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Sample records for standard clinical tests

  1. 42 CFR 493.1457 - Standard; Clinical consultant responsibilities.

    Science.gov (United States)

    2010-10-01

    ... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived Testing Laboratories Performing High Complexity Testing § 493.1457 Standard; Clinical consultant... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

  2. 42 CFR 493.1419 - Standard; Clinical consultant responsibilities.

    Science.gov (United States)

    2010-10-01

    ... Testing Laboratories Performing Moderate Complexity Testing § 493.1419 Standard; Clinical consultant... clinical consultation to the laboratory's clients; (b) Be available to assist the laboratory's clients in... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Clinical consultant responsibilities. 493...

  3. 42 CFR 493.1276 - Standard: Clinical cytogenetics.

    Science.gov (United States)

    2010-10-01

    ... SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic Systems § 493.1276 Standard: Clinical cytogenetics. (a) The laboratory must have policies and procedures for ensuring accurate and reliable patient specimen identification during the process...

  4. Proposed quality control guidelines for National Committee for Clinical Laboratory Standards Susceptibility Tests using the veterinary antimicrobial agent tiamulin.

    Science.gov (United States)

    Pfaller, M A; Jones, R N; Walter, D H

    2001-01-01

    Quality control guidelines for standardized antimicrobial susceptibility test methods are critical for the continuing accuracy of these clinical tests. In this report, quality control limits were proposed for the veterinary antimicrobial agent tiamulin with minimum inhibitory concentration (MIC) ranges of three or four log(2) dilution steps in two different medium formulations. Disk diffusion zone diameter ranges were proposed for tiamulin tested against Actinobacillus pleuropneumoniae ATCC 27090 (12-18 mm) and Staphylococcus aureus ATCC 25923 (25-32 mm). The data from eight participating laboratories produced 100% of results within proposed MIC limits (8-32 microg/mL), and 95.8-97.0% of zones were found within suggested zone diameter QC guidelines. These proposed QC ranges should be validated by in-use results from veterinary clinical laboratories.

  5. MASTER: a model to improve and standardize clinical breakpoints for antimicrobial susceptibility testing using forecast probabilities.

    Science.gov (United States)

    Blöchliger, Nicolas; Keller, Peter M; Böttger, Erik C; Hombach, Michael

    2017-09-01

    The procedure for setting clinical breakpoints (CBPs) for antimicrobial susceptibility has been poorly standardized with respect to population data, pharmacokinetic parameters and clinical outcome. Tools to standardize CBP setting could result in improved antibiogram forecast probabilities. We propose a model to estimate probabilities for methodological categorization errors and defined zones of methodological uncertainty (ZMUs), i.e. ranges of zone diameters that cannot reliably be classified. The impact of ZMUs on methodological error rates was used for CBP optimization. The model distinguishes theoretical true inhibition zone diameters from observed diameters, which suffer from methodological variation. True diameter distributions are described with a normal mixture model. The model was fitted to observed inhibition zone diameters of clinical Escherichia coli strains. Repeated measurements for a quality control strain were used to quantify methodological variation. For 9 of 13 antibiotics analysed, our model predicted error rates of  0.1% for ampicillin, cefoxitin, cefuroxime and amoxicillin/clavulanic acid. Increasing the susceptible CBP (cefoxitin) and introducing ZMUs (ampicillin, cefuroxime, amoxicillin/clavulanic acid) decreased error rates to < 0.1%. ZMUs contained low numbers of isolates for ampicillin and cefuroxime (3% and 6%), whereas the ZMU for amoxicillin/clavulanic acid contained 41% of all isolates and was considered not practical. We demonstrate that CBPs can be improved and standardized by minimizing methodological categorization error rates. ZMUs may be introduced if an intermediate zone is not appropriate for pharmacokinetic/pharmacodynamic or drug dosing reasons. Optimized CBPs will provide a standardized antibiotic susceptibility testing interpretation at a defined level of probability. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For

  6. The skin prick test – European standards

    Directory of Open Access Journals (Sweden)

    Heinzerling Lucie

    2013-02-01

    Full Text Available Abstract Skin prick testing is an essential test procedure to confirm sensitization in IgE-mediated allergic disease in subjects with rhinoconjunctivitis, asthma, urticaria, anapylaxis, atopic eczema and food and drug allergy. This manuscript reviews the available evidence including Medline and Embase searches, abstracts of international allergy meetings and position papers from the world allergy literature. The recommended method of prick testing includes the appropriate use of specific allergen extracts, positive and negative controls, interpretation of the tests after 15 – 20 minutes of application, with a positive result defined as a wheal ≥3 mm diameter. A standard prick test panel for Europe for inhalants is proposed and includes hazel (Corylus avellana, alder (Alnus incana, birch (Betula alba, plane (Platanus vulgaris, cypress (Cupressus sempervirens, grass mix (Poa pratensis, Dactilis glomerata, Lolium perenne, Phleum pratense, Festuca pratensis, Helictotrichon pretense, Olive (Olea europaea, mugwort (Artemisia vulgaris, ragweed (Ambrosia artemisiifolia, Alternaria alternata (tenuis, Cladosporium herbarum, Aspergillus fumigatus, Parietaria, cat, dog, Dermatophagoides pteronyssinus, Dermatophagoides farinae, and cockroach (Blatella germanica. Standardization of the skin test procedures and standard panels for different geographic locations are encouraged worldwide to permit better comparisons for diagnostic, clinical and research purposes.

  7. Non-standard patch test

    Directory of Open Access Journals (Sweden)

    Astri Adelia

    2018-06-01

    Full Text Available In managing contact dermatitis, identification of the causative agent is essential to prevent recurrent complaints. Patch test is the gold standard to identify the causative agent. Nowadays, there are many patch test standard materials available in the market, but do not include all the materials that potentially cause contact dermatitis. Patch test using patient’s own products or later we refer to as non-standard materials, is very helpful in identifying the causative agents of contact dermatitis. Guidance is needed in producing non-standard patch test materials in order to avoid test results discrepancy.

  8. Clinical investigation of 14C-urea breath test

    International Nuclear Information System (INIS)

    Yu Yongli; Zhu Ruisen; Ji Hong; Luo Quanyong

    2000-01-01

    To investigate clinical value of 14 C-urea breath test ( 14 C-UBT) for the diagnosis of Helicobacter pylori(Hp), 70 patients were both performed gastroscopy (taking gastric mucosae biopsy for rapid urease test and histology) and 14 C-UBT (some patients by Hp-IgG or DNAHp test also) within two days. The positive cases of both rapid urease test and histology was defined as 'gold standard' of Hp-positive, whereas the negative cases of both rapid urease test and histology as 'gold standard' of Hp-negative. The sensitivity of 14 C-UBT was 93.2%, the specificity 73.1%, and the diagnostic accuracy 85.7%. The difference (comparing with 'gold standard') was not marked (x 2 = 0.9 0.05(1) 2 = 3.84, P>0.05). But the diagnostic accuracy of 14 C-UBT (85.7%) and Hp-IgG (50%) had a marked difference (x 2 13.80>x 0.01(1) 2 = 6.64, P 14 C-UBT was easy to operate, reliable and suitable for clinical application

  9. Reliability, standard error, and minimum detectable change of clinical pressure pain threshold testing in people with and without acute neck pain.

    Science.gov (United States)

    Walton, David M; Macdermid, Joy C; Nielson, Warren; Teasell, Robert W; Chiasson, Marco; Brown, Lauren

    2011-09-01

    Clinical measurement. To evaluate the intrarater, interrater, and test-retest reliability of an accessible digital algometer, and to determine the minimum detectable change in normal healthy individuals and a clinical population with neck pain. Pressure pain threshold testing may be a valuable assessment and prognostic indicator for people with neck pain. To date, most of this research has been completed using algometers that are too resource intensive for routine clinical use. Novice raters (physiotherapy students or clinical physiotherapists) were trained to perform algometry testing over 2 clinically relevant sites: the angle of the upper trapezius and the belly of the tibialis anterior. A convenience sample of normal healthy individuals and a clinical sample of people with neck pain were tested by 2 different raters (all participants) and on 2 different days (healthy participants only). Intraclass correlation coefficient (ICC), standard error of measurement, and minimum detectable change were calculated. A total of 60 healthy volunteers and 40 people with neck pain were recruited. Intrarater reliability was almost perfect (ICC = 0.94-0.97), interrater reliability was substantial to near perfect (ICC = 0.79-0.90), and test-retest reliability was substantial (ICC = 0.76-0.79). Smaller change was detectable in the trapezius compared to the tibialis anterior. This study provides evidence that novice raters can perform digital algometry with adequate reliability for research and clinical use in people with and without neck pain.

  10. Establishment of quality assessment standard for mammographic equipment: evaluation of phantom and clinical images

    International Nuclear Information System (INIS)

    Lee, Sung Hoon; Choe, Yeon Hyeon; Chung, Soo Young

    2005-01-01

    The purpose of this study was to establish a quality standard for mammographic equipment Korea and to eventually improve mammographic quality in clinics and hospitals throughout Korea by educating technicians and clinic personnel. For the phantom test and on site assessment, we visited 37 sites and examined 43 sets of mammographic equipment. Items that were examined include phantom test, radiation dose measurement, developer assessment, etc. The phantom images were assessed visually and by optical density measurements. For the clinical image assessment, clinical images from 371 sites were examined following the new Korean standard for clinical image evaluation. The items examined include labeling, positioning, contrast, exposure, artifacts, collimation among others. Quality standard of mammographic equipment was satisfied in all equipment on site visits. Average mean glandular dose was 114.9 mRad. All phantom image test scores were over 10 points (average, 10.8 points). However, optical density measurements were below 1.2 in 9 sets of equipment (20.9%). Clinical image evaluation revealed appropriate image quality in 83.5%, while images from non-radiologist clinics were adequate in 74.6% (91/122), which was the lowest score of any group. Images were satisfactory in 59.0% (219/371) based on evaluation by specialists following the new Korean standard for clinical image evaluation. Satisfactory images had a mean score of 81.7 (1 S.D. =8.9) and unsatisfactory images had a mean score of 61.9 (1 S.D = 11). The correlation coefficient between the two observers was 0.93 (ρ < 0.01) in 49 consecutive cases. The results of the phantom tests suggest that optical density measurements should be performed as part of a new quality standard for mammographic equipment. The new clinical evaluation criteria that was used in this study can be implemented with some modifications for future mammography quality control by the Korean government

  11. [Clinical investigation of basophil activation test as a complementary test for house dust mite allergen].

    Science.gov (United States)

    Ren, H L; Li, J D; Miao, Y H; Xu, T

    2018-03-01

    Objective: To investigate the clinical application of glass micro fiber basophil activation test (BAT) used as a complementary test for house dust mite allergen. Method: Forty patients with clinical diagnosed allergic rhinitis was test by three methods for house dust mite allergen, skin prick test(SPT),Immuno CAP sIgE, and BAT in vitro. The sensitivity and specificity of glass micro fiber were accessed, and the consistency between BAT, SPT, and Immuno sIgE was analyzed. As in vivo provocation was not performed, gold standard is regarded as the combination of medical history and positive reports of SPT and/or ImmunoCAP sIgE test. Result: Twentythree patients are diagnosed as house dust mite allergic rhinitis by gold standard. The sensitivity and specificity of glass micro fiber BAT were 60.9% and 88.2%, the sensitivity of SPT and sIgE was 87.0% and sIgE 73.9%. The correlation rates between BAT with SPT is 0.67( P house dust mite allergic rhinitis, BAT have a good consistency with SPT and sIgE, while as it has only moderate consistency with "gold standard", further studies are needed to prove its clinical significance. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

  12. Clinical Laboratory Tests in Some Acute Exogenous Poisonings.

    Science.gov (United States)

    Tufkova, Stoilka G; Yankov, Ivan V; Paskaleva, Diana A

    2017-09-01

    There is no specific toxicological screening of clinical laboratory parameters in clinical toxicology when it comes to acute exogenous poisoning. To determine routine clinical laboratory parameters and indicators for assessment of vital functions in patients with acute intoxications. One hundred and fifty-three patients were included in the present study. They were hospitalized in the Department of Clinical Toxicology at St. George University Hospital, Plovdiv for cerebral toxicity inducing medication (n = 45), alcohol (n = 40), heroin abuse (n = 33). The controls were 35. The laboratory tests were conducted in compliance with the standards of the clinical laboratory. We used the following statistical analyses: analysis of variance (the ucriterion of normal distribution, the Student's t-test, dispersion analysis based on ANOVA) and non-parametric analysis. Based on the routine hematological parameters with statistically significant changes in three groups of poisoning are: red blood cells, hematocrit, hemoglobin (except alcohol intoxication) and leukocytes. We found statistically significant changes in serum total protein, sodium and bilirubin. The highest statistical significance is the increased activity of AST and ALT. We present a model for selection of clinical laboratory tests for severe acute poisoning with modern equipment under standardized conditions. The results of the study suggest that the clinical laboratory constellation we used can be used as a mandatory element in the diagnosis of moderate and severe intoxication with the mentioned toxic substances.

  13. Clinical quality standards for radiotherapy

    Science.gov (United States)

    2012-01-01

    Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:23788854

  14. Contribution of diagnostic tests for the etiological assessment of uveitis, data from the ULISSE study (Uveitis: Clinical and medicoeconomic evaluation of a standardized strategy of the etiological diagnosis).

    Science.gov (United States)

    Grumet, Pierre; Kodjikian, Laurent; de Parisot, Audrey; Errera, Marie-Hélène; Sedira, Neila; Heron, Emmanuel; Pérard, Laurent; Cornut, Pierre-Loïc; Schneider, Christelle; Rivière, Sophie; Ollé, Priscille; Pugnet, Grégory; Cathébras, Pascal; Manoli, Pierre; Bodaghi, Bahram; Saadoun, David; Baillif, Stéphanie; Tieulie, Nathalie; Andre, Marc; Chiambaretta, Frédéric; Bonin, Nicolas; Bielefeld, Philip; Bron, Alain; Mouriaux, Frédéric; Bienvenu, Boris; Vicente, Stéphanie; Bin, Sylvie; Labetoulle, Marc; Broussolle, Christiane; Jamilloux, Yvan; Decullier, Evelyne; Sève, Pascal

    2018-04-01

    ULISSE is the only study that prospectively assessed the efficiency of a standardized strategy, compared to an open strategy for the etiologic diagnosis of uveitis. Our aim was to evaluate the diagnostic yield of the tests prescribed in the ULISSE study to clarify their relevance. ULISSE is a non-inferiority, prospective, multicenter and cluster randomized study. The standardized strategy is a two-steps strategy: in the first step, common standard tests were performed, and in the second step, tests were guided by the clinical and anatomic type of uveitis. We reported the relevance of the diagnostic tests used in the standardized strategy, as well as the profitability of the tests that were prescribed to more than twenty patients in each group. Based on diagnostic criteria, either an ophthalmologist, or an internist, established the profitability of a test by considering whether the test lead to a diagnosis or not. Among the 676 patients included (standardized 303; open 373), a diagnosis was made for 152 (50.4%) in the standardized group and 203 (54.4%) in the open group. The most common entities were HLA-B27 associated uveitis (22%), spondyloarthritis (11%), sarcoidosis (18%), tuberculosis (10.7%) and herpes virus infections (8.5%). Among the first step's systematic tests, tuberculin skin test was the most contributive investigation (17.1%), followed by chest X-ray (8.4%), C reactive protein and ESR (6.6% and 5.1%), complete blood count (2.2%) and VDRL (2.0%). The second step's most often contributive tests were: HLA B27 (56.3%), chest-CT (30.3%) and angiotensin converting enzyme (ACE) (16.5%). HLA B27 and ACE were significantly more contributive in the standardized group than in the open group. Immunological tests were never contributive. Among the free investigations, or among the investigations guided by clinical or paraclinical findings, the most often contributive tests were: Quantiferon® (24%), electrophoresis of serum protein (7.8%) and sacroiliac imagery

  15. Enhancing translation: guidelines for standard pre-clinical experiments in mdx mice.

    Science.gov (United States)

    Willmann, Raffaella; De Luca, Annamaria; Benatar, Michael; Grounds, Miranda; Dubach, Judith; Raymackers, Jean-Marc; Nagaraju, Kanneboyina

    2012-01-01

    Duchenne Muscular Dystrophy is an X-linked disorder that affects boys and leads to muscle wasting and death due to cardiac involvement and respiratory complications. The cause is the absence of dystrophin, a large structural protein indispensable for muscle cell function and viability. The mdx mouse has become the standard animal model for pre-clinical evaluation of potential therapeutic treatments. Recent years have seen a rapid increase in the number of experimental compounds being evaluated in the mdx mouse. There is, however, much variability in the design of these pre-clinical experimental studies. This has made it difficult to interpret and compare published data from different laboratories and to evaluate the potential of a treatment for application to patients. The authors therefore propose the introduction of a standard study design for the mdx mouse model. Several aspects, including animal care, sampling times and choice of tissues, as well as recommended endpoints and methodologies are addressed and, for each aspect, a standard procedure is proposed. Testing of all new molecules/drugs using a widely accepted and agreed upon standard experimental protocol would greatly improve the power of pre-clinical experimentations and help identifying promising therapies for the translation into clinical trials for boys with Duchenne Muscular Dystrophy. Copyright © 2011 Elsevier B.V. All rights reserved.

  16. Estándares de calidad en los ensayos clínicos: ISO 9001-Buena Práctica Clínica Quality standards in clinical tests. ISO 9001: Good Clinical Practice

    Directory of Open Access Journals (Sweden)

    Sandra Álvarez Guerra

    2005-12-01

    Full Text Available La calidad en los ensayos clínicos conducidos por los centros de investigación por contrato , constituye un factor de suma importancia. En la actualidad estas instituciones usan como estándar de calidad la Buena Práctica Clínica. Sin embargo, su combinación con la Norma ISO 9001:2000, estándar de calidad, internacionalmente utilizado, no se ha generalizado. Para demostrar la factibilidad que el uso conjunto de estas normas brindan a las organizaciones se decidió establecer reflexiones para demostrar cómo se complementan ambos estándares de calidad en la realización de ensayos clínicos. Para esto se revisó bibliografía actualizada en dichos temas. Se valoraron aspectos en común como: clientes, responsabilidad, tratamiento de datos generados, estadística, control de la calidad y documentos esenciales. Por medio de estos aspectos ambas normas tributan a la calidad del ensayo clínico, para una mejor protección al paciente, resultados confiables, satisfacción de los clientes, internos y externos, que garanticen la mejora continua, y establecer planes de contingencia y medidas preventivas. Se concluye que ambas normativas no están en contraposición y pueden ser utilizadas como vía capaz de garantizar excelencia en el servicio brindado.The quality of clinical tests conducted by the research centers on contract is a very important factor. Nowadays, these institutions use Good Clinical Practice as the quality standard. However, the combination of the latter with internationally used ISO 9001:2000 quality standard has not yet been generalized. In order to prove the feasibility that the joint use of these standards offers to organizations, it was decided to reflect on the way both quality standards complement each other in the performance of clinical tests. To this end, updated literature review was made. Common aspects such as clients, responsibility, treatment of data, statistics, quality control and essential documents were

  17. Historical Evolution of NASA Standard Materials Testing with Hypergolic Propellants and Ammonia (NASA Standard 6001 Test 15)

    Science.gov (United States)

    Greene, Benjamin; McClure, Mark B.

    2012-01-01

    The NASA Johnson Space Center White Sands Test Facility (WSTF) has performed testing of hazardous and reactive aerospace fluids, including hypergolic propellants, with materials since the 1960s with the Apollo program. Amongst other test activities, Test 15 is a NASA standard test for evaluating the reactivity of materials with selected aerospace fluids, in particular hydrazine, monomethylhydrazine, uns-dimethylhydrazine, Aerozine 50, dinitrogen tetroxide oxidizers, and ammonia. This manuscript provides an overview of the history of Test 15 over a timeline ranging from prior to its development and first implementation as a NASA standard test in 1974 to its current refinement. Precursor documents to NASA standard tests, as they are currently known, are reviewed. A related supplementary test, international standardization, and enhancements to Test 15 are also discussed. Because WSTF was instrumental in the development and implementation of Test 15, WSTF experience and practices are referred to in this manuscript.

  18. Standard Test Method for Sandwich Corrosion Test

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This test method defines the procedure for evaluating the corrosivity of aircraft maintenance chemicals, when present between faying surfaces (sandwich) of aluminum alloys commonly used for aircraft structures. This test method is intended to be used in the qualification and approval of compounds employed in aircraft maintenance operations. 1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information. 1.3 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific hazard statements appear in Section 9.

  19. Use of the National Committee for Clinical Laboratory Standards Guidelines for Disk Diffusion Susceptibility Testing in New York State Laboratories

    Science.gov (United States)

    Kiehlbauch, Julia A.; Hannett, George E.; Salfinger, Max; Archinal, Wendy; Monserrat, Catherine; Carlyn, Cynthia

    2000-01-01

    Accurate antimicrobial susceptibility testing is vital for patient care and surveillance of emerging antimicrobial resistance. The National Committee for Clinical Laboratory Standards (NCCLS) outlines generally agreed upon guidelines for reliable and reproducible results. In January 1997 we surveyed 320 laboratories participating in the New York State Clinical Evaluation Program for General Bacteriology proficiency testing. Our survey addressed compliance with NCCLS susceptibility testing guidelines for bacterial species designated a problem (Staphylococcus aureus and Enterococcus species) or fastidious (Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae) organism. Specifically, we assessed compliance with guidelines for inoculum preparation, medium choice, number of disks per plate, and incubation conditions for disk diffusion tests. We also included length of incubation for S. aureus and Enterococcus species. We found overall compliance with the five characteristics listed above in 80 of 153 responding laboratories (50.6%) for S. aureus and 72 of 151 (47.7%) laboratories for Enterococcus species. The most common problem was an incubation time shortened to less than 24 h. Overall compliance with the first four characteristics was reported by 92 of 221 (41.6%) laboratories for S. pneumoniae, 49 of 163 (30.1%) laboratories for H. influenzae, and 11 of 77 (14.3%) laboratories for N. gonorrhoeae. Laboratories varied from NCCLS guidelines by placing an excess number of disks per plate. Laboratories also reported using alternative media for Enterococcus species, N. gonorrhoeae, and H. influenzae. This study demonstrates a need for education among clinical laboratories to increase compliance with NCCLS guidelines. PMID:10970381

  20. Advances in the use of inhalation provocation tests in clinical evaluation

    NARCIS (Netherlands)

    Hargreave, F. E.; Ramsdale, E. H.; Sterk, P. J.; Juniper, E. F.

    1985-01-01

    Recent advances in the use of inhalation provocation tests in the clinical evaluation of asthma have been made with methacholine and histamine tests. The tests can be better standardized and the results more accurately interpreted. The ease of stimulation of bronchoconstriction by methacholine and

  1. Initial clinical test of a breast-PET scanner

    International Nuclear Information System (INIS)

    Raylman, Raymond R.; Koren, Courtney; Schreiman, Judith S.; Majewski, Stan; Marano, Gary D.; Abraham, Jame; Kurian, Sobha; Hazard, Hannah; Filburn, Shannon

    2011-01-01

    The goal of this initial clinical study was to test a new positron emission/tomography imager and biopsy system (PEM/PET) in a small group of selected subjects to assess its clinical imaging capabilities. Specifically, the main task of this study is to determine whether the new system can successfully be used to produce images of known breast cancer and compare them to those acquired by standard techniques. The PEM/PET system consists of two pairs of rotating radiation detectors located beneath a patient table. The scanner has a spatial resolution of ∼2 mm in all three dimensions. The subjects consisted of five patients diagnosed with locally advanced breast cancer ranging in age from 40 to 55 years old scheduled for pre-treatment, conventional whole body PET imaging with F-18 Fluorodeoxyglucose (FDG). The primary lesions were at least 2 cm in diameter. The images from the PEM/PET system demonstrated that this system is capable of identifying some lesions not visible in standard mammograms. Furthermore, while the relatively large lesions imaged in this study where all visualised by a standard whole body PET/CT scanner, some of the morphology of the tumours (ductal infiltration, for example) was better defined with the PEM/PET system. Significantly, these images were obtained immediately following a standard whole body PET scan. The initial testing of the new PEM/PET system demonstrated that the new system is capable of producing good quality breast-PET images compared standard methods.

  2. Testing the Standard Model

    CERN Document Server

    Riles, K

    1998-01-01

    The Large Electron Project (LEP) accelerator near Geneva, more than any other instrument, has rigorously tested the predictions of the Standard Model of elementary particles. LEP measurements have probed the theory from many different directions and, so far, the Standard Model has prevailed. The rigour of these tests has allowed LEP physicists to determine unequivocally the number of fundamental 'generations' of elementary particles. These tests also allowed physicists to ascertain the mass of the top quark in advance of its discovery. Recent increases in the accelerator's energy allow new measurements to be undertaken, measurements that may uncover directly or indirectly the long-sought Higgs particle, believed to impart mass to all other particles.

  3. Agreement between gastrointestinal panel testing and standard microbiology methods for detecting pathogens in suspected infectious gastroenteritis: Test evaluation and meta-analysis in the absence of a reference standard.

    Science.gov (United States)

    Freeman, Karoline; Tsertsvadze, Alexander; Taylor-Phillips, Sian; McCarthy, Noel; Mistry, Hema; Manuel, Rohini; Mason, James

    2017-01-01

    Multiplex gastrointestinal pathogen panel (GPP) tests simultaneously identify bacterial, viral and parasitic pathogens from the stool samples of patients with suspected infectious gastroenteritis presenting in hospital or the community. We undertook a systematic review to compare the accuracy of GPP tests with standard microbiology techniques. Searches in Medline, Embase, Web of Science and the Cochrane library were undertaken from inception to January 2016. Eligible studies compared GPP tests with standard microbiology techniques in patients with suspected gastroenteritis. Quality assessment of included studies used tailored QUADAS-2. In the absence of a reference standard we analysed test performance taking GPP tests and standard microbiology techniques in turn as the benchmark test, using random effects meta-analysis of proportions. No study provided an adequate reference standard with which to compare the test accuracy of GPP and conventional tests. Ten studies informed a meta-analysis of positive and negative agreement. Positive agreement across all pathogens was 0.93 (95% CI 0.90 to 0.96) when conventional methods were the benchmark and 0.68 (95% CI: 0.58 to 0.77) when GPP provided the benchmark. Negative agreement was high in both instances due to the high proportion of negative cases. GPP testing produced a greater number of pathogen-positive findings than conventional testing. It is unclear whether these additional 'positives' are clinically important. GPP testing has the potential to simplify testing and accelerate reporting when compared to conventional microbiology methods. However the impact of GPP testing upon the management, treatment and outcome of patients is poorly understood and further studies are needed to evaluate the health economic impact of GPP testing compared with standard methods. The review protocol is registered with PROSPERO as CRD42016033320.

  4. Implementing a Standardized Social Networks Testing Strategy in a Low HIV Prevalence Jurisdiction.

    Science.gov (United States)

    Schumann, Casey; Kahn, Danielle; Broaddus, Michelle; Dougherty, Jacob; Elderbrook, Megan; Vergeront, James; Westergaard, Ryan

    2018-05-15

    Alternative HIV testing strategies are needed to engage individuals not reached by traditional clinical or non-clinical testing programs. A social networks recruitment strategy, in which people at risk for or living with HIV are enlisted and trained by community-based agencies to recruit individuals from their social, sexual, or drug-using networks for HIV testing, demonstrates higher positivity rates compared to other non-clinical recruitment strategies in some jurisdictions. During 2013-2015, a social networks testing protocol was implemented in Wisconsin to standardize an existing social networks testing program. Six community-based, non-clinical agencies with multiple sites throughout the state implemented the protocol over the 2-year period. Both quantitative and qualitative data were collected. The new positivity rate (0.49%) through social networks testing did not differ from that of traditional counseling, testing, and referral recruitment methods (0.48%). Although social networks testing did not yield a higher new positivity rate compared to other testing strategies, it proved to be successful at reaching high risk individuals who may not otherwise engage in HIV testing.

  5. Evaluation of Suitability of Non-Standardized Test Block for Ultrasonic Testing

    International Nuclear Information System (INIS)

    Kwon, Ho Young; Lim, Jong Ho; Kang, Sei Sun

    2000-01-01

    Standard Test Block(STB) for UT(Ultrasonic Testing) is a block approved by authoritative for material, shape and quality. STB is used for characteristic tests, sensitivity calibration and control of the time base range of UT inspection devices. The material, size and chemical components of STB should be strictly controlled to meet the related standards such as ASTM and JIS because it has an effect upon sensitivity, resolution and reproductivity of UT. The STBs which are not approved are sometimes used because the qualified STBs are very expensive. So, the purpose of this study is to survey the characteristics, quality and usability of Non-Standardized Test Blocks. Non-Standardized Test Blocks did not meet the standard requirements in size or chemical components, and ultrasonic characteristics. Therefore if the Non-Standardized Test Blocks are used without being tested, it's likely to cause errors in detecting the location and measuring the size of the defects

  6. [Quality Management and Quality Specifications of Laboratory Tests in Clinical Studies--Challenges in Pre-Analytical Processes in Clinical Laboratories].

    Science.gov (United States)

    Ishibashi, Midori

    2015-01-01

    The cost, speed, and quality are the three important factors recently indicated by the Ministry of Health, Labour and Welfare (MHLW) for the purpose of accelerating clinical studies. Based on this background, the importance of laboratory tests is increasing, especially in the evaluation of clinical study participants' entry and safety, and drug efficacy. To assure the quality of laboratory tests, providing high-quality laboratory tests is mandatory. For providing adequate quality assurance in laboratory tests, quality control in the three fields of pre-analytical, analytical, and post-analytical processes is extremely important. There are, however, no detailed written requirements concerning specimen collection, handling, preparation, storage, and shipping. Most laboratory tests for clinical studies are performed onsite in a local laboratory; however, a part of laboratory tests is done in offsite central laboratories after specimen shipping. As factors affecting laboratory tests, individual and inter-individual variations are well-known. Besides these factors, standardizing the factors of specimen collection, handling, preparation, storage, and shipping, may improve and maintain the high quality of clinical studies in general. Furthermore, the analytical method, units, and reference interval are also important factors. It is concluded that, to overcome the problems derived from pre-analytical processes, it is necessary to standardize specimen handling in a broad sense.

  7. Legal standard of care: a shift from the traditional Bolam test.

    Science.gov (United States)

    Samanta, Ash; Samanta, Jo

    2003-01-01

    An essential component of an action in negligence against a doctor is proof that the doctor failed to provide the required standard of care under the circumstances. Traditionally the standard of care in law has been determined according to the Bolam test. This is based on the principle that a doctor does not breach the legal standard of care, and is therefore not negligent, if the practice is supported by a responsible body of similar professionals. The Bolam principle, however, has been perceived as being excessively reliant upon medical testimony supporting the defendant. The judgment given by the House of Lords in the recent case of Bolitho imposes a requirement that the standard proclaimed must be justified on a logical basis and must have considered the risks and benefits of competing options. The effect of Bolitho is that the court will take a more enquiring stance to test the medical evidence offered by both parties in litigation, in order to reach its own conclusions. Recent case law shows how the court has applied the Bolitho approach in determining the standard of care in cases of clinical negligence. An understanding of this approach and of the shift from the traditional Bolam test is relevant to all medical practitioners, particularly in a climate that is increasingly litigious.

  8. Standard Guide for Testing Polymer Matrix Composite Materials

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2011-01-01

    1.1 This guide summarizes the application of ASTM standard test methods (and other supporting standards) to continuous-fiber reinforced polymer matrix composite materials. The most commonly used or most applicable ASTM standards are included, emphasizing use of standards of Committee D30 on Composite Materials. 1.2 This guide does not cover all possible standards that could apply to polymer matrix composites and restricts discussion to the documented scope. Commonly used but non-standard industry extensions of test method scopes, such as application of static test methods to fatigue testing, are not discussed. A more complete summary of general composite testing standards, including non-ASTM test methods, is included in the Composite Materials Handbook (MIL-HDBK-17). Additional specific recommendations for testing textile (fabric, braided) composites are contained in Guide D6856. 1.3 This guide does not specify a system of measurement; the systems specified within each of the referenced standards shall appl...

  9. The evolution of a clinical database: from local to standardized clinical languages.

    OpenAIRE

    Prophet, C. M.

    2000-01-01

    For more than twenty years, the University of Iowa Hospitals and Clinics Nursing Informatics (UIHC NI) has been developing a clinical database to support patient care planning and documentation in the INFORMM NIS (Information Network for Online Retrieval & Medical Management Nursing Information System). Beginning in 1992, the database content was revised to standardize orders and to incorporate the Standardized Nursing Languages (SNLs) of the North American Nursing Diagnosis Association (NAND...

  10. Clinical implementation of KRAS testing in metastatic colorectal carcinoma: the pathologist's perspective.

    Science.gov (United States)

    Ross, Jeffrey S

    2012-10-01

    Mutation status of the KRAS gene identifies a distinct disease subtype of metastatic colorectal carcinoma that does not respond to antibody therapeutics targeting the epidermal growth factor receptor. This is currently the only validated marker in metastatic colorectal carcinoma with a clear implication in treatment selection. KRAS testing is widely accepted in clinical practice to guide metastatic colorectal carcinoma therapeutic decisions, and there are many commercially available platforms to perform the test. To evaluate the critical role of pathologists in the full implementation of KRAS testing by optimizing tumor tissue collection and fixation procedures and by choosing testing technologies and reliable Clinical Laboratory Improvement Amendments of 1988-certified laboratories to perform the tests. Prospective clinical trials, retrospective studies, and quality assessment and survey reports were identified in the following databases: PubMed, American Society of Clinical Oncology Proceedings (American Society of Clinical Oncology Annual Meeting and Gastrointestinal Cancer Symposium) and European Society for Medical Oncology Proceedings (Annals of Oncology European Society for Medical Oncology Congress and Annals of Oncology World Congress on Gastrointestinal Cancers). More bona fide standards are needed to address the variety of available test methods, which have different performance characteristics including speed, sensitivity to detect rare mutations, and technical requirements. Refined standards addressing timing of KRAS testing, laboratory performance and accuracy, quality assurance and control, proper tissue collection, and appropriate result reporting would also be greatly beneficial. Pathologists should be aware that the amount of information they need to manage will increase, because future trends and technological advances will enhance the predictive power of diagnostic tests or the scope of the biomarker panels tested routinely across tumor types.

  11. Resource utilization after introduction of a standardized clinical assessment and management plan.

    Science.gov (United States)

    Friedman, Kevin G; Rathod, Rahul H; Farias, Michael; Graham, Dionne; Powell, Andrew J; Fulton, David R; Newburger, Jane W; Colan, Steven D; Jenkins, Kathy J; Lock, James E

    2010-01-01

    A Standardized Clinical Assessment and Management Plan (SCAMP) is a novel quality improvement initiative that standardizes the assessment and management of all patients who carry a predefined diagnosis. Based on periodic review of systemically collected data the SCAMP is designed to be modified to improve its own algorithm. One of the objectives of a SCAMP is to identify and reduce resource utilization and patient care costs. We retrospectively reviewed resource utilization in the first 93 arterial switch operation (ASO) SCAMP patients and 186 age-matched control ASO patients. We compared diagnostic and laboratory testing obtained at the initial SCAMP clinic visit and control patient visits. To evaluate the effect of the SCAMP over time, the number of clinic visits per patient year and echocardiograms per patient year in historical control ASO patients were compared to the projected rates for ASO SCAMP participants. Cardiac magnetic resonance imaging (MRI), stress echocardiogram, and lipid profile utilization were higher in the initial SCAMP clinic visit group than in age-matched control patients. Total echocardiogram and lung scan usage were similar. Chest X-ray and exercise stress testing were obtained less in SCAMP patients. ASO SCAMP patients are projected to have 0.5 clinic visits and 0.5 echocardiograms per year. Historical control patients had more clinic visits (1.2 vs. 0.5 visits/patient year, P<.01) and a higher echocardiogram rate (0.92 vs. 0.5 echocardiograms/patient year, P<.01) Implementation of a SCAMP may initially lead to increased resource utilization, but over time resource utilization is projected to decrease.

  12. Neutron Sources for Standard-Based Testing

    Energy Technology Data Exchange (ETDEWEB)

    Radev, Radoslav [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); McLean, Thomas [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2014-11-10

    The DHS TC Standards and the consensus ANSI Standards use 252Cf as the neutron source for performance testing because its energy spectrum is similar to the 235U and 239Pu fission sources used in nuclear weapons. An emission rate of 20,000 ± 20% neutrons per second is used for testing of the radiological requirements both in the ANSI standards and the TCS. Determination of the accurate neutron emission rate of the test source is important for maintaining consistency and agreement between testing results obtained at different testing facilities. Several characteristics in the manufacture and the decay of the source need to be understood and accounted for in order to make an accurate measurement of the performance of the neutron detection instrument. Additionally, neutron response characteristics of the particular instrument need to be known and taken into account as well as neutron scattering in the testing environment.

  13. [Accreditation of clinical laboratories based on ISO standards].

    Science.gov (United States)

    Kawai, Tadashi

    2004-11-01

    International Organization for Standardization (ISO) have published two international standards (IS) to be used for accreditation of clinical laboratories; ISO/IEC 17025:1999 and ISO 15189:2003. Any laboratory accreditation body must satisfy the requirements stated in ISO/IEC Guide 58. In order to maintain the quality of the laboratory accreditation bodies worldwide, the International Laboratory Accreditation Cooperation (ILAC) has established the mutual recognition arrangement (MRA). In Japan, the International Accreditation Japan (IAJapan) and the Japan Accreditation Board for Conformity Assessment (JAB) are the members of the ILAC/MRA group. In 2003, the Japanese Committee for Clinical Laboratory Standards (JCCLS) and the JAB have established the Development Committee of Clinical Laboratory Accreditation Program (CLAP), in order to establish the CLAP, probably starting in 2005.

  14. Tests on standard concrete samples

    CERN Multimedia

    CERN PhotoLab

    1973-01-01

    Compression and tensile tests on standard concrete samples. The use of centrifugal force in tensile testing has been developed by the SB Division and the instruments were built in the Central workshops.

  15. GA(2)LEN skin test study II: clinical relevance of inhalant allergen sensitizations in Europe

    DEFF Research Database (Denmark)

    Burbach, G J; Heinzerling, L M; Edenharter, G

    2009-01-01

    BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance was ...... the clinical relevance of positive skin prick tests and calls for further studies, which may, ultimately, help increase the positive predictive value of allergy testing.......BACKGROUND: Skin prick testing is the standard for diagnosing IgE-mediated allergies. A positive skin prick reaction, however, does not always correlate with clinical symptoms. A large database from a Global Asthma and Allergy European Network (GA(2)LEN) study with data on clinical relevance...... was used to determine the clinical relevance of sensitizations against the 18 most frequent inhalant allergens in Europe. The study population consisted of patients referred to one of the 17 allergy centres in 14 European countries (n = 3034, median age = 33 years). The aim of the study was to assess...

  16. Standardized training in nurse model travel clinics.

    Science.gov (United States)

    Sofarelli, Theresa A; Ricks, Jane H; Anand, Rahul; Hale, Devon C

    2011-01-01

    International travel plays a significant role in the emergence and redistribution of major human diseases. The importance of travel medicine clinics for preventing morbidity and mortality has been increasingly appreciated, although few studies have thus far examined the management and staff training strategies that result in successful travel-clinic operations. Here, we describe an example of travel-clinic operation and management coordinated through the University of Utah School of Medicine, Division of Infectious Diseases. This program, which involves eight separate clinics distributed statewide, functions both to provide patient consult and care services, as well as medical provider training and continuing medical education (CME). Initial training, the use of standardized forms and protocols, routine chart reviews and monthly continuing education meetings are the distinguishing attributes of this program. An Infectious Disease team consisting of one medical doctor (MD) and a physician assistant (PA) act as consultants to travel nurses who comprise the majority of clinic staff. Eight clinics distributed throughout the state of Utah serve approximately 6,000 travelers a year. Pre-travel medical services are provided by 11 nurses, including 10 registered nurses (RNs) and 1 licensed practical nurse (LPN). This trained nursing staff receives continuing travel medical education and participate in the training of new providers. All nurses have completed a full training program and 7 of the 11 (64%) of clinic nursing staff serve more than 10 patients a week. Quality assurance measures show that approximately 0.5% of charts reviewed contain a vaccine or prescription error which require patient notification for correction. Using an initial training program, standardized patient intake forms, vaccine and prescription protocols, preprinted prescriptions, and regular CME, highly trained nurses at travel clinics are able to provide standardized pre-travel care to

  17. Standard test method for dynamic tear testing of metallic materials

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1983-01-01

    1.1 This test method covers the dynamic tear (DT) test using specimens that are 3/16 in. to 5/8 in. (5 mm to 16 mm) inclusive in thickness. 1.2 This test method is applicable to materials with a minimum thickness of 3/16 in. (5 mm). 1.3 The pressed-knife procedure described for sharpening the notch tip generally limits this test method to materials with a hardness level less than 36 HRC. Note 1—The designation 36 HRC is a Rockwell hardness number of 36 on Rockwell C scale as defined in Test Methods E 18. 1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  18. Testing the standard model

    International Nuclear Information System (INIS)

    Gordon, H.; Marciano, W.; Williams, H.H.

    1982-01-01

    We summarize here the results of the standard model group which has studied the ways in which different facilities may be used to test in detail what we now call the standard model, that is SU/sub c/(3) x SU(2) x U(1). The topics considered are: W +- , Z 0 mass, width; sin 2 theta/sub W/ and neutral current couplings; W + W - , Wγ; Higgs; QCD; toponium and naked quarks; glueballs; mixing angles; and heavy ions

  19. Implementing Home Health Standards in Clinical Practice.

    Science.gov (United States)

    Gorski, Lisa A

    2016-02-01

    In 1986, the American Nurses Association (ANA) published the first Standards of Home Health Practice. Revised in 1992 and expanded in 1999 to become Home Health Nursing: Scope and Standards of Practice, it was revised in 2008 and again in 2014. In the 2014 edition, there are 6 standards of home healthcare nursing practice and 10 standards of professional performance for home healthcare nursing. The focus of this article is to describe the home healthcare standards and to provide guidance for implementation in clinical practice. It is strongly encouraged that home healthcare administrators, educators, and staff obtain a copy of the standards and fully read this essential home healthcare resource.

  20. Standardized Testing and the Construction of Governable Persons

    Science.gov (United States)

    Graham, Cameron; Neu, Dean

    2004-01-01

    While debates over standardized testing are ubiquitous, there has been relatively little consideration of how today's standardized testing practices have arisen. The current study provides a chronology of standardized testing within Alberta, Canada. Starting from prior work by Foucault and others on "governmentality", we propose that the…

  1. Comparison of test protocols for standard room/corner tests

    Science.gov (United States)

    R. H. White; M. A. Dietenberger; H. Tran; O. Grexa; L. Richardson; K. Sumathipala; M. Janssens

    1998-01-01

    As part of international efforts to evaluate alternative reaction-to-fire tests, several series of room/comer tests have been conducted. This paper reviews the overall results of related projects in which different test protocols for standard room/corner tests were used. Differences in the test protocols involved two options for the ignition burner scenario and whether...

  2. Development of job standards for clinical nutrition therapy for dyslipidemia patients.

    Science.gov (United States)

    Kang, Min-Jae; Seo, Jung-Sook; Kim, Eun-Mi; Park, Mi-Sun; Woo, Mi-Hye; Ju, Dal-Lae; Wie, Gyung-Ah; Lee, Song-Mi; Cha, Jin-A; Sohn, Cheong-Min

    2015-04-01

    Dyslipidemia has significantly contributed to the increase of death and morbidity rates related to cardiovascular diseases. Clinical nutrition service provided by dietitians has been reported to have a positive effect on relief of medical symptoms or reducing the further medical costs. However, there is a lack of researches to identify key competencies and job standard for clinical dietitians to care patients with dyslipidemia. Therefore, the purpose of this study was to analyze the job components of clinical dietitian and develop the standard for professional practice to provide effective nutrition management for dyslipidemia patients. The current status of clinical nutrition therapy for dyslipidemia patients in hospitals with 300 or more beds was studied. After duty tasks and task elements of nutrition care process for dyslipidemia clinical dietitians were developed by developing a curriculum (DACUM) analysis method. The developed job standards were pretested in order to evaluate job performance, difficulty, and job standards. As a result, the job standard included four jobs, 18 tasks, and 53 task elements, and specific job description includes 73 basic services and 26 recommended services. When clinical dietitians managing dyslipidemia patients performed their practice according to this job standard for 30 patients the job performance rate was 68.3%. Therefore, the job standards of clinical dietitians for clinical nutrition service for dyslipidemia patients proposed in this study can be effectively used by hospitals.

  3. Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

    Directory of Open Access Journals (Sweden)

    Tropp Hans

    2005-06-01

    Full Text Available Abstract Background The tissue origin of low back pain (LBP or referred lower extremity symptoms (LES may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216 with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement

  4. Standard test method for guided bend test for ductility of welds

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 This test method covers a guided bend test for the determination of soundness and ductility of welds in ferrous and nonferrous products. Defects, not shown by X rays, may appear in the surface of a specimen when it is subjected to progressive localized overstressing. This guided bend test has been developed primarily for plates and is not intended to be substituted for other methods of bend testing. 1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. Note 1—For additional information see Terminology E 6, and American Welding Society Standard D 1.1. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  5. Standard test method for drop-weight tear tests of ferritic steels

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2003-01-01

    1.1 This test method covers drop-weight tear tests (DWTT) on ferritic steels with thicknesses between 3.18 and 19.1 mm. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  6. Standard test methods for rockwell hardness of metallic materials

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2008-01-01

    1.1 These test methods cover the determination of the Rockwell hardness and the Rockwell superficial hardness of metallic materials by the Rockwell indentation hardness principle. This standard provides the requirements for Rockwell hardness machines and the procedures for performing Rockwell hardness tests. 1.2 This standard includes additional requirements in annexes: Verification of Rockwell Hardness Testing Machines Annex A1 Rockwell Hardness Standardizing Machines Annex A2 Standardization of Rockwell Indenters Annex A3 Standardization of Rockwell Hardness Test Blocks Annex A4 Guidelines for Determining the Minimum Thickness of a Test Piece Annex A5 Hardness Value Corrections When Testing on Convex Cylindrical Surfaces Annex A6 1.3 This standard includes nonmandatory information in appendixes which relates to the Rockwell hardness test. List of ASTM Standards Giving Hardness Values Corresponding to Tensile Strength Appendix X1 Examples of Procedures for Determining Rockwell Hardness Uncertainty Appendix X...

  7. Standard test methods for rockwell hardness of metallic materials

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2011-01-01

    1.1 These test methods cover the determination of the Rockwell hardness and the Rockwell superficial hardness of metallic materials by the Rockwell indentation hardness principle. This standard provides the requirements for Rockwell hardness machines and the procedures for performing Rockwell hardness tests. 1.2 This standard includes additional requirements in annexes: Verification of Rockwell Hardness Testing Machines Annex A1 Rockwell Hardness Standardizing Machines Annex A2 Standardization of Rockwell Indenters Annex A3 Standardization of Rockwell Hardness Test Blocks Annex A4 Guidelines for Determining the Minimum Thickness of a Test Piece Annex A5 Hardness Value Corrections When Testing on Convex Cylindrical Surfaces Annex A6 1.3 This standard includes nonmandatory information in appendixes which relates to the Rockwell hardness test. List of ASTM Standards Giving Hardness Values Corresponding to Tensile Strength Appendix X1 Examples of Procedures for Determining Rockwell Hardness Uncertainty Appendix X...

  8. EMG of the hip adductor muscles in six clinical examination tests.

    Science.gov (United States)

    Lovell, Gregory A; Blanch, Peter D; Barnes, Christopher J

    2012-08-01

    To assess activation of muscles of hip adduction using EMG and force analysis during standard clinical tests, and compare athletes with and without a prior history of groin pain. Controlled laboratory study. 21 male athletes from an elite junior soccer program. Bilateral surface EMG recordings of the adductor magnus, adductor longus, gracilis and pectineus as well as a unilateral fine-wire EMG of the pectineus were made during isometric holds in six clinical examination tests. A load cell was used to measure force data. Test type was a significant factor in the EMG output for all four muscles (all muscles p stronger than Hips 45, Hips 90 and Side lay. BMI (body mass index) was a significant factor (p Muscle EMG varied significantly with clinical test position. Athletes with previous groin injury had a significant fall in some EMG outputs. Copyright © 2011 Elsevier Ltd. All rights reserved.

  9. Standard Test Methods for Wet Insulation Integrity Testing of Photovoltaic Modules

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2007-01-01

    1.1 These test methods provide procedures to determine the insulation resistance of a photovoltaic (PV) module, i.e. the electrical resistance between the module's internal electrical components and its exposed, electrically conductive, non-current carrying parts and surfaces. 1.2 The insulation integrity procedures are a combination of wet insulation resistance and wet dielectric voltage withstand test procedures. 1.3 These procedures are similar to and reference the insulation integrity test procedures described in Test Methods E 1462, with the difference being that the photovoltaic module under test is immersed in a wetting solution during the procedures. 1.4 These test methods do not establish pass or fail levels. The determination of acceptable or unacceptable results is beyond the scope of these test methods. 1.5 The values stated in SI units are to be regarded as the standard. 1.6 There is no similar or equivalent ISO standard. 1.7 This standard does not purport to address all of the safety conce...

  10. Towards reporting standards for neuropsychological study results: A proposal to minimize communication errors with standardized qualitative descriptors for normalized test scores.

    Science.gov (United States)

    Schoenberg, Mike R; Rum, Ruba S

    2017-11-01

    Rapid, clear and efficient communication of neuropsychological results is essential to benefit patient care. Errors in communication are a lead cause of medical errors; nevertheless, there remains a lack of consistency in how neuropsychological scores are communicated. A major limitation in the communication of neuropsychological results is the inconsistent use of qualitative descriptors for standardized test scores and the use of vague terminology. PubMed search from 1 Jan 2007 to 1 Aug 2016 to identify guidelines or consensus statements for the description and reporting of qualitative terms to communicate neuropsychological test scores was conducted. The review found the use of confusing and overlapping terms to describe various ranges of percentile standardized test scores. In response, we propose a simplified set of qualitative descriptors for normalized test scores (Q-Simple) as a means to reduce errors in communicating test results. The Q-Simple qualitative terms are: 'very superior', 'superior', 'high average', 'average', 'low average', 'borderline' and 'abnormal/impaired'. A case example illustrates the proposed Q-Simple qualitative classification system to communicate neuropsychological results for neurosurgical planning. The Q-Simple qualitative descriptor system is aimed as a means to improve and standardize communication of standardized neuropsychological test scores. Research are needed to further evaluate neuropsychological communication errors. Conveying the clinical implications of neuropsychological results in a manner that minimizes risk for communication errors is a quintessential component of evidence-based practice. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. A standard for test reliability in group research.

    Science.gov (United States)

    Ellis, Jules L

    2013-03-01

    Many authors adhere to the rule that test reliabilities should be at least .70 or .80 in group research. This article introduces a new standard according to which reliabilities can be evaluated. This standard is based on the costs or time of the experiment and of administering the test. For example, if test administration costs are 7 % of the total experimental costs, the efficient value of the reliability is .93. If the actual reliability of a test is equal to this efficient reliability, the test size maximizes the statistical power of the experiment, given the costs. As a standard in experimental research, it is proposed that the reliability of the dependent variable be close to the efficient reliability. Adhering to this standard will enhance the statistical power and reduce the costs of experiments.

  12. Development of Abbreviated Nine-Item Forms of the Raven's Standard Progressive Matrices Test

    Science.gov (United States)

    Bilker, Warren B.; Hansen, John A.; Brensinger, Colleen M.; Richard, Jan; Gur, Raquel E.; Gur, Ruben C.

    2012-01-01

    The Raven's Standard Progressive Matrices (RSPM) is a 60-item test for measuring abstract reasoning, considered a nonverbal estimate of fluid intelligence, and often included in clinical assessment batteries and research on patients with cognitive deficits. The goal was to develop and apply a predictive model approach to reduce the number of items…

  13. How does additional diagnostic testing influence the initial diagnosis in patients with cognitive complaints in a memory clinic setting?

    NARCIS (Netherlands)

    Meijs, A.P.; Claassen, J.A.H.R.; Olde Rikkert, M.G.M.; Schalk, B.W.M; Meulenbroek, O.V.; Kessels, R.P.C.; Melis, R.J.F.

    2015-01-01

    Background: patients suspected of dementia frequently undergo additional diagnostic testing (e.g. brain imaging or neuropsychological assessment) after standard clinical assessment at a memory clinic. This study investigates the use of additional testing in an academic outpatient memory clinic and

  14. How does additional diagnostic testing influence the initial diagnosis in patients with cognitive complaints in a memory clinic setting?

    NARCIS (Netherlands)

    Meijs, A.P.; Claassen, J.A.; Olde Rikkert, M.G.M.; Schalk, B.W.M; Meulenbroek, O.V.; Kessels, R.P.C.; Melis, R.J.F.

    2015-01-01

    BACKGROUND: patients suspected of dementia frequently undergo additional diagnostic testing (e.g. brain imaging or neuropsychological assessment) after standard clinical assessment at a memory clinic. This study investigates the use of additional testing in an academic outpatient memory clinic and

  15. Standards for the culture and quality control of umbilical cord mesenchymal stromal cells for neurorestorative clinical application (2017

    Directory of Open Access Journals (Sweden)

    Ao Q

    2017-12-01

    Full Text Available Qiang Ao,1,* Juan Xiao,2,3,* Yanqiu Yu,4 Gengsheng Mao,2 Qingyan Zou,5 Wenyong Gao,2,3 Hongyun Huang2,3 On behalf of Neurorestoratology Professional Committee of Chinese Medical Doctor Association (Chinese Association of Neurorestoratology 1Department of Tissue Engineering, China Medical University, Shen Yang, 2Institute of Neurorestoratology, General Hospital of Armed Police Forces, Beijing, 3Cell Therapy Center, Beijing Hongtianji Neuroscience Academy, Beijing, 4Department of Pathophysiology, China Medical University, Shen Yang, 5Guangdong 999 Brain Hospital, Guangzhou, People’s Republic of China *These authors contributed equally to this work Abstract: Formulating common standards for the culture and quality control of umbilical cord mesenchymal stromal cells (MSCs is crucial for the standardization of clinical neurorestorative therapy. But to date, there have been no standardized guidelines for the culture and quality control of MSCs in neurorestorative clinical application. Based on a relatively comprehensive review of published clinical studies as well as the existing methods of MSC culture and quality control, the Chinese Association of Neurorestoratology has developed standards for the culture and quality control of umbilical cord MSCs which possess the potential in neurorestorative clinical application. These guidelines include standardized training and management procedures for laboratory operators; standardized use and management of materials and equipment; standardized collection, culture and proliferation of umbilical cord MSCs; standardized management for cell preservation, transport and related safeguard measures; as well as standardization of a clean environment, routine maintenance and related tests and examinations and so on. These guidelines represent the minimum required standards for the culture and quality control of umbilical cord MSCs for potential use in current neurorestorative clinical therapy, and will be further

  16. Standard Test Method for Wet Insulation Integrity Testing of Photovoltaic Arrays

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This test method covers a procedure to determine the insulation resistance of a photovoltaic (PV) array (or its component strings), that is, the electrical resistance between the array's internal electrical components and is exposed, electrically conductive, non-current carrying parts and surfaces of the array. 1.2 This test method does not establish pass or fail levels. The determination of acceptable or unacceptable results is beyond the scope of this test method. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  17. Improving clinical cognitive testing: report of the AAN Behavioral Neurology Section Workgroup.

    Science.gov (United States)

    Daffner, Kirk R; Gale, Seth A; Barrett, A M; Boeve, Bradley F; Chatterjee, Anjan; Coslett, H Branch; D'Esposito, Mark; Finney, Glen R; Gitelman, Darren R; Hart, John J; Lerner, Alan J; Meador, Kimford J; Pietras, Alison C; Voeller, Kytja S; Kaufer, Daniel I

    2015-09-08

    To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. © 2015 American Academy of Neurology.

  18. Correlation Between Screening Mammography Interpretive Performance on a Test Set and Performance in Clinical Practice.

    Science.gov (United States)

    Miglioretti, Diana L; Ichikawa, Laura; Smith, Robert A; Buist, Diana S M; Carney, Patricia A; Geller, Berta; Monsees, Barbara; Onega, Tracy; Rosenberg, Robert; Sickles, Edward A; Yankaskas, Bonnie C; Kerlikowske, Karla

    2017-10-01

    Evidence is inconsistent about whether radiologists' interpretive performance on a screening mammography test set reflects their performance in clinical practice. This study aimed to estimate the correlation between test set and clinical performance and determine if the correlation is influenced by cancer prevalence or lesion difficulty in the test set. This institutional review board-approved study randomized 83 radiologists from six Breast Cancer Surveillance Consortium registries to assess one of four test sets of 109 screening mammograms each; 48 radiologists completed a fifth test set of 110 mammograms 2 years later. Test sets differed in number of cancer cases and difficulty of lesion detection. Test set sensitivity and specificity were estimated using woman-level and breast-level recall with cancer status and expert opinion as gold standards. Clinical performance was estimated using women-level recall with cancer status as the gold standard. Spearman rank correlations between test set and clinical performance with 95% confidence intervals (CI) were estimated. For test sets with fewer cancers (N = 15) that were more difficult to detect, correlations were weak to moderate for sensitivity (woman level = 0.46, 95% CI = 0.16, 0.69; breast level = 0.35, 95% CI = 0.03, 0.61) and weak for specificity (0.24, 95% CI = 0.01, 0.45) relative to expert recall. Correlations for test sets with more cancers (N = 30) were close to 0 and not statistically significant. Correlations between screening performance on a test set and performance in clinical practice are not strong. Test set performance more accurately reflects performance in clinical practice if cancer prevalence is low and lesions are challenging to detect. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

  19. Repeat testing of low-level HIV-1 RNA: assay performance and implementation in clinical trials.

    Science.gov (United States)

    White, Kirsten; Garner, Will; Wei, Lilian; Eron, Joseph J; Zhong, Lijie; Miller, Michael D; Martin, Hal; Plummer, Andrew; Tran-Muchowski, Cecilia; Lindstrom, Kim; Porter, James; Piontkowsky, David; Light, Angela; Reiske, Heinz; Quirk, Erin

    2018-05-15

    Assess the performance of HIV-1 RNA repeat testing of stored samples in cases of low-level viremia during clinical trials. Prospective and retrospective analysis of randomized clinical trial samples and reference standards. To evaluate assay variability of the Cobas AmpliPrep/Cobas TaqMan HIV-1 Test, v2.0, three separate sources of samples were utilized: the World Health Organization (WHO) HIV reference standard (assayed using 50 independent measurements at six viral loads <200 copies/ml), retrospective analysis of four to six aliquots of plasma samples from four clinical trial participants, and prospective repeat testing of 120 samples from participants in randomized trials with low-level viremia. The TaqMan assay on the WHO HIV-1 RNA standards at viral loads <200 copies/ml performed within the expected variability according to assay specifications. However, standards with low viral loads of 36 and 18 copies/ml reported values of ≥ 50 copies/ml in 66 and 18% of tests, respectively. In participants treated with antiretrovirals who had unexpected viremia of 50-200 copies/ml after achieving <50 copies/ml, retesting of multiple aliquots of stored plasma found <50 copies/ml in nearly all cases upon retesting (14/15; 93%). Repeat testing was prospectively implemented in four clinical trials for all samples with virologic rebound of 50-200 copies/ml (n = 120 samples from 92 participants) from which 42% (50/120) had a retest result of less than 50 copies/ml and 58% (70/120) retested ≥ 50 copies/ml. The TaqMan HIV-1 RNA assay shows variability around 50 copies/ml that affects clinical trial results and may impact clinical practice. In participants with a history of viral load suppression, unexpected low-level viremia may be because of assay variability rather than low drug adherence or true virologic failure. Retesting a stored aliquot of the same sample may differentiate between assay variability and virologic failure as the source of viremia

  20. The development of clinical document standards for semantic interoperability in china.

    Science.gov (United States)

    Yang, Peng; Pan, Feng; Liu, Danhong; Xu, Yongyong; Wan, Yi; Tu, Haibo; Tang, Xuejun; Hu, Jianping

    2011-12-01

    This study is aimed at developing a set of data groups (DGs) to be employed as reusable building blocks for the construction of the eight most common clinical documents used in China's general hospitals in order to achieve their structural and semantic standardization. The Diagnostics knowledge framework, the related approaches taken from the Health Level Seven (HL7), the Integrating the Healthcare Enterprise (IHE), and the Healthcare Information Technology Standards Panel (HITSP) and 1,487 original clinical records were considered together to form the DG architecture and data sets. The internal structure, content, and semantics of each DG were then defined by mapping each DG data set to a corresponding Clinical Document Architecture data element and matching each DG data set to the metadata in the Chinese National Health Data Dictionary. By using the DGs as reusable building blocks, standardized structures and semantics regarding the clinical documents for semantic interoperability were able to be constructed. Altogether, 5 header DGs, 48 section DGs, and 17 entry DGs were developed. Several issues regarding the DGs, including their internal structure, identifiers, data set names, definitions, length and format, data types, and value sets, were further defined. Standardized structures and semantics regarding the eight clinical documents were structured by the DGs. This approach of constructing clinical document standards using DGs is a feasible standard-driven solution useful in preparing documents possessing semantic interoperability among the disparate information systems in China. These standards need to be validated and refined through further study.

  1. The false sero-negativity of brucella standard agglutination test: Prozone phenomenon

    Directory of Open Access Journals (Sweden)

    İrfan Binici

    2011-12-01

    Full Text Available Objectives: We aimed to assess prozone phenomenon that is quite rare and causes false negativity in serological diagnosisof brucellosis with standard dilution titers.Materials and methods: In this study the tests of four cases that have false negative serological results were evaluated.Blood cultures were obtained from all cases while cerebrospinal fluid cultures were studied in the two cases. Standardagglutination test (SAT and Coombs test were performed to all patients.Results: SAT and Coombs test was negative in titers up to 1/640 in all cases. The SAT and Coombs tests in cerebrospinalfluid (CSF of the two cases with neurobrucellosis diagnosis were negative, as well. Since the clinical and laboratoryfindings suggested the brucellosis, the serums were restudied by diluting up to 1/10240 titer and we saw that the first3 cases became positive at a titer of 1/1280. The fourth case remained negative and therefore, we applied high dilutionCoombs test. This time the test gave a positive result at 1/10240 titer beginning from 1/2560 titer. B.melitensis wasisolated from two cases.Conclusion: SAT and Coombs’ test must be diluted to titers 1/2560 or more in order to exclude false sero-negativity incases with clinical and laboratory findings suggesting brucellosis. J Microbiol Infect Dis 2011; 1(3:110-113

  2. Neurorestorative clinical application standards for the culture and quality control of olfactory ensheathing cells

    Directory of Open Access Journals (Sweden)

    Xiao J

    2017-09-01

    laboratory operators; standardized use and management of materials and equipment; standardized collection, culture, and proliferation of OECs obtained from fetal olfactory bulbs; standardized management for cell preservation, transport, and related safeguard measures; and the standardization of a clean environment, routine maintenance, and related tests and examinations. Our goal in publishing this set of standards is to promote the worldwide safety, effectiveness, and replicability of utilizing OECs obtained from fetal olfactory bulbs for neurorestorative clinical application. Keywords: standardization, cell culture, quality control, olfactory ensheathing glial cells, neurorestorative clinical application, neurorestoratology, translational medicine

  3. Clinic flow for STI, HIV, and TB patients in an urban infectious disease clinic offering point-of-care testing services in Durban, South Africa.

    Science.gov (United States)

    Stime, Katrina J; Garrett, Nigel; Sookrajh, Yukteshwar; Dorward, Jienchi; Dlamini, Ntuthu; Olowolagba, Ayo; Sharma, Monisha; Barnabas, Ruanne V; Drain, Paul K

    2018-05-11

    Many clinics in Southern Africa have long waiting times. The implementation of point-of-care (POC) tests to accelerate diagnosis and improve clinical management in resource-limited settings may improve or worsen clinic flow and waiting times. The objective of this study was to describe clinic flow with special emphasis on the impact of POC testing at a large urban public healthcare clinic in Durban, South Africa. We used time and motion methods to directly observe patients and practitioners. We created patient flow maps and recorded individual patient waiting and consultation times for patients seeking STI, TB, or HIV care. We conducted semi-structured interviews with 20 clinic staff to ascertain staff opinions on clinic flow and POC test implementation. Among 121 observed patients, the total number of queues ranged from 4 to 7 and total visit times ranged from 0:14 (hours:minutes) to 7:38. Patients waited a mean of 2:05 for standard-of-care STI management, and approximately 4:56 for STI POC diagnostic testing. Stable HIV patients who collected antiretroviral therapy refills waited a mean of 2:42 in the standard queue and 2:26 in the fast-track queue. A rapid TB test on a small sample of patients with the Xpert MTB/RIF assay and treatment initiation took a mean of 6:56, and 40% of patients presenting with TB-related symptoms were asked to return for an additional clinic visit to obtain test results. For all groups, the mean clinical assessment time with a nurse or physician was 7 to 9 min, which accounted for 2 to 6% of total visit time. Staff identified poor clinic flow and personnel shortages as areas of concern that may pose challenges to expanding POC tests in the current clinic environment. This busy urban clinic had multiple patient queues, long clinical visits, and short clinical encounters. Although POC testing ensured patients received a diagnosis sooner, it more than doubled the time STI patients spent at the clinic and did not result in same

  4. Non-destructive testing. The current state of standards and qualification and certification for leak testing

    International Nuclear Information System (INIS)

    Tamura, Yoshikazu

    2011-01-01

    Domestic standards of the leak testing are enacted as one of Japan Industrial Standards. The conformity is advanced between these domestic standards and ISO (International Organization for Standardization) standard. ISO9712 (Non-destructive testing-Qualification and certification of personnel) was revised to include the leak testing of qualification and certification in 2005. The preparation working group of qualification and certification for leak testing is planning start aiming at the system in one and a half years. (author)

  5. [Possible relation between clinical guidelines and legal standard of medicine].

    Science.gov (United States)

    Furukawa, Toshiharu; Kitagawa, Yuko

    2010-10-01

    Legal standard of medicine is not equal across the all kinds of medical institutions. Each medical institution is required its respective standard of medicine in which its doctors are expected to have studied medical informations, which have been spread among medical institutions with similar characteristics. Therefore, in principle, clinical guidelines for the treatment of a disease formed by public committees do not directly become the medical standards of respective disease treatment. However, doctors would be legally required to practice medicine with reference to the clinical guidelines because medical informations, mediated by internet or many kinds of media, have been spread very fast to all medical institutions these days. Moreover, doctors would be required to inform their patients of non-standardized new treatments, even if such treatments are not listed in clinical guidelines in case patients have special concern about new treat-

  6. Standard Test Method for Testing Nonmetallic Seal Materials by Immersion in a Simulated Geothermal Test Fluid

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1985-01-01

    1.1 This test method covers a procedure for a laboratory test for performing an initial evaluation (screening) of nonmetallic seal materials by immersion in a simulated geothermal test fluid. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For specific precautionary statements, see Section 6 and 11.7.

  7. Standard Test Method for Hydrophobic Surface Films by the Atomizer Test

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1965-01-01

    1.1 This test method covers the detection of the presence of hydrophobic (nonwetting) films on surfaces and the presence of hydrophobic organic materials in processing ambients. When properly conducted, the test will enable detection of fractional molecular layers of hydrophobic organic contaminants. On very rough or porous surfaces the sensitivity of the test may be significantly decreased. 1.2 The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are for information only. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  8. Current quality assurance concepts and considerations for quality control of in-clinic biochemistry testing.

    Science.gov (United States)

    Lester, Sally; Harr, K E; Rishniw, Mark; Pion, Paul

    2013-01-15

    Quality assurance is an implied concept inherent in every consumer's purchase of a product or service. In laboratory testing, quality assurance encompasses preanalytic (sampling, transport, and handling prior to testing), analytic (measurement), and postanalytic (reporting and interpretation) factors. Quality-assurance programs require that procedures are in place to detect errors in all 3 components and that the procedures are characterized by both documentation and correction of errors. There are regulatory bodies that provide mandatory standards for and regulation of human medical laboratories. No such regulations exist for veterinary laboratory testing. The American Society for Veterinary Clinical Pathology (ASVCP) Quality Assurance and Laboratory Standards Committee was formed in 1996 in response to concerns of ASVCP members about quality assurance and quality control in laboratories performing veterinary testing. Guidelines for veterinary laboratory testing have been developed by the ASVCP. The purpose of this report was to provide an overview of selected quality-assurance concepts and to provide recommendations for quality control for in-clinic biochemistry testing in general veterinary practice.

  9. Standard test method for tension testing of structural alloys in liquid helium

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This test method describes procedures for the tension testing of structural alloys in liquid helium. The format is similar to that of other ASTM tension test standards, but the contents include modifications for cryogenic testing which requires special apparatus, smaller specimens, and concern for serrated yielding, adiabatic heating, and strain-rate effects. 1.2 To conduct a tension test by this standard, the specimen in a cryostat is fully submerged in normal liquid helium (He I) and tested using crosshead displacement control at a nominal strain rate of 10−3 s−1 or less. Tests using force control or high strain rates are not considered. 1.3 This standard specifies methods for the measurement of yield strength, tensile strength, elongation, and reduction of area. The determination of the elastic modulus is treated in Test Method E 111. Note 1—The boiling point of normal liquid helium (He I) at sea level is 4.2 K (−269°C or −452.1°F or 7.6°R). It decreases with geographic elevation and is...

  10. Standard practice for modified salt spray (fog) testing

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This practice covers and sets forth conditions for five modifications in salt spray (fog) testing for specification purposes. These are in chronological order of their development: 1.1.1 Annex A1, acetic acid-salt spray test, continuous. 1.1.2 Annex A2, cyclic acidified salt spray test. 1.1.3 Annex A3, seawater acidified test, cyclic (SWAAT). 1.1.4 Annex A4, SO2 salt spray test, cyclic. 1.1.5 Annex A5, dilute electrolyte cyclic fog dry test. 1.2 This practice does not prescribe the type of modification, test specimen or exposure periods to be used for a specific product, nor the interpretation to be given to the results. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to consult and establish appropriate safety and health practices and determine the applicabilit...

  11. Robotic Needle Guide for Prostate Brachytherapy: Clinical Testing of Feasibility and Performance

    Science.gov (United States)

    Song, Danny Y; Burdette, Everette C; Fiene, Jonathan; Armour, Elwood; Kronreif, Gernot; Deguet, Anton; Zhang, Zhe; Iordachita, Iulian; Fichtinger, Gabor; Kazanzides, Peter

    2010-01-01

    Purpose Optimization of prostate brachytherapy is constrained by tissue deflection of needles and fixed spacing of template holes. We developed and clinically tested a robotic guide towards the goal of allowing greater freedom of needle placement. Methods and Materials The robot consists of a small tubular needle guide attached to a robotically controlled arm. The apparatus is mounted and calibrated to operate in the same coordinate frame as a standard template. Translation in x and y directions over the perineum ±40mm are possible. Needle insertion is performed manually. Results Five patients were treated in an IRB-approved study. Confirmatory measurements of robotic movements for initial 3 patients using infrared tracking showed mean error of 0.489 mm (SD 0.328 mm). Fine adjustments in needle positioning were possible when tissue deflection was encountered; adjustments were performed in 54/179 (30.2%) needles placed, with 36/179 (20.1%) adjustments of > 2mm. Twenty-seven insertions were intentionally altered to positions between the standard template grid to improve the dosimetric plan or avoid structures such as pubic bone and blood vessels. Conclusions Robotic needle positioning provided a means of compensating for needle deflections as well as the ability to intentionally place needles into areas between the standard template holes. To our knowledge, these results represent the first clinical testing of such a system. Future work will be incorporation of direct control of the robot by the physician, adding software algorithms to help avoid robot collisions with the ultrasound, and testing the angulation capability in the clinical setting. PMID:20729152

  12. Standards for educational and psychological testing

    CERN Document Server

    2014-01-01

    Developed jointly by the American Educational Research Association, American Psychological Association, and the National Council on Measurement in Education, Standards for Educational and Psychological Testing (Revised 2014) addresses professional and technical issues of test development and use in education, psychology, and employment. It includes changes in federal law and measurement trends affecting validity, testing individuals with disabilities or different linguistic backgrounds, and new types of tests, as well as new uses of existing tests.

  13. The influence of standards and clinical guidelines on prosthetic and orthotic service quality: a scoping review.

    Science.gov (United States)

    Sadeghi-Demneh, Ebrahim; Forghany, Saeed; Onmanee, Pornsuree; Trinler, Ursula; Dillon, Michael P; Baker, Richard

    2017-06-20

    Standards and guidelines are an integral part of prosthetic and orthotic service delivery in the developed world underpinned by an assumption that they lead to improved services. Implementing them has a cost, however, and that cost needs to be justified, particularly in resource-limited environments. This scoping review thus asks the question, "What is the evidence of the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics?" A structured search of three electronic databases (Medline, Scopus and Web of Science) followed by manual searching of title, abstract and full text, yielded 29 articles. Four categories of papers were identified: Descriptions and Commentaries (17 papers), Guideline Development (7), Guideline Testing (2) and Standards implementation (3). No articles were explicitly designed to assess the impact of standards and guidelines on service delivery outcomes in prosthetics and orthotics. Studies tended to be commentaries on or descriptions of guideline development, testing or implementation of standards. The literature is not sufficiently well developed to warrant the cost and effort of a systematic review. Future primary research should seek to demonstrate whether and how guidelines and standards improve the outcomes for people that require prostheses, orthoses and other assistive devices. Implications for Rehabilitation International Standards and Clinical Guidelines are now an integral part of clinical service provision in prosthetics and orthotics in the developed world. Complying with standards and guidelines has a cost and, particularly in resource-limited environments, it should be possible to justify this in terms of the resulting benefits. This scoping review concludes that there have been no previous studies designed to directly quantify the effects of implementing standards and guidelines on service delivery.

  14. Standard specification for agencies performing nondestructive testing

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This specification covers minimum requirements for agencies performing nondestructive testing (NDT). 1.2 When using this specification to assess the capability of, or to accredit NDT agencies, Guide E 1359 shall be used as a basis for the survey. It can be supplemented as necessary with more detail in order to meet the auditor's specific needs. 1.3 This specification can be used as a basis to evaluate testing or inspection agencies, or both, and is intended for use for the qualifying or accrediting, or both, of testing or inspection agencies, public or private. 1.4 The use of SI or inch-pound units, or combination thereof, will be the responsibility of the technical committee whose standards are referred to in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to...

  15. Standard test methods for elevated temperature tension tests of metallic materials

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 These test methods cover procedure and equipment for the determination of tensile strength, yield strength, elongation, and reduction of area of metallic materials at elevated temperatures. 1.2 Determination of modulus of elasticity and proportional limit are not included. 1.3 Tension tests under conditions of rapid heating or rapid strain rates are not included. 1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  16. Is the standard model really tested?

    International Nuclear Information System (INIS)

    Takasugi, E.

    1989-01-01

    It is discussed how the standard model is really tested. Among various tests, I concentrate on the CP violation phenomena in K and B meson system. Especially, the resent hope to overcome the theoretical uncertainty in the evaluation on the CP violation of K meson system is discussed. (author)

  17. Standard Ship Test and Inspection Plan, Procedures and Database

    National Research Council Canada - National Science Library

    1999-01-01

    ... construction schedules and increased cost is the area of test and inspection. This project investigates existing rules and regulations for testing and inspection of commercial ships and identifies differences and similarities within the requirements. The results include comparison matrices, a standard test plan, a set of standard test procedures, and a sample test database developed for a typical commercial ship.

  18. Quality standards for DNA sequence variation databases to improve clinical management under development in Australia

    Directory of Open Access Journals (Sweden)

    B. Bennetts

    2014-09-01

    Full Text Available Despite the routine nature of comparing sequence variations identified during clinical testing to database records, few databases meet quality requirements for clinical diagnostics. To address this issue, The Royal College of Pathologists of Australasia (RCPA in collaboration with the Human Genetics Society of Australasia (HGSA, and the Human Variome Project (HVP is developing standards for DNA sequence variation databases intended for use in the Australian clinical environment. The outputs of this project will be promoted to other health systems and accreditation bodies by the Human Variome Project to support the development of similar frameworks in other jurisdictions.

  19. Clinical tests to diagnose lumbar spondylolysis and spondylolisthesis: A systematic review.

    Science.gov (United States)

    Alqarni, Abdullah M; Schneiders, Anthony G; Cook, Chad E; Hendrick, Paul A

    2015-08-01

    The aim of this paper was to systematically review the diagnostic ability of clinical tests to detect lumbar spondylolysis and spondylolisthesis. A systematic literature search of six databases, with no language restrictions, from 1950 to 2014 was concluded on February 1, 2014. Clinical tests were required to be compared against imaging reference standards and report, or allow computation, of common diagnostic values. The systematic search yielded a total of 5164 articles with 57 retained for full-text examination, from which 4 met the full inclusion criteria for the review. Study heterogeneity precluded a meta-analysis of included studies. Fifteen different clinical tests were evaluated for their ability to diagnose lumbar spondylolisthesis and one test for its ability to diagnose lumbar spondylolysis. The one-legged hyperextension test demonstrated low to moderate sensitivity (50%-73%) and low specificity (17%-32%) to diagnose lumbar spondylolysis, while the lumbar spinous process palpation test was the optimal diagnostic test for lumbar spondylolisthesis; returning high specificity (87%-100%) and moderate to high sensitivity (60-88) values. Lumbar spondylolysis and spondylolisthesis are identifiable causes of LBP in athletes. There appears to be utility to lumbar spinous process palpation for the diagnosis of lumbar spondylolisthesis, however the one-legged hyperextension test has virtually no value in diagnosing patients with spondylolysis. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Standard test method for galling resistance of material couples

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2008-01-01

    1.1 This test method covers a laboratory test that ranks the galling resistance of material couples using a quantitative measure. Bare metals, alloys, nonmetallic materials, coatings, and surface modified materials may be evaluated by this test method. 1.2 This test method is not designed for evaluating the galling resistance of material couples sliding under lubricated conditions, because galling usually will not occur under lubricated sliding conditions using this test method. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  1. Standard test methods for characterizing duplex grain sizes

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 These test methods provide simple guidelines for deciding whether a duplex grain size exists. The test methods separate duplex grain sizes into one of two distinct classes, then into specific types within those classes, and provide systems for grain size characterization of each type. 1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety concerns associated with its use. It is the responsibility of the user of this standard to consult appropriate safety and health practices and determine the applicability of regulatory limitations prior to its use.

  2. Organizational, technical, physical and clinical quality standards for radiotherapy

    Science.gov (United States)

    Bogusz-Czerniewicz, Marta; Kaźmierczak, Daniel

    2012-01-01

    Background Indisputably, radiotherapy has become an entirely interdisciplinary specialty. This situation requires efficient planning, verification, monitoring, quality control and constant improvement of all aspects of service delivery, referring both to patients’ (including diagnosis, prescription and method of treatment, its justification, realization and follow up) and organizational, technical and physics matters. Aim The aim of this work was to develop technical, physics and clinical quality standards for radiotherapy. This paper presents chosen standards for each of the aforementioned category. Materials and methods For the development of quality standards the comparison analysis of EU and Polish acts of law passed between 1980 and 2010 was conducted, the universal industrial ISO norm 9001:2008 referring to quality management system was reviewed. Recommendations of this norm were completed with detailed quality standards based on the author's 11 year work experience and the review of articles on quality assurance and quality control standards for radiotherapy published between 1984 and 2009 and the review of current recommendations and guidelines of American, International, European and National bodies (associations, societies, agencies such as AAPM, ESTRO, IAEA, and OECI) for quality assurance and quality management in radiotherapy. Results As a result 352 quality standards for radiotherapy were developed and categorized into the following three groups: (1) organizational standards, (2) physics and technical standards and (3) clinical standards. Conclusions Proposed quality standards for radiotherapy, can be used by any institution using ionizing radiation for medical procedures. Nevertheless standards are only of value if they are implemented, reviewed, audited and improved and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:24377023

  3. Pad-weighing test performed with standardized bladder volume

    DEFF Research Database (Denmark)

    Lose, G; Rosenkilde, P; Gammelgaard, J

    1988-01-01

    The result of the one-hour pad-weighing test proposed by the International Continence Society has been demonstrated to depend on the urine load during the test. To increase reproducibility of the pad-weighing test by minimizing the influence of variation in urine load the test was done with a sta...... to +/- 24 g between two tests. It is concluded that this setup (i.e., standardized bladder volume) of the one-hour pad-weighing test allows for a more reliable assessment of urinary incontinence for quantitative purposes....... with a standardized bladder volume (50% of the cystometric bladder capacity). Twenty-five female patients with stress or mixed incontinence underwent two separate tests. Test-retest results were highly correlated (r = 0.97, p less than 0.001). Nonetheless, analysis of test-retest differences revealed a variation up...

  4. Standard Test Method for Hydrophobic Surface Films by the Water-Break Test

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 This test method covers the detection of the presence of hydrophobic (nonwetting) films on surfaces and the presence of hydrophobic organic materials in processing ambients. When properly conducted, the test will enable detection of molecular layers of hydrophobic organic contaminants. On very rough or porous surfaces, the sensitivity of the test may be significantly decreased. 1.2 The values stated in SI units are to be regarded as the standard. The inch-pound values given in parentheses are for information only. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  5. 42 CFR 493.1281 - Standard: Comparison of test results.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Comparison of test results. 493.1281 Section 493.1281 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Testing Analytic Systems § 493.1281 Standard: Comparison of test results. (a) If a laboratory performs the...

  6. Standard leach tests for nuclear waste materials

    International Nuclear Information System (INIS)

    Strachan, D.M.; Barnes, B.O.; Turcotte, R.P.

    1980-01-01

    Five leach tests were conducted to study time-dependent leaching of waste forms (glass). The first four tests include temperature as a variable and the use of three standard leachants. Three of the tests are static and two are dynamic (flow). This paper discusses the waste-form leach tests and presents some representative data. 4 figures

  7. Cognitive Fatigue Influences Students’ Performance on Standardized Tests

    DEFF Research Database (Denmark)

    Sievertsen, Hans Henrik; Gino, Francesca; Piovesan, Marco

    2016-01-01

    We identify one potential source of bias that influences children’s performance on standardized tests and that is predictable based on psychological theory: the time at which students take the test. Using test data for all children attending Danish public schools between school years 2009....../10 and 2012/13, we find that, for every hour later in the day, test scores decrease by 0.9% of an SD. In addition, a 20- to 30-minute break improves average test scores. Time of day affects students’ test performance because, over the course of a regular day, students’ mental resources get taxed. Thus......, as the day wears on, students become increasingly fatigued and consequently more likely to underperform on a standardized test....

  8. The Standardization of Tests: Criteria and Criticisms

    Science.gov (United States)

    Weiner, Paul S.; Hoock, William C.

    1973-01-01

    Following a review of the procedures involved in the establishment of norms for standardized tests, the specific procedures used to establish norms for three tests commonly used in speech and language pathology are critically examined. (LS)

  9. [How do hospital clinical laboratories and laboratory testing companies cooperate and build reciprocal relations?].

    Science.gov (United States)

    Kawano, Seiji

    2014-12-01

    As the 2nd Joint Symposium of the Japanese Society of Laboratory Medicine and the Japanese Association of Laboratory Pathologists, the symposium on clinical test out-sourcing and branch laboratories was held at the 60th General Meeting of the Japanese Society of Laboratory Medicine on November 2nd, 2013 in Kobe. For the symposium, we conducted a questionnaire survey on the usage of clinical test out-sourcing and the introduction of branch laboratories to clinical laboratories of Japanese university hospitals, both private and public, between July 25th and August 20th, 2013. Seventy-two hospitals responded to the questionnaire survey, consisting of 41 public medical school hospitals and 31 private ones. According to the survey, the selection of each clinical test for out-sourcing was mainly determined by the capacities of hospital clinical laboratories and their equipment, as well as the profitability of each test. The main concerns of clinical laboratory members of university hospitals involved the continuity of measurement principles, traceability, and standardization of reference values for each test. They strongly requested the interchangeability and computerization of test data between laboratory testing companies. A branch laboratory was introduced to six hospitals, all of which were private medical college hospitals, out of 72 university hospitals, and eight of the other hospitals were open to its introduction. The merits and demerits of introducing a branch laboratory were also discussed. (Review).

  10. Standard test method for wear testing with a pin-on-disk apparatus

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2005-01-01

    1.1 This test method covers a laboratory procedure for determining the wear of materials during sliding using a pin-on-disk apparatus. Materials are tested in pairs under nominally non-abrasive conditions. The principal areas of experimental attention in using this type of apparatus to measure wear are described. The coefficient of friction may also be determined. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  11. "Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.

    Science.gov (United States)

    Nikendei, C; Ganschow, P; Groener, J B; Huwendiek, S; Köchel, A; Köhl-Hackert, N; Pjontek, R; Rodrian, J; Scheibe, F; Stadler, A-K; Steiner, T; Stiepak, J; Tabatabai, J; Utz, A; Kadmon, M

    2016-01-01

    The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects "Heidelberg standard examination" and "Heidelberg standard procedures", which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.

  12. 76 FR 74078 - Standard Mail Market Test

    Science.gov (United States)

    2011-11-30

    ... POSTAL REGULATORY COMMISSION [Docket No. MT2011-3; Order No. 998] Standard Mail Market Test AGENCY... Service application for an exemption from the annual revenue limitation that applies to market tests of... limitation in any year during the test of an experimental market dominant product.\\1\\ Pursuant to 39 U.S.C...

  13. Standardization of waste acceptance test methods by the Materials Characterization Center

    International Nuclear Information System (INIS)

    Slate, S.C.

    1985-01-01

    This paper describes the role of standardized test methods in demonstrating the acceptability of high-level waste (HLW) forms for disposal. Key waste acceptance tests are standardized by the Materials Characterization Center (MCC), which the US Department of Energy (DOE) has established as the central agency in the United States for the standardization of test methods for nuclear waste materials. This paper describes the basic three-step process that is used to show that waste is acceptable for disposal and discusses how standardized tests are used in this process. Several of the key test methods and their areas of application are described. Finally, future plans are discussed for using standardized tests to show waste acceptance. 9 refs., 1 tab

  14. The Analysis of the Psychological Tests Using In Educational Institutions According To the Testing Standards

    Directory of Open Access Journals (Sweden)

    Ezgi MOR DİRLİK

    2017-12-01

    Full Text Available The purpose of this research is to analyze four psychological tests which are frequently used in the Guidance and Research Centers and in the guidance services of the schools according to the standards for educational and psychological testing of APA (American Psychological Association and test adaption standards of ITC (International Testing Commission. The tests were determined based on the goal- oriented sample selecting method and were selected from the most frequently used psychological tests in Guidance and Research Centers and school’s guidance centers. These tests are: Scale of Academic Self-Concept (Akademik Benlik Kavramı Ölçeği-ABKÖ, Evaluation of Early Childhood Development Tool (Gazi Erken Çocukluk Gelişimi Değerlendirme Aracı-GEÇDA, Primary Mental Abilities 7-11 (TKT 7-11, and Wechsler Intelligence Scale for Children Revised Form (WISC-R. In this research, the chapters related to the validity, reliability and test development and revision of “Standards For Educational And Psychological Testing” (APA, 1999 and the adaptation standards developed by ITC were translated into Turkish and a checklist was created by using these documents. The checklist has got two forms as short and long form. The tests were analyzed according to the short form of the checklist by researcher. In order to examine the reliability of these analyses, the analyses were repeated in three weeks’ time. Data of these analyses were exported to the Statistical Package for Social Sciences (SPSS 20.0 and descriptive analysis was perfomed. As a result of this research, the meeting levels of the psychological tests to the test standards in the checklist and the features of the tests which should be improved according to the validity, reliability, test development and revision and test adaptation were determined. In conclusion, the standards analyzed have not been met satisfactorily by ABKÖ and GEÇDA, and according to the analyses of the realibility

  15. Study on the testing standards of quality assurance for CT image

    International Nuclear Information System (INIS)

    Liu Jingxin; Yang Haishan; Liu Gang; Wang Liyun

    2000-01-01

    Objective: To establish national testing standards of quality assurance for CT image. Methods: 104 sets of CT system were tested using quality assurance test phantoms and devices including American RMI 461A, RMI 463, MDH 1015 C with ION Chamber, Sweden UNF 9004 kvp meter. These CT were made from different manufacturers including out of date of CT and state-of-art spiral CT system. Thirteen kinds of standards on CT from different countries and 87 sets of technical specifications of CT were collected. The results of the test were compared using phantoms of RMI, Victoreen, Catphan on the same CT system (Siemens HQS). Results: Based on the test results of this study, with reference to the foreign standards and some of regulations in China, CT test items should include high contrast resolution, low contrast resolution, noise, uniformity, mean CT unit, dose slice thickness, localization light, positioning of patient support and gantry tilt. Standards including acceptance test, status test, and constancy test were made in specification. Among them, constancy test equals to IEC 122-2-6; items and results in acceptance test are stricter than in the status test; and low contrast resolution, uniformity, localization light accuracy and positioning of patient support in the acceptance test are even stricter than that in foreign standards. Conclusion: The testing standards of quality assurance for CT developed in this study shows practical and useful in China, which supplemented to the existing international standards

  16. Innovating cystic fibrosis clinical trial designs in an era of successful standard of care therapies.

    Science.gov (United States)

    VanDevanter, Donald R; Mayer-Hamblett, Nicole

    2017-11-01

    Evolving cystic fibrosis 'standards of care' have influenced recent cystic fibrosis clinical trial designs for new therapies; care additions/improvements will require innovative trial designs to maximize feasibility and efficacy detection. Three cystic fibrosis therapeutic areas (pulmonary exacerbations, Pseudomonas aeruginosa airway infections, and reduced cystic fibrosis transmembrane conductance regulator [CFTR] protein function) differ with respect to the duration for which recognized 'standards of care' have been available. However, developers of new therapies in all the three areas are affected by similar challenges: standards of care have become so strongly entrenched that traditional placebo-controlled studies in cystic fibrosis populations likely to benefit from newer therapies have become less and less feasible. Today, patients/clinicians are more likely to entertain participation in active-comparator trial designs, that have substantial challenges of their own. Foremost among these are the selection of 'valid' active comparator(s), estimation of a comparator's current clinical efficacy (required for testing noninferiority hypotheses), and effective blinding of commercially available comparators. Recent and future cystic fibrosis clinical trial designs will have to creatively address this collateral result of successful past development of effective cystic fibrosis therapies: patients and clinicians are much less likely to accept simple, placebo-controlled studies to evaluate future therapies.

  17. 49 CFR 219.701 - Standards for drug and alcohol testing.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Standards for drug and alcohol testing. 219.701... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION CONTROL OF ALCOHOL AND DRUG USE Drug and Alcohol Testing Procedures § 219.701 Standards for drug and alcohol testing. (a) Drug testing required or authorized by subparts B...

  18. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2013-01-01

    Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

  19. How does additional diagnostic testing influence the initial diagnosis in patients with cognitive complaints in a memory clinic setting?

    Science.gov (United States)

    Meijs, Anouk P; Claassen, Jurgen A H R; Rikkert, Marcel G M Olde; Schalk, Bianca W M; Meulenbroek, Olga; Kessels, Roy P C; Melis, René J F

    2015-01-01

    patients suspected of dementia frequently undergo additional diagnostic testing (e.g. brain imaging or neuropsychological assessment) after standard clinical assessment at a memory clinic. This study investigates the use of additional testing in an academic outpatient memory clinic and how it influences the initial diagnosis. the initial diagnosis after standard clinical assessment (history, laboratory tests, cognitive screening and physical and neurological examination) and the final diagnosis after additional testing of 752 memory clinic patients were collected. We specifically registered if, and what type of, additional testing was requested. additional testing was performed in 518 patients (69%), 67% of whom underwent magnetic resonance imaging, 45% had neuropsychological assessment, 14% had cerebrospinal fluid analysis and 49% had (combinations of) other tests. This led to a modification of the initial diagnosis in 17% of the patients. The frequency of change was highest in patients with an initial non-Alzheimer's disease (AD) dementia diagnosis (54%, compared with 11 and 14% in patients with AD and 'no dementia'; P testing 44% was diagnosed with AD, 9% with non-AD dementia and 47% with 'no dementia'. additional testing should especially be considered in non-AD patients. In the large group of patients with an initial AD or 'no dementia' diagnosis, additional tests have little diagnostic impact and may perhaps be used with more restraint. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  20. Standards for radiation protection instrumentation: design of safety standards and testing procedures

    International Nuclear Information System (INIS)

    Meissner, Frank

    2008-01-01

    This paper describes by means of examples the role of safety standards for radiation protection and the testing and qualification procedures. The development and qualification of radiation protection instrumentation is a significant part of the work of TUV NORD SysTec, an independent expert organisation in Germany. The German Nuclear Safety Standards Commission (KTA) establishes regulations in the field of nuclear safety. The examples presented may be of importance for governments and nuclear safety authorities, for nuclear operators and for manufacturers worldwide. They demonstrate the advantage of standards in the design of radiation protection instrumentation for new power plants, in the upgrade of existing instrumentation to nuclear safety standards or in the application of safety standards to newly developed equipment. Furthermore, they show how authorities may proceed when safety standards for radiation protection instrumentation are not yet established or require actualization. (author)

  1. Slovak Office of Standards, Metrology and Testing. Annual Report 2001

    International Nuclear Information System (INIS)

    2002-01-01

    A brief account of activities carried out by the Slovak Office of Standards, Metrology and Testing of the Slovak Republic in 2001 is presented. These activities are reported under the headings: (1) Introduction by the President of the Slovak Office of Standards, Metrology and Testing; (2) The Vice-president's Unit Standardization and Quality; (3) The President's Office; (4) Chief Inspector Department; (5) Legislative-juridical Department; (6) Department of Economy; (7) Department of International Co-operation; (8) Department of European Integration; (9) Department of Metrology; (10) Department of Testing; (11) Department of the Cyclotron Centre SR; (12) Slovak Institute of Metrology; (13) Slovak Standards Institution; (14) Slovak Metrology Inspectorate; (15) Slovak Legal Metrology; (16) Measuring Techniques - Technocentre - MTT; Abbreviations; (17) Technical Testing Institute Piestany; (18) Testing Institute of Transport and Earthmoving Machinery - SUDST

  2. Radioactive material package test standards and performance requirements - public perception

    International Nuclear Information System (INIS)

    Pope, R.B.; Shappert, L.B.; Rawl, R.R.

    1992-01-01

    This paper addresses issues related to the public perception of the regulatory test standards and performance requirements for packaging and transporting radioactive material. Specifically, it addresses the adequacy of the package performance standards and testing for Type B packages, which are those packages designed for transporting the most hazardous quantities and forms of radioactive material. Type B packages are designed to withstand accident conditions in transport. To improve public perception, the public needs to better understand: (a) the regulatory standards and requirements themselves, (b) the extensive history underlying their development, and (c) the soundness of the technical foundation. The public needs to be fully informed on studies, tests, and analyses that have been carried out worldwide and form the basis of the regulatory standards and requirements. This paper provides specific information aimed at improving the public perception of packages test standards

  3. International Standardization of the Clinical Dosimetry of Beta Radiation Brachytherapy Sources: Progress of an ISO Standard

    Science.gov (United States)

    Soares, Christopher

    2006-03-01

    In 2004 a new work item proposal (NWIP) was accepted by the International Organization for Standardization (ISO) Technical Committee 85 (TC85 -- Nuclear Energy), Subcommittee 2 (Radiation Protection) for the development of a standard for the clinical dosimetry of beta radiation sources used for brachytherapy. To develop this standard, a new Working Group (WG 22 - Ionizing Radiation Dosimetry and Protocols in Medical Applications) was formed. The standard is based on the work of an ad-hoc working group initiated by the Dosimetry task group of the Deutsches Insitiut für Normung (DIN). Initially the work was geared mainly towards the needs of intravascular brachytherapy, but with the decline of this application, more focus has been placed on the challenges of accurate dosimetry for the concave eye plaques used to treat ocular melanoma. Guidance is given for dosimetry formalisms, reference data to be used, calibrations, measurement methods, modeling, uncertainty determinations, treatment planning and reporting, and clinical quality control. The document is currently undergoing review by the ISO member bodies for acceptance as a Committee Draft (CD) with publication of the final standard expected by 2007. There are opportunities for other ISO standards for medical dosimetry within the framework of WG22.

  4. Feline genetics: clinical applications and genetic testing.

    Science.gov (United States)

    Lyons, Leslie A

    2010-11-01

    DNA testing for domestic cat diseases and appearance traits is a rapidly growing asset for veterinary medicine. Approximately 33 genes contain 50 mutations that cause feline health problems or alterations in the cat's appearance. A variety of commercial laboratories can now perform cat genetic diagnostics, allowing both the veterinary clinician and the private owner to obtain DNA test results. DNA is easily obtained from a cat via a buccal swab with a standard cotton bud or cytological brush, allowing DNA samples to be easily sent to any laboratory in the world. The DNA test results identify carriers of the traits, predict the incidence of traits from breeding programs, and influence medical prognoses and treatments. An overall goal of identifying these genetic mutations is the correction of the defect via gene therapies and designer drug therapies. Thus, genetic testing is an effective preventative medicine and a potential ultimate cure. However, genetic diagnostic tests may still be novel for many veterinary practitioners and their application in the clinical setting needs to have the same scrutiny as any other diagnostic procedure. This article will review the genetic tests for the domestic cat, potential sources of error for genetic testing, and the pros and cons of DNA results in veterinary medicine. Highlighted are genetic tests specific to the individual cat, which are a part of the cat's internal genome. Copyright © 2010 Elsevier Inc. All rights reserved.

  5. Clinical diagnosis of Graves’ or non-Graves’ hyperthyroidism compared to TSH receptor antibody test

    Directory of Open Access Journals (Sweden)

    Lauren Bell

    2018-04-01

    Full Text Available Background: TSH receptor antibody (TRAb is considered the gold standard diagnostic test for the autoimmunity of Graves’ disease (GD, which is commonly diagnosed clinically. Aim: To evaluate the true positive (sensitivity and true negative (specificity rates of clinical diagnosis of GD or non-GD hyperthyroidism compared to the TRAb test. Setting: University teaching hospital in North West England. Participants: Patients in the Endocrinology service who had a TRAb measurement between December 2009 and October 2015. Methods: Electronic patient records were studied retrospectively for a pre-TRAb clinical diagnosis of GD or non-GD hyperthyroidism. We examined descriptive statistics and binary classification tests; Fisher exact test was used to analyse contingency tables. Results: We identified 316 patients with a mean age of 45 (range, 17–89 years; 247 (78% were women. Compared to the TRAb result, clinical diagnosis had a sensitivity of 88%, specificity 66%, positive predictive value 72%, negative predictive value 84%, false negative rate 12%, false positive rate 34%, positive likelihood ratio 2.6 and negative likelihood ratio 0.2 (P < 0.0001. Conclusions: Clinicians were liable to both over- and under-diagnose GD. The TRAb test can help reduce the number of incorrect or unknown diagnoses in the initial clinical assessment of patients presenting with hyperthyroidism.

  6. Lyral has been included in the patch test standard series in Germany.

    Science.gov (United States)

    Geier, Johannes; Brasch, Jochen; Schnuch, Axel; Lessmann, Holger; Pirker, Claudia; Frosch, Peter J

    2002-05-01

    Lyral 5% pet. was tested in 3245 consecutive patch test patients in 20 departments of dermatology in order (i) to check the diagnostic quality of this patch test preparation, (ii) to examine concomitant reactions to Lyral and fragrance mix (FM), and (iii) to assess the frequency of contact allergy to Lyral in an unselected patch test population of German dermatological clinics. 62 patients reacted to Lyral, i.e. 1.9%. One third of the positive reactions were + + and + + +. The reaction index was 0.27. Thus, the test preparation can be regarded a good diagnostic tool. Lyral and fragrance mix (FM) were tested in parallel in 3185 patients. Of these, 300 (9.4%) reacted to FM, and 59 (1.9%) to Lyral. In 40 patients, positive reactions to both occurred, which is 13.3% of those reacting to FM, and 67.8% of those reacting to Lyral. So the concordance of positive test reactions to Lyral and FM was only slight. Based on these results, the German Contact Dermatitis Research Group (DKG) decided to add Lyral 5% pet. to the standard series.

  7. Interpreting Results from the Standardized UXO Test Sites

    National Research Council Canada - National Science Library

    May, Michael; Tuley, Michael

    2007-01-01

    ...) and the Environmental Security Technology Certification Program (ESCTP) to complete a detailed analysis of the results of testing carried out at the Standardized Unexploded Ordnance (UXO) Test Sites...

  8. CPM Test-Retest Reliability: "Standard" vs "Single Test-Stimulus" Protocols.

    Science.gov (United States)

    Granovsky, Yelena; Miller-Barmak, Adi; Goldstein, Oren; Sprecher, Elliot; Yarnitsky, David

    2016-03-01

    Assessment of pain inhibitory mechanisms using conditioned pain modulation (CPM) is relevant clinically in prediction of pain and analgesic efficacy. Our objective is to provide necessary estimates of intersession CPM reliability, to enable transformation of the CPM paradigm into a clinical tool. Two cohorts of young healthy subjects (N = 65) participated in two dual-session studies. In Study I, a Bath-Thermode CPM protocol was used, with hot water immersion and contact heat as conditioning- and test-stimuli, respectively, in a classical parallel CPM design introducing test-stimulus first, and then the conditioning- and repeated test-stimuli in parallel. Study II consisted of two CPM protocols: 1) Two-Thermodes, one for each of the stimuli, in the same parallel design as above, and 2) single test-stimulus (STS) protocol with a single administration of a contact heat test-stimulus, partially overlapped in time by a remote shorter contact heat as conditioning stimulus. Test-retest reliability was assessed within 3-7 days. The STS-CPM had superior reliability intraclass correlation (ICC 2 ,: 1  = 0.59) over Bath-Thermode (ICC 2 ,: 1  = 0.34) or Two-Thermodes (ICC 2 ,: 1  = 0.21) protocols. The hand immersion conditioning pain had higher reliability than thermode pain (ICC 2 ,: 1  = 0.76 vs ICC 2 ,: 1  = 0.16). Conditioned test-stimulus pain scores were of good (ICC 2 ,: 1  = 0.62) or fair (ICC 2 ,: 1  = 0.43) reliability for the Bath-Thermode and the STS, respectively, but not for the Two-Thermodes protocol (ICC 2 ,: 1  = 0.20). The newly developed STS-CPM paradigm was more reliable than other CPM protocols tested here, and should be further investigated for its clinical relevance. It appears that large contact size of the conditioning-stimulus and use of single rather than dual test-stimulus pain contribute to augmentation of CPM reliability. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e

  9. Standard test method for isotopic analysis of uranium hexafluoride by double standard single-collector gas mass spectrometer method

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This is a quantitative test method applicable to determining the mass percent of uranium isotopes in uranium hexafluoride (UF6) samples with 235U concentrations between 0.1 and 5.0 mass %. 1.2 This test method may be applicable for the entire range of 235U concentrations for which adequate standards are available. 1.3 This test method is for analysis by a gas magnetic sector mass spectrometer with a single collector using interpolation to determine the isotopic concentration of an unknown sample between two characterized UF6 standards. 1.4 This test method is to replace the existing test method currently published in Test Methods C761 and is used in the nuclear fuel cycle for UF6 isotopic analyses. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appro...

  10. Clinical longitudinal standards for height, weight, height velocity, weight velocity, and stages of puberty.

    Science.gov (United States)

    Tanner, J M; Whitehouse, R H

    1976-01-01

    New charts for height, weight, height velocity, and weight velocity are presented for clinical (as opposed to population survey) use. They are based on longitudinal-type growth curves, using the same data as in the British 1965 growth standards. In the velocity standards centiles are given for children who are early- and late-maturing as well as for those who mature at the average age (thus extending the use of the previous charts). Limits of normality for the age of occurrence of the adolescent growth spurt are given and also for the successive stages of penis, testes, and pubic hair development in boys, and for stages of breast and pubic hair development in girls. PMID:952550

  11. A clinical investigation of motivation to change standards and cognitions about failure in perfectionism.

    Science.gov (United States)

    Egan, Sarah J; Piek, Jan P; Dyck, Murray J; Rees, Clare S; Hagger, Martin S

    2013-10-01

    Clinical perfectionism is a transdiagnostic process that has been found to maintain eating disorders, anxiety disorders and depression. Cognitive behavioural models explaining the maintenance of clinical perfectionism emphasize the contribution of dichotomous thinking and resetting standards higher following both success and failure in meeting their goals. There has been a paucity of research examining the predictions of the models and motivation to change perfectionism. Motivation to change is important as individuals with clinical perfectionism often report many perceived benefits of their perfectionism; they are, therefore, likely to be ambivalent regarding changing perfectionism. The aim was to compare qualitative responses regarding questions about motivation to change standards and cognitions regarding failure to meet a personal standard in two contrasting groups with high and low negative perfectionism. Negative perfectionism refers to concern over not meeting personal standards. A clinical group with a range of axis 1 diagnoses who were elevated on negative perfectionism were compared to a group of athletes who were low on negative perfectionism. Results indicated that the clinical group perceived many negative consequences of their perfectionism. They also, however, reported numerous benefits and the majority stated that they would prefer not to change their perfectionism. The clinical group also reported dichotomous thinking and preferring to either keep standards the same or reset standards higher following failure, whilst the athlete group reported they would keep standards the same or set them lower. The findings support predictions of the cognitive behavioural model of clinical perfectionism.

  12. The Tanzania experience: clinical laboratory testing harmonization and equipment standardization at different levels of a tiered health laboratory system.

    Science.gov (United States)

    Massambu, Charles; Mwangi, Christina

    2009-06-01

    The rapid scale-up of the care and treatment programs in Tanzania during the preceding 4 years has greatly increased the demand for quality laboratory services for diagnosis of HIV and monitoring patients during antiretroviral therapy. Laboratory services were not in a position to cope with this demand owing to poor infrastructure, lack of human resources, erratic and/or lack of reagent supply and commodities, and slow manual technologies. With the limited human resources in the laboratory and the need for scaling up the care and treatment program, it became necessary to install automated equipment and train personnel for the increased volume of testing and new tests across all laboratory levels. With the numerous partners procuring equipment, the possibility of a multitude of equipment platforms with attendant challenges for procurement of reagents, maintenance of equipment, and quality assurance arose. Tanzania, therefore, had to harmonize laboratory tests and standardize laboratory equipment at different levels of the laboratory network. The process of harmonization of tests and standardization of equipment included assessment of laboratories, review of guidelines, development of a national laboratory operational plan, and stakeholder advocacy. This document outlines this process.

  13. DOE standard: Quality assurance inspection and testing of HEPA filters

    International Nuclear Information System (INIS)

    1999-02-01

    This standard establishes essential elements for the quality assurance inspection and testing of HEPA filters by US Department of Energy (DOE)-accepted Filter Test Facilities (FTF). The standard specifies HEPA filter quality assurance inspection and testing practices established in DOE-STD-3022-98, DOE HEPA Filter Test Program, and provides a basis for the preparation of written operating procedures for primary FTF functions

  14. Framework for a Comparative Accelerated Testing Standard for PV Modules: Preprint

    Energy Technology Data Exchange (ETDEWEB)

    Kurtz, S.; Wohlgemuth, J.; Yamamichi, M.; Sample, T.; Miller, D.; Meakin, D.; Monokroussos, C.; TamizhMani, M.; Kempe, M.; Jordan, D.; Bosco, N.; Hacke, P.; Bermudez, V.; Kondo, M.

    2013-08-01

    As the photovoltaic industry has grown, the interest in comparative accelerated testing has also grown. Private test labs offer testing services that apply greater stress than the standard qualification tests as tools for differentiating products and for gaining increased confidence in long-term PV investments. While the value of a single international standard for comparative accelerated testing is widely acknowledged, the development of a consensus is difficult. This paper strives to identify a technical basis for a comparative standard.

  15. Standardized waste form test methods

    International Nuclear Information System (INIS)

    Slate, S.C.

    1984-01-01

    The Materials Characterization Center (MCC) is developing standard tests to characterize nuclear waste forms. Development of the first thirteen tests was originally initiated to provide data to compare different high-level waste (HLW) forms and to characterize their basic performance. The current status of the first thirteen MCC tests and some sample test results are presented: the radiation stability tests (MCC-6 and 12) and the tensile-strength test (MCC-11) are approved; the static leach tests (MCC-1, 2, and 3) are being reviewed for full approval; the thermal stability (MCC-7) and microstructure evaluation (MCC-13) methods are being considered for the first time; and the flowing leach test methods (MCC-4 and 5), the gas generation methods (MCC-8 and 9), and the brittle fracture method (MCC-10) are indefinitely delayed. Sample static leach test data on the ARM-1 approved reference material are presented. Established tests and proposed new tests will be used to meet new testing needs. For waste form production, tests on stability and composition measurement are needed to provide data to ensure waste form quality. In transporation, data are needed to evaluate the effects of accidents on canisterized waste forms. The new MCC-15 accident test method and some data are presented. Compliance testing needs required by the recent draft repository waste acceptance specifications are described. These specifications will control waste form contents, processing, and performance

  16. Standardized waste form test methods

    International Nuclear Information System (INIS)

    Slate, S.C.

    1984-11-01

    The Materials Characterization Center (MCC) is developing standard tests to characterize nuclear waste forms. Development of the first thirteen tests was originally initiated to provide data to compare different high-level waste (HLW) forms and to characterize their basic performance. The current status of the first thirteen MCC tests and some sample test results is presented: The radiation stability tests (MCC-6 and 12) and the tensile-strength test (MCC-11) are approved; the static leach tests (MCC-1, 2, and 3) are being reviewed for full approval; the thermal stability (MCC-7) and microstructure evaluation (MCC-13) methods are being considered for the first time; and the flowing leach tests methods (MCC-4 and 5), the gas generation methods (MCC-8 and 9), and the brittle fracture method (MCC-10) are indefinitely delayed. Sample static leach test data on the ARM-1 approved reference material are presented. Established tests and proposed new tests will be used to meet new testing needs. For waste form production, tests on stability and composition measurement are needed to provide data to ensure waste form quality. In transportation, data are needed to evaluate the effects of accidents on canisterized waste forms. The new MCC-15 accident test method and some data are presented. Compliance testing needs required by the recent draft repository waste acceptance specifications are described. These specifications will control waste form contents, processing, and performance. 2 references, 2 figures

  17. Patch testing with Indian standard series

    Directory of Open Access Journals (Sweden)

    Narendra G

    2002-01-01

    Full Text Available Hundred patients (61 males, 39 females suspected to have allergic contact dermatitis were patch tested with Indian standard series (ISS. Forty four showed one or more positive reactions. The frequent sensitizers observed were nickel sulphate-12 (15%, potassium dichromate-11 (13.75%, cobalt chloride and colophony-7 (8.75% each, fragrance mix and thiuram mix-6 (7.5% each. The ISS differs from the European Standard Series by inclusion of propylene glycol, nitrofurazone, gentamicin, chlorocresol, PEG-400 and ethylenediamine chloride where assesquiterpene lactone mix and primin allergens are excluded.

  18. Standard guide for conducting exfoliation corrosion tests in aluminum alloys

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1992-01-01

    1.1 This guide differs from the usual ASTM standard in that it does not address a specific test. Rather, it is an introductory guide for new users of other standard exfoliation test methods, (see Terminology G 15 for definition of exfoliation). 1.2 This guide covers aspects of specimen preparation, exposure, inspection, and evaluation for conducting exfoliation tests on aluminum alloys in both laboratory accelerated environments and in natural, outdoor atmospheres. The intent is to clarify any gaps in existent test methods. 1.3 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  19. SUSCEPTIBILITY TEST FOR FUNGI: CLINICAL AND LABORATORIAL CORRELATIONS IN MEDICAL MYCOLOGY

    Directory of Open Access Journals (Sweden)

    Ana ALASTRUEY-IZQUIERDO

    2015-09-01

    Full Text Available SUMMARYDuring recent decades, antifungal susceptibility testing has become standardized and nowadays has the same role of the antibacterial susceptibility testing in microbiology laboratories. American and European standards have been developed, as well as equivalent commercial systems which are more appropriate for clinical laboratories. The detection of resistant strains by means of these systems has allowed the study and understanding of the molecular basis and the mechanisms of resistance of fungal species to antifungal agents. In addition, many studies on the correlation of in vitro results with the outcome of patients have been performed, reaching the conclusion that infections caused by resistant strains have worse outcome than those caused by susceptible fungal isolates. These studies have allowed the development of interpretative breakpoints for Candida spp. and Aspergillus spp., the most frequent agents of fungal infections in the world. In summary, antifungal susceptibility tests have become essential tools to guide the treatment of fungal diseases, to know the local and global disease epidemiology, and to identify resistance to antifungals.

  20. Stress Optical Coefficient, Test Methodology, and Glass Standard Evaluation

    Science.gov (United States)

    2016-05-01

    ARL-TN-0756 ● MAY 2016 US Army Research Laboratory Stress Optical Coefficient, Test Methodology , and Glass Standard Evaluation...Stress Optical Coefficient, Test Methodology , and Glass Standard Evaluation by Clayton M Weiss Oak Ridge Institute for Science and Education...ORISE), Belcamp, MD Parimal J Patel Weapons and Materials Research Directorate, ARL Approved for public release; distribution is

  1. Standard Operating Procedure for Accelerated Corrosion Testing at ARL

    Science.gov (United States)

    2017-11-01

    ARL-TN-0855 ● NOV 2017 US Army Research Laboratory Standard Operating Procedure for Accelerated Corrosion Testing at ARL by... Corrosion Testing at ARL by Thomas A Considine Weapons and Materials Research Directorate, ARL Approved for public...November 2017 2. REPORT TYPE Technical Note 3. DATES COVERED (From - To) 4. TITLE AND SUBTITLE Standard Operating Procedure for Accelerated

  2. Minimum reporting standards for clinical research on groin pain in athletes

    DEFF Research Database (Denmark)

    Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

    2015-01-01

    Groin pain in athletes is a priority area for sports physiotherapy and sports medicine research. Heterogeneous studies with low methodological quality dominate research related to groin pain in athletes. Low-quality studies undermine the external validity of research findings and limit the ability...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...... are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes...

  3. Standard requirements for GCP-compliant data management in multinational clinical trials

    LENUS (Irish Health Repository)

    Ohmann, Christian

    2011-03-22

    Abstract Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit

  4. Standard Test Method for Oxyacetylene Ablation Testing of Thermal Insulation Materials

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2008-01-01

    1.1 This test method covers the screening of ablative materials to determine the relative thermal insulation effectiveness when tested as a flat panel in an environment of a steady flow of hot gas provided by an oxyacetylene burner. 1.2 This test method should be used to measure and describe the properties of materials, products, or assemblies in response to heat and flame under controlled laboratory conditions and should not be used to describe or appraise the fire hazard of materials, products, or assemblies under actual fire conditions. However, results of this test method may be used as elements of a fire risk assessment which takes into account all of the factors which are pertinent to an assessment of the fire hazard of a particular end use. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limi...

  5. The need for international standardization in clinical beta dosimetry for brachytherapy

    International Nuclear Information System (INIS)

    Quast, U.; Boehm, J.; Kaulich, T.W.

    2002-01-01

    Beta radiation has found increasing interest in radiotherapy. Besides the curative treatment of small and medium-sized intraocular tumors by means of ophthalmic beta radiation plaques, intravascular brachytherapy has proven to successfully overcome the severe problem of restenosis after interventional treatment of arterial stenosis in coronaries and peripheral vessels in many clinical trials with a large number of patients. Prior to initiating procedures applying beta radiation in radiotherapy, however, there is a common need to specify methods for the determination and specification of the absorbed dose to water or tissue and their spatial distributions. The IAEA-TECDOC-1274 Calibration of photon and beta ray sources used in brachytherapy (2002) is a help for photon brachytherapy calibration. But, for beta seed and line sources, IAEA recommends well type ionization chambers as working standards which are far from measuring absorbed dose to water of the radiation clinically used. Although the application of such working standards seems to be more precise, large errors can occur when the medical physicist has to convert the calibration data to absorbed dose to water of the beta radiation emitted. The user must believe that the source is equally activated and that the manufacturer did not change the design and construction of the source encapsulation. With the DGMP Report 16 (2001) Guidelines for medical physical aspects of intravascular brachytherapy a very detailed code of practice is given, especially for the calibration and clinical dosimetry of intravascular beta radiation sources. As there is a global need for standardization in clinical dosimetry for intravascular brachytherapy utilizing beta radiation, the DIN-NAR, the German committee on standardization in radiology, task group dosimetry, has initiated an international adhoc working group for a new ISO work item proposal on the standardization of procedures in clinical dosimetry to guarantee reliable

  6. Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project.

    Science.gov (United States)

    Anderson, H Vernon; Weintraub, William S; Radford, Martha J; Kremers, Mark S; Roe, Matthew T; Shaw, Richard E; Pinchotti, Dana M; Tcheng, James E

    2013-05-07

    Relatively little attention has been focused on standardization of data exchange in clinical research studies and patient care activities. Both are usually managed locally using separate and generally incompatible data systems at individual hospitals or clinics. In the past decade there have been nascent efforts to create data standards for clinical research and patient care data, and to some extent these are helpful in providing a degree of uniformity. Nonetheless, these data standards generally have not been converted into accepted computer-based language structures that could permit reliable data exchange across computer networks. The National Cardiovascular Research Infrastructure (NCRI) project was initiated with a major objective of creating a model framework for standard data exchange in all clinical research, clinical registry, and patient care environments, including all electronic health records. The goal is complete syntactic and semantic interoperability. A Data Standards Workgroup was established to create or identify and then harmonize clinical definitions for a base set of standardized cardiovascular data elements that could be used in this network infrastructure. Recognizing the need for continuity with prior efforts, the Workgroup examined existing data standards sources. A basic set of 353 elements was selected. The NCRI staff then collaborated with the 2 major technical standards organizations in health care, the Clinical Data Interchange Standards Consortium and Health Level Seven International, as well as with staff from the National Cancer Institute Enterprise Vocabulary Services. Modeling and mapping were performed to represent (instantiate) the data elements in appropriate technical computer language structures for endorsement as an accepted data standard for public access and use. Fully implemented, these elements will facilitate clinical research, registry reporting, administrative reporting and regulatory compliance, and patient care

  7. 42 CFR 493.1423 - Standard; Testing personnel qualifications.

    Science.gov (United States)

    2010-10-01

    ..., or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical... stability and storage; (F) The skills required to implement the quality control policies and procedures of... HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Personnel for Nonwaived...

  8. Toward Clarity in Clinical Vitamin D Status Assessment: 25(OH)D Assay Standardization.

    Science.gov (United States)

    Binkley, Neil; Carter, Graham D

    2017-12-01

    Widespread variation in 25-hydroxyvitamin D (25(OH)D) assays continues to compromise efforts to develop clinical and public health guidelines regarding vitamin D status. The Vitamin D Standardization Program helps alleviate this problem. Reference measurement procedures and standard reference materials have been developed to allow current, prospective, and retrospective standardization of 25(OH)D results. Despite advances in 25(OH)D measurement, substantial variability in clinical laboratory 25(OH)D measurement persists. Existing guidelines have not used standardized data and, as a result, it seems unlikely that consensus regarding definitions of vitamin D deficiency, inadequacy, sufficiency, and excess will soon be reached. Until evidence-based consensus is reached, a reasonable clinical approach is advocated. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Standard practice for conducting atmospheric corrosion tests on metals

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This practice covers and defines conditions for exposure of metals and alloys to the weather. It sets forth the general procedures that should be followed in any atmospheric test. It is presented as an aid in conducting atmospheric corrosion tests so that some of the pitfalls of such testing may be avoided. As such, it is concerned mainly with panel exposures to obtain data for comparison purposes. 1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of whoever uses this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  10. A clinical utility study of exome sequencing versus conventional genetic testing in pediatric neurology.

    Science.gov (United States)

    Vissers, Lisenka E L M; van Nimwegen, Kirsten J M; Schieving, Jolanda H; Kamsteeg, Erik-Jan; Kleefstra, Tjitske; Yntema, Helger G; Pfundt, Rolph; van der Wilt, Gert Jan; Krabbenborg, Lotte; Brunner, Han G; van der Burg, Simone; Grutters, Janneke; Veltman, Joris A; Willemsen, Michèl A A P

    2017-09-01

    Implementation of novel genetic diagnostic tests is generally driven by technological advances because they promise shorter turnaround times and/or higher diagnostic yields. Other aspects, including impact on clinical management or cost-effectiveness, are often not assessed in detail prior to implementation. We studied the clinical utility of whole-exome sequencing (WES) in complex pediatric neurology in terms of diagnostic yield and costs. We analyzed 150 patients (and their parents) presenting with complex neurological disorders of suspected genetic origin. In a parallel study, all patients received both the standard diagnostic workup (e.g., cerebral imaging, muscle biopsies or lumbar punctures, and sequential gene-by-gene-based testing) and WES simultaneously. Our unique study design allowed direct comparison of diagnostic yield of both trajectories and provided insight into the economic implications of implementing WES in this diagnostic trajectory. We showed that WES identified significantly more conclusive diagnoses (29.3%) than the standard care pathway (7.3%) without incurring higher costs. Exploratory analysis of WES as a first-tier diagnostic test indicates that WES may even be cost-saving, depending on the extent of other tests being omitted. Our data support such a use of WES in pediatric neurology for disorders of presumed genetic origin.Genet Med advance online publication 23 March 2017.

  11. Standard Guide for Conducting Corrosion Tests in Field Applications

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2008-01-01

    1.1 This guide covers procedures for conducting corrosion tests in plant equipment or systems under operating conditions to evaluate the corrosion resistance of engineering materials. It does not cover electrochemical methods for determining corrosion rates. 1.1.1 While intended primarily for immersion tests, general guidelines provided can be applicable for exposure of test specimens in plant atmospheres, provided that placement and orientation of the test specimens is non-restrictive to air circulation. 1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. See also 10.4.2.

  12. Standardized Definitions for Code Verification Test Problems

    Energy Technology Data Exchange (ETDEWEB)

    Doebling, Scott William [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-09-14

    This document contains standardized definitions for several commonly used code verification test problems. These definitions are intended to contain sufficient information to set up the test problem in a computational physics code. These definitions are intended to be used in conjunction with exact solutions to these problems generated using Exact- Pack, www.github.com/lanl/exactpack.

  13. Clinical Image Evaluation of Film Mammograms in Korea: Comparison with the ACR Standard

    International Nuclear Information System (INIS)

    Gwak, Yeon Joo; Kim, Hye Jung; Kwak, Jin Young; Son, Eun Ju; Ko, Kyung Hee; Lee, Jin Hwa; Lim, Hyo Soon; Lee, You Jin; Park, Ji Won; Shin, Kyung Min; Jang, Yun-Jin

    2013-01-01

    The goal of this study is to compare the overall quality of film mammograms taken according to the Korean standards with the American College of Radiology (ACR) standard for clinical image evaluation and to identify means of improving mammography quality in Korea. Four hundred and sixty eight sets of film mammograms were evaluated with respect to the Korean and ACR standards for clinical image evaluation. The pass and failure rates of mammograms were compared by medical facility types. Average scores in each category of the two standards were evaluated. Receiver operating characteristic curve analysis was used to identify an optimal Korean standard pass mark by taking the ACR standard as the reference standard. 93.6% (438/468) of mammograms passed the Korean standard, whereas only 80.1% (375/468) passed the ACR standard (p < 0.001). Non-radiologic private clinics had the lowest pass rate (88.1%: Korean standard, 71.8%: ACR standard) and the lowest total score (76.0) by the Korean standard. Average scores of positioning were lowest (19.3/29 by the Korean standard and 3.7/5 by the ACR standard). A cutoff score of 77.0 for the Korean standard was found to correspond to a pass level when the ACR standard was applied. We suggest that tighter regulations, such as, raising the Korean pass mark, subtracting more for severe deficiencies, or considering a very low scores in even a single category as failure, are needed to improve the quality of mammography in Korea

  14. DOE standard: Filter test facility quality program plan

    International Nuclear Information System (INIS)

    1999-02-01

    This standard was developed primarily for application in US Department of Energy programs. It contains specific direction for HEPA filter testing performed at a DOE-accepted HEPA Filter Test Facility (FTF). Beneficial comments (recommendations, additions, deletions) and any pertinent data that may improve this document should be sent to the Office of Nuclear Safety Policy and Standards (EH-31), US Department of Energy, Washington, DC 20585, by letter or by using the self-addressed Document Improvement Proposal form (DOE F 1300.3) appearing at the end of this document

  15. Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

    Science.gov (United States)

    Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

    2016-04-01

    The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

  16. Precision tests of the Standard Model

    International Nuclear Information System (INIS)

    Ol'shevskij, A.G.

    1996-01-01

    The present status of the precision measurements of electroweak observables is discussed with the special emphasis on the results obtained recently. All together these measurements provide the basis for the stringent test of the Standard Model and determination of the SM parameters. 22 refs., 23 figs., 11 tabs

  17. Inter-rater reliability of three standardized functional tests in patients with low back pain

    Science.gov (United States)

    Tidstrand, Johan; Horneij, Eva

    2009-01-01

    Background Of all patients with low back pain, 85% are diagnosed as "non-specific lumbar pain". Lumbar instability has been described as one specific diagnosis which several authors have described as delayed muscular responses, impaired postural control as well as impaired muscular coordination among these patients. This has mostly been measured and evaluated in a laboratory setting. There are few standardized and evaluated functional tests, examining functional muscular coordination which are also applicable in the non-laboratory setting. In ordinary clinical work, tests of functional muscular coordination should be easy to apply. The aim of this present study was to therefore standardize and examine the inter-rater reliability of three functional tests of muscular functional coordination of the lumbar spine in patients with low back pain. Methods Nineteen consecutive individuals, ten men and nine women were included. (Mean age 42 years, SD ± 12 yrs). Two independent examiners assessed three tests: "single limb stance", "sitting on a Bobath ball with one leg lifted" and "unilateral pelvic lift" on the same occasion. The standardization procedure took altered positions of the spine or pelvis and compensatory movements of the free extremities into account. The inter-rater reliability was analyzed by Cohen's kappa coefficient (κ) and by percentage agreement. Results The inter-rater reliability for the right and the left leg respectively was: for the single limb stance very good (κ: 0.88–1.0), for sitting on a Bobath ball good (κ: 0.79) and very good (κ: 0.88) and for the unilateral pelvic lift: good (κ: 0.61) and moderate (κ: 0.47). Conclusion The present study showed good to very good inter-rater reliability for two standardized tests, that is, the single-limb stance and sitting on a Bobath-ball with one leg lifted. Inter-rater reliability for the unilateral pelvic lift test was moderate to good. Validation of the tests in their ability to evaluate lumbar

  18. Inter-rater reliability of three standardized functional tests in patients with low back pain

    Directory of Open Access Journals (Sweden)

    Tidstrand Johan

    2009-06-01

    Full Text Available Abstract Background Of all patients with low back pain, 85% are diagnosed as "non-specific lumbar pain". Lumbar instability has been described as one specific diagnosis which several authors have described as delayed muscular responses, impaired postural control as well as impaired muscular coordination among these patients. This has mostly been measured and evaluated in a laboratory setting. There are few standardized and evaluated functional tests, examining functional muscular coordination which are also applicable in the non-laboratory setting. In ordinary clinical work, tests of functional muscular coordination should be easy to apply. The aim of this present study was to therefore standardize and examine the inter-rater reliability of three functional tests of muscular functional coordination of the lumbar spine in patients with low back pain. Methods Nineteen consecutive individuals, ten men and nine women were included. (Mean age 42 years, SD ± 12 yrs. Two independent examiners assessed three tests: "single limb stance", "sitting on a Bobath ball with one leg lifted" and "unilateral pelvic lift" on the same occasion. The standardization procedure took altered positions of the spine or pelvis and compensatory movements of the free extremities into account. The inter-rater reliability was analyzed by Cohen's kappa coefficient (κ and by percentage agreement. Results The inter-rater reliability for the right and the left leg respectively was: for the single limb stance very good (κ: 0.88–1.0, for sitting on a Bobath ball good (κ: 0.79 and very good (κ: 0.88 and for the unilateral pelvic lift: good (κ: 0.61 and moderate (κ: 0.47. Conclusion The present study showed good to very good inter-rater reliability for two standardized tests, that is, the single-limb stance and sitting on a Bobath-ball with one leg lifted. Inter-rater reliability for the unilateral pelvic lift test was moderate to good. Validation of the tests in their

  19. Clinical balance assessment: perceptions of commonly-used standardized measures and current practices among physiotherapists in Ontario, Canada.

    Science.gov (United States)

    Sibley, Kathryn M; Straus, Sharon E; Inness, Elizabeth L; Salbach, Nancy M; Jaglal, Susan B

    2013-03-20

    Balance impairment is common in multiple clinical populations, and comprehensive assessment is important for identifying impairments, planning individualized treatment programs, and evaluating change over time. However, little information is available regarding whether clinicians who treat balance are satisfied with existing assessment tools. In 2010 we conducted a cross-sectional survey of balance assessment practices among physiotherapists in Ontario, Canada, and reported on the use of standardized balance measures (Sibley et al. 2011 Physical Therapy; 91: 1583-91). The purpose of this study was to analyse additional survey data and i) evaluate satisfaction with current balance assessment practices and standardized measures among physiotherapists who treat adult or geriatric populations with balance impairment, and ii) identify factors associated with satisfaction. The questionnaire was distributed to 1000 practicing physiotherapists. This analysis focuses on questions in which respondents were asked to rate their general perceptions about balance assessment, the perceived utility of individual standardized balance measures, whether they wanted to improve balance assessment practices, and why. Data were summarized with descriptive statistics and utility of individual measures was compared across clinical practice areas (orthopaedic, neurological, geriatric or general rehabilitation). The questionnaire was completed by 369 respondents, of which 43.4% of respondents agreed that existing standardized measures of balance meet their needs. In ratings of individual measures, the Single Leg Stance test and Berg Balance Scale were perceived as useful for clinical decision-making and evaluating change over time by over 70% of respondents, and the Timed Up-and-Go test was perceived as useful for decision-making by 56.9% of respondents and useful for evaluating change over time by 62.9% of respondents, but there were significant differences across practice groups. Seventy

  20. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

  1. Clinical acceptance testing and scanner comparison of ultrasound shear wave elastography.

    Science.gov (United States)

    Long, Zaiyang; Tradup, Donald J; Song, Pengfei; Stekel, Scott F; Chen, Shigao; Glazebrook, Katrina N; Hangiandreou, Nicholas J

    2018-03-15

    Because of the rapidly growing use of ultrasound shear wave elastography (SWE) in clinical practices, there is a significant need for development of clinical physics performance assessment methods for this technology. This study aims to report two clinical medical physicists' tasks: (a) acceptance testing (AT) of SWE function on ten commercial ultrasound systems for clinical liver application and (b) comparison of SWE measurements of targets across vendors for clinical musculoskeletal application. For AT, ten GE LOGIQ E9 XDclear 2.0 scanners with ten C1-6-D and ten 9L-D transducers were studied using two commercial homogenous phantoms. Five measurements were acquired at two depths for each scanner/transducer pair by two operators. Additional tests were performed to access effects of different coupling media, phantom locations and operators. System deviations were less than 5% of group mean or three times standard deviation; therefore, all systems passed AT. A test protocol was provided based on results that no statistically significant difference was observed between using ultrasound gel and salt water for coupling, among different phantom locations, and that interoperator and intraoperator coefficient of variation was less than 3%. For SWE target measurements, two systems were compared - a Supersonic Aixplorer scanner with a SL10-2 and a SL15-4 transducer, and an abovementioned GE scanner with 9L-D transducer. Two stepped cylinders with diameters of 4.05-10.40 mm were measured both longitudinally and transaxially. Target shear wave speed quantification was performed using an in-house MATLAB program. Using the target shear wave speed deduced from phantom specs as a reference, SL15-4 performed the best at the measured depth. However, it was challenging to reliably measure a 4.05 mm target for either system. The reported test methods and results could provide important information when dealing with SWE-related tasks in the clinical environment. © 2018 The Authors

  2. Survey of clinical infant lung function testing practices.

    Science.gov (United States)

    Peterson-Carmichael, Stacey L; Rosenfeld, Margaret; Ascher, Simon B; Hornik, Christoph P; Arets, H G M; Davis, Stephanie D; Hall, Graham L

    2014-02-01

    Data supporting the clinical use of infant lung function (ILF) tests are limited making the interpretation of clinical ILF measures difficult. To evaluate current ILF testing practices and to survey users regarding the indications, limitations and perceived clinical benefits of ILF testing. We created a 26-item survey hosted on the European Respiratory Society (ERS) website between January and May 2010. Notifications were sent to members of the ERS, American Thoracic Society and the Asian Pacific Society of Respirology. Responses were sought from ILF laboratory directors and pediatric respirologists. The survey assessed the clinical indications, patient populations, equipment and reference data used, and perceived limitations of ILF testing. We received 148 responses with 98 respondents having ILF equipment and performing testing in a clinical capacity. Centers in North America were less likely to perform ≥50 studies/year than centers in Europe or other continents (13% vs. 41%). Most respondents used ILF data to either "start a new therapy" (78%) or "help decide about initiation of further diagnostic workup such as bronchoscopy, chest CT or serological testing" (69%). Factors reported as limiting clinical ILF testing were need for sedation, uncertainty regarding clinical impact of study results and time intensive nature of the study. Clinical practices associated with ILF testing vary significantly; centers that perform more studies are more likely to use the results for clinical purposes and decision making. The future of ILF testing is uncertain in the face of the limitations perceived by the survey respondents. © 2013 Wiley Periodicals, Inc.

  3. Standard test method for determination of surface lubrication on flexible webs

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1999-01-01

    1.1 This test method has been used since 1988 as an ANSI/ISO standard test for determination of lubrication on processed photographic films. Its purpose was to determine the presence of process-surviving lubricants on photographic films. It is the purpose of this test method to expand the applicability of this test method to other flexible webs that may need lubrication for suitable performance. This test measures the breakaway (static) coefficient of friction of a metal rider on the web by the inclined plane method. The objectives of the test is to determine if a web surface has a lubricant present or not. It is not intended to assign a friction coefficient to a material. It is not intended to rank lubricants. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish ...

  4. Environmental contact factors in eczema and the results of patch testing Chinese patients with a modified European standard series of allergens.

    Science.gov (United States)

    Li, Lin-Feng; Guo, Jing; Wang, Jing

    2004-07-01

    Environmental contact factors in eczema were investigated in China by clinical questionnaire and patch testing patients with a modified European standard series of allergens. 217 consecutive eczema patients were studied. Contact dermatitis (CD) was clinically diagnosed in 30% of the patients. Among the patients patch tested, 46 patients had clinically diagnosed allergic CD (ACD), 20 patients clinically had non-ACD (NACD) (including 16 cases of irritant contact dermatitis, 1 case of phototoxic contact reaction and 3 cases of asteatotic eczema) and 115 patients had clinically suspected ACD. 45 patients (98%) in the ACD group went on to have relevant patch test results. The most common ACD was from metals, fragrance materials, cosmetics and rubber materials. The most common contact allergens identified were nickel, fragrance mix, para-phenylenediamine (PPD), carba mix and thimerosal. No adverse reactions were observed to patch testing, except for pruritus in patch-test-positive patients. The positive rate of patch testing in ACD was much higher than that in NACD (98% versus 15%, P China.

  5. Evaluation of a clinic-based cholinesterase test kit for the Washington State Cholinesterase Monitoring Program.

    Science.gov (United States)

    Hofmann, Jonathan N; Carden, Angela; Fenske, Richard A; Ruark, Harold E; Keifer, Matthew C

    2008-07-01

    The Washington State Cholinesterase Monitoring Program for pesticide handlers requires blood draws at local clinics, with samples tested at a central laboratory. At present, workers with inhibited cholinesterase activity may be re-exposed before they can be removed from work. In this study we explored the option of on-site testing at local clinics using the EQM Test-mate Kittrade mark, a portable cholinesterase test kit. Test kit cholinesterase activity measurements were performed on 50 blood samples by our research staff, and compared to measurements on the same samples by the Washington State Public Health Laboratory. Another set of samples was also analyzed with the test kit by medical staff at an eastern Washington clinic. Triplicate measurements with the test kit had a 3.3% average coefficient of variation (CV) for plasma cholinesterase (PChE), and a 3.5% average CV for erythrocyte cholinesterase (AChE) measurements. The kit's PChE measurements were similar to PHL measurements (average ratio of 0.98) when performed in the laboratory, but had a tendency to underestimate activity when used in the clinic setting (average ratio of 0.87). The kit systematically overestimated AChE activity by 42-48% relative to the PHL measurements, regardless of where the samples were analyzed. This easy-to-use test kit appeared to be a viable method for clinic-based PChE measurements, but was less consistent for AChE measurements performed in the clinic. Absolute measurements with the kit need to be evaluated carefully relative to standardized methods. (c) 2008 Wiley-Liss, Inc.

  6. Standards for Educational and Psychological Testing, 2014 Edition

    Science.gov (United States)

    American Educational Research Association (AERA), 2014

    2014-01-01

    Developed jointly by the American Educational Research Association, American Psychological Association, and the National Council on Measurement in Education, "Standards for Educational and Psychological Testing" (Revised 2014) addresses professional and technical issues of test development and use in education, psychology, and…

  7. USL/DBMS NASA/PC R and D project system testing standards

    Science.gov (United States)

    Dominick, Wayne D. (Editor); Kavi, Srinu; Moreau, Dennis R.; Yan, Lin

    1984-01-01

    A set of system testing standards to be used in the development of all C software within the NASA/PC Research and Development Project is established. Testing will be considered in two phases: the program testing phase and the system testing phase. The objective of these standards is to provide guidelines for the planning and conduct of program and software system testing.

  8. Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical

  9. Experimentally testing the standard cosmological model

    Energy Technology Data Exchange (ETDEWEB)

    Schramm, D.N. (Chicago Univ., IL (USA) Fermi National Accelerator Lab., Batavia, IL (USA))

    1990-11-01

    The standard model of cosmology, the big bang, is now being tested and confirmed to remarkable accuracy. Recent high precision measurements relate to the microwave background; and big bang nucleosynthesis. This paper focuses on the latter since that relates more directly to high energy experiments. In particular, the recent LEP (and SLC) results on the number of neutrinos are discussed as a positive laboratory test of the standard cosmology scenario. Discussion is presented on the improved light element observational data as well as the improved neutron lifetime data. alternate nucleosynthesis scenarios of decaying matter or of quark-hadron induced inhomogeneities are discussed. It is shown that when these scenarios are made to fit the observed abundances accurately, the resulting conclusions on the baryonic density relative to the critical density, {Omega}{sub b}, remain approximately the same as in the standard homogeneous case, thus, adding to the robustness of the standard model conclusion that {Omega}{sub b} {approximately} 0.06. This latter point is the deriving force behind the need for non-baryonic dark matter (assuming {Omega}{sub total} = 1) and the need for dark baryonic matter, since {Omega}{sub visible} < {Omega}{sub b}. Recent accelerator constraints on non-baryonic matter are discussed, showing that any massive cold dark matter candidate must now have a mass M{sub x} {approx gt} 20 GeV and an interaction weaker than the Z{sup 0} coupling to a neutrino. It is also noted that recent hints regarding the solar neutrino experiments coupled with the see-saw model for {nu}-masses may imply that the {nu}{sub {tau}} is a good hot dark matter candidate. 73 refs., 5 figs.

  10. Experimentally testing the standard cosmological model

    International Nuclear Information System (INIS)

    Schramm, D.N.

    1990-11-01

    The standard model of cosmology, the big bang, is now being tested and confirmed to remarkable accuracy. Recent high precision measurements relate to the microwave background; and big bang nucleosynthesis. This paper focuses on the latter since that relates more directly to high energy experiments. In particular, the recent LEP (and SLC) results on the number of neutrinos are discussed as a positive laboratory test of the standard cosmology scenario. Discussion is presented on the improved light element observational data as well as the improved neutron lifetime data. alternate nucleosynthesis scenarios of decaying matter or of quark-hadron induced inhomogeneities are discussed. It is shown that when these scenarios are made to fit the observed abundances accurately, the resulting conclusions on the baryonic density relative to the critical density, Ω b , remain approximately the same as in the standard homogeneous case, thus, adding to the robustness of the standard model conclusion that Ω b ∼ 0.06. This latter point is the deriving force behind the need for non-baryonic dark matter (assuming Ω total = 1) and the need for dark baryonic matter, since Ω visible b . Recent accelerator constraints on non-baryonic matter are discussed, showing that any massive cold dark matter candidate must now have a mass M x approx-gt 20 GeV and an interaction weaker than the Z 0 coupling to a neutrino. It is also noted that recent hints regarding the solar neutrino experiments coupled with the see-saw model for ν-masses may imply that the ν τ is a good hot dark matter candidate. 73 refs., 5 figs

  11. “Heidelberg standard examination” and “Heidelberg standard procedures” – Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education

    Science.gov (United States)

    Nikendei, C.; Ganschow, P.; Groener, J. B.; Huwendiek, S.; Köchel, A.; Köhl-Hackert, N.; Pjontek, R.; Rodrian, J.; Scheibe, F.; Stadler, A.-K.; Steiner, T.; Stiepak, J.; Tabatabai, J.; Utz, A.; Kadmon, M.

    2016-01-01

    The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects “Heidelberg standard examination” and “Heidelberg standard procedures”, which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties. PMID:27579354

  12. Quality management and accreditation in a mixed research and clinical hair testing analytical laboratory setting-a review.

    Science.gov (United States)

    Fulga, Netta

    2013-06-01

    Quality management and accreditation in the analytical laboratory setting are developing rapidly and becoming the standard worldwide. Quality management refers to all the activities used by organizations to ensure product or service consistency. Accreditation is a formal recognition by an authoritative regulatory body that a laboratory is competent to perform examinations and report results. The Motherisk Drug Testing Laboratory is licensed to operate at the Hospital for Sick Children in Toronto, Ontario. The laboratory performs toxicology tests of hair and meconium samples for research and clinical purposes. Most of the samples are involved in a chain of custody cases. Establishing a quality management system and achieving accreditation became mandatory by legislation for all Ontario clinical laboratories since 2003. The Ontario Laboratory Accreditation program is based on International Organization for Standardization 15189-Medical laboratories-Particular requirements for quality and competence, an international standard that has been adopted as a national standard in Canada. The implementation of a quality management system involves management commitment, planning and staff education, documentation of the system, validation of processes, and assessment against the requirements. The maintenance of a quality management system requires control and monitoring of the entire laboratory path of workflow. The process of transformation of a research/clinical laboratory into an accredited laboratory, and the benefits of maintaining an effective quality management system, are presented in this article.

  13. Comparison of Size Modulation Standard Automated Perimetry and Conventional Standard Automated Perimetry with a 10-2 Test Program in Glaucoma Patients.

    Science.gov (United States)

    Hirasawa, Kazunori; Takahashi, Natsumi; Satou, Tsukasa; Kasahara, Masayuki; Matsumura, Kazuhiro; Shoji, Nobuyuki

    2017-08-01

    This prospective observational study compared the performance of size modulation standard automated perimetry with the Octopus 600 10-2 test program, with stimulus size modulation during testing, based on stimulus intensity and conventional standard automated perimetry, with that of the Humphrey 10-2 test program in glaucoma patients. Eighty-seven eyes of 87 glaucoma patients underwent size modulation standard automated perimetry with Dynamic strategy and conventional standard automated perimetry using the SITA standard strategy. The main outcome measures were global indices, point-wise threshold, visual defect size and depth, reliability indices, and test duration; these were compared between size modulation standard automated perimetry and conventional standard automated perimetry. Global indices and point-wise threshold values between size modulation standard automated perimetry and conventional standard automated perimetry were moderately to strongly correlated (p 33.40, p modulation standard automated perimetry than with conventional standard automated perimetry, but the visual-field defect size was smaller (p modulation-standard automated perimetry than on conventional standard automated perimetry. The reliability indices, particularly the false-negative response, of size modulation standard automated perimetry were worse than those of conventional standard automated perimetry (p modulation standard automated perimetry than with conventional standard automated perimetry (p = 0.02). Global indices and the point-wise threshold value of the two testing modalities correlated well. However, the potential of a large stimulus presented at an area with a decreased sensitivity with size modulation standard automated perimetry could underestimate the actual threshold in the 10-2 test protocol, as compared with conventional standard automated perimetry.

  14. Successful Integration of Hepatitis C Virus Point-of-Care Tests into the Denver Metro Health Clinic

    Directory of Open Access Journals (Sweden)

    A. Jewett

    2013-01-01

    Full Text Available Background. The Centers for Disease Control and Prevention (CDC recommends testing and linkage to care for persons most likely infected with hepatitis C virus (HCV, including persons with human immunodeficiency virus. We explored facilitators and barriers to integrating HCV point-of-care (POC testing into standard operations at an urban STD clinic. Methods. The OraQuick HCV rapid antibody test was integrated at the Denver Metro Health Clinic (DMHC. All clients with at least one risk factor were offered the POC test. Research staff conducted interviews with clients (three HCV positive and nine HCV negative. Focus groups were conducted with triage staff, providers, and linkage-to-care counselors. Results. Clients were pleased with the ease of use and rapid return of results from the HCV POC test. Integrating the test into this setting required more time but was not overly burdensome. While counseling messages were clear to staff, clients retained little knowledge of hepatitis C infection or factors related to risk. Barriers to integrating the HCV POC test into clinic operations were loss to follow-up and access to care. Conclusion. DMHC successfully integrated HCV POC testing and piloted a HCV linkage-to-care program. Providing testing opportunities at STD clinics could increase identification of persons with HCV infection.

  15. Clinical patch test data evaluated by multivariate analysis. Danish Contact Dermatitis Group

    DEFF Research Database (Denmark)

    Christophersen, J; Menné, T; Tanghøj, P

    1989-01-01

    The aim of the present study was to evaluate the influence of individual explanatory factors, such as sex, age, atopy, test time and presence of diseased skin, on clinical patch test results, by application of multivariate statistical analysis. The study population was 2166 consecutive patients...... patch tested with the standard series of the International Contact Dermatitis Research Group (ICDRG) by members of the Danish Contact Dermatitis Group (DCDG) over a period of 6 months. For the 8 test allergens most often found positive (nickel, fragrance-mix, cobalt, chromate, balsam of Peru, carba......-mix, colophony, and formaldehyde), one or more individual factors were of significance for the risk of being sensitized, except for chromate and formaldehyde. It is concluded that patch test results can be compared only after stratification of the material or by multivariate analysis....

  16. Annual meeting 1996 'Nondestructive materials testing'. German, Austrian and Swiss nondestructive materials testing standards as mirrored by international standardization. Vol. 1. Lectures

    International Nuclear Information System (INIS)

    1996-01-01

    The volume contains 45 lectures which were given at the annual meeting of the German Society for Nondestructive Testing on May 13-15, 1996 at Lindau. The main subjects were: Standardization of nondestructive testing, irradiation testing, ultrasonic testing and electromagnetic processes. 13 individual articles were included in the ENERGY database. (MM) [de

  17. Annual meeting 1996 'Nondestructive material testing'. German, Austrian and Swiss nondestructive materials testing standards as mirrored by international standardization. Vol. 2. Posters

    International Nuclear Information System (INIS)

    1996-01-01

    The volume contains 49 poster articles which were presented at the Annual Meeting of the German Society for Nondestructive Testing at Lindau on May 13-15, 1996. The main subjects were: Standardization of nondestructive testing, irradiation testing, ultrasonic testing and electromagnetic processes. 16 individual articles were included in the ENERGY databank. (MM) [de

  18. Certifying a university ENT clinic using the ISO 9001:2000 international standard.

    Science.gov (United States)

    Helbig, Matthias; Helbig, Silke; Kahla-Witzsch, Heike A; Kroll, Tobias; May, Angelika

    2010-01-01

    Against statutory duties to introduce quality management systems, the increased importance of this subject has led to numerous activities in various public health institutions. Following the International Standardization Organization (ISO 9001:2000) prerequisites, Frankfurt Goethe University Hospital ENT clinic staff introduced a quality management system. This paper aims to investigate this process. Designing, planning and implementing the quality management system is described. Under the supervision of an executive quality management board, clinic quality goals were defined. Thereafter, several quality management teams performed an actual state analysis as well as developing and realising improvement proposals. Finally a quality management manual containing binding standards and working instructions concerning all patient care, research and teaching aspects was written. Successful certification by a neutral body ascertained that the clinic's quality management system conformed to current national and international standards while restructuring and reform improved procedural efficiency. The paper shows that mplementing the quality management system requires considerable effort but patients as well as staff profit considerably from the innovation. On the whole, the positive impact on structure and workflow in a specialist clinic predominates. Therefore, implementing a quality management system in all the clinic's wards and departments is recommended.

  19. Panel-Based Clinical Genetic Testing in 85 Children with Inherited Retinal Disease.

    Science.gov (United States)

    Taylor, Rachel L; Parry, Neil R A; Barton, Stephanie J; Campbell, Christopher; Delaney, Claire M; Ellingford, Jamie M; Hall, Georgina; Hardcastle, Claire; Morarji, Jiten; Nichol, Elisabeth J; Williams, Lindsi C; Douzgou, Sofia; Clayton-Smith, Jill; Ramsden, Simon C; Sharma, Vinod; Biswas, Susmito; Lloyd, I Chris; Ashworth, Jane L; Black, Graeme C; Sergouniotis, Panagiotis I

    2017-07-01

    To assess the clinical usefulness of genetic testing in a pediatric population with inherited retinal disease (IRD). Single-center retrospective case series. Eighty-five unrelated children with a diagnosis of isolated or syndromic IRD who were referred for clinical genetic testing between January 2014 and July 2016. Participants underwent a detailed ophthalmic examination, accompanied by electrodiagnostic testing (EDT) and dysmorphologic assessment where appropriate. Ocular and extraocular features were recorded using Human Phenotype Ontology terms. Subsequently, multigene panel testing (105 or 177 IRD-associated genes) was performed in an accredited diagnostic laboratory, followed by clinical variant interpretation. Diagnostic yield and clinical usefulness of genetic testing. Overall, 78.8% of patients (n = 67) received a probable molecular diagnosis; 7.5% (n = 5) of these had autosomal dominant disease, 25.4% (n = 17) had X-linked disease, and 67.2% (n = 45) had autosomal recessive disease. In a further 5.9% of patients (n = 5), a single heterozygous ABCA4 variant was identified; all these participants had a spectrum of clinical features consistent with ABCA4 retinopathy. Most participants (84.7%; n = 72) had undergone EDT and 81.9% (n = 59) of these patients received a probable molecular diagnosis. The genes most frequently mutated in the present cohort were CACNA1F and ABCA4, accounting for 14.9% (n = 10) and 11.9% (n = 8) of diagnoses respectively. Notably, in many cases, genetic testing helped to distinguish stationary from progressive IRD subtypes and to establish a precise diagnosis in a timely fashion. Multigene panel testing pointed to a molecular diagnosis in 84.7% of children with IRD. The diagnostic yield in the study population was significantly higher compared with that in previously reported unselected IRD cohorts. Approaches similar to the one described herein are expected to become a standard component of care in pediatric ophthalmology

  20. Sweat test for cystic fibrosis: Wearable sweat sensor vs. standard laboratory test.

    Science.gov (United States)

    Choi, Dong-Hoon; Thaxton, Abigail; Jeong, In Cheol; Kim, Kain; Sosnay, Patrick R; Cutting, Garry R; Searson, Peter C

    2018-03-23

    Sweat chloride testing for diagnosis of cystic fibrosis (CF) involves sweat induction, collection and handling, and measurement in an analytical lab. We have developed a wearable sensor with an integrated salt bridge for real-time measurement of sweat chloride concentration. Here, in a proof-of-concept study, we compare the performance of the sensor to current clinical practice in CF patients and healthy subjects. Sweat was induced on both forearms of 10 individuals with CF and 10 healthy subjects using pilocarpine iontophoresis. A Macroduct sweat collection device was attached to one arm and sweat was collected for 30 min and then sent for laboratory analysis. A sensor was attached to the other arm and the chloride ion concentration monitored in real time for 30 min using a Bluetooth transceiver and smart phone app. Stable sweat chloride measurements were obtained within 15 min following sweat induction using the wearable sensor. We define the detection time as the time at which the standard deviation of the real-time chloride ion concentration remained below 2 mEq/L for 5 min. The sweat volume for sensor measurements at the detection time was 13.1 ± 11.4 μL (SD), in many cases lower than the minimum sweat volume of 15 μL for conventional testing. The mean difference between sweat chloride concentrations measured by the sensor and the conventional laboratory practice was 6.2 ± 9.5 mEq/L (SD), close to the arm-to-arm variation of about 3 mEq/L. The Pearson correlation coefficient between the two measurements was 0.97 highlighting the excellent agreement between the two methods. A wearable sensor can be used to make real-time measurements of sweat chloride within 15 min following sweat induction, requiring a small sweat volume, and with excellent agreement to standard methods. Copyright © 2018 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

  1. Standard test method for measuring pH of soil for use in corrosion testing

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1995-01-01

    1.1 This test method covers a procedure for determining the pH of a soil in corrosion testing. The principle use of the test is to supplement soil resistivity measurements and thereby identify conditions under which the corrosion of metals in soil may be accentuated (see G 57 - 78 (1984)). 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  2. Fractional flow reserve derived from coronary CT angiography in stable coronary disease: a new standard in non-invasive testing?

    International Nuclear Information System (INIS)

    Noergaard, B.L.; Jensen, J.M.; Leipsic, J.

    2015-01-01

    Fractional flow reserve (FFR) measured during invasive coronary angiography is the gold standard for lesion-specific decisions on coronary revascularization in patients with stable coronary artery disease (CAD). Current guidelines recommend non-invasive functional or anatomic testing as a gatekeeper to the catheterization laboratory. However, the ''holy grail'' in non-invasive testing of CAD is to establish a single test that quantifies both coronary lesion severity and the associated ischemia. Most evidence to date of such a test is based on the addition of computational analysis of FFR to the anatomic information obtained from standard-acquired coronary CTA data sets at rest (FFR CT ). This review summarizes the clinical evidence for the use of FFR CT in stable CAD in context to the diagnostic performance of other non-invasive testing modalities. (orig.)

  3. 46 CFR 54.10-10 - Standard hydrostatic test (modifies UG-99).

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 2 2010-10-01 2010-10-01 false Standard hydrostatic test (modifies UG-99). 54.10-10... PRESSURE VESSELS Inspection, Reports, and Stamping § 54.10-10 Standard hydrostatic test (modifies UG-99). (a) All pressure vessels shall satisfactorily pass the hydrostatic test prescribed by this section...

  4. Nondestructive testing standards and the ASME code

    International Nuclear Information System (INIS)

    Spanner, J.C.

    1991-04-01

    Nondestructive testing (NDT) requirements and standards are an important part of the ASME Boiler and Pressure Vessel Code. In this paper, the evolution of these requirements and standards is reviewed in the context of the unique technical and legal stature of the ASME Code. The coherent and consistent manner by which the ASME Code rules are organized is described, and the interrelationship between the various ASME Code sections, the piping codes, and the ASTM Standards is discussed. Significant changes occurred in ASME Sections 5 and 11 during the 1980s, and these are highlighted along with projections and comments regarding future trends and changes in these important documents. 4 refs., 8 tabs

  5. Medical Paraclinical Standards, Political Economy of Clinic, and Patients’ Clinical Dependency; A Critical Conversation Analysis of Clinical Counseling in South of Iran

    Science.gov (United States)

    Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

    2014-01-01

    Background: Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. Methods: The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. Results: Results show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Conclusion: Although we can’t condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can’t reduce it to instrumental and linear methods of body treatment. PMID:25349858

  6. Medical paraclinical standards, political economy of clinic, and patients' clinical dependency; a critical conversation analysis of clinical counseling in South of iran.

    Science.gov (United States)

    Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

    2014-07-01

    Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. RESULTS show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Although we can't condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can't reduce it to instrumental and linear methods of body treatment.

  7. [Clinical Tests Testing New Therapies for Stargardt Disease].

    Science.gov (United States)

    Kousal, B; Ďuďáková, Ľ; Hlavatá, L; Lišková, P

    2016-02-01

    To provide information on currently ongoing clinical trials for Stargardt disease. We have searched the clinical trial register (www.clinicaltrials.gov) for the keyword "Stargardt" and list active ongoing studies. There are currently eight registered clinical trials enrolling patients with Stargardt disease; all in phase I or II aiming at four mechanisms of action: inhibition of the production of vitamin A toxic dimers, gene therapy restoring wild type transcription of the ABCA4 gene, neuroprotection preventing retinal cells from oxidative damage, and replacement of the damaged retinal pigment epithelium using stem cell therapy. The basic prerequisite for enrolment in the vast majority of clinical trials is confirmation of the clinical diagnosis by mutational analysis. The wide variety of therapies that are registered as clinical trials for Stargardt disease significantly raises the possibility that effective treatments will be available in the near future for this currently incurable condition and that molecular genetic testing should be increasingly considered. Stargardt disease, clinical trial, ABCA4, mutation.

  8. Standard practice for conducting and evaluating laboratory corrosions tests in soils

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1999-01-01

    1.1 This practice covers procedures for conducting laboratory corrosion tests in soils to evaluate the corrosive attack on engineering materials. 1.2 This practice covers specimen selection and preparation, test environments, and evaluation of test results. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  9. Standard practice for conducting moist SO2 tests

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 This practice covers the apparatus and procedure to be used in conducting qualitative assessment tests in accordance with the requirements of material or product specifications by means of specimen exposure to condensed moisture containing sulfur dioxide. 1.2 The exposure conditions may be varied to suit particular requirements and this practice includes provisions for use of different concentrations of sulfur dioxide and for tests either running continuously or in cycles of alternate exposure to the sulfur dioxide containing atmosphere and to the ambient atmosphere. 1.3 The variant of the test to be used, the exposure period required, the type of test specimen, and the criteria of failure are not prescribed by this practice. Such details are provided in appropriate material and product purchase specifications. 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. 1.5 This standard does not purport to address all of the safety c...

  10. [Modularization by the open standard. (I)].

    Science.gov (United States)

    Hirano, H

    2000-10-01

    We are proceeding with the project called "Open LA21 Project" in the course of the clinical laboratory automation toward the 21st century. With the modular system that realizes integration, downsizing, a reasonable price, and is the future course in the clinical testing automation system as well, we aim to establish common standards among manufacturers as the only way to create user friendly market environments where the proper competition exists among the manufacturers. The common standards which are in preparation by the participating companies as "Open module system standards" are the standards which are going to be made public. They are intended to guarantee connection, compatibility of the products in conformity with the standards. In this project, we intend to realize the modular system that integrates each field, such as chemistry, hematology, coagulation/fibrinolysis, immunology, urinalysis in an early stage, and contribute positively to restructuring and upgrading the "raison d'etre" of the 21st century clinical testing.

  11. Balancing standardized testing with personalized training in surgery

    Directory of Open Access Journals (Sweden)

    Ahmed A

    2016-12-01

    Full Text Available Aadil Ahmed, Muhammad Abbas Abid, Nasir I Bhatti Department of Otolaryngology-Head and Neck Surgery, The Johns Hopkins School of Medicine, Baltimore, MD, USA Abstract: Students pursuing a medical career in the US are subject to standardized testing at regular intervals. These standardized tests not only quantify the milestones students have already achieved, but also define the path for future achievements. The purpose of these examinations is to help students become self-directed, lifelong learners – an essential attribute of a medical professional. However, whether preparing for these examinations actually makes students such disciplined learners needs to be examined. Especially during residency training with its limited time and unpredictable exposure, trainees must learn in the most efficient way for their learning styles, and thus develop attributes that will be helpful to them in their medical career. In this review, we propose that a personalized, learner-centered approach tailored to residents’ educational needs and preferences can not only fulfill learning interests and objectives but also serve as a time-efficient and cost-effective approach for graduate medical education. Keywords: standardized testing, personalized training, surgery

  12. Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

    Science.gov (United States)

    Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

    2015-10-01

    Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

  13. Does standard deviation matter? Using "standard deviation" to quantify security of multistage testing.

    Science.gov (United States)

    Wang, Chun; Zheng, Yi; Chang, Hua-Hua

    2014-01-01

    With the advent of web-based technology, online testing is becoming a mainstream mode in large-scale educational assessments. Most online tests are administered continuously in a testing window, which may post test security problems because examinees who take the test earlier may share information with those who take the test later. Researchers have proposed various statistical indices to assess the test security, and one most often used index is the average test-overlap rate, which was further generalized to the item pooling index (Chang & Zhang, 2002, 2003). These indices, however, are all defined as the means (that is, the expected proportion of common items among examinees) and they were originally proposed for computerized adaptive testing (CAT). Recently, multistage testing (MST) has become a popular alternative to CAT. The unique features of MST make it important to report not only the mean, but also the standard deviation (SD) of test overlap rate, as we advocate in this paper. The standard deviation of test overlap rate adds important information to the test security profile, because for the same mean, a large SD reflects that certain groups of examinees share more common items than other groups. In this study, we analytically derived the lower bounds of the SD under MST, with the results under CAT as a benchmark. It is shown that when the mean overlap rate is the same between MST and CAT, the SD of test overlap tends to be larger in MST. A simulation study was conducted to provide empirical evidence. We also compared the security of MST under the single-pool versus the multiple-pool designs; both analytical and simulation studies show that the non-overlapping multiple-pool design will slightly increase the security risk.

  14. Routine pharmacogenetic testing in clinical practice: dream or reality?

    Science.gov (United States)

    Grossman, Iris

    2007-10-01

    Pharmacogenetics (PGx) has become progressively popular in recent years, thanks to growing anticipation among scientists, healthcare providers and the general public for the incorporation of genetic tests into the diagnostic arsenal at the physician's disposal. Indeed, much research has been dedicated to elucidation of genetic determinants underlying interindividual variability in pharmacokinetic parameters, as well as drug safety and efficacy. However, few PGx applications have thus far been realized in healthcare management. This review uses examples from PGx research of psychiatric drugs to illustrate why the current published findings are inadequate and insufficient for utilization as routine clinical predictors of treatment safety, efficacy or dosing. I therefore suggest the necessary steps to demonstrate the validity, utility and cost-effectiveness of PGx. These recommendations include a whole range of aspects, starting from standardization of criteria and assessment of the technical quality of genotyping assays, up to design of prospective PGx studies, providing the basis for reimbursement programs to be recognized in routine clinical practice.

  15. Private Pilot Practical Test Standards for Airplane (SEL, MEL, SES, MES)

    Science.gov (United States)

    1995-05-01

    The Private Pilot - Airplane Practical Test Standards book has been : published by the Federal Aviation Administration (FAA) to establish the : standards for the private pilot certification practical tests for the airplane : category and the single-e...

  16. Validity of Forced Eyelid Closure Test: A Novel Clinical Screening Test for Ocular Myasthenia Gravis.

    Science.gov (United States)

    Apinyawasisuk, Supanut; Zhou, Xinkai; Tian, Jack J; Garcia, Giancarlo A; Karanjia, Rustum; Sadun, Alfredo A

    2017-09-01

    Forced eyelid closure test (FECT) is a clinical screening test developed from the original Cogan lid twitch (CLT) sign to assist in the diagnosis of ocular myasthenia gravis (OMG), We evaluated the sensitivity and specificity of FECT compared with CLT and benchmarked to standard diagnostic tests. This study was a retrospective chart review of 48 patients using electronic medical records of those that presented with ptosis and/or diplopia at Doheny Eye Institute, University of California, Los Angeles between February 2015 and April 2016. Patients without FECT testing were excluded. FECT and CLT results, and final diagnosis were recorded. To perform FECT, the patient was asked to squeeze his or her eyelids shut for 5-10 seconds then open quickly and fixate in primary position. The excessive upward overshoot of eyelids movement indicated a positive FECT. The test was performed by a neuro-ophthalmologist before establishing the diagnosis. Patients who had equivocal test results and/or inconclusive final diagnosis were excluded. Of the 48 patients studied, 18 patients (37.5%) had positive FECT; 15 of whom had a final diagnosis of OMG (83.3%). Of the 30 patients with negative FECT, 1 had OMG (3.3%). Of the 48 patients, 35 patients also had a documented CLT result (72.9%). CLT was positive in 11 of these 35 patients (31.4%), and 9 of these 11 had OMG (81.8%). Of the 24 patients with negative CLT, 2 of them had OMG (8.3%). Sensitivity and specificity of FECT were 94% and 91% (joint 95% confidence region: sensitivity × specificity = [0.70, 1] × [0.75, 1]). The relative true-positive fraction (rTPF) between FECT and CLT was 1.15; the relative false-positive fraction was 1.31. FECT is a simple clinical screening test with good sensitivity and specificity for OMG.

  17. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  18. Standardized Patients Provide a Reliable Assessment of Athletic Training Students' Clinical Skills

    Science.gov (United States)

    Armstrong, Kirk J.; Jarriel, Amanda J.

    2016-01-01

    Context: Providing students reliable objective feedback regarding their clinical performance is of great value for ongoing clinical skill assessment. Since a standardized patient (SP) is trained to consistently portray the case, students can be assessed and receive immediate feedback within the same clinical encounter; however, no research, to our…

  19. Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

    Science.gov (United States)

    Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

    2017-11-01

    Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. A proposed standard round compact specimen for plane strain fracture toughness testing

    Science.gov (United States)

    Underwood, J. H.; Newman, J. C., Jr.; Seeley, R. R.

    1980-01-01

    A round, disk-shaped specimen is proposed as a standard test specimen for addition to ASTM Test for Plane-Strain Fracture Toughness of Metallic Materials (E 399-78A). The specimen is diametrically cracked, and loaded in the same way as the existing standard compact specimen. Tests and analyses were performed to verify that the proposed round compact specimen and associated stress intensity factor K solution are appropriate for a standard plane strain fracture toughness test. The use of the round compact specimen for other fracture tests is described.

  1. [Laboratory accreditation and proficiency testing].

    Science.gov (United States)

    Kuwa, Katsuhiko

    2003-05-01

    ISO/TC 212 covering clinical laboratory testing and in vitro diagnostic test systems will issue the international standard for medical laboratory quality and competence requirements, ISO 15189. This standard is based on the ISO/IEC 17025, general requirements for competence of testing and calibration laboratories and ISO 9001, quality management systems-requirements. Clinical laboratory services are essential to patient care and therefore should be available to meet the needs of all patients and clinical personnel responsible for human health care. If a laboratory seeks accreditation, it should select an accreditation body that operates according to this international standard and in a manner which takes into account the particular requirements of clinical laboratories. Proficiency testing should be available to evaluate the calibration laboratories and reference measurement laboratories in clinical medicine. Reference measurement procedures should be of precise and the analytical principle of measurement applied should ensure reliability. We should be prepared to establish a quality management system and proficiency testing in clinical laboratories.

  2. Responsiveness of clinical tests for people with neck pain

    DEFF Research Database (Denmark)

    Jørgensen, René; Ris, Inge; Juhl, Carsten

    2017-01-01

    of four clinical tests which are low cost and easy to perform in a clinical setting, including the craniocervical flexion test, cervical active range of movement, test for the cervical extensors and pressure pain threshold testing. METHODS: This study is a secondary analysis of data collected......BACKGROUND: Responsiveness of a clinical test is highly relevant in order to evaluate the effect of a given intervention. However, the responsiveness of clinical tests for people with neck pain has not been adequately evaluated. The objective of the present study was to examine the responsiveness...... in a previously published randomised controlled trial. Participants were randomized to either physical training, exercises and pain education combined or pain education only. Participants were tested on the clinical tests at baseline and at 4-month follow-up. An anchor-based approach using Receiver Operator...

  3. The need for European professional standards and the challenges facing clinical microbiology.

    Science.gov (United States)

    Humphreys, H; Nagy, E; Kahlmeter, G; Ruijs, G J H M

    2010-06-01

    Microorganisms spread across national boundaries and the professional activities of clinical (medical) microbiologists are critical in minimising their impact. Clinical microbiologists participate in many activities, e.g. diagnosis, antibiotic therapy, and there is a need for a set of professional standards for Europe with a common curriculum, to build upon the current strengths of the specialty and to facilitate the free movement of specialists within the European Union. Such standards will also better highlight the important contribution of clinical microbiologists to healthcare. There is a move to larger centralised microbiology laboratories often located off-site from an acute hospital, driven by the concentration of resources, amalgamation of services, outsourcing of diagnostics, automation, an explosion in the range of staff competencies and accreditation. Large off-site centralised microbiology laboratories are often distant to the patient and may not facilitate the early detection of microbial spread. Ultimately, the needs of patients and the public are paramount in deciding on the future direction of clinical microbiology. Potential conflicts between integration on an acute hospital site and centralisation can be resolved by a common set of professional standards and a team-based approach that puts patients first.

  4. A review of standardized patients in clinical education: Implications for speech-language pathology programs.

    Science.gov (United States)

    Hill, Anne E; Davidson, Bronwyn J; Theodoros, Deborah G

    2010-06-01

    The use of standardized patients has been reported as a viable addition to traditional models of professional practice education in medicine, nursing and allied health programs. Educational programs rely on the inclusion of work-integrated learning components in order to graduate competent practitioners. Allied health programs world-wide have reported increasing difficulty in attaining sufficient traditional placements for students within the workplace. In response to this, allied health professionals are challenged to be innovative and problem-solving in the development and maintenance of clinical education placements and to consider potential alternative learning opportunities for students. Whilst there is a bank of literature describing the use of standardized patients in medicine and nursing, reports of its use in speech-language pathology clinical education are limited. Therefore, this paper aims to (1) provide a review of literature reporting on the use of standardized patients within medical and allied health professions with particular reference to use in speech-language pathology, (2) discuss methodological and practical issues involved in establishing and maintaining a standardized patient program and (3) identify future directions for research and clinical programs using standardized patients to build foundation clinical skills such as communication, interpersonal interaction and interviewing.

  5. Result of standard patch test in patients suspected of having allergic contact dermatitis.

    Science.gov (United States)

    Wongpiyabovorn, Jongkonnee; Puvabanditsin, Porntip

    2005-09-01

    Contact dermatitis is a common skin disease. Disease was diagnosed by a history of contact substance together with geographic distribution of lesion. Up till now, standard patch test is one of the most reliable test to identify and confirm causative agent of allergic contact dermatitis. To determine the rate of positive standard patch test and to identify the common allergen of contact dermatitis in Thailand, we performed the standard patch test in 129 patients, suspected having allergic contact dermatitis at Department of Dermatology, King Chulalongkorn Memorial Hospital, Thailand from June 1, 2003 to September 1, 2004. The rate of positive standard patch test is 59.7% (n = 77/129). The most 3 common positive allergens were nickel sulfate (18.60%), cobalt chloride (17.05%) and fragrance mix (14.73%), respectively. The chance of positive standard patch test significantly correlated with sex (woman), initial diagnosis as contact dermatitis and history of house-worker (p = 0.017, p = 0.005 and p = 0.023, respectively). Whereas, there were no significant correlation between the chance of positive standard patch test and age of patient, location of lesion, history of recurrence, history of atopy, history of drug and food allergy. In addition, history of metal allergy significantly correlated with the chance of positive nickel sulfate or cobalt chloride in standard patch test (p = 0.017). In conclusion, this study demonstrated the prevalence of causative allergen of contact dermatitis in Thai patients using that standard patch test. Moreover, our data shown that the chance positive standard patch test was greater in patient, who were women or initial diagnosed as contact dermatitis or had history of houseworker or history of metal allergy.

  6. Road map for the clinical application of the basophil activation test in food allergy.

    Science.gov (United States)

    Santos, A F; Shreffler, W G

    2017-09-01

    The diagnosis of IgE-mediated food allergy based solely on the clinical history and the documentation of specific IgE to whole allergen extract or single allergens is often ambiguous, requiring oral food challenges (OFCs), with the attendant risk and inconvenience to the patient, to confirm the diagnosis of food allergy. This is a considerable proportion of patients assessed in allergy clinics. The basophil activation test (BAT) has emerged as having superior specificity and comparable sensitivity to diagnose food allergy, when compared with skin prick test and specific IgE. BAT, therefore, may reduce the number of OFC required for accurate diagnosis, particularly positive OFC. BAT can also be used to monitor resolution of food allergy and the clinical response to immunomodulatory treatments. Given the practicalities involved in the performance of BAT, we propose that it can be applied for selected cases where the history, skin prick test and/or specific IgE are not definitive for the diagnosis of food allergy. In the cases that the BAT is positive, food allergy is sufficiently confirmed without OFC; in the cases that BAT is negative or the patient has non-responder basophils, OFC may still be indicated. However, broad clinical application of BAT demands further standardization of the laboratory procedure and of the flow cytometry data analyses, as well as clinical validation of BAT as a diagnostic test for multiple target allergens and confirmation of its feasibility and cost-effectiveness in multiple settings. © 2017 The Authors. Clinical & Experimental Allergy published by John Wiley & Sons Ltd.

  7. Development of standard testing methods for nuclear-waste forms

    International Nuclear Information System (INIS)

    Mendel, J.E.; Nelson, R.D.

    1981-11-01

    Standard test methods for waste package component development and design, safety analyses, and licensing are being developed for the Nuclear Waste Materials Handbook. This paper describes mainly the testing methods for obtaining waste form materials data

  8. Standard test method for liquid impingement erosion using rotating apparatus

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This test method covers tests in which solid specimens are eroded or otherwise damaged by repeated discrete impacts of liquid drops or jets. Among the collateral forms of damage considered are degradation of optical properties of window materials, and penetration, separation, or destruction of coatings. The objective of the tests may be to determine the resistance to erosion or other damage of the materials or coatings under test, or to investigate the damage mechanisms and the effect of test variables. Because of the specialized nature of these tests and the desire in many cases to simulate to some degree the expected service environment, the specification of a standard apparatus is not deemed practicable. This test method gives guidance in setting up a test, and specifies test and analysis procedures and reporting requirements that can be followed even with quite widely differing materials, test facilities, and test conditions. It also provides a standardized scale of erosion resistance numbers applicab...

  9. Studies on mycobacterium tuberculosis sensitivity test by using the method of rapid radiometry with appendixes of clinical results

    International Nuclear Information System (INIS)

    Yang Yongqing; Jiang Yimin; Lu Wendong; Zhu Rongen

    1987-01-01

    Three standard strains of mycobacterium tuberculosis (H 37 RV-fully sensitive, SM-R1000 μg/ml, RFP-R 100 μg/ml) were tested with 10 concentration of 5 antitubercular agent, INH, SM, PAS, RFP and EB. 114 isolates of mycobacterium tuberculosis taken from patients were tested with INH, PAS, SM and RFP. They were agreed with the results of standard Lowenstein-Jensen method in 81.7%. 82% of the isolate test were completed within 5 days. The method may be used in routine clinical work. The liquid media prepared by authors do not require human serum albumin and it is less expensive and readily available

  10. Standard practice for instrumented indentation testing

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2007-01-01

    1.1 This practice defines the basic steps of Instrumented Indentation Testing (IIT) and establishes the requirements, accuracies, and capabilities needed by an instrument to successfully perform the test and produce the data that can be used for the determination of indentation hardness and other material characteristics. IIT is a mechanical test that measures the response of a material to the imposed stress and strain of a shaped indenter by forcing the indenter into a material and monitoring the force on, and displacement of, the indenter as a function of time during the full loading-unloading test cycle. 1.2 The operational features of an IIT instrument, as well as requirements for Instrument Verification Annex A1), Standardized Reference Blocks (Annex A2) and Indenter Requirements (Annex A3) are defined. This practice is not intended to be a complete purchase specification for an IIT instrument. 1.3 With the exception of the non-mandatory Appendix X4, this practice does not define the analysis necessary...

  11. Applicability Evaluation of Job Standards for Diabetes Nutritional Management by Clinical Dietitian.

    Science.gov (United States)

    Baek, Young Jin; Oh, Na Gyeong; Sohn, Cheong-Min; Woo, Mi-Hye; Lee, Seung Min; Ju, Dal Lae; Seo, Jung-Sook

    2017-04-01

    This study was conducted to evaluate applicability of job standards for diabetes nutrition management by hospital clinical dietitians. In order to promote the clinical nutrition services, it is necessary to present job standards of clinical dietitian and to actively apply these standardized tasks to the medical institution sites. The job standard of clinical dietitians for diabetic nutrition management was distributed to hospitals over 300 beds. Questionnaire was collected from 96 clinical dietitians of 40 tertiary hospitals, 47 general hospitals, and 9 hospitals. Based on each 5-point scale, the importance of overall duty was 4.4 ± 0.5, performance was 3.6 ± 0.8, and difficulty was 3.1 ± 0.7. 'Nutrition intervention' was 4.5 ± 0.5 for task importance, 'nutrition assessment' was 4.0 ± 0.7 for performance, and 'nutrition diagnosis' was 3.4 ± 0.9 for difficulty. These 3 items were high in each category. Based on the grid diagram, the tasks of both high importance and high performance were 'checking basic information,' 'checking medical history and therapy plan,' 'decision of nutritional needs,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.' The tasks with high importance but low performance were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'monitoring of nutrition intervention process.' The tasks of both high importance and high difficulty were 'derivation of nutrition diagnosis,' 'planning of nutrition intervention,' 'supply of foods and nutrients,' 'education of nutrition and self-management,' and 'monitoring of nutrition intervention process.' The tasks of both high performance and high difficulty were 'documentation of nutrition assessment,' 'supply of foods and nutrients,' and 'education of nutrition and self-management.'

  12. Assessing cultural validity in standardized tests in stem education

    Science.gov (United States)

    Gassant, Lunes

    This quantitative ex post facto study examined how race and gender, as elements of culture, influence the development of common misconceptions among STEM students. Primary data came from a standardized test: the Digital Logic Concept Inventory (DLCI) developed by Drs. Geoffrey L. Herman, Michael C. Louis, and Craig Zilles from the University of Illinois at Urbana-Champaign. The sample consisted of a cohort of 82 STEM students recruited from three universities in Northern Louisiana. Microsoft Excel and the Statistical Package for the Social Sciences (SPSS) were used for data computation. Two key concepts, several sub concepts, and 19 misconceptions were tested through 11 items in the DLCI. Statistical analyses based on both the Classical Test Theory (Spearman, 1904) and the Item Response Theory (Lord, 1952) yielded similar results: some misconceptions in the DLCI can reliably be predicted by the Race or the Gender of the test taker. The research is significant because it has shown that some misconceptions in a STEM discipline attracted students with similar ethnic backgrounds differently; thus, leading to the existence of some cultural bias in the standardized test. Therefore the study encourages further research in cultural validity in standardized tests. With culturally valid tests, it will be possible to increase the effectiveness of targeted teaching and learning strategies for STEM students from diverse ethnic backgrounds. To some extent, this dissertation has contributed to understanding, better, the gap between high enrollment rates and low graduation rates among African American students and also among other minority students in STEM disciplines.

  13. Standard Test Method for Determining the Linearity of a Photovoltaic Device Parameter with Respect To a Test Parameter

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2005-01-01

    1.1 This test method determines the degree of linearity of a photovoltaic device parameter with respect to a test parameter, for example, short-circuit current with respect to irradiance. 1.2 The linearity determined by this test method applies only at the time of testing, and implies no past or future performance level. 1.3 This test method applies only to non-concentrator terrestrial photovoltaic devices. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  14. Standard guide for conducting and evaluating galvanic corrosion tests in electrolytes

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1981-01-01

    1.1 This guide covers conducting and evaluating galvanic corrosion tests to characterize the behavior of two dissimilar metals in electrical contact in an electrolyte under low-flow conditions. It can be adapted to wrought or cast metals and alloys. 1.2 This guide covers the selection of materials, specimen preparation, test environment, method of exposure, and method for evaluating the results to characterize the behavior of galvanic couples in an electrolyte. Note 1—Additional information on galvanic corrosion testing and examples of the conduct and evaluation of galvanic corrosion tests in electrolytes are given in Refs (1) through (7). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicabil...

  15. IEEE C37.98-1987: IEEE standard seismic testing of relays

    International Nuclear Information System (INIS)

    Anon.

    1992-01-01

    This standard specifies the procedures to be used in the seismic testing of relays used in power system facilities. The standard is concerned with the determination of the seismic fragility level of relays and also gives recommendations for proof testing. The purpose of this standard is to establish procedures for determining the seismic capabilities of protective and auxiliary relays. These procedures employ what has been called fragility testing in IEEE Std 344-1987. To define the conditions for fragility testing of relays, parameters in three separate areas must be specified. In general, they are (1) the electrical settings and inputs to the relay, and other information to define its conditions during the test; (2) the change in state, deviation in operating characteristics or tolerances, or other change of performance of the relay that constitutes failure; (3) the seismic vibration environment to be imposed during the test. Since it is not possible to define the conditions for every conceivable application for all relays, those parameters, which in practice encompass the majority of applications, have been specified in this standard. When the application of the relay is other than as specified under any of (1), (2), and (3), or if it is not practical to apply existing results of fragility tests to that new application, then proof testing must be performed for that new case

  16. The Weighted Airman Promotion System: Standardizing Test Scores

    Science.gov (United States)

    2008-01-01

    u th o ri ze d Top 3/E6 ratio, inventory 1401206040 100 70 130 5R 2F 2G 3N 2M 2A 4J 4C 4P 4T 4B 1W 2T 3P 1T 4A 2S 5J 1A 1S1C 6F 4N 7S 4R 4E 1N 3A 3V...System: Standardizing Test Scores AFHRL convened a panel to identify the relevant factors to consider, and then sit as a promotion board and rank...Costs If the Air Force decided to standardize test scores, there would be three basic types of costs: implementation costs, marketing costs, and

  17. Clinical and Cost-Effectiveness of Procalcitonin Test for Prodromal Meningococcal Disease-A Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Jennifer M Bell

    Full Text Available Despite vaccines and improved medical intensive care, clinicians must continue to be vigilant of possible Meningococcal Disease in children. The objective was to establish if the procalcitonin test was a cost-effective adjunct for prodromal Meningococcal Disease in children presenting at emergency department with fever without source.Data to evaluate procalcitonin, C-reactive protein and white cell count tests as indicators of Meningococcal Disease were collected from six independent studies identified through a systematic literature search, applying PRISMA guidelines. The data included 881 children with fever without source in developed countries.The optimal cut-off value for the procalcitonin, C-reactive protein and white cell count tests, each as an indicator of Meningococcal Disease, was determined. Summary Receiver Operator Curve analysis determined the overall diagnostic performance of each test with 95% confidence intervals. A decision analytic model was designed to reflect realistic clinical pathways for a child presenting with fever without source by comparing two diagnostic strategies: standard testing using combined C-reactive protein and white cell count tests compared to standard testing plus procalcitonin test. The costs of each of the four diagnosis groups (true positive, false negative, true negative and false positive were assessed from a National Health Service payer perspective. The procalcitonin test was more accurate (sensitivity=0.89, 95%CI=0.76-0.96; specificity=0.74, 95%CI=0.4-0.92 for early Meningococcal Disease compared to standard testing alone (sensitivity=0.47, 95%CI=0.32-0.62; specificity=0.8, 95% CI=0.64-0.9. Decision analytic model outcomes indicated that the incremental cost effectiveness ratio for the base case was £-8,137.25 (US $ -13,371.94 per correctly treated patient.Procalcitonin plus standard recommended tests, improved the discriminatory ability for fatal Meningococcal Disease and was more cost

  18. Standardization of Tests for Advanced Composites

    OpenAIRE

    石川, 隆司; ISHIKAWA, Takashi; 野口, 義男; NOGUCHI, Yoshio; 濱口, 泰正; HAMAGUCHI, Yasumasa

    2003-01-01

    Advanced composites are essentially the only feasible materials for the construction of newly developed aerospace vehicle. However, the path to be followed for the validation, evaluation and certification of composite aircraft structures is quite different from that of traditional metallic aircraft structures, and the importance of a composites database is now well recognized. A key issue in constructing a fully descriptive composites database is to establish standard composite test methods, ...

  19. Standardization of penetrating radiation testing system

    International Nuclear Information System (INIS)

    Wiley, P.A.; Aronson, H.L.

    1979-01-01

    Standardization is provided to control system gain of a penetrating radiation testing system by periodically inspecting a reference object in the same manner as the product samples so as to generate a stabilization signal which is compared to a reference signal. The difference, if any, between the stabilization signal and the reference signal is integrated and the integrated signal is used to correct the gain of the system

  20. Resource reduction in pediatric chest pain: Standardized clinical assessment and management plan.

    Science.gov (United States)

    Saleeb, Susan F; McLaughlin, Sarah R; Graham, Dionne A; Friedman, Kevin G; Fulton, David R

    2018-01-01

    Using a Standardized Clinical Assessment and Management Plan (SCAMP) for pediatric patients presenting to clinic with chest pain, we evaluated the cost impact associated with implementation of the care algorithm. Prior to introduction of the SCAMP, we analyzed charges for 406 patients with chest pain, seen in 2009, and predicted 21% reduction of overall charges had the SCAMP methodology been used. The SCAMP recommended an echocardiogram for history, examination, or ECG findings suggestive of a cardiac etiology for chest pain. Resource utilization was reviewed for 1517 patients (7-21 years) enrolled in the SCAMP from July 2010 to April 2014. Compared to the 2009 historic cohort, patients evaluated by the SCAMP had higher rates of exertional chest pain (45% vs 37%) and positive family history (5% vs 1%). The SCAMP cohort had fewer abnormal physical examination findings (1% vs 6%) and abnormal electrocardiograms (3% vs 5%). Echocardiogram use increased in the SCAMP cohort compared to the 2009 historic cohort (45% vs 41%), whereas all other ancillary testing was reduced: exercise stress testing (4% SCAMP vs 28% historic), Holter (4% vs 7%), event monitors (3% vs 10%), and MRI (1% vs 2%). Total charges were reduced by 22% ($822 625) by use of the Chest Pain SCAMP, despite a higher percentage of patients for whom echocardiogram was recommended compared to the historic cohort. The Chest Pain SCAMP effectively streamlines cardiac testing and reduces resource utilization. Further reductions can be made by algorithm refinement regarding echocardiograms for exertional symptoms. © 2017 Wiley Periodicals, Inc.

  1. Evaluation of a new in-clinic test system to detect feline immunodeficiency virus and feline leukemia virus infection.

    Science.gov (United States)

    Sand, Christina; Englert, Theresa; Egberink, Herman; Lutz, Hans; Hartmann, Katrin

    2010-06-01

    Many in-house tests for the diagnosis of feline immunodeficiency virus (FIV) and feline leukemia virus (FeLV) infection are licensed for use in veterinary practice. A new test with unknown performance has recently appeared on the market. The aims of this study were to define the efficacy of a new in-clinic test system, the Anigen Rapid FIV Ab/FeLV Ag Test, and to compare it with the current leading in-clinic test, the SNAP Kombi Plus FeLV Antigen/FIB Antibody Test. Three-hundred serum samples from randomly selected healthy and diseased cats presented to the Clinic of Small Animal Medicine at Ludwig Maximilian University were tested using both the Anigen Rapid Test and the SNAP Kombi Plus Test. Diagnostic sensitivity, specificity, and positive and negative predictive values were calculated for both tests using Western blot as the gold standard for verification of FIV infection and PCR as the gold standard for FeLV infection. The presence of antibodies against FIV was confirmed by Western blot in 9/300 samples (prevalence 3%). FeLV DNA was detected by PCR in 15/300 samples (prevalence 5%). For FIV infection the Anigen Rapid Test had a sensitivity of 88.9%, specificity of 99.7%, positive predictive value of 88.9%, and negative predictive value of 99.7%. For FeLV infection, the Anigen Rapid Test had a sensitivity of 40.0%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 96.9%. Diagnostic accuracy was similar to that of the SNAP Kombi Plus Test. The new Anigen Rapid FIV Ab/FeLV Ag Test performed very well and can be recommended for use in veterinary practice.

  2. Political Judgement, Freedom of Thought, and Standardized Testing: A Critical Enquiry

    Science.gov (United States)

    Schuler, Matthew Edward

    2012-01-01

    The practice of "standardized" testing has been embedded in United States federal education policy since at least the passage of the Elementary and Secondary Education Act of 1965. The roots of standardized testing in American education, grounded in Kantian "Modern Thought," can be traced to the U.S. Military Academy at…

  3. IEEE C37.98-1978: IEEE standard seismic testing of relays

    International Nuclear Information System (INIS)

    Anon.

    1992-01-01

    This standard specifies the procedures to be used in the seismic testing of relays used in power system facilities. The standard is concerned with the determination of the seismic fragility level of relays and also gives recommendations for proof testing. The purpose of this standard is to establish procedures for determining the seismic capabilities of protective and auxiliary relays. These procedures employ what has been called fragility testing in ANSI/IEEE Std 344-1975, Recommended Practices for Seismic Qualification of Class 1E Equipment for Nuclear Power Generating Stations. In order to define the conditions for fragility testing of relays, parameters in three separate areas must be specified. In general they are: (1) the electrical settings and inputs to the relay, and other information to define its conditions during the test; (2) the change in state, deviation in operating characteristics or tolerances, or other change of performance of the relay which constitutes failure; (3) the seismic vibration environment to be imposed during the test. Since it is not possible to define the conditions for every conceivable application for all relays, those parameters, which in practice encompass the majority of applications, have been specified in this standard. When the application of the relay is other than as specified under any of (1), (2), and (3), or if it is not practical to apply existing results of fragility tests to that new case

  4. Integrating usability testing and think-aloud protocol analysis with "near-live" clinical simulations in evaluating clinical decision support.

    Science.gov (United States)

    Li, Alice C; Kannry, Joseph L; Kushniruk, Andre; Chrimes, Dillon; McGinn, Thomas G; Edonyabo, Daniel; Mann, Devin M

    2012-11-01

    Usability evaluations can improve the usability and workflow integration of clinical decision support (CDS). Traditional usability testing using scripted scenarios with think-aloud protocol analysis provide a useful but incomplete assessment of how new CDS tools interact with users and clinical workflow. "Near-live" clinical simulations are a newer usability evaluation tool that more closely mimics clinical workflow and that allows for a complementary evaluation of CDS usability as well as impact on workflow. This study employed two phases of testing a new CDS tool that embedded clinical prediction rules (an evidence-based medicine tool) into primary care workflow within a commercial electronic health record. Phase I applied usability testing involving "think-aloud" protocol analysis of 8 primary care providers encountering several scripted clinical scenarios. Phase II used "near-live" clinical simulations of 8 providers interacting with video clips of standardized trained patient actors enacting the clinical scenario. In both phases, all sessions were audiotaped and had screen-capture software activated for onscreen recordings. Transcripts were coded using qualitative analysis methods. In Phase I, the impact of the CDS on navigation and workflow were associated with the largest volume of negative comments (accounting for over 90% of user raised issues) while the overall usability and the content of the CDS were associated with the most positive comments. However, usability had a positive-to-negative comment ratio of only 0.93 reflecting mixed perceptions about the usability of the CDS. In Phase II, the duration of encounters with simulated patients was approximately 12 min with 71% of the clinical prediction rules being activated after half of the visit had already elapsed. Upon activation, providers accepted the CDS tool pathway 82% of times offered and completed all of its elements in 53% of all simulation cases. Only 12.2% of encounter time was spent using the

  5. Further examination of embedded performance validity indicators for the Conners' Continuous Performance Test and Brief Test of Attention in a large outpatient clinical sample.

    Science.gov (United States)

    Sharland, Michael J; Waring, Stephen C; Johnson, Brian P; Taran, Allise M; Rusin, Travis A; Pattock, Andrew M; Palcher, Jeanette A

    2018-01-01

    Assessing test performance validity is a standard clinical practice and although studies have examined the utility of cognitive/memory measures, few have examined attention measures as indicators of performance validity beyond the Reliable Digit Span. The current study further investigates the classification probability of embedded Performance Validity Tests (PVTs) within the Brief Test of Attention (BTA) and the Conners' Continuous Performance Test (CPT-II), in a large clinical sample. This was a retrospective study of 615 patients consecutively referred for comprehensive outpatient neuropsychological evaluation. Non-credible performance was defined two ways: failure on one or more PVTs and failure on two or more PVTs. Classification probability of the BTA and CPT-II into non-credible groups was assessed. Sensitivity, specificity, positive predictive value, and negative predictive value were derived to identify clinically relevant cut-off scores. When using failure on two or more PVTs as the indicator for non-credible responding compared to failure on one or more PVTs, highest classification probability, or area under the curve (AUC), was achieved by the BTA (AUC = .87 vs. .79). CPT-II Omission, Commission, and Total Errors exhibited higher classification probability as well. Overall, these findings corroborate previous findings, extending them to a large clinical sample. BTA and CPT-II are useful embedded performance validity indicators within a clinical battery but should not be used in isolation without other performance validity indicators.

  6. Performance testing of HEPA filters: Progress towards a European standard procedure

    Energy Technology Data Exchange (ETDEWEB)

    Dyment, J.

    1997-08-01

    Proposals for a future European testing procedure for {open_quotes}High Efficiency Particulate Air Filters (HEPA and ULPA){close_quotes} are being developed by CEN (Comite Europeen de Normalisation). The new standard will be given the status of national standard in participating countries, conflicting national standards being withdrawn. The standard will comprise 5 parts covering the grouping and classification of HEPA and ULPA filters according to their efficiency, fundamental principles of testing, marking etc (in part 1). Part 2 will cover aerosol production, measurement principles, counting equipment and statistics. Parts 3-5 will cover testing flat sheet media, leak testing of filter elements and the efficiency testing of filter elements respectively. The efficiency test methods allow the use of either homogeneous monodisperse or polydisperse aerosols for the determination of particulate filtration efficiencies as a function of particle size. The particle size at which maximum penetration occurs is first determined in flat sheet media tests; tests on filter elements (constructed using the same filter medium) may be carried out using either a homogeneous monodisperse aerosol of the size at which maximum penetration occurs (MPPS) or a polydisperse aerosol whose median size is close to the MPPS. Tests with monodisperse aerosols may be conducted using condensation nucleus counting equipment; tests using polydisperse test aerosols require the use of optical sizing particle counters. When determining the efficiency of filter elements the downstream aerosol concentrations may be determined from air samples obtained using either an overall method (single point sampling after mixing) or a scan method. The scan method also allows {open_quotes}local{close_quotes} efficiency values to be determined. 1 ref., 1 fig., 1 tab.

  7. [Clinical exercise testing and the Fick equation: strategic thinking for optimizing diagnosis].

    Science.gov (United States)

    Perrault, H; Richard, R

    2012-04-01

    This article examines the expected exercise-induced changes in the components of the oxygen transport system as described by the Fick equation with a view to enable a critical analysis of a standard incremental exercise test to identify normal and abnormal patterns of responses and generate hypotheses as to potential physiological and/or pathophysiological causes. The text reviews basic physiological principals and provides useful reminders of standard equations that serve to integrate circulatory, respiratory and skeletal muscle functions. More specifically, the article provides a conceptual and quantitative framework linking the exercise-induced increase in whole body oxygen uptake to central circulatory and peripheral circulatory factors with the view to establish the normalcy of response. Thus, the article reviews the exercise response to cardiac output determinants and provides qualitative and quantitative perspective bases for making assumptions on the peripheral circulatory factors and oxygen use. Finally, the article demonstrates the usefulness of exercise testing as an effective integrative physiological approach to develop clinical reasoning or verify pathophysiological outcomes. Copyright © 2012 SPLF. Published by Elsevier Masson SAS. All rights reserved.

  8. FY 1999 project on the development of new industry support type international standards. Standardization of evaluation method of the genetic testing system; 1999 nendo shinki sangyo shiengata kokusai hyojunka kaihatsu jigyo seika hokokusho. Idenshi kensa system no hyoka hoho no hyojunka

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-03-01

    Aiming at applying standards as international standards, an experimental study was conducted on the standardization of the genetic testing system in Japan and abroad. The FY 1999 results were summarized. As to the unification of testing data processing, analysis of the present state and experimental study were made on the following: sampling method for appropriate testing, selection of anti-coagulants, method to preserve specimens, method to transport them, description of clinical observations in test request paper, method to evaluate performance of test reagents including restriction enzyme, temperature calibration method for equipment, sterilization method, incineration method of specimens, long-term storage of DNA samples, etc. The results were proposed as standard operation procedures after study/discussion at the comprehensive survey committee. Concerning the setting of criteria values in data analysis and the standardization of report form, survey/study were conducted also on ethical/legal/social problems from an aspect of privacy protection of patients. As a result, a total system from the reception of genetic testing to the report making was prepared. (NEDO)

  9. Standard Specification for Steel Blades Used with the Photovoltaic Module Surface Cut Test

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This specification specifies the recommended physical characteristics of the steel blades required for the surface cut test described in ANSI/UL 1703 (Section 24) and IEC 61730-2 (Paragraph 10.3). 1.2 ANSI/UL 1703 and IEC 61730-2 are standards for photovoltaic module safety testing. 1.3 This standard provides additional fabrication details for the surface cut test blades that are not provided in ANSI/UL 1703 or IEC 61730-2. Surface cut test blades that have out-of-tolerance corner radii or burrs are known to cause erroneous test results, either passes or failures. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  10. Erythema-index of clinical patch test reactions

    DEFF Research Database (Denmark)

    Jemec, G B; Johansen, J D

    1995-01-01

    that the method could be used for the grading of eczematous reactions in a clinical setting as well. OBJECTIVE: To assess the usefulness of the erythema index for the quantification of eczematous reactions using the Derma-Spectrometer (Cortex technology, Hadsund, Denmark) in a clinical setting. METHOD......: The erythema index of 56 patch test reactions ranging from +? to +++, was compared to regional controls and negative patch tests (189). The effects of intrumental application pressure was studied in 5 volunteers. Statistical analysis was carried out using Mann-Whitney and Jonckheere-Terpstra tests. RESULTS......: The erythema-index was significantly higher in all degrees of patch test reactions than in uninvolved regional skin or negative patch tests. It also showed a significant positive trend for higher values in +, ++ and +++ reactions (P

  11. Standard operation procedures for conducting the on-the-road driving test, and measurement of the standard deviation of lateral position (SDLP).

    Science.gov (United States)

    Verster, Joris C; Roth, Thomas

    2011-01-01

    This review discusses the methodology of the standardized on-the-road driving test and standard operation procedures to conduct the test and analyze the data. The on-the-road driving test has proven to be a sensitive and reliable method to examine driving ability after administration of central nervous system (CNS) drugs. The test is performed on a public highway in normal traffic. Subjects are instructed to drive with a steady lateral position and constant speed. Its primary parameter, the standard deviation of lateral position (SDLP), ie, an index of 'weaving', is a stable measure of driving performance with high test-retest reliability. SDLP differences from placebo are dose-dependent, and do not depend on the subject's baseline driving skills (placebo SDLP). It is important that standard operation procedures are applied to conduct the test and analyze the data in order to allow comparisons between studies from different sites.

  12. Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).

    Science.gov (United States)

    Labhardt, Niklaus Daniel; Ringera, Isaac; Lejone, Thabo Ishmael; Masethothi, Phofu; Thaanyane, T'sepang; Kamele, Mashaete; Gupta, Ravi Shankar; Thin, Kyaw; Cerutti, Bernard; Klimkait, Thomas; Fritz, Christiane; Glass, Tracy Renée

    2016-04-14

    Achievement of the UNAIDS 90-90-90 targets in Sub-Sahara Africa is challenged by a weak care-cascade with poor linkage to care and retention in care. Community-based HIV testing and counselling (HTC) is widely used in African countries. However, rates of linkage to care and initiation of antiretroviral therapy (ART) in individuals who tested HIV-positive are often very low. A frequently cited reason for non-linkage to care is the time-consuming pre-ART assessment often requiring several clinic visits before ART-initiation. This two-armed open-label randomized controlled trial compares in individuals tested HIV-positive during community-based HTC the proposition of same-day community-based ART-initiation to the standard of care pre-ART assessment at the clinic. Home-based HTC campaigns will be conducted in catchment areas of six clinics in rural Lesotho. Households where at least one individual tested HIV positive will be randomized. In the standard of care group individuals receive post-test counselling and referral to the nearest clinic for pre-ART assessment and counselling. Once they have started ART the follow-up schedule foresees monthly clinic visits. Individuals randomized to the intervention group receive on the spot point-of-care pre-ART assessment and adherence counselling with the proposition to start ART that same day. Once they have started ART, follow-up clinic visits will be less frequent. First primary outcome is linkage to care (individual presents at the clinic at least once within 3 months after the HIV test). The second primary outcome is viral suppression 12 months after enrolment in the study. We plan to enrol a minimum of 260 households with 1:1 allocation and parallel assignment into both arms. This trial will show if in individuals tested HIV-positive during community-based HTC campaigns the proposition of same-day ART initiation in the community, combined with less frequent follow-up visits at the clinic could be a pragmatic approach to

  13. Standard test method for measurement of web/roller friction characteristics

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2003-01-01

    1.1 This test method covers the simulation of a roller/web transport tribosystem and the measurement of the static and kinetic coefficient of friction of the web/roller couple when sliding occurs between the two. The objective of this test method is to provide users with web/roller friction information that can be used for process control, design calculations, and for any other function where web/roller friction needs to be known. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  14. Standard Test Method for Abrasive Wear Resistance of Cemented

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2005-01-01

    1.1 This test method covers the determination of abrasive wear resistance of cemented carbides. 1.2 The values stated in inch-pound units are to be regarded as the standard. The SI equivalents of inch-pound units are in parentheses and may be approximate. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  15. Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

    Science.gov (United States)

    Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

    2015-01-01

    Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

  16. Puzzle test: A tool for non-analytical clinical reasoning assessment.

    Science.gov (United States)

    Monajemi, Alireza; Yaghmaei, Minoo

    2016-01-01

    Most contemporary clinical reasoning tests typically assess non-automatic thinking. Therefore, a test is needed to measure automatic reasoning or pattern recognition, which has been largely neglected in clinical reasoning tests. The Puzzle Test (PT) is dedicated to assess automatic clinical reasoning in routine situations. This test has been introduced first in 2009 by Monajemi et al in the Olympiad for Medical Sciences Students.PT is an item format that has gained acceptance in medical education, but no detailed guidelines exist for this test's format, construction and scoring. In this article, a format is described and the steps to prepare and administer valid and reliable PTs are presented. PT examines a specific clinical reasoning task: Pattern recognition. PT does not replace other clinical reasoning assessment tools. However, it complements them in strategies for assessing comprehensive clinical reasoning.

  17. Clinical Application Of Serological Tests For Syphilis

    OpenAIRE

    Lawee, David

    1980-01-01

    This article differentiates and describes the serological tests for syphilis— antitreponemal antibody tests (TPI, FTA-ABS, TPHA), non-treponemal antigen test (VDRL)—their clinical and serological correlation, the responses to therapy and the biologically false positive syndrome.

  18. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes.

    Science.gov (United States)

    Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary's metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration.

  19. 42 CFR 493.1252 - Standard: Test systems, equipment, instruments, reagents, materials, and supplies.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Test systems, equipment, instruments... SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY... storage of reagents and specimens, accurate and reliable test system operation, and test result reporting...

  20. Clinical investigation of radioallergosorbent test (RAST)

    International Nuclear Information System (INIS)

    Okuda, Minoru; Usami, Atsushi

    1974-01-01

    Relationship of radioallergosorbent test (RAST), intracutaneous reaction, serum IgE determination and RMCD (Rat Mast Cell Degranulation Test) in subjects with tick allergy was compared in order to investigate clinical application for nasal allergy. 1. RAST is suitable for clinical examinations as determination of IgE. Because it is simple in technique, a technical expert can treat many subjects within a short time, and the result can be decleared within 2 days. 2. RAST was high in specificity and was consistent with clinical findings. RAST positive was thought to be allergy by the antigen, but RAST negative could not deny allergy by the antigen. 3. Correlation of some degree was found to exist between RAST and intracutaneous reaction or degree of induced reaction or threshold value of antigen intracutaneous reaction. But degree of intracutaneous reaction and induced reaction and threshold value of intracutaneous reaction could not be determined from the result of RAST. 4. Determination of IgE antibody by RAST was more useful in clinical study than that of IgE or IgE antibody by RMCD. (Oyama, S.)

  1. 78 FR 17875 - Commercial Driver's License Testing and Commercial Learner's Permit Standards

    Science.gov (United States)

    2013-03-25

    ... [Docket No. FMCSA-2007-27659] RIN 2126-AB59 Commercial Driver's License Testing and Commercial Learner's.... The 2011 final rule amended the commercial driver's license (CDL) knowledge and skills testing standards and established new minimum Federal standards for States to issue the commercial learner's permit...

  2. Hydrogen Field Test Standard: Laboratory and Field Performance

    Science.gov (United States)

    Pope, Jodie G.; Wright, John D.

    2015-01-01

    The National Institute of Standards and Technology (NIST) developed a prototype field test standard (FTS) that incorporates three test methods that could be used by state weights and measures inspectors to periodically verify the accuracy of retail hydrogen dispensers, much as gasoline dispensers are tested today. The three field test methods are: 1) gravimetric, 2) Pressure, Volume, Temperature (PVT), and 3) master meter. The FTS was tested in NIST's Transient Flow Facility with helium gas and in the field at a hydrogen dispenser location. All three methods agree within 0.57 % and 1.53 % for all test drafts of helium gas in the laboratory setting and of hydrogen gas in the field, respectively. The time required to perform six test drafts is similar for all three methods, ranging from 6 h for the gravimetric and master meter methods to 8 h for the PVT method. The laboratory tests show that 1) it is critical to wait for thermal equilibrium to achieve density measurements in the FTS that meet the desired uncertainty requirements for the PVT and master meter methods; in general, we found a wait time of 20 minutes introduces errors methods, respectively and 2) buoyancy corrections are important for the lowest uncertainty gravimetric measurements. The field tests show that sensor drift can become a largest component of uncertainty that is not present in the laboratory setting. The scale was calibrated after it was set up at the field location. Checks of the calibration throughout testing showed drift of 0.031 %. Calibration of the master meter and the pressure sensors prior to travel to the field location and upon return showed significant drifts in their calibrations; 0.14 % and up to 1.7 %, respectively. This highlights the need for better sensor selection and/or more robust sensor testing prior to putting into field service. All three test methods are capable of being successfully performed in the field and give equivalent answers if proper sensors without drift are

  3. Standard test method for plutonium assay by plutonium (III) diode array spectrophotometry

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 This test method describes the determination of total plutonium as plutonium(III) in nitrate and chloride solutions. The technique is applicable to solutions of plutonium dioxide powders and pellets (Test Methods C 697), nuclear grade mixed oxides (Test Methods C 698), plutonium metal (Test Methods C 758), and plutonium nitrate solutions (Test Methods C 759). Solid samples are dissolved using the appropriate dissolution techniques described in Practice C 1168. The use of this technique for other plutonium-bearing materials has been reported (1-5), but final determination of applicability must be made by the user. The applicable concentration range for plutonium sample solutions is 10–200 g Pu/L. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropria...

  4. Standard test method for conducting drop-weight test to determine nil-ductility transition temperature of ferritic steels

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2006-01-01

    1.1 This test method covers the determination of the nil-ductility transition (NDT) temperature of ferritic steels, 5/8 in. (15.9 mm) and thicker. 1.2 This test method may be used whenever the inquiry, contract, order, or specification states that the steels are subject to fracture toughness requirements as determined by the drop-weight test. 1.3 The values stated in inch-pound units are to be regarded as the standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  5. Experimental test of the renormalizability consequences of the standard electroweak theory

    International Nuclear Information System (INIS)

    Bardin, D.Yu.

    1984-01-01

    The present status of the one-loop radiative corrections calculations in the standard electroweak theory is discussed. The possibilities of experimental tests of the higher order predictions of the standard theory is analysed in view of recent data, inclu-ing CERN p anti pcolcider data on Msub(W) and Msub(Z) measurement. The perspectives of these tests in the near future experiments are discussed

  6. Consistency test of the standard model

    International Nuclear Information System (INIS)

    Pawlowski, M.; Raczka, R.

    1997-01-01

    If the 'Higgs mass' is not the physical mass of a real particle but rather an effective ultraviolet cutoff then a process energy dependence of this cutoff must be admitted. Precision data from at least two energy scale experimental points are necessary to test this hypothesis. The first set of precision data is provided by the Z-boson peak experiments. We argue that the second set can be given by 10-20 GeV e + e - colliders. We pay attention to the special role of tau polarization experiments that can be sensitive to the 'Higgs mass' for a sample of ∼ 10 8 produced tau pairs. We argue that such a study may be regarded as a negative selfconsistency test of the Standard Model and of most of its extensions

  7. Standard Test Method for Testing Polymeric Seal Materials for Geothermal and/or High Temperature Service Under Sealing Stress

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1985-01-01

    1.1 This test method covers the initial evaluation of (screening) polymeric materials for seals under static sealing stress and at elevated temperatures. 1.2 This test method applies to geothermal service only if used in conjunction with Test Method E 1068. 1.3 The test fluid is distilled water. 1.4 The values stated in SI units are to be regarded as the standard. The values in parentheses are for information only. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  8. Standard Guide for Testing Materials for Aerospace Plastic Transparent Enclosures

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2008-01-01

    1.1 This guide is intended to summarize the standard test methods available on individual and composite materials utilized in fabrication of aerospace plastic transparent enclosures. As such, it is intended to specifically include transparent thermoplastics, transparent elastomers, and reinforced plastics, whether thermoplastic or thermosetting. 1.2 This guide is intended as an aid in the search for test methods pertinent to Aerospace Plastic Transparent Enclosures. It should be understood that all methods listed may not apply to all enclosures. 1.3 The standards included refer to the properties or aspects listed in Table 1. The properties or aspects are listed in alphabetical order and the descriptions used are intended to facilitate the search. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limi...

  9. Comparison of anthropometry with photogrammetry based on a standardized clinical photographic technique using a cephalostat and chair.

    Science.gov (United States)

    Han, Kihwan; Kwon, Hyuk Joon; Choi, Tae Hyun; Kim, Jun Hyung; Son, Daegu

    2010-03-01

    The aim of this study was to standardize clinical photogrammetric techniques, and to compare anthropometry with photogrammetry. To standardize clinical photography, we have developed a photographic cephalostat and chair. We investigated the repeatability of the standardized clinical photogrammetric technique. Then, with 40 landmarks, a total of 96 anthropometric measurement items was obtained from 100 Koreans. Ninety six photogrammetric measurements from the same subjects were also obtained from standardized clinical photographs using Adobe Photoshop version 7.0 (Adobe Systems Corporation, San Jose, CA, USA). The photogrammetric and anthropometric measurement data (mm, degree) were then compared. A coefficient was obtained by dividing the anthropometric measurements by the photogrammetric measurements. The repeatability of the standardized photography was statistically significantly high (p=0.463). Among the 96 measurement items, 44 items were reliable; for these items the photogrammetric measurements were not different to the anthropometric measurements. The remaining 52 items must be classified as unreliable. By developing a photographic cephalostat and chair, we have standardized clinical photogrammetric techniques. The reliable set of measurement items can be used as anthropometric measurements. For unreliable measurement items, applying a suitable coefficient to the photogrammetric measurement allows the anthropometric measurement to be obtained indirectly.

  10. Finding a vein or obtaining consent: a qualitative study of hepatitis C testing in GP methadone clinics.

    Science.gov (United States)

    Perry, Mark; Chew-Graham, Carolyn

    2003-10-01

    Informed consent is a professional norm, but the promotion of testing for infectious disease in organized clinics and the introduction of targets for uptake, such as those for human immunodeficiency virus (HIV) testing in antenatal clinics, might impair truly voluntary consent. Hepatitis C virus (HCV) is highly prevalent among intravenous drug users (IDUs) and the 'offer' of a serological test for HCV antibodies is now seen as a national standard within drug misuse services, including GP methadone clinics. We hoped that GPs' descriptions of the context and offer of HCV testing could provide an exploratory study of consent within primary care clinics. The aim of this study was to understand GPs' ethical practice when negotiating consent to HCV testing with IDUs. A qualitative semi-structured interview study of 20 GPs in Greater Manchester was carried out. GPs reported that they or their attached drug workers commonly tested for HCV, and many stressed the need for good teamwork and building relationships with 'stable' IDUs before testing. GPs' views on the beneficence of testing and their practices in obtaining consent were diverse. GPs' discourse highlighted important management problems: (i) the adequacy of preparation of some IDUs for testing; (ii) 'opportunistic' HCV testing; and (iii) GPs' recognition of denial after testing. While GPs offered little explicit ethical reflection, occasionally they remarked on tendencies to control a patient's decision, and a deviant case analysis demonstrates how poor teamwork can be associated with coercion. GPs' descriptions suggest that an effective informed consent process is the norm for HCV testing within GP methadone clinics. Importantly, a minority of GPs alluded to the directive effect of team protocols or other problems in obtaining valid consent. We offer recommendations for managing testing to ensure voluntary choice.

  11. A standardization of the physical tests for external irradiation measuring detectors

    International Nuclear Information System (INIS)

    1977-05-01

    This report is the result of a standardization work, realized within the Radioprotection Services of the A.E.C., of the physical tests for dectors measuring external irradiations. Among the various tests mentionned, calibration and the establishment of the relative spectral response are treated in details. As far as calibration is concerned, the standardization refers to: the reference detector, the reference radiation source, the installation and calibration procedure. As for the relative spectral response the standardization refers to: the reference detector, the radiation sources to be used. High flux detectors and those for pulse electromagnetic radiations are also dealt with [fr

  12. 77 FR 26989 - Commercial Driver's License Testing and Commercial Learner's Permit Standards

    Science.gov (United States)

    2012-05-08

    ... [Docket No. FMCSA-2007-27659] RIN 2126-AB02 Commercial Driver's License Testing and Commercial Learner's... effective on July 8, 2011. That final rule amended the commercial driver's license (CDL) knowledge and skills testing standards and established new minimum Federal standards for States to issue the commercial...

  13. An inspection standard of fuel for the high temperature engineering test reactor

    International Nuclear Information System (INIS)

    Kobayashi, Fumiaki; Shiozawa, Shusaku; Sawa, Kazuhiro; Sato, Sadao; Hayashi, Kimio; Fukuda, Kosaku; Kaneko, Mitsunobu; Sato, Tsutomu.

    1992-06-01

    The High Temperature Engineering Test Reactor (HTTR) uses the fuel comprising coated fuel particles. A general inspection standard for the coated particle fuel, however, has not been established in Japan. Therefore, it has been necessary to prescribe the inspection standard of the fuel for HTTR. Under these circumstances, a fuel inspection standard of HTTR has been established under cooperation of fuel specialists both inside and outside of JAERI on referring to the inspection methods adopted in USA, Germany and Japan for HTGR fuels. Since a large number of coated fuel particle samples is needed to inspect the HTTR fuel, the sampling inspection standard has also been established considering the inspection efficiency. This report presents the inspection and the sampling standards together with an explanation of these standards. These standards will be applied to the HTTR fuel acceptance tests. (author)

  14. Months backward test: A review of its use in clinical studies.

    Science.gov (United States)

    Meagher, James; Leonard, Maeve; Donoghue, Laura; O'Regan, Niamh; Timmons, Suzanne; Exton, Chris; Cullen, Walter; Dunne, Colum; Adamis, Dimitrios; Maclullich, Alasdair J; Meagher, David

    2015-09-22

    To review the use of the Months Backwards Test (MBT) in clinical and research contexts. We conducted a systematic review of reports relating to the MBT based upon a search of PsychINFO and MEDLINE between January 1980 and December 2014. Only reports that specifically described findings pertaining to the MBT were included. Findings were considered in terms of rating procedures, testing performance, psychometric properties, neuropsychological studies and use in clinical populations. We identified 22 data reports. The MBT is administered and rated in a variety of ways with very little consistency across studies. It has been used to assess various cognitive functions including focused and sustained attention as well as central processing speed. Performance can be assessed in terms of the ability to accurately complete the test without errors ("MB accuracy"), and time taken to complete the test ("MB duration"). Completion time in cognitively intact subjects is usually upper limits of 60-90 s typically applied in studies. The majority of cognitively intact adults can complete the test without error such that any errors of omission are strongly suggestive of cognitive dysfunction. Coverage of clinical populations, including those with significant cognitive difficulties is high with the majority of subjects able to engage with MBT procedures. Performance correlates highly with other cognitive tests, especially of attention, including the digit span backwards, trailmaking test B, serial threes and sevens, tests of simple and complex choice reaction time, delayed story recall and standardized list learning measures. Test-retest and inter-rater reliability are high (both > 0.90). Functional magnetic resonance imaging studies comparing the months forward test and MBT indicate greater involvement of more complex networks (bilateral middle and inferior frontal gyri, the posterior parietal cortex and the left anterior cingulate gyrus) for backwards cognitive processing. The MBT

  15. NedWind 25 Blade Testing at NREL for the European Standards Measurement and Testing Program

    Energy Technology Data Exchange (ETDEWEB)

    Larwood, S.; Musial, W.; Freebury, G.; Beattie, A.G.

    2001-04-19

    In the mid-90s the European community initiated the Standards, Measurements, and Testing (SMT) program to harmonize testing and measurement procedures in several industries. Within the program, a project was carried out called the European Wind Turbine Testing Procedure Development. The second part of that project, called Blade Test Methods and Techniques, included the United States and was devised to help blade-testing laboratories harmonize their testing methods. This report provides the results of those tests conducted by the National Renewable Energy Laboratory.

  16. Clinical applications of preimplantation genetic testing.

    Science.gov (United States)

    Brezina, Paul R; Kutteh, William H

    2015-02-19

    Genetic diagnostic technologies are rapidly changing the way medicine is practiced. Preimplantation genetic testing is a well established application of genetic testing within the context of in vitro fertilization cycles. It involves obtaining a cell(s) from a developing embryo in culture, which is then subjected to genetic diagnostic analysis; the resulting information is used to guide which embryos are transferred into the uterus. The potential applications and use of this technology have increased in recent years. Experts agree that preimplantation genetic diagnosis is clinically appropriate for many known genetic disorders. However, some applications of such testing, such as preimplantation genetic screening for aneuploidy, remain controversial. Clinical data suggest that preimplantation genetic screening may be useful, but further studies are needed to quantify the size of the effect and who would benefit most. © BMJ Publishing Group Ltd 2015.

  17. Providing support to nursing students in the clinical environment: a nursing standard requirement.

    Science.gov (United States)

    Anderson, Carina; Moxham, Lorna; Broadbent, Marc

    2016-10-01

    This discussion paper poses the question 'What enables or deters Registered Nurses to take up their professional responsibility to support undergraduate nursing students through the provision of clinical education?'. Embedded within many nursing standards are expectations that Registered Nurses provide support and professional development to undergraduate nursing students undertaking clinical placements. Expectations within nursing standards that Registered Nurses provide support and professional development to nursing students are important because nursing students depend on Registered Nurses to help them to become competent practitioners. Contributing factors that enable and deter Registered Nurses from fulfilling this expectation to support nursing students in their clinical learning include; workloads, preparedness for the teaching role, confidence in teaching and awareness of the competency requirement to support students. Factors exist which can enable or deter Registered Nurses from carrying out the licence requirement to provide clinical education and support to nursing students.

  18. [Standardization of terminology in laboratory medicine I].

    Science.gov (United States)

    Yoon, Soo Young; Yoon, Jong Hyun; Min, Won Ki; Lim, Hwan Sub; Song, Junghan; Chae, Seok Lae; Lee, Chang Kyu; Kwon, Jung Ah; Lee, Kap No

    2007-04-01

    Standardization of medical terminology is essential for data transmission between health-care institutions or clinical laboratories and for maximizing the benefits of information technology. Purpose of our study was to standardize the medical terms used in the clinical laboratory, such as test names, units, terms used in result descriptions, etc. During the first year of the study, we developed a standard database of concept names for laboratory terms, which covered the terms used in government health care centers, their branch offices, and primary health care units. Laboratory terms were collected from the electronic data interchange (EDI) codes from National Health Insurance Corporation (NHIC), Logical Observation Identifier Names and Codes (LOINC) database, community health centers and their branch offices, and clinical laboratories of representative university medical centers. For standard expression, we referred to the English-Korean/ Korean-English medical dictionary of Korean Medical Association and the rules for foreign language translation. Programs for mapping between LOINC DB and EDI code and for translating English to Korean were developed. A Korean standard laboratory terminology database containing six axial concept names such as components, property, time aspect, system (specimen), scale type, and method type was established for 7,508 test observations. Short names and a mapping table for EDI codes and Unified Medical Language System (UMLS) were added. Synonym tables for concept names, words used in the database, and six axial terms were prepared to make it easier to find the standard terminology with common terms used in the field of laboratory medicine. Here we report for the first time a Korean standard laboratory terminology database for test names, result description terms, result units covering most laboratory tests in primary healthcare centers.

  19. Standard test method for calibration of surface/stress measuring devices

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1997-01-01

    Return to Contents page 1.1 This test method covers calibration or verification of calibration, or both, of surface-stress measuring devices used to measure stress in annealed and heat-strengthened or tempered glass using polariscopic or refractometry based principles. 1.2 This test method is nondestructive. 1.3 This test method uses transmitted light, and therefore, is applicable to light-transmitting glasses. 1.4 This test method is not applicable to chemically tempered glass. 1.5 Using the procedure described, surface stresses can be measured only on the “tin” side of float glass. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  20. Test-retest reliability of the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale.

    Science.gov (United States)

    Gustafsson, Margareta; Blomberg, Karin; Holmefur, Marie

    2015-07-01

    The Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) scale evaluates the student nurses' perception of the learning environment and supervision within the clinical placement. It has never been tested in a replication study. The aim of the present study was to evaluate the test-retest reliability of the CLES + T scale. The CLES + T scale was administered twice to a group of 42 student nurses, with a one-week interval. Test-retest reliability was determined by calculations of Intraclass Correlation Coefficients (ICCs) and weighted Kappa coefficients. Standard Error of Measurements (SEM) and Smallest Detectable Difference (SDD) determined the precision of individual scores. Bland-Altman plots were created for analyses of systematic differences between the test occasions. The results of the study showed that the stability over time was good to excellent (ICC 0.88-0.96) in the sub-dimensions "Supervisory relationship", "Pedagogical atmosphere on the ward" and "Role of the nurse teacher". Measurements of "Premises of nursing on the ward" and "Leadership style of the manager" had lower but still acceptable stability (ICC 0.70-0.75). No systematic differences occurred between the test occasions. This study supports the usefulness of the CLES + T scale as a reliable measure of the student nurses' perception of the learning environment within the clinical placement at a hospital. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. Baseline Assessment of 25-Hydroxyvitamin D Reference Material and Proficiency Testing/External Quality Assurance Material Commutability: A Vitamin D Standardization Program Study.

    Science.gov (United States)

    Phinney, Karen W; Sempos, Christopher T; Tai, Susan S-C; Camara, Johanna E; Wise, Stephen A; Eckfeldt, John H; Hoofnagle, Andrew N; Carter, Graham D; Jones, Julia; Myers, Gary L; Durazo-Arvizu, Ramon; Miller, W Greg; Bachmann, Lorin M; Young, Ian S; Pettit, Juanita; Caldwell, Grahame; Liu, Andrew; Brooks, Stephen P J; Sarafin, Kurtis; Thamm, Michael; Mensink, Gert B M; Busch, Markus; Rabenberg, Martina; Cashman, Kevin D; Kiely, Mairead; Galvin, Karen; Zhang, Joy Y; Kinsella, Michael; Oh, Kyungwon; Lee, Sun-Wha; Jung, Chae L; Cox, Lorna; Goldberg, Gail; Guberg, Kate; Meadows, Sarah; Prentice, Ann; Tian, Lu; Brannon, Patsy M; Lucas, Robyn M; Crump, Peter M; Cavalier, Etienne; Merkel, Joyce; Betz, Joseph M

    2017-09-01

    The Vitamin D Standardization Program (VDSP) coordinated a study in 2012 to assess the commutability of reference materials and proficiency testing/external quality assurance materials for total 25-hydroxyvitamin D [25(OH)D] in human serum, the primary indicator of vitamin D status. A set of 50 single-donor serum samples as well as 17 reference and proficiency testing/external quality assessment materials were analyzed by participating laboratories that used either immunoassay or LC-MS methods for total 25(OH)D. The commutability test materials included National Institute of Standards and Technology Standard Reference Material 972a Vitamin D Metabolites in Human Serum as well as materials from the College of American Pathologists and the Vitamin D External Quality Assessment Scheme. Study protocols and data analysis procedures were in accordance with Clinical and Laboratory Standards Institute guidelines. The majority of the test materials were found to be commutable with the methods used in this commutability study. These results provide guidance for laboratories needing to choose appropriate reference materials and select proficiency or external quality assessment programs and will serve as a foundation for additional VDSP studies.

  2. [The challenges of standardization in clinical diagnostic laboratories of medical organizations].

    Science.gov (United States)

    Men'shikov, V V

    2013-04-01

    The generalized data concerning the conditions of application of regulations of national standards in clinical diagnostic laboratories of medical organizations is presented. The primary information was provided by 14 regions of 6 federal administrative okrugs of Russia. The causes of challenges of application of requirements of standards are presented. They are mostly related with insufficient financial support, lacking of manpower, difficulties with reagents supply, inadequate technical maintenance of devices and absence of support of administration of medical organizations. The recommendations are formulated concerning the necessity of publishing the document of Minzdrav of Russia to determine the need in application of standards in laboratory practice.

  3. [Implementation of quality standard UNE-EN ISO/IEC 17043 in the External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].

    Science.gov (United States)

    Poveda Gabaldón, Marta; Ovies, María Rosario; Orta Mira, Nieves; Serrano, M del Remedio Guna; Avila, Javier; Giménez, Alicia; Cardona, Concepción Gimeno

    2011-12-01

    The quality standard "UNE-EN-ISO 17043: 2010. Conformity assessment. General requirements for proficiency testing" applies to centers that organize intercomparisons in all areas. In the case of clinical microbiology laboratories, these intercomparisons must meet the management and technical standards required to achieve maximum quality in the performance of microbiological analysis and the preparation of test items (sample, product, data or other information used in the proficiency test) to enable them to be accredited. Once accredited, these laboratories can operate as a tool for quality control laboratories and competency assessment. In Spain, accreditation is granted by the Spanish Accreditation Body [Entidad Nacional de Acreditación (ENAC)]. The objective of this review is to explain how to apply the requirements of the standard to laboratories providing intercomparisons in the field of clinical microbiology (the organization responsible for all the tasks related to the development and operation of a proficiency testing program). This requires defining the scope and specifying the technical requirements (personnel management, control of equipment, facilities and environment, the design of the proficiency testing and data analysis for performance evaluation, communication with participants and confidentiality) and management requirements (document control, purchasing control, monitoring of complaints / claims, non-compliance, internal audits and management reviews). Copyright © 2011 Elsevier España S.L. All rights reserved.

  4. Testing Pneumonia Vaccines in the Elderly: Determining a Case Definition for Pneumococcal Pneumonia in the Absence of a Gold Standard.

    Science.gov (United States)

    Jokinen, Jukka; Snellman, Marja; Palmu, Arto A; Saukkoriipi, Annika; Verlant, Vincent; Pascal, Thierry; Devaster, Jeanne-Marie; Hausdorff, William P; Kilpi, Terhi M

    2017-12-15

    Clinical assessments of vaccines to prevent pneumococcal (Pnc) community-acquired pneumonia (CAP) require sensitive and specific case definitions, but there is no gold standard diagnostic test. To develop a new case definition suitable for vaccine efficacy studies, we applied latent class analysis (LCA) to the results from seven diagnostic tests for Pnc etiology on clinical specimens from 323 elderly radiologically-confirmed pneumonia cases enrolled in The Finnish Community-Acquired Pneumonia Epidemiology study during 2005-2007. Compared to the conventional use of LCA, which is mainly to determine sensitivities and specificities of different tests, we instead used LCA as an appropriate instrument to predict the probability of Pnc etiology for each CAP case based on their test profiles, and utilized the predictions to minimize the sample size that would be needed for a vaccine efficacy trial. When compared to the conventional laboratory criteria of encapsulated Pnc in blood culture or in high-quality sputum culture or urine antigen positivity, our optimized case definition for PncCAP resulted in a trial sample size which was almost 20,000 subjects smaller. We believe that our novel application of LCA detailed here to determine a case definition for PncCAP could also be similarly applied to other diseases without a gold standard. © The Author(s) 2017. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health.

  5. Similar tests and the standardized log likelihood ratio statistic

    DEFF Research Database (Denmark)

    Jensen, Jens Ledet

    1986-01-01

    When testing an affine hypothesis in an exponential family the 'ideal' procedure is to calculate the exact similar test, or an approximation to this, based on the conditional distribution given the minimal sufficient statistic under the null hypothesis. By contrast to this there is a 'primitive......' approach in which the marginal distribution of a test statistic considered and any nuisance parameter appearing in the test statistic is replaced by an estimate. We show here that when using standardized likelihood ratio statistics the 'primitive' procedure is in fact an 'ideal' procedure to order O(n -3...

  6. Standard Test Method for Gel Time of Carbon Fiber-Epoxy Prepreg

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1999-01-01

    1.1 This test method covers the determination of gel time of carbon fiber-epoxy tape and sheet. The test method is suitable for the measurement of gel time of resin systems having either high or low viscosity. 1.2 The values stated in SI units are to be regarded as standard. The values in parentheses are for reference only. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  7. Pilot test of ANSI draft standard N13.29 environmental dosimetry -- Performance criteria for testing

    International Nuclear Information System (INIS)

    Klemic, G.; Shebell, P.; Monetti, M.; Raccah, F.; Sengupta, S.

    1998-09-01

    American National Standards Institute Draft N13.29 describes performance tests for environmental radiation dosimetry providers. If approved it would be the first step toward applying the types of performance testing now required in personnel dosimetry to environmental radiation monitoring. The objective of this study was to pilot test the draft standard, before it undergoes final balloting, on a small group of dosimetry providers that were selected to provide a mix of facility types, thermoluminescent dosimeter designs and monitoring program applications. The first phase of the pilot test involved exposing dosimeters to laboratory photon, beta, and x-ray sources at routine and accident dose levels. In the second phase, dosimeters were subjected to ninety days of simulated environmental conditions in an environmental chamber that cycled through extremes of temperature and humidity. Two out of seven participants passed all categories of the laboratory testing phase, and all seven passed the environmental test phase. While some relatively minor deficiencies were uncovered in the course of the pilot test, the results show that draft N13.29 describes useful tests that could be appropriate for environmental dosimetry providers. An appendix to this report contains recommendations that should be addressed by the N13.29 working group before draft N13.29 is submitted for balloting

  8. Standardized Testing Practices: Effect on Graduation and NCLEX® Pass Rates.

    Science.gov (United States)

    Randolph, Pamela K

    The use standardized testing in pre-licensure nursing programs has been accompanied by conflicting reports of effective practices. The purpose of this project was to describe standardized testing practices in one states' nursing programs and discover if the use of a cut score or oversight of remediation had any effect on (a) first time NCLEX® pass rates, (b) on-time graduation (OTG) or (c) the combination of (a) and (b). Administrators of 38 nursing programs in one Southwest state were sent surveys; surveys were returned by 34 programs (89%). Survey responses were compared to each program's NCLEX pass rate and on-time graduation rate; t-tests were conducted for significant differences associated with a required minimum score (cut score) and oversight of remediation. There were no significant differences in NCLEX pass or on-time graduation rates related to establishment of a cut score. There was a significant difference when the NCLEX pass rate and on-time graduation rate were combined (Outcome Index "OI") with significantly higher program outcomes (P=.02.) for programs without cut-scores. There were no differences associated with faculty oversight of remediation. The results of this study do not support establishment of a cut-score when implementing a standardized testing. Copyright © 2016. Published by Elsevier Inc.

  9. Group study of an "undercover" test for visuospatial neglect: invisible cancellation can reveal more neglect than standard cancellation.

    Science.gov (United States)

    Wojciulik, E; Rorden, C; Clarke, K; Husain, M; Driver, J

    2004-09-01

    Visual neglect is a relatively common deficit after brain damage, particularly strokes. Cancellation tests provide standard clinical measures of neglect severity and deficits in daily life. A recent single-case study introduced a new variation on standard cancellation. Instead of making a visible mark on each target found, the patient made invisible marks (recorded with carbon paper underneath, for later scoring). Such invisible cancellation was found to reveal more neglect than cancellation with visible marks. Here we test the generality of this. Twenty three successive cases with suspected neglect each performed cancellation with visible or invisible marks. Neglect of contralesional targets was more pronounced with invisible marks. Indeed, about half of the patients only showed neglect in this version. For cases showing more neglect with invisible marks, stronger neglect of contralesional targets correlated with more revisits to ipsilesional targets for making additional invisible marks upon them. These results indicate that cancellation with invisible marks can reveal more neglect than standard cancellation with visible marks, while still providing a practical bedside test. Our observations may be consistent with recent proposals that demands on spatial working memory (required to keep track of previously found items only when marked invisibly) can exacerbate spatial neglect.

  10. 78 FR 34423 - Aviation Rulemaking Advisory Committee (ARAC) Airman Testing Standards and Training Working Group...

    Science.gov (United States)

    2013-06-07

    ... the relevance, reliability, validity, and effectiveness of the FAA's aeronautical testing and training... Rulemaking Advisory Committee (ARAC) Airman Testing Standards and Training Working Group (ATSTWG) AGENCY... Certification Standards (ACS) documents developed by the Airman Testing Standards and Training WG for the...

  11. Standard test method for measuring waste glass or glass ceramic durability by vapor hydration test

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 The vapor hydration test method can be used to study the corrosion of a waste forms such as glasses and glass ceramics upon exposure to water vapor at elevated temperatures. In addition, the alteration phases that form can be used as indicators of those phases that may form under repository conditions. These tests; which allow altering of glass at high surface area to solution volume ratio; provide useful information regarding the alteration phases that are formed, the disposition of radioactive and hazardous components, and the alteration kinetics under the specific test conditions. This information may be used in performance assessment (McGrail et al, 2002 (1) for example). 1.2 This test method must be performed in accordance with all quality assurance requirements for acceptance of the data. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practice...

  12. Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

    Science.gov (United States)

    Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

    2013-01-01

    Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

  13. Validity of clinical outcome measures to evaluate ankle range of motion during the weight-bearing lunge test.

    Science.gov (United States)

    Hall, Emily A; Docherty, Carrie L

    2017-07-01

    To determine the concurrent validity of standard clinical outcome measures compared to laboratory outcome measure while performing the weight-bearing lunge test (WBLT). Cross-sectional study. Fifty participants performed the WBLT to determine dorsiflexion ROM using four different measurement techniques: dorsiflexion angle with digital inclinometer at 15cm distal to the tibial tuberosity (°), dorsiflexion angle with inclinometer at tibial tuberosity (°), maximum lunge distance (cm), and dorsiflexion angle using a 2D motion capture system (°). Outcome measures were recorded concurrently during each trial. To establish concurrent validity, Pearson product-moment correlation coefficients (r) were conducted, comparing each dependent variable to the 2D motion capture analysis (identified as the reference standard). A higher correlation indicates strong concurrent validity. There was a high correlation between each measurement technique and the reference standard. Specifically the correlation between the inclinometer placement at 15cm below the tibial tuberosity (44.9°±5.5°) and the motion capture angle (27.0°±6.0°) was r=0.76 (p=0.001), between the inclinometer placement at the tibial tuberosity angle (39.0°±4.6°) and the motion capture angle was r=0.71 (p=0.001), and between the distance from the wall clinical measure (10.3±3.0cm) to the motion capture angle was r=0.74 (p=0.001). This study determined that the clinical measures used during the WBLT have a high correlation with the reference standard for assessing dorsiflexion range of motion. Therefore, obtaining maximum lunge distance and inclinometer angles are both valid assessments during the weight-bearing lunge test. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  14. Sensitivity and Specificity of Clinical and Laboratory Otolith Function Tests.

    Science.gov (United States)

    Kumar, Lokesh; Thakar, Alok; Thakur, Bhaskar; Sikka, Kapil

    2017-10-01

    To evaluate clinic based and laboratory tests of otolith function for their sensitivity and specificity in demarcating unilateral compensated complete vestibular deficit from normal. Prospective cross-sectional study. Tertiary care hospital vestibular physiology laboratory. Control group-30 healthy adults, 20-45 years age; Case group-15 subjects post vestibular shwannoma excision or post-labyrinthectomy with compensated unilateral complete audio-vestibular loss. Otolith function evaluation by precise clinical testing (head tilt test-HTT; subjective visual vertical-SVV) and laboratory testing (headroll-eye counterroll-HR-ECR; vesibular evoked myogenic potentials-cVEMP). Sensitivity and specificity of clinical and laboratory tests in differentiating case and control subjects. Measurable test results were universally obtained with clinical otolith tests (SVV; HTT) but not with laboratory tests. The HR-ECR test did not indicate any definitive wave forms in 10% controls and 26% cases. cVEMP responses were absent in 10% controls.HTT test with normative cutoff at 2 degrees deviations from vertical noted as 93.33% sensitive and 100% specific. SVV test with normative cutoff at 1.3 degrees noted as 100% sensitive and 100% specific. Laboratory tests demonstrated poorer specificities owing primarily to significant unresponsiveness in normal controls. Clinical otolith function tests, if conducted with precision, demonstrate greater ability than laboratory testing in discriminating normal controls from cases with unilateral complete compensated vestibular dysfunction.

  15. The Performance of Standardized Patients in Portraying Clinical Scenarios in Speech-Language Therapy

    Science.gov (United States)

    Hill, Anne E.; Davidson, Bronwyn J.; Theodoros, Deborah G.

    2013-01-01

    Background: Standardized patients (SPs) are frequently included in the clinical preparation of students in the health sciences. An acknowledged benefit of using SPs is the opportunity to provide a standardized method by which students can demonstrate and develop their competency. Relatively little is known, however, about the capacity of SPs to…

  16. Analysis of standard problem six (Semiscale test S-02-6) data

    International Nuclear Information System (INIS)

    Cartmill, C.E.

    1977-08-01

    Test S-02-6 of the Semiscale Mod-1 blowdown heat transfer test series was conducted to supply data for the U.S. Nuclear Regulatory Commission Standard Problem Six. To determine the credibility of the data and thus establish the validity of Standard Problem Six, an analysis of the results of Test S-02-6 was performed and is presented. This analysis consisted of investigations of system hydraulic and core thermal data. The credibility of the system hydraulic data was investigated through comparisons of the data with data and calculations from related sources (Test S-02-4) and, when necessary, through assessment of physical events. The credibility of the core thermal data was based on a thorough analysis of physical events. The results of these investigations substantiate the validity of Test S-02-6 data

  17. The use of the standard exercise test to establish the clinical significance of mild echocardiographic changes in a Thoroughbred poor performer : clinical communication

    Directory of Open Access Journals (Sweden)

    C. Meyer

    2004-06-01

    Full Text Available A 4-year-old Thoroughbred gelding racehorse was referred to the Onderstepoort Veterinary Academic Hospital (OVAH with a history of post-race distress and collapse. In the absence of any obvious abnormalities in the preceding diagnostic work-up, a standard exercise test was performed to determine an underlying cause for the post-race distress reported. In this particular case oxygen desaturation became evident at speeds as slow as 6 m/s, where PO2 was measured at 82.3 mm Hg. Similarly at a blood pH of 7.28, PCO2 had dropped to 30.0mm Hg indicating a combined metabolic acidosis and respiratory alkalosis. The cause of the distress was attributed to a severe hypoxia, with an associated hypocapnoea, confirmed on blood gas analyses, where PO2 levels obtained were as low as 56.6 mm Hg with a mean PCO2 level of 25.4 mm Hg during strenuous exercise. Arterial oxygenation returned to normal immediately after cessation of exercise to 106.44 mm Hg, while the hypocapnoeic alkalosis, PCO2 25.67 mm Hg, persisted until the animal's breathing normalized. The results obtained were indicative of a dynamic cardiac insufficiency present during exercise. The combination of an aortic stenosis and a mitral valve insufficiency may have resulted in a condition similar to that described as high-altitude pulmonary oedema, with respiratory changes and compensation as for acute altitude disease. The results obtained were indicative of a dynamic cardiac insufficiency present during exercise and substantiate the fact that an extensive diagnostic regime may be required to establish a cause for poor performance and that the standard exercise test remains an integral part of this work-up.

  18. Criterion and convergent validity of the Montreal cognitive assessment with screening and standardized neuropsychological testing.

    Science.gov (United States)

    Lam, Benjamin; Middleton, Laura E; Masellis, Mario; Stuss, Donald T; Harry, Robin D; Kiss, Alex; Black, Sandra E

    2013-12-01

    To compare the validity of the Montreal Cognitive Assessment (MoCA) with the criterion standard of standardized neuropsychological testing and to compare the convergent validity of the MoCA with that of existing screening tools and global measures of cognition. Cross-sectional observational study. Tertiary care hospital-based cognitive neurology subspecialty clinic. A convenience sample of 107 individuals with mild Alzheimer's disease (AD, n=75) or mild cognitive impairment (MCI, n=32) from the Sunnybrook Dementia Study. In addition to the MoCA, all participants completed the Mini-Mental State Examination (MMSE), the Mattis Dementia Rating Scale (DRS), and detailed neuropsychological testing. Convergent validity was supported, with MoCA scores correlating well with the MMSE (correlation coefficient (r)=0.66, Pvalidity was supported, with MoCA subscores according to cognitive domain correlating well with analogous neuropsychological tests and, in the case of memory (area under the receiver operating characteristic curve (AUC)=0.86), executive (AUC=0.79), and visuospatial function (AUC=0.79), being reasonably sensitive to impairment in those domains. The MoCA is a valid assessment of cognition that shows good agreement with existing screening tools and global measures (convergent validity) and was superior to the MMSE in this regard. The MoCA domain-specific subscores align with performance on more-detailed neuropsychological tests, suggesting not only good criterion validity for the MoCA, but also that it may be useful in guiding further neuropsychological testing. © 2013, Copyright the Authors Journal compilation © 2013, The American Geriatrics Society.

  19. The Vise/Vice of Standardized Testing: National Depreciation by Quantification.

    Science.gov (United States)

    Farrell, Edmund J.

    Current uses of standardized English tests are adversely affecting students, misleading lay people, and having a pernicious effect on the English profession. These tests are severely limited, incapable of assessing speaking skill and effectiveness, reading interests, appreciation of literature, listening skill, understanding and appreciation of…

  20. Ultrasonic transverse velocity calibration of standard blocks for use in non-destructive testing

    International Nuclear Information System (INIS)

    Silva, C E R; Braz, D S; Maggi, L E; Felix, R P B Costa

    2015-01-01

    Standard blocks are employed in the verification of the equipment used in Ultrasound Non-Destructive Testing. To assure the metrology reliability of all the measurement process, it is necessary to calibrate or certify these Standard blocks. In this work, the transverse wave velocity and main dimensions were assessed according to the specifications ISO Standards. For transverse wave velocity measurement, a 5 MHz transverse wave transducer, a waveform generator, an oscilloscope and a computer with a program developed in LabVIEW TM were used. Concerning the transverse wave velocity calibration, only two Standard blocks of the 4 tested is in accordance with the standard

  1. Multicultural Standardization and Validation of TEMAS, a Thematic Apperception Test.

    Science.gov (United States)

    Costantino, Giuseppe; Malgady, Robert G.

    Mental health clinical services research has emphasized the urgency of developing new psychometric instruments for non-biased psychological assessment of minority and non-minority children of diverse cultural groups in the United States. Background multicultural standardization and validation information is presented for Tell-Me-A-Story (TEMAS)--a…

  2. SPORT AND EXERCISE PHYSIOLOGY TESTING Volume one: Sport Testing Volume two: Exercise and Clinical Testing

    Directory of Open Access Journals (Sweden)

    Edward M. Winter

    2007-03-01

    Full Text Available DESCRIPTION The objective of the book is to discuss the theoretical and practical aspects of physiological testing in exercise and sports which is essential to evaluate and monitor developing exercise performance for athletes and public health, and improving quality of life for patients.A board of leading sport and exercise physiologists and scientists are gathered to discuss physiological assessments that have proven validity and reliability, both in sport and health relevant issues. Incidentally, it updates the reader about the current subjects of physiological exertion testing in both research and clinical procedures. Both volumes individually cover the increasing number of available research and review publications, and theoretical explanations are supported by practical examples. A step-by-step and/or checklist method is used in appropriate sections which make the guides more user-friendly than most. PURPOSE The first volume is designed to help readers develop an understanding of the essential concepts of sport specific testing whereas the second volume aims at making the exercise and clinical specific testing comprehensible, dealing with both technical terms and the theories underlying the importance of these tests. AUDIENCE As Guidelines books of the British Association of Sport and Exercise Sciences, it will be of interest to a wide range of students, researchers and practitioners in the sport and exercise disciplines whether they work in the laboratory or in the field. FEATURES The first volume features immediate practical requirements particularly in sport testing. It is composed of five parts with detailed sub-sections in all of them. The topics of the parts are: i general principles, ii methodological issues, iii general procedures, iv sport specific procedures, v special populations.The second volume is also presented in five parts, again with sub-sections in all of them, but considering the requirements in clinical and exercise

  3. Do School-Based Tutoring Programs Significantly Improve Student Performance on Standardized Tests?

    Science.gov (United States)

    Rothman, Terri; Henderson, Mary

    2011-01-01

    This study used a pre-post, nonequivalent control group design to examine the impact of an in-district, after-school tutoring program on eighth grade students' standardized test scores in language arts and mathematics. Students who had scored in the near-passing range on either the language arts or mathematics aspect of a standardized test at the…

  4. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop.

    Science.gov (United States)

    Jabs, Douglas A; Nussenblatt, Robert B; Rosenbaum, James T

    2005-09-01

    To begin a process of standardizing the methods for reporting clinical data in the field of uveitis. Consensus workshop. Members of an international working group were surveyed about diagnostic terminology, inflammation grading schema, and outcome measures, and the results used to develop a series of proposals to better standardize the use of these entities. Small groups employed nominal group techniques to achieve consensus on several of these issues. The group affirmed that an anatomic classification of uveitis should be used as a framework for subsequent work on diagnostic criteria for specific uveitic syndromes, and that the classification of uveitis entities should be on the basis of the location of the inflammation and not on the presence of structural complications. Issues regarding the use of the terms "intermediate uveitis," "pars planitis," "panuveitis," and descriptors of the onset and course of the uveitis were addressed. The following were adopted: standardized grading schema for anterior chamber cells, anterior chamber flare, and for vitreous haze; standardized methods of recording structural complications of uveitis; standardized definitions of outcomes, including "inactive" inflammation, "improvement'; and "worsening" of the inflammation, and "corticosteroid sparing," and standardized guidelines for reporting visual acuity outcomes. A process of standardizing the approach to reporting clinical data in uveitis research has begun, and several terms have been standardized.

  5. Furosemide/Fludrocortisone Test and Clinical Parameters to Diagnose Incomplete Distal Renal Tubular Acidosis in Kidney Stone Formers.

    Science.gov (United States)

    Dhayat, Nasser A; Gradwell, Michael W; Pathare, Ganesh; Anderegg, Manuel; Schneider, Lisa; Luethi, David; Mattmann, Cedric; Moe, Orson W; Vogt, Bruno; Fuster, Daniel G

    2017-09-07

    Incomplete distal renal tubular acidosis is a well known cause of calcareous nephrolithiasis but the prevalence is unknown, mostly due to lack of accepted diagnostic tests and criteria. The ammonium chloride test is considered as gold standard for the diagnosis of incomplete distal renal tubular acidosis, but the furosemide/fludrocortisone test was recently proposed as an alternative. Because of the lack of rigorous comparative studies, the validity of the furosemide/fludrocortisone test in stone formers remains unknown. In addition, the performance of conventional, nonprovocative parameters in predicting incomplete distal renal tubular acidosis has not been studied. We conducted a prospective study in an unselected cohort of 170 stone formers that underwent sequential ammonium chloride and furosemide/fludrocortisone testing. Using the ammonium chloride test as gold standard, the prevalence of incomplete distal renal tubular acidosis was 8%. Sensitivity and specificity of the furosemide/fludrocortisone test were 77% and 85%, respectively, yielding a positive predictive value of 30% and a negative predictive value of 98%. Testing of several nonprovocative clinical parameters in the prediction of incomplete distal renal tubular acidosis revealed fasting morning urinary pH and plasma potassium as the most discriminative parameters. The combination of a fasting morning urinary threshold pH 3.8 mEq/L yielded a negative predictive value of 98% with a sensitivity of 85% and a specificity of 77% for the diagnosis of incomplete distal renal tubular acidosis. The furosemide/fludrocortisone test can be used for incomplete distal renal tubular acidosis screening in stone formers, but an abnormal furosemide/fludrocortisone test result needs confirmation by ammonium chloride testing. Our data furthermore indicate that incomplete distal renal tubular acidosis can reliably be excluded in stone formers by use of nonprovocative clinical parameters. Copyright © 2017 by the American

  6. Fabrication and Testing of Pyramidal X- Band Standard Horn Antenna

    Directory of Open Access Journals (Sweden)

    Hasan F. Khazaal

    2017-11-01

    Full Text Available Standard horn antennas are an important device to evaluate many types of antennas, since they are used as a reference to any type of antennas within the microwave frequency bands. In this project the fabrication process and tests of standard horn antenna operating at X-band frequencies have been proposed. The fabricated antenna passed through multi stages of processing of its parts until assembling the final product. These stages are (milling, bending, fitting and welding. The assembled antenna subjected to two types of tests to evaluate its performance. The first one is the test by two port network analyzer to point out S & Z parameters, input resistance, and the voltage standing wave ratio of the horn, while the second test was done using un-echoic chamber to measure the gain, side lobes level and the half power beam width. The results of testing come nearly as a theoretical value of the most important of antenna parameters, like; gain, side lobe level, -3 dB beam width, return loss and voltage standing wave ratio "VSWR", input Impedance.

  7. Standard Test Method for Normal Spectral Emittance at Elevated Temperatures

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1972-01-01

    1.1 This test method describes a highly accurate technique for measuring the normal spectral emittance of electrically conducting materials or materials with electrically conducting substrates, in the temperature range from 600 to 1400 K, and at wavelengths from 1 to 35 μm. 1.2 The test method requires expensive equipment and rather elaborate precautions, but produces data that are accurate to within a few percent. It is suitable for research laboratories where the highest precision and accuracy are desired, but is not recommended for routine production or acceptance testing. However, because of its high accuracy this test method can be used as a referee method to be applied to production and acceptance testing in cases of dispute. 1.3 The values stated in SI units are to be regarded as the standard. The values in parentheses are for information only. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this stan...

  8. Testing a bedside personal computer Clinical Care Classification System for nursing students using Microsoft Access.

    Science.gov (United States)

    Feeg, Veronica D; Saba, Virginia K; Feeg, Alan N

    2008-01-01

    This study tested a personal computer-based version of the Sabacare Clinical Care Classification System on students' performance of charting patient care plans. The application was designed as an inexpensive alternative to teach electronic charting for use on any laptop or personal computer with Windows and Microsoft Access. The data-based system was tested in a randomized trial with the control group using a type-in text-based-only system also mounted on a laptop at the bedside in the laboratory. Student care plans were more complete using the data-based system over the type-in text version. Students were more positive but not necessarily more efficient with the data-based system. The results demonstrate that the application is effective for improving student nursing care charting using the nursing process and capturing patient care information with a language that is standardized and ready for integration with other patient electronic health record data. It can be implemented on a bedside stand in the clinical laboratory or used to aggregate care planning over a student's clinical experience.

  9. Testing an extrapolation chamber in computed tomography standard beams

    Science.gov (United States)

    Castro, M. C.; Silva, N. F.; Caldas, L. V. E.

    2018-03-01

    The computed tomography (CT) is responsible for the highest dose values to the patients. Therefore, the radiation doses in this procedure must be accurate. However, there is no primary standard system for this kind of radiation beam yet. In order to search for a CT primary standard, an extrapolation ionization chamber built at the Calibration Laboratory (LCI) of the Instituto de Pesquisas Energéticas e Nucleares (IPEN), was tested in this work. The results showed to be within the international recommended limits.

  10. Standard Waste Box Lid Screw Removal Option Testing

    International Nuclear Information System (INIS)

    Anast, Kurt Roy

    2016-01-01

    This report provides results from test work conducted to resolve the removal of screws securing the standard waste box (SWB) lids that hold the remediated nitrate salt (RNS) drums. The test work evaluated equipment and process alternatives for removing the 42 screws that hold the SWB lid in place. The screws were secured with a red Loctite thread locker that makes removal very difficult because the rivets that the screw threads into would slip before the screw could be freed from the rivet, making it impossible to remove the screw and therefore the SWB lid.

  11. Standard Waste Box Lid Screw Removal Option Testing

    Energy Technology Data Exchange (ETDEWEB)

    Anast, Kurt Roy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-03-11

    This report provides results from test work conducted to resolve the removal of screws securing the standard waste box (SWB) lids that hold the remediated nitrate salt (RNS) drums. The test work evaluated equipment and process alternatives for removing the 42 screws that hold the SWB lid in place. The screws were secured with a red Loctite thread locker that makes removal very difficult because the rivets that the screw threads into would slip before the screw could be freed from the rivet, making it impossible to remove the screw and therefore the SWB lid.

  12. The Standard-Model Extension and Gravitational Tests

    Directory of Open Access Journals (Sweden)

    Jay D. Tasson

    2016-10-01

    Full Text Available The Standard-Model Extension (SME provides a comprehensive effective field-theory framework for the study of CPT and Lorentz symmetry. This work reviews the structure and philosophy of the SME and provides some intuitive examples of symmetry violation. The results of recent gravitational tests performed within the SME are summarized including analysis of results from the Laser Interferometer Gravitational-Wave Observatory (LIGO, sensitivities achieved in short-range gravity experiments, constraints from cosmic-ray data, and results achieved by studying planetary ephemerids. Some proposals and ongoing efforts will also be considered including gravimeter tests, tests of the Weak Equivalence Principle, and antimatter experiments. Our review of the above topics is augmented by several original extensions of the relevant work. We present new examples of symmetry violation in the SME and use the cosmic-ray analysis to place first-ever constraints on 81 additional operators.

  13. Interference by pralidoxime (PAM) salts in clinical laboratory tests.

    Science.gov (United States)

    Nagase, Sumika; Kohguchi, Katsunori; Tohyama, Kaoru; Watanabe, Mikio; Iwatani, Yoshinori

    2013-02-01

    Drugs sometimes alter the results of clinical laboratory tests. We examined the effects of pralidoxime (PAM) salts, a medicine used to treat organophosphorus poisoning, on clinical laboratory test results for the first time. The effects of PAM salts on glucose (GLU) measurements were examined using a point-of-care testing (POCT) meter, four self-monitoring of blood glucose (SMBG) meters, and two biochemical autoanalyzers. The effects of PAM salts on other clinical tests were also evaluated. The addition of PAM iodide or potassium iodide, but not of PAM chloride or potassium chloride, to blood samples increased the GLU values measured by one POCT meter and 4 SMBG meters using the enzyme electrode (hydrogen peroxidase or oxygen electrode) method. On the other hand, PAM iodide or PAM chloride, but not KI or KCl, affected the values measured at 340 nm by an autoanalyzer using absorption spectrophotometry in 8 of 14 clinical laboratory tests. The absorption spectrum of PAM changed from 294 to 338 nm due to the reaction between PAM and the alkaline buffer, a component of the measuring reagents. PAM iodide increases the GLU values measured by the enzyme electrode method, and PAM salts affected the values measured at 340 nm by absorption spectrophotometry in many other clinical test items. Copyright © 2012 Elsevier B.V. All rights reserved.

  14. Department of Energy standard for the performance testing of personnel dosimetry systems

    International Nuclear Information System (INIS)

    1986-12-01

    This standard is intended to be used in the Department of Energy Laboratory Accreditation Program (DOELAP) for personnel dosimetry systems. It is based on the American National Standards Institute's (ANSI) ''Criteria for Testing Personnel Dosimetry Performance,'' ANSI N13.11-1983, recommendations made to DOE in ''Guidelines for the Calibration of Personnel Dosimeters,'' Pacific Northwest Laboratory (PNL)-4515 and comments received during peer review by DOE and DOE contractor personnel. The recommendations contained in PNL-4515 were based on an evaluation of ANSI N13.11 conducted for the Office of Nuclear Safety, DOE, by PNL. Parts of ANSI N13.11 that did not require modification were used essentially intact in this standard to maintain consistency with nationally recognized standards. Modifications to this standard have resulted from several DOE/DOE contractor reviews and a pilot testing session. An initial peer review by selected DOE and DOE contractor representatives on technical content was conducted in 1983. A review by DOE field offices, program offices, and contractors was conducted in mid-1984. A pilot performance testing session sponsored by the Office of Nuclear Safety was conducted in early 1985 by the Radiological and Environmental Sciences Laboratory, Idaho Falls. Results of the pilot test were reviewed in late 1985 by a DOE and DOE contractor committee. 11 refs., 4 tabs

  15. 21 CFR 862.1825 - Vitamin D test system.

    Science.gov (United States)

    2010-04-01

    ... clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other... standards of the National Committee on Clinical Laboratory Standards. [63 FR 40366, July 29, 1998] ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...

  16. Preliminary results of testing bioassay analytical performance standards

    International Nuclear Information System (INIS)

    Fisher, D.R.; Robinson, A.V.; Hadley, R.T.

    1983-08-01

    The analytical performance of both in vivo and in vitro bioassay laboratories is being studied to determine the capability of these laboratories to meet the minimum criteria for accuracy and precision specified in the draft ANSI Standard N13.30, Performance Criteria for Radiobioassay. This paper presents preliminary results of the first round of testing

  17. A single standard for in-place testing of DOE HEPA filters - not

    Energy Technology Data Exchange (ETDEWEB)

    Mokler, B.V. [Los Alamos National Laboratory, NM (United States)

    1995-02-01

    This article is a review of arguments against the use of a single standard for in-place testing of DOE HEPA filters. The author feels that the term `standard` entails mandatory compliance. Additionally, the author feels that the variety of DOE HEPA systems requiring in-place testing is such that the guidance for testing must be written in a permissive fashion, allowing options and alternatives. With this in mind, it is not possible to write a single document entailing mandatory compliance for all DOE facilities.

  18. Development of transfer standard devices for ensuring the accurate calibration of ultrasonic physical therapy machines in clinical use

    International Nuclear Information System (INIS)

    Hekkenberg, R T; Richards, A; Beissner, K; Zeqiri, B; Prout, G; Cantrall, Ch; Bezemer, R A; Koch, Ch; Hodnett, M

    2004-01-01

    Physical therapy ultrasound is widely applied to patients. However, many devices do not comply with the relevant standard stating that the actual power output shall be within ±20% of the device indication. Extreme cases have been reported: from delivering effectively no ultrasound or operating at maximum power at all powers indicated. This can potentially lead to patient injury as well as mistreatment. The present European (EC) project is an ongoing attempt to improve the quality of the treatment of patients being treated with ultrasonic physical-therapy. A Portable ultrasound Power Standard (PPS) is being developed and accurately calibrated. The PPS includes: Ultrasound transducers (including one exhibiting an unusual output) and a driver for the ultrasound transducers that has calibration and proficiency test functions. Also included with the PPS is a Cavitation Detector to determine the onset of cavitation occurring within the propagation medium. The PPS will be suitable for conducting in-the-field accreditation (proficiency testing and calibration). In order to be accredited it will be important to be able to show traceability of the calibration, the calibration process and qualification of testing staff. The clinical user will benefit from traceability because treatments will be performed more reliably

  19. Quality standards for sample collection in coagulation testing.

    Science.gov (United States)

    Lippi, Giuseppe; Salvagno, Gian Luca; Montagnana, Martina; Lima-Oliveira, Gabriel; Guidi, Gian Cesare; Favaloro, Emmanuel J

    2012-09-01

    Preanalytical activities, especially those directly connected with blood sample collection and handling, are the most vulnerable steps throughout the testing process. The receipt of unsuitable samples is commonplace in laboratory practice and represents a serious problem, given the reliability of test results can be adversely compromised following analysis of these specimens. The basic criteria for an appropriate and safe venipuncture are nearly identical to those used for collecting blood for clinical chemistry and immunochemistry testing, and entail proper patient identification, use of the correct technique, as well as appropriate devices and needles. There are, however, some peculiar aspects, which are deemed to be particularly critical when collecting quality specimens for clot-based tests, and these require clearer recognition. These include prevention of prolonged venous stasis, collection of nonhemolyzed specimens, order of draw, and appropriate filling and mixing of the primary collection tubes. All of these important preanalytical issues are discussed in this article, and evidence-based suggestions as well as recommendations on how to obtain a high-quality sample for coagulation testing are also illustrated. We have also performed an investigation aimed to identify variation of test results due to underfilling of primary blood tubes, and have identified a clinically significant bias in test results when tubes are drawn at less than 89% of total fill for activated partial thromboplastin time, less than 78% for fibrinogen, and less than 67% for coagulation factor VIII, whereas prothrombin time and activated protein C resistance remain relatively reliable even in tubes drawn at 67% of the nominal volume. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  20. Educators Questioning Timing of State Tests Reflecting Standards

    Science.gov (United States)

    Gewertz, Catherine

    2013-01-01

    New York is ahead of most states in its work to design detailed curricula and professional development for the common core and to build brand-new tests to reflect them. What's unfolding in the Empire State as a result of that work illustrates the way the common standards can pressure changes in the education landscape, and torque the tensions…

  1. Standardization of food allergen extracts for skin prick test

    DEFF Research Database (Denmark)

    Skamstrup Hansen, K; Bindslev-Jensen, C; Skov, P S

    2001-01-01

    The aim of the study was to standardize and evaluate technically optimized food allergen extracts for use in skin prick test (SPT). The standardization procedure comprised 36 allergic histories in 32 food allergic patients with 21 healthy, non-atopic individuals serving as controls. The patients...... had a history of allergic symptoms upon ingestion of either cow's milk (n=3), hen's egg (n=9), wheat (n=4), hazelnut (n=14) or cod (n=6). They also had specific IgE in serum to the food in question and a positive SPT with a fresh preparation of the food. The diagnosis had been confirmed by a double......-blind, placebo-controlled food challenge, except for the hazelnut-allergic patients. The controls were subjected to an open food challenge with all the foods to ensure tolerance. The standardization was performed by means of titrated SPT in accordance with the guidelines on biological standardization from...

  2. Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

    Science.gov (United States)

    Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

    2018-02-23

    Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.

  3. Standard test method for compressive (crushing) strength of fired whiteware materials

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2006-01-01

    1.1 This test method covers two test procedures (A and B) for the determination of the compressive strength of fired whiteware materials. 1.2 Procedure A is generally applicable to whiteware products of low- to moderately high-strength levels (up to 150 000 psi or 1030 MPa). 1.3 Procedure B is specifically devised for testing of high-strength ceramics (over 100 000 psi or 690 MPa). 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  4. A Step Towards Electric Propulsion Testing Standards: Pressure Measurements and Effective Pumping Speeds

    Science.gov (United States)

    Dankanich, John W.; Swiatek, Michael W.; Yim, John T.

    2012-01-01

    The electric propulsion community has been implored to establish and implement a set of universally applicable test standards during the research, development, and qualification of electric propulsion systems. Existing practices are fallible and result in testing variations which leads to suspicious results, large margins in application, or aversion to mission infusion. Performance measurements and life testing under appropriate conditions can be costly and lengthy. Measurement practices must be consistent, accurate, and repeatable. Additionally, the measurements must be universally transportable across facilities throughout the development, qualification, spacecraft integration and on-orbit performance. A preliminary step to progress towards universally applicable testing standards is outlined for facility pressure measurements and effective pumping speed calculations. The standard has been applied to multiple facilities at the NASA Glenn Research Center. Test results and analyses of universality of measurements are presented herein.

  5. Standard Reference Test Method for Making Potentiostatic and Potentiodynamic Anodic Polarization Measurements

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2004-01-01

    1.1 This test method covers an experimental procedure for checking experimental technique and instrumentation. If followed, this test method will provide repeatable potentiostatic and potentiodynamic anodic polarization measurements that will reproduce data determined by others at other times and in other laboratories provided all laboratories are testing reference samples from the same lot of Type 430 stainless steel. 1.2 Values stated in SI units are to be regarded as the standard. Inch-pound units given in parentheses are for information only. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  6. New Standards for the Validation of EMC Test Sites particularly above 1 GHz

    Directory of Open Access Journals (Sweden)

    S. Battermann

    2005-01-01

    Full Text Available Standards for the validation of alternative test sites with conducting groundplane exist for the frequency range 30-1000 MHz since the end of the eighties. Recently the procedure for fully anechoic rooms (FAR has been included in CISPR 16 after more than 10 years intensive discussion in standards committees (CENELEC, 2002; CISPR, 2004. But there are no standards available for the validation of alternative test sites above 1 GHz. The responsible working group (WG1 in CISPR/A has drawn up the 7th common draft (CD. A CDV will be published in spring 2005. The German standards committee VDE AK 767.4.1 participates in the drafting of the standard. All suggested measurement procedures proposed in the last CDs have been investigated by measurements and theoretical analysis. This contribution describes the basic ideas and problems of the validation procedure of the test site. Furthermore measurement results and numerical calculations will be presented especially for the use of omni-directional antennas.

  7. Stress-testing the Standard Model at the LHC

    CERN Document Server

    2016-01-01

    With the high-energy run of the LHC now underway, and clear manifestations of beyond-Standard-Model physics not yet seen in data from the previous run, the search for new physics at the LHC may be a quest for small deviations with big consequences. If clear signals are present, precise predictions and measurements will again be crucial for extracting the maximum information from the data, as in the case of the Higgs boson. Precision will therefore remain a key theme for particle physics research in the coming years. The conference will provide a forum for experimentalists and theorists to identify the challenges and refine the tools for high-precision tests of the Standard Model and searches for signals of new physics at Run II of the LHC. Topics to be discussed include: pinning down Standard Model corrections to key LHC processes; combining fixed-order QCD calculations with all-order resummations and parton showers; new developments in jet physics concerning jet substructure, associated jets and boosted je...

  8. A scheme for the audit of scientific and technological standards in clinical nuclear medicine

    International Nuclear Information System (INIS)

    Perkins, A.C.; Jarritt, P.H.

    2002-01-01

    Aim: Audit is the process whereby the quality of a service is monitored and optimised. It forms an essential component of the quality assurance process, whether by self-assessment or by external peer review. In the UK the British Nuclear Medicine Society (BNMS) has undertaken external organisational audit of departments providing clinical nuclear medicine services. This work aimed to develop a more thorough and service specific process for the audit of scientific and technological standards in nuclear medicine. Materials and Methods: The audit process has been implemented using written audit documents to facilitate the audit procedure. A questionnaire forms part of the formal documentation for audit of the scientific and technical standards of a clinical service. Scientific and technical standards were derived from a number of sources including legal requirements, regulatory obligations, notes for guidance, peer reviewed publications and accepted good clinical practice (GCP). Results: The audit process graded the standards of an individual department according to legal or safety requirements (Grade A), good practice (Grade B) and desirable aspects of service delivery (Grade C). The standards have been allocated into eight main categories. These are: Instrumentation; Software and data protection; Electrical Safety; Mechanical Safety; Workstation Safety; The Control of Substances Hazardous to Health (COSHH); Radiation Protection; Scientific and Technical staffing levels. During the audit visit a detailed inspection of clinical and laboratory areas and department written documentation is also necessary to validate the data obtained. Conclusion: The printed scheme now provides a means for external audit or self-assessment. There should be evidence of a well-organised and safe environment for both patients and staff. Health and Safety legislation requires written local rules and these records should be available to demonstrate the standard of service provision. Other

  9. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial

    Science.gov (United States)

    Parkin, Patricia C; Willan, Andrew R; Schuh, Suzanne

    2011-01-01

    Objective To determine if rapid rather than standard intravenous rehydration results in improved hydration and clinical outcomes when administered to children with gastroenteritis. Design Single centre, two arm, parallel randomised pragmatic controlled trial. Blocked randomisation stratified by site. Participants, caregivers, outcome assessors, investigators, and statisticians were blinded to the treatment assignment. Setting Paediatric emergency department in a tertiary care centre in Toronto, Canada. Participants 226 children aged 3 months to 11 years; complete follow-up was obtained on 223 (99%). Eligible children were aged over 90 days, had a diagnosis of dehydration secondary to gastroenteritis, had not responded to oral rehydration, and had been prescribed intravenous rehydration. Children were excluded if they weighed less than 5 kg or more than 33 kg, required fluid restriction, had a suspected surgical condition, or had an insurmountable language barrier. Children were also excluded if they had a history of a chronic systemic disease, abdominal surgery, bilious or bloody vomit, hypotension, or hypoglycaemia or hyperglycaemia. Interventions Rapid (60 mL/kg) or standard (20 mL/kg) rehydration with 0.9% saline over an hour; subsequent fluids administered according to protocol. Main outcome measures Primary outcome: clinical rehydration, assessed with a validated scale, two hours after the start of treatment. Secondary outcomes: prolonged treatment, mean clinical dehydration scores over the four hour study period, time to discharge, repeat visits to emergency department, adequate oral intake, and physician’s comfort with discharge. Data from all randomised patients were included in an intention to treat analysis. Results 114 patients were randomised to rapid rehydration and 112 to standard. One child was withdrawn because of severe hyponatraemia at baseline. There was no evidence of a difference between the rapid and standard rehydration groups in the

  10. [Changes in clinical standards and the need for adjusting legal standards of care from the point of view of civil law].

    Science.gov (United States)

    Rosenberger, Rainer

    2007-01-01

    The legal standard of medical care is laid down in Sect. 276 of the German Civil Code (principle of due diligence). It applies to both contractual and tortious liability and likewise to the treatment of patients insured under the statutory health insurance scheme and self-payers. The legal standard of care conforms to the clinical standards because medical liability means medical professional liability. Liability law does not distinguish between different standards of care in the treatment of patients insured under the statutory health insurance scheme on the one hand and privately insured patients on the other. Changes in clinical standards immediately affect liability law without the need for formal adaptation of the legal standard of care. Liability law cannot claim more diligence than that owed from a medical point of view. Legislative changes that result in a lowering of medical standards (reduction in the quality of treatment) will have to be accepted by liability law, even if these are regulations pertaining to Social Law (SGB V, Book 5 of the German Social Code). In this respect, the principle of legal unity applies. In consideration of this kind of changes the due diligence requirements for the treatment of patients insured under the statutory health insurance scheme and privately insured patients remain basically equal. If these changes lead to an increase of risk for the patient, the resulting liabilities are not to be attributed to the therapist. What remains to be seen is whether there will be an increased attempt to minimise risk by "additionally purchasing health care services".

  11. Assessing the reliability of the borderline regression method as a standard setting procedure for objective structured clinical examination

    Directory of Open Access Journals (Sweden)

    Sara Mortaz Hejri

    2013-01-01

    Full Text Available Background: One of the methods used for standard setting is the borderline regression method (BRM. This study aims to assess the reliability of BRM when the pass-fail standard in an objective structured clinical examination (OSCE was calculated by averaging the BRM standards obtained for each station separately. Materials and Methods: In nine stations of the OSCE with direct observation the examiners gave each student a checklist score and a global score. Using a linear regression model for each station, we calculated the checklist score cut-off on the regression equation for the global scale cut-off set at 2. The OSCE pass-fail standard was defined as the average of all station′s standard. To determine the reliability, the root mean square error (RMSE was calculated. The R2 coefficient and the inter-grade discrimination were calculated to assess the quality of OSCE. Results: The mean total test score was 60.78. The OSCE pass-fail standard and its RMSE were 47.37 and 0.55, respectively. The R2 coefficients ranged from 0.44 to 0.79. The inter-grade discrimination score varied greatly among stations. Conclusion: The RMSE of the standard was very small indicating that BRM is a reliable method of setting standard for OSCE, which has the advantage of providing data for quality assurance.

  12. Standards for Lithotripter Performance

    Science.gov (United States)

    Schultheiss, Reiner; Doerffel, Michael

    2008-09-01

    Standards for lithotripsy have been developed by the International Electrotechnical Commission (IEC) and the FDA. In addition to the existing regulations and norms for the manufacturers, special standards were developed to address a treatment method developed in the early 1980's using extracorporeal shock waves. Initially, the FDA regulated the premarket approval process for lithotripters as a Class III device but reclassified lithotripters in 2000 to a Class II device. The corresponding guidance document for showing the substantial equivalence of new devices with predicate devices will be described in detail. The FDA guidance document is very useful in helping device manufacturers: (i) develop technical performance testing for a shock wave lithotripter within the parameters of an FDA submission, and (ii) conduct clinical performance testing via at least one clinical confirmation study with a small number of subjects. Unfortunately although the submitted data are available at the FDA they are not available in the marketplace and this causes difficulties for physicians in deciding which device to use. The results of the technical performance testing of the LithoGold™ are provided.

  13. Difficulties Using Standardized Tests to Identify the Receptive Expressive Gap in Bilingual Children's Vocabularies.

    Science.gov (United States)

    Gibson, Todd A; Oller, D Kimbrough; Jarmulowicz, Linda

    2018-03-01

    Receptive standardized vocabulary scores have been found to be much higher than expressive standardized vocabulary scores in children with Spanish as L1, learning L2 (English) in school (Gibson et al., 2012). Here we present evidence suggesting the receptive-expressive gap may be harder to evaluate than previously thought because widely-used standardized tests may not offer comparable normed scores. Furthermore monolingual Spanish-speaking children tested in Mexico and monolingual English-speaking children in the US showed other, yet different statistically significant discrepancies between receptive and expressive scores. Results suggest comparisons across widely used standardized tests in attempts to assess a receptive-expressive gap are precarious.

  14. Web 2.0-based crowdsourcing for high-quality gold standard development in clinical natural language processing.

    Science.gov (United States)

    Zhai, Haijun; Lingren, Todd; Deleger, Louise; Li, Qi; Kaiser, Megan; Stoutenborough, Laura; Solti, Imre

    2013-04-02

    A high-quality gold standard is vital for supervised, machine learning-based, clinical natural language processing (NLP) systems. In clinical NLP projects, expert annotators traditionally create the gold standard. However, traditional annotation is expensive and time-consuming. To reduce the cost of annotation, general NLP projects have turned to crowdsourcing based on Web 2.0 technology, which involves submitting smaller subtasks to a coordinated marketplace of workers on the Internet. Many studies have been conducted in the area of crowdsourcing, but only a few have focused on tasks in the general NLP field and only a handful in the biomedical domain, usually based upon very small pilot sample sizes. In addition, the quality of the crowdsourced biomedical NLP corpora were never exceptional when compared to traditionally-developed gold standards. The previously reported results on medical named entity annotation task showed a 0.68 F-measure based agreement between crowdsourced and traditionally-developed corpora. Building upon previous work from the general crowdsourcing research, this study investigated the usability of crowdsourcing in the clinical NLP domain with special emphasis on achieving high agreement between crowdsourced and traditionally-developed corpora. To build the gold standard for evaluating the crowdsourcing workers' performance, 1042 clinical trial announcements (CTAs) from the ClinicalTrials.gov website were randomly selected and double annotated for medication names, medication types, and linked attributes. For the experiments, we used CrowdFlower, an Amazon Mechanical Turk-based crowdsourcing platform. We calculated sensitivity, precision, and F-measure to evaluate the quality of the crowd's work and tested the statistical significance (Pcrowdsourced and traditionally-developed annotations. The agreement between the crowd's annotations and the traditionally-generated corpora was high for: (1) annotations (0.87, F-measure for medication names

  15. Recent progress on test evidence, standardization and design of protection for exterior openings

    Directory of Open Access Journals (Sweden)

    Strøm Ruth Astrid

    2016-01-01

    A number of different fire scenarios that elements in vented facades/constructions can be exposed to have been studied. New test standards have been developed for the last few years and are explained. Finally, this paper evaluate how different fire stop products perform in different fire scenarios and which test standards are applicable.

  16. Standard Test Method for Thermal Oxidative Resistance of Carbon Fibers

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1982-01-01

    1.1 This test method covers the apparatus and procedure for the determination of the weight loss of carbon fibers, exposed to ambient hot air, as a means of characterizing their oxidative resistance. 1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units which are provided for information only and are not considered standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For specific hazard information, see Section 8.

  17. Corporate Schooling Meets Corporate Media: Standards, Testing, and Technophilia

    Science.gov (United States)

    Saltman, Kenneth J.

    2016-01-01

    Educational publishing corporations and media corporations in the United States have been converging, especially through the promotion of standardization, testing, and for-profit educational technologies. Media and technology companies--including News Corp, Apple, and Microsoft--have significantly expanded their presence in public schools to sell…

  18. Standard software for automated testing of infrared imagers, IRWindows, in practical applications

    Science.gov (United States)

    Irwin, Alan; Nicklin, Robert L.

    1998-08-01

    In the past, ad-hoc and manual testing of infrared images hasn't been a deterrent to the characterization of these systems due to the low volume of production and high ratio of skilled personnel to the quantity of units under test. However, with higher volume production, increasing numbers of development labs in emerging markets, and the push towards less expensive, faster development cycles, there is a strong need for standardized testing that is quickly configurable by test engineers, which can be run by less experienced test technicians, and which produce repeatable, accurate results. The IRWindowsTM system addresses these needs using a standard computing platform and existing automated IR test equipment. This paper looks at the general capabilities of the IRWindowsTM system, and then examines the specific results from its application in the PalmIR and Automotive IR production environments.

  19. 76 FR 51993 - Draft Guidance for Industry on Standards for Clinical Trial Imaging Endpoints; Availability

    Science.gov (United States)

    2011-08-19

    ... clinical trials of therapeutic drugs and biological products. The draft guidance describes standards... important imaging endpoint is used in a clinical trial of a therapeutic drug or biological product... Services to the Chairman of [[Page 51994

  20. Usability Testing of a Complex Clinical Decision Support Tool in the Emergency Department: Lessons Learned.

    Science.gov (United States)

    Press, Anne; McCullagh, Lauren; Khan, Sundas; Schachter, Andy; Pardo, Salvatore; McGinn, Thomas

    2015-09-10

    As the electronic health record (EHR) becomes the preferred documentation tool across medical practices, health care organizations are pushing for clinical decision support systems (CDSS) to help bring clinical decision support (CDS) tools to the forefront of patient-physician interactions. A CDSS is integrated into the EHR and allows physicians to easily utilize CDS tools. However, often CDSS are integrated into the EHR without an initial phase of usability testing, resulting in poor adoption rates. Usability testing is important because it evaluates a CDSS by testing it on actual users. This paper outlines the usability phase of a study, which will test the impact of integration of the Wells CDSS for pulmonary embolism (PE) diagnosis into a large urban emergency department, where workflow is often chaotic and high stakes decisions are frequently made. We hypothesize that conducting usability testing prior to integration of the Wells score into an emergency room EHR will result in increased adoption rates by physicians. The objective of the study was to conduct usability testing for the integration of the Wells clinical prediction rule into a tertiary care center's emergency department EHR. We conducted usability testing of a CDS tool in the emergency department EHR. The CDS tool consisted of the Wells rule for PE in the form of a calculator and was triggered off computed tomography (CT) orders or patients' chief complaint. The study was conducted at a tertiary hospital in Queens, New York. There were seven residents that were recruited and participated in two phases of usability testing. The usability testing employed a "think aloud" method and "near-live" clinical simulation, where care providers interacted with standardized patients enacting a clinical scenario. Both phases were audiotaped, video-taped, and had screen-capture software activated for onscreen recordings. Phase I: Data from the "think-aloud" phase of the study showed an overall positive outlook on

  1. [Static posturography versus clinical tests in elderly people with vestibular pathology].

    Science.gov (United States)

    Ortuño-Cortés, Miguel A; Martín-Sanz, Eduardo; Barona-de Guzmán, Rafael

    2008-01-01

    Balance can be quantified by clinical tests and through instrumental studies. The objective of this paper is to determine the correlation between static posturography and 4 clinical tests of balance in elderly people with vestibular disorders and to identify its capability to discriminate the groups studied. 60 patients with vestibular disorders and 60 healthy subjects performed 4 clinical tests (one leg standing with opened eyes, Timed Up and Go, Tinetti and Berg tests) and a static posturography analysis (NedSVE/IBV system) under 4 conditions: Romberg Test, Eyes Open (REO), Romberg Test, Eyes Closed (REC), Romberg Test on Foam with Eyes Open (RFEO), and Romberg Test on Foam with Eyes Closed (RFEC). RFEO correlated best with the clinical tests and RFEC was the worst. RFEO distinguished between healthy individuals and decompensated patients. RFEO gave the best information about postural balance in the elderly. RFEC was not useful. Static posturography can be useful to distinguish vestibular compensation status.

  2. Clinical implications of using the arm motor ability test in stroke rehabilitation.

    Science.gov (United States)

    O'Dell, Michael W; Kim, Grace; Finnen, Lisa Rivera; Polistena, Caitlin

    2011-05-01

    To identify all published studies using the Arm Motor Ability Test (AMAT), a standardized, laboratory-based measure for selected upper extremity activities of daily living (ADLs); and to summarize its current uses and provide recommendations for its future use. An Ovid online search was performed using the terms "Arm Motor Ability Test" and "AMAT." The reference lists of all articles obtained were reviewed for additional studies not appearing in the literature search. In addition, the original manual for the use and administration of the AMAT was reviewed. All studies examining the psychometric properties of the AMAT or using the AMAT as an outcome measure were identified. Articles simply mentioning the AMAT without providing data and case reports or abstracts (other than those addressing a specific aspect of the scale of interest) were excluded. Studies were reviewed by the primary author. No formal system of quality review was used. The AMAT has been used as an outcome measure in stroke rehabilitation research examining upper extremity robotics, functional electrical stimulation, and cortical stimulation. The most recent version contains 10 ADL tasks, each of which is composed of 1 to 3 subtasks. Of the 3 domains originally proposed, only the "functional ability" domain is routinely assessed. Psychometric studies have demonstrated good reliability and at least reasonable construct validity. The instrument's sensitivity to change over time is less well established, and no recommendation can be made regarding a minimal clinically important difference. We recommend that the 10-item version of the AMAT and assessment of only the functional ability domain be adopted as standard going forward. Further research should include examination of sensitivity over time, minimal clinically important change, reliability and validity in the mid and lower range of scores, and in neurologic diagnoses other than stroke. Copyright © 2011 American Congress of Rehabilitation Medicine

  3. Pharmacogenetic testing through the direct-to-consumer genetic testing company 23andMe.

    Science.gov (United States)

    Lu, Mengfei; Lewis, Cathryn M; Traylor, Matthew

    2017-06-19

    Rapid advances in scientific research have led to an increase in public awareness of genetic testing and pharmacogenetics. Direct-to-consumer (DTC) genetic testing companies, such as 23andMe, allow consumers to access their genetic information directly through an online service without the involvement of healthcare professionals. Here, we evaluate the clinical relevance of pharmacogenetic tests reported by 23andMe in their UK tests. The research papers listed under each 23andMe report were evaluated, extracting information on effect size, sample size and ethnicity. A wider literature search was performed to provide a fuller assessment of the pharmacogenetic test and variants were matched to FDA recommendations. Additional evidence from CPIC guidelines, PharmGKB, and Dutch Pharmacogenetics Working Group was reviewed to determine current clinical practice. The value of the tests across ethnic groups was determined, including information on linkage disequilibrium between the tested SNP and causal pharmacogenetic variant, where relevant. 23andMe offers 12 pharmacogenetic tests to their UK customers, some of which are in standard clinical practice, and others which are less widely applied. The clinical validity and clinical utility varies extensively between tests. The variants tested are likely to have different degrees of sensitivity due to different risk allele frequencies and linkage disequilibrium patterns across populations. The clinical relevance depends on the ethnicity of the individual and variability of pharmacogenetic markers. Further research is required to determine causal variants and provide more complete assessment of drug response and side effects. 23andMe reports provide some useful pharmacogenetics information, mirroring clinical tests that are in standard use. Other tests are unspecific, providing limited guidance and may not be useful for patients without professional interpretation. Nevertheless, DTC companies like 23andMe act as a powerful

  4. International survey on D-dimer test reporting: a call for standardization.

    Science.gov (United States)

    Lippi, Giuseppe; Tripodi, Armando; Simundic, Ana-Maria; Favaloro, Emmanuel J

    2015-04-01

    D-dimer is the biochemical gold standard for diagnosing a variety of thrombotic disorders, but result reporting is heterogeneous in clinical laboratories. A specific five-item questionnaire was developed to gain a clear picture of the current standardization of D-dimer test results. The questionnaire was opened online (December 24, 2014-February 10, 2015) on the platform "Google Drive (Google Inc., Mountain View; CA)," and widely disseminated worldwide by newsletters and alerts. A total of 409 responses were obtained during the period of data capture, the largest of which were from Italy (136; 33%), Australia (55; 22%), Croatia (29; 7%), Serbia (26; 6%), and the United States (21; 5%). Most respondents belonged to laboratories in general hospitals (208; 51%), followed by laboratories in university hospitals (104; 26%), and the private sector (94; 23%). The majority of respondents (i.e., 246; 60%) indicated the use of fibrinogen equivalent unit for expressing D-dimer results, with significant heterogeneities across countries and health care settings. The highest prevalence of laboratories indicated they were using "ng/mL" (139; 34%), followed by "mg/L" (136; 33%), and "µg/L" (73; 18%), with significant heterogeneity across countries but not among different health care settings. Expectedly, the vast majority of laboratories (379; 93%) declared to be using a fixed cutoff rather than an age-adjusted threshold, with no significant heterogeneity across countries and health care settings. The results of this survey attest that at least 28 different combinations of measurement units are currently used to report D-dimer results worldwide, and this evidence underscores the urgent need for more effective international joined efforts aimed to promote a worldwide standardization of D-dimer results reporting. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  5. Standardization Efforts for Mechanical Testing and Design of Advanced Ceramic Materials and Components

    Science.gov (United States)

    Salem, Jonathan A.; Jenkins, Michael G.

    2003-01-01

    Advanced aerospace systems occasionally require the use of very brittle materials such as sapphire and ultra-high temperature ceramics. Although great progress has been made in the development of methods and standards for machining, testing and design of component from these materials, additional development and dissemination of standard practices is needed. ASTM Committee C28 on Advanced Ceramics and ISO TC 206 have taken a lead role in the standardization of testing for ceramics, and recent efforts and needs in standards development by Committee C28 on Advanced Ceramics will be summarized. In some cases, the engineers, etc. involved are unaware of the latest developments, and traditional approaches applicable to other material systems are applied. Two examples of flight hardware failures that might have been prevented via education and standardization will be presented.

  6. The Stice model of overeating: Tests in clinical and non-clinical samples

    NARCIS (Netherlands)

    Strien, T. van; Engels, R.C.M.E.; Leeuwe, J.F.J. van; Snoek, H.M.

    2005-01-01

    The present study tested the dual pathway model of Stice [Stice, E (1994). A review of the evidence for a sociocultural model of bulimia nervosa and an exploration of the mechanisms of action. Clinical Psychology Review, 14, 633-661 and Stice, E. (2001). A prospective test of the dual-pathway model

  7. SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

    Science.gov (United States)

    Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

    2015-12-01

    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

  8. A comparison of two standard-setting approaches in high-stakes clinical performance assessment using generalizability theory.

    Science.gov (United States)

    Richter Lagha, Regina A; Boscardin, Christy K; May, Win; Fung, Cha-Chi

    2012-08-01

    Scoring clinical assessments in a reliable and valid manner using criterion-referenced standards remains an important issue and directly affects decisions made regarding examinee proficiency. This generalizability study of students' clinical performance examination (CPX) scores examines the reliability of those scores and of their interpretation, particularly according to a newly introduced, "critical actions" criterion-referenced standard and scoring approach. The authors applied a generalizability framework to the performance scores of 477 third-year students attending three different medical schools in 2008. The norm-referenced standard included all station checklist items. The criterion-referenced standard included only those items deemed critical to patient care by a faculty panel. The authors calculated and compared variance components and generalizability coefficients for each standard across six common stations. Norm-referenced scores had moderate generalizability (ρ = 0.51), whereas criterion-referenced scores showed low dependability (φ = 0.20). The estimated 63% of measurement error associated with the person-by-station interaction suggests case specificity. Increasing the number of stations on the CPX from 6 to 24, an impractical solution both for cost and time, would still yield only moderate dependability (φ = 0.50). Though the performance assessment of complex skills, like clinical competence, seems intrinsically valid, careful consideration of the scoring standard and approach is needed to avoid misinterpretation of proficiency. Further study is needed to determine how best to improve the reliability of criterion-referenced scores, by implementing changes to the examination structure, the process of standard-setting, or both.

  9. Standard test method for electrochemical critical pitting temperature testing of stainless steels

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1999-01-01

    1.1 This test method covers a procedure for the evaluation of the resistance of stainless steel and related alloys to pitting corrosion based on the concept of the determination of a potential independent critical pitting temperature (CPT). 1.2 This test methods applies to wrought and cast products including but not restricted to plate, sheet, tubing, bar, forgings, and welds, (see Note 1). Note 1—Examples of CPT measurements on sheet, plate, tubing, and welded specimens for various stainless steels can be found in Ref (1). See the research reports (Section 14). 1.3 The standard parameters recommended in this test method are suitable for characterizing the CPT of austenitic stainless steels and other related alloys with a corrosion resistance ranging from that corresponding to solution annealed UNS S31600 (Type 316 stainless steel) to solution annealed UNS S31254 (6 % Mo stainless steel). 1.4 This test method may be extended to stainless steels and other alloys related to stainless steel that have a CPT...

  10. Standard Test Method for Solar Transmittance (Terrestrial) of Sheet Materials Using Sunlight

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1986-01-01

    1.1 This test method covers the measurement of solar transmittance (terrestrial) of materials in sheet form by using a pyranometer, an enclosure, and the sun as the energy source. 1.2 This test method also allows measurement of solar transmittance at angles other than normal incidence. 1.3 This test method is applicable to sheet materials that are transparent, translucent, textured, or patterned. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  11. Standard Test Method for Solar Photometric Transmittance of Sheet Materials Using Sunlight

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1996-01-01

    1.1 This test method covers the measurement of solar photometric transmittance of materials in sheet form. Solar photometric transmittance is measured using a photometer (illuminance meter) in an enclosure with the sun and sky as the source of radiation. The enclosure and method of test is specified in Test Method E 1175 (or Test Method E 1084). 1.2 The purpose of this test method is to specify a photometric sensor to be used with the procedure for measuring the solar photometric transmittance of sheet materials containing inhomogeneities in their optical properties. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  12. A primary standard for the calibration of sniffer test leak devices

    Science.gov (United States)

    Jousten, Karl; Becker, Ute

    2009-10-01

    Test leaks with a gas flow to atmospheric pressure are often called sniffer test leaks. They are used to calibrate leak detectors for sniffing applications. Sniffer test leaks need calibration against a standard. A primary standard for the calibration of sniffer test leaks with relatively low measurement uncertainties is described. It is assured that the measurement result is traceable to the relevant SI units and that there is a well-known and complete measurement uncertainty budget. The measurement range of the system is from 4 × 10-11 mol s-1 (corresponding to 10-4 Pa l s-1 at 23 °C) to 4 × 10-9 mol s-1 (10-2 Pa l s-1 at 23 °C), which is the most often needed range in industry of around 1 g loss per year of the cooling agent R134a. The temperature where the calibration can be carried out may vary from 18 °C to 30 °C. The flow rate of any test gas not condensing in this temperature range can be measured.

  13. Standard test method for exfoliation corrosion susceptibility in 2XXX and 7XXX Series Aluminum Alloys (EXCO Test)

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2007-01-01

    1.1 This test method covers a procedure for constant immersion exfoliation corrosion (EXCO) testing of high-strength 2XXX and 7XXX series aluminum alloys. Note 1—This test method was originally developed for research and development purposes; however, it is referenced, in specific material specifications, as applicable for evaluating production material (refer to Section 14 on Precision and Bias). 1.2 This test method applies to all wrought products such as sheet, plate, extrusions, and forgings produced from conventional ingot metallurgy process. 1.3 This test method can be used with any form of specimen or part that can be immersed in the test solution. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  14. Standard test method for measurement of oxidation-reduction potential (ORP) of soil

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This test method covers a procedure and related test equipment for measuring oxidation-reduction potential (ORP) of soil samples removed from the ground. 1.2 The procedure in Section 9 is appropriate for field and laboratory measurements. 1.3 Accurate measurement of oxidation-reduction potential aids in the analysis of soil corrosivity and its impact on buried metallic structure corrosion rates. 1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  15. Comparison study of judged clinical skills competence from standard setting ratings generated under different administration conditions.

    Science.gov (United States)

    Roberts, William L; Boulet, John; Sandella, Jeanne

    2017-12-01

    When the safety of the public is at stake, it is particularly relevant for licensing and credentialing exam agencies to use defensible standard setting methods to categorize candidates into competence categories (e.g., pass/fail). The aim of this study was to gather evidence to support change to the Comprehensive Osteopathic Medical Licensing-USA Level 2-Performance Evaluation standard setting design and administrative process. Twenty-two video recordings of candidates assessed for clinical competence were randomly selected from the 2014-2015 Humanistic domain test score distribution ranging from the highest to lowest quintile of performance. Nineteen panelists convened at the same site to receive training and practice prior to generating judgments of qualified or not qualified performance to each of the twenty videos. At the end of training, one panel remained onsite to complete their judgments and the second panel was released and given 1 week to observe the same twenty videos and complete their judgments offsite. The two one-sided test procedure established equivalence between panel group means at the 0.05 confidence level, controlling for rater errors within each panel group. From a practical cost-effective and administrative resource perspective, results from this study suggest it is possible to diverge from typical panel groups, who are sequestered the entire time onsite, to larger numbers of panelists who can make their judgments offsite with little impact on judged samples of qualified performance. Standard setting designs having panelists train together and then allowing those to provide judgments yields equivalent ratings and, ultimately, similar cut scores.

  16. Genetic testing of aetiology of intellectual disability in a dedicated physical healthcare outpatient clinic for adults with intellectual disability.

    Science.gov (United States)

    Wallace, R A

    2016-02-01

    No guidelines exist for assessment of aetiology of intellectual disability in adults with intellectual disability by adult physicians, although robust guidelines exist for paediatric populations. It was speculated that the paediatric guidelines would also be suitable for adults. In rural/regional setting with limited clinical genetics, to perform a quality assurance evaluation on genetics assessment of aetiology of developmental disability in adults attending a dedicated healthcare clinic for adults with intellectual disability, compared results with paediatric standards, speculates if these seem appropriate for adults and speculates on a role for clinical genetics services. Retrospective chart audit of eligible patients looking at genetic clinical assessment, tests selected (molecular karyotype, G banding, metabolics), and yields of positive results. The results were compared with the recommended paediatric guidelines. Of 117 eligible adult patients, ideal genetic history was incomplete for 40% of patients without Down syndrome because of physician cause and lack of information. The number of abnormal genetic results increased from 46% to 66%, mainly from the molecular karyotype, though not all may have been clinically relevant. The improved yield from this test was similar to that in paediatric studies. Use of G banding and metabolic testing could be refined. Improvement can be made in clinical genetic assessment, but results generally support use of molecular karyotyping as first tier testing of cause of unknown intellectual disability in adults, as in the case for paediatric populations. The study highlights a necessary complementary role for clinical geneticists to interpret abnormal results. © 2016 Royal Australasian College of Physicians.

  17. Ethnic identity, school connectedness, and achievement in standardized tests among Mexican-origin youth.

    Science.gov (United States)

    Santos, Carlos E; Collins, Mary Ann

    2016-07-01

    The aim of this study was to investigate the association between school connectedness and performance in standardized test scores and whether this association was moderated by ethnic private regard. The study combines self-report data with school district reported data on standardized test scores in reading and math and free and reduced lunch status. Participants included 436 Mexican-origin youth attending a middle school in a southwestern U.S. state. Participants were on average 12.34 years of age (SD = .95) and 51.8% female and 48.2% male. After controlling for age, gender, free and reduced lunch status, and generational status, school connectedness and ethnic private regard were both positive predictors of standardized test scores in reading and math. Results also revealed a significant interaction between school connectedness and ethnic private regard in predicting standardized test scores in reading, such that participants who were low on ethnic private regard and low on school connectedness reported lower levels of achievement compared to participants who were low on ethnic private regard but high on school connectedness. At high levels of ethnic private regard, high or low levels of school connectedness were not associated with higher or lower standardized test scores in reading. The findings in this study provide support for the protective role that ethnic private regard plays in the educational experiences of Mexican-origin youth and highlights how the local school context may play a role in shaping this finding. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  18. An introduction to the 'Psycho-Physiological-Stress-Test' (PPST-A standardized instrument for evaluating stress reactions.

    Directory of Open Access Journals (Sweden)

    Elisabeth Neureiter

    Full Text Available Using a standardized instrument to evaluate patients' stress reactions has become more important in daily clinical routines. Different signs or symptoms of stress are often unilaterally explored: the physiological, psychological or social aspects of stress disorders are each viewed on a single dimension. However, all dimensions afflict patients who have persistent health problems due to chronic stress. Therefore, it is important to use a multidimensional approach to acquire data. The 'Psycho-Physiological-Stress-Test' (PPST was established to achieve a comprehensive understanding of stress and was further developed at the Charité-Universitätsmedizin Berlin in collaboration with the Psychological Department of Freie Universität Berlin. The PPST includes a series of varying stress phases, embedded in two periods of rest. Physiological and psychological parameters are simultaneously measured throughout the test session. Specifically, the PPST activates the sympathetic stress axis, which is measured by heart rate, blood pressure, respiration depth and rate, electro dermal activation and muscle tension (frontalis, masseter, trapezius. Psychological data are simultaneously collected, and include performance, motivation, emotion and behavior. After conducting this diagnostic test, it is possible to identify individual stress patterns that can be discussed with the individual patient to develop and recommend (outpatient treatment strategies. This paper introduces the PPST as a standardized way to evaluate stress reactions by presenting the results from a sample of psychosomatic inpatients (n = 139 who were treated in Charité-Universitätsmedizin Berlin, Germany. We observed that the varying testing conditions provoked adjusted changes in the different physiological parameters and psychological levels.

  19. Standard Test Method for Bond Strength of Ceramic Tile to Portland Cement Paste

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 This test method covers the determination of the ability of glazed ceramic wall tile, ceramic mosaic tile, quarry tile, and pavers to be bonded to portland cement paste. This test method includes both face-mounted and back-mounted tile. 1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  20. Non-prescription medicines: a process for standards development and testing in community pharmacy.

    Science.gov (United States)

    Benrimoj, Shalom Charlie I; Gilbert, Andrew; Quintrell, Neil; Neto, Abilio C de Almeida

    2007-08-01

    The objective of the study was to develop and test standards of practice for handling non-prescription medicines. In consultation with pharmacy registering authorities, key professional and consumer groups and selected community pharmacists, standards of practice were developed in the areas of Resource Management; Professional Practice; Pharmacy Design and Environment; and Rights and Needs of Customers. These standards defined and described minimum professional activities required in the provision of non-prescription medicines at a consistent and measurable level of practice. Seven standards were described and further defined by 20 criteria, including practice indicators. The Standards were tested in 40 community pharmacies in two States and after further adaptation, endorsed by all Australian pharmacy registering authorities and major Australian pharmacy and consumer organisations. The consultation process effectively engaged practicing pharmacists in developing standards to enable community pharmacists meet their legislative and professional responsibilities. Community pharmacies were audited against a set of standards of practice for handling non-prescription medicines developed in this project. Pharmacies were audited on the Standards at baseline, mid-intervention and post-intervention. Behavior of community pharmacists and their staff in relation to these standards was measured by conducting pseudo-patron visits to participating pharmacies. The testing process demonstrated a significant improvement in the quality of service delivered by staff in community pharmacies in the management of requests involving non-prescription medicines. The use of pseudo-patron visits, as a training tool with immediate feedback, was an acceptable and effective method of achieving changes in practice. Feedback from staff in the pharmacies regarding the pseudo-patron visits was very positive. Results demonstrated the methodology employed was effective in increasing overall

  1. Standard test method for radiochemical determination of plutonium in Soil by alpha spectroscopy

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2011-01-01

    1.1 This test method covers the determination of plutonium in soils at levels of detection dependent on count time, sample size, detector, background, and tracer yield. This test method describes one acceptable approach to the determination of plutonium in soil. 1.2 This test method is designed for 10 g of soil, previously collected and treated as described in Practices C998 and C999, but sample sizes up to 50 g may be analyzed by this test method. This test method may not be able to completely dissolve all forms of plutonium in the soil matrix. 1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific hazard statements are given in Section 9.

  2. Whole-body magnetic resonance angiography of patients using a standard clinical scanner

    Energy Technology Data Exchange (ETDEWEB)

    Hansen, Tomas; Wikstroem, Johan; Eriksson, Mats-Ola; Lundberg, Anders; Ahlstroem, Haakan [Uppsala University Hospital, Department of Diagnostic Radiology, Uppsala (Sweden); Johansson, Lars [Uppsala University Hospital, Uppsala (Sweden); Ljungman, Christer [Uppsala University Hospital, Department of Vascular Surgery, Uppsala (Sweden); Hoogeven, Romhild [Philips Medical Systems, MR Clinical Science, Best (Netherlands)

    2006-01-01

    The purpose of this study was to evaluate the technique of whole-body magnetic resonance angiography (MRA) of patients with a standard clinical scanner. Thirty-three patients referred for stenoses, occlusions, aneurysms, assessment of patency of vascular grafts, vasculitis and vascular aplasia were examined in a 1.5-T scanner using its standard body coil. Three-dimensional sequences were acquired in four stations after administration of one intravenous injection of 40 ml conventional gadolinium contrast agent. Different vessel segments were evaluated as either diagnostic or nondiagnostic and regarding the presence of stenoses with more than 50% diameter reduction, occlusions or aneurysms. Of 923 vessel segments, 67 were not evaluable because of poor contrast filling (n=31), motion artefacts (n=20), venous overlap (n=12) and other reasons (n=4). Stenoses of more than 50%, occlusions or aneurysms were observed in 26 patients (129 segments). In nine patients additional unsuspected pathology was found. In 10 out of 14 patients (71/79 segments) there was conformity between MRA and digital subtraction angiography regarding the grade of stenosis. This study shows that whole-body MRA with a standard clinical scanner is feasible. Motion artefacts and the timing of the contrast agent through the different segments are still problems to be solved. (orig.)

  3. Audit, guidelines and standards: clinical governance for hip fracture care in Scotland.

    Science.gov (United States)

    Currie, Colin T; Hutchison, James D

    To report on experience of national-level audit, guidelines and standards for hip fracture care in Scotland. Scottish Hip Fracture Audit (from 1993) documents case-mix, process and outcomes of hip fracture care in Scotland. Evidence-based national guidelines on hip fracture care are available (1997, updated 2002). Hip fracture serves as a tracer condition by the health quality assurance authority for its work on older people, which reported in 2004. Audit data are used locally to document care and support and monitor service developments. Synergy between the guidelines and the audit provides a means of improving care locally and monitoring care nationally. External review by the quality assurance body shows to what extent guideline-based standards relating to A&E care, pre-operative delay, multidisciplinary care and audit participation are met. Three national-level initiatives on hip fracture care have delivered: Reliable and large-scale comparative information on case-mix, care and outcomes; evidence-based recommendations on care; and nationally accountable standards inspected and reported by the national health quality assurance authority. These developments are linked and synergistic, and enjoy both clinical and managerial support. They provide an evolving framework for clinical governance, with casemix-adjusted outcome assessment for hip fracture care as a next step.

  4. Standard Test Method for Preparing Aircraft Cleaning Compounds, Liquid Type, Water Base, for Storage Stability Testing

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 This test method covers the determination of the stability in storage, of liquid, water-base chemical cleaning compounds, used to clean the exterior surfaces of aircraft. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  5. Platelet function testing: methods of assessment and clinical utility.

    LENUS (Irish Health Repository)

    Mylotte, Darren

    2012-02-01

    Platelets play a central role in the regulation of both thrombosis and haemostasis yet tests of platelet function have, until recently, been exclusively used in the diagnosis and management of bleeding disorders. Recent advances have demonstrated the clinical utility of platelet function testing in patients with cardiovascular disease. The ex vivo measurement of response to antiplatelet therapies (aspirin and clopidogrel), by an ever-increasing array of platelet function tests, is with some assays, predictive of adverse clinical events and thus, represents an emerging area of interest for both the clinician and basic scientist. This review article will describe the advantages and disadvantages of the currently available methods of measuring platelet function and discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

  6. Platelet function testing: methods of assessment and clinical utility.

    LENUS (Irish Health Repository)

    Mylotte, Darren

    2011-01-01

    Platelets play a central role in the regulation of both thrombosis and haemostasis yet tests of platelet function have, until recently, been exclusively used in the diagnosis and management of bleeding disorders. Recent advances have demonstrated the clinical utility of platelet function testing in patients with cardiovascular disease. The ex vivo measurement of response to antiplatelet therapies (aspirin and clopidogrel), by an ever-increasing array of platelet function tests, is with some assays, predictive of adverse clinical events and thus, represents an emerging area of interest for both the clinician and basic scientist. This review article will describe the advantages and disadvantages of the currently available methods of measuring platelet function and discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

  7. Standard practice for torque calibration of testing machines and devices

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This practice covers procedures and requirements for the calibration of torque for static and quasi-static torque capable testing machines or devices. These may, or may not, have torque indicating systems and include those devices used for the calibration of hand torque tools. Testing machines may be calibrated by one of the three following methods or combination thereof: 1.1.1 Use of standard weights and lever arms. 1.1.2 Use of elastic torque measuring devices. 1.1.3 Use of elastic force measuring devices and lever arms. 1.1.4 Any of the methods require a specific uncertainty of measurement and a traceability derived from national standards of mass and length. 1.2 The procedures of 1.1.1, 1.1.2, and 1.1.3 apply to the calibration of the torque-indicating systems associated with the testing machine, such as a scale, dial, marked or unmarked recorder chart, digital display, etc. In all cases the buyer/owner/user must designate the torque-indicating system(s) to be calibrated and included in the repor...

  8. Standard Test Method for Half-Cell Potentials of Uncoated Reinforcing Steel in Concrete

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This test method covers the estimation of the electrical corrosion potential of uncoated reinforcing steel in field and laboratory concrete, for the purpose of determining the corrosion activity of the reinforcing steel. 1.2 This test method is limited by electrical circuitry. Concrete surface in building interiors and desert environments lose sufficient moisture so that the concrete resistivity becomes so high that special testing techniques not covered in this test method may be required (see 5.1.4.1). Concrete surfaces that are coated or treated with sealers may not provide an acceptable electrical circuit. The basic configuration of the electrical circuit is shown in Fig. 1. 1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It ...

  9. Sub-clinical mastitis prevalent in dairy cows in Chittagong district of Bangladesh: detection by different screening tests

    Directory of Open Access Journals (Sweden)

    Mukti Barua

    2014-07-01

    Full Text Available Aim: Mastitis is recognized as one of the most costly health disorder affecting dairy cows. An epidemiological study was carried out at some selected farms in Chittagong district of Bangladesh to determine the prevalence and risk factors of sub-clinical mastitis (SCM in dairy cows. Materials and Methods: For conducting the study, some dairy farms of Chittagong were selected from urban and periurban areas by stratified random sampling. A total of 444 quarter samples of 111 (56 from commercial dairy farms and 55 from backyards lactating dairy cows were considered. Sub-clinical mastitis (SCM was determined using three different indirect screening tests: California Mastitis Test (CMT, White Slide Test (WST and Surf Field Mastitis Test (SFMT. Sensitivity and specificity were also determined to measure the accuracy of those tests. Results: The prevalence of SCM by CMT, WST and SFMT were 32.43% (n=144, 33.56% (n=149 and 31.53% (n=140, respectively. Distribution of SCM in relation to different variables at quarter level and animal level was also recorded. The prevalence of SCM was significantly (P4 than others at quarter level. No significant difference (P>0.05 was found in relation to breed. Using CMT as a gold standard, sensitivity and specificity of WST and SFMT were also calculated at 95% confidence interval. The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value and disease prevalence by WST and SFMT were comparable. Conclusion: This study recommends that regular screening of sub-clinical mastitis will reduce the prevalence of sub-clinical mastitis. The most effective way to control sub-clinical mastitis is to take preventive measures such as regular cleaning of the floor, keeping the udder clean, milkman's cleanliness, dry cow therapy specially in high yielding dairy cows.

  10. Standard Test Method for Gravimetric Determination of Nonvolatile Residue from Cleanroom Gloves

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2011-01-01

    1.1 This test method covers the determination of solvent extractable nonvolatile residue (NVR) from gloves used in cleanrooms where spacecraft are assembled, cleaned, or tested. 1.2 The NVR of interest is that which can be extracted from gloves using a specified solvent that has been selected for its extracting qualities, or because it is representative of solvents used in the particular facility. Alternative solvents may be used, but since their use may result in different values being generated, they must be identified in the procedure data sheet. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  11. Standard Test Method for Gravimetric Determination of Nonvolatile Residue From Cleanroom Wipers

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2006-01-01

    1.1 This test method covers the determination of solvent extractable nonvolatile residue (NVR) from wipers used in assembly, cleaning, or testing of spacecraft, but not from those used for analytical surface sampling of hardware. 1.2 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.3 The NVR of interest is that which can be extracted from cleanroom wipers using a specified solvent that has been selected for its extractive qualities. Alternative solvents may be selected, but since their use may result in different values being generated, they must be identified in the procedure data sheet. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  12. Standardized computer-based organized reporting of EEG

    DEFF Research Database (Denmark)

    Beniczky, Sándor; Aurlien, Harald; Brøgger, Jan C.

    2017-01-01

    Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted in the se......Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted...... in the second, revised version of SCORE (Standardized Computer-based Organized Reporting of EEG), which is presented in this paper. The revised terminology was implemented in a software package (SCORE EEG), which was tested in clinical practice on 12,160 EEG recordings. Standardized terms implemented in SCORE...... are used to report the features of clinical relevance, extracted while assessing the EEGs. Selection of the terms is context sensitive: initial choices determine the subsequently presented sets of additional choices. This process automatically generates a report and feeds these features into a database...

  13. Development of ASTM Standard for SiC-SiC Joint Testing Final Scientific/Technical Report

    Energy Technology Data Exchange (ETDEWEB)

    Jacobsen, George [General Atomics, San Diego, CA (United States); Back, Christina [General Atomics, San Diego, CA (United States)

    2015-10-30

    As the nuclear industry moves to advanced ceramic based materials for cladding and core structural materials for a variety of advanced reactors, new standards and test methods are required for material development and licensing purposes. For example, General Atomics (GA) is actively developing silicon carbide (SiC) based composite cladding (SiC-SiC) for its Energy Multiplier Module (EM2), a high efficiency gas cooled fast reactor. Through DOE funding via the advanced reactor concept program, GA developed a new test method for the nominal joint strength of an endplug sealed to advanced ceramic tubes, Fig. 1-1, at ambient and elevated temperatures called the endplug pushout (EPPO) test. This test utilizes widely available universal mechanical testers coupled with clam shell heaters, and specimen size is relatively small, making it a viable post irradiation test method. The culmination of this effort was a draft of an ASTM test standard that will be submitted for approval to the ASTM C28 ceramic committee. Once the standard has been vetted by the ceramics test community, an industry wide standard methodology to test joined tubular ceramic components will be available for the entire nuclear materials community.

  14. Combining Immunotherapy with Standard Glioblastoma Therapy

    Science.gov (United States)

    This clinical trial is testing standard therapy (surgery, radiation and temozolomide) plus immunotherapy with pembrolizumab with or without a cancer treatment vaccine for patients with newly diagnosed glioblastoma, a common and deadly type of brain tumor.

  15. Evaluation of clinical methods for peroneal muscle testing.

    Science.gov (United States)

    Sarig-Bahat, Hilla; Krasovsky, Andrei; Sprecher, Elliot

    2013-03-01

    Manual muscle testing of the peroneal muscles is well accepted as a testing method in musculoskeletal physiotherapy for the assessment of the foot and ankle. The peroneus longus and brevis are primary evertors and secondary plantar flexors of the ankle joint. However, some international textbooks describe them as dorsi flexors, when instructing peroneal muscle testing. The identified variability raised a question whether these educational texts are reflected in the clinical field. The purposes of this study were to investigate what are the methods commonly used in the clinical field for peroneal muscle testing and to evaluate their compatibility with functional anatomy. A cross-sectional study was conducted, using an electronic questionnaire sent to 143 Israeli physiotherapists in the musculoskeletal field. The survey questioned on the anatomical location of manual resistance and the combination of motions resisted. Ninety-seven responses were received. The majority (69%) of respondents related correctly to the peronei as evertors, but asserted that resistance should be located over the dorsal aspect of the fifth metatarsus, thereby disregarding the peroneus longus. Moreover, 38% of the respondents described the peronei as dorsi flexors, rather than plantar flexors. Only 2% selected the correct method of resisting plantarflexion and eversion at the base of the first metatarsus. We consider this technique to be the most compatible with the anatomy of the peroneus longus and brevis. The Fisher-Freeman-Halton test indicated that there was a significant relationship between responses on the questions (P = 0.0253, 95% CI 0.0249-0.0257), thus justifying further correspondence analysis. The correspondence analysis found no clustering of the answers that were compatible with anatomical evidence and were applied in the correct technique, but did demonstrate a common error, resisting dorsiflexion rather than plantarflexion, which was in agreement with the described

  16. International standardization of instruments for neutron irradiation tests

    International Nuclear Information System (INIS)

    Tanimoto, Masataka; Shibata, Akira; Nakamura, Jinichi; Tsuchiya, Kunihiko; Cho, M.; Lee, C.; Park, S.; Choo, K.

    2012-01-01

    The JMTR in JAEA and HANARO in KAERI are the foremost testing/research reactors in the world and these are expected to contribute to many nuclear fields. As a part of instrument development in irradiation field, information exchange of instruments started from 2010 under the cooperation agreements between KAERI and JAEA. The instruments developed in JMTR and HANARO are introduced and cooperation experiments as future plan are discussed for international standardization. (author)

  17. Precision tests of quantum chromodynamics and the standard model

    International Nuclear Information System (INIS)

    Brodsky, S.J.; Lu, H.J.

    1995-06-01

    The authors discuss three topics relevant to testing the Standard Model to high precision: commensurate scale relations, which relate observables to each other in perturbation theory without renormalization scale or scheme ambiguity, the relationship of compositeness to anomalous moments, and new methods for measuring the anomalous magnetic and quadrupole moments of the W and Z

  18. Standardized Testing and School Segregation: Like Tinder for Fire?

    Science.gov (United States)

    Knoester, Matthew; Au, Wayne

    2017-01-01

    Recent research suggests that high-stakes standardized testing has played a negative role in the segregation of children by race and class in schools. In this article we review research on the overall effects of segregation, the positive and negative aspects of how desegregation plans were carried out following the 1954 Supreme Court decision…

  19. Randomized comparison of vaginal self-sampling by standard vs. dry swabs for Human papillomavirus testing

    International Nuclear Information System (INIS)

    Eperon, Isabelle; Vassilakos, Pierre; Navarria, Isabelle; Menoud, Pierre-Alain; Gauthier, Aude; Pache, Jean-Claude; Boulvain, Michel; Untiet, Sarah; Petignat, Patrick

    2013-01-01

    To evaluate if human papillomavirus (HPV) self-sampling (Self-HPV) using a dry vaginal swab is a valid alternative for HPV testing. Women attending colposcopy clinic were recruited to collect two consecutive Self-HPV samples: a Self-HPV using a dry swab (S-DRY) and a Self-HPV using a standard wet transport medium (S-WET). These samples were analyzed for HPV using real time PCR (Roche Cobas). Participants were randomized to determine the order of the tests. Questionnaires assessing preferences and acceptability for both tests were conducted. Subsequently, women were invited for colposcopic examination; a physician collected a cervical sample (physician-sampling) with a broom-type device and placed it into a liquid-based cytology medium. Specimens were then processed for the production of cytology slides and a Hybrid Capture HPV DNA test (Qiagen) was performed from the residual liquid. Biopsies were performed if indicated. Unweighted kappa statistics (κ) and McNemar tests were used to measure the agreement among the sampling methods. A total of 120 women were randomized. Overall HPV prevalence was 68.7% (95% Confidence Interval (CI) 59.3–77.2) by S-WET, 54.4% (95% CI 44.8–63.9) by S-DRY and 53.8% (95% CI 43.8–63.7) by HC. Among paired samples (S-WET and S-DRY), the overall agreement was good (85.7%; 95% CI 77.8–91.6) and the κ was substantial (0.70; 95% CI 0.57-0.70). The proportion of positive type-specific HPV agreement was also good (77.3%; 95% CI 68.2-84.9). No differences in sensitivity for cervical intraepithelial neoplasia grade one (CIN1) or worse between the two Self-HPV tests were observed. Women reported the two Self-HPV tests as highly acceptable. Self-HPV using dry swab transfer does not appear to compromise specimen integrity. Further study in a large screening population is needed. ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01316120

  20. Effects of Motor Learning on Clinical Isokinetic Test Performance in Knee Osteoarthritis Patients

    Directory of Open Access Journals (Sweden)

    José Messias Rodrigues-da-Silva

    Full Text Available OBJECTIVES: To analyze the effects of motor learning on knee extension-flexion isokinetic performance in knee osteoarthritis patients. METHODS: One hundred and thirty-six middle-aged and older sedentary individuals (111 women, 64.3±9.9 years with knee osteoarthritis (130 patients with bilateral and who had never performed isokinetic testing underwent two bilateral knee extension-flexion (concentric-concentric isokinetic evaluations (5 repetitions at 60°/sec. The tests were first performed on the dominant leg with 2 min of recovery between test, and following a standardized warm-up that included 3 submaximal isokinetic repetitions. The same procedure was repeated on the non-dominant leg. The peak torque, peak torque adjusted for the body weight, total work, coefficient of variation and agonist/antagonist ratio were compared between tests. RESULTS: Patients showed significant improvements in test 2 compared to test 1, including higher levels of peak torque, peak torque adjusted for body weight and total work, as well as lower coefficients of variation. The agonist/antagonist relationship did not significantly change between tests. No significant differences were found between the right and left legs for all variables. CONCLUSION: The results suggest that performing two tests with a short recovery (2 min between them could be used to reduce motor learning effects on clinical isokinetic testing of the knee joint in knee osteoarthritis patients.

  1. Seminar on standards, standardization, quality control and interlaboratory test programmes

    Energy Technology Data Exchange (ETDEWEB)

    de Bievre, P. [Central Bureau for Nuclear Measurements, Geel (Belgium)

    1978-12-15

    The author gives a resume on the proper use of standards and standardization of measurement procedures. Results of measurements obtained on the same instrument and on the same series of standards of different isotopic compositions are displayed.

  2. The status of ANSI N13.11 - The dosimeter performance test standard

    International Nuclear Information System (INIS)

    Sims, C.S.

    1991-01-01

    The standard designated ANSI N13.11 was issued in 1983 and is the basis for the dosimeter performance test associated with the National Voluntary Laboratory Accreditation Program (NVLAP). The standard is important because the Nuclear Regulatory Commission requires that all licensees use personnel dosimeters processed by NVLAP-accredited processors. The standard has undergone review and modifications have been recommended. Historical information concerning the development and utilization of the present standard, ANSI N13.11-1983, is presented. Details associated with the review of the standard (e.g., policy, group selection) are then given. Finally, the modifications recommended by the review group are discussed

  3. Effect of home testing of international normalized ratio on clinical events.

    Science.gov (United States)

    Matchar, David B; Jacobson, Alan; Dolor, Rowena; Edson, Robert; Uyeda, Lauren; Phibbs, Ciaran S; Vertrees, Julia E; Shih, Mei-Chiung; Holodniy, Mark; Lavori, Philip

    2010-10-21

    Warfarin anticoagulation reduces thromboembolic complications in patients with atrial fibrillation or mechanical heart valves, but effective management is complex, and the international normalized ratio (INR) is often outside the target range. As compared with venous plasma testing, point-of-care INR measuring devices allow greater testing frequency and patient involvement and may improve clinical outcomes. We randomly assigned 2922 patients who were taking warfarin because of mechanical heart valves or atrial fibrillation and who were competent in the use of point-of-care INR devices to either weekly self-testing at home or monthly high-quality testing in a clinic. The primary end point was the time to a first major event (stroke, major bleeding episode, or death). The patients were followed for 2.0 to 4.75 years, for a total of 8730 patient-years of follow-up. The time to the first primary event was not significantly longer in the self-testing group than in the clinic-testing group (hazard ratio, 0.88; 95% confidence interval, 0.75 to 1.04; P=0.14). The two groups had similar rates of clinical outcomes except that the self-testing group reported more minor bleeding episodes. Over the entire follow-up period, the self-testing group had a small but significant improvement in the percentage of time during which the INR was within the target range (absolute difference between groups, 3.8 percentage points; P<0.001). At 2 years of follow-up, the self-testing group also had a small but significant improvement in patient satisfaction with anticoagulation therapy (P=0.002) and quality of life (P<0.001). As compared with monthly high-quality clinic testing, weekly self-testing did not delay the time to a first stroke, major bleeding episode, or death to the extent suggested by prior studies. These results do not support the superiority of self-testing over clinic testing in reducing the risk of stroke, major bleeding episode, and death among patients taking warfarin

  4. Pre-Clinical Tests of an Integrated CMOS Biomolecular Sensor for Cardiac Diseases Diagnosis.

    Science.gov (United States)

    Lee, Jen-Kuang; Wang, I-Shun; Huang, Chi-Hsien; Chen, Yih-Fan; Huang, Nien-Tsu; Lin, Chih-Ting

    2017-11-26

    Coronary artery disease and its related complications pose great threats to human health. In this work, we aim to clinically evaluate a CMOS field-effect biomolecular sensor for cardiac biomarkers, cardiac-specific troponin-I (cTnI), N -terminal prohormone brain natriuretic peptide (NT-proBNP), and interleukin-6 (IL-6). The CMOS biosensor is implemented via a standard commercialized 0.35 μm CMOS process. To validate the sensing characteristics, in buffer conditions, the developed CMOS biosensor has identified the detection limits of IL-6, cTnI, and NT-proBNP as being 45 pM, 32 pM, and 32 pM, respectively. In clinical serum conditions, furthermore, the developed CMOS biosensor performs a good correlation with an enzyme-linked immuno-sorbent assay (ELISA) obtained from a hospital central laboratory. Based on this work, the CMOS field-effect biosensor poses good potential for accomplishing the needs of a point-of-care testing (POCT) system for heart disease diagnosis.

  5. Standards for Radiation Effects Testing: Ensuring Scientific Rigor in the Face of Budget Realities and Modern Device Challenges

    Science.gov (United States)

    Lauenstein, J M.

    2015-01-01

    An overview is presented of the space radiation environment and its effects on electrical, electronic, and electromechanical parts. Relevant test standards and guidelines are listed. Test standards and guidelines are necessary to ensure best practices, minimize and bound systematic and random errors, and to ensure comparable results from different testers and vendors. Test standards are by their nature static but exist in a dynamic environment of advancing technology and radiation effects research. New technologies, failure mechanisms, and advancement in our understanding of known failure mechanisms drive the revision or development of test standards. Changes to standards must be weighed against their impact on cost and existing part qualifications. There must be consensus on new best practices. The complexity of some new technologies exceeds the scope of existing test standards and may require development of a guideline specific to the technology. Examples are given to illuminate the value and limitations of key radiation test standards as well as the challenges in keeping these standards up to date.

  6. Development and evaluation of Standard Operating Procedures (SOPs) for quality control tests and radiological protection activities in a Nuclear Medicine Service

    Energy Technology Data Exchange (ETDEWEB)

    Krempser, Alexandre R., E-mail: krempser@peb.ufrj.br [Universidade Federal do Rio de Janeiro (PEB/COPPE/UFRJ), RJ (Brazil). Programa de Engenharia Biomedica; Soares, Alexandre B. [Universidade Federal do Rio de Janeiro (IF/UFRJ), Rio de Janeiro, RJ (Brazil). Inst. de Fisica; Corbo, Rossana [Universidade Federal do Rio de Janeiro (FM/UFRJ), Rio de Janeiro, RJ (Brazil). Dept. de Radiologia

    2011-07-01

    The quality management in Nuclear Medicine Services is a requirement of national and international standards. The Brazilian regulatory agency in health surveillance, the Agencia Nacional de Vigilancia Sanitaria (ANVISA), in its Resolucao de Diretoria Colegiada (Collegiate Directory Resolution) no. 38, requires the elaboration of documents describing the technical and clinical routine activities. This study aimed to elaborate, implement and evaluate Standard Operating Procedures (SOPs) for quality control tests and radiological protection activities in the Nuclear Medicine Service of a university hospital. Eighteen SOPs were developed, involving tasks related to dose calibrator, gamma camera, Geiger-Muller detectors and radiological protection activities. The performance of its application was evaluated for a period of six months. It was observed a reduction in 75% of reported operational errors and 42% of the number of reported incidents with contamination by radioactive material. The SOPs were adequate and successful in its application. New procedures involving clinical activities will also be developed and evaluated. (author)

  7. Social inequality and HIV-testing: Comparing home- and clinic-based testing in rural Malawi

    Directory of Open Access Journals (Sweden)

    Alexander A. Weinreb

    2009-10-01

    Full Text Available The plan to increase HIV testing is a cornerstone of the international health strategy against the HIV/AIDS epidemic, particularly in sub-Saharan Africa. This paper highlights a problematic aspect of that plan: the reliance on clinic- rather than home-based testing. First, drawing on DHS data from across Africa, we demonstrate the substantial differences in socio-demographic and economic profiles between those who report having ever had an HIV test, and those who report never having had one. Then, using data from a random household survey in rural Malawi, we show that substituting home-based for clinic-based testing may eliminate this source of inequality between those tested and those not tested. This result, which is stable across modeling frameworks, has important implications for accurately and equitably addressing the counseling and treatment programs that comprise the international health strategy against AIDS, and that promise to shape the future trajectory of the epidemic in Africa and beyond.

  8. Modeling Floor Effects in Standardized Vocabulary Test Scores in a Sample of Low SES Hispanic Preschool Children under the Multilevel Structural Equation Modeling Framework

    Directory of Open Access Journals (Sweden)

    Leina Zhu

    2017-12-01

    Full Text Available Researchers and practitioners often use standardized vocabulary tests such as the Peabody Picture Vocabulary Test-4 (PPVT-4; Dunn and Dunn, 2007 and its companion, the Expressive Vocabulary Test-2 (EVT-2; Williams, 2007, to assess English vocabulary skills as an indicator of children's school readiness. Despite their psychometric excellence in the norm sample, issues arise when standardized vocabulary tests are used to asses children from culturally, linguistically and ethnically diverse backgrounds (e.g., Spanish-speaking English language learners or delayed in some manner. One of the biggest challenges is establishing the appropriateness of these measures with non-English or non-standard English speaking children as often they score one to two standard deviations below expected levels (e.g., Lonigan et al., 2013. This study re-examines the issues in analyzing the PPVT-4 and EVT-2 scores in a sample of 4-to-5-year-old low SES Hispanic preschool children who were part of a larger randomized clinical trial on the effects of a supplemental English shared-reading vocabulary curriculum (Pollard-Durodola et al., 2016. It was found that data exhibited strong floor effects and the presence of floor effects made it difficult to differentiate the invention group and the control group on their vocabulary growth in the intervention. A simulation study is then presented under the multilevel structural equation modeling (MSEM framework and results revealed that in regular multilevel data analysis, ignoring floor effects in the outcome variables led to biased results in parameter estimates, standard error estimates, and significance tests. Our findings suggest caution in analyzing and interpreting scores of ethnically and culturally diverse children on standardized vocabulary tests (e.g., floor effects. It is recommended appropriate analytical methods that take into account floor effects in outcome variables should be considered.

  9. Standardized computer-based organized reporting of EEG

    DEFF Research Database (Denmark)

    Beniczky, Sándor; Aurlien, Harald; Brøgger, Jan C.

    2017-01-01

    Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted in the se......Standardized terminology for computer-based assessment and reporting of EEG has been previously developed in Europe. The International Federation of Clinical Neurophysiology established a taskforce in 2013 to develop this further, and to reach international consensus. This work resulted...... in the second, revised version of SCORE (Standardized Computer-based Organized Reporting of EEG), which is presented in this paper. The revised terminology was implemented in a software package (SCORE EEG), which was tested in clinical practice on 12,160 EEG recordings. Standardized terms implemented in SCORE....... In the end, the diagnostic significance is scored, using a standardized list of terms. SCORE has specific modules for scoring seizures (including seizure semiology and ictal EEG patterns), neonatal recordings (including features specific for this age group), and for Critical Care EEG Terminology. SCORE...

  10. Overburden Stress Normalization and Rod Length Corrections for the Standard Penetration Test (SPT)

    OpenAIRE

    Deger, Tonguc Tolga

    2014-01-01

    The Standard Penetration Test (SPT) has been a staple of geotechnical engineering practice for more than 70 years. Empirical correlations based on in situ SPT data provide an important basis for assessment of a broad range of engineering parameters, and for empirically based analysis and design methods spanning a significant number of areas of geotechnical practice. Despite this longstanding record of usage, the test itself is relatively poorly standardized with regard to the allowable variab...

  11. Practical issues for testing thin film PV modules at standard test conditions.

    OpenAIRE

    Marín González, Omar; Raga Arroyo, Manuela Pilar; Alonso Garcia, M. Carmen; Muñoz-García, Miguel Angel

    2013-01-01

    Thin film photovoltaic (TF) modules have gained importance in the photovoltaic (PV) market. New PV plants increasingly use TF technologies. In order to have a reliable sample of a PV module population, a huge number of modules must be measured. There is a big variety of materials used in TF technology. Some of these modules are made of amorphous or microcrystalline silicon. Other are made of CIS or CdTe. Not all these materials respond the same under standard test conditions (STC) of power...

  12. Standard Test Method for Resin Flow of Carbon Fiber-Epoxy Prepreg

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1999-01-01

    1.1 This test method covers the determination of the amount of resin flow that will take place from prepreg tape or sheet under given conditions of temperature and pressure. 1.2 The values stated in SI units are to be regarded as standard. The values in parentheses are for reference only. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  13. Syndromic Panel-Based Testing in Clinical Microbiology.

    Science.gov (United States)

    Ramanan, Poornima; Bryson, Alexandra L; Binnicker, Matthew J; Pritt, Bobbi S; Patel, Robin

    2018-01-01

    The recent development of commercial panel-based molecular diagnostics for the rapid detection of pathogens in positive blood culture bottles, respiratory specimens, stool, and cerebrospinal fluid has resulted in a paradigm shift in clinical microbiology and clinical practice. This review focuses on U.S. Food and Drug Administration (FDA)-approved/cleared multiplex molecular panels with more than five targets designed to assist in the diagnosis of bloodstream, respiratory tract, gastrointestinal, or central nervous system infections. While these panel-based assays have the clear advantages of a rapid turnaround time and the detection of a large number of microorganisms and promise to improve health care, they present certain challenges, including cost and the definition of ideal test utilization strategies (i.e., optimal ordering) and test interpretation. Copyright © 2017 American Society for Microbiology.

  14. Standard Test Methods for Insulation Integrity and Ground Path Continuity of Photovoltaic Modules

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2000-01-01

    1.1 These test methods cover procedures for (1) testing for current leakage between the electrical circuit of a photovoltaic module and its external components while a user-specified voltage is applied and (2) for testing for possible module insulation breakdown (dielectric voltage withstand test). 1.2 A procedure is described for measuring the insulation resistance between the electrical circuit of a photovoltaic module and its external components (insulation resistance test). 1.3 A procedure is provided for verifying that electrical continuity exists between the exposed external conductive surfaces of the module, such as the frame, structural members, or edge closures, and its grounding point (ground path continuity test). 1.4 This test method does not establish pass or fail levels. The determination of acceptable or unacceptable results is beyond the scope of this test method. 1.5 There is no similar or equivalent ISO standard. This standard does not purport to address all of the safety concerns, if a...

  15. Problems in Standardization of Orthodontic Shear Bond Strength Tests; A Brief Review

    Directory of Open Access Journals (Sweden)

    M.S. A. Akhoundi

    2005-03-01

    Full Text Available Bonding brackets to the enamel surface has gained much popularity today. New adhesive systems have been introduced and marketed and a considerable increase in research regarding bond strength has been published. A considerable amount of these studies deal with shear bond strength of adhesives designed for orthodontic purpose.Previous studies have used variety of test designs. This diversity in test design is due to the fact that there is no standard method for evaluating shear bond strength in orthodontics. Therefore comparison of data obtained from different study is almost impossible.This article tries to briefly discuss the developments occurred in the process of shear bond strength measurement of orthodontic adhesives with an emphasis on the type of test set up and load application.Although the test designs for measuring shear bond strength in orthodontics are still far from ideal, attempts must be made to standardize these tests especially in order to makecomparison of different data easier. It is recommended that test designs be set up in such a manner that better matches with the purpose of the study.

  16. Standard test method for damage to contacting solid surfaces under fretting conditions

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This test method covers the studying or ranking the susceptibility of candidate materials to fretting corrosion or fretting wear for the purposes of material selection for applications where fretting corrosion or fretting wear can limit serviceability. 1.2 This test method uses a tribological bench test apparatus with a mechanism or device that will produce the necessary relative motion between a contacting hemispherical rider and a flat counterface. The rider is pressed against the flat counterface with a loading mass. The test method is intended for use in room temperature air, but future editions could include fretting in the presence of lubricants or other environments. 1.3 The purpose of this test method is to rub two solid surfaces together under controlled fretting conditions and to quantify the damage to both surfaces in units of volume loss for the test method. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5...

  17. Standardization of test conditions for gamma camera performance measurement

    International Nuclear Information System (INIS)

    Jordan, K.

    1980-01-01

    The actual way of measuring gamma camera performance is to use point sources or flood sources in air, often in combination with bar phantoms. This method mostly brings best performance parameters for cameras but it has nothing in common with the use of a camera in clinical practice. Particular in the case of low energy emitters, like Tc-99m, the influence of scattered radiation over the performance of cameras is very high. Therefore it is important to have test conditions of radionuclide imaging devices, that will approach as best as practicable the measuring conditions in clinical applications. It is therefore a good news that the International Electrochemical Commission IEC has prepared a draft 'Characteristics and test conditions of radionuclide imaging devices' which is now submitted to the national committees for formal approval under the Six Months' Rule. Some essential points of this document are discussed in the paper. (orig.) [de

  18. Corporate Testing: Standards, Profits, and the Demise of the Public Sphere

    Science.gov (United States)

    Leistyna, Pepi

    2007-01-01

    This article examines the standardized high-stakes testing in the wake of the No Child Left Behind (NCLB) movement. It focuses on the political economy of the testing industry; that is, a look into the ownership, intent, and regulation of the private forces that produce, provide materials, prep sessions, and tutorials for and evaluate, report on,…

  19. Standard Specification for Solar Simulation for Terrestrial Photovoltaic Testing

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This specification provides means for classifying solar simulators intended for indoor testing of photovoltaic devices (solar cells or modules), according to their spectral match to a reference spectral irradiance, non-uniformity of spatial irradiance, and temporal instability of irradiance. 1.2 Testing of photovoltaic devices may require the use of solar simulators. Test Methods that require specific classification of simulators as defined in this specification include Test Methods E948, E1036, and E1362. 1.3 This standard is applicable to both pulsed and steady state simulators and includes recommended test requirements used for classifying such simulators. 1.4 A solar simulator usually consists of three major components: (1) light source(s) and associated power supply; (2) any optics and filters required to modify the output beam to meet the classification requirements in Section 4; and (3) the necessary controls to operate the simulator, adjust irradiance, etc. 1.5 A light source that does not mee...

  20. Standard testing procedures for optical fiber and unshielded twisted pair at Sandia National Laboratories

    Energy Technology Data Exchange (ETDEWEB)

    Adams, R.L.

    1993-11-01

    This document will establish a working standard for testing optical fiber and unshielded twisted pair cables included in the Lab-wide telecommunications cabling system. The purpose of these standard testing procedures is to deliver to all Sandians a reliable, low-maintenance, state-of-the-art, ubiquitous telecommunications cabling infrastructure capable of satisfying all current and future telecommunication needs.

  1. Clinical assessment, design and performance testing of mobile shower commodes for adults with spinal cord injury: an exploratory review.

    Science.gov (United States)

    Friesen, Emma; Theodoros, Deborah; Russell, Trevor

    2013-07-01

    The purpose of this article is to explore evidence concerning clinical assessment, design and performance testing of mobile shower commodes used by adults with spinal cord injury (SCI). Searches of electronic databases, conference proceedings and key journals were undertaken with no restriction on language or study design. Keywords included spinal cord injury, lesion, sanichair, sanitary chair, shower chair, bowel chair and commode. A total of 20 publications were included in this review. Common approaches to clinical assessments were questionnaires and observational analysis to assess bowel care routines, function and skin integrity. Design features addressed access for bowel care, postural support, transfers, stability, use in wet environments and skin integrity. Objective performance measures addressed requirements for static stability, backward-sloping seat angles, arm supports and seat materials. Evidence reviewed was of low methodological quality and lacking in validated instruments to guide clinical practice. Further high-quality research is needed to identify bathing, showering and personal hygiene tasks affecting mobile shower commodes use and to develop validated clinical assessment tools. Performance testing to published standards is also needed.

  2. Standard test method for radiochemical determination of uranium isotopes in urine by alpha spectrometry

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2011-01-01

    1.1 This test method is applicable to the determination of uranium in urine at levels of detection dependent on sample size, count time, detector background, and tracer yield. It is designed as a screening tool for detection of possible exposure of occupational workers. 1.2 This test method is designed for 50 mL of urine. This test method does not address the sampling protocol or sample preservation methods associated with its use. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  3. 78 FR 70324 - Thy Hydrostatic Testing Provision of the Portable Fire Extinguishers Standard; Extension of the...

    Science.gov (United States)

    2013-11-25

    ... Hydrostatic Testing Provision of the Portable Fire Extinguishers Standard; Extension of the Office of...) approval of the information collection requirements contained in the Hydrostatic Testing provision of the... Hydrostatic Testing Provision of the Portable Fire Extinguishers Standard are necessary to reduce workers...

  4. Benefits of a Pharmacology Antimalarial Reference Standard and Proficiency Testing Program Provided by the Worldwide Antimalarial Resistance Network (WWARN)

    Science.gov (United States)

    Lourens, Chris; Lindegardh, Niklas; Barnes, Karen I.; Guerin, Philippe J.; Sibley, Carol H.; White, Nicholas J.

    2014-01-01

    Comprehensive assessment of antimalarial drug resistance should include measurements of antimalarial blood or plasma concentrations in clinical trials and in individual assessments of treatment failure so that true resistance can be differentiated from inadequate drug exposure. Pharmacometric modeling is necessary to assess pharmacokinetic-pharmacodynamic relationships in different populations to optimize dosing. To accomplish both effectively and to allow comparison of data from different laboratories, it is essential that drug concentration measurement is accurate. Proficiency testing (PT) of laboratory procedures is necessary for verification of assay results. Within the Worldwide Antimalarial Resistance Network (WWARN), the goal of the quality assurance/quality control (QA/QC) program is to facilitate and sustain high-quality antimalarial assays. The QA/QC program consists of an international PT program for pharmacology laboratories and a reference material (RM) program for the provision of antimalarial drug standards, metabolites, and internal standards for laboratory use. The RM program currently distributes accurately weighed quantities of antimalarial drug standards, metabolites, and internal standards to 44 pharmacology, in vitro, and drug quality testing laboratories. The pharmacology PT program has sent samples to eight laboratories in four rounds of testing. WWARN technical experts have provided advice for correcting identified problems to improve performance of subsequent analysis and ultimately improved the quality of data. Many participants have demonstrated substantial improvements over subsequent rounds of PT. The WWARN QA/QC program has improved the quality and value of antimalarial drug measurement in laboratories globally. It is a model that has potential to be applied to strengthening laboratories more widely and improving the therapeutics of other infectious diseases. PMID:24777099

  5. Antimicrobial effect of hydroalcoholic extract of saturega multica and zinc oxide namoparticle on coagulase gene expression on clinical and standard samples of MRSA (Methicilin resistant staph aureus

    Directory of Open Access Journals (Sweden)

    F Moridikia

    2016-06-01

    Full Text Available Background & aim: Methicillin-resistant Staphylococcus aureus (MRSA as nosocomial pathogens have been causing severe and deadly diseases around the world.  Coagulase is an important virulence factor for this bacterium and exisist in all staphylococcus aureus isolates. In recent years, studies carried out into the effects of medicinal plants, nanoparticles against bacteria and pathogenic bacteria’s expression genes. The aim of this study was to investigate the antimicrobial effect of satureja mutica hydroalcoholic extract, zinc oxide nanoparticle, and zinc complex on the coagulase gene expression in clinical and standard isolates of methicillin-resistant staphylococcus aureus (MRSA Methods: In the present quasi-experimental study, using micro dilution and MTT, the minimum inhibitory concentration (MIC of hydro-alcoholic extracts of satureja mutica and zinc oxide nanoparticles were tested against MRSA strains. By polymerase chain reaction ((RT- PCR coa gene expression in satureja mutica extract and zinc oxide nanoparticles treated were qualitatively evaluated. Data were analyzed using statistical tests Results: The MIC of hydro alcoholic extract of Satureja mutica  for standard strains and clinical S. aureus  were 3000 and 1500 µg/ml respectively, whereas, the MIC  of nanoparticle zinc oxide on Standards and clinical isolates  were 40 and 20 µg/ml.The hydro alcoholic extract of Satureja mutica on MIC concentration has significant inhibitory effect on coagulase gene expression but no effect was seen for clinical and standard MRSA. Conclusion: The results show a decline in the coa gene expression in vitro by RT- PCR method using satureja mutica  , but no effect on gene expression Housekeeping arc C. An inhibitory effect was observed on bacterial growth by zinc oxide nanoparticles, but no inhibitory effect on gene expression was seen.

  6. 42 CFR 493.1274 - Standard: Cytology.

    Science.gov (United States)

    2010-10-01

    ... (CONTINUED) STANDARDS AND CERTIFICATION LABORATORY REQUIREMENTS Quality System for Nonwaived Testing Analytic... must be completed before reporting patient results. (2) Laboratory comparison of clinical information... applicable requirements of this subpart K. (h) Documentation. The laboratory must document all control...

  7. 45 CFR 170.455 - Testing and certification to newer versions of certain standards.

    Science.gov (United States)

    2010-10-01

    ... INFORMATION TECHNOLOGY HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY Temporary Certification Program for HIT § 170.455 Testing and certification to newer versions of certain standards. (a) ONC-ATCBs...

  8. Standard Test Method for Measuring Heat Flux Using a Water-Cooled Calorimeter

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2005-01-01

    1.1 This test method covers the measurement of a steady heat flux to a given water-cooled surface by means of a system energy balance. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  9. New clinical validation method for automated sphygmomanometer: a proposal by Japan ISO-WG for sphygmomanometer standard.

    Science.gov (United States)

    Shirasaki, Osamu; Asou, Yosuke; Takahashi, Yukio

    2007-12-01

    Owing to fast or stepwise cuff deflation, or measuring at places other than the upper arm, the clinical accuracy of most recent automated sphygmomanometers (auto-BPMs) cannot be validated by one-arm simultaneous comparison, which would be the only accurate validation method based on auscultation. Two main alternative methods are provided by current standards, that is, two-arm simultaneous comparison (method 1) and one-arm sequential comparison (method 2); however, the accuracy of these validation methods might not be sufficient to compensate for the suspicious accuracy in lateral blood pressure (BP) differences (LD) and/or BP variations (BPV) between the device and reference readings. Thus, the Japan ISO-WG for sphygmomanometer standards has been studying a new method that might improve validation accuracy (method 3). The purpose of this study is to determine the appropriateness of method 3 by comparing immunity to LD and BPV with those of the current validation methods (methods 1 and 2). The validation accuracy of the above three methods was assessed in human participants [N=120, 45+/-15.3 years (mean+/-SD)]. An oscillometric automated monitor, Omron HEM-762, was used as the tested device. When compared with the others, methods 1 and 3 showed a smaller intra-individual standard deviation of device error (SD1), suggesting their higher reproducibility of validation. The SD1 by method 2 (P=0.004) significantly correlated with the participant's BP, supporting our hypothesis that the increased SD of device error by method 2 is at least partially caused by essential BPV. Method 3 showed a significantly (P=0.0044) smaller interparticipant SD of device error (SD2), suggesting its higher interparticipant consistency of validation. Among the methods of validation of the clinical accuracy of auto-BPMs, method 3, which showed the highest reproducibility and highest interparticipant consistency, can be proposed as being the most appropriate.

  10. 'False-positive' and 'false-negative' test results in clinical urine drug testing.

    Science.gov (United States)

    Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

    2009-08-01

    The terms 'false-positive' and 'false-negative' are widely used in discussions of urine drug test (UDT) results. These terms are inadequate because they are used in different ways by physicians and laboratory professionals and they are too narrow to encompass the larger universe of potentially misleading, inappropriate and unexpected drug test results. This larger universe, while not solely comprised of technically 'true' or 'false' positive or negative test results, presents comparable interpretive challenges with corresponding clinical implications. In this review, we propose the terms 'potentially inappropriate' positive or negative test results in reference to UDT results that are ambiguous or unexpected and subject to misinterpretation. Causes of potentially inappropriate positive UDT results include in vivo metabolic conversions of a drug, exposure to nonillicit sources of a drug and laboratory error. Causes of potentially inappropriate negative UDT results include limited assay specificity, absence of drug in the urine, presence of drug in the urine, but below established assay cutoff, specimen manipulation and laboratory error. Clinical UDT interpretation is a complicated task requiring knowledge of recent prescription, over-the-counter and herbal drug administration, drug metabolism and analytical sensitivities and specificities.

  11. Evaluation of a draft standard on performance specifications for health physics instrumentation: results for environmental tests

    International Nuclear Information System (INIS)

    Kenoyer, J.L.; Swinth, K.L.; Mashburn, K.R.; Selby, J.M.

    1984-06-01

    Draft ANSI Standard N42.17 on performance specifications for health physics instrumentation is currently being evaluated by the Pacific Northwest Laboratory. Evaluation is performed by testing a cross-section of currently available instruments with testing procedures based on specifications of the standard and then determining the degree of conformance to the various elements of the proposed standard. Data will be presented on the performance of a cross-section of beta-gamma survey instruments under various environmental tests. Test results that will be presented include temperature effects, humidity effects, radio frequency (r.f.) susceptibility, ambient pressure effects, vibration effects, and shock effects. Tests performed to date show that most instruments will meet the temperature, humidity, and ambient pressure tests. A large variability is noted among instruments from the same or different vendors. Preliminary r.f. susceptibility tests have shown large artificial responses at some frequencies for specific instruments. The presentation will also include a discussion of procedures used in the testing and weaknesses identified in the proposed standard

  12. Achieving Innovation and Affordability Through Standardization of Materials Development and Testing

    Science.gov (United States)

    Bray, M. H.; Zook, L. M.; Raley, R. E.; Chapman, C.

    2011-01-01

    The successful expansion of development, innovation, and production within the aeronautics industry during the 20th century was facilitated by collaboration of government agencies with the commercial aviation companies. One of the initial products conceived from the collaboration was the ANC-5 Bulletin, first published in 1937. The ANC-5 Bulletin had intended to standardize the requirements of various government agencies in the design of aircraft structure. The national space policy shift in priority for NASA with an emphasis on transferring the travel to low earth orbit to commercial space providers highlights an opportunity and a need for the national and global space industries. The same collaboration and standardization that is documented and maintained by the industry within MIL-HDBK-5 (MMPDS-01) and MIL-HBDK-17 (nonmetallic mechanical properties) can also be exploited to standardize the thermal performance properties, processing methods, test methods, and analytical methods for use in aircraft and spacecraft design and associated propulsion systems. In addition to the definition of thermal performance description and standardization, the standardization for test methods and analysis for extreme environments (high temperature, cryogenics, deep space radiation, etc) would also be highly valuable to the industry. Its subsequent revisions and conversion to MIL-HDBK-5 and then MMPDS-01 established and then expanded to contain standardized mechanical property design values and other related design information for metallic materials used in aircraft, missiles, and space vehicles. It also includes guidance on standardization of composition, processing, and analytical methods for presentation and inclusion into the handbook. This standardization enabled an expansion of the technologies to provide efficiency and reliability to the consumers. It can be established that many individual programs within the government agencies have been overcome with development costs

  13. Standard Test Method for Water Absorption of Core Materials for Structural Sandwich Constructions

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2001-01-01

    1.1 This test method covers the determination of the relative amount of water absorption by various types of structural core materials when immersed or in a high relative humidity environment. This test method is intended to apply to only structural core materials; honeycomb, foam, and balsa wood. 1.2 The values stated in SI units are to be regarded as the standard. The inch-pound units given may be approximate. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  14. The O3-Vet project: integration of a standard nomenclature of clinical terms in a veterinary electronic medical record for veterinary hospitals.

    Science.gov (United States)

    Zaninelli, M; Campagnoli, A; Reyes, M; Rojas, V

    2012-11-01

    In order to improve the hospital information system of the Chilean University Hospital, the Veterinary Medicine School of Universidad de Chile made a research cooperation with Università San Raffaele Roma to develop and test a new release of the O3-Vet software application. O3-Vet was selected by the Chilean University mainly for two reasons: (1) it uses human medicine standardized technologies such as "Health Level 7" (HL7) and "Integrating the Healthcare Enterprise" (IHE), which allow a good level of data sharing and hospital management; (2) it is open source, which means it can be adapted to specific hospital needs. In the new release, a subset of diagnostic terms was added from the "Systematized Nomenclature of Medicine Clinical Terms" (SNOMED CT), selected by the "American Animal Hospital Association" (AAHA) to standardize the filing of clinical data and its retrieval. Results from a limited survey of veterinarians of the University (n=9) show that the new release improved the management of the Chilean University Hospital and the ability to retrieve useful clinical data. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  15. Clinical utility and validity of minoxidil response testing in androgenetic alopecia.

    Science.gov (United States)

    Goren, Andy; Shapiro, Jerry; Roberts, Janet; McCoy, John; Desai, Nisha; Zarrab, Zoulikha; Pietrzak, Aldona; Lotti, Torello

    2015-01-01

    Clinical response to 5% topical minoxidil for the treatment of androgenetic alopecia (AGA) is typically observed after 3-6 months. Approximately 40% of patients will regrow hair. Given the prolonged treatment time required to elicit a response, a diagnostic test for ruling out nonresponders would have significant clinical utility. Two studies have previously reported that sulfotransferase enzyme activity in plucked hair follicles predicts a patient's response to topical minoxidil therapy. The aim of this study was to assess the clinical utility and validity of minoxidil response testing. In this communication, the present authors conducted an analysis of completed and ongoing studies of minoxidil response testing. The analysis confirmed the clinical utility of a sulfotransferase enzyme test in successfully ruling out 95.9% of nonresponders to topical minoxidil for the treatment of AGA. © 2014 Wiley Periodicals, Inc.

  16. Standard-E hydrogen monitoring system shop acceptance test procedure

    Energy Technology Data Exchange (ETDEWEB)

    Schneider, T.C.

    1997-10-02

    The purpose of this report is to document that the Standard-E Hydrogen Monitoring Systems (SHMS-E), fabricated by Mid-Columbia Engineering (MCE) for installation on the Waste Tank Farms in the Hanford 200 Areas, are constructed as intended by the design. The ATP performance will verify proper system fabrication.

  17. Standard-E hydrogen monitoring system shop acceptance test report

    International Nuclear Information System (INIS)

    Schneider, T.C.

    1997-01-01

    The purpose of this report is to document that the Standard-E Hydrogen Monitoring Systems (SHMS-E), fabricated by Mid-Columbia Engineering (MCE) for installation on the Waste Tank Farms in the Hanford 200 Areas, are constructed as intended by the design. The ATP performance will verify proper system fabrication

  18. Standardization of Data for Clinical Use and Research in Spinal Cord Injury

    DEFF Research Database (Denmark)

    Biering-Sørensen, Fin; Noonan, Vanessa K

    2016-01-01

    for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged...... to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements......Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able...

  19. Patient perspectives with abbreviated versus standard pre-test HIV counseling in the prenatal setting: a randomized-controlled, non-inferiority trial.

    Science.gov (United States)

    Cohan, Deborah; Gomez, Elvira; Greenberg, Mara; Washington, Sierra; Charlebois, Edwin D

    2009-01-01

    In the US, an unacceptably high percentage of pregnant women do not undergo prenatal HIV testing. Previous studies have found increased uptake of prenatal HIV testing with abbreviated pre-test counseling, however little is known about patient decision making, testing satisfaction and knowledge in this setting. A randomized-controlled, non-inferiority trial was conducted from October 2006 through February 2008 at San Francisco General Hospital (SFGH), the public teaching hospital of the City and County of San Francisco. A total of 278 English- and Spanish-speaking pregnant women were randomized to receive either abbreviated or standard nurse-performed HIV test counseling at the initial prenatal visit. Patient decision making experience was compared between abbreviated versus standard HIV counseling strategies among a sample of low-income, urban, ethnically diverse prenatal patients. The primary outcome was the decisional conflict score (DCS) using O'Connor low-literacy scale and secondary outcomes included satisfaction with test decision, basic HIV knowledge and HIV testing uptake. We conducted an intention-to-treat analysis of 278 women--134 (48.2%) in the abbreviated arm (AA) and 144 (51.8%) in the standard arm (SA). There was no significant difference in the proportion of women with low decisional conflict (71.6% in AA vs. 76.4% in SA, p = .37), and the observed mean difference between the groups of 3.88 (95% CI: -0.65, 8.41) did not exceed the non-inferiority margin. HIV testing uptake was very high (97. 8%) and did not differ significantly between the 2 groups (99.3% in AA vs. 96.5% in SA, p = .12). Likewise, there was no difference in satisfaction with testing decision (97.8% in AA vs. 99.3% in SA, p = .36). However, women in AA had significantly lower mean HIV knowledge scores (78.4%) compared to women in SA (83.7%, pprocess, while associated with slightly lower knowledge, does not compromise patient decision making or satisfaction regarding HIV testing

  20. Effectiveness of Standardized Patient Simulations in Teaching Clinical Communication Skills to Dental Students.

    Science.gov (United States)

    McKenzie, Carly T; Tilashalski, Ken R; Peterson, Dawn Taylor; White, Marjorie Lee

    2017-10-01

    The aim of this study was to investigate dental students' long-term retention of clinical communication skills learned in a second-year standardized patient simulation at one U.S. dental school. Retention was measured by students' performance with an actual patient during their fourth year. The high-fidelity simulation exercise focused on clinical communication skills took place during the spring term of the students' second year. The effect of the simulation was measured by comparing the fourth-year clinical performance of two groups: those who had participated in the simulation (intervention group; Class of 2016) and those who had not (no intervention/control group; Class of 2015). In the no intervention group, all 47 students participated; in the intervention group, 58 of 59 students participated. Both instructor assessments and students' self-assessments were used to evaluate the effectiveness of key patient interaction principles as well as comprehensive presentation of multiple treatment options. The results showed that students in the intervention group more frequently included cost during their treatment option presentation than did students in the no intervention group. The instructor ratings showed that the intervention group included all key treatment option components except duration more frequently than did the no intervention group. However, the simulation experience did not result in significantly more effective student-patient clinical communication on any of the items measured. This study presents limited evidence of the effectiveness of a standardized patient simulation to improve dental students' long-term clinical communication skills with respect to thorough presentation of treatment options to a patient.

  1. Standard test method for measurement of corrosion potentials of Aluminum alloys

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1997-01-01

    1.1 This test method covers a procedure for measurement of the corrosion potential (see Note 1) of an aluminum alloy in an aqueous solution of sodium chloride with enough hydrogen peroxide added to provide an ample supply of cathodic reactant. Note 1—The corrosion potential is sometimes referred to as the open-circuit solution or rest potential. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  2. Standard practice for preparing, cleaning, and evaluating corrosion test specimens

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2003-01-01

    1.1 This practice covers suggested procedures for preparing bare, solid metal specimens for tests, for removing corrosion products after the test has been completed, and for evaluating the corrosion damage that has occurred. Emphasis is placed on procedures related to the evaluation of corrosion by mass loss and pitting measurements. (Warning—In many cases the corrosion product on the reactive metals titanium and zirconium is a hard and tightly bonded oxide that defies removal by chemical or ordinary mechanical means. In many such cases, corrosion rates are established by mass gain rather than mass loss.) 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. For specific precautionary statements, see 1 and 7.2.

  3. [Procedure of seed quality testing and seed grading standard of Prunus humilis].

    Science.gov (United States)

    Wen, Hao; Ren, Guang-Xi; Gao, Ya; Luo, Jun; Liu, Chun-Sheng; Li, Wei-Dong

    2014-11-01

    So far there exists no corresponding quality test procedures and grading standards for the seed of Prunus humilis, which is one of the important source of base of semen pruni. Therefor we set up test procedures that are adapt to characteristics of the P. humilis seed through the study of the test of sampling, seed purity, thousand-grain weight, seed moisture, seed viability and germination percentage. 50 cases of seed specimens of P. humilis tested. The related data were analyzed by cluster analysis. Through this research, the seed quality test procedure was developed, and the seed quality grading standard was formulated. The seed quality of each grade should meet the following requirements: for first grade seeds, germination percentage ≥ 68%, thousand-grain weight 383 g, purity ≥ 93%, seed moisture ≤ 5%; for second grade seeds, germination percentage ≥ 26%, thousand-grain weight ≥ 266 g, purity ≥ 73%, seed moisture ≤9%; for third grade seeds, germination percentage ≥ 10%, purity ≥ 50%, thousand-grain weight ≥ 08 g, seed moisture ≤ 13%.

  4. Choose of standard materials in the method of β-testing new materials' mass thickness

    International Nuclear Information System (INIS)

    Chen Zhong

    2007-01-01

    To make sure of the standard mass thickness in beta radials testing mass thickness, this paper calculate using M. C. method and get the result of the relations between the beta radials' transmission rate of different energies and mass thickness in different materials. This result prove that in method of beta test mass thickness choosing materials whose elements are close as standard materials are viable. (authors)

  5. Diagnosis and management of clinical and subclinical cobalamin deficiencies: why controversies persist in the age of sensitive metabolic testing.

    Science.gov (United States)

    Carmel, Ralph

    2013-05-01

    In the past two decades, sensitive biochemical tests have uncovered cobalamin deficiency much more frequently than ever before. Almost all cases involve mild, biochemical changes without clinical manifestations (subclinical cobalamin deficiency; SCCD), whose health impact is unclear. Because the causes of SCCD are most often unknown, nonmalabsorptive, and seldom documented, controversy and confusion surround the diagnostic criteria and, inevitably, consequences and management of SCCD. To complicate matters, our grasp of the rarer clinical deficiency, usually a serious, progressive medical disease rooted in severe malabsorption, has receded as absorption testing has disappeared. Reexamining the accumulation of assumptions and misperceptions about cobalamin deficiency and distinguishing SCCD from clinical deficiency is long overdue. The biology of cobalamin provides an important starting point: cobalamin stores exceed daily losses so greatly and binding proteins regulate absorption so effectively that deficiency typically achieves clinical expression only after years of severe, relentless malabsorption. Dietary insufficiency, mild, partial malabsorption, and other incomplete, intermittent causes can usually produce only SCCD. Thus, the most fundamental difference between the two deficiencies is the relentlessness of the underlying cause, which determines prognosis and health impact. Inattention to absorptive status has exacerbated the limitations of biochemical testing. All the biochemical tests are highly sensitive but specificity is poor, no diagnostic gold standard exists, and diagnostic cutpoints fluctuate excessively. To limit the adverse diagnostic consequences, the diagnosis of SCCD, whose need for treatment is unclear, should be deferred unless at least two tests are abnormal. Indeed, cobalamin biology indicates that the absorption system, while enhancing cobalamin delivery, also sets a strict upper limit on it, which suggests that cobalamin excess is

  6. Clinical trial or standard treatment? Shared decision making at the department of oncology

    DEFF Research Database (Denmark)

    Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

    2016-01-01

    Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

  7. Standard Test Method for Measuring Heat-Transfer Rate Using a Thermal Capacitance (Slug) Calorimeter

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2008-01-01

    1.1 This test method describes the measurement of heat transfer rate using a thermal capacitance-type calorimeter which assumes one-dimensional heat conduction into a cylindrical piece of material (slug) with known physical properties. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. Note 1—For information see Test Methods E 285, E 422, E 458, E 459, and E 511.

  8. Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa.

    Directory of Open Access Journals (Sweden)

    Ziningi Jaya

    Full Text Available Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC clinics in rural KwaZulu-Natal (KZN, South Africa.We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic's compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor. A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05.Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2% of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics' average rating score for compliance to the WHO guidelines ranged

  9. Evaluating quality management systems for HIV rapid testing services in primary healthcare clinics in rural KwaZulu-Natal, South Africa.

    Science.gov (United States)

    Jaya, Ziningi; Drain, Paul K; Mashamba-Thompson, Tivani P

    2017-01-01

    Rapid HIV tests have improved access to HIV diagnosis and treatment by providing quick and convenient testing in rural clinics and resource-limited settings. In this study, we evaluated the quality management system for voluntary and provider-initiated point-of-care HIV testing in primary healthcare (PHC) clinics in rural KwaZulu-Natal (KZN), South Africa. We conducted a quality assessment audit in eleven PHC clinics that offer voluntary HIV testing and counselling in rural KZN, South Africa from August 2015 to October 2016. All the participating clinics were purposively selected from the province-wide survey of diagnostic services. We completed an on-site monitoring checklist, adopted from the WHO guidelines for assuring accuracy and reliability of HIV rapid tests, to assess the quality management system for HIV rapid testing at each clinic. To determine clinic's compliance to WHO quality standards for HIV rapid testing the following quality measure was used, a 3-point scale (high, moderate and poor). A high score was defined as a percentage rating of 90 to 100%, moderate was defined as a percentage rating of 70 to 90%, and poor was defined as a percentage rating of less than 70%. Clinic audit scores were summarized and compared. We employed Pearson pair wise correlation coefficient to determine correlations between clinics audit scores and clinic and clinics characteristics. Linear regression model was computed to estimate statistical significance of the correlates. Correlations were reported as significant at p ≤0.05. Nine out of 11 audited rural PHC clinics are located outside 20Km of the nearest town and hospital. Majority (18.2%) of the audited rural PHC clinics reported that HIV rapid test was performed by HIV lay counsellors. Overall, ten clinics were rated moderate, in terms of their compliance to the stipulated WHO guidelines. Audit results showed that rural PHC clinics' average rating score for compliance to the WHO guidelines ranged between 64.4% (CI

  10. Setting pass scores for clinical skills assessment.

    Science.gov (United States)

    Liu, Min; Liu, Keh-Min

    2008-12-01

    In a clinical skills assessment, the decision to pass or fail an examinee should be based on the test content or on the examinees' performance. The process of deciding a pass score is known as setting a standard of the examination. This requires a properly selected panel of expert judges and a suitable standard setting method, which best fits the purpose of the examination. Six standard setting methods that are often used in clinical skills assessment are described to provide an overview of the standard setting process.

  11. [Innovative Prenatal Testing: Clinical Applications and Ethical Considerations].

    Science.gov (United States)

    Huang, Mei-Chih; Lin, Shio-Jean; Chen, Chih-Ling; Huang, Tzu-Jung

    2017-10-01

    The biomedical technology related to prenatal screen/diagnosis has developed rapidly in recent decades. Many prenatal genetic examinations are now available to assist pregnant women to better understand the status and development of their fetus. Moreover, many commercial advertisements for innovative prenatal examinations are now shown in the media. Cell-free DNA Screening (cfDNA screening), a non-invasive prenatal testing (NIPT) procedure, is a safe and high accuracy test that may be done at an earlier gestational age to screen for fetal aneuploidy. The following questions should be considered when applying cfDNA screening in clinical practice: 1. what is cfDNA screening, 2. who are its potential users, and 3. what ethical and policy considerations are associated with this examination? This article provides relevant information, clinical practice guidelines, and ethical / policy considerations related to cfDNA screening. Discussing cases involving different clinical situations helps promote understanding of cfDNA screening and maternal-care quality.

  12. What do standard radiography and clinical examination tell about the shoulder with cuff tear arthropathy?

    Directory of Open Access Journals (Sweden)

    Favard Luc

    2011-01-01

    Full Text Available Abstract Background This study evaluates the preoperative conventional anteroposterior radiography and clinical testing in non-operated patients with cuff tear arthropathy. It analyses the radiological findings in relation to the status of the rotator cuff and clinical status as also the clinical testing in relation to the rotator cuff quality. The aim of the study is to define the usefulness of radiography and clinical examination in cuff tear arthropathy. Methods This study analyses the preoperative radiological (AP-view, (Artro-CT-scan or MRI-scan and clinical characteristics (Constant-Murley-score plus active and passive mobility testing and the peroperative findings in a cohort of 307 patients. These patients were part of a multicenter, retrospective, consecutive study of the French Orthopaedic Society (SOFCOT-2006. All patients had no surgical antecedents and were all treated with prosthetic shoulder surgery for a painful irreparable cuff tear arthropathy (reverse-(84% or hemi-(8% or double cup-bipolar prosthesis (8%. Results A positive significancy could be found for the relationship between clinical testing and the rotator cuff quality; between acromiohumeral distance and posterior rotator cuff quality; between femoralization and posterior rotator cuff quality. Conclusion A conventional antero-posterior radiograph can not provide any predictive information on the clinical status of the patient. The subscapular muscle can be well tested by the press belly test and the teres minor muscle can be well tested by the hornblower' sign and by the exorotation lag signs. The upward migration index and the presence of femoralization are good indicators for the evaluation of the posterior rotator cuff. An inferior coracoid tip positioning suggests rotator cuff disease.

  13. A studentized permutation test for three-arm trials in the 'gold standard' design.

    Science.gov (United States)

    Mütze, Tobias; Konietschke, Frank; Munk, Axel; Friede, Tim

    2017-03-15

    The 'gold standard' design for three-arm trials refers to trials with an active control and a placebo control in addition to the experimental treatment group. This trial design is recommended when being ethically justifiable and it allows the simultaneous comparison of experimental treatment, active control, and placebo. Parametric testing methods have been studied plentifully over the past years. However, these methods often tend to be liberal or conservative when distributional assumptions are not met particularly with small sample sizes. In this article, we introduce a studentized permutation test for testing non-inferiority and superiority of the experimental treatment compared with the active control in three-arm trials in the 'gold standard' design. The performance of the studentized permutation test for finite sample sizes is assessed in a Monte Carlo simulation study under various parameter constellations. Emphasis is put on whether the studentized permutation test meets the target significance level. For comparison purposes, commonly used Wald-type tests, which do not make any distributional assumptions, are included in the simulation study. The simulation study shows that the presented studentized permutation test for assessing non-inferiority in three-arm trials in the 'gold standard' design outperforms its competitors, for instance the test based on a quasi-Poisson model, for count data. The methods discussed in this paper are implemented in the R package ThreeArmedTrials which is available on the comprehensive R archive network (CRAN). Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  14. An improved standard total dose test for CMOS space electronics

    International Nuclear Information System (INIS)

    Fleetwood, D.M.; Winokur, P.S.; Riewe, L.C.; Pease, R.L.

    1989-01-01

    The postirradiation response of hardened and commercial CMOS devices is investigated as a function of total dose, dose rate, and annealing time and temperature. Cobalt-60 irradiation at ≅ 200 rad(SiO 2 )/s followed by a 1-week 100 degrees C biased anneal and testing is shown to be an effective screen of hardened devices for space use. However, a similar screen and single-point test performed after Co-60 irradiation and elevated temperature anneal cannot be generally defined for commercial devices. In the absence of detailed knowledge about device and circuit radiation response, a two-point standard test is proposed to ensure space surviability of CMOS circuits: a Co-60 irradiation and test to screen against oxide-trapped charge related failures, and an additional rebound test to screen against interface-trap related failures. Testing implications for bipolar technologies are also discussed

  15. The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

    Science.gov (United States)

    Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

    2017-06-01

    The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

  16. Juvenile food limitation in standard tests: a warning to ecotoxicologists.

    NARCIS (Netherlands)

    Zimmer, E.I.; Jager, T.; Ducrot, V.; Kooijman, S.A.L.M.

    2012-01-01

    Standard ecotoxicological tests are as simple as possible and food sources are mainly chosen for practical reasons. Since some organisms change their food preferences during the life-cycle, they might be food limited at some stage if we do not account for such a switch. As organisms tend to respond

  17. Clinical and radiological instability following standard fenestration discectomy

    Directory of Open Access Journals (Sweden)

    Mascarenhas Amrithlal

    2009-01-01

    signs of instability are seen even in asymptomatic patients and so are not as reliable as clinical signs of instability. Standard fenestration discectomy does not destabilize the spine more than microdiscectomy.

  18. Standard Test Method for Measuring Optical Angular Deviation of Transparent Parts

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1996-01-01

    1.1 This test method covers measuring the angular deviation of a light ray imposed by transparent parts such as aircraft windscreens and canopies. The results are uncontaminated by the effects of lateral displacement, and the procedure may be performed in a relatively short optical path length. This is not intended as a referee standard. It is one convenient method for measuring angular deviations through transparent windows. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  19. Usage of Latent Class Analysis in Diagnostic Microbiology in the Absence of Gold Standard Test

    Directory of Open Access Journals (Sweden)

    Gul Bayram Abiha

    2016-12-01

    Full Text Available The evaluation of performance of various tests diagnostic tests in the absence of gold standard is an important problem. Latent class analysis (LCA is a statistical analysis method known for many years, especially in the absence of a gold standard for evaluation of diagnostic tests so that LCA has found its wide application area. During the last decade, LCA method has widely used in for determining sensivity and specifity of different microbiological tests. It has investigated in the diagnosis of mycobacterium tuberculosis, mycobacterium bovis, human papilloma virus, bordetella pertussis, influenza viruses, hepatitis E virus (HEV, hepatitis C virus (HCV and other various viral infections. Researchers have compared several diagnostic tests for the diagnosis of different pathogens with LCA. We aimed to evaluate performance of latent class analysis method used microbiological diagnosis in various diseases in several researches. When we took into account all of these tests' results, we suppose that LCA is a good statistical analysis method to assess different test performances in the absence of gold standard. [Archives Medical Review Journal 2016; 25(4.000: 467-488

  20. A Multi-Year Plan for Research, Development, and Prototype Testing of Standard Modular Hydropower Technology

    Energy Technology Data Exchange (ETDEWEB)

    Smith, Brennan T. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Welch, Tim [U.S. Department of Energy (DOE), Washington, DC (United States).Office of Energy Efficiency and Renewable Energy (EERE); Witt, Adam M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Stewart, Kevin M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Lee, Kyutae [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); DeNeale, Scott T. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Bevelhimer, Mark S. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Burress, Timothy A. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Pracheil, Brenda M. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Pries, Jason L. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); O' Connor, Patrick W. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Curd, Shelaine L. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Ekici, Kivanc [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Univ. of Tennessee, Knoxville, TN (United States); Papanicolaou, Thanos [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Univ. of Tennessee, Knoxville, TN (United States); Tsakiris, Achilleas [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Univ. of Tennessee, Knoxville, TN (United States); Kutz, Benjamin [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Univ. of Tennessee, Knoxville, TN (United States); Bishop, Norm [Knight Piesold, Denver, CO (United States); McKeown, Alisha [McKeown and Associates, Moberly, MO (United States); Rabon, Daniel [U.S. Department of Energy (DOE), Washington, DC (United States).Office of Energy Efficiency and Renewable Energy (EERE); Zimmerman, Gregory P. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Uria Martinez, Rocio [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); McManamay, Ryan A. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2017-02-01

    The Multi-Year Plan for Research, Development, and Prototype Testing of Standard Modular Hydropower Technology (MYRP) presents a strategy for specifying, designing, testing, and demonstrating the efficacy of standard modular hydropower (SMH) as an environmentally compatible and cost-optimized renewable electricity generation technology. The MYRP provides the context, background, and vision for testing the SMH hypothesis: if standardization, modularity, and preservation of stream functionality become essential and fully realized features of hydropower technology, project design, and regulatory processes, they will enable previously unrealized levels of new project development with increased acceptance, reduced costs, increased predictability of outcomes, and increased value to stakeholders. To achieve success in this effort, the MYRP outlines a framework of stakeholder-validated criteria, models, design tools, testing facilities, and assessment protocols that will facilitate the development of next-generation hydropower technologies.

  1. Aspergillus Polymerase Chain Reaction: Systematic Review of Evidence for Clinical Use in Comparison With Antigen Testing

    Science.gov (United States)

    White, P. Lewis; Wingard, John R.; Bretagne, Stéphane; Löffler, Jürgen; Patterson, Thomas F.; Slavin, Monica A.; Barnes, Rosemary A.; Pappas, Peter G.; Donnelly, J. Peter

    2015-01-01

    Background. Aspergillus polymerase chain reaction (PCR) was excluded from the European Organisation for the Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) definitions of invasive fungal disease because of limited standardization and validation. The definitions are being revised. Methods. A systematic literature review was performed to identify analytical and clinical information available on inclusion of galactomannan enzyme immunoassay (GM-EIA) (2002) and β-d-glucan (2008), providing a minimal threshold when considering PCR. Categorical parameters and statistical performance were compared. Results. When incorporated, GM-EIA and β-d-glucan sensitivities and specificities for diagnosing invasive aspergillosis were 81.6% and 91.6%, and 76.9% and 89.4%, respectively. Aspergillus PCR has similar sensitivity and specificity (76.8%–88.0% and 75.0%–94.5%, respectively) and comparable utility. Methodological recommendations and commercial PCR assays assist standardization. Although all tests have limitations, currently, PCR is the only test with independent quality control. Conclusions. We propose that there is sufficient evidence that is at least equivalent to that used to include GM-EIA and β-d-glucan testing, and that PCR is now mature enough for inclusion in the EORTC/MSG definitions. PMID:26113653

  2. Evaluation of Fatigue Behavior in Dental Implants from In Vitro Clinical Tests: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Rosa Rojo

    2018-05-01

    Full Text Available In the area of dentistry, there is a wide variety of designs of dental implant and materials, especially titanium, which aims to avoid failures and increase their clinical durability. The purpose of this review was to evaluate fatigue behavior in different connections and implant materials, as well as their loading conditions and response to failure. In vitro tests under normal and dynamic loading conditions evaluating fatigue at implant and abutment connection were included. A search was conducted in PubMed, Scopus, and Science Direct. Data extraction was performed independently by two reviewers. The quality of selected studies was assessed using the Cochrane Handbook proposed by the tool for clinical trials. Nineteen studies were included. Fourteen studies had an unclear risk and five had high risk of bias. Due to the heterogeneity of the data and the evaluation of the quality of the studies, meta-analysis could not be performed. Evidence from this study suggests that both internal and morse taper connections presented a better behavior to failure. However, it is necessary to unify criteria in the methodological design of in vitro studies, following methodological guidelines and establishing conditions that allow the homogenization of designs in ISO (International Organization for Standardization standards.

  3. Current clinical trials testing combinations of immunotherapy and radiation.

    Science.gov (United States)

    Crittenden, Marka; Kohrt, Holbrook; Levy, Ronald; Jones, Jennifer; Camphausen, Kevin; Dicker, Adam; Demaria, Sandra; Formenti, Silvia

    2015-01-01

    Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an abscopal effect. Granulocyte-macrophage colony-stimulating factor was administered during radiotherapy to a metastatic site in patients with metastatic solid tumors to translate evidence obtained in a murine model of syngeneic mammary carcinoma treated with cytokine FLT-3L and radiation. Subsequent clinical availability of vaccines and immune checkpoint inhibitors has triggered a wave of enthusiasm for testing them in combination with radiotherapy. Examples of ongoing clinical trials are described in this report. Importantly, most of these trials include careful immune monitoring of the patients enrolled and will generate important data about the proimmunogenic effects of radiation in combination with a variety of immune modulators, in different disease settings. Results of these studies are building a platform of evidence for radiotherapy as an adjuvant to immunotherapy and encourage the growth of this novel field of radiation oncology. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Characterization and Comparison of the 10-2 SITA-Standard and Fast Algorithms

    Directory of Open Access Journals (Sweden)

    Yaniv Barkana

    2012-01-01

    Full Text Available Purpose: To compare the 10-2 SITA-standard and SITA-fast visual field programs in patients with glaucoma. Methods: We enrolled 26 patients with open angle glaucoma with involvement of at least one paracentral location on 24-2 SITA-standard field test. Each subject performed 10-2 SITA-standard and SITA-fast tests. Within 2 months this sequence of tests was repeated. Results: SITA-fast was 30% shorter than SITA-standard (5.5±1.1 vs 7.9±1.1 minutes, <0.001. Mean MD was statistically significantly higher for SITA-standard compared with SITA-fast at first visit (Δ=0.3 dB, =0.017 but not second visit. Inter-visit difference in MD or in number of depressed points was not significant for both programs. Bland-Altman analysis showed that clinically significant variations can exist in individual instances between the 2 programs and between repeat tests with the same program. Conclusions: The 10-2 SITA-fast algorithm is significantly shorter than SITA-standard. The two programs have similar long-term variability. Average same-visit between-program and same-program between-visit sensitivity results were similar for the study population, but clinically significant variability was observed for some individual test pairs. Group inter- and intra-program test results may be comparable, but in the management of the individual patient field change should be verified by repeat testing.

  5. BARTTest: Community-Standard Atmospheric Radiative-Transfer and Retrieval Tests

    Science.gov (United States)

    Harrington, Joseph; Himes, Michael D.; Cubillos, Patricio E.; Blecic, Jasmina; Challener, Ryan C.

    2018-01-01

    Atmospheric radiative transfer (RT) codes are used both to predict planetary and brown-dwarf spectra and in retrieval algorithms to infer atmospheric chemistry, clouds, and thermal structure from observations. Observational plans, theoretical models, and scientific results depend on the correctness of these calculations. Yet, the calculations are complex and the codes implementing them are often written without modern software-verification techniques. The community needs a suite of test calculations with analytically, numerically, or at least community-verified results. We therefore present the Bayesian Atmospheric Radiative Transfer Test Suite, or BARTTest. BARTTest has four categories of tests: analytically verified RT tests of simple atmospheres (single line in single layer, line blends, saturation, isothermal, multiple line-list combination, etc.), community-verified RT tests of complex atmospheres, synthetic retrieval tests on simulated data with known answers, and community-verified real-data retrieval tests.BARTTest is open-source software intended for community use and further development. It is available at https://github.com/ExOSPORTS/BARTTest. We propose this test suite as a standard for verifying atmospheric RT and retrieval codes, analogous to the Held-Suarez test for general circulation models. This work was supported by NASA Planetary Atmospheres grant NX12AI69G, NASA Astrophysics Data Analysis Program grant NNX13AF38G, and NASA Exoplanets Research Program grant NNX17AB62G.

  6. Developing a Standard Method of Test for Packaged, Solid-Desiccant Based Dehumidification Systems

    International Nuclear Information System (INIS)

    Sand, J.R.

    2001-01-01

    A draft Method of Test (MOT) has been proposed for packaged, air-to-air, desiccant-based dehumidifier systems that incorporate a thermally-regenerated desiccant material for dehumidification. This MOT is intended to function as the ''system'' testing and rating compliment to the desiccant ''component'' (desiccant wheels and/or cassettes) MOT (ASHRAE 1998) and rating standard (ARI 1998) already adopted by industry. This draft standard applies to ''packaged systems'' that: Use desiccants for dehumidification of conditioned air for buildings; Use heated air for regeneration of the desiccant material; Include fans for moving process and regeneration air; May include other system components for filtering, pre-cooling, post-cooling, or heating conditioned air; and May include other components for humidification of conditioned air. The proposed draft applies to four different system operating modes depending on whether outdoor or indoor air is used for process air and regeneration air streams . Only the ''ventilation'' mode which uses outdoor air for both process and regeneration inlets is evaluated in this paper. Performance of the dehumidification system is presented in terms that would be most familiar and useful to designers of building HVAC systems to facilitate integration of desiccant equipment with more conventional hardware. Parametric performance results from a modified, commercial desiccant dehumidifier undergoing laboratory testing were used as data input to evaluate the draft standard. Performance results calculated from this experimental input, results from an error-checking/heat-balance verification test built into the standard, and estimated comparisons between desiccant and similarly performing conventional dehumidification equipment are calculated and presented. Some variations in test procedures are suggested to aid in analytical assessment of individual component performance

  7. Standard test method for plutonium by Iron (II)/Chromium (VI) amperometric titration

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2002-01-01

    1.1 This test method covers the determination of plutonium in unirradiated nuclear-grade plutonium dioxide, uranium-plutonium mixed oxides with uranium (U)/plutonium (Pu) ratios up to 21, plutonium metal, and plutonium nitrate solutions. Optimum quantities of plutonium to measure are 7 to 15 mg. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  8. Setting Pass Scores for Clinical Skills Assessment

    Directory of Open Access Journals (Sweden)

    Min Liu

    2008-12-01

    Full Text Available In a clinical skills assessment, the decision to pass or fail an examinee should be based on the test content or on the examinees' performance. The process of deciding a pass score is known as setting a standard of the examination. This requires a properly selected panel of expert judges and a suitable standard setting method, which best fits the purpose of the examination. Six standard setting methods that are often used in clinical skills assessment are described to provide an overview of the standard setting process.

  9. Toward a Qualitative Analysis of Standardized Tests Using an Information Processing Model.

    Science.gov (United States)

    Armour-Thomas, Eleanor

    The use of standardized tests and test data to detect and address differences in cognitive styles is advocated here. To this end, the paper describes the componential theory of intelligence addressed by Sternberg et. al. This theory defines the components of intelligence by function and level of generality, including: (1) metacomponents: higher…

  10. Atopy patch tests in young adult patients with atopic dermatitis and controls: dose-response relationship, objective reading, reproducibility and clinical interpretation.

    Science.gov (United States)

    Bygum, Anette; Mortz, Charlotte Gotthard; Andersen, Klaus Ejner

    2003-01-01

    The clinical interpretation and reproducibility of atopy patch tests was studied in 23 selected young adult patients with atopic dermatitis and 25 healthy controls using standard inhalant allergens. Non-invasive measurements were used for objective assessment of test reactions and the participants were retested after 6 weeks. Ten of 19 (53%) evaluable patients with atopic dermatitis had at least one positive atopy patch test. However, there was no clear clinical relevance of the atopy patch test results when related to patient history and distribution of dermatitis. Reproducible and dose-dependent results were obtained with Dermatophagoides pteronyssinus, grass and cat with a reproducibility rate of 0.69 to 0.81 in patients and 0.60-0.96 in controls. A unique finding was a significant positive correlation between a positive atopy patch test, allergen dose and increase in transepidermal water loss and erythema, while measurement of capacitance did not distinguish between positive and negative reactions. The results of the present study do not support the routine use of atopy patch tests in the evaluation of adult patients with atopic dermatitis.

  11. Standard Test Method for Electrical Performance of Photovoltaic Cells Using Reference Cells Under Simulated Sunlight

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This test method covers the determination of the electrical performance of a photovoltaic cell under simulated sunlight by means of a calibrated reference cell procedure. 1.2 Electrical performance measurements are reported with respect to a select set of standard reporting conditions (SRC) (see Table 1) or to user-specified conditions. 1.2.1 The SRC or user-specified conditions include the cell temperature, the total irradiance, and the reference spectral irradiance distribution. 1.3 This test method is applicable only to photovoltaic cells with a linear response over the range of interest. 1.4 The cell parameters determined by this test method apply only at the time of test, and imply no past or future performance level. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this s...

  12. Standard-B auto grab sampler hydrogen monitoring system, Acceptance Test Report

    International Nuclear Information System (INIS)

    Lott, D.T.

    1995-01-01

    Project W-369, Watch List Tank Hydrogen Monitors, installed a Standard-C Hydrogen Monitoring System (SHMS) on the Flammable gas waste tank AN-104. General Support Projects (8K510) was support by Test Engineering (7CH30) in the performance of the Acceptance Test Procedures (ATP) to qualify the SHMS cabinets on the waste tank. The ATP's performance was controlled by Tank Farm work package. This completed ATP is transmitted by EDT-601748 as an Acceptance Test Report (ATR) in accordance with WHC-6-1, EP 4.2 and EP 1.12

  13. Experimental tests of the standard model

    International Nuclear Information System (INIS)

    Nodulman, L.

    1998-01-01

    The title implies an impossibly broad field, as the Standard Model includes the fermion matter states, as well as the forces and fields of SU(3) x SU(2) x U(1). For practical purposes, I will confine myself to electroweak unification, as discussed in the lectures of M. Herrero. Quarks and mixing were discussed in the lectures of R. Aleksan, and leptons and mixing were discussed in the lectures of K. Nakamura. I will essentially assume universality, that is flavor independence, rather than discussing tests of it. I will not pursue tests of QED beyond noting the consistency and precision of measurements of α EM in various processes including the Lamb shift, the anomalous magnetic moment (g-2) of the electron, and the quantum Hall effect. The fantastic precision and agreement of these predictions and measurements is something that convinces people that there may be something to this science enterprise. Also impressive is the success of the ''Universal Fermi Interaction'' description of beta decay processes, or in more modern parlance, weak charged current interactions. With one coupling constant G F , most precisely determined in muon decay, a huge number of nuclear instabilities are described. The slightly slow rate for neutron beta decay was one of the initial pieces of evidence for Cabbibo mixing, now generalized so that all charged current decays of any flavor are covered

  14. Adaption and Standardization of the Test of Visual-Motor Skills Revised

    Directory of Open Access Journals (Sweden)

    Mozhgan Farahbod

    2004-06-01

    Full Text Available Objective: This research has been carried out with the aim of adaptation, standardization and finding the validity and reliability of Visual-Motor Skills-revised Test for children. Materials & Methods: A multi-stage sampling from the children of the city of Tehran resulted in a sample of 1281 subjects, ages 2,11 through 13,11.the test consisted of 23 geometric designs and each of the designs was assessed through a definite criteria and was scored as errors(weakness and accuracies(strength.For adaptation and standardization of this test, at first step the examiner`s manual and the test items were translated into Farsi. The final form of the test was obtained after performing the pre-tryout and tryout stages, and doing the data analysis by classic model of reliability. Internal consistency coefficients of the subtests were obtained by Cronbach`s Alpha time consistency of the subtests and compound scores were obtained by test-retest. Alpha coefficients for the compound scores were obtained by Guilford formula, which is designed for estimating the compound scores. To obtain the content validity, criterion-related validity and construct validity of the subtests and compound scores, appropriate methods were used. Results: The results obtained ensure the applicability of this test for the evaluation of visual-motor skills of children of Tehran. Conclusion: According to the findings, this test can be used for the disorders in eye-hand coordination, the identification of children with disorders in visual – motor skills. It can also be used for the documentation of the development of fine – motor skills specially in visual – motor skills in 3-14 years – old children.

  15. Standard Practice for Quality Management Systems for Nondestructive Testing Agencies

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This practice covers general requirements for the establishment and maintenance of a quality management system for agencies engaged in nondestructive testing (NDT). 1.2 This practice utilizes criteria contained in Practice E 543. 1.3 This practice utilizes criteria contained in American National Standard ANSI/ISO/ASQ Q9001–2000, Quality management systems—Requirements. 1.4 This practice recognizes the importance of establishing minimum safety criteria. 1.5 The use of SI or inch-pound units, or combinations thereof, will be the responsibility of the technical committee whose standards are referred to in this standard. 1.6 This practice does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this practice to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  16. Informed consent for clinical trials: a comparative study of standard versus simplified forms.

    Science.gov (United States)

    Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

    1998-05-06

    A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (Pinformed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

  17. Standard test method for determining nodularity and nodule count in ductile iron using image analysis

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2011-01-01

    1.1 This test method is used to determine the percent nodularity and the nodule count per unit area (that is, number of nodules per mm2) using a light microscopical image of graphite in nodular cast iron. Images generated by other devices, such as a scanning electron microscope, are not specifically addressed, but can be utilized if the system is calibrated in both x and y directions. 1.2 Measurement of secondary or temper carbon in other types of cast iron, for example, malleable cast iron or in graphitic tool steels, is not specifically included in this standard because of the different graphite shapes and sizes inherent to such grades 1.3 This standard deals only with the recommended test method and nothing in it should be construed as defining or establishing limits of acceptability or fitness for purpose of the material tested. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 This standard does not purport to address al...

  18. Diagnostic tests for Helicobacter pylori : A prospective evaluation of their accuracy, without selecting a single test as the gold standard

    NARCIS (Netherlands)

    Thijs, J C; van Zwet, A A; Thijs, W J; Oey, H B; Karrenbeld, A; Stellaard, F; Luijt, D S; Meyer, B C; Kleibeuker, J H

    1996-01-01

    OBJECTIVE: To assess the accuracy of six commonly used diagnostic tests for Helicobacter pylori in a prospective study without using any specific test as the gold standard (the patient was regarded as H. pylori-infected if two or more tests, whatever their nature, were positive). METHODS: In 105

  19. Speech-in-Noise Tests and Supra-threshold Auditory Evoked Potentials as Metrics for Noise Damage and Clinical Trial Outcome Measures.

    Science.gov (United States)

    Le Prell, Colleen G; Brungart, Douglas S

    2016-09-01

    In humans, the accepted clinical standards for detecting hearing loss are the behavioral audiogram, based on the absolute detection threshold of pure-tones, and the threshold auditory brainstem response (ABR). The audiogram and the threshold ABR are reliable and sensitive measures of hearing thresholds in human listeners. However, recent results from noise-exposed animals demonstrate that noise exposure can cause substantial neurodegeneration in the peripheral auditory system without degrading pure-tone audiometric thresholds. It has been suggested that clinical measures of auditory performance conducted with stimuli presented above the detection threshold may be more sensitive than the behavioral audiogram in detecting early-stage noise-induced hearing loss in listeners with audiometric thresholds within normal limits. Supra-threshold speech-in-noise testing and supra-threshold ABR responses are reviewed here, given that they may be useful supplements to the behavioral audiogram for assessment of possible neurodegeneration in noise-exposed listeners. Supra-threshold tests may be useful for assessing the effects of noise on the human inner ear, and the effectiveness of interventions designed to prevent noise trauma. The current state of the science does not necessarily allow us to define a single set of best practice protocols. Nonetheless, we encourage investigators to incorporate these metrics into test batteries when feasible, with an effort to standardize procedures to the greatest extent possible as new reports emerge.

  20. Standard-Chinese Lexical Neighborhood Test in normal-hearing young children.

    Science.gov (United States)

    Liu, Chang; Liu, Sha; Zhang, Ning; Yang, Yilin; Kong, Ying; Zhang, Luo

    2011-06-01

    The purposes of the present study were to establish the Standard-Chinese version of Lexical Neighborhood Test (LNT) and to examine the lexical and age effects on spoken-word recognition in normal-hearing children. Six lists of monosyllabic and six lists of disyllabic words (20 words/list) were selected from the database of daily speech materials for normal-hearing (NH) children of ages 3-5 years. The lists were further divided into "easy" and "hard" halves according to the word frequency and neighborhood density in the database based on the theory of Neighborhood Activation Model (NAM). Ninety-six NH children (age ranged between 4.0 and 7.0 years) were divided into three different age groups of 1-year intervals. Speech-perception tests were conducted using the Standard-Chinese monosyllabic and disyllabic LNT. The inter-list performance was found to be equivalent and inter-rater reliability was high with 92.5-95% consistency. Results of word-recognition scores showed that the lexical effects were all significant. Children scored higher with disyllabic words than with monosyllabic words. "Easy" words scored higher than "hard" words. The word-recognition performance also increased with age in each lexical category. A multiple linear regression analysis showed that neighborhood density, age, and word frequency appeared to have increasingly more contributions to Chinese word recognition. The results of the present study indicated that performances of Chinese word recognition were influenced by word frequency, age, and neighborhood density, with word frequency playing a major role. These results were consistent with those in other languages, supporting the application of NAM in the Chinese language. The development of Standard-Chinese version of LNT and the establishment of a database of children of 4-6 years old can provide a reliable means for spoken-word recognition test in children with hearing impairment. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  1. Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators

    Science.gov (United States)

    2017-01-01

    Background Clinicians, such as respiratory therapists and physicians, are often required to set up pieces of medical equipment that use inconsistent terminology. Current lung ventilator terminology that is used by different manufacturers contributes to the risk of usage errors, and in turn the risk of ventilator-associated lung injuries and other conditions. Human factors and communication issues are often associated with ventilator-related sentinel events, and inconsistent ventilator terminology compounds these issues. This paper describes our proposed protocol, which will be implemented at the University of Waterloo, Canada when this project is externally funded. Objective We propose to determine whether a standardized vocabulary improves the ease of use, safety, and utility as it relates to the usability of medical devices, compared to legacy medical devices from multiple manufacturers, which use different terms. Methods We hypothesize that usage errors by clinicians will be lower when standardization is consistently applied by all manufacturers. The proposed study will experimentally examine the impact of standardized nomenclature on performance declines in the use of an unfamiliar ventilator product in clinically relevant scenarios. Participants will be respiratory therapy practitioners and trainees, and we propose studying approximately 60 participants. Results The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Conclusions The proposed study will help us better understand the effects of standardization on medical device usability. The study will also help identify any terms in the International Organization for Standardization (ISO) Draft International Standard (DIS) 19223 that may be associated with recurrent errors. Amendments to the standard will be proposed if recurrent errors are identified. This report contributes a protocol that can be used to assess the effect of

  2. Recommended reporting standards for test accuracy studies of infectious diseases of finfish, amphibians, molluscs and crustaceans: the STRADAS-aquatic checklist

    Science.gov (United States)

    Gardner, Ian A; Whittington, Richard J; Caraguel, Charles G B; Hick, Paul; Moody, Nicholas J G; Corbeil, Serge; Garver, Kyle A.; Warg, Janet V.; Arzul, Isabelle; Purcell, Maureen; St. J. Crane, Mark; Waltzek, Thomas B.; Olesen, Niels J; Lagno, Alicia Gallardo

    2016-01-01

    Complete and transparent reporting of key elements of diagnostic accuracy studies for infectious diseases in cultured and wild aquatic animals benefits end-users of these tests, enabling the rational design of surveillance programs, the assessment of test results from clinical cases and comparisons of diagnostic test performance. Based on deficiencies in the Standards for Reporting of Diagnostic Accuracy (STARD) guidelines identified in a prior finfish study (Gardner et al. 2014), we adapted the Standards for Reporting of Animal Diagnostic Accuracy Studies—paratuberculosis (STRADAS-paraTB) checklist of 25 reporting items to increase their relevance to finfish, amphibians, molluscs, and crustaceans and provided examples and explanations for each item. The checklist, known as STRADAS-aquatic, was developed and refined by an expert group of 14 transdisciplinary scientists with experience in test evaluation studies using field and experimental samples, in operation of reference laboratories for aquatic animal pathogens, and in development of international aquatic animal health policy. The main changes to the STRADAS-paraTB checklist were to nomenclature related to the species, the addition of guidelines for experimental challenge studies, and the designation of some items as relevant only to experimental studies and ante-mortem tests. We believe that adoption of these guidelines will improve reporting of primary studies of test accuracy for aquatic animal diseases and facilitate assessment of their fitness-for-purpose. Given the importance of diagnostic tests to underpin the Sanitary and Phytosanitary agreement of the World Trade Organization, the principles outlined in this paper should be applied to other World Organisation for Animal Health (OIE)-relevant species.

  3. The usefulness of the mannitol challenge test for asthma

    DEFF Research Database (Denmark)

    Porsbjerg, Celeste; Sverrild, Asger; Backer, Vibeke

    2013-01-01

    The mannitol test was developed as an easy-to-use, safe, standardized bronchial challenge test for diagnosing asthma in a wide range of clinical settings. The mannitol test has a moderate sensitivity and will only detect approximately 60% of asthma cases. Hence, a negative mannitol test cannot be......-inflammatory therapy. In this review, the current knowledge on the usefulness of the mannitol in a clinical setting as well as in clinical trials is presented and outstanding questions on the usefulness of the test are discussed.......The mannitol test was developed as an easy-to-use, safe, standardized bronchial challenge test for diagnosing asthma in a wide range of clinical settings. The mannitol test has a moderate sensitivity and will only detect approximately 60% of asthma cases. Hence, a negative mannitol test cannot...... be used to rule out asthma. The advantage of the mannitol test is a high specificity. In an individual with symptoms suggestive of asthma, a positive test indicates a high likelihood of asthma with ongoing airway inflammation and seems useful for detecting asthma requiring regular anti...

  4. Prototype of a Standards-Based EHR and Genetic Test Reporting Tool Coupled with HL7-Compliant Infobuttons

    Science.gov (United States)

    Crump, Jacob K.; Del Fiol, Guilherme; Williams, Marc S.; Freimuth, Robert R.

    2018-01-01

    Integration of genetic information is becoming increasingly important in clinical practice. However, genetic information is often ambiguous and difficult to understand, and clinicians have reported low-self-efficacy in integrating genetics into their care routine. The Health Level Seven (HL7) Infobutton standard helps to integrate online knowledge resources within Electronic Health Records (EHRs) and is required for EHR certification in the US. We implemented a prototype of a standards-based genetic reporting application coupled with infobuttons leveraging the Infobutton and Fast Healthcare Interoperability Resources (FHIR) Standards. Infobutton capabilities were provided by Open Infobutton, an open source package compliant with the HL7 Infobutton Standard. The resulting prototype demonstrates how standards-based reporting of genetic results, coupled with curated knowledge resources, can provide dynamic access to clinical knowledge on demand at the point of care. The proposed functionality can be enabled within any EHR system that has been certified through the US Meaningful Use program.

  5. Vehicle to Grid Communication Standards Development, Testing and Validation - Status Report

    Energy Technology Data Exchange (ETDEWEB)

    Gowri, Krishnan; Pratt, Richard M.; Tuffner, Francis K.; Kintner-Meyer, Michael CW

    2011-09-01

    In the US, more than 10,000 electric vehicles (EV) have been delivered to consumers during the first three quarters of 2011. A large majority of these vehicles are battery electric, often requiring 220 volt charging. Though the vehicle manufacturers and charging station manufacturers have provided consumers options for charging preferences, there are no existing communications between consumers and the utilities to manage the charging demand. There is also wide variation between manufacturers in their approach to support vehicle charging. There are in-vehicle networks, charging station networks, utility networks each using either cellular, Wi-Fi, ZigBee or other proprietary communication technology with no standards currently available for interoperability. The current situation of ad-hoc solutions is a major barrier to the wide adoption of electric vehicles. SAE, the International Standards Organization/International Electrotechnical Commission (ISO/IEC), ANSI, National Institute of Standards and Technology (NIST) and several industrial organizations are working towards the development of interoperability standards. PNNL has participated in the development and testing of these standards in an effort to accelerate the adoption and development of communication modules.

  6. Asymmetric dark matter annihilation as a test of non-standard cosmologies

    International Nuclear Information System (INIS)

    Gelmini, Graciela B.; Huh, Ji-Haeng; Rehagen, Thomas

    2013-01-01

    We show that the relic abundance of the minority component of asymmetric dark matter can be very sensitive to the expansion rate of the Universe and the temperature of transition between a non-standard pre-Big Bang Nucleosynthesis cosmological phase and the standard radiation dominated phase, if chemical decoupling happens before this transition. In particular, because the annihilation cross section of asymmetric dark matter is typically larger than that of symmetric dark matter in the standard cosmology, the decrease in relic density of the minority component in non-standard cosmologies with respect to the majority component may be compensated by the increase in annihilation cross section, so that the annihilation rate at present of asymmetric dark matter, contrary to general belief, could be larger than that of symmetric dark matter in the standard cosmology. Thus, if the annihilation cross section of the asymmetric dark matter candidate is known, the annihilation rate at present, if detectable, could be used to test the Universe before Big Bang Nucleosynthesis, an epoch from which we do not yet have any data

  7. Standard practice for preparation and use of direct tension stress-corrosion test specimens

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1985-01-01

    1.1 This practice covers procedures for designing, preparing, and using ASTM standard tension test specimens for investigating susceptibility to stress-corrosion cracking. Axially loaded specimens may be stressed quantitatively with equipment for application of either a constant load, constant strain, or with a continuously increasing strain. 1.2 Tension test specimens are adaptable for testing a wide variety of product forms as well as parts joined by welding, riveting, or various other methods. 1.3 The exposure of specimens in a corrosive environment is treated only briefly because other standards are being prepared to deal with this aspect. Meanwhile, the investigator is referred to Practices G35, G36, G37, and G44, and to ASTM Special Technical Publication 425 (1).

  8. Standard Test Methods for Properties of Continuous Filament Carbon and Graphite Fiber Tows

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    1999-01-01

    1.1 These test methods cover the preparation and tensile testing of resin-impregnated and consolidated test specimens made from continuous filament carbon and graphite yarns, rovings, and tows to determine their tensile properties. 1.2 These test methods also cover the determination of the density and mass per unit length of the yarn, roving, or tow to provide supplementary data for tensile property calculation. 1.3 These test methods include a procedure for sizing removal to provide the preferred desized fiber samples for density measurement. This procedure may also be used to determine the weight percent sizing. 1.4 These test methods include a procedure for determining the weight percent moisture adsorption of carbon or graphite fiber. 1.5 The values stated in SI units are to be regarded as the standard. The values in parentheses are for information only. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of t...

  9. Radiotherapy for pediatric brain tumors: Standard of care, current clinical trials, and new directions

    International Nuclear Information System (INIS)

    Kun, Larry E.

    1996-01-01

    Objectives: To review the clinical characteristics of childhood brain tumors, including neurologic signs, neuroimaging and neuropathology. To critically assess indications for therapy relevant to presenting characteristics, age, and disease status. To discuss current management strategies including neurosurgery, radiation therapy, and chemotherapy. To analyze current clinical trials and future directions of clinical research. Brain tumors account for 20% of neoplastic diseases in children. The most common tumors include astrocytoma and malignant gliomas, medulloblastoma and supratentorial PNET's, ependymoma, craniopharyngioma, and intracranial germ cell tumors. Tumor type and clinical course are often correlated with age at presentation and anatomic site. The clinical characteristics and disease extent largely determine the relative merits of available 'standard' and investigational therapeutic approaches. Treatment outcome, including disease control and functional integrity, is dependent upon age at presentation, tumor type, and disease extent. An understanding of the clinical, neuroimaging, and histologic characteristics as they relate to decisions regarding therapy is critical to the radiation oncologist. Appropriate radiation therapy is central to curative therapy for a majority of pediatric brain tumor presentations. Technical advances in neurosurgery provide greater safety for 'gross total resection' in a majority of hemispheric astrocytomas and medulloblastomas. The relative roles of 'standard' radiation therapy and evolving chemotherapy for centrally located astrocytomas (e.g., diencephalic, optic pathway) need to be analyzed in the context of initial and overall disease control, neurotoxicities, and potential modifications in the risk:benefit ratio apparent in the introduction of precision radiation techniques. Modifications in radiation delivery are fundamental to current investigations in medulloblastoma; the rationale for contemporary and projected

  10. A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research.

    Science.gov (United States)

    Cofiel, Luciana; Zammar, Guilherme R; Zaveri, Amrapali J; Shah, Jatin Y; Carvalho, Elias; Nahm, Meredith; Kesselring, Gustavo; Pietrobon, Ricardo

    2010-12-31

    Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. Future studies should explore ways of creating mechanisms which decrease the time and cost

  11. A system dynamics analysis determining willingness to wait and pay for the implementation of data standards in clinical research

    Science.gov (United States)

    2010-01-01

    Background Industry standards provide rigorous descriptions of required data presentation, with the aim of ensuring compatibility across different clinical studies. However despite their crucial importance, these standards are often not used as expected in the development of clinical research. The reasons for this lack of compliance could be related to the high cost and time-intensive nature of the process of data standards implementation. The objective of this study was to evaluate the value of the extra time and cost required for different levels of data standardisation and the likelihood of researchers to comply with these levels. Since we believe that the cost and time necessary for the implementation of data standards can change over time, System Dynamics (SD) analysis was used to investigate how these variables interact and influence the adoption of data standards by clinical researchers. Methods Three levels of data standards implementation were defined through focus group discussion involving four clinical research investigators. Ten Brazilian and eighteen American investigators responded to an online questionnaire which presented possible standards implementation scenarios, with respondents asked to choose one of two options available in each scenario. A random effects ordered probit model was used to estimate the effect of cost and time on investigators' willingness to adhere to data standards. The SD model was used to demonstrate the relationship between degrees of data standardisation and subsequent variation in cost and time required to start the associated study. Results A preference for low cost and rapid implementation times was observed, with investigators more likely to incur costs than to accept a time delay in project start-up. SD analysis indicated that although initially extra time and cost are necessary for clinical study standardisation, there is a decrease in both over time. Conclusions Future studies should explore ways of creating

  12. Nucleic acid tests for the detection of alpha human papillomaviruses.

    Science.gov (United States)

    Poljak, Mario; Cuzick, Jack; Kocjan, Boštjan J; Iftner, Thomas; Dillner, Joakim; Arbyn, Marc

    2012-11-20

    Testing for high-risk types of alpha human papillomaviruses (HPV) is an invaluable part of clinical guidelines for cervical carcinoma screening, management and treatment. In this comprehensive inventory of commercial tests for detection of alpha-HPV, we identified at least 125 distinct HPV tests and at least 84 variants of the original tests. However, only a small subset of HPV tests has documented clinical performance for any of the standard HPV testing indications. For more than 75% of HPV tests currently on the market, no single publication in peer-reviewed literature can be identified. HPV tests that have not been validated and lack proof of reliability, reproducibility and accuracy should not be used in clinical management. Once incorporated in the lab, it is essential that the whole procedure of HPV testing is subject to continuous and rigorous quality assurance to avoid sub-optimal, potentially harmful practices. Manufacturers of HPV tests are urged to put more effort into evaluating their current and future products analytically, using international standards, and for clinical applications, using clinically validated endpoints. To assist with analytical validation, the World Health Organization is developing international standards for HPV types other than HPV16 and HPV18 and is planning development of external quality control panels specifically designed to be used for performance evaluation of current and future HPV tests. There is a need for more competitively priced HPV tests, especially for resource-poor countries, and uniform test validation criteria based on international standards should enable issuing more competitive and fair tender notices for purchasing. Automation systems allowing large-scale testing, as well as further increases in clinical performance, are the main needs in the further improvement of HPV tests. This article forms part of a special supplement entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine

  13. Standardization of Data for Clinical Use and Research in Spinal Cord Injury

    Science.gov (United States)

    Biering-Sørensen, Fin; Noonan, Vanessa K.

    2016-01-01

    Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able to be uniformly collected at any SCI center or within any SCI study. Standardization will make it possible to collect information from larger SCI populations for multi-center research studies. With this aim, the international SCI community has obtained consensus regarding the best available data and measures for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society’s International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements Project within SCI and discuss future opportunities. PMID:27529284

  14. Ultrasonic testing standard of fusion joint for polythylene(PE) pipeline

    International Nuclear Information System (INIS)

    Lee, Euy Jong; Hur, Sam Suk; Chae, Gug Byeong

    2006-01-01

    The polyethylene(PE) pipes are widely used to transport city gas worldwide with steel pipes. Generally, Steel pipe are used for high pressure line and PE pipe for low pressure line whose pressure is less than 4 kg/m 2 . The steel pipe line are subject to 100 percent Radiographic Testing(RT) during installation stage, on the contrary, there has been no the established testing method for the welding fusion joint of polyethylene pipes, so all quality control is limited only Visual Testing(VT) or management of Fusion welding equipment. Even though PE pipeline is exposed to lower pressure than steel pipeline, the gas leakage from PE pipe may result in almost the same serious consequence from steel pipeline. So, it is necessary to develop the reliable testing standard for PE pipeline from the point of view of NDT engineers.

  15. A Study on the Improvement of Safety Testing Standards and Methods for Mammography

    International Nuclear Information System (INIS)

    Choi, Seon Hyeong; Jung, Ah Young; Yong, Hwan Seok; Kim, Do Wan; Jang, Gi Won; Cha, Sang Hoon; Jo, Sang Won; Park, Ji Koon

    2012-01-01

    To establish the improved national safety testing standards and methods for mammography. We investigated and compared the current status of mammographic equipment installation with the national and international safety and quality control programs and methods. We established and verified the draft for safety testing standards and methods. We propose that the investigations of the conductor system, hardware leakage radiation profile, illumination intensity test, comparison between X-ray and light photon exposure, X-ray dose exposure on the chest wall, compression equipment size, timing equipment, and the average effective radiation dose, should all be maintained as they are in the present state without any changes. However, the exposure radiation dose reproducibility, kVp and mAs, and the half value layer tests should be reconsidered and revised. Moreover, compression pressure and autonomic exposure control system (AEC) tests should be included as new criteria. Other parameter controls included in the phantom image analysis which overlap with total quality assurance should be excluded. We recommend that AEC and compression pressure tests should be included as new criteria and the methods for the exposure radiation dose reproducibility, kVp, and mAs, and half value layer tests should be reconsidered and revised.

  16. Testing of camera performance standards at steady and local overloading

    International Nuclear Information System (INIS)

    Keszthelyine Landori, S.; Adorjanne Farkas, M.; Csirik, J.

    1983-01-01

    Camera performance standards are usually given for low count rates and uniform irradiation. A conventional analog gamma camera system (Gamma MB 9100 manufactured under the know-how of Picker DC 4/12 in Hungary) was studied on the basis of the Picker test procedure and the NEMA standard system. Uniformity, linearity, spatial and energy resolution were measured at high count rates and uniform irradiation (steady overloading). Linearity was studied at local overloading. Linearity, spatial and energy resolution were measured by a 1024-channel analyzer-computer system of KFKI, Hungary. The data were evaluated on the basis of NEMA standards, while uniformity was measured by the Gamma data processing system and evaluated by special SEGAMS programs. Performance variations were studied between 7500 cps and 75.000 cps pulse rates. Spatial and energy resolution were influenced strongly, uniformity slightly by pulse rates, while linearity did not change at all. Linearity was not influenced even by local overloading. (author)

  17. Standard test method for measurement of roll wave optical distortion in heat-treated flat glass

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2008-01-01

    1.1 This test method is applicable to the determination of the peak-to-valley depth and peak-to-peak distances of the out-of-plane deformation referred to as roll wave which occurs in flat, heat-treated architectural glass substrates processed in a heat processing continuous or oscillating conveyance oven. 1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard. 1.3 This test method does not address other flatness issues like edge kink, ream, pocket distortion, bow, or other distortions outside of roll wave as defined in this test method. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  18. Analytical performance of centrifuge-based device for clinical chemistry testing.

    Science.gov (United States)

    Suk-Anake, Jamikorn; Promptmas, Chamras

    2012-01-01

    A centrifuge-based device has been introduced to the Samsung Blood Analyzer (SBA). The verification of this analyzer is essential to meet the ISO15189 standard. Analytical performance was evaluated according to the NCCLS EP05-A method. The results of plasma samples were compared between the SBA and a Hitachi 917 analyzer according to the NCCLS EP09-A2-IR method. Percent recovery was determined via analysis of original control serum and spiked serum. Within-run precision was found to be 0.00 - 6.61% and 0.96 - 5.99% in normal- and abnormal-level assays, respectively, while between-run precision was 1.31 - 9.09% and 0.89 - 6.92%, respectively. The correlation coefficients (r) were > 0.990. The SBA presented analytical accuracy at 96.64 +/- 3.39% to 102.82 +/- 2.75% and 98.31 +/- 4.04% to 103.61 +/- 8.28% recovery, respectively. The results obtained verify that all of the 13 tests performed using the SBA demonstrates good and reliable precision suitable for use in qualified clinical chemistry laboratory service.

  19. 15N liver function tests - concept, validity, clinical use

    International Nuclear Information System (INIS)

    Faust, H.; Jung, K.; Krumbiegel, P.; Hirschberg, K.; Reinhardt, R.; Junghans, P.

    1987-01-01

    Several liver function tests using the oral application of a nitrogen compound labelled with 15 N and the subsequent determination of 15 N in a certain fraction of urine by emission spectrometry are described. Because of the key position of the liver in the metabolism of nitrogen compounds the results of these tests allow conclusions concerning disturbances of special liver functions. Instructions for the clinical use of the '[ 15 N]Ammonium Test', '[ 15 N]Hippurate Test' the '[ 15 N]Methacetin Test', and the '[ 15 N]Glycine Test' are given. (author)

  20. Standardization, Validity and Reliability Study of Gülhane Aphasia Test-2 (GAT-2

    Directory of Open Access Journals (Sweden)

    İlknur Maviş

    2007-04-01

    Full Text Available OBJECTIVE: Gülhane Aphasia Test-2 (GAT-2 has been developed to show the presence of a language disorder ‘aphasia’ and to give the clinician implications for the accompanying speech disorders such as apraxia and dysarthria. OBJECTIVE: The aim of the study was to report standardization, validity and reliability study of GAT-2. METHODS: : 10 healthy individuals were tested initially for the pilot study. 134 healthy individual was included to the standardization study and 30 individuals with aphasia and 11 individuals with right brain injury was included to the validation study. The inter group GAT-2 score differentiations and the effects of age, years of education, sex variances were observed. GAT-2 cut-off scores were calculated by the scores of healthy individuals. GAT-2 test-retest reliability and inter-observer reliability was calculated. RESULTS: Healthy individuals’ GAT-2 scores were significantly different from the GAT-2 scores of aphasic patients, but not from right brain injured patients’. Healthy individuals’ GAT-2 scores were not affected from the sex, age variances but from years of education, so cut-off scores were calculated by this variance. GAT-2 scores of aphasic patients were not affected from age, sex and years of education. Test-retest and inter-observer reliability and internal consistency results showed that GAT-2 is a highly reliable aphasia screening test. CONCLUSION: GAT-2 was found to be a standardized, highly reliable and a valid aphasia test for Turkish stroke patients with aphasia

  1. Toward the establishment of standardized in vitro tests for lipid-based formulations, part 4

    DEFF Research Database (Denmark)

    Williams, Hywel D; Sassene, Philip; Kleberg, Karen

    2014-01-01

    The Lipid Formulation Classification System Consortium looks to develop standardized in vitro tests and to generate much-needed performance criteria for lipid-based formulations (LBFs). This article highlights the value of performing a second, more stressful digestion test to identify LBFs near...... a performance threshold and to facilitate lead formulation selection in instances where several LBF prototypes perform adequately under standard digestion conditions (but where further discrimination is necessary). Stressed digestion tests can be designed based on an understanding of the factors that affect LBF...... development, and facilitate dialogue with the regulatory authorities. This classification system is based on the concept that performance evaluations across three in vitro tests, designed to subject a LBF to progressively more challenging conditions, will enable effective LBF discrimination and performance...

  2. The effect of instructional methodology on high school students natural sciences standardized tests scores

    Science.gov (United States)

    Powell, P. E.

    Educators have recently come to consider inquiry based instruction as a more effective method of instruction than didactic instruction. Experience based learning theory suggests that student performance is linked to teaching method. However, research is limited on inquiry teaching and its effectiveness on preparing students to perform well on standardized tests. The purpose of the study to investigate whether one of these two teaching methodologies was more effective in increasing student performance on standardized science tests. The quasi experimental quantitative study was comprised of two stages. Stage 1 used a survey to identify teaching methods of a convenience sample of 57 teacher participants and determined level of inquiry used in instruction to place participants into instructional groups (the independent variable). Stage 2 used analysis of covariance (ANCOVA) to compare posttest scores on a standardized exam by teaching method. Additional analyses were conducted to examine the differences in science achievement by ethnicity, gender, and socioeconomic status by teaching methodology. Results demonstrated a statistically significant gain in test scores when taught using inquiry based instruction. Subpopulation analyses indicated all groups showed improved mean standardized test scores except African American students. The findings benefit teachers and students by presenting data supporting a method of content delivery that increases teacher efficacy and produces students with a greater cognition of science content that meets the school's mission and goals.

  3. Comparing the disk-diffusion and agar dilution tests for Neisseria gonorrhoeae antimicrobial susceptibility testing

    Directory of Open Access Journals (Sweden)

    Hsi Liu

    2016-11-01

    Full Text Available Abstract Background We assessed the validity of testing for antimicrobial susceptibility of clinical and mutant Neisseria gonorrhoeae (GC isolates by disk diffusion in comparison to agar dilution, and Etest® (bioMerieux, France, respectively, for three third generation extended spectrum cephalosporins (ESC: ceftriaxone (CRO, cefixime (CFX, and cefpodoxime (CPD. Methods One hundred and five clinical isolates and ten laboratory-mutants were tested following Clinical Laboratory Standard Institute (CLSI and manufacturer’s standards for each of the three methods. The measured diameters by the disk diffusion method were tested for correlation with the MIC values by agar dilution. In addition, comparisons with the Etest® were made. Categorical results for concordance, based on standard CLSI cutoffs, between the disk diffusion and the other two methods, respectively, were tested using the Chi-square statistics. Reproducibility was tested for CFX across a 6-month interval by repeated disk tests. Results Across all 115 specimens, the disk diffusion tests produced good categorical agreements, exhibiting concordance of 93.1%, 92.1%, and 90.4% with agar dilution and 93.0%, 92.1%, and 90.4% with Etest®, for CRO, CFX, and CPD, respectively. Pearson correlations between disk-diffusion diameters and agar dilution MIC’s were -0.59, -0.67, and -0.81 for CRO, CFX, and CPD, respectively. The correlations between disk diffusion and Etest® were -0.58, -0.73, and -0.49. Pearson correlation between the CFX disk readings over a 6-month interval was 91%. Conclusions Disk diffusion tests remain to be a useful, reliable and fast screening method for qualitative antimicrobial susceptibility testing for ceftriaxone, cefixime, and cefpodoxime.

  4. Inter-tester reliability of selected clinical tests for long-lasting temporomandibular disorders.

    Science.gov (United States)

    Julsvoll, Elisabeth Heggem; Vøllestad, Nina Køpke; Opseth, Gro; Robinson, Hilde Stendal

    2017-09-01

    Clinical tests used to examine patients with temporomandibular disorders vary in methodological quality, and some are not tested for reliability. The purpose of this cross-sectional study was to evaluate inter-tester reliability of clinical tests and a cluster of tests used to examine patients with long-lasting temporomandibular disorders. Forty patients with pain in the temporomandibular area treated by health-professionals were included. They were between 18-70 years, had 65 symptomatic (33 right/32 left) and 15 asymptomatic joints. Two manual therapists examined all participants with selected tests. Percentage agreement and the kappa coefficient ( k ) with 95% confidence interval (CI) were used to evaluate the tests with categorical outcomes. For tests with continuous outcomes, the relative inter-tester reliability was assessed by the intraclass-correlation-coefficient (ICC 3,1 , 95% CI) and the absolute reliability was calculated by the smallest detectable change (SDC). The best reliability among single tests was found for the dental stick test, the joint-sound test ( k  = 0.80-1.0) and range of mouth-opening (ICC 3,1 (95% CI) = 0.97 (0.95-0.98) and SDC = 4 mm). The reliability of cluster of tests was excellent with both four and five positive tests out of seven. The reliability was good to excellent for the clinical tests and the cluster of tests when performed by experienced therapists. The tests are feasible for use in the clinical setting. They require no advanced equipment and are easy to perform.

  5. Mechanical characteristics of historic mortars from tests on small-sample non-standard on small-sample non-standard specimens

    Czech Academy of Sciences Publication Activity Database

    Drdácký, Miloš; Slížková, Zuzana

    2008-01-01

    Roč. 17, č. 1 (2008), s. 20-29 ISSN 1407-7353 R&D Projects: GA ČR(CZ) GA103/06/1609 Institutional research plan: CEZ:AV0Z20710524 Keywords : small-sample non-standard testing * lime * historic mortar Subject RIV: AL - Art, Architecture, Cultural Heritage

  6. Standard-Model Tests with Superallowed β-Decay: An Important Application of Very Precise Mass Measurements

    International Nuclear Information System (INIS)

    Hardy, J. C.; Towner, I. S.

    2001-01-01

    Superallowed β-decay provides a sensitive means for probing the limitations of the Electroweak Standard Model. To date, the strengths (ft-values) of superallowed 0 +→ 0 + β-decay transitions have been determined with high precision from nine different short-lived nuclei, ranging from 10 C to 54 Co. Each result leads to an independent measure for the vector coupling constant G V and collectively the nine values can be used to test the conservation of the weak vector current (CVC). Within current uncertainties, the results support CVC to better than a few parts in 10,000 - a clear success for the Standard Model! However, when the average value of G V , as determined in this way, is combined with data from decays of the muon and kaon to test another prediction of the Standard Model, the result is much more provocative. A test of the unitarity of the Cabibbo-Kobayashi-Maskawa matrix fails by more than two standard deviations. This result can be made more definitive by experiments that require extremely precise mass measurements, in some cases on very short-lived (≤100 ms) nuclei. This talk presents the current status and future prospects for these Standard-Model tests, emphasizing the role of precise mass, or mass-difference measurements. There remains a real challenge to mass-measurement technique with the opportunity for significant new results

  7. Consensus based reporting standards for diagnostic test accuracy studies for paratuberculosis in ruminants.

    NARCIS (Netherlands)

    Gardner, I.A.; Nielsen, S.S.; Whittington, R.J.; Collins, M.T.; Bakker, D.; Harris, B.; Sreevatsan, S.; Lombard, J.E.; Sweeney, R.; Smith, D.R.; Gavalchin, J.; Eda, S.

    2011-01-01

    The Standards for Reporting of Diagnostic Accuracy (STARD) statement (www.stard-statement.org) was developed to encourage complete and transparent reporting of key elements of test accuracy studies in human medicine. The statement was motivated by widespread evidence of bias in test accuracy studies

  8. Standard Practice for Recording Data from Atmospheric Corrosion Tests of Metallic-Coated Steel Specimens

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2010-01-01

    1.1 This practice covers a procedure for recording data of atmospheric corrosion tests of metallic-coated steel specimens. Its objective is the assurance of (1) complete identification of materials before testing, (2) objective reporting of material appearance during visual inspections, and (3) adequate photographic, micrographic, and chemical laboratory examinations at specific stages of deterioration, and at the end of the tests. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  9. Standardized procedure for eddy-current testing of stainless steel, thin-walled nuclear fuel element cladding tubes

    Energy Technology Data Exchange (ETDEWEB)

    Barat, P; Raj, B; Bhattacharya, D K [Reactor Research Centre, Kalpakkam (India)

    1982-10-01

    Thin-walled nuclear fuel cladding tubes made of AISI 316 stainless steel have been examined by eddy-current testing. Standardization of the procedures has required investigations on optimizing the test frequency, finding a method to locate a defect with respect to the probe reference end, and the use of standard defects and sequential metallography of natural defects detected by eddy-current testing, to understand the influence of the nature of defects on the impedance output signals. Test frequency and method of locating the defect were optimized by the use of standard defects made by machining in reference cladding tubes. Subsequent metallography of natural defects detected by eddy-current testing revealed mainly clusters of inclusions but also other types of defects. The effect of the distribution of inclusions along the length of the tube on the impedance output is discussed.

  10. [Study on seed quality test and quality standard of Lonicera macranthoides].

    Science.gov (United States)

    Zhang, Ying; Xu, Jin; Li, Long-Yun; Cui, Guang-Lin; She, Yue-Hui

    2016-04-01

    Referring to the rules for agricultural seed testing (GB/T 3543-1995) issued by China, the test of sampling, purity, thousand seed weight, moisture, viability, relative conductivity and germination rate had been studied for seed quality test methods of Lonicera macranthoides. The seed quality from 38 different collection areas was measured to establish quality classification standard by K-means clustering. The results showed that at least 7.5 g seeds should be sampled, and passed 20-mesh sieve for purity analysis.The 500-seed method used to measure thousand seed weight. The moisture was determined by crushed seeds dried in high temperature (130±2) ℃ for 3 h.The viability determined by 25 ℃ 0.1% TTC stained 5h in dark. 1.0 g seeds soaked in 50 ml ultra pure water in 25 ℃ for 12 hours to determine the relative conductivity. The seed by 4 ℃stratification for 80 days were cultured on paper at 15 ℃. Quality of the seeds from different areas was divided into three grades. The primary seed quality classification standard was established.The I grade and II grade were recommend use in production. Copyright© by the Chinese Pharmaceutical Association.

  11. Protective efficacy of standard Edmonston-Zagreb measles vaccination in infants aged 4.5 months: interim analysis of a randomised clinical trial.

    Science.gov (United States)

    Martins, Cesário L; Garly, May-Lill; Balé, Carlito; Rodrigues, Amabelia; Ravn, Henrik; Whittle, Hilton C; Lisse, Ida M; Aaby, Peter

    2008-07-24

    To examine the protective efficacy of measles vaccination in infants in a low income country before 9 months of age. Randomised clinical trial. 1333 infants aged 4.5 months: 441 in treatment group and 892 in control group. Urban area in Guinea-Bissau. Measles vaccination using standard titre Edmonston-Zagreb vaccine at 4.5 months of age. Vaccine efficacy against measles infection, admission to hospital for measles, and measles mortality before standard vaccination at 9 months of age. 28% of the children tested at 4.5 months of age had protective levels of maternal antibodies against measles at enrolment. After early vaccination against measles 92% had measles antibodies at 9 months of age. A measles outbreak offered a unique situation for testing the efficacy of early measles vaccination. During the outbreak, 96 children developed measles; 19% of unvaccinated children had measles before 9 months of age. The monthly incidence of measles among the 441 children enrolled in the treatment arm was 0.7% and among the 892 enrolled in the control arm was 3.1%. Early vaccination with the Edmonston-Zagreb measles vaccine prevented infection; vaccine efficacy for children with serologically confirmed measles and definite clinical measles was 94% (95% confidence interval 77% to 99%), for admissions to hospital for measles was 100% (46% to 100%), and for measles mortality was 100% (-42% to 100%). The number needed to treat to prevent one case of measles between ages 4.5 months and 9 months during the epidemic was 7.2 (6.8 to 9.2). The treatment group tended to have lower overall mortality (mortality rate ratio 0.18, 0.02 to 1.36) although this was not significant. In low income countries, maternal antibody levels against measles may be low and severe outbreaks of measles can occur in infants before the recommended age of vaccination at 9 months. Outbreaks of measles may be curtailed by measles vaccination using the Edmonston-Zagreb vaccine as early as 4.5 months of age. TRIAL

  12. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent.

    Directory of Open Access Journals (Sweden)

    Winnie Bergstedt

    2010-06-01

    Full Text Available Tuberculin is still the only available skin test reagent for the diagnosis of mycobacterial infection. The product has a remarkable sensitivity, but poor specificity. Previous studies, including two human phase I clinical trials, have indicated that rdESAT-6 has a potential as an improved skin test reagent. Animal studies have shown that the sensitivity may be increased by inclusion of the genetically related CFP-10 antigen in the preparation without loosing specificity.In this study a Lactococcus fermented, recombinant skin test reagent consisting of a 1ratio1 wt/wt of rdESAT-6 and CFP-10 was manufactured according to GMP standards and tested for the first time in 42 healthy adult volunteers. The two doses of 0.01 microg or 0.1 microg were injected intradermally by the Mantoux technique with 6 or 12 weeks interval. No serious adverse events and only mild adverse reactions were reported. The reagent elicited a positive skin test reaction after the first injection in one participant, who most likely was latently infected with M. tuberculosis as indicated by an appreciable IFN gamma response just below the Quantiferon(R cut-off level at the screening visit. None of the remaining participants in the four groups had any skin test reactions and sensitisation by the reagent could therefore be excluded.The investigational skin test reagent rdESAT-6 and CFP-10 appeared safe and non-sensitising in this first-in-man clinical trial in human volunteers and can now be tested in larger clinical trials involving individuals with latent M. tuberculosis infection or active TB disease.ClinicalTrials.gov NCT00793702.

  13. Diagnostic accuracy of the gravity stress test and clinical signs in cases of isolated supination-external rotation-type lateral malleolar fractures.

    Science.gov (United States)

    Nortunen, S; Flinkkilä, T; Lantto, I; Kortekangas, T; Niinimäki, J; Ohtonen, P; Pakarinen, H

    2015-08-01

    We prospectively assessed the diagnostic accuracy of the gravity stress test and clinical findings to evaluate the stability of the ankle mortise in patients with supination-external rotation-type fractures of the lateral malleolus without widening of the medial clear space. The cohort included 79 patients with a mean age of 44 years (16 to 82). Two surgeons assessed medial tenderness, swelling and ecchymosis and performed the external rotation (ER) stress test (a reference standard). A diagnostic radiographer performed the gravity stress test. For the gravity stress test, the positive likelihood ratio (LR) was 5.80 with a 95% confidence interval (CI) of 2.75 to 12.27, and the negative LR was 0.15 (95% CI 0.07 to 0.35), suggesting a moderate change from the pre-test probability. Medial tenderness, both alone and in combination with swelling and/or ecchymosis, indicated a small change (positive LR, 2.74 to 3.25; negative LR, 0.38 to 0.47), whereas swelling and ecchymosis indicated only minimal changes (positive LR, 1.41 to 1.65; negative LR, 0.38 to 0.47). In conclusion, when gravity stress test results are in agreement with clinical findings, the result is likely to predict stability of the ankle mortise with an accuracy equivalent to ER stress test results. When clinical examination suggests a medial-side injury, however, the gravity stress test may give a false negative result. ©2015 The British Editorial Society of Bone & Joint Surgery.

  14. Clinically significant discrepancies between sleep problems assessed by standard clinical tools and actigraphy

    Directory of Open Access Journals (Sweden)

    Kjersti Marie Blytt

    2017-10-01

    Full Text Available Abstract Background Sleep disturbances are widespread among nursing home (NH patients and associated with numerous negative consequences. Identifying and treating them should therefore be of high clinical priority. No prior studies have investigated the degree to which sleep disturbances as detected by actigraphy and by the sleep-related items in the Cornell Scale for Depression in Dementia (CSDD and the Neuropsychiatric Inventory – Nursing Home version (NPI-NH provide comparable results. Such knowledge is highly needed, since both questionnaires are used in clinical settings and studies use the NPI-NH sleep item to measure sleep disturbances. For this reason, insight into their relative (disadvantages is valuable. Method Cross-sectional study of 83 NH patients. Sleep was objectively measured with actigraphy for 7 days, and rated by NH staff with the sleep items in the CSDD and the NPI-NH, and results were compared. McNemar's tests were conducted to investigate whether there were significant differences between the pairs of relevant measures. Cohen's Kappa tests were used to investigate the degree of agreement between the pairs of relevant actigraphy, NPI-NH and CSDD measures. Sensitivity and specificity analyses were conducted for each of the pairs, and receiver operating characteristics (ROC curves were designed as a plot of the true positive rate against the false positive rate for the diagnostic test. Results Proxy-raters reported sleep disturbances in 20.5% of patients assessed with NPI-NH and 18.1% (difficulty falling asleep, 43.4% (multiple awakenings and 3.6% (early morning awakenings of patients had sleep disturbances assessed with CSDD. Our results showed significant differences (p<0.001 between actigraphy measures and proxy-rated sleep by the NPI-NH and CSDD. Sensitivity and specificity analyses supported these results. Conclusions Compared to actigraphy, proxy-raters clearly underreported NH patients' sleep disturbances as assessed

  15. Comparison of the peripheral blood eosinophil count using near-patient testing and standard automated laboratory measurement in healthy, asthmatic and COPD subjects

    Directory of Open Access Journals (Sweden)

    Hambleton K

    2017-09-01

    Full Text Available Kirsty Hambleton, Clare M Connolly, Catherine Borg, Joanne H Davies, Helen P Jeffers, Richard EK Russell, Mona Bafadhel Respiratory Medicine Unit, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK Abstract: Near-patient testing (NPT allows clinical decisions to be made in a rapid and convenient manner and is often cost effective. In COPD the peripheral blood eosinophil count has been demonstrated to have utility in providing prognostic information and predicting response to treatment during an acute exacerbation. For this potential to be achieved having a reliable NPT of blood eosinophil count would be extremely useful. Therefore, we investigated the use of the HemoCue® WBC Diff System and evaluated its sensitivity and specificity in healthy, asthmatic and COPD subjects. This method requires a simple skin prick of blood and was compared to standard venepuncture laboratory analysis. The HemoCue® WBC Diff System measured the peripheral blood eosinophil count in healthy, asthma and COPD subjects with very close correlation to the eosinophil count as measured by standard venepuncture. The correlations were unaffected by disease status. This method for the measurement of the peripheral blood eosinophil count has the potential to provide rapid near-patient results and thus influence the speed of management decisions in the treatment of airway diseases. Keywords: asthma, chronic obstructive pulmonary disease, eosinophils, near-patient testing

  16. The standard of spirometry in the RSA | Basson | South African ...

    African Journals Online (AJOL)

    Standards for high-quality lung function testing have not yet been formally adopted in the RSA, despite the increase in the performance of spirometry. A study was undertaken to determine the standard of spirometry in clinical practice in this country. Forty-five spirometer users agreed to participate. Responses to a ...

  17. 42 CFR 493.1453 - Condition: Laboratories performing high complexity testing; clinical consultant.

    Science.gov (United States)

    2010-10-01

    ... Condition: Laboratories performing high complexity testing; clinical consultant. The laboratory must have a... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Laboratories performing high complexity testing; clinical consultant. 493.1453 Section 493.1453 Public Health CENTERS FOR MEDICARE & MEDICAID...

  18. Limited diagnostic accuracy of magnetic resonance imaging and clinical tests for detecting partial-thickness tears of the rotator cuff.

    Science.gov (United States)

    Brockmeyer, Matthias; Schmitt, Cornelia; Haupert, Alexander; Kohn, Dieter; Lorbach, Olaf

    2017-12-01

    The reliable diagnosis of partial-thickness tears of the rotator cuff is still elusive in clinical practise. Therefore, the purpose of the study was to determine the diagnostic accuracy of MR imaging and clinical tests for detecting partial-thickness tears of the rotator cuff as well as the combination of these parameters. 334 consecutive shoulder arthroscopies for rotator cuff pathologies performed during the time period between 2010 and 2012 were analyzed retrospectively for the findings of common clinical signs for rotator cuff lesions and preoperative MR imaging. These were compared with the intraoperative arthroscopic findings as "gold standard". The reports of the MR imaging were evaluated with regard to the integrity of the rotator cuff. The Ellman Classification was used to define partial-thickness tears of the rotator cuff in accordance with the arthroscopic findings. Descriptive statistics, sensitivity, specificity, positive and negative predictive value were calculated. MR imaging showed 80 partial-thickness and 70 full-thickness tears of the rotator cuff. The arthroscopic examination confirmed 64 partial-thickness tears of which 52 needed debridement or refixation of the rotator cuff. Sensitivity for MR imaging to identify partial-thickness tears was 51.6%, specificity 77.2%, positive predictive value 41.3% and negative predictive value 83.7%. For the Jobe-test, sensitivity was 64.1%, specificity 43.2%, positive predictive value 25.9% and negative predictive value 79.5%. Sensitivity for the Impingement-sign was 76.7%, specificity 46.6%, positive predictive value 30.8% and negative predictive value 86.5%. For the combination of MR imaging, Jobe-test and Impingement-sign sensitivity was 46.9%, specificity 85.4%, positive predictive value 50% and negative predictive value 83.8%. The diagnostic accuracy of MR imaging and clinical tests (Jobe-test and Impingement-sign) alone is limited for detecting partial-thickness tears of the rotator cuff. Additionally

  19. Nuclear reactor pressure vessel surveillance capsule examinations. Application of American Society for Testing and Materials Standards

    International Nuclear Information System (INIS)

    Perrin, J.S.

    1978-01-01

    A series of pressure vessel surveillance capsules is installed in each commercial nuclear power plant in the United States. A capsule typically contains neutron dose meters, thermal monitors, tensile specimens, and Charpy V-notch impact specimens. In order to determine property changes of the pressure vessel resulting from irradiation, surveillance capsules are periodically removed during the life of a reactor and examined. There are numerous standards, regulations, and codes governing US pressure vessel surveillance capsule programmes. These are put out by the US Nuclear Regulatory Commission, the Boiler and Pressure Vessel Committee of the American Society of Mechanical Engineers, and the American Society for Testing and Materials (ASTM). A majority of the pertinent ASTM standards are under the jurisdiction of ASTM Committee E-10 on Nuclear Applications and Measurements of Radiation Effects. The standards, regulations, and codes pertaining to pressure vessel surveillance play an important role in ensuring reliability of the nuclear pressure vessels. ASTM E 185-73 is the Standard Recommended Practice for Surveillance Tests for Nuclear Reactors. This standard recommends procedures for both the irradiation and subsequent testing of surveillance capsules. ASTM E 185-73 references many additional specialized ASTM standards to be followed in specific areas of a surveillance capsule examination. A key element of surveillance capsule programmes is the Charpy V-notch impact test, used to define curves of fracture behaviour over a range of temperatures. The data from these tests are used to define the adjusted reference temperature used in determining pressure-temperature operating curves for a nuclear power plant. (author)

  20. European AIDS Clinical Society Second Standard of Care Meeting, Brussels 16-17 November 2016

    DEFF Research Database (Denmark)

    De Wit, S; Battegay, M; D'Arminio Monforte, A

    2018-01-01

    The European AIDS Clinical Society (EACS) organized a second meeting on Standard of Care in Europe on November 16-17 th, 2016. The aims of the meeting were to discuss and propose actions on three topics, namely: Adherence to guidelines for treatment initiation, treatment monitoring and outcomes, ...

  1. WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

    Energy Technology Data Exchange (ETDEWEB)

    Gabriel, P. [University of Pennsylvania (United States)

    2015-06-15

    Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, it is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented.

  2. WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

    International Nuclear Information System (INIS)

    Gabriel, P.

    2015-01-01

    Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, it is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented

  3. SEU testing of a novel hardened register implemented using standard CMOS technology

    International Nuclear Information System (INIS)

    Monnier, T.; Roche, F.M.; Cosculluela, J.; Velazco, R.

    1999-01-01

    A novel memory structure, designed to tolerate SEU perturbations, has been implemented in registers and tested. The design was completed using a standard submicron nonradiation hardened CMOS technology. This paper presents the results of heavy ions tests which evidence the noticeable improvement of the SEU-robustness with an increased LET threshold and reduced cross-section, without significant impact to die real estate, write time, or power consumption

  4. Standard test method for initial screening of corrosion inhibiting admixtures for steel in concrete

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2007-01-01

    1.1 This test method covers a procedure for determining the effects of chemical admixtures on the corrosion of metals in concrete. This test method can be used to evaluate materials intended to inhibit chloride-induced corrosion of steel in concrete. It can also be used to evaluate the corrosivity of admixtures by themselves or in a chloride environment. This test is not applicable for emulsions. 1.2 &solely-SI-units; 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  5. The Development and Validation of the Test Of Astronomy STandards (TOAST)

    Science.gov (United States)

    Slater, Stephanie J.

    2014-01-01

    The Test Of Astronomy STandards (TOAST) is a comprehensive assessment instrument designed to measure students' general astronomy content knowledge. Built upon the research embedded within a generation of astronomy assessments designed to measure single concepts, the TOAST is appropriate to measure across an entire astronomy course. The TOAST's…

  6. Special physical examination tests for superior labrum anterior-posterior shoulder tears: an examination of clinical usefulness.

    Science.gov (United States)

    Sandrey, Michelle A

    2013-01-01

    criteria, 95% confidence intervals were calculated for each sensitivity, specificity, and positive and negative likelihood ratio reported. No specific information was provided about the procedure if the reviewers disagreed on how the evaluation criteria were applied. The specific search criteria led to the identification of 29 full-text articles. The studies were reviewed, and inclusion and exclusion criteria were applied. This resulted in 14 excluded studies and 15 eligible studies for analysis. Of the 15 eligible studies, 1 evaluated only a single physical examination test for a SLAP lesion or biceps tendon injury, and 10 studies evaluated 2 to 6 physical examination tests for a SLAP lesion or biceps tendon injury. Nine studies reported sensitivities and specificities greater than 75%, 4 had sensitivities less than 75%, 3 had specificities less than 75%, 1 did not report sensitivity, and 2 did not report specificities. When validity was assessed for those 15 papers, only 1 study that evaluated the biceps tendon met the 5 critical appraisal criteria of Calvert et al and calculated 95% confidence intervals. When the Speed and Yergason tests were each compared with the gold standard (arthroscopy), the confidence intervals for the positive and negative likelihood ratios spanned 1. This indicated that the test result is unlikely to change the odds of having or not having the condition, respectively. The literature currently used as a reference for teaching in medical schools and continuing education lacks the necessary validity to help rule in or out a SLAP lesion or biceps tendon involvement. Based on the results from the systematic review conducted by Calvert et al, no tests clinically diagnose a SLAP lesion. This is a cause for concern as magnetic resonance imaging or magnetic resonance arthrography, which are frequently used to assess a possible SLAP lesion, may also have diagnostic flaws and may be cost prohibitive. Performing arthroscopy on every patient to rule the

  7. Standard test method for ranking resistance of materials to sliding wear using block-on-ring wear test

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2005-01-01

    1.1 This test method covers laboratory procedures for determining the resistance of materials to sliding wear. The test utilizes a block-on-ring friction and wear testing machine to rank pairs of materials according to their sliding wear characteristics under various conditions. 1.2 An important attribute of this test is that it is very flexible. Any material that can be fabricated into, or applied to, blocks and rings can be tested. Thus, the potential materials combinations are endless. However, the interlaboratory testing has been limited to metals. In addition, the test can be run with various lubricants, liquids, or gaseous atmospheres, as desired, to simulate service conditions. Rotational speed and load can also be varied to better correspond to service requirements. 1.3 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. Wear test results are reported as the volume loss in cubic millimetres for both the block and ring. Materials...

  8. Clinical Applications of CO2 and H2 Breath Test

    Directory of Open Access Journals (Sweden)

    ZHAO Si-qian;CHEN Bao-jun;LUO Zhi-fu

    2016-08-01

    Full Text Available Breath test is non-invasive, high sensitivity and high specificity. In this article, CO2 breath test, H2 breath test and their clinical applications were elaborated. The main applications of CO2 breath test include helicobacter pylori test, liver function detection, gastric emptying test, insulin resistance test, pancreatic exocrine secretion test, etc. H2 breath test can be applied in the diagnosis of lactose malabsorption and detecting small intestinal bacterial overgrowth. With further research, the breath test is expected to be applied in more diseases diagnosis.

  9. Postimplant Dosimetry Using a Monte Carlo Dose Calculation Engine: A New Clinical Standard

    International Nuclear Information System (INIS)

    Carrier, Jean-Francois; D'Amours, Michel; Verhaegen, Frank; Reniers, Brigitte; Martin, Andre-Guy; Vigneault, Eric; Beaulieu, Luc

    2007-01-01

    Purpose: To use the Monte Carlo (MC) method as a dose calculation engine for postimplant dosimetry. To compare the results with clinically approved data for a sample of 28 patients. Two effects not taken into account by the clinical calculation, interseed attenuation and tissue composition, are being specifically investigated. Methods and Materials: An automated MC program was developed. The dose distributions were calculated for the target volume and organs at risk (OAR) for 28 patients. Additional MC techniques were developed to focus specifically on the interseed attenuation and tissue effects. Results: For the clinical target volume (CTV) D 90 parameter, the mean difference between the clinical technique and the complete MC method is 10.7 Gy, with cases reaching up to 17 Gy. For all cases, the clinical technique overestimates the deposited dose in the CTV. This overestimation is mainly from a combination of two effects: the interseed attenuation (average, 6.8 Gy) and tissue composition (average, 4.1 Gy). The deposited dose in the OARs is also overestimated in the clinical calculation. Conclusions: The clinical technique systematically overestimates the deposited dose in the prostate and in the OARs. To reduce this systematic inaccuracy, the MC method should be considered in establishing a new standard for clinical postimplant dosimetry and dose-outcome studies in a near future

  10. [Clinical research XVII. χ(2) test, from the expected to the observed].

    Science.gov (United States)

    Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez, Marcela; Talavera, Juan O

    2013-01-01

    When you want to show if there is a statistical association or differences between categorical variables, it is recommended to use the χ(2) test. This nonparametric test is one of the most used in clinical research; it contrasts nominal or ordinal qualitative variables that are observed in clinical practice. This test calculates the p value that determines whether differences between groups are real or due to chance. The χ(2) test is the basis of other tests to analyze qualitative ordinal variables as χ(2) for linear trend, which compares three groups with two outcomes or McNemar test, which contrasts two related samples (a before and afterward comparison) or Mantel-Haenszel χ(2), which controls for potential confounding variables. When using small samples, where the expected results are less than 5, Fisher's exact test should be used. These tests are the most widely used in the medical literature; however, they do not give us the magnitude or the direction of the event and a proper interpretation that requires clinical judgment is needed.

  11. SDT: The Brazilian Standardization of the Silver Drawing Test of Cognition and Emotion.

    Science.gov (United States)

    Allessandrini, Cristina Dias; Duarte, Jose Luclano Miranda; Bianco, Marisa Fernandes; Dupas, Margarida Azevedo

    1998-01-01

    The Silver Drawing Test of Cognition and Emotion was standardized for Brazilian children (N=2,000). ANOVA results are presented for age and education groups from early grades on, including distinguishing adult education levels; results are compared for U.S. and Brazilian populations. Growth in test scores, emotional content responses, and…

  12. Red Blood Cell Mechanical Fragility Test for Clinical Research Applications.

    Science.gov (United States)

    Ziegler, Luke A; Olia, Salim E; Kameneva, Marina V

    2017-07-01

    Red blood cell (RBC) susceptibility to mechanically induced hemolysis, or RBC mechanical fragility (MF), is an important parameter in the characterization of erythrocyte membrane health. The rocker bead test (RBT) and associated calculated mechanical fragility index (MFI) is a simple method for the assessment of RBC MF. Requiring a minimum of 15.5 mL of blood and necessitating adjustment of hematocrit (Ht) to a "standard" value (40%), the current RBT is not suitable for use in most studies involving human subjects. To address these limitations, we propose a 6.5 mL reduced volume RBT and corresponding modified MFI (MMFI) that does not require prior Ht adjustment. This new method was assessed for i) correlation to the existing text, ii) to quantify the effect of Ht on MFI, and iii) validation by reexamining the protective effect of plasma proteins on RBC MF. The reduced volume RBT strongly correlated (r = 0.941) with the established large volume RBT at matched Hts, and an equation was developed to calculate MMFI: a numerical estimation (R 2  = 0.923) of MFI if performed with the reduced volume RBT at "standard" (40%) Ht. An inversely proportional relationship was found between plasma protein concentration and RBC MF using the MMFI-reduced volume method, supporting previous literature findings. The new reduced volume RBT and modified MFI will allow for the measurement of RBC MF in clinical and preclinical studies involving humans or small animals. © 2017 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  13. [Precautions of physical performance requirements and test methods during product standard drafting process of medical devices].

    Science.gov (United States)

    Song, Jin-Zi; Wan, Min; Xu, Hui; Yao, Xiu-Jun; Zhang, Bo; Wang, Jin-Hong

    2009-09-01

    The major idea of this article is to discuss standardization and normalization for the product standard of medical devices. Analyze the problem related to the physical performance requirements and test methods during product standard drafting process and make corresponding suggestions.

  14. Standard test method for determining the susceptibility to intergranular corrosion of 5XXX series Aluminum alloys by mass loss after exposure to nitric acid (NAMLT Test)

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2004-01-01

    1.1 This test method describes a procedure for constant immersion intergranular corrosion testing of 5XXX series aluminum alloys. 1.2 This test method is applicable only to wrought products. 1.3 This test method covers type of specimen, specimen preparation, test environment, and method of exposure. 1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  15. Standard test method for creep-fatigue testing

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This test method covers the determination of mechanical properties pertaining to creep-fatigue deformation or crack formation in nominally homogeneous materials, or both by the use of test specimens subjected to uniaxial forces under isothermal conditions. It concerns fatigue testing at strain rates or with cycles involving sufficiently long hold times to be responsible for the cyclic deformation response and cycles to crack formation to be affected by creep (and oxidation). It is intended as a test method for fatigue testing performed in support of such activities as materials research and development, mechanical design, process and quality control, product performance, and failure analysis. The cyclic conditions responsible for creep-fatigue deformation and cracking vary with material and with temperature for a given material. 1.2 The use of this test method is limited to specimens and does not cover testing of full-scale components, structures, or consumer products. 1.3 This test method is primarily ...

  16. The Quest for Standard Tests in Prioritizing Water Use Rights in ...

    African Journals Online (AJOL)

    Moreover, there are problems of depletion, pollution, water grabbing, wastage of water, and water crisis that are attributable to lack of comprehensive regulations, or confusions in putting policy options. The regulatory tools lack clarity and sufficiency with regard to the incorporation of standard tests. There is thus the need for ...

  17. The internal consistency of the standard gamble: tests after adjusting for prospect theory.

    Science.gov (United States)

    Oliver, Adam

    2003-07-01

    This article reports a study that tests whether the internal consistency of the standard gamble can be improved upon by incorporating loss weighting and probability transformation parameters in the standard gamble valuation procedure. Five alternatives to the standard EU formulation are considered: (1) probability transformation within an EU framework; and, within a prospect theory framework, (2) loss weighting and full probability transformation, (3) no loss weighting and full probability transformation, (4) loss weighting and no probability transformation, and (5) loss weighting and partial probability transformation. Of the five alternatives, only the prospect theory formulation with loss weighting and no probability transformation offers an improvement in internal consistency over the standard EU valuation procedure.

  18. A new condition for assessing the clinical efficiency of a diagnostic test.

    Science.gov (United States)

    Bokhari, Ehsan; Hubert, Lawrence

    2015-09-01

    When prediction using a diagnostic test outperforms simple prediction using base rates, the test is said to be "clinically efficient," a term first introduced into the literature by Meehl and Rosen (1955) in Psychological Bulletin. This article provides three equivalent conditions for determining the clinical efficiency of a diagnostic test: (a) Meehl-Rosen (Meehl & Rosen, 1955); (b) Dawes (Dawes, 1962); and (c) the Bokhari-Hubert condition, introduced here for the first time. Clinical efficiency is then generalized to situations where misclassification costs are considered unequal (for example, false negatives are more costly than false positives). As an illustration, the clinical efficiency of an actuarial device for predicting violent and dangerous behavior is examined that was developed as part of the MacArthur Violence Risk Assessment Study. (c) 2015 APA, all rights reserved.

  19. The cost of implementing rapid HIV testing in sexually transmitted disease clinics in the United States.

    Science.gov (United States)

    Eggman, Ashley A; Feaster, Daniel J; Leff, Jared A; Golden, Matthew R; Castellon, Pedro C; Gooden, Lauren; Matheson, Tim; Colfax, Grant N; Metsch, Lisa R; Schackman, Bruce R

    2014-09-01

    Rapid HIV testing in high-risk populations can increase the number of persons who learn their HIV status and avoid spending clinic resources to locate persons identified as HIV infected. We determined the cost to sexually transmitted disease (STD) clinics of point-of-care rapid HIV testing using data from 7 public clinics that participated in a randomized trial of rapid testing with and without brief patient-centered risk reduction counseling in 2010. Costs included counselor and trainer time, supplies, and clinic overhead. We applied national labor rates and test costs. We calculated median clinic start-up costs and mean cost per patient tested, and projected incremental annual costs of implementing universal rapid HIV testing compared with current testing practices. Criteria for offering rapid HIV testing and methods for delivering nonrapid test results varied among clinics before the trial. Rapid HIV testing cost an average of US $22/patient without brief risk reduction counseling and US $46/patient with counseling in these 7 clinics. Median start-up costs per clinic were US $1100 and US $16,100 without and with counseling, respectively. Estimated incremental annual costs per clinic of implementing universal rapid HIV testing varied by whether or not brief counseling is conducted and by current clinic testing practices, ranging from a savings of US $19,500 to a cost of US $40,700 without counseling and a cost of US $98,000 to US $153,900 with counseling. Universal rapid HIV testing in STD clinics with same-day results can be implemented at relatively low cost to STD clinics, if brief risk reduction counseling is not offered.

  20. Potential facilitators and barriers to adopting standard treatment guidelines in clinical practice.

    Science.gov (United States)

    Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia

    2017-04-18

    Purpose The purpose of this paper is to assess medicines information sources accessed by clinicians, if sources differed in theory and practice and to find out the barriers and facilitators to effective guideline adoption. Design/methodology/approach In all, 183 doctors were surveyed. Barriers and facilitators were classified as: communication; potential adopters; innovation; organization characteristics and environmental/social/economic context. Findings Most of the clinicians accessed multiple information sources including standard treatment guidelines, but also consulted seniors/colleagues in practice. The top three factors influencing clinical practice guideline adoption were innovation characteristics, environmental context and individual characteristics. The respondents differed in the following areas: concerns about flexibility offered by the guideline; denying patients' individuality; professional autonomy; insights into gaps in current practice and evidence-based practice; changing practices with little or no benefit. Barriers included negative staff attitudes/beliefs, guideline integration into organizational structures/processes, time/resource constraints. Fearing third parties (government and insurance companies) restricting medicines reimbursement and poor liability protection offered by the guidelines emerged as the barriers. Facilitators include aligning organizational structures/processes with the innovation; providing leadership support to guide diffusion; increasing awareness and enabling early innovation during pre/in-service training, with regular feedback on outcomes and use. Practical implications Guideline adoption in clinical practice is partly within doctors' control. There are other key prevailing factors in the local context such as environmental, social context, professional and organizational culture affecting its adoption. Organizational policy and accreditation standards necessitating adherence can serve as a driver. Originality

  1. Standard Test Method for Dust Erosion Resistance of Optical and Infrared Transparent Materials and Coatings

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2005-01-01

    1.1 This test method covers the resistance of transparent plastics and coatings used in aerospace windscreens, canopies, and viewports to surface erosion as a result of dust impingement. This test method simulates flight through a defined particle cloud environment by means of independent control of particle size, velocity, impact angle, mass loading, and test duration. 1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  2. Development of test practice requirements for a standard method on fracture toughness testing in the transition range

    International Nuclear Information System (INIS)

    McCabe, D.E.; Zerbst, U.; Heerens, J.

    1993-01-01

    This report covers the resolution of several issues that are relevant to the ductile to brittle transition range of structural steels. One of this issues was to compare a statistical-based weakest-link method to constraint data adjustment methods for modeling the specimen size effects on fracture toughness. Another was to explore the concept of a universal transition temperature curve shape (Master Curve). Data from a Materials Properties Council round robin activity were used to test the proposals empirically. The findings of this study are inclosed in an activity for the development of a draft standard test procedure ''Test Practice for Fracture Toughness in the Transition Range''. (orig.) [de

  3. Aligning English grammar testing with European language standards

    Directory of Open Access Journals (Sweden)

    Bodrič Radmila

    2015-01-01

    Full Text Available In recent years, foreign language testing has gained in significance with the advent of The Common European Framework of Reference for Languages (2001 (CEFR, a European language document which set comparable standards for learning, teaching and assessing foreign languages. The CEFR was used to set the research aim of this paper - testing grammar at level B2. The main aim of the research was to determine grammatical competence at level B2 and additional aims included: (a determining which particular areas of grammar need to be learned by students at level B2, (b formulating grammatical descriptors for each individual area of grammar, (c determining the test’s threshold level which would fulfil the criteria for grammatical competence at level B2, and (d determining the extent to which students have mastered the given areas. The pre-testing was followed by the main testing on the sample of 164 students in two secondary schools. The results indicated that the quantity and quality of grammatical competence was lower than expected: 47% of the population failed to fulfil the basic level of grammatical competence. The causes may be attributed to the factors of a subjective and objective nature. Level B2 is demanding qualitatively as well as quantitatively, regarding both the formal and the functional complexity and scope of language use, which requires intensive language production, high levels of motivation and sound working habits in order to master the given grammatical structures.

  4. Limits of clinical tests to screen autonomic function in diabetes type 1.

    Science.gov (United States)

    Ducher, M; Bertram, D; Sagnol, I; Cerutti, C; Thivolet, C; Fauvel, J P

    2001-11-01

    A precocious detection of cardiac autonomic dysfunction is of major clinical interest that could lead to a more intensive supervision of diabetic patients. However, classical clinical exploration of cardiac autonomic function is not easy to undertake in a reproducible way. Thus, respective interests of autonomic nervous parameters provided by both clinical tests and computerized analysis of resting blood pressure were checked in type 1 diabetic patients without orthostatic hypotension and microalbuminuria. Thirteen diabetic subjects matched for age and gender to thirteen healthy subjects volunteered to participate to the study. From clinical tests (standing up, deep breathing, Valsalva maneuver, handgrip test), autonomic function was scored according to Ewing's methodology. Analysis of resting beat to beat blood pressure provided autonomic indices of the cardiac function (spectral analysis or Z analysis). 5 of the 13 diabetic patients exhibited a pathological score (more than one pathological response) suggesting the presence of cardiovascular autonomic dysfunction. The most discriminative test was the deep breathing test. However, spectral indices of BP recordings and baro-reflex sensitivity (BRS) of these 5 subjects were similar to those of healthy subjects and of remaining diabetic subjects. Alteration in Ewing's score given by clinical tests may not reflect an alteration of cardiac autonomic function in asymptomatic type 1 diabetic patients, because spectral indices of sympathetic and parasympathetic (including BRS) function were within normal range. Our results strongly suggest to confront results provided by both methodologies before concluding to an autonomic cardiac impairment in asymptomatic diabetic patients.

  5. Clinical laboratory accreditation in India.

    Science.gov (United States)

    Handoo, Anil; Sood, Swaroop Krishan

    2012-06-01

    Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.

  6. Clinical balance tests, proprioceptive system and adolescent idiopathic scoliosis.

    Science.gov (United States)

    Le Berre, Morgane; Guyot, Marc-Alexandre; Agnani, Olivier; Bourdeauducq, Isabelle; Versyp, Marie-Christine; Donze, Cécile; Thévenon, André; Catanzariti, Jean-Francois

    2017-06-01

    Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spinal column of unknown etiology. Multiple factors could be involved, including neurosensory pathways and, potentially, an elective disorder of dynamic proprioception. The purpose of this study was to determine whether routine balance tests could be used to demonstrate an elective alteration of dynamic proprioception in AIS. This was a multicentre case-control study based on prospectively collected clinical data, in three hospitals pediatric, with spine consultation, from January 2013 through April 2015. From an original population of 547 adolescents, inclusion and non-inclusion criteria indentified 114 adolescents with right thoracic AIS (mean age 14.5 ± 1.9 years, Cobb angle 35.7 ± 15.3°) and 81 matched adolescents without scoliosis (mean age 14.1 ± 1.9 years). Participants performed three routine clinical balance tests to assess the static and dynamic proprioception: the Fukuda-Utenberger stepping test (angle of rotation in degrees and distance of displacement in cm) to assess dynamic balance; the sharpened Romberg test and the unipedal stance test (eyes closed) to assess static balance. There was no significant difference between AIS subjects and controls for the static tests, but there was a significant difference for the dynamic test for both measures: distance of displacement (p tests can be performed in routine practice. Their validity as a biomarker for screening and monitoring purposes should be assessed.

  7. Standard test method for color and color difference of whitewares by abriged spectrophotometry

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2001-01-01

    1.1 This test method describes the instrumental measurement of the reflection properties and color of ceramic glazes and other whitewares by the use of a spectrophotometer or spectrocolorimeter with a hemispherical optical measuring system, such as an integrating sphere. 1.2 The test method is suitable for use with most specimens having an exterior flat surface large enough to cover the spectrophotometer sample port. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

  8. Evaluation of a draft standard on performance specifications for health physics instrumentation. Initial results for radiological tests

    International Nuclear Information System (INIS)

    Swinth, K.L.; Kenoyer, J.L.; Mileham, A.P.; Kathren, R.L.; Selby, J.M.

    1983-06-01

    The draft ANSI standard N42.17D2 on performance specifications for health physics instrumentation is currently being evaluated by the Pacific Northwest Laboratory. The primary objective of the project is the evaluation of the applicability and practicality of the proposed standard through testing of a cross-section of currently available commercial instruments to determine how well they conform to the standard. The standard is being tested against instruments such as ionization chambers, G.M. detectors, alpha survey meters, and neutron dose equivalent survey meters. This paper presents results of the preliminary radiological performance tests on ionization chambers and G.M. detectors. This includes both the data generated during the tests and a discussion of procedures developed to perform the testing. Results are reported for response time, accuracy, precision, radiation overloads, and angular dependence. In addition, results are reported for parameters that affect instrument performance including battery lifetime, geotropism and stability. Initial test indicates that some of the instruments will not meet the criteria specified in ANSI N42.17D2. Results cover approximately 40 instruments that have been obtained by direct purchase, by loan from instrument vendors or by loan from others including DOE licensees

  9. Impact of HIPAA's minimum necessary standard on genomic data sharing.

    Science.gov (United States)

    Evans, Barbara J; Jarvik, Gail P

    2018-04-01

    This article provides a brief introduction to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions. This research used the Thomson Reuters Westlaw database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data sharing. We considered relevant example cases of genomic data-sharing needs. In a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized-whether for research, public health, or clinical interpretation and medical practice support-affects how the minimum necessary standard applies and its overall impact on data access and use. There is no clear regulatory guidance on how to apply HIPAA's minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows.

  10. Aminopenicillin-associated exanthem: lymphocyte transformation testing revisited.

    Science.gov (United States)

    Trautmann, A; Seitz, C S; Stoevesandt, J; Kerstan, A

    2014-12-01

    The lymphocyte transformation test (LTT) has been promoted as in-vitro test for diagnosis of drug hypersensitivity. For determination of statistical LTT sensitivity, series of patients with clinically uniform reactions followed by complete drug hypersensitivity work-up are mandatory. Assessment of LTT specificity requires control patients who tolerated exposure to the drug studied. To prospectively determine the diagnostic value of the LTT in a clinically and diagnostically well-defined series of patients. Patients with exanthematous skin eruptions after ampicillin (AMP) intake were included in this study. After exclusion or confirmation of delayed-onset allergic AMP hypersensitivity by skin and provocation testing, two independent LTTs were performed: one standard LTT and a modified LTT with additional anti-CD3/anti-CD28 monoclonal antibody stimulation. By testing, delayed-onset allergic AMP hypersensitivity was diagnosed in 11 patients and definitely ruled out in 26. The standard LTT reached a diagnostic sensitivity of 54.5% while the modified LTT yielded 72.7%. However, the methodical test modification resulted in a decline of specificity from 92.3% (standard LTT) to 76.9%. In cases of AMP-associated exanthems, the diagnostic value of the LTT compared with routine allergy testing is limited. When evaluating such exanthems, provocation testing remains the gold standard. Delayed reading of intradermal skin tests remains most useful to avoid positive provocation reactions. © 2014 John Wiley & Sons Ltd.

  11. Trichomonas vaginalis Nucleic Acid Amplification Testing at an Urban HIV Clinic.

    Science.gov (United States)

    Muzny, Christina A; Burkholder, Greer A; Fry, Karen R; Austin, Erika L; Schwebke, Jane R

    2016-08-01

    Trichomonas vaginalis is the most common nonviral sexually transmitted infection. T. vaginalis nucleic acid amplification testing (NAAT) recently became available at the University of Alabama at Birmingham human immunodeficiency virus (HIV) clinic. The objective of this study was to determine the uptake of T. vaginalis NAAT testing among clinic providers during the first year of test availability in addition to T. vaginalis prevalence and predictors based on NAAT results. This was a retrospective review of HIV+ women and men ages ≥16 years at the University of Alabama at Birmingham HIV Clinic, including those receiving a T. vaginalis NAAT on a genitourinary specimen. Between August 2014 and August 2015, 3163 HIV+ patients were seen (768 women, 2395 men), of whom 861 (27.3%) received a T. vaginalis NAAT; 402 women (52.3%) and 459 men (19.2%). Among those with T. vaginalis NAAT results, 70 (17.4%) of 402 women and 12 (2.6%) of 459 men (9 men who have sex with women, 1 man who has sex with men, 2 unknown) tested positive. In adjusted analyses for women, age ≤40 years (odds ratio [OR], 2.93; 95% confidence interval [CI], 1.23-6.96), current cocaine use (OR, 4.86; 95% CI, 1.57-15.06), and CD4 vaginalis NAAT. For those with a positive T. vaginalis NAAT, treatment was prescribed for 65 (92.9%) of 70 women and 10 (83.3%) of 12 men. Initial uptake of T. vaginalis NAAT testing was modest at this HIV clinic yet identified a high prevalence among women tested. Emphasis on the need for testing in HIV+ women is necessary.

  12. ACCESS, Absolute Color Calibration Experiment for Standard Stars: Integration, Test, and Ground Performance

    Science.gov (United States)

    Kaiser, Mary Elizabeth; Morris, Matthew; Aldoroty, Lauren; Kurucz, Robert; McCandliss, Stephan; Rauscher, Bernard; Kimble, Randy; Kruk, Jeffrey; Wright, Edward L.; Feldman, Paul; Riess, Adam; Gardner, Jonathon; Bohlin, Ralph; Deustua, Susana; Dixon, Van; Sahnow, David J.; Perlmutter, Saul

    2018-01-01

    Establishing improved spectrophotometric standards is important for a broad range of missions and is relevant to many astrophysical problems. Systematic errors associated with astrophysical data used to probe fundamental astrophysical questions, such as SNeIa observations used to constrain dark energy theories, now exceed the statistical errors associated with merged databases of these measurements. ACCESS, “Absolute Color Calibration Experiment for Standard Stars”, is a series of rocket-borne sub-orbital missions and ground-based experiments designed to enable improvements in the precision of the astrophysical flux scale through the transfer of absolute laboratory detector standards from the National Institute of Standards and Technology (NIST) to a network of stellar standards with a calibration accuracy of 1% and a spectral resolving power of 500 across the 0.35‑1.7μm bandpass. To achieve this goal ACCESS (1) observes HST/ Calspec stars (2) above the atmosphere to eliminate telluric spectral contaminants (e.g. OH) (3) using a single optical path and (HgCdTe) detector (4) that is calibrated to NIST laboratory standards and (5) monitored on the ground and in-flight using a on-board calibration monitor. The observations are (6) cross-checked and extended through the generation of stellar atmosphere models for the targets. The ACCESS telescope and spectrograph have been designed, fabricated, and integrated. Subsystems have been tested. Performance results for subsystems, operations testing, and the integrated spectrograph will be presented. NASA sounding rocket grant NNX17AC83G supports this work.

  13. Testing devices or experimental systems? Cancer clinical trials take the genomic turn.

    Science.gov (United States)

    Nelson, Nicole C; Keating, Peter; Cambrosio, Alberto; Aguilar-Mahecha, Adriana; Basik, Mark

    2014-06-01

    Clinical trials are often described as machine-like systems for generating specific information concerning drug safety and efficacy, and are understood as a component of the industrial drug development processes. This paper argues that contemporary clinical trials in oncology are not reducible to mere drug testing. Drawing on ethnographic fieldwork and interviews with researchers in the field of oncology from 2010 to 2013, we introduce a conceptual contrast between trials as testing machines and trials as clinical experimental systems to draw attention to the ways trials are increasingly being used to ask open-ended scientific questions. When viewed as testing machines, clinical trials are seen as a means to produce answers to straightforward questions and deviations from the protocol are seen as bugs in the system; but practitioners can also treat trials as clinical experimental systems to investigate as yet undefined problems and where heterogeneity becomes a means to produce novel biological or clinical insights. The rise of "biomarker-driven" clinical trials in oncology, which link measurable biological characteristics such as genetic mutations to clinical features such as a patient's response to a particular drug, exemplifies a trend towards more experimental styles of clinical work. These transformations are congruent with changes in the institutional structure of clinical research in oncology, including a movement towards more flexible, networked research arrangements, and towards using individual patients as model systems for asking biological questions. Copyright © 2014 Elsevier Ltd. All rights reserved.

  14. ANTIFUNGAL SUSCEPTIBILITY TESTING: CURRENT ROLE FROM THE CLINICAL LABORATORY PERSPECTIVE

    Directory of Open Access Journals (Sweden)

    Brunella Posteraro

    2014-04-01

    Full Text Available Despite availability of many antifungal agents, antifungal clinical resistance occurs, perhaps as a result of an infecting organism found to be resistant in vitro to one or more antifungals tested. Thus, antifungal susceptibility testing (AFST results, if timely generated by the clinical microbiology and communicated to clinicians, can aid them in the therapeutic decision making, especially for difficult-to-treat invasive candidiasis and aspergillosis. Although recently refined AFST methods are commercially available to allow a close antifungal resistance surveillance in many clinical setting, novel assays, relying on short-time antifungal drug exposure of fungal isolates, are upcoming tools for AFST. Based on emerging technologies such as flow cytometry, MALDI-TOF mass spectrometry, and isothermal microcalorimetry, these assays could provide a reliable means for quicker and sensitive assessment of AFST.

  15. Electric Vehicle Communications Standards Testing and Validation - Phase II: SAE J2931/1

    Energy Technology Data Exchange (ETDEWEB)

    Pratt, Richard M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Gowri, Krishnan [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2013-01-15

    Vehicle to grid communication standards enable interoperability among vehicles, charging stations and utility providers and provide the capability to implement charge management. Several standards initiatives by the Society of Automobile Engineers (SAE), International Standards Organization and International Electrotechnical Commission (ISO/IEC), and ZigBee/HomePlug Alliance are developing requirements for communication messages and protocols. Recent work by the Electric Power Research Institute (EPRI) in collaboration with SAE and automobile manufacturers has identified vehicle to grid communication performance requirements and developed a test plan as part of SAE J2931/1 committee work. This laboratory test plan was approved by the SAE J2931/1 committee and included test configurations, test methods, and performance requirements to verify reliability, robustness, repeatability, maximum communication distance, and authentication features of power line carrier (PLC) communication modules at the internet protocol layer level. The goal of the testing effort was to select a communication technology that would enable automobile manufacturers to begin the development and implementation process. The EPRI/Argonne National Laboratory (ANL)/Pacific Northwest National Laboratory (PNNL) testing teams divided the testing so that results for each test could be presented by two teams, performing the tests independently. The PNNL team performed narrowband PLC testing including the Texas Instruments (TI) Concerto, Ariane Controls AC-CPM1, and the MAXIM Tahoe 2 evaluation boards. The scope of testing was limited to measuring the vendor systems communication performance between Electric Vehicle Support Equipment (EVSE) and plug-in electric vehicles (PEV). The testing scope did not address PEV’s CAN bus to PLC or PLC to EVSE (Wi-Fi, cellular, PLC Mains, etc.) communication integration. In particular, no evaluation was performed to delineate the effort needed to translate the IPv6

  16. International, multi-center standardization of acute graft-versus-host disease clinical data collection: a report from the MAGIC consortium

    Science.gov (United States)

    Harris, Andrew C.; Young, Rachel; Devine, Steven; Hogan, William J.; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A.; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S.; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L.M.; Levine, John E.

    2015-01-01

    Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and non-relapse mortality following allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed upon by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multi-center clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance was following discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture which may improve the reproducibility of GVHD clinical trials after further prospective validation. PMID:26386318

  17. Alternate performance standard project: Interpreting the post-construction test

    International Nuclear Information System (INIS)

    Williamson, A.D.; McDonough, S.E.

    1993-01-01

    The paper describes the results of a project commissioned by the State of Florida, in cooperation with the US Environmental Protection Agency, as one portion of the Florida Radon Research Program (FRRP). The purpose of the FRRP is to provide technical support for a statewide Building Standard for Radon-Resistant Construction currently in the rulemaking process. In this case the information provides technical background for a post-construction radon test specified as a performance element of the code which accompanies the prescriptive alternative that does not incorporate active radon reduction systems

  18. Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

    Science.gov (United States)

    Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

    2018-04-20

    Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

  19. ORAL CLINICAL LONG CASE PRESENTATION, THE NEED FOR STANDARDIZATION AND DOCUMENTATION.

    Science.gov (United States)

    Agodirin, S O; Olatoke, S A; Rahman, G A; Agbakwuru, E A; Kolawole, O A

    2015-01-01

    The oral presentation of the clinical long case is commonly an implied knowledge. The challenge of the presentation is compounded by the examiners' preferences and sometimes inadequate understanding of what should be assessed. To highlight the different opinions and misconceptions of trainers as the basis for improving our understanding and assessment of oral presentation of the clinical long case. Questionnaire was administered during the West African College of Surgeons fellowship clinical examinations and at their workplaces. Eligibility criteria included being a surgeon, a trainer and responding to all questions. Of the 72 questionnaires that were returned, 36(50%) were eligible for the analysis. The 36 respondents were from 14 centers in Nigeria and Ghana. Fifty-two percent were examiners at the postgraduate medical colleges and 9(25%) were professors. Eight(22.2%) indicated they were unaware of the separate methods of oral presentation for different occasions while 21( 58.3%) respondents were aware that candidate used the "5Cs" method and the traditional compartmentalized method in long case oral presentation. Eleven(30.6%) wanted postgraduates to present differently on a much higher level than undergraduate despite not encountering same in literature and 21(58.3%) indicated it was an unwritten rule. Seventeen (47.2%) had not previously encountered the "5Cs" of history of presenting complaint in literature also 17(47.2%) teach it to medical students and their junior residents. This study has shown that examiners definitely have varying opinions on what form the oral presentation of the clinical long case at surgery fellowship/professional examination should be and it translates to their expectations of the residents or clinical students. This highlights the need for standardization and consensus of what is expected at a formal oral presentation during the clinical long case examination in order to avoid subjectivity and bias.

  20. Risk Management for Point-of-Care Testing

    OpenAIRE

    James, H. Nichols

    2014-01-01

    Point-of-care testing (POCT) is growing in popularity, and with this growth comes an increased chance of errors. Risk management is a way to reduce errors. Originally developed for the manufacturing industry, risk management principles have application for improving the quality of test results in the clinical laboratory. The Clinical and Laboratory Standards Institute (CLSI), EP23-A Laboratory Quality Control based on Risk Management guideline, introduces risk management to the clinical labor...