An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: First round

International Nuclear Information System (INIS)

Ehling, G.; Hecht, M.; Heusener, A.; Huesler, J.; Gamer, A.O.; Loveren, H. van; Maurer, Th.; Riecke, K.; Ullmann, L.; Ulrich, P.; Vandebriel, R.; Vohr, H.-W.

2005-01-01

The new OECD guideline 429 (skin sensitization: local lymph node assay) is based upon a protocol, which utilises the incorporation of radioactivity into DNA as a measure for cell proliferation in vivo. The guideline also enables the use of alternative endpoints in order to assess draining lymph node (LN) cell proliferation. Here we describe the first round of an inter-laboratory validation of alternative endpoints in the LLNA conducted in seven laboratories. The validation study was managed and supervised by the Swiss Agency for Therapeutic Products, Swissmedic. Statistical analyses of all data were performed by an independent centre at the University of Bern, Department of Statistics. Ear-draining, LN weight and cell count were used to assess proliferation instead of radioactive labeling of lymph node cells. In addition, the acute inflammatory skin reaction was measured by ear swelling and weight of circular biopsies of the ears to identify skin irritating properties of the test items. Hexylcinnamaldehyde (HCA) and three blinded test items were applied to female, 8-10 weeks old NMRI and BALB/c mice. Results were sent via the independent study coordinator to the statistician. The results of this first round showed that the alternative endpoints of the LLNA are sensitive and robust parameters. The use of ear weights added an important parameter assessing the skin irritation potential, which supports the differentiation of pure irritative from contact allergenic potential. There were absolute no discrepancies between the categorisation of the three test substances A-C determined by each single participating laboratories. The results highlighted also that many parameters do have an impact on the strength of the responses. Therefore, such parameters have to be taken into consideration for the categorisation of compounds due to their relative sensitizing potencies

An European inter-laboratory validation of alternative endpoints of the murine local lymph node assay: 2nd round.

Science.gov (United States)

Ehling, G; Hecht, M; Heusener, A; Huesler, J; Gamer, A O; van Loveren, H; Maurer, Th; Riecke, K; Ullmann, L; Ulrich, P; Vandebriel, R; Vohr, H-W

2005-08-15

The original local lymph node assay (LLNA) is based on the use of radioactive labelling to measure cell proliferation. Other endpoints for the assessment of proliferation are also authorized by the OECD Guideline 429 provided there is appropriate scientific support, including full citations and description of the methodology (OECD, 2002. OECD Guideline for the Testing of Chemicals; Skin Sensitization: Local Lymph Node Assay, Guideline 429. Paris, adopted 24th April 2002.). Here, we describe the outcome of the second round of an inter-laboratory validation of alternative endpoints in the LLNA conducted in nine laboratories in Europe. The validation study was managed and supervised by the Swiss Agency for Therapeutic Products (Swissmedic) in Bern. Ear-draining lymph node (LN) weight and cell counts were used to assess LN cell proliferation instead of [3H]TdR incorporation. In addition, the acute inflammatory skin reaction was measured by ear weight determination of circular biopsies of the ears to identify skin irritation properties of the test items. The statistical analysis was performed in the department of statistics at the university of Bern. Similar to the EC(3) values defined for the radioactive method, threshold values were calculated for the endpoints measured in this modification of the LLNA. It was concluded that all parameters measured have to be taken into consideration for the categorisation of compounds due to their sensitising potencies. Therefore, an assessment scheme has been developed which turned out to be of great importance to consistently assess sensitisation versus irritancy based on the data of the different parameters. In contrast to the radioactive method, irritants have been picked up by all the laboratories applying this assessment scheme.

Inter-laboratory exercise on steroid estrogens in aqueous samples

International Nuclear Information System (INIS)

Heath, E.; Kosjek, T.; Andersen, H.R.; Holten Luetzhoft, H.-C.; Adolfson Erici, M.; Coquery, M.; Duering, R.-A.; Gans, O.; Guignard, C.; Karlsson, P.; Manciot, F.; Moldovan, Z.; Patureau, D.; Cruceru, L.; Sacher, F.; Ledin, A.

2010-01-01

An inter-laboratory comparison exercise was organized among European laboratories, under the aegis of EU COST Action 636: 'Xenobiotics in Urban Water Cycle'. The objective was to evaluate the performance of testing laboratories determining 'Endocrine Disrupting Compounds' (EDC) in various aqueous matrices. As the main task three steroid estrogens: 17α-ethinylestradiol, 17β-estradiol and estrone were determined in four spiked aqueous matrices: tap water, river water and wastewater treatment plant influent and effluent using GC-MS and LC-MS/MS. Results were compared and discussed according to the analytical techniques applied, the accuracy and reproducibility of the analytical methods and the nature of the sample matrices. Overall, the results obtained in this inter-laboratory exercise reveal a high level of competence among the participating laboratories for the detection of steroid estrogens in water samples indicating that GC-MS as well as LC-MS/MS can equally be employed for the analysis of natural and synthetic hormones. - Herein are presented the results of the first international inter-laboratory study on determination of selected steroid hormones in environmental aqueous samples.

Inter-Laboratory Comparison for Calibration of Relative Humidity Devices Among Accredited Laboratories in Malaysia

Science.gov (United States)

Hussain, F.; Khairuddin, S.; Othman, H.

2017-01-01

An inter-laboratory comparison in relative humidity measurements among accredited laboratories has been coordinated by the National Metrology Institute of Malaysia. It was carried out to determine the performance of the participating laboratories. The objective of the comparison was to acknowledge the participating laboratories competencies and to verify the level of accuracies declared in their scope of accreditation, in accordance with the MS ISO/IEC 17025 accreditation. The measurement parameter involved was relative humidity for the range of 30-90 %rh at a nominal temperature of 50°C. Eight accredited laboratories participated in the inter-laboratory comparison. Two units of artifacts have been circulated among the participants as the transfer standards.

Inter-laboratory exercise on steroid estrogens in aqueous samples

Energy Technology Data Exchange (ETDEWEB)

Heath, E., E-mail: ester.heath@ijs.s [Department of Environmental Sciences, Jozef Stefan Institute, Jamova 39, 1000 Ljubljana (Slovenia); Kosjek, T. [Department of Environmental Sciences, Jozef Stefan Institute, Jamova 39, 1000 Ljubljana (Slovenia); Andersen, H.R.; Holten Luetzhoft, H.-C. [Department of Environmental Engineering, Technical University of Denmark, Miljoevej 113, DK-2800 Kgs. Lyngby (Denmark); Adolfson Erici, M. [Stockholm University, ITM SE-106 91 Stockholm (Sweden); Coquery, M. [Cemagref, U.R. QELY, F-69336 Lyon (France); Duering, R.-A. [Giessen University, Institute of Soil Science and Soil Conservation, Giessen (Germany); Gans, O. [Umweltbundesamt GmbH, Unit Organic Analysis, Spittelauer Laende 5, 1090 Vienna (Austria); Guignard, C. [CRP Gabriel Lippmann, EVA, 41 rue du Brill, L-4422 Belvaux (Luxembourg); Karlsson, P. [Lantmannen Analycen AB, Research and Development, Sjoehagsgatan 3 Box 905, 5319, Lidkoeping (Sweden); Manciot, F. [CAE VEOLIA ENVIRONMENT, 1 Place de Turenne, 94417 Saint Maurice Cedex (France); Moldovan, Z. [National Institute of Research and Development for Isotopic and Molecular Technology, Mass Spectrometry Department, Str. Donath 65-103, 400293 Cluj-Napoca (Romania); Patureau, D. [INRA, UR50, Laboratoire de Biotechnologie de l' Environnemet (LBE), Avenue des etangs, F-11100 Narbonne (France); Cruceru, L. [Pollution Control Department, National Research Institute for Industrial Ecology (ECOIND), Sos.Panduri 90-92, sector 5, Bucharest (Romania); Sacher, F. [DVGW-Technologiezentrum Wasser, Karlsruher Strasse 84, 76139 Karlsruhe (Germany); Ledin, A. [Department of Environmental Engineering, Technical University of Denmark, Miljoevej 113, DK-2800 Kgs. Lyngby (Denmark)

2010-03-15

An inter-laboratory comparison exercise was organized among European laboratories, under the aegis of EU COST Action 636: 'Xenobiotics in Urban Water Cycle'. The objective was to evaluate the performance of testing laboratories determining 'Endocrine Disrupting Compounds' (EDC) in various aqueous matrices. As the main task three steroid estrogens: 17alpha-ethinylestradiol, 17beta-estradiol and estrone were determined in four spiked aqueous matrices: tap water, river water and wastewater treatment plant influent and effluent using GC-MS and LC-MS/MS. Results were compared and discussed according to the analytical techniques applied, the accuracy and reproducibility of the analytical methods and the nature of the sample matrices. Overall, the results obtained in this inter-laboratory exercise reveal a high level of competence among the participating laboratories for the detection of steroid estrogens in water samples indicating that GC-MS as well as LC-MS/MS can equally be employed for the analysis of natural and synthetic hormones. - Herein are presented the results of the first international inter-laboratory study on determination of selected steroid hormones in environmental aqueous samples.

Comparison of inter-trial recovery times for the determination of critical power and W' in cycling.

Science.gov (United States)

Karsten, Bettina; Hopker, James; Jobson, Simon A; Baker, Jonathan; Petrigna, Luca; Klose, Andreas; Beedie, Christopher

2017-07-01

Critical Power (CP) and W' are often determined using multi-day testing protocols. To investigate this cumbersome testing method, the purpose of this study was to compare the differences between the conventional use of a 24-h inter-trial recovery time with those of 3 h and 30 min for the determination of CP and W'. 9 moderately trained cyclists performed an incremental test to exhaustion to establish the power output associated with the maximum oxygen uptake (p[Formula: see text] max ), and 3 protocols requiring time-to-exhaustion trials at a constant work-rate performed at 80%, 100% and 105% of p[Formula: see text] max. Design: Protocol A utilised 24-h inter-trial recovery (CP 24 /W' 24 ), protocol B utilised 3-h inter-trial recovery (CP 3 /W' 3 ), and protocol C used 30-min inter-trial recovery period (CP 0.5 /W' 0.5 ). CP and W' were calculated using the inverse time (1/t) versus power (P) relation (P = W'(1/t) + CP). 95% Limits of Agreement between protocol A and B were -9 to 15 W; -7.4 to 7.8 kJ (CP/W') and between protocol A and protocol C they were -27 to 22 W; -7.2 to 15.1 kJ (CP/W'). Compared to criterion protocol A, the average prediction error of protocol B was 2.5% (CP) and 25.6% (W'), whilst for protocol C it was 3.7% (CP) and 32.9% (W'). 3-h and 30-min inter-trial recovery time protocols provide valid methods of determining CP but not W' in cycling.

Genetically modified organisms in food and feed : annual report 2010 of the Dutch National Reference Laboratory

NARCIS (Netherlands)

Scholtens-Toma, I.M.J.; Molenaar, B.; Zaaijer, S.; Voorhuijzen, M.M.; Prins, T.W.; Kok, E.J.

2011-01-01

This is the annual report of the Dutch National Reference Laboratory (NRL) for Genetically Modified Food and Feed (RIKILT - Institue of Food Safety). The report gives an overview of the NRL activities carried out in 2010. In 2010 RIKILT participated in one ring trial for inter laboratory validation

An inter-laboratory validation of a real time PCR assay to measure host excretion of bacterial pathogens, particularly of Mycobacterium bovis.

Directory of Open Access Journals (Sweden)

Emma R Travis

Full Text Available Advances in the diagnosis of Mycobacterium bovis infection in wildlife hosts may benefit the development of sustainable approaches to the management of bovine tuberculosis in cattle. In the present study, three laboratories from two different countries participated in a validation trial to evaluate the reliability and reproducibility of a real time PCR assay in the detection and quantification of M. bovis from environmental samples. The sample panels consisted of negative badger faeces spiked with a dilution series of M. bovis BCG Pasteur and of field samples of faeces from badgers of unknown infection status taken from badger latrines in areas with high and low incidence of bovine TB (bTB in cattle. Samples were tested with a previously optimised methodology. The experimental design involved rigorous testing which highlighted a number of potential pitfalls in the analysis of environmental samples using real time PCR. Despite minor variation between operators and laboratories, the validation study demonstrated good concordance between the three laboratories: on the spiked panels, the test showed high levels of agreement in terms of positive/negative detection, with high specificity (100% and high sensitivity (97% at levels of 10(5 cells g(-1 and above. Quantitative analysis of the data revealed low variability in recovery of BCG cells between laboratories and operators. On the field samples, the test showed high reproducibility both in terms of positive/negative detection and in the number of cells detected, despite low numbers of samples identified as positive by any laboratory. Use of a parallel PCR inhibition control assay revealed negligible PCR-interfering chemicals co-extracted with the DNA. This is the first example of a multi-laboratory validation of a real time PCR assay for the detection of mycobacteria in environmental samples. Field studies are now required to determine how best to apply the assay for population-level b

Intra- and inter-laboratory validation of a dipstick immunoassay for the detection of tropane alkaloids hyoscyamine and scopolamine in animal feed.

Science.gov (United States)

Mulder, Patrick P J; von Holst, Christoph; Nivarlet, Noan; van Egmond, Hans P

2014-01-01

Tropane alkaloids (TAs) are toxic secondary metabolites produced by plants of, inter alia, the genera Datura (thorn apple) and Atropa (deadly nightshade). The most relevant TAs are (-)-L-hyoscyamine and (-)-L-scopolamine, which act as antagonists of acetylcholine muscarinic receptors and can induce a variety of distinct toxic syndromes in mammals (anti-cholinergic poisoning). The European Union has regulated the presence of seeds of Datura sp. in animal feeds, specifying that the content should not exceed 1000 mg kg(-1) (Directive 2002/32/EC). For materials that have not been ground, visual screening methods are often used to comply with these regulations, but these cannot be used for ground materials and compound feeds. Immunological assays, preferably in dipstick format, can be a simple and cost-effective approach to monitor feedstuffs in an HACCP setting in control laboratories. So far no reports have been published on immunoassays that are capable of detecting both hyoscyamine and scopolamine with equal sensitivity and that can be used, preferably in dipstick format, for application as a fast screening tool in feed analysis. This study presents the results obtained for the in-house and inter-laboratory validation of a dipstick immunoassay for the detection of hyoscyamine and scopolamine in animal feed. The target level was set at 800 µg kg(-1) for the sum of both alkaloids. By using a representative set of compound feeds during validation and a robust study design, a reliable impression of the relevant characteristics of the assay could be obtained. The dipstick test displayed similar sensitivity towards the two alkaloids and it could be concluded that the test has a very low probability of producing a false-positive result at blank level or a false-negative result at target level. The assay can be used for monitoring of TAs in feedstuffs, but has also potential as a quick screening tool in food- or feed-related poisonings.

Fresh biological reference materials. Use in inter laboratory studies and as CRMs

International Nuclear Information System (INIS)

De Boer, J.

1999-01-01

Biological reference materials were prepared and packed in tins and glass jars to be used in inter laboratory studies on chlorobiphenyls and organochlorine pesticides, and trace metals, respectively. The materials were homogenised, sterilised and packed as wet tissue, which is unique for the purpose of inter laboratory studies and offers the advantage of studying the extraction and destruction steps of the analytical methods. In addition to their use in inter laboratory studies, some materials have been prepared or are being prepared as certified reference material for chlorobiphenyl analysis. (author)

An inter-laboratory comparison of Si isotope reference materials

NARCIS (Netherlands)

Reynolds, B.C.; Aggarwal, J.; André, L.; Baxter, B.; Beucher, C.; Brzezinski, M.A.; Engström, E.; Georg, R.B.; Land, M.; Leng, M.J.; Opfergelt, S.; Rodushkin, I.; Sloane, H.J.; Van den Boorn, S.H.J.M.; Vroon, P.Z.; Cardinal, D.

2007-01-01

Three Si isotope materials have been used for an inter-laboratory comparison exercise to ensure reproducibility between international laboratories investigating natural Si isotope variations using a variety of chemical preparation methods and mass spectrometric techniques. These proposed standard

Inter-laboratory analysis of selected genetically modified plant reference materials with digital PCR.

Science.gov (United States)

Dobnik, David; Demšar, Tina; Huber, Ingrid; Gerdes, Lars; Broeders, Sylvia; Roosens, Nancy; Debode, Frederic; Berben, Gilbert; Žel, Jana

2018-01-01

Digital PCR (dPCR), as a new technology in the field of genetically modified (GM) organism (GMO) testing, enables determination of absolute target copy numbers. The purpose of our study was to test the transferability of methods designed for quantitative PCR (qPCR) to dPCR and to carry out an inter-laboratory comparison of the performance of two different dPCR platforms when determining the absolute GM copy numbers and GM copy number ratio in reference materials certified for GM content in mass fraction. Overall results in terms of measured GM% were within acceptable variation limits for both tested dPCR systems. However, the determined absolute copy numbers for individual genes or events showed higher variability between laboratories in one third of the cases, most possibly due to variability in the technical work, droplet size variability, and analysis of the raw data. GMO quantification with dPCR and qPCR was comparable. As methods originally designed for qPCR performed well in dPCR systems, already validated qPCR assays can most generally be used for dPCR technology with the purpose of GMO detection. Graphical abstract The output of three different PCR-based platforms was assessed in an inter-laboratory comparison.

Inter-Trial Gait Variability Reduction Using Continous Curve Registration

National Research Council Canada - National Science Library

Sadeghi, H

2001-01-01

Timing in peak gait values shifts slightly between gait trials. When gait data are averaged, some of the standard deviation can be associated to this inter-trial variability unless normalization is carried out beforehand...

Plasma creatinine in dogs: intra- and inter-laboratory variation in 10 European veterinary laboratories

Directory of Open Access Journals (Sweden)

Ulleberg Thomas

2011-04-01

Full Text Available Abstract Background There is substantial variation in reported reference intervals for canine plasma creatinine among veterinary laboratories, thereby influencing the clinical assessment of analytical results. The aims of the study was to determine the inter- and intra-laboratory variation in plasma creatinine among 10 veterinary laboratories, and to compare results from each laboratory with the upper limit of its reference interval. Methods Samples were collected from 10 healthy dogs, 10 dogs with expected intermediate plasma creatinine concentrations, and 10 dogs with azotemia. Overlap was observed for the first two groups. The 30 samples were divided into 3 batches and shipped in random order by postal delivery for plasma creatinine determination. Statistical testing was performed in accordance with ISO standard methodology. Results Inter- and intra-laboratory variation was clinically acceptable as plasma creatinine values for most samples were usually of the same magnitude. A few extreme outliers caused three laboratories to fail statistical testing for consistency. Laboratory sample means above or below the overall sample mean, did not unequivocally reflect high or low reference intervals in that laboratory. Conclusions In spite of close analytical results, further standardization among laboratories is warranted. The discrepant reference intervals seem to largely reflect different populations used in establishing the reference intervals, rather than analytical variation due to different laboratory methods.

Sample requirements and design of an inter-laboratory trial for radiocarbon laboratories

NARCIS (Netherlands)

Bryant, C; Carmi, [No Value; Cook, G; Gulliksen, S; Harkness, D; Heinemeier, J; McGee, E; Naysmith, P; Possnert, G; van der Plicht, H; van Strydonck, M; Carmi, Israel

2000-01-01

An on-going inter-comparison programme which is focused on assessing and establishing consensus protocols to be applied in the identification, selection and sub-sampling of materials for subsequent C-14 analysis is described. The outcome of the programme will provide a detailed quantification of the

OECD validation study to assess intra- and inter-laboratory reproducibility of the zebrafish embryo toxicity test for acute aquatic toxicity testing.

Science.gov (United States)

Busquet, François; Strecker, Ruben; Rawlings, Jane M; Belanger, Scott E; Braunbeck, Thomas; Carr, Gregory J; Cenijn, Peter; Fochtman, Przemyslaw; Gourmelon, Anne; Hübler, Nicole; Kleensang, André; Knöbel, Melanie; Kussatz, Carola; Legler, Juliette; Lillicrap, Adam; Martínez-Jerónimo, Fernando; Polleichtner, Christian; Rzodeczko, Helena; Salinas, Edward; Schneider, Katharina E; Scholz, Stefan; van den Brandhof, Evert-Jan; van der Ven, Leo T M; Walter-Rohde, Susanne; Weigt, Stefan; Witters, Hilda; Halder, Marlies

2014-08-01

The OECD validation study of the zebrafish embryo acute toxicity test (ZFET) for acute aquatic toxicity testing evaluated the ZFET reproducibility by testing 20 chemicals at 5 different concentrations in 3 independent runs in at least 3 laboratories. Stock solutions and test concentrations were analytically confirmed for 11 chemicals. Newly fertilised zebrafish eggs (20/concentration and control) were exposed for 96h to chemicals. Four apical endpoints were recorded daily as indicators of acute lethality: coagulation of the embryo, lack of somite formation, non-detachment of the tail bud from the yolk sac and lack of heartbeat. Results (LC50 values for 48/96h exposure) show that the ZFET is a robust method with a good intra- and inter-laboratory reproducibility (CV30%) for some very toxic or volatile chemicals, and chemicals tested close to their limit of solubility. The ZFET is now available as OECD Test Guideline 236. Considering the high predictive capacity of the ZFET demonstrated by Belanger et al. (2013) in their retrospective analysis of acute fish toxicity and fish embryo acute toxicity data, the ZFET is ready to be considered for acute fish toxicity for regulatory purposes. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Empirical insights and considerations for the OBT inter-laboratory comparison of environmental samples

International Nuclear Information System (INIS)

Kim, Sang-Bog; Roche, Jennifer

2013-01-01

Organically bound tritium (OBT) is an important tritium species that can be measured in most environmental samples, but has only recently been recognized as a species of tritium in these samples. Currently, OBT is not routinely measured by environmental monitoring laboratories around the world. There are no certified reference materials (CRMs) for environmental samples. Thus, quality assurance (QA), or verification of the accuracy of the OBT measurement, is not possible. Alternatively, quality control (QC), or verification of the precision of the OBT measurement, can be achieved. In the past, there have been differences in OBT analysis results between environmental laboratories. A possible reason for the discrepancies may be differences in analytical methods. Therefore, inter-laboratory OBT comparisons among the environmental laboratories are important and would provide a good opportunity for adopting a reference OBT analytical procedure. Due to the analytical issues, only limited information is available on OBT measurement. Previously conducted OBT inter-laboratory practices are reviewed and the findings are described. Based on our experiences, a few considerations were suggested for the international OBT inter-laboratory comparison exercise to be completed in the near future. -- Highlights: ► Inter-laboratory OBT comparisons would provide a good opportunity for developing reference OBT analytical procedures. ► The measurement of environmental OBT concentrations has a higher associated uncertainty. ► Certified reference materials for OBT in environmental samples are required

Inter-laboratory proficiency tests to detect viral fish diseases

DEFF Research Database (Denmark)

Kahns, Søren; Nicolajsen, Nicole; Skall, Helle Frank

An inter-laboratory proficiency test has ben provided by the European Community Laboratory (CRL) for Fish Diseases every year since 1996. The test is provided to all European National Reference Laboratories (NRLs) that are obliged to participate and to a limited number of non-European NRLs, making......) but also to assess their ability to differentiate other fish viruses as spring viraemia of carp virus, infectious pancreatic necrosis virus, perch rhabdovirus etc. Five coded ampoules are provided to participants containing lyophilised supernatant from infected cell cultures. The CRL collect the data...

Reliability on intra-laboratory and inter-laboratory data of hair mineral analysis comparing with blood analysis.

Science.gov (United States)

Namkoong, Sun; Hong, Seung Phil; Kim, Myung Hwa; Park, Byung Cheol

2013-02-01

Nowadays, although its clinical value remains controversial institutions utilize hair mineral analysis. Arguments about the reliability of hair mineral analysis persist, and there have been evaluations of commercial laboratories performing hair mineral analysis. The objective of this study was to assess the reliability of intra-laboratory and inter-laboratory data at three commercial laboratories conducting hair mineral analysis, compared to serum mineral analysis. Two divided hair samples taken from near the scalp were submitted for analysis at the same time, to all laboratories, from one healthy volunteer. Each laboratory sent a report consisting of quantitative results and their interpretation of health implications. Differences among intra-laboratory and interlaboratory data were analyzed using SPSS version 12.0 (SPSS Inc., USA). All the laboratories used identical methods for quantitative analysis, and they generated consistent numerical results according to Friedman analysis of variance. However, the normal reference ranges of each laboratory varied. As such, each laboratory interpreted the patient's health differently. On intra-laboratory data, Wilcoxon analysis suggested they generated relatively coherent data, but laboratory B could not in one element, so its reliability was doubtful. In comparison with the blood test, laboratory C generated identical results, but not laboratory A and B. Hair mineral analysis has its limitations, considering the reliability of inter and intra laboratory analysis comparing with blood analysis. As such, clinicians should be cautious when applying hair mineral analysis as an ancillary tool. Each laboratory included in this study requires continuous refinement from now on for inducing standardized normal reference levels.

Laboratory diagnostic methods, system of quality and validation

Directory of Open Access Journals (Sweden)

Ašanin Ružica

2005-01-01

Full Text Available It is known that laboratory investigations secure safe and reliable results that provide a final confirmation of the quality of work. Ideas, planning, knowledge, skills, experience, and environment, along with good laboratory practice, quality control and reliability of quality, make the area of biological investigations very complex. In recent years, quality control, including the control of work in the laboratory, is based on international standards and is used at that level. The implementation of widely recognized international standards, such as the International Standard ISO/IEC 17025 (1 and the implementing of the quality system series ISO/IEC 9000 (2 have become the imperative on the grounds of which laboratories have a formal, visible and corresponding system of quality. The diagnostic methods that are used must constantly yield results which identify the animal as positive or negative, and the precise status of the animal is determined with a predefined degree of statistical significance. Methods applied on a selected population reduce the risk of obtaining falsely positive or falsely negative results. A condition for this are well conceived and documented methods, with the application of the corresponding reagents, and work with professional and skilled staff. This process requires also a consistent implementation of the most rigorous experimental plans, epidemiological and statistical data and estimations, with constant monitoring of the validity of the applied methods. Such an approach is necessary in order to cut down the number of misconceptions and accidental mistakes, for a referent population of animals on which the validity of a method is tested. Once a valid method is included in daily routine investigations, it is necessary to apply constant monitoring for the purpose of internal quality control, in order adequately to evaluate its reproducibility and reliability. Consequently, it is necessary at least twice yearly to conduct

Empirical insights and considerations for the OBT inter-laboratory comparison of environmental samples.

Science.gov (United States)

Kim, Sang-Bog; Roche, Jennifer

2013-08-01

Organically bound tritium (OBT) is an important tritium species that can be measured in most environmental samples, but has only recently been recognized as a species of tritium in these samples. Currently, OBT is not routinely measured by environmental monitoring laboratories around the world. There are no certified reference materials (CRMs) for environmental samples. Thus, quality assurance (QA), or verification of the accuracy of the OBT measurement, is not possible. Alternatively, quality control (QC), or verification of the precision of the OBT measurement, can be achieved. In the past, there have been differences in OBT analysis results between environmental laboratories. A possible reason for the discrepancies may be differences in analytical methods. Therefore, inter-laboratory OBT comparisons among the environmental laboratories are important and would provide a good opportunity for adopting a reference OBT analytical procedure. Due to the analytical issues, only limited information is available on OBT measurement. Previously conducted OBT inter-laboratory practices are reviewed and the findings are described. Based on our experiences, a few considerations were suggested for the international OBT inter-laboratory comparison exercise to be completed in the near future. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

Continuous Analytical Performances Monitoring at the On-Site Laboratory through Proficiency, Inter-Laboratory Testing and Inter-Comparison Analytical Methods

International Nuclear Information System (INIS)

Duhamel, G.; Decaillon, J.-G.; Dashdondog, S.; Kim, C.-K.; Toervenyi, A.; Hara, S.; Kato, S.; Kawaguchi, T.; Matsuzawa, K.

2015-01-01

Since 2008, as one measure to strengthen its quality management system, the On-Site Laboratory for nuclear safeguards at the Rokkasho Reprocessing Plant, has increased its participation in domestic and international proficiency and inter-laboratory testing for the purpose of determining analytical method accuracy, precision and robustness but also to support method development and improvement. This paper provides a description of the testing and its scheduling. It presents the way the testing was optimized to cover most of the analytical methods at the OSL. The paper presents the methodology used for the evaluation of the obtained results based on Analysis of variance (ANOVA). Results are discussed with respect to random, systematic and long term systematic error. (author)

Inter operability of smart field devices on an open field-bus: from laboratory tests to on-site applications

International Nuclear Information System (INIS)

Piguet, M.; Favennec, J.M.

1997-01-01

The paper presents a field trial held in EDF's R and D laboratories concerning smart field instruments (sensors, I/O modules, transmitters) operating on the WorldFIP field-bus. The trial put into operation a supervisory control and data acquisition (SCADA) system on the field-bus with available industrial field devices and software tools. The field trial enables EDF's teams to address the inter-operability issue regarding smart field devices and to prepare the forthcoming step from analog to fully digital measurement technology by evaluating new services and higher performances provided. Possible architectures for process control and on-site testing purposes have been identified. A first application for a flow-measuring rig is under way. It implements a WorldFIP field-bus based DCS with FIP/HART multiplexers, FIP and HART smart devices (sensors and actuators) and a field management system. (authors)

Inter-laboratory study to characterize the detection of serum antibodies against porcine epidemic diarrhoea virus.

Science.gov (United States)

Strandbygaard, Bertel; Lavazza, Antonio; Lelli, Davide; Blanchard, Yannick; Grasland, Béatrice; Poder, Sophie Le; Rose, Nicolas; Steinbach, Falko; van der Poel, Wim H M; Widén, Frederik; Belsham, Graham J; Bøtner, Anette

2016-12-25

Porcine epidemic diarrhea virus (PEDV) has caused extensive economic losses to pig producers in many countries. It was recently introduced, for the first time, into North America and outbreaks have occurred again in multiple countries within Europe as well. To assess the properties of various diagnostic assays for the detection of PEDV infection, multiple panels of porcine sera have been shared and tested for the presence of antibodies against PEDV in an inter-laboratory ring trial. Different laboratories have used a variety of "in house" ELISAs and also one commercial assay. The sensitivity and specificity of each assay has been estimated using a Bayesian analysis applied to the ring trial results obtained with the different assays in the absence of a gold standard. Although different characteristics were found, it can be concluded that each of the assays used can detect infection of pigs at a herd level by either the early European strains of PEDV or the recently circulating strains (INDEL and non-INDEL). However, not all the assays seem suitable for demonstrating freedom from disease in a country. The results from individual animals, especially when the infection has occurred within an experimental situation, show more variation. Copyright © 2016. Published by Elsevier B.V.

Inter laboratory comparison on Industrial Computed Tomography

DEFF Research Database (Denmark)

Angel, Jais Andreas Breusch; De Chiffre, Leonardo; Larsen, Erik

The ‘CIA-CT comparison - Inter laboratory comparison on industrial Computed Tomography” is organized by DTU Department of Mechanical Engineering within the Danish project “Centre for Industrial Application of CT scanning - CIA-CT”. The project is co-financed by the Danish Ministry of Science......, Technology and Innovation. The comparison aims to collect information about measurement performance in state-of the-art industrial CT (Computed Tomography) scanning. Since CT scanning has entered the field of manufacturing and coordinate metrology, evaluation of uncertainty of measurement with assessment...

Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse.

Science.gov (United States)

Martínez-Granados, Luis; Serrano, María; González-Utor, Antonio; Ortíz, Nereyda; Badajoz, Vicente; Olaya, Enrique; Prados, Nicolás; Boada, Montse; Castilla, Jose A

2017-01-01

The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC) of time lapse, performed in 2014, with the classical EQC of the Spanish Society for the Study of Reproductive Biology (ASEBIR) performed in 2013 and 2014. In total, 24 laboratories (8 using EmbryoScope™, 15 using Primo Vision™ and one with both platforms) took part in the pilot study. The clinics that used EmbryoScope™ analysed 31 embryos and those using Primo Vision™ analysed 35. The classical EQC was implemented by 39 clinics, based on an analysis of 25 embryos per year. Both groups were required to evaluate various qualitative morphological variables (cell fragmentation, the presence of vacuoles, blastomere asymmetry and multinucleation), to classify the embryos in accordance with ASEBIR criteria and to stipulate the clinical decision taken. In the EQC time-lapse pilot study, the groups were asked to determine, as well as the above characteristics, the embryo development times, the number, opposition and size of pronuclei, the direct division of 1 into 3 cells and/or of 3 into 5 cells and false divisions. The degree of agreement was determined by calculating the intra-class correlation coefficients and the coefficient of variation for the quantitative variables and the Gwet index for the qualitative variables. For both EmbryoScope™ and Primo Vision™, two periods of greater inter-laboratory variability were observed in the times of embryo development events. One peak of variability was recorded among the laboratories addressing the first embryo events (extrusion of the second polar body and the appearance of pronuclei); the second peak took place between the times corresponding to the 8-cell and morula stages. In most of the qualitative variables analysed regarding embryo development, there was almost

Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse.

Directory of Open Access Journals (Sweden)

Luis Martínez-Granados

Full Text Available The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC of time lapse, performed in 2014, with the classical EQC of the Spanish Society for the Study of Reproductive Biology (ASEBIR performed in 2013 and 2014. In total, 24 laboratories (8 using EmbryoScope™, 15 using Primo Vision™ and one with both platforms took part in the pilot study. The clinics that used EmbryoScope™ analysed 31 embryos and those using Primo Vision™ analysed 35. The classical EQC was implemented by 39 clinics, based on an analysis of 25 embryos per year. Both groups were required to evaluate various qualitative morphological variables (cell fragmentation, the presence of vacuoles, blastomere asymmetry and multinucleation, to classify the embryos in accordance with ASEBIR criteria and to stipulate the clinical decision taken. In the EQC time-lapse pilot study, the groups were asked to determine, as well as the above characteristics, the embryo development times, the number, opposition and size of pronuclei, the direct division of 1 into 3 cells and/or of 3 into 5 cells and false divisions. The degree of agreement was determined by calculating the intra-class correlation coefficients and the coefficient of variation for the quantitative variables and the Gwet index for the qualitative variables. For both EmbryoScope™ and Primo Vision™, two periods of greater inter-laboratory variability were observed in the times of embryo development events. One peak of variability was recorded among the laboratories addressing the first embryo events (extrusion of the second polar body and the appearance of pronuclei; the second peak took place between the times corresponding to the 8-cell and morula stages. In most of the qualitative variables analysed regarding embryo development, there

Inter-laboratory and inter-assay comparison on two real-time PCR techniques for quantification of PCV2 nucleic acid extracted from field samples

DEFF Research Database (Denmark)

Hjulsager, Charlotte Kristiane; Grau-Roma, L.; Sibila, M.

2009-01-01

Several real-time PCR assays for quantification of PCV2 DNA (qPCR) have been described in the literature. and different in-house assays are being used by laboratories around the world. A general threshold of it copies of PCV2 per millilitre serum for postweaning multisystemic wasting syndrome (PMWS......) diagnosis has been suggested. However, neither inter-laboratory nor inter-assay comparisons have been published so far. In the present study two different qPCR probe assays Used routinely in two laboratories were compared on DNA extracted From serum, nasal and rectal swabs. Results showed a significant...

Quantifying inter-laboratory variability in stable isotope analysis of ancient skeletal remains.

Directory of Open Access Journals (Sweden)

William J Pestle

Full Text Available Over the past forty years, stable isotope analysis of bone (and tooth collagen and hydroxyapatite has become a mainstay of archaeological and paleoanthropological reconstructions of paleodiet and paleoenvironment. Despite this method's frequent use across anthropological subdisciplines (and beyond, the present work represents the first attempt at gauging the effects of inter-laboratory variability engendered by differences in a sample preparation, and b analysis (instrumentation, working standards, and data calibration. Replicate analyses of a 14C-dated ancient human bone by twenty-one archaeological and paleoecological stable isotope laboratories revealed significant inter-laboratory isotopic variation for both collagen and carbonate. For bone collagen, we found a sizeable range of 1.8‰ for δ13Ccol and 1.9‰ for δ15Ncol among laboratories, but an interpretatively insignificant average pairwise difference of 0.2‰ and 0.4‰ for δ13Ccol and δ15Ncol respectively. For bone hydroxyapatite the observed range increased to a troublingly large 3.5‰ for δ13Cap and 6.7‰ for δ18Oap, with average pairwise differences of 0.6‰ for δ13Cap and a disquieting 2.0‰ for δ18Oap. In order to assess the effects of preparation versus analysis on isotopic variability among laboratories, a subset of the samples prepared by the participating laboratories were analyzed a second time on the same instrument. Based on this duplicate analysis, it was determined that roughly half of the isotopic variability among laboratories could be attributed to differences in sample preparation, with the other half resulting from differences in analysis (instrumentation, working standards, and data calibration. These findings have serious implications for choices made in the preparation and extraction of target biomolecules, the comparison of results obtained from different laboratories, and the interpretation of small differences in bone collagen and hydroxyapatite

Quantifying inter-laboratory variability in stable isotope analysis of ancient skeletal remains.

Science.gov (United States)

Pestle, William J; Crowley, Brooke E; Weirauch, Matthew T

2014-01-01

Over the past forty years, stable isotope analysis of bone (and tooth) collagen and hydroxyapatite has become a mainstay of archaeological and paleoanthropological reconstructions of paleodiet and paleoenvironment. Despite this method's frequent use across anthropological subdisciplines (and beyond), the present work represents the first attempt at gauging the effects of inter-laboratory variability engendered by differences in a) sample preparation, and b) analysis (instrumentation, working standards, and data calibration). Replicate analyses of a 14C-dated ancient human bone by twenty-one archaeological and paleoecological stable isotope laboratories revealed significant inter-laboratory isotopic variation for both collagen and carbonate. For bone collagen, we found a sizeable range of 1.8‰ for δ13Ccol and 1.9‰ for δ15Ncol among laboratories, but an interpretatively insignificant average pairwise difference of 0.2‰ and 0.4‰ for δ13Ccol and δ15Ncol respectively. For bone hydroxyapatite the observed range increased to a troublingly large 3.5‰ for δ13Cap and 6.7‰ for δ18Oap, with average pairwise differences of 0.6‰ for δ13Cap and a disquieting 2.0‰ for δ18Oap. In order to assess the effects of preparation versus analysis on isotopic variability among laboratories, a subset of the samples prepared by the participating laboratories were analyzed a second time on the same instrument. Based on this duplicate analysis, it was determined that roughly half of the isotopic variability among laboratories could be attributed to differences in sample preparation, with the other half resulting from differences in analysis (instrumentation, working standards, and data calibration). These findings have serious implications for choices made in the preparation and extraction of target biomolecules, the comparison of results obtained from different laboratories, and the interpretation of small differences in bone collagen and hydroxyapatite isotope values

Inter-laboratory comparisons. Determination of actinides in excreta

International Nuclear Information System (INIS)

Berard, P.; Cavadore, D.; Harduin, J.C.

1995-01-01

Inter-laboratory tests are a means of assessing the analytical coherence of medical laboratories. In radio toxicology, this kind of exercise makes it possible to keep up with laboratory know-how and with the evolution and relative performances of analytical techniques (precision and reproducibility). However, the goal of the laboratories taking part in these annual exercises is not only to check the accuracy of their results. The analytical discussions and the chance to compare experience enrich the groups general competence. French biologists have been organizing annual radio toxicology intercomparison exercises since 1978. The exercises are carried out within the framework of a working group (GT1) operating under the aegis of the French Atomic Energy Commission's (CEA) Medical Coordinator. Using reports and diagrams which present the results obtained by the participants in the form of syntheses, the authors describe how the exercises for determining actinides in excreta (urine and faeces) are organized, how the results are evaluated in terms of the analytical methods used, and the improvements made in analytical and metrological performance. Up until 1985, these exercises were limited to French laboratories. Since then, the exercises have acquired an international dimension, opening up to include interested foreign radio chemists, initially from European laboratories, and now from laboratories worldwide. At the present time, 35 laboratories representing 9 countries take part regularly in these intercomparison exercises. (author). 6 refs., 9 figs

Evaluation of NAA laboratory results in inter-comparison on determination of trace elements in food and environmental samples

International Nuclear Information System (INIS)

Diah Dwiana Lestiani; Syukria Kurniawati; Natalia Adventini

2012-01-01

Inter-comparison program is a good tool for improving quality and to enhance the accuracy and precision of the analytical techniques. By participating in this program, laboratories could demonstrate their capability and ensuring the quality of analysis results generated by analytical laboratories. The Neutron Activation Analysis (NAA) laboratory at National Nuclear Energy Agency of Indonesia (BATAN), Nuclear Technology Center for Materials and Radiometry-PTNBR laboratory participated in inter-comparison tests organized by NAA working group. Inter-comparison BATAN 2009 was the third inter-laboratory analysis test within that project. The participating laboratories were asked to analyze for trace elements using neutron activation analysis as the primary technique. Three materials were distributed to the participants representing foodstuff, and environmental material samples. Samples were irradiated in rabbit facility of G.A. Siwabessy reactor with neutron flux ~ 10 13 n.cm -2 .s -1 , and counted with HPGe detector of gamma spectrometry. Several trace elements in these samples were detected. The accuracy and precision evaluation based on International Atomic Energy Agency (IAEA) criteria was applied. In this paper the PTNBR NAA laboratory results is evaluated. (author)

Recovery of Pavlovian sign-tracking (autoshaping) following the discontinuation of inter-trial interval food in rats.

Science.gov (United States)

Kearns, David N; Weiss, Stanley J

2007-07-01

In pigeons, Pavlovian autoshaped keypecking produced by keylight-food pairings has been eliminated by introducing food during periods between CS presentations (i.e., during the inter-trial intervals). Keypecking eliminated in this manner reappears when the inter-trial USs are discontinued even though the CS is no longer paired with US. The present experiment investigated whether this recovery of responding produced by discontinuing unpaired inter-trial US presentations could be extended to another species, rats, within a Pavlovian sign-tracking paradigm. Rats were initially trained on a procedure where insertion of one retractable lever (CS(+)) was followed, response independently, with food, while insertion of another lever (CS(-)) was not paired with food. Rats quickly came to contact the CS(+) lever at high rates, but contacted the CS(-) lever infrequently. In the next phase, CS(+) was no longer followed by food. Explicitly unpaired food was presented only during the inter-trial intervals when both levers were absent. This treatment essentially eliminated the sign-tracking response. In the final phase, the unpaired inter-trial food presentations were discontinued while both CSs continued to be presented without food. This produced a significant recovery of the sign-tracking elicited by the CS(+) lever, extending the species generality of the Pavlovian resurgence phenomenon that has previously only been reported in pigeons, to rats.

Forecasting Sensorimotor Adaptability from Baseline Inter-Trial Correlations

Science.gov (United States)

Beaton, K. H.; Bloomberg, J. J.

2016-01-01

One of the greatest challenges for sensorimotor adaptation to the spaceflight environment is the large variability in symptoms, and corresponding functional impairments, from one crewmember to the next. This renders preflight training and countermeasure development difficult, as a "one-size-fits-all" approach is inappropriate. Therefore, it would be highly advantageous to know ahead of time which crewmembers might have more difficulty adjusting to the novel g-levels inherent to spaceflight. This information could guide individually customized countermeasures, which would enable more efficient use of crew time and provide better outcomes. The principal aim of this work is to look for baseline performance metrics that relate to locomotor adaptability. We propose a novel hypothesis that considers baseline inter-trial correlations, the trial-to-trial fluctuations ("noise") in motor performance, as a predictor of individual adaptive capabilities.

An inter-laboratory comparison of arsenic analysis in Bangladesh. Draft report

International Nuclear Information System (INIS)

Aggarwal, P.K.; Dargie, M.; Groening, M.; Kulkarni, K.M.; Gibson, J.J.

2001-03-01

The International Atomic Energy Agency (IAEA) conducted an evaluation of the quality of arsenic analysis in Bangladesh through an inter-laboratory comparison of the analysis of synthetic standards and field samples. A set of 8 synthetic standards with arsenic concentrations ranging from 0 to about 500 μg/kg, traceable to an internationally recognized standard solution of arsenic, were prepared by the IAEA and provided to the participating laboratories. In addition, two samples of drinking water were collected from near Dhaka by the local office of the World Health Organization (WHO) and provided to all participating laboratories and the IAEA for analysis. Out of the 25 laboratories who received the synthetic standards and field samples, 17 laboratories submitted results to the IAEA for comparison. The reported arsenic concentrations have a wide range with values much higher or much lower than the expected value. Analysis of field samples shows a range of values from 0 to 396 μg/kg. Less than one third of the participating laboratories obtained results that were within about 20% of the expected values (about 60 μg/kg) obtained by a laboratory cooperating with the IAEA (University of Rochester). Results of this inter-laboratory comparison point to a lack of consistency in the analytical results that have been and are being obtained in Bangladesh. More importantly, drinking water wells where elevated arsenic concentrations have been found may in fact have low concentrations. Similarly, wells that have been found to be free of arsenic may in fact have substantially higher arsenic concentrations. The quality and reliability of arsenic analysis needs to be established and continually evaluated in order to identify all affected areas and to provide appropriate mitigation

Face validity and inter-rater reliability of the Danish version of the modified-Yale Preoperative Anxiety Scale

DEFF Research Database (Denmark)

Skovby, Pernille; Rask, Charlotte Ulrikka; Dall, Rolf

2014-01-01

-YPAS to Danish cultural and linguistic conditions and to test face validity and inter-reliability in a clinical setting. Materials and methods The translation was performed in accordance with WHO guidelines. Face validity as well as linguistic difficulties of the Danish version was tested and solved in a focus...... of the m-YPAS as suitable and relevant, i.e. the face validity satisfactory. Inter-rater reliability analysis revealed that inter-observer agreement at induction 1 were good to very good (kw: 0.63–0.98) and at induction 2, the agreement was good to very good (kw: 0.72–0.96). ICC for the overall weighted...... anxiety score was in: induction 1:0.92 and induction 2: 0.92 Conclusion Standardized and validated assessment tools are needed to evaluate interventions aiming to reduce preoperative anxiety in children. The Danish m-YPAS had a satisfactory face validity and inter-reliability, based on a minor empirical...

Plasma creatinine in dogs: intra- and inter-laboratory variation in 10 European veterinary laborat

NARCIS (Netherlands)

Mrs. Ulleberg, T.; Robben, J.H.; Nordahl, K.; Mr. Ulleberg, T.; Heiene, R.

2011-01-01

Abstract BACKGROUND: There is substantial variation in reported reference intervals for canine plasma creatinine among veterinary laboratories, thereby influencing the clinical assessment of analytical results. The aims of the study was to determine the inter- and intra-laboratory variation in

Dicentric chromosome aberration analysis using giemsa and centromere specific fluorescence in-situ hybridization for biological dosimetry: An inter- and intra-laboratory comparison in Indian laboratories

International Nuclear Information System (INIS)

Bhavani, M.; Tamizh Selvan, G.; Kaur, Harpreet; Adhikari, J.S.; Vijayalakshmi, J.; Venkatachalam, P.; Chaudhury, N.K.

2014-01-01

To facilitate efficient handling of large samples, an attempt towards networking of laboratories in India for biological dosimetry was carried out. Human peripheral blood samples were exposed to 60 Co γ-radiation for ten different doses (0–5 Gy) at a dose rate of 0.7 and 2 Gy/min. The chromosomal aberrations (CA) were scored in Giemsa-stained and fluorescence in-situ hybridization with centromere-specific probes. No significant difference (p>0.05) was observed in the CA yield for given doses except 4 and 5 Gy, between the laboratories, among the scorers and also staining methods adapted suggest the reliability and validates the inter-lab comparisons exercise for triage applications. - Highlights: • This is the first report from India on Networking for Biological Dosimetry preparedness using dicentric chromosomal (DC) aberration assay. • There is no significant difference in the in vitro dose response curve (Slope, Intercept, Curvature) constructed among the two labs. • No significant variation in the scoring of DC aberrations between the scorers irrespective of labs. • The DC results obtained by the labs from the Giemsa stained metaphase preparations were confirmed with centromere specific-FISH for further reliability and validity

Inter-laboratory variation in DNA damage using a standard comet assay protocol

DEFF Research Database (Denmark)

Forchhammer, Lykke; Ersson, Clara; Loft, Steffen

2012-01-01

determined the baseline level of DNA strand breaks (SBs)/alkaline labile sites and formamidopyrimidine DNA glycosylase (FPG)-sensitive sites in coded samples of mononuclear blood cells (MNBCs) from healthy volunteers. There were technical problems in seven laboratories in adopting the standard protocol...... analysed by the standard protocol. The SBs and FPG-sensitive sites were measured in the same experiment, indicating that the large spread in the latter lesions was the main reason for the reduced inter-laboratory variation. However, it remains worrying that half of the participating laboratories obtained...

The OECD validation program of the H295R steroidogenesis assay for the identification of in vitro inhibitors and inducers of testosterone and estradiol production. Phase 2: Inter-laboratory pre-validation studies

DEFF Research Database (Denmark)

Hecker, Markus; Hollert, Henner; Cooper, Ralph

2007-01-01

plate was run in conjunction with the chemical exposure plate to account for inter-assay variation. Each chemical exposure was conducted two or three times. Results. All laboratories successfully detected increases and/or decreases in hormone production by H295R cells after exposure to the different...

Inter-laboratory project q calibration of SANS instruments using silver behenate

International Nuclear Information System (INIS)

Ikram, Abarrul; Gunawan; Edy Giri, Putra; Suzuki, Jun-ichi; Knott, Robert

2000-01-01

The inter-laboratory project for q-calibration of SANS (small angle neutron scattering) using silver behenate was carried out among Indonesia National Nuclear Energy Agency (BATAN), Japan Atomic Energy Research Institute (JAERI) and Australian Nuclear Science and Technology Organization (ANSTO). The standard sample of silver behenate, [CH 3 (CH 2 ) 20 COOAg](AgBE), has been assessed as an international standard for the calibration of both x-ray and neutron scattering instruments. The results indicate excellent agreement for q calibration obtained among the three laboratories, BATAN, JAERI and ANSTO. (Y. Kazumata)

Integration of new biological and physical retrospective dosimetry methods into EU emergency response plans - joint RENEB and EURADOS inter-laboratory comparisons.

Science.gov (United States)

Ainsbury, Elizabeth; Badie, Christophe; Barnard, Stephen; Manning, Grainne; Moquet, Jayne; Abend, Michael; Antunes, Ana Catarina; Barrios, Lleonard; Bassinet, Celine; Beinke, Christina; Bortolin, Emanuela; Bossin, Lily; Bricknell, Clare; Brzoska, Kamil; Buraczewska, Iwona; Castaño, Carlos Huertas; Čemusová, Zina; Christiansson, Maria; Cordero, Santiago Mateos; Cosler, Guillaume; Monaca, Sara Della; Desangles, François; Discher, Michael; Dominguez, Inmaculada; Doucha-Senf, Sven; Eakins, Jon; Fattibene, Paola; Filippi, Silvia; Frenzel, Monika; Georgieva, Dimka; Gregoire, Eric; Guogyte, Kamile; Hadjidekova, Valeria; Hadjiiska, Ljubomira; Hristova, Rositsa; Karakosta, Maria; Kis, Enikő; Kriehuber, Ralf; Lee, Jungil; Lloyd, David; Lumniczky, Katalin; Lyng, Fiona; Macaeva, Ellina; Majewski, Matthaeus; Vanda Martins, S; McKeever, Stephen W S; Meade, Aidan; Medipally, Dinesh; Meschini, Roberta; M'kacher, Radhia; Gil, Octávia Monteiro; Montero, Alegria; Moreno, Mercedes; Noditi, Mihaela; Oestreicher, Ursula; Oskamp, Dominik; Palitti, Fabrizio; Palma, Valentina; Pantelias, Gabriel; Pateux, Jerome; Patrono, Clarice; Pepe, Gaetano; Port, Matthias; Prieto, María Jesús; Quattrini, Maria Cristina; Quintens, Roel; Ricoul, Michelle; Roy, Laurence; Sabatier, Laure; Sebastià, Natividad; Sholom, Sergey; Sommer, Sylwester; Staynova, Albena; Strunz, Sonja; Terzoudi, Georgia; Testa, Antonella; Trompier, Francois; Valente, Marco; Hoey, Olivier Van; Veronese, Ivan; Wojcik, Andrzej; Woda, Clemens

2017-01-01

RENEB, 'Realising the European Network of Biodosimetry and Physical Retrospective Dosimetry,' is a network for research and emergency response mutual assistance in biodosimetry within the EU. Within this extremely active network, a number of new dosimetry methods have recently been proposed or developed. There is a requirement to test and/or validate these candidate techniques and inter-comparison exercises are a well-established method for such validation. The authors present details of inter-comparisons of four such new methods: dicentric chromosome analysis including telomere and centromere staining; the gene expression assay carried out in whole blood; Raman spectroscopy on blood lymphocytes, and detection of radiation-induced thermoluminescent signals in glass screens taken from mobile phones. In general the results show good agreement between the laboratories and methods within the expected levels of uncertainty, and thus demonstrate that there is a lot of potential for each of the candidate techniques. Further work is required before the new methods can be included within the suite of reliable dosimetry methods for use by RENEB partners and others in routine and emergency response scenarios.

Development and inter-laboratory validation of unlabeled probe melting curve analysis for detection of JAK2 V617F mutation in polycythemia vera.

Science.gov (United States)

Wu, Zhiyuan; Yuan, Hong; Zhang, Xinju; Liu, Weiwei; Xu, Jinhua; Zhang, Wei; Guan, Ming

2011-01-01

JAK2 V617F, a somatic point mutation that leads to constitutive JAK2 phosphorylation and kinase activation, has been incorporated into the WHO classification and diagnostic criteria of myeloid neoplasms. Although various approaches such as restriction fragment length polymorphism, amplification refractory mutation system and real-time PCR have been developed for its detection, a generic rapid closed-tube method, which can be utilized on routine genetic testing instruments with stability and cost-efficiency, has not been described. Asymmetric PCR for detection of JAK2 V617F with a 3'-blocked unlabeled probe, saturate dye and subsequent melting curve analysis was performed on a Rotor-Gene® Q real-time cycler to establish the methodology. We compared this method to the existing amplification refractory mutation systems and direct sequencing. Hereafter, the broad applicability of this unlabeled probe melting method was also validated on three diverse real-time systems (Roche LightCycler® 480, Applied Biosystems ABI® 7500 and Eppendorf Mastercycler® ep realplex) in two different laboratories. The unlabeled probe melting analysis could genotype JAK2 V617F mutation explicitly with a 3% mutation load detecting sensitivity. At level of 5% mutation load, the intra- and inter-assay CVs of probe-DNA heteroduplex (mutation/wild type) covered 3.14%/3.55% and 1.72%/1.29% respectively. The method could equally discriminate mutant from wild type samples on the other three real-time instruments. With a high detecting sensitivity, unlabeled probe melting curve analysis is more applicable to disclose JAK2 V617F mutation than conventional methodologies. Verified with the favorable inter- and intra-assay reproducibility, unlabeled probe melting analysis provided a generic mutation detecting alternative for real-time instruments.

Development and inter-laboratory validation of unlabeled probe melting curve analysis for detection of JAK2 V617F mutation in polycythemia vera.

Directory of Open Access Journals (Sweden)

Zhiyuan Wu

Full Text Available BACKGROUND: JAK2 V617F, a somatic point mutation that leads to constitutive JAK2 phosphorylation and kinase activation, has been incorporated into the WHO classification and diagnostic criteria of myeloid neoplasms. Although various approaches such as restriction fragment length polymorphism, amplification refractory mutation system and real-time PCR have been developed for its detection, a generic rapid closed-tube method, which can be utilized on routine genetic testing instruments with stability and cost-efficiency, has not been described. METHODOLOGY/PRINCIPAL FINDINGS: Asymmetric PCR for detection of JAK2 V617F with a 3'-blocked unlabeled probe, saturate dye and subsequent melting curve analysis was performed on a Rotor-Gene® Q real-time cycler to establish the methodology. We compared this method to the existing amplification refractory mutation systems and direct sequencing. Hereafter, the broad applicability of this unlabeled probe melting method was also validated on three diverse real-time systems (Roche LightCycler® 480, Applied Biosystems ABI® 7500 and Eppendorf Mastercycler® ep realplex in two different laboratories. The unlabeled probe melting analysis could genotype JAK2 V617F mutation explicitly with a 3% mutation load detecting sensitivity. At level of 5% mutation load, the intra- and inter-assay CVs of probe-DNA heteroduplex (mutation/wild type covered 3.14%/3.55% and 1.72%/1.29% respectively. The method could equally discriminate mutant from wild type samples on the other three real-time instruments. CONCLUSIONS: With a high detecting sensitivity, unlabeled probe melting curve analysis is more applicable to disclose JAK2 V617F mutation than conventional methodologies. Verified with the favorable inter- and intra-assay reproducibility, unlabeled probe melting analysis provided a generic mutation detecting alternative for real-time instruments.

Lessons learnt from participation in international inter-comparison exercise for environmental radioactivity measurement

International Nuclear Information System (INIS)

Jha, S.K.; Pulhani, Vandana; Sartandel, Sangeeta

2016-06-01

Environmental Radioactivity Measurement Section of Health Physics Division is regularly carrying out surveillance of the radioactivity concentration in the environment. The laboratory participates in the inter-comparison exercises conducted by various international agencies for quality assurance and quality control of analytical estimations. This report summarizes the results of the analysis of radioactivity in environmental matrices of the inter-comparison exercises. The participation in inter-comparison exercises has demonstrated competence in radionuclide identification and estimations, equivalence with the results of other participating laboratories, validated adopted analytical methods, introduced traceability to measurement etc. at national and international level. (author)

Laboratory and software applications for clinical trials: the global laboratory environment.

Science.gov (United States)

Briscoe, Chad

2011-11-01

The Applied Pharmaceutical Software Meeting is held annually. It is sponsored by The Boston Society, a not-for-profit organization that coordinates a series of meetings within the global pharmaceutical industry. The meeting generally focuses on laboratory applications, but in recent years has expanded to include some software applications for clinical trials. The 2011 meeting emphasized the global laboratory environment. Global clinical trials generate massive amounts of data in many locations that must be centralized and processed for efficient analysis. Thus, the meeting had a strong focus on establishing networks and systems for dealing with the computer infrastructure to support such environments. In addition to the globally installed laboratory information management system, electronic laboratory notebook and other traditional laboratory applications, cloud computing is quickly becoming the answer to provide efficient, inexpensive options for managing the large volumes of data and computing power, and thus it served as a central theme for the meeting.

INTER LABORATORY COMBAT HELMET BLUNT IMPACT TEST METHOD COMPARISON

Science.gov (United States)

2018-03-26

data by Instrumentation for Impact  Test , SAE standard J211‐1 [4]. Although the entire curve is collected, the interest of this  project  team  solely...HELMET BLUNT IMPACT TEST METHOD COMPARISON by Tony J. Kayhart Charles A. Hewitt and Jonathan Cyganik March 2018 Final...INTER-LABORATORY COMBAT HELMET BLUNT IMPACT TEST METHOD COMPARISON 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR

Evaluation of the analytic performance of laboratories: inter-laboratorial study of the spectroscopy of atomic absorption

International Nuclear Information System (INIS)

Wong Wong, S. M.

1996-01-01

The author made an inter-laboratorial study, with the participation of 18 national laboratories, that have spectrophotometer of atomic absorption. To evaluate the methods of analysis of lead, sodium, potasium, calcium, magnesium, zinc, copper, manganese, and iron, in the ambit of mg/l. The samples, distributed in four rounds to the laboratories, were prepared from primary patterns, deionized and distilled water. The study evaluated the homogeneity and stability, and verified its concentration, using as a reference method, the spectrometry method of Inductively Coupled Plasma emission (1CP). To obtain the characteristics of analytic performance, it applied the norm ASTM E 691. To evaluated the analytic performance, it used harmonized protocol of the International Union of Pure and applied chemistry (IUPAC). The study obtained the 29% of the laboratories had a satisfactory analytic performance, 9% had a questionable performance and 62% made an unsatisfactory analytic performance, according to the IUPAC norm. The results of the values of the characteristic performance method, show that there is no intercomparability between the laboratories, which is attributed to the different methodologies of analysis. (S. Grainger)

NVN 5694 intra laboratory validation. Feasibility study for interlaboratory- validation

International Nuclear Information System (INIS)

Voors, P.I.; Baard, J.H.

1998-11-01

Within the project NORMSTAR 2 a number of Dutch prenormative protocols have been defined for radioactivity measurements. Some of these protocols, e.g. the Dutch prenormative protocol NVN 5694, titled Methods for radiochemical determination of polonium-210 and lead-210, have not been validated, neither by intralaboratory nor interlaboratory studies. Validation studies are conducted within the framework of the programme 'Normalisatie and Validatie van Milieumethoden 1993-1997' (Standardization and Validation of test methods for environmental parameters) of the Dutch Ministry of Housing, Physical Planning and the Environment (VROM). The aims of this study were (a) a critical evaluation of the protocol, (b) investigation on the feasibility of an interlaboratory study, and (c) the interlaboratory validation of NVN 5694. The evaluation of the protocol resulted in a list of deficiencies varying from missing references to incorrect formulae. From the survey by interview it appeared that for each type of material, there are 4 to 7 laboratories willing to participate in a interlaboratory validation study. This reflects the situation in 1997. Consequently, if 4 or 6 (the minimal number) laboratories are participating and each laboratory analyses 3 subsamples, the uncertainty in the repeatability standard deviation is 49 or 40 %, respectively. If the ratio of reproducibility standard deviation to the repeatability standard deviation is equal to 1 or 2, then the uncertainty in the reproducibility standard deviation increases from 42 to 67 % and from 34 to 52 % for 4 or 6 laboratories, respectively. The intralaboratory validation was established on four different types of materials. Three types of materials (milkpowder condensate and filter) were prepared in the laboratory using the raw material and certified Pb-210 solutions, and one (sediment) was obtained from the IAEA. The ECN-prepared reference materials were used after testing on homogeneity. The pre-normative protocol can

OECD validation study to assess intra- and inter-laboratory reproducibility of the zebrafish embryo toxicity test for acute aquatic toxicity testing

NARCIS (Netherlands)

Busquet, F.; Strecker, R.; Rawlings, J.M.; Belanger, S.E.; Braunbeck, T.; Carr, G.J.; Cenijn, P.H.; Fochtman, P.; Gourmelon, A.; Hübler, N.; Kleensang, A.; Knöbel, M.; Kussatz, C.; Legler, J.; Lillicrap, A.; Martínez-Jerónimo, F.; Polleichtner, C.; Rzodeczko, H.; Salinas, E.; Schneider, K.E.; Scholz, S.; van den Brandhof, E.J.; van der Ven, L.T.; Walter-Rohde, S.; Weigt, S.; Witters, H.; Halder, M.

2014-01-01

A The OECD validation study of the zebrafish embryo acute toxicity test (ZFET) for acute aquatic toxicity testing evaluated the ZFET reproducibility by testing 20 chemicals at 5 different concentrations in 3 independent runs in at least 3 laboratories. Stock solutions and test concentrations were

The 3"r"d inter laboratory comparison in the determination of elements in foodstuff with neutron activation analysis method

International Nuclear Information System (INIS)

Muji Wiyono; Dadong Iskandar; Wahyudi

2010-01-01

The 3"r"d inter laboratory comparison in the determination of elements in the foodstuff with NAA method held by PTBIN-BATAN Laboratory has been carried out. Six laboratories in BATAN were participated in the program with each code were: Lab. 01, Lab. 02, Lab. 03, Lab. 04, Lab. 05 and Lab. 06. Lab KKL PTKMR-BATAN was a participant with Lab. 06 code number. The received samples of foodstuff were prepared and irradiated in the RS-03 rabbit system of GA. Siwabessy multi purpose reactor. The irradiated samples were counted by using gamma spectrometer with HPGe detector to determine the content of elements. Result of the analysis was reported to the coordinator to be evaluated whether the sample was passed or rejected. Result of the coordinator laboratory evaluated that, 9 elements identified by Lab. KKL PTKMR-BATAN had four elements such as; Al, K, Cu and Se were passed (accepted) and other elements such as; Mn, Na, Ca, Fe and Zn were rejected. The elements number that passed in the 3"r"d inter laboratory comparison was less than those of earlier inter laboratory comparison, this was due to elemental content in the analyzed samples was very low. (author)

RTOG: Updated results of randomized trials

International Nuclear Information System (INIS)

Curran, Walter J.

1997-01-01

Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

Validation of Inter-Subject Training for Hidden Markov Models Applied to Gait Phase Detection in Children with Cerebral Palsy

Directory of Open Access Journals (Sweden)

Juri Taborri

2015-09-01

Full Text Available Gait-phase recognition is a necessary functionality to drive robotic rehabilitation devices for lower limbs. Hidden Markov Models (HMMs represent a viable solution, but they need subject-specific training, making data processing very time-consuming. Here, we validated an inter-subject procedure to avoid the intra-subject one in two, four and six gait-phase models in pediatric subjects. The inter-subject procedure consists in the identification of a standardized parameter set to adapt the model to measurements. We tested the inter-subject procedure both on scalar and distributed classifiers. Ten healthy children and ten hemiplegic children, each equipped with two Inertial Measurement Units placed on shank and foot, were recruited. The sagittal component of angular velocity was recorded by gyroscopes while subjects performed four walking trials on a treadmill. The goodness of classifiers was evaluated with the Receiver Operating Characteristic. The results provided a goodness from good to optimum for all examined classifiers (0 < G < 0.6, with the best performance for the distributed classifier in two-phase recognition (G = 0.02. Differences were found among gait partitioning models, while no differences were found between training procedures with the exception of the shank classifier. Our results raise the possibility of avoiding subject-specific training in HMM for gait-phase recognition and its implementation to control exoskeletons for the pediatric population.

Participation of the Laboratorio de Radiotoxicologia of IPEN, SP, Brazil, in laboratory inter-comparison programs

International Nuclear Information System (INIS)

Mesquita, Sueli Alexandra de; Carneiro, Janete Cristina G.

2005-01-01

The Radiotoxicology Laboratory (LRT) of IPEN/CNEN-SP has as mission to assess internal internal contamination from individuals through qualitative and quantitative analysis of radionuclides present in biological samples. The LRT is able to meet the demand for in vitro monitoring and radiological and nuclear emergencies, both in the case of occupational exposures, as individuals. With the purpose of increasing the reliability of the test results, and keeping it up to date on new analytical techniques, the LRT participates annually in two laboratory inter-comparison programs: a national, the PNI (Programa Nacional de Intercomparacao), promoted by IRD/CNEN and an international from PROCORAD (Association for the Promotion of Quality Controls in Radiotoxicological Bioassay). The present work shows the performance of the LRT by means of the results obtained in the exercises for the quantification of natural uranium and uranium isotopes, promoted by both the inter-comparison programs in the year of 2004. The analysis of the obtained results demonstrates the good performance achieved by LRT, and confirms the sustainability of its quality system, required in calibration and testing laboratories

Inter-laboratory assessment of a prototype multiplex kit for determination of recent HIV-1 infection.

Directory of Open Access Journals (Sweden)

Kelly A Curtis

Full Text Available BACKGROUND: Accurate and reliable laboratory-based assays are needed for estimating HIV-1 incidence from cross-sectional samples. We recently described the development of a customized, HIV-1-specific Bio-Plex assay that allows for the measurement of HIV-specific antibody levels and avidity to multiple analytes for improved HIV-1 incidence estimates. METHODS: To assess intra- and inter-laboratory assay performance, prototype multiplex kits were developed and evaluated by three distinct laboratories. Longitudinal seroconversion specimens were tested in parallel by each laboratory and kit performance was compared to that of an in-house assay. Additionally, the ability of the kit to distinguish recent from long-term HIV-1 infection, as compared to the in-house assay, was determined by comparing the reactivity of known recent (infected 12 months drug naïve specimens. RESULTS: Although the range of reactivity for each analyte varied between the prototype kit and in-house assay, a measurable distinction in reactivity between recent and long-term specimens was observed with both assays in all three laboratories. Additionally, kit performance was consistent between all three laboratories. The intra-assay coefficient of variation (CV, between sample replicates for all laboratories, ranged from 0.5% to 6.1%. The inter-laboratory CVs ranged from 8.5% to 21.3% for gp160-avidity index (a and gp120-normalized mean fluorescent intensity (MFI value (n, respectively. CONCLUSION: We demonstrate the feasibility of producing a multiplex kit for measuring HIV antibody levels and avidity, with the potential for improved incidence estimates based on multi-analyte algorithms. The availability of a commercial kit will facilitate the transfer of technology among diverse laboratories for widespread assay use.

Implementing the Science Assessment Standards: Developing and validating a set of laboratory assessment tasks in high school biology

Science.gov (United States)

Saha, Gouranga Chandra

Very often a number of factors, especially time, space and money, deter many science educators from using inquiry-based, hands-on, laboratory practical tasks as alternative assessment instruments in science. A shortage of valid inquiry-based laboratory tasks for high school biology has been cited. Driven by this need, this study addressed the following three research questions: (1) How can laboratory-based performance tasks be designed and developed that are doable by students for whom they are designed/written? (2) Do student responses to the laboratory-based performance tasks validly represent at least some of the intended process skills that new biology learning goals want students to acquire? (3) Are the laboratory-based performance tasks psychometrically consistent as individual tasks and as a set? To answer these questions, three tasks were used from the six biology tasks initially designed and developed by an iterative process of trial testing. Analyses of data from 224 students showed that performance-based laboratory tasks that are doable by all students require careful and iterative process of development. Although the students demonstrated more skill in performing than planning and reasoning, their performances at the item level were very poor for some items. Possible reasons for the poor performances have been discussed and suggestions on how to remediate the deficiencies have been made. Empirical evidences for validity and reliability of the instrument have been presented both from the classical and the modern validity criteria point of view. Limitations of the study have been identified. Finally implications of the study and directions for further research have been discussed.

An Inter-Laboratory Comparison for the Urinary Acrolein Biomarker 3-Hydroxypropyl-Mercapturic Acid (3-HPMA

Directory of Open Access Journals (Sweden)

Scherer Gerhard

2017-01-01

Full Text Available An inter-laboratory comparison study on the acrolein biomarker of exposure 3-hydroxypropyl-mercapturic acid (3-HPMA with 12 laboratories from 7 globally distributed countries was performed. The laboratories received coded triplicates of 4 spiked and lyophilized urine samples (LU, 12 samples as well as 5 authentic urine pool samples (PU, 15 samples covering the 3-HPMA concentration range from background (non-smoking to heavy smoking levels for analysis by using their own (in-house analytical method. All laboratories applied liquid chromatography with tandem mass spectrometry (LC-MS/MS, with most of them (10 of 12 using solid phase extraction (SPE as sample work-up procedure. The intra-laboratory variation (indicating repeatability was determined by calculating the standard deviation (sr and the coefficient of variation (CVr of the triplicates, whereas the inter-laboratory variation (indicating reproducibility was determined by calculating the standard deviation between laboratories (sR and the corresponding coefficient of variation (CVR. After removal of outlier samples or laboratories, the mean CVr values for LU and PU test samples ranged from 2.1–3.6% (mean: 2.8% and 2.4–3.7% (mean: 3.3%, respectively, indicating good repeatability for the determination of 3-HPMA in both sample types. CVR for LU and PU test samples ranged from 9.1–31.9% (mean: 18.8% and 13.9–27.0% (mean: 18.5%, respectively, indicating limited reproducibility in 3-HPMA analysis for both sample types. Re-calculation of the PU results by applying an embedded calibration (EC, derived from the reported peak areas for the LU test samples, somewhat improved the CVR values (range: 9.6–28.8%, mean: 16.7%.

Method Validation Procedure in Gamma Spectroscopy Laboratory

International Nuclear Information System (INIS)

El Samad, O.; Baydoun, R.

2008-01-01

The present work describes the methodology followed for the application of ISO 17025 standards in gamma spectroscopy laboratory at the Lebanese Atomic Energy Commission including the management and technical requirements. A set of documents, written procedures and records were prepared to achieve the management part. The technical requirements, internal method validation was applied through the estimation of trueness, repeatability , minimum detectable activity and combined uncertainty, participation in IAEA proficiency tests assure the external method validation, specially that the gamma spectroscopy lab is a member of ALMERA network (Analytical Laboratories for the Measurements of Environmental Radioactivity). Some of these results are presented in this paper. (author)

Analytical difficulties facing today's regulatory laboratories: issues in method validation.

Science.gov (United States)

MacNeil, James D

2012-08-01

The challenges facing analytical laboratories today are not unlike those faced in the past, although both the degree of complexity and the rate of change have increased. Challenges such as development and maintenance of expertise, maintenance and up-dating of equipment, and the introduction of new test methods have always been familiar themes for analytical laboratories, but international guidelines for laboratories involved in the import and export testing of food require management of such changes in a context which includes quality assurance, accreditation, and method validation considerations. Decisions as to when a change in a method requires re-validation of the method or on the design of a validation scheme for a complex multi-residue method require a well-considered strategy, based on a current knowledge of international guidance documents and regulatory requirements, as well the laboratory's quality system requirements. Validation demonstrates that a method is 'fit for purpose', so the requirement for validation should be assessed in terms of the intended use of a method and, in the case of change or modification of a method, whether that change or modification may affect a previously validated performance characteristic. In general, method validation involves method scope, calibration-related parameters, method precision, and recovery. Any method change which may affect method scope or any performance parameters will require re-validation. Some typical situations involving change in methods are discussed and a decision process proposed for selection of appropriate validation measures. © 2012 John Wiley & Sons, Ltd.

Validity of randomized clinical trials in gastroenterology from 1964-2000

DEFF Research Database (Denmark)

Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

2002-01-01

The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

An inter- laboratory proficiency testing exercise for rabies diagnosis in Latin America and the Caribbean.

Directory of Open Access Journals (Sweden)

Alfonso Clavijo

2017-04-01

Full Text Available The direct fluorescent antibody test (DFA, is performed in all rabies reference laboratories across Latin America and the Caribbean (LAC. Despite DFA being a critical capacity in the control of rabies, there is not a standardized protocol in the region. We describe the results of the first inter-laboratory proficiency exercise of national rabies laboratories in LAC countries as part of the regional efforts towards dog-maintained rabies elimination in the American region. Twenty three laboratories affiliated to the Ministries of Health and Ministries of Agriculture participated in this exercise. In addition, the laboratories completed an online questionnaire to assess laboratory practices. Answers to the online questionnaire indicated large variability in the laboratories throughput, equipment used, protocols availability, quality control standards and biosafety requirements. Our results will inform actions to improve and harmonize laboratory rabies capacities across LAC in support for the regional efforts towards elimination of dog-maintained rabies.

Performance evaluation of nitrogen isotope ratio determination in marine and lacustrine sediments: An inter-laboratory comparison

NARCIS (Netherlands)

Bahlmann, E.; Bernasconi, S.M.; Bouillon, S.; Houtekamer, M.J.; Korntheuer, M.; Langenberg, F.; Mayr, C.; Metzke, M.; Middelburg, J.J.; Nagel, B.; Struck, U.; Voß, M.; Emeis, K.C.

2010-01-01

Nitrogen isotopes of organic matter are increasingly studied in marine biogeochemistry and geology, plant and animal ecology, and paleoceanography. Here, we present results of an inter-laboratory test on determination of nitrogen isotope ratios in marine and lacustrine sediments. Six different

Inter-laboratory comparisons of hexenuronic acid measurements in kraft eucalyptus pulps using a UV-Vis spectroscopic method

Science.gov (United States)

J.Y. Zhu; H.F Zhou; Chai X.S.; Donna Johannes; Richard Pope; Cristina Valls; M. Blanca Roncero

2014-01-01

An inter-laboratory comparison of a UV-Vis spectroscopic method (TAPPI T 282 om-13 “Hexeneuronic acid content of chemical pulp”) for hexeneuronic acid measurements was conducted using three eucalyptus kraft pulps. The pulp samples were produced in a laboratory at kappa numbers of approximately 14, 20, and 35. The hexeneuronic acid contents of the three pulps were...

Validation in the cytopathology laboratory: its time has come.

Science.gov (United States)

Haack, Lori A; Shalkham, John

2007-08-01

The cytology laboratory has traditionally performed a relatively small variety of tests. The testing processes employed were generally manually performed and included preparation of glass slide materials, staining of these slides, coverslipping, and microscopic evaluation of the cellular material. Instrumentation in the cytology laboratory was very limited and included a centrifuge, membrane filtration system, and possibly an automated staining machine. If instruments were added, for example, a liquid based preparation device or an automated coverslipping device; the instruments were rarely checked to assure they were operating properly before implementation into clinical practice. In addition, little documentation was maintained with regards to the instrument performance evaluation process. Increasing automation and expansion of testing options have changed how cytopathology is practiced. There are many new devices employed for the preparation of specimens, staining and coverslipping of slides, and evaluation of cellular material. The increasing use of molecular testing methods in cytopathology further adds to the changing landscape of cytopathology. New instrumentation and testing methods are routinely being introduced and the cytopathology laboratory must assure that the testing performed is accurate and consistent. Cytopathology laboratory professionals need to appreciate the value of validation of the tests we perform and the instruments we use in order to best serve the patient. Our clinical laboratory colleagues have traditionally performed validation on both instruments and test methods before using them for clinical testing. If cytopathology wants to perform the complex testing being introduced and effectively utilize new instrumentation, we need to understand the value of validation and how we apply validation to our laboratory practice. Copyright 2007 Wiley-Liss, Inc.

Inter-laboratory comparison of cell lines for susceptibility to three viruses: VHSV, IHNV and IPNV

DEFF Research Database (Denmark)

Lorenzen, Ellen; Carstensen, Bendix; Olesen, Niels Jørgen

1999-01-01

Eleven European National Reference Laboratories participated in an inter-laboratory comparison of the susceptibility of 5 selected cell lines to 3 fish pathogenic viruses. The test included viral hemorrhagic septicaemia virus (VHSV), infectious hematopoietic necrosis virus (IHNV) and infectious...... pancreatic necrosis Virus (IPNV), and the cell lines derived from bluegill fry (BF-2), chinook salmon embryo (CHSE-214), epithelioma papulosum cyprini (EPC), fathead minnow (FHM) and rainbow trout gonad (RTG-2). The results showed that for isolation of VHSV, BF-2 and RTG-2 cells performed equally well...

Inter-disciplinary Interactions in Underground Laboratories

Science.gov (United States)

Wang, J. S.; Bettini, A.

2010-12-01

facilities needed for next generation of underground assessments and experiments. There are growing interests in developing multi-disciplinary programs in DULs and some URLs have rooms set aside for physics experiments. Examples of DULs and URLs with interactions between earth sciences and physics include Gran Sasso in Italy, Kaimioka in Japan, Canfranc in Spain, LSBB in France, WIPP in New Mexico, DUSEL in South Dakota, and Jing Ping deep tunnel underground laboratory proposal in China. Instruments of common interests include interferometers, laser strain meters, seismic networks, tiltmeters, gravimeters, magnetometers, and other sensors to detect signals over different frequencies and water chemical analyses, including radon concentrations. Radon emissions are of concern for physics experiments and are studied as possible precursors of earthquakes. Measuring geoneutrino flux and energy spectrum in different locations is of interests to both physics and earth sciences. The contributions of U and Th in the crust and the mantle to the energy production in the Earth can be studied. One final note is that our ongoing reviews are aimed to contribute to technological innovations anticipated through inter-disciplinary interactions.

Valid methods: the quality assurance of test method development, validation, approval, and transfer for veterinary testing laboratories.

Science.gov (United States)

Wiegers, Ann L

2003-07-01

Third-party accreditation is a valuable tool to demonstrate a laboratory's competence to conduct testing. Accreditation, internationally and in the United States, has been discussed previously. However, accreditation is only I part of establishing data credibility. A validated test method is the first component of a valid measurement system. Validation is defined as confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. The international and national standard ISO/IEC 17025 recognizes the importance of validated methods and requires that laboratory-developed methods or methods adopted by the laboratory be appropriate for the intended use. Validated methods are therefore required and their use agreed to by the client (i.e., end users of the test results such as veterinarians, animal health programs, and owners). ISO/IEC 17025 also requires that the introduction of methods developed by the laboratory for its own use be a planned activity conducted by qualified personnel with adequate resources. This article discusses considerations and recommendations for the conduct of veterinary diagnostic test method development, validation, evaluation, approval, and transfer to the user laboratory in the ISO/IEC 17025 environment. These recommendations are based on those of nationally and internationally accepted standards and guidelines, as well as those of reputable and experienced technical bodies. They are also based on the author's experience in the evaluation of method development and transfer projects, validation data, and the implementation of quality management systems in the area of method development.

Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO 15189.

Science.gov (United States)

Biljak, Vanja Radisic; Ozvald, Ivan; Radeljak, Andrea; Majdenic, Kresimir; Lasic, Branka; Siftar, Zoran; Lovrencic, Marijana Vucic; Flegar-Mestric, Zlata

2012-01-01

The aim of the study was to present a protocol for laboratory information system (LIS) and hospital information system (HIS) validation at the Institute of Clinical Chemistry and Laboratory Medicine of the Merkur University Hospital, Zagreb, Croatia. Validity of data traceability was checked by entering all test requests for virtual patient into HIS/LIS and printing corresponding barcoded labels that provided laboratory analyzers with the information on requested tests. The original printouts of the test results from laboratory analyzer(s) were compared with the data obtained from LIS and entered into the provided template. Transfer of data from LIS to HIS was examined by requesting all tests in HIS and creating real data in a finding generated in LIS. Data obtained from LIS and HIS were entered into a corresponding template. The main outcome measure was the accuracy of transfer obtained from laboratory analyzers and results transferred from LIS and HIS expressed as percentage (%). The accuracy of data transfer from laboratory analyzers to LIS was 99.5% and of that from LIS to HIS 100%. We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose.

Patients' and observers' perceptions of involvement differ. Validation study on inter-relating measures for shared decision making.

Directory of Open Access Journals (Sweden)

Jürgen Kasper

Full Text Available OBJECTIVE: Patient involvement into medical decisions as conceived in the shared decision making method (SDM is essential in evidence based medicine. However, it is not conclusively evident how best to define, realize and evaluate involvement to enable patients making informed choices. We aimed at investigating the ability of four measures to indicate patient involvement. While use and reporting of these instruments might imply wide overlap regarding the addressed constructs this assumption seems questionable with respect to the diversity of the perspectives from which the assessments are administered. METHODS: The study investigated a nested cohort (N = 79 of a randomized trial evaluating a patient decision aid on immunotherapy for multiple sclerosis. Convergent validities were calculated between observer ratings of videotaped physician-patient consultations (OPTION and patients' perceptions of the communication (Shared Decision Making Questionnaire, Control Preference Scale & Decisional Conflict Scale. RESULTS: OPTION reliability was high to excellent. Communication performance was low according to OPTION and high according to the three patient administered measures. No correlations were found between observer and patient judges, neither for means nor for single items. Patient report measures showed some moderate correlations. CONCLUSION: Existing SDM measures do not refer to a single construct. A gold standard is missing to decide whether any of these measures has the potential to indicate patient involvement. PRACTICE IMPLICATIONS: Pronounced heterogeneity of the underpinning constructs implies difficulties regarding the interpretation of existing evidence on the efficacy of SDM. Consideration of communication theory and basic definitions of SDM would recommend an inter-subjective focus of measurement. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN25267500.

Inter-laboratory validation of the modified murine local lymph node assay based on 5-bromo-2'-deoxyuridine incorporation.

Science.gov (United States)

Kojima, Hajime; Takeyoshi, Masahiro; Sozu, Takashi; Awogi, Takumi; Arima, Kazunori; Idehara, Kenji; Ikarashi, Yoshiaki; Kanazawa, Yukiko; Maki, Eiji; Omori, Takashi; Yuasa, Atsuko; Yoshimura, Isao

2011-01-01

The murine local lymph node assay (LLNA) is a well-established alternative to the guinea pig maximization test (GPMT) or Buehler test (BT) for the assessment of the skin sensitizing ability of a drug, cosmetic material, pesticide or industrial chemical. Instead of radioisotope using in this method, Takeyoshi M. et al. (2001) has developed a modified LLNA based on the 5-bromo-2'-deoxyuridine (BrdU) incorporation (LLNA:BrdU-ELISA). The LLNA:BrdU-ELISA is practically identical to the LLNA methodology excluding the use of BrdU, for which a single intraperitoneal injection of BrdU is made on day 4, and colorimetric detection of cell turnover. We conducted the validation study to evaluate the reliability and relevance of LLNA:BrdU-ELISA. The experiment involved 7 laboratories, wherein 10 chemicals were examined under blinded conditions. In this study, 3 chemicals were examined in all laboratories and the remaining 7 were examined in 3 laboratories. The data were expressed as the BrdU incorporation using an ELISA method for each group, and the stimulation index (SI) for each chemical-treated group was determined as the increase in the BrdU incorporation relative to the concurrent vehicle control group. An SI of 2 was set as the cut-off value for exhibiting skin sensitization activity. The results obtained in the experiments conducted for all 10 chemicals were sufficiently consistent with small variations in their SI values. The sensitivity, specificity, and accuracy of LLNA:BrdU-ELISA against those of GPMT/BT were 7/7 (100%), 3/3 (100%), and 10/10 (100%), respectively. Copyright © 2010 John Wiley & Sons, Ltd.

Status Report of the Inter-Laboratory Task Force on Remote Operation

Energy Technology Data Exchange (ETDEWEB)

Phinney, Nan

2001-12-13

The next generation of particle accelerators will be major projects which may require a new mode of international and inter-laboratory collaboration. They are likely to be too costly to be funded by a single nation and too large to be built by a single laboratory. The tremendous technical challenge of a new facility requires a critical mass of highly qualified and experienced physicists and engineers. These experts are presently distributed among the major accelerator centers around the world and it is believed important to maintain and develop this broad base of expertise. The successful accelerator technology development of recent decades depended on extensive exchange of people with complementary technical skills. Therefore, it is desirable and probably necessary that several accelerator laboratories will participate in any future project. A consequence of a multi-laboratory project is that the accelerator will be located a considerable distance from most of the contributing institutions which design, build and operate it. These considerations led the International Committee for Future Accelerators to initiate a study on the general and technical implications of such a collaboration. Two task forces were formed in February 2000 to conduct this study and they were asked to prepare a report on a time scale of one year. The task force on Remote Operation included members from most of the major accelerator laboratories around the world with expertise on accelerator operation, controls software, communication technologies, hardware design and maintenance. The task force members gathered information from the experts at their own institutions and from available experience in other fields, particularly astronomy.

Inter-Rater Reliability and Validity of the Australian Football League’s Kicking and Handball Tests

Science.gov (United States)

Cripps, Ashley J.; Hopper, Luke S.; Joyce, Christopher

2015-01-01

Talent identification tests used at the Australian Football League’s National Draft Combine assess the capacities of athletes to compete at a professional level. Tests created for the National Draft Combine are also commonly used for talent identification and athlete development in development pathways. The skills tests created by the Australian Football League required players to either handball (striking the ball with the hand) or kick to a series of 6 randomly generated targets. Assessors subjectively rate each skill execution giving a 0-5 score for each disposal. This study aimed to investigate the inter-rater reliability and validity of the skills tests at an adolescent sub-elite level. Male Australian footballers were recruited from sub-elite adolescent teams (n = 121, age = 15.7 ± 0.3 years, height = 1.77 ± 0.07 m, mass = 69.17 ± 8.08 kg). The coaches (n = 7) of each team were also recruited. Inter-rater reliability was assessed using Inter-class correlations (ICC) and Limits of Agreement statistics. Both the kicking (ICC = 0.96, p handball tests (ICC = 0.89, p handball test. Key points The skill tests created by the AFL demonstrated acceptable levels of relative and absolute inter-rater reliability. Both the AFL’s skills tests are able to differentiate between athletes dominant and non-dominant limbs. However, only the kicking test could consistently differentiated between score outcomes over a range of Australian Football specific disposal distances. Both tests demonstrated poor concurrent validity, with no correlation found between coaches’ perceptions of technical skills and actual skill outcomes measured. PMID:26336356

Comet assay in reconstructed 3D human epidermal skin models—investigation of intra- and inter-laboratory reproducibility with coded chemicals

Science.gov (United States)

Pfuhler, Stefan

2013-01-01

Reconstructed 3D human epidermal skin models are being used increasingly for safety testing of chemicals. Based on EpiDerm™ tissues, an assay was developed in which the tissues were topically exposed to test chemicals for 3h followed by cell isolation and assessment of DNA damage using the comet assay. Inter-laboratory reproducibility of the 3D skin comet assay was initially demonstrated using two model genotoxic carcinogens, methyl methane sulfonate (MMS) and 4-nitroquinoline-n-oxide, and the results showed good concordance among three different laboratories and with in vivo data. In Phase 2 of the project, intra- and inter-laboratory reproducibility was investigated with five coded compounds with different genotoxicity liability tested at three different laboratories. For the genotoxic carcinogens MMS and N-ethyl-N-nitrosourea, all laboratories reported a dose-related and statistically significant increase (P 30% cell loss), and the overall response was comparable in all laboratories despite some differences in doses tested. The results of the collaborative study for the coded compounds were generally reproducible among the laboratories involved and intra-laboratory reproducibility was also good. These data indicate that the comet assay in EpiDerm™ skin models is a promising model for the safety assessment of compounds with a dermal route of exposure. PMID:24150594

Canadian inter-laboratory organically bound tritium (OBT) analysis exercise.

Science.gov (United States)

Kim, S B; Olfert, J; Baglan, N; St-Amant, N; Carter, B; Clark, I; Bucur, C

2015-12-01

Tritium emissions are one of the main concerns with regard to CANDU reactors and Canadian nuclear facilities. After the Fukushima accident, the Canadian Nuclear Regulatory Commission suggested that models used in risk assessment of Canadian nuclear facilities be firmly based on measured data. Procedures for measurement of tritium as HTO (tritiated water) are well established, but there are no standard methods and certified reference materials for measurement of organically bound tritium (OBT) in environmental samples. This paper describes and discusses an inter-laboratory comparison study in which OBT in three different dried environmental samples (fish, Swiss chard and potato) was measured to evaluate OBT analysis methods currently used by CANDU Owners Group (COG) members. The variations in the measured OBT activity concentrations between all laboratories were less than approximately 20%, with a total uncertainty between 11 and 17%. Based on the results using the dried samples, the current OBT analysis methods for combustion, distillation and counting are generally acceptable. However, a complete consensus OBT analysis methodology with respect to freeze-drying, rinsing, combustion, distillation and counting is required. Also, an exercise using low-level tritium samples (less than 100 Bq/L or 20 Bq/kg-fresh) would be useful in the near future to more fully evaluate the current OBT analysis methods. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity

Directory of Open Access Journals (Sweden)

Birtwhistle Richard

2003-12-01

Full Text Available Abstract Background Controlled clinical trials of health care interventions are either explanatory or pragmatic. Explanatory trials test whether an intervention is efficacious; that is, whether it can have a beneficial effect in an ideal situation. Pragmatic trials measure effectiveness; they measure the degree of beneficial effect in real clinical practice. In pragmatic trials, a balance between external validity (generalizability of the results and internal validity (reliability or accuracy of the results needs to be achieved. The explanatory trial seeks to maximize the internal validity by assuring rigorous control of all variables other than the intervention. The pragmatic trial seeks to maximize external validity to ensure that the results can be generalized. However the danger of pragmatic trials is that internal validity may be overly compromised in the effort to ensure generalizability. We are conducting two pragmatic randomized controlled trials on interventions in the management of hypertension in primary care. We describe the design of the trials and the steps taken to deal with the competing demands of external and internal validity. Discussion External validity is maximized by having few exclusion criteria and by allowing flexibility in the interpretation of the intervention and in management decisions. Internal validity is maximized by decreasing contamination bias through cluster randomization, and decreasing observer and assessment bias, in these non-blinded trials, through baseline data collection prior to randomization, automating the outcomes assessment with 24 hour ambulatory blood pressure monitors, and blinding the data analysis. Summary Clinical trials conducted in community practices present investigators with difficult methodological choices related to maintaining a balance between internal validity (reliability of the results and external validity (generalizability. The attempt to achieve methodological purity can

Precision and linearity targets for validation of an IFNγ ELISPOT, cytokine flow cytometry, and tetramer assay using CMV peptides

Directory of Open Access Journals (Sweden)

Lyerly Herbert K

2008-03-01

Full Text Available Abstract Background Single-cell assays of immune function are increasingly used to monitor T cell responses in immunotherapy clinical trials. Standardization and validation of such assays are therefore important to interpretation of the clinical trial data. Here we assess the levels of intra-assay, inter-assay, and inter-operator precision, as well as linearity, of CD8+ T cell IFNγ-based ELISPOT and cytokine flow cytometry (CFC, as well as tetramer assays. Results Precision was measured in cryopreserved PBMC with a low, medium, or high response level to a CMV pp65 peptide or peptide mixture. Intra-assay precision was assessed using 6 replicates per assay; inter-assay precision was assessed by performing 8 assays on different days; and inter-operator precision was assessed using 3 different operators working on the same day. Percent CV values ranged from 4% to 133% depending upon the assay and response level. Linearity was measured by diluting PBMC from a high responder into PBMC from a non-responder, and yielded R2 values from 0.85 to 0.99 depending upon the assay and antigen. Conclusion These data provide target values for precision and linearity of single-cell assays for those wishing to validate these assays in their own laboratories. They also allow for comparison of the precision and linearity of ELISPOT, CFC, and tetramer across a range of response levels. There was a trend toward tetramer assays showing the highest precision, followed closely by CFC, and then ELISPOT; while all three assays had similar linearity. These findings are contingent upon the use of optimized protocols for each assay.

Laboratory research at the clinical trials of Veterinary medicinal Products

OpenAIRE

ZHYLA M.I.

2011-01-01

The article analyses the importance of laboratory test methods, namely pathomorfological at conduct of clinical trials. The article focuses on complex laboratory diagnostics at determination of clinical condition of animals, safety and efficacy of tested medicinal product.

DTU PMU Laboratory Development - Testing and Validation

OpenAIRE

Garcia-Valle, Rodrigo; Yang, Guang-Ya; Martin, Kenneth E.; Nielsen, Arne Hejde; Østergaard, Jacob

2010-01-01

This is a report of the results of phasor measurement unit (PMU) laboratory development and testing done at the Centre for Electric Technology (CET), Technical University of Denmark (DTU). Analysis of the PMU performance first required the development of tools to convert the DTU PMU data into IEEE standard, and the validation is done for the DTU-PMU via a validated commercial PMU. The commercial PMU has been tested from the authors' previous efforts, where the response can be expected to foll...

Establishment of Valid Laboratory Case Definition for Human Leptospirosis

NARCIS (Netherlands)

M.G.A. Goris (Marga); M.M.G. Leeflang (Mariska); K.R. Boer (Kimberly); M. Goeijenbier (Marco); E.C.M. van Gorp (Eric); J.F.P. Wagenaar (Jiri); R.A. Hartskeerl (Rudy)

2011-01-01

textabstractLaboratory case definition of leptospirosis is scarcely de ned by a solid evaluation that determines cut-off values in the tests that are applied. This study describes the process of determining optimal cut-off titers of laboratory tests for leptospirosis for a valid case definition of

Results from the Savannah River Laboratory model validation workshop

International Nuclear Information System (INIS)

Pepper, D.W.

1981-01-01

To evaluate existing and newly developed air pollution models used in DOE-funded laboratories, the Savannah River Laboratory sponsored a model validation workshop. The workshop used Kr-85 measurements and meteorology data obtained at SRL during 1975 to 1977. Individual laboratories used models to calculate daily, weekly, monthly or annual test periods. Cumulative integrated air concentrations were reported at each grid point and at each of the eight sampler locations

Valid, legally defensible data from your analytical laboratories

International Nuclear Information System (INIS)

Gay, D.D.; Allen, V.C.

1989-01-01

This paper discusses the definition of valid, legally defensible data. The authors describe the expectations of project managers and what should be gleaned from the laboratory in regard to analytical data

Modified sphygmomanometer test for the assessment of strength of the trunk, upper and lower limbs muscles in subjects with subacute stroke: reliability and validity.

Science.gov (United States)

Aguiar, Larissa T; Lara, Eliza M; Martins, Julia C; Teixeira-Salmela, Luci F; Quintino, Ludmylla F; Christo, Paulo P; DE Morais Fairaa, Christina

2016-10-01

Limitations in activities have been related to weakness of the upper limbs (UL), lower limbs (LL) and trunk muscles after stroke. Therefore, the measurement of strength after stroke becomes essential. The Modified Sphygmomanometer Test (MST) is an alternative method for the measurement of strength, since it is cheap and provides objective values. However, no studies have investigated the measurement properties of the MST in sub-acute stroke. To investigate the test-retest and inter-rater reliabilities and criterion-related validity of the MST for the measurement of strength of the UL, LL, and trunk muscles in subjects with sub-acute stroke, and verify whether the number of trials would affect the results. Diagnostic accuracy. Local community, out-patient clinics, and university laboratory. Sixty- five subjects with sub-acute stroke (62±14 years) participated of the present study. The strength of 36 muscular groups was measured with the MST and dynamometers (criterion standard). To investigate whether the number of trials would affect the results, analysis of variance was applied. For the test-retest and inter-rater reliabilities and criterion-related validity of the MST, intra-class correlation coefficients (ICC), Pearson correlation coefficients, and coefficients of determination were calculated. Similar results were found for all muscular groups and number of trials (0.01≤F≤0.14; 0.87≤p≤0.99) with significant and adequate values of test-retest (0.57≤ICC≥0.98) (exception: first trial of the non-paretic ankle dorsiflexors) and inter-rater (0.50≤ICC≥0.99) (exception: non-paretic ankle plantar flexors) reliabilities and validity (0.70≤r≥0.95; p≤0.001). The values obtained with the MST were good predictors of those obtained with the dynamometers (0.54≤r2≤0.90). In general, the MST showed adequate reliabilities and criterion-related validity for measuring strength of subjects with sub-acute stroke, and only one trial, after familiarization

Predicting skin sensitization potential and inter-laboratory reproducibility of a human Cell Line Activation Test (h-CLAT) in the European Cosmetics Association (COLIPA) ring trials.

Science.gov (United States)

Sakaguchi, Hitoshi; Ryan, Cindy; Ovigne, Jean-Marc; Schroeder, Klaus R; Ashikaga, Takao

2010-09-01

Regulatory policies in Europe prohibited the testing of cosmetic ingredients in animals for a number of toxicological endpoints. Currently no validated non-animal test methods exist for skin sensitization. Evaluation of changes in cell surface marker expression in dendritic cell (DC)-surrogate cell lines represents one non-animal approach. The human Cell Line Activation Test (h-CLAT) examines the level of CD86 and CD54 expression on the surface of THP-1 cells, a human monocytic leukemia cell line, following 24h of chemical exposure. To examine protocol transferability, between-lab reproducibility, and predictive capacity, the h-CLAT has been evaluated by five independent laboratories in several ring trials (RTs) coordinated by the European Cosmetics Association (COLIPA). The results of the first and second RTs demonstrated that the protocol was transferable and basically had good between-lab reproducibility and predictivity, but there were some false negative data. To improve performance, protocol and prediction model were modified. Using the modified prediction model in the first and second RT, accuracy was improved. However, about 15% of the outcomes were not correctly identified, which exposes some of the limitations of the assay. For the chemicals evaluated, the limitation may due to chemical being a weak allergen or having low solubility (ex. alpha-hexylcinnamaldehyde). The third RT evaluated the modified prediction model and satisfactory results were obtained. From the RT data, the feasibility of utilizing cell lines as surrogate DC in development of in vitro skin sensitization methods shows promise. The data also support initiating formal pre-validation of the h-CLAT in order to fully understand the capabilities and limitations of the assay. Copyright 2010 Elsevier Ltd. All rights reserved.

Improved inter-observer agreement of an expert review panel in an oncology treatment trial--Insights from a structured interventional process.

Science.gov (United States)

Nestle, Ursula; Rischke, Hans Christian; Eschmann, Susanne Martina; Holl, Gabriele; Tosch, Marco; Miederer, Matthias; Plotkin, Michail; Essler, Markus; Puskas, Cornelia; Schimek-Jasch, Tanja; Duncker-Rohr, Viola; Rühl, Friederike; Leifert, Anja; Mix, Michael; Grosu, Anca-Ligia; König, Jochem; Vach, Werner

2015-11-01

Oncologic imaging is a key for successful cancer treatment. While the quality assurance (QA) of image acquisition protocols has already been focussed, QA of reading and reporting offers still room for improvement. The latter was addressed in the context of a prospective multicentre trial on fluoro-deoxyglucose (FDG)-positron-emission tomography (PET)/CT-based chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC). An expert panel was prospectively installed performing blinded reviews of mediastinal NSCLC involvement in FDG-PET/CT. Due to a high initial reporting inter-observer disagreement, the independent data monitoring committee (IDMC) triggered an interventional harmonisation process, which overall involved 11 experts uttering 6855 blinded diagnostic statements. After assessing the baseline inter-observer agreement (IOA) of a blinded re-review (phase 1), a discussion process led to improved reading criteria (phase 2). Those underwent a validation study (phase 3) and were then implemented into the study routine. After 2 months (phase 4) and 1 year (phase 5), the IOA was reassessed. The initial overall IOA was moderate (kappa 0.52 CT; 0.53 PET). After improvement of reading criteria, the kappa values improved substantially (kappa 0.61 CT; 0.66 PET), which was retained until the late reassessment (kappa 0.71 CT; 0.67 PET). Subjective uncertainty was highly predictive for low IOA. The IOA of an expert panel was significantly improved by a structured interventional harmonisation process which could be a model for future clinical trials. Furthermore, the low IOA in reporting nodal involvement in NSCLC may bear consequences for individual patient care. Copyright © 2015 Elsevier Ltd. All rights reserved.

Validity and reliability of balance assessment software using the Nintendo Wii balance board: usability and validation.

Science.gov (United States)

Park, Dae-Sung; Lee, GyuChang

2014-06-10

A balance test provides important information such as the standard to judge an individual's functional recovery or make the prediction of falls. The development of a tool for a balance test that is inexpensive and widely available is needed, especially in clinical settings. The Wii Balance Board (WBB) is designed to test balance, but there is little software used in balance tests, and there are few studies on reliability and validity. Thus, we developed a balance assessment software using the Nintendo Wii Balance Board, investigated its reliability and validity, and compared it with a laboratory-grade force platform. Twenty healthy adults participated in our study. The participants participated in the test for inter-rater reliability, intra-rater reliability, and concurrent validity. The tests were performed with balance assessment software using the Nintendo Wii balance board and a laboratory-grade force platform. Data such as Center of Pressure (COP) path length and COP velocity were acquired from the assessment systems. The inter-rater reliability, the intra-rater reliability, and concurrent validity were analyzed by an intraclass correlation coefficient (ICC) value and a standard error of measurement (SEM). The inter-rater reliability (ICC: 0.89-0.79, SEM in path length: 7.14-1.90, SEM in velocity: 0.74-0.07), intra-rater reliability (ICC: 0.92-0.70, SEM in path length: 7.59-2.04, SEM in velocity: 0.80-0.07), and concurrent validity (ICC: 0.87-0.73, SEM in path length: 5.94-0.32, SEM in velocity: 0.62-0.08) were high in terms of COP path length and COP velocity. The balance assessment software incorporating the Nintendo Wii balance board was used in our study and was found to be a reliable assessment device. In clinical settings, the device can be remarkably inexpensive, portable, and convenient for the balance assessment.

Round-Robin Studies on Roll-Processed ITO-free Organic Tandem Solar Cells Combined with Inter-Laboratory Stability Studies

DEFF Research Database (Denmark)

Livi, Francesco; Søndergaard, Roar R.; Andersen, Thomas Rieks

2015-01-01

Roll-processed, indium tin oxide (ITO)-free, flexible, organic tandem solar cells and modules have been realized and used in round-robin studies as well as in parallel inter-laboratory stability studies. The tandem cells/modules show no significant difference in comparison to their single...

Analytic Validation of Immunohistochemistry Assays: New Benchmark Data From a Survey of 1085 Laboratories.

Science.gov (United States)

Stuart, Lauren N; Volmar, Keith E; Nowak, Jan A; Fatheree, Lisa A; Souers, Rhona J; Fitzgibbons, Patrick L; Goldsmith, Jeffrey D; Astles, J Rex; Nakhleh, Raouf E

2017-09-01

- A cooperative agreement between the College of American Pathologists (CAP) and the United States Centers for Disease Control and Prevention was undertaken to measure laboratories' awareness and implementation of an evidence-based laboratory practice guideline (LPG) on immunohistochemical (IHC) validation practices published in 2014. - To establish new benchmark data on IHC laboratory practices. - A 2015 survey on IHC assay validation practices was sent to laboratories subscribed to specific CAP proficiency testing programs and to additional nonsubscribing laboratories that perform IHC testing. Specific questions were designed to capture laboratory practices not addressed in a 2010 survey. - The analysis was based on responses from 1085 laboratories that perform IHC staining. Ninety-six percent (809 of 844) always documented validation of IHC assays. Sixty percent (648 of 1078) had separate procedures for predictive and nonpredictive markers, 42.7% (220 of 515) had procedures for laboratory-developed tests, 50% (349 of 697) had procedures for testing cytologic specimens, and 46.2% (363 of 785) had procedures for testing decalcified specimens. Minimum case numbers were specified by 85.9% (720 of 838) of laboratories for nonpredictive markers and 76% (584 of 768) for predictive markers. Median concordance requirements were 95% for both types. For initial validation, 75.4% (538 of 714) of laboratories adopted the 20-case minimum for nonpredictive markers and 45.9% (266 of 579) adopted the 40-case minimum for predictive markers as outlined in the 2014 LPG. The most common method for validation was correlation with morphology and expected results. Laboratories also reported which assay changes necessitated revalidation and their minimum case requirements. - Benchmark data on current IHC validation practices and procedures may help laboratories understand the issues and influence further refinement of LPG recommendations.

Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues.

Science.gov (United States)

Mourya, Devendra T; Yadav, Pragya D; Khare, Ajay; Khan, Anwar H

2017-10-01

With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process.

The OECD validation program of the H295R steroidogenesis assay: Phase 3. Final inter-laboratory validation study

DEFF Research Database (Denmark)

Hecker, Markus; Hollert, Henner; Cooper, Ralph

2011-01-01

In response to increasing concerns regarding the potential of chemicals to interact with the endocrine system of humans and wildlife, various national and international programs have been initiated with the aim to develop new guidelines for the screening and testing of these chemicals in vertebra......In response to increasing concerns regarding the potential of chemicals to interact with the endocrine system of humans and wildlife, various national and international programs have been initiated with the aim to develop new guidelines for the screening and testing of these chemicals...... in vertebrates. Here, we report on the validation of an in vitro assay, the H295R steroidogenesis assay, to detect chemicals with the potential to inhibit or induce the production of the sex steroid hormones testosterone (T) and 17β-estradiol (E2) in preparation for the development of an Organization...... for Economic Cooperation and Development (OECD) test guideline.A previously optimized and pre-validated protocol was used to assess the potential of 28 chemicals of diverse structures and properties to validate the H295R steroidogenesis assay. These chemicals are comprised of known endocrine-active chemicals...

Software validation applied to spreadsheets used in laboratories working under ISO/IEC 17025

Science.gov (United States)

Banegas, J. M.; Orué, M. W.

2016-07-01

Several documents deal with software validation. Nevertheless, more are too complex to be applied to validate spreadsheets - surely the most used software in laboratories working under ISO/IEC 17025. The method proposed in this work is intended to be directly applied to validate spreadsheets. It includes a systematic way to document requirements, operational aspects regarding to validation, and a simple method to keep records of validation results and modifications history. This method is actually being used in an accredited calibration laboratory, showing to be practical and efficient.

Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues

Directory of Open Access Journals (Sweden)

Devendra T Mourya

2017-01-01

Full Text Available With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process.

Validation and inter-rater reliability of a three item falls risk screening tool

Directory of Open Access Journals (Sweden)

Catherine Maree Said

2017-11-01

Full Text Available Abstract Background Falls screening tools are routinely used in hospital settings and the psychometric properties of tools should be examined in the setting in which they are used. The aim of this study was to explore the concurrent and predictive validity of the Austin Health Falls Risk Screening Tool (AHFRST, compared with The Northern Hospital Modified St Thomas’s Risk Assessment Tool (TNH-STRATIFY, and the inter-rater reliability of the AHFRST. Methods A research physiotherapist used the AHFRST and TNH-STRATIFY to classify 130 participants admitted to Austin Health (five acute wards, n = 115 two subacute wards n = 15; median length of stay 6 days IQR 3–12 as ‘High’ or ‘Low’ falls risk. The AHFRST was also completed by nursing staff on patient admission. Falls data was collected from the hospital incident reporting system. Results Six falls occurred during the study period (fall rate of 4.6 falls per 1000 bed days. There was substantial agreement between the AHFRST and the TNH-STRATIFY (Kappa = 0.68, 95% CI 0.52–0.78. Both tools had poor predictive validity, with low specificity (AHFRST 46.0%, 95% CI 37.0–55.1; TNH-STRATIFY 34.7%, 95% CI 26.4–43.7 and positive predictive values (AHFRST 5.6%, 95% CI 1.6–13.8; TNH-STRATIFY 6.9%, 95% CI 2.6–14.4. The AHFRST showed moderate inter-rater reliability (Kappa = 0.54, 95% CI = 0.36–0.67, p < 0.001 although 18 patients did not have the AHFRST completed by nursing staff. Conclusions There was an acceptable level of agreement between the 3 item AHFRST classification of falls risk and the longer, 9 item TNH-STRATIFY classification. However, both tools demonstrated limited predictive validity in the Austin Health population. The results highlight the importance of evaluating the validity of falls screening tools, and the clinical utility of these tools should be reconsidered.

Elemental Characterization of Soil and Sediment Using NAA Technique for BATAN Inter Laboratory Comparison

International Nuclear Information System (INIS)

Syukria Kurniawati; Diah Dwiana Lestiani; Natalia Adventini

2009-01-01

Elemental characterization of soil and sediment samples using neutron activation analysis (NAA) for BATAN inter laboratory comparison have been conducted. TAR laboratory have been accredited by KAN since 2006, participating the test to evaluate and maintain its capability as testing laboratory that implemented ISO/IEC 17025. Samples from PTBIN were dried at 110°C for 2 hours and homogenized. The samples were irradiated at rabbit system of Multi-Purpose Reactor G.A Siwabessy for 1, 2, 10 and 60 minutes, then counted using HPGe gamma spectrometer. Several statistical test were applied such as μ-test, relative deviation, acceptance criteria for accuracy and precision. The result showed that soil contains V, Al, Ca, Mn, Na, K, As, Fe, Zn and Hg. From accuracy and precision, final status for 9 elements were passed but Ca was rejected, while V, Al, Mn, Cr, Fe, Zn and Co were detected in sediment samples. Final status for V, Al, Mn, Cr, Fe and Co elements were passed but Zn was rejected. (author)

Assessment and reduction of comet assay variation in relation to DNA damage: studies from the European Comet Assay Validation Group

DEFF Research Database (Denmark)

Møller, Peter; Möller, Lennart; Godschalk, Roger W L

2010-01-01

The alkaline single cell gel electrophoresis (comet) assay has become a widely used method for the detection of DNA damage and repair in cells and tissues. Still, it has been difficult to compare results from different investigators because of differences in assay conditions and because the data...... are reported in different units. The European Comet Assay Validation Group (ECVAG) was established for the purpose of validation of the comet assay with respect to measures of DNA damage formation and its repair. The results from this inter-laboratory validation trail showed a large variation in measured level...... reliability for the measurement of DNA damage by the comet assay but there is still a need for further validation to reduce both assay and inter-laboratory variation....

Use of HOMA-IR to diagnose non-alcoholic fatty liver disease: a population-based and inter-laboratory study.

Science.gov (United States)

Isokuortti, Elina; Zhou, You; Peltonen, Markku; Bugianesi, Elisabetta; Clement, Karine; Bonnefont-Rousselot, Dominique; Lacorte, Jean-Marc; Gastaldelli, Amalia; Schuppan, Detlef; Schattenberg, Jörn M; Hakkarainen, Antti; Lundbom, Nina; Jousilahti, Pekka; Männistö, Satu; Keinänen-Kiukaanniemi, Sirkka; Saltevo, Juha; Anstee, Quentin M; Yki-Järvinen, Hannele

2017-10-01

Recent European guidelines for non-alcoholic fatty liver disease (NAFLD) call for reference values for HOMA-IR. In this study, we aimed to determine: (1) the upper limit of normal HOMA-IR in two population-based cohorts; (2) the HOMA-IR corresponding to NAFLD; (3) the effect of sex and PNPLA3 genotype at rs738409 on HOMA-IR; and (4) inter-laboratory variations in HOMA-IR. We identified healthy individuals in two population-based cohorts (FINRISK 2007 [n = 5024] and the Programme for Prevention of Type 2 Diabetes in Finland [FIN-D2D; n = 2849]) to define the upper 95th percentile of HOMA-IR. Non-obese individuals with normal fasting glucose levels, no excessive alcohol use, no known diseases and no use of any drugs were considered healthy. The optimal HOMA-IR cut-off for NAFLD (liver fat ≥5.56%, based on the Dallas Heart Study) was determined in 368 non-diabetic individuals (35% with NAFLD), whose liver fat was measured using proton magnetic resonance spectroscopy ( 1 H-MRS). Samples from ten individuals were simultaneously analysed for HOMA-IR in seven European laboratories. The upper 95th percentiles of HOMA-IR were 1.9 and 2.0 in healthy individuals in the FINRISK (n = 1167) and FIN-D2D (n = 459) cohorts. Sex or PNPLA3 genotype did not influence these values. The optimal HOMA-IR cut-off for NAFLD was 1.9 (sensitivity 87%, specificity 79%). A HOMA-IR of 2.0 corresponded to normal liver fat (HOMA-IR measured in Helsinki corresponded to 1.3, 1.6, 1.8, 1.8, 2.0 and 2.1 in six other laboratories. The inter-laboratory CV% of HOMA-IR was 25% due to inter-assay variation in insulin (25%) rather than glucose (5%) measurements. The upper limit of HOMA-IR in population-based cohorts closely corresponds to that of normal liver fat. Standardisation of insulin assays would be the first step towards definition of normal values for HOMA-IR.

Patients' and observers' perceptions of involvement differ. Validation study on inter-relating measures for shared decision making.

Science.gov (United States)

Kasper, Jürgen; Heesen, Christoph; Köpke, Sascha; Fulcher, Gary; Geiger, Friedemann

2011-01-01

Patient involvement into medical decisions as conceived in the shared decision making method (SDM) is essential in evidence based medicine. However, it is not conclusively evident how best to define, realize and evaluate involvement to enable patients making informed choices. We aimed at investigating the ability of four measures to indicate patient involvement. While use and reporting of these instruments might imply wide overlap regarding the addressed constructs this assumption seems questionable with respect to the diversity of the perspectives from which the assessments are administered. The study investigated a nested cohort (N = 79) of a randomized trial evaluating a patient decision aid on immunotherapy for multiple sclerosis. Convergent validities were calculated between observer ratings of videotaped physician-patient consultations (OPTION) and patients' perceptions of the communication (Shared Decision Making Questionnaire, Control Preference Scale & Decisional Conflict Scale). OPTION reliability was high to excellent. Communication performance was low according to OPTION and high according to the three patient administered measures. No correlations were found between observer and patient judges, neither for means nor for single items. Patient report measures showed some moderate correlations. Existing SDM measures do not refer to a single construct. A gold standard is missing to decide whether any of these measures has the potential to indicate patient involvement. Pronounced heterogeneity of the underpinning constructs implies difficulties regarding the interpretation of existing evidence on the efficacy of SDM. Consideration of communication theory and basic definitions of SDM would recommend an inter-subjective focus of measurement. Controlled-Trials.com ISRCTN25267500.

Inter-laboratory evaluation of three flagellin PCR/RFLP methods for typing Campylobacter jejuni and C-coli: the CAMPYNET experience

DEFF Research Database (Denmark)

Harrington, Clare S.; Moran, L.; Ridley, A.M.

2003-01-01

Aims: To compare typeability, discriminatory ability, and inter-laboratory reproducibility of three flagellin PCR/RFLP(fla typing) methods previously described for Campylobacter. Methods and Results: The sample set(n = 100) was diverse, including both C. jejuni (n = 85) and C. coli (n = 15). Two ...

The Role of Laboratory Experiments in the Validation of Field Data

DEFF Research Database (Denmark)

Mouneyrac, Catherine; Lagarde, Fabienne; Chatel, Amelie

2017-01-01

The ubiquitous presence and persistency of microplastics (MPs) in aquatic environments are of particular concern, since they constitute a potential threat to marine organisms and ecosystems. However, evaluating this threat and the impacts of MP on aquatic organisms is challenging. MPs form a very...... and to what degree these complexities are addressed in the current literature, to: (1) evaluate how well laboratory studies, investigated so far, represent environmentally relevant processes and scenarios and (2) suggest directions for future research The Role of Laboratory Experiments in the Validation...... of Field Data | Request PDF. Available from: https://www.researchgate.net/publication/310360438_The_Role_of_Laboratory_Experiments_in_the_Validation_of_Field_Data [accessed Jan 15 2018]....

The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder.

Science.gov (United States)

Berk, Michael; Dodd, Seetal; Dean, Olivia M; Kohlmann, Kristy; Berk, Lesley; Malhi, Gin S

2010-10-01

Berk M, Dodd S, Dean OM, Kohlmann K, Berk L, Malhi GS. The validity and internal structure of the Bipolar Depression Rating Scale: data from a clinical trial of N-acetylcysteine as adjunctive therapy in bipolar disorder. The phenomenology of unipolar and bipolar disorders differ in a number of ways, such as the presence of mixed states and atypical features. Conventional depression rating instruments are designed to capture the characteristics of unipolar depression and have limitations in capturing the breadth of bipolar disorder. The Bipolar Depression Rating Scale (BDRS) was administered together with the Montgomery Asberg Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) in a double-blind randomised placebo-controlled clinical trial of N-acetyl cysteine for bipolar disorder (N = 75). A factor analysis showed a two-factor solution: depression and mixed symptom clusters. The BDRS has strong internal consistency (Cronbach's alpha = 0.917), the depression cluster showed robust correlation with the MADRS (r = 0.865) and the mixed subscale correlated with the YMRS (r = 0.750). The BDRS has good internal validity and inter-rater reliability and is sensitive to change in the context of a clinical trial.

An inter-laboratory comparison study on transfer, persistence and recovery of DNA from cable ties.

Science.gov (United States)

Steensma, Kristy; Ansell, Ricky; Clarisse, Lindy; Connolly, Edward; Kloosterman, Ate D; McKenna, Louise G; van Oorschot, Roland A H; Szkuta, Bianca; Kokshoorn, Bas

2017-11-01

To address questions on the activity that led to the deposition of biological traces in a particular case, general information on the probabilities of transfer, persistence and recovery of cellular material in relevant scenarios is necessary. These figures may be derived from experimental data described in forensic literature when conditions relevant to the case were included. The experimental methodology regarding sampling, DNA extraction, DNA typing and profile interpretation that were used to generate these published data may differ from those applied in the case and thus the applicability of the literature data may be questioned. To assess the level of variability that different laboratories obtain when similar exhibits are analysed, we performed an inter-laboratory study between four partner laboratories. Five sets of 20 cable ties bound by different volunteers were distributed to the participating laboratories and sampled and processed according to the in-house protocols. Differences were found for the amount of retrieved DNA, as well as for the reportability and composition of the DNA profiles. These differences also resulted in different probabilities of transfer, persistence and recovery for each laboratory. Nevertheless, when applied to a case example, these differences resulted in similar assignments of weight of evidence given activity-level propositions. Copyright © 2017 Elsevier B.V. All rights reserved.

On the stability of a variety of organic photovoltaic devices by IPCE and in situ IPCE analyses: the ISOS-3 inter-laboratory collaboration

NARCIS (Netherlands)

Teran-Escobar, G.; Tanenbaum, D.M.; Voroshazi, E.; Hermenau, M.; Norrman, K.; Lloyd, M.T.; Galagan, Y.O.; Zimmermann, B.; Hösel, M.; Dam, H.F.; Jorgensen, M.; Gevorgyan, S.; Kudret, S.; Maes, W.; Lutsen, L.; Vanderzande, D.; Würfel, U.; Andriessen, H.A.J.M.; Rösch, R.; Hoppe, H.; Rivaton, A.; Uzunoglu, G.Y.; Germack, D.; Andreasen, B.; Madsen, M.V.; Bundgaard, E.; Krebs, F.C.; Lira-Cantu, M.

2012-01-01

This work is part of the inter-laboratory collaboration to study the stability of seven distinct sets of state-of-the-art organic photovoltaic (OPV) devices prepared by leading research laboratories. All devices have been shipped to and degraded at RISO-DTU up to 1830 hours in accordance with

DTU PMU Laboratory Development - Testing and Validation

DEFF Research Database (Denmark)

Garcia-Valle, Rodrigo; Yang, Guang-Ya; Martin, Kenneth E.

2010-01-01

This is a report of the results of phasor measurement unit (PMU) laboratory development and testing done at the Centre for Electric Technology (CET), Technical University of Denmark (DTU). Analysis of the PMU performance first required the development of tools to convert the DTU PMU data into IEEE...... standard, and the validation is done for the DTU-PMU via a validated commercial PMU. The commercial PMU has been tested from the authors' previous efforts, where the response can be expected to follow known patterns and provide confirmation about the test system to confirm the design and settings....... In a nutshell, having 2 PMUs that observe same signals provides validation of the operation and flags questionable results with more certainty. Moreover, the performance and accuracy of the DTU-PMU is tested acquiring good and precise results, when compared with a commercial phasor measurement device, PMU-1....

Improvement of AOAC Official Method 984.27 for the determination of nine nutritional elements in food products by Inductively coupled plasma-atomic emission spectroscopy after microwave digestion: single-laboratory validation and ring trial.

Science.gov (United States)

Poitevin, Eric; Nicolas, Marine; Graveleau, Laetitia; Richoz, Janique; Andrey, Daniel; Monard, Florence

2009-01-01

A single-laboratory validation (SLV) and a ring trial (RT) were undertaken to determine nine nutritional elements in food products by inductively coupled plasma-atomic emission spectroscopy in order to improve and update AOAC Official Method 984.27. The improvements involved optimized microwave digestion, selected analytical lines, internal standardization, and ion buffering. Simultaneous determination of nine elements (calcium, copper, iron, potassium, magnesium, manganese, sodium, phosphorus, and zinc) was made in food products. Sample digestion was performed through wet digestion of food samples by microwave technology with either closed or open vessel systems. Validation was performed to characterize the method for selectivity, sensitivity, linearity, accuracy, precision, recovery, ruggedness, and uncertainty. The robustness and efficiency of this method was proved through a successful internal RT using experienced food industry laboratories. Performance characteristics are reported for 13 certified and in-house reference materials, populating the AOAC triangle food sectors, which fulfilled AOAC criteria and recommendations for accuracy (trueness, recovery, and z-scores) and precision (repeatability and reproducibility RSD and HorRat values) regarding SLV and RT. This multielemental method is cost-efficient, time-saving, accurate, and fit-for-purpose according to ISO 17025 Norm and AOAC acceptability criteria, and is proposed as an improved version of AOAC Official Method 984.27 for fortified food products, including infant formula.

P2-2: Effects of Color Preview History on Inter-Trial Inhibition of Selective Attention

Directory of Open Access Journals (Sweden)

Eunsam Shin

2012-10-01

Full Text Available The distractor previewing effect (DPE refers to the phenomenon that search times for target colors that were previewed (target preview or TP in a preceding target-absent display (TAD are slower than for distractor colors that were previewed (distractor preview, DP in the TAD. The DPE is explained as attentional inhibition for the features associated with TADs. We investigated history effects of this inter-trial inhibition by manipulating color preview history and examined the DPE using RT and the N2pc (an electrophysiological index of attention allocation. The TAD, ranging from 0 to 2, was followed by a target-present display in which participants responded to the shape of a color-oddball. For the 2TADs, a single color (red or green was repeated twice or the two colors were alternated, resulting in TTP, DDP, TDP, and DTP conditions depending on which color (target or distractor in the search display was previewed. The 1TADs resulted in the TP and the DP, and the 0TADs comprised immediate search trials. RTs showed: (a the TP was slower than the DP; (b the TTP and DDP were slowest and fastest, respectively, and between these the DTP was slower than the TDP; (c the TTP-DDP difference doubled the TP-DP difference due to the RT increase in the TTP. The conditions with slower RTs corresponded with late onsets and smaller amplitudes in the N2pc. These results suggest that effects of color preview history are cumulative with weight on more recent events and support the idea of inter-trial inhibition of target selection.

Analytical validation of a reference laboratory ELISA for the detection of feline leukemia virus p27 antigen.

Science.gov (United States)

Buch, Jesse S; Clark, Genevieve H; Cahill, Roberta; Thatcher, Brendon; Smith, Peter; Chandrashekar, Ramaswamy; Leutenegger, Christian M; O'Connor, Thomas P; Beall, Melissa J

2017-09-01

Feline leukemia virus (FeLV) is an oncogenic retrovirus of cats. Immunoassays for the p27 core protein of FeLV aid in the detection of FeLV infections. Commercial microtiter-plate ELISAs have rapid protocols and visual result interpretation, limiting their usefulness in high-throughput situations. The purpose of our study was to validate the PetChek FeLV 15 ELISA, which is designed for the reference laboratory, and incorporates sequential, orthogonal screening and confirmatory protocols. A cutoff for the screening assay was established with 100% accuracy using 309 feline samples (244 negative, 65 positive) defined by the combined results of FeLV PCR and an independent reference p27 antigen ELISA. Precision of the screening assay was measured using a panel of 3 samples (negative, low-positive, and high-positive). The intra-assay coefficient of variation (CV) was 3.9-7.9%; the inter-assay CV was 6.0-8.6%. For the confirmatory assay, the intra-assay CV was 3.0-4.7%, and the inter-assay CV was 7.4-9.7%. The analytical sensitivity for p27 antigen was 3.7 ng/mL for inactivated whole FeLV and 1.2 ng/mL for purified recombinant FeLV p27. Analytical specificity was demonstrated based on the absence of cross-reactivity to related retroviruses. No interference was observed for samples containing added bilirubin, hemoglobin, or lipids. Based on these results, the new high-throughput design of the PetChek FeLV 15 ELISA makes it suitable for use in reference laboratory settings and maintains overall analytical performance.

Relative validity of a food frequency questionnaire used in the Inter99 study

DEFF Research Database (Denmark)

Toft, U.; Kristoffersen, Lars; Ladelund, S.

2008-01-01

OBJECTIVE: To evaluate the validity of the Inter99 food frequency questionnaire (FFQ) compared with a 28-days' diet history and biomarkers. SUBJECTS: A random sample of 13 016 individuals were drawn from a general population and invited for a health screening programme. Participation rate was 52.......5%. All high-risk individuals were re-invited for assessment after 1 and 3 years and completed a 198-item FFQ at all three occasions. Participants attending for 3 years follow-up were invited to participate in the validation study, including a 28-days' diet history, a 24-h urine collection and a fasting...... blood sample. Overall, 264 subjects participated. RESULTS: Spearman's rank correlation coefficients between the two dietary methods ranged from 0.31(beta-carotene) to 0.64 (fruits) in men and from 0.31 (polyunsaturated fat and sodium) to 0.64 (fruits) for women. The proportion of individuals classified...

The Role of Cedex s Railway Inter operability Laboratory (RIL) in the European ERTMS

International Nuclear Information System (INIS)

Tamarit Rodriguez de Huici, J.

2015-01-01

The RIL is the most recently laboratory set up within CEDEXs premises. From the start, it has aimed to support the development of rail transport at both European and Spanish levels. This article describes the role played by CEDEX-RIL in the development of ERTMS, and the close link which from its inception, has existed between this system and the EMSET project, in which the feasibility of the European Railway inter operability was demonstrated with the participation of the whole European signalling industry. The key factor for the success of this project was the creation of both and independent laboratory and testing sites which, right from the very beginning, enjoyed the confidence of the industry, thus allowing for the first time the execution of cross tests between companies. Finally, and equally important, this paper shows the fruitful evolution followed by the laboratory aforementioned, which, from its establishment, has evolved from performing tests on generic ERTMS constituents to undertaking, first, remote tests jointly carried out between specific commercial projects with different suppliers on track and on-board; and, second, Handover tests between diverse RBC suppliers. (Author)

Validation criteria of an internal dosimetry laboratory in vivo

International Nuclear Information System (INIS)

Alfaro L, M. de las M.

2014-10-01

People working with radioactive materials, under certain circumstances (e.g. not using the proper protective equipment, an incident not covered, etc.) could be incorporated into the body. The radiation protection programs include direct measurement methods -in vivo- or indirect -in vitro- or both, to know that radioactive material is incorporated into the body. The monitoring measurements of internal contamination or (Radio-bioassay) are carried out with the purpose of determining the amount of radioactive material incorporated in the body; estimate the effective dose and committed dose; management administration of radiation protection; appropriate medical management; and to provide the data necessary for the legal requirements and the preservation of records. The measurement methods used in the monitoring of internal contamination must be validated by the combination of the following processes: calibration, using standards reference materials and/or simulators; execute systematic research, using control samples; and intercomparison between laboratories and performance tests. In this paper the validation criteria of an internal dosimetry laboratory in vivo are presented following the information provided by the standard ANSI N13-30-1996 and ISO/TEC 17025-2005 as are the criteria of facilities, staff training, interpretation of measurements, performance criteria for monitoring of internal contamination in vivo, results reporting and records retention. Thereby we achieve standardized quantitative performance criteria of truthfulness, accuracy and detection limit and a consensus on statistical definitions to establish the validation plan of a monitoring laboratory of internal contamination in vivo. (Author)

Verification of Electromagnetic Field Measurements via Inter-laboratory Comparison Measurements

Directory of Open Access Journals (Sweden)

M. Mann

2005-01-01

Full Text Available An inter-laboratory comparison of field strength measurements was conducted in order to verify the comparability of high-frequency electromagnetic field measurements. For this purpose, 17 participating teams hosted by the working group "procedures of exposure determination" of the LAI (Länderausschuss für Immissionsschutz, state committee on immission control determined the field strength at given stations around a hospital situation. At those stations very different signals were generated, such as sine wave signals at 27MHz and 433MHz, signals from a diathermy device in Continuous-Wave (CW and Pulse-Width-Modulation (PWM mode, from a GSM base station at 900MHz and 1800MHz, from a UMTS base station, from a babyphone device and from a DECT cordless phone. This contribution describes the evaluation of the measured values and the approach to the computation of a reference value. Considering various sources of electromagnetic fields in the areas of personal safety at work and of immission control, the most important results are presented and the conclusions drawn are discussed.

On the stability of a variety of organic photovoltaic devices by IPCE and in situ IPCE analyses – the ISOS-3 inter-laboratory collaboration

DEFF Research Database (Denmark)

Teran-Escobar, Gerardo; Tanenbaum, David; Voroshazi, Eszter

2012-01-01

This work is part of the inter-laboratory collaboration to study the stability of seven distinct sets of state-of-the-art organic photovoltaic (OPV) devices prepared by leading research laboratories. All devices have been shipped to and degraded at RISØ-DTU up to 1830 hours in accordance...

An initial limited biodosimetry inter-comparison exercise: FOI and DRDC Ottawa

International Nuclear Information System (INIS)

Stricklin, D.; Wilkinson, D.; Arvidsson, E.; Prud'homme-Lalonde, L.; Thorleifson, E.; Mullins, D.; Lachapelle, S.

2007-01-01

While biodosimetry is a valuable tool in radiation dose assessment, the dicentric assay, which is the most validated method to date, requires some degree of technical competence. Recently published ISO guidelines indicate the need for documenting competence and establishment of quality control programs. Inter-laboratory comparisons are required to document the ability to perform reproducible and accurate assessments. FOI and DRDC Ottawa have conducted an initial limited biodosimetry exercise inter-comparison for quality assurance purposes. The exercise involved blinded exchange of three previously prepared slides from each laboratory from samples that had been evaluated for each lab's dose-response curve. Approximately 100 cells from each slide were evaluated and aberration frequencies reported and compared to the expected frequencies. The limited number of cells evaluated for each sample could not permit statistically distinguishing a 20% difference in all the samples. However, the results indicated reasonable agreement in analyses for all samples for triage purposes. Comparison of aberration frequencies, rather than dose estimates, further illustrates consistent scoring criteria between the two laboratories. The exercise conducted by FOI and DRDC Ottawa provided an efficient means of documenting expertise. Such cooperation further establishes the international biodosimetry network and ensures our readiness for emergency response

[Validation of a questionnaire to evaluate patient safety in clinical laboratories].

Science.gov (United States)

Giménez Marín, Ángeles; Rivas-Ruiz, Francisco

2012-01-01

The aim of this study was to prepare, pilot and validate a questionnaire to evaluate patient safety in the specific context of clinical laboratories. A specific questionnaire on patient safety in the laboratory, with 62 items grouped into six areas, was developed, taking into consideration the diverse human and laboratory contextual factors which may contribute to producing errors. A pilot study of 30 interviews was carried out, including validity and reliability analyses using principal components factor analysis and Cronbach's alpha. Subsequently, 240 questionnaires were sent to 21 hospitals, followed by a test-retest of 41 questionnaires with the definitive version. The sample analyzed was composed of 225 questionnaires (an overall response rate of 80%). Of the 62 items initially assessed, 17 were eliminated due to non-compliance with the criteria established before the principal components factor analysis was performed. For the 45 remaining items, 12 components were identified, with an cumulative variance of 69.5%. In seven of the 10 components with two or more items, Cronbach's alpha was higher than 0.7. The questionnaire items assessed in the test-retest were found to be stable. We present the first questionnaire with sufficiently proven validity and reliability for evaluating patient safety in the specific context of clinical laboratories. This questionnaire provides a useful instrument to perform a subsequent macrostudy of hospital clinical laboratories in Spain. The questionnaire can also be used to monitor and promote commitment to patient safety within the search for continuous quality improvement. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

Pasteurization: A reliable method for preservation of nutrient in seawater samples for inter-laboratory and field applications

OpenAIRE

Daniel, Anne; Kerouel, Roger; Aminot, Alain

2012-01-01

Following previous work, the production of reference material for nutrients in seawater, using pasteurization as a preservation method, was carried out seven times between 2006 and 2010 in the framework of inter-laboratory exercises. The preparation of samples from natural seawater allowed to become depleted in nutrients then spiked, bottled and pasteurized, is described. Five main nutrients are involved in this study: ammonium, nitrite, nitrate, phosphate and silicate. Bottles are in glass f...

Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis.

Science.gov (United States)

Banks, Jamie L; Marotta, Charles A

2007-03-01

The modified Rankin scale (mRS), a clinician-reported measure of global disability, is widely applied for evaluating stroke patient outcomes and as an end point in randomized clinical trials. Extensive evidence on the validity of the mRS exists across a large but fragmented literature. As new treatments for acute ischemic stroke are submitted for agency approval, an appreciation of the mRS's attributes, specifically its relationship to other stroke evaluation scales, would be valuable for decision-makers to properly assess the impact of a new drug on treatment paradigms. The purpose of this report is to assemble and systematically assess the properties of the mRS to provide decision-makers with pertinent evaluative information. A Medline search was conducted to identify reports in the peer-reviewed medical literature (1957-2006) that provide information on the structure, validation, scoring, and psychometric properties of the mRS and its use in clinical trials. The selection of articles was based on defined criteria that included relevance, study design and use of appropriate statistical methods. Of 224 articles identified by the literature search, 50 were selected for detailed assessment. Inter-rater reliability with the mRS is moderate and improves with structured interviews (kappa 0.56 versus 0.78); strong test-re-test reliability (kappa=0.81 to 0.95) has been reported. Numerous studies demonstrate the construct validity of the mRS by its relationships to physiological indicators such as stroke type, lesion size, perfusion and neurological impairment. Convergent validity between the mRS and other disability scales is well documented. Patient comorbidities and socioeconomic factors should be considered in properly applying and interpreting the mRS. Recent analyses suggest that randomized clinical trials of acute stroke treatments may require a smaller sample size if the mRS is used as a primary end point rather than the Barthel Index. Multiple types of evidence

Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues

OpenAIRE

Devendra T Mourya; Pragya D Yadav; Ajay Khare; Anwar H Khan

2017-01-01

With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no ac...

Validation and Inter-comparison Against Observations of GODAE Ocean View Ocean Prediction Systems

Science.gov (United States)

Xu, J.; Davidson, F. J. M.; Smith, G. C.; Lu, Y.; Hernandez, F.; Regnier, C.; Drevillon, M.; Ryan, A.; Martin, M.; Spindler, T. D.; Brassington, G. B.; Oke, P. R.

2016-02-01

For weather forecasts, validation of forecast performance is done at the end user level as well as by the meteorological forecast centers. In the development of Ocean Prediction Capacity, the same level of care for ocean forecast performance and validation is needed. Herein we present results from a validation against observations of 6 Global Ocean Forecast Systems under the GODAE OceanView International Collaboration Network. These systems include the Global Ocean Ice Forecast System (GIOPS) developed by the Government of Canada, two systems PSY3 and PSY4 from the French Mercator-Ocean Ocean Forecasting Group, the FOAM system from UK met office, HYCOM-RTOFS from NOAA/NCEP/NWA of USA, and the Australian Bluelink-OceanMAPS system from the CSIRO, the Australian Meteorological Bureau and the Australian Navy.The observation data used in the comparison are sea surface temperature, sub-surface temperature, sub-surface salinity, sea level anomaly, and sea ice total concentration data. Results of the inter-comparison demonstrate forecast performance limits, strengths and weaknesses of each of the six systems. This work establishes validation protocols and routines by which all new prediction systems developed under the CONCEPTS Collaborative Network will be benchmarked prior to approval for operations. This includes anticipated delivery of CONCEPTS regional prediction systems over the next two years including a pan Canadian 1/12th degree resolution ice ocean prediction system and limited area 1/36th degree resolution prediction systems. The validation approach of comparing forecasts to observations at the time and location of the observation is called Class 4 metrics. It has been adopted by major international ocean prediction centers, and will be recommended to JCOMM-WMO as routine validation approach for operational oceanography worldwide.

Balancing ballistic protection against physiological strain: evidence from laboratory and field trials.

Science.gov (United States)

Taylor, Nigel A S; Burdon, Catriona A; van den Heuvel, Anne M J; Fogarty, Alison L; Notley, Sean R; Hunt, Andrew P; Billing, Daniel C; Drain, Jace R; Silk, Aaron J; Patterson, Mark J; Peoples, Gregory E

2016-02-01

This project was based on the premise that decisions concerning the ballistic protection provided to defence personnel should derive from an evaluation of the balance between protection level and its impact on physiological function, mobility, and operational capability. Civilians and soldiers participated in laboratory- and field-based studies in which ensembles providing five levels of ballistic protection were evaluated, each with progressive increases in protection, mass (3.4-11.0 kg), and surface-area coverage (0.25-0.52 m(2)). Physiological trials were conducted on volunteers (N = 8) in a laboratory, under hot-dry conditions simulating an urban patrol: walking at 4 km·h(-1) (90 min) and 6 km·h(-1) (30 min or to fatigue). Field-based trials were used to evaluate tactical battlefield movements (mobility) of soldiers (N = 31) under tropical conditions, and across functional tests of power, speed, agility, endurance, and balance. Finally, trials were conducted at a jungle training centre, with soldiers (N = 32) patrolling under tropical conditions (averaging 5 h). In the laboratory, work tolerance was reduced as protection increased, with deep-body temperature climbing relentlessly. However, the protective ensembles could be grouped into two equally stressful categories, each providing a different level of ballistic protection. This outcome was supported during the mobility trials, with the greatest performance decrement evident during fire and movement simulations, as the ensemble mass was increased (-2.12%·kg(-1)). The jungle patrol trials similarly supported this outcome. Therefore, although ballistic protection does increase physiological strain, this research has provided a basis on which to determine how that strain can be balanced against the mission-specific level of required personal protection.

Assessing variability in chemical acute toxicity of unionid mussels: Influence of intra- and inter-laboratory testing, life stage, and species - SETAC Abstract

Science.gov (United States)

We developed a toxicity database for unionid mussels to examine the extent of intra- and inter-laboratory variability in acute toxicity tests with mussel larvae (glochidia) and juveniles; the extent of differential sensitivity of the two life stages; and the variation in sensitiv...

Calculation of the inter-nuclei separation of HD+

International Nuclear Information System (INIS)

Zhu Zhousen; Shi Miangong; Tang Ayou; Yang Baifang; Miao Jingwei

1993-01-01

With the Ritz variational principle, the authors calculate the inter nuclei separation of the HD + molecular ion, and introduces a method to calculate the inter nuclei separations of other simple non-symmetry two-atom molecular ions. One way to work out the trial wave function is provided

Validating a conceptual model for an inter-professional approach to shared decision making: a mixed methods study

Science.gov (United States)

Légaré, France; Stacey, Dawn; Gagnon, Susie; Dunn, Sandy; Pluye, Pierre; Frosch, Dominick; Kryworuchko, Jennifer; Elwyn, Glyn; Gagnon, Marie-Pierre; Graham, Ian D

2011-01-01

Rationale, aims and objectives Following increased interest in having inter-professional (IP) health care teams engage patients in decision making, we developed a conceptual model for an IP approach to shared decision making (SDM) in primary care. We assessed the validity of the model with stakeholders in Canada. Methods In 15 individual interviews and 7 group interviews with 79 stakeholders, we asked them to: (1) propose changes to the IP-SDM model; (2) identify barriers and facilitators to the model's implementation in clinical practice; and (3) assess the model using a theory appraisal questionnaire. We performed a thematic analysis of the transcripts and a descriptive analysis of the questionnaires. Results Stakeholders suggested placing the patient at its centre; extending the concept of family to include significant others; clarifying outcomes; highlighting the concept of time; merging the micro, meso and macro levels in one figure; and recognizing the influence of the environment and emotions. The most common barriers identified were time constraints, insufficient resources and an imbalance of power among health professionals. The most common facilitators were education and training in inter-professionalism and SDM, motivation to achieve an IP approach to SDM, and mutual knowledge and understanding of disciplinary roles. Most stakeholders considered that the concepts and relationships between the concepts were clear and rated the model as logical, testable, having clear schematic representation, and being relevant to inter-professional collaboration, SDM and primary care. Conclusions Stakeholders validated the new IP-SDM model for primary care settings and proposed few modifications. Future research should assess if the model helps implement SDM in IP clinical practice. PMID:20695950

Inter-observer and inter-examination variability of manual vertebral bone attenuation measurements on computed tomography

International Nuclear Information System (INIS)

Pompe, Esther; Lammers, Jan-Willem J.; Jong, Pim A. de; Jong, Werner U. de; Takx, Richard A.P.; Eikendal, Anouk L.M.; Willemink, Martin J.; Mohamed Hoesein, Firdaus A.A.; Oudkerk, Matthijs; Budde, Ricardo P.J.

2016-01-01

To determine inter-observer and inter-examination variability of manual attenuation measurements of the vertebrae in low-dose unenhanced chest computed tomography (CT). Three hundred and sixty-seven lung cancer screening trial participants who underwent baseline and repeat unenhanced low-dose CT after 3 months because of an indeterminate lung nodule were included. The CT attenuation value of the first lumbar vertebrae (L1) was measured in all CTs by one observer to obtain inter-examination reliability. Six observers performed measurements in 100 randomly selected CTs to determine agreement with limits of agreement and Bland-Altman plots and reliability with intraclass correlation coefficients (ICCs). Reclassification analyses were performed using a threshold of 110 HU to define osteoporosis. Inter-examination reliability was excellent with an ICC of 0.92 (p < 0.001). Inter-examination limits of agreement ranged from -26 to 28 HU with a mean difference of 1 ± 14 HU. Inter-observer reliability ICCs ranged from 0.70 to 0.91. Inter-examination variability led to 11.2 % reclassification of participants and inter-observer variability led to 22.1 % reclassification. Vertebral attenuation values can be manually quantified with good to excellent inter-examination and inter-observer reliability on unenhanced low-dose chest CT. This information is valuable for early detection of osteoporosis on low-dose chest CT. (orig.)

Laboratory Validation and Demonstrations of Non-Hexavalent Chromium Conversion Coatings for Steel Substrates (Briefing Charts)

Science.gov (United States)

2011-02-01

UNCLASSIFIED: Approved for public release; distribution unlimited. Laboratory Validation and Demonstrations of Non- Hexavalent Chromium Conversion...00-00-2011 4. TITLE AND SUBTITLE Laboratory Validation and Demonstrations of Non- Hexavalent Chromium Conversion Coatings for Steel Substrates 5a...to MRAP II Acquisition Pretreatment /conversion coatings omitted: • Hex- chrome pretreatments prohibited for new ground vehicles • Hydrogen

Combined Characterization Techniques to Understand the Stability of a Variety of Organic Photovoltaic Devices - the ISOS-3 inter- laboratory collaboration

DEFF Research Database (Denmark)

Lira-Cantu, Monica; Tanenbaum, David M.; Norrman, Kion

2012-01-01

. The results reported from the combination of the different characterization techniques results in a proposed degradation mechanism. The final conclusion is that the failure of the photovoltaic response of the device with time under full sun solar simulation, is mainly due to the degradation of the electrodes...... and not to the active materials of the solar cell.......This work is part of the inter-laboratory collaboration to study the stability of seven distinct sets of state-of-the-art organic photovoltaic (OPVs) devices prepared by leading research laboratories. All devices have been shipped to and degraded at the Danish Technical University (DTU, formerly...

Inter- and intra-laboratory study to determine the reproducibility of toxicogenomics datasets.

Science.gov (United States)

Scott, D J; Devonshire, A S; Adeleye, Y A; Schutte, M E; Rodrigues, M R; Wilkes, T M; Sacco, M G; Gribaldo, L; Fabbri, M; Coecke, S; Whelan, M; Skinner, N; Bennett, A; White, A; Foy, C A

2011-11-28

The application of toxicogenomics as a predictive tool for chemical risk assessment has been under evaluation by the toxicology community for more than a decade. However, it predominately remains a tool for investigative research rather than for regulatory risk assessment. In this study, we assessed whether the current generation of microarray technology in combination with an in vitro experimental design was capable of generating robust, reproducible data of sufficient quality to show promise as a tool for regulatory risk assessment. To this end, we designed a prospective collaborative study to determine the level of inter- and intra-laboratory reproducibility between three independent laboratories. All test centres (TCs) adopted the same protocols for all aspects of the toxicogenomic experiment including cell culture, chemical exposure, RNA extraction, microarray data generation and analysis. As a case study, the genotoxic carcinogen benzo[a]pyrene (B[a]P) and the human hepatoma cell line HepG2 were used to generate three comparable toxicogenomic data sets. High levels of technical reproducibility were demonstrated using a widely employed gene expression microarray platform. While differences at the global transcriptome level were observed between the TCs, a common subset of B[a]P responsive genes (n=400 gene probes) was identified at all TCs which included many genes previously reported in the literature as B[a]P responsive. These data show promise that the current generation of microarray technology, in combination with a standard in vitro experimental design, can produce robust data that can be generated reproducibly in independent laboratories. Future work will need to determine whether such reproducible in vitro model(s) can be predictive for a range of toxic chemicals with different mechanisms of action and thus be considered as part of future testing regimes for regulatory risk assessment. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Inter-laboratory comparison of HITU power measurement methods and capabilities

International Nuclear Information System (INIS)

Jenderka, K V; Durando, G; Karaboece, B; Rajagopal, S; Shaw, A

2011-01-01

High Intensity Therapeutic Ultrasound (HITU) is gaining in importance among the spectrum of therapeutic options to combat cancer. HITU has already been approved and is in clinical use for the treatment of organs like the prostate, the liver and the uterus. Nevertheless, the metrology of the applied high power ultrasound fields, and in consequence, reliable treatment planning and monitoring, is still a challenge. As part of a European Metrology Research Programme project, the four National Metrology Institutes from the UK, Germany, Italy and Turkey conducted an inter-laboratory comparison of their power measurement capabilities at power levels of 5, 25, 75 and 150 W each at frequencies of 1.1, 1.5 and 3.3 MHz. The task was to measure the total, time-averaged ultrasonic output power, emitted by the circulated transducers under specified electrical excitation conditions into an anechoic water load, and the actual rms transducer input voltage. The output value to be reported was the electro-acoustic radiation conductance including the associated standard and expanded uncertainties. Several different measurement techniques were applied to gain further insight into HITU power measurement. The deviations from the calculated comparison reference value found for the different techniques are discussed and conclusions for the further improvement of measuring procedures are drawn.

Inter-laboratory comparison of HITU power measurement methods and capabilities

Energy Technology Data Exchange (ETDEWEB)

Jenderka, K V [Physikalisch-Technische Bundesanstalt (PTB), Bundesallee 100, 38116 Braunschweig (Germany); Durando, G [Istituto Nazionale di Ricerca Metrologica (INRIM), Strada delle Cacce 91, 10135 Torino (Italy); Karaboece, B [Tuebitak Ulusal Metroloji Enstituesue (UME), P.K. 54 41470 Gebze-Kocaeli (Turkey); Rajagopal, S; Shaw, A, E-mail: kvjend@ieee.org [National Physical Laboratory (NPL), Hampton Road, Teddington, TW11 0LW (United Kingdom)

2011-02-01

High Intensity Therapeutic Ultrasound (HITU) is gaining in importance among the spectrum of therapeutic options to combat cancer. HITU has already been approved and is in clinical use for the treatment of organs like the prostate, the liver and the uterus. Nevertheless, the metrology of the applied high power ultrasound fields, and in consequence, reliable treatment planning and monitoring, is still a challenge. As part of a European Metrology Research Programme project, the four National Metrology Institutes from the UK, Germany, Italy and Turkey conducted an inter-laboratory comparison of their power measurement capabilities at power levels of 5, 25, 75 and 150 W each at frequencies of 1.1, 1.5 and 3.3 MHz. The task was to measure the total, time-averaged ultrasonic output power, emitted by the circulated transducers under specified electrical excitation conditions into an anechoic water load, and the actual rms transducer input voltage. The output value to be reported was the electro-acoustic radiation conductance including the associated standard and expanded uncertainties. Several different measurement techniques were applied to gain further insight into HITU power measurement. The deviations from the calculated comparison reference value found for the different techniques are discussed and conclusions for the further improvement of measuring procedures are drawn.

Development and inter-laboratory assessment of droplet digital PCR assays for multiplex quantification of 15 genetically modified soybean lines.

Science.gov (United States)

Košir, Alexandra Bogožalec; Spilsberg, Bjørn; Holst-Jensen, Arne; Žel, Jana; Dobnik, David

2017-08-17

Quantification of genetically modified organisms (GMOs) in food and feed products is often required for their labelling or for tolerance thresholds. Standard-curve-based simplex quantitative polymerase chain reaction (qPCR) is the prevailing technology, which is often combined with screening analysis. With the rapidly growing number of GMOs on the world market, qPCR analysis becomes laborious and expensive. Innovative cost-effective approaches are therefore urgently needed. Here, we report the development and inter-laboratory assessment of multiplex assays to quantify GMO soybean using droplet digital PCR (ddPCR). The assays were developed to facilitate testing of foods and feed for compliance with current GMO regulations in the European Union (EU). Within the EU, the threshold for labelling is 0.9% for authorised GMOs per ingredient. Furthermore, the EU has set a technical zero tolerance limit of 0.1% for certain unauthorised GMOs. The novel multiplex ddPCR assays developed target 11 GMO soybean lines that are currently authorised, and four that are tolerated, pending authorisation in the EU. Potential significant improvements in cost efficiency are demonstrated. Performance was assessed for the critical parameters, including limits of detection and quantification, and trueness, repeatability, and robustness. Inter-laboratory performance was also determined on a number of proficiency programme and real-life samples.

Are You "Tilting at Windmills" or Undertaking a Valid Clinical Trial?

Science.gov (United States)

Zariffa, Jose; Kramer, John L.K.

2011-01-01

In this review, several aspects surrounding the choice of a therapeutic intervention and the conduct of clinical trials are discussed. Some of the background for why human studies have evolved to their current state is also included. Specifically, the following questions have been addressed: 1) What criteria should be used to determine whether a scientific discovery or invention is worthy of translation to human application? 2) What recent scientific advance warrants a deeper understanding of clinical trials by everyone? 3) What are the different types and phases of a clinical trial? 4) What characteristics of a human disorder should be noted, tracked, or stratified for a clinical trial and what inclusion /exclusion criteria are important to enrolling appropriate trial subjects? 5) What are the different study designs that can be used in a clinical trial program? 6) What confounding factors can alter the accurate interpretation of clinical trial outcomes? 7) What are the success rates of clinical trials and what can we learn from previous clinical trials? 8) What are the essential principles for the conduct of valid clinical trials? PMID:21786433

On the stability of a variety of organic photovoltaic devices by IPCE and in situ IPCE analyses - the ISOS-3 inter-laboratory collaboration

OpenAIRE

Terán-Escobar, Gerardo; Krebs, Frederik C.; Lira-Cantú, Mónica

2012-01-01

This work is part of the inter-laboratory collaboration to study the stability of seven distinct sets of state-of-the-art organic photovoltaic (OPV) devices prepared by leading research laboratories. All devices have been shipped to and degraded at RISempty set-DTU up to 1830 hours in accordance with established ISOS-3 protocols under defined illumination conditions. In this work, we apply the Incident Photon-to-Electron Conversion Efficiency (IPCE) and the in situ IPCE techniques to determin...

Status Report of the Inter-Laboratory Task Force on Remote Operation

International Nuclear Information System (INIS)

Phinney, Nan

2001-01-01

The next generation of particle accelerators will be major projects which may require a new mode of international and inter-laboratory collaboration. They are likely to be too costly to be funded by a single nation and too large to be built by a single laboratory. The tremendous technical challenge of a new facility requires a critical mass of highly qualified and experienced physicists and engineers. These experts are presently distributed among the major accelerator centers around the world and it is believed important to maintain and develop this broad base of expertise. The successful accelerator technology development of recent decades depended on extensive exchange of people with complementary technical skills. Therefore, it is desirable and probably necessary that several accelerator laboratories will participate in any future project. A consequence of a multi-laboratory project is that the accelerator will be located a considerable distance from most of the contributing institutions which design, build and operate it. These considerations led the International Committee for Future Accelerators to initiate a study on the general and technical implications of such a collaboration. Two task forces were formed in February 2000 to conduct this study and they were asked to prepare a report on a time scale of one year. The task force on Remote Operation included members from most of the major accelerator laboratories around the world with expertise on accelerator operation, controls software, communication technologies, hardware design and maintenance. The task force members gathered information from the experts at their own institutions and from available experience in other fields, particularly astronomy. The task force on Remote Operations began by developing a model for an international multi-laboratory collaboration to construct and operate an accelerator facility. This model is described in section 3. While it is clear that there are numerous alternative

Validity of diagnoses, procedures, and laboratory data in Japanese administrative data.

Science.gov (United States)

Yamana, Hayato; Moriwaki, Mutsuko; Horiguchi, Hiromasa; Kodan, Mariko; Fushimi, Kiyohide; Yasunaga, Hideo

2017-10-01

Validation of recorded data is a prerequisite for studies that utilize administrative databases. The present study evaluated the validity of diagnoses and procedure records in the Japanese Diagnosis Procedure Combination (DPC) data, along with laboratory test results in the newly-introduced Standardized Structured Medical Record Information Exchange (SS-MIX) data. Between November 2015 and February 2016, we conducted chart reviews of 315 patients hospitalized between April 2014 and March 2015 in four middle-sized acute-care hospitals in Shizuoka, Kochi, Fukuoka, and Saga Prefectures and used them as reference standards. The sensitivity and specificity of DPC data in identifying 16 diseases and 10 common procedures were identified. The accuracy of SS-MIX data for 13 laboratory test results was also examined. The specificity of diagnoses in the DPC data exceeded 96%, while the sensitivity was below 50% for seven diseases and variable across diseases. When limited to primary diagnoses, the sensitivity and specificity were 78.9% and 93.2%, respectively. The sensitivity of procedure records exceeded 90% for six procedures, and the specificity exceeded 90% for nine procedures. Agreement between the SS-MIX data and the chart reviews was above 95% for all 13 items. The validity of diagnoses and procedure records in the DPC data and laboratory results in the SS-MIX data was high in general, supporting their use in future studies. Copyright © 2017 The Authors. Production and hosting by Elsevier B.V. All rights reserved.

Applicability of the DPPH assay for evaluating the antioxidant capacity of food additives - inter-laboratory evaluation study -.

Science.gov (United States)

Shimamura, Tomoko; Sumikura, Yoshihiro; Yamazaki, Takeshi; Tada, Atsuko; Kashiwagi, Takehiro; Ishikawa, Hiroya; Matsui, Toshiro; Sugimoto, Naoki; Akiyama, Hiroshi; Ukeda, Hiroyuki

2014-01-01

An inter-laboratory evaluation study was conducted in order to evaluate the antioxidant capacity of food additives by using a 1,1-diphenyl-2-picrylhydrazyl (DPPH) assay. Four antioxidants used as existing food additives (i.e., tea extract, grape seed extract, enju extract, and d-α-tocopherol) and 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid (Trolox) were used as analytical samples, and 14 laboratories participated in this study. The repeatability relative standard deviation (RSD(r)) of the IC50 of Trolox, four antioxidants, and the Trolox equivalent antioxidant capacity (TEAC) were 1.8-2.2%, 2.2-2.9%, and 2.1-2.5%, respectively. Thus, the proposed DPPH assay showed good performance within the same laboratory. The reproducibility relative standard deviation (RSD(R)) of IC50 of Trolox, four antioxidants, and TEAC were 4.0-7.9%, 6.0-11%, and 3.7-9.3%, respectively. The RSD(R)/RSD(r) values of TEAC were lower than, or nearly equal to, those of IC50 of the four antioxidants, suggesting that the use of TEAC was effective for reducing the variance among the laboratories. These results showed that the proposed DPPH assay could be used as a standard method to evaluate the antioxidant capacity of food additives.

Intra- and inter-laboratory validation of a dipstick immunoassay for the detection of tropane alkaloids hyoscyamine and scopolamine in animal feed

NARCIS (Netherlands)

Mulder, P.P.J.; Holst, von C.; Nivarlet, N.; Egmond, van H.P.

2014-01-01

Tropane alkaloids (TAs) are toxic secondary metabolites produced by plants of, inter alia, the genera Datura (thorn apple) and Atropa (deadly nightshade). The most relevant TAs are (-)-L-hyoscyamine and (-)-L-scopolamine, which act as antagonists of acetylcholine muscarinic receptors and can induce

Use of HOMA-IR to diagnose non-alcoholic fatty liver disease: a population-based and inter-laboratory study

OpenAIRE

Isokuortti, Elina; Zhou, You; Peltonen, Markku; Bugianesi, Elisabetta; Clement, Karine; Bonnefont-Rousselot, Dominique; Lacorte, Jean-Marc; Gastaldelli, Amalia; Schuppan, Detlef; Schattenberg, Jörn M.; Hakkarainen, Antti; Lundbom, Nina; Jousilahti, Pekka; Männistö, Satu; Keinänen-Kiukaanniemi, Sirkka

2017-01-01

Aims/hypothesis\\ud \\ud Recent European guidelines for non-alcoholic fatty liver disease (NAFLD) call for reference values for HOMA-IR. In this study, we aimed to determine: (1) the upper limit of normal HOMA-IR in two population-based cohorts; (2) the HOMA-IR corresponding to NAFLD; (3) the effect of sex and PNPLA3 genotype at rs738409 on HOMA-IR; and (4) inter-laboratory variations in HOMA-IR.\\ud \\ud Methods\\ud \\ud We identified healthy individuals in two population-based cohorts (FINRISK 20...

A validation study of new cryopreservation bags for implementation in a blood and marrow transplant laboratory.

Science.gov (United States)

Pomper, Gregory J; Wilson, Emily; Isom, Scott; Hurd, David D

2011-06-01

A new cryopreservation bag for hematopoietic cell transplantation requires validation as a safe alternative to the bag currently being used in the laboratory. The new bag was validated using both laboratory and clinical criteria. Laboratory validation proceeded using paired samples of mononuclear cells processed using standard procedures. Cells cryopreserved in the new and old bags were compared for viability, cell counts, CD34 enumeration, colony-forming unit assays, and bag integrity. After completion of laboratory investigations, engraftment with the new bags was followed and compared to historical engraftment using the old bags. There were no significant differences between the old and new bags detected using laboratory studies. Bag integrity was equivalent. The validation data suggested impaired cell function after cryopreservation in the new bags, but there were no significant differences in engraftment potential using either material. Days to engraftment was longer using the new bags, but statistical analysis revealed an association with CD34 dose and not with cryopreservation bag type. The new bags were noninferior to the old bags. A change in cryopreservation bag type may appear to affect cell function and potentially affect engraftment. Multiple analyses may be needed to understand the effect of cell processing changes. © 2010 American Association of Blood Banks.

Principles of Single-Laboratory Validation of Analytical Methods for Testing the Chemical Composition of Pesticides

Energy Technology Data Exchange (ETDEWEB)

Ambrus, A. [Hungarian Food Safety Office, Budapest (Hungary)

2009-07-15

Underlying theoretical and practical approaches towards pesticide formulation analysis are discussed, i.e. general principles, performance characteristics, applicability of validation data, verification of method performance, and adaptation of validated methods by other laboratories. The principles of single laboratory validation of analytical methods for testing the chemical composition of pesticides are outlined. Also the theoretical background is described for performing pesticide formulation analysis as outlined in ISO, CIPAC/AOAC and IUPAC guidelines, including methodological characteristics such as specificity, selectivity, linearity, accuracy, trueness, precision and bias. Appendices I–III hereof give practical and elaborated examples on how to use the Horwitz approach and formulae for estimating the target standard deviation towards acceptable analytical repeatability. The estimation of trueness and the establishment of typical within-laboratory reproducibility are treated in greater detail by means of worked-out examples. (author)

REIMEP-22 inter-laboratory comparison: "U Age Dating - Determination of the production date of a uranium certified test sample"

OpenAIRE

VENCHIARUTTI CELIA; VARGA ZSOLT; RICHTER Stephan; JAKOPIC Rozle; MAYER Klaus; AREGBE Yetunde

2015-01-01

The REIMEP-22 inter-laboratory comparison aimed at determining the production date of a uranium certified test sample (i.e. the last chemical separation date of the material). Participants in REIMEP-22 on "U Age Dating - Determination of the production date of a uranium certified test sample" received one low-enriched 20 mg uranium sample for mass spectrometry measurements and/or one 50 mg uranium sample for D-spectrometry measurements, with an undisclosed value for the production date. They ...

The relationship between external and internal validity of randomized controlled trials: A sample of hypertension trials from China.

Science.gov (United States)

Zhang, Xin; Wu, Yuxia; Ren, Pengwei; Liu, Xueting; Kang, Deying

2015-10-30

To explore the relationship between the external validity and the internal validity of hypertension RCTs conducted in China. Comprehensive literature searches were performed in Medline, Embase, Cochrane Central Register of Controlled Trials (CCTR), CBMdisc (Chinese biomedical literature database), CNKI (China National Knowledge Infrastructure/China Academic Journals Full-text Database) and VIP (Chinese scientific journals database) as well as advanced search strategies were used to locate hypertension RCTs. The risk of bias in RCTs was assessed by a modified scale, Jadad scale respectively, and then studies with 3 or more grading scores were included for the purpose of evaluating of external validity. A data extract form including 4 domains and 25 items was used to explore relationship of the external validity and the internal validity. Statistic analyses were performed by using SPSS software, version 21.0 (SPSS, Chicago, IL). 226 hypertension RCTs were included for final analysis. RCTs conducted in university affiliated hospitals (P internal validity. Multi-center studies (median = 4.0, IQR = 2.0) were scored higher internal validity score than single-center studies (median = 3.0, IQR = 1.0) (P internal validity (P = 0.004). Multivariate regression indicated sample size, industry-funding, quality of life (QOL) taken as measure and the university affiliated hospital as trial setting had statistical significance (P external validity of RCTs do associate with the internal validity, that do not stand in an easy relationship to each other. Regarding the poor reporting, other possible links between two variables need to trace in the future methodological researches.

Validation of simple and inexpensive algometry using sphygmomanometer cuff and neuromuscular junction monitor with standardized laboratory algometer

Science.gov (United States)

Durga, Padmaja; Wudaru, Sreedhar Reddy; Khambam, Sunil Kumar Reddy; Chandra, Shobha Jagadish; Ramachandran, Gopinath

2016-01-01

Background and Aims: The availability, ergonomics and economics prohibit the routine use of algometers in clinical practice and research by the anesthesiologists. A simple bedside technique of quantitative pain measurement would enable the routine use of algometry. We proposed to validate simple pain provocation using sphygmomanometer cuff and the electric stimulation of neuromuscular junction monitor (TOF-guard, Organon Teknika) to measure pain against a standardized laboratory pressure algometer. Material and Methods: Pain detection threshold (Pdt) and pain tolerance threshold (Ptt) were measured in forty healthy volunteers of both genders, using the above three techniques. All measurements were repeated three times. The co-efficient of inter-rater reliability (or consistency) between three independent measurements obtained from each of the techniques was determined by Cronbach's co-efficient alpha (α C). The correlation between the mean Pdt and Ptt values recorded by standardized algometer and the sphygmomanometer technique and nerve stimulator technique was performed using Pearson Correlation. An r >0.5 and a two-tailed significance of algometer and the tested techniques. Results: There was a good inter-rater reliability (α C > 0.7) for the three techniques. There was a good correlation with r >0.65 (P algometer and the two techniques being tested as alternatives for algometer to measure pain. Conclusion: The sphygmomanometer cuff technique and electrical stimulation with the peripheral nerve stimulator to measure pain threshold and tolerance provide a simple, efficient, repeatable measure of pain intensity and can be used as suitable alternatives to standard algometers. PMID:27006546

Validating the InterVA model to estimate the burden of mortality from verbal autopsy data: a population-based cross-sectional study.

Directory of Open Access Journals (Sweden)

Sebsibe Tadesse

Full Text Available BACKGROUND: In countries with incomplete or no vital registration systems, verbal autopsy data are often reviewed by physicians in order to assign the probable cause of death. But in addition to being time and energy consuming, the method is liable to produce inconsistent results. The aim of this study is to validate the InterVA model for estimating the burden of mortality from verbal autopsy data by using physician review as a reference standard. METHODS AND FINDINGS: A population-based cross-sectional study was conducted from March to April, 2012. All adults aged ≥ 14 years and died between 01 January, 2010 and 15 February, 2012 were included in the study. The verbal autopsy interviews were reviewed by the InterVA model and physicians to estimate cause-specific mortality fractions. Cohen's kappa statistic, sensitivity, specificity, positive predictive value, and negative predictive value were applied to compare the agreement between the InterVA model and the physician review. A total of 408 adult deaths were studied. There was a general similarity and just slight differences between the InterVA model and the physicians in assigning cause-specific mortality. Both approaches showed an overall agreement in 298 (73% cases [kappa = 0.49, 95% CI: 0.37-0.60]. The observed sensitivities and specificities across causes of death categories varied from 13.3% to 81.9% and 77.7% to 99.5%, respectively. CONCLUSIONS: In understanding the burden of disease and setting health intervention priorities in areas that lack reliable vital registration systems, an accurate analysis of verbal autopsies is essential. Therefore, users should be aware of the suboptimal performance of the InterVA model. Similar validation studies need to be undertaken considering the limitation of the physician review as gold standard since physicians may misinterpret some of the verbal autopsy data and finally reach a wrong conclusion of the cause of death.

To the Geoportal and Beyond! Preparing the Earth Observing Laboratory's Datasets for Inter-Repository Discovery

Science.gov (United States)

Gordon, S.; Dattore, E.; Williams, S.

2014-12-01

Even when a data center makes it's datasets accessible, they can still be hard to discover if the user is unaware of the laboratory or organization the data center supports. NCAR's Earth Observing Laboratory (EOL) is no exception. In response to this problem and as an inquiry into the feasibility of inter-connecting all of NCAR's repositories at a discovery layer, ESRI's Geoportal was researched. It was determined that an implementation of Geoportal would be a good choice to build a proof of concept model of inter-repository discovery around. This collaborative project between the University of Illinois and NCAR is coordinated through the Data Curation Education in Research Centers program. This program is funded by the Institute of Museum and Library Services.Geoportal is open source software. It serves as an aggregation point for metadata catalogs of earth science datasets, with a focus on geospatial information. EOL's metadata is in static THREDDS catalogs. Geoportal can only create records from a THREDDS Data Server. The first step was to make EOL metadata more accessible by utilizing the ISO 19115-2 standard. It was also decided to create DIF records so EOL datasets could be ingested in NASA's Global Change Master Directory (GCMD). To offer records for harvest, it was decided to develop an OAI-PMH server. To make a compliant server, the OAI_DC standard was also implemented. A server was written in Perl to serve a set of static records. We created a sample set of records in ISO 19115-2, FGDC, DIF, and OAI_DC. We utilized GCMD shared vocabularies to enhance discoverability and precision. The proof of concept was tested and verified by having another NCAR laboratory's Geoportal harvest our sample set. To prepare for production, templates for each standard were developed and mapped to the database. These templates will help the automated creation of records. Once the OAI-PMH server is re-written in a Grails framework a dynamic representation of EOL's metadata will

Bamboo as Soil Reinforcement: A Laboratory Trial

Directory of Open Access Journals (Sweden)

Alhaji Mohammed MUSTAPHA

2008-12-01

Full Text Available A lateritic soil classified as A-6 under AASHTO soil classification system was reinforced with 0, 1, 2 and 3 bamboo specimens at laboratory trial level to evaluate its unconfined compressive strength (UCS and modulus of rigidity. The soil specimens were molded in cylindrical form of 38mm diameter and 76mm height while the bamboo specimens were trimmed in to circular plates of 34mm diameter and 3mm thickness. The trial soil specimens are: soil specimen without bamboo specimen (0 bamboo, soil specimen with one bamboo specimen in the center (1 bamboo, soil specimen with one bamboo specimen on top and one at the bottom (2 bamboos and soil specimen with one bamboo specimen on top, center and bottom (3 bamboos. Though, the dry density of the molded soil specimen decreased from 1.638Mg/m3 at 0 bamboo to 1.470Mg/m2 at 3 bamboos, the UCS increased from 226KN/m2 at 0 bamboo to 621KN/m2 at 3 bamboos. Also, for each of the 3 percentage strains (0.5, 1.0 and 1.5% considered, the modulus of rigidity increased with bamboo specimens.

Validity and inter-rater reliability of medio-lateral knee motion observed during a single-limb mini squat

DEFF Research Database (Denmark)

Ageberg, Eva; Bennell, Kim L; Hunt, Michael A

2010-01-01

Muscle function may influence the risk of knee injury and outcomes following injury. Clinical tests, such as a single-limb mini squat, resemble conditions of daily life and are easy to administer. Fewer squats per 30 seconds indicate poorer function. However, the quality of movement, such as the ......, such as the medio-lateral knee motion may also be important. The aim was to validate an observational clinical test of assessing the medio-lateral knee motion, using a three-dimensional (3-D) motion analysis system. In addition, the inter-rater reliability was evaluated....

An inter-laboratory stability study of roll-to-roll coated flexible polymer solar modules

DEFF Research Database (Denmark)

Gevorgyan, Suren; Medford, Andrew James; Bundgaard, Eva

2011-01-01

A large number of flexible polymer solar modules comprising 16 serially connected individual cells was prepared at the experimental workshop at Risø DTU. The photoactive layer was prepared from several varieties of P3HT (Merck, Plextronics, BASF and Risø DTU) and two varieties of ZnO (nanoparticu......A large number of flexible polymer solar modules comprising 16 serially connected individual cells was prepared at the experimental workshop at Risø DTU. The photoactive layer was prepared from several varieties of P3HT (Merck, Plextronics, BASF and Risø DTU) and two varieties of Zn......O (nanoparticulate, thin film) were employed as electron transport layers. The devices were all tested at Risø DTU and the functional devices were subjected to an inter-laboratory study involving the performance and the stability of modules over time in the dark, under light soaking and outdoor conditions. 24...

The Validation of NAA Method Used as Test Method in Serpong NAA Laboratory

International Nuclear Information System (INIS)

Rina-Mulyaningsih, Th.

2004-01-01

The Validation Of NAA Method Used As Test Method In Serpong NAA Laboratory. NAA Method is a non standard testing method. The testing laboratory shall validate its using method to ensure and confirm that it is suitable with application. The validation of NAA methods have been done with the parameters of accuracy, precision, repeatability and selectivity. The NIST 1573a Tomato Leaves, NIES 10C Rice flour unpolished and standard elements were used in this testing program. The result of testing with NIST 1573a showed that the elements of Na, Zn, Al and Mn are met from acceptance criteria of accuracy and precision, whereas Co is rejected. The result of testing with NIES 10C showed that Na and Zn elements are met from acceptance criteria of accuracy and precision, but Mn element is rejected. The result of selectivity test showed that the value of quantity is between 0.1-2.5 μg, depend on the elements. (author)

Blinding in randomized control trials: the enigma unraveled.

Directory of Open Access Journals (Sweden)

Vartika Saxena

2016-03-01

Full Text Available The search for new treatments and testing of new ideas begins in the laboratory and then established in clinical research settings. Studies addressing the same therapeutic problem may produce conflicting results hence Randomised Clinical Trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. The next challenge face by the medical community is the validity of such trials as theses tend to deviate from the truth because of various biases. For the avoidance of the same it has been suggested that the validity or quality of primary trials should be assessed under blind conditions. Thus blinding, is a crucial method for reducing bias in randomized clinical trials. Blinding can be defined as withholding information about the assigned interventions from people involved in the trial who may potentially be prejudiced by this knowledge. In this article we make an effort to define blinding, explain its chronology, hierarchy and discuss methods of blinding, its assessment, its possibility, un-blinding and finally the latest guidelines.

VALIDITY OF THE CONNECTION INTER-LEXICAL A-SEMANTICS IN THE COGNITIVE MODEL OF PROCESSING PRAXIS

Directory of Open Access Journals (Sweden)

P. G. Gómez

2011-07-01

Full Text Available Rothia Gonzalez et al. (1991, 1997 postulated a cognitive model of praxis on which changes were proposed (Cubelli et al., 2000, including the removal of the direct path between both input praxicon and output. Was suggested that to validate an inter-lexical a-semantics path (Cubelli et al., 2000 would enough to find a patientwith preserved ability for imitate familiar gestures, but with disturbances in the ability to access to the meaning of familiar gestures and alterations in ability for imitate unfamiliar gestures. The aim of this work is present two patients whose patterns ofperformance on praxis supports the existence of a pathway inter-lexical a-semantic. We evaluated two patients with Alzheimer type dementia unlikely with a battery of cognitive assessment of apraxia (Politis 2003. Both patients show alterations in test of Imitation of unfamiliar gestures and on tasks which assess semantic action objecttool watching and naming by function, with good performance on the task of imitating familiar gestures. Based on cognitive models of praxis Rothia Gonzalez et al. (1991, 1997 and Cubelli et al. (2000 is require a direct connection between both input praxicon and output to explain the performance of these patients. Of thus, the performance pattern showing both patients confirms existence of a pathway.Interlexical asemantics

Laboratory-scale trials of electrolytic treatment on industrial wastewaters: microbiological aspects.

Science.gov (United States)

Zanardini, E; Valle, A; Gigliotti, C; Papagno, G; Ranalli, G; Sorlini, C

2002-09-01

Animal, civil and industrial waste matter is a source of potential chemical, microbiological and air pollutants. In populated areas the presence of faecal bacteria and the production of malodorous compounds during waste storage and in the tanks of wastewater treatment plants, can cause concern. The general aim of the work was to study electrolytic waste treatment (recently applied on animal slurry) using low electric current across graphite and copper electrodes, determining its effect on the microflora of sludge, collected from the equalisation basin of an industrial aerobic wastewater treatment plant, and on odour emission abatement. Biochemical and enzymatic indicators like ATP content and a pool of 19 enzymatic activities were tested, comparing them with viable cell counts by traditional microbiological methods, to verify the validity of such indicators in monitoring the electrolytic treatment and to assess their correlation with odour reduction. The preliminary results of our laboratory-scale trials showed that in the presence of inert electrodes, such as graphite, metabolic activity is stimulated, whereas with copper electrodes the ATP content and some enzymatic activities are inhibited quite considerably after only four days, this being accompanied by a marked reduction in odour. Consideration was also given to the total copper released from the electrodes and its recovery using iron electrodes.

Evolution and validation of a personal form of an instrument for assessing science laboratory classroom environments

Science.gov (United States)

Fraser, Barry J.; Giddings, Geoffrey J.; McRobbie, Campbell J.

The research reported in this article makes two distinctive contributions to the field of classroom environment research. First, because existing instruments are unsuitable for science laboratory classes, the Science Laboratory Environment Inventory (SLEI) was developed and validated. Second, a new Personal form of the SLEI (involving a student's perceptions of his or her own role within the class) was developed and validated in conjunction with the conventional Class form (involving a student's perceptions of the class as a whole), and its usefulness was investigated. The instrument was cross-nationally fieldtested with 5,447 students in 269 senior high school and university classes in six countries, and cross-validated with 1,594 senior high school students in 92 classes in Australia. Each SLEI scale exhibited satisfactory internal consistency reliability, discriminant validity, and factorial validity, and differentiated between the perceptions of students in different classes. A variety of applications with the new instrument furnished evidence about its usefulness and revealed that science laboratory classes are dominated by closed-ended activities; mean scores obtained on the Class form were consistently somewhat more favorable than on the corresponding Personal form; females generally held more favorable perceptions than males, but these differences were somewhat larger for the Personal form than the Class form; associations existed between attitudinal outcomes and laboratory environment dimensions; and the Class and Personal forms of the SLEI each accounted for unique variance in student outcomes which was independent of that accounted for by the other form.

GC-MS determination of creatinine in human biological fluids as pentafluorobenzyl derivative in clinical studies and biomonitoring: Inter-laboratory comparison in urine with Jaffé, HPLC and enzymatic assays.

Science.gov (United States)

Tsikas, Dimitrios; Wolf, Alexander; Mitschke, Anja; Gutzki, Frank-Mathias; Will, Wolfgang; Bader, Michael

2010-10-01

In consideration of its relatively constant urinary excretion rate, creatinine in urine is a useful biochemical parameter to correct the urinary excretion rate of endogenous and exogenous biomolecules. Assays based on the reaction of creatinine and picric acid first reported by Jaffé in 1886 still belong to the most frequently used laboratory approaches for creatinine measurement in urine. Further analytical methods for creatinine include HPLC-UV, GC-MS, and LC-MS and LC-MS/MS approaches. In the present article we report on the development, validation and biomedical application of a new GC-MS method for the reliable quantitative determination of creatinine in human urine, plasma and serum. This method is based on the derivatization of creatinine (d(0)-Crea) and the internal standard [methyl-trideutero]creatinine (d(3)-Crea) with pentafluorobenzyl (PFB) bromide in the biological sample directly or after dilution with phosphate buffered saline, extraction of the reaction products with toluene and quantification in 1-μl aliquots of the toluene extract by selected-ion monitoring of m/z 112 for d(0)-Crea-PFB and m/z 115 for d(3)-Crea-PFB in the electron-capture negative-ion chemical ionization mode. The limit of detection of the method is 100 amol of creatinine. In an inter-laboratory study on urine samples from 100 healthy subjects, the GC-MS method was used to test the reliability of currently used Jaffé, enzymatic and HPLC assays in clinical and occupational studies. The results of the inter-laboratory study indicate that all three tested methods allow for satisfactory quantification of creatinine in human urine. The GC-MS method is suitable for use as a reference method for urinary creatinine in humans. In serum, creatine was found to contribute to creatinine up to 20% when measured by the present GC-MS method. The application of the GC-MS method can be extended to other biological samples such as saliva. Copyright © 2010 Elsevier B.V. All rights reserved.

Development of performance assessment instrument based contextual learning for measuring students laboratory skills

Science.gov (United States)

Susilaningsih, E.; Khotimah, K.; Nurhayati, S.

2018-04-01

The assessment of laboratory skill in general hasn’t specific guideline in assessment, while the individual assessment of students during a performance and skill in performing laboratory is still not been observed and measured properly. Alternative assessment that can be used to measure student laboratory skill is use performance assessment. The purpose of this study was to determine whether the performance assessment instrument that the result of research can be used to assess basic skills student laboratory. This research was conducted by the Research and Development. The result of the data analysis performance assessment instruments developed feasible to implement and validation result 62.5 with very good categories for observation sheets laboratory skills and all of the components with the very good category. The procedure is the preliminary stages of research and development stages. Preliminary stages are divided in two, namely the field studies and literature studies. The development stages are divided into several parts, namely 1) development of the type instrument, 2) validation by an expert, 3) a limited scale trial, 4) large-scale trials and 5) implementation of the product. The instrument included in the category of effective because 26 from 29 students have very high laboratory skill and high laboratory skill. The research of performance assessment instrument is standard and can be used to assess basic skill student laboratory.

Genetic structure and inter-generic relationship of closed colony of laboratory rodents based on RAPD markers.

Science.gov (United States)

Kumar, Mahadeo; Kumar, Sharad

2014-11-01

Molecular genetic analysis was performed using random amplified polymorphic DNA (RAPD) on three commonly used laboratory bred rodent genera viz. mouse (Mus musculus), rat (Rattus norvegicus) and guinea pig (Cavia porcellus) as sampled from the breeding colony maintained at the Animal Facility, CSIR-Indian Institute of Toxicology Research, Lucknow. In this study, 60 samples, 20 from each genus, were analyzed for evaluation of genetic structure of rodent stocks based on polymorphic bands using RAPD markers. Thirty five random primers were assessed for RAPD analysis. Out of 35, only 20 primers generated a total of 56.88% polymorphic bands among mice, rats and guinea pigs. The results revealed significantly variant and distinct fingerprint patterns specific to each of the genus. Within-genera analysis, the highest (89.0%) amount of genetic homogeneity was observed in mice samples and the least (79.3%) were observed in guinea pig samples. The amount of genetic homogeneity was observed very high within all genera. The average genetic diversity index observed was low (0.045) for mice and high (0.094) for guinea pigs. The inter-generic distances were maximum (0.8775) between mice and guinea pigs; and the minimum (0.5143) between rats and mice. The study proved that the RAPD markers are useful as genetic markers for assessment of genetic structure as well as inter-generic variability assessments.

Using pathology-specific laboratory profiles in Clinical Pathology to reduce inappropriate test requesting: two completed audit cycles

Science.gov (United States)

2012-01-01

Background Systematic reviews have shown that, although well prepared, the Consensus Guidelines have failed to change clinical practice. In the healthcare district of Castelnovo né Monti (Reggio Emilia, Italy), it became necessary for the GPs and Clinical Pathologists to work together to jointly define laboratory profiles. Methods Observational study with two cycles of retrospective audit on test request forms, in a primary care setting. Objectives of the study were to develop pathology-specific laboratory profiles and to increase the number of provisional diagnoses on laboratory test request forms. A Multiprofessional Multidisciplinary Inter-hospital Work Team developed pathology-specific laboratory profiles for more effective test requesting. After 8 training sessions that used a combined strategy with multifaceted interventions, the 23 General Practitioners (GPs) in the trial district (Castelnovo nè Monti) tested the profiles; the 21 GPs in the Puianello district were the control group; all GPs in both districts participated in the trial. All laboratory tests for both healthcare districts are performed at the Laboratory located in the trial district. A baseline and a 1-year audit were performed in both districts on the GPs’ request forms. Results Seven pathology-specific laboratory profiles for outpatients were developed. In the year after the first audit cycle: 1) the number of tests requested in the trial district was distinctly lower than that in the previous year, with a decrease of about 5% (p < 0.001); 2) the provisional diagnosis on the request forms was 52.8% in the trial district and 42% in the control district (P < 0.001); 3) the decrease of the number of tests on each request form was much more marked in the trial district (8.73 vs. 10.77; p < 0.001). Conclusions The first audit cycle showed a significant decrease in the number of tests ordered only in the trial district. The combined strategy used in this study improved the

Measuring the validity and reliability of the Apple Watch as a physical activity monitor.

Science.gov (United States)

Zhang, Peng; Godin, Steven D; Owens, Matthew V

2018-04-04

This study aimed to investigate the validity and reliability of the energy expenditure (EE) estimation of Apple Watch among college students. Thirty college students completed two sets of three 10-minute treadmill walking and running trials while wearing three Apple Watches and being connected to indirect calorimetry. The walking trials were at speeds of 54, 80, and 107 m•min-1 while the running trials were at 134, 161, 188m•min-1. Energy expenditure comparisons were made using Two-way ANOVA with repeatedmeasures. Reliability was analyzed by Intraclass Correlation. There was no significant device x speed interactions (F (15, 696) = 1.113, p = 0.341) between the indirect calorimetry (criterion) and Apple Watch. The lowest Inter-Class Correlation (ICC) scores were 0.49 (95%CI) at 54 while the highest were 0.72 (95%CI) at 107 and 134 m•min-1. Apple Watch demonstrated a low to moderate validity and reliability on measuring EE.

Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

Science.gov (United States)

Malmivaara, Antti

2016-09-01

Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

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

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

Validation of an analytical method for the determination of spiramycin, virginiamycin and tylosin in feeding-stuffs bij thin-layer chromatography and bio-autography

NARCIS (Netherlands)

Vincent, U.; Gizzi, G.; Holst, von C.; Jong, de J.; Michard, J.

2007-01-01

An inter-laboratory validation was carried out to determine the performance characteristics of an analytical method based on thin-layer chromatography (TLC) coupled to microbiological detection (bio-autography) for screening feed samples for the presence of spiramycin, tylosin and virginiamycin.

Does an inter-flaw length control the accuracy of rupture forecasting in geological materials?

Science.gov (United States)

Vasseur, Jérémie; Wadsworth, Fabian B.; Heap, Michael J.; Main, Ian G.; Lavallée, Yan; Dingwell, Donald B.

2017-10-01

Multi-scale failure of porous materials is an important phenomenon in nature and in material physics - from controlled laboratory tests to rockbursts, landslides, volcanic eruptions and earthquakes. A key unsolved research question is how to accurately forecast the time of system-sized catastrophic failure, based on observations of precursory events such as acoustic emissions (AE) in laboratory samples, or, on a larger scale, small earthquakes. Until now, the length scale associated with precursory events has not been well quantified, resulting in forecasting tools that are often unreliable. Here we test the hypothesis that the accuracy of the forecast failure time depends on the inter-flaw distance in the starting material. We use new experimental datasets for the deformation of porous materials to infer the critical crack length at failure from a static damage mechanics model. The style of acceleration of AE rate prior to failure, and the accuracy of forecast failure time, both depend on whether the cracks can span the inter-flaw length or not. A smooth inverse power-law acceleration of AE rate to failure, and an accurate forecast, occurs when the cracks are sufficiently long to bridge pore spaces. When this is not the case, the predicted failure time is much less accurate and failure is preceded by an exponential AE rate trend. Finally, we provide a quantitative and pragmatic correction for the systematic error in the forecast failure time, valid for structurally isotropic porous materials, which could be tested against larger-scale natural failure events, with suitable scaling for the relevant inter-flaw distances.

ADMS-AIRPORT: MODEL INTER-COMPARISIONS AND MODEL VALIDATION

OpenAIRE

Carruthers, David; McHugh, Christine; Church, Stephanie; Jackson, Mark; Williams, Matt; Price, Catheryn; Lad, Chetan

2008-01-01

Abstract: The functionality of ADMS-Airport and details of its use in the Model Inter-comparison Study of the Project for the Sustainable Development of Heathrow Airport (PSDH) have previously been presented, Carruthers et al (2007). A distinguishing feature is the treatment of jet engine emissions as moving jet sources rather than averaging these emissions into volume sources as is the case in some other models. In this presentation two further studies are presented which each contribu...

HEPA filter leaching concept validation trials at the Idaho Chemical Processing Plant

International Nuclear Information System (INIS)

Chakravartty, A.C.

1995-04-01

The enclosed report documents six New Waste Calcining Facility (NWCF) HEPA filter leaching trials conducted at the Idaho Chemical Processing Plant using a filter leaching system to validate the filter leaching treatment concept. The test results show that a modified filter leaching system will be able to successfully remove both hazardous and radiological constituents to RCRA disposal levels. Based on the success of the filter leach trials, the existing leaching system will be modified to provide a safe, simple, effective, and operationally flexible filter leaching system

A study on the effects of inter-organizational factors on the supply chain performance

Directory of Open Access Journals (Sweden)

Mohammad Mahdi Parhizgar

2012-10-01

Full Text Available In the current competitive environment, managers do their best to convert organizations under their supervision into competitive and responsive through creating capability of timely delivery of quality products and services. In the other word, they try to create value for their customers, which yield more profitability for stakeholders. In line with this, determining of inter-organizational factors and the relationships among these variables and supply chain performance plays an important role in achieving these objectives. The relationship modeling is a type of multiple criteria decision-making (MCDM problem, which requires applying experts to determine the relationships. The Decision Making Trial and Evaluation Laboratory (DEMATEL is an MCDM tool, which not only can convert the relationships among cause and effect criteria into a visual structural framework, but also it can be used as a technique to handle the inner dependences within a set of criteria. This paper proposes an effective solution based on DEMATEL approach to help managers evaluate the relationships between inter-organizational factors and supply chain performance.

Practical aspects during sterilization validation for medical devices at IRASM Microbiological Laboratory

International Nuclear Information System (INIS)

Trandafir, L.; Ene, M.; Alexandru, M.; Constantin, M.; Ionita, A.; Zorila, F.; Moise, I.V.

2011-01-01

Complete text of publication follows. The state of being free of living microorganisms is called sterility. The sterility state can be achieved by different means of sterilization. In practice the results of the process cannot be fully verified by tests, so the efficacy of the sterilization process must be validated. ISO 11137 established regulations for setting or substantiating the dose for achieving the desired sterility assurance level. The validation studies can be designed in particular for different types of product. Each product needs distinct protocol for bioburden determination and sterility testing. During time, the Microbiological Laboratories from Multipurpose Irradiation Center deals with different types of products, mainly for VD max 25 method. When it comes to microbiological evaluation the most challenging was cotton gauze. Special situation for establishing the sterilization validation method appears in cases of cotton, packed in large quantities. VD max 25 method can not be applied for items with average bioburden more than 1000 CFU / pack, no matter which is the weight of the package. This is a method limitation and implies increased costs for manufacturer, when choosing other method. For microbiological tests, culture condition should be selected in both cases the bioburden and sterility testing. These are time and money consuming. The costs can be reduced if taking into account some aspects. Reason for performing the bacteriostasis-fungistasis just for sterility testing will be given. The present study puts forward aspects during the validation studies for medical devices (cotton wool, cotton gauze, surgical sutures, dental screws), at IRASM Microbiological Laboratory.

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

Science.gov (United States)

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

2014-12-01

The OECD test guideline development program has been extended in 2011 to establish a partial life-cycle protocol for assessing the reproductive toxicity of chemicals to several mollusk species, including the great pond snail Lymnaea stagnalis. In this paper, we summarize the standard draft protocol for a reproduction test with this species, and present inter-comparison results obtained in a 56-day prevalidation ring-test using this protocol. Seven European laboratories performed semi-static tests with cultured snails of the strain Renilys® exposed to nominal concentrations of cadmium chloride (from 53 to 608μgCdL(-1)). Cd concentrations in test solutions were analytically determined to confirm accuracy in the metal exposure concentrations in all laboratories. Physico-chemical and biological validity criteria (namely dissolved oxygen content >60% ASV, water temperature 20±1°C, control snail survival >80% and control snail fecundity >8 egg-masses per snail over the test period) were met in all laboratories which consistently demonstrated the reproductive toxicity of Cd in snails using the proposed draft protocol. Effect concentrations for fecundity after 56days were reproducible between laboratories (68inter-laboratory reproducibility coefficient of variation (CV) for the Cd LC50-56d values was 8.19%. The inter-laboratory comparison of fecundity within the controls gave a CV of 29.12%, while exposure to Cd gave a CV of 25.49% based on the EC50-56d values. The OECD has acknowledged the success of this prevalidation exercise and a validation ring-test involving 14 laboratories in Europe, North- and South-America is currently being implemented using four chemicals (Cd, prochloraz, trenbolone

Effects of background noise on inter-trial phase coherence and auditory N1-P2 responses to speech stimuli.

Science.gov (United States)

Koerner, Tess K; Zhang, Yang

2015-10-01

This study investigated the effects of a speech-babble background noise on inter-trial phase coherence (ITPC, also referred to as phase locking value (PLV)) and auditory event-related responses (AERP) to speech sounds. Specifically, we analyzed EEG data from 11 normal hearing subjects to examine whether ITPC can predict noise-induced variations in the obligatory N1-P2 complex response. N1-P2 amplitude and latency data were obtained for the /bu/syllable in quiet and noise listening conditions. ITPC data in delta, theta, and alpha frequency bands were calculated for the N1-P2 responses in the two passive listening conditions. Consistent with previous studies, background noise produced significant amplitude reduction and latency increase in N1 and P2, which were accompanied by significant ITPC decreases in all the three frequency bands. Correlation analyses further revealed that variations in ITPC were able to predict the amplitude and latency variations in N1-P2. The results suggest that trial-by-trial analysis of cortical neural synchrony is a valuable tool in understanding the modulatory effects of background noise on AERP measures. Copyright © 2015 Elsevier B.V. All rights reserved.

Safety assessment of inter-channel / inter-system digital communications: A defensive measures approach

International Nuclear Information System (INIS)

Thuy, N. N. Q.

2006-01-01

Inappropriately designed inter-channel and inter-system digital communications could initiate common cause failure of multiple channels or multiple systems. Defensive measures were introduced in EPRI report TR-1002835 (Guideline for Performing Defense-in-Depth and Diversity Assessments for Digital Upgrades) to assess, on a deterministic basis, the susceptibility of digital systems architectures to common-cause failures. This paper suggests how this approach could be applied to assess inter-channel and inter-system digital communications from a safety standpoint. The first step of the approach is to systematically identify the so called 'influence factors' that one end of the data communication path can have on the other. Potential factors to be considered would typically include data values, data volumes and data rates. The second step of the approach is to characterize the ways possible failures of a given end of the communication path could affect these influence factors (e.g., incorrect data values, excessive data rates, time-outs, incorrect data volumes). The third step is to analyze the designed-in measures taken to guarantee independence of the other end. In addition to classical error detection and correction codes, typical defensive measures are one-way data communication, fixed-rate data communication, fixed-volume data communication, validation of data values. (authors)

Evaluation of different biomarkers to predict individual radiosensitivity in an inter-laboratory comparison--lessons for future studies.

Directory of Open Access Journals (Sweden)

Burkhard Greve

Full Text Available Radiotherapy is a powerful cure for several types of solid tumours, but its application is often limited because of severe side effects in individual patients. With the aim to find biomarkers capable of predicting normal tissue side reactions we analysed the radiation responses of cells from individual head and neck tumour and breast cancer patients of different clinical radiosensitivity in a multicentric study. Multiple parameters of cellular radiosensitivity were analysed in coded samples of peripheral blood lymphocytes (PBLs and derived lymphoblastoid cell lines (LCLs from 15 clinical radio-hypersensitive tumour patients and compared to age- and sex-matched non-radiosensitive patient controls and 15 lymphoblastoid cell lines from age- and sex- matched healthy controls of the KORA study. Experimental parameters included ionizing radiation (IR-induced cell death (AnnexinV, induction and repair of DNA strand breaks (Comet assay, induction of yH2AX foci (as a result of DNA double strand breaks, and whole genome expression analyses. Considerable inter-individual differences in IR-induced DNA strand breaks and their repair and/or cell death could be detected in primary and immortalised cells with the applied assays. The group of clinically radiosensitive patients was not unequivocally distinguishable from normal responding patients nor were individual overreacting patients in the test system unambiguously identified by two different laboratories. Thus, the in vitro test systems investigated here seem not to be appropriate for a general prediction of clinical reactions during or after radiotherapy due to the experimental variability compared to the small effect of radiation sensitivity. Genome-wide expression analysis however revealed a set of 67 marker genes which were differentially induced 6 h after in vitro-irradiation in lymphocytes from radio-hypersensitive and non-radiosensitive patients. These results warrant future validation in larger

Prevalence of diabetes treatment effect modifiers: the external validity of trials to older adults.

Science.gov (United States)

Weiss, Carlos O; Boyd, Cynthia M; Wolff, Jennifer L; Leff, Bruce

2012-08-01

Potential treatment effect modifiers (TEMs) are specific diseases or conditions with a well-described mechanism for treatment effect modification. The prevalence of TEMs in older adults with type 2 diabetes mellitus (DM) is unknown. Objectives were to 1) determine the prevalence of pre-specified potential TEMs; 2) demonstrate the potential impact of TEMs in the older adult population using a simulated trial; 3) identify TEM combinations associated with number of hospitalizations to test construct validity. Data are from the nationally-representative United States National Health and Examination Survey, 1999-2004: 8646 Civilian, non-institutionalized adults aged 45-64 or 65+ years, including 1443 with DM. TEMs were anemia, congestive heart failure, liver inflammation, polypharmacy, renal insufficiency, cognitive impairment, dizziness, frequent mental distress, mobility difficulty, and visual impairment. A trial was simulated to examine prevalence of potential TEM impact. The cross-sectional association between TEM patterns and number of hospitalizations was estimated to assess construct validity. The prevalence of TEMs was substantial such that 19.0% (95% CI 14.8-23.2) of middle-aged adults and 38.0% (95% CI 33.4-42.5) of older adults had any two. A simulated trial with modest levels of interaction suggested the prevalence of TEMs could nullify treatment benefit in 3.9-27.2% of older adults with DM. Compared to having DM alone, hospitalization rate was increased by several combinations of TEMs with substantial prevalence. We provide national benchmarks that can be used to evaluate TEM prevalence reported by clinical trials of DM, and correspondingly their external validity to older adults.

Impact of botanical extracts derived from Melia azedarach and Azadirachta indica on populations of Plutella xylostella and its natural enemies: A field test of laboratory findings

NARCIS (Netherlands)

Charleston, D.S.; Kfir, R.; Dicke, M.; Vet, L.E.M.

2006-01-01

Differences between results from ecological laboratory studies and what actually happens in the field can be large. Therefore, field experiments are essential to validate laboratory findings. In previous laboratory trials we investigated the impact of aqueous leaf extracts from the syringa tree,

Impact of botanical extracts derived from Melia azedarach and Azadirachta indica on populations of Plutella xylostella and its natural enemies: a field test of laboratory findings

NARCIS (Netherlands)

Charleston, D.S.; Kfir, R.; Dicke, M.; Vet, L.E.M.

2006-01-01

Differences between results from ecological laboratory studies and what actually happens in the field can be large. Therefore, field experiments are essential to validate laboratory findings. In previous laboratory trials we investigated the impact of aqueous leaf extracts from the syringa tree,

[Statistical approach to evaluate the occurrence of out-of acceptable ranges and accuracy for antimicrobial susceptibility tests in inter-laboratory quality control program].

Science.gov (United States)

Ueno, Tamio; Matuda, Junichi; Yamane, Nobuhisa

2013-03-01

To evaluate the occurrence of out-of acceptable ranges and accuracy of antimicrobial susceptibility tests, we applied a new statistical tool to the Inter-Laboratory Quality Control Program established by the Kyushu Quality Control Research Group. First, we defined acceptable ranges of minimum inhibitory concentration (MIC) for broth microdilution tests and inhibitory zone diameter for disk diffusion tests on the basis of Clinical and Laboratory Standards Institute (CLSI) M100-S21. In the analysis, more than two out-of acceptable range results in the 20 tests were considered as not allowable according to the CLSI document. Of the 90 participating laboratories, 46 (51%) experienced one or more occurrences of out-of acceptable range results. Then, a binomial test was applied to each participating laboratory. The results indicated that the occurrences of out-of acceptable range results in the 11 laboratories were significantly higher when compared to the CLSI recommendation (allowable rate laboratory was statistically compared with zero using a Student's t-test. The results revealed that 5 of the 11 above laboratories reported erroneous test results that systematically drifted to the side of resistance. In conclusion, our statistical approach has enabled us to detect significantly higher occurrences and source of interpretive errors in antimicrobial susceptibility tests; therefore, this approach can provide us with additional information that can improve the accuracy of the test results in clinical microbiology laboratories.

REIMEP-22 U age dating - Determination of the production date of a uranium certified test sample Inter-laboratory comparison, Report to participants

OpenAIRE

VENCHIARUTTI CELIA; VARGA ZSOLT; RICHTER Stephan; NICHOLL Adrian; KRAJKO JUDIT; JAKOPIC Rozle; MAYER Klaus; AREGBE Yetunde

2015-01-01

The REIMEP-22 inter-laboratory comparison (ILC) "U Age Dating - Determination of the production date of a uranium certified test sample" was organised by JRC-IRMM as support to the Nuclear Forensics International Technical Working Group (ITWG) This ILC was organised prior to the release of the candidate certified reference material IRMM-1000, produced in cooperation with JRC-ITU. The aim of REIMEP-22 was to determine the production date of the uranium certified test sample (i.e. the last chem...

Mixing Methods in Randomized Controlled Trials (RCTs): Validation, Contextualization, Triangulation, and Control

Science.gov (United States)

Spillane, James P.; Pareja, Amber Stitziel; Dorner, Lisa; Barnes, Carol; May, Henry; Huff, Jason; Camburn, Eric

2010-01-01

In this paper we described how we mixed research approaches in a Randomized Control Trial (RCT) of a school principal professional development program. Using examples from our study we illustrate how combining qualitative and quantitative data can address some key challenges from validating instruments and measures of mediator variables to…

33 CFR 209.340 - Laboratory investigations and materials testing.

Science.gov (United States)

2010-07-01

... hydraulic laboratories, and to the Inter-Agency Sedimentation Project. (c) References. (1) AR 37-20. (2) AR... ordinary business channels. (3) Performance of the work will not interfere with provisions of services... with the same procedures as apply to Division Materials Laboratories. (3) Inter-Agency Sedimentation...

Biochar: from laboratory mechanisms through the greenhouse to field trials

Science.gov (United States)

Masiello, C. A.; Gao, X.; Dugan, B.; Silberg, J. J.; Zygourakis, K.; Alvarez, P. J. J.

2014-12-01

The biochar community is excellent at pointing to individual cases where biochar amendment has changed soil properties, with some studies showing significant improvements in crop yields, reduction in nutrient export, and remediation of pollutants. However, many studies exist which do not show improvements, and in some cases, studies clearly show detrimental outcomes. The next, crucial step in biochar science and engineering research will be to develop a process-based understanding of how biochar acts to improve soil properties. In particular, we need a better mechanistic understanding of how biochar sorbs and desorbs contaminants, how it interacts with soil water, and how it interacts with the soil microbial community. These mechanistic studies need to encompass processes that range from the nanometer to the kilometer scale. At the nanometer scale, we need a predictive model of how biochar will sorb and desorb hydrocarbons, nutrients, and toxic metals. At the micrometer scale we need models that explain biochar's effects on soil water, especially the plant-available fraction of soil water. The micrometer scale is also where mechanistic information is neeed about microbial processes. At the macroscale we need physical models to describe the landscape mobility of biochar, because biochar that washes away from fields can no longer provide crop benefits. To be most informative, biochar research should occur along a lab-greenhouse-field trial trajectory. Laboratory experiments should aim determine what mechanisms may act to control biochar-soil processes, and then greenhouse experiments can be used to test the significance of lab-derived mechanisms in short, highly replicated, controlled experiments. Once evidence of effect is determined from greenhouse experiments, field trials are merited. Field trials are the gold standard needed prior to full deployment, but results from field trials cannot be extrapolated to other field sites without the mechanistic backup provided

Development of an in vitro skin sensitization test using human cell lines; human Cell Line Activation Test (h-CLAT). II. An inter-laboratory study of the h-CLAT.

Science.gov (United States)

Sakaguchi, H; Ashikaga, T; Miyazawa, M; Yoshida, Y; Ito, Y; Yoneyama, K; Hirota, M; Itagaki, H; Toyoda, H; Suzuki, H

2006-08-01

Recent regulatory changes have placed a major emphasis on in vitro safety testing and alternative models. In regard to skin sensitization tests, dendritic cells (DCs) derived from human peripheral blood have been considered in the development of new in vitro alternatives. Human cell lines have been also reported recently. In our previous study, we suggested that measuring CD86 and/or CD54 expression on THP-1 cells (human monocytic leukemia cell line) could be used as an in vitro skin sensitization method. An inter-laboratory study among two laboratories was undertaken in Japan in order to further develop an in vitro skin sensitization model. In the present study, we used two human cell lines: THP-1 and U-937 (human histiocytic lymphoma cell line). First we optimized our test protocol (refer to the related paper entitled "optimization of the h-CLAT protocol" within this journal) and then we did an inter-laboratory validation with nine chemicals using the optimized protocol. We measured the expression of CD86 and CD54 on the above cells using flow cytometry after a 24h and 48h exposure to six known allergens (e.g., DNCB, pPD, NiSO(4)) and three non-allergens (e.g., SLS, tween 80). For the sample test concentration, four doses (0.1x, 0.5x, 1x, and 2x of the 50% inhibitory concentration (IC(50))) were evaluated. IC(50) was calculated using MTT assay. We found that allergens/non-allergens were better predicted using THP-1 cells compared to U-937 cells following a 24 h and a 48 h exposure. We also found that the 24h treatment time tended to have a better accuracy than the 48 h treatment time for THP-1 cells. Expression of CD86 and CD54 were good predictive markers for THP-1 cells, but for U-937 cells, expression of CD86 was a better predictor than CD54, at the 24h and the 48 h treatment time. The accuracy also improved when both markers (CD86 and CD54) were used as compared with a single marker for THP-1 cells. Both laboratories gave a good prediction of allergen

Biological dosimetry by the triage dicentric chromosome assay - Further validation of international networking

Energy Technology Data Exchange (ETDEWEB)

Wilkins, Ruth C., E-mail: Ruth.Wilkins@hc-sc.gc.ca [Health Canada, Ottawa, ON K1A 0K9 (Canada); Romm, Horst; Oestreicher, Ursula [Bundesamt fur Strahlenschutz, 38226 Salzgitter (Germany); Marro, Leonora [Health Canada, Ottawa, ON K1A 0K9 (Canada); Yoshida, Mitsuaki A. [Biological Dosimetry Section, Dept. of Dose Assessment, Research Center for Radiation Emergency Medicine, NIRS, 4-9-1 Anagawa, Inage-ku, Chiba 263-8555 (Japan); Department Radiation Biology, Institute of Radiation Emergency Medicine, Hirosaki University Graduate School of Health Sciences, 66-1 Hon-cho, Hirosaki, Aomori 036-8564 (Japan); Suto, Y. [Biological Dosimetry Section, Dept. of Dose Assessment, Research Center for Radiation Emergency Medicine, NIRS, 4-9-1 Anagawa, Inage-ku, Chiba 263-8555 (Japan); Prasanna, Pataje G.S. [National Cancer Institute, Division of Cancer Treatment and Diagnosis, Radiation Research Program, 6130 Executive Blvd., MSC 7440, Bethesda, MD 20892-7440 (United States)

2011-09-15

Biological dosimetry is an essential tool for estimating radiation doses received to personnel when physical dosimetry is not available or inadequate. The current preferred biodosimetry method is based on the measurement of radiation-specific dicentric chromosomes in exposed individuals' peripheral blood lymphocytes. However, this method is labor-, time- and expertise-demanding. Consequently, for mass casualty applications, strategies have been developed to increase its throughput. One such strategy is to develop validated cytogenetic biodosimetry laboratory networks, both national and international. In a previous study, the dicentric chromosome assay (DCA) was validated in our cytogenetic biodosimetry network involving five geographically dispersed laboratories. A complementary strategy to further enhance the throughput of the DCA among inter-laboratory networks is to use a triage DCA where dose assessments are made by truncating the labor-demanding and time-consuming metaphase spread analysis to 20 - 50 metaphase spreads instead of routine 500 - 1000 metaphase spread analysis. Our laboratory network also validated this triage DCA, however, these dose estimates were made using calibration curves generated in each laboratory from the blood samples irradiated in a single laboratory. In an emergency situation, dose estimates made using pre-existing calibration curves which may vary according to radiation type and dose rate and therefore influence the assessed dose. Here, we analyze the effect of using a pre-existing calibration curve on assessed dose among our network laboratories. The dose estimates were made by analyzing 1000 metaphase spreads as well as triage quality scoring and compared to actual physical doses applied to the samples for validation. The dose estimates in the laboratory partners were in good agreement with the applied physical doses and determined to be adequate for guidance in the treatment of acute radiation syndrome.

An RF power amplifier with inter-metal-shuffled capacitor for inter-stage matching in a digital CMOS process

Energy Technology Data Exchange (ETDEWEB)

Feng Xiaoxing; Zhang Xing; Ge Binjie; Wang Xin' an, E-mail: wangxa@szpku.edu.c [Key Laboratory of Integrated Microsystems, Shenzhen Graduate School of Peking University, Shenzhen 518055 (China)

2009-06-01

One challenge of the implementation of fully-integrated RF power amplifiers into a deep submicro digital CMOS process is that no capacitor is available, especially no high density capacitor. To address this problem, a two-stage class-AB power amplifier with inter-stage matching realized by an inter-metal coupling capacitor is designed in a 180-nm digital CMOS process. This paper compares three structures of inter-metal coupling capacitors with metal-insulator-metal (MIM) capacitor regarding their capacitor density. Detailed simulations are carried out for the leakage, the voltage dependency, the temperature dependency, and the quality factor between an inter-metal shuffled (IMS) capacitor and an MIM capacitor. Finally, an IMS capacitor is chosen to perform the inter-stage matching. The techniques are validated via the design and implement of a two-stage class-AB RF power amplifier for an UHF RFID application. The PA occupies 370 x 200 mum{sup 2} without pads in the 180-nm digital CMOS process and outputs 21.1 dBm with 40% drain efficiency and 28.1 dB power gain at 915 MHz from a single 3.3 V power supply.

An RF power amplifier with inter-metal-shuffled capacitor for inter-stage matching in a digital CMOS process

International Nuclear Information System (INIS)

Feng Xiaoxing; Zhang Xing; Ge Binjie; Wang Xin'an

2009-01-01

One challenge of the implementation of fully-integrated RF power amplifiers into a deep submicro digital CMOS process is that no capacitor is available, especially no high density capacitor. To address this problem, a two-stage class-AB power amplifier with inter-stage matching realized by an inter-metal coupling capacitor is designed in a 180-nm digital CMOS process. This paper compares three structures of inter-metal coupling capacitors with metal-insulator-metal (MIM) capacitor regarding their capacitor density. Detailed simulations are carried out for the leakage, the voltage dependency, the temperature dependency, and the quality factor between an inter-metal shuffled (IMS) capacitor and an MIM capacitor. Finally, an IMS capacitor is chosen to perform the inter-stage matching. The techniques are validated via the design and implement of a two-stage class-AB RF power amplifier for an UHF RFID application. The PA occupies 370 x 200 μm 2 without pads in the 180-nm digital CMOS process and outputs 21.1 dBm with 40% drain efficiency and 28.1 dB power gain at 915 MHz from a single 3.3 V power supply.

Validation of a same-day real-time PCR method for screening of meat and carcass swabs for Salmonella

Science.gov (United States)

2009-01-01

Background One of the major sources of human Salmonella infections is meat. Therefore, efficient and rapid monitoring of Salmonella in the meat production chain is necessary. Validation of alternative methods is needed to prove that the performance is equal to established methods. Very few of the published PCR methods for Salmonella have been validated in collaborative studies. This study describes a validation including comparative and collaborative trials, based on the recommendations from the Nordic organization for validation of alternative microbiological methods (NordVal) of a same-day, non-commercial real-time PCR method for detection of Salmonella in meat and carcass swabs. Results The comparative trial was performed against a reference method (NMKL-71:5, 1999) using artificially and naturally contaminated samples (60 minced veal and pork meat samples, 60 poultry neck-skins, and 120 pig carcass swabs). The relative accuracy was 99%, relative detection level 100%, relative sensitivity 103% and relative specificity 100%. The collaborative trial included six laboratories testing minced meat, poultry neck-skins, and carcass swabs as un-inoculated samples and samples artificially contaminated with 1–10 CFU/25 g, and 10–100 CFU/25 g. Valid results were obtained from five of the laboratories and used for the statistical analysis. Apart from one of the non-inoculated samples being false positive with PCR for one of the laboratories, no false positive or false negative results were reported. Partly based on results obtained in this study, the method has obtained NordVal approval for analysis of Salmonella in meat and carcass swabs. The PCR method was transferred to a production laboratory and the performance was compared with the BAX Salmonella test on 39 pork samples artificially contaminated with Salmonella. There was no significant difference in the results obtained by the two methods. Conclusion The real-time PCR method for detection of Salmonella in meat

Preliminary Validation and Reliability Testing of the Montreal Instrument for Cat Arthritis Testing, for Use by Veterinarians, in a Colony of Laboratory Cats

Science.gov (United States)

Klinck, Mary P.; Rialland, Pascale; Guillot, Martin; Moreau, Maxim; Frank, Diane; Troncy, Eric

2015-01-01

Simple Summary Feline osteoarthritis (OA) is challenging to diagnose. A pain scale was developed for use by veterinarians, in association with their physical examination, and tested for reliability and validity. The scale items were: Interaction with the examiner, Exploration of the room, Body Posture, Gait, Body Condition, condition of Coat and Claws, and abnormal Findings or Cat Reaction upon joint Palpation. Expert review supported the scale content. Two studies using laboratory-housed cats found the most promising results for Gait and Body Posture, in terms of distinguishing between OA and non-OA cats, repeatability of results, and correlations with objectively measured kinetics (weight-bearing). Abstract Subtle signs and conflicting physical and radiographic findings make feline osteoarthritis (OA) challenging to diagnose. A physical examination-based assessment was developed, consisting of eight items: Interaction, Exploration, Posture, Gait, Body Condition, Coat and Claws, (joint) Palpation–Findings, and Palpation–Cat Reaction. Content (experts) and face (veterinary students) validity were excellent. Construct validity, internal consistency, and intra- and inter-rater reliability were assessed via a pilot and main study, using laboratory-housed cats with and without OA. Gait distinguished OA status in the pilot (p = 0.05) study. In the main study, no scale item achieved statistically significant OA detection. Forelimb peak vertical ground reaction force (PVF) correlated inversely with Gait (Rhos = −0.38 (p = 0.03) to −0.41 (p = 0.02)). Body Posture correlated with Gait, and inversely with forelimb PVF at two of three time points (Rhos = −0.38 (p = 0.03) to −0.43 (p = 0.01)). Palpation (Findings, Cat Reaction) did not distinguish OA from non-OA cats. Palpation—Cat Reaction (Forelimbs) correlated inversely with forelimb PVF at two time points (Rhos = −0.41 (p = 0.02) to −0.41 (p = 0.01)), but scores were highly variable, and poorly reliable

Experience of an inter-laboratory exercise for the determination of Carbon-14 in biological samples

International Nuclear Information System (INIS)

Baburajan, A.; Rajaram, S.; D'Souza, Renita Shiny; Nayak, Rasmi; Karunakara, N.; Ravi, P.M.; Tripathi, R.M.

2018-01-01

Carbon-14 is one of the naturally occurring cosmogenic nuclide with long half life of 5730 y and beta energy, E max : 156 keV produced continuously in the outer atmosphere. It is also produced by the anthropogenic activities like nuclear weapon test, nuclear power plant etc. contributing to the atmospheric inventory. The 14 CO 2 gets incorporated with the plant species during photosynthesis and ultimately reaches to man through food chain. It is important to accurately quantify the level of 14 C in different biological matrices for the computation of radiation dose due to ingestion. There are different methods available for the determination of 14 C in biological samples. The oxidation of the dried sample is one of the methods used for liberating the 14 CO 2 and which in turn re-absorbed using Carbo Sorb and subjected to Liquid scintillation analyses with Permaflour scintillator solution. The paper deals with the quality assurance programme initiated by ESL, Tarapur along with ESL, Kalpakkam and CARER, Mangalore University and share the experience of the inter-laboratory comparison exercise

Cardiac valve calcifications on low-dose unenhanced ungated chest computed tomography: inter-observer and inter-examination reliability, agreement and variability

International Nuclear Information System (INIS)

Hamersvelt, Robbert W. van; Willemink, Martin J.; Takx, Richard A.P.; Eikendal, Anouk L.M.; Budde, Ricardo P.J.; Leiner, Tim; Jong, Pim A. de; Mol, Christian P.; Isgum, Ivana

2014-01-01

To determine inter-observer and inter-examination variability for aortic valve calcification (AVC) and mitral valve and annulus calcification (MC) in low-dose unenhanced ungated lung cancer screening chest computed tomography (CT). We included 578 lung cancer screening trial participants who were examined by CT twice within 3 months to follow indeterminate pulmonary nodules. On these CTs, AVC and MC were measured in cubic millimetres. One hundred CTs were examined by five observers to determine the inter-observer variability. Reliability was assessed by kappa statistics (κ) and intra-class correlation coefficients (ICCs). Variability was expressed as the mean difference ± standard deviation (SD). Inter-examination reliability was excellent for AVC (κ = 0.94, ICC = 0.96) and MC (κ = 0.95, ICC = 0.90). Inter-examination variability was 12.7 ± 118.2 mm 3 for AVC and 31.5 ± 219.2 mm 3 for MC. Inter-observer reliability ranged from κ = 0.68 to κ = 0.92 for AVC and from κ = 0.20 to κ = 0.66 for MC. Inter-observer ICC was 0.94 for AVC and ranged from 0.56 to 0.97 for MC. Inter-observer variability ranged from -30.5 ± 252.0 mm 3 to 84.0 ± 240.5 mm 3 for AVC and from -95.2 ± 210.0 mm 3 to 303.7 ± 501.6 mm 3 for MC. AVC can be quantified with excellent reliability on ungated unenhanced low-dose chest CT, but manual detection of MC can be subject to substantial inter-observer variability. Lung cancer screening CT may be used for detection and quantification of cardiac valve calcifications. (orig.)

Selection criteria limit generalizability of smoking pharmacotherapy studies differentially across clinical trials and laboratory studies: A systematic review on varenicline.

Science.gov (United States)

Motschman, Courtney A; Gass, Julie C; Wray, Jennifer M; Germeroth, Lisa J; Schlienz, Nicolas J; Munoz, Diana A; Moore, Faith E; Rhodes, Jessica D; Hawk, Larry W; Tiffany, Stephen T

2016-12-01

The selection criteria used in clinical trials for smoking cessation and in laboratory studies that seek to understand mechanisms responsible for treatment outcomes may limit their generalizability to one another and to the general population. We reviewed studies on varenicline versus placebo and compared eligibility criteria and participant characteristics of clinical trials (N=23) and laboratory studies (N=22) across study type and to nationally representative survey data on adult, daily USA smokers (2014 National Health Interview Survey; 2014 National Survey on Drug Use and Health). Relative to laboratory studies, clinical trials more commonly reported excluding smokers who were unmotivated to quit and for specific medical conditions (e.g., cardiovascular disease, COPD), although both study types frequently reported excluding for general medical or psychiatric reasons. Laboratory versus clinical samples smoked less, had lower nicotine dependence, were younger, and more homogeneous with respect to smoking level and nicotine dependence. Application of common eligibility criteria to national survey data resulted in considerable elimination of the daily-smoking population for both clinical trials (≥47%) and laboratory studies (≥39%). Relative to the target population, studies in this review recruited participants who smoked considerably more and had a later smoking onset age, and were under-representative of Caucasians. Results suggest that selection criteria of varenicline studies limit generalizability in meaningful ways, and differences in criteria across study type may undermine efforts at translational research. Recommendations for improvements in participant selection and reporting standards are discussed. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Validation of a basic neurosonology laboratory for detecting cervical carotid artery stenosis.

Science.gov (United States)

de la Cruz Cosme, C; Dawid Milner, M S; Ojeda Burgos, G; Gallardo Tur, A; Márquez Martínez, M; Segura, T

2017-03-24

Most of the cases of ischaemic stroke in our setting are of atherothrombotic origin. Detecting intracranial and cervical carotid artery stenosis in patients with ischaemic stroke is therefore essential. Ultrasonography has become the tool of choice for diagnosing carotid artery stenosis because it is both readily accessibility and reliable. However, use of this technique must be validated in each laboratory. The purpose of this study is to validate Doppler ultrasound in our laboratory as a means of detecting severe carotid artery stenosis. We conducted an observational descriptive study to evaluate diagnostic tests. The results from transcranial and cervical carotid Doppler ultrasound scans conducted by neurologists were compared to those from carotid duplex scans performed by radiologists in patients diagnosed with stroke. Arteriography was considered the gold standard (MR angiography, CT angiography, or conventional arteriography). Our sample included 228 patients. Transcranial and cervical carotid Doppler ultrasound showed a sensitivity of 95% and specificity of 100% for detection of carotid artery stenosis > 70%, whereas carotid duplex displayed a sensitivity of 87% and a specificity of 94%. Transcranial carotid Doppler ultrasound achieved a sensitivity of 78% and a specificity of 98% for detection of intracranial stenosis. Doppler ultrasound in our neurosonology laboratory was found to be a useful diagnostic tool for detecting cervical carotid artery stenosis and demonstrated superiority to carotid duplex despite the lack of B-mode. Furthermore, this technique was found to be useful for detecting intracranial stenosis. Copyright © 2017 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Assessing validity of observational intervention studies – the Benchmarking Controlled Trials

Science.gov (United States)

Malmivaara, Antti

2016-01-01

Abstract Background: Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. Aims: To create and pilot test a checklist for appraising methodological validity of a BCT. Methods: The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. Results: The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. Conclusions: The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies.Key messagesBenchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. PMID:27238631

Validation of the OECD reproduction test guideline with the New Zealand mudsnail Potamopyrgus antipodarum using trenbolone and prochloraz.

Science.gov (United States)

Geiß, Cornelia; Ruppert, Katharina; Askem, Clare; Barroso, Carlos; Faber, Daniel; Ducrot, Virginie; Holbech, Henrik; Hutchinson, Thomas H; Kajankari, Paula; Kinnberg, Karin Lund; Lagadic, Laurent; Matthiessen, Peter; Morris, Steve; Neiman, Maurine; Penttinen, Olli-Pekka; Sanchez-Marin, Paula; Teigeler, Matthias; Weltje, Lennart; Oehlmann, Jörg

2017-04-01

The Organisation for Economic Cooperation and Development (OECD) provides several standard test methods for the environmental hazard assessment of chemicals, mainly based on primary producers, arthropods, and fish. In April 2016, two new test guidelines with two mollusc species representing different reproductive strategies were approved by OECD member countries. One test guideline describes a 28-day reproduction test with the parthenogenetic New Zealand mudsnail Potamopyrgus antipodarum. The main endpoint of the test is reproduction, reflected by the embryo number in the brood pouch per female. The development of a new OECD test guideline involves several phases including inter-laboratory validation studies to demonstrate the robustness of the proposed test design and the reproducibility of the test results. Therefore, a ring test of the reproduction test with P. antipodarum was conducted including eight laboratories with the test substances trenbolone and prochloraz and results are presented here. Most laboratories could meet test validity criteria, thus demonstrating the robustness of the proposed test protocol. Trenbolone did not have an effect on the reproduction of the snails at the tested concentration range (nominal: 10-1000 ng/L). For prochloraz, laboratories produced similar EC 10 and NOEC values, showing the inter-laboratory reproducibility of results. The average EC 10 and NOEC values for reproduction (with coefficient of variation) were 26.2 µg/L (61.7%) and 29.7 µg/L (32.9%), respectively. This ring test shows that the mudsnail reproduction test is a well-suited tool for use in the chronic aquatic hazard and risk assessment of chemicals.

External validation of a decision tree early warning score using only laboratory data

DEFF Research Database (Denmark)

Holm Atkins, Tara E; Öhman, Malin C; Brabrand, Mikkel

2018-01-01

INTRODUCTION: Early warning scores (EWS) have been developed to identify the degree of illness severity among acutely ill patients. One system, The Laboratory Decision Tree Early Warning Score (LDT-EWS) is wholly laboratory data based. Laboratory data was used in the development of a rare...... computerized method, developing a decision tree analysis. This article externally validates LDT-EWS, which is obligatory for an EWS before clinical use. METHOD: We conducted a retrospective review of prospectively collected data based on a time limited sample of all patients admitted through the medical......) and calibration (precision) as Hosmer-Lemeshow Goodness of fit test. RESULTS: A total of 5858 patients were admitted and 4902 included (83.7%). In-hospital mortality in our final dataset (n=4902) was 3.5%. Discriminatory power (95% CI), identifying in-hospital death was 0.809 (0.777-0.842). Calibration was good...

Reliability and validity of the Wolfram Unified Rating Scale (WURS

Directory of Open Access Journals (Sweden)

Nguyen Chau

2012-11-01

Full Text Available Abstract Background Wolfram syndrome (WFS is a rare, neurodegenerative disease that typically presents with childhood onset insulin dependent diabetes mellitus, followed by optic atrophy, diabetes insipidus, deafness, and neurological and psychiatric dysfunction. There is no cure for the disease, but recent advances in research have improved understanding of the disease course. Measuring disease severity and progression with reliable and validated tools is a prerequisite for clinical trials of any new intervention for neurodegenerative conditions. To this end, we developed the Wolfram Unified Rating Scale (WURS to measure the severity and individual variability of WFS symptoms. The aim of this study is to develop and test the reliability and validity of the Wolfram Unified Rating Scale (WURS. Methods A rating scale of disease severity in WFS was developed by modifying a standardized assessment for another neurodegenerative condition (Batten disease. WFS experts scored the representativeness of WURS items for the disease. The WURS was administered to 13 individuals with WFS (6-25 years of age. Motor, balance, mood and quality of life were also evaluated with standard instruments. Inter-rater reliability, internal consistency reliability, concurrent, predictive and content validity of the WURS were calculated. Results The WURS had high inter-rater reliability (ICCs>.93, moderate to high internal consistency reliability (Cronbach’s α = 0.78-0.91 and demonstrated good concurrent and predictive validity. There were significant correlations between the WURS Physical Assessment and motor and balance tests (rs>.67, ps>.76, ps=-.86, p=.001. The WURS demonstrated acceptable content validity (Scale-Content Validity Index=0.83. Conclusions These preliminary findings demonstrate that the WURS has acceptable reliability and validity and captures individual differences in disease severity in children and young adults with WFS.

Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study

Science.gov (United States)

2012-01-01

Background A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. Methods Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. Results The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. Conclusion Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity. PMID:22510227

Development of health inter-professional telemedicine practice through simulation scenario training with students of physiotherapy-, occupational therapy-, medical laboratory technology, and nursing education

DEFF Research Database (Denmark)

Nortvig, Anne-Mette; Vestergaard, Kitt

. Aims: The purpose of the project was • to develop practice oriented competences related to telemedicine in an inter-professional and a cross-sectoral context among health professional students of physiotherapy-, occupational therapy-, medical laboratory technology-, and nursing education. • to motivate...... and retain male students by the use of simulation training that involves technology. Methodology: The project was settled as a cross-professional telemedicine course on health educations. Nursing students (N=20) and physiotherapy students (N=34) participated actively and the scenarios were filmed and enacted...

Preliminary Validation and Reliability Testing of the Montreal Instrument for Cat Arthritis Testing, for Use by Veterinarians, in a Colony of Laboratory Cats

Directory of Open Access Journals (Sweden)

Mary P. Klinck

2015-12-01

Full Text Available Subtle signs and conflicting physical and radiographic findings make feline osteoarthritis (OA challenging to diagnose. A physical examination-based assessment was developed, consisting of eight items: Interaction, Exploration, Posture, Gait, Body Condition, Coat and Claws, (joint Palpation–Findings, and Palpation–Cat Reaction. Content (experts and face (veterinary students validity were excellent. Construct validity, internal consistency, and intra- and inter-rater reliability were assessed via a pilot and main study, using laboratory-housed cats with and without OA. Gait distinguished OA status in the pilot ( p = 0.05 study. In the main study, no scale item achieved statistically significant OA detection. Forelimb peak vertical ground reaction force (PVF correlated inversely with Gait (Rho s = −0.38 ( p = 0.03 to −0.41 ( p = 0.02. Body Posture correlated with Gait, and inversely with forelimb PVF at two of three time points (Rho s = −0.38 ( p = 0.03 to −0.43 ( p = 0.01. Palpation (Findings, Cat Reaction did not distinguish OA from non-OA cats. Palpation—Cat Reaction (Forelimbs correlated inversely with forelimb PVF at two time points (Rho s = −0.41 ( p = 0.02 to −0.41 ( p = 0.01, but scores were highly variable, and poorly reliable. Gait and Posture require improved sensitivity, and Palpation should be interpreted cautiously, in diagnosing feline OA.

Cardiac valve calcifications on low-dose unenhanced ungated chest computed tomography: inter-observer and inter-examination reliability, agreement and variability

Energy Technology Data Exchange (ETDEWEB)

Hamersvelt, Robbert W. van; Willemink, Martin J.; Takx, Richard A.P.; Eikendal, Anouk L.M.; Budde, Ricardo P.J.; Leiner, Tim; Jong, Pim A. de [University Medical Center Utrecht, Department of Radiology, Utrecht (Netherlands); Mol, Christian P.; Isgum, Ivana [University Medical Center Utrecht, Image Sciences Institute, Utrecht (Netherlands)

2014-07-15

To determine inter-observer and inter-examination variability for aortic valve calcification (AVC) and mitral valve and annulus calcification (MC) in low-dose unenhanced ungated lung cancer screening chest computed tomography (CT). We included 578 lung cancer screening trial participants who were examined by CT twice within 3 months to follow indeterminate pulmonary nodules. On these CTs, AVC and MC were measured in cubic millimetres. One hundred CTs were examined by five observers to determine the inter-observer variability. Reliability was assessed by kappa statistics (κ) and intra-class correlation coefficients (ICCs). Variability was expressed as the mean difference ± standard deviation (SD). Inter-examination reliability was excellent for AVC (κ = 0.94, ICC = 0.96) and MC (κ = 0.95, ICC = 0.90). Inter-examination variability was 12.7 ± 118.2 mm{sup 3} for AVC and 31.5 ± 219.2 mm{sup 3} for MC. Inter-observer reliability ranged from κ = 0.68 to κ = 0.92 for AVC and from κ = 0.20 to κ = 0.66 for MC. Inter-observer ICC was 0.94 for AVC and ranged from 0.56 to 0.97 for MC. Inter-observer variability ranged from -30.5 ± 252.0 mm{sup 3} to 84.0 ± 240.5 mm{sup 3} for AVC and from -95.2 ± 210.0 mm{sup 3} to 303.7 ± 501.6 mm{sup 3} for MC. AVC can be quantified with excellent reliability on ungated unenhanced low-dose chest CT, but manual detection of MC can be subject to substantial inter-observer variability. Lung cancer screening CT may be used for detection and quantification of cardiac valve calcifications. (orig.)

Quantitative assessment of inter-clinician variability of target volume delineation for medulloblastoma: quality assurance for the SIOP PNET 4 trial protocol

International Nuclear Information System (INIS)

Coles, Charlotte E.; Hoole, Andrew C.F.; Harden, Susan V; Burnet, Neil G.; Twyman, Nicola; Taylor, Roger E.; Kortmann, Rolf D.; Williams, Michael V.

2003-01-01

Background and purpose: To assess inter-clinician variability amongst specialist paediatric radiation oncologists in delineating clinical target volumes for treating medulloblastoma as a quality assurance exercise prior to the introduction of the SIOP PNET 4 trial protocol of conformal radiotherapy to the posterior fossa and tumour bed. Patients and methods: Participants from 17 UK centres attended an educational meeting and then completed a clinical planning exercise to outline: (1) the whole posterior fossa and (2) the tumour bed. Quantitative analysis of the volumes, lengths, spatial positioning and axial planes for each individual was carried out and variation between individuals analysed. Results: Outlining of the posterior fossa was reasonably consistent, although most variation was seen in defining the superior border of the tentorium. A major difference was the decision whether or not to include the post-surgical meningocoele in the clinical target volume (CTV). The CTV for the tumour bed was under treated by all participants due to lack of inclusion of pre-operative tumour extent. Conclusions: This exercise demonstrated several ambiguities in the draft protocol and highlighted particular areas of inter-clinician variation. Consequently the protocol was revised and improved to take account of these findings. We recommend that planning exercises, in conjunction with education and training, should be implemented before the start of any new radiotherapy trial. In the future, the use of image transfer will allow prospective peer review of target volumes before treatment commences. These measures are essential to ensure that alterations in clinical practice are achieved in a uniform way

A step forward in molecular diagnostics of lyssaviruses--results of a ring trial among European laboratories.

Directory of Open Access Journals (Sweden)

Melina Fischer

Full Text Available Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial specifically designed on the use of reverse transcription polymerase chain reaction (RT-PCR for detection of lyssavirus genomic RNA was organized. The trial focussed on assessment and comparison of the performance of conventional and real-time assays. In total, 16 European laboratories participated. All participants were asked to investigate a panel of defined lyssavirus RNAs, consisting of Rabies virus (RABV and European bat lyssavirus 1 and 2 (EBLV-1 and -2 RNA samples, with systems available in their laboratory. The ring trial allowed the important conclusion that conventional RT-PCR assays were really robust assays tested with a high concordance between different laboratories and assays. The real-time RT-PCR system by Wakeley et al. (2005 in combination with an intercalating dye, and the combined version by Hoffmann and co-workers (2010 showed good sensitivity for the detection of all RABV samples included in this test panel. Furthermore, all used EBLV-specific assays, real-time RT-PCRs as well as conventional RT-PCR systems, were shown to be suitable for a reliable detection of EBLVs. It has to be mentioned that differences were seen in the performance between both the individual RT-PCR systems and the laboratories. Laboratories which used more than one molecular assay for testing the sample panel always concluded a correct sample result. Due to the markedly high genetic diversity of lyssaviruses, the application of different assays in diagnostics is needed to achieve a maximum of diagnostic accuracy. To improve the knowledge about the diagnostic performance proficiency testing at an international level is recommended before using lyssavirus molecular

Electronic laboratory system reduces errors in National Tuberculosis Program: a cluster randomized controlled trial.

Science.gov (United States)

Blaya, J A; Shin, S S; Yale, G; Suarez, C; Asencios, L; Contreras, C; Rodriguez, P; Kim, J; Cegielski, P; Fraser, H S F

2010-08-01

To evaluate the impact of the e-Chasqui laboratory information system in reducing reporting errors compared to the current paper system. Cluster randomized controlled trial in 76 health centers (HCs) between 2004 and 2008. Baseline data were collected every 4 months for 12 months. HCs were then randomly assigned to intervention (e-Chasqui) or control (paper). Further data were collected for the same months the following year. Comparisons were made between intervention and control HCs, and before and after the intervention. Intervention HCs had respectively 82% and 87% fewer errors in reporting results for drug susceptibility tests (2.1% vs. 11.9%, P = 0.001, OR 0.17, 95%CI 0.09-0.31) and cultures (2.0% vs. 15.1%, P Chasqui users sent on average three electronic error reports per week to the laboratories. e-Chasqui reduced the number of missing laboratory results at point-of-care health centers. Clinical users confirmed viewing electronic results not available on paper. Reporting errors to the laboratory using e-Chasqui promoted continuous quality improvement. The e-Chasqui laboratory information system is an important part of laboratory infrastructure improvements to support multidrug-resistant tuberculosis care in Peru.

Construct validity and inter-rater reliability of the Dutch activity measure for post-acute care "6-clicks" basic mobility form to assess the mobility of hospitalized patients.

Science.gov (United States)

Geelen, Sven Jacobus Gertruda; Valkenet, Karin; Veenhof, Cindy

2018-05-12

To evaluate the construct validity and the inter-rater reliability of the Dutch Activity Measure for Post-Acute Care "6-clicks" Basic Mobility short form measuring the patient's mobility in Dutch hospital care. First, the "6-clicks" was translated by using a forward-backward translation protocol. Next, 64 patients were assessed by the physiotherapist to determine the validity while being admitted to the Internal Medicine wards of a university medical center. Six hypotheses were tested regarding the construct "mobility" which showed that: Better "6-clicks" scores were related to less restrictive pre-admission living situations (p = 0.011), less restrictive discharge locations (p = 0.001), more independence in activities of daily living (p = 0.001) and less physiotherapy visits (p Dutch "6-clicks" shows a good construct validity and moderate-to-excellent inter-rater reliability when used to assess the mobility of hospitalized patients. Implications for Rehabilitation Even though various measurement tools have been developed, it appears the majority of physiotherapists working in a hospital currently do not use these tools as a standard part of their care. The Activity Measure for Post-Acute Care "6-clicks" Basic Mobility is the only tool which is designed to be short, easy to use within usual care and has been validated in the entire hospital population. This study shows that the Dutch version of the Activity Measure for Post-Acute Care "6-clicks" Basic Mobility form is a valid, easy to use, quick tool to assess the basic mobility of Dutch hospitalized patients.

77 FR 6867 - Practice Guide for Proposed Trial Rules

Science.gov (United States)

2012-02-09

... new trial proceedings to be conducted by the Patent Trial and Appeal Board (Board) including inter... conducted by the Board including: (1) Inter partes review (IPR); (2) post-grant review (PGR); (3) a... response to the petition, including a simple statement that patent owner elects not to respond to the...

Intra-laboratory validation of a human cell based in vitro angiogenesis assay for testing angiogenesis modulators

Directory of Open Access Journals (Sweden)

Jertta-Riina Sarkanen

2011-01-01

Full Text Available The developed standardized human cell based in vitro angiogenesis assay was intra-laboratory validated to verify that the method is reliable and relevant for routine testing of modulators of angiogenesis e.g. pharmaceuticals and industrial chemicals. This assay is based on the earlier published method but it was improved and shown to be more sensitive and rapid than the previous assay. The performance of the assay was assessed by using 6 reference chemicals, which are widely used pharmaceuticals that inhibit angiogenesis: acetyl salicylic acid, erlotinib, 2-methoxyestradiol, levamisole, thalidomide, and anti-vascular endothelial growth factor. In the intra-laboratory validation, the sensitivity of the assay (upper and lower limits of detection and linearity of response in tubule formation, batch to batch variation in tubule formation between different Master cell bank batches, and precision as well as the reliability of the assay (reproducibility and repeatability were tested. The pre-set acceptance criteria for the intra-laboratory validation study were met. The relevance of the assay in man was investigated by comparing the effects of reference chemicals and their concentrations to the published human data. The comparison showed a good concordance, which indicates that this human cell based angiogenesis model predicts well the effects in man and has the potential to be used to supplement and/or replace of animal tests.

Increasing the number of inter-arch contacts improves mastication in adults with Down syndrome: a prospective controlled trial.

Science.gov (United States)

Hennequin, Martine; Mazille, Marie-Noëlle; Cousson, Pierre-Yves; Nicolas, Emmanuel

2015-06-01

Feeding difficulties due to their condition have been widely described for babies, children and adults with Down syndrome (DS). A previous study demonstrated that, compared with wearing a placebo appliance, wearing an occlusal appliance increased inter-arch dental contacts, improved the oral health status of adults with DS and normalised their mandibular rest position. This longitudinal prospective controlled trial aimed to evaluate whether increasing inter-arch contacts in adults with DS would lead to improved masticatory efficiency. Fourteen subjects with DS (mean age±SD: 28.5±9.3years) and twelve controls without DS (24.6±1.0years) were video recorded while chewing samples of carrot and peanuts with and without an oral appliance that was designed to equalise the number of posterior functional units (PFUs) in both groups. Three parameters were collected during mastication for 15cycles and until swallowing: food refusals, food bolus granulometry (D50) and kinematic parameters of the chewing process (number of cycles, chewing duration and cycle frequency within the chewing sequence). In the DS group, increasing the number of PFUs led to a decrease in bolus particle size, to fewer masticatory cycles needed to produce a bolus ready for swallowing and to a decrease in the occurrence of food refusal, while mean chewing frequency did not vary. In the control group, bolus granulometry and chewing time increased with appliance wear while mean chewing frequency decreased. These changes clearly indicate a functional improvement in subjects with DS. This study also demonstrated a causal relationship between the number of functional pairs of posterior teeth and improved mastication. Any evaluation of feeding behaviour in persons with DS should consider inter-arch dental contacts as an explicative variable for feeding problems and their nutritional and respiratory consequences. Copyright © 2015 Elsevier Inc. All rights reserved.

Performance evaluation of elemental analysis/isotope ratio mass spectrometry methods for the determination of the D/H ratio in tetramethylurea and other compounds--results of a laboratory inter-comparison.

Science.gov (United States)

Bréas, Olivier; Thomas, Freddy; Zeleny, Reinhard; Calderone, Giovanni; Jamin, Eric; Guillou, Claude

2007-01-01

Tetramethylurea (TMU) with a certified D/H ratio is the internal standard for Site-specific Natural Isotope Fractionation measured by Nuclear Magnetic Resonance (SNIF-NMR) analysis of wine ethanol for detection of possible adulterations (Commission Regulation 2676/90). A new batch of a TMU certified reference material (CRM) is currently being prepared. Whereas SNIF-NMR has been employed up to now, Elemental Analysis/Isotope Ratio Mass Spectrometry ((2)H-EA-IRMS) was envisaged as the method of choice for value assignment of the new CRM, as more precise (better repeatable) data might be obtained, resulting in lower uncertainty of the certified value. In order to evaluate the accuracy and intra- and inter-laboratory reproducibility of (2)H-EA-IRMS methods, a laboratory inter-comparison was carried out by analysing TMU and other organic compounds, as well as some waters. The results revealed that experienced laboratories are capable of generating robust and well comparable data, which highlights the emerging potential of IRMS in food authenticity testing. However, a systematic bias between IRMS and SNIF-NMR reference data was observed for TMU; this lack of data consistency rules out the (2)H-IRMS technique for the characterisation measurement of the new TMU CRM.

Determination of Ethanol in Kombucha Products: Single-Laboratory Validation, First Action 2016.12.

Science.gov (United States)

Ebersole, Blake; Liu, Ying; Schmidt, Rich; Eckert, Matt; Brown, Paula N

2017-05-01

Kombucha is a fermented nonalcoholic beverage that has drawn government attention due to the possible presence of excess ethanol (≥0.5% alcohol by volume; ABV). A validated method that provides better precision and accuracy for measuring ethanol levels in kombucha is urgently needed by the kombucha industry. The current study validated a method for determining ethanol content in commercial kombucha products. The ethanol content in kombucha was measured using headspace GC with flame ionization detection. An ethanol standard curve ranging from 0.05 to 5.09% ABV was used, with correlation coefficients greater than 99.9%. The method detection limit was 0.003% ABV and the LOQ was 0.01% ABV. The RSDr ranged from 1.62 to 2.21% and the Horwitz ratio ranged from 0.4 to 0.6. The average accuracy of the method was 98.2%. This method was validated following the guidelines for single-laboratory validation by AOAC INTERNATIONAL and meets the requirements set by AOAC SMPR 2016.001, "Standard Method Performance Requirements for Determination of Ethanol in Kombucha."

OSL surface exposure dating of a lithic quarry in Tibet: Laboratory validation and application

DEFF Research Database (Denmark)

Gliganic, L.A.; Meyer, M.C.; Sohbati, R.

2018-01-01

developed OSL Surface exposure dating technique (OSL-Surf) to date flake scars at lithic quarry sites. We performed the first quantitative validation of the model describing the OSL-Surf dating technique using a controlled laboratory experiment. Our results show that longer laboratory bleaching durations......-depth profile that could be used to calibrate the model to estimate the exposure duration of a flake scar associated with human exploitation of the area. Finally, we observe that the μ parameter of the OSL-Surf model varies considerably between the laboratory-bleached and two naturally daylight-bleached...... datasets, despite having identical lithologies. We thus infer that, in addition to lithological controls, the μ parameter is primarily sensitive to the daylight irradiation geometry and only weakly dependent on spectrum of the incident light; this interpretation implies a narrow effective bleaching...

A distributed framework for inter-domain virtual network embedding

Science.gov (United States)

Wang, Zihua; Han, Yanni; Lin, Tao; Tang, Hui

2013-03-01

Network virtualization has been a promising technology for overcoming the Internet impasse. A main challenge in network virtualization is the efficient assignment of virtual resources. Existing work focused on intra-domain solutions whereas inter-domain situation is more practical in realistic setting. In this paper, we present a distributed inter-domain framework for mapping virtual networks to physical networks which can ameliorate the performance of the virtual network embedding. The distributed framework is based on a Multi-agent approach. A set of messages for information exchange is defined. We design different operations and IPTV use scenarios to validate the advantages of our framework. Use cases shows that our framework can solve the inter-domain problem efficiently.

Inter-rater and intra-rater reliability of the Bahasa Melayu version of Rose Angina Questionnaire.

Science.gov (United States)

Hassan, N B; Choudhury, S R; Naing, L; Conroy, R M; Rahman, A R A

2007-01-01

The objective of the study is to translate the Rose Questionnaire (RQ) into a Bahasa Melayu version and adapt it cross-culturally, and to measure its inter-rater and intrarater reliability. This cross sectional study was conducted in the respondents' homes or workplaces in Kelantan, Malaysia. One hundred respondents aged 30 and above with different socio-demographic status were interviewed for face validity. For each inter-rater and intra-rater reliability, a sample of 150 respondents was interviewed. Inter-rater and intra-rater reliabilities were assessed by Cohen's kappa. The overall inter-rater agreements by the five pair of interviewers at point one and two were 0.86, and intrarater reliability by the five interviewers on the seven-item questionnaire at poinone and two was 0.88, as measured by kappa coefficient. The translated Malay version of RQ demonstrated an almost perfect inter-rater and intra-rater reliability and further validation such as sensitivity and specificity analysis of this translated questionnaire is highly recommended.

ASSERT validation against the Stern Laboratories' single-phase pressure drop tests

International Nuclear Information System (INIS)

Waddington, G.M.; Kiteley, J.C.; Carver, M.B.

1995-01-01

This paper describes the preliminary validation of ASSERT-IV against the single-phase pressure drop tests from the 37-element CHF (critical heat flux) experiments conducted at Stern Laboratories, and shows how this study fits into the overall ASSERT validation plan. The effects on the pressure drop of several friction and form loss models are evaluated, including the geometry-based K-factor model. The choice of friction factor has a small effect on the predicted channel pressure drop, compared to the form loss model choice. Using the uniform K-factors of Hameed, the computed pressure drops are in excellent agreement with the experimental results from the nominal pressure tube tests. For future ASSERT applications, either Hameed's uniform K-factors or the geometry-based model using Idelchik's thick-edged orifice equation are recommended, as are the friction factor correlations of Colebrook-White, Selander, and Aly and Groeneveld. More analysis of the geometry-based K-factor model is required. (author). 23 refs., 4 tabs., 9 figs

Harmonization of radiobiological assays: why and how?

International Nuclear Information System (INIS)

Prasanna, Pataje G.

2014-01-01

The International Atomic Energy Agency has made available a technical manual for cytogenetic biodosimetry assays (dicentric chromosome aberration (DCA) and cytokinesis-block micronucleus (CBMN) assays) used for radiation dose assessment in radiation accidents. The International Standardization Organization, which develops standards and guidelines, also provides an avenue for laboratory accreditation, has developed guidelines and recommendations for performing cytogenetic biodosimetry assays. Harmonization of DCA and CBMN assays, has improved their accuracy. Double-blinded inter-laboratory comparison studies involving several networks have further validated DCA and CBMN assays and improved the confidence in their potential use for radiation dose assessment in mass casualties. This kind of international harmonization is lacking for pre-clinical radiobiology assays. The widely used pre-clinical assays that are relatively important to set stage for clinical trials include clonogenic assays, flow-cytometry assays, apoptotic assays, and tumor regression and growth delay assays. However, significant inter-laboratory variations occur with respect to data among laboratories. This raises concerns on the reliability and reproducibility of preclinical data that drives further development and translation. Lack of reproducibility may stem from a variety of factors such as poor scientist training, less than optimal experimental design, inadequate description of methodology, and impulse to publish only the positive data etc. Availability of technical manuals, standard operating procedures, accreditation avenues for laboratories performing such assays, inter-laboratory comparisons, and use of standardized protocols are necessary to enhance reliability and reproducibility. Thus, it is important that radiobiological assays are harmonized for laboratory protocols to ensure successful translation of pre-clinical research on radiation effect modulators to help design clinic trials with

The definition of radiological signs in gastric ulcer and assessment of their validity by inter-observer variation study.

Science.gov (United States)

Schulman, A; Simpkins, K C

1975-07-01

The initial aim was to program a computer with information on the frequency of radiological signs in benign and malignant gastric ulcers in order to obtain a percentage probability of benignancy or malignancy in succeeding ulcers in clinical practice. However, only four of the many signs described in gastric ulcer were confirmed to be of validity (i.e. reliable existence) by an inter-observer variation study using two observers and the films from 69 barium meal examinations. These were projection or non-projection of the in-profile ulcer, presence or absence of adjacent mucosal folds, good or poor definition of the in-face ulcer's edge, and extension of radiating folds to the in-face ulcer's edge. A few more remained unassessed due to insufficient numbers of relevant cases. It is condluced that: as defined in the literature the majority of radiological signs in this field are of uncertain existence; and the four that were found to be valid do not fully describe the important appearances that may be seen in benign and malignant ulcers and would be inadequate to differentiate them to a sufficiently high degree of probability.

Fuzzy-logic based strategy for validation of multiplex methods: example with qualitative GMO assays.

Science.gov (United States)

Bellocchi, Gianni; Bertholet, Vincent; Hamels, Sandrine; Moens, W; Remacle, José; Van den Eede, Guy

2010-02-01

This paper illustrates the advantages that a fuzzy-based aggregation method could bring into the validation of a multiplex method for GMO detection (DualChip GMO kit, Eppendorf). Guidelines for validation of chemical, bio-chemical, pharmaceutical and genetic methods have been developed and ad hoc validation statistics are available and routinely used, for in-house and inter-laboratory testing, and decision-making. Fuzzy logic allows summarising the information obtained by independent validation statistics into one synthetic indicator of overall method performance. The microarray technology, introduced for simultaneous identification of multiple GMOs, poses specific validation issues (patterns of performance for a variety of GMOs at different concentrations). A fuzzy-based indicator for overall evaluation is illustrated in this paper, and applied to validation data for different genetically modified elements. Remarks were drawn on the analytical results. The fuzzy-logic based rules were shown to be applicable to improve interpretation of results and facilitate overall evaluation of the multiplex method.

Development, validation and evaluation of an analytical method for the determination of monomeric and oligomeric procyanidins in apple extracts.

Science.gov (United States)

Hollands, Wendy J; Voorspoels, Stefan; Jacobs, Griet; Aaby, Kjersti; Meisland, Ane; Garcia-Villalba, Rocio; Tomas-Barberan, Francisco; Piskula, Mariusz K; Mawson, Deborah; Vovk, Irena; Needs, Paul W; Kroon, Paul A

2017-04-28

There is a lack of data for individual oligomeric procyanidins in apples and apple extracts. Our aim was to develop, validate and evaluate an analytical method for the separation, identification and quantification of monomeric and oligomeric flavanols in apple extracts. To achieve this, we prepared two types of flavanol extracts from freeze-dried apples; one was an epicatechin-rich extract containing ∼30% (w/w) monomeric (-)-epicatechin which also contained oligomeric procyanidins (Extract A), the second was an oligomeric procyanidin-rich extract depleted of epicatechin (Extract B). The parameters considered for method optimisation were HPLC columns and conditions, sample heating, mass of extract and dilution volumes. The performance characteristics considered for method validation included standard linearity, method sensitivity, precision and trueness. Eight laboratories participated in the method evaluation. Chromatographic separation of the analytes was best achieved utilizing a Hilic column with a binary mobile phase consisting of acidic acetonitrile and acidic aqueous methanol. The final method showed linearity for epicatechin in the range 5-100μg/mL with a correlation co-efficient >0.999. Intra-day and inter-day precision of the analytes ranged from 2 to 6% and 2 to 13% respectively. Up to dp3, trueness of the method was >95% but decreased with increasing dp. Within laboratory precision showed RSD values <5 and 10% for monomers and oligomers, respectively. Between laboratory precision was 4 and 15% (Extract A) and 7 and 30% (Extract B) for monomers and oligomers, respectively. An analytical method for the separation, identification and quantification of procyanidins in an apple extract was developed, validated and assessed. The results of the inter-laboratory evaluation indicate that the method is reliable and reproducible. Copyright © 2017. Published by Elsevier B.V.

External validity of randomized controlled trials in older adults, a systematic review.

Directory of Open Access Journals (Sweden)

Floor J van Deudekom

Full Text Available To critically assess the external validity of randomized controlled trials (RCTs it is important to know what older adults have been enrolled in the trials. The aim of this systematic review is to study what proportion of trials specifically designed for older patients report on somatic status, physical and mental functioning, social environment and frailty in the patient characteristics.PubMed was searched for articles published in 2012 and only RCTs were included. Articles were further excluded if not conducted with humans or only secondary analyses were reported. A random sample of 10% was drawn. The current review analyzed this random sample and further selected trials when the reported mean age was ≥ 60 years. We extracted geriatric assessments from the population descriptives or the in- and exclusion criteria.In total 1396 trials were analyzed and 300 trials included. The median of the reported mean age was 66 (IQR 63-70 and the median percentage of men in the trials was 60 (IQR 45-72. In 34% of the RCTs specifically designed for older patients somatic status, physical and mental functioning, social environment or frailty were reported in the population descriptives or the in- and exclusion criteria. Physical and mental functioning was reported most frequently (22% and 14%. When selecting RCTs on a mean age of 70 or 80 years the report of geriatric assessments in the patient characteristics was 46% and 85% respectively but represent only 5% and 1% of the trials.Somatic status, physical and mental functioning, social environment and frailty are underreported even in RCTs specifically designed for older patients published in 2012. Therefore, it is unclear for clinicians to which older patients the results can be applied. We recommend systematic to transparently report these relevant characteristics of older participants included in RCTs.

The bogus taste test: Validity as a measure of laboratory food intake

OpenAIRE

Robinson, Eric; Haynes, Ashleigh; Hardman, Charlotte A.; Kemps, Eva; Higgs, Suzanne; Jones, Andrew

2017-01-01

Because overconsumption of food contributes to ill health, understanding what affects how much people eat is of importance. The ?bogus? taste test is a measure widely used in eating behaviour research to identify factors that may have a causal effect on food intake. However, there has been no examination of the validity of the bogus taste test as a measure of food intake. We conducted a participant level analysis of 31 published laboratory studies that used the taste test to measure food inta...

Collaborative trial validation study of two methods, one based on high performance liquid chromatography-tandem mass spectrometry and on gas chromatography-mass spectrometry for the determination of acrylamide in bakery and potato products.

Science.gov (United States)

Wenzl, Thomas; Karasek, Lubomir; Rosen, Johan; Hellenaes, Karl-Erik; Crews, Colin; Castle, Laurence; Anklam, Elke

2006-11-03

A European inter-laboratory study was conducted to validate two analytical procedures for the determination of acrylamide in bakery ware (crispbreads, biscuits) and potato products (chips), within a concentration range from about 20 microg/kg to about 9000 microgg/kg. The methods are based on gas chromatography-mass spectrometry (GC-MS) of the derivatised analyte and on high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) of native acrylamide. Isotope dilution with isotopically labelled acrylamide was an integral part of both methods. The study was evaluated according to internationally accepted guidelines. The performance of the HPLC-MS/MS method was found to be superior to that of the GC-MS method and to be fit-for-the-purpose.

Extra-analytical quality indicators and laboratory performances.

Science.gov (United States)

Sciacovelli, Laura; Aita, Ada; Plebani, Mario

2017-07-01

In the last few years much progress has been made in raising the awareness of laboratory medicine professionals about the effectiveness of quality indicators (QIs) in monitoring, and improving upon, performances in the extra-analytical phases of the Total Testing Process (TTP). An effective system for management of QIs includes the implementation of an internal assessment system and participation in inter-laboratory comparison. A well-designed internal assessment system allows the identification of critical activities and their systematic monitoring. Active participation in inter-laboratory comparison provides information on the performance level of one laboratory with respect to that of other participating laboratories. In order to guarantee the use of appropriate QIs and facilitate their implementation, many laboratories have adopted the Model of Quality Indicators (MQI) proposed by Working Group "Laboratory Errors and Patient Safety" (WG-LEPS) of IFCC, since 2008, which is the result of international consensus and continuous experimentation, and updating to meet new, constantly emerging needs. Data from participating laboratories are collected monthly and reports describing the statistical results and evaluating laboratory data, utilizing the Six Sigma metric, issued regularly. Although the results demonstrate that the processes need to be improved upon, overall the comparison with data collected in 2014 shows a general stability of quality levels and that an improvement has been achieved over time for some activities. The continuous monitoring of QI data allows identification all possible improvements, thus highlighting the value of participation in the inter-laboratory program proposed by WG-LEPS. The active participation of numerous laboratories will guarantee an ever more significant State-of-the-Art, promote the reduction of errors and improve quality of the TTP, thus guaranteeing patient safety. Copyright © 2017. Published by Elsevier Inc.

INTER-ACT: prevention of pregnancy complications through an e-health driven interpregnancy lifestyle intervention - study protocol of a multicentre randomised controlled trial.

Science.gov (United States)

Bogaerts, Annick; Ameye, Lieveke; Bijlholt, Margriet; Amuli, Kelly; Heynickx, Dorine; Devlieger, Roland

2017-05-26

Excessive maternal pre-pregnancy and gestational weight gain are related to pregnancy- and birth outcomes. The interpregnancy time window offers a unique opportunity to intervene in order to acquire a healthy lifestyle before the start of a new pregnancy. INTER-ACT is an e-health driven multicentre randomised controlled intervention trial targeting women at high risk of pregnancy- and birth related complications. Eligible women are recruited for the study at day 2 or 3 postpartum. At week 6 postpartum, participants are randomised into the intervention or control arm of the study. The intervention focuses on weight, diet, physical activity and mental well-being, and comprises face-to-face coaching, in which behavioural change techniques are central, and use of a mobile application, which is Bluetooth-connected to a weighing scale and activity tracker. The intervention is rolled out postpartum (4 coaching sessions between week 6 and month 6) and in a new pregnancy (3 coaching sessions, one in each trimester of pregnancy); the mobile app is used throughout the two intervention phases. Data collection includes data from the medical record of the participants (pregnancy outcomes and medical history), anthropometric data (height, weight, waist- and hip circumferences, skinfold thickness and body composition by bio-electrical impedance analysis), data from the mobile app (physical activity and weight; intervention group only) and questionnaires (socio-demographics, breastfeeding, food intake, physical activity, lifestyle, psychosocial factors and process evaluation). Medical record data are collected at inclusion and at delivery of the subsequent pregnancy. All other data are collected at week 6 and month 6 postpartum and every subsequent 6 months until a new pregnancy, and in every trimester in the new pregnancy. Primary outcome is the composite endpoint score of pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, and large

The reliability and validity of radiological assessment for patellar instability. A systematic review and meta-analysis

Energy Technology Data Exchange (ETDEWEB)

Smith, Toby O. [University of East Anglia, Faculty of Health, Norwich (United Kingdom); Davies, Leigh [Norfolk and Norwich University Hospital, Norwich (United Kingdom); Toms, Andoni P.; Donell, Simon T. [University of East Anglia, Faculty of Health, Norwich (United Kingdom); Norfolk and Norwich University Hospital, Norwich (United Kingdom); Hing, Caroline B. [St George' s Hospital, London (United Kingdom)

2011-04-15

To determine the discriminative validity and reliability of the evidence base using meta-analysis. A review of published sources using the databases AMED, CINHAL, EMBASE, MEDLINE, Scopus and the Cochrane Library, and for unpublished material was conducted. All studies assessing the reliability, validity, sensitivity or specificity of magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound (US) of the patellofemoral joint of patients following patellar dislocation, subluxation or instability, were included. A meta-analysis was performed to assess the difference in radiological measurements between healthy controls and subjects with patellar instability in order to assess discrimination validity. A narrative assessment was used to evaluate the inter- and intra-observer reliability as well as the sensitivity and specificity of specific radiological measurements. A total of 27 studies were reviewed. The findings indicated that there was acceptable inter-observer and intra-observer reliability and validity for different methods of assessing patellar height and the sulcus angle with X-ray, MRI and CT methods, and the tibial tubercle-trochlear groove (TT-TG) assessed using CT. There was poor reliability or validity for the assessment of severity of trochlear dysplasia and the sulcus angle using US. There is insufficient evidence to determine the reliability, validity, sensitivity or specificity of tests such as the congruence angle, lateral patellar displacement, lateral patellar tilt, trochlear depth, boss height, the crossing sign or Wiberg patellar classification. A critical appraisal of the literature identified a number of recurrent methodological limitations. Further study is recommended to evaluate the reliability and validity of these radiological outcomes using well-designed radiological trials. (orig.)

The reliability and validity of radiological assessment for patellar instability. A systematic review and meta-analysis

International Nuclear Information System (INIS)

Smith, Toby O.; Davies, Leigh; Toms, Andoni P.; Donell, Simon T.; Hing, Caroline B.

2011-01-01

To determine the discriminative validity and reliability of the evidence base using meta-analysis. A review of published sources using the databases AMED, CINHAL, EMBASE, MEDLINE, Scopus and the Cochrane Library, and for unpublished material was conducted. All studies assessing the reliability, validity, sensitivity or specificity of magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound (US) of the patellofemoral joint of patients following patellar dislocation, subluxation or instability, were included. A meta-analysis was performed to assess the difference in radiological measurements between healthy controls and subjects with patellar instability in order to assess discrimination validity. A narrative assessment was used to evaluate the inter- and intra-observer reliability as well as the sensitivity and specificity of specific radiological measurements. A total of 27 studies were reviewed. The findings indicated that there was acceptable inter-observer and intra-observer reliability and validity for different methods of assessing patellar height and the sulcus angle with X-ray, MRI and CT methods, and the tibial tubercle-trochlear groove (TT-TG) assessed using CT. There was poor reliability or validity for the assessment of severity of trochlear dysplasia and the sulcus angle using US. There is insufficient evidence to determine the reliability, validity, sensitivity or specificity of tests such as the congruence angle, lateral patellar displacement, lateral patellar tilt, trochlear depth, boss height, the crossing sign or Wiberg patellar classification. A critical appraisal of the literature identified a number of recurrent methodological limitations. Further study is recommended to evaluate the reliability and validity of these radiological outcomes using well-designed radiological trials. (orig.)

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

Science.gov (United States)

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

2013-11-01

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

Exploration of task performance tests in a physics laboratory

Science.gov (United States)

Liu, Dan; El Turkey, Houssein

2017-11-01

In this article, we investigate the implementation of task performance tests in an undergraduate physics laboratory. Two performance tests were carried out over two semesters using the task of building a DC circuit. The first implementation in Spring 2014 had certain concerns such as the privacy of students’ testing and their ‘trial and error’ attempts. These concerns were addressed in Fall 2015 through implementing a second performance test. The second implementation was administered differently but the content of the two tests was the same. We discuss the validity of both implementations and present the correlation (or lack of) between the time that students needed to complete the tests and their grades from a paper-based laboratory assessment method.

Validation of a Hot Water Distribution Model Using Laboratory and Field Data

Energy Technology Data Exchange (ETDEWEB)

Backman, C.; Hoeschele, M.

2013-07-01

Characterizing the performance of hot water distribution systems is a critical step in developing best practice guidelines for the design and installation of high performance hot water systems. Developing and validating simulation models is critical to this effort, as well as collecting accurate input data to drive the models. In this project, the ARBI team validated the newly developed TRNSYS Type 604 pipe model against both detailed laboratory and field distribution system performance data. Validation efforts indicate that the model performs very well in handling different pipe materials, insulation cases, and varying hot water load conditions. Limitations of the model include the complexity of setting up the input file and long simulation run times. In addition to completing validation activities, this project looked at recent field hot water studies to better understand use patterns and potential behavioral changes as homeowners convert from conventional storage water heaters to gas tankless units. Based on these datasets, we conclude that the current Energy Factor test procedure overestimates typical use and underestimates the number of hot water draws. This has implications for both equipment and distribution system performance. Gas tankless water heaters were found to impact how people use hot water, but the data does not necessarily suggest an increase in usage. Further study in hot water usage and patterns is needed to better define these characteristics in different climates and home vintages.

Laboratory-based validation of the baseline sensors of the ITER diagnostic residual gas analyzer

International Nuclear Information System (INIS)

Klepper, C.C.; Biewer, T.M.; Marcus, C.; Graves, V.B.; Andrew, P.; Hughes, S.; Gardner, W.L.

2017-01-01

The divertor-specific ITER Diagnostic Residual Gas Analyzer (DRGA) will provide essential information relating to DT fusion plasma performance. This includes pulse-resolving measurements of the fuel isotopic mix reaching the pumping ducts, as well as the concentration of the helium generated as the ash of the fusion reaction. In the present baseline design, the cluster of sensors attached to this diagnostic's differentially pumped analysis chamber assembly includes a radiation compatible version of a commercial quadrupole mass spectrometer, as well as an optical gas analyzer using a plasma-based light excitation source. This paper reports on a laboratory study intended to validate the performance of this sensor cluster, with emphasis on the detection limit of the isotopic measurement. This validation study was carried out in a laboratory set-up that closely prototyped the analysis chamber assembly configuration of the baseline design. This includes an ITER-specific placement of the optical gas measurement downstream from the first turbine of the chamber's turbo-molecular pump to provide sufficient light emission while preserving the gas dynamics conditions that allow for /textasciitilde 1 s response time from the sensor cluster [1].

Laboratory-based validation of the baseline sensors of the ITER diagnostic residual gas analyzer

Science.gov (United States)

Klepper, C. C.; Biewer, T. M.; Marcus, C.; Andrew, P.; Gardner, W. L.; Graves, V. B.; Hughes, S.

2017-10-01

The divertor-specific ITER Diagnostic Residual Gas Analyzer (DRGA) will provide essential information relating to DT fusion plasma performance. This includes pulse-resolving measurements of the fuel isotopic mix reaching the pumping ducts, as well as the concentration of the helium generated as the ash of the fusion reaction. In the present baseline design, the cluster of sensors attached to this diagnostic's differentially pumped analysis chamber assembly includes a radiation compatible version of a commercial quadrupole mass spectrometer, as well as an optical gas analyzer using a plasma-based light excitation source. This paper reports on a laboratory study intended to validate the performance of this sensor cluster, with emphasis on the detection limit of the isotopic measurement. This validation study was carried out in a laboratory set-up that closely prototyped the analysis chamber assembly configuration of the baseline design. This includes an ITER-specific placement of the optical gas measurement downstream from the first turbine of the chamber's turbo-molecular pump to provide sufficient light emission while preserving the gas dynamics conditions that allow for \\textasciitilde 1 s response time from the sensor cluster [1].

Laboratory-based validation of the baseline sensors of the ITER diagnostic residual gas analyzer

Energy Technology Data Exchange (ETDEWEB)

Biewer, Theodore M. [ORNL; Marcus, Chris [ORNL; Klepper, C Christopher [ORNL; Andrew, Philip [ITER Organization, Cadarache, France; Gardner, W. L. [United States ITER Project Office; Graves, Van B. [ORNL; Hughes, Shaun [ITER Organization, Saint Paul Lez Durance, France

2017-10-01

The divertor-specific ITER Diagnostic Residual Gas Analyzer (DRGA) will provide essential information relating to DT fusion plasma performance. This includes pulse-resolving measurements of the fuel isotopic mix reaching the pumping ducts, as well as the concentration of the helium generated as the ash of the fusion reaction. In the present baseline design, the cluster of sensors attached to this diagnostic's differentially pumped analysis chamber assembly includes a radiation compatible version of a commercial quadrupole mass spectrometer, as well as an optical gas analyzer using a plasma-based light excitation source. This paper reports on a laboratory study intended to validate the performance of this sensor cluster, with emphasis on the detection limit of the isotopic measurement. This validation study was carried out in a laboratory set-up that closely prototyped the analysis chamber assembly configuration of the baseline design. This includes an ITER-specific placement of the optical gas measurement downstream from the first turbine of the chamber's turbo-molecular pump to provide sufficient light emission while preserving the gas dynamics conditions that allow for \\textasciitilde 1 s response time from the sensor cluster [1].

Content Validity Index and Intra- and Inter-Rater Reliability of a New Muscle Strength/Endurance Test Battery for Swedish Soldiers.

Directory of Open Access Journals (Sweden)

Helena Larsson

Full Text Available The objective of this study was to examine the content validity of commonly used muscle performance tests in military personnel and to investigate the reliability of a proposed test battery. For the content validity investigation, thirty selected tests were those described in the literature and/or commonly used in the Nordic and North Atlantic Treaty Organization (NATO countries. Nine selected experts rated, on a four-point Likert scale, the relevance of these tests in relation to five different work tasks: lifting, carrying equipment on the body or in the hands, climbing, and digging. Thereafter, a content validity index (CVI was calculated for each work task. The result showed excellent CVI (≥0.78 for sixteen tests, which comprised of one or more of the military work tasks. Three of the tests; the functional lower-limb loading test (the Ranger test, dead-lift with kettlebells, and back extension, showed excellent content validity for four of the work tasks. For the development of a new muscle strength/endurance test battery, these three tests were further supplemented with two other tests, namely, the chins and side-bridge test. The inter-rater reliability was high (intraclass correlation coefficient, ICC2,1 0.99 for all five tests. The intra-rater reliability was good to high (ICC3,1 0.82-0.96 with an acceptable standard error of mean (SEM, except for the side-bridge test (SEM%>15. Thus, the final suggested test battery for a valid and reliable evaluation of soldiers' muscle performance comprised the following four tests; the Ranger test, dead-lift with kettlebells, chins, and back extension test. The criterion-related validity of the test battery should be further evaluated for soldiers exposed to varying physical workload.

Validation experiment of a numerically processed millimeter-wave interferometer in a laboratory

Energy Technology Data Exchange (ETDEWEB)

Kogi, Y., E-mail: kogi@fit.ac.jp; Higashi, T.; Matsukawa, S. [Department of Information Electronics, Fukuoka Institute of Technology, Fukuoka 811-0295 (Japan); Mase, A. [Art, Science and Technology Center for Cooperative Research, Kyushu University, Kasuga, Fukuoka 816-0811 (Japan); Kohagura, J.; Yoshikawa, M. [Plasma Research Center, University of Tsukuba, Tsukuba, Ibaraki 305-8577 (Japan); Nagayama, Y.; Kawahata, K. [National Institute for Fusion Science, Toki, Gifu 509-5202 (Japan); Kuwahara, D. [Tokyo University of Agriculture and Technology, Koganei, Tokyo 184-8588 (Japan)

2014-11-15

We propose a new interferometer system for density profile measurements. This system produces multiple measurement chords by a leaky-wave antenna driven by multiple frequency inputs. The proposed system was validated in laboratory evaluation experiments. We confirmed that the interferometer generates a clear image of a Teflon plate as well as the phase shift corresponding to the plate thickness. In another experiment, we confirmed that quasi-optical mirrors can produce multiple measurement chords; however, the finite spot size of the probe beam degrades the sharpness of the resulting image.

An inter-lab comparison determination of radionuclides in soil samples by γ-apectrometry

International Nuclear Information System (INIS)

Pan Jingquan; Zhang Shurong; Xu Cuihua

1986-01-01

The results of an inter-lab comparison of quantitative determination of radionuclides in two soil samples and in an imitated one used as standard reference material by direct γ-spectrometry are presented and discussed. The methods of preparation of the three samples, its homogeneity and the procedures used in this inter-lab comparison are also described. Fifteen laboratories in China participated in this program. The contents of main radionuclides in the samples were estimated by statistical treatment of the reproted data. More than 91% of these laboratories obtained mean values with relative standard deviation below 20%, and in 88% of them the average values we e within the range of the standard reference values with deviation less than 10%. Statistical analysis showed that random error might be underestimated or systematic error might exist in a few laboratories

A new AMS facility at Inter University Accelerator Centre, New Delhi

Science.gov (United States)

Kumar, Pankaj; Chopra, S.; Pattanaik, J. K.; Ojha, S.; Gargari, S.; Joshi, R.; Kanjilal, D.

2015-10-01

Inter University Accelerator Centre (IUAC), a national facility of government of India, is having a 15UD Pelletron accelerator for multidisciplinary ion beam based research programs. Recently, a new accelerator mass spectrometry (AMS) facility has been developed after incorporating many changes in the existing 15UD Pelletron accelerator. A clean chemistry laboratory for 10Be and 26Al with all the modern facilities has also been developed for the chemical processing of samples. 10Be measurements on sediment samples, inter laboratory comparison results and 26Al measurements on standard samples are presented in this paper. In addition to the 10Be and 26Al AMS facilities, a new 14C AMS facility based on a dedicated 500 kV tandem ion accelerator with two cesium sputter ion sources, is also being setup at IUAC.

U.S. laboratory and field trials of metofluthrin (SumiOne) emanators for reducing mosquito biting outdoors.

Science.gov (United States)

Lucas, J R; Shono, Y; Iwasaki, T; Ishiwatari, T; Spero, N; Benzon, G

2007-03-01

Metofluthrin (SumiOne is a novel, vapor-active pyrethroid that is highly effective against mosquitoes. Laboratory and field trials were conducted in the United States to evaluate the mosquito repellent activity of metofluthrin-treated paper substrates ("emanators"). Initial studies were conducted to evaluate the field performance of 900-cm(2) paper fan emanators impregnated with 160 mg metofluthrin, where Aedes canadensis was the predominant species. Emanators reduced landing rates on human volunteers by between 85% and 100% compared to untreated controls. Subsequent tests with 4,000-cm(2) paper strip emanators impregnated with 200 mg metofluthrin were conducted in a wind tunnel as a precursor to conducting field trials using human bait and laboratory-reared Aedes aegypti. Paper strips, which were pre-aged in a fume hood to determine duration of protection, gave 89-91% reductions in landing rates compared with controls. Similar reductions in biting activity were also noted. Following these tests, field trials to assess effect on landing rates were conducted with emanators positioned 1.22 m on either side of volunteers protected from biting by Tyvek suits, with pre- and posttreatment counts being made. In Florida (predominantly Ochlerotatus spp.) 91-95% reductions were noted 10-30 min after emanators were deployed, while in Washington State (mostly Aedes vexans) 95-97% reductions were observed. These results demonstrate that metofluthrin-treated emanators are highly effective at repelling mosquitoes.

Large Cancer Drug Trial Helps Move Precision Medicine Toward the Mainstream | Frederick National Laboratory for Cancer Research

Science.gov (United States)

A landmark cancer drug trial is helping set the stage for moving precision medicine into the mainstream of clinical practice, according to a new study. The study, reported in the Journal of Molecular Diagnostics, validates a procedure used in the dru

Universal immunogenicity validation and assessment during early biotherapeutic development to support a green laboratory.

Science.gov (United States)

Bautista, Ami C; Zhou, Lei; Jawa, Vibha

2013-10-01

Immunogenicity support during nonclinical biotherapeutic development can be resource intensive if supported by conventional methodologies. A universal indirect species-specific immunoassay can eliminate the need for biotherapeutic-specific anti-drug antibody immunoassays without compromising quality. By implementing the R's of sustainability (reduce, reuse, rethink), conservation of resources and greener laboratory practices were achieved in this study. Statistical analysis across four biotherapeutics supported identification of consistent product performance standards (cut points, sensitivity and reference limits) and a streamlined universal anti-drug antibody immunoassay method implementation strategy. We propose an efficient, fit-for-purpose, scientifically and statistically supported nonclinical immunogenicity assessment strategy. Utilization of a universal method and streamlined validation, while retaining comparability to conventional immunoassays and meeting the industry recommended standards, provides environmental credits in the scientific laboratory. Collectively, individual reductions in critical material consumption, energy usage, waste and non-environment friendly consumables, such as plastic and paper, support a greener laboratory environment.

A Step Forward in Molecular Diagnostics of Lyssaviruses – Results of a Ring Trial among European Laboratories

DEFF Research Database (Denmark)

Fischer, Melina; Wernike, Kerstin; Freuling, Conrad M.

2013-01-01

Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial...... participants were asked to investigate a panel of defined lyssavirus RNAs, consisting of Rabies virus (RABV) and European bat lyssavirus 1 and 2 (EBLV-1 and -2) RNA samples, with systems available in their laboratory. The ring trial allowed the important conclusion that conventional RT-PCR assays were really...

Validation of the Provincial Transfer Authorization Centre database: a comprehensive database containing records of all inter-facility patient transfers in the province of Ontario

Directory of Open Access Journals (Sweden)

MacDonald Russell D

2006-10-01

Full Text Available Abstract Background The Provincial Transfer Authorization Centre (PTAC was established as a part of the emergency response in Ontario, Canada to the Severe Acute Respiratory Syndrome (SARS outbreak in 2003. Prior to 2003, data relating to inter-facility patient transfers were not collected in a systematic manner. Then, in an emergency setting, a comprehensive database with a complex data collection process was established. For the first time in Ontario, population-based data for patient movement between healthcare facilities for a population of twelve million are available. The PTAC database stores all patient transfer data in a large database. There are few population-based patient transfer databases and the PTAC database is believed to be the largest example to house this novel dataset. A patient transfer database has also never been validated. This paper presents the validation of the PTAC database. Methods A random sample of 100 patient inter-facility transfer records was compared to the corresponding institutional patient records from the sending healthcare facilities. Measures of agreement, including sensitivity, were calculated for the 12 common data variables. Results Of the 100 randomly selected patient transfer records, 95 (95% of the corresponding institutional patient records were located. Data variables in the categories patient demographics, facility identification and timing of transfer and reason and urgency of transfer had strong agreement levels. The 10 most commonly used data variables had accuracy rates that ranged from 85.3% to 100% and error rates ranging from 0 to 12.6%. These same variables had sensitivity values ranging from 0.87 to 1.0. Conclusion The very high level of agreement between institutional patient records and the PTAC data for fields compared in this study supports the validity of the PTAC database. For the first time, a population-based patient transfer database has been established. Although it was created

A Method for Estimating BeiDou Inter-frequency Satellite Clock Bias

Directory of Open Access Journals (Sweden)

LI Haojun

2016-02-01

Full Text Available A new method for estimating the BeiDou inter-frequency satellite clock bias is proposed, considering the shortage of the current methods. The constant and variable parts of the inter-frequency satellite clock bias are considered in the new method. The data from 10 observation stations are processed to validate the new method. The characterizations of the BeiDou inter-frequency satellite clock bias are also analyzed using the computed results. The results of the BeiDou inter-frequency satellite clock bias indicate that it is stable in the short term. The estimated BeiDou inter-frequency satellite clock bias results are molded. The model results show that the 10 parameters of model for each satellite can express the BeiDou inter-frequency satellite clock bias well and the accuracy reaches cm level. When the model parameters of the first day are used to compute the BeiDou inter-frequency satellite clock bias of the second day, the accuracy also reaches cm level. Based on the stability and modeling, a strategy for the BeiDou satellite clock service is presented to provide the reference of our BeiDou.

Implementation of a digital preparation validation tool in dental skills laboratory training.

Science.gov (United States)

Kozarovska, A; Larsson, C

2018-05-01

To describe the implementation of a digital tool for preparation validation and evaluate it as an aid in students' self-assessment. Students at the final semester of skills laboratory training were asked to use a digital preparation validation tool (PVT) when performing two different tasks; preparation of crowns for teeth 11 and 21. The students were divided into two groups. Group A self-assessed and scanned all three attempts at 21 ("prep-and-scan"). Group B self-assessed all attempts chose the best one and scanned it ("best-of-three"). The situation was reversed for 11. The students assessed five parameters of the preparation and marked them as approved (A) or failed (F). These marks were compared with the information from the PVT. The students also completed a questionnaire. Each question was rated from 1 to 5. Teachers' opinions were collected at staff meetings throughout the project. Most students in the "prep-and-scan" groups showed an increase in agreement between their self-assessment and the information from the PVT, whereas students in the "best-of-three" groups showed lower levels of agreement. All students rated the PVT positively. Most strongly agreed that the tool was helpful in developing skills (mean 4.15), easy to use (mean 4.23) and that it added benefits in comparison to existing assessment tools (mean 4.05). They did not however, fully agree that the tool is time efficient (mean 2.55), and they did not consider it a substitute for verbal teacher feedback. Teachers' feedback suggested advantages of the tool in the form of ease of use, visual aid and increasing interest and motivation during skills laboratory training however, they did not notice a reduction in need of verbal feedback. Within the limitations of the study, our conclusion is that a digital PVT may be a valuable adjunct to other assessment tools in skills laboratory training. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Validation of a same-day real-time PCR method for screening of meat and carcass swabs for Salmonella

DEFF Research Database (Denmark)

Löfström, Charlotta; Krause, Michael; Josefsen, Mathilde Hartmann

2009-01-01

of the published PCR methods for Salmonella have been validated in collaborative studies. This study describes a validation including comparative and collaborative trials, based on the recommendations from the Nordic organization for validation of alternative microbiological methods (NordVal) of a same-day, non....... Partly based on results obtained in this study, the method has obtained NordVal approval for analysis of Salmonella in meat and carcass swabs. The PCR method was transferred to a production laboratory and the performance was compared with the BAX Salmonella test on 39 pork samples artificially...... contaminated with Salmonella. There was no significant difference in the results obtained by the two methods. Conclusion: The real-time PCR method for detection of Salmonella in meat and carcass swabs was validated in comparative and collaborative trials according to NordVal recommendations. The PCR method...

Can Findings from Randomized Controlled Trials of Social Skills Training in Autism Spectrum Disorder Be Generalized? The Neglected Dimension of External Validity

Science.gov (United States)

Jonsson, Ulf; Olsson, Nora Choque; Bölte, Sven

2016-01-01

Systematic reviews have traditionally focused on internal validity, while external validity often has been overlooked. In this study, we systematically reviewed determinants of external validity in the accumulated randomized controlled trials of social skills group interventions for children and adolescents with autism spectrum disorder. We…

Medizinbibliotheken: inter:disziplinär – inter:national –inter:aktiv

Directory of Open Access Journals (Sweden)

Bauer, Bruno

2017-12-01

Full Text Available The focus of the current issue 3/2017 of GMS Medizin – Bibliothek – Information is the annual conference 2017 of the German Medical Libraries Association in Vienna. The motto of the conference was “Medical Libraries: inter:disciplinary – inter:national – inter:active”. The authors in this issue are Bruno Bauer (Austrian Transition to Open Access 2017–2020, Beata Górczynska (Development and structure of Polish veterinary school system and its libraries, Katharina Heldt, Henriette Senst & Jessica Riedel (Salon on the institute’s history: outstanding artifacts. 28.01.2016 to 15.12.2016, Jutta Matrisciano, Martina Semmler-Schmetz & Saskia Rohmer (Advice – From info snack to special menu: Solutions of the MedMA-Bib, Stefan Nortmann (The ‘Ersti-Café’ of the Medical Branch Library Münster, Sandra Rümmele (Toolbox: The new teaching library project of the Central Medical Library of the University Medical Center Hamburg-Eppendorf, Eva Seidlmayer & Christoph Poley (One Health – Transdisciplinarity at ZB MED and Heike Andermann (“Medical Libraries: inter:disciplinary – inter:national – inter:active”. Annual Meeting of the German Medical Library Association (AGMB, September 25 to 27, 2017 in Vienna. Furthermore this focus issue features articles from Stefan Grün & Christoph Poley (Statistical evaluation of semantic entities from metadata and full text on German Medical Science corpora and Iris Reimann (German MLA News; Competition of the German MLA Pioneer projects in medical libraries 2017: Introduction of the winners; Competition of the German MLA (AGMB Pioneer projects in medical libraries 2018 – Announcement.

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

Science.gov (United States)

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

2014-01-01

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

Foot-and-mouth disease virus: A first inter-laboratory comparison trial to evaluate virus isolation and RT-PCR detection methods.

NARCIS (Netherlands)

Ferris, N.P.; King, D.P.; Reid, S.M.; Hutchings, G.H.; Shawa, A.E.; Paton, D.J.; Goris, N.; Haas, B.; Hoffmann, B.; Brocchi, E.; Bugnetti, M.; Dekker, A.; Clerq, De K.

2006-01-01

Five European reference laboratories participated in an exercise to evaluate the sensitivity and specificity of their routinely employed RT-PCR tests and cell cultures for the detection and isolation of foot-and-mouth disease (FMD) virus. Five identical sets of 20 coded samples were prepared from 10

Validation of a new strength measurement device for amyotrophic lateral sclerosis clinical trials.

Science.gov (United States)

Andres, Patricia L; Skerry, Linda M; Munsat, Theodore L; Thornell, Brenda J; Szymonifka, Jackie; Schoenfeld, David A; Cudkowicz, Merit E

2012-01-01

Strength measures with reduced variability and higher sensitivity could improve efficiency in clinical trials of amyotrophic lateral sclerosis (ALS). The Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure force in 12 muscle groups. In this study we evaluate the reliability and validity of the ATLIS testing protocol. Twenty healthy adults and 10 patients with ALS were tested twice by the same or by different evaluators to determine test-retest and interrater reliability. Twenty healthy adults were examined using ATLIS and a well-validated strength testing protocol (TQNE) to assess criterion-based validity. Mean absolute variation between tests was 8.6%, and intraclass correlation coefficients for each muscle group were high (range 0.82-0.99). The Pearson correlation coefficient of mean ATLIS and TQNE scores was 0.90. A subject survey demonstrated high user acceptance of ATLIS. ATLIS is convenient for patients and evaluators, produces precise strength measurements, and is easily moved between examining rooms. Copyright © 2011 Wiley Periodicals, Inc.

A new AMS facility at Inter University Accelerator Centre, New Delhi

Energy Technology Data Exchange (ETDEWEB)

Kumar, Pankaj, E-mail: pkb@iuac.res.in [Inter-University Accelerator Center (IUAC), New Delhi (India); Chopra, S. [Inter-University Accelerator Center (IUAC), New Delhi (India); Pattanaik, J.K. [Department of Earth Sciences, Indian Institute of Science Education and Research Kolkata, Nadia, WB (India); Ojha, S.; Gargari, S.; Joshi, R.; Kanjilal, D. [Inter-University Accelerator Center (IUAC), New Delhi (India)

2015-10-15

Inter University Accelerator Centre (IUAC), a national facility of government of India, is having a 15UD Pelletron accelerator for multidisciplinary ion beam based research programs. Recently, a new accelerator mass spectrometry (AMS) facility has been developed after incorporating many changes in the existing 15UD Pelletron accelerator. A clean chemistry laboratory for {sup 10}Be and {sup 26}Al with all the modern facilities has also been developed for the chemical processing of samples. {sup 10}Be measurements on sediment samples, inter laboratory comparison results and {sup 26}Al measurements on standard samples are presented in this paper. In addition to the {sup 10}Be and {sup 26}Al AMS facilities, a new {sup 14}C AMS facility based on a dedicated 500 kV tandem ion accelerator with two cesium sputter ion sources, is also being setup at IUAC.

The development, validation, and utility of the Diabetes Prevention Trial-Type 1 Risk Score (DPTRS).

Science.gov (United States)

Sosenko, Jay M; Skyler, Jay S; Palmer, Jerry P

2015-08-01

This report details the development, validation, and utility of the Diabetes Prevention Trial-Type 1 (DPT-1) Risk Score (DPTRS) for type 1 diabetes (T1D). Proportional hazards regression was used to develop the DPTRS model which includes the glucose and C-peptide sums from oral glucose tolerance tests at 30, 60, 90, and 120 min, the log fasting C-peptide, age, and the log BMI. The DPTRS was externally validated in the TrialNet Natural History Study cohort (TNNHS). In a study of the application of the DPTRS, the findings showed that it could be used to identify normoglycemic individuals who were at a similar risk for T1D as those with dysglycemia. The DPTRS could also be used to identify lower risk dysglycemic individuals. Risk estimates of individuals deemed to be at higher risk according to DPTRS values did not differ significantly between the DPT-1 and the TNNHS; whereas, the risk estimates for those with dysglycemia were significantly higher in DPT-1. Individuals with very high DPTRS values were found to be at such marked risk for T1D that they could reasonably be considered to be in a pre-diabetic state. The findings indicate that the DPTRS has utility in T1D prevention trials and for identifying pre-diabetic individuals.

Heart rate variability during acute psychosocial stress: A randomized cross-over trial of verbal and non-verbal laboratory stressors.

Science.gov (United States)

Brugnera, Agostino; Zarbo, Cristina; Tarvainen, Mika P; Marchettini, Paolo; Adorni, Roberta; Compare, Angelo

2018-05-01

Acute psychosocial stress is typically investigated in laboratory settings using protocols with distinctive characteristics. For example, some tasks involve the action of speaking, which seems to alter Heart Rate Variability (HRV) through acute changes in respiration patterns. However, it is still unknown which task induces the strongest subjective and autonomic stress response. The present cross-over randomized trial sought to investigate the differences in perceived stress and in linear and non-linear analyses of HRV between three different verbal (Speech and Stroop) and non-verbal (Montreal Imaging Stress Task; MIST) stress tasks, in a sample of 60 healthy adults (51.7% females; mean age = 25.6 ± 3.83 years). Analyses were run controlling for respiration rates. Participants reported similar levels of perceived stress across the three tasks. However, MIST induced a stronger cardiovascular response than Speech and Stroop tasks, even after controlling for respiration rates. Finally, women reported higher levels of perceived stress and lower HRV both at rest and in response to acute psychosocial stressors, compared to men. Taken together, our results suggest the presence of gender-related differences during psychophysiological experiments on stress. They also suggest that verbal activity masked the vagal withdrawal through altered respiration patterns imposed by speaking. Therefore, our findings support the use of highly-standardized math task, such as MIST, as a valid and reliable alternative to verbal protocols during laboratory studies on stress. Copyright © 2018 Elsevier B.V. All rights reserved.

Comparative Indoor and Outdoor Degradation of Organic Photovoltaic Cells via Inter-laboratory Collaboration

DEFF Research Database (Denmark)

Owens, Charles; Ferguson, Gretta Mae; Hermenau, Martin

2015-01-01

We report on the degradation of organic photovoltaic (OPV) cells in both indoor and outdoor environments. Eight different research groups contributed state of the art OPV cells to be studied at Pomona College. Power conversion efficiency, fill factor, and IV curves were collected at regular inter...

Angiographic core laboratory reproducibility analyses: implications for planning clinical trials using coronary angiography and left ventriculography end-points.

Science.gov (United States)

Steigen, Terje K; Claudio, Cheryl; Abbott, David; Schulzer, Michael; Burton, Jeff; Tymchak, Wayne; Buller, Christopher E; John Mancini, G B

2008-06-01

To assess reproducibility of core laboratory performance and impact on sample size calculations. Little information exists about overall reproducibility of core laboratories in contradistinction to performance of individual technicians. Also, qualitative parameters are being adjudicated increasingly as either primary or secondary end-points. The comparative impact of using diverse indexes on sample sizes has not been previously reported. We compared initial and repeat assessments of five quantitative parameters [e.g., minimum lumen diameter (MLD), ejection fraction (EF), etc.] and six qualitative parameters [e.g., TIMI myocardial perfusion grade (TMPG) or thrombus grade (TTG), etc.], as performed by differing technicians and separated by a year or more. Sample sizes were calculated from these results. TMPG and TTG were also adjudicated by a second core laboratory. MLD and EF were the most reproducible, yielding the smallest sample size calculations, whereas percent diameter stenosis and centerline wall motion require substantially larger trials. Of the qualitative parameters, all except TIMI flow grade gave reproducibility characteristics yielding sample sizes of many 100's of patients. Reproducibility of TMPG and TTG was only moderately good both within and between core laboratories, underscoring an intrinsic difficulty in assessing these. Core laboratories can be shown to provide reproducibility performance that is comparable to performance commonly ascribed to individual technicians. The differences in reproducibility yield huge differences in sample size when comparing quantitative and qualitative parameters. TMPG and TTG are intrinsically difficult to assess and conclusions based on these parameters should arise only from very large trials.

Inter-trial alignment of EEG data and phase-locking

Science.gov (United States)

Testorf, M. E.; Horak, P.; Connolly, A.; Holmes, G. L.; Jobst, B. C.

2015-09-01

Neuro-scientific studies are often aimed at imaging brain activity, which is time-locked to external stimuli. This provides the possibility to use statistical methods to extract even weak signal components, which occur with each stimulus. For electroencephalographic recordings this concept is limited by inevitable time jitter, which cannot be controlled in all cases. Our study is based on a cross-correlation analysis of trials to alignment trials based on the recorded data. This is demonstrated both with simulated signals and with clinical EEG data, which were recorded intracranially. Special attention is given to the evaluation of the time-frequency resolved phase-locking across multiple trails.

Validation of a laboratory method for evaluating dynamic properties of reconstructed equine racetrack surfaces.

Directory of Open Access Journals (Sweden)

Jacob J Setterbo

Full Text Available Racetrack surface is a risk factor for racehorse injuries and fatalities. Current research indicates that race surface mechanical properties may be influenced by material composition, moisture content, temperature, and maintenance. Race surface mechanical testing in a controlled laboratory setting would allow for objective evaluation of dynamic properties of surface and factors that affect surface behavior.To develop a method for reconstruction of race surfaces in the laboratory and validate the method by comparison with racetrack measurements of dynamic surface properties.Track-testing device (TTD impact tests were conducted to simulate equine hoof impact on dirt and synthetic race surfaces; tests were performed both in situ (racetrack and using laboratory reconstructions of harvested surface materials. Clegg Hammer in situ measurements were used to guide surface reconstruction in the laboratory. Dynamic surface properties were compared between in situ and laboratory settings. Relationships between racetrack TTD and Clegg Hammer measurements were analyzed using stepwise multiple linear regression.Most dynamic surface property setting differences (racetrack-laboratory were small relative to surface material type differences (dirt-synthetic. Clegg Hammer measurements were more strongly correlated with TTD measurements on the synthetic surface than the dirt surface. On the dirt surface, Clegg Hammer decelerations were negatively correlated with TTD forces.Laboratory reconstruction of racetrack surfaces guided by Clegg Hammer measurements yielded TTD impact measurements similar to in situ values. The negative correlation between TTD and Clegg Hammer measurements confirms the importance of instrument mass when drawing conclusions from testing results. Lighter impact devices may be less appropriate for assessing dynamic surface properties compared to testing equipment designed to simulate hoof impact (TTD.Dynamic impact properties of race surfaces

Lead isotopic compositions of environmental certified reference materials for an inter-laboratory comparison of lead isotope analysis

International Nuclear Information System (INIS)

Aung, Nyein Nyein; Uryu, Tsutomu; Yoshinaga, Jun

2004-01-01

Lead isotope ratios, viz. 207 Pb/ 206 Pb and 208 Pb/ 206 Pb, of the commercially available certified reference materials (CRMs) issued in Japan are presented with an objective to provide a data set, which will be useful for the quality assurance of analytical procedures, instrumental performance and method validation of the laboratories involved in environmental lead isotope ratio analysis. The analytical method used in the present study was inductively coupled plasma quadrupole mass spectrometry (ICPQMS) presented by acid digestion and with/without chemical separation of lead from the matrix. The precision of the measurements in terms of the relative standard deviation (RSD) of triplicated analyses was 0.19% and 0.14%, for 207 Pb/ 206 Pb and 208 Pb/ 206 Pb, respectively. The trueness of lead isotope ratio measurements of the present study was tested with a few CRMs, which have been analyzed by other analytical methods and reported in various literature. The lead isotopic ratios of 18 environmental matrix CRMs (including 6 CRMs analyzed for our method validation) are presented and the distribution of their ratios is briefly discussed. (author)

External validity of randomized controlled trials of glycaemic control and vascular disease: how representative are participants?

Science.gov (United States)

Saunders, C; Byrne, C D; Guthrie, B; Lindsay, R S; McKnight, J A; Philip, S; Sattar, N; Walker, J J; Wild, S H

2013-03-01

To describe the proportion of people with Type 2 diabetes living in Scotland who meet eligibility criteria for inclusion in several large randomized controlled trials of glycaemic control to inform physicians and guideline developers about the generalizibility of trial results. A literature review was performed to identify large trials assessing the impact of glycaemic control on risk of macrovascular disease. Inclusion and exclusion criteria from each trial were applied to data on the population of people with a diagnosis of Type 2 diabetes living in Scotland in 2008 (n = 180,590) in a population-based cross-sectional study and the number and proportion of people eligible for each trial was determined. Seven trials were identified. The proportion of people with Type 2 diabetes who met the eligibility criteria for the trials ranged from 3.5 to 50.7%. Trial participants were younger at age of diagnosis of diabetes and at time of trial recruitment than in the Scottish study population. The application of upper age criteria excluded the largest proportion of patients, with up to 39% of people with Type 2 diabetes ineligible for a trial with the most stringent criteria based on age alone. We found that many of the large trials of glycaemic control among people with Type 2 diabetes have limited external validity when applied to a population-based cohort of people with Type 2 diabetes. In particular, the age distribution of trial participants often does not reflect that of people with Type 2 diabetes in a contemporary British population. © 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.

Inter-laboratory validation of procedures for measuring 8-oxo-7,8-dihydrooxoguanine/8-oxo-7,8-dihydro-2`-deoxyguanosine in DNA

DEFF Research Database (Denmark)

Collins, A.R.; Gedik, C.M.; Wood, S.

2002-01-01

The aim of ESCODD, a European Commission funded Concerted Action, is to improve the precision and accuracy of methods for measuring 8-oxo-7,8-dihydroguanine (8-oxoGua) or the nucleoside (8-oxodG). On two occasions, participating laboratories received samples of different concentrations of 8-oxodG...

Aging impairs deliberation and behavioral flexibility in inter-temporal choice

Directory of Open Access Journals (Sweden)

Yannick-Andre eBreton

2015-03-01

Full Text Available Inter-temporal choice depends on multiple, interacting systems, some of which may be compromised with age. Some of these systems may be responsible for ongoing trial-by-trial choice strategies. Some may represent the consequences of action. Some may be necessary for the coupling between anticipated consequences and strategies currently in use, flexibly guiding behavior. When faced with a difficult decision, rats will orient back and forth, a behavior termed ``vicarious trial and error'' (VTE. Recent experiments have linked the occurrence of VTE to hippocampal search processes and behavioral flexibility. We tested 5 month (n=6, 9 month (n=8 and over-27 month-old (n=10 rats on a Spatial Adjusting Delay Discounting task to examine how aging impacted lap-by-lap strategies and VTE during inter-temporal choice. Rats chose between spatially separated food goals that provided a smaller-sooner or larger-later reward. On each lap, the delay to the larger-later reward was adjusted as a function of the rat's decisions, increasing by 1 second after delayed-side choices and decreasing by 1 second after non-delayed side choices. The strategies that aged rats used differed from those used in young and adult rats. Moreover, aged rats produced reliably more VTE behaviors, for protracted periods of time, uncoupled from behavioral flexibility.

[The development and validation of the methods for the quantitative determination of sibutramine derivatives in dietary supplements].

Science.gov (United States)

Stern, K I; Malkova, T L

The objective of the present study was the development and validation of sibutramine demethylated derivatives, desmethyl sibutramine and didesmethyl sibutramine. Gas-liquid chromatography with the flame ionization detector was used for the quantitative determination of the above substances in dietary supplements. The conditions for the chromatographic determination of the analytes in the presence of the reference standard, methyl stearate, were proposed allowing to achieve the efficient separation. The method has the necessary sensitivity, specificity, linearity, accuracy, and precision (on the intra-day and inter-day basis) which suggests its good validation characteristics. The proposed method can be employed in the analytical laboratories for the quantitative determination of sibutramine derivatives in biologically active dietary supplements.

Development and validation of optimal cut-off value in inter-arm systolic blood pressure difference for prediction of cardiovascular events.

Science.gov (United States)

Hirono, Akira; Kusunose, Kenya; Kageyama, Norihito; Sumitomo, Masayuki; Abe, Masahiro; Fujinaga, Hiroyuki; Sata, Masataka

2018-01-01

An inter-arm systolic blood pressure difference (IAD) is associated with cardiovascular disease. The aim of this study was to develop and validate the optimal cut-off value of IAD as a predictor of major adverse cardiac events in patients with arteriosclerosis risk factors. From 2009 to 2014, 1076 patients who had at least one cardiovascular risk factor were included in the analysis. We defined 700 randomly selected patients as a development cohort to confirm that IAD was the predictor of cardiovascular events and to determine optimal cut-off value of IAD. Next, we validated outcomes in the remaining 376 patients as a validation cohort. The blood pressure (BP) of both arms measurements were done simultaneously using the ankle-brachial blood pressure index (ABI) form of automatic device. The primary endpoint was the cardiovascular event and secondary endpoint was the all-cause mortality. During a median period of 2.8 years, 143 patients reached the primary endpoint in the development cohort. In the multivariate Cox proportional hazards analysis, IAD was the strong predictor of cardiovascular events (hazard ratio: 1.03, 95% confidence interval: 1.01-1.05, p=0.005). The receiver operating characteristic curve revealed that 5mmHg was the optimal cut-off point of IAD to predict cardiovascular events (p<0.001). In the validation cohort, the presence of a large IAD (IAD ≥5mmHg) was significantly associated with the primary endpoint (p=0.021). IAD is significantly associated with future cardiovascular events in patients with arteriosclerosis risk factors. The optimal cut-off value of IAD is 5mmHg. Copyright © 2017 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

PIG's Speed Estimated with Pressure Transducers and Hall Effect Sensor: An Industrial Application of Sensors to Validate a Testing Laboratory.

Science.gov (United States)

Lima, Gustavo F; Freitas, Victor C G; Araújo, Renan P; Maitelli, André L; Salazar, Andrés O

2017-09-15

The pipeline inspection using a device called Pipeline Inspection Gauge (PIG) is safe and reliable when the PIG is at low speeds during inspection. We built a Testing Laboratory, containing a testing loop and supervisory system to study speed control techniques for PIGs. The objective of this work is to present and validate the Testing Laboratory, which will allow development of a speed controller for PIGs and solve an existing problem in the oil industry. The experimental methodology used throughout the project is also presented. We installed pressure transducers on pipeline outer walls to detect the PIG's movement and, with data from supervisory, calculated an average speed of 0.43 m/s. At the same time, the electronic board inside the PIG received data from odometer and calculated an average speed of 0.45 m/s. We found an error of 4.44%, which is experimentally acceptable. The results showed that it is possible to successfully build a Testing Laboratory to detect the PIG's passage and estimate its speed. The validation of the Testing Laboratory using data from the odometer and its auxiliary electronic was very successful. Lastly, we hope to develop more research in the oil industry area using this Testing Laboratory.

Validation of a Hot Water Distribution Model Using Laboratory and Field Data

Energy Technology Data Exchange (ETDEWEB)

Backman, C. [Alliance for Residential Building Innovation (ARBI), Davis, CA (United States); Hoeschele, M. [Alliance for Residential Building Innovation (ARBI), Davis, CA (United States)

2013-07-01

Characterizing the performance of hot water distribution systems is a critical step in developing best practice guidelines for the design and installation of high performance hot water systems. Developing and validating simulation models is critical to this effort, as well as collecting accurate input data to drive the models. In this project, the Building America research team ARBI validated the newly developed TRNSYS Type 604 pipe model against both detailed laboratory and field distribution system performance data. Validation efforts indicate that the model performs very well in handling different pipe materials, insulation cases, and varying hot water load conditions. Limitations of the model include the complexity of setting up the input file and long simulation run times. This project also looked at recent field hot water studies to better understand use patterns and potential behavioral changes as homeowners convert from conventional storage water heaters to gas tankless units. The team concluded that the current Energy Factor test procedure overestimates typical use and underestimates the number of hot water draws, which has implications for both equipment and distribution system performance. Gas tankless water heaters were found to impact how people use hot water, but the data does not necessarily suggest an increase in usage. Further study in hot water usage and patterns is needed to better define these characteristics in different climates and home vintages.

Los Alamos and Lawrence Livermore National Laboratories Code-to-Code Comparison of Inter Lab Test Problem 1 for Asteroid Impact Hazard Mitigation

Energy Technology Data Exchange (ETDEWEB)

Weaver, Robert P. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Miller, Paul [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Howley, Kirsten [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Ferguson, Jim Michael [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Gisler, Galen Ross [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Plesko, Catherine Suzanne [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Managan, Rob [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Owen, Mike [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Wasem, Joseph [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Bruck-Syal, Megan [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)

2016-01-15

The NNSA Laboratories have entered into an interagency collaboration with the National Aeronautics and Space Administration (NASA) to explore strategies for prevention of Earth impacts by asteroids. Assessment of such strategies relies upon use of sophisticated multi-physics simulation codes. This document describes the task of verifying and cross-validating, between Lawrence Livermore National Laboratory (LLNL) and Los Alamos National Laboratory (LANL), modeling capabilities and methods to be employed as part of the NNSA-NASA collaboration. The approach has been to develop a set of test problems and then to compare and contrast results obtained by use of a suite of codes, including MCNP, RAGE, Mercury, Ares, and Spheral. This document provides a short description of the codes, an overview of the idealized test problems, and discussion of the results for deflection by kinetic impactors and stand-off nuclear explosions.

Validity of Qualis database as a predictor of evidence hierarchy and risk of bias in randomized controlled trials: a case study in dentistry

Directory of Open Access Journals (Sweden)

Christiane Alves Ferreira

2011-01-01

Full Text Available OBJECTIVE: To evaluate the validity of the Qualis database in identifying the levels of scientific evidence and the quality of randomized controlled trials indexed in the Lilacs database. METHODS: We selected 40 open-access journals and performed a page-by-page hand search, to identify published articles according to the type of study during a period of six years. Classification of studies was performed by independent reviewers assessed for their reliability. Randomized controlled trials were identified for separate evaluation of risk of bias using four dimensions: generation of allocation sequence, allocation concealment, blinding, and incomplete outcome data. The Qualis classification was considered to be the outcome variable. The statistical tests used included Kappa, Spearman's correlation, Kendall-tau and ordinal regressions. RESULTS: Studies with low levels of scientific evidence received similar Qualis classifications when compared to studies with high levels of evidence. In addition, randomized controlled trials with a high risk of bias for the generation of allocation sequences and allocation concealment were more likely to be published in journals with higher Qualis levels. DISCUSSION: The hierarchy level of the scientific evidence as classified by type of research design, as well as by the validity of studies according to the bias control level, was not correlated or associated with Qualis stratification. CONCLUSION: Qualis classifications for journals are not an approximate or indirect predictor of the validity of randomized controlled trials published in these journals and are therefore not a legitimate or appropriate indicator of the validity of randomized controlled trials.

[Inter-and intra-operator variability in the analysis of semen parameters: results from a quality control program].

Science.gov (United States)

Daoud, Salima; Chakroun-Feki, Nozha; Sellami, Afifa; Ammar-Keskes, Leila; Rebai, Tarek

2016-01-01

Semen analysis is a key part of male infertility investigation. The necessity of quality management implementation in the andrology laboratory has been recognized in order to ensure the reliability of its results. The aim of this study was to evaluate intra- and inter-individual variability in the assessment of semen parameters in our laboratory through a quality control programme. Four participants from the laboratory with different experience levels have participated in this study. Semen samples of varying quality were assessed for sperm motility, concentration and morphology and the results were used to evaluate inter-participant variability. In addition, replicates of each semen sample were analyzed to determine intra-individual variability for semen parameters analysis. The average values of inter-participant coefficients of variation for sperm motility, concentration and morphology were 12.8%, 19.8% and 48.9% respectively. The mean intra-participant coefficients of variation were, respectively, 6.9%, 12.3% and 42.7% for sperm motility, concentration and morphology. Despite some random errors of under- or overestimation, the overall results remained within the limits of acceptability for all participants. Sperm morphology assessment was particularly influenced by the participant's level of experience. The present data emphasize the need for appropriate training of the laboratory staff and for regular participation in internal quality control programmes in order to improve the reliability of laboratory results.

Chromogenic in situ hybridisation for the assessment of HER2 status in breast cancer: an international validation ring study

Science.gov (United States)

van de Vijver, Marc; Bilous, Michael; Hanna, Wedad; Hofmann, Manfred; Kristel, Petra; Penault-Llorca, Frédérique; Rüschoff, Josef

2007-01-01

Introduction Before any new methodology can be introduced into the routine diagnostic setting it must be technically validated against the established standards. To this end, a ring study involving five international pathology laboratories was initiated to validate chromogenic in situ hybridisation (CISH) against fluorescence in situ hybridisation (FISH) and immunohistochemistry (IHC) as a test for assessing human epidermal growth factor receptor 2 (HER2) status in breast cancer. Methods Each laboratory performed CISH, FISH and IHC on its own samples. Unstained sections from each case were also sent to another participating laboratory for blinded retesting by CISH ('outside CISH'). Results A total of 211 invasive breast carcinoma cases were tested. In 76 cases with high amplification (HER2/CEP17 ratio >4.0) by FISH, 73 cases (96%) scored positive (scores ≥ 6) by 'outside CISH'. For FISH-negative cases (HER2/CEP17 ratio CISH scores indicating no amplification (score ≤ 5), and only three cases were positive by CISH; in the three remaining cases, no CISH result could be obtained. For cases with low-level amplification using FISH (HER2/CEP17 ratio 2.0–4.0), 20 of 35 had CISH scores indicating gene amplification. Inter-laboratory concordance was also very high: 95% for normal HER2 copy number (1–5 copies); and 92% for cases with HER2 copy numbers ≥ 6. CISH intra-laboratory concordance with IHC was 92% for IHC-negative cases (IHC 0/1+) and 91% for IHC 3+ cases. Among IHC 2+ cases, CISH was 100% concordant with samples showing high amplification by FISH, and 94% concordant with FISH-negative samples. Conclusion These results show that CISH inter- and intra-laboratory concordance to FISH and IHC is very high, even in equivocal IHC 2+ cases. Therefore, we conclude that CISH is a methodology that is a viable alternative to FISH in the HER2 testing algorithm. PMID:17922920

High-throughput screening assay used in pharmacognosy: Selection, optimization and validation of methods of enzymatic inhibition by UV-visible spectrophotometry

Directory of Open Access Journals (Sweden)

Graciela Granados-Guzmán

2014-02-01

Full Text Available In research laboratories of both organic synthesis and extraction of natural products, every day a lot of products that can potentially introduce some biological activity are obtained. Therefore it is necessary to have in vitro assays, which provide reliable information for further evaluation in in vivo systems. From this point of view, in recent years has intensified the use of high-throughput screening assays. Such trials should be optimized and validated for accurate and precise results, i.e. reliable. The present review addresses the steps needed to develop and validate bioanalytical methods, emphasizing UV-Visible spectrophotometry as detection system. Particularly focuses on the selection of the method, the optimization to determine the best experimental conditions, validation, implementation of optimized and validated method to real samples, and finally maintenance and possible transfer it to a new laboratory.

Reducing Inter-Laboratory Differences between Semen Analyses Using Z Score and Regression Transformations

Directory of Open Access Journals (Sweden)

Esther Leushuis

2016-12-01

Full Text Available Background: Standardization of the semen analysis may improve reproducibility. We assessed variability between laboratories in semen analyses and evaluated whether a transformation using Z scores and regression statistics was able to reduce this variability. Materials and Methods: We performed a retrospective cohort study. We calculated between-laboratory coefficients of variation (CVB for sperm concentration and for morphology. Subsequently, we standardized the semen analysis results by calculating laboratory specific Z scores, and by using regression. We used analysis of variance for four semen parameters to assess systematic differences between laboratories before and after the transformations, both in the circulation samples and in the samples obtained in the prospective cohort study in the Netherlands between January 2002 and February 2004. Results: The mean CVB was 7% for sperm concentration (range 3 to 13% and 32% for sperm morphology (range 18 to 51%. The differences between the laboratories were statistically significant for all semen parameters (all P<0.001. Standardization using Z scores did not reduce the differences in semen analysis results between the laboratories (all P<0.001. Conclusion: There exists large between-laboratory variability for sperm morphology and small, but statistically significant, between-laboratory variation for sperm concentration. Standardization using Z scores does not eliminate between-laboratory variability.

Development and Psychometric Properties of an Assessment for Persons with Intellectual Disability--The InterRAI ID

Science.gov (United States)

Martin, Lynn; Hirdes, John P.; Fries, Brant E.; Smith, Trevor F.

2007-01-01

This paper describes the development of the interRAI-Intellectual Disability (interRAI ID), a comprehensive instrument that assesses all key domains of interest to service providers relative to a person with an intellectual disability (ID). The authors report on the reliability and validity of embedded scales for cognition, self-care, aggression,…

Toddler physical activity study: laboratory and community studies to evaluate accelerometer validity and correlates

Directory of Open Access Journals (Sweden)

Erin R. Hager

2016-09-01

Full Text Available Abstract Background Toddlerhood is an important age for physical activity (PA promotion to prevent obesity and support a physically active lifestyle throughout childhood. Accurate assessment of PA is needed to determine trends/correlates of PA, time spent in sedentary, light, or moderate-vigorous PA (MVPA, and the effectiveness of PA promotion programs. Due to the limited availability of objective measures that have been validated and evaluated for feasibility in community studies, it is unclear which subgroups of toddlers are at the highest risk for inactivity. Using Actical ankle accelerometry, the objectives of this study are to develop valid thresholds, examine feasibility, and examine demographic/ anthropometric PA correlates of MVPA among toddlers from low-income families. Methods Two studies were conducted with toddlers (12–36 months. Laboratory Study (n = 24- Two Actical accelerometers were placed on the ankle. PA was observed using the Child Activity Rating Scale (CARS, prescribed activities. Analyses included device equivalence reliability (correlation: activity counts of two Acticals, criterion-related validity (correlation: activity counts and CARS ratings, and sensitivity/specificity for thresholds. Community Study (n = 277, low-income mother-toddler dyads recruited- An Actical was worn on the ankle for > 7 days (goal >5, 24-h days. Height/weight was measured. Mothers reported demographics. Analyses included frequencies (feasibility and stepwise multiple linear regression (sMLR. Results Laboratory Study- Acticals demonstrated reliability (r = 0.980 and validity (r = 0.75. Thresholds demonstrated sensitivity (86 % and specificity (88 %. Community Study- 86 % wore accelerometer, 69 % had valid data (mean = 5.2 days. Primary reasons for missing/invalid data: refusal (14 % and wear-time ≤2 days (11 %. The MVPA threshold (>2200 cpm yielded 54 min/day. In sMLR, MVPA was associated with age (older�

Validation and application of FTIR spectroscopy in raw milk analysis

Directory of Open Access Journals (Sweden)

Kučević Denis S.

2017-01-01

Full Text Available The aim of this study was to investigate whether FTIR spectroscopy is an accurate and valid technique for the assessment of quality parameters in raw cow's milk: fat, protein, lactose, and total solids. The assessment was based on calibration series and comparison with reference material. Furthermore, it takes into account the results obtained in the inter-laboratory comparisons (proficiency testing. The calibration samples were purchased from the accredited regional reference laboratories. The validation parameters included linearity, accuracy, repeatability, reproducibility, and robustness. The linearity ratio was 0.95%. The biases calculated for the fat, protein, lactose and dry matter were -0.33, 0.31, -0.25, and 0.06 respectively. The F value from the F-test was used to determine the significant differences between two independent sets of the results. The obtained results were as follows: 1.469 for fat, 1.634 for protein, 1.192 for lactose, and 0.528 for dry matter. The intra-laboratory reproducibility calculated as the Horwitz Ratios for all parameters were within the criterion limits (0.5 to 0.8. The data obtained for carry-over were 0.27% for fat, 0.52% for protein, 0.47% for lactose, and 0.47% for dry matter. Based on the obtained results it can be concluded that the FTIR spectroscopy is a reliable instrumental technique for the determination of fat, protein, lactose and total solids in raw cow's milk.

Semi-physiologic model validation and bioequivalence trials simulation to select the best analyte for acetylsalicylic acid.

Science.gov (United States)

Cuesta-Gragera, Ana; Navarro-Fontestad, Carmen; Mangas-Sanjuan, Victor; González-Álvarez, Isabel; García-Arieta, Alfredo; Trocóniz, Iñaki F; Casabó, Vicente G; Bermejo, Marival

2015-07-10

The objective of this paper is to apply a previously developed semi-physiologic pharmacokinetic model implemented in NONMEM to simulate bioequivalence trials (BE) of acetyl salicylic acid (ASA) in order to validate the model performance against ASA human experimental data. ASA is a drug with first-pass hepatic and intestinal metabolism following Michaelis-Menten kinetics that leads to the formation of two main metabolites in two generations (first and second generation metabolites). The first aim was to adapt the semi-physiological model for ASA in NOMMEN using ASA pharmacokinetic parameters from literature, showing its sequential metabolism. The second aim was to validate this model by comparing the results obtained in NONMEM simulations with published experimental data at a dose of 1000 mg. The validated model was used to simulate bioequivalence trials at 3 dose schemes (100, 1000 and 3000 mg) and with 6 test formulations with decreasing in vivo dissolution rate constants versus the reference formulation (kD 8-0.25 h (-1)). Finally, the third aim was to determine which analyte (parent drug, first generation or second generation metabolite) was more sensitive to changes in formulation performance. The validation results showed that the concentration-time curves obtained with the simulations reproduced closely the published experimental data, confirming model performance. The parent drug (ASA) was the analyte that showed to be more sensitive to the decrease in pharmaceutical quality, with the highest decrease in Cmax and AUC ratio between test and reference formulations. Copyright © 2015 Elsevier B.V. All rights reserved.

Comparison of swallowing outcomes of laryngotracheal separation versus total laryngectomy in a validated ovine model of profound oropharyngeal dysphagia.

Science.gov (United States)

Venkatesan, N N; Johnson, C M; Siddiqui, M T; Cates, D J; Kuhn, M A; Postma, G N; Belafsky, P C

2017-04-01

To validate the ovine model of profound oropharyngeal dysphagia and compare swallowing outcomes of laryngotracheal separation with those of total laryngectomy. Under real-time fluoroscopy, swallowing trials were conducted using the head and neck of two Dorper cross ewes and one human cadaver, secured in lateral fluoroscopic orientation. Barium trials were administered at baseline, pre- and post-laryngohyoid suspension, following laryngotracheal separation, and following laryngectomy in the ovine model. Mean pre-intervention Penetration Aspiration Scale and National Institutes of Health Swallow Safety Scale scores were 8 ± 0 and 6 ± 0 respectively in sheep and human cadavers, with 100 per cent intra- and inter-species reproducibility. These scores improved to 1 ± 0 and 2 ± 0 post-laryngohyoid suspension (p < 0.01). Aerodigestive tract residue was 18.6 ± 2.4 ml at baseline, 15.4 ± 3.8 ml after laryngotracheal separation and 3.0 ± 0.7 ml after total laryngectomy (p < 0.001). The ovine model displayed perfect intra- and inter- species reliability for the Penetration Aspiration Scale and Swallow Safety Scale. Less aerodigestive tract residue after narrow-field laryngectomy suggests that swallowing outcomes after total laryngectomy are superior to those after laryngotracheal separation.

Validation by simulation of a clinical trial model using the standardized mean and variance criteria.

Science.gov (United States)

Abbas, Ismail; Rovira, Joan; Casanovas, Josep

2006-12-01

To develop and validate a model of a clinical trial that evaluates the changes in cholesterol level as a surrogate marker for lipodystrophy in HIV subjects under alternative antiretroviral regimes, i.e., treatment with Protease Inhibitors vs. a combination of nevirapine and other antiretroviral drugs. Five simulation models were developed based on different assumptions, on treatment variability and pattern of cholesterol reduction over time. The last recorded cholesterol level, the difference from the baseline, the average difference from the baseline and level evolution, are the considered endpoints. Specific validation criteria based on a 10% minus or plus standardized distance in means and variances were used to compare the real and the simulated data. The validity criterion was met by all models for considered endpoints. However, only two models met the validity criterion when all endpoints were considered. The model based on the assumption that within-subjects variability of cholesterol levels changes over time is the one that minimizes the validity criterion, standardized distance equal to or less than 1% minus or plus. Simulation is a useful technique for calibration, estimation, and evaluation of models, which allows us to relax the often overly restrictive assumptions regarding parameters required by analytical approaches. The validity criterion can also be used to select the preferred model for design optimization, until additional data are obtained allowing an external validation of the model.

Authentication scheme for routine verification of genetically similar laboratory colonies: a trial with Anopheles gambiae

Directory of Open Access Journals (Sweden)

Sutcliffe Alice C

2009-10-01

Full Text Available Abstract Background When rearing morphologically indistinguishable laboratory strains concurrently, the threat of unintentional genetic contamination is constant. Avoidance of accidental mixing of strains is difficult due to the use of common equipment, technician error, or the possibility of self relocation by adult mosquitoes ("free fliers". In many cases, laboratory strains are difficult to distinguish because of morphological and genetic similarity, especially when laboratory colonies are isolates of certain traits from the same parental strain, such as eye color mutants, individuals with certain chromosomal arrangements or high levels of insecticide resistance. Thus, proving genetic integrity could seem incredibly time-consuming or impossible. On the other hand, lacking proof of genetically isolated laboratory strains could question the validity of research results. Results We present a method for establishing authentication matrices to routinely distinguish and confirm that laboratory strains have not become physically or genetically mixed through contamination events in the laboratory. We show a specific example with application to Anopheles gambiae sensu stricto strains at the Malaria Research and Reference Reagent Resource Center. This authentication matrix is essentially a series of tests yielding a strain-specific combination of results. Conclusion These matrix-based methodologies are useful for several mosquito and insect populations but must be specifically tailored and altered for each laboratory based on the potential contaminants available at any given time. The desired resulting authentication plan would utilize the least amount of routine effort possible while ensuring the integrity of the strains.

Beetroot Juice Improves On-Water 500 M Time-Trial Performance, and Laboratory-Based Paddling Economy in National and International-Level Kayak Athletes.

Science.gov (United States)

Peeling, Peter; Cox, Gregory R; Bullock, Nicola; Burke, Louise M

2015-06-01

We assessed the ingestion of a beetroot juice supplement (BR) on 4-min laboratory-based kayak performance in national level male (n = 6) athletes (Study A), and on 500 m on-water kayak time-trial (TT) performance in international level female (n = 5) athletes (Study B). In Study A, participants completed three laboratory-based sessions on a kayak ergometer, including a 7 × 4 min step test, and two 4 min maximal effort performance trials. Two and a half hours before the warm-up of each 4 min performance trial, athletes received either a 70 ml BR shot containing ~4.8 mmol of nitrate, or a placebo equivalent (BRPLA). The distance covered over the 4 min TT was not different between conditions; however, the average VO2 over the 4 min period was significantly lower in BR (p = .04), resulting in an improved exercise economy (p = .05). In Study B, participants completed two field-based 500 m TTs, separated by 4 days. Two hours before each trial, athletes received either two 70 ml BR shots containing ~9.6 mmol of nitrate, or a placebo equivalent (BRPLA). BR supplementation significantly enhanced TT performance by 1.7% (p = .01). Our results show that in national-level male kayak athletes, commercially available BR shots (70 ml) containing ~4.8 mmol of nitrate improved exercise economy during laboratory-based tasks predominantly reliant on the aerobic energy system. Furthermore, greater volumes of BR (140 ml; ~9.6 mmol nitrate) provided to international-level female kayak athletes resulted in enhancements to TT performance in the field.

Inter-laboratory verification of European pharmacopoeia monograph on derivative spectrophotometry method and its application for chitosan hydrochloride.

Science.gov (United States)

Marković, Bojan; Ignjatović, Janko; Vujadinović, Mirjana; Savić, Vedrana; Vladimirov, Sote; Karljiković-Rajić, Katarina

2015-01-01

Inter-laboratory verification of European pharmacopoeia (EP) monograph on derivative spectrophotometry (DS) method and its application for chitosan hydrochloride was carried out on two generation of instruments (earlier GBC Cintra 20 and current technology TS Evolution 300). Instruments operate with different versions of Savitzky-Golay algorithm and modes of generating digital derivative spectra. For resolution power parameter, defined as the amplitude ratio A/B in DS method EP monograph, comparable results were obtained only with algorithm's parameters smoothing points (SP) 7 and the 2nd degree polynomial and those provided corresponding data with other two modes on TS Evolution 300 Medium digital indirect and Medium digital direct. Using quoted algorithm's parameters, the differences in percentages between the amplitude ratio A/B averages, were within accepted criteria (±3%) for assay of drug product for method transfer. The deviation of 1.76% for the degree of deacetylation assessment of chitosan hydrochloride, determined on two instruments, (amplitude (1)D202; the 2nd degree polynomial and SP 9 in Savitzky-Golay algorithm), was acceptable, since it was within allowed criteria (±2%) for assay deviation of drug substance, for method transfer in pharmaceutical analyses. Copyright © 2015 Elsevier B.V. All rights reserved.

Fine structure in the inter-critical heat-affected zone of HQ130 super ...

Indian Academy of Sciences (India)

Unknown

†Key Laboratory of Liquid Structure and Heredity of Materials, Ministry of Education, ... The microstructure in the inter-critical heat-affected zone (ICHAZ) of HQ130 steel, has been .... Ac3. The microhardness was measured by using the.

Rating the methodological quality of single-subject designs and n-of-1 trials: introducing the Single-Case Experimental Design (SCED) Scale.

Science.gov (United States)

Tate, Robyn L; McDonald, Skye; Perdices, Michael; Togher, Leanne; Schultz, Regina; Savage, Sharon

2008-08-01

Rating scales that assess methodological quality of clinical trials provide a means to critically appraise the literature. Scales are currently available to rate randomised and non-randomised controlled trials, but there are none that assess single-subject designs. The Single-Case Experimental Design (SCED) Scale was developed for this purpose and evaluated for reliability. Six clinical researchers who were trained and experienced in rating methodological quality of clinical trials developed the scale and participated in reliability studies. The SCED Scale is an 11-item rating scale for single-subject designs, of which 10 items are used to assess methodological quality and use of statistical analysis. The scale was developed and refined over a 3-year period. Content validity was addressed by identifying items to reduce the main sources of bias in single-case methodology as stipulated by authorities in the field, which were empirically tested against 85 published reports. Inter-rater reliability was assessed using a random sample of 20/312 single-subject reports archived in the Psychological Database of Brain Impairment Treatment Efficacy (PsycBITE). Inter-rater reliability for the total score was excellent, both for individual raters (overall ICC = 0.84; 95% confidence interval 0.73-0.92) and for consensus ratings between pairs of raters (overall ICC = 0.88; 95% confidence interval 0.78-0.95). Item reliability was fair to excellent for consensus ratings between pairs of raters (range k = 0.48 to 1.00). The results were replicated with two independent novice raters who were trained in the use of the scale (ICC = 0.88, 95% confidence interval 0.73-0.95). The SCED Scale thus provides a brief and valid evaluation of methodological quality of single-subject designs, with the total score demonstrating excellent inter-rater reliability using both individual and consensus ratings. Items from the scale can also be used as a checklist in the design, reporting and critical

Safety and Toxicity of Saw palmetto in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Trial

Science.gov (United States)

Avins, Andrew L.; Lee, Jeannette Y.; Meyers, Catherine M.; Barry, Michael J.

2013-01-01

Purpose Extracts of the saw palmetto berry are used by many men in the U.S. as self-treatment for lower urinary tract symptoms due to benign prostatic hyperplasia. While the most recent data from double-blind clinical trials do not support efficacy superior to that of placebo, there are few data on the toxicity of saw palmetto. Materials and Methods 369 patients were randomized in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) trial; 357 participants are included in this modified intention-to-treat analysis. Participants were randomized to 320mg, 640mg, and 960mg daily of an ethanolic saw palmetto extract or an identical-appearing placebo, in an escalating manner at 6-month intervals, for a total of 18 months follow-up. Adverse-event assessments, vital signs, and blood and urine laboratory tests were obtained at regular intervals. Results There were no statistically significant differences between groups in rates of serious or non-serious adverse events, changes in vital signs, digital prostate exam findings, or study withdrawal rates. Overall, there were no significant inter-group differences in the occurrence of laboratory-test abnormalities; differences in individual laboratory tests were uncommon and small in magnitude. No evidence of significant dose-response phenomena were identified. Conclusions The saw palmetto extract used in the CAMUS trial showed no evidence of toxicity at doses up to three times the usual clinical dose over a period of 18 months. PMID:23063633

Lawrence Livermore National Laboratory Probabilistic Seismic Hazard Codes Validation

International Nuclear Information System (INIS)

Savy, J B

2003-01-01

Probabilistic Seismic Hazard Analysis (PSHA) is a methodology that estimates the likelihood that various levels of earthquake-caused ground motion will be exceeded at a given location in a given future time-period. LLNL has been developing the methodology and codes in support of the Nuclear Regulatory Commission (NRC) needs for reviews of site licensing of nuclear power plants, since 1978. A number of existing computer codes have been validated and still can lead to ranges of hazard estimates in some cases. Until now, the seismic hazard community had not agreed on any specific method for evaluation of these codes. The Earthquake Engineering Research Institute (EERI) and the Pacific Engineering Earthquake Research (PEER) center organized an exercise in testing of existing codes with the aim of developing a series of standard tests that future developers could use to evaluate and calibrate their own codes. Seven code developers participated in the exercise, on a voluntary basis. Lawrence Livermore National laboratory participated with some support from the NRC. The final product of the study will include a series of criteria for judging of the validity of the results provided by a computer code. This EERI/PEER project was first planned to be completed by June of 2003. As the group neared completion of the tests, the managing team decided that new tests were necessary. As a result, the present report documents only the work performed to this point. It demonstrates that the computer codes developed by LLNL perform all calculations correctly and as intended. Differences exist between the results of the codes tested, that are attributed to a series of assumptions, on the parameters and models, that the developers had to make. The managing team is planning a new series of tests to help in reaching a consensus on these assumptions

Validity and reliability of a novel immunosuppressive adverse effects scoring system in renal transplant recipients.

Science.gov (United States)

Meaney, Calvin J; Arabi, Ziad; Venuto, Rocco C; Consiglio, Joseph D; Wilding, Gregory E; Tornatore, Kathleen M

2014-06-12

After renal transplantation, many patients experience adverse effects from maintenance immunosuppressive drugs. When these adverse effects occur, patient adherence with immunosuppression may be reduced and impact allograft survival. If these adverse effects could be prospectively monitored in an objective manner and possibly prevented, adherence to immunosuppressive regimens could be optimized and allograft survival improved. Prospective, standardized clinical approaches to assess immunosuppressive adverse effects by health care providers are limited. Therefore, we developed and evaluated the application, reliability and validity of a novel adverse effects scoring system in renal transplant recipients receiving calcineurin inhibitor (cyclosporine or tacrolimus) and mycophenolic acid based immunosuppressive therapy. The scoring system included 18 non-renal adverse effects organized into gastrointestinal, central nervous system and aesthetic domains developed by a multidisciplinary physician group. Nephrologists employed this standardized adverse effect evaluation in stable renal transplant patients using physical exam, review of systems, recent laboratory results, and medication adherence assessment during a clinic visit. Stable renal transplant recipients in two clinical studies were evaluated and received immunosuppressive regimens comprised of either cyclosporine or tacrolimus with mycophenolic acid. Face, content, and construct validity were assessed to document these adverse effect evaluations. Inter-rater reliability was determined using the Kappa statistic and intra-class correlation. A total of 58 renal transplant recipients were assessed using the adverse effects scoring system confirming face validity. Nephrologists (subject matter experts) rated the 18 adverse effects as: 3.1 ± 0.75 out of 4 (maximum) regarding clinical importance to verify content validity. The adverse effects scoring system distinguished 1.75-fold increased gastrointestinal adverse

PIDIE, plutonium isotopic determination inter-comparison exercise

International Nuclear Information System (INIS)

Harry, R.J.S.

1990-07-01

PIDIE (Plutonium Isotopic Determination Inter-comparison Exercise) is one of the projects of the ESARDA Working Group on Techniques and Standards for Non-Destructive Analysis. PIDIE is placed against the historical background of the general development of international standards. Its results are also reviewed in the light of the original purpose of the project. Sets of seven sealed Pu samples of different isotopic composition, each containing 0,45 grammes, were sent to the 9 participating laboratories for three separate determinations of the unknown isotopic composition, to investigate error sources and , if possible to improve the knowledge of γ-emission probabilities. An additional question was to examine the possible improvement of such measurements using reference samples. No important bias has been observed in the results of this inter-comparison. The apparent improvement in the precision and accuracy of the result seems to arise from both better equipment and more elaborate spectrum evaluation methods. (author). 39 refs.; 1 fig.; 5 tabs

Validity of a heart rate monitor during work in the laboratory and on the Space Shuttle

Science.gov (United States)

Moore, A. D. Jr; Lee, S. M.; Greenisen, M. C.; Bishop, P.

1997-01-01

Accurate heart rate measurement during work is required for many industrial hygiene and ergonomics situations. The purpose of this investigation was to determine the validity of heart rate measurements obtained by a simple, lightweight, commercially available wrist-worn heart rate monitor (HRM) during work (cycle exercise) sessions conducted in the laboratory and also during the particularly challenging work environment of space flight. Three different comparisons were made. The first compared HRM data to simultaneous electrocardiogram (ECG) recordings of varying heart rates that were generated by an ECG simulator. The second compared HRM data to ECG recordings collected during work sessions of 14 subjects in the laboratory. Finally, ECG downlink and HRM data were compared in four astronauts who performed cycle exercise during space flight. The data were analyzed using regression techniques. The results were that the HRM recorded virtually identical heart rates compared with ECG recordings for the data set generated by an ECG simulator. The regression equation for the relationship between ECG versus HRM heart rate data during work in the laboratory was: ECG HR = 0.99 x (HRM) + 0.82 (r2 = 0.99). Finally, the agreement between ECG downlink data and HRM data during space flight was also very high, with the regression equation being: Downlink ECG HR = 1.05 x (HRM) -5.71 (r2 = 0.99). The results of this study indicate that the HRM provides accurate data and may be used to reliably obtain valid data regarding heart rate responses during work.

Effects of inter-limb asymmetries on physical and sports performance: a systematic review.

Science.gov (United States)

Bishop, Chris; Turner, Anthony; Read, Paul

2018-05-01

The prevalence of inter-limb asymmetries has been reported in numerous studies across a wide range of sports and physical qualities; however, few have analysed their effects on physical and sports performance. A systematic review of the literature was undertaken using the Medline and SPORT Discus databases, with all articles required to meet a specified criteria based on a quality review. Eighteen articles met the inclusion criteria, relating participant asymmetry scores to physical and sports performance measures. The findings of this systematic review indicate that inter-limb differences in strength may be detrimental to jumping, kicking and cycling performance. When inter-limb asymmetries are quantified during jumping based exercises, they have been primarily used to examine their association with change of direction speed with mixed findings. Inter-limb asymmetries have also been quantified in anthropometry, sprinting, dynamic balance and sport-specific actions, again with inconsistent findings. However, all results have been reported using associative analysis with physical or sport performance metrics with no randomised controlled trials included. Further research is warranted to understand the mechanisms that underpin inter-limb differences and the magnitude of performance changes that can be accounted for by these asymmetries.

A "Smart" Force-Limiting Instrument for Microsurgery: Laboratory and In Vivo Validation.

Directory of Open Access Journals (Sweden)

Hani J Marcus

Full Text Available Residents are required to learn a multitude of skills during their microsurgical training. One such skill is the judicious application of force when handling delicate tissue. An instrument has been developed that indicates to the surgeon when a force threshold has been exceeded by providing vibrotactile feedback. The objective of this study was to validate the use of this "smart" force-limiting instrument for microsurgery. A laboratory and an in vivo experiment were performed to evaluate the force-limiting instrument. In the laboratory experiment, twelve novice surgeons were randomly allocated to use either the force-limiting instrument or a standard instrument. Surgeons were then asked to perform microsurgical dissection in a model. In the in vivo experiment, an intermediate surgeon performed microsurgical dissection in a stepwise fashion, alternating every 30 seconds between use of the force-limiting instrument and a standard instrument. The primary outcomes were the forces exerted and the OSATS scores. In the laboratory experiment, the maximal forces exerted by novices using the force-limiting instrument were significantly less than using a standard instrument, and were comparable to intermediate and expert surgeons (0.637N versus 4.576N; p = 0.007. In the in vivo experiment, the maximal forces exerted with the force-limiting instrument were also significantly less than with a standard instrument (0.441N versus 0.742N; p 0.1. In conclusion, the development and use of this force-limiting instrument in a clinical setting may improve patient safety.

Multi-laboratory testing of a screening method for world trade center (WTC) collapse dust

International Nuclear Information System (INIS)

Rosati, Jacky A.; Bern, Amy M.; Willis, Robert D.; Blanchard, Fredrick T.; Conner, Teri L.; Kahn, Henry D.; Friedman, David

2008-01-01

The September 11, 2001 attack on the World Trade Center (WTC) covered a large area of downtown New York City with dust and debris. This paper describes the testing of an analytical method designed to evaluate whether sampled dust contains dust that may have originated from the collapse of the WTC. Using dust samples collected from locations affected and not affected (referred to as 'background' locations) by the collapse, a scanning electron microscopy (SEM) analysis method was developed to screen for three materials that are believed to be present in large quantities in WTC dusts: slag wool, concrete, and gypsum. An inter-laboratory evaluation of the method was implemented by having eight laboratories analyze a number of 'blind' dust samples, consisting of confirmed background dust and confirmed background dust spiked with varying amounts of dust affected by the WTC collapse. The levels of gypsum and concrete in the spiked samples were indistinguishable from the levels in the background samples. Measurements of slag wool in dust demonstrated potential for distinguishing between spiked and background samples in spite of considerable within and between laboratory variability. Slag wool measurements appear to be sufficiently sensitive to distinguish dust spiked with 5% WTC-affected dust from 22 out of 25 background dust samples. Additional development work and inter-laboratory testing of the slag wool component will be necessary to improve the precision and accuracy of the method and reduce inter- and intra-laboratory variability from levels observed in the inter-laboratory evaluation

Reducing communication delays and improving quality of care with a tuberculosis laboratory information system in resource poor environments: a cluster randomized controlled trial.

Science.gov (United States)

Blaya, Joaquín A; Shin, Sonya S; Yagui, Martin; Contreras, Carmen; Cegielski, Peter; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Bayona, Jaime; Kim, Jihoon; Fraser, Hamish S F

2014-01-01

Lost, delayed or incorrect laboratory results are associated with delays in initiating treatment. Delays in treatment for Multi-Drug Resistant Tuberculosis (MDR-TB) can worsen patient outcomes and increase transmission. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting). 78 primary Health Centers (HCs) in Lima, Peru. Participants lived within the catchment area of participating HCs and had at least one MDR-TB risk factor. The study design was a cluster randomized controlled trial with baseline data. The intervention was the e-Chasqui web-based laboratory information system. Main outcome measures were: times to communicate a result; to start or change a patient's treatment; and for that patient to culture convert. 1671 patients were enrolled. Intervention HCs took significantly less time to receive drug susceptibility test (DST) (median 11 vs. 17 days, Hazard Ratio 0.67 [0.62-0.72]) and culture (5 vs. 8 days, 0.68 [0.65-0.72]) results. The time to treatment was not significantly different, but patients in intervention HCs took 16 days (20%) less time to culture convert (p = 0.047). The eChasqui system reduced the time to communicate results between laboratories and HCs and time to culture conversion. It is now used in over 259 HCs covering 4.1 million people. This is the first randomized controlled trial of a laboratory information system in a developing country for any disease and the only study worldwide to show clinical impact of such a system. ClinicalTrials.gov NCT01201941.

Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda.

Science.gov (United States)

Ssengooba, Willy; Gelderbloem, Sebastian J; Mboowa, Gerald; Wajja, Anne; Namaganda, Carolyn; Musoke, Philippa; Mayanja-Kizza, Harriet; Joloba, Moses Lutaakome

2015-01-15

Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility. Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode. The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P 80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012. From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality performance standards in resource-limited countries. With the demonstrated quality of work, the laboratory attracted more research groups and post-pioneer funding, which helped to ensure sustainability. The high skilled experts in this research laboratory also continue to provide an excellent resource for the needed national discussion of the laboratory and quality management systems.

Ella-V and technology usage technology usage in an english language and literacy acquisition validation randomized controlled trial study

OpenAIRE

Roisin P. Corcoran; Steven M. Ross; Beverly J. Irby; Fuhui Tong; Rafael Lara-Alecio; Cindy Guerrero

2014-01-01

This paper describes the use of technology to provide virtual professional development (VPD) for teachers and to conduct classroom observations in a study of English Language Learner (ELL) instruction in grades K–3. The technology applications were part of a cluster randomized control trial (RCT) design for a federally funded longitudinal validation study of a particular program, English Language and Literacy Acquisition-Validation, ELLA- V, to determine its degree of impact on English oral l...

Quantification of pyrrolizidine alkaloids in North American plants and honey by LC-MS: single laboratory validation.

Science.gov (United States)

Mudge, Elizabeth M; Jones, A Maxwell P; Brown, Paula N

2015-01-01

Pyrrolizidine alkaloids (PAs) are a class of naturally occurring compounds produced by many flowering plants around the World. Their presence as contaminants in food systems has become a significant concern in recent years. For example, PAs are often found as contaminants in honey through pollen transfer. A validated method was developed for the quantification of four pyrrolizidine alkaloids and one pyrrolizidine alkaloid N-oxide in plants and honey grown and produced in British Columbia. The method was optimised for extraction efficiency from the plant materials and then subjected to a single-laboratory validation to assess repeatability, accuracy, selectivity, LOD, LOQ and method linearity. The PA content in plants ranged from1.0 to 307.8 µg/g with repeatability precision between 3.8 and 20.8% RSD. HorRat values were within acceptable limits and ranged from 0.62 to 1.63 for plant material and 0.56-1.82 for honey samples. Method accuracy was determined through spike studies with recoveries ranging from 84.6 to 108.2% from the raw material negative control and from 82.1-106.0 % for the pyrrolizidine alkaloids in corn syrup. Based on the findings in this single-laboratory validation, this method is suitable for the quantitation of lycopsamine, senecionine, senecionine N-oxide, heliosupine and echimidine in common comfrey (Symphytum officinale), tansy ragwort (Senecio jacobaea), blueweed (Echium vulgare) and hound's tongue (Cynoglossum officinale) and for PA quantitation in honey and found that PA contaminants were present at low levels in BC honey.

Single laboratory validation of the determination of yohimbine in yohimbe bark and related dietary supplements using UHPLC/UV/MS

Science.gov (United States)

A single laboratory validation has been performed on a practical ultra high-performance liquid chromatography (UHPLC), diode array detection (DAD), and tandem mass spectrometry (MS) method for determination of yohimbine in yohimbe barks and related dietary supplements. Good separation was achieved u...

Ring trial 2016 for Bluetongue virus detection by real-time RT-PCR in France.

Science.gov (United States)

Sailleau, Corinne; Viarouge, Cyril; Breard, Emmanuel; Vitour, Damien; Zientara, Stephan

2017-05-01

Since the unexpected emergence of BTV-8 in Northern Europe and the incursion of BTV-8 and 1 in France in 2006-2007, molecular diagnosis has considerably evolved. Several real-time RT-PCR (rtRT-PCR) methods have been developed and published, and are currently being used in many countries across Europe for BTV detection and typing. In France, the national reference laboratory (NRL) for orbiviruses develops and validates 'ready-to-use' kits with private companies for viral RNA detection. The regional laboratories network that was set up to deal with a heavy demand for analyses has used these available kits. From 2007, ring tests were organized to monitor the performance of the French laboratories. This study presents the results of 63 regional laboratories in the ring trial organized in 2016. Blood samples were sent to the laboratories. Participants were asked to use the rtRT-PCR methods in place in their laboratory, for detection of all BTV serotypes and specifically BTV-8. The French regional laboratories are able to detect and genotype BTV in affected animals. Despite the use of several methods (i.e. RNA extraction and different commercial rtRT-PCRs), the network is homogeneous. The ring trial demonstrated that the French regional veterinary laboratories have reliable and robust BTV diagnostic tools for BTV genome detection.

Calculating and optimizing inter-electrode capacitances of charge division microchannel plate detectors

Energy Technology Data Exchange (ETDEWEB)

Xing, Yan [Changchun Institute of Optics, Fine Mechanics and Physics, Chinese Academy of Sciences, Changchun 130033 (China); University of Chinese Academy of Sciences, Beijing 100049 (China); Chen, Bo, E-mail: chenb@ciomp.ac.cn [Changchun Institute of Optics, Fine Mechanics and Physics, Chinese Academy of Sciences, Changchun 130033 (China); Zhang, Hong-Ji; Wang, Hai-Feng; He, Ling-Ping [Changchun Institute of Optics, Fine Mechanics and Physics, Chinese Academy of Sciences, Changchun 130033 (China); Jin, Fang-Yuan [Changchun Institute of Optics, Fine Mechanics and Physics, Chinese Academy of Sciences, Changchun 130033 (China); University of Chinese Academy of Sciences, Beijing 100049 (China)

2016-04-01

Based on the principle of charge division microchannel plate detectors, the inter-electrode capacitances of charge division anodes which are related to electronic noise of the charge sensitive amplifier and crosstalk effect of the anode are presented. Under all the requirements of charge division microchannel plate detectors such as the imaging linearity and spatial resolution, decreasing the inter-electrode capacitances is one way to improve the imaging performance. In this paper, we illustrate the simulation process of calculating the inter-electrode capacitances. Moreover, a Wedge and Strip (WSZ) anode is fabricated with the picosecond laser micromachining process. Comparing the simulated capacitances and measured capacitances, the three-dimensional finite element method is proved to be valid. Furthermore, by adjusting the design parameters of the anode, the effects of the substrate permittivity, insulation width and the size of pitch on the inter-electrode capacitances have been analysed. The structure of the charge division anode has been optimized based on the simulation data.

Toronto 2001 Inter-governmental Declaration on Clean Air

International Nuclear Information System (INIS)

2001-01-01

This formal declaration commits the municipalities in the Greater Toronto Area, the provincial government of Ontario, and the federal government in Ottawa to undertake certain specific actions to improve air quality in their respective areas of jurisdiction, recognizing the validity of claims made by experts in numerous studies, linking air pollution to premature deaths, illnesses and hospitalization in major Canadian cities. The declaration also recognizes the validity of scientific claims as to the relationship between solar radiation, ambient heat, ground level ozone and global climate change, and the role played in air pollution by fossil fuel combustion. The Declaration calls for cooperation of all governments operating in the Greater Toronto Area to take inter-governmental actions to improve air quality by following up on key issues identified at annual Summits and by supporting the planning of future Summits, by working together with the Toronto Organizing Committee for the Olympic Games to ensure that the 2008 Olympic Games will contribute to a legacy of clean air for the Toronto region, and by implementing a social marketing campaign to help householders reduce both home energy use and vehicle kilometres travelled by 20 per cent. Beyond these inter-governmental commitments, special commitments of individual municipalities, and the provincial and federal governments also form part of the Declaration

Evaluation of TEG(®) and RoTEM(®) inter-changeability in trauma patients.

Science.gov (United States)

Hagemo, Jostein S; Næss, Paal A; Johansson, Pär; Windeløv, Nis A; Cohen, Mitchell Jay; Røislien, Jo; Brohi, Karim; Heier, Hans Erik; Hestnes, Morten; Gaarder, Christine

2013-05-01

Massive haemorrhage is a leading cause of preventable deaths in trauma. Traumatic coagulopathy is frequently present early after trauma, and is associated with increased mortality. A number of recent trials suggest that viscoelastic haemostatic assays (VHA), such as thromboelastography and thromboelastometry, are useful tools in guiding transfusion. Treatment algorithms exist for the use of VHAs but are not validated in traumatic haemorrhage. In this study we examined the inter-changeability of two commonly used VHAs, TEG(®) and RoTEM(®). A total of 184 trauma patients over the age of 18, requiring full trauma team activation, were included at three different hospitals in three different countries (Copenhagen, Denmark, San Francisco, CA, USA and Oslo, Norway). Blood samples were drawn immediately upon arrival, and TEG(®) and RoTEM(®) analyzed simultaneously. Correlations were calculated using. Spearman's rank correlation coefficient. Agreement was evaluated by Bland-Altman plots and calculation of limits of agreement. The mean ISS in the total population was 17, and the mortality was 16.5%. Mean base excess was -2.8 (SD: 4.2). The correlation coefficient for corresponding values for the two devices was 0.24 for the R-time vs CT in all centres combined. For the K-time vs CFT the correlation was 0.48, for the α-angleTEG vs α-angleRoTEM 0.44, and for MA vs MCF 0.76. Limits of agreement exceeded the preset clinically acceptable deviation of 10% for all variables in all centres except for MA/MCF in one centre (Copenhagen). Generally, correlation coefficients were lower and agreement poorer in the one centre (Oslo) where measurements were performed bedside by clinicians. Inter-changeability between TEG(®) and RoTEM(®) is limited in the trauma setting. Agreement seems poorer when clinicians operate the devices. Development and validation of separate treatment algorithms for the two devices is required. Copyright © 2012 Elsevier Ltd. All rights reserved.

Laboratory support during and after the Ebola virus endgame: Towards a sustained laboratory infrastructure

NARCIS (Netherlands)

I. Goodfellow; C.B.E.M. Reusken (Chantal); M.P.G. Koopmans D.V.M. (Marion)

2015-01-01

textabstractThe Ebola virus epidemic in West Africa is on the brink of entering a second phase in which the (inter)national efforts to slow down virus transmission will be engaged to end the epidemic. The response community must consider the longevity of their current laboratory support, as it is

Validation of a PCR-based method for the detection of various rendered materials in feedstuffs using a forensic DNA extraction kit.

Science.gov (United States)

Myers, Michael J; Yancy, Haile F; Araneta, Michael; Armour, Jennifer; Derr, Janice; Hoostelaere, Lawrence A D; Farmer, Doris; Jackson, Falana; Kiessling, William M; Koch, Henry; Lin, Huahua; Liu, Yan; Mowlds, Gabrielle; Pinero, David; Riter, Ken L; Sedwick, John; Shen, Yuelian; Wetherington, June; Younkins, Ronsha

2006-01-01

A method trial was initiated to validate the use of a commercial DNA forensic kit to extract DNA from animal feed as part of a PCR-based method. Four different PCR primer pairs (one bovine pair, one porcine pair, one ovine primer pair, and one multispecies pair) were also evaluated. Each laboratory was required to analyze a total of 120 dairy feed samples either not fortified (control, true negative) or fortified with bovine meat and bone meal, porcine meat and bone meal (PMBM), or lamb meal. Feeds were fortified with the animal meals at a concentration of 0.1% (wt/wt). Ten laboratories participated in this trial, and each laboratory was required to evaluate two different primer pairs, i.e., each PCR primer pair was evaluated by five different laboratories. The method was considered to be validated for a given animal source when three or more laboratories achieved at least 97% accuracy (29 correct of 30 samples for 96.7% accuracy, rounded up to 97%) in detecting the fortified samples for that source. Using this criterion, the method was validated for the bovine primer because three laboratories met the criterion, with an average accuracy of 98.9%. The average false-positive rate was 3.0% in these laboratories. A fourth laboratory was 80% accurate in identifying the samples fortified with bovine meat and bone meal. A fifth laboratory was not able to consistently extract the DNA from the feed samples and did not achieve the criterion for accuracy for either the bovine or multispecies PCR primers. For the porcine primers, the method was validated, with four laboratories meeting the criterion for accuracy with an average accuracy of 99.2%. The fifth laboratory had a 93.3% accuracy outcome for the porcine primer. Collectively, these five laboratories had a 1.3% false-positive rate for the porcine primer. No laboratory was able to meet the criterion for accuracy with the ovine primers, most likely because of problems with the synthesis of the primer pair; none of the

Validation of a search strategy to identify nutrition trials in PubMed using the relative recall method.

Science.gov (United States)

Durão, Solange; Kredo, Tamara; Volmink, Jimmy

2015-06-01

To develop, assess, and maximize the sensitivity of a search strategy to identify diet and nutrition trials in PubMed using relative recall. We developed a search strategy to identify diet and nutrition trials in PubMed. We then constructed a gold standard reference set to validate the identified trials using the relative recall method. Relative recall was calculated by dividing the number of references from the gold standard our search strategy identified by the total number of references in the gold standard. Our gold standard comprised 298 trials, derived from 16 included systematic reviews. The initial search strategy identified 242 of 298 references, with a relative recall of 81.2% [95% confidence interval (CI): 76.3%, 85.5%]. We analyzed titles and abstracts of the 56 missed references for possible additional terms. We then modified the search strategy accordingly. The relative recall of the final search strategy was 88.6% (95% CI: 84.4%, 91.9%). We developed a search strategy to identify diet and nutrition trials in PubMed with a high relative recall (sensitivity). This could be useful for establishing a nutrition trials register to support the conduct of future research, including systematic reviews. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates

DEFF Research Database (Denmark)

Dellson, P; Nilbert, M; Bendahl, P-O

2011-01-01

for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about......Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used...... the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials....

Leishmaniasis direct agglutination test: using pictorials as training materials to reduce inter-reader variability and improve accuracy.

Directory of Open Access Journals (Sweden)

Emily R Adams

Full Text Available BACKGROUND: The Direct Agglutination Test (DAT has a high diagnostic accuracy and remains, in some geographical areas, part of the diagnostic algorithm for Visceral Leishmaniasis (VL. However, subjective interpretation of results introduces potential for inter-reader variation. We report an assessment of inter-laboratory agreement and propose a pictorial-based approach to standardize reading of the DAT. METHODOLOGY: In preparation for a comparative evaluation of immunochromatographic diagnostics for VL, a proficiency panel of 15 well-characterized sera, DAT-antigen from a single batch and common protocol was sent to nine laboratories in Latin-America, East-Africa and Asia. Agreement (i.e., equal titre or within 1 titer with the reading by the reference laboratory was computed. Due to significant inter-laboratory disagreement on-site refresher training was provided to all technicians performing DAT. Photos of training plates were made, and end-titres agreed upon by experienced users of DAT within the Visceral-Leishmaniasis Laboratory-Network (VL-LN. RESULTS: Pre-training, concordance in DAT results with reference laboratories was only 50%, although agreement on negative sera was high (94%. After refresher training concordance increased to 84%; agreement on negative controls increased to 98%. Variance in readings significantly decreased after training from 3.3 titres to an average of 1.0 titre (two-sample Wilcoxon rank-sum (Mann-Whitney test (z = -3,624 and p = 0.0003. CONCLUSION: The most probable explanation for disagreement was subjective endpoint reading. Using pictorials as training materials may be a useful tool to reduce disparity in results and promote more standardized reading of DAT, without compromising diagnostic sensitivity.

A Spanish validation of the Coma Recovery Scale-Revised (CRS-R).

Science.gov (United States)

Tamashiro, Mercedes; Rivas, Maria Elisa; Ron, Melania; Salierno, Fernando; Dalera, Marisol; Olmos, Lisandro

2014-01-01

Analysis of inter-rater reliability and concurrent validity. To determine measurement properties of a Spanish version of The Coma Recovery Scale-Revised (CRS-R). A sample of 35 in-patients with severe acquired brain injury. To test concurrent validity of the translated scale, the Glasgow Coma Scale (GSC) and Disability Rating Scale (DRS) were also administered. Two experts in the field were recruited to assess inter-rater agreement. Inter-rater reliability was good for total CRS-R scores (Cronbach α = 0.973, p = 0.001). Sub-scale analysis showed moderate-to-high inter-rater agreement. Total CRS-R scores correlated significantly (p < 0.05) with total GCS (r = 0.74) and DRS (r = 0.54) scores, indicating acceptable concurrent validity. The Spanish version of CRS-R can be administered reliably by trained and experienced examiners. CRS-R appears capable of differentiating patients in Emergence from Minimally Conscious State (EMCS) or in Minimally Conscious State (MCS) from those in a Vegetative State (VS).

Validating the Technology Acceptance Model in the Context of the Laboratory Information System-Electronic Health Record Interface System

Science.gov (United States)

Aquino, Cesar A.

2014-01-01

This study represents a research validating the efficacy of Davis' Technology Acceptance Model (TAM) by pairing it with the Organizational Change Readiness Theory (OCRT) to develop another extension to the TAM, using the medical Laboratory Information Systems (LIS)--Electronic Health Records (EHR) interface as the medium. The TAM posits that it is…

When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

Science.gov (United States)

Jull, J; Whitehead, M; Petticrew, M; Kristjansson, E; Gough, D; Petkovic, J; Volmink, J; Weijer, C; Taljaard, M; Edwards, S; Mbuagbaw, L; Cookson, R; McGowan, J; Lyddiatt, A; Boyer, Y; Cuervo, L G; Armstrong, R; White, H; Yoganathan, M; Pantoja, T; Shea, B; Pottie, K; Norheim, O; Baird, S; Robberstad, B; Sommerfelt, H; Asada, Y; Wells, G; Tugwell, P; Welch, V

2017-09-25

Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Validation of Physical Activity Tracking via Android Smartphones Compared to ActiGraph Accelerometer: Laboratory-Based and Free-Living Validation Studies.

Science.gov (United States)

Hekler, Eric B; Buman, Matthew P; Grieco, Lauren; Rosenberger, Mary; Winter, Sandra J; Haskell, William; King, Abby C

2015-04-15

There is increasing interest in using smartphones as stand-alone physical activity monitors via their built-in accelerometers, but there is presently limited data on the validity of this approach. The purpose of this work was to determine the validity and reliability of 3 Android smartphones for measuring physical activity among midlife and older adults. A laboratory (study 1) and a free-living (study 2) protocol were conducted. In study 1, individuals engaged in prescribed activities including sedentary (eg, sitting), light (sweeping), moderate (eg, walking 3 mph on a treadmill), and vigorous (eg, jogging 5 mph on a treadmill) activity over a 2-hour period wearing both an ActiGraph and 3 Android smartphones (ie, HTC MyTouch, Google Nexus One, and Motorola Cliq). In the free-living study, individuals engaged in usual daily activities over 7 days while wearing an Android smartphone (Google Nexus One) and an ActiGraph. Study 1 included 15 participants (age: mean 55.5, SD 6.6 years; women: 56%, 8/15). Correlations between the ActiGraph and the 3 phones were strong to very strong (ρ=.77-.82). Further, after excluding bicycling and standing, cut-point derived classifications of activities yielded a high percentage of activities classified correctly according to intensity level (eg, 78%-91% by phone) that were similar to the ActiGraph's percent correctly classified (ie, 91%). Study 2 included 23 participants (age: mean 57.0, SD 6.4 years; women: 74%, 17/23). Within the free-living context, results suggested a moderate correlation (ie, ρ=.59, PAndroid smartphone can provide comparable estimates of physical activity to an ActiGraph in both a laboratory-based and free-living context for estimating sedentary and MVPA and that different Android smartphones may reliably confer similar estimates.

ISOTHERMAL AIR INGRESS VALIDATION EXPERIMENTS AT IDAHO NATIONAL LABORATORY: DESCRIPTION AND SUMMARY OF DATA

International Nuclear Information System (INIS)

Oh, Chang H.; Kim, Eung S.

2010-01-01

Idaho National Laboratory performed air ingress experiments as part of validating computational fluid dynamics code (CFD). An isothermal stratified flow experiment was designed and set to understand stratified flow phenomena in the very high temperature gas cooled reactor (VHTR) and to provide experimental data for validating computer codes. The isothermal experiment focused on three flow characteristics unique in the VHTR air-ingress accident: stratified flow in the horizontal pipe, stratified flow expansion at the pipe and vessel junction, and stratified flow around supporting structures. Brine and sucrose were used as heavy fluids and water was used as light fluids. The density ratios were changed between 0.87 and 0.98. This experiment clearly showed that a stratified flow between heavy and light fluids is generated even for very small density differences. The code was validated by conducting blind CFD simulations and comparing the results to the experimental data. A grid sensitivity study was also performed based on the Richardson extrapolation and the grid convergence index method for modeling confidence. As a result, the calculated current speed showed very good agreement with the experimental data, indicating that the current CFD methods are suitable for predicting density gradient stratified flow phenomena in the air-ingress accident.

Laboratory compliance with the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 testing guidelines: a 3-year comparison of validation procedures.

Science.gov (United States)

Dyhdalo, Kathryn S; Fitzgibbons, Patrick L; Goldsmith, Jeffery D; Souers, Rhona J; Nakhleh, Raouf E

2014-07-01

The American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) published guidelines in 2007 regarding testing accuracy, interpretation, and reporting of results for HER2 studies. A 2008 survey identified areas needing improved compliance. To reassess laboratory response to those guidelines following a full accreditation cycle for an updated snapshot of laboratory practices regarding ASCO/CAP guidelines. In 2011, a survey was distributed with the HER2 immunohistochemistry (IHC) proficiency testing program identical to the 2008 survey. Of the 1150 surveys sent, 977 (85.0%) were returned, comparable to the original survey response in 2008 (757 of 907; 83.5%). New participants submitted 124 of 977 (12.7%) surveys. The median laboratory accession rate was 14,788 cases with 211 HER2 tests performed annually. Testing was validated with fluorescence in situ hybridization in 49.1% (443 of 902) of the laboratories; 26.3% (224 of 853) of the laboratories used another IHC assay. The median number of cases to validate fluorescence in situ hybridization (n = 40) and IHC (n = 27) was similar to those in 2008. Ninety-five percent concordance with fluorescence in situ hybridization was achieved by 76.5% (254 of 332) of laboratories for IHC(-) findings and 70.4% (233 of 331) for IHC(+) cases. Ninety-five percent concordance with another IHC assay was achieved by 71.1% (118 of 168) of the laboratories for negative findings and 69.6% (112 of 161) of the laboratories for positive cases. The proportion of laboratories interpreting HER2 IHC using ASCO/CAP guidelines (86.6% [798 of 921] in 2011; 83.8% [605 of 722] in 2008) remains similar. Although fixation time improvements have been made, assay validation deficiencies still exist. The results of this survey were shared within the CAP, including the Laboratory Accreditation Program and the ASCO/CAP panel revising the HER2 guidelines published in October 2013. The Laboratory Accreditation Program checklist was

Validation of a densimeter calibration procedure for a secondary calibration laboratory

International Nuclear Information System (INIS)

Alpizar Herrera, Juan Carlos

2014-01-01

A survey was conducted to quantify the need for calibration of a density measurement instrument at the research units at the Sede Rodrigo Facio of the Universidad de Costa Rica. A calibration procedure was documented for the instrument that presented the highest demand in the survey by the calibration service. A study of INTE-ISO/IEC 17025: 2005 and specifically in section 5.4 of this standard was done, to document the procedure for calibrating densimeters. Densimeter calibration procedures and standards were sought from different national and international sources. The method of hydrostatic weighing or Cuckow method was the basis of the defined procedure. Documenting the calibration procedure and creating other documents was performed for data acquisition log, intermediate calculation log and calibration certificate copy. A veracity test was performed using as reference laboratory a laboratory of calibration secondary national as part of the validation process of the documented procedure. The results of the E_n statistic of 0.41; 0.34 and 0.46 for the calibration points 90%, 50% and 10% were obtained for the densimeter scale respectively. A reproducibility analysis of the method was performed with satisfactory results. Different suppliers were contacted to estimate the economic costs of the equipment and materials, needed to develop the documented method of densimeter calibration. The acquisition of an analytical balance was recommended, instead of a precision scale, in order to improve the results obtained with the documented method [es

Simulated patient training: Using inter-rater reliability to evaluate simulated patient consistency in nursing education.

Science.gov (United States)

MacLean, Sharon; Geddes, Fiona; Kelly, Michelle; Della, Phillip

2018-03-01

Simulated patients (SPs) are frequently used for training nursing students in communication skills. An acknowledged benefit of using SPs is the opportunity to provide a standardized approach by which participants can demonstrate and develop communication skills. However, relatively little evidence is available on how to best facilitate and evaluate the reliability and accuracy of SPs' performances. The aim of this study is to investigate the effectiveness of an evidenced based SP training framework to ensure standardization of SPs. The training framework was employed to improve inter-rater reliability of SPs. A quasi-experimental study was employed to assess SP post-training understanding of simulation scenario parameters using inter-rater reliability agreement indices. Two phases of data collection took place. Initially a trial phase including audio-visual (AV) recordings of two undergraduate nursing students completing a simulation scenario is rated by eight SPs using the Interpersonal Communication Assessments Scale (ICAS) and Quality of Discharge Teaching Scale (QDTS). In phase 2, eight SP raters and four nursing faculty raters independently evaluated students' (N=42) communication practices using the QDTS. Intraclass correlation coefficients (ICC) were >0.80 for both stages of the study in clinical communication skills. The results support the premise that if trained appropriately, SPs have a high degree of reliability and validity to both facilitate and evaluate student performance in nurse education. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

Validity and reliability of the single-trial line drill test of anaerobic power in basketball players.

Science.gov (United States)

Fatouros, I G; Laparidis, K; Kambas, A; Chatzinikolaou, A; Techlikidou, E; Katrabasas, I; Douroudos, I; Leontsini, D; Berberidou, F; Draganidis, D; Christoforidis, C; Tsoukas, D; Kelis, S; Taxildaris, K

2011-03-01

This study evaluated the validity, reliability, and sensitivity of the single-trial line drill test (SLDT) for anaerobic power assessment. Twenty-four volunteers were assigned to either a control (C, N.=12) or an experimental (BP, N.=12 basketball players) group. SLDT's (time-to-complete) concurrent validity was evaluated against the Wingate testing (WAnT: mean [MP] and peak power [PP]) and a 30-sec vertical jump testing test (VJT: mean height and MP). Blood lactate concentration was measured at rest and immediately post-test. SLDT's reliability [test-retest intraclass correlation coefficients (ICC), coefficient of variation (CV), Bland-Altman plots] and sensitivity were determined (one-way ANOVA). Kendall's tau correlation analysis revealed correlations (Pbasketball players.

INTER-RATER RELIABILITY FOR MOVEMENT PATTERN ANALYSIS (MPA: MEASURING PATTERNING OF BEHAVIORS VERSUS DISCRETE BEHAVIOR COUNTS AS INDICATORS OF DECISION-MAKING STYLE

Directory of Open Access Journals (Sweden)

Brenda L Connors

2014-06-01

Full Text Available The unique yield of collecting observational data on human movement has received increasing attention in a number of domains, including the study of decision-making style. As such, interest has grown in the nuances of core methodological issues, including the best ways of assessing inter-rater reliability. In this paper we focus on one key topic – the distinction between establishing reliability for the patterning of behaviors as opposed to the computation of raw counts – and suggest that reliability for each be compared empirically rather than determined a priori. We illustrate by assessing inter-rater reliability for key outcome measures derived from Movement Pattern Analysis (MPA, an observational methodology that records body movements as indicators of decision-making style with demonstrated predictive validity. While reliability ranged from moderate to good for raw counts of behaviors reflecting each of two Overall Factors generated within MPA (Assertion and Perspective, inter-rater reliability for patterning (proportional indicators of each factor was significantly higher and excellent (ICC = .89. Furthermore, patterning, as compared to raw counts, provided better prediction of observable decision-making process assessed in the laboratory. These analyses support the utility of using an empirical approach to inform the consideration of measuring discrete behavioral counts versus patterning of behaviors when determining inter-rater reliability of observable behavior. They also speak to the substantial reliability that may be achieved via application of theoretically grounded observational systems such as MPA that reveal thinking and action motivations via visible movement patterns.

Impact of providing fee data on laboratory test ordering: a controlled clinical trial.

Science.gov (United States)

Feldman, Leonard S; Shihab, Hasan M; Thiemann, David; Yeh, Hsin-Chieh; Ardolino, Margaret; Mandell, Steven; Brotman, Daniel J

2013-05-27

Inpatient care providers often order laboratory tests without any appreciation for the costs of the tests. To determine whether we could decrease the number of laboratory tests ordered by presenting providers with test fees at the time of order entry in a tertiary care hospital, without adding extra steps to the ordering process. Controlled clinical trial. Tertiary care hospital. All providers, including physicians and nonphysicians, who ordered laboratory tests through the computerized provider order entry system at The Johns Hopkins Hospital. We randomly assigned 61 diagnostic laboratory tests to an "active" arm (fee displayed) or to a control arm (fee not displayed). During a 6-month baseline period (November 10, 2008, through May 9, 2009), we did not display any fee data. During a 6-month intervention period 1 year later (November 10, 2009, through May 9, 2010), we displayed fees, based on the Medicare allowable fee, for active tests only. We examined changes in the total number of orders placed, the frequency of ordered tests (per patient-day), and total charges associated with the orders according to the time period (baseline vs intervention period) and by study group (active test vs control). For the active arm tests, rates of test ordering were reduced from 3.72 tests per patient-day in the baseline period to 3.40 tests per patient-day in the intervention period (8.59% decrease; 95% CI, -8.99% to -8.19%). For control arm tests, ordering increased from 1.15 to 1.22 tests per patient-day from the baseline period to the intervention period (5.64% increase; 95% CI, 4.90% to 6.39%) (P fee data to providers at the time of order entry resulted in a modest decrease in test ordering. Adoption of this intervention may reduce the number of inappropriately ordered diagnostic tests.

The bogus taste test: Validity as a measure of laboratory food intake.

Science.gov (United States)

Robinson, Eric; Haynes, Ashleigh; Hardman, Charlotte A; Kemps, Eva; Higgs, Suzanne; Jones, Andrew

2017-09-01

Because overconsumption of food contributes to ill health, understanding what affects how much people eat is of importance. The 'bogus' taste test is a measure widely used in eating behaviour research to identify factors that may have a causal effect on food intake. However, there has been no examination of the validity of the bogus taste test as a measure of food intake. We conducted a participant level analysis of 31 published laboratory studies that used the taste test to measure food intake. We assessed whether the taste test was sensitive to experimental manipulations hypothesized to increase or decrease food intake. We examined construct validity by testing whether participant sex, hunger and liking of taste test food were associated with the amount of food consumed in the taste test. In addition, we also examined whether BMI (body mass index), trait measures of dietary restraint and over-eating in response to palatable food cues were associated with food consumption. Results indicated that the taste test was sensitive to experimental manipulations hypothesized to increase or decrease food intake. Factors that were reliably associated with increased consumption during the taste test were being male, have a higher baseline hunger, liking of the taste test food and a greater tendency to overeat in response to palatable food cues, whereas trait dietary restraint and BMI were not. These results indicate that the bogus taste test is likely to be a valid measure of food intake and can be used to identify factors that have a causal effect on food intake. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

W4E HYDROPOWER DIRECT DRIVE IN-LINE HYDROTURBINE GENERATOR FULL SCALE PROTOTYPE VALIDATION TESTING REPORT MAY 2013 ALDEN LABORATORIES

Energy Technology Data Exchange (ETDEWEB)

Cox, Chad W [GZA GeoEnvironmental,Inc.

2013-09-24

The W4E is a patent-pending, direct-drive, variable force turbine/generator. The equipment generates electricity through the water dependent engagement of a ring of rotating magnets with coils mounted on a stator ring. Validation testing of the W4e was performed at Alden Laboratories in the Spring of 2013. The testing was independently observed and validated by GZA GeoEnvironmental, Inc. The observations made during testing and the results of the testing are included in the Test Summary Report

Validation of the one pass measure for motivational interviewing competence.

Science.gov (United States)

McMaster, Fiona; Resnicow, Ken

2015-04-01

This paper examines the psychometric properties of the OnePass coding system: a new, user-friendly tool for evaluating practitioner competence in motivational interviewing (MI). We provide data on reliability and validity with the current gold-standard: Motivational Interviewing Treatment Integrity tool (MITI). We compared scores from 27 videotaped MI sessions performed by student counselors trained in MI and simulated patients using both OnePass and MITI, with three different raters for each tool. Reliability was estimated using intra-class coefficients (ICCs), and validity was assessed using Pearson's r. OnePass had high levels of inter-rater reliability with 19/23 items found from substantial to almost perfect agreement. Taking the pair of scores with the highest inter-rater reliability on the MITI, the concurrent validity between the two measures ranged from moderate to high. Validity was highest for evocation, autonomy, direction and empathy. OnePass appears to have good inter-rater reliability while capturing similar dimensions of MI as the MITI. Despite the moderate concurrent validity with the MITI, the OnePass shows promise in evaluating both traditional and novel interpretations of MI. OnePass may be a useful tool for developing and improving practitioner competence in MI where access to MITI coders is limited. Copyright © 2015. Published by Elsevier Ireland Ltd.

Clinical Trials

Medline Plus

Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

Verification and validation of predictive computer programs describing the near and far-field chemistry of radioactive waste disposal systems

International Nuclear Information System (INIS)

Read, D.; Broyd, T.W.

1988-01-01

This paper provides an introduction to CHEMVAL, an international project concerned with establishing the applicability of chemical speciation and coupled transport models to the simulation of realistic waste disposal situations. The project aims to validate computer-based models quantitatively by comparison with laboratory and field experiments. Verification of the various computer programs employed by research organisations within the European Community is ensured through close inter-laboratory collaboration. The compilation and review of thermodynamic data forms an essential aspect of this work and has led to the production of an internally consistent standard CHEMVAL database. The sensitivity of results to variation in fundamental constants is being monitored at each stage of the project and, where feasible, complementary laboratory studies are used to improve the data set. Currently, thirteen organisations from five countries are participating in CHEMVAL which forms part of the Commission of European Communities' MIRAGE 2 programme of research. (orig.)

The Role of Cedex s Railway Inter operability Laboratory (RIL) in the European ERTMS; Actuaciones del Laboratorio de Interoperabilidad ferroviaria (LIF) del CEDEX en el despliegue Europeo ERTMS

Energy Technology Data Exchange (ETDEWEB)

Tamarit Rodriguez de Huici, J.

2015-07-01

The RIL is the most recently laboratory set up within CEDEXs premises. From the start, it has aimed to support the development of rail transport at both European and Spanish levels. This article describes the role played by CEDEX-RIL in the development of ERTMS, and the close link which from its inception, has existed between this system and the EMSET project, in which the feasibility of the European Railway inter operability was demonstrated with the participation of the whole European signalling industry. The key factor for the success of this project was the creation of both and independent laboratory and testing sites which, right from the very beginning, enjoyed the confidence of the industry, thus allowing for the first time the execution of cross tests between companies. Finally, and equally important, this paper shows the fruitful evolution followed by the laboratory aforementioned, which, from its establishment, has evolved from performing tests on generic ERTMS constituents to undertaking, first, remote tests jointly carried out between specific commercial projects with different suppliers on track and on-board; and, second, Handover tests between diverse RBC suppliers. (Author)

Food and Drug Administration process validation activities to support 99Mo production at Sandia National Laboratories

International Nuclear Information System (INIS)

McDonald, M.J.; Bourcier, S.C.; Talley, D.G.

1997-01-01

Prior to 1989 99 Mo was produced in the US by a single supplier, Cintichem Inc., Tuxedo, NY. Because of problems associated with operating its facility, in 1989 Cintichem elected to decommission the facility rather than incur the costs for repair. The demise of the 99 Mo capability at Cintichem left the US totally reliant upon a single foreign source, Nordion International, located in Ottawa Canada. In 1992 the DOE purchased the Cintichem 99 Mo Production Process and Drug Master File (DMF). In 1994 the DOE funded Sandia National Laboratories (SNL) to produce 99 Mo. Although Cintichem produced 99 Mo and 99m Tc generators for many years, there was no requirement for process validation which is now required by the Food and Drug Administration (FDA). In addition to the validation requirement, the requirements for current Good manufacturing Practices were codified into law. The purpose of this paper is to describe the process validation being conducted at SNL for the qualification of SNL as a supplier of 99 Mo to US pharmaceutical companies

External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

Directory of Open Access Journals (Sweden)

Sean C Murphy

Full Text Available Nucleic acid testing (NAT for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally <0.5 log10 parasites/mL except for one laboratory where the EQA effort identified likely reasons for a general quantitative shift. The within-laboratory variation for all assays was low at <10% coefficient of variation across a range of parasite densities. Based on this study, we propose to create a Molecular Malaria Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

TOTAL REPLACEMENT OF FISHMEAL WITH AN ORGANICALLY CERTIFIED YEAST–BASED PROTEIN IN PACIFIC WHITE SHRIMP (Litopenaeus Vannamei DIETS: LABORATORY AND FIELD TRIALS

Directory of Open Access Journals (Sweden)

Ewen McLean

2006-04-01

Full Text Available The feasibility of totally replacing the fishmeal component of marine shrimp (Litopenaeus vannamei diets was examined both in the laboratory setting and during a full–scale commercial trial. Animals were fed either a traditional fishmeal–based diet or one in which complete replacement of fishmeal, on a per protein basis, was manufactured using a yeast–based product, NuPro®. Laboratory studies determined that irrespective of diet fed, no difference in shrimp performance (weight gain, survival and SGR occurred. A field trial was thus activated to determine whether lab–scale studies were transferable to the commercial setting. Trials were conducted in earthen ponds from mid–June to early November 2005. Ponds were initially stocked with PL12–16 shrimp at a rate of 100,000 per hectare. At trial end, ponds receiving the NuPro®–based feed had equivalent growth to that of shrimp fed the traditional, fishmeal–based diet. Percent increase in weight from initial values and survival for the NuPro® ponds was 296, 269 and 275%, and 78, 76 and 85% respectively, whereas that for the fishmeal–based diet was 305% and 80% respectively. Noteworthy was that within pond size variation of L. vannamei was lower in NuPro® fed animals (±2.3 g when compared against animals receiving the traditional feed (±4.1 g. Overall observations from the field trial indicate the importance of the »bioreactor« pond with respect to the supply of energy to sustain shrimp growth potential.

The Development of a Novel, Validated, Rapid and Simple Method for the Detection of Sarcocystis fayeri in Horse Meat in the Sanitary Control Setting.

Science.gov (United States)

Furukawa, Masato; Minegishi, Yasutaka; Izumiyama, Shinji; Yagita, Kenji; Mori, Hideto; Uemura, Taku; Etoh, Yoshiki; Maeda, Eriko; Sasaki, Mari; Ichinose, Kazuya; Harada, Seiya; Kamata, Yoichi; Otagiri, Masaki; Sugita-Konishi, Yoshiko; Ohnishi, Takahiro

2016-01-01

Sarcocystis fayeri (S. fayeri) is a newly identified causative agent of foodborne disease that is associated with the consumption of raw horse meat. The testing methods prescribed by the Ministry of Health, Labour and Welfare of Japan are time consuming and require the use of expensive equipment and a high level of technical expertise. Accordingly, these methods are not suitable for use in the routine sanitary control setting to prevent outbreaks of foodborne disease. In order to solve these problems, we have developed a new, rapid and simple testing method using LAMP, which takes only 1 hour to perform and which does not involve the use of any expensive equipment or expert techniques. For the validation of this method, an inter-laboratory study was performed among 5 institutes using 10 samples infected with various concentrations of S. fayeri. The results of the inter-laboratory study demonstrated that our LAMP method could detect S. fayeri at concentrations greater than 10(4) copies/g. Thus, this new method could be useful in screening for S. fayeri as a routine sanitary control procedure.

Validation criteria of an internal dosimetry laboratory in vivo; Criterios para la validacion de un laboratorio de dosimetria interna in vivo

Energy Technology Data Exchange (ETDEWEB)

Alfaro L, M. de las M., E-mail: mercedes.alfaro@inin.gob.mx [ININ, Carretera Mexico-Toluca s/n, 52750 Ocoyoacac, Estado de Mexico (Mexico)

2014-10-15

People working with radioactive materials, under certain circumstances (e.g. not using the proper protective equipment, an incident not covered, etc.) could be incorporated into the body. The radiation protection programs include direct measurement methods -in vivo- or indirect -in vitro- or both, to know that radioactive material is incorporated into the body. The monitoring measurements of internal contamination or (Radio-bioassay) are carried out with the purpose of determining the amount of radioactive material incorporated in the body; estimate the effective dose and committed dose; management administration of radiation protection; appropriate medical management; and to provide the data necessary for the legal requirements and the preservation of records. The measurement methods used in the monitoring of internal contamination must be validated by the combination of the following processes: calibration, using standards reference materials and/or simulators; execute systematic research, using control samples; and intercomparison between laboratories and performance tests. In this paper the validation criteria of an internal dosimetry laboratory in vivo are presented following the information provided by the standard ANSI N13-30-1996 and ISO/TEC 17025-2005 as are the criteria of facilities, staff training, interpretation of measurements, performance criteria for monitoring of internal contamination in vivo, results reporting and records retention. Thereby we achieve standardized quantitative performance criteria of truthfulness, accuracy and detection limit and a consensus on statistical definitions to establish the validation plan of a monitoring laboratory of internal contamination in vivo. (Author)

Measuring physiological and pathological femoral anteversion using a biplanar low-dose X-ray system: validity, reliability, and discriminative ability in cerebral palsy

Energy Technology Data Exchange (ETDEWEB)

Thepaut, Matthias [Laboratoire de Traitement de l' Information Medicale, INSERM U1101, Brest (France); CHRU de Brest, Hopital Morvan, Service de chirurgie pediatrique, Brest (France); Brochard, Sylvain [Laboratoire de Traitement de l' Information Medicale, INSERM U1101, Brest (France); CHRU de Brest, Hopital Morvan, Service de Medecine Physique et de Readaptation, Brest (France); Universite de Bretagne Occidentale, Brest (France); Leboucher, Julien [Laboratoire de Traitement de l' Information Medicale, INSERM U1101, Brest (France); Lempereur, Mathieu [Laboratoire de Traitement de l' Information Medicale, INSERM U1101, Brest (France); CHRU de Brest, Hopital Morvan, Service de Medecine Physique et de Readaptation, Brest (France); Stindel, Eric [Laboratoire de Traitement de l' Information Medicale, INSERM U1101, Brest (France); CHRU de Brest, La Cavale Blanche, Service d' Orthopedie-Traumatologie, Brest (France); Universite de Bretagne Occidentale, Brest (France); Tissot, Valentin [CHRU de Brest, Service de radiologie, Brest (France); Borotikar, Bhushan S. [Laboratoire de Traitement de l' Information Medicale, INSERM U1101, Brest (France); Institut Mines-Telecom, Telecom Bretagne, Brest (France)

2016-02-15

The aims of this study were to evaluate the concurrent validity and reliability of a low-dose biplanar X-ray system (Ld-BPR) for the measurement of femoral anteversion (FA) by comparing Ld-BPR-based three-dimensional measures with CT-scan-based measures and to assess the discriminative ability of this method in children with cerebral palsy. Fifty dry femora were scanned using both a CT scan and the Ld-BPR system. Ten femora were artificially modified to mimic a range of anteversion from -30 to +60 and scanned by both modalities. FA was quantified using the images from both modalities and statistically compared for concurrent validity. Intra- and inter-observer reliability of the Ld-BPR system was also determined. Further, Ld-BPR data from 16 hemiplegic and 22 diplegic children were analyzed for its discriminative ability. The concurrent validity between the Ld-BPR and CT-scan measures was excellent (R {sup 2} = 0.83-0.84) and no significant differences were found. The intra- and inter-trial reliability were excellent (ICCs = 0.98 and 0.97) with limits of agreement of (-2.28 ; +2.65 ) and (-2.76 ; +3.38 ) respectively. Further, no significant effects of angle or method were found in the sample of modified femora. Ld-BPR measures for FA were significantly different between healthy and impaired femora. The excellent concurrent validity with the CT scan modality, the excellent reliability, and the ability to discriminate pathological conditions evaluated by this study make this radiological method suitable for a validated use across hospitals and research institutes. (orig.)

Validation of a PCR-based method for detection of food-borne thermotolerant Campylobacters in a multicenter collaborative trial

DEFF Research Database (Denmark)

Josefsen, Mathilde Hartmann; Cook, N.; D'Agostino, M.

2004-01-01

A PCR-based method for rapid detection of food-borne thermotolerant campylobacters was evaluated through a collaborative trial with 12 laboratories testing spiked carcass rinse samples. The method showed an interlaboratory diagnostic sensitivity of 96.7% and a diagnostic specificity of 100% for c......% for chicken samples, while these values were 94.2 and 83.3%, respectively, for pig samples....

Determination of methylmercury in marine biota samples with advanced mercury analyzer: method validation.

Science.gov (United States)

Azemard, Sabine; Vassileva, Emilia

2015-06-01

In this paper, we present a simple, fast and cost-effective method for determination of methyl mercury (MeHg) in marine samples. All important parameters influencing the sample preparation process were investigated and optimized. Full validation of the method was performed in accordance to the ISO-17025 (ISO/IEC, 2005) and Eurachem guidelines. Blanks, selectivity, working range (0.09-3.0ng), recovery (92-108%), intermediate precision (1.7-4.5%), traceability, limit of detection (0.009ng), limit of quantification (0.045ng) and expanded uncertainty (15%, k=2) were assessed. Estimation of the uncertainty contribution of each parameter and the demonstration of traceability of measurement results was provided as well. Furthermore, the selectivity of the method was studied by analyzing the same sample extracts by advanced mercury analyzer (AMA) and gas chromatography-atomic fluorescence spectrometry (GC-AFS). Additional validation of the proposed procedure was effectuated by participation in the IAEA-461 worldwide inter-laboratory comparison exercises. Copyright © 2014 Elsevier Ltd. All rights reserved.

Impact of the implementation of a well-designed electronic laboratory notebook on bioanalytical laboratory function.

Science.gov (United States)

Zeng, Jianing; Hillman, Mark; Arnold, Mark

2011-07-01

This paper shares experiences of the Bristol-Myers Squibb Company during the design, validation and implementation of an electronic laboratory notebook (ELN) into the GLP/regulated bioanalytical analysis area, as well as addresses the impact on bioanalytical laboratory functions with the implementation of the electronic notebook. Some of the key points covered are: knowledge management - the project-based electronic notebook takes full advantage of the available technology that focuses on data organization and sharing so that scientific data generated by individual scientists became department knowledge; bioanalytical workflows in the ELN - the custom-built workflows that include data entry templates, validated calculation processes, integration with laboratory information management systems/laboratory instruments, and reporting capability improve the data quality and overall workflow efficiency; regulatory compliance - carefully designed notebook reviewing processes, cross referencing of distributed information, audit trail and software validation reduce compliance risks. By taking into consideration both data generation and project documentation needs, a well-designed ELN can deliver significant improvements in laboratory efficiency, work productivity, and regulatory compliance.

Clinical trials radiotherapy treatment plan review software : is this the first quantified assessment

International Nuclear Information System (INIS)

Hatton, J.A.; Cornes, D.A.

2011-01-01

Full text: Clinical trials require robust quality assurance (QA) procedures to ensure commonality of all treatments, with independent reviews to assess compliance with trial protocols. All clinical trials tools, including QA software, require testing for validity and reliability. enabling inter- and intra-trial comparison. Unlike clinical radiotherapy treatment planning (RTP) systems, review software has no published guidelines. This study describes the design and development of a test suite to quantify the performance of review software in TROG clinical trials. Test areas are image handling and reconstruction; geometric accuracy; dosimetric accuracy; dose-volume histogram (DVH) calculation; display of plan parameters. TROG have developed tests for commissioning plan review software, assessed with SWAN 2.3, and CMS Elekta FocalPro. While image handling tests were based on published guidelines for RTP systems, dosimetric tests used the TROG QA case review requirements. Treatment plans represented systems of all manufacturers (Pinnacle, Eclipse, Xio and Oncentra) used in Australasian centres. The test suite identified areas for SW A software development, including the DVH algorithm, changed to reduce calculation time. Results, in Fig. I, for known volumes of varying shapes and sizes, demonstrate differences between SWAN 2.1 and 2.3 when compared with Eclipse. Liaison with SWAN programmers enabled re-instatement of 2.1 algorithm. The test suite has quantified the RTP review software, prioritised areas for development with the programmers, and improved the user experience.

Operational trials of single- and multi-element CR-39 dosemeters for the DIDO and PLUTO reactors at the Harwell Laboratory

International Nuclear Information System (INIS)

Gallacher, G.G.; Perks, C.A.

1993-01-01

Single- and multi-element CR-39 dosemeters, developed at the Harwell Laboratory, and a commercially available multi-element CR-39 dosemeter (obtained from Track Analysis Systems Ltd), were evaluated for their potential as neutron dosemeters for personnel working at Harwell Laboratory's research reactors. Owing to the angular dependence of the CR-39 (processed using electrochemical etching), the single-element dosemeter was found to be impractical. Consequently, a multi-element dosemeter was developed, which consisted of a cube of side 36 mm with CR-39 elements (also processed using electrochemical etching) attached to each of the sides. Although this dosemeter was technically suitable for this type of dosimetry, it was considered to be unacceptably bulky in personnel trials. The commercially available CR-39 dosemeter tested was much smaller (the CR-39 was only chemically etched) and this was considered to be acceptable as a personnel dosemeter. In addition, trials with personnel working at active handling glove boxes indicated that single-element dosemeters might be adequate, but further work would be needed to verify this. (author)

Multicentre validation of 4-well azole agar plates as a screening method for detection of clinically relevant azole-resistant Aspergillus fumigatus

DEFF Research Database (Denmark)

Arendrup, Maiken Cavling; Verweij, Paul E; Mouton, Johan W

2017-01-01

Objectives: Azole-resistant Aspergillus fumigatus is emerging worldwide. Reference susceptibility testing methods are technically demanding and no validated commercial susceptibility tests for moulds currently exist. In this multicentre study a 4-well azole-containing screening agar method...... following E.Def 9.3. In-house and commercial 4-well plates containing agars supplemented with 4 mg/L itraconazole, 1 mg/L voriconazole, 0.5 mg/L posaconazole and no antifungal, respectively, were evaluated. Growth was scored (0-3) by two independent observers in three laboratories. Inter-plate, inter...... agreement (no growth versus growth) was excellent (median 95%-100%, range 87%-100%, overall). The overall sensitivity and specificity for the 4-well plate (no growth versus growth) was 99% (range 97%-100%) and 99% (95%-100%), respectively. The sensitivity for simulated WT/mutant specimens was 94% (range 83...

Enhanced inter-subject brain computer interface with associative sensorimotor oscillations.

Science.gov (United States)

Saha, Simanto; Ahmed, Khawza I; Mostafa, Raqibul; Khandoker, Ahsan H; Hadjileontiadis, Leontios

2017-02-01

Electroencephalography (EEG) captures electrophysiological signatures of cortical events from the scalp with high-dimensional electrode montages. Usually, excessive sources produce outliers and potentially affect the actual event related sources. Besides, EEG manifests inherent inter-subject variability of the brain dynamics, at the resting state and/or under the performance of task(s), caused probably due to the instantaneous fluctuation of psychophysiological states. A wavelet coherence (WC) analysis for optimally selecting associative inter-subject channels is proposed here and is being used to boost performances of motor imagery (MI)-based inter-subject brain computer interface (BCI). The underlying hypothesis is that optimally associative inter-subject channels can reduce the effects of outliers and, thus, eliminate dissimilar cortical patterns. The proposed approach has been tested on the dataset IVa from BCI competition III, including EEG data acquired from five healthy subjects who were given visual cues to perform 280 trials of MI for the right hand and right foot. Experimental results have shown increased classification accuracy (81.79%) using the WC-based selected 16 channels compared to the one (56.79%) achieved using all the available 118 channels. The associative channels lie mostly around the sensorimotor regions of the brain, reinforced by the previous literature, describing spatial brain dynamics during sensorimotor oscillations. Apparently, the proposed approach paves the way for optimised EEG channel selection that could boost further the efficiency and real-time performance of BCI systems.

Evaluation and validation of social and psychological markers in randomised trials of complex interventions in mental health: a methodological research programme.

Science.gov (United States)

Dunn, Graham; Emsley, Richard; Liu, Hanhua; Landau, Sabine; Green, Jonathan; White, Ian; Pickles, Andrew

2015-11-01

The development of the capability and capacity to evaluate the outcomes of trials of complex interventions is a key priority of the National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The evaluation of complex treatment programmes for mental illness (e.g. cognitive-behavioural therapy for depression or psychosis) not only is a vital component of this research in its own right but also provides a well-established model for the evaluation of complex interventions in other clinical areas. In the context of efficacy and mechanism evaluation (EME) there is a particular need for robust methods for making valid causal inference in explanatory analyses of the mechanisms of treatment-induced change in clinical outcomes in randomised clinical trials. The key objective was to produce statistical methods to enable trial investigators to make valid causal inferences about the mechanisms of treatment-induced change in these clinical outcomes. The primary objective of this report is to disseminate this methodology, aiming specifically at trial practitioners. The three components of the research were (1) the extension of instrumental variable (IV) methods to latent growth curve models and growth mixture models for repeated-measures data; (2) the development of designs and regression methods for parallel trials; and (3) the evaluation of the sensitivity/robustness of findings to the assumptions necessary for model identifiability. We illustrate our methods with applications from psychological and psychosocial intervention trials, keeping the technical details to a minimum, leaving the reporting of the more theoretical and mathematically demanding results for publication in appropriate specialist journals. We show how to estimate treatment effects and introduce methods for EME. We explain the use of IV methods and principal stratification to evaluate the role of putative treatment effect mediators and therapeutic process measures. These results are

Automatic segmentation of myocardium at risk from contrast enhanced SSFP CMR: validation against expert readers and SPECT

International Nuclear Information System (INIS)

Tufvesson, Jane; Carlsson, Marcus; Aletras, Anthony H.; Engblom, Henrik; Deux, Jean-François; Koul, Sasha; Sörensson, Peder; Pernow, John; Atar, Dan; Erlinge, David; Arheden, Håkan; Heiberg, Einar

2016-01-01

Efficacy of reperfusion therapy can be assessed as myocardial salvage index (MSI) by determining the size of myocardium at risk (MaR) and myocardial infarction (MI), (MSI = 1-MI/MaR). Cardiovascular magnetic resonance (CMR) can be used to assess MI by late gadolinium enhancement (LGE) and MaR by either T2-weighted imaging or contrast enhanced SSFP (CE-SSFP). Automatic segmentation algorithms have been developed and validated for MI by LGE as well as for MaR by T2-weighted imaging. There are, however, no algorithms available for CE-SSFP. Therefore, the aim of this study was to develop and validate automatic segmentation of MaR in CE-SSFP. The automatic algorithm applies surface coil intensity correction and classifies myocardial intensities by Expectation Maximization to define a MaR region based on a priori regional criteria, and infarct region from LGE. Automatic segmentation was validated against manual delineation by expert readers in 183 patients with reperfused acute MI from two multi-center randomized clinical trials (RCT) (CHILL-MI and MITOCARE) and against myocardial perfusion SPECT in an additional set (n = 16). Endocardial and epicardial borders were manually delineated at end-diastole and end-systole. Manual delineation of MaR was used as reference and inter-observer variability was assessed for both manual delineation and automatic segmentation of MaR in a subset of patients (n = 15). MaR was expressed as percent of left ventricular mass (%LVM) and analyzed by bias (mean ± standard deviation). Regional agreement was analyzed by Dice Similarity Coefficient (DSC) (mean ± standard deviation). MaR assessed by manual and automatic segmentation were 36 ± 10 % and 37 ± 11 %LVM respectively with bias 1 ± 6 %LVM and regional agreement DSC 0.85 ± 0.08 (n = 183). MaR assessed by SPECT and CE-SSFP automatic segmentation were 27 ± 10 %LVM and 29 ± 7 %LVM respectively with bias 2 ± 7 %LVM. Inter-observer variability was 0 ± 3 %LVM for manual delineation and

Validation of modified forms of the PedsQL generic core scales and cancer module scales for adolescents and young adults (AYA) with cancer or a blood disorder.

Science.gov (United States)

Ewing, Jane E; King, Madeleine T; Smith, Narelle F

2009-03-01

To validate two health-related quality of life (HRQOL) measures, the PedsQL Generic Core and Cancer Module adolescent forms (13-18 years), after modification for 16-25-year-old adolescents and young adults (AYA) with cancer or a blood disorder. AYA patients and nominated proxies were recruited from three Sydney hospitals. Modified forms were administered by telephone or in clinics/wards. Analyses included correlations, factor analysis, and analysis of variance of known-groups (defined by the Memorial Symptom Assessment Scale). Eighty-eight patients and 79 proxies completed questionnaires. Factor structures consistent with those of the unmodified forms confirmed construct validity. Cronbach's alpha ranged 0.81-0.98. Inter-scale correlations were as hypothesized, confirming discriminant validity. Statistically significant differences between groups with mild, moderate, and severe symptoms (P < 0.05) confirmed clinical validity. These modified forms provide reliable and valid measures of HRQOL in AYA with cancer or a blood disorder, suitable for clinical trials, research, and practice.

Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates.

Science.gov (United States)

Dellson, P; Nilbert, M; Bendahl, P-O; Malmström, P; Carlsson, C

2011-07-01

Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials. © 2010 Blackwell Publishing Ltd.

Assessing physiotherapists' communication skills for promoting patient autonomy for self-management: reliability and validity of the communication evaluation in rehabilitation tool.

Science.gov (United States)

Murray, Aileen; Hall, Amanda; Williams, Geoffrey C; McDonough, Suzanne M; Ntoumanis, Nikos; Taylor, Ian; Jackson, Ben; Copsey, Bethan; Hurley, Deirdre A; Matthews, James

2018-02-27

To assess the inter-rater reliability and concurrent validity of the Communication Evaluation in Rehabilitation Tool, which aims to externally assess physiotherapists competency in using Self-Determination Theory-based communication strategies in practice. Audio recordings of initial consultations between 24 physiotherapists and 24 patients with chronic low back pain in four hospitals in Ireland were obtained as part of a larger randomised controlled trial. Three raters, all of whom had Ph.Ds in psychology and expertise in motivation and physical activity, independently listened to the 24 audio recordings and completed the 18-item Communication Evaluation in Rehabilitation Tool. Inter-rater reliability between all three raters was assessed using intraclass correlation coefficients. Concurrent validity was assessed using Pearson's r correlations with a reference standard, the Health Care Climate Questionnaire. The total score for the Communication Evaluation in Rehabilitation Tool is an average of all 18 items. Total scores demonstrated good inter-rater reliability (Intraclass Correlation Coefficient (ICC) = 0.8) and concurrent validity with the Health Care Climate Questionnaire total score (range: r = 0.7-0.88). Item-level scores of the Communication Evaluation in Rehabilitation Tool identified five items that need improvement. Results provide preliminary evidence to support future use and testing of the Communication Evaluation in Rehabilitation Tool. Implications for Rehabilitation Promoting patient autonomy is a learned skill and while interventions exist to train clinicians in these skills there are no tools to assess how well clinicians use these skills when interacting with a patient. The lack of robust assessment has severe implications regarding both the fidelity of clinician training packages and resulting outcomes for promoting patient autonomy. This study has developed a novel measurement tool Communication Evaluation in Rehabilitation Tool and a

Validity and Reliability of a Digital Inclinometer to Assess Knee Joint Position Sense in an Open Kinetic Chain.

Science.gov (United States)

Romero-Franco, Natalia; Montaño-Munuera, Juan Antonio; Fernández-Domínguez, Juan Carlos; Jiménez-Reyes, Pedro

2017-12-18

New methods are being validated to easily evaluate the knee joint position sense (JPS) due to its role in sports movement and the risk of injury. However, no studies to date have considered the open kinetic chain (OKC) technique, despite the biomechanical differences compared to closed kinetic chain movements. To analyze the validity and reliability of a digital inclinometer to measure the knee JPS in the OKC movement. The validity, inter-tester and intra-tester reliability of a digital inclinometer for measuring knee JPS were evaluated. Sports research laboratory. Eighteen athletes (11 males and 7 females; 28.4 ± 6.6 years; 71.9 ± 14.0 kg; 1.77 ± 0.09 m; 22.8 ± 3.2 kg/m 2 ) voluntary participated in this study. Absolute angular error (AAE), relative angular error (RAE) and variable angular error (VAE) of knee JPS in an OKC. Intraclass correlation coefficient (ICC) and standard error of the mean (SEM) were calculated to determine the validity and reliability of the inclinometer. Data showed excellent validity of the inclinometer to obtain proprioceptive errors compared to the video analysis in JPS tasks (AAE: ICC = 0.981, SEM = 0.08; RAE: ICC = 0.974, SEM = 0.12; VAE: ICC = 0.973, SEM = 0.07). Inter-tester reliability was also excellent for all the proprioceptive errors (AAE: ICC = 0.967, SEM = 0.04; RAE: ICC = 0.974, SEM = 0.03; VAE: ICC = 0.939, SEM = 0.08). Similar results were obtained for intra-tester reliability (AAE: ICC = 0.861, SEM = 0.1; RAE: ICC = 0.894, SEM = 0.1; VAE: ICC = 0.700, SEM = 0.2). The digital inclinometer is a valid and reliable method to assess the knee JPS in OKC. Sport professionals may evaluate the knee JPS to monitor its deterioration during training or improvements throughout the rehabilitation process.

Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance.

Science.gov (United States)

Holloway, Laura; Humphrey, Louise; Heron, Louise; Pilling, Claire; Kitchen, Helen; Højbjerre, Lise; Strandberg-Larsen, Martin; Hansen, Brian Bekker

2014-07-22

Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI

Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance

Science.gov (United States)

2014-01-01

Background Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials. Methods A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials. Results The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and

Brief Self-Efficacy Scales for use in Weight-Loss Trials: Preliminary Evidence of Validity

Science.gov (United States)

Wilson, Kathryn E.; Harden, Samantha M.; Almeida, Fabio A.; You, Wen; Hill, Jennie L.; Goessl, Cody; Estabrooks, Paul A.

2015-01-01

Self-efficacy is a commonly included cognitive variable in weight-loss trials, but there is little uniformity in its measurement. Weight-loss trials frequently focus on physical activity (PA) and eating behavior, as well as weight loss, but no survey is available that offers reliable measurement of self-efficacy as it relates to each of these targeted outcomes. The purpose of this study was to test the psychometric properties of brief, pragmatic self-efficacy scales specific to PA, healthful eating and weight-loss (4 items each). An adult sample (n=1790) from 28 worksites enrolled in a worksite weight-loss program completed the self-efficacy scale, as well as measures of PA, dietary fat intake, and weight, at baseline, 6-, and 12-months. The hypothesized factor structure was tested through confirmatory factor analysis, which supported the expected factor structure for three latent self-efficacy factors, specific to PA, healthful eating, and weight-loss. Measurement equivalence/invariance between relevant demographic groups, and over time was also supported. Parallel growth processes in self-efficacy factors and outcomes (PA, fat intake, and weight) support the predictive validity of score interpretations. Overall, this initial series of psychometric analyses supports the interpretation that scores on these scales reflect self-efficacy for PA, healthful eating, and weight-loss. The use of this instrument in large-scale weight-loss trials is encouraged. PMID:26619093

On the stability of a variety of organic photovoltaic devices by IPCE and in situ IPCE analyses--the ISOS-3 inter-laboratory collaboration.

Science.gov (United States)

Teran-Escobar, Gerardo; Tanenbaum, David M; Voroshazi, Eszter; Hermenau, Martin; Norrman, Kion; Lloyd, Matthew T; Galagan, Yulia; Zimmermann, Birger; Hösel, Markus; Dam, Henrik F; Jørgensen, Mikkel; Gevorgyan, Suren; Kudret, Suleyman; Maes, Wouter; Lutsen, Laurence; Vanderzande, Dirk; Würfel, Uli; Andriessen, Ronn; Rösch, Roland; Hoppe, Harald; Rivaton, Agnès; Uzunoğlu, Gülşah Y; Germack, David; Andreasen, Birgitta; Madsen, Morten V; Bundgaard, Eva; Krebs, Frederik C; Lira-Cantu, Monica

2012-09-07

This work is part of the inter-laboratory collaboration to study the stability of seven distinct sets of state-of-the-art organic photovoltaic (OPV) devices prepared by leading research laboratories. All devices have been shipped to and degraded at RISØ-DTU up to 1830 hours in accordance with established ISOS-3 protocols under defined illumination conditions. In this work, we apply the Incident Photon-to-Electron Conversion Efficiency (IPCE) and the in situ IPCE techniques to determine the relation between solar cell performance and solar cell stability. Different ageing conditions were considered: accelerated full sun simulation, low level indoor fluorescent lighting and dark storage. The devices were also monitored under conditions of ambient and inert (N(2)) atmospheres, which allows for the identification of the solar cell materials more susceptible to degradation by ambient air (oxygen and moisture). The different OPVs configurations permitted the study of the intrinsic stability of the devices depending on: two different ITO-replacement alternatives, two different hole extraction layers (PEDOT:PSS and MoO(3)), and two different P3HT-based polymers. The response of un-encapsulated devices to ambient atmosphere offered insight into the importance of moisture in solar cell performance. Our results demonstrate that the IPCE and the in situ IPCE techniques are valuable analytical methods to understand device degradation and solar cell lifetime.

Validation of the Six Sigma Z-score for the quality assessment of clinical laboratory timeliness.

Science.gov (United States)

Ialongo, Cristiano; Bernardini, Sergio

2018-03-28

The International Federation of Clinical Chemistry and Laboratory Medicine has introduced in recent times the turnaround time (TAT) as mandatory quality indicator for the postanalytical phase. Classic TAT indicators, namely, average, median, 90th percentile and proportion of acceptable test (PAT), are in use since almost 40 years and to date represent the mainstay for gauging the laboratory timeliness. In this study, we investigated the performance of the Six Sigma Z-score, which was previously introduced as a device for the quantitative assessment of timeliness. A numerical simulation was obtained modeling the actual TAT data set using the log-logistic probability density function. Five thousand replicates for each size of the artificial TAT random sample (n=20, 50, 250 and 1000) were generated, and different laboratory conditions were simulated manipulating the PDF in order to generate more or less variable data. The Z-score and the classic TAT indicators were assessed for precision (%CV), robustness toward right-tailing (precision at different sample variability), sensitivity and specificity. Z-score showed sensitivity and specificity comparable to PAT (≈80% with n≥250), but superior precision that ranged within 20% by moderately small sized samples (n≥50); furthermore, Z-score was less affected by the value of the cutoff used for setting the acceptable TAT, as well as by the sample variability that reflected into the magnitude of right-tailing. The Z-score was a valid indicator of laboratory timeliness and a suitable device to improve as well as to maintain the achieved quality level.

Effect of a Multi-Dimensional and Inter-Sectoral Intervention on the Adherence of Psychiatric Patients.

Directory of Open Access Journals (Sweden)

Anne Pauly

Full Text Available In psychiatry, hospital stays and transitions to the ambulatory sector are susceptible to major changes in drug therapy that lead to complex medication regimens and common non-adherence among psychiatric patients. A multi-dimensional and inter-sectoral intervention is hypothesized to improve the adherence of psychiatric patients to their pharmacotherapy.269 patients from a German university hospital were included in a prospective, open, clinical trial with consecutive control and intervention groups. Control patients (09/2012-03/2013 received usual care, whereas intervention patients (05/2013-12/2013 underwent a program to enhance adherence during their stay and up to three months after discharge. The program consisted of therapy simplification and individualized patient education (multi-dimensional component during the stay and at discharge, as well as subsequent phone calls after discharge (inter-sectoral component. Adherence was measured by the "Medication Adherence Report Scale" (MARS and the "Drug Attitude Inventory" (DAI.The improvement in the MARS score between admission and three months after discharge was 1.33 points (95% CI: 0.73-1.93 higher in the intervention group compared to controls. In addition, the DAI score improved 1.93 points (95% CI: 1.15-2.72 more for intervention patients.These two findings indicate significantly higher medication adherence following the investigated multi-dimensional and inter-sectoral program.German Clinical Trials Register DRKS00006358.

Five-Kilometers Time Trial: Preliminary Validation of a Short Test for Cycling Performance Evaluation.

Science.gov (United States)

Dantas, Jose Luiz; Pereira, Gleber; Nakamura, Fabio Yuzo

2015-09-01

The five-kilometer time trial (TT5km) has been used to assess aerobic endurance performance without further investigation of its validity. This study aimed to perform a preliminary validation of the TT5km to rank well-trained cyclists based on aerobic endurance fitness and assess changes of the aerobic endurance performance. After the incremental test, 20 cyclists (age = 31.3 ± 7.9 years; body mass index = 22.7 ± 1.5 kg/m(2); maximal aerobic power = 360.5 ± 49.5 W) performed the TT5km twice, collecting performance (time to complete, absolute and relative power output, average speed) and physiological responses (heart rate and electromyography activity). The validation criteria were pacing strategy, absolute and relative reliability, validity, and sensitivity. Sensitivity index was obtained from the ratio between the smallest worthwhile change and typical error. The TT5km showed high absolute (coefficient of variation 0.95) reliability of performance variables, whereas it presented low reliability of physiological responses. The TT5km performance variables were highly correlated with the aerobic endurance indices obtained from incremental test (r > 0.70). These variables showed adequate sensitivity index (> 1). TT5km is a valid test to rank the aerobic endurance fitness of well-trained cyclists and to differentiate changes on aerobic endurance performance. Coaches can detect performance changes through either absolute (± 17.7 W) or relative power output (± 0.3 W.kg(-1)), the time to complete the test (± 13.4 s) and the average speed (± 1.0 km.h(-1)). Furthermore, TT5km performance can also be used to rank the athletes according to their aerobic endurance fitness.

Application of flexible scope in large testing laboratories

Directory of Open Access Journals (Sweden)

Carina Di Candia

2011-04-01

Full Text Available According as the international definition of Flexible Scope, a laboratory must demonstrate face with the accreditation body that it has the knowledge, experience and competence to work within the full range of its flexible scope, as well as possessing suitable laboratory environments and equipment. The laboratory must also demonstrate that it has a management system in place that can control its proposed approach while continuing to comply with the requirements of ISO 17025:2005. In case of UKAS (Unites Kingdom Accreditation Service, prior to offering accreditation for flexible scope they must have a high degree of confidence that the staff are technically competent and that the management system controlling certain key processes as development, review, validation and authorization.LATU apply these requirements since 2004 as "Unified Tests". Until this date, LATU was doing the same type of tests in different materials departments using different equipment, personal, and testing quality control. In order to that were defined cross disciplinary groups to analyze this topic approaching in personal competence and quality control tests improvement, and resource's decrease. For example, LATU has the Unified Test Tensile Strength accredited by UKAS in: corrugated and solid fiberboard, paper board, linerboard, cork plugs, plastic bags, plastic sheeting, paper, woven fabrics, plastic woven bags and woven plastic. As a result of the Unified Tests was generated a general unified manage procedure with unified criteria's, responsibilities and actions. Was written a unique testing procedure not only with the actual flexible scope and the flexibilities limits but also the compliance requirements of ISO 17025 and the accreditations body methodology. We could decrease the amount of documentation to control. Was defined the methodology and implemented periodicaly internal inter comparisons between departments in order to valid the unified tests and has a unique

Assessment of the nursing care product (APROCENF: a reliability and construct validity study

Directory of Open Access Journals (Sweden)

Danielle Fabiana Cucolo

Full Text Available ABSTRACT Objectives: to verify the reliability and construct validity estimates of the "Assessment of nursing care product" scale (APROCENF and its applicability. Methods: this validation study included a sample of 40 (inter-rater reliability and 172 (construct validity assessments performed by nurses at the end of the work shift at nine inpatient services of a teaching hospital in the Brazilian Southeast. The data were collected between February and September/2014 with interruptions. Cronbach's alpha and Spearman's correlation coefficients were calculated, as well as the intraclass correlation and the weighted kappa index (inter-rater reliability. Exploratory factor analysis was used with principal component extraction and varimax rotation (construct validity. Results: the internal consistency revealed an alpha coefficient of 0.85, item-item correlation ranging between 0.13 and 0.61 and item-total correlation between 0.43 and 0.69. Inter-rater equivalence was obtained and all items evidenced significant factor loadings. Conclusion: this research evidenced the reliability and construct validity of the scale to assess the nursing care product. Its application in nursing practice permits identifying improvements needed in the production process, contributing to management and care decisions.

Quality assurance trials for Ki67 assessment in pathology.

Science.gov (United States)

Raap, M; Ließem, S; Rüschoff, J; Fisseler-Eckhoff, A; Reiner, A; Dirnhofer, S; von Wasielewski, R; Kreipe, H

2017-10-01

Ki67 is a broadly used proliferation marker in surgical pathology with an obvious need for standardization to improve reproducibility of assessment. Here, we present results of the so far only existing round robin tests on Ki67, organized annually in Germany, Austria, and Switzerland from 2010 to 2015 with up to 160 participating laboratories (QuIP). In each quality assessment trial, eight probes from each breast cancer, neuroendocrine tumor, and malignant lymphoma were compiled on a tissue microarray (TMA). TMAs were stained in the participants' laboratories with antibodies and procedures also applied in their daily routine. Participating pathologists were expected to assign Ki67 values to one of four different categories for each tumor type. All local stainings and evaluations were reassessed by the organizing panel and compared to a preset standard. On average, 95% of participants reached the benchmark of over 80% concordance rates with the Ki67 category pre-established by the panel. Automatization and type of antibody did not affect the success rate. Concordance rates differed between tumor entities being highest in each tumor type with either very high or very low labeling indices. Lower rates were seen for intermediate Ki67 levels. Staining quality improved during the observation period as did inter-observer concordance with 85% of participants achieving excellent agreement (kappa > 0.8) in the first year and over 95% in 2015. In conclusion, regular external quality assurance trials have been established as a tool to improve the reproducibility and reliability of the prognostic and predictive proliferation marker Ki67.

Development of a quality-assessment tool for experimental bruxism studies: reliability and validity.

Science.gov (United States)

Dawson, Andreas; Raphael, Karen G; Glaros, Alan; Axelsson, Susanna; Arima, Taro; Ernberg, Malin; Farella, Mauro; Lobbezoo, Frank; Manfredini, Daniele; Michelotti, Ambra; Svensson, Peter; List, Thomas

2013-01-01

To combine empirical evidence and expert opinion in a formal consensus method in order to develop a quality-assessment tool for experimental bruxism studies in systematic reviews. Tool development comprised five steps: (1) preliminary decisions, (2) item generation, (3) face-validity assessment, (4) reliability and discriminitive validity assessment, and (5) instrument refinement. The kappa value and phi-coefficient were calculated to assess inter-observer reliability and discriminative ability, respectively. Following preliminary decisions and a literature review, a list of 52 items to be considered for inclusion in the tool was compiled. Eleven experts were invited to join a Delphi panel and 10 accepted. Four Delphi rounds reduced the preliminary tool-Quality-Assessment Tool for Experimental Bruxism Studies (Qu-ATEBS)- to 8 items: study aim, study sample, control condition or group, study design, experimental bruxism task, statistics, interpretation of results, and conflict of interest statement. Consensus among the Delphi panelists yielded good face validity. Inter-observer reliability was acceptable (k = 0.77). Discriminative validity was excellent (phi coefficient 1.0; P reviews of experimental bruxism studies, exhibits face validity, excellent discriminative validity, and acceptable inter-observer reliability. Development of quality assessment tools for many other topics in the orofacial pain literature is needed and may follow the described procedure.

The Health Informatics Trial Enhancement Project (HITE: Using routinely collected primary care data to identify potential participants for a depression trial

Directory of Open Access Journals (Sweden)

Lyons Ronan A

2010-04-01

Full Text Available Abstract Background Recruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely collected data to identify potential trial participants. We discuss the strengths and limitations of this approach, assess its potential value, report challenges and ethical issues encountered. Methods Swansea University's Health Information Research Unit's Secure Anonymised Information Linkage (SAIL database of routinely collected health records was interrogated, using Structured Query Language (SQL. Read codes were used to create an algorithm of inclusion/exclusion criteria with which to identify suitable anonymous participants. Two independent clinicians rated the eligibility of the potential participants' identified. Inter-rater reliability was assessed using the kappa statistic and inter-class correlation. Results The study population (N = 37263 comprised all adults registered at five general practices in Swansea UK. Using the algorithm 867 anonymous potential participants were identified. The sensitivity and specificity results > 0.9 suggested a high degree of accuracy from the algorithm. The inter-rater reliability results indicated strong agreement between the confirming raters. The Intra Class Correlation Coefficient (Cronbach's Alpha > 0.9, suggested excellent agreement and Kappa coefficient > 0.8; almost perfect agreement. Conclusions This proof of concept study showed that routinely collected primary care data can be used to identify potential participants for a pragmatic randomised controlled trial of folate augmentation of antidepressant therapy for the treatment of depression. Further work will be needed to assess generalisability to other conditions and settings and the inclusion of this approach to support Electronic Enhanced Recruitment (EER.

Atlas-based segmentation technique incorporating inter-observer delineation uncertainty for whole breast

International Nuclear Information System (INIS)

Bell, L R; Pogson, E M; Metcalfe, P; Holloway, L; Dowling, J A

2017-01-01

Accurate, efficient auto-segmentation methods are essential for the clinical efficacy of adaptive radiotherapy delivered with highly conformal techniques. Current atlas based auto-segmentation techniques are adequate in this respect, however fail to account for inter-observer variation. An atlas-based segmentation method that incorporates inter-observer variation is proposed. This method is validated for a whole breast radiotherapy cohort containing 28 CT datasets with CTVs delineated by eight observers. To optimise atlas accuracy, the cohort was divided into categories by mean body mass index and laterality, with atlas’ generated for each in a leave-one-out approach. Observer CTVs were merged and thresholded to generate an auto-segmentation model representing both inter-observer and inter-patient differences. For each category, the atlas was registered to the left-out dataset to enable propagation of the auto-segmentation from atlas space. Auto-segmentation time was recorded. The segmentation was compared to the gold-standard contour using the dice similarity coefficient (DSC) and mean absolute surface distance (MASD). Comparison with the smallest and largest CTV was also made. This atlas-based auto-segmentation method incorporating inter-observer variation was shown to be efficient (<4min) and accurate for whole breast radiotherapy, with good agreement (DSC>0.7, MASD <9.3mm) between the auto-segmented contours and CTV volumes. (paper)

Improving the Accuracy of Laplacian Estimation with Novel Variable Inter-Ring Distances Concentric Ring Electrodes

Directory of Open Access Journals (Sweden)

Oleksandr Makeyev

2016-06-01

Full Text Available Noninvasive concentric ring electrodes are a promising alternative to conventional disc electrodes. Currently, the superiority of tripolar concentric ring electrodes over disc electrodes, in particular, in accuracy of Laplacian estimation, has been demonstrated in a range of applications. In our recent work, we have shown that accuracy of Laplacian estimation can be improved with multipolar concentric ring electrodes using a general approach to estimation of the Laplacian for an (n + 1-polar electrode with n rings using the (4n + 1-point method for n ≥ 2. This paper takes the next step toward further improving the Laplacian estimate by proposing novel variable inter-ring distances concentric ring electrodes. Derived using a modified (4n + 1-point method, linearly increasing and decreasing inter-ring distances tripolar (n = 2 and quadripolar (n = 3 electrode configurations are compared to their constant inter-ring distances counterparts. Finite element method modeling and analytic results are consistent and suggest that increasing inter-ring distances electrode configurations may decrease the truncation error resulting in more accurate Laplacian estimates compared to respective constant inter-ring distances configurations. For currently used tripolar electrode configuration, the truncation error may be decreased more than two-fold, while for the quadripolar configuration more than a six-fold decrease is expected.

Improving the Accuracy of Laplacian Estimation with Novel Variable Inter-Ring Distances Concentric Ring Electrodes

Science.gov (United States)

Makeyev, Oleksandr; Besio, Walter G.

2016-01-01

Noninvasive concentric ring electrodes are a promising alternative to conventional disc electrodes. Currently, the superiority of tripolar concentric ring electrodes over disc electrodes, in particular, in accuracy of Laplacian estimation, has been demonstrated in a range of applications. In our recent work, we have shown that accuracy of Laplacian estimation can be improved with multipolar concentric ring electrodes using a general approach to estimation of the Laplacian for an (n + 1)-polar electrode with n rings using the (4n + 1)-point method for n ≥ 2. This paper takes the next step toward further improving the Laplacian estimate by proposing novel variable inter-ring distances concentric ring electrodes. Derived using a modified (4n + 1)-point method, linearly increasing and decreasing inter-ring distances tripolar (n = 2) and quadripolar (n = 3) electrode configurations are compared to their constant inter-ring distances counterparts. Finite element method modeling and analytic results are consistent and suggest that increasing inter-ring distances electrode configurations may decrease the truncation error resulting in more accurate Laplacian estimates compared to respective constant inter-ring distances configurations. For currently used tripolar electrode configuration, the truncation error may be decreased more than two-fold, while for the quadripolar configuration more than a six-fold decrease is expected. PMID:27294933

Inter-rater agreement on PIVC-associated phlebitis signs, symptoms and scales.

Science.gov (United States)

Marsh, Nicole; Mihala, Gabor; Ray-Barruel, Gillian; Webster, Joan; Wallis, Marianne C; Rickard, Claire M

2015-10-01

Many peripheral intravenous catheter (PIVC) infusion phlebitis scales and definitions are used internationally, although no existing scale has demonstrated comprehensive reliability and validity. We examined inter-rater agreement between registered nurses on signs, symptoms and scales commonly used in phlebitis assessment. Seven PIVC-associated phlebitis signs/symptoms (pain, tenderness, swelling, erythema, palpable venous cord, purulent discharge and warmth) were observed daily by two raters (a research nurse and registered nurse). These data were modelled into phlebitis scores using 10 different tools. Proportions of agreement (e.g. positive, negative), observed and expected agreements, Cohen's kappa, the maximum achievable kappa, prevalence- and bias-adjusted kappa were calculated. Two hundred ten patients were recruited across three hospitals, with 247 sets of paired observations undertaken. The second rater was blinded to the first's findings. The Catney and Rittenberg scales were the most sensitive (phlebitis in >20% of observations), whereas the Curran, Lanbeck and Rickard scales were the most restrictive (≤2% phlebitis). Only tenderness and the Catney (one of pain, tenderness, erythema or palpable cord) and Rittenberg scales (one of erythema, swelling, tenderness or pain) had acceptable (more than two-thirds, 66.7%) levels of inter-rater agreement. Inter-rater agreement for phlebitis assessment signs/symptoms and scales is low. This likely contributes to the high degree of variability in phlebitis rates in literature. We recommend further research into assessment of infrequent signs/symptoms and the Catney or Rittenberg scales. New approaches to evaluating vein irritation that are valid, reliable and based on their ability to predict complications need exploration. © 2015 John Wiley & Sons, Ltd.

Procedures For Microbial-Ecology Laboratory

Science.gov (United States)

Huff, Timothy L.

1993-01-01

Microbial Ecology Laboratory Procedures Manual provides concise and well-defined instructions on routine technical procedures to be followed in microbiological laboratory to ensure safety, analytical control, and validity of results.

Analytical validation of a new point-of-care assay for serum amyloid A in horses.

Science.gov (United States)

Schwartz, D; Pusterla, N; Jacobsen, S; Christopher, M M

2018-01-17

Serum amyloid A (SAA) is a major acute phase protein in horses. A new point-of-care (POC) test for SAA (Stablelab) is available, but studies evaluating its analytical accuracy are lacking. To evaluate the analytical performance of the SAA POC test by 1) determining linearity and precision, 2) comparing results in whole blood with those in serum or plasma, and 3) comparing POC results with those obtained using a previously validated turbidimetric immunoassay (TIA). Assay validation. Analytical validation of the POC test was done in accordance with American Society of Veterinary Clinical Pathology guidelines using residual equine serum/plasma and whole blood samples from the Clinical Pathology Laboratory at the University of California-Davis. A TIA was used as the reference method. We also evaluated the effect of haematocrit (HCT). The POC test was linear for SAA concentrations of up to at least 1000 μg/mL (r = 0.991). Intra-assay CVs were 13, 18 and 15% at high (782 μg/mL), intermediate (116 μg/mL) and low (64 μg/mL) concentrations. Inter-assay (inter-batch) CVs were 45, 14 and 15% at high (1372 μg/mL), intermediate (140 μg/mL) and low (56 μg/mL) concentrations. SAA results in whole blood were significantly lower than those in serum/plasma (P = 0.0002), but were positively correlated (r = 0.908) and not affected by HCT (P = 0.261); proportional negative bias was observed in samples with SAA>500 μg/mL. The difference between methods exceeded the 95% confidence interval of the combined imprecision of both methods (15%). Analytical validation could not be performed in whole blood, the sample most likely to be used stall side. The POC test has acceptable accuracy and precision in equine serum/plasma with SAA concentrations of up to at least 1000 μg/mL. Low inter-batch precision at high concentrations may affect serial measurements, and the use of the same test batch and sample type (serum/plasma or whole blood) is recommended. Comparison of results between the

The ideal laboratory information system.

Science.gov (United States)

Sepulveda, Jorge L; Young, Donald S

2013-08-01

Laboratory information systems (LIS) are critical components of the operation of clinical laboratories. However, the functionalities of LIS have lagged significantly behind the capacities of current hardware and software technologies, while the complexity of the information produced by clinical laboratories has been increasing over time and will soon undergo rapid expansion with the use of new, high-throughput and high-dimensionality laboratory tests. In the broadest sense, LIS are essential to manage the flow of information between health care providers, patients, and laboratories and should be designed to optimize not only laboratory operations but also personalized clinical care. To list suggestions for designing LIS with the goal of optimizing the operation of clinical laboratories while improving clinical care by intelligent management of laboratory information. Literature review, interviews with laboratory users, and personal experience and opinion. Laboratory information systems can improve laboratory operations and improve patient care. Specific suggestions for improving the function of LIS are listed under the following sections: (1) Information Security, (2) Test Ordering, (3) Specimen Collection, Accessioning, and Processing, (4) Analytic Phase, (5) Result Entry and Validation, (6) Result Reporting, (7) Notification Management, (8) Data Mining and Cross-sectional Reports, (9) Method Validation, (10) Quality Management, (11) Administrative and Financial Issues, and (12) Other Operational Issues.

Validation of a structured training and assessment curriculum for technical skill acquisition in minimally invasive surgery: a randomized controlled trial.

Science.gov (United States)

Palter, Vanessa N; Orzech, Neil; Reznick, Richard K; Grantcharov, Teodor P

2013-02-01

: To develop and validate an ex vivo comprehensive curriculum for a basic laparoscopic procedure. : Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex vivo training on learning curves in the operating room (OR), nor the effect on nontechnical proficiency has been investigated. : This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured training and assessment curriculum (STAC) group or conventional residency training. The STAC consisted of case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and nontechnical skills. : Residents in the STAC group outperformed residents in the conventional group in the first (P = 0.004), second (P = 0.036), third (P = 0.021), and fourth (P = 0.023) laparoscopic cholecystectomies. The conventional group demonstrated a significant learning curve in the OR (P = 0.015) in contrast to the STAC group (P = 0.032). Residents in the STAC group also had significantly higher nontechnical skills (P = 0.027). : Participating in the STAC shifted the learning curve for a basic laparoscopic procedure from the operating room into the simulation laboratory. STAC-trained residents had superior technical proficiency in the OR and nontechnical skills compared with conventionally trained residents. (The study registration ID is NCT01560494.).

BurnCase 3D software validation study: Burn size measurement accuracy and inter-rater reliability.

Science.gov (United States)

Parvizi, Daryousch; Giretzlehner, Michael; Wurzer, Paul; Klein, Limor Dinur; Shoham, Yaron; Bohanon, Fredrick J; Haller, Herbert L; Tuca, Alexandru; Branski, Ludwik K; Lumenta, David B; Herndon, David N; Kamolz, Lars-P

2016-03-01

The aim of this study was to compare the accuracy of burn size estimation using the computer-assisted software BurnCase 3D (RISC Software GmbH, Hagenberg, Austria) with that using a 2D scan, considered to be the actual burn size. Thirty artificial burn areas were pre planned and prepared on three mannequins (one child, one female, and one male). Five trained physicians (raters) were asked to assess the size of all wound areas using BurnCase 3D software. The results were then compared with the real wound areas, as determined by 2D planimetry imaging. To examine inter-rater reliability, we performed an intraclass correlation analysis with a 95% confidence interval. The mean wound area estimations of the five raters using BurnCase 3D were in total 20.7±0.9% for the child, 27.2±1.5% for the female and 16.5±0.1% for the male mannequin. Our analysis showed relative overestimations of 0.4%, 2.8% and 1.5% for the child, female and male mannequins respectively, compared to the 2D scan. The intraclass correlation between the single raters for mean percentage of the artificial burn areas was 98.6%. There was also a high intraclass correlation between the single raters and the 2D Scan visible. BurnCase 3D is a valid and reliable tool for the determination of total body surface area burned in standard models. Further clinical studies including different pediatric and overweight adult mannequins are warranted. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Multicenter evaluation of molecular and culture-dependent diagnostics for Shigella species and Entero-invasive Escherichia coli in the Netherlands

NARCIS (Netherlands)

van den Beld, Maaike J. C.; Friedrich, Alexander W.; van Zanten, Evert; Reubsaet, Frans A. G.; Kooistra-Smid, Mirjam A. M. D.; Rossen, John W. A.

2016-01-01

An inter-laboratory collaborative trial for the evaluation of diagnostics for detection and identification of Shigella species and Entero-invasive Escherichia coil (EIEC) was performed. Sixteen Medical Microbiological Laboratories (MMLs) participated. MMLs were interviewed about their diagnostic

Validity And Reliability Of The Stages Cycling Power Meter.

Science.gov (United States)

Granier, Cyril; Hausswirth, Christophe; Dorel, Sylvain; Yann, Le Meur

2017-09-06

This study aimed to determine the validity and the reliability of the Stages power meter crank system (Boulder, United States) during several laboratory cycling tasks. Eleven trained participants completed laboratory cycling trials on an indoor cycle fitted with SRM Professional and Stages systems. The trials consisted of an incremental test at 100W, 200W, 300W, 400W and four 7s sprints. The level of pedaling asymmetry was determined for each cycling intensity during a similar protocol completed on a Lode Excalibur Sport ergometer. The reliability of Stages and SRM power meters was compared by repeating the incremental test during a test-retest protocol on a Cyclus 2 ergometer. Over power ranges of 100-1250W the Stages system produced trivial to small differences compared to the SRM (standardized typical error values of 0.06, 0.24 and 0.08 for the incremental, sprint and combined trials, respectively). A large correlation was reported between the difference in power output (PO) between the two systems and the level of pedaling asymmetry (r=0.58, p system according to the level of pedaling asymmetry provided only marginal improvements in PO measures. The reliability of the Stages power meter at the sub-maximal intensities was similar to the SRM Professional model (coefficient of variation: 2.1 and 1.3% for Stages and SRM, respectively). The Stages system is a suitable device for PO measurements, except when a typical error of measurement power ranges of 100-1250W is expected.

Institute of Laboratory Animal Research

National Research Council Canada - National Science Library

Dell, Ralph

2000-01-01

...; and reports on specific issues of humane care and use of laboratory animals. ILAR's mission is to help improve the availability, quality, care, and humane and scientifically valid use of laboratory animals...

Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories.

Science.gov (United States)

Torlakovic, Emina E; Cheung, Carol C; D'Arrigo, Corrado; Dietel, Manfred; Francis, Glenn D; Gilks, C Blake; Hall, Jacqueline A; Hornick, Jason L; Ibrahim, Merdol; Marchetti, Antonio; Miller, Keith; van Krieken, J Han; Nielsen, Soren; Swanson, Paul E; Vyberg, Mogens; Zhou, Xiaoge; Taylor, Clive R

2017-03-01

Validation of immunohistochemistry (IHC) assays is a subject that is of great importance to clinical practice as well as basic research and clinical trials. When applied to clinical practice and focused on patient safety, validation of IHC assays creates objective evidence that IHC assays used for patient care are "fit-for-purpose." Validation of IHC assays needs to be properly informed by and modeled to assess the purpose of the IHC assay, which will further determine what sphere of validation is required, as well as the scope, type, and tier of technical validation. These concepts will be defined in this review, part 3 of the 4-part series "Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine."

Ultrasound monitoring of inter-knee distances during gait.

Science.gov (United States)

Lai, Daniel T H; Wrigley, Tim V; Palaniswami, M

2009-01-01

Knee osteoarthritis is an extremely common, debilitating disease associated with pain and loss of function. There is considerable interest in monitoring lower limb alignment due to its close association with joint overload leading to disease progression. The effects of gait modifications that can lower joint loading are of particular interest. Here we describe an ultrasound-based system for monitoring an important aspect of dynamic lower limb alignment, the inter-knee distance during walking. Monitoring this gait parameter should facilitate studies in reducing knee loading, a primary risk factor of knee osteoarthritis progression. The portable device is composed of an ultrasound sensor connected to an Intel iMote2 equipped with Bluetooth wireless capability. Static tests and calibration results show that the sensor possesses an effective beam envelope of 120 degrees, with maximum distance errors of 10% at the envelope edges. Dynamic walking trials reveal close correlation of inter-knee distance trends between that measured by an optical system (Optotrak Certus NDI) and the sensor device. The maximum average root mean square error was found to be 1.46 cm. Future work will focus on improving the accuracy of the device.

REIMEP-22 inter-laboratory comparison. ''U Age Dating - determination of the production date of a uranium certified test sample''

Energy Technology Data Exchange (ETDEWEB)

Venchiarutti, Celia; Richter, Stephan; Jakopic, Rozle; Aregbe, Yetunde [European Commission, Joint Research Centre (JRC), Geel (Belgium). Institute for Reference Materials and Measurements (IRMM); Varga, Zsolt; Mayer, Klaus [European Commission, Joint Research Centre (JRC), Karlsruhe (Germany). Institute for Transuranium Elements (ITU)

2015-07-01

The REIMEP-22 inter-laboratory comparison aimed at determining the production date of a uranium certified test sample (i.e. the last chemical separation date of the material). Participants in REIMEP-22 on ''U Age Dating - Determination of the production date of a uranium certified test sample'' received one low-enriched 20 mg uranium sample for mass spectrometry measurements and/or one 50 mg uranium sample for a-spectrometry measurements, with an undisclosed value for the production date. They were asked to report the isotope amount ratios n({sup 230}Th)/n({sup 234}U) for the 20 mg uranium sample and/or the activity ratios A({sup 230}Th)/A({sup 234}U) for the 50 mg uranium sample in addition to the calculated production date of the certified test samples with its uncertainty. Reporting of the {sup 231}Pa/{sup 235}U ratio and the respective calculated production date was optional. Eleven laboratories reported results in REIMEP-22. Two of them reported results for both the 20 mg and 50 mg uranium certified test samples. The measurement capability of the participants was assessed against the independent REIMEP-22 reference value by means of z- and zeta-scores in compliance with ISO 13528:2005. Furthermore a performance assessment criterion for acceptable uncertainty was applied to evaluate the participants' results. In general, the REIMEP-22 participants' results were satisfactory. This confirms the analytical capabilities of laboratories to determine accurately the age of uranium materials with low amount of ingrown thorium (young certified test sample). The Joint Research Centre of the European Commission (EC-JRC) organised REIMEP-22 in parallel to the preparation and certification of a uranium reference material certified for the production date (IRMM-1000a and IRMM-1000b).

Inter-laboratory comparison study of gamma cameras in Pakistan

International Nuclear Information System (INIS)

Shahid, M.A.; Mumtaz-ul-Haq

1988-01-01

The evaluation of the performance of both instrument and the physician are important in any quality assurance programme in nuclear medicine imaging. The IAEA launched a similar program in 1984 under its Regional Cooperation Agreement program in South Asian Countries. The first part of the study consisted of the evaluation of imaging equipment by imaging IAEA-WHO Simulated Anatomic Liver Phantom (SALP) and its interpretation by the physician. From Pakistan, 8 gamma cameras from 7 laboratories were used for the study and 16 physician interpreted in the SALP images. This paper reports the results of SALP images from Pakistan and shows the efficacy of 80 to 100% as regards the quality of image obtained and the interpretation done by the physicians. (author)

Inter-rater reliability of diagnostic criteria for sacroiliac joint-, disc- and facet joint pain.

Science.gov (United States)

van Tilburg, Cornelis W J; Groeneweg, Johannes G; Stronks, Dirk L; Huygen, Frank J P M

2017-01-01

Several diagnostic criteria sets are described in the literature to identify low back pain subtypes, but very little is known about the inter-rater reliability of these criteria. We conducted a study to determine the reliability of diagnostic tests that point towards SI joint-, disc- or facet joint pain. Inter-rater reliability study alongside three randomized clinical trials. Multidisciplinary pain center of general hospital. Patients aged 18 or more with medical history and physical examination suggestive of sacroiliac joint-, disc- and facet joint pain on lumbar level. Making use of nowadays most common used diagnostic criteria, a physical examination is taken independently by three physicians (two pain physicians and one orthopedic surgeon). Inter-rater reliability (Kappa (κ) measure of agreement) and significance (p) between raters are presented. Strengths of agreement, indicated with κ values above 0,20, are presented in order of agreement. One hundred patients were included. None of the parameters from the physical investigation had κ values of more than 0.21 (fair) in all pairs of raters. Between two raters (C and D), there was an almost perfect agreement on three parameters, more specifically ``Abnormal sensory and motor examination, hyperactive or diminished reflexes'', ``Sitting exam shows no reflex, motor or sensory signs in the legs'' and ``Straight leg raising (Laségue) negative between 30 and 70 degrees of flexion''. The ``Drop test positive'' parameters had moderate strength of agreement between raters A and D and fair strength between raters A and B. The ``Digital interspinous pressure test positive'' had moderate strength of agreement between raters C and D and fair strength of agreement between raters A and B as well as raters B and C. Three other parameters had a fair strength of agreement between two raters, all other parameters had a slight or poor strength of agreement. Inter-rater reliability, confidence intervals and significance of

High inter-rater reliability, agreement, and convergent validity of Constant score in patients with clavicle fractures

DEFF Research Database (Denmark)

Ban, Ilija; Troelsen, Anders; Kristensen, Morten Tange

2016-01-01

BACKGROUND: The Constant score (CS) has been the primary endpoint in most studies on clavicle fractures. However, the CS was not developed to assess patients with clavicle fractures. Our aim was to examine inter-rater reliability and agreement of the CS in patients with clavicle fractures...... standardized CS assessment at a mean of 6.8 weeks (SD, 1.0 weeks) after injury. Reliability and agreement of the CS were determined by 2 raters. The interclass correlation coefficient (ICC2,1), standard error of measurement, minimal detectable change, Cronbach α coefficient, and Pearson correlation coefficient...... were estimated. RESULTS: Inter-rater reliability of the total CS was excellent (interclass correlation coefficient, 0.94; 95% confidence interval, 0.88-0.97), with no systematic difference between the 2 raters (P = .75). The standard error of measurement (measurement error at the group level) was 4...

Reliability and Validity of the Dutch Physical Activity Questionnaires for Children (PAQ-C) and Adolescents (PAQ-A).

Science.gov (United States)

Bervoets, Liene; Van Noten, Caroline; Van Roosbroeck, Sofie; Hansen, Dominique; Van Hoorenbeeck, Kim; Verheyen, Els; Van Hal, Guido; Vankerckhoven, Vanessa

2014-01-01

This study was designed to validate the Dutch Physical Activity Questionnaires for Children (PAQ-C) and Adolescents (PAQ-A). After adjustment of the original Canadian PAQ-C and PAQ-A (i.e. translation/back-translation and evaluation by expert committee), content validity of both PAQs was assessed and calculated using item-level (I-CVI) and scale-level (S-CVI) content validity indexes. Inter-item and inter-rater reliability of 196 PAQ-C and 95 PAQ-A filled in by both children or adolescents and their parent, were evaluated. Inter-item reliability was calculated by Cronbach's alpha (α) and inter-rater reliability was examined by percent observed agreement and weighted kappa (κ). Concurrent validity of PAQ-A was examined in a subsample of 28 obese and 16 normal-weight children by comparing it with concurrently measured physical activity using a maximal cardiopulmonary exercise test for the assessment of peak oxygen uptake (VO2 peak). For both PAQs, I-CVI ranged 0.67-1.00. S-CVI was 0.89 for PAQ-C and 0.90 for PAQ-A. A total of 192 PAQ-C and 94 PAQ-A were fully completed by both child and parent. Cronbach's α was 0.777 for PAQ-C and 0.758 for PAQ-A. Percent agreement ranged 59.9-74.0% for PAQ-C and 51.1-77.7% for PAQ-A, and weighted κ ranged 0.48-0.69 for PAQ-C and 0.51-0.68 for PAQ-A. The correlation between total PAQ-A score and VO2 peak - corrected for age, gender, height and weight - was 0.516 (p = 0.001). Both PAQs have an excellent content validity, an acceptable inter-item reliability and a moderate to good strength of inter-rater agreement. In addition, total PAQ-A score showed a moderate positive correlation with VO2 peak. Both PAQs have an acceptable to good reliability and validity, however, further validity testing is recommended to provide a more complete assessment of both PAQs.

Determination of antimycin-A in water by liquid chromatographic/mass spectrometry: single-laboratory validation.

Science.gov (United States)

Bernardy, Jeffry A; Hubert, Terrance D; Ogorek, Jacob M; Schmidt, Larry J

2013-01-01

An LC/MS method was developed and validated for the quantitative determination and confirmation of antimycin-A (ANT-A) in water from lakes or streams. Three different water sample volumes (25, 50, and 250 mL) were evaluated. ANT-A was stabilized in the field by immediately extracting it from water into anhydrous acetone using SPE. The stabilized concentrated samples were then transported to a laboratory and analyzed by LC/MS using negative electrospray ionization. The method was determined to have adequate accuracy (78 to 113% recovery), precision (0.77 to 7.5% RSD with samples > or = 500 ng/L and 4.8 to 17% RSD with samples < or = 100 ng/L), linearity, and robustness over an LOQ range from 8 to 51 600 ng/L.

Safety, reliability, and validity of a physiologic definition of bronchopulmonary dysplasia.

Science.gov (United States)

Walsh, Michele C; Wilson-Costello, Deanna; Zadell, Arlene; Newman, Nancy; Fanaroff, Avroy

2003-09-01

Bronchopulmonary dysplasia (BPD) is the focus of many intervention trials, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. Thus, we wished to define BPD by a standardized oxygen saturation monitoring at 36 weeks corrected age, and compare this physiologic definition with the standard clinical definition of BPD based solely on oxygen administration. A total of 199 consecutive very low birthweight infants (VLBW, 501 to 1500 g birthweight) were assessed prospectively at 36+/-1 weeks corrected age. Neonates on positive pressure support or receiving >30% supplemental oxygen were assigned the outcome BPD. Those receiving or =88% for 60 minutes) or "BPD" (saturation reliability, test-retest reliability, and validity of the physiologic definition vs the clinical definition were assessed. A total of 199 VLBW were assessed, of whom 45 (36%) were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks corrected age. The physiologic definition identified 15 infants treated with oxygen who successfully passed the saturation monitoring test in room air. The physiologic definition diagnosed BPD in 30 (24%) of the cohort. All infants were safely studied. The test was highly reliable (inter-rater reliability, kappa=1.0; test-retest reliability, kappa=0.83) and highly correlated with discharge home in oxygen, length of hospital stay, and hospital readmissions in the first year of life. The physiologic definition of BPD is safe, feasible, reliable, and valid and improves the precision of the diagnosis of BPD. This may be of benefit in future multicenter clinical trials.

Correction of gene expression data: Performance-dependency on inter-replicate and inter-treatment biases.

Science.gov (United States)

Darbani, Behrooz; Stewart, C Neal; Noeparvar, Shahin; Borg, Søren

2014-10-20

This report investigates for the first time the potential inter-treatment bias source of cell number for gene expression studies. Cell-number bias can affect gene expression analysis when comparing samples with unequal total cellular RNA content or with different RNA extraction efficiencies. For maximal reliability of analysis, therefore, comparisons should be performed at the cellular level. This could be accomplished using an appropriate correction method that can detect and remove the inter-treatment bias for cell-number. Based on inter-treatment variations of reference genes, we introduce an analytical approach to examine the suitability of correction methods by considering the inter-treatment bias as well as the inter-replicate variance, which allows use of the best correction method with minimum residual bias. Analyses of RNA sequencing and microarray data showed that the efficiencies of correction methods are influenced by the inter-treatment bias as well as the inter-replicate variance. Therefore, we recommend inspecting both of the bias sources in order to apply the most efficient correction method. As an alternative correction strategy, sequential application of different correction approaches is also advised. Copyright © 2014 Elsevier B.V. All rights reserved.

A Six Sigma Trial For Reduction of Error Rates in Pathology Laboratory.

Science.gov (United States)

Tosuner, Zeynep; Gücin, Zühal; Kiran, Tuğçe; Büyükpinarbaşili, Nur; Turna, Seval; Taşkiran, Olcay; Arici, Dilek Sema

2016-01-01

A major target of quality assurance is the minimization of error rates in order to enhance patient safety. Six Sigma is a method targeting zero error (3.4 errors per million events) used in industry. The five main principles of Six Sigma are defining, measuring, analysis, improvement and control. Using this methodology, the causes of errors can be examined and process improvement strategies can be identified. The aim of our study was to evaluate the utility of Six Sigma methodology in error reduction in our pathology laboratory. The errors encountered between April 2014 and April 2015 were recorded by the pathology personnel. Error follow-up forms were examined by the quality control supervisor, administrative supervisor and the head of the department. Using Six Sigma methodology, the rate of errors was measured monthly and the distribution of errors at the preanalytic, analytic and postanalytical phases was analysed. Improvement strategies were reclaimed in the monthly intradepartmental meetings and the control of the units with high error rates was provided. Fifty-six (52.4%) of 107 recorded errors in total were at the pre-analytic phase. Forty-five errors (42%) were recorded as analytical and 6 errors (5.6%) as post-analytical. Two of the 45 errors were major irrevocable errors. The error rate was 6.8 per million in the first half of the year and 1.3 per million in the second half, decreasing by 79.77%. The Six Sigma trial in our pathology laboratory provided the reduction of the error rates mainly in the pre-analytic and analytic phases.

Age and Practice Effects on Inter-manual Performance Asymmetry

Directory of Open Access Journals (Sweden)

Karen L Francis

2015-01-01

Full Text Available Manual dexterity declines with increasing age however, the way in which inter-manual asymmetry responds to aging is unclear. Our purpose was to determine the effect of age and practice on inter-manual performance asymmetry in an isometric force pinch line tracing task that varied in difficulty within segments. Thirty right handed participants, 5 males and 5 females in each of three age groups, young (Y20, young-old (O70, and old-old (O80, practiced an isometric force pinch task for 10 trials with each hand on each of five consecutive days. Inter-manual performance asymmetry of the right and left hands was analyzed with a repeated measures ANOVA of asymmetry with age groups, practice, task difficulty, and hand as factors. The within-individual magnitude of asymmetry was also analyzed with a repeated measures ANOVA of manual asymmetry calculated as an asymmetry index (AI. Post hoc pair-wise comparisons were performed when significance was found. We observed no inter-manual performance asymmetry on this isometric tracing task among any of the age groups, either in the hand performance differences or in the magnitude of the asymmetry index (AI. Age and practice interacted in terms of manual performance: the Y20 and O70 group improved accuracy and task time across the five days of practice but the O80 group did not. However, practice did not differentially affect the AI for accuracy or task time for any group. Accuracy of performance of the two hands was differentially affected by practice. All age groups exhibited poorer performance and larger AIs on the most difficult segments of the task (3 and 6 and this did not change with practice.

Drug-eluting or bare-metal stents for large coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

DEFF Research Database (Denmark)

Pfisterer, M.; Bertel, O.; Bonetti, P.O.

2008-01-01

or refute this hypothesis, we set up an 11-center 4-country prospective trial of 2260 consecutive patients treated with >= 3.0-mm stents only, randomized to receive Cypher (Johnson & Johnson, Miami Lakes, FL), Vision (Abbott Vascular, Abbott Laboratories, IL), or Xience stents (Abbott Vascular). Only...

Field-scale multi-phase LNAPL remediation: Validating a new computational framework against sequential field pilot trials.

Science.gov (United States)

Sookhak Lari, Kaveh; Johnston, Colin D; Rayner, John L; Davis, Greg B

2018-03-05

Remediation of subsurface systems, including groundwater, soil and soil gas, contaminated with light non-aqueous phase liquids (LNAPLs) is challenging. Field-scale pilot trials of multi-phase remediation were undertaken at a site to determine the effectiveness of recovery options. Sequential LNAPL skimming and vacuum-enhanced skimming, with and without water table drawdown were trialled over 78days; in total extracting over 5m 3 of LNAPL. For the first time, a multi-component simulation framework (including the multi-phase multi-component code TMVOC-MP and processing codes) was developed and applied to simulate the broad range of multi-phase remediation and recovery methods used in the field trials. This framework was validated against the sequential pilot trials by comparing predicted and measured LNAPL mass removal rates and compositional changes. The framework was tested on both a Cray supercomputer and a cluster. Simulations mimicked trends in LNAPL recovery rates (from 0.14 to 3mL/s) across all remediation techniques each operating over periods of 4-14days over the 78day trial. The code also approximated order of magnitude compositional changes of hazardous chemical concentrations in extracted gas during vacuum-enhanced recovery. The verified framework enables longer term prediction of the effectiveness of remediation approaches allowing better determination of remediation endpoints and long-term risks. Copyright © 2017 Commonwealth Scientific and Industrial Research Organisation. Published by Elsevier B.V. All rights reserved.

The Reliability and Validity of a Four-Minute Running Time-Trial in Assessing V˙O2max and Performance

Directory of Open Access Journals (Sweden)

Kerry McGawley

2017-05-01

Full Text Available Introduction: Traditional graded-exercise tests to volitional exhaustion (GXTs are limited by the need to establish starting workloads, stage durations, and step increments. Short-duration time-trials (TTs may be easier to implement and more ecologically valid in terms of real-world athletic events. The purpose of the current study was to assess the reliability and validity of maximal oxygen uptake (V˙O2max and performance measured during a traditional GXT (STEP and a four-minute running time-trial (RunTT.Methods: Ten recreational runners (age: 32 ± 7 years; body mass: 69 ± 10 kg completed five STEP tests with a verification phase (VER and five self-paced RunTTs on a treadmill. The order of the STEP/VER and RunTT trials was alternated and counter-balanced. Performance was measured as time to exhaustion (TTE for STEP and VER and distance covered for RunTT.Results: The coefficient of variation (CV for V˙O2max was similar between STEP, VER, and RunTT (1.9 ± 1.0, 2.2 ± 1.1, and 1.8 ± 0.8%, respectively, but varied for performance between the three types of test (4.5 ± 1.9, 9.7 ± 3.5, and 1.8 ± 0.7% for STEP, VER, and RunTT, respectively. Bland-Altman limits of agreement (bias ± 95% showed V˙O2max to be 1.6 ± 3.6 mL·kg−1·min−1 higher for STEP vs. RunTT. Peak HR was also significantly higher during STEP compared with RunTT (P = 0.019.Conclusion: A four-minute running time-trial appears to provide more reliable performance data in comparison to an incremental test to exhaustion, but may underestimate V˙O2max.

Reliability and Validity of the Dutch Physical Activity Questionnaires for Children (PAQ-C) and Adolescents (PAQ-A)

OpenAIRE

Bervoets, Liene; Van Noten, Caroline; Van Roosbroeck, Sofie; Hansen, Dominique; Van Hoorenbeeck, Kim; Verheyen, Els; Van Hal, Guido; Vankerckhoven, Vanessa

2014-01-01

Background This study was designed to validate the Dutch Physical Activity Questionnaires for Children (PAQ-C) and Adolescents (PAQ-A). Methods After adjustment of the original Canadian PAQ-C and PAQ-A (i.e. translation/back-translation and evaluation by expert committee), content validity of both PAQs was assessed and calculated using item-level (I-CVI) and scale-level (S-CVI) content validity indexes. Inter-item and inter-rater reliability of 196 PAQ-C and 95 PAQ-A filled in by both childre...

An inter-laboratory study to test the ability of amendments to reduce the availability of Cd, Pb, and Zn in situ

International Nuclear Information System (INIS)

Brown, Sally; Christensen, Barbara; Lombi, Enzo; McLaughlin, Mike; McGrath, Steve; Colpaert, Jan; Vangronsveld, Jaco

2005-01-01

An international inter-laboratory research program investigated the effectiveness of in situ remediation of soils contaminated by cadmium, lead and zinc, measuring changes in soil and soil solution chemistry, plants and soil microbiota. A common soil, from mine wastes in Jasper County MO, was used. The soil was pH 5.9, had low organic matter (1.2 g kg -1 C) and total Cd, Pb, and Zn concentrations of 92, 5022, and 18 532 mg kg -1 , respectively. Amendments included lime, phosphorus (P), red mud (RM), cyclonic ashes (CA), biosolids (BIO), and water treatment residuals (WTR). Both soil solution and NH 4 NO 3 extractable metals were decreased by all treatments. Phytotoxicity of metals was reduced, with plants grown in P treatments having the highest yields and lowest metal concentration (0.5, 7.2 and 406 mg kg -1 Cd, Pb, and Zn). Response of soil micro-organisms was similar to plant responses. Phosphorus addition reduced the physiologically based extraction test Pb from 84% of total Pb extracted in the untreated soil to 34.1%. - Addition of phosphorus to Pb, Zn and Cd contaminated mine waste was able to reduce metal toxicity for a range of biological endpoints

The seismic cycle at subduction thrusts: 2. Dynamic implications of geodynamic simulations validated with laboratory models

KAUST Repository

van Dinther, Y.

2013-04-01

The physics governing the seismic cycle at seismically active subduction zones remains poorly understood due to restricted direct observations in time and space. To investigate subduction zone dynamics and associated interplate seismicity, we validate a continuum, visco-elasto-plastic numerical model with a new laboratory approach (Paper 1). The analogous laboratory setup includes a visco-elastic gelatin wedge underthrusted by a rigid plate with defined velocity-weakening and -strengthening regions. Our geodynamic simulation approach includes velocity-weakening friction to spontaneously generate a series of fast frictional instabilities that correspond to analog earthquakes. A match between numerical and laboratory source parameters is obtained when velocity-strengthening is applied in the aseismic regions to stabilize the rupture. Spontaneous evolution of absolute stresses leads to nucleation by coalescence of neighboring patches, mainly occurring at evolving asperities near the seismogenic zone limits. Consequently, a crack-, or occasionally even pulse-like, rupture propagates toward the opposite side of the seismogenic zone by increasing stresses ahead of its rupture front, until it arrests on a barrier. The resulting surface displacements qualitatively agree with geodetic observations and show landward and, from near the downdip limit, upward interseismic motions. These are rebound and reversed coseismically. This slip increases adjacent stresses, which are relaxed postseismically by afterslip and thereby produce persistent seaward motions. The wide range of observed physical phenomena, including back-propagation and repeated slip, and the agreement with laboratory results demonstrate that visco-elasto-plastic geodynamic models with rate-dependent friction form a new tool that can greatly contribute to our understanding of the seismic cycle at subduction zones.

The seismic cycle at subduction thrusts: 2. Dynamic implications of geodynamic simulations validated with laboratory models

KAUST Repository

van Dinther, Y.; Gerya, T. V.; Dalguer, L. A.; Corbi, F.; Funiciello, F.; Mai, Paul Martin

2013-01-01

The physics governing the seismic cycle at seismically active subduction zones remains poorly understood due to restricted direct observations in time and space. To investigate subduction zone dynamics and associated interplate seismicity, we validate a continuum, visco-elasto-plastic numerical model with a new laboratory approach (Paper 1). The analogous laboratory setup includes a visco-elastic gelatin wedge underthrusted by a rigid plate with defined velocity-weakening and -strengthening regions. Our geodynamic simulation approach includes velocity-weakening friction to spontaneously generate a series of fast frictional instabilities that correspond to analog earthquakes. A match between numerical and laboratory source parameters is obtained when velocity-strengthening is applied in the aseismic regions to stabilize the rupture. Spontaneous evolution of absolute stresses leads to nucleation by coalescence of neighboring patches, mainly occurring at evolving asperities near the seismogenic zone limits. Consequently, a crack-, or occasionally even pulse-like, rupture propagates toward the opposite side of the seismogenic zone by increasing stresses ahead of its rupture front, until it arrests on a barrier. The resulting surface displacements qualitatively agree with geodetic observations and show landward and, from near the downdip limit, upward interseismic motions. These are rebound and reversed coseismically. This slip increases adjacent stresses, which are relaxed postseismically by afterslip and thereby produce persistent seaward motions. The wide range of observed physical phenomena, including back-propagation and repeated slip, and the agreement with laboratory results demonstrate that visco-elasto-plastic geodynamic models with rate-dependent friction form a new tool that can greatly contribute to our understanding of the seismic cycle at subduction zones.

Video conference platforms: A tool to foster collaboration during inter-organizational in vivo simulations

Directory of Open Access Journals (Sweden)

Cecilia Lemus-Martinez

2011-10-01

Full Text Available Inter-organizational problem solving of emergencies and extreme events are complex research fields where scarce experimental data is available. To address this problem, the Inter-GAP In Vivo System, was developed to run behavioural experiments of complex crisis. The system design and testing included three categories of participants: for pilot testing, first year university students; for theoretical validity, college students engaged in emergency management programs; and for field validity, expert decision makers who managed major crises. A comparative assessment was performed to select the most suitable video conferencing software commercially available, since it was more cost-efficient to acquire a tool already developed and customized it to the experiment needs than it was to design a new one. Software features analyzed were: ease of use, recording capabilities, format delivery options and security. The Inter-GAP In Vivo System setup was implemented on the video conference platform selected. The system performance was evaluated at three levels: technical setup, task design and work flow processes. The actual experimentation showed that the conferencing software is a versatile tool to enhance collaboration between stakeholders from different organizations, due to the audiovisual contact participants can establish, where non verbal cues can be interchanged along the problem solving processes. Potential future system applications include: collaborative and cross – functional training between organizations.

Design of DC-60 specialized accelerator for the Inter-disciplinary Laboratory Complex by the L.N. Gumilev Eurasian State University

International Nuclear Information System (INIS)

Gikal, B.N.; Itkis, M.G.; Dmitriev, S.N.; Gul'bekyan, G.G.; Franko, J.; ); Kadyrzhanov, K.K.; Arzumanov, A.A.; Borisenko, A.N.; Lysukhin, S.N.

2001-01-01

Design of the Inter-disciplinary Laboratory Complex by the L.N. Eurasian State University allows development and implementation of specialized heavy ion accelerator. According requirements of research programme the most optimal accelerator is compact cyclotron with fixed magnetic field and varying frequency of high-frequency system in dependence on mass rate to accelerated ions charge. The accelerator has two accelerating modes - on 4 and 6 harmonics, that allow to accelerate ions from C to Xe with energies from 0.4 to 1.6 MeV/nucleon. The beam take out is occurring by electrostatic deflector. The beam will be transporting to physical unit for research conducting. The cyclotron is equipped with ECR source and axial beam injection system.The extending voltage on the ion source is 10-25 k W. On the injection line it is planning to create the channel - after analyzing magnet -for using of satellite beams, that allow to conduct experiments on a low energy ions beams. In all accelerating modes the ions energy does not exceeds the Coulomb barrier and so the unit is radiation safe. The cyclotron complex could be used for fulfilment of a wide circle of research and applied tasks, as well as for students and postgraduates training

The relaxation exercise and social support trial-resst: study protocol for a randomized community based trial

Directory of Open Access Journals (Sweden)

Nakkash Rima

2011-08-01

Full Text Available Abstract Background Studies suggests a possible link between vaginal discharge and common mental distress, as well as highlight the implications of the subjective burden of disease and its link with mental health. Methods/Design This is a community-based intervention trial that aims to evaluate the impact of a psycho-social intervention on medically unexplained vaginal discharge (MUVD in a group of married, low-income Lebanese women, aged 18-49, and suffering from low to moderate levels of anxiety and/or depression. The intervention consisted of 12 sessions of structured social support, problem solving techniques, group discussions and trainer-supervised relaxation exercises (twice per week over six weeks. Women were recruited from Hey el Selloum, a southern disadvantaged suburb of Beirut, Lebanon, during an open recruitment campaign. The primary outcome was self-reported MUVD, upon ruling out reproductive tract infections (RTIs, through lab analysis. Anxiety and/or depression symptoms were the secondary outcomes for this trial. These were assessed using an Arabic validated version of the Hopkins Symptoms Checklist-25 (HSCL-25. Assessments were done at baseline and six months using face-to face interviews, pelvic examinations and laboratory tests. Women were randomized into either intervention or control group. Intent to treat analysis will be used. Discussion The results will indicate whether the proposed psychosocial intervention was effective in reducing MUVD (possibly mediated by common mental distress. Trial Registration The trial is registered at the Wellcome Trust Registry, ISRCTN assigned: ISRCTN: ISRCTN98441241

Inter-laboratory comparison of turkey in ovo carcinogenicity assessment (IOCA) of hepatocarcinogens.

Science.gov (United States)

Enzmann, H; Brunnemann, K; Iatropoulos, M; Shpyleva, S; Lukyanova, N; Todor, I; Moore, M; Spicher, K; Chekhun, V; Tsuda, H; Williams, G

2013-09-01

In three independent laboratories carcinogens (diethylnitrosamine, DEN, 4-(N-methyl-N-nitrosamino)-1-(3-pyridyl)-1-butanone, NNK) and non-carcinogens (N-nitrosoproline, nicotine) were evaluated in turkey eggs for in ovo carcinogenicity assessment (IOCA). Compounds were injected into aseptic fertilized eggs. After incubation for 24 days, foci of altered hepatocytes (FAH), some with a pseudoglandular structure and/or signs of compression of the surrounding tissue were observed in the fetal liver. All laboratories were able to distinguish unequivocally the hepatocarcinogen-exposed groups from those exposed to non-carcinogens or the vehicle controls, based on the pre-specified evaluation parameters: tumor-like lesions, pseudoglandular areas and FAH. In addition to focal changes, only the carcinogens induced hepatocellular karyomegaly. Lower doses of the carcinogens, which did not induce FAH, were sufficient to induce hepatocellular karyomegaly. After exposure to 4 mg DEN, gall bladder agenesis was observed in all fetuses. The IOCA may be a valuable tool for early investigative studies on carcinogenicity and since it does not use rodents may complement chronic rat or mouse bioassays. Test substances that are positive in both rodents and fertilized turkey eggs are most probably trans-species carcinogens with particular significance for humans. The good concordance observed among the three laboratories demonstrates that the IOCA is a reliable and robust method. Copyright © 2012 Elsevier GmbH. All rights reserved.

Geographic differences in time to culture conversion in liquid media: Tuberculosis Trials Consortium study 28. Culture conversion is delayed in Africa.

Directory of Open Access Journals (Sweden)

William R Mac Kenzie

2011-04-01

Full Text Available Tuberculosis Trials Consortium Study 28, was a double blind, randomized, placebo-controlled, phase 2 clinical trial examining smear positive pulmonary Mycobacterium tuberculosis. Over the course of intensive phase therapy, patients from African sites had substantially delayed and lower rates of culture conversion to negative in liquid media compared to non-African patients. We explored potential explanations of this finding.In TBTC Study 28, protocol-correct patients (n = 328 provided spot sputum specimens for M. tuberculosis culture in liquid media, at baseline and weeks 2, 4, 6 and 8 of study therapy. We compared sputum culture conversion for African and non-African patients stratified by four baseline measures of disease severity: AFB smear quantification, extent of disease on chest radiograph, cavity size and the number of days to detection of M. tuberculosis in liquid media using the Kaplan-Meier product-limit method. We evaluated specimen processing and culture procedures used at 29 study laboratories serving 27 sites.African TB patients had more extensive disease at enrollment than non-African patients. However, African patients with the least disease by the 4 measures of disease severity had conversion rates on liquid media that were substantially lower than conversion rates in non-African patients with the greatest extent of disease. HIV infection, smoking and diabetes did not explain delayed conversion in Africa. Some inter-site variation in laboratory processing and culture procedures within accepted practice for clinical diagnostic laboratories was found.Compared with patients from non-African sites, African patients being treated for TB had delayed sputum culture conversion and lower sputum conversion rates in liquid media that were not explained by baseline severity of disease, HIV status, age, smoking, diabetes or race. Further investigation is warranted into whether modest variation in laboratory processes substantially

Validation of administrative and clinical case definitions for gestational diabetes mellitus against laboratory results.

Science.gov (United States)

Bowker, S L; Savu, A; Donovan, L E; Johnson, J A; Kaul, P

2017-06-01

To examine the validity of International Classification of Disease, version 10 (ICD-10) codes for gestational diabetes mellitus in administrative databases (outpatient and inpatient), and in a clinical perinatal database (Alberta Perinatal Health Program), using laboratory data as the 'gold standard'. Women aged 12-54 years with in-hospital, singleton deliveries between 1 October 2008 and 31 March 2010 in Alberta, Canada were included in the study. A gestational diabetes diagnosis was defined in the laboratory data as ≥2 abnormal values on a 75-g oral glucose tolerance test or a 50-g glucose screen ≥10.3 mmol/l. Of 58 338 pregnancies, 2085 (3.6%) met gestational diabetes criteria based on laboratory data. The gestational diabetes rates in outpatient only, inpatient only, outpatient or inpatient combined, and Alberta Perinatal Health Program databases were 5.2% (3051), 4.8% (2791), 5.8% (3367) and 4.8% (2825), respectively. Although the outpatient or inpatient combined data achieved the highest sensitivity (92%) and specificity (97%), it was associated with a positive predictive value of only 57%. The majority of the false-positives (78%), however, had one abnormal value on oral glucose tolerance test, corresponding to a diagnosis of impaired glucose tolerance in pregnancy. The ICD-10 codes for gestational diabetes in administrative databases, especially when outpatient and inpatient databases are combined, can be used to reliably estimate the burden of the disease at the population level. Because impaired glucose tolerance in pregnancy and gestational diabetes may be managed similarly in clinical practice, impaired glucose tolerance in pregnancy is often coded as gestational diabetes. © 2016 Diabetes UK.

Intra- and inter-brain synchronization during musical improvisation on the guitar.

Science.gov (United States)

Müller, Viktor; Sänger, Johanna; Lindenberger, Ulman

2013-01-01

Humans interact with the environment through sensory and motor acts. Some of these interactions require synchronization among two or more individuals. Multiple-trial designs, which we have used in past work to study interbrain synchronization in the course of joint action, constrain the range of observable interactions. To overcome the limitations of multiple-trial designs, we conducted single-trial analyses of electroencephalography (EEG) signals recorded from eight pairs of guitarists engaged in musical improvisation. We identified hyper-brain networks based on a complex interplay of different frequencies. The intra-brain connections primarily involved higher frequencies (e.g., beta), whereas inter-brain connections primarily operated at lower frequencies (e.g., delta and theta). The topology of hyper-brain networks was frequency-dependent, with a tendency to become more regular at higher frequencies. We also found hyper-brain modules that included nodes (i.e., EEG electrodes) from both brains. Some of the observed network properties were related to musical roles during improvisation. Our findings replicate and extend earlier work and point to mechanisms that enable individuals to engage in temporally coordinated joint action.

Sandia National Laboratories: Fabrication, Testing and Validation

Science.gov (United States)

digital and analog elements. * Cadence Process-Design Kit. Structured ASIC Sandia National Laboratories demonstrate complex multilevel devices such as micro-mass-analysis systems up to 25 microns thick and novel possible to fabricate a wide very large variety of useful devices. Micro-Mass-Analysis Systems Applications

Investigation into stutter ratio variability between different laboratories.

Science.gov (United States)

Bright, Jo-Anne; Curran, James M

2014-11-01

The determination of parameters such as stutter ratio is important to inform a laboratory's forensic DNA profile interpretation strategy. As part of a large data analysis project to implement a continuous model of DNA profile interpretation we analysed stutter ratio data from eight different forensic laboratories for the Promega PowerPlex(®) 21 multiplex. This allowed a comparison of inter laboratory variation. The maximum difference for any one laboratory from the average of the best fit determined by the model was 0.31%. These results indicate that stutter ratios calculated from samples analysed using the same profiling kit are not expected to differ between laboratories, even those using different capillary electrophoresis platforms. A common set of laboratory parameters are able to be generated and used for profile interpretation at all laboratories using the same multiplex and cycle number, potentially reducing the need for individual laboratories to determine stutter ratios. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Development and validation of a toddler silhouette scale.

Science.gov (United States)

Hager, Erin R; McGill, Adrienne E; Black, Maureen M

2010-02-01

The purpose of this study is to develop and validate a toddler silhouette scale. A seven-point scale was developed by an artist based on photographs of 15 toddlers (6 males, 9 females) varying in race/ethnicity and body size, and a list of phenotypic descriptions of toddlers of varying body sizes. Content validity, age-appropriateness, and gender and race/ethnicity neutrality were assessed among 180 pediatric health professionals and 129 parents of toddlers. Inter- and intrarater reliability and concurrent validity were assessed by having 138 pediatric health professionals match the silhouettes with photographs of toddlers. Assessments of content validity revealed that most health professionals (74.6%) and parents of toddlers (63.6%) ordered all seven silhouettes correctly, and interobserver agreement for weight status classification was high (kappa = 0.710, r = 0.827, P gender (68.5%) and race/ethnicity (77.3%) neutral. The inter-rater reliability, based on matching silhouettes with photographs, was 0.787 (Cronbach's alpha) and the intrarater reliability was 0.855 (P parents' perception of and satisfaction with their toddler's body size. Interventions can be targeted toward parents who have inaccurate perceptions of or are dissatisfied with their toddler's body size.

Inter-trial coherence as a marker of cortical phase synchrony in children with sensorineural hearing loss and auditory neuropathy spectrum disorder fitted with hearing aids and cochlear implants

Science.gov (United States)

Nash-Kille, Amy; Sharma, Anu

2014-01-01

Objective Although brainstem dys-synchrony is a hallmark of children with auditory neuropathy spectrum disorder (ANSD), little is known about how the lack of neural synchrony manifests at more central levels. We used time-frequency single-trial EEG analyses (i.e., inter-trial coherence; ITC), to examine cortical phase synchrony in children with normal hearing (NH), sensorineural hearing loss (SNHL) and ANSD. Methods Single trial time-frequency analyses were performed on cortical auditory evoked responses from 41 NH children, 91 children with ANSD and 50 children with SNHL. The latter two groups included children who received intervention via hearing aids and cochlear implants. ITC measures were compared between groups as a function of hearing loss, intervention type, and cortical maturational status. Results In children with SNHL, ITC decreased as severity of hearing loss increased. Children with ANSD revealed lower levels of ITC relative to children with NH or SNHL, regardless of intervention. Children with ANSD who received cochlear implants showed significant improvements in ITC with increasing experience with their implants. Conclusions Cortical phase coherence is significantly reduced as a result of both severe-to-profound SNHL and ANSD. Significance ITC provides a window into the brain oscillations underlying the averaged cortical auditory evoked response. Our results provide a first description of deficits in cortical phase synchrony in children with SNHL and ANSD. PMID:24360131

Inter-operator and inter-device agreement and reliability of the SEM Scanner.

Science.gov (United States)

Clendenin, Marta; Jaradeh, Kindah; Shamirian, Anasheh; Rhodes, Shannon L

2015-02-01

The SEM Scanner is a medical device designed for use by healthcare providers as part of pressure ulcer prevention programs. The objective of this study was to evaluate the inter-rater and inter-device agreement and reliability of the SEM Scanner. Thirty-one (31) volunteers free of pressure ulcers or broken skin at the sternum, sacrum, and heels were assessed with the SEM Scanner. Each of three operators utilized each of three devices to collect readings from four anatomical sites (sternum, sacrum, left and right heels) on each subject for a total of 108 readings per subject collected over approximately 30 min. For each combination of operator-device-anatomical site, three SEM readings were collected. Inter-operator and inter-device agreement and reliability were estimated. Over the course of this study, more than 3000 SEM Scanner readings were collected. Agreement between operators was good with mean differences ranging from -0.01 to 0.11. Inter-operator and inter-device reliability exceeded 0.80 at all anatomical sites assessed. The results of this study demonstrate the high reliability and good agreement of the SEM Scanner across different operators and different devices. Given the limitations of current methods to prevent and detect pressure ulcers, the SEM Scanner shows promise as an objective, reliable tool for assessing the presence or absence of pressure-induced tissue damage such as pressure ulcers. Copyright © 2015 Bruin Biometrics, LLC. Published by Elsevier Ltd.. All rights reserved.

Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

DEFF Research Database (Denmark)

Price II, William Nicholson; Minssen, Timo

2015-01-01

public trust in drugs and industry and the possibility of facilitating large cross-border clinical trials for, inter alia, rare diseases5. Despite these benefits, the costs and concerns associated with opening up trial data are also substantial—for patients (patient privacy), for research (related...

Reliability and validity of a nutrition and physical activity environmental self-assessment for child care

Directory of Open Access Journals (Sweden)

Ammerman Alice S

2007-07-01

Full Text Available Abstract Background Few assessment instruments have examined the nutrition and physical activity environments in child care, and none are self-administered. Given the emerging focus on child care settings as a target for intervention, a valid and reliable measure of the nutrition and physical activity environment is needed. Methods To measure inter-rater reliability, 59 child care center directors and 109 staff completed the self-assessment concurrently, but independently. Three weeks later, a repeat self-assessment was completed by a sub-sample of 38 directors to assess test-retest reliability. To assess criterion validity, a researcher-administered environmental assessment was conducted at 69 centers and was compared to a self-assessment completed by the director. A weighted kappa test statistic and percent agreement were calculated to assess agreement for each question on the self-assessment. Results For inter-rater reliability, kappa statistics ranged from 0.20 to 1.00 across all questions. Test-retest reliability of the self-assessment yielded kappa statistics that ranged from 0.07 to 1.00. The inter-quartile kappa statistic ranges for inter-rater and test-retest reliability were 0.45 to 0.63 and 0.27 to 0.45, respectively. When percent agreement was calculated, questions ranged from 52.6% to 100% for inter-rater reliability and 34.3% to 100% for test-retest reliability. Kappa statistics for validity ranged from -0.01 to 0.79, with an inter-quartile range of 0.08 to 0.34. Percent agreement for validity ranged from 12.9% to 93.7%. Conclusion This study provides estimates of criterion validity, inter-rater reliability and test-retest reliability for an environmental nutrition and physical activity self-assessment instrument for child care. Results indicate that the self-assessment is a stable and reasonably accurate instrument for use with child care interventions. We therefore recommend the Nutrition and Physical Activity Self-Assessment for

The validity and reliability of the Turkish version of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) in patients with mild and moderate Alzheimer's disease and normal subjects.

Science.gov (United States)

Mavioglu, H; Gedizlioglu, M; Akyel, S; Aslaner, T; Eser, E

2006-03-01

The cognitive subscale of the Alzheimer's Disease Assesment Scale (ADAS-Cog) is the most widely used test in clinical trials dealing with Alzheimer's disease (AD). The aim of this study was to investigate the validity and reliability of the Turkish version of ADAS-Cog. Twenty-nine patients with AD, fulfilling NINCDS-ADRDA criteria of probable AD, who were in stage 3-5 according to the Global Deterioration Scale (GDS), and 27 non-demented control subjects with similar age, gender and educational status were recruited for the study. The Turkish version of ADAS-Cog, Standardized Mini Mental Status Examination (MMSE) and Short Orientation-Memory-Concentration Test (SOMCT) were applied to both of the groups. Inter-rater reliability, internal consistency, test-retest reliability; face validity, differential validity and convergent validity were statistically analyzed. Both MMSE and ADAS-Cog have significantly differentiated patients with AD and control subjects (p ADAS-Cog scores in AD group (r: -0.739). ADAS-Cog was also highly significantly correlated with GDS (r: 0.720) and SOMCT (r: 0.738). For the group with AD, control and whole cohort coefficients of internal consistency, Cronbach's alpha: 0.800, 0.515, 0.873 were found respectively. Inter-rater reliability for total ADAS-Cog score was found as ICC: 0.99 and 0.98 and test-retest reliability was found as ICC: 0.91 and 0.95 for demented and nondemented subjects, respectively. The Turkish version of ADAS-Cog has been found to be highly reliable and valid in differentiating patients with mild and moderate AD from nondemented subjects.

Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints

Science.gov (United States)

Renfro, Lindsay A.; Shi, Qian; Xue, Yuan; Li, Junlong; Shang, Hongwei; Sargent, Daniel J.

2014-01-01

Evaluation of candidate surrogate endpoints using individual patient data from multiple clinical trials is considered the gold standard approach to validate surrogates at both patient and trial levels. However, this approach assumes the availability of patient-level data from a relatively large collection of similar trials, which may not be possible to achieve for a given disease application. One common solution to the problem of too few similar trials involves performing trial-level surrogacy analyses on trial sub-units (e.g., centers within trials), thereby artificially increasing the trial-level sample size for feasibility of the multi-trial analysis. To date, the practical impact of treating trial sub-units (centers) identically to trials in multi-trial surrogacy analyses remains unexplored, and conditions under which this ad hoc solution may in fact be reasonable have not been identified. We perform a simulation study to identify such conditions, and demonstrate practical implications using a multi-trial dataset of patients with early stage colon cancer. PMID:25061255

Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements

NARCIS (Netherlands)

Nieuwenhuis, Joost B.; Irving, Elaine; Oude Rengerink, Katrien; Lloyd, Emily; Goetz, Iris; Grobbee, Diederick E.; Stolk, Pieter; Groenwold, Rolf H H; Zuidgeest, Mira G P

2016-01-01

OBJECTIVE: To illustrate how pragmatic trial design elements, or inserting explanatory trial elements in pragmatic trials affect validity, generalizability, precision and operational feasibility. STUDY DESIGN AND SETTING: From illustrative examples identified through the IMI Get Real Consortium, we

Single Laboratory Validated Method for Determination of Cylindrospermopsin and Anatoxin-a in Ambient Water by Liquid Chromatography/ Tandem Mass Spectrometry (LC/MS/MS)

Science.gov (United States)

This product is an LC/MS/MS single laboratory validated method for the determination of cylindrospermopsin and anatoxin-a in ambient waters. The product contains step-by-step instructions for sample preparation, analyses, preservation, sample holding time and QC protocols to ensu...

Empirical properties of inter-cancellation durations in the Chinese stock market

Directory of Open Access Journals (Sweden)

Gao-Feng eGu

2014-03-01

Full Text Available Order cancellation process plays a crucial role in the dynamics of price formation in order-driven stock markets and is important in the construction and validation of computational finance models. Based on the order flow data of 23 liquid stocks traded on the Shenzhen Stock Exchange in 2003, we investigate the empirical statistical properties of inter-cancellation durations in units of events defined as the waiting times between two consecutive cancellations. The inter-cancellation durations for both buy and sell orders of all the stocks favor a $q$-exponential distribution when the maximum likelihood estimation method is adopted; In contrast, both cancelled buy orders of 9 stocks and cancelled sell orders of 4 stocks prefer Weibull distribution when the nonlinear least-square estimation is used. Applying detrended fluctuation analysis (DFA, centered detrending moving average (CDMA and multifractal detrended fluctuation analysis (MF-DFA methods, we unveil that the inter-cancellation duration time series process long memory and multifractal nature for both buy and sell cancellations of all the stocks. Our findings show that order cancellation processes exhibit long-range correlated bursty behaviors and are thus not Poissonian.

Inter-rater agreement of comorbid DSM-IV personality disorders in substance abusers

Directory of Open Access Journals (Sweden)

Thylstrup Birgitte

2008-05-01

Full Text Available Abstract Background Little is known about the inter-rater agreement of personality disorders in clinical settings. Methods Clinicians rated 75 patients with substance use disorders on the DSM-IV criteria of personality disorders in random order, and on rating scales representing the severity of each. Results Convergent validity agreement was moderate (range for r = 0.55, 0.67 for cluster B disorders rated with DSM-IV criteria, and discriminant validity was moderate for eight of the ten personality disorders. Convergent validity of the rating scales was only moderate for antisocial and narcissistic personality disorder. Discussion Dimensional ratings may be used in research studies and clinical practice with some caution, and may be collected as one of several sources of information to describe the personality of a patient.

Validity of using tri-axial accelerometers to measure human movement - Part II: Step counts at a wide range of gait velocities.

Science.gov (United States)

Fortune, Emma; Lugade, Vipul; Morrow, Melissa; Kaufman, Kenton

2014-06-01

A subject-specific step counting method with a high accuracy level at all walking speeds is needed to assess the functional level of impaired patients. The study aim was to validate step counts and cadence calculations from acceleration data by comparison to video data during dynamic activity. Custom-built activity monitors, each containing one tri-axial accelerometer, were placed on the ankles, thigh, and waist of 11 healthy adults. ICC values were greater than 0.98 for video inter-rater reliability of all step counts. The activity monitoring system (AMS) algorithm demonstrated a median (interquartile range; IQR) agreement of 92% (8%) with visual observations during walking/jogging trials at gait velocities ranging from 0.1 to 4.8m/s, while FitBits (ankle and waist), and a Nike Fuelband (wrist) demonstrated agreements of 92% (36%), 93% (22%), and 33% (35%), respectively. The algorithm results demonstrated high median (IQR) step detection sensitivity (95% (2%)), positive predictive value (PPV) (99% (1%)), and agreement (97% (3%)) during a laboratory-based simulated free-living protocol. The algorithm also showed high median (IQR) sensitivity, PPV, and agreement identifying walking steps (91% (5%), 98% (4%), and 96% (5%)), jogging steps (97% (6%), 100% (1%), and 95% (6%)), and less than 3% mean error in cadence calculations. Copyright © 2014 IPEM. Published by Elsevier Ltd. All rights reserved.

The Laboratory-Based Intermountain Validated Exacerbation (LIVE Score Identifies Chronic Obstructive Pulmonary Disease Patients at High Mortality Risk

Directory of Open Access Journals (Sweden)

Denitza P. Blagev

2018-06-01

Full Text Available Background: Identifying COPD patients at high risk for mortality or healthcare utilization remains a challenge. A robust system for identifying high-risk COPD patients using Electronic Health Record (EHR data would empower targeting interventions aimed at ensuring guideline compliance and multimorbidity management. The purpose of this study was to empirically derive, validate, and characterize subgroups of COPD patients based on routinely collected clinical data widely available within the EHR.Methods: Cluster analysis was used in 5,006 patients with COPD at Intermountain to identify clusters based on a large collection of clinical variables. Recursive Partitioning (RP was then used to determine a preferred tree that assigned patients to clusters based on a parsimonious variable subset. The mortality, COPD exacerbations, and comorbidity profile of the identified groups were examined. The findings were validated in an independent Intermountain cohort and in external cohorts from the United States Veterans Affairs (VA and University of Chicago Medicine systems.Measurements and Main Results: The RP algorithm identified five LIVE Scores based on laboratory values: albumin, creatinine, chloride, potassium, and hemoglobin. The groups were characterized by increasing risk of mortality. The lowest risk, LIVE Score 5 had 8% 4-year mortality vs. 56% in the highest risk LIVE Score 1 (p < 0.001. These findings were validated in the VA cohort (n = 83,134, an expanded Intermountain cohort (n = 48,871 and in the University of Chicago system (n = 3,236. Higher mortality groups also had higher COPD exacerbation rates and comorbidity rates.Conclusions: In large clinical datasets across different organizations, the LIVE Score utilizes existing laboratory data for COPD patients, and may be used to stratify risk for mortality and COPD exacerbations.

Reliability and criterion validity of an observation protocol for working technique assessments in cash register work.

Science.gov (United States)

Palm, Peter; Josephson, Malin; Mathiassen, Svend Erik; Kjellberg, Katarina

2016-06-01

We evaluated the intra- and inter-observer reliability and criterion validity of an observation protocol, developed in an iterative process involving practicing ergonomists, for assessment of working technique during cash register work for the purpose of preventing upper extremity symptoms. Two ergonomists independently assessed 17 15-min videos of cash register work on two occasions each, as a basis for examining reliability. Criterion validity was assessed by comparing these assessments with meticulous video-based analyses by researchers. Intra-observer reliability was acceptable (i.e. proportional agreement >0.7 and kappa >0.4) for 10/10 questions. Inter-observer reliability was acceptable for only 3/10 questions. An acceptable inter-observer reliability combined with an acceptable criterion validity was obtained only for one working technique aspect, 'Quality of movements'. Thus, major elements of the cashiers' working technique could not be assessed with an acceptable accuracy from short periods of observations by one observer, such as often desired by practitioners. Practitioner Summary: We examined an observation protocol for assessing working technique in cash register work. It was feasible in use, but inter-observer reliability and criterion validity were generally not acceptable when working technique aspects were assessed from short periods of work. We recommend the protocol to be used for educational purposes only.

Comparison of a New Cobinamide-Based Method to a Standard Laboratory Method for Measuring Cyanide in Human Blood

Science.gov (United States)

Swezey, Robert; Shinn, Walter; Green, Carol; Drover, David R.; Hammer, Gregory B.; Schulman, Scott R.; Zajicek, Anne; Jett, David A.; Boss, Gerry R.

2013-01-01

Most hospital laboratories do not measure blood cyanide concentrations, and samples must be sent to reference laboratories. A simple method is needed for measuring cyanide in hospitals. The authors previously developed a method to quantify cyanide based on the high binding affinity of the vitamin B12 analog, cobinamide, for cyanide and a major spectral change observed for cyanide-bound cobinamide. This method is now validated in human blood, and the findings include a mean inter-assay accuracy of 99.1%, precision of 8.75% and a lower limit of quantification of 3.27 µM cyanide. The method was applied to blood samples from children treated with sodium nitroprusside and it yielded measurable results in 88 of 172 samples (51%), whereas the reference laboratory yielded results in only 19 samples (11%). In all 19 samples, the cobinamide-based method also yielded measurable results. The two methods showed reasonable agreement when analyzed by linear regression, but not when analyzed by a standard error of the estimate or paired t-test. Differences in results between the two methods may be because samples were assayed at different times on different sample types. The cobinamide-based method is applicable to human blood, and can be used in hospital laboratories and emergency rooms. PMID:23653045

The proportion valid effect in covert orienting: strategic control or implicit learning?

Science.gov (United States)

Risko, Evan F; Stolz, Jennifer A

2010-03-01

It is well known that the difference in performance between valid and invalid trials in the covert orienting paradigm (i.e., the cueing effect) increases as the proportion of valid trials increases. This proportion valid effect is widely assumed to reflect "strategic" control over the distribution of attention. In the present experiments we determine if this effect results from an explicit strategy or implicit learning by probing participant's awareness of the proportion of valid trials. Results support the idea that the proportion valid effect in the covert orienting paradigm reflects implicit learning not an explicit strategy.

Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test

Directory of Open Access Journals (Sweden)

Kronenwett Ralf

2012-10-01

Full Text Available Abstract Background EndoPredict (EP is a clinically validated multianalyte gene expression test to predict distant metastasis in ER-positive, HER2-negative breast cancer treated with endocrine therapy alone. The test is based on the combined analysis of 12 genes in formalin-fixed, paraffin-embedded (FFPE tissue by reverse transcription-quantitative real-time PCR (RT-qPCR. Recently, it was shown that EP is feasible for reliable decentralized assessment of gene expression. The aim of this study was the analytical validation of the performance characteristics of the assay and its verification in a molecular-pathological routine laboratory. Methods Gene expression values to calculate the EP score were assayed by one-step RT-qPCR using RNA from FFPE tumor tissue. Limit of blank, limit of detection, linear range, and PCR efficiency were assessed for each of the 12 PCR assays using serial samples dilutions. Different breast cancer samples were used to evaluate RNA input range, precision and inter-laboratory variability. Results PCR assays were linear up to Cq values between 35.1 and 37.2. Amplification efficiencies ranged from 75% to 101%. The RNA input range without considerable change of the EP score was between 0.16 and 18.5 ng/μl. Analysis of precision (variation of day, day time, instrument, operator, reagent lots resulted in a total noise (standard deviation of 0.16 EP score units on a scale from 0 to 15. The major part of the total noise (SD 0.14 was caused by the replicate-to-replicate noise of the PCR assays (repeatability and was not associated with different operating conditions (reproducibility. Performance characteristics established in the manufacturer’s laboratory were verified in a routine molecular pathology laboratory. Comparison of 10 tumor samples analyzed in two different laboratories showed a Pearson coefficient of 0.995 and a mean deviation of 0.15 score units. Conclusions The EP test showed reproducible performance

Decentral gene expression analysis: analytical validation of the Endopredict genomic multianalyte breast cancer prognosis test

International Nuclear Information System (INIS)

Kronenwett, Ralf; Brase, Jan C; Weber, Karsten E; Fisch, Karin; Müller, Berit M; Schmidt, Marcus; Filipits, Martin; Dubsky, Peter; Petry, Christoph; Dietel, Manfred; Denkert, Carsten; Bohmann, Kerstin; Prinzler, Judith; Sinn, Bruno V; Haufe, Franziska; Roth, Claudia; Averdick, Manuela; Ropers, Tanja; Windbergs, Claudia

2012-01-01

EndoPredict (EP) is a clinically validated multianalyte gene expression test to predict distant metastasis in ER-positive, HER2-negative breast cancer treated with endocrine therapy alone. The test is based on the combined analysis of 12 genes in formalin-fixed, paraffin-embedded (FFPE) tissue by reverse transcription-quantitative real-time PCR (RT-qPCR). Recently, it was shown that EP is feasible for reliable decentralized assessment of gene expression. The aim of this study was the analytical validation of the performance characteristics of the assay and its verification in a molecular-pathological routine laboratory. Gene expression values to calculate the EP score were assayed by one-step RT-qPCR using RNA from FFPE tumor tissue. Limit of blank, limit of detection, linear range, and PCR efficiency were assessed for each of the 12 PCR assays using serial samples dilutions. Different breast cancer samples were used to evaluate RNA input range, precision and inter-laboratory variability. PCR assays were linear up to C q values between 35.1 and 37.2. Amplification efficiencies ranged from 75% to 101%. The RNA input range without considerable change of the EP score was between 0.16 and 18.5 ng/μl. Analysis of precision (variation of day, day time, instrument, operator, reagent lots) resulted in a total noise (standard deviation) of 0.16 EP score units on a scale from 0 to 15. The major part of the total noise (SD 0.14) was caused by the replicate-to-replicate noise of the PCR assays (repeatability) and was not associated with different operating conditions (reproducibility). Performance characteristics established in the manufacturer’s laboratory were verified in a routine molecular pathology laboratory. Comparison of 10 tumor samples analyzed in two different laboratories showed a Pearson coefficient of 0.995 and a mean deviation of 0.15 score units. The EP test showed reproducible performance characteristics with good precision and negligible laboratory-to-laboratory

External quality assurance of malaria nucleic acid testing for clinical trials and eradication surveillance.

Science.gov (United States)

Murphy, Sean C; Hermsen, Cornelus C; Douglas, Alexander D; Edwards, Nick J; Petersen, Ines; Fahle, Gary A; Adams, Matthew; Berry, Andrea A; Billman, Zachary P; Gilbert, Sarah C; Laurens, Matthew B; Leroy, Odile; Lyke, Kristen E; Plowe, Christopher V; Seilie, Annette M; Strauss, Kathleen A; Teelen, Karina; Hill, Adrian V S; Sauerwein, Robert W

2014-01-01

Nucleic acid testing (NAT) for malaria parasites is an increasingly recommended diagnostic endpoint in clinical trials of vaccine and drug candidates and is also important in surveillance of malaria control and elimination efforts. A variety of reported NAT assays have been described, yet no formal external quality assurance (EQA) program provides validation for the assays in use. Here, we report results of an EQA exercise for malaria NAT assays. Among five centers conducting controlled human malaria infection trials, all centers achieved 100% specificity and demonstrated limits of detection consistent with each laboratory's pre-stated expectations. Quantitative bias of reported results compared to expected results was generally Quality Assessment program that fulfills the need for EQA of malaria NAT assays worldwide.

Safety in the Chemical Laboratory

Science.gov (United States)

Steere, Norman V., Ed.

1973-01-01

Suggests laboratory instructors preserve the necessary evidence after an incident in classroom. Included is a checklist for gathering evidence that trial lawyers will need to present defense adequately. (CC)

Validity and inter-rater reliability of medio-lateral knee motion observed during a single-limb mini squat

Directory of Open Access Journals (Sweden)

Simic Milena

2010-11-01

Full Text Available Abstract Background Muscle function may influence the risk of knee injury and outcomes following injury. Clinical tests, such as a single-limb mini squat, resemble conditions of daily life and are easy to administer. Fewer squats per 30 seconds indicate poorer function. However, the quality of movement, such as the medio-lateral knee motion may also be important. The aim was to validate an observational clinical test of assessing the medio-lateral knee motion, using a three-dimensional (3-D motion analysis system. In addition, the inter-rater reliability was evaluated. Methods Twenty-five (17 women non-injured participants (mean age 25.6 years, range 18-37 were included. Visual analysis of the medio-lateral knee motion, scored as knee-over-foot or knee-medial-to-foot by two raters, and 3-D kinematic data were collected simultaneously during a single-limb mini squat. Frontal plane 2-D peak tibial, thigh, and knee varus-valgus angles, and 3-D peak hip internal-external rotation, and knee varus-valgus angles were calculated. Results Ten subjects were scored as having a knee-medial-to-foot position and 15 subjects a knee-over-foot position assessed by visual inspection. In 2-D, the peak tibial angle (mean 89.0 (SE 0.7 vs mean 86.3 (SE 0.4 degrees, p = 0.001 and peak thigh angle (mean 77.4 (SE 1.0 vs mean 81.2 (SE 0.5 degrees, p = 0.001 with respect to the horizontal, indicated that the knee was more medially placed than the ankle and thigh, respectively. Thus, the knee was in more valgus (mean 11.6 (SE 1.5 vs 5.0 (SE 0.8 degrees, p 0.90 and 96 between raters. Conclusions Medio-lateral motion of the knee can reliably be assessed during a single-leg mini-squat. The test is valid in 2-D, while the actual movement, in 3-D, is mainly exhibited as increased internal hip rotation. The single-limb mini squat is feasible and easy to administer in the clinical setting and in research to address lower extremity movement quality.

Non-laboratory-based self-assessment screening score for non-alcoholic fatty liver disease: development, validation and comparison with other scores.

Directory of Open Access Journals (Sweden)

Yong-ho Lee

Full Text Available Non-alcoholic fatty liver disease (NAFLD is a prevalent and rapidly increasing disease worldwide; however, no widely accepted screening models to assess the risk of NAFLD are available. Therefore, we aimed to develop and validate a self-assessment score for NAFLD in the general population using two independent cohorts.The development cohort comprised 15676 subjects (8313 males and 7363 females who visited the National Health Insurance Service Ilsan Hospital in Korea in 2008-2010. Anthropometric, clinical, and laboratory data were examined during regular health check-ups and fatty liver diagnosed by abdominal ultrasound. Logistic regression analysis was conducted to determine predictors of prevalent NAFLD and to derive risk scores/models. We validated our models and compared them with other existing methods using an external cohort (N = 66868.The simple self-assessment score consists of age, sex, waist circumference, body mass index, history of diabetes and dyslipidemia, alcohol intake, physical activity and menopause status, which are independently associated with NAFLD, and has a value of 0-15. A cut-off point of ≥ 8 defined 58% of males and 36% of females as being at high-risk of NAFLD, and yielded a sensitivity of 80% in men (77% in women, a specificity of 67% (81%, a positive predictive value of 72% (63%, a negative predictive value of 76% (89% and an AUC of 0.82 (0.88. Comparable results were obtained using the validation dataset. The comprehensive NAFLD score, which includes additional laboratory parameters, has enhanced discrimination ability, with an AUC of 0.86 for males and 0.91 for females. Both simple and comprehensive NAFLD scores were significantly increased in subjects with higher fatty liver grades or severity of liver conditions (e.g., simple steatosis, steatohepatitis.The new non-laboratory-based self-assessment score may be useful for identifying individuals at high-risk of NAFLD. Further studies are warranted to evaluate

Developing Guided Inquiry-Based Student Lab Worksheet for Laboratory Knowledge Course

Science.gov (United States)

Rahmi, Y. L.; Novriyanti, E.; Ardi, A.; Rifandi, R.

2018-04-01

The course of laboratory knowledge is an introductory course for biology students to follow various lectures practicing in the biology laboratory. Learning activities of laboratory knowledge course at this time in the Biology Department, Universitas Negeri Padang has not been completed by supporting learning media such as student lab worksheet. Guided inquiry learning model is one of the learning models that can be integrated into laboratory activity. The study aimed to produce student lab worksheet based on guided inquiry for laboratory knowledge course and to determine the validity of lab worksheet. The research was conducted using research and developmet (R&D) model. The instruments used in data collection in this research were questionnaire for student needed analysis and questionnaire to measure the student lab worksheet validity. The data obtained was quantitative from several validators. The validators consist of three lecturers. The percentage of a student lab worksheet validity was 94.18 which can be categorized was very good.

Assessment of generalizability, applicability and predictability (GAP) for evaluating external validity in studies of universal family-based prevention of alcohol misuse in young people: systematic methodological review of randomized controlled trials.

Science.gov (United States)

Fernandez-Hermida, Jose Ramon; Calafat, Amador; Becoña, Elisardo; Tsertsvadze, Alexander; Foxcroft, David R

2012-09-01

To assess external validity characteristics of studies from two Cochrane Systematic Reviews of the effectiveness of universal family-based prevention of alcohol misuse in young people. Two reviewers used an a priori developed external validity rating form and independently assessed three external validity dimensions of generalizability, applicability and predictability (GAP) in randomized controlled trials. The majority (69%) of the included 29 studies were rated 'unclear' on the reporting of sufficient information for judging generalizability from sample to study population. Ten studies (35%) were rated 'unclear' on the reporting of sufficient information for judging applicability to other populations and settings. No study provided an assessment of the validity of the trial end-point measures for subsequent mortality, morbidity, quality of life or other economic or social outcomes. Similarly, no study reported on the validity of surrogate measures using established criteria for assessing surrogate end-points. Studies evaluating the benefits of family-based prevention of alcohol misuse in young people are generally inadequate at reporting information relevant to generalizability of the findings or implications for health or social outcomes. Researchers, study authors, peer reviewers, journal editors and scientific societies should take steps to improve the reporting of information relevant to external validity in prevention trials. © 2012 The Authors. Addiction © 2012 Society for the Study of Addiction.

The reliability and validity of the Turkish version of Fullerton Advanced Balance (FAB-T) scale.

Science.gov (United States)

Iyigun, Gozde; Kirmizigil, Berkiye; Angin, Ender; Oksuz, Sevim; Can, Filiz; Eker, Levent; Rose, Debra J

2018-06-04

The aim of this study was to evaluate the reliability and validity of the Turkish version of the FAB(FAB-T) scale in the older Turkish adults. The reliability and validity of the scale was tested on 200 community-dwelling older adults. FAB-T scale was scored by different physiotherapists on different days to evaluate inter-rater and intrarater reliability. The Berg Balance Scale (BBS) was used for the evaluation of convergent validity, and the content validity of the FAB-T scale was investigated. The FAB-T scale showed very high inter- and intra-rater reliability. For inter-rater agreement, on the individual test items and total score ICC values were 0.92 (95 %CI; 0.90-0.94) and 0.96 (95% CI; 0.95-0.97) respectively. The intra-rater agreement, on the individual test items and total score ICC values were 0.93 (95 %CI; 0.91- 0.95) and 0.96 (95% CI; 0.95- 0.97) respectively. There was a good agreement between the FAB-T and BBS scales. A high correlation was found between the BBS and FAB-T scales [rho = 0.70 (%95 CI; 0.62-0.76)] indicating good convergent validity. Considering the content validity of the FAB-T scale, no floor (floor score: 0%) or ceiling (ceiling score: 6.5%) effect was detected. The FAB-T scale was successfully translated from the original English version (FAB) and demonstrated strong psychometric features. It was found that the FAB-T scale has very high inter-rater and intra-rater reliability. Considering the convergent validity, the scale has high correlation with the BBS. The FAB-T has no floor and ceiling effect. Copyright © 2018 Elsevier B.V. All rights reserved.

Novel assessment tools to evaluate clinical and laboratory responses in a subset of patients enrolled in the Rituximab in Myositis trial.

Science.gov (United States)

Rider, Lisa G; Yip, Adrienne L; Horkayne-Szakaly, Iren; Volochayev, Rita; Shrader, Joseph A; Turner, Maria L; Kong, Heidi H; Jain, Minal S; Jansen, Anna V; Oddis, Chester V; Fleisher, Thomas A; Miller, Frederick W

2014-01-01

We aimed to assess changes in myositis core set measures and ancillary clinical and laboratory data from the National Institutes of Health's subset of patients enrolled in the Rituximab in Myositis trial. Eighteen patients (5 dermatomyositis, 8 polymyositis, 5 juvenile dermatomyositis) completed more in-depth testing of muscle strength and cutaneous assessments, patient-reported outcomes, and laboratory tests before and after administration of rituximab. Percentage change in individual measures and in the definitions of improvement (DOIs) and standardized response means were examined over 44 weeks. Core set activity measures improved by 18-70% from weeks 0-44 and were sensitive to change. Fifteen patients met the DOI at week 44, 9 patients met a DOI 50% response, and 4 met a DOI 70% response. Muscle strength and function measures were more sensitive to change than cutaneous assessments. Constitutional, gastrointestinal, and pulmonary systems improved 44-70%. Patient-reported outcomes improved up to 28%. CD20+ B cells were depleted in the periphery, but B cell depletion was not associated with clinical improvement at week 16. This subset of patients had high rates of clinical response to rituximab, similar to patients in the overall trial. Most measures were responsive, and muscle strength had a greater degree of change than cutaneous assessments. Several novel assessment tools, including measures of strength and function, extra-muscular organ activity, fatigue, and health-related quality of life, are promising for use in future myositis trials. Further study of B cell-depleting therapies in myositis, particularly in treatment-naïve patients, is warranted.

Bio-Oil Analysis Laboratory Procedures | Bioenergy | NREL

Science.gov (United States)

Bio-Oil Analysis Laboratory Procedures Bio-Oil Analysis Laboratory Procedures NREL develops laboratory analytical procedures (LAPs) for the analysis of raw and upgraded pyrolysis bio-oils. These standard procedures have been validated and allow for reliable bio-oil analysis. Procedures Determination

Videoconference-based mini mental state examination: a validation study.

Science.gov (United States)

Timpano, Francesca; Pirrotta, Fabio; Bonanno, Lilla; Marino, Silvia; Marra, Angela; Bramanti, Placido; Lanzafame, Pietro

2013-12-01

Neuropsychological testing is a prime criterion of good practice to document cognitive deficits in a rapidly aging population. Telecommunication technologies may overcome limitations related to test administration. We compared performance of the Italian videoconference-based version of the Mini Mental State Examination (VMMSE) with performance of the standard MMSE administered face-to-face (F2F), to validate the Italian version of the 28-item VMMSE. To validate the Italian version of the VMMSE, we compared its performance with standard F2F. The sample (n=342) was administered three VMMSEs within 6 weeks after F2F testing. We identified the optimal cutoff through the receiver operating characteristic curve, as well as the VMMSE consistency through inter- and intrarater reliability (Inter/RR and Intra/RR) analysis. We found high levels of sensitivity and specificity for the optimal VMMSE cutoff identification and an accuracy of 0.96 (95% confidence interval 0.94-0.98). Intra/RR and inter/RR were highly significant. This study demonstrates that VMMSE is a valid instrument in clinical and research screening and monitoring of subjects affected by cognitive disorders. This study shows a significant correlation between videoconference assessment and the F2F one, providing an important impetus to expand studies and the knowledge about the usefulness of tele-assistance services. Our findings have important implications for both longitudinal assistance and clinical care of demented patients.

Publishing nutrition research: validity, reliability, and diagnostic test assessment in nutrition-related research.

Science.gov (United States)

Gleason, Philip M; Harris, Jeffrey; Sheean, Patricia M; Boushey, Carol J; Bruemmer, Barbara

2010-03-01

This is the sixth in a series of monographs on research design and analysis. The purpose of this article is to describe and discuss several concepts related to the measurement of nutrition-related characteristics and outcomes, including validity, reliability, and diagnostic tests. The article reviews the methodologic issues related to capturing the various aspects of a given nutrition measure's reliability, including test-retest, inter-item, and interobserver or inter-rater reliability. Similarly, it covers content validity, indicators of absolute vs relative validity, and internal vs external validity. With respect to diagnostic assessment, the article summarizes the concepts of sensitivity and specificity. The hope is that dietetics practitioners will be able to both use high-quality measures of nutrition concepts in their research and recognize these measures in research completed by others. Copyright 2010 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

Development of an inter-atomic potential for the Pd-H binary system.

Energy Technology Data Exchange (ETDEWEB)

Zimmerman, Jonathan A.; Hoyt, Jeffrey John (McMaster University, Hamilton, Ontario, Canada); Leonard, Francois Leonard; Griffin, Joshua D.; Zhou, Xiao Wang

2007-09-01

Ongoing research at Sandia National Laboratories has been in the area of developing models and simulation methods that can be used to uncover and illuminate the material defects created during He bubble growth in aging bulk metal tritides. Previous efforts have used molecular dynamics calculations to examine the physical mechanisms by which growing He bubbles in a Pd metal lattice create material defects. However, these efforts focused only on the growth of He bubbles in pure Pd and not on bubble growth in the material of interest, palladium tritide (PdT), or its non-radioactive isotope palladium hydride (PdH). The reason for this is that existing inter-atomic potentials do not adequately describe the thermodynamics of the Pd-H system, which includes a miscibility gap that leads to phase separation of the dilute (alpha) and concentrated (beta) alloys of H in Pd at room temperature. This document will report the results of research to either find or develop inter-atomic potentials for the Pd-H and Pd-T systems, including our efforts to use experimental data and density functional theory calculations to create an inter-atomic potential for this unique metal alloy system.

Validity and reliability of a low-cost digital dynamometer for measuring isometric strength of lower limb.

Science.gov (United States)

Romero-Franco, Natalia; Jiménez-Reyes, Pedro; Montaño-Munuera, Juan A

2017-11-01

Lower limb isometric strength is a key parameter to monitor the training process or recognise muscle weakness and injury risk. However, valid and reliable methods to evaluate it often require high-cost tools. The aim of this study was to analyse the concurrent validity and reliability of a low-cost digital dynamometer for measuring isometric strength in lower limb. Eleven physically active and healthy participants performed maximal isometric strength for: flexion and extension of ankle, flexion and extension of knee, flexion, extension, adduction, abduction, internal and external rotation of hip. Data obtained by the digital dynamometer were compared with the isokinetic dynamometer to examine its concurrent validity. Data obtained by the digital dynamometer from 2 different evaluators and 2 different sessions were compared to examine its inter-rater and intra-rater reliability. Intra-class correlation (ICC) for validity was excellent in every movement (ICC > 0.9). Intra and inter-tester reliability was excellent for all the movements assessed (ICC > 0.75). The low-cost digital dynamometer demonstrated strong concurrent validity and excellent intra and inter-tester reliability for assessing isometric strength in the main lower limb movements.

Validation of the 3D Skin Comet assay using full thickness skin models: Transferability and reproducibility.

Science.gov (United States)

Reisinger, Kerstin; Blatz, Veronika; Brinkmann, Joep; Downs, Thomas R; Fischer, Anja; Henkler, Frank; Hoffmann, Sebastian; Krul, Cyrille; Liebsch, Manfred; Luch, Andreas; Pirow, Ralph; Reus, Astrid A; Schulz, Markus; Pfuhler, Stefan

2018-03-01

Recently revised OECD Testing Guidelines highlight the importance of considering the first site-of-contact when investigating the genotoxic hazard. Thus far, only in vivo approaches are available to address the dermal route of exposure. The 3D Skin Comet and Reconstructed Skin Micronucleus (RSMN) assays intend to close this gap in the in vitro genotoxicity toolbox by investigating DNA damage after topical application. This represents the most relevant route of exposure for a variety of compounds found in household products, cosmetics, and industrial chemicals. The comet assay methodology is able to detect both chromosomal damage and DNA lesions that may give rise to gene mutations, thereby complementing the RSMN which detects only chromosomal damage. Here, the comet assay was adapted to two reconstructed full thickness human skin models: the EpiDerm™- and Phenion ® Full-Thickness Skin Models. First, tissue-specific protocols for the isolation of single cells and the general comet assay were transferred to European and US-American laboratories. After establishment of the assay, the protocol was then further optimized with appropriate cytotoxicity measurements and the use of aphidicolin, a DNA repair inhibitor, to improve the assay's sensitivity. In the first phase of an ongoing validation study eight chemicals were tested in three laboratories each using the Phenion ® Full-Thickness Skin Model, informing several validation modules. Ultimately, the 3D Skin Comet assay demonstrated a high predictive capacity and good intra- and inter-laboratory reproducibility with four laboratories reaching a 100% predictivity and the fifth yielding 70%. The data are intended to demonstrate the use of the 3D Skin Comet assay as a new in vitro tool for following up on positive findings from the standard in vitro genotoxicity test battery for dermally applied chemicals, ultimately helping to drive the regulatory acceptance of the assay. To expand the database, the validation will

Standards Performance Continuum: Development and Validation of a Measure of Effective Pedagogy.

Science.gov (United States)

Doherty, R. William; Hilberg, R. Soleste; Epaloose, Georgia; Tharp, Roland G.

2002-01-01

Describes the development and validation of the Standards Performance Continuum (SPC) for assessing teacher performance of the Standards for Effective Pedagogy. Three studies involving Florida, California, and New Mexico public school teachers provided evidence of inter-rater reliability, concurrent validity, and criterion-related validity…

Conceptualizing inter-organizational triads

DEFF Research Database (Denmark)

Vedel, Mette; Holma, Anne-Maria; Havila, Virpi

2016-01-01

of inter-organizational phenomena. However, not all studies involving a context of three actors are actually examining triads. This paper offers a robust definition of three-actor constellations qualifying as triads. Moreover, it elaborates on different types of inter-organizational triads, based on two...... aspects of collectivity; cohesion and the ability to act as a single entity. The definition of inter-organizational triads and the categorization of different types of triads will hopefully encourage further studies of triads; the smallest and simplest network which offers insights, which cannot...

Pretreating dogwood seedlings with simulated acidic precipitation increases dogwood anthracnose symptoms in greenhouse-laboratory trials

Energy Technology Data Exchange (ETDEWEB)

Anderson, R.L.; Knighten, J. (USDA Forest Service, Resistance Screening Center, Asheville, NC (United States)); Berrange, P.; Lawton, K.A. (USDA Forest Service, Center for Forest Environmental Studies, Dry Branch, GA (United States)); Britton, K.O. (USDA Forest Service, Southeastern Forest Experiment Station, Athens, GA (United States))

1993-01-01

Dogwood anthracnose is the most damaging disease of flowering dogwood (Cornus florida L.) in a large part of the tree's natural range. It is caused by Discula destructiva infection. Previous attempts to inoculate C. florida to produce anthracnose symptoms have met with limited success except when the leaves were pretreated with acidic water, suggesting that acidic precipitation may predispose dogwoods to the disease. This hypothesis was tested in two greenhouse-laboratory studies in which year-old C. florida seedlings were randomly assigned to four treatments of simulated rain (pH 2.5, 3.5, 4.5, and 5.5) in 1989 and 1990. After 10 applications over a 42-d period, the seedlings were moved to a temperature-controlled laboratory, placed in plastic bags, humidified, and sprayed with a spore suspension of five D. destructiva isolates. About 30 d layter, the seedlings were examined for the percentage of leaves exhibiting anthracnose symptoms and disease severity on affected leaves. Both trials showed that as the acidity of the simulated rain increased, the incidence and severity of anthracnose leaf symptoms increased. The 1989 study included a soil lime treatment that showed the same trend but the overall occurrence and severity of symptoms was higher. 17 refs., 5 tabs.

Catch-up validation study of an in vitro skin irritation test method based on an open source reconstructed epidermis (phase II).

Science.gov (United States)

Groeber, F; Schober, L; Schmid, F F; Traube, A; Kolbus-Hernandez, S; Daton, K; Hoffmann, S; Petersohn, D; Schäfer-Korting, M; Walles, H; Mewes, K R

2016-10-01

To replace the Draize skin irritation assay (OECD guideline 404) several test methods based on reconstructed human epidermis (RHE) have been developed and were adopted in the OECD test guideline 439. However, all validated test methods in the guideline are linked to RHE provided by only three companies. Thus, the availability of these test models is dependent on the commercial interest of the producer. To overcome this limitation and thus to increase the accessibility of in vitro skin irritation testing, an open source reconstructed epidermis (OS-REp) was introduced. To demonstrate the capacity of the OS-REp in regulatory risk assessment, a catch-up validation study was performed. The participating laboratories used in-house generated OS-REp to assess the set of 20 reference substances according to the performance standards amending the OECD test guideline 439. Testing was performed under blinded conditions. The within-laboratory reproducibility of 87% and the inter-laboratory reproducibility of 85% prove a high reliability of irritancy testing using the OS-REp protocol. In addition, the prediction capacity was with an accuracy of 80% comparable to previous published RHE based test protocols. Taken together the results indicate that the OS-REp test method can be used as a standalone alternative skin irritation test replacing the OECD test guideline 404. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The effect of the inter-phase delay interval in the spontaneous object recognition test for pigs

DEFF Research Database (Denmark)

Kornum, Birgitte Rahbek; Thygesen, Kristin Sjølie; Nielsen, Thomas Rune

2007-01-01

In the neuroscience community interest for using the pig is growing. Several disease models have been developed creating a need for validation of behavioural paradigms in these animals. Here, we report the effect of different inter-phase delay intervals on the performance of Göttingen minipigs...

Importance of stand density, inter row spacing, "mother" and "father" row distance in corn seed production

Directory of Open Access Journals (Sweden)

Marinković Branko

2006-01-01

Full Text Available Importance of stand density, "mother" and "father" row distance is very important for corn seed production. Inter row spacing from 70,60 and 50 cm, and their influence on "mother" grain yield was investigated during 7 years trials. In seed production, at density ratio 6 + 2, beside inter row spacing, yield influence on stand density was followed as well. Five stand densities (40.8000, 52.900, 64.900, 79.400, 89.300, total plant number per ha and density ration 6 + 2, was investigated. The next results were obtained: at 70 cm inter row spacing, the highest yield was achieved with the 64.900 plant/ha stand density (4.35 tha-1 "mother" seed. At the first row, yield was higher for 360 and 550 kgha-1 in dependence from the second and the third "mother" row. At 60 cm inter row spacing, yield was increasing till the highest density, and significant difference, in relation to 40.800 plants/ha, was at 79.400 plants/ha stands density. At the second and the third row in rela­tion to the first "mother" row, yield difference was 430 and 510 kgha-1. The same conclusions can be made at the 50 cm inter row spacing. With the "mother" row space increasing, yield was decreased for 370 and 460 kgha-1.

Predictive Accuracy of the PanCan Lung Cancer Risk Prediction Model -External Validation based on CT from the Danish Lung Cancer Screening Trial

NARCIS (Netherlands)

Wille, M.M.W.; Riel, S.J. van; Saghir, Z.; Dirksen, A.; Pedersen, J.H.; Jacobs, C.; Thomsen, L.H.u.; Scholten, E.T.; Skovgaard, L.T.; Ginneken, B. van

2015-01-01

Lung cancer risk models should be externally validated to test generalizability and clinical usefulness. The Danish Lung Cancer Screening Trial (DLCST) is a population-based prospective cohort study, used to assess the discriminative performances of the PanCan models.From the DLCST database, 1,152

Validation of the qi blood yin yang deficiency questionnaire on chronic fatigue.

Science.gov (United States)

Kim, Jihye; Ku, Boncho; Kim, Keun Ho

2016-01-01

Chronic fatigue (CF) reflects an imbalance of inter-organ functions or of the four essential physiological components qi, blood (xue), yin, and yang. CF can be subdivided into different patterns. However, there are no diagnostic methods for CF. This study aimed to clinically validate a pattern identification method by identifying correlations between CF and responses to the qi blood yin yang deficiency questionnaire (QBYY-Q). Participants were recruited between May and June 2014 through the Kyung Hee University Korean Medicine hospital website and via posters and comprised 129 CF patients diagnosed with the United States Centers for Disease Control and Prevention (1994) criteria. Participants who had organic diseases that explained the CF were excluded. A total of 159 participants were asked to complete the QBYY-Q, the fatigue severity scale, and the Chalder fatigue scale. The latter two questionnaires were used to assess convergent validity with the QBYY-Q. Among the 129 CF participants, 70 and 59 had chronic fatigue syndrome and idiopathic chronic fatigue, respectively. Two Korean medical doctors independently assessed participants' qi, blood, yin, and yang deficiency patterns using QBYY deficiency pattern identification guidelines. Based on the results of a preliminary study of the QBYY-Q, we selected 32 reliable items for symptoms corresponding to each deficiency pattern. The items were used to estimate internal consistency and construct validity. Multinomial logistic regression analysis was performed for scores on each deficiency pattern. The data were means and standard deviations or numbers of participants and proportions for continuous and categorical variables, respectively. A statistical significance level of P yin, and yang deficiency were 45.1, 58.0, 52.2, and 63.4 %, respectively. Each QBYY-Q deficiency score was positively associated with each corresponding deficiency pattern. Qi deficiency was used as a reference category. Odds ratios of blood, yin

An inter-laboratory study to test the ability of amendments to reduce the availability of Cd, Pb, and Zn in situ

Energy Technology Data Exchange (ETDEWEB)

Brown, Sally [Box 352100 University of Washington, Seattle, WA 98195 (United States)]. E-mail: slb@u.washington.edu; Christensen, Barbara [Box 352100 University of Washington, Seattle, WA 98195 (United States); Lombi, Enzo [CSIRO Land and Water PMB, 2 Glen Osmond, Adelaide, South Australia (Australia)]. E-mail: enzo.lombi@csiro.au; McLaughlin, Mike [CSIRO Land and Water PMB, 2 Glen Osmond, Adelaide, South Australia (Australia)]. E-mail: mike.mclaughlin@csiro.au; McGrath, Steve [Rothamsted Research, Harpenden, Herts AL5 2JQ (United Kingdom)]. E-mail: steve.mcgrath@bbsrc.ac.uk; Colpaert, Jan [Limburgs Universitair, Centrum Universitaire Campus, Building D, BE 3590 Diepenbeek (Belgium); Vangronsveld, Jaco [Limburgs Universitair, Centrum Universitaire Campus, Building D, BE 3590 Diepenbeek (Belgium)]. E-mail: jvangron@luc.ac.be