) to propose a generic model that can be instantiated for any specific guidelines; 2) to use eXtensible Markup Language (XML) as a guideline representation language to instantiate the generic model for a specific guideline. Our model is an object representation of a clinical algorithm, it has been validated by running two different guidelines issued by a French official Agency. In spite of some limitations, we found that this model is expressive enough to represent complex guidelines devoted to diabetes and hypertension management. We conclude that XML can be used as a description format to structure guidelines and as an interface between paper-based guidelines and computer applications.

Considerations in the Derivation of Water Quality Criteria for Endocrine-disrupting Chemicals

EPA Science Inventory

When the USEPA’s 1985 guidelines for deriving numerical water quality criteria (WQC) for the protection of aquatic life were developed there was little anticipation that endocrine-disrupting chemicals (EDCs) would be come a widespread environmental issue. While the basic guidelin...

Curriculum Planning Guidelines for Tobacco Use Prevention and Education.

ERIC Educational Resources Information Center

Montana State Office of Public Instruction, Helena.

This curriculum planning guide is designed to help Montana school districts design an appropriate tobacco use prevention and education program. It focuses on: "Tobacco Use Prevention Education: The OPI (Office of Public Instruction) Perspective"; "Instructional Guidelines" (key issues in program planning and major health…

Curricular Guidelines for Pharmacy Education: Substance Abuse and Addictive Disease.

ERIC Educational Resources Information Center

Baldwin, Jeffrey N.; And Others

1991-01-01

American Association of Colleges of Pharmacy guidelines for required and elective instructional content concerning substance abuse for pharmacy students is presented. Recommended required content includes psychosocial aspects of drug use; pharmacology and toxicology; identification, intervention, and treatment of addiction; and legal issues.…

78 FR 39649 - Passenger Vessels Accessibility Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

... ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD 36 CFR Part 1196 [Docket No. ATBCB-2013-0003] RIN 3014-AA11 Passenger Vessels Accessibility Guidelines Correction In proposed rule document 2013-14367, appearing on pages 38102- 38159 in the issue of Tuesday, June 25, 2013, make the following...

Practical Design Guidelines of qZSI Based Step-Up DC/DC Converter

NASA Astrophysics Data System (ADS)

Zakis, Janis; Vinnikov, Dmitri; Roasto, Indrek; Jalakas, Tanel

2010-01-01

This paper presents some design guidelines for a new voltage fed step-up DC/DC isolated converter. The most significant advantage of proposed converter is voltage buck-boost operation on single stage. The most promising application for proposed converter is in the field of distributed power generation e.g. fuel cells or photovoltaic. The most sensitive issues - such as power losses caused by high currents in the input side of converter and high transient overvoltages across the inverter bridge caused by stray inductances were discussed and solved. The proposals and recommendations to overcome these issues are given in the paper. The Selection and design guidelines of converter elements are proposed and explained. The prototype of proposed converter was built and experimentally tested. Some results are presented and evaluated.

Sector-specific issues and reporting methodologies supporting the General Guidelines for the voluntary reporting of greenhouse gases under Section 1605(b) of the Energy Policy Act of 1992. Volume 2: Part 4, Transportation sector; Part 5, Forestry sector; Part 6, Agricultural sector

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

Not Available

This volume, the second of two such volumes, contains sector-specific guidance in support of the General Guidelines for the voluntary reporting of greenhouse gas emissions and carbon sequestration. This voluntary reporting program was authorized by Congress in Section 1605(b) of the Energy Policy Act of 1992. The General Guidelines, bound separately from this volume, provide the overall rationale for the program, discuss in general how to analyze emissions and emission reduction/carbon sequestration projects, and address programmatic issues such as minimum reporting requirements, time parameters, international projects, confidentiality, and certification. Together, the General Guidelines and the guidance in these supporting documentsmore » will provide concepts and approaches needed to prepare the reporting forms. This second volume of sector-specific guidance covers the transportation sector, the forestry sector, and the agricultural sector.« less

Scientific Reporting: Raising the Standards.

PubMed

McLeroy, Kenneth R; Garney, Whitney; Mayo-Wilson, Evan; Grant, Sean

2016-10-01

This article is based on a presentation that was made at the 2014 annual meeting of the editorial board of Health Education & Behavior. The article addresses critical issues related to standards of scientific reporting in journals, including concerns about external and internal validity and reporting bias. It reviews current reporting guidelines, effects of adopting guidelines, and offers suggestions for improving reporting. The evidence about the effects of guideline adoption and implementation is briefly reviewed. Recommendations for adoption and implementation of appropriate guidelines, including considerations for journals, are provided. © 2016 Society for Public Health Education.

Periodontics and the new CDC guidelines.

PubMed

Basquill, Linda C; Basquill, Patrick J

2004-07-01

On December 19, 2003, the Centers for Disease Control and Prevention released the Guidelines for Infection Control in Dental Health-Care Settings--2003. The publication was the first comprehensive dental infection control update since 1993. Although the guidelines are not directed toward a particular dental specialty, some recommendations may have a significant impact on the practice of periodontics because of the nature of the procedures that are considered routine to the specialty. This article deals with some of the issues addressed in the guidelines, highlighting topics of special interest to periodontists.

Introduction to resuscitation of the newborn infant. ARC and NZRC Guideline 2010.

PubMed

2011-08-01

• Introduction to Resuscitation of the Newborn Infant. ARC and NZRC Guideline 2010 • Planning for Neonatal Resuscitation and Identification of the Newborn Infant at Risk. ARC and NZRC Guideline 2010 • Assessment of the Newborn Infant. ARC and NZRC Guideline 2010 • Airway Management and Mask Ventilation of the Newborn Infant. ARC and NZRC Guideline 2010 • Tracheal Intubation and Ventilation of the Newborn Infant. ARC and NZRC Guideline 2010 • Chest Compressions during Resuscitation of the Newborn Infant. ARC and NZRC Guideline 2010 • Medication or Fluids for the Resuscitation of the Newborn Infant. ARC and NZRC Guideline 2010 • The Resuscitation of the Newborn Infant in Special Circumstances. ARC and NZRC Guideline 2010 • After the Resuscitation of a Newborn Infant. ARC and NZRC Guideline 2010 • Ethical Issues in Resuscitation of the Newborn Infant. ARC and NZRC Guideline 2010. © 2011 The Authors. EMA © 2011 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

Manual on the proper use of lutetium-177-labeled somatostatin analogue (Lu-177-DOTA-TATE) injectable in radionuclide therapy (2nd ed.).

PubMed

Hosono, Makoto; Ikebuchi, Hideharu; Nakamura, Yoshihide; Nakamura, Nobutaka; Yamada, Takahiro; Yanagida, Sachiko; Kitaoka, Asami; Kojima, Kiyotaka; Sugano, Hiroyasu; Kinuya, Seigo; Inoue, Tomio; Hatazawa, Jun

2018-04-01

Here we present the guideline for the treatment of neuroendocrine tumors using Lu-177-DOTA-TATE on the basis of radiation safety aspects in Japan. This guideline was prepared by a study supported by Ministry of Health, Labour, and Welfare, and approved by Japanese Society of Nuclear Medicine. Lu-177-DOTA-TATE treatment in Japan should be carried out according to this guideline. Although this guideline is applied in Japan, the issues for radiation protection shown in this guideline are considered internationally useful as well. Only the original Japanese version is the formal document.

The current situation regarding the establishment of national ethical guidelines for biomedical research in Thailand and its neighboring countries.

PubMed

Kojima, Somei; Waikagul, Jitra; Rojekittikhun, Wichit; Keicho, Naoto

2005-05-01

This study discusses the establishment of ethical guidelines for ethical review for biomedical research performed in Thailand, and to some extent, in neighboring countries. There are differences, from country to country, at national and institutional levels regarding guidelines for ethical review committees. Only a handbook issued by Mahidol University describes guidelines for human genetic research and on research dealing with reproductive technology. Both these areas require special consideration to avoid violating human dignity, rights, and confidentiality. This indicates that further efforts should be made to establish research guidelines and/or principles dealing with the human genome.

Microvolume protein concentration determination using the NanoDrop 2000c spectrophotometer.

PubMed

Desjardins, Philippe; Hansen, Joel B; Allen, Michael

2009-11-04

Traditional spectrophotometry requires placing samples into cuvettes or capillaries. This is often impractical due to the limited sample volumes often used for protein analysis. The Thermo Scientific NanoDrop 2000c Spectrophotometer solves this issue with an innovative sample retention system that holds microvolume samples between two measurement surfaces using the surface tension properties of liquids, enabling the quantification of samples in volumes as low as 0.5-2 microL. The elimination of cuvettes or capillaries allows real time changes in path length, which reduces the measurement time while greatly increasing the dynamic range of protein concentrations that can be measured. The need for dilutions is also eliminated, and preparations for sample quantification are relatively easy as the measurement surfaces can be simply wiped with laboratory wipe. This video article presents modifications to traditional protein concentration determination methods for quantification of microvolume amounts of protein using A280 absorbance readings or the BCA colorimetric assay.

Unresolved Technical Issues in Fair Interest Measurement.

ERIC Educational Resources Information Center

Cole, Nancy S.

The problem of sex differences in interest measurement involves many technical issues and procedures. The purpose of this paper is to provide a description of the technical problems involved in construction, scoring, and interpretation of interest measures as related to sex differences and to suggest guidelines within these technical issues which…

[European community guidelines and standards in indoor air quality: what proposals for Italy].

PubMed

Settimo, Gaetano; D'Alessandro, Daniela

2014-01-01

Indoor air quality is an issue on which to focus because of the increasing number of exposed population and in view of the strong public feeling on this issue. This paper reports the rules of EU and several European countries about indoor air quality, focusing on the initiatives performed in Italy to respond to WHO recommendations. Several EU countries have introduced in their legislation rules relating to indoor air quality. At the moment, in Italy, a reference rule has not been issued. For this reason, up to date main informations concerning some guidelines or reference values in indoor air, to be used for a first comparison, are those obtained by the scientific literature, or by the guidelines issued by other European countries or, for analogy, by other standard values such as limit or reference values regarding outdoor air. Even the EU, while reaffirming the priority of energy efficiency measures, recommends healthier indoor environments and the development of a specific European strategy on the issue of indoor air quality. The National Study Group on indoor pollution of the Italian National Health Institute (ISS), is working for the development of shared technical and scientific documents, in order to provide greater uniformity of actions at national level, waiting for a legal framework for indoor air quality, in the light of the indication already produced by the WHO.

High-Throughput HPLC-MS/MS Method for Quantification of Ibuprofen Enantiomers in Human Plasma: Focus on Investigation of Metabolite Interference.

PubMed

Nakov, Natalija; Bogdanovska, Liljana; Acevska, Jelena; Tonic-Ribarska, Jasmina; Petkovska, Rumenka; Dimitrovska, Aneta; Kasabova, Lilia; Svinarov, Dobrin

2016-11-01

In this research, as a part of the development of fast and reliable HPLC-MS/MS method for quantification of ibuprofen (IBP) enantiomers in human plasma, the possibility of IBP acylglucoronide (IBP-Glu) back-conversion was assessed. This involved investigation of in source and in vitro back-conversion. The separation of IBP enantiomers, its metabolite and rac-IBP-d3 (internal standard), was achieved within 6 min using Chiracel OJ-RH chromatographic column (150 × 2.1 mm, 5 μm). The followed selected reaction monitoring transitions for IBP-Glu (m/z 381.4 → 205.4, m/z 381.4 → 161.4 and m/z 205.4 → 161.4) implied that under the optimized electrospray ionization parameters, in source back-conversion of IBP-Glu was insignificant. The results obtained after liquid-liquid extraction of plasma samples spiked with IBP-Glu revealed that the amount of IBP enantiomers generated by IBP-Glu back-conversion was far <20% of lower limit of quantification sample. These results indicate that the presence of IBP-Glu in real samples will not affect the quantification of the IBP enantiomers; thereby reliability of the method was improved. Additional advantage of the method is the short analysis time making it suitable for the large number of samples. The method was fully validated according to the EMA guideline and was shown to meet all requirements to be applied in a pharmacokinetic study. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Oral History: Playing by the Rules.

ERIC Educational Resources Information Center

Oshinsky, David M.

1990-01-01

Describes oral history interviewing techniques that the author used to research his biography of Joseph McCarthy before the American Historical Association (AHA) issued its seven guidelines on interview use. These guidelines focus on taping sessions, signed releases, written transcripts, respecting human dignity, and placing materials in archive…

Guideline for Optical Character Recognition Forms.

ERIC Educational Resources Information Center

National Bureau of Standards (DOC), Washington, DC.

This publication provides materials relating to the design, preparation, acquisition, inspection, and application of Optical Character Recognition (OCR) forms in data entry systems. Since the materials are advisory and tutorial in nature, this publication has been issued as a guideline rather than as a standard in the Federal Information…

Life in a Regulated Environment: Do You Comply with Environmental Laws?

ERIC Educational Resources Information Center

McKeague, Kevin J.

1994-01-01

Discusses the following issues: (1) implications of the Americans with Disabilities Act; (2) Asbestos Hazard Emergency Response Act regulations; (3) new lead guidelines; (4) requirements regarding underground storage tanks; (5) potential indoor air quality requirements; and (6) Occupational Safety and Health Administration guidelines. (MLF)

Guidelines for Child Custody Evaluations in Family Law Proceedings

ERIC Educational Resources Information Center

American Psychologist, 2010

2010-01-01

Family law proceedings encompass a broad range of issues, including custody, maintenance, support, valuation, visitation, relocation, and termination of parental rights. The following guidelines address what are commonly termed child custody evaluations, involving disputes over decision making, caretaking, and access in the wake of marital or…

Financing Continuing Education in Mental Health.

ERIC Educational Resources Information Center

Southern Regional Education Board, Atlanta, GA.

Based on a study of the component parts of the mental health continuing education system, this publication presents guidelines for the following fiscal functions: determining funding needs, obtaining funds, budgeting funds, expending funds, and cost accounting. In addition to considering these components, the guidelines explore principal issues in…

78 FR 16783 - Approval and Promulgation of Implementation Plans; Georgia; Control Techniques Guidelines and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-19

... Promulgation of Implementation Plans; Georgia; Control Techniques Guidelines and Reasonably Available Control...), related to reasonably available control technology (RACT) requirements. This correcting amendment corrects... October 21, 2009, SIP submittal for certain source categories for which EPA has issued control technique...

Planning for Accessibility.

ERIC Educational Resources Information Center

Spoor, Dana L.

1997-01-01

Argues that barrier-free designs should be incorporated in the first steps of school facility planning to avoid the difficulties in meeting Americans with Disabilities Act (ADA) guidelines during renovations. Explains why not all barriers need be removed to make a facility accessible to everyone. Discusses issues involving ADA guidelines and child…

The development of clinical practice guidelines and guidance statements of the American College of Physicians: summary of methods.

PubMed

Qaseem, Amir; Snow, Vincenza; Owens, Douglas K; Shekelle, Paul

2010-08-03

The American College of Physicians (ACP) established its evidence-based clinical practice guidelines program in 1981. The ACP's Guidelines Committee and the staff of the Clinical Programs and Quality of Care Department develop the clinical recommendations. The ACP develops 2 different types of clinical recommendations: clinical practice guidelines and clinical guidance statements. The ACP clinical practice guidelines and guidance statements follow a multistep development process that includes a systematic review of the evidence, deliberation of the evidence by the committee, summary recommendations, and evidence and recommendation grading. All ACP clinical practice guidelines and clinical guidance statements, if not updated, are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.

Learning, techniques, and complications of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Guideline.

PubMed

Polkowski, M; Larghi, A; Weynand, B; Boustière, C; Giovannini, M; Pujol, B; Dumonceau, J-M

2012-02-01

This article is the second of a two-part publication that expresses the current view of the European Society of Gastrointestinal Endoscopy (ESGE) about endoscopic ultrasound (EUS)-guided sampling, including EUS-guided fine needle aspiration (EUS-FNA) and EUS-guided Trucut biopsy. The first part (the Clinical Guideline) focused on the results obtained with EUS-guided sampling, and the role of this technique in patient management, and made recommendations on circumstances that warrant its use. The current Technical Guideline discusses issues related to learning, techniques, and complications of EUS-guided sampling, and to processing of specimens. Technical issues related to maximizing the diagnostic yield (e.g., rapid on-site cytopathological evaluation, needle diameter, microcore isolation for histopathological examination, and adequate number of needle passes) are discussed and recommendations are made for various settings, including solid and cystic pancreatic lesions, submucosal tumors, and lymph nodes. The target readership for the Clinical Guideline mostly includes gastroenterologists, oncologists, internists, and surgeons while the Technical Guideline should be most useful to endoscopists who perform EUS-guided sampling. A two-page executive summary of evidence statements and recommendations is provided. © Georg Thieme Verlag KG Stuttgart · New York.

[The Nutritional Care Experience of a Post-Operative Periampullary Cancer Patient With Cachexia].

PubMed

Liou, Yan-Ting; Chiang, Pin-Yi; Shun, Shiow-Ching

2016-04-01

Cachexia is one of the most widely overlooked of the syndromes that are experienced by cancer patients. This syndrome is especially prevalent among patients with gastroenterology tract cancer. Although the National Comprehensive Cancer Network (NCCN) issued palliative-care practice guidelines for cachexia in 2015, guidelines have yet to be issued for the clinical setting. The authors reviewed the literature and applied their clinical experience to create an approach for identifying the degree of cachexia in a post-operative patient with periampullary cancer. This approach assesses the nutritional status, physical status, laboratory results, and gastrointestinal system functions of the patient using the Cachexia Assessment Scale (CAS) and NCCN Practice Guidelines for Cachexia. The patient improved under nursing care with an increase in nutritional intake and physical activity facilitating their process of post-surgical physical recovery. The authors hope that this experience using the combined CAS-NCCN Practice Guidelines will help clinical caregivers better understand how to apply the relevant guidelines in clinical settings. The developed approach may help nurses assess the comprehensive nutrition status of patients and related factors in order to provide interventions that will decrease the progression of cachexia effectively and promote quality of life.

Mental health and psychosocial support in crisis and conflict: report of the Mental Health Working Group.

PubMed

Allden, K; Jones, L; Weissbecker, I; Wessells, M; Bolton, P; Betancourt, T S; Hijazi, Z; Galappatti, A; Yamout, R; Patel, P; Sumathipala, A

2009-01-01

The Working Group on Mental Health and Psychosocial Support was convened as part of the 2009 Harvard Humanitarian Action Summit. The Working Group chose to focus on ethical issues in mental health and psychosocial research and programming in humanitarian settings. The Working Group built on previous work and recommendations, such as the Inter-Agency Standing Committee's Guidelines on Mental Health and Psychosocial Support in Emergency Settings. The objective of this working group was to address one of the factors contributing to the deficiency of research and the need to develop the evidence base on mental health and psychosocial support interventions during complex emergencies by proposing ethical research guidelines. Outcomes research is vital for effective program development in emergency settings, but to date, no comprehensive ethical guidelines exist for guiding such research efforts. Working Group members conducted literature reviews which included peer-reviewed publications, agency reports, and relevant guidelines on the following topics: general ethical principles in research, cross-cultural issues, research in resource-poor countries, and specific populations such as trauma and torture survivors, refugees, minorities, children and youth, and the mentally ill. Working Group members also shared key points regarding ethical issues encountered in their own research and fieldwork. The group adapted a broad definition of the term "research", which encompasses needs assessments and data gathering, as well as monitoring and evaluation. The guidelines are conceptualized as applying to formal and informal processes of assessment and evaluation in which researchers as well as most service providers engage. The group reached consensus that it would be unethical not to conduct research and evaluate outcomes of mental health and psychosocial interventions in emergency settings, given that there currently is very little good evidence base for such interventions. Overarching themes and issues generated by the group for further study and articulation included: purpose and benefits of research, issues of validity, neutrality, risk, subject selection and participation, confidentiality, consent, and dissemination of results. The group outlined several key topics and recommendations that address ethical issues in conducting mental health and psychosocial research in humanitarian settings. The group views this set of recommendations as a living document to be further developed and refined based on input from colleagues representing different regions of the globe with an emphasis on input from colleagues from low-resource countries.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

PubMed

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2016-01-01

When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review

PubMed Central

Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

2016-01-01

Background When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. Aim To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. Method A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. Results The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. Conclusions The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure. PMID:26938863

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY PROTOCOL FOR STANDARDIZED PRODUCTION OF CLINICAL PRACTICE GUIDELINES, ALGORITHMS, AND CHECKLISTS - 2017 UPDATE.

PubMed

Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Camacho, Pauline; Correa, Ricardo; Figaro, M Kathleen; Garber, Jeffrey R; Jasim, Sina; Pantalone, Kevin M; Trence, Dace; Upala, Sikarin

2017-08-01

Clinical practice guideline (CPG), clinical practice algorithm (CPA), and clinical checklist (CC, collectively CPGAC) development is a high priority of the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE). This 2017 update in CPG development consists of (1) a paradigm change wherein first, environmental scans identify important clinical issues and needs, second, CPA construction focuses on these clinical issues and needs, and third, CPG provide CPA node/edge-specific scientific substantiation and appended CC; (2) inclusion of new technical semantic and numerical descriptors for evidence types, subjective factors, and qualifiers; and (3) incorporation of patient-centered care components such as economics and transcultural adaptations, as well as implementation, validation, and evaluation strategies. This third point highlights the dominating factors of personal finances, governmental influences, and third-party payer dictates on CPGAC implementation, which ultimately impact CPGAC development. The AACE/ACE guidelines for the CPGAC program is a successful and ongoing iterative exercise to optimize endocrine care in a changing and challenging healthcare environment. AACE = American Association of Clinical Endocrinologists ACC = American College of Cardiology ACE = American College of Endocrinology ASeRT = ACE Scientific Referencing Team BEL = best evidence level CC = clinical checklist CPA = clinical practice algorithm CPG = clinical practice guideline CPGAC = clinical practice guideline, algorithm, and checklist EBM = evidence-based medicine EHR = electronic health record EL = evidence level G4GAC = Guidelines for Guidelines, Algorithms, and Checklists GAC = guidelines, algorithms, and checklists HCP = healthcare professional(s) POEMS = patient-oriented evidence that matters PRCT = prospective randomized controlled trial.

Installation Restoration Program. Phase 2. Confirmation/Quantification. Stage 1. Volume 1.

DTIC Science & Technology

1987-04-29

Dichlorobenzene 4000.0 U.S. EPA estimate of safe levels of toxicants in drinking water for human health effects (Federal Register. 28 November 1980). (2... Plastic bottle 40C 500 ml TOC Glass bottle 40 C; H 2 So4 to pHɚ 250 al Metals Plastic bottle HNO3 to pHɚ 500 ml Volatile organics Glass vial with 40C... safe levels of toxicants in drinking water for human health effects (Federal Register. 28 November 1980). 4-3 TABLE 4-2. REGULATORY GUIDELINES OR

Determination of boron in uranium aluminum silicon alloy by spectrophotometry and estimation of expanded uncertainty in measurement

NASA Astrophysics Data System (ADS)

Ramanjaneyulu, P. S.; Sayi, Y. S.; Ramakumar, K. L.

2008-08-01

Quantification of boron in diverse materials of relevance in nuclear technology is essential in view of its high thermal neutron absorption cross section. A simple and sensitive method has been developed for the determination of boron in uranium-aluminum-silicon alloy, based on leaching of boron with 6 M HCl and H 2O 2, its selective separation by solvent extraction with 2-ethyl hexane 1,3-diol and quantification by spectrophotometry using curcumin. The method has been evaluated by standard addition method and validated by inductively coupled plasma-atomic emission spectroscopy. Relative standard deviation and absolute detection limit of the method are 3.0% (at 1 σ level) and 12 ng, respectively. All possible sources of uncertainties in the methodology have been individually assessed, following the International Organization for Standardization guidelines. The combined uncertainty is calculated employing uncertainty propagation formulae. The expanded uncertainty in the measurement at 95% confidence level (coverage factor 2) is 8.840%.

QUANTIFICATION OF GLYCYRRHIZIN BIOMARKER IN GLYCYRRHIZA GLABRA RHIZOME AND BABY HERBAL FORMULATIONS BY VALIDATED RP-HPTLC METHODS

PubMed Central

Alam, Prawez; Foudah, Ahmed I.; Zaatout, Hala H.; T, Kamal Y; Abdel-Kader, Maged S.

2017-01-01

Background: A simple and sensitive thin-layer chromatographic method has been established for quantification of glycyrrhizin in Glycyrrhiza glabra rhizome and baby herbal formulations by validated Reverse Phase HPTLC method. Materials and Methods: RP-HPTLC Method was carried out using glass coated with RP-18 silica gel 60 F254S HPTLC plates using methanol-water (7: 3 v/v) as mobile phase. Results: The developed plate was scanned and quantified densitometrically at 256 nm. Glycyrrhizin peaks from Glycyrrhiza glabra rhizome and baby herbal formulations were identified by comparing their single spot at Rf = 0.63 ± 0.01. Linear regression analysis revealed a good linear relationship between peak area and amount of glycyrrhizin in the range of 2000-7000 ng/band. Conclusion: The method was validated, in accordance with ICH guidelines for precision, accuracy, and robustness. The proposed method will be useful to enumerate the therapeutic dose of glycyrrhizin in herbal formulations as well as in bulk drug. PMID:28573236

The development and validation of an UHPLC–MS/MS method for the rapid quantification of the antiretroviral agent dapivirine in human plasma

PubMed Central

Seserko, Lauren A; Emory, Joshua F; Hendrix, Craig W; Marzinke, Mark A

2014-01-01

Background Dapivirine is a non-nucleoside reverse transcriptase inhibitor designed to prevent HIV-1 viral replication and subsequent propagation. A sensitive method is required to quantify plasma concentrations to assess drug efficacy. Results Dapivirine-spiked plasma was combined with acetonitrile containing deuterated IS and was processed for analysis. The method has an analytical measuring range from 20 to 10,000 pg/ml. For the LLOQ, low, mid and high QCs, intra- and inter-assay precision (%CV) ranged from 5.58 to 13.89% and 5.23 to 13.36%, respectively, and intra- and inter-day accuracy (% deviation) ranged from -5.61 to 0.75% and -4.30 to 6.24%, respectively. Conclusion A robust and sensitive LC–MS/MS assay for the high-throughput quantification of the antiretroviral drug dapivirine in human plasma was developed and validated following bioanalytical validation guidelines. The assay meets criteria for the analysis of samples from large research trials. PMID:24256358

The development and validation of an UHPLC-MS/MS method for the rapid quantification of the antiretroviral agent dapivirine in human plasma.

PubMed

Seserko, Lauren A; Emory, Joshua F; Hendrix, Craig W; Marzinke, Mark A

2013-11-01

Dapivirine is a non-nucleoside reverse transcriptase inhibitor designed to prevent HIV-1 viral replication and subsequent propagation. A sensitive method is required to quantify plasma concentrations to assess drug efficacy. Dapivirine-spiked plasma was combined with acetonitrile containing deuterated IS and was processed for analysis. The method has an analytical measuring range from 20 to 10,000 pg/ml. For the LLOQ, low, mid and high QCs, intra- and inter-assay precision (%CV) ranged from 5.58 to 13.89% and 5.23 to 13.36%, respectively, and intra- and inter-day accuracy (% deviation) ranged from -5.61 to 0.75% and -4.30 to 6.24%, respectively. A robust and sensitive LC-MS/MS assay for the high-throughput quantification of the antiretroviral drug dapivirine in human plasma was developed and validated following bioanalytical validation guidelines. The assay meets criteria for the analysis of samples from large research trials.

Π4U: A high performance computing framework for Bayesian uncertainty quantification of complex models

NASA Astrophysics Data System (ADS)

Hadjidoukas, P. E.; Angelikopoulos, P.; Papadimitriou, C.; Koumoutsakos, P.

2015-03-01

We present Π4U, an extensible framework, for non-intrusive Bayesian Uncertainty Quantification and Propagation (UQ+P) of complex and computationally demanding physical models, that can exploit massively parallel computer architectures. The framework incorporates Laplace asymptotic approximations as well as stochastic algorithms, along with distributed numerical differentiation and task-based parallelism for heterogeneous clusters. Sampling is based on the Transitional Markov Chain Monte Carlo (TMCMC) algorithm and its variants. The optimization tasks associated with the asymptotic approximations are treated via the Covariance Matrix Adaptation Evolution Strategy (CMA-ES). A modified subset simulation method is used for posterior reliability measurements of rare events. The framework accommodates scheduling of multiple physical model evaluations based on an adaptive load balancing library and shows excellent scalability. In addition to the software framework, we also provide guidelines as to the applicability and efficiency of Bayesian tools when applied to computationally demanding physical models. Theoretical and computational developments are demonstrated with applications drawn from molecular dynamics, structural dynamics and granular flow.

Rapid method for the quantification of hydroquinone concentration: chemiluminescent analysis.

PubMed

Chen, Tung-Sheng; Liou, Show-Yih; Kuo, Wei-Wen; Wu, Hsi-Chin; Jong, Gwo-Ping; Wang, Hsueh-Fang; Shen, Chia-Yao; Padma, V Vijaya; Huang, Chih-Yang; Chang, Yen-Lin

2015-11-01

Topical hydroquinone serves as a skin whitener and is usually available in cosmetics or on prescription based on the hydroquinone concentration. Quantification of hydroquinone content therefore becomes an important issue in topical agents. High-performance liquid chromatography (HPLC) is the commonest method for determining hydroquinone content in topical agents, but this method is time-consuming and uses many solvents that can become an environmental issue. We report a rapid method for quantifying hydroquinone content by chemiluminescent analysis. Hydroquinone induces the production of hydrogen peroxide in the presence of basic compounds. Hydrogen peroxide induced by hydroquinone oxidized light-emitting materials such as lucigenin, resulted in the production of ultra-weak chemiluminescence that was detected by a chemiluminescence analyzer. The intensity of the chemiluminescence was found to be proportional to the hydroquinone concentration. We suggest that the rapid (measurement time, 60 s) and virtually solvent-free (solvent volume, <2 mL) chemiluminescent method described here for quantifying hydroquinone content may be an alternative to HPLC analysis. Copyright © 2015 John Wiley & Sons, Ltd.

Issues of human rabies immunoglobulin and vaccine: policy versus practice.

PubMed

Folb, Jonathan E; Cooke, Richard P D

2007-03-01

A retrospective audit was conducted of all issues of rabies vaccine or human rabies immunoglobulin (HRIG) from the Clinical Microbiology Department at University Hospital Aintree for post-exposure prophylaxis. The appropriateness of management was reviewed by a blinded panel, which used guidelines issued by the Health Protection Agency (HPA) as a standard. Thirty-six enquiries, on average 9 days following exposure, led to issues of HRIG, rabies vaccine or both. Dog bites accounted for the majority of incidents. In no cases was the biting animal recorded as having been observed for signs of rabies. Management was judged to have been inappropriate in 9 cases, and documentation was judged to have been unsatisfactory in 13 cases. This study has highlighted several areas of ambiguity in the current guidelines, and a number of deficiencies in the information prompted by the standardized proformas used to deal with post-exposure queries.

Addressing Authorship Issues Prospectively: A Heuristic Approach.

PubMed

Roberts, Laura Weiss

2017-02-01

Collaborative writing in academic medicine gives rise to more richly informed scholarship, and yet challenging ethical issues surrounding authorship are commonly encountered. International guidelines on authorship help clarify whether individuals who have contributed to a completed scholarly work have been correctly included as authors, but these guidelines do not facilitate intentional and proactive authorship planning or decisions regarding authorship order.In this Commentary, the author presents a heuristic approach to help collaborators clarify, anticipate, and resolve practical and ethically important authorship issues as they engage in the process of developing manuscripts. As this approach illustrates, assignment of authorship should balance work effort and professional responsibility, reflecting the effort and intellectual contribution and the public accountability of the individuals who participate in the work. Using a heuristic approach for managing authorship issues prospectively can foster an ethical, collaborative writing process in which individuals are properly recognized for their contributions.

Addressing the need for staff support among nurses caring for the AIDS population.

PubMed

Pasacreta, J V; Jacobsen, P B

1989-01-01

More and more nurses are caring for individuals with AIDS-spectrum disorders. When nurses become involved in hospital-based AIDS treatment, major psychosocial issues can arise. In settings where nursing personnel have limited or no experience working with patients with AIDS, fear of contagion is a major issue. This fear has both rational and irrational components. In general, providing up-to-date information in a small group setting can effectively reduce irrational fears. Rational fears, which are not as easily dealt with, should be a stimulus for behavior change (e.g., adoption of precautionary guidelines for reducing the possibility of accidental infection). Different issues arise among nurses specializing in AIDS care and include burnout, a sense of professional isolation, and the need to establish personal boundaries in dealing with patients. Guidelines are offered for establishing a group approach to address these concerns and to handle the sensitive issues that may arise.

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...

Guidelines for a Changing World

ERIC Educational Resources Information Center

Wood, Jo Nell; Brack, Karen

2011-01-01

This article investigates the issues surrounding teachers' use of social networking media and their First Amendment rights. It focuses on the need to develop a school district policy outlining specific guidelines for the use of technology and social networking. It also focuses on the changing world of technology and social networking as well as…

Equilibrium Partitioning: What's it Good for and How do you Know if it Works?

EPA Science Inventory

Much has been written about the use of equilibrium partitioning (EqP) as an approach for deriving sediment quality guidelines, and about whether guidelines so derived “work.” The purpose of this presentation is to discuss issues relevant to judging whether equilibrium partitioni...

Guidelines for the Development of Computerized Student Information Systems.

ERIC Educational Resources Information Center

Armes, Nancy, Ed.; And Others

Designed to provide guidelines for the development of computerized student information systems, this report raises policy issues and questions to be resolved at the campus level and describes a variety of computer-generated reports and records that can assist in educational decision making and planning. Introductory material discusses the…

Duty-to-Warn Guidelines for Mental Health Counselors.

ERIC Educational Resources Information Center

Costa, Luann; Altekruse, Michael

1994-01-01

Summarizes legal cases in which duty-to-warn was an issue. Suggests that guidelines for counselors are few and lack definition. Offers a model to guide counselors in making clinical judgments in cases and case examples to exemplify possible ethical dilemmas in the practice of counseling. Includes 36 citations. (Author/CRR)

IOM committee members respond to Endocrine Society vitamin D guideline

USDA-ARS?s Scientific Manuscript database

In early 2011, a committee convened by the Institute of Medicine issued a report on the Dietary Reference Intakes for calcium and vitamin D. The Endocrine Society Task Force in July 2011 published a guideline for the evaluation, treatment, and prevention of vitamin D deficiency. Although these repor...

Planning Guidelines for Primary Schools, Issue 1.

ERIC Educational Resources Information Center

Department of Education and Science, Tullamore (Ireland). Planning and Building Unit.

This planning guide, reflecting recent changes in the educational system in Ireland, offers guidelines for designing primary schools that need to provide additional space for the growing range of teaching and support services. It addresses increased sizes of general purpose rooms, extra floor area provision for classroom storage, administration,…

Guidelines, Criteria, and Rules of Thumb for Evaluating Normed and Standardized Assessment Instruments in Psychology.

ERIC Educational Resources Information Center

Cicchetti, Domenic V.

1994-01-01

In the context of developing assessment instruments in psychology, issues of standardization, norming procedures, and test reliability and validity are discussed. Criteria, guidelines, and rules of thumb are provided to help the clinician with instrument selection for a given psychological assessment. (SLD)

Guidelines for the Analysis of Responsibility in Governmental Communication.

ERIC Educational Resources Information Center

Gouran, Dennis S.

This paper discusses specific issues involving governmental conduct in communication with the public, outlines a set of conditions that frequently stimulate social interest in governmental responsibility, and develops a corresponding set of guidelines for use in the evaluation of instances of questionable governmental conduct in communication.…

A Rationale for Criterion-Referenced Proficiency Testing

ERIC Educational Resources Information Center

Clifford, Ray

2016-01-01

This article summarizes some of the technical issues that add to the complexity of language testing. It focuses in particular on the criterion-referenced nature of the ACTFL Proficiency Guidelines-Speaking; and it proposes a criterion-referenced interpretation of the ACTFL guidelines for reading and listening. It then demonstrates how using…

Library and Classroom Use of Copyrighted Videotapes and Computer Software.

ERIC Educational Resources Information Center

Reed, Mary Hutchings; Stanek, Debra

1986-01-01

This pullout guide addresses issues regarding library use of copyrighted videotapes and computer software. Guidelines for videotapes cover in-classroom use, in-library use in public library, loan, and duplication. Guidelines for computer software cover purchase conditions, avoiding license restrictions, loaning, archival copies, and in-library and…

Applying LD Documentation Guidelines at the Postsecondary Level: Decision Making with Sparse or Missing Data

ERIC Educational Resources Information Center

Banerjee, Manju; Madaus, Joseph W.; Gelbar, Nicholas

2015-01-01

A key issue in fostering transition to postsecondary education for students with disabilities is documentation verifying the nature of the disability and supporting the need for services and reasonable accommodations. Documentation guidelines assist postsecondary disability service providers in making decisions about eligibility and reasonable…

Guidelines for Nonsexist Use of Language

ERIC Educational Resources Information Center

School Counselor, 1976

1976-01-01

An APA task force, after critically analyzing graduate level psychology textbooks, found sex bias in the style of these books as well as in reporting more studies by males than by females. To avoid future bias, the task force has issued certain guidelines and principles which are listed in this article. (SE)

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-19

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

Best Practices for Mental Health in Child Welfare: Screening, Assessment, and Treatment Guidelines

ERIC Educational Resources Information Center

Romanelli, Lisa Hunter; Landsverk, John; Levitt, Jessica Mass; Leslie, Laurel K.; Hurley, Maia M.; Bellonci, Christopher; Gries, Leonard T.; Pecora, Peter J.; Jensen, Peter S.

2009-01-01

The Best Practices for Mental Health in Child Welfare Consensus Conference focused on developing guidelines in five key areas (screening and assessment, psychosocial interventions, psychopharmacologic treatment, parent engagement, and youth empowerment) related to children's mental health. This paper provides an overview of issues related to the…

Workshop on problem areas associated with developing carcinogen guidelines

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

Not Available

1984-06-01

A workshop was conducted to discuss problem areas associated with developing carcinogen guidelines. Session topics included (1) definition of a carcinogen for regulatory purposes; (2) potency; (3) risk assessment; (4) uncertainties; (5) de minimis quantity; and (6) legal and regulatory issues. Separate abstracts have been prepared for individual papers. (ACR)

Representation primitives, process models and patient data in computer-interpretable clinical practice guidelines: a literature review of guideline representation models.

PubMed

Wang, Dongwen; Peleg, Mor; Tu, Samson W; Boxwala, Aziz A; Greenes, Robert A; Patel, Vimla L; Shortliffe, Edward H

2002-12-18

Representation of clinical practice guidelines in a computer-interpretable format is a critical issue for guideline development, implementation, and evaluation. We studied 11 types of guideline representation models that can be used to encode guidelines in computer-interpretable formats. We have consistently found in all reviewed models that primitives for representation of actions and decisions are necessary components of a guideline representation model. Patient states and execution states are important concepts that closely relate to each other. Scheduling constraints on representation primitives can be modeled as sequences, concurrences, alternatives, and loops in a guideline's application process. Nesting of guidelines provides multiple views to a guideline with different granularities. Integration of guidelines with electronic medical records can be facilitated by the introduction of a formal model for patient data. Data collection, decision, patient state, and intervention constitute four basic types of primitives in a guideline's logic flow. Decisions clarify our understanding on a patient's clinical state, while interventions lead to the change from one patient state to another.

Practical guidelines addressing ethical issues pertaining to the curation of human locus-specific variation databases (LSDBs)

PubMed Central

Povey, Sue; Al Aqeel, Aida I; Cambon-Thomsen, Anne; Dalgleish, Raymond; den Dunnen, Johan T; Firth, Helen V; Greenblatt, Marc S; Barash, Carol Isaacson; Parker, Michael; Patrinos, George P; Savige, Judith; Sobrido, Maria-Jesus; Winship, Ingrid; Cotton, Richard GH

2010-01-01

More than 1,000 Web-based locus-specific variation databases (LSDBs) are listed on the Website of the Human Genetic Variation Society (HGVS). These individual efforts, which often relate phenotype to genotype, are a valuable source of information for clinicians, patients, and their families, as well as for basic research. The initiators of the Human Variome Project recently recognized that having access to some of the immense resources of unpublished information already present in diagnostic laboratories would provide critical data to help manage genetic disorders. However, there are significant ethical issues involved in sharing these data worldwide. An international working group presents second-generation guidelines addressing ethical issues relating to the curation of human LSDBs that provide information via a Web-based interface. It is intended that these should help current and future curators and may also inform the future decisions of ethics committees and legislators. These guidelines have been reviewed by the Ethics Committee of the Human Genome Organization (HUGO). Hum Mutat 31:–6, 2010. © 2010 Wiley-Liss, Inc. PMID:20683926

High-performance Thin-layer Chromatographic-densitometric Quantification and Recovery of Bioactive Compounds for Identification of Elite Chemotypes of Gloriosa superba L. Collected from Sikkim Himalayas (India)

PubMed Central

Misra, Ankita; Shukla, Pushpendra Kumar; Kumar, Bhanu; Chand, Jai; Kushwaha, Poonam; Khalid, Md.; Singh Rawat, Ajay Kumar; Srivastava, Sharad

2017-01-01

Background: Gloriosa superba L. (Colchicaceae) is used as adjuvant therapy in gout for its potential antimitotic activity due to high colchicine(s) alkaloids. Objective: This study aimed to develop an easy, cheap, precise, and accurate high-performance thin-layer chromatographic (HPTLC) validated method for simultaneous quantification of bioactive alkaloids (colchicine and gloriosine) in G. superba L. and to identify its elite chemotype(s) from Sikkim Himalayas (India). Methods: The HPTLC chromatographic method was developed using mobile phase of chloroform: acetone: diethyl amine (5:4:1) at λmax of 350 nm. Results: Five germplasms were collected from targeted region, and on morpho-anatomical inspection, no significant variation was observed among them. Quantification data reveal that content of colchicine (Rf: 0.72) and gloriosine (Rf: 0.61) varies from 0.035%–0.150% to 0.006%–0.032% (dry wt. basis). Linearity of method was obtained in the concentration range of 100–400 ng/spot of marker(s), exhibiting regression coefficient of 0.9987 (colchicine) and 0.9983 (gloriosine) with optimum recovery of 97.79 ± 3.86 and 100.023% ± 0.01%, respectively. Limit of detection and limit of quantification were analyzed, respectively, as 6.245, 18.926 and 8.024, 24.316 (ng). Two germplasms, namely NBG-27 and NBG-26, were found to be elite chemotype of both the markers. Conclusion: The developed method is validated in terms of accuracy, recovery, and precision studies as per the ICH guidelines (2005) and can be adopted for the simultaneous quantification of colchicine and gloriosine in phytopharmaceuticals. In addition, this study is relevant to explore the chemotypic variability in metabolite content for commercial and medicinal purposes. SUMMARY An easy, cheap, precise, and accurate high performance thin layer chromatographic (HPTLC) validated method for simultaneous quantification of bioactive alkaloids (colchicine and gloriosine) in G. superba L.Five germplasms were collected from targeted region, and on morpho anatomical inspection, no significant variation was observed among themQuantification data reveal that content of colchicine (Rf: 0.72) and gloriosine (Rf: 0.61) varies from 0.035%–0.150% to 0.006%–0.032% (dry wt. basis)Two germplasms, namely NBG 27 and NBG 26, were found to be elite chemotype of both the markers. PMID:29142436

High-performance Thin-layer Chromatographic-densitometric Quantification and Recovery of Bioactive Compounds for Identification of Elite Chemotypes of Gloriosa superba L. Collected from Sikkim Himalayas (India).

PubMed

Misra, Ankita; Shukla, Pushpendra Kumar; Kumar, Bhanu; Chand, Jai; Kushwaha, Poonam; Khalid, Md; Singh Rawat, Ajay Kumar; Srivastava, Sharad

2017-10-01

Gloriosa superba L. (Colchicaceae) is used as adjuvant therapy in gout for its potential antimitotic activity due to high colchicine(s) alkaloids. This study aimed to develop an easy, cheap, precise, and accurate high-performance thin-layer chromatographic (HPTLC) validated method for simultaneous quantification of bioactive alkaloids (colchicine and gloriosine) in G. superba L. and to identify its elite chemotype(s) from Sikkim Himalayas (India). The HPTLC chromatographic method was developed using mobile phase of chloroform: acetone: diethyl amine (5:4:1) at λ max of 350 nm. Five germplasms were collected from targeted region, and on morpho-anatomical inspection, no significant variation was observed among them. Quantification data reveal that content of colchicine ( R f : 0.72) and gloriosine ( R f : 0.61) varies from 0.035%-0.150% to 0.006%-0.032% (dry wt. basis). Linearity of method was obtained in the concentration range of 100-400 ng/spot of marker(s), exhibiting regression coefficient of 0.9987 (colchicine) and 0.9983 (gloriosine) with optimum recovery of 97.79 ± 3.86 and 100.023% ± 0.01%, respectively. Limit of detection and limit of quantification were analyzed, respectively, as 6.245, 18.926 and 8.024, 24.316 (ng). Two germplasms, namely NBG-27 and NBG-26, were found to be elite chemotype of both the markers. The developed method is validated in terms of accuracy, recovery, and precision studies as per the ICH guidelines (2005) and can be adopted for the simultaneous quantification of colchicine and gloriosine in phytopharmaceuticals. In addition, this study is relevant to explore the chemotypic variability in metabolite content for commercial and medicinal purposes. An easy, cheap, precise, and accurate high performance thin layer chromatographic (HPTLC) validated method for simultaneous quantification of bioactive alkaloids (colchicine and gloriosine) in G. superba L.Five germplasms were collected from targeted region, and on morpho anatomical inspection, no significant variation was observed among themQuantification data reveal that content of colchicine (Rf: 0.72) and gloriosine (Rf: 0.61) varies from 0.035%-0.150% to 0.006%-0.032% (dry wt. basis)Two germplasms, namely NBG 27 and NBG 26, were found to be elite chemotype of both the markers.

A context-adaptable approach to clinical guidelines.

PubMed

Terenziani, Paolo; Montani, Stefania; Bottrighi, Alessio; Torchio, Mauro; Molino, Gianpaolo; Correndo, Gianluca

2004-01-01

One of the most relevant obstacles to the use and dissemination of clinical guidelines is the gap between the generality of guidelines (as defined, e.g., by physicians' committees) and the peculiarities of the specific context of application. In particular, general guidelines do not take into account the fact that the tools needed for laboratory and instrumental investigations might be unavailable at a given hospital. Moreover, computer-based guideline managers must also be integrated with the Hospital Information System (HIS), and usually different DBMS are adopted by different hospitals. The GLARE (Guideline Acquisition, Representation and Execution) system addresses these issues by providing a facility for automatic resource-based adaptation of guidelines to the specific context of application, and by providing a modular architecture in which only limited and well-localised changes are needed to integrate the system with the HIS at hand.

[Preoperative fasting guidelines: an update].

PubMed

López Muñoz, A C; Busto Aguirreurreta, N; Tomás Braulio, J

2015-03-01

Anesthesiology societies have issued various guidelines on preoperative fasting since 1990, not only to decrease the incidence of lung aspiration and anesthetic morbidity, but also to increase patient comfort prior to anesthesia. Some of these societies have been updating their guidelines, as such that, since 2010, we now have 2 evidence-based preoperative fasting guidelines available. In this article, an attempt is made to review these updated guidelines, as well as the current instructions for more controversial patients such as infants, the obese, and a particular type of ophthalmic surgery. Copyright © 2014 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

State Enforcement of Civil Rights in Vocational Education: Partner or Stepchild? A Report on Implementation of Section II of the 1979 Vocational Education Guidelines by the Office for Civil Rights, U.S. Department of Education.

ERIC Educational Resources Information Center

Chachkin, Norman

An investigation was conducted of state enforcement of the Vocational Education Guidelines issued in 1979 to prevent discrimination on the basis of race, national origin, sex, or handicap in vocational training. The guidelines are administered by the Office of Civil Rights (OCR) through methods of administration (MOA) developed by the states that…

Development and validation of an LC-ESI-MS/MS method for the quantification of D-84, reboxetine and citalopram for their use in MS Binding Assays addressing the monoamine transporters hDAT, hSERT and hNET.

PubMed

Neiens, Patrick; De Simone, Angela; Ramershoven, Anna; Höfner, Georg; Allmendinger, Lars; Wanner, Klaus T

2018-03-03

MS Binding Assays represent a label-free alternative to radioligand binding assays. In this study, we present an LC-ESI-MS/MS method for the quantification of (R,R)-4-(2-benzhydryloxyethyl)-1-(4-fluorobenzyl)piperidin-3-ol [(R,R)-D-84, (R,R)-1], (S,S)-reboxetine [(S,S)-2], and (S)-citalopram [(S)-3] employed as highly selective nonlabeled reporter ligands in MS Binding Assays addressing the dopamine [DAT, (R,R)-D-84], norepinephrine [NET, (S,S)-reboxetine] and serotonin transporter [SERT, (S)-citalopram], respectively. The developed LC-ESI-MS/MS method uses a pentafluorphenyl stationary phase in combination with a mobile phase composed of acetonitrile and ammonium formate buffer for chromatography and a triple quadrupole mass spectrometer in the multiple reaction monitoring mode for mass spectrometric detection. Quantification is based on deuterated derivatives of all three analytes serving as internal standards. The established LC-ESI-MS/MS method enables fast, robust, selective and highly sensitive quantification of all three reporter ligands in a single chromatographic run. The method was validated according to the Center for Drug Evaluation and Research (CDER) guideline for bioanalytical method validation regarding selectivity, accuracy, precision, calibration curve and sensitivity. Finally, filtration-based MS Binding Assays were performed for all three monoamine transporters based on this LC-ESI-MS/MS quantification method as read out. The affinities determined in saturation experiments for (R,R)-D-84 toward hDAT, for (S,S)-reboxetine toward hNET, and for (S)-citalopram toward hSERT, respectively, were in good accordance with results from literature, clearly demonstrating that the established MS Binding Assays have the potential to be an efficient alternative to radioligand binding assays widely used for this purpose so far. Copyright © 2018 John Wiley & Sons, Ltd.

Immobilized Metal Affinity Chromatography Coupled to Multiple Reaction Monitoring Enables Reproducible Quantification of Phospho-signaling*

PubMed Central

Kennedy, Jacob J.; Yan, Ping; Zhao, Lei; Ivey, Richard G.; Voytovich, Uliana J.; Moore, Heather D.; Lin, Chenwei; Pogosova-Agadjanyan, Era L.; Stirewalt, Derek L.; Reding, Kerryn W.; Whiteaker, Jeffrey R.; Paulovich, Amanda G.

2016-01-01

A major goal in cell signaling research is the quantification of phosphorylation pharmacodynamics following perturbations. Traditional methods of studying cellular phospho-signaling measure one analyte at a time with poor standardization, rendering them inadequate for interrogating network biology and contributing to the irreproducibility of preclinical research. In this study, we test the feasibility of circumventing these issues by coupling immobilized metal affinity chromatography (IMAC)-based enrichment of phosphopeptides with targeted, multiple reaction monitoring (MRM) mass spectrometry to achieve precise, specific, standardized, multiplex quantification of phospho-signaling responses. A multiplex immobilized metal affinity chromatography- multiple reaction monitoring assay targeting phospho-analytes responsive to DNA damage was configured, analytically characterized, and deployed to generate phospho-pharmacodynamic curves from primary and immortalized human cells experiencing genotoxic stress. The multiplexed assays demonstrated linear ranges of ≥3 orders of magnitude, median lower limit of quantification of 0.64 fmol on column, median intra-assay variability of 9.3%, median inter-assay variability of 12.7%, and median total CV of 16.0%. The multiplex immobilized metal affinity chromatography- multiple reaction monitoring assay enabled robust quantification of 107 DNA damage-responsive phosphosites from human cells following DNA damage. The assays have been made publicly available as a resource to the community. The approach is generally applicable, enabling wide interrogation of signaling networks. PMID:26621847

Current Work in Linguistics. University of Pennsylvania Working Papers in Linguistics, Volume 5, Number 2.

ERIC Educational Resources Information Center

Dimitriadis, Alexis, Ed.; Lee, Hikyoung, Ed.; Moisset, Christine, Ed.; Williams, Alexander, Ed.

This issue includes the following articles: "A Multi-Modal Analysis of Anaphora and Ellipsis" (Gerhard Jager); "Amount Quantification, Referentiality, and Long Wh-Movement" (Anthony Kroch); "Valency in Kannada: Evidence for Interpretive Morphology" (Jeffrey Lidz); "Vietnamese 'Morphology' and the Definition of…

Safe commuting factors from existing guidelines in Malaysia: a review for the construction sector

NASA Astrophysics Data System (ADS)

Sukor, E. S. A.; Suratkon, A.; Mohammad, H.; Yaman, S. K.

2018-04-01

The construction industry is a very active and dynamic industry, which proceeding as one of the significant industry that contributing to the country’s economy. Unfortunately, the construction industry has also earned the reputation of being the riskiest industry because of the higher rates of accidents and fatalities. Nevertheless, overwhelming focus by many on the accident in the workplace has shaded the alarming issue of the construction-related commuting accident. As reported by the Malaysia’s Social Security Organisation (SOCSO) in 2016, the number of commuting accidents and the compensations paid is increasing each year, and it is including the construction sector. Aware of the importance of safe commuting, several Malaysian agencies have developed their guidelines specifically for the improvement of such issue. Regrettably, the number of guidelines published does not exemplify the improvement of such issue when the number of commuting accidents is on the rise, especially for the construction sector. Therefore, this preliminary research was conducted to identify the safe commuting factors from the existing guidelines through manual document analysis. The finding shows that there are four (4) major categories namely; (1) driver/human factor, (2) vehicle factor, (3) environment factor, and (4) others. Hence, the research posits for subsequent exploration to ensure strategic implementation of those factors that will benefit the Malaysia’s construction sector.

Guidelines: Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly.

PubMed

Tamber, Mandeep S; Nikas, Dimitrios; Beier, Alexandra; Baird, Lissa C; Bauer, David F; Durham, Susan; Klimo, Paul; Lin, Alexander Y; Mazzola, Catherine; McClung-Smith, Catherine; Mitchell, Laura; Tyagi, Rachana; Flannery, Ann Marie

2016-11-01

No evidence-based guidelines exist on the role of cranial-molding orthosis (helmet) therapy for patients with positional plagiocephaly. To address the clinical question: "Does helmet therapy provide effective treatment for positional plagiocephaly?" and to make treatment recommendations based on the available evidence. The US National Library of Medicine Medline database and the Cochrane Library were queried by using MeSH headings and key words relevant to the objective of this systematic review. Abstracts were reviewed, after which studies meeting the inclusion criteria were selected and graded according to their quality of evidence (Classes I-III). Evidentiary tables were constructed that summarized pertinent study results, and, based on the quality of the literature, recommendations were made (Levels I-III). Fifteen articles met criteria for inclusion into the evidence tables. There was 1 prospective randomized controlled trial (Class II), 5 prospective comparative studies (Class II), and 9 retrospective comparative studies (Class II). There is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy. Specific criteria regarding the measurement and quantification of deformity and the most appropriate time window in infancy for treatment of positional plagiocephaly with a helmet remains elusive. In general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_5.

The New Substance Abuse and Mental Health Services Administration Oral Fluid Cutoffs for Cocaine and Heroin-Related Analytes Applied to an Addiction Medicine Setting: Important, Unanticipated Findings with LC-MS/MS.

PubMed

Flood, James G; Khaliq, Tahira; Bishop, Kenneth A; Griggs, David A

2016-05-01

We implemented oral fluid (OF) as an alternative specimen type to urine for detection of cocaine (COC) and opiate abuse in outpatient addiction medicine clinics. We implemented a 2-μg/L limit of quantification OF LC-MS/MS assay and compiled and reviewed all findings from a 22-month collection period for COC, benzoylecgonine (BZE), codeine (COD), 6-acetylmorphine (MAM), and morphine (MOR). We also compared the results of our clinical samples at different OF cutoffs and analytes specified in the new 2015 SAMHSA OF guidelines. Of 3608 OF samples, COC and BZE were positive in 593 and 508, respectively. COC or BZE was positive in 662 samples. Importantly and unexpectedly, 154 samples were COC positive and BZE negative, with 125 having COC 2.0-7.9 μg/L. A simulation with the new guideline cutoffs confirmed 65% (430 of 662) of all COC- or BZE-positive data set samples. Similarly, the new guidelines confirmed 44% (263 of 603) of data set samples positive for MOR or COD. Simulation found that the new, lower MAM guideline cutoffs detected 89% of the 382 MAM-positive samples in the data set, 104 of which the new guidelines had identified as negative for MOR and COD. COC (not BZE) is the dominant low-concentration OF analyte in an addiction medicine setting. This information will aid OF test interpretation. It also illustrates the importance of the 2015 guideline's new immunoassay cross-reactivity requirements and the likely improvement in detection of heroin use stemming from the new, lower MAM cutoffs. © 2016 American Association for Clinical Chemistry.

The full spectrum of ethical issues in the care of patients with ALS: a systematic qualitative review.

PubMed

Seitzer, F; Kahrass, H; Neitzke, G; Strech, D

2016-02-01

Dealing systematically with ethical issues in amyotrophic lateral sclerosis (ALS) care requires an unbiased awareness of all the relevant ethical issues. The aim of the study was to determine systematically and transparently the full spectrum of ethical issues in ALS care. We conducted a systematic review in Medline and Google Books (restricted to English and German literature published between 1993 and 2014). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in ALS care. The literature review retrieved 56 references that together mentioned a spectrum of 103 ethical issues in ALS care. The spectrum was structured into six major categories that consist of first and second-order categories of ethical issues. The systematically derived spectrum of ethical issues in ALS care presented in this paper raises awareness and understanding of the complexity of ethical issues in ALS care. It also offers a basis for the systematic development of informational and training materials for health professionals, patients and their relatives, and society as a whole. Finally, it supports a rational and fair selection of all those ethical issues that should be addressed in health policies, position papers and clinical practice guidelines. Further research is needed to identify ways to systematically select the most relevant ethical issues not only in the clinical environment, but also for the development of clinical practice guidelines.

Saudi lung cancer management guidelines 2017

PubMed Central

Jazieh, Abdul Rahman; Al Kattan, Khaled; Bamousa, Ahmed; Al Olayan, Ashwaq; Abdelwarith, Ahmed; Ansari, Jawaher; Al Twairqi, Abdullah; Al Fayea, Turki; Al Saleh, Khalid; Al Husaini, Hamed; Abdelhafiez, Nafisa; Mahrous, Mervat; Faris, Medhat; Al Omair, Ameen; Hebshi, Adnan; Al Shehri, Salem; Al Dayel, Foad; Bamefleh, Hanaa; Khalbuss, Walid; Al Ghanem, Sarah; Loutfi, Shukri; Khankan, Azzam; Al Rujaib, Meshael; Al Ghamdi, Majed; Ibrahim, Nagwa; Swied, Abdulmonem; Al Kayait, Mohammad; Datario, Marie

2017-01-01

BACKGROUND: Lung cancer management is getting more complex due to the rapid advances in all aspects of diagnostic and therapeutic options. Developing guidelines is critical to help practitioners provide standard of care. METHODS: The Saudi Lung Cancer Guidelines Committee (SLCGC) multidisciplinary members from different specialties and from various regions and healthcare sectors of the country reviewed and updated all lung cancer guidelines with appropriate labeling of level of evidence. Supporting documents to help healthcare professionals were developed. RESULTS: Detailed lung cancer management guidelines were finalized with appropriate resources for systemic therapy and short reviews highlighting important issues. Stage based disease management recommendation were included. A summary explanation for complex topics were included in addition to tables of approved systemic therapy. CONCLUSION: A multidisciplinary lung cancer guidelines was developed and will be disseminated across the country. PMID:29118855

Saudi lung cancer management guidelines 2017.

PubMed

Jazieh, Abdul Rahman; Al Kattan, Khaled; Bamousa, Ahmed; Al Olayan, Ashwaq; Abdelwarith, Ahmed; Ansari, Jawaher; Al Twairqi, Abdullah; Al Fayea, Turki; Al Saleh, Khalid; Al Husaini, Hamed; Abdelhafiez, Nafisa; Mahrous, Mervat; Faris, Medhat; Al Omair, Ameen; Hebshi, Adnan; Al Shehri, Salem; Al Dayel, Foad; Bamefleh, Hanaa; Khalbuss, Walid; Al Ghanem, Sarah; Loutfi, Shukri; Khankan, Azzam; Al Rujaib, Meshael; Al Ghamdi, Majed; Ibrahim, Nagwa; Swied, Abdulmonem; Al Kayait, Mohammad; Datario, Marie

2017-01-01

Lung cancer management is getting more complex due to the rapid advances in all aspects of diagnostic and therapeutic options. Developing guidelines is critical to help practitioners provide standard of care. The Saudi Lung Cancer Guidelines Committee (SLCGC) multidisciplinary members from different specialties and from various regions and healthcare sectors of the country reviewed and updated all lung cancer guidelines with appropriate labeling of level of evidence. Supporting documents to help healthcare professionals were developed. Detailed lung cancer management guidelines were finalized with appropriate resources for systemic therapy and short reviews highlighting important issues. Stage based disease management recommendation were included. A summary explanation for complex topics were included in addition to tables of approved systemic therapy. A multidisciplinary lung cancer guidelines was developed and will be disseminated across the country.

Establishing Ion Ratio Thresholds Based on Absolute Peak Area for Absolute Protein Quantification using Protein Cleavage Isotope Dilution Mass Spectrometry

PubMed Central

Loziuk, Philip L.; Sederoff, Ronald R.; Chiang, Vincent L.; Muddiman, David C.

2014-01-01

Quantitative mass spectrometry has become central to the field of proteomics and metabolomics. Selected reaction monitoring is a widely used method for the absolute quantification of proteins and metabolites. This method renders high specificity using several product ions measured simultaneously. With growing interest in quantification of molecular species in complex biological samples, confident identification and quantitation has been of particular concern. A method to confirm purity or contamination of product ion spectra has become necessary for achieving accurate and precise quantification. Ion abundance ratio assessments were introduced to alleviate some of these issues. Ion abundance ratios are based on the consistent relative abundance (RA) of specific product ions with respect to the total abundance of all product ions. To date, no standardized method of implementing ion abundance ratios has been established. Thresholds by which product ion contamination is confirmed vary widely and are often arbitrary. This study sought to establish criteria by which the relative abundance of product ions can be evaluated in an absolute quantification experiment. These findings suggest that evaluation of the absolute ion abundance for any given transition is necessary in order to effectively implement RA thresholds. Overall, the variation of the RA value was observed to be relatively constant beyond an absolute threshold ion abundance. Finally, these RA values were observed to fluctuate significantly over a 3 year period, suggesting that these values should be assessed as close as possible to the time at which data is collected for quantification. PMID:25154770

A systematic review of recent clinical practice guidelines and best practice statements for the evaluation of the infertile male.

PubMed

Esteves, Sandro C; Chan, Peter

2015-09-01

We systematically identified and reviewed the methods and consistency of recommendations of recently developed clinical practice guidelines (CPG) and best practice statements (BPS) on the evaluation of the infertile male. MEDLINE and related engines as well as guidelines' Web sites were searched for CPG and BPS written in English on the general evaluation of male infertility published between January 2008 and April 2015. Four guidelines were identified, all of which reported to have been recently updated. Systematic review was not consistently used in the BPS despite being reported in the CPG. Only one of them reported having a patient representative in its development team. The CPG issued by the European Association of Urology (EAU) graded some recommendations and related that to levels (but not quality) of evidence. Overall, the BPS issued respectively by the American Urological Association and American Society for Reproductive Medicine concurred with each other, but both differed from the EAU guidelines with regard to methods of collection, extraction and interpretation of data. None of the guidelines incorporated health economics. Important specific limitations of conventional semen analysis results were ignored by all guidelines. Besides variation in the methodological quality, implementation strategies were not reported in two out of four guidelines. While the various panels of experts who contributed to the development of the CPG and BPS reviewed should be commended on their tremendous efforts aiming to establish a clinical standard in both the evaluation and management of male infertility, we recognized inconsistencies in the methodology of their synthesis and in the contents of their final recommendations. These discrepancies pose a barrier in the general implementation of these guidelines and may limit their utility in standardizing clinical practice or improving health-related outcomes. Continuous efforts are needed to generate high-quality evidence to allow further development of these important guidelines for the evaluation and management of males suffering from infertility.

A high-performance liquid chromatographic-tandem mass spectrometric method for the determination of ethyl glucuronide and ethyl sulfate in urine validated according to forensic guidelines.

PubMed

Albermann, M E; Musshoff, F; Madea, B

2012-01-01

Ethyl glucuronide (EtG) and ethyl sulfate (EtS) are powerful markers for alcohol intake and abuse. Several analytical procedures for the quantification of EtG and EtG in serum and urine have been developed so far. Many of the published methods show limits of detections (LODs) or limits of quantifications (LOQs) for EtG in urine within the range of 0.1 mg/L or higher. Since this is the actual cutoff value for proving abstinence in Germany, problems may occur if urine samples are highly diluted. In this paper, the validation of a highly sensitive, fast and simple LC-MS-MS for the determination of EtG and EtS in urine is described. The calibration curves for EtG and EtS is linear over the whole range (0.025-2.0 mg/L). Very low detection limits can be achieved (LOD: EtG 0.005 mg/L, EtS 0.005 mg/L; and LOQ: EtG 0.019 mg/L, EtS 0.015 mg/L). All data for selectivity, precision and accuracy, recovery, as well as for the processed sample and the freeze/thaw stability, comply with the guidelines of the German Society of Toxicological and Forensic Chemistry. Strong matrix-related effects can be compensated for by using an internal standard. Finally, the applicability of the procedure is proven by analysis of 87 human urine samples and by successful participation in interlaboratory comparison tests. © The Author [2011]. Published by Oxford University Press. All rights reserved.

Prevention Activities in Professional Psychology: A Reaction to the Prevention Guidelines

ERIC Educational Resources Information Center

Rivera-Mosquera, Evelyn; Dowd, E. Thomas; Mitchell-Blanks, Marsha

2007-01-01

In this reaction article, the authors provide a historical context for prevention activities and their place in psychological practice. They then discuss the prevention guidelines in the Major Contribution authored by S. M. Hage et al. (2007 [this issue]) and provide their critique. Finally, the authors offer ideas for the future specific…

Guidelines for Public Libraries in the 21st Century.

ERIC Educational Resources Information Center

Gill, Philip

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

A Case Study of the Implementation of Chinese Kindergarten Mathematics Curriculum

ERIC Educational Resources Information Center

Hu, Bi Ying; Fuentes, Sarah Quebec; Wang, Chun Yan; Ye, Feiwei

2014-01-01

In 2001, the Chinese Ministry of Education issued Guidelines for Preschool Education (GPE) (trial version) to call on early childhood practitioners to use a child-centered and play-based approach to teaching and learning. The guidelines also include mathematics within the science domain and described its standards in a way that significantly…

Increasing the Openness of Education as an Approach to Promoting Educational Reform and Development

ERIC Educational Resources Information Center

Jinqiu, He

2012-01-01

This paper presents the main content of the portion on "increasing the openness of China's education" in the "National Medium- and Long-Term Educational Reform and Development Guideline (2010-20)" (hereafter abbreviated as the "Guideline") and the key issues studied and discussed in the formulation process. Issues…

Energy Design Guidelines for High Performance Schools: Temperate and Humid Climates.

ERIC Educational Resources Information Center

Department of Energy, Washington, DC. Office of Energy Efficiency and Renewable Energy.

The U.S. Department of Energy's EnergySmart Schools provides school boards, administrators, and design staff with guidance to help them make informed decisions about energy and environmental issues important to school systems and communities. The design guidelines presented in this document outline high performance principles for the new or…

Energy Design Guidelines for High Performance Schools: Hot and Humid Climates.

ERIC Educational Resources Information Center

National Renewable Energy Lab. (DOE), Golden, CO.

The U.S. Department of Energy's EnergySmart Schools provides school boards, administrators, and design staff with guidance to help them make informed decisions about energy and environmental issues important to school systems and communities. The design guidelines presented in this document outline high performance principles for the new or…

Energy Design Guidelines for High Performance Schools: Cool and Humid Climates.

ERIC Educational Resources Information Center

National Renewable Energy Lab. (DOE), Golden, CO.

The U.S. Department of Energy's EnergySmart Schools provides school boards, administrators, and design staff with guidance to help them make informed decisions about energy and environmental issues important to school systems and communities. The design guidelines presented in this document outline high performance principles for the new or…

Energy Design Guidelines for High Performance Schools: Temperate and Mixed Climates.

ERIC Educational Resources Information Center

National Renewable Energy Lab. (DOE), Golden, CO.

The U.S. Department of Energy's EnergySmart Schools provides school boards, administrators, and design staff with guidance to help them make informed decisions about energy and environmental issues important to school systems and communities. The design guidelines presented in this document outline high performance principles for the new or…

Energy Design Guidelines for High Performance Schools: Cool and Dry Climates.

ERIC Educational Resources Information Center

National Renewable Energy Lab. (DOE), Golden, CO.

The U.S. Department of Energy's EnergySmart Schools provides school boards, administrators, and design staff with guidance to help them make informed decisions about energy and environmental issues important to school systems and communities. The design guidelines presented in this document outline high performance principles for the new or…

Energy Design Guidelines for High Performance Schools: Cold and Humid Climates.

ERIC Educational Resources Information Center

Department of Energy, Washington, DC. Office of Energy Efficiency and Renewable Energy.

The U.S. Department of Energy's EnergySmart Schools provides school boards, administrators, and design staff with guidance to help them make informed decisions about energy and environmental issues important to school systems and communities. The design guidelines presented in this document outline high performance principles for the new or…

Toward a New Diversity: Guidelines for a Staff Diversity/Affirmative Action Plan.

ERIC Educational Resources Information Center

California Community Colleges, Sacramento. Office of the Chancellor.

These guidelines for California's community colleges specify required elements of a staff diversity/affirmative action plan, recommend sound practices and activities that will maximize the likelihood of success, and provide information on, and required elements of, related issues such as sexual harassment, handicap discrimination, and AIDS in the…

Facilitating Children's Divorce Adjustment: Guidelines for Parents and Practitioners. Issues in Education.

ERIC Educational Resources Information Center

Langenbrunner, Mary

2000-01-01

Provides guidelines to facilitate children's emotional adjustment to their parents' divorce. Suggestions include avoiding arguing in front of children, allowing children to spend quality time with both parents, keeping children's daily routines as normal as possible, avoiding putting children in the middle or in the "missing parent" role, allowing…

Solar Energy Task Force Report: Technical Training Guidelines.

ERIC Educational Resources Information Center

O'Connor, Kevin

This task force report offers guidelines and information for the development of vocational education programs oriented to the commercial application of solar energy in water and space heating. After Section I introduces the Solar Energy Task Force and its activities, Section II outlines the task force's objectives and raises several issues and…

Comparison Among Recommendations for the Management of Arterial Hypertension Issued by Last US, Canadian, British and European Guidelines.

PubMed

Antza, Christina; Doundoulakis, Ioannis; Stabouli, Stella; Kotsis, Vasilios

2018-03-01

Guidelines for the management of hypertension have been issued by different hypertension societies or organizations. Despite many similarities one can identify major differences in the diagnosis, management and treatment of the hypertensive patients among ESH/ESC, NICE, Canadian and NJC8 guidelines. Differences that can be identified are in the definition of hypertension in the elderly population, the optimal blood pressure targets in different hypertensive populations such as patients with diabetes and chronic kidney disease patients and the choose of the initial and appropriate antihypertensive agent depending on comorbidities of the treated population. Everyday clinical praxis physicians are confused by these differences and these incongruities contribute to doctor and patient inertia to reduce blood pressure levels at an optimal level. Community physicians cannot easily distinguish what recommendations are the best to be used for their patients. The critical view of these differences can also help the guidelines committees to make appropriate changes and finally to agree to a global view of recommendations for the management and treatment of hypertension.

Specific guidelines for assessing and improving the methodological quality of economic evaluations of newborn screening

PubMed Central

2012-01-01

Background Economic evaluation of newborn screening poses specific methodological challenges. Amongst others, these challenges refer to the use of quality adjusted life years (QALYs) in newborns, and which costs and outcomes need to be considered in a full evaluation of newborn screening programmes. Because of the increasing scale and scope of such programmes, a better understanding of the methods of high-quality economic evaluations may be crucial for both producers/authors and consumers/reviewers of newborn screening-related economic evaluations. The aim of this study was therefore to develop specific guidelines designed to assess and improve the methodological quality of economic evaluations in newborn screening. Methods To develop the guidelines, existing guidelines for assessing the quality of economic evaluations were identified through a literature search, and were reviewed and consolidated using a deductive iterative approach. In a subsequent test phase, these guidelines were applied to various economic evaluations which acted as case studies. Results The guidelines for assessing and improving the methodological quality of economic evaluations in newborn screening are organized into 11 categories: “bibliographic details”, “study question and design”, “modelling”, “health outcomes”, “costs”, “discounting”, “presentation of results”, “sensitivity analyses”, “discussion”, “conclusions”, and “commentary”. Conclusions The application of the guidelines highlights important issues regarding newborn screening-related economic evaluations, and underscores the need for such issues to be afforded greater consideration in future economic evaluations. The variety in methodological quality detected by this study reveals the need for specific guidelines on the appropriate methods for conducting sound economic evaluations in newborn screening. PMID:22947299

[Guidelines for Trainings in Inter-/Transcultural Competence for Psychotherapists].

PubMed

von Lersner, Ulrike; Baschin, Kirsten; Wormeck, Imke; Mösko, Mike Oliver

2016-02-01

The ongoing globalization leads to the fact that intercultural aspects are becoming more important in recent years. Unfortunately, the psychosocial sector in general as well as psychotherapists in particular are not sufficiently trained for those issues. In the German speaking countries so far there were no guidelines for the conceptualization of intercultural trainings for psychotherapists. In the present study guidelines for trainings of inter-/transcultural competence of medical and psychological psychotherapists have been developed. An extensive data base was collected including a systematic international literature research, qualitative expert interviews, a quantitative survey among therapists and 8 focus groups with clients as well as therapists from different cultural backgrounds. The guidelines for trainings were then extracted in a 2-step consensus procedure. The guidelines define learning objectives which should be achieved in a training. They also describe the structural as well as substantive requirements which should be met in such a training. In addition to knowledge on cultural issues that should be acquired in a training the guidelines put high emphasis on the self reflection of training participants on their own cultural embededness as well as on the aquisition of culturally sensitive skills. Regarding demographic trends in Germany trainings for intercultural competence should become an obligatory element in the training of psychotherapists. The guidelines represent a high-quality base for the conceptualization as well as the evaluation of such trainings. The guidelines developed here represent an instrument for the improvement of the training of therapists in Germany in the field of transcultural psychology. In the long term they could contribute to the intercultural opening of the German mental health system and improve the quality of psychotherapeutical treatment of migrants in Germany. © Georg Thieme Verlag KG Stuttgart · New York.

How equity is addressed in clinical practice guidelines: a content analysis

PubMed Central

Shi, Chunhu; Tian, Jinhui; Wang, Quan; Petkovic, Jennifer; Ren, Dan; Yang, Kehu; Yang, Yang

2014-01-01

Objectives Considering equity into guidelines presents methodological challenges. This study aims to qualitatively synthesise the methods for incorporating equity in clinical practice guidelines (CPGs). Setting Content analysis of methodological publications. Eligibility criteria for selecting studies Methodological publications were included if they provided checklists/frameworks on when, how and to what extent equity should be incorporated in CPGs. Data sources We electronically searched MEDLINE, retrieved references, and browsed guideline development organisation websites from inception to January 2013. After study selection by two authors, general characteristics and checklists items/framework components from included studies were extracted. Based on the questions or items from checklists/frameworks (unit of analysis), content analysis was conducted to identify themes and questions/items were grouped into these themes. Primary outcomes The primary outcomes were methodological themes and processes on how to address equity issues in guideline development. Results 8 studies with 10 publications were included from 3405 citations. In total, a list of 87 questions/items was generated from 17 checklists/frameworks. After content analysis, questions were grouped into eight themes (‘scoping questions’, ‘searching relevant evidence’, ‘appraising evidence and recommendations’, ‘formulating recommendations’, ‘monitoring implementation’, ‘providing a flow chart to include equity in CPGs’, and ‘others: reporting of guidelines and comments from stakeholders’ for CPG developers and ‘assessing the quality of CPGs’ for CPG users). Four included studies covered more than five of these themes. We also summarised the process of guideline development based on the themes mentioned above. Conclusions For disadvantaged population-specific CPGs, eight important methodological issues identified in this review should be considered when including equity in CPGs under the guidance of a scientific guideline development manual. PMID:25479795

Feminist Family Therapy: Ethical Considerations for the Clinician.

ERIC Educational Resources Information Center

Costa, Luann; Sorenson, Jody

1993-01-01

Notes the traditional minimization of gender and power issues in the cultural context by systemic family therapists. Presents five questions that can serve as guidelines in examining ethical and personal issues and provides ethical considerations for the clinician. (Author/NB)

Critical Issues in Research Design in Action Research in an SME Development Context

ERIC Educational Resources Information Center

McGrath, Helen; O'Toole, Thomas

2012-01-01

Purpose: The main aim of this paper is to develop guidelines on the critical issues to consider in research design in an action research (AR) environment for SME network capability development. Design/methodology/approach: The issues in research design for AR studies are developed from the authors' experience in running learning sets but, in…

Legal issues in the development and use of clinical practice guidelines.

PubMed

Gevers, S

2001-01-01

Over the last ten years, the development and dissemination of practice guidelines has increased at a rapid pace. From a legal point of view, it should always be made clear whether a guideline has been developed to improve the quality of care and is based on medical evidence and professional experience, or whether other concerns and considerations (organisational, financial) did prevail. Guidelines should not simply be imposed on health professionals; that would result in a standardisation of care that does no justice to individual patient needs and preferences. Patients have the right to be informed about reasonable and realistic treatment alternatives, even if they are not included in the guideline. Using cost effectiveness analysis in guideline development can help to reduce care of dubious effectiveness. But if cost considerations are used as a reason to limit effective medical care, the guidelines in question need political legitimation.

75 FR 63484 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-15

... Bone Metastasis in Cancer; Use: In Decision Memorandum CAG-00065R, issued on February 26, 2010, the... that for Medicare beneficiaries receiving NaF-18 PET scan to identify bone metastasis in cancer is... or to guide subsequent treatment strategy by the identification, location and quantification of bone...

Critical evaluation of models used to study agricultural phosphorus and water quality

USDA-ARS?s Scientific Manuscript database

This article uses examples from recent research to evaluate select issues related to developing models that simulate phosphorus in the environment. Models are valuable because they force scientists to formalize understanding of P systems and identify knowledge gaps, and allow quantification of P tra...

Pretreatment of woody biomass for biofuel production: energy efficiency, technologies, and recalcitrance

Treesearch

J.Y. Zhu; Xuejun Pan; Ronald S. Jr. Zalesny

2010-01-01

This mini review discusses several key technical issues associated with cellulosic ethanol production from woody biomass: energy consumption for woody biomass pretreatment, pretreatment energy efficiency, woody biomass pretreatment technologies, and quantification of woody biomass recalcitrance. Both total sugar yield and pretreatment energy efficiency, defined as the...

Introducing the new BTS Guideline: Management of non-tuberculous mycobacterial pulmonary disease (NTM-PD).

PubMed

Haworth, Charles S; Floto, R Andres

2017-11-01

The new BTS Guidelines for the management of non-tuberculous mycobacterial pulmonary disease combine the best available evidence with expert consensus to generate a set of pragmatic Guidelines, published as a supplement to this issue of Thorax, to assist in the management of these challenging infections. © 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.

Recommendations for harmonization of data collection and analysis of developmental neurotoxicity endpoints in regulatory guideline studies: Proceedings of workshops presented at Society of Toxicology and joint Teratology Society and Neurobehavioral Teratology Society meetings.

PubMed

Li, Abby A; Sheets, Larry P; Raffaele, Kathleen; Moser, Virginia; Hofstra, Angela; Hoberman, Alan; Makris, Susan L; Garman, Robert; Bolon, Brad; Kaufmann, Wolfgang; Auer, Roland; Lau, Edmund; Vidmar, Thomas; Bowers, Wayne J

2017-09-01

The potential for developmental neurotoxicity (DNT) of environmental chemicals may be evaluated using specific test guidelines from the US Environmental Protection Agency or the Organisation for Economic Cooperation and Development (OECD). These guidelines generate neurobehavioral, neuropathological, and morphometric data that are evaluated by regulatory agencies globally. Data from these DNT guideline studies, or the more recent OECD extended one-generation reproductive toxicity guideline, play a pivotal role in children's health risk assessment in different world areas. Data from the same study may be interpreted differently by regulatory authorities in different countries resulting in inconsistent evaluations that may lead to inconsistencies in risk assessment decisions internationally, resulting in regional differences in public health protection or in commercial trade barriers. These issues of data interpretation and reporting are also relevant to juvenile and pre-postnatal studies conducted more routinely for pharmaceuticals and veterinary medicines. There is a need for development of recommendations geared toward the operational needs of the regulatory scientific reviewers who apply these studies in risk assessments, as well as the scientists who generate DNT data sets. The workshops summarized here draw upon the experience of the authors representing government, industry, contract research organizations, and academia to discuss the scientific issues that have emerged from diverse regulatory evaluations. Although various regulatory bodies have different risk management decisions and labeling requirements that are difficult to harmonize, the workshops provided an opportunity to work toward more harmonized scientific approaches for evaluating DNT data within the context of different regulatory frameworks. Five speakers and their coauthors with neurotoxicology, neuropathology, and regulatory toxicology expertise discussed issues of variability, data reporting and analysis, and expectations in DNT data that are encountered by regulatory authorities. In addition, principles for harmonized evaluation of data were suggested using guideline DNT data as case studies. Copyright © 2017. Published by Elsevier Inc.

Nuclear safety policy working group recommendations on nuclear propulsion safety for the space exploration initiative

NASA Technical Reports Server (NTRS)

Marshall, Albert C.; Lee, James H.; Mcculloch, William H.; Sawyer, J. Charles, Jr.; Bari, Robert A.; Cullingford, Hatice S.; Hardy, Alva C.; Niederauer, George F.; Remp, Kerry; Rice, John W.

1993-01-01

An interagency Nuclear Safety Working Group (NSPWG) was chartered to recommend nuclear safety policy, requirements, and guidelines for the Space Exploration Initiative (SEI) nuclear propulsion program. These recommendations, which are contained in this report, should facilitate the implementation of mission planning and conceptual design studies. The NSPWG has recommended a top-level policy to provide the guiding principles for the development and implementation of the SEI nuclear propulsion safety program. In addition, the NSPWG has reviewed safety issues for nuclear propulsion and recommended top-level safety requirements and guidelines to address these issues. These recommendations should be useful for the development of the program's top-level requirements for safety functions (referred to as Safety Functional Requirements). The safety requirements and guidelines address the following topics: reactor start-up, inadvertent criticality, radiological release and exposure, disposal, entry, safeguards, risk/reliability, operational safety, ground testing, and other considerations.

User-programmer dialogue: Guidelines for designing menus and help files for interactive computer systems

NASA Technical Reports Server (NTRS)

Carlson, P. A.

1983-01-01

This document is a set of guidelines to aid a programmer in making the various decisions necessary for a clear user-programmer dialogue. Its goal is to promote an effective and efficient transfer of information between programmer and user. These guidelines are divided into four sections: (1) Format, (2) Sequence, (3) Audience, and (4) Aim. Format, in terms of this study, means the spatial and structural presentation of information. Sequence deals with the procedural aspects of multiple panel displays. This section looks at the issues of timelines of presentation, modularization of information, and patterns of user behavior. Audience looks at the relationship among programmer, user, and message. It covers the issues of analyzing the audience's knowledge, attitudes, and needs, anticipating the audience's inferences, and identifying textual ambiguities. The programmer's aim or intention shows up in everything from tone to format. Aim considers the programmer's purpose.

Excessive and disproportionate advertising in peer-reviewed journals.

PubMed

Friedman, Lee S; Richter, Elihu D

2006-01-01

The International Committee of Medical Journal Editors (ICMJE) has outlined ethical guidelines concerning the advertising practices of peer-reviewed journals that briefly discuss issues of excessive and disproportionate advertising. The authors evaluated these guidelines using quantitative data, assessing the types and frequencies of advertising in 2001 print issues of NEJM and JAMA, two principal members of ICMJE. Advertising ratios (ratio of advertisements to editorial content) were near unity in NEJM and 0.30 in JAMA, compared with reported ratios of 0.15 among low-circulation specialty science journals and 0.80 among high-circulation consumer magazines. In both journals, five corporations placed more than 50% of all display advertisements. The findings suggest a dissonance between the ethical guidelines and the de facto advertising practices of arguably the two most important member journals of the ICMJE. There is a need to define and apply standards for excessive and disproportionate advertising.

A review of improved ethical practices in environmental and public health research: case examples from native communities.

PubMed

Quigley, Dianne

2006-04-01

This article presents a review of 14 case studies and articles of research ethics issues in the conduct of environmental and public health research with Native American and other indigenous populations. The purpose of this review is to highlight new practices in the ethical conduct of research with native community populations. The findings from this review can promote more dialogue and policy development on the issue of community protections in research. Formal guidelines exist in ethical codes for individual rights as human subjects, but there is a lack of development on community rights in the ethics of research. This review illustrates how community-based participatory research practices can provide working guidelines that can overcome past research harms. More important, the compilations of guidelines offer tested field methods for improving the ethical conduct of research with native community populations.

[Guidelines for wise utilization of knee imaging].

PubMed

Finestone, Aharon S; Eshed, Iris; Freedman, Yehuda; Beer, Yiftah; Bar-Sever, Zvi; Kots, Yavvgeni; Adar, Eliyahu; Mann, Gideon

2012-02-01

The knee is a complex structure afflicted with diverse pathologies. Correct management of knee complaints demands wise utilization of imaging modalities, considering their accuracy in the specific clinical situation, the patient's safety and availability and financial issues. Some of these considerations are universal, while others are local, depending on medical and insurance systems. There is controversy and unclearness regarding the best imaging modality in different clinical situations. To develop clinical guidelines for utilizing knee imaging. Leading physicians in specialties associated with knee disease and imaging were invited to participate in a panel on the guidelines. Controversies were settled in the main panel or in sub-panels. The panel agreed on the principles in choosing from the various modalities, primarily medical accuracy, followed by patient safety, availability and cost. There was agreement that the physician is responsible to choose the most appropriate diagnostic tool, consulting, when necessary, on the advantages, limitations and risks of the various imaging modalities. A comprehensive table was compiled with the importance of the different imaging modalities in various clinical situations. For the first time, Israeli guidelines on wise utilization of knee imaging are presented. They take into consideration the clinical situations and also availability and financial issues specific to Israel. These guidelines will serve physicians of several disciplines and medical insurers to improve patient management efficiently.

Guidelines for psychological practice with older adults.

PubMed

2014-01-01

The "Guidelines for Psychological Practice With Older Adults" are intended to assist psychologists in evaluating their own readiness for working with older adults and in seeking and using appropriate education and training to increase their knowledge, skills, and experience relevant to this area of practice. The specific goals of these professional practice guidelines are to provide practitioners with (a) a frame of reference for engaging in clinical work with older adults and (b) basic information and further references in the areas of attitudes, general aspects of aging, clinical issues, assessment, intervention, consultation, professional issues, and continuing education and training relative to work with this group. The guidelines recognize and appreciate that there are numerous methods and pathways whereby psychologists may gain expertise and/or seek training in working with older adults. This document is designed to offer recommendations on those areas of awareness, knowledge, and clinical skills considered as applicable to this work, rather than prescribing specific training methods to be followed. The guidelines also recognize that some psychologists will specialize in the provision of services to older adults and may therefore seek more extensive training consistent with practicing within the formally recognized specialty of Professional Geropsychology (APA, 2010c). PsycINFO Database Record (c) 2014 APA, all rights reserved.

Simultaneous quantification of fentanyl, sufentanil, cefazolin, doxapram and keto-doxapram in plasma using liquid chromatography - tandem mass spectrometry.

PubMed

Flint, Robert B; Bahmany, Soma; van der Nagel, Bart C H; Koch, Birgit C P

2018-05-16

A simple and specific UPLC-MS/MS method was developed and validated for simultaneous quantification of fentanyl, sufentanil, cefazolin, doxapram and its active metabolite keto-doxapram. The internal standard was fentanyl-d5 for all analytes. Chromatographic separation was achieved with a reversed phase Acquity UPLC HSS T3 column with a run-time of only 5.0 minutes per injected sample. Gradient elution was performed with a mobile phase consisting of ammonium acetate, formic acid in Milli-Q ultrapure water or in methanol with a total flow rate of 0.4 mL minute -1 . A plasma volume of only 50 μL was required to achieve both adequate accuracy and precision. Calibration curves of all 5 analytes were linear. All analytes were stable for at least 48 hours in the autosampler. The method was validated according to US Food and Drug Administration guidelines. This method allows quantification of fentanyl, sufentanil, cefazolin, doxapram and keto-doxapram, which serves purposes for research, as well as therapeutic drug monitoring, if applicable. The strength of this method is the combination of a small sample volume, a short run-time, a deuterated internal standard, an easy sample preparation method and the ability to simultaneously quantify all analytes in one run. This article is protected by copyright. All rights reserved.

Different mathematical processing of absorption, ratio and derivative spectra for quantification of mixtures containing minor component: An application to the analysis of the recently co-formulated antidiabetic drugs; canagliflozin and metformin

NASA Astrophysics Data System (ADS)

Lotfy, Hayam M.; Mohamed, Dalia; Elshahed, Mona S.

2018-01-01

In the presented work several spectrophotometric methods were performed for the quantification of canagliflozin (CGZ) and metformin hydrochloride (MTF) simultaneously in their binary mixture. Two of these methods; response correlation (RC) and advanced balance point-spectrum subtraction (ABP-SS) were developed and introduced for the first time in this work, where the latter method (ABP-SS) was performed on both the zero order and the first derivative spectra of the drugs. Besides, two recently established methods; advanced amplitude modulation (AAM) and advanced absorbance subtraction (AAS) were also accomplished. All the proposed methods were validated in accordance to the ICH guidelines, where all methods were proved to be accurate and precise. Additionally, the linearity range, limit of detection and limit of quantification were determined and the selectivity was examined through the analysis of laboratory prepared mixtures and the combined dosage form of the drugs. The proposed methods were capable of determining the two drugs in the ratio present in the pharmaceutical formulation CGZ:MTF (1:17) without the requirement of any preliminary separation, further dilution or standard spiking. The results obtained by the proposed methods were in compliance with the reported chromatographic method when compared statistically, proving the absence of any significant difference in accuracy and precision between the proposed and reported methods.

Antidepressants detection and quantification in whole blood samples by GC-MS/MS, for forensic purposes.

PubMed

Truta, Liliana; Castro, André L; Tarelho, Sónia; Costa, Pedro; Sales, M Goreti F; Teixeira, Helena M

2016-09-05

Depression is among the most prevalent psychiatric disorders of our society, leading to an increase in antidepressant drug consumption that needs to be accurately determined in whole blood samples in Forensic Toxicology Laboratories. For this purpose, this work presents a new gas chromatography tandem mass spectrometry (GC-MS/MS) method targeting the simultaneous and rapid determination of 14 common Antidepressants in whole blood: 13 Antidepressants (amitriptyline, citalopram, clomipramine, dothiepin, fluoxetine, imipramine, mianserin, mirtazapine, nortryptiline, paroxetine, sertraline, trimipramine and venlafaxine) and 1 Metabolite (N-desmethylclomipramine). Solid-phase extraction was used prior to chromatographic separation. Chromatographic and MS/MS parameters were selected to improve sensitivity, peak resolution and unequivocal identification of the eluted analyte. The detection was performed on a triple quadrupole tandem MS in selected ion monitoring (SIM) mode in tandem, using electronic impact ionization. Clomipramine-D3 and trimipramine-D3 were used as deutered internal standards. The validation parameters included linearity, limits of detection, lower limit of quantification, selectivity/specificity, extraction efficiency, carry-over, precision and robustness, and followed internationally accepted guidelines. Limits of quantification and detection were lower than therapeutic and sub-therapeutic concentration ranges. Overall, the method offered good selectivity, robustness and quick response (<16min) for typical concentration ranges, both for therapeutic and lethal levels. Copyright © 2016 Elsevier B.V. All rights reserved.

High-resolution monitoring of nutrients in groundwater and surface waters: process understanding, quantification of loads and concentrations, and management applications

NASA Astrophysics Data System (ADS)

van Geer, Frans C.; Kronvang, Brian; Broers, Hans Peter

2016-09-01

Four sessions on "Monitoring Strategies: temporal trends in groundwater and surface water quality and quantity" at the EGU conferences in 2012, 2013, 2014, and 2015 and a special issue of HESS form the background for this overview of the current state of high-resolution monitoring of nutrients. The overview includes a summary of technologies applied in high-frequency monitoring of nutrients in the special issue. Moreover, we present a new assessment of the objectives behind high-frequency monitoring as classified into three main groups: (i) improved understanding of the underlying hydrological, chemical, and biological processes (PU); (ii) quantification of true nutrient concentrations and loads (Q); and (iii) operational management, including evaluation of the effects of mitigation measures (M). The contributions in the special issue focus on the implementation of high-frequency monitoring within the broader context of policy making and management of water in Europe for support of EU directives such as the Water Framework Directive, the Groundwater Directive, and the Nitrates Directive. The overview presented enabled us to highlight the typical objectives encountered in the application of high-frequency monitoring and to reflect on future developments and research needs in this growing field of expertise.

Volunteers in plastic surgery guidelines for providing surgical care for children in the less developed world: part II. Ethical considerations.

PubMed

Schneider, William J; Migliori, Mark R; Gosain, Arun K; Gregory, George; Flick, Randall

2011-09-01

Many international volunteer groups provide free reconstructive plastic surgery for the poor and underserved in developing countries. An essential issue in providing this care is that it meets consistent guidelines for both quality and safety-a topic that has been addressed previously. An equally important consideration is how to provide that care in an ethical manner. No literature presently addresses the various issues involved in making those decisions. With these ethical considerations in mind, the Volunteers in Plastic Surgery Committee of the American Society of Plastic Surgeons/Plastic Surgery Foundation undertook a project to create a comprehensive set of guidelines for volunteer groups planning to provide this type of reconstructive plastic surgery in developing countries. The committee worked in conjunction with the Society for Pediatric Anesthesia on this project. The Board of the American Society of Plastic Surgeons/Plastic Surgery Foundation has approved the ethical guidelines created for the delivery of care in developing countries. The guidelines address the variety of ethical decisions that may be faced by a team working in an underdeveloped country. These guidelines make it possible for a humanitarian effort to anticipate the types of ethical decisions that are often encountered and be prepared to deal with them appropriately. Any group seeking to undertake an international mission trip in plastic surgery should be able to go to one source to find a detailed discussion of the perceived needs in providing ethical humanitarian care. This document was created to satisfy that need and is a companion to our original guidelines addressing safety and quality.

Simultaneous Quantification of Dexpanthenol and Resorcinol from Hair Care Formulation Using Liquid Chromatography: Method Development and Validation.

PubMed

De, Amit Kumar; Chowdhury, Partha Pratim; Chattapadhyay, Shyamaprasad

2016-01-01

The current study presents the simultaneous quantification of dexpanthenol and resorcinol from marketed hair care formulation. Dexpanthenol is often present as an active ingredient in personal care products for its beautifying and invigorating properties and restorative and smoothing properties. On the other hand resorcinol is mainly prescribed for the treatment of seborrheic dermatitis of scalp. The toxic side effects of resorcinol limit its use in dermatological preparations. Therefore an accurate quantification technique for the simultaneous estimation of these two components can be helpful for the formulation industries for the accurate analysis of their product quality. In the current study a high performance liquid chromatographic technique has been developed using a C18 column and a mobile phase consisting of phosphate buffer of pH = 2.8 following a gradient elution. The mobile phase flow rate was 0.6 mL per minute and the detection wavelength was 210 nm for dexpanthenol and 280 nm for resorcinol. The linearity study was carried out using five solutions having concentrations ranging between 10.34 μg·mL(-1) and 82.69 μg·mL(-1) (r (2) = 0.999) for resorcinol and 10.44 μg·mL(-1) and 83.50 μg·mL(-1) (r (2) = 0.998) for dexpanthenol. The method has been validated as per ICH Q2(R1) guidelines. The ease of single step sample preparation, accuracy, and precision (intraday and interday) study presents the method suitable for the simultaneous quantification of dexpanthenol and resorcinol from any personal care product and dermatological preparations containing these two ingredients.

Simultaneous Quantification of Dexpanthenol and Resorcinol from Hair Care Formulation Using Liquid Chromatography: Method Development and Validation

PubMed Central

De, Amit Kumar; Chowdhury, Partha Pratim; Chattapadhyay, Shyamaprasad

2016-01-01

The current study presents the simultaneous quantification of dexpanthenol and resorcinol from marketed hair care formulation. Dexpanthenol is often present as an active ingredient in personal care products for its beautifying and invigorating properties and restorative and smoothing properties. On the other hand resorcinol is mainly prescribed for the treatment of seborrheic dermatitis of scalp. The toxic side effects of resorcinol limit its use in dermatological preparations. Therefore an accurate quantification technique for the simultaneous estimation of these two components can be helpful for the formulation industries for the accurate analysis of their product quality. In the current study a high performance liquid chromatographic technique has been developed using a C18 column and a mobile phase consisting of phosphate buffer of pH = 2.8 following a gradient elution. The mobile phase flow rate was 0.6 mL per minute and the detection wavelength was 210 nm for dexpanthenol and 280 nm for resorcinol. The linearity study was carried out using five solutions having concentrations ranging between 10.34 μg·mL−1 and 82.69 μg·mL−1 (r 2 = 0.999) for resorcinol and 10.44 μg·mL−1 and 83.50 μg·mL−1 (r 2 = 0.998) for dexpanthenol. The method has been validated as per ICH Q2(R1) guidelines. The ease of single step sample preparation, accuracy, and precision (intraday and interday) study presents the method suitable for the simultaneous quantification of dexpanthenol and resorcinol from any personal care product and dermatological preparations containing these two ingredients. PMID:27042377

Ultrahigh-performance liquid chromatography/electrospray ionization linear ion trap Orbitrap mass spectrometry of antioxidants (amines and phenols) applied in lubricant engineering.

PubMed

Kassler, Alexander; Pittenauer, Ernst; Doerr, Nicole; Allmaier, Guenter

2014-01-15

For the qualification and quantification of antioxidants (aromatic amines and sterically hindered phenols), most of them applied as lubricant additives, two ultrahigh-performance liquid chromatography (UHPLC) electrospray ionization mass spectrometric methods applying the positive and negative ion mode have been developed for lubricant design and engineering thus allowing e.g. the study of the degradation of lubricants. Based on the different chemical properties of the two groups of antioxidants, two methods offering a fast separation (10 min) without prior derivatization were developed. In order to reach these requirements, UHPLC was coupled with an LTQ Orbitrap hybrid tandem mass spectrometer with positive and negative ion electrospray ionization for simultaneous detection of spectra from UHPLC-high-resolution (HR)-MS (full scan mode) and UHPLC-low-resolution linear ion trap MS(2) (LITMS(2)), which we term UHPLC/HRMS-LITMS(2). All 20 analytes investigated could be qualified by an UHPLC/HRMS-LITMS(2) approach consisting of simultaneous UHPLC/HRMS (elemental composition) and UHPLC/LITMS(2) (diagnostic product ions) according to EC guidelines. Quantification was based on an UHPLC/LITMS(2) approach due to increased sensitivity and selectivity compared to UHPLC/HRMS. Absolute quantification was only feasible for seven analytes with well-specified purity of references whereas relative quantification was obtainable for another nine antioxidants. All of them showed good standard deviation and repeatability. The combined methods allow qualitative and quantitative determination of a wide variety of different antioxidants including aminic/phenolic compounds applied in lubricant engineering. These data show that the developed methods will be versatile tools for further research on identification and characterization of the thermo-oxidative degradation products of antioxidants in lubricants. Copyright © 2013 John Wiley & Sons, Ltd.

Markers of anthropogenic contamination: A validated method for quantification of pharmaceuticals, illicit drug metabolites, perfluorinated compounds, and plasticisers in sewage treatment effluent and rain runoff.

PubMed

Wilkinson, John L; Swinden, Julian; Hooda, Peter S; Barker, James; Barton, Stephen

2016-09-01

An effective, specific and accurate method is presented for the quantification of 13 markers of anthropogenic contaminants in water using solid phase extraction (SPE) followed by high performance liquid chromatography (HPLC) tandem mass spectrometry (MS/MS). Validation was conducted according to the International Conference on Harmonisation (ICH) guidelines. Method recoveries ranged from 77 to 114% and limits of quantification between 0.75 and 4.91 ng/L. A study was undertaken to quantify the concentrations and loadings of the selected contaminants in 6 sewage treatment works (STW) effluent discharges as well as concentrations in 5 rain-driven street runoffs and field drainages. Detection frequencies in STW effluent ranged from 25% (ethinylestradiol) to 100% (benzoylecgonine, bisphenol-A (BPA), bisphenol-S (BPS) and diclofenac). Average concentrations of detected compounds in STW effluents ranged from 3.62 ng/L (ethinylestradiol) to 210 ng/L (BPA). Levels of perfluorinated compounds (PFCs) perfluorooctanoic acid (PFOA) and perfluorononanoic acid (PFNA) as well as the plasticiser BPA were found in street runoff at maximum levels of 1160 ng/L, 647 ng/L and 2405 ng/L respectively (8.52, 3.09 and 2.7 times more concentrated than maximum levels in STW effluents respectively). Rain-driven street runoff may have an effect on levels of PFCs and plasticisers in receiving rivers and should be further investigated. Together, this method with the 13 selected contaminants enables the quantification of various markers of anthropogenic pollutants: inter alia pharmaceuticals, illicit drugs and their metabolites from humans and improper disposal of drugs, while the plasticisers and perfluorinated compounds may also indicate contamination from industrial and transport activity (street runoff). Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of an analytical method for the targeted screening and multi-residue quantification of environmental contaminants in urine by liquid chromatography coupled to high resolution mass spectrometry for evaluation of human exposures.

PubMed

Cortéjade, A; Kiss, A; Cren, C; Vulliet, E; Buleté, A

2016-01-01

The aim of this study was to develop an analytical method and contribute to the assessment of the Exposome. Thus, a targeted analysis of a wide range of contaminants in contact with humans on daily routines in urine was developed. The method focused on a list of 38 contaminants, including 12 pesticides, one metabolite of pesticide, seven veterinary drugs, five parabens, one UV filter, one plastic additive, two surfactants and nine substances found in different products present in the everyday human environment. These contaminants were analyzed by high performance liquid chromatography coupled to high resolution mass spectrometry (HPLC-HRMS) with a quadrupole-time-of-flight (QqToF) instrument from a raw urinary matrix. A validation according to the FDA guidelines was employed to evaluate the specificity, linear or quadratic curve fitting, inter- and intra-day precision, accuracy and limits of detection and quantification (LOQ). The developed analysis allows for the quantification of 23 contaminants in the urine samples, with the LOQs ranging between 4.3 ng.mL(-1) and 113.2 ng.mL(-1). This method was applied to 17 urine samples. Among the targeted contaminants, four compounds were detected in samples. One of the contaminants (tributyl phosphate) was detected below the LOQ. The three others (4-hydroxybenzoic acid, sodium dodecylbenzenesulfonate and O,O-diethyl thiophosphate potassium) were detected but did not fulfill the validation criteria for quantification. Among these four compounds, two of them were found in all samples: tributyl phosphate and the surfactant sodium dodecylbenzenesulfonate. Copyright © 2015 Elsevier B.V. All rights reserved.

The Content of Statistical Requirements for Authors in Biomedical Research Journals.

PubMed

Liu, Tian-Yi; Cai, Si-Yu; Nie, Xiao-Lu; Lyu, Ya-Qi; Peng, Xiao-Xia; Feng, Guo-Shuang

2016-10-20

Robust statistical designing, sound statistical analysis, and standardized presentation are important to enhance the quality and transparency of biomedical research. This systematic review was conducted to summarize the statistical reporting requirements introduced by biomedical research journals with an impact factor of 10 or above so that researchers are able to give statistical issues' serious considerations not only at the stage of data analysis but also at the stage of methodological design. Detailed statistical instructions for authors were downloaded from the homepage of each of the included journals or obtained from the editors directly via email. Then, we described the types and numbers of statistical guidelines introduced by different press groups. Items of statistical reporting guideline as well as particular requirements were summarized in frequency, which were grouped into design, method of analysis, and presentation, respectively. Finally, updated statistical guidelines and particular requirements for improvement were summed up. Totally, 21 of 23 press groups introduced at least one statistical guideline. More than half of press groups can update their statistical instruction for authors gradually relative to issues of new statistical reporting guidelines. In addition, 16 press groups, covering 44 journals, address particular statistical requirements. The most of the particular requirements focused on the performance of statistical analysis and transparency in statistical reporting, including "address issues relevant to research design, including participant flow diagram, eligibility criteria, and sample size estimation," and "statistical methods and the reasons." Statistical requirements for authors are becoming increasingly perfected. Statistical requirements for authors remind researchers that they should make sufficient consideration not only in regards to statistical methods during the research design, but also standardized statistical reporting, which would be beneficial in providing stronger evidence and making a greater critical appraisal of evidence more accessible.

Ethics-sensitivity of the Ghana national integrated strategic response plan for pandemic influenza.

PubMed

Laar, Amos; DeBruin, Debra

2015-05-07

Many commentators call for a more ethical approach to planning for influenza pandemics. In the developed world, some pandemic preparedness plans have already been examined from an ethical viewpoint. This paper assesses the attention given to ethics issues by the Ghana National Integrated Strategic Plan for Pandemic Influenza (NISPPI). We critically analyzed the Ghana NISPPI's sensitivity to ethics issues to determine how well it reflects ethical commitments and principles identified in our review of global pandemic preparedness literature, existing pandemic plans, and relevant ethics frameworks. This paper reveals that important ethical issues have not been addressed in the Ghana NISPPI. Several important ethical issues are unanticipated, unacknowledged, and unplanned for. These include guidelines on allocation of scarce resources, the duties of healthcare workers, ethics-sensitive operational guidelines/protocols, and compensation programs. The NISPPI also pays scant attention to use of vaccines and antivirals, border issues and cooperation with neighboring countries, justification for delineated actions, and outbreak simulations. Feedback and communication plans are nebulous, while leadership, coordination, and budgeting are quite detailed. With respect to presentation, the NISPPI's text is organized around five thematic areas. While each area implicates ethical issues, NISPPI treatment of these areas consistently fails to address them. Our analysis reveals a lack of consideration of ethics by the NISPPI. We contend that, while the plan's content and fundamental assumptions provide support for implementation of the delineated public health actions, its consideration of ethical issues is poor. Deficiencies include a failure to incorporate guidelines that ensure fair distribution of scarce resources and a lack of justification for delineated procedures. Until these deficiencies are recognized and addressed, Ghana runs the risk of rolling out unjust and ethically indefensible actions with real negative effects in the event of a pandemic. Soliciting inputs from the public and consultation with ethicists during the next revision of the NISPPI will be useful in addressing these issues.

77 FR 2778 - Sentencing Guidelines for United States Courts

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-19

...Pursuant to section 994(a), (o), and (p) of title 28, United States Code, the United States Sentencing Commission is considering promulgating certain amendments to the sentencing guidelines, policy statements, and commentary. This notice sets forth the proposed amendments and, for each proposed amendment, a synopsis of the issues addressed by that amendment. This notice also sets forth a number of issues for comment, some of which are set forth together with the proposed amendments; some of which are set forth independent of any proposed amendment; and one of which (regarding retroactive application of proposed amendments) is set forth in the SUPPLEMENTARY INFORMATION portion of this notice. The proposed amendments and issues for comment in this notice are as follows: (1) A proposed amendment on fraud and related offenses, including (A) An issue for comment in response to the issue of harm to the public and financial markets, as raised by each of two directives to the Commission in section 1079A of the Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111-203; (B) a proposed change to Sec. 2B1.4 (Insider Trading) to implement the directive in section 1079A(a)(1) of that Act, and related issues for comment on insider trading, securities fraud, and similar offenses; (C) proposed changes to Sec. 2B1.1 (Theft, Property Destruction, and Fraud) regarding mortgage fraud offenses to implement the directive in section 1079A(a)(2) of that Act, and a related issue for comment on mortgage fraud and financial institution fraud; and (D) issues for comment on the impact of the loss table in Sec. 2B1.1(b)(1) and the victims table in Sec. 2B1.1(b)(2) in cases involving relatively large loss amounts; (2) a proposed amendment on offenses involving controlled substances and chemical precursors, including (A) an issue for comment on offenses involving N-Benzylpiperazine (BZP); and (B) a proposed change to Sec. 2D1.11 (Unlawfully Distributing, Importing, Exporting or Possessing a Listed Chemical; Attempt or Conspiracy) that would create a guidelines ``safety valve'' provision for offenses involving chemical precursors that would be analogous to the provision in Sec. 2D1.1 (Unlawful Manufacturing, Importing, Exporting, or Trafficking (Including Possession with Intent to Commit These Offenses); Attempt or Conspiracy); (3) a proposed amendment on human rights offenses, including (A) a proposed guideline applicable to human rights offenses; (B) proposed changes to Sec. 2L2.1 (Trafficking in a Document Relating to Naturalization, Citizenship, or Legal Resident Status, or a United States Passport; False Statement in Respect to the Citizenship or Immigration Status of Another; Fraudulent Marriage to Assist Alien to Evade Immigration Law) and Sec. 2L2.2 (Fraudulently Acquiring Documents Relating to Naturalization, Citizenship, or Legal Resident Status for Own Use; False Personation or Fraudulent Marriage by Alien to Evade Immigration Law; Fraudulently Acquiring or Improperly Using a United States Passport) to address cases in which the offense of conviction is for immigration or naturalization fraud but the defendant had committed a serious human rights offense; and (C) related issues for comment on human rights offenses; (4) a proposed amendment to Sec. 2L1.2 (Unlawfully Entering or Remaining in the United States) to respond to a circuit conflict over application of the term ``sentence imposed'' in that guideline when the defendant's original ``sentence imposed'' was lengthened after the defendant was deported; (5) a proposed amendment presenting options for specifying the types of documents that may be considered in determining whether a particular prior conviction fits within a particular category of crimes for purposes of specific guideline provisions, and related issues for comment; (6) a proposed amendment to Sec. 4A1.2 (Definitions and Instructions for Computing Criminal History) to respond to an application issue regarding when a defendant's prior sentence for driving while intoxicated or driving under the influence (and similar offenses by whatever name they are known) is counted toward the defendant's criminal history score; (7) a proposed amendment to Sec. 4B1.2 (Definitions of Terms Used in Section 4B1.1) to respond to differences among the circuits on when, if at all, burglary of a non- dwelling qualifies as a crime of violence for purposes of the guidelines, and related issues for comment; (8) a proposed amendment to Sec. 5G1.2 (Sentencing on Multiple Counts of Conviction) to respond to an application issue regarding the applicable guideline range in a case in which the defendant is sentenced on multiple counts of conviction, at least one of which involves a mandatory minimum sentence that is greater than the minimum of the otherwise applicable guideline range; (9) a proposed amendment to Sec. 5K2.19 (Post-Sentencing Rehabilitative Efforts) to respond to Pepper v. United States, 131 S.Ct. 1229 (2011), which held, among other things, that a defendant's post-sentencing rehabilitative efforts may be considered when the defendant is resentenced after appeal; and (10) a proposed amendment in response to miscellaneous issues arising from legislation recently enacted, including (A) proposed changes to Sec. 2P1.2 (Providing or Possessing Contraband in Prison) to respond to the Cell Phone Contraband Act of 2010, Public Law 111-225, and (B) proposed changes to Appendix A (Statutory Index) to address certain criminal provisions in the Prevent All Cigarette Trafficking Act of 2009, Public Law 111-154, the Indian Arts and Crafts Amendments Act of 2010, Public Law 111-211, the Animal Crush Video Prohibition Act of 2010, Public Law 111-294, and certain other statutes, and a related issue for comment.

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

PubMed

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

2011-07-01

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

Guidelines on common cold for traditional Chinese medicine based on pattern differentiation.

PubMed

Jiao, Yang; Liu, Jianping; Jiang, Liangduo; Liu, Qingquan; Li, Xiaoli; Zhang, Shunan; Zhao, Baixiao; Wang, Tianfang

2013-08-01

To establish the guidelines on common cold treated with Traditional Chinese Medicine (TCM) in terms of pattern identification. The guidelines were formulated by using the basic patterns common cold in China Pharmacopeia integrated with findings from systematic literature review and the experts' consensus on the issue in question. Common cold was divided into four patterns in the guidelines. The medications were recommended respectively: Ganmaoqingre granule for wind-cold exterior syndrome, Yinqiaojiedu granule for wind-heat exterior syndrome, Huoxiangzhengqi Wan for summer-heat dampness exterior syndrome and Shensu Wan for wind-cold exterior syndrome accompanied with Qi deficiency. The guidelines were primarily derived from the practice experience of TCM and the experts' consensus. The process was not strictly evidence-based because of lacking enough clinical studies. Further refinement of the guidelines should be needed as more studies are available.

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

PubMed

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

2011-06-01

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

Real-time PCR machine system modeling and a systematic approach for the robust design of a real-time PCR-on-a-chip system.

PubMed

Lee, Da-Sheng

2010-01-01

Chip-based DNA quantification systems are widespread, and used in many point-of-care applications. However, instruments for such applications may not be maintained or calibrated regularly. Since machine reliability is a key issue for normal operation, this study presents a system model of the real-time Polymerase Chain Reaction (PCR) machine to analyze the instrument design through numerical experiments. Based on model analysis, a systematic approach was developed to lower the variation of DNA quantification and achieve a robust design for a real-time PCR-on-a-chip system. Accelerated lift testing was adopted to evaluate the reliability of the chip prototype. According to the life test plan, this proposed real-time PCR-on-a-chip system was simulated to work continuously for over three years with similar reproducibility in DNA quantification. This not only shows the robustness of the lab-on-a-chip system, but also verifies the effectiveness of our systematic method for achieving a robust design.

Image-guided spatial localization of heterogeneous compartments for magnetic resonance

PubMed Central

An, Li; Shen, Jun

2015-01-01

Purpose: Image-guided localization SPectral Localization Achieved by Sensitivity Heterogeneity (SPLASH) allows rapid measurement of signals from irregularly shaped anatomical compartments without using phase encoding gradients. Here, the authors propose a novel method to address the issue of heterogeneous signal distribution within the localized compartments. Methods: Each compartment was subdivided into multiple subcompartments and their spectra were solved by Tikhonov regularization to enforce smoothness within each compartment. The spectrum of a given compartment was generated by combining the spectra of the components of that compartment. The proposed method was first tested using Monte Carlo simulations and then applied to reconstructing in vivo spectra from irregularly shaped ischemic stroke and normal tissue compartments. Results: Monte Carlo simulations demonstrate that the proposed regularized SPLASH method significantly reduces localization and metabolite quantification errors. In vivo results show that the intracompartment regularization results in ∼40% reduction of error in metabolite quantification. Conclusions: The proposed method significantly reduces localization errors and metabolite quantification errors caused by intracompartment heterogeneous signal distribution. PMID:26328977

Microvolume Protein Concentration Determination using the NanoDrop 2000c Spectrophotometer

PubMed Central

Desjardins, Philippe; Hansen, Joel B.; Allen, Michael

2009-01-01

Traditional spectrophotometry requires placing samples into cuvettes or capillaries. This is often impractical due to the limited sample volumes often used for protein analysis. The Thermo Scientific NanoDrop 2000c Spectrophotometer solves this issue with an innovative sample retention system that holds microvolume samples between two measurement surfaces using the surface tension properties of liquids, enabling the quantification of samples in volumes as low as 0.5-2 μL. The elimination of cuvettes or capillaries allows real time changes in path length, which reduces the measurement time while greatly increasing the dynamic range of protein concentrations that can be measured. The need for dilutions is also eliminated, and preparations for sample quantification are relatively easy as the measurement surfaces can be simply wiped with laboratory wipe. This video article presents modifications to traditional protein concentration determination methods for quantification of microvolume amounts of protein using A280 absorbance readings or the BCA colorimetric assay. PMID:19890248

32 CFR 56.9 - Ensuring compliance with this part in Federal financial assistance programs and activities.

Code of Federal Regulations, 2012 CFR

2012-07-01

... approval of these supplementary guidelines from the ASD(MRA&L), or designee, before issuing them. Prior to their issuance, the ASD(MRA&L), or designee, shall submit supplementary guidelines prepared pursuant to... Components deal with the employment of civilians in programs and activities subject to this part the ASD(MRA...

32 CFR 56.9 - Ensuring compliance with this part in Federal financial assistance programs and activities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... approval of these supplementary guidelines from the ASD(MRA&L), or designee, before issuing them. Prior to their issuance, the ASD(MRA&L), or designee, shall submit supplementary guidelines prepared pursuant to... Components deal with the employment of civilians in programs and activities subject to this part the ASD(MRA...

32 CFR 56.9 - Ensuring compliance with this part in Federal financial assistance programs and activities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... approval of these supplementary guidelines from the ASD(MRA&L), or designee, before issuing them. Prior to their issuance, the ASD(MRA&L), or designee, shall submit supplementary guidelines prepared pursuant to... Components deal with the employment of civilians in programs and activities subject to this part the ASD(MRA...

Online Identity: Guidelines for Discerning Covert Racism in Blogs

ERIC Educational Resources Information Center

Kurubacak, Gulsun

2008-01-01

Blogs are web sites, which have the specific themes and are updated with the latest news, views, and trends including philosophical reflections, opinions, and social and/or political issues. Due to representing the personality of the author or the web site, the main purpose of this article is to discuss the guidelines of discerning covert racism…

A Study of the Implementation of Sex Education in Hong Kong Secondary Schools

ERIC Educational Resources Information Center

Che, Fok Shui

2005-01-01

Sex education is not treated as an important subject in the school curriculum of Hong Kong. The Hong Kong Education Department issued in 1986 and 1997, respectively, two guidelines on sex education for schools' reference. The 1997 Guidelines cover a broader conceptual framework relating to different aspects of human sexuality and also include…

Concerns of Parents and Teachers of Children with Autism in Elementary School

ERIC Educational Resources Information Center

Azad, Gazi; Mandell, David S.

2016-01-01

Many consensus guidelines encourage parents and teachers to openly communicate about their concerns regarding their children. These guidelines attest to the importance of achieving consensus about what issues are most critical and how to address them. The purpose of this study was to examine whether parents and teachers (1) agree about their…

77 FR 26238 - Fisheries of the United States; National Standard 1 Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-03

... this work, a number of issues regarding the application of the NS1 Guidelines were identified that may.... Further guidance on how OY should be specified to balance the multiple considerations in mixed-stock.... Under the MSA, stocks that have a life cycle of approximately 1 year and stocks subject to international...

Brief Report: Stony Brook Guidelines on the Ethics of the Care of People with Autism and Their Families

ERIC Educational Resources Information Center

Post, Stephen G.; Pomeroy, John; Keirns, Carla C.; Cover, Virginia Isaacs; Dorn, Michael Leverett; Boroson, Louis; Boroson, Florence; Coulehan, Anne; Coulehan, Jack; Covell, Kim; Kubasek, Kim; Luchsinger, Elizabeth; Nichols, Shana; Parles, James; Schreiber, Linda; Tetenbaum, Samara P.; Walsh, Rose Ann

2013-01-01

The increased prevalence of autism spectrum disorders (ASD), with associated societal and clinical impacts, calls for a broad community-based dialogue on treatment related ethical and social issues. The Stony Brook Guidelines, based on a community dialogue process with affected individuals, families and professionals, identify and discuss the…

Children and Youth Assisted by Medical Technology in Educational Settings: Guidelines for Care. Second Edition.

ERIC Educational Resources Information Center

Porter, Stephanie, Ed.; Haynie, Marilynn, Ed.; Bierle, Timaree, Ed.; Caldwell, Terry Heintz, Ed.; Palfrey, Judith S., Ed.

This manual is intended to provide specific guidelines for meeting the needs of students who are assisted by medical technology in the educational setting. The manual is divided into two sections: Section 1 discusses principles and issues concerned with applying medical technology in schools, and Section 2 details the various procedures and…

NASA Safety Standard: Guidelines and Assessment Procedures for Limiting Orbital Debris

NASA Technical Reports Server (NTRS)

1995-01-01

Collision with orbital debris is a hazard of growing concern as historically accepted practices and procedures have allowed man-made objects to accumulate in orbit. To limit future debris generation, NASA Management Instruction (NMI) 1700.8, 'Policy to Limit Orbital Debris Generation,' was issued in April of 1993. The NMI requires each program to conduct a formal assessment of the potential to generate orbital debris. This document serves as a companion to NMI 1700.08 and provides each NASA program with specific guidelines and assessment methods to assure compliance with the NMI. Each main debris assessment issue (e.g., Post Mission Disposal) is developed in a separate chapter.

Planetary protection issues for the MESUR mission: Probability of growth (Pg)

NASA Technical Reports Server (NTRS)

Klein, Harold P. (Editor)

1993-01-01

The purpose of the workshop was to re-evaluate the existing guidelines for the probability of growth of terrestrial organisms on Mars that were established by the National Academy of Sciences following the Viking Mission. A panel of specialists in microbiology and allied fields reviewed this issue in the light of current information about the physical and chemical environments expected on Mars. Their deliberations resulted in the virtually unanimous conclusion that the existing Pg guidelines were either appropriate or that the values for Pg should be further reduced. Individual assessments of this problem by each of the participants, together with those of additional invited experts are included.

[Methodological and operational notes for the assessment and management of the risk of work-related stress].

PubMed

De Ambrogi, Francesco; Ratti, Elisabetta Ceppi

2011-01-01

Today the Italian national debate over the Work-Related Stress Risk Assessment methodology is rather heated. Several methodological proposals and guidelines have been published in recent months, not least those by the "Commissione Consultiva". But despite this wide range of proposals, it appears that there is still a lack of attention to some of the basic methodological issues that must be taken into account in order to correctly implement the above-mentioned guidelines. The aim of this paper is to outline these methodological issues. In order to achieve this, the most authoritative methodological proposals and guidelines have been reviewed. The study focuses in particular on the methodological issues that could lead to important biases if not considered properly. The study leads to some considerations about the methodological validity of a Work-Related Stress Risk Assessment based exclusively on the literal interpretation of the considered proposals. Furthermore, the study provides some hints and working hypotheses on how to overcome these methodological limits. This study should be considered as a starting point for further investigations and debate on the Work-Related Stress Risk Assessment methodology on a national level.

The Room Where It Happens: A Skeptic's Analysis of the New Heart Failure Guidelines.

PubMed

Packer, Milton

2016-09-01

New heart failure guidelines have been issued during the past several months, both in the United States and in Europe, in response to recent advances in and the approval of new drugs for the treatment of heart failure. Although guidelines documents are often viewed as authoritative and purely evidence-based, there are replete with meaningful (and inexplicable) inconsistencies, which derive from a review of the same body of scientific data by different groups. This satirical review highlights several examples of the entertaining foolishness of recent guideline documents in the good-natured hope that physicians will understand what the guidelines are, and more importantly, what they are not. Specifically, this paper describes the emergence of a new nonexistent disease; the strange battle between 2 bradycardic drugs (digoxin and ivabradine); the confusion that reigns over the positioning and dosing of inhibitors of the renin-angiotensin system; and the special recommendations that have been issued for certain special populations. As Otto von Bismarck remarked, guideline deliberations are like sausages; it is better not to see them being made. Yet, even after they are ready for public view, we should be cautious. Practitioners who rely on them for clinical decision-making engage in an unnecessary form of self-deception; those who read them literally and adhere to them strictly do not practice evidence-based medicine; and those who delve into them in a search for the truth are destined to be disappointed. Copyright © 2016 Elsevier Inc. All rights reserved.

Issues in Peer Review of the Scientific Basis for Regulatory Decisions.

ERIC Educational Resources Information Center

American Chemical Society, Washington, DC.

This document is intended to provide a discussion of the issues that need to be addressed in the development of peer review guidelines, the options for addressing the issues, and a range of views about such options. The document focuses on peer review with regard to regulatory decisions and contains major sections which deal with: (1) what should…

School Quality in the Cloud: Guidelines for Authorizing Virtual Charter Schools. Authorizing Matters. Issue Brief. Cyber Series

ERIC Educational Resources Information Center

Lin, Margaret

2011-01-01

This Issue Brief, an update of "Authorizing Virtual Charter Schools: Rules of the Road on the Digital Highway" by Gregg Vanourek, is part of NACSA's Cyber series, which addresses issues in policy and practice that concern authorizing online schools and blended learning. It aims to improve authorizer understanding and oversight of online…

Uncertainty Estimation Cheat Sheet for Probabilistic Risk Assessment

NASA Technical Reports Server (NTRS)

Britton, Paul; Al Hassan, Mohammad; Ring, Robert

2017-01-01

Quantitative results for aerospace engineering problems are influenced by many sources of uncertainty. Uncertainty analysis aims to make a technical contribution to decision-making through the quantification of uncertainties in the relevant variables as well as through the propagation of these uncertainties up to the result. Uncertainty can be thought of as a measure of the 'goodness' of a result and is typically represented as statistical dispersion. This paper will explain common measures of centrality and dispersion; and-with examples-will provide guidelines for how they may be estimated to ensure effective technical contributions to decision-making.

Manual ahorro de energia en la industria (Energy conservation manual for industry)

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

Not Available

1983-01-01

This manual gives general guidelines on which to base an energy conservation program, signals situations and opportunities for energy savings in an industrial plant, provides information for easy quantification of energy loss, and signals how to correct deficiencies in certain important aspects such as combustion and insulation. One chapter deals with heat audits, an extremely useful tool for identifying areas on which one should concentrate to achieve energy savings. The manual also describes general heating systems with a view to pointing out ways to increase efficiency and eliminate defects, including steam systems and oil, coal, and firewood combustion.

Debating Real-World Issues.

ERIC Educational Resources Information Center

Koenig, Maureen

2001-01-01

Presents three different scientific issues to students and uses debate as a way of gaining information. Involves information collection on the topic, team preparation, and debate between teams. Includes debate format and presentation guidelines, suggestions for debate questions, information on areas to explore when preparing to debate the question…

77 FR 58086 - Fisheries of the United States; National Standard 1 Guidelines; Reopening of Public Comment Period

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-19

... issues, NMFS feels reopening the comment period will provide for a fuller range of public input on the... management and the complexity of the issues, NMFS feels reopening the comment period will provide for a...

Bond Issues.

ERIC Educational Resources Information Center

Pollack, Rachel H.

2000-01-01

Notes trends toward increased borrowing by colleges and universities and offers guidelines for institutions that are considering issuing bonds to raise money for capital projects. Discussion covers advantages of using bond financing, how use of bonds impacts on traditional fund raising, other cautions and concerns, and some troubling aspects of…

Dutch Research on Knowledge-Based Instructional Systems: Introduction to the Special Issue.

ERIC Educational Resources Information Center

van Merrienboer, Jeroen J. G.

1994-01-01

Provides an overview of this issue that reviews Dutch research concerning knowledge-based instructional systems. Topics discussed include experimental research, conceptual models, design considerations, and guidelines; the design of student diagnostic modules, instructional modules, and interface modules; second-language teaching; intelligent…

Korean Medication Algorithm for Depressive Disorder: Comparisons with Other Treatment Guidelines

PubMed Central

Wang, Hee Ryung; Park, Young-Min; Lee, Hwang Bin; Song, Hoo Rim; Jeong, Jong-Hyun; Seo, Jeong Seok; Lim, Eun-Sung; Hong, Jeong-Wan; Kim, Won; Jon, Duk-In; Hong, Jin-Pyo; Woo, Young Sup; Min, Kyung Joon

2014-01-01

We aimed to compare the recommendations of the Korean Medication Algorithm Project for Depressive Disorder 2012 (KMAP-DD 2012) with other recently published treatment guidelines for depressive disorder. We reviewed a total of five recently published global treatment guidelines and compared each treatment recommendation of the KMAP-DD 2012 with those in other guidelines. For initial treatment recommendations, there were no significant major differences across guidelines. However, in the case of nonresponse or incomplete response to initial treatment, the second recommended treatment step varied across guidelines. For maintenance therapy, medication dose and duration differed among treatment guidelines. Further, there were several discrepancies in the recommendations for each subtype of depressive disorder across guidelines. For treatment in special populations, there were no significant differences in overall recommendations. This comparison identifies that, by and large, the treatment recommendations of the KMAP-DD 2012 are similar to those of other treatment guidelines and reflect current changes in prescription pattern for depression based on accumulated research data. Further studies will be needed to address several issues identified in our review. PMID:24605117

Drugged driving in Louisiana : quantification of its impact on public health and implications for legislation, enforcement and prosecution.

DOT National Transportation Integrated Search

2015-07-20

Drugged driving, i.e., driving under the influence of drugs, is considered a rising public health issue in the US and the rest of the world, yet due to underreporting and limitations of existing data, not much is known about the frequency of drugged ...

Bias in Mental Testing.

ERIC Educational Resources Information Center

Jensen, Arthur R.

The first eight chapters of this book introduce the topic of test bias. The basic issues involved in criticisms of mental tests and arguments about test bias include: (1) variety of tests and test items; (2) scaling of scores and the form of the distribution of abilities in the population; (3) quantification of subpopulation differences; (4)…

Analysis of biomass dynamics derived from spectral trajectories.

Treesearch

S.L. Powell; W.B. Cohen; R.E. Kennedy

2007-01-01

Quantification of the rates and variability of forest disturbance and regrowth at continental scales remains a critical challenge. We have undertaken an effort to address these issues, through funding from NASA, by coordinating research efforts between the USDA Forest Service Forest Inventory and Analysis (FIA) and the North American Carbon Program (NACP). We present...

Quantification of hsp70 mRNA from the Cryptosporidium parvum in soil by reverse transcription real-time PCR

EPA Science Inventory

As one of the leading causes of waterborne enteric disease, Cryptosporidium parvum poses significant threat to public health. Besides water, soil can also become an important environmental source of C. parvum once polluted. Detection of viable C. parvum in soil is a key issue whe...

UNESCO Guidelines on Intercultural Education

ERIC Educational Resources Information Center

United Nations Educational, Scientific and Cultural Organization (UNESCO), 2007

2007-01-01

This paper aims to synthesize the central issues surrounding Intercultural Education, and presents the fundamental guiding principles for an intercultural approach to education as viewed by UNESCO. It is divided into three parts. Part I outlines the key issues surrounding Intercultural Education, as well as its objectives and basic operating…

76 FR 55213 - Commercial Transportation of Equines to Slaughter

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 88 [Docket No... regulations were issued pursuant to the provisions of the Federal Agriculture Improvement and Reform Act of... and special needs, authorized the Secretary of Agriculture to issue guidelines for the regulation of...

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

75 FR 53643 - Examination Guidelines Update: Developments in the Obviousness Inquiry After KSR v.Teleflex

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-01

...The United States Patent and Trademark Office (USPTO or Office) is issuing an update (2010 KSR Guidelines Update) to its obviousness guidelines for its personnel to be used when applying the law of obviousness under 35 U.S.C. 103. This 2010 KSR Guidelines Update highlights case law developments on obviousness under 35 U.S.C. 103 since the 2007 decision by the United States Supreme Court (Supreme Court) in KSR Int'l Co. v. Teleflex Inc. These guidelines are intended to be used by Office personnel in conjunction with the guidance in the Manual of Patent Examining Procedure when applying the law of obviousness under 35 U.S.C. 103. Members of the public are invited to provide comments on the 2010 KSR Guidelines Update. The Office is especially interested in receiving suggestions of recent decisional law in the field of obviousness that would have particular value as teaching tools.

Guidelines for handling radioactively contaminated decedents.

PubMed

Wood, Charles M; DePaolo, Frank; Whitaker, Doggett

2008-05-01

The Centers for Disease Control and Prevention recently issued guidelines for medical examiners, coroners, and morticians in dealing with decedents after detonation of an improvised nuclear device (IND) or radiological dispersal device (RDD) (). Partners in this effort included the New York City Office of Chief Medical Examiner and the National Funeral Directors' Association. This paper describes the handling techniques required for loose surface contamination, radioactive shrapnel, and internal contamination caused by inhaling or ingesting radioactive materials from an IND or RDD, and provides suggested guidelines for medical examiners, coroners, and morticians to deal with these situations.

[Guideline for the Diagnosis and Treatment of COPD Patients - Issued by the German Respiratory Society and the German Atemwegsliga in Cooperation with the Austrian Society of Pneumology].

PubMed

Vogelmeier, C; Buhl, R; Burghuber, O; Criée, C-P; Ewig, S; Godnic-Cvar, J; Hartl, S; Herth, F; Kardos, P; Kenn, K; Nowak, D; Rabe, K F; Studnicka, M; Watz, H; Welte, T; Windisch, W; Worth, H

2018-04-01

This document is a revision of the guideline for diagnosis and treatment of COPD that replaces the version from 2007. A multitude of recent reports regarding risk factors, diagnosis, assessment, prevention and pharmacological as well as non-pharmacological treatment options made a major revision mandatory. The new guideline is based on the GOLD document taking into account specifics in Germany and Austria. © Georg Thieme Verlag KG Stuttgart · New York.

Protein turnover measurement using selected reaction monitoring-mass spectrometry (SRM-MS)

PubMed Central

Holman, Stephen W.; Hammond, Dean E.; Simpson, Deborah M.; Waters, John; Hurst, Jane L.

2016-01-01

Protein turnover represents an important mechanism in the functioning of cells, with deregulated synthesis and degradation of proteins implicated in many diseased states. Therefore, proteomics strategies to measure turnover rates with high confidence are of vital importance to understanding many biological processes. In this study, the more widely used approach of non-targeted precursor ion signal intensity (MS1) quantification is compared with selected reaction monitoring (SRM), a data acquisition strategy that records data for specific peptides, to determine if improved quantitative data would be obtained using a targeted quantification approach. Using mouse liver as a model system, turnover measurement of four tricarboxylic acid cycle proteins was performed using both MS1 and SRM quantification strategies. SRM outperformed MS1 in terms of sensitivity and selectivity of measurement, allowing more confident determination of protein turnover rates. SRM data are acquired using cheaper and more widely available tandem quadrupole mass spectrometers, making the approach accessible to a larger number of researchers than MS1 quantification, which is best performed on high mass resolution instruments. SRM acquisition is ideally suited to focused studies where the turnover of tens of proteins is measured, making it applicable in determining the dynamics of proteins complexes and complete metabolic pathways. This article is part of the themed issue ‘Quantitative mass spectrometry’. PMID:27644981

Near-infrared spectroscopy for the detection and quantification of bacterial contaminations in pharmaceutical products.

PubMed

Quintelas, Cristina; Mesquita, Daniela P; Lopes, João A; Ferreira, Eugénio C; Sousa, Clara

2015-08-15

Accurate detection and quantification of microbiological contaminations remains an issue mainly due the lack of rapid and precise analytical techniques. Standard methods are expensive and time-consuming being associated to high economic losses and public health threats. In the context of pharmaceutical industry, the development of fast analytical techniques able to overcome these limitations is crucial and spectroscopic techniques might constitute a reliable alternative. In this work we proved the ability of Fourier transform near infrared spectroscopy (FT-NIRS) to detect and quantify bacteria (Bacillus subtilis, Escherichia coli, Pseudomonas fluorescens, Salmonella enterica, Staphylococcus epidermidis) from 10 to 10(8) CFUs/mL in sterile saline solutions (NaCl 0.9%). Partial least squares discriminant analysis (PLSDA) models showed that FT-NIRS was able to discriminate between sterile and contaminated solutions for all bacteria as well as to identify the contaminant bacteria. Partial least squares (PLS) models allowed bacterial quantification with limits of detection ranging from 5.1 to 9 CFU/mL for E. coli and B. subtilis, respectively. This methodology was successfully validated in three pharmaceutical preparations (contact lens solution, cough syrup and topic anti-inflammatory solution) proving that this technique possess a high potential to be routinely used for the detection and quantification of bacterial contaminations. Copyright © 2015 Elsevier B.V. All rights reserved.

Optimization of High-Throughput Sequencing Kinetics for determining enzymatic rate constants of thousands of RNA substrates

PubMed Central

Niland, Courtney N.; Jankowsky, Eckhard; Harris, Michael E.

2016-01-01

Quantification of the specificity of RNA binding proteins and RNA processing enzymes is essential to understanding their fundamental roles in biological processes. High Throughput Sequencing Kinetics (HTS-Kin) uses high throughput sequencing and internal competition kinetics to simultaneously monitor the processing rate constants of thousands of substrates by RNA processing enzymes. This technique has provided unprecedented insight into the substrate specificity of the tRNA processing endonuclease ribonuclease P. Here, we investigate the accuracy and robustness of measurements associated with each step of the HTS-Kin procedure. We examine the effect of substrate concentration on the observed rate constant, determine the optimal kinetic parameters, and provide guidelines for reducing error in amplification of the substrate population. Importantly, we find that high-throughput sequencing, and experimental reproducibility contribute their own sources of error, and these are the main sources of imprecision in the quantified results when otherwise optimized guidelines are followed. PMID:27296633

Multiple Myeloma, Version 2.2016

PubMed Central

Anderson, Kenneth C.; Alsina, Melissa; Atanackovic, Djordje; Biermann, J. Sybil; Chandler, Jason C.; Costello, Caitlin; Djulbegovic, Benjamin; Fung, Henry C.; Gasparetto, Cristina; Godby, Kelly; Hofmeister, Craig; Holmberg, Leona; Holstein, Sarah; Huff, Carol Ann; Kassim, Adetola; Krishnan, Amrita Y.; Kumar, Shaji K.; Liedtke, Michaela; Lunning, Matthew; Raje, Noopur; Singhal, Seema; Smith, Clayton; Somlo, George; Stockerl-Goldstein, Keith; Treon, Steven P.; Weber, Donna; Yahalom, Joachim; Shead, Dorothy A.; Kumar, Rashmi

2016-01-01

Multiple myeloma (MM) is a malignant neoplasm of plasma cells that accumulate in bone marrow, leading to bone destruction and marrow failure. Recent statistics from the American Cancer Society indicate that the incidence of MM is increasing. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) included in this issue address management of patients with solitary plasmacytoma and newly diagnosed MM. PMID:26553768

School Desegregation in Minneapolis, Minnesota: A Staff Report of the U.S. Commission on Civil Rights.

ERIC Educational Resources Information Center

Commission on Civil Rights, Washington, DC.

The desegregation of the Minneapolis, Minnesota schools was initiated in 1972, although the process leading to desegregation actually began in 1967 when the board of education adopted its first human relations guidelines and announced a voluntary urban transfer program. In 1970 the state of Minnesota issued desegregation guidelines which set a 30%…

Selecting and Planning for an Automated Library System: Guidelines for Libraries.

ERIC Educational Resources Information Center

Piccininni, James

Guidelines are given for automating a library. Issues arising in automation are illustrated through the experience of the Doherty Library of the University of St. Thomas, Houston (Texas). The first step is to decide what type of system is right for the needs of the library and its patrons. In considering vendors of systems, it is important to…

Travel Guide to Healthy School Meals: School Menu Planning to Meet Our Children's Nutritional Needs.

ERIC Educational Resources Information Center

Oregon State Dept. of Education, Salem.

In 1994, Congress passed the Healthy Meals for Healthy Americans Act, requiring that Child Nutrition Programs comply with the Dietary Guidelines for Americans and meet nutrient standards. In 1995, the U.S. Department of Agriculture (USDA) issued new regulations to define how the Dietary Guidelines would be applied to school meals, called the…

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

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

Children Who Lose Their Parents to HIV/AIDS: Agency Guidelines for Adoptive and Kinship Placement.

ERIC Educational Resources Information Center

Merkel-Holguin, Lisa

Across the United States and world, children who lose their parents to HIV/AIDS are one of the fasted emerging groups affected by this epidemic. Increasingly, child welfare and family service agencies are helping infected parents to secure legal and permanent care arrangements for their children. These guidelines address the issues of placing…

Medical professionalism: a tale of two doctors.

PubMed

Gorrindo, Tristan; Groves, James E

2011-01-01

The AMA's social media guidelines provide physicians with some basic rules for maintaining professional boundaries when engaging in online activities. Left unanswered are questions about how these guidelines are to be implemented by physicians of different generations. By examining the issues of privacy and technological skill through the eyes of digital natives and digital immigrants, the challenges associated with medical e-professionalism become clear.

The development of guidelines for drug and alcohol dependence treatment: affecting policy and practice.

PubMed

Heather, N; Mattick, R P

1994-01-01

The rationale and methodology behind the Australian Quality Assurance Project is described. The Project aimed to develop guidelines for treatment content based on three sources of information: research findings, current practice and expert opinion. The issue of the gap between research and practice is discussed, as well as the role of dissemination in altering clinician behaviour.

The Pregnancy Discrimination Act: employer health insurance plans must cover prescription contraceptives.

PubMed

Kurtz, J M; Mehoves, C

2001-09-01

The Equal Employment Opportunity Commission (EEOC), which recently took the position that employer health plans are required, in many instances, to cover prescription contraceptives, has issued guidelines to assist employers in complying with the law prohibiting discrimination on the basis of sex and pregnancy. Employers should review these guidelines carefully in relation to their health care plans.

Religious Music, the Public Schools, and the Establishment Clause: A Review of Federal Case Law

ERIC Educational Resources Information Center

Cranmore, Jeff; Fossey, Richard

2014-01-01

Various issues relating to education and religion continue to appear in federal court. One issue that is most relevant to music educators is the use of religious music in school music curriculum. Although no federal guidelines exist as to what is acceptable usage, a number of federal cases have addressed the various issues, from the use of…

School Age Child Care: Common Issues in Program Design and Evaluation with Annotated Bibliography. Australian Early Childhood Resource Booklets No. 2.

ERIC Educational Resources Information Center

Piscitelli, Barbara

Noting an increase in demand for school-age child care offerings, with no corresponding establishment of guidelines for program development, this booklet addresses design and evaluation issues in school age child care (SACC) in Australia. The booklet is largely based on two surveys of SACC programs conducted in 1986. The issues discussed in the…

A qualitative and quantitative HPTLC densitometry method for the analysis of cannabinoids in Cannabis sativa L.

PubMed

Fischedick, Justin T; Glas, Ronald; Hazekamp, Arno; Verpoorte, Rob

2009-01-01

Cannabis and cannabinoid based medicines are currently under serious investigation for legitimate development as medicinal agents, necessitating new low-cost, high-throughput analytical methods for quality control. The goal of this study was to develop and validate, according to ICH guidelines, a simple rapid HPTLC method for the quantification of Delta(9)-tetrahydrocannabinol (Delta(9)-THC) and qualitative analysis of other main neutral cannabinoids found in cannabis. The method was developed and validated with the use of pure cannabinoid reference standards and two medicinal cannabis cultivars. Accuracy was determined by comparing results obtained from the HTPLC method with those obtained from a validated HPLC method. Delta(9)-THC gives linear calibration curves in the range of 50-500 ng at 206 nm with a linear regression of y = 11.858x + 125.99 and r(2) = 0.9968. Results have shown that the HPTLC method is reproducible and accurate for the quantification of Delta(9)-THC in cannabis. The method is also useful for the qualitative screening of the main neutral cannabinoids found in cannabis cultivars.

Optimization and validation of a method using UHPLC-fluorescence for the analysis of polycyclic aromatic hydrocarbons in cold-pressed vegetable oils.

PubMed

Silva, Simone Alves da; Sampaio, Geni Rodrigues; Torres, Elizabeth Aparecida Ferraz da Silva

2017-04-15

Among the different food categories, the oils and fats are important sources of exposure to polycyclic aromatic hydrocarbons (PAHs), a group of organic chemical contaminants. The use of a validated method is essential to obtain reliable analytical results since the legislation establishes maximum limits in different foods. The objective of this study was to optimize and validate a method for the quantification of four PAHs [benzo(a)anthracene, chrysene, benzo(b)fluoranthene, benzo(a)pyrene] in vegetable oils. The samples were submitted to liquid-liquid extraction, followed by solid-phase extraction, and analyzed by ultra-high performance liquid chromatography. Under the optimized conditions, the validation parameters were evaluated according to the INMETRO Guidelines: linearity (r2 >0.99), selectivity (no matrix interference), limits of detection (0.08-0.30μgkg -1 ) and quantification (0.25-1.00μgkg -1 ), recovery (80.13-100.04%), repeatability and intermediate precision (<10% RSD). The method was found to be adequate for routine analysis of PAHs in the vegetable oils evaluated. Copyright © 2016. Published by Elsevier Ltd.

Capillary zone electrophoresis for the determination of amodiaquine and three of its synthetic impurities in pharmaceutical formulations.

PubMed

Mufusama, Jean-Pierre; Hoellein, Ludwig; Feineis, Doris; Holzgrabe, Ulrike; Bringmann, Gerhard

2018-05-29

A simple and robust CZE method was developed for the separation and quantification of the antimalarial compound amodiaquine as well as three of its synthetic impurities at a concentration equal to or lower than 0.5%. For capillary electrophoresis, a fused-silica capillary, a background electrolyte of 100 mM sodium phosphate buffer at a pH value of 6.2, a voltage of +20 kV, and a detection wavelength of 220 nm were used, allowing the determination of the analytes within 20 minutes. The method was validated according to the guideline Q2(R1) of the International Council for Harmonization with respect to linearity, precision, accuracy, limit of detection and limit of quantification, and was successfully applied to evaluate the quality of drug samples collected in the Democratic Republic of the Congo. Quantitative analysis results obtained by the CZE method were compared to those obtained with the contemporary HPLC method described in The International Pharmacopoeia. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Serving our communities better. Guidelines for planning and developing integrated delivery networks.

PubMed

Prybil, L; Golden, P; Ballance, X

1995-04-01

In 1994 the Daughters of Charity National Health System-East Central (DCNHS-East Central) adopted 11 guidelines to help corporate staff and local leaders plan and develop integrated networks. Guideline 1 emphasizes needs-based strategic planning. Guideline 2 focuses on the community-based network planning process, recommending a team approach and ongoing communication with the local ordinary. In guidelines 3 through 5, the DCNHS-East Central Board of Directors spells out key issues that must be covered in proposals ultimately presented for governance action. Guideline 6 presents three core elements that should characterize all CBNs in which DCNHS-East Central institutions participate. Guideline 7 emphasizes that all CBN proposals and agreements must be clear with respect to the Catholic identity of DCNHS-East Central institutions. Guidelines 8 and 9 require that proposed changes to traditional policies and management practices be explicit in CBN proposals. The tenth guideline requires that all CBN proposals indicate an explicit evaluation function. The final guideline underscores that regardless of the strategic fit or how well a CBN is designed, it is unlikely to succeed unless both internal and external relationships are based on a solid foundation of honesty, mutual respect, and trust.

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

PubMed

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

2005-01-01

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

Supportive Care Treatment Guidelines: Value, Limitations, and Opportunities

PubMed Central

Peterson, Douglas E.; Bensadoun, Rene-Jean; Lalla, Rajesh V.; McGuire, Deborah B.

2013-01-01

Evidence-based guidelines in clinical oncology practice are now prominent, with emphasis on clinical, health outcome and economic perspectives. Given the complexity of cancer management, a multidisciplinary approach is essential. Evidence-based guidelines to address supportive cancer care have merged expert opinion, systematic evaluation of clinical and research data, and meta-analyses of clinical trials. Production of supportive care guidelines by the interdisciplinary team is dependent on sufficient high-quality research studies. Once published, it is essential they be customized at institutional and national levels. Implementation in clinical practice is perhaps the greatest challenge. Optimal management occurs through integration of country-specific issues, including care access, healthcare resources, information technology, and national coordination of healthcare practices. The purpose of this article is to: (1) provide an overview of interdisciplinary cancer management using evidence-based guidelines; (2) delineate the theory and practice of guideline dissemination, utilization and outcome assessment; and (3) recommend future research strategies to maximize guidelines use in clinical practice. PMID:21600365

Acromegaly: an endocrine society clinical practice guideline.

PubMed

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

2014-11-01

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

[Clinical practice guidelines: juridical and medico legal issues in health care malpractice liability].

PubMed

Moreschi, Carlo; Broi, Ugo Da

2014-01-01

Clinical Practice Guidelines are clinical tools addressed to medical and health professionals and are normally employed to improve quality and safety of diagnostic and therapeutical procedures but may sometimes limit the autonomy of medical and other health care professionals. The adherence to Clinical Practice Guidelines should not be an exclusive step to evaluate the liability and respect of standards of care in case of medico-legal investigations being each clinical case very specific. Medical liability and respect of standards of care should be evaluated with the support of Clinical Practice Guidelines and the extensive examination of all specific features, professional background and experience requested to treat each single patient.

WHO Treatment Guidelines for Drug-Resistant Tuberculosis, 2016 Update: Applicability in South Korea

PubMed Central

2017-01-01

Despite progress made in tuberculosis control worldwide, the disease burden and treatment outcome of multidrug-resistant tuberculosis (MDR-TB) patients have remained virtually unchanged. In 2016, the World Health Organization released new guidelines for the management of MDR-TB. The guidelines are intended to improve detection rate and treatment outcome for MDR-TB through novel, rapid molecular testing and shorter treatment regimens. Key changes include the introduction of a new, shorter MDR-TB treatment regimen, a new classification of medicines and updated recommendations for the conventional MDR-TB regimen. This paper will review these key changes and discuss the potential issues with regard to the implementation of these guidelines in South Korea. PMID:28905529

a Review on Legal Traceability of Gnss Measurements in the Malaysian Cadastral Practice

NASA Astrophysics Data System (ADS)

Gill, J.; Shariff, N. S.; Omar, K. M.; Din, A. H. M.; Amin, Z. M.

2016-09-01

As the dependency on Global Navigation Satellite System (GNSS) in surveying has been growing over the years, the need for legal traceability of GNSS measurements has become a significant matter. In Malaysia, with the advent of the Malaysia Real-time Kinematic Network (MyRTKnet), GNSS surveying has revolutionised land survey and mapping. Correspondingly, the Department of Survey and Mapping Malaysia (DSMM) amended and published standard regulations and guidelines concerning cadastral survey, i.e., Cadastral Survey Regulations 2009, to include GNSS measurements. However, these regulations and guidelines has not comprehensively incorporated legal traceability of GNSS measurements; which is a prerequisite for cadastral surveys as it requires reliable and conclusive evidence for issues such as boundary disputes. The first objective of this paper is to review and discuss the legal traceability of GNSS measurements. Secondly, it will highlight the current practice and issues, i.e., with regard to legal traceability, within the present Malaysian cadastral regulation and guidelines, in relation to the prevalently adopted Network RTK (N-RTK) technique, GNSS instrument calibrations, and reference stations' accuracy. Lastly, a rudimentary best practice guideline for GNSS surveying in cadastral survey for Malaysia is proposed. It is expected that this paper will contribute to the implementation of a best practice guideline, which is inclusive of legal traceability of GNSS measurements, for the Malaysian cadastral practice.

Healthcare workers' knowledge and perceptions of the risks associated with emerging extensively drug-resistant bacteria.

PubMed

Celeste, C; Jolivet, S; Bonneton, M; Brun-Buisson, C; Jansen, C

2017-11-01

Guidelines have been issued in 2010 to prevent the spread of emerging extensively resistant bacteria (eXDR), but their implementation is difficult. We aimed to evaluate healthcare workers' (HCW) knowledge and their risk perception to identify barriers to the implementation of guidelines. Semi-structured interviews were conducted at a University Hospital, where case patients are regularly admitted. The interviews focused on HCW's knowledge, risk perception, and challenges met. The evaluation of HCW's knowledge and contagiousness and perception of severity of eXDR carriage were analyzed statistically. Risk perception and opinion about guidelines were analyzed by qualitative description. One hundred and twenty-one HCWs were interviewed. The category of HCW, having searched for information on resistant bacteria, and having taken care of case patients were associated with better knowledge. The HCW category, age, type of unit, seniority, and having taken care of case patients were associated with risk perceptions. Qualitative analysis identified 61 themes. HCWs were extremely concerned by the spread of bacteria within the hospital. The main challenges identified were organizational and communication issues. HCWs reported a lack of knowledge and a lack of resources to implement guidelines. Strategies to improve guidelines implementation must be based on a better availability of resources, better communication, and new educational methods. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

The Educator's Guide to Preventing Child Sexual Abuse.

ERIC Educational Resources Information Center

Nelson, Mary, Ed.; Clark, Kay, Ed.

This collection of articles was created to give professionals and educators an informed overview of current issues in the field of child sexual abuse prevention. Articles are grouped under the headings of Introduction, Issues in Child Sexual Abuse Prevention, and Guidelines for Prevention Education and include: (1) "Prevention Education in…

Nuclear Issues: Strategies and Worksheets. Health Education.

ERIC Educational Resources Information Center

Lantieri, Linda; And Others

This document is designed to provide students with an opportunity to share feelings and clarify their own values given the facts about nuclear technology. Using this short curriculum, students should be able to: (1) explore their associations with nuclear issues; (2) analyze guidelines for conflict resolution in personal situations; (3) analyze…

Recruiting & Retaining Women: A Self-Assessment Guide for Law Enforcement.

ERIC Educational Resources Information Center

Harrington, Penny E.

This document presents information, guidelines, and resource materials to help law enforcement administrators address issues related to recruiting and retaining women in law enforcement. Its 14 chapters contain the following sections: statement of the problem; legal issues; possible solutions, model policies, and practices; expert assistance,…

A Performer's Creative Processes: Implications for Teaching and Learning Musical Interpretation

ERIC Educational Resources Information Center

Silverman, Marissa

2008-01-01

The purpose of this study is to investigate aspects of musical interpretation and suggest guidelines for developing performance students' interpretative processes. Since musical interpretation involves basic issues concerning the nature of music, and competing concepts of "interpretation" and its teaching, an overview of these issues is given.…

Great Decisions '86.

ERIC Educational Resources Information Center

Hoepli, Nancy L., Ed.

Designed to initiate discussion of foreign policy decisions, this book contains an analysis of eight foreign policy issues confronting the United States in 1986. Each unit provides the background and guidelines to provide perspective to assist in understanding foreign policy crises. The units included in this issue are: (1) "How Foreign Policy Is…

Assessment of Health Issues and Concerns of Israeli Seventh Graders during School Physician Examinations: A Pilot Study

ERIC Educational Resources Information Center

Knishkowy, Barry; Amitai, Yona; Hardoff, Daniel; Levy, Yehoshua; Kiro, Amnon

2007-01-01

Background: The "AMA Guidelines for Adolescent Preventive Services" (GAPS) recommends annual medical evaluations during adolescence, emphasizing screening and counseling regarding psychosocial issues. In Israel, seventh graders undergo medical examinations within the school health services, focusing on the detection of physical…

Analytical Method Validation of High-Performance Liquid Chromatography and Stability-Indicating Study of Medroxyprogesterone Acetate Intravaginal Sponges

PubMed Central

Batrawi, Nidal; Wahdan, Shorouq; Abualhasan, Murad

2017-01-01

Medroxyprogesterone acetate is widely used in veterinary medicine as intravaginal dosage for the synchronization of breeding cycle in ewes and goats. The main goal of this study was to develop reverse-phase high-performance liquid chromatography method for the quantification of medroxyprogesterone acetate in veterinary vaginal sponges. A single high-performance liquid chromatography/UV isocratic run was used for the analytical assay of the active ingredient medroxyprogesterone. The chromatographic system consisted of a reverse-phase C18 column as the stationary phase and a mixture of 60% acetonitrile and 40% potassium dihydrogen phosphate buffer as the mobile phase; the pH was adjusted to 5.6. The method was validated according to the International Council for Harmonisation (ICH) guidelines. Forced degradation studies were also performed to evaluate the stability-indicating properties and specificity of the method. Medroxyprogesterone was eluted at 5.9 minutes. The linearity of the method was confirmed in the range of 0.0576 to 0.1134 mg/mL (R2 > 0.999). The limit of quantification was shown to be 3.9 µg/mL. Precision and accuracy ranges were found to be %RSD <0.2 and 98% to 102%, respectively. Medroxyprogesterone capacity factor value of 2.1, tailing factor value of 1.03, and resolution value of 3.9 were obtained in accordance with ICH guidelines. Based on the obtained results, a rapid, precise, accurate, sensitive, and cost-effective analysis procedure was proposed for quantitative determination of medroxyprogesterone in vaginal sponges. This analytical method is the only available method to analyse medroxyprogesterone in veterinary intravaginal dosage form. PMID:28469407

Anticipating issues related to increasing preimplantation genetic diagnosis use: a research agenda.

PubMed

Klitzman, Robert; Appelbaum, Paul S; Chung, Wendy; Sauer, Mark

2008-01-01

Increasing use of preimplantation genetic diagnosis (PGD) poses numerous clinical, social, psychological, ethical, legal and policy dilemmas, many of which have received little attention. Patients and providers are now considering and using PGD for a widening array of genetic disorders, and patients may increasingly seek 'designer babies.' In the USA, although governmental oversight policies have been discussed, few specific guidelines exist. Hence, increasingly, patients and providers will face challenging ethical and policy questions of when and for whom to use PGD, and how it should be financed. These issues should be better clarified and addressed through collection of data concerning the current use of PGD in the USA, including factors involved in decision making about PGD use, as well as the education of the various communities that are, and should be, involved in its implementation. Improved understanding of these issues will ultimately enhance the development and implementation of future clinical guidelines and policies.

Sexual harassment in the workplace: guidelines for educating healthcare managers.

PubMed

Robinson, Robert K; Franklin, Geralyn Mcclure; Tinney, Cathie H; Crow, Stephen M; Hartman, Sandra J

2005-01-01

Actionable sexual harassment is defined as a violation of Title VII of the Civil Rights Act of 1964. In recent years, there have been a number of significant developments in sexual harassment case law and litigation including: (1) nationwide legal recognition for same-sex sexual harassment; (2) increased standards on employer liability for sexual harassment perpetrated by supervisory and managerial personnel; and (3) guidelines for mitigating damages when employers are found liable. These developments are of particular concern in those professions such as healthcare in which women historically have been represented as a significant portion of the workforce. Moreover, because management and supervisory relationships in healthcare are often cloudy, harassment by "supervisors" in healthcare settings can be an issue of special concern. In this article, we review relevant issues related to sexual harassment and provide guidance in dealing with the issue in the workplace.

Microplastics in the environment: Challenges in analytical chemistry - A review.

PubMed

Silva, Ana B; Bastos, Ana S; Justino, Celine I L; da Costa, João P; Duarte, Armando C; Rocha-Santos, Teresa A P

2018-08-09

Microplastics can be present in the environment as manufactured microplastics (known as primary microplastics) or resulting from the continuous weathering of plastic litter, which yields progressively smaller plastic fragments (known as secondary microplastics). Herein, we discuss the numerous issues associated with the analysis of microplastics, and to a less extent of nanoplastics, in environmental samples (water, sediments, and biological tissues), from their sampling and sample handling to their identification and quantification. The analytical quality control and quality assurance associated with the validation of analytical methods and use of reference materials for the quantification of microplastics are also discussed, as well as the current challenges within this field of research and possible routes to overcome such limitations. Copyright © 2018 Elsevier B.V. All rights reserved.

[Health protection for rural workers: the need to standardize techniques for quantifying dermal exposure to pesticides].

PubMed

Selmi, Giuliana da Fontoura Rodrigues; Trapé, Angelo Zanaga

2014-05-01

Quantification of dermal exposure to pesticides in rural workers, used in risk assessment, can be performed with different techniques such as patches or whole body evaluation. However, the wide variety of methods can jeopardize the process by producing disparate results, depending on the principles in sample collection. A critical review was thus performed on the main techniques for quantifying dermal exposure, calling attention to this issue and the need to establish a single methodology for quantification of dermal exposure in rural workers. Such harmonization of different techniques should help achieve safer and healthier working conditions. Techniques that can provide reliable exposure data are an essential first step towards avoiding harm to workers' health.

Critical factors determining the quantification capability of matrix-assisted laser desorption/ionization– time-of-flight mass spectrometry

PubMed Central

Wang, Chia-Chen; Lai, Yin-Hung; Ou, Yu-Meng; Chang, Huan-Tsung; Wang, Yi-Sheng

2016-01-01

Quantitative analysis with mass spectrometry (MS) is important but challenging. Matrix-assisted laser desorption/ionization (MALDI) coupled with time-of-flight (TOF) MS offers superior sensitivity, resolution and speed, but such techniques have numerous disadvantages that hinder quantitative analyses. This review summarizes essential obstacles to analyte quantification with MALDI-TOF MS, including the complex ionization mechanism of MALDI, sensitive characteristics of the applied electric fields and the mass-dependent detection efficiency of ion detectors. General quantitative ionization and desorption interpretations of ion production are described. Important instrument parameters and available methods of MALDI-TOF MS used for quantitative analysis are also reviewed. This article is part of the themed issue ‘Quantitative mass spectrometry’. PMID:27644968

Computerization of guidelines: a knowledge specification method to convert text to detailed decision tree for electronic implementation.

PubMed

Aguirre-Junco, Angel-Ricardo; Colombet, Isabelle; Zunino, Sylvain; Jaulent, Marie-Christine; Leneveut, Laurence; Chatellier, Gilles

2004-01-01

The initial step for the computerization of guidelines is the knowledge specification from the prose text of guidelines. We describe a method of knowledge specification based on a structured and systematic analysis of text allowing detailed specification of a decision tree. We use decision tables to validate the decision algorithm and decision trees to specify and represent this algorithm, along with elementary messages of recommendation. Edition tools are also necessary to facilitate the process of validation and workflow between expert physicians who will validate the specified knowledge and computer scientist who will encode the specified knowledge in a guide-line model. Applied to eleven different guidelines issued by an official agency, the method allows a quick and valid computerization and integration in a larger decision support system called EsPeR (Personalized Estimate of Risks). The quality of the text guidelines is however still to be developed further. The method used for computerization could help to define a framework usable at the initial step of guideline development in order to produce guidelines ready for electronic implementation.

Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on the Role of Cranial Molding Orthosis (Helmet) Therapy for Patients With Positional Plagiocephaly.

PubMed

Tamber, Mandeep S; Nikas, Dimitrios; Beier, Alexandra; Baird, Lissa C; Bauer, David F; Durham, Susan; Klimo, Paul; Lin, Alexander Y; Mazzola, Catherine; McClung-Smith, Catherine; Mitchell, Laura; Tyagi, Rachana; Flannery, Ann Marie

2016-11-01

No evidence-based guidelines exist on the role of cranial-molding orthosis (helmet) therapy for patients with positional plagiocephaly. To address the clinical question: "Does helmet therapy provide effective treatment for positional plagiocephaly?" and to make treatment recommendations based on the available evidence. The US National Library of Medicine Medline database and the Cochrane Library were queried by using MeSH headings and key words relevant to the objective of this systematic review. Abstracts were reviewed, after which studies meeting the inclusion criteria were selected and graded according to their quality of evidence (Classes I-III). Evidentiary tables were constructed that summarized pertinent study results, and, based on the quality of the literature, recommendations were made (Levels I-III). Fifteen articles met criteria for inclusion into the evidence tables. There was 1 prospective randomized controlled trial (Class II), 5 prospective comparative studies (Class II), and 9 retrospective comparative studies (Class II). There is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy. Specific criteria regarding the measurement and quantification of deformity and the most appropriate time window in infancy for treatment of positional plagiocephaly with a helmet remains elusive. In general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. The full guidelines document can be located at https://www.cns.org/guidelines/guidelines-management-patients-positional-plagiocephaly/Chapter_5.

Evidence-based guidelines for use of probiotics in preterm neonates.

PubMed

Deshpande, Girish C; Rao, Shripada C; Keil, Anthony D; Patole, Sanjay K

2011-08-02

Current evidence indicates that probiotic supplementation significantly reduces all-cause mortality and definite necrotising enterocolitis without significant adverse effects in preterm neonates. As the debate about the pros and cons of routine probiotic supplementation continues, many institutions are satisfied with the current evidence and wish to use probiotics routinely. Because of the lack of detail on many practical aspects of probiotic supplementation, clinician-friendly guidelines are urgently needed to optimise use of probiotics in preterm neonates. To develop evidence-based guidelines for probiotic supplementation in preterm neonates. To develop core guidelines on use of probiotics, including strain selection, dose and duration of supplementation, we primarily used the data from our recent updated systematic review of randomised controlled trials. For equally important issues including strain identification, monitoring for adverse effects, product format, storage and transport, and regulatory hurdles, a comprehensive literature search, covering the period 1966-2010 without restriction on the study design, was conducted, using the databases PubMed and EMBASE, and the proceedings of scientific conferences; these data were used in our updated systematic review. In this review, we present guidelines, including level of evidence, for the practical aspects (for example, strain selection, dose, duration, clinical and laboratory surveillance) of probiotic supplementation, and for dealing with non-clinical but important issues (for example, regulatory requirements, product format). Evidence was inadequate in some areas, and these should be a target for further research. We hope that these evidence-based guidelines will help to optimise the use of probiotics in preterm neonates. Continued research is essential to provide answers to the current gaps in knowledge about probiotics.

School nutrition guidelines: overview of the implementation and evaluation.

PubMed

Gregorič, Matej; Pograjc, Larisa; Pavlovec, Alenka; Simčič, Marjan; Gabrijelčič Blenkuš, Mojca

2015-06-01

To holistically evaluate the extent of implementation of dietary guidelines in schools and present various monitoring systems. The study comprises three methods: (i) a cross-sectional survey (process evaluation); (ii) an indicator-based evaluation (menu quality); and (iii) a 5 d weighed food record of school lunches (output evaluation). Slovenian primary schools. A total 234 food-service managers from 488 schools completed a self-administrated questionnaire for process evaluation; 177 out of 194 randomly selected schools provided menus for menu quality evaluation; and 120 school lunches from twenty-four schools were measured and nutritionally analysed for output evaluation. The survey among food-service managers revealed high levels of implementation at almost all process evaluation areas of the guidelines. An even more successful implementation of these guidelines was found in relation to organization cultural issues as compared with technical issues. Differences found in some process evaluation areas were related to location, size and socio-economic characteristics of schools. Evaluation of school menu quality demonstrated that score values followed a normal distribution. Higher (better) nutrition scores were found in larger-sized schools and corresponding municipalities with higher socio-economic status. School lunches did not meet minimum recommendations for energy, carbohydrates or dietary fibre intake, nor for six vitamins and three (macro, micro and trace) elements. The implementation of the guidelines was achieved differently at distinct levels. The presented multilevel evaluation suggests that different success in implementation might be attributed to different characteristics of individual schools. System changes might also be needed to support and improve implementation of the guidelines.

Guidelines as rationing tools: a qualitative analysis of psychosocial patient selection criteria for cardiac procedures

PubMed Central

Giacomini, Mita K.; Cook, Deborah J.; Streiner, David L.; Anand, Sonia S.

2001-01-01

Background Cardiac procedure guidelines often include psychosocial criteria for selecting patients that potentially introduce social value judgements into clinical decisions and decisions about the rationing of care. The aim of this study was to investigate the terms and justifications for and the meanings of psychosocial patient characteristics used in cardiac procedure guidelines. Methods We selected English-language guidelines published since 1990 and chapters in textbooks published since 1989. These guidelines amalgamated multiple sources of evidence and expertise and made recommendations regarding patient selection for specific procedures. A multidisciplinary team of physicians and social scientists extracted passages regarding psychosocial criteria and developed categories and conceptual relationships to describe and interpret their content. Results Sixty-five papers met the criteria for inclusion in the study. Forty-five (69%) mentioned psychosocial criteria as procedure indications or contraindications. The latter fell into several categories, including behavioural and psychological issues, relationships with significant others, financial resources, social roles and environmental circumstances. Interpretation Psychosocial characteristics are portrayed as having 2 roles in patient selection: as risk factors intrinsic to the candidate or as indicators of need for special intervention. Guidelines typically simply list psychosocial contraindications without clarifying their specific nature or providing any justification for their use. Psychosocial considerations can help in the evaluation of patients for cardiac procedures, but they become ethically controversial when used to restrict access. The use of psychosocial indications and contraindications could be improved by more precise descriptions of the psychosocial problem at issue, explanations regarding why the criterion matters and justification of the characteristic using a biological rationale or research evidence. PMID:11258209

Summary of the British Transplantation Society UK Guidelines for Living Donor Liver Transplantation.

PubMed

Manas, Derek; Burnapp, Lisa; Andrews, Peter Antony

2016-06-01

The British Transplantation Society Guidelines for Living Donor Liver Transplantation was published in July 2015 and is the first national guideline in the field of living donor liver transplantation. The guideline aims to review the evidence relating to the evaluation process of both recipient and donor candidates; address the moral and ethical issues surrounding the procedure; outline the technical aspects of the procedure, including the middle hepatic vein controversy and the "small for size syndrome"; review donor and recipient outcomes and complications including donor mortality; and examine evidence relating to the advantages and disadvantages of living donor liver transplantation. In line with previous guidelines published by the BTS, the guideline has used the Grading of Recommendations Assessment, Development and Evaluation system to rate the strength of evidence and recommendations. This article summarizes the Statements of Recommendation contained in the guideline, which provide a framework for the delivery of living liver donation in the United Kingdom and may be of wide international interest. It is recommended that the full guideline document is consulted for details of the relevant references and evidence base. This may be accessed at http://www.bts.org.uk/BTS/Guidelines_Standards/Current/BTS/Guidelines_Standards/Current_Guidelines.aspx?hkey=e285ca32-5920-4613-ac08-fa9fd90915b5.

[Cancer pain management: Systematic review and critical appraisal of clinical practice guidelines].

PubMed

Martínez-Nicolás, I; Ángel-García, D; Saturno, P J; López-Soriano, F

2016-01-01

Although several clinical practice guidelines have been developed in the last decades, cancer pain management is still deficient. The purpose of this work was to carry out a comprehensive and systematic literature review of current clinical practice guidelines on cancer pain management, and critically appraise their methodology and content in order to evaluate their quality and validity to cope with this public health issue. A systematic review was performed in the main databases, using English, French and Spanish as languages, from 2008 to 2013. Reporting and methodological quality was rated with the Appraisal of Guidelines, Research and Evaluation II (AGREE-II) tool, including an inter-rater reliability analysis. Guideline recommendations were extracted and classified into several categories and levels of evidence, aiming to analyse guidelines variability and evidence-based content comprehensiveness. Six guidelines were included. A wide variability was found in both reporting and methodological quality of guidelines, as well as in the content and the level of evidence of their recommendations. The Scottish Intercollegiate Guidelines Network guideline was the best rated using AGREE-II, while the Sociedad Española de Oncología Médica guideline was the worst rated. The Ministry of Health Malaysia guideline was the most comprehensive, and the Scottish Intercollegiate Guidelines Network guideline was the second one. The current guidelines on cancer pain management have limited quality and content. We recommend Ministry of Health Malaysia and Scottish Intercollegiate Guidelines Network guidelines, whilst Sociedad Española de Oncología Médica guideline still needs to improve. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Developing guidelines for postgraduate dental educators in the UK.

PubMed

Bullock, A D; Firmstone, V R; Falcon, H C

2010-01-09

Commissioned by the UK Committee of Postgraduate Dental Deans and Directors (COPDEND), the purpose of this work was to establish UK guidelines for dental educators. The final document comprises 79 statements, in eight domains. Each domain has four zones related to what dental educators (1) know, (2) do with members of the dental team as learners, (3) do with other dental educators as learners and (4) lead on. Launched in November 2008, the document provides a framework of good practice for use in the employment, development and management of dental educators in the UK. The guidelines are readily available from the COPDEND website. A key purpose of this paper is to report on the process of development and a central part of that was the integration of feedback and consultation on early drafts. These processes elicited a total of 102 responses. Issues raised in consultation included: (1) how the zones interrelate; (2) differentiation between domains; (3) measurability; and (4) implementation challenges. This paper includes our responses to these issues.

WHO Expert Committee on Biological Standardization.

PubMed

2002-01-01

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and quality control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on issues relevant to international guidelines, recommendations and other matters related to the manufacture and quality control of biologicals. This is followed by information on the status and development of reference materials for bovine spongiform encephalopathy, various antigens, blood products, cytokines, growth factors and endocrinological substances. The second part of the report, of particular interest to manufacturers and national control authorities, contains sets of recommendations for the production and control of poliomyelitis vaccine (oral) and poliomyelitis vaccine (inactivated) and guidelines for the production and control of live attenuated Japanese encephalitis vaccine. Also included are lists of recommendations and guidelines for biological substances used in medicine, and other relevant documents.

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 validated LC-MS/MS assay for simultaneous quantification of methotrexate and tofacitinib in rat plasma: application to a pharmacokinetic study.

PubMed

Sharma, Kuldeep; Giri, Kalpeshkumar; Dhiman, Vinay; Dixit, Abhishek; Zainuddin, Mohd; Mullangi, Ramesh

2015-05-01

A highly sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for simultaneous quantification of methotrexate (MTX) and tofacitinib (TFB) in rat plasma (50 μL) using phenacetin as an internal standard (IS), as per the US Food and Drug Administration guidelines. After a solid-phase extraction procedure, the separation of the analytes and IS was performed on a Chromolith RP₁₈e column using an isocratic mobile phase of 5 m m ammonium acetate (pH 5.0) and acetonitrile at a ratio of 25:75 (v/v) using flow-gradient with a total run time of 3.5 min. The detection was performed in multiple reaction monitoring mode, using the transitions of m/z 455.2 → 308.3, m/z 313.2 → 149.2 and m/z 180.3 → 110.2 for MTX, TFB and IS, respectively. The calibration curves were linear over the range of 0.49-91.0 and 0.40-74.4 ng/mL for MTX and TFB, respectively. The intra- and interday accuracy and precision values for MTX and TFB were <15% at low quality control (QC), medium QC and high QC and <20% at lower limit of quantification. The validated assay was applied to derive the pharmacokinetic parameters for MTX and TFB post-dosing of MTX and TFB orally and intravenously to rats. Copyright © 2014 John Wiley & Sons, Ltd.

New Insights into the in situ Microscopic Visualization and Quantification of Inorganic Polyphosphate Stores by 4’,6-Diamidino-2-Phenylindole (DAPI)-Staining

PubMed Central

Gomes, F.M.; Ramos, I.B.; Wendt, C.; Girard-Dias, W.; De Souza, W.; Machado, E.A.; K. Miranda, E.A.

2013-01-01

Inorganic polyphosphate (PolyP) is a biological polymer that plays important roles in the cell physiology of both prokaryotic and eukaryotic organisms. Among the available methods for PolyP localization and quantification, a 4’,6-diamidino-2-phenylindole(DAPI)-based assay has been used for visualization of PolyP-rich organelles. Due to differences in DAPI permeability to different compartments and/or PolyP retention after fixation, a general protocol for DAPI-PolyP staining has not yet been established. Here, we tested different protocols for DAPI-PolyP detection in a range of samples with different levels of DAPI permeability, including subcellular fractions, free-living cells and cryosections of fixed tissues. Subcellular fractions of PolyP-rich organelles yielded DAPI-PolyP fluorescence, although those with a complex external layer usually required longer incubation times, previous aldehyde fixation and/or detergent permeabilization. DAPI-PolyP was also detected in cryosections of OCT-embedded tissues analyzed by multiphoton microscopy. In addition, a semi-quantitative fluorimetric analysis of DAPI-stained fractions showed PolyP mobilization in a similar fashion to what has been demonstrated with the use of enzyme-based quantitative protocols. Taken together, our results support the use of DAPI for both PolyP visualization and quantification, although specific steps are suggested as a general guideline for DAPI-PolyP staining in biological samples with different degrees of DAPI and PolyP permeability. PMID:24441187

Easy-Assessment of Levofloxacin and Minocycline in Relevant Biomimetic Media by HPLC-UV Analysis.

PubMed

Matos, Ana C; Pinto, Rosana V; Bettencourt, Ana F

2017-08-01

Simple, economic and environmental friendly high-performance liquid chromatography methods for levofloxacin and minocycline quantification in biomimetic media were developed and validate including their stability at body temperature, an often neglected evaluation parameter. Both methods are similar only differing in the wavelength setting, i.e., for levofloxacin and minocycline quantification the UV detection was set at 284 and at 273 nm, respectively. The separation of both antibiotics was achieved using a reversed-phase column and a mobile phase consisting of acetonitrile and water (15:85) with 0.6% triethylamine, adjusted to pH 3. As an internal standard for levofloxacin quantification, minocycline was used and vice versa. The calibration curves for both methods were linear (r = 0.99) over a concentration range of 0.3-16 μg/mL and 0.5-16 μg/mL for levofloxacin and minocycline, respectively, with precision, accuracy and recovery in agreement with international guidelines requirement. Levofloxacin revealed stability in all media and conditions, including at 37°C, with exception to freeze-thaw cycle conditions. Minocycline presented a more accentuated degradation profile over prolonged time courses, when compared to levofloxacin. Reported data is of utmost interest for pharma and biomaterials fields regarding the research and development of new local drug-delivery-systems containing either of these two antibiotics, namely when monitoring the in vitro release studies of those systems. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Development of a High-Performance Liquid Chromatography–Tandem Mass Spectrometry Method for the Identification and Quantification of CP-47,497, CP-47,497-C8 and JWH-250 in Mouse Brain

PubMed Central

Samano, Kimberly L.; Poklis, Justin L.; Lichtman, Aron H.; Poklis, Alphonse

2014-01-01

While Marijuana continues to be the most widely used illicit drug, abuse of synthetic cannabinoid (SCB) compounds in ‘Spice’ or ‘K2’ herbal incense products has emerged as a significant public health concern in many European countries and in the USA. Several of these SCBs have been declared Schedule I controlled substances but detection and quantification in biological samples remain a challenge. Therefore, we present a liquid chromatography–tandem mass spectrometry method after liquid–liquid extraction for the quantitation of CP-47,497, CP-47,497-C8 and JWH-250 in mouse brain. We report data for linearity, limit of quantification, accuracy/bias, precision, recovery, selectivity, carryover, matrix effects and stability experiments which were developed and fully validated based on Scientific Working Group for Forensic Toxicology guidelines for forensic toxicology method validation. Acceptable coefficients of variation for accuracy/bias, within- and between-run precision and selectivity were determined, with all values within ±15% of the target concentration. Validation experiments revealed degradation of CP-47, 497 and CP-47,497-C8 at different temperatures, and significant ion suppression was produced in brain for all compounds tested. The method was successfully applied to detect and quantify CP-47,497 in brains from mice demonstrating significant cannabimimetic behavioral effects as assessed by the classical tetrad paradigm. PMID:24816398

Drugged driving in Louisiana: quantification of its impact on public health and implications for legislation, enforcement, and prosecution : final report.

DOT National Transportation Integrated Search

2017-02-01

Drugged driving, i.e., driving under the influence of drugs, is considered a rising public health issue in the US and the rest of the world, yet due to underreporting and limitations of existing data, not much is known about the frequency of drugged ...

Introduction to the Centers for Disease Control and Prevention and the Healthcare Infection Control Practices Advisory Committee Guideline for the Prevention of Surgical Site Infections.

PubMed

Solomkin, Joseph S; Mazuski, John; Blanchard, Joan C; Itani, Kamal M F; Ricks, Philip; Dellinger, E Patchen; Allen, George; Kelz, Rachel; Reinke, Caroline E; Berríos-Torres, Sandra I

Surgical site infection (SSI) is a common type of health-care-associated infection (HAI) and adds considerably to the individual, social, and economic costs of surgical treatment. This document serves to introduce the updated Guideline for the Prevention of SSI from the Centers for Disease Control and Prevention (CDC) and the Healthcare Infection Control Practices Advisory Committee (HICPAC). The Core section of the guideline addresses issues relevant to multiple surgical specialties and procedures. The second procedure-specific section focuses on a high-volume, high-burden procedure: Prosthetic joint arthroplasty. While many elements of the 1999 guideline remain current, others warrant updating to incorporate new knowledge and changes in the patient population, operative techniques, emerging pathogens, and guideline development methodology.

A patient workflow management system built on guidelines.

PubMed Central

Dazzi, L.; Fassino, C.; Saracco, R.; Quaglini, S.; Stefanelli, M.

1997-01-01

To provide high quality, shared, and distributed medical care, clinical and organizational issues need to be integrated. This work describes a methodology for developing a Patient Workflow Management System, based on a detailed model of both the medical work process and the organizational structure. We assume that the medical work process is represented through clinical practice guidelines, and that an ontological description of the organization is available. Thus, we developed tools 1) for acquiring the medical knowledge contained into a guideline, 2) to translate the derived formalized guideline into a computational formalism, precisely a Petri Net, 3) to maintain different representation levels. The high level representation guarantees that the Patient Workflow follows the guideline prescriptions, while the low level takes into account the specific organization characteristics and allow allocating resources for managing a specific patient in daily practice. PMID:9357606

Overview of entry risk predictions

NASA Astrophysics Data System (ADS)

Mrozinski, R.; Mendeck, G.; Cutri-Kohart, R.

Risk to people on the ground from uncontrolled entries of spacecraft is a primary concern when analyzing end-of-life disposal options for satellites. Countries must balance this risk with the need to mitigate an exponentially growing space debris population. Currently the United States does this via guidelines that call for a satellite to be disposed of in a controlled manner if an uncontrolled entry would be too risky to people on the ground. This risk is measured by a quantity called "casualty expectation", or E , where casualty expectation is defined as the expectedc number of people suffering death or injury due to a spacecraft entry event. If Ec exceeds 1 in 10,000, U. S. guidelines state that the entry should be controlled rather than uncontrolled. Since this guideline can have serious impacts on the cost, lifetime, and even the mission and functionality of a satellite, it is critical that this quantity be estimated well, and decision makers understand all assumptions and limitations inherent in the resulting value. This paper discusses several issues regarding estimates of casualty expectation, beginning with an overview of relevant United States policies and guidelines. The equation the space industry typically uses to estimate casualty expectation is presented, along with a look at the sensitivity of the results to the typical assumptions, models, and initial condition uncertainties. Differences in these modeling issues with respect to launch failure Ec estimates are included in the discussion. An alternate quantity to assess risks due to spacecraft entries is introduced. "Probability of casualty", or Pc , is defined as the probability of one or more instances of people suffering death or injury due to a spacecraft entry event. The equation to estimate Pc is derived, where the same assumptions, modeling, and initial condition issues for Ec apply. Several examples are then given of both Ec and Pc estimate calculations. Due to the difficult issues in estimating both Ec and Pc, it is argued that "true" absolute quantities can never be computed. However, E and Pc are ideal for relativec analyses against a standard tool that eliminates these issues. Such a tool is recommended for assessing compliance with requirements of regulating institutions.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part II - preanalytical issues.

PubMed

Davis, Bruce H; Dasgupta, Amar; Kussick, Steven; Han, Jin-Yeong; Estrellado, Annalee

2013-01-01

Flow cytometry and other technologies of cell-based fluorescence assays are as a matter of good laboratory practice required to validate all assays, which when in clinical practice may pass through regulatory review processes using criteria often defined with a soluble analyte in plasma or serum samples in mind. Recently the U.S. Food and Drug Administration (FDA) has entered into a public dialogue in the U.S. regarding their regulatory interest in laboratory developed tests (LDTs) or so-called "home brew" assays performed in clinical laboratories. The absence of well-defined guidelines for validation of cell-based assays using fluorescence detection has thus become a subject of concern for the International Council for Standardization of Haematology (ICSH) and International Clinical Cytometry Society (ICCS). Accordingly, a group of over 40 international experts in the areas of test development, test validation, and clinical practice of a variety of assay types using flow cytometry and/or morphologic image analysis were invited to develop a set of practical guidelines useful to in vitro diagnostic (IVD) innovators, clinical laboratories, regulatory scientists, and laboratory inspectors. The focus of the group was restricted to fluorescence reporter reagents, although some common principles are shared by immunohistochemistry or immunocytochemistry techniques and noted where appropriate. The work product of this two year effort is the content of this special issue of this journal, which is published as 5 separate articles, this being Validation of Cell-based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS - Part II - Preanalytical issues. © 2013 International Clinical Cytometry Society. © 2013 International Clinical Cytometry Society.

Driving under the influence of cannabis: pitfalls, validation, and quality control of a UPLC-MS/MS method for the quantification of tetrahydrocannabinol in oral fluid collected with StatSure, Quantisal, or Certus collector.

PubMed

Wille, Sarah M R; Di Fazio, Vincent; Ramírez-Fernandez, Maria del Mar; Kummer, Natalie; Samyn, Nele

2013-02-01

"Driving under the influence of drugs" (DUID) has a large impact on the worldwide mortality risk. Therefore, DUID legislations based on impairment or analytical limits are adopted. Drug detection in oral fluid is of interest due to the ease of sampling during roadside controls. The prevalence of Δ9-tetrahydrocannabinol (THC) in seriously injured drivers ranges from 0.5% to 7.6% in Europe. For these reasons, the quantification of THC in oral fluid collected with 3 alternative on-site collectors is presented and discussed in this publication. An ultra-performance liquid chromatography-mass spectrometric quantification method for THC in oral fluid samples collected with the StatSure (Diagnostic Systems), Quantisal (Immunalysis), and Certus (Concateno) devices was validated according to the international guidelines. Small sample volumes of 100-200 μL were extracted using hexane. Special attention was paid to factors such as matrix effects, THC adsorption onto the collector, and stability in the collection fluid. A relatively high-throughput analysis was developed and validated according to ISO 17025 requirements. Although the effects of the matrix on the quantification could be minimized using a deuterated internal standard, and stability was acceptable according the validation data, adsorption of THC onto the collectors was a problem. For the StatSure device, THC was totally recovered from the collector pad after storage for 24 hours at room temperature or 7 days at 4°C. A loss of 15%-25% was observed for the Quantisal collector, whereas the recovery from the Certus device was irreproducible (relative standard deviation, 44%-85%) and low (29%-80%). During the roadside setting, a practical problem arose: small volumes of oral fluid (eg, 300 μL) were collected. However, THC was easily detected and concentrations ranged from 8 to 922 ng/mL in neat oral fluid. A relatively high-throughput analysis (40 samples in 4 hours) adapted for routine DUID analysis was developed and validated for THC quantification in oral fluid samples collected from drivers under the influence of cannabis.

Direct PCR amplification of forensic touch and other challenging DNA samples: A review.

PubMed

Cavanaugh, Sarah E; Bathrick, Abigail S

2018-01-01

DNA evidence sample processing typically involves DNA extraction, quantification, and STR amplification; however, DNA loss can occur at both the DNA extraction and quantification steps, which is not ideal for forensic evidence containing low levels of DNA. Direct PCR amplification of forensic unknown samples has been suggested as a means to circumvent extraction and quantification, thereby retaining the DNA typically lost during those procedures. Direct PCR amplification is a method in which a sample is added directly to an amplification reaction without being subjected to prior DNA extraction, purification, or quantification. It allows for maximum quantities of DNA to be targeted, minimizes opportunities for error and contamination, and reduces the time and monetary resources required to process samples, although data analysis may take longer as the increased DNA detection sensitivity of direct PCR may lead to more instances of complex mixtures. ISO 17025 accredited laboratories have successfully implemented direct PCR for limited purposes (e.g., high-throughput databanking analysis), and recent studies indicate that direct PCR can be an effective method for processing low-yield evidence samples. Despite its benefits, direct PCR has yet to be widely implemented across laboratories for the processing of evidentiary items. While forensic DNA laboratories are always interested in new methods that will maximize the quantity and quality of genetic information obtained from evidentiary items, there is often a lag between the advent of useful methodologies and their integration into laboratories. Delayed implementation of direct PCR of evidentiary items can be attributed to a variety of factors, including regulatory guidelines that prevent laboratories from omitting the quantification step when processing forensic unknown samples, as is the case in the United States, and, more broadly, a reluctance to validate a technique that is not widely used for evidence samples. The advantages of direct PCR of forensic evidentiary samples justify a re-examination of the factors that have delayed widespread implementation of this method and of the evidence supporting its use. In this review, the current and potential future uses of direct PCR in forensic DNA laboratories are summarized. Copyright © 2017 Elsevier B.V. All rights reserved.

Deciphering the Epigenetic Code: An Overview of DNA Methylation Analysis Methods

PubMed Central

Umer, Muhammad

2013-01-01

Abstract Significance: Methylation of cytosine in DNA is linked with gene regulation, and this has profound implications in development, normal biology, and disease conditions in many eukaryotic organisms. A wide range of methods and approaches exist for its identification, quantification, and mapping within the genome. While the earliest approaches were nonspecific and were at best useful for quantification of total methylated cytosines in the chunk of DNA, this field has seen considerable progress and development over the past decades. Recent Advances: Methods for DNA methylation analysis differ in their coverage and sensitivity, and the method of choice depends on the intended application and desired level of information. Potential results include global methyl cytosine content, degree of methylation at specific loci, or genome-wide methylation maps. Introduction of more advanced approaches to DNA methylation analysis, such as microarray platforms and massively parallel sequencing, has brought us closer to unveiling the whole methylome. Critical Issues: Sensitive quantification of DNA methylation from degraded and minute quantities of DNA and high-throughput DNA methylation mapping of single cells still remain a challenge. Future Directions: Developments in DNA sequencing technologies as well as the methods for identification and mapping of 5-hydroxymethylcytosine are expected to augment our current understanding of epigenomics. Here we present an overview of methodologies available for DNA methylation analysis with special focus on recent developments in genome-wide and high-throughput methods. While the application focus relates to cancer research, the methods are equally relevant to broader issues of epigenetics and redox science in this special forum. Antioxid. Redox Signal. 18, 1972–1986. PMID:23121567

Interpersonal conflict: strategies and guidelines for resolution.

PubMed

Wolfe, D E; Bushardt, S C

1985-02-01

Historically, management theorists have recommended the avoidance or suppression of conflict. Modern management theorists recognize interpersonal conflict as an inevitable byproduct of growth and change. The issue is no longer avoidance of conflict but the strategy by which conflict is resolved. Various strategies of conflict resolution and the consequences of each are discussed in this article, along with guidelines for the effective use of confrontation strategy.

Connecting Marketing and Implementation Research and Library Program Development: A Case Study of the Implementation of [U.S.] National Guidelines and Standards.

ERIC Educational Resources Information Center

Haycock, Ken; Cavill, Pat

This case study examined: (1) what market research is required for planning for the implementation of "Information Power: Building Partnerships for Learning," the 1998 national guidelines for effective school library media programs; (2) what issues need to be addressed and what target audiences are required to effect change, as well as…

A Grounded Theory Approach to Examining Design and Usability Guidelines for Four-Year Tribal College Web Sites

ERIC Educational Resources Information Center

Broberg, Loretta L.

2011-01-01

With the increasing awareness of design and usability issues in regards to websites, in this case tribal college websites, there is an increasing desire to have a set of guidelines to assist in determining design and usability for academic websites. Though there is an overwhelming amount of information available to researchers in this subject area…

Risk/Requirements Trade-off Guidelines for Low Cost Satellite Systems

NASA Technical Reports Server (NTRS)

Cornford, Steven L.; Man, Kin F.

1996-01-01

The accelerating trend toward faster, better, cheaper missions places increasing emphasis on the trade-offs between requirements and risk to reduce cost and development times, while still improving quality and reliability. The Risk/Requirement Trade-off Guidelines discussed in this paper are part of an integrated approach to address the main issues by focusing on the sum of prevention, analysis, control, or test (PACT) processes.

Nondiscrimination on the basis of handicap; procedures and guidelines relating to health care for handicapped infants--HHS. Final rules.

PubMed

1984-01-12

These are final rules on procedures and guidelines relating to nondiscrimination on the basis of handicap in connection with health care for handicapped infants. These rules are issued under the authority of section 504 of the Rehabilitation Act of 1973, which prohibits discrimination on the basis of handicap in programs and activities receiving Federal financial assistance.

Role and Responsibilities of the School Nurse (Registered Nurse) and the Child with Special Health Care Needs. Guidelines.

ERIC Educational Resources Information Center

Maryland State Board of Nursing, Baltimore.

This set of guidelines by the Maryland Board of Nursing presents the role and responsibilities of the school nurse in relation to the child with special health care needs. The introduction identifies four basic issues including necessary level of preparation, who determines what nursing care can be delegated, under what conditions nursing care can…

An overview on ethical issues about sperm donation.

PubMed

Gong, Dan; Liu, Yu-Lin; Zheng, Zhong; Tian, Yi-Fei; Li, Zheng

2009-11-01

Beyond the scientific progress in assisted reproductive technologies (ART), it is necessary to discuss the ethical considerations behind these advances. Ethical issues concerning sperm donation have been considered and discussed by government and non-governmental agencies, the public, media and academic institutions in many countries. Recommendations and guidelines concerning sperm donation issues vary from country to country and between professional groups within countries. This paper attempts to present an overview of findings and reports from various agencies concerning the ethics of sperm donation. The following topics are considered: limiting the number of donor offspring; minimizing risk of infection and genetics from sperm donors; age requirements for sperm donors; and anonymity versus non-anonymity of sperm donors. The diversity of policies shows that each country has its unique set of guidelines tailored toward its own specific needs. Similarly, countries designing their own procedures and guidelines concerning reproductive medicine must tailor them toward their own needs and practical considerations. In Mainland China, the anonymous policy for sperm donation should still be carried out, and the number of donor offspring should be revaluated. ART procedures must be conducted in a way that is respectful of those involved. Ethical principles must respect the interests and welfare of persons who will be born as well as the health and psychosocial welfare of all participants, including sperm donors.

The Indian National Association for Study of the Liver (INASL) Consensus on Prevention, Diagnosis and Management of Hepatocellular Carcinoma in India: The Puri Recommendations

PubMed Central

Kumar, Ashish; Acharya, Subrat K.; Singh, Shivaram P.; Saraswat, Vivek A.; Arora, Anil; Duseja, Ajay; Goenka, Mahesh K.; Jain, Deepali; Kar, Premashish; Kumar, Manoj; Kumaran, Vinay; Mohandas, Kunisshery M.; Panda, Dipanjan; Paul, Shashi B.; Ramachandran, Jeyamani; Ramesh, Hariharan; Rao, Padaki N.; Shah, Samir R.; Sharma, Hanish; Thandassery, Ragesh B.

2014-01-01

Hepatocellular carcinoma (HCC) is one of the major causes of morbidity, mortality and healthcare expenditure in patients with chronic liver disease. There are no consensus guidelines on diagnosis and management of HCC in India. The Indian National Association for Study of the Liver (INASL) set up a Task-Force on HCC in 2011, with a mandate to develop consensus guidelines for diagnosis and management of HCC, relevant to disease patterns and clinical practices in India. The Task-Force first identified various contentious issues on various aspects of HCC and these issues were allotted to individual members of the Task-Force who reviewed them in detail. The Task-Force used the Oxford Center for Evidence Based Medicine—Levels of Evidence of 2009 for developing an evidence-based approach. A 2-day round table discussion was held on 9th and 10th February, 2013 at Puri, Odisha, to discuss, debate, and finalize the consensus statements. The members of the Task-Force reviewed and discussed the existing literature at this meeting and formulated the INASL consensus statements for each of the issues. We present here the INASL consensus guidelines (The Puri Recommendations) on prevention, diagnosis and management of HCC in India. PMID:25755608

The Indian National Association for Study of the Liver (INASL) Consensus on Prevention, Diagnosis and Management of Hepatocellular Carcinoma in India: The Puri Recommendations.

PubMed

Kumar, Ashish; Acharya, Subrat K; Singh, Shivaram P; Saraswat, Vivek A; Arora, Anil; Duseja, Ajay; Goenka, Mahesh K; Jain, Deepali; Kar, Premashish; Kumar, Manoj; Kumaran, Vinay; Mohandas, Kunisshery M; Panda, Dipanjan; Paul, Shashi B; Ramachandran, Jeyamani; Ramesh, Hariharan; Rao, Padaki N; Shah, Samir R; Sharma, Hanish; Thandassery, Ragesh B

2014-08-01

Hepatocellular carcinoma (HCC) is one of the major causes of morbidity, mortality and healthcare expenditure in patients with chronic liver disease. There are no consensus guidelines on diagnosis and management of HCC in India. The Indian National Association for Study of the Liver (INASL) set up a Task-Force on HCC in 2011, with a mandate to develop consensus guidelines for diagnosis and management of HCC, relevant to disease patterns and clinical practices in India. The Task-Force first identified various contentious issues on various aspects of HCC and these issues were allotted to individual members of the Task-Force who reviewed them in detail. The Task-Force used the Oxford Center for Evidence Based Medicine-Levels of Evidence of 2009 for developing an evidence-based approach. A 2-day round table discussion was held on 9th and 10th February, 2013 at Puri, Odisha, to discuss, debate, and finalize the consensus statements. The members of the Task-Force reviewed and discussed the existing literature at this meeting and formulated the INASL consensus statements for each of the issues. We present here the INASL consensus guidelines (The Puri Recommendations) on prevention, diagnosis and management of HCC in India.

Consumer involvement in topic and outcome selection in the development of clinical practice guidelines.

PubMed

Tong, Allison; Lopez-Vargas, Pamela; Howell, Martin; Phoon, Richard; Johnson, David; Campbell, Denise; Walker, Rowan G; Craig, Jonathan C

2012-12-01

Consumer involvement in guideline development is advocated, but minimal participation, such as a nominated consumer representative on a guideline working group, can inhibit their decision-making power and contribution. Little is known about how to involve consumers more effectively in guideline development. To describe a targeted approach for involving consumers actively in guideline development, by focusing on topic and outcome selection, and to discuss the impact on content and structure of the final guideline. Descriptive study. Patients and carers (n = 24) from a tertiary hospital in Sydney attended three structured peer-facilitated workshops to complete group-based exercises on topic and outcome selection for guidelines for early stage chronic kidney disease. These workshops were run in parallel with the guideline-writing group. For each exercise, participants formed small groups and facilitated their own discussion, recorded their responses and presented them to the wider group. The topics and outcomes identified were fed back to the guideline writers. The participants actively engaged in the workshop discussions and articulated topics and outcomes they perceived should be included in clinical guidelines. Four main changes to guideline-related outputs were observed. A new guideline subtopic was introduced, guidelines were consumer-endorsed, guideline recommendations and suggestions for clinical care were augmented with consumer-focused issues, and plain English guidelines were developed. Consumer workshops in parallel and feeding into guideline development can be a feasible and effective approach for active consumer contribution. This process can inform the development of both consumer-focused guidelines for clinicians and specific versions for consumers. © 2011 Blackwell Publishing Ltd.

Underreporting of conflicts of interest in clinical practice guidelines: cross sectional study

PubMed Central

2013-01-01

Background Conflicts of interest affect recommendations in clinical guidelines and disclosure of such conflicts is important. However, not all conflicts of interest are disclosed. Using a public available disclosure list we determined the prevalence and underreporting of conflicts of interest among authors of clinical guidelines on drug treatments. Methods We included up to five guidelines published from July 2010 to March 2012 from each Danish clinical specialty society. Using the disclosure list of the Danish Health and Medicines Authority, we identified author conflicts of interest and compared them with the disclosures in the guidelines. For each guideline we extracted methodological characteristics of guideline development. Results Forty-five guidelines from 14 specialty societies were included. Of 254 authors, 135 (53%) had conflicts of interest, corresponding to 43 of the 45 guidelines (96%) having one or more authors with a conflict of interest. Only one of the 45 guidelines (2%) disclosed author conflicts of interest. The most common type of conflict of interest (83 of the 135) was being a consultant, an advisory board member or a company employee. Only 10 guidelines (22%) described the methods used for guideline development, 27 (60%) used references in the text and 11 (24%) graded the types of evidence. Conclusions Conflicts of interest were common, but disclosures were very rare. Most guidelines did not describe how they were developed and many did not describe the evidence behind specific recommendations. Publicly available disclosure lists may assist guideline issuing bodies in ensuring that all conflicts are disclosed. PMID:23642105

A study of a self diagnostic platform for the detection of A2 biomarker for Leishmania donovani

NASA Astrophysics Data System (ADS)

Roche, Philip J. R.; Cheung, Maurice C.; Najih, Mohamed; McCall, Laura-Isobel; Fakih, Ibrahim; Chodavarapu, Vamsy P.; Ward, Brian; Ndao, Momar; Kirk, Andrew G.

2012-03-01

Visceral leishmaniasis (L.donovani) is a protozoan infection that attacks mononuclear phagocytes and causes the liver and spleen damage that can cause death. The investigation presented is a proof of concept development applying a plasmonic diagnostic platform with simple microfluidic sample delivery and optical readout. An immune-assay method is applied to the quantification of A2 protein, a highly immunogenic biomarker for the pathogen. Quantification of A2 was performed in the ng/ml range, analysis by ELISA suggested that a limit of 0.1ng/ml of A2 is approximate to 1 pathogen per ml and the sensing system shows the potential to deliver a similar level of quantification. Significant reduction in assay complexity as further enzyme linked enhancement is not required when applying a plasmonic methodology to an immunoassay. The basic instrumentation required for a portable device and potential dual optical readout where both plasmonic and photoluminescent response are assessed and investigated including consideration of the application of the device to testing where non-literate communication of results is considered and issues of performance are addressed.

Recommendations and Standardization of Biomarker Quantification Using NMR-Based Metabolomics with Particular Focus on Urinary Analysis.

PubMed

Emwas, Abdul-Hamid; Roy, Raja; McKay, Ryan T; Ryan, Danielle; Brennan, Lorraine; Tenori, Leonardo; Luchinat, Claudio; Gao, Xin; Zeri, Ana Carolina; Gowda, G A Nagana; Raftery, Daniel; Steinbeck, Christoph; Salek, Reza M; Wishart, David S

2016-02-05

NMR-based metabolomics has shown considerable promise in disease diagnosis and biomarker discovery because it allows one to nondestructively identify and quantify large numbers of novel metabolite biomarkers in both biofluids and tissues. Precise metabolite quantification is a prerequisite to move any chemical biomarker or biomarker panel from the lab to the clinic. Among the biofluids commonly used for disease diagnosis and prognosis, urine has several advantages. It is abundant, sterile, and easily obtained, needs little sample preparation, and does not require invasive medical procedures for collection. Furthermore, urine captures and concentrates many "unwanted" or "undesirable" compounds throughout the body, providing a rich source of potentially useful disease biomarkers; however, incredible variation in urine chemical concentrations makes analysis of urine and identification of useful urinary biomarkers by NMR challenging. We discuss a number of the most significant issues regarding NMR-based urinary metabolomics with specific emphasis on metabolite quantification for disease biomarker applications and propose data collection and instrumental recommendations regarding NMR pulse sequences, acceptable acquisition parameter ranges, relaxation effects on quantitation, proper handling of instrumental differences, sample preparation, and biomarker assessment.

Real-time PCR Machine System Modeling and a Systematic Approach for the Robust Design of a Real-time PCR-on-a-Chip System

PubMed Central

Lee, Da-Sheng

2010-01-01

Chip-based DNA quantification systems are widespread, and used in many point-of-care applications. However, instruments for such applications may not be maintained or calibrated regularly. Since machine reliability is a key issue for normal operation, this study presents a system model of the real-time Polymerase Chain Reaction (PCR) machine to analyze the instrument design through numerical experiments. Based on model analysis, a systematic approach was developed to lower the variation of DNA quantification and achieve a robust design for a real-time PCR-on-a-chip system. Accelerated lift testing was adopted to evaluate the reliability of the chip prototype. According to the life test plan, this proposed real-time PCR-on-a-chip system was simulated to work continuously for over three years with similar reproducibility in DNA quantification. This not only shows the robustness of the lab-on-a-chip system, but also verifies the effectiveness of our systematic method for achieving a robust design. PMID:22315563

A Spanish model for quantification and management of construction waste.

PubMed

Solís-Guzmán, Jaime; Marrero, Madelyn; Montes-Delgado, Maria Victoria; Ramírez-de-Arellano, Antonio

2009-09-01

Currently, construction and demolition waste (C&D waste) is a worldwide issue that concerns not only governments but also the building actors involved in construction activity. In Spain, a new national decree has been regulating the production and management of C&D waste since February 2008. The present work describes the waste management model that has inspired this decree: the Alcores model implemented with good results in Los Alcores Community (Seville, Spain). A detailed model is also provided to estimate the volume of waste that is expected to be generated on the building site. The quantification of C&D waste volume, from the project stage, is essential for the building actors to properly plan and control its disposal. This quantification model has been developed by studying 100 dwelling projects, especially their bill of quantities, and defining three coefficients to estimate the demolished volume (CT), the wreckage volume (CR) and the packaging volume (CE). Finally, two case studies are included to illustrate the usefulness of the model to estimate C&D waste volume in both new construction and demolition projects.

Perioperative management in myasthenia gravis: republication of a systematic review and a proposal by the guideline committee of the Japanese Association for Chest Surgery 2014.

PubMed

Kadota, Yoshihisa; Horio, Hirotoshi; Mori, Takeshi; Sawabata, Noriyoshi; Goto, Taichiro; Yamashita, Shin-ichi; Nagayasu, Takeshi; Iwasaki, Akinori

2015-04-01

Thymectomy is regarded as a useful therapeutic option for myasthenia gravis (MG), though perioperative management in MG patients is largely empirical. While evidence-based medicine is limited in the perioperative management of MG patients, treatment guidelines are required as a benchmark. We selected issues faced by physicians in clinical practice in the perioperative management of extended thymectomy for MG, and examined them with a review of the literature. The present guidelines have reached the stage of consensus within the Japanese Association for Chest Surgery.

EASE Guidelines for Authors and Translators of Scientific Articles to be Published in English

PubMed Central

2014-01-01

This concise and readable set of editorial guidelines was first published by the European Association of Science Editors (EASE) in 2010 and is updated annually. It is freely available in more than 20 languages at http://ease.org.uk/publications/author-guidelines. The document is aimed to help scientists worldwide in successful presentation of their research results and in correct translation of manuscripts into English. Moreover, it draws attention to ethical issues, like authorship criteria, plagiarism, conflict of interests, etc. Eight appendices provide examples or more detailed information on selected topics (Abstracts, Ambiguity, Cohesion, Ethics, Plurals, Simplicity, Spelling, and Text-tables). Widespread use of EASE Guidelines should increase the efficiency of international scientific communication. PMID:25132718

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.

EASE Guidelines for Authors and Translators of Scientific Articles to be Published in English.

PubMed

2014-06-01

This concise and readable set of editorial guidelines was first published by the European Association of Science Editors (EASE) in 2010 and is updated annually. It is freely available in more than 20 languages at http://ease.org.uk/publications/author-guidelines. The document is aimed to help scientists worldwide in successful presentation of their research results and in correct translation of manuscripts into English. Moreover, it draws attention to ethical issues, like authorship criteria, plagiarism, conflict of interests, etc. Eight appendices provide examples or more detailed information on selected topics (Abstracts, Ambiguity, Cohesion, Ethics, Plurals, Simplicity, Spelling, and Text-tables). Widespread use of EASE Guidelines should increase the efficiency of international scientific communication.

Commentary: Revisiting "Guidelines for Using Technology to Prepare Social Studies Teachers"

ERIC Educational Resources Information Center

Hartshorne, Richard; Waring, Scott M.

2015-01-01

In Hicks, Lee, Berson, Bolick, and Diem (2014), the authors revisited and revised a series of principles focusing on the preparation of social studies teachers for using digital technologies in the classroom, originally presented in the inaugural issue of "Contemporary Issues in Technology and Teacher Education" (Mason et al., 2000).…

Ethical Issues Concerning the Use of Videoconferencing To Supervise International Social Work Field Practicum Students.

ERIC Educational Resources Information Center

Panos, Patrick T.; Panos, Angelea; Cox, Shirley E.; Roby, Jini L.; Matheson, Kenneth W.

2002-01-01

Examines current ethical guidelines affecting the use of videoconferencing in the supervision of social work students nationally and internationally. Suggests protocols to address ethical and professional practice issues that are likely to arise as a result of using videoconferencing to conduct supervision across international borders. (EV)

Reading Recovery and ESEA Chapter 1: Issues and Possibilities.

ERIC Educational Resources Information Center

Zajano, Nancy C.

The simultaneous implementation of Reading Recovery (an early intervention program designed to help children "at risk" of failure in their first year of reading instruction) and Chapter 1 programs in schools raises a number of issues as educators attempt to provide effective reading instruction within the policies and guidelines of both…

Global Norms: Towards Some Guidelines for Aggregating Personality Norms across Countries

ERIC Educational Resources Information Center

Bartram, Dave

2008-01-01

The article discusses issues relating to the international use of personality inventories, especially those in which organizations make comparisons between people from differing cultures or countries or those with different languages. The focus is on the issue of norming and the use of national versus multinational norms. It is noted that…

Guidelines for qualifying cleaning and verification materials

NASA Technical Reports Server (NTRS)

Webb, D.

1995-01-01

This document is intended to provide guidance in identifying technical issues which must be addressed in a comprehensive qualification plan for materials used in cleaning and cleanliness verification processes. Information presented herein is intended to facilitate development of a definitive checklist that should address all pertinent materials issues when down selecting a cleaning/verification media.

Inclusive E-Learning - Towards an Integrated System Design.

PubMed

Patzer, Yasmin; Pinkwart, Niels

2017-01-01

At first sight there seem to be issues combining technical accessibility guidelines and educational needs when designing inclusive E-Learning. Furthermore Universal Design for Learning seems to contradict individualization. In this paper we address both issues with an inclusive E-Learning design for the LAYA system, which targets disabled and non-disabled learners.

Mandated Reporting of Suspected Child Abuse: Ethics, Law and Policy. First Edition.

ERIC Educational Resources Information Center

Kalichman, Seth C.

Intended for those working in the human services professions as well as students, clinicians, and researchers, this book provides specific suggestions and guidelines for dealing with the ethical issue of required reporting of known or suspected child abuse. The book provides a comprehensive review of research findings, ethical issues, and current…

77 FR 17496 - Fisheries and Habitat Conservation and Migratory Birds Programs; Final Land-Based Wind Energy...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... resulting from construction, operation, and maintenance of land-based wind energy facilities. DATES: These...) established the Wind Turbine Guidelines Advisory Committee (Committee) under the Federal Advisory Committee... concern over certain issues such as the effects of wind turbine noise on wildlife, these issues have not...

Sexual Harassment, Parts I, II, and III.

ERIC Educational Resources Information Center

Douglas, Joel M., Ed.

1992-01-01

Three separate newsletter issues examine the issue of sexual harassment on college campuses. Part I contains a general introduction to the topic and two articles. The first of these discusses the definition of sexual harassment by the United States Equal Employment Opportunity Commission (EEOC) and the courts, the EEOC guidelines on conduct of a…

Development of human factors guidelines for advanced traveler information systems and commercial vehicle operations : definition and prioritization of research studies

DOT National Transportation Integrated Search

1997-03-01

The goal of the activities documented in this report was to produce a prioritized list of candidate studies and issues that would guide data acquisition in this project. This goal was accomplished in three steps. First, 91 issues were compiled from e...

Selected Legal Issues in Catholic Schools.

ERIC Educational Resources Information Center

Shaughnessy, Mary Angela

This book examines legal issues that affect Catholic high schools. Chapter 1 discusses sources of the law and how fairness and due process, federal and state statutes, and various guidelines shape the law. Tort law, corporal punishment, search and seizure, defamation of character, and negligence are covered in chapter 2. Chapter 3 details issues…

LEA in Private: A Privacy and Data Protection Framework for a Learning Analytics Toolbox

ERIC Educational Resources Information Center

Steiner, Christina M.; Kickmeier-Rust, Michael D.; Albert, Dietrich

2016-01-01

To find a balance between learning analytics research and individual privacy, learning analytics initiatives need to appropriately address ethical, privacy, and data protection issues. A range of general guidelines, model codes, and principles for handling ethical issues and for appropriate data and privacy protection are available, which may…

Streaming for Mathematics in Victorian Secondary Schools

ERIC Educational Resources Information Center

Forgasz, Helen

2010-01-01

Streaming (or ability grouping) for mathematics learning is a contentious issue. It can also be considered an issue of equity or social justice as some students may be adversely affected by the practice. Currently, the Victorian Department of Education and Early Childhood Development (DEECD) does not appear to have clear guidelines on streaming.…

Informed consent in human experimentation before the Nuremberg code.

PubMed

Vollmann, J; Winau, R

1996-12-07

The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

Impact of a Brief Training on Medical Resident Screening for Alcohol Misuse and Illicit Drug Use

PubMed Central

Gunderson, Erik W.; Levin, Frances R.; Owen, Patricia

2011-01-01

Educational initiatives are needed to improve primary care substance use screening. This study assesses the impact on 24 medical residents of a 2.5-day curriculum combining experiential and manual-based training on screening for alcohol misuse and illicit drug use. A retrospective chart review of new primary care outpatients demonstrated that nearly all were asked about current alcohol use before and after curriculum participation. Adherence to national screening guidelines on quantification of alcohol consumption modestly improved (p < .05), as did inquiry about current illicit drug use (p < .05). Continued efforts are needed to enhance educational initiatives for primary care physicians. PMID:18393059

Uncertainty Estimation Cheat Sheet for Probabilistic Risk Assessment

NASA Technical Reports Server (NTRS)

Britton, Paul T.; Al Hassan, Mohammad; Ring, Robert W.

2017-01-01

"Uncertainty analysis itself is uncertain, therefore, you cannot evaluate it exactly," Source Uncertain Quantitative results for aerospace engineering problems are influenced by many sources of uncertainty. Uncertainty analysis aims to make a technical contribution to decision-making through the quantification of uncertainties in the relevant variables as well as through the propagation of these uncertainties up to the result. Uncertainty can be thought of as a measure of the 'goodness' of a result and is typically represented as statistical dispersion. This paper will explain common measures of centrality and dispersion; and-with examples-will provide guidelines for how they may be estimated to ensure effective technical contributions to decision-making.

Lognormal Uncertainty Estimation for Failure Rates

NASA Technical Reports Server (NTRS)

Britton, Paul T.; Al Hassan, Mohammad; Ring, Robert W.

2017-01-01

"Uncertainty analysis itself is uncertain, therefore, you cannot evaluate it exactly," Source Uncertain. Quantitative results for aerospace engineering problems are influenced by many sources of uncertainty. Uncertainty analysis aims to make a technical contribution to decision-making through the quantification of uncertainties in the relevant variables as well as through the propagation of these uncertainties up to the result. Uncertainty can be thought of as a measure of the 'goodness' of a result and is typically represented as statistical dispersion. This presentation will explain common measures of centrality and dispersion; and-with examples-will provide guidelines for how they may be estimated to ensure effective technical contributions to decision-making.

Impact of a brief training on medical resident screening for alcohol misuse and illicit drug use.

PubMed

Gunderson, Erik W; Levin, Frances R; Owen, Patricia

2008-01-01

Educational initiatives are needed to improve primary care substance use screening. This study assesses the impact on 24 medical residents of a 2.5-day curriculum combining experiential and manual-based training on screening for alcohol misuse and illicit drug use. A retrospective chart review of new primary care outpatients demonstrated that nearly all were asked about current alcohol use before and after curriculum participation. Adherence to national screening guidelines on quantification of alcohol consumption modestly improved (p < .05), as did inquiry about current illicit drug use (p < .05). Continued efforts are needed to enhance educational initiatives for primary care physicians.

Quality control of herbs: determination of amino acids in Althaea officinalis, Matricaria chamomilla and Taraxacum officinale.

PubMed

Qureshi, Muhammad Nasimullah; Stecher, Guenther; Bonn, Guenther Karl

2014-05-01

Analysis of raw materials and final products need reliable methods for the standardization of natural product drugs. Legal guideline also emphasizes on the qualitative and quantitative analyses of the plant constituents in an herbal product. In this study, thin layer chromatography (TLC) and amino acid analyzer was used for the determination of amino acids in plant extracts. Samples for this study were standards and aqueous extracts from Althaea officinalis, Matricaria chamomilla and Taraxacum officinale. Different amino acids in the extracts were detected through TLC. An automatic amino acid analyzer was used for the quantification of amino acids in the plant extracts under study.

Conflict of Interest Policies and Industry Relationships of Guideline Development Group Members: A Cross-Sectional Study of Clinical Practice Guidelines for Depression.

PubMed

Cosgrove, Lisa; Krimsky, Sheldon; Wheeler, Emily E; Peters, Shannon M; Brodt, Madeline; Shaughnessy, Allen F

2017-01-01

Because of increased attention to the issue of trustworthiness of clinical practice guidelines, it may be that both transparency and management of industry associations of guideline development groups (GDGs) have improved. The purpose of the present study was to assess a) the disclosure requirements of GDGs in a cross-section of guidelines for major depression; and, b) the extent and type of conflicts of panel members. Treatment guidelines for major depression were identified and searched for conflict of interest policies and disclosure statements. Multi-modal screens for undeclared conflicts were also conducted. Fourteen guidelines with a total of 172 panel members were included in the analysis. Eleven of the 14 guidelines (78%) had a stated conflict of interest policy or disclosure statement, although the policies varied widely. Most (57%) of the guidelines were developed by panels that had members with industry financial ties to drug companies that manufacture antidepressant medication. However, only a minority of total panel members (18%) had such conflicts of interest. Drug company speakers bureau participation was the most common type of conflict. Although some progress has been made, organizations that develop guidelines should continue to work toward greater transparency and minimization of financial conflicts of interest.

Syncope

MedlinePlus

... Bridging Disciplines Circulation at Major Meetings Special Themed Issues Global Impact of the 2017 ACC/AHA Hypertension Guidelines Circulation Supplements Cardiovascular Case Series ECG Challenge Hospitals of History Brigham and ...

Patient factors associated with guideline-concordant treatment of anxiety and depression in primary care.

PubMed

Prins, Marijn A; Verhaak, Peter F M; Smolders, Mirrian; Laurant, Miranda G H; van der Meer, Klaas; Spreeuwenberg, Peter; van Marwijk, Harm W J; Penninx, Brenda W J H; Bensing, Jozien M

2010-07-01

To identify associations of patient characteristics (predisposing, enabling and need factors) with guideline-concordant care for anxiety and depression in primary care. Analysis of data from the Netherlands Study of Depression and Anxiety (NESDA). Seven hundred and twenty-one patients with a current anxiety or depressive disorder, recruited from 67 general practitioners (GPs), were included. Diagnoses according to the Diagnostic and Statistic Manual of Mental Disorders, fourth edition (DSM-IV) were made using a structured and widely validated assessment. Socio-demographic and enabling characteristics, severity of symptoms, disability, (under treatment for) chronic somatic conditions, perceived need for care, beliefs and evaluations of care were measured by questionnaires. Actual care data were derived from electronic medical records. Criteria for guideline-concordant care were based on general practice guidelines, issued by the Dutch College of General Practitioners. Two hundred and eighty-one (39%) patients received guideline-concordant care. High education level, accessibility of care, comorbidity of anxiety and depression, and severity and disability scores were positively associated with receiving guideline-concordant care in univariate analyses. In multivariate multi-level logistic regression models, significant associations with the clinical need factors disappeared. Positive evaluations of accessibility of care increased the chance (OR = 1.31; 95%-CI = 1.05-1.65; p = 0.02) of receiving guideline-concordant care, as well as perceiving any need for medication (OR = 2.99; 95%-CI = 1.84-4.85; p < 0.001), counseling (OR = 2.25; 95%-CI = 1.29-3.95; p = 0.005) or a referral (OR = 1.83; 95%-CI = 1.09-3.09; p = 0.02). A low educational level decreased the odds (OR = 0.33; 95%-CI = 0.11-0.98; p = 0.04) of receiving guideline-concordant care. This study shows that education level, accessibility of care and patients' perceived needs for care are more strongly associated with the delivery of guideline-concordant care for anxiety or depression than clinical need factors. Initiatives to improve GPs' communication skills around mental health issues, and to improve recognition of people suffering from anxiety disorders, could increase the number of patients receiving treatment for depression and anxiety in primary care.

Exploring work-related issues on corporate sustainability.

PubMed

Brunoro, C M; Bolis, I; Sznelwar, L I

2015-01-01

In a research project about work-related issues and corporate sustainability conducted in Brazil, the goal was to better understand how work-related issues were addressed in the corporate context. Particularly, there are some specific initiatives that serve as guides to organizational decisions, which make their performance indicators for the context of corporate sustainability. 1) To explore the presence of work-related issues and their origins in corporate sustainability approach, analyzing a) corporate disclosures; b) sustainability guidelines that are identified as relevant in corporate disclosures; c) documents that are related to sustainable development and also identified as key-documents for these guidelines and initiatives. 2) To present the activity-centered ergonomics and psychodynamics of work contributions to work-related issues in a corporate sustainability approach. An exploratory study based on multiple sources of evidence that were performed from 2012 to 2013, including interviews with companies that engaged in corporate sustainability and document analysis using the content analysis approach. Work-related issues have been presented since the earliest sustainable development documents. It is feasible to construct an empirical framework for work-related issues and corporate sustainability approaches. 1) Although some authors argue that corporate sustainability has its roots based only on the environmental dimension, there is strong empirical evidence showing that social dimension aspects such as work-related issues have been present since the beginning. 2) Some indicators should be redesigned to more precisely translate the reality of some workplaces, particularly those indicators related to organizational design and mental health.

A challenging issue: Detection of white matter hyperintensities in neonatal brain MRI.

PubMed

Morel, Baptiste; Yongchao Xu; Virzi, Alessio; Geraud, Thierry; Adamsbaum, Catherine; Bloch, Isabelle

2016-08-01

The progress of magnetic resonance imaging (MRI) allows for a precise exploration of the brain of premature infants at term equivalent age. The so-called DEHSI (diffuse excessive high signal intensity) of the white matter of premature brains remains a challenging issue in terms of definition, and thus of interpretation. We propose a semi-automatic detection and quantification method of white matter hyperintensities in MRI relying on morphological operators and max-tree representations, which constitutes a powerful tool to help radiologists to improve their interpretation. Results show better reproducibility and robustness than interactive segmentation.

Revision of the ICH guideline on detection of toxicity to reproduction for medicinal products: SWOT analysis.

PubMed

Barrow, Paul

2016-09-01

SWOT analysis was used to gain insights and perspectives into the revision of the ICH S5(R2) guideline on detection of toxicity to reproduction for medicinal products. The current ICH guideline was rapidly adopted worldwide and has an excellent safety record for more than 20 years. The revised guideline should aim to further improve reproductive and developmental (DART) safety testing for new drugs. Alternative methods to animal experiments should be used whenever possible. Modern technology should be used to obtain high quality data from fewer animals. Additions to the guideline should include considerations on the following: limit dose setting, maternal toxicity, biopharmaceuticals, vaccines, testing strategies by indication, developmental immunotoxicity, and male-mediated developmental toxicity. Emerging issues, such as epigenetics and the microbiome, will most likely pose challenges to DART testing in the future. It is hoped that the new guideline will be adopted even outside the ICH regions. Copyright © 2016 Elsevier Inc. All rights reserved.

Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease.

PubMed

Cameron, Daniel J; Johnson, Lorraine B; Maloney, Elizabeth L

2014-09-01

Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions - the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1-13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols.

Guideline implementation strategies for specialist mental healthcare.

PubMed

Girlanda, Francesca; Fiedler, Ines; Ay, Esra; Barbui, Corrado; Koesters, Markus

2013-07-01

Clinical practice guidelines in mental healthcare are viewed as an essential asset if appropriately developed and implemented. The purpose of this article was to review the existing literature on how guidelines should be implemented to optimize their impact on provider performance and patient outcomes in specialist mental healthcare settings. Findings from recent studies suggest a trend toward an improvement in process and patient outcomes following guideline implementation. However, studies are heterogeneous in terms of design, implementation strategies and outcome measures, making it very difficult to draw firm conclusions about which implementation strategy is effective in different healthcare contexts. Current knowledge about how guidelines should be implemented is still sparse and inconclusive in mental healthcare. Future studies should attempt to employ more rigorous designs, including random allocation of patients or clusters of patients, to shed further light on this compelling issue. Research on guideline implementation strategies should additionally take into account potential barriers to knowledge translation, which can heavily influence the implementability of treatment recommendations.

What Do Ethical Guidelines for Epidemiology Say About an Ethics Review? A Qualitative Systematic Review.

PubMed

Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius

2017-06-01

Epidemiological research is subject to an ethics review. The aim of this qualitative review is to compare existing ethical guidelines in English for epidemiological research and public health practice in regard to the scope and matter of an ethics review. Authors systematically searched PubMed, Google Scholar and Google Search for ethical guidelines. Qualitative analysis (constant comparative method) was applied to categorize important aspects of the an ethics review process. Eight ethical guidelines in English for epidemiological research were retrieved. Five main categories that are relevant to the review of epidemiological research by Institutional Review Boards/Research Ethics Committees were distinguished. Within the scope of main categories, fifty-nine subcategories were analyzed. There are important differences between the guidelines in terms of the scope and matter of an ethics review. Not all guidelines encompass all identified ethically important issues, and some do not define precisely the scope and matter of an ethics review, leaving much to the ethics of the individual researchers and the discretion of IRBs/RECs.

[Guidelines for employment policies in Europe and national action plans: opportunities for people with disabilities].

PubMed

Niehaus, M

2000-06-01

The scourge of unemployment has been roundly identified throughout Europe as the most pressing social and economic problem on the current political agenda. At Luxembourg in November 1997, the European Jobs Summit brought Europe's leaders together in an historic occasion that mapped out employment guidelines for Europe. The Luxembourg Jobs Summit agreed a set of guidelines for the Member States employment policy under four pillars, employability, entrepreneurship, adaptability, and equal opportunities. One guideline referred to promoting integration of people with disabilities into working life. The Member States subsequently agreed to incorporate the Guidelines into national employment action plans. The question of this paper is, to what extent do employment guidelines and National Action Plans improve the opportunities of disabled persons? This paper seeks to establish a set of fundamental issues concerning employment and disability. Included in this analysis are recommendations in order to achieve a better presence of disabled people in National Action Plans in future.

Evidence assessments and guideline recommendations in Lyme disease: the clinical management of known tick bites, erythema migrans rashes and persistent disease

PubMed Central

Cameron, Daniel J; Johnson, Lorraine B; Maloney, Elizabeth L

2014-01-01

Evidence-based guidelines for the management of patients with Lyme disease were developed by the International Lyme and Associated Diseases Society (ILADS). The guidelines address three clinical questions – the usefulness of antibiotic prophylaxis for known tick bites, the effectiveness of erythema migrans treatment and the role of antibiotic retreatment in patients with persistent manifestations of Lyme disease. Healthcare providers who evaluate and manage patients with Lyme disease are the intended users of the new ILADS guidelines, which replace those issued in 2004 (Exp Rev Anti-infect Ther 2004;2:S1–13). These clinical practice guidelines are intended to assist clinicians by presenting evidence-based treatment recommendations, which follow the Grading of Recommendations Assessment, Development and Evaluation system. ILADS guidelines are not intended to be the sole source of guidance in managing Lyme disease and they should not be viewed as a substitute for clinical judgment nor used to establish treatment protocols. PMID:25077519

The wound/burn guidelines - 6: Guidelines for the management of burns.

PubMed

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

2016-09-01

Burns are a common type of skin injury encountered at all levels of medical facilities from private clinics to core hospitals. Minor burns heal by topical treatment alone, but moderate to severe burns require systemic management, and skin grafting is often necessary also for topical treatment. Inappropriate initial treatment or delay of initial treatment may exert adverse effects on the subsequent treatment and course. Therefore, accurate evaluation of the severity and initiation of appropriate treatment are necessary. The Guidelines for the Management of Burn Injuries were issued in March 2009 from the Japanese Society for Burn Injuries as guidelines concerning burns, but they were focused on the treatment for extensive and severe burns in the acute period. Therefore, we prepared guidelines intended to support the appropriate diagnosis and initial treatment for patients with burns that are commonly encountered including minor as well as moderate and severe cases. Because of this intention of the present guidelines, there is no recommendation of individual surgical procedures. © 2016 Japanese Dermatological Association.