Validation of a multimarker model for assessing risk of type 2 diabetes from a five-year prospective study of 6784 Danish people (Inter99).

PubMed

Urdea, Mickey; Kolberg, Janice; Wilber, Judith; Gerwien, Robert; Moler, Edward; Rowe, Michael; Jorgensen, Paul; Hansen, Torben; Pedersen, Oluf; Jørgensen, Torben; Borch-Johnsen, Knut

2009-07-01

Improved identification of subjects at high risk for development of type 2 diabetes would allow preventive interventions to be targeted toward individuals most likely to benefit. In previous research, predictive biomarkers were identified and used to develop multivariate models to assess an individual's risk of developing diabetes. Here we describe the training and validation of the PreDx Diabetes Risk Score (DRS) model in a clinical laboratory setting using baseline serum samples from subjects in the Inter99 cohort, a population-based primary prevention study of cardiovascular disease. Among 6784 subjects free of diabetes at baseline, 215 subjects progressed to diabetes (converters) during five years of follow-up. A nested case-control study was performed using serum samples from 202 converters and 597 randomly selected nonconverters. Samples were randomly assigned to equally sized training and validation sets. Seven biomarkers were measured using assays developed for use in a clinical reference laboratory. The PreDx DRS model performed better on the training set (area under the curve [AUC] = 0.837) than fasting plasma glucose alone (AUC = 0.779). When applied to the sequestered validation set, the PreDx DRS showed the same performance (AUC = 0.838), thus validating the model. This model had a better AUC than any other single measure from a fasting sample. Moreover, the model provided further risk stratification among high-risk subpopulations with impaired fasting glucose or metabolic syndrome. The PreDx DRS provides the absolute risk of diabetes conversion in five years for subjects identified to be "at risk" using the clinical factors. Copyright 2009 Diabetes Technology Society.

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

PubMed

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 (68

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

PubMed

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.

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

PubMed

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.

Multi-laboratory validation study of multilocus variable-number tandem repeat analysis (MLVA) for Salmonella enterica serovar Enteritidis, 2015

PubMed Central

Peters, Tansy; Bertrand, Sophie; Björkman, Jonas T; Brandal, Lin T; Brown, Derek J; Erdõsi, Tímea; Heck, Max; Ibrahem, Salha; Johansson, Karin; Kornschober, Christian; Kotila, Saara M; Le Hello, Simon; Lienemann, Taru; Mattheus, Wesley; Nielsen, Eva Møller; Ragimbeau, Catherine; Rumore, Jillian; Sabol, Ashley; Torpdahl, Mia; Trees, Eija; Tuohy, Alma; de Pinna, Elizabeth

2017-01-01

Multilocus variable-number tandem repeat analysis (MLVA) is a rapid and reproducible typing method that is an important tool for investigation, as well as detection, of national and multinational outbreaks of a range of food-borne pathogens. Salmonella enterica serovar Enteritidis is the most common Salmonella serovar associated with human salmonellosis in the European Union/European Economic Area and North America. Fourteen laboratories from 13 countries in Europe and North America participated in a validation study for MLVA of S. Enteritidis targeting five loci. Following normalisation of fragment sizes using a set of reference strains, a blinded set of 24 strains with known allele sizes was analysed by each participant. The S. Enteritidis 5-loci MLVA protocol was shown to produce internationally comparable results as more than 90% of the participants reported less than 5% discrepant MLVA profiles. All 14 participating laboratories performed well, even those where experience with this typing method was limited. The raw fragment length data were consistent throughout, and the inter-laboratory validation helped to standardise the conversion of raw data to repeat numbers with at least two countries updating their internal procedures. However, differences in assigned MLVA profiles remain between well-established protocols and should be taken into account when exchanging data. PMID:28277220

Analysis of DDT and its metabolites in soil and water samples obtained in the vicinity of a closed-down factory in Bangladesh using various extraction methods.

PubMed

Al Mahmud, M N U; Khalil, Farzana; Rahman, Md Musfiqur; Mamun, M I R; Shoeb, Mohammad; Abd El-Aty, A M; Park, Jong-Hyouk; Shin, Ho-Chul; Nahar, Nilufar; Shim, Jae-Han

2015-12-01

This study was conducted to monitor the spread of dichlorodiphenyltrichloroethane (DDT) and its metabolites (dichlorodiphenyldichloroethylene (DDE), dichlorodiphenyldichloroethane (DDD)) in soil and water to regions surrounding a closed DDT factory in Bangladesh. This fulfillment was accomplished using inter-method and inter-laboratory validation studies. DDTs (DDT and its metabolites) from soil samples were extracted using microwave-assisted extraction (MAE), supercritical fluid extraction (SFE), and solvent extraction (SE). Inter-laboratory calibration was assessed by SE, and all methods were validated by intra- and inter-day accuracy (expressed as recovery %) and precision (expressed as relative standard deviation (RSD)) in the same laboratory, at three fortified concentrations (n = 4). DDTs extracted from water samples by liquid-liquid partitioning and all samples were analyzed by gas chromatography (GC)-electron capture detector (ECD) and confirmed by GC/mass spectrometry (GC/MS). Linearities expressed as determination coefficients (R (2)) were ≥0.995 for matrix-matched calibrations. The recovery rate was in the range of 72-120 and 83-110%, with <15% RSD in soil and water, respectively. The limit of quantification (LOQ) was 0.0165 mg kg(-1) in soil and 0.132 μg L(-1) in water. Greater quantities of DDTs were extracted from soil using the MAE and SE techniques than with the SFE method. Higher amounts of DDTs were discovered in the southern (2.2-936 × 10(2) mg kg(-1)) or southwestern (86.3-2067 × 10(2) mg kg(-1)) direction from the factory than in the eastern direction (1.0-48.6 × 10(2) mg kg(-1)). An exception was the soil sample collected 50 ft (15.24 m) east (2904 × 10(2) mg kg(-1)) of the factory. The spread of DDTs in the water bodies (0.59-3.01 μg L(-1)) was approximately equal in all directions. We concluded that DDTs might have been dumped randomly around the warehouse after the closing of the factory.

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

PubMed

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.

THE DEVELOPMENT AND INTER-LABORATORY VERIFICATION OF LC-MS LIBRARIES FOR ORGANIC CHEMICALS OF ENVIRONMENTAL CONCERN

EPA Science Inventory

The development, verification, and comparison study between LC-MS libraries for two manufacturers’ instruments and a verified protocol are discussed. The LC-MS library protocol was verified through an inter-laboratory study that involved Federal, State, and private laboratories. ...

Comparative Validation of Five Quantitative Rapid Test Kits for the Analysis of Salt Iodine Content: Laboratory Performance, User- and Field-Friendliness

PubMed Central

Rohner, Fabian; Kangambèga, Marcelline O.; Khan, Noor; Kargougou, Robert; Garnier, Denis; Sanou, Ibrahima; Ouaro, Bertine D.; Petry, Nicolai; Wirth, James P.; Jooste, Pieter

2015-01-01

Background Iodine deficiency has important health and development consequences and the introduction of iodized salt as national programs has been a great public health success in the past decades. To render national salt iodization programs sustainable and ensure adequate iodization levels, simple methods to quantitatively assess whether salt is adequately iodized are required. Several methods claim to be simple and reliable, and are available on the market or are in development. Objective This work has validated the currently available quantitative rapid test kits (quantRTK) in a comparative manner for both their laboratory performance and ease of use in field settings. Methods Laboratory performance parameters (linearity, detection and quantification limit, intra- and inter-assay imprecision) were conducted on 5 quantRTK. We assessed inter-operator imprecision using salt of different quality along with the comparison of 59 salt samples from across the globe; measurements were made both in a laboratory and a field setting by technicians and non-technicians. Results from the quantRTK were compared against iodometric titration for validity. An ‘ease-of-use’ rating system was developed to identify the most suitable quantRTK for a given task. Results Most of the devices showed acceptable laboratory performance, but for some of the devices, use by non-technicians revealed poorer performance when working in a routine manner. Of the quantRTK tested, the iCheck® and I-Reader® showed most consistent performance and ease of use, and a newly developed paper-based method (saltPAD) holds promise if further developed. Conclusions User- and field-friendly devices are now available and the most appropriate quantRTK can be selected depending on the number of samples and the budget available. PMID:26401655

Inter-laboratory comparison study on measuring semi-volatile organic chemicals in standards and air samples.

PubMed

Su, Yushan; Hung, Hayley

2010-11-01

Measurements of semi-volatile organic chemicals (SVOCs) were compared among 21 laboratories from 7 countries through the analysis of standards, a blind sample, an air extract, and an atmospheric dust sample. Measurement accuracy strongly depended on analytes, laboratories, and types of standards and samples. Intra-laboratory precision was generally good with relative standard deviations (RSDs) of triplicate injections <10% and with median differences of duplicate samples between 2.1 and 22%. Inter-laboratory variability, measured by RSDs of all measurements, was in the range of 2.8-58% in analyzing standards, and 6.9-190% in analyzing blind sample and air extract. Inter-laboratory precision was poorer when samples were subject to cleanup processes, or when SVOCs were quantified at low concentrations. In general, inter-laboratory differences up to a factor of 2 can be expected to analyze atmospheric SVOCs. When comparing air measurements from different laboratories, caution should be exercised if the data variability is less than the inter-laboratory differences. 2010. Published by Elsevier Ltd. All rights reserved.

Multi-laboratory validation study of multilocus variable-number tandem repeat analysis (MLVA) for Salmonella enterica serovar Enteritidis, 2015.

PubMed

Peters, Tansy; Bertrand, Sophie; Björkman, Jonas T; Brandal, Lin T; Brown, Derek J; Erdõsi, Tímea; Heck, Max; Ibrahem, Salha; Johansson, Karin; Kornschober, Christian; Kotila, Saara M; Le Hello, Simon; Lienemann, Taru; Mattheus, Wesley; Nielsen, Eva Møller; Ragimbeau, Catherine; Rumore, Jillian; Sabol, Ashley; Torpdahl, Mia; Trees, Eija; Tuohy, Alma; de Pinna, Elizabeth

2017-03-02

Multilocus variable-number tandem repeat analysis (MLVA) is a rapid and reproducible typing method that is an important tool for investigation, as well as detection, of national and multinational outbreaks of a range of food-borne pathogens. Salmonella enterica serovar Enteritidis is the most common Salmonella serovar associated with human salmonellosis in the European Union/European Economic Area and North America. Fourteen laboratories from 13 countries in Europe and North America participated in a validation study for MLVA of S. Enteritidis targeting five loci. Following normalisation of fragment sizes using a set of reference strains, a blinded set of 24 strains with known allele sizes was analysed by each participant. The S. Enteritidis 5-loci MLVA protocol was shown to produce internationally comparable results as more than 90% of the participants reported less than 5% discrepant MLVA profiles. All 14 participating laboratories performed well, even those where experience with this typing method was limited. The raw fragment length data were consistent throughout, and the inter-laboratory validation helped to standardise the conversion of raw data to repeat numbers with at least two countries updating their internal procedures. However, differences in assigned MLVA profiles remain between well-established protocols and should be taken into account when exchanging data. This article is copyright of The Authors, 2017.

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

PubMed

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.

A Reference Method for Measuring Emissions of SVOCs in ...

EPA Pesticide Factsheets

Semivolatile organic compounds (SVOCs) are indoor air pollutants that may may have significant adverse effects on human health, and emission of SVOCs from building materials and consumer products is of growing concern. Few chamber studies have been conducted due to the challenges associated with SVOC analysis and the lack of validation procedures. Thus there is an urgent need for a reliable and accurate chamber test method to verify the performance of these measurements. A reference method employing a specially-designed chamber and experimental protocol has been developed and is undergoing extensive evaluation. A pilot interlaboratory study (ILS) has been conducted with five laboratories performing chamber tests under identical conditions. Results showed inter-laboratory variations at 25% for SVOC emission rates, with greater agreement observed between intra-laboratory measurements for most of the participating laboratories. The measured concentration profiles also compared reasonably well to the mechanistic model, demonstrating the feasibility of the proposed reference method to independently assess laboratory performance and validate SVOC emission tests. There is an urgent need for improved understanding of the measurement uncertainties associated with SVOC emissions testing. The creation of specially-designed chambers and well-characterized materials serves as a critical prerequisite for improving the procedure used to measure SVOCs emitted from indoor

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

PubMed

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-perfect inter-laboratory agreement among conventional morphological assessment (CMA), EmbryoScope™ and Primo Vision™, except for false divisions, vacuoles and asymmetry (users of all methods) and multinucleation (users of Primo Vision™), where the degree of agreement was lower. The inter-laboratory agreement on embryo classification according to the ASEBIR criteria was moderate-substantial (Gwet 0.41-0.80) for the laboratories using CMA and EmbryoScope™, and fair-moderate (Gwet 0.21-0.60) for those using Primo Vision™. The inter-laboratory agreement for clinical decision was moderate (Gwet 0.41-0.60) on day 5 for CMA users and almost perfect (Gwet 0.81-1) for time-lapse users. In conclusion, time-lapse technology does not improve inter-laboratory agreement on embryo classification or the analysis of each morphological variable. Moreover, depending on the time-lapse platform used, inter-laboratory agreement may be lower than that obtained by CMA. However, inter-laboratory agreement on clinical decisions is improved with the use of time lapse, regardless of the platform used.

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

PubMed Central

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-perfect inter-laboratory agreement among conventional morphological assessment (CMA), EmbryoScope™ and Primo Vision™, except for false divisions, vacuoles and asymmetry (users of all methods) and multinucleation (users of Primo Vision™), where the degree of agreement was lower. The inter-laboratory agreement on embryo classification according to the ASEBIR criteria was moderate-substantial (Gwet 0.41–0.80) for the laboratories using CMA and EmbryoScope™, and fair-moderate (Gwet 0.21–0.60) for those using Primo Vision™. The inter-laboratory agreement for clinical decision was moderate (Gwet 0.41–0.60) on day 5 for CMA users and almost perfect (Gwet 0.81–1) for time-lapse users. In conclusion, time-lapse technology does not improve inter-laboratory agreement on embryo classification or the analysis of each morphological variable. Moreover, depending on the time-lapse platform used, inter-laboratory agreement may be lower than that obtained by CMA. However, inter-laboratory agreement on clinical decisions is improved with the use of time lapse, regardless of the platform used. PMID:28841654

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

PubMed Central

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 stability is required. PMID:19490644

Evaluation of platelet adhesion and activation on polymers: Round-robin study to assess inter-center variability.

PubMed

Braune, S; Sperling, C; Maitz, M F; Steinseifer, U; Clauser, J; Hiebl, B; Krajewski, S; Wendel, H P; Jung, F

2017-10-01

The regulatory agencies provide recommendations rather than protocols or standard operation procedures for the hemocompatibility evaluation of novel materials e.g. for cardiovascular applications. Thus, there is a lack of specifications with regard to test setups and procedures. As a consequence, laboratories worldwide perform in vitro assays under substantially different test conditions, so that inter-laboratory and inter-study comparisons are impossible. Here, we report about a prospective, randomized and double-blind multicenter trial which demonstrates that standardization of in vitro test protocols allows a reproducible assessment of platelet adhesion and activation from fresh human platelet rich plasma as possible indicators of the thrombogenicity of cardiovascular implants. Standardization of the reported static in vitro setup resulted in a laboratory independent scoring of the following materials: poly(dimethyl siloxane) (PDMS), poly(ethylene terephthalate) (PET) and poly(tetrafluoro ethylene) (PTFE). The results of this in vitro study provide evidence that inter-laboratory and inter-study comparisons can be achieved for the evaluation of the adhesion and activation of platelets on blood-contacting biomaterials by stringent standardization of test protocols. Copyright © 2017 Elsevier B.V. All rights reserved.

Pilot Inter-Laboratory Studies for Evaluating Weathering-Induced Release of Carbon Nanotubes from Solid Matrices

EPA Science Inventory

Nanomaterials are increasingly being used in polymer composites to enhance the properties of these materials. Here we present results of a pilot inter-laboratory study to simulate the effects of weathering on the potential release of multiwalled carbon nanotubes (MWCNT) from thei...

Catch-up validation study of an in vitro skin irritation test method based on an open source reconstructed epidermis (phase II).

PubMed

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.

Optimisation of an analytical method and results from the inter-laboratory comparison of the migration of regulated substances from food packaging into the new mandatory European Union simulant for dry foodstuffs.

PubMed

Jakubowska, Natalia; Beldì, Giorgia; Peychès Bach, Aurélie; Simoneau, Catherine

2014-01-01

This paper presents the outcome of the development, optimisation and validation at European Union level of an analytical method for using poly(2,6-diphenyl phenylene oxide--PPPO), which is stipulated in Regulation (EU) No. 10/2011, as food simulant E for testing specific migration from plastics into dry foodstuffs. Two methods for fortifying respectively PPPO and a low-density polyethylene (LDPE) film with surrogate substances that are relevant to food contact were developed. A protocol for cleaning the PPPO and an efficient analytical method were developed for the quantification of butylhydroxytoluene (BHT), benzophenone (BP), diisobutylphthalate (DiBP), bis(2-ethylhexyl) adipate (DEHA) and 1,2-cyclohexanedicarboxylic acid, diisononyl ester (DINCH) from PPPO. A protocol for a migration test from plastics using small migration cells was also developed. The method was validated by an inter-laboratory comparison (ILC) with 16 national reference laboratories for food contact materials in the European Union. This allowed for the first time data to be obtained on the precision and laboratory performance of both migration and quantification. The results showed that the validation ILC was successful even when taking into account the complexity of the exercise. The results showed that the method performance was 7-9% repeatability standard deviation (rSD) for most substances (regardless of concentration), with 12% rSD for the high level of BHT and for DiBP at very low levels. The reproducibility standard deviation results for the 16 European Union laboratories were in the range of 20-30% for the quantification from PPPO (for the three levels of concentrations of the five substances) and 15-40% from migration experiments from the fortified plastic at 60°C for 10 days and subsequent quantification. Considering the lack of data previously available in the literature, this work has demonstrated that the validation of a method is possible both for migration from a film and for quantification into a corresponding simulant for specific migration.

Pre-trial inter-laboratory analytical validation of the FOCUS4 personalised therapy trial.

PubMed

Richman, Susan D; Adams, Richard; Quirke, Phil; Butler, Rachel; Hemmings, Gemma; Chambers, Phil; Roberts, Helen; James, Michelle D; Wozniak, Sue; Bathia, Riya; Pugh, Cheryl; Maughan, Timothy; Jasani, Bharat

2016-01-01

Molecular characterisation of tumours is increasing personalisation of cancer therapy, tailored to an individual and their cancer. FOCUS4 is a molecularly stratified clinical trial for patients with advanced colorectal cancer. During an initial 16-week period of standard first-line chemotherapy, tumour tissue will undergo several molecular assays, with the results used for cohort allocation, then randomisation. Laboratories in Leeds and Cardiff will perform the molecular testing. The results of a rigorous pre-trial inter-laboratory analytical validation are presented and discussed. Wales Cancer Bank supplied FFPE tumour blocks from 97 mCRC patients with consent for use in further research. Both laboratories processed each sample according to an agreed definitive FOCUS4 laboratory protocol, reporting results directly to the MRC Trial Management Group for independent cross-referencing. Pyrosequencing analysis of mutation status at KRAS codons12/13/61/146, NRAS codons12/13/61, BRAF codon600 and PIK3CA codons542/545/546/1047, generated highly concordant results. Two samples gave discrepant results; in one a PIK3CA mutation was detected only in Leeds, and in the other, a PIK3CA mutation was only detected in Cardiff. pTEN and mismatch repair (MMR) protein expression was assessed by immunohistochemistry (IHC) resulting in 6/97 discordant results for pTEN and 5/388 for MMR, resolved upon joint review. Tumour heterogeneity was likely responsible for pyrosequencing discrepancies. The presence of signet-ring cells, necrosis, mucin, edge-effects and over-counterstaining influenced IHC discrepancies. Pre-trial assay analytical validation is essential to ensure appropriate selection of patients for targeted therapies. This is feasible for both mutation testing and immunohistochemical assays and must be built into the workup of such trials. ISRCTN90061564. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Inter-laboratory validation of an inexpensive streamlined method to measure inorganic arsenic in rice grain.

PubMed

Chaney, Rufus L; Green, Carrie E; Lehotay, Steven J

2018-05-04

With the establishment by CODEX of a 200 ng/g limit of inorganic arsenic (iAs) in polished rice grain, more analyses of iAs will be necessary to ensure compliance in regulatory and trade applications, to assess quality control in commercial rice production, and to conduct research involving iAs in rice crops. Although analytical methods using high-performance liquid chromatography-inductively coupled plasma-mass spectrometry (HPLC-ICP-MS) have been demonstrated for full speciation of As, this expensive and time-consuming approach is excessive when regulations are based only on iAs. We report a streamlined sample preparation and analysis of iAs in powdered rice based on heated extraction with 0.28 M HNO 3 followed by hydride generation (HG) under control of acidity and other simple conditions. Analysis of iAs is then conducted using flow-injection HG and inexpensive ICP-atomic emission spectroscopy (AES) or other detection means. A key innovation compared with previous methods was to increase the acidity of the reagent solution with 4 M HCl (prior to reduction of As 5+ to As 3+ ), which minimized interferences from dimethylarsinic acid. An inter-laboratory method validation was conducted among 12 laboratories worldwide in the analysis of six shared blind duplicates and a NIST Standard Reference Material involving different types of rice and iAs levels. Also, four laboratories used the standard HPLC-ICP-MS method to analyze the samples. The results between the methods were not significantly different, and the Horwitz ratio averaged 0.52 for the new method, which meets official method validation criteria. Thus, the simpler, more versatile, and less expensive method may be used by laboratories for several purposes to accurately determine iAs in rice grain. Graphical abstract Comparison of iAs results from new and FDA methods.

Method and platform standardization in MRM-based quantitative plasma proteomics.

PubMed

Percy, Andrew J; Chambers, Andrew G; Yang, Juncong; Jackson, Angela M; Domanski, Dominik; Burkhart, Julia; Sickmann, Albert; Borchers, Christoph H

2013-12-16

There exists a growing demand in the proteomics community to standardize experimental methods and liquid chromatography-mass spectrometry (LC/MS) platforms in order to enable the acquisition of more precise and accurate quantitative data. This necessity is heightened by the evolving trend of verifying and validating candidate disease biomarkers in complex biofluids, such as blood plasma, through targeted multiple reaction monitoring (MRM)-based approaches with stable isotope-labeled standards (SIS). Considering the lack of performance standards for quantitative plasma proteomics, we previously developed two reference kits to evaluate the MRM with SIS peptide approach using undepleted and non-enriched human plasma. The first kit tests the effectiveness of the LC/MRM-MS platform (kit #1), while the second evaluates the performance of an entire analytical workflow (kit #2). Here, these kits have been refined for practical use and then evaluated through intra- and inter-laboratory testing on 6 common LC/MS platforms. For an identical panel of 22 plasma proteins, similar concentrations were determined, regardless of the kit, instrument platform, and laboratory of analysis. These results demonstrate the value of the kit and reinforce the utility of standardized methods and protocols. The proteomics community needs standardized experimental protocols and quality control methods in order to improve the reproducibility of MS-based quantitative data. This need is heightened by the evolving trend for MRM-based validation of proposed disease biomarkers in complex biofluids such as blood plasma. We have developed two kits to assist in the inter- and intra-laboratory quality control of MRM experiments: the first kit tests the effectiveness of the LC/MRM-MS platform (kit #1), while the second evaluates the performance of an entire analytical workflow (kit #2). In this paper, we report the use of these kits in intra- and inter-laboratory testing on 6 common LC/MS platforms. This article is part of a Special Issue entitled: Standardization and Quality Control in Proteomics. © 2013.

A new iPhone application for measuring active craniocervical range of motion in patients with non-specific neck pain: a reliability and validity study.

PubMed

Pourahmadi, Mohammad Reza; Bagheri, Rasool; Taghipour, Morteza; Takamjani, Ismail Ebrahimi; Sarrafzadeh, Javad; Mohseni-Bandpei, Mohammad Ali

2018-03-01

Measurement of cervical spine range of motion (ROM) is often considered to be an essential component of cervical spine physiotherapy assessment. This study aimed to investigate the reliability and validity of an iPhone application (app) (Goniometer Pro) for measuring active craniocervical ROM (ACCROM) in patients with non-specific neck pain. A cross-sectional study was conducted at the musculoskeletal biomechanics laboratory located at Iran University of Medical Sciences. Forty non-specific neck pain patients participated in this study. The outcome measure was the ACCROM, including flexion, extension, lateral flexion, and rotation. Following the recruitment process, ACCROM was measured using a universal goniometer (UG) and iPhone 7 app. Two blinded examiners each used the UG and iPhone to measure ACCROM in the following sequences: flexion, extension, lateral flexion, and rotation. The second (2 hours later) and third (48 hours later) sessions were carried out in the same manner as the first session. Intraclass correlation coefficient (ICC) models were used to determine the intra-rater and inter-rater reliability. The Pearson correlation coefficients were used to establish concurrent validity of the iPhone app. Minimum detectable change at the 95% confidence level (MDC 95 ) was also computed. Good intra-rater and inter-rater reliability was demonstrated for the goniometer with ICC values of ≥0.66 and ≥0.70 and the iPhone app with ICC values of ≥0.62 and ≥0.65, respectively. The MDC 95 ranged from 2.21° to 12.50° for the intra-rater analysis and from 3.40° to 12.61° for the inter-rater analysis. The concurrent validity between the two instruments was high, with r valuesof ≥0.63. The magnitude of the differences between the UG and iPhone app values (effect sizes) was small, with Cohen d values of ≤0.17. The iPhone app possesses good reliability and high validity. It seems that this app can be used for measuring ACCROM. Copyright © 2017 Elsevier Inc. All rights reserved.

Reproducibility of telomere length assessment: an international collaborative study.

PubMed

Martin-Ruiz, Carmen M; Baird, Duncan; Roger, Laureline; Boukamp, Petra; Krunic, Damir; Cawthon, Richard; Dokter, Martin M; van der Harst, Pim; Bekaert, Sofie; de Meyer, Tim; Roos, Goran; Svenson, Ulrika; Codd, Veryan; Samani, Nilesh J; McGlynn, Liane; Shiels, Paul G; Pooley, Karen A; Dunning, Alison M; Cooper, Rachel; Wong, Andrew; Kingston, Andrew; von Zglinicki, Thomas

2015-10-01

Telomere length is a putative biomarker of ageing, morbidity and mortality. Its application is hampered by lack of widely applicable reference ranges and uncertainty regarding the present limits of measurement reproducibility within and between laboratories. We instigated an international collaborative study of telomere length assessment: 10 different laboratories, employing 3 different techniques [Southern blotting, single telomere length analysis (STELA) and real-time quantitative PCR (qPCR)] performed two rounds of fully blinded measurements on 10 human DNA samples per round to enable unbiased assessment of intra- and inter-batch variation between laboratories and techniques. Absolute results from different laboratories differed widely and could thus not be compared directly, but rankings of relative telomere lengths were highly correlated (correlation coefficients of 0.63-0.99). Intra-technique correlations were similar for Southern blotting and qPCR and were stronger than inter-technique ones. However, inter-laboratory coefficients of variation (CVs) averaged about 10% for Southern blotting and STELA and more than 20% for qPCR. This difference was compensated for by a higher dynamic range for the qPCR method as shown by equal variance after z-scoring. Technical variation per laboratory, measured as median of intra- and inter-batch CVs, ranged from 1.4% to 9.5%, with differences between laboratories only marginally significant (P = 0.06). Gel-based and PCR-based techniques were not different in accuracy. Intra- and inter-laboratory technical variation severely limits the usefulness of data pooling and excludes sharing of reference ranges between laboratories. We propose to establish a common set of physical telomere length standards to improve comparability of telomere length estimates between laboratories. © The Author 2014. Published by Oxford University Press on behalf of the International Epidemiological Association.

A Profilometry-Based Dentifrice Abrasion Method for V8 Brushing Machines Part III: Multi-Laboratory Validation Testing of RDA-PE.

PubMed

Schneiderman, Eva; Colón, Ellen L; White, Donald J; Schemehorn, Bruce; Ganovsky, Tara; Haider, Amir; Garcia-Godoy, Franklin; Morrow, Brian R; Srimaneepong, Viritpon; Chumprasert, Sujin

2017-09-01

We have previously reported on progress toward the refinement of profilometry-based abrasivity testing of dentifrices using a V8 brushing machine and tactile or optical measurement of dentin wear. The general application of this technique may be advanced by demonstration of successful inter-laboratory confirmation of the method. The objective of this study was to explore the capability of different laboratories in the assessment of dentifrice abrasivity using a profilometry-based evaluation technique developed in our Mason laboratories. In addition, we wanted to assess the interchangeability of human and bovine specimens. Participating laboratories were instructed in methods associated with Radioactive Dentin Abrasivity-Profilometry Equivalent (RDA-PE) evaluation, including site visits to discuss critical elements of specimen preparation, masking, profilometry scanning, and procedures. Laboratories were likewise instructed on the requirement for demonstration of proportional linearity as a key condition for validation of the technique. Laboratories were provided with four test dentifrices, blinded for testing, with a broad range of abrasivity. In each laboratory, a calibration curve was developed for varying V8 brushing strokes (0, 4,000, and 10,000 strokes) with the ISO abrasive standard. Proportional linearity was determined as the ratio of standard abrasion mean depths created with 4,000 and 10,000 strokes (2.5 fold differences). Criteria for successful calibration within the method (established in our Mason laboratory) was set at proportional linearity = 2.5 ± 0.3. RDA-PE was compared to Radiotracer RDA for the four test dentifrices, with the latter obtained by averages from three independent Radiotracer RDA sites. Individual laboratories and their results were compared by 1) proportional linearity and 2) acquired RDA-PE values for test pastes. Five sites participated in the study. One site did not pass proportional linearity objectives. Data for this site are not reported at the request of the researchers. Three of the remaining four sites reported herein tested human dentin and all three met proportional linearity objectives for human dentin. Three of four sites participated in testing bovine dentin and all three met the proportional linearity objectives for bovine dentin. RDA-PE values for test dentifrices were similar between sites. All four sites that met proportional linearity requirement successfully identified the dentifrice formulated above the industry standard 250 RDA (as RDA-PE). The profilometry method showed at least as good reproducibility and differentiation as Radiotracer assessments. It was demonstrated that human and bovine specimens could be used interchangeably. The standardized RDA-PE method was reproduced in multiple laboratories in this inter-laboratory study. Evidence supports that this method is a suitable technique for ISO method 11609 Annex B.

Inter-laboratory validation of an inexpensive streamlined method to measure inorganic arsenic in rice grain

USDA-ARS?s Scientific Manuscript database

With the establishment by CODEX of a 200 ng/g limit of inorganic arsenic (iAs) in polished rice grain, more analyses of iAs will be necessary to ensure compliance in regulatory and trade applications, to assess quality control in commercial rice production, and to conduct research involving iAs in r...

Validity Of The Nintendo Wii Balance Board To Assess Weight Bearing Asymmetry During Sit-To-Stand And Return-To-Sit Task

PubMed Central

Abujaber, Sumayeh; Gillispie, Gregory; Marmon, Adam; Zeni, Joseph

2015-01-01

Weight bearing asymmetry is common in patients with unilateral lower limb musculoskeletal pathologies. The Nintendo Wii Balance Board (WBB) has been suggested as a low-cost and widely-available tool to measure weight bearing asymmetry in a clinical environment; however no study has evaluated the validity of this tool during dynamic tasks. Therefore, the purpose of this study was to determine the concurrent validity of force measurements acquired from the WBB as compared to laboratory force plates. Thirty-five individuals before, or within 1 year of total joint arthroplasty performed a sit-to-stand and return-to-sit task in two conditions. First, subjects performed the task with both feet placed on a single WBB. Second, the task was repeated with each foot placed on an individual laboratory force plate. Peak vertical ground reaction force (VGRF) under each foot and the inter-limb symmetry ratio were calculated. Validity was examined using Intraclass Correlation Coefficients (ICC), regression analysis, 95% limits of agreement and Bland-Altman plots. Force plates and the WBB exhibited excellent agreement for all outcome measurements (ICC =0.83–0.99). Bland-Altman plots showed no obvious relationship between the difference and the mean for the peak VGRF, but there was a consistent trend in which VGRF on the unaffected side was lower and VGRF on the affected side was higher when using the WBB. However, these consistent biases can be adjusted for by utilizing regression equations that estimate the force plate values based on the WBB force. The WBB may serve as a valid, suitable, and low-cost alternative to expensive, laboratory force plates for measuring weight bearing asymmetry in clinical settings. PMID:25715680

Validity of the Nintendo Wii Balance Board to assess weight bearing asymmetry during sit-to-stand and return-to-sit task.

PubMed

Abujaber, Sumayeh; Gillispie, Gregory; Marmon, Adam; Zeni, Joseph

2015-02-01

Weight bearing asymmetry is common in patients with unilateral lower limb musculoskeletal pathologies. The Nintendo Wii Balance Board (WBB) has been suggested as a low-cost and widely-available tool to measure weight bearing asymmetry in a clinical environment; however no study has evaluated the validity of this tool during dynamic tasks. Therefore, the purpose of this study was to determine the concurrent validity of force measurements acquired from the WBB as compared to laboratory force plates. Thirty-five individuals before, or within 1 year of total joint arthroplasty performed a sit-to-stand and return-to-sit task in two conditions. First, subjects performed the task with both feet placed on a single WBB. Second, the task was repeated with each foot placed on an individual laboratory force plate. Peak vertical ground reaction force (VGRF) under each foot and the inter-limb symmetry ratio were calculated. Validity was examined using Intraclass Correlation Coefficients (ICC), regression analysis, 95% limits of agreement and Bland-Altman plots. Force plates and the WBB exhibited excellent agreement for all outcome measurements (ICC=0.83-0.99). Bland-Altman plots showed no obvious relationship between the difference and the mean for the peak VGRF, but there was a consistent trend in which VGRF on the unaffected side was lower and VGRF on the affected side was higher when using the WBB. However, these consistent biases can be adjusted for by utilizing regression equations that estimate the force plate values based on the WBB force. The WBB may serve as a valid, suitable, and low-cost alternative to expensive, laboratory force plates for measuring weight bearing asymmetry in clinical settings. Copyright © 2015 Elsevier B.V. All rights reserved.

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

PubMed

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.

Validation of numerical codes for impact and explosion cratering: Impacts on strengthless and metal targets

NASA Astrophysics Data System (ADS)

Pierazzo, E.; Artemieva, N.; Asphaug, E.; Baldwin, E. C.; Cazamias, J.; Coker, R.; Collins, G. S.; Crawford, D. A.; Davison, T.; Elbeshausen, D.; Holsapple, K. A.; Housen, K. R.; Korycansky, D. G.; Wünnemann, K.

2008-12-01

Over the last few decades, rapid improvement of computer capabilities has allowed impact cratering to be modeled with increasing complexity and realism, and has paved the way for a new era of numerical modeling of the impact process, including full, three-dimensional (3D) simulations. When properly benchmarked and validated against observation, computer models offer a powerful tool for understanding the mechanics of impact crater formation. This work presents results from the first phase of a project to benchmark and validate shock codes. A variety of 2D and 3D codes were used in this study, from commercial products like AUTODYN, to codes developed within the scientific community like SOVA, SPH, ZEUS-MP, iSALE, and codes developed at U.S. National Laboratories like CTH, SAGE/RAGE, and ALE3D. Benchmark calculations of shock wave propagation in aluminum-on-aluminum impacts were performed to examine the agreement between codes for simple idealized problems. The benchmark simulations show that variability in code results is to be expected due to differences in the underlying solution algorithm of each code, artificial stability parameters, spatial and temporal resolution, and material models. Overall, the inter-code variability in peak shock pressure as a function of distance is around 10 to 20%. In general, if the impactor is resolved by at least 20 cells across its radius, the underestimation of peak shock pressure due to spatial resolution is less than 10%. In addition to the benchmark tests, three validation tests were performed to examine the ability of the codes to reproduce the time evolution of crater radius and depth observed in vertical laboratory impacts in water and two well-characterized aluminum alloys. Results from these calculations are in good agreement with experiments. There appears to be a general tendency of shock physics codes to underestimate the radius of the forming crater. Overall, the discrepancy between the model and experiment results is between 10 and 20%, similar to the inter-code variability.

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

PubMed

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

2006-11-03

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

Informed palliative care in nursing homes through the interRAI Palliative Care instrument: a study protocol based on the Medical Research Council framework.

PubMed

Hermans, Kirsten; Spruytte, Nele; Cohen, Joachim; Van Audenhove, Chantal; Declercq, Anja

2014-12-05

Nursing homes are important locations for palliative care. Through comprehensive geriatric assessments (CGAs), evaluations can be made of palliative care needs of nursing home residents. The interRAI Palliative Care instrument (interRAI PC) is a CGA that evaluates diverse palliative care needs of adults in all healthcare settings. The evaluation results in Client Assessment Protocols (CAPs: indications of problems that need addressing) and Scales (e.g. Palliative Index for Mortality (PIM)) which can be used to design, evaluate and adjust care plans. This study aims to examine the effect of using the interRAI PC on the quality of palliative care in nursing homes. Additionally, it aims to evaluate the feasibility and validity of the interRAI PC. This study covers phases 0, I and II of the Medical Research Council (MRC) framework for designing and evaluating complex interventions, with a longitudinal, quasi-experimental pretest-posttest design and with mixed methods of evaluation. In phase 0, a systematic literature search is conducted. In phase I, the interRAI PC is adapted for use in Belgium and implemented on the BelRAI-website and a practical training is developed. In phase II, the intervention is tested in fifteen nursing homes. Participating nursing homes fill out the interRAI PC during one year for all residents receiving palliative care. Using a pretest-posttest design with quasi-random assignment to the intervention or control group, the effect of the interRAI PC on the quality of palliative care is evaluated with the Palliative care Outcome Scale (POS). Psychometric analysis is conducted to evaluate the predictive validity of the PIM and the convergent validity of the CAP 'Mood' of the interRAI PC. Qualitative data regarding the usability and face validity of the instrument are collected through focus groups, interviews and field notes. This is the first study to evaluate the validity and effect of the interRAI PC in nursing homes, following a methodology based on the MRC framework. This approach improves the study design and implementation and will contribute to a higher generalizability of results. The final result will be a psychometrically evaluated CGA for nursing home residents receiving palliative care. ClinicalTrials.gov NCT02281032. Registered October 30th, 2014.

Inter-laboratory trial of a standardized sediment contact test with the aquatic plant Myriophyllum aquaticum (ISO 16191).

PubMed

Feiler, Ute; Ratte, Monika; Arts, Gertie; Bazin, Christine; Brauer, Frank; Casado, Carmen; Dören, Laszlo; Eklund, Britta; Gilberg, Daniel; Grote, Matthias; Gonsior, Guido; Hafner, Christoph; Kopf, Willi; Lemnitzer, Bernd; Liedtke, Anja; Matthias, Uwe; Okos, Ewa; Pandard, Pascal; Scheerbaum, Dirk; Schmitt-Jansen, Mechthild; Stewart, Kathleen; Teodorovic, Ivana; Wenzel, Andrea; Pluta, Hans-Jürgen

2014-03-01

A whole-sediment toxicity test with Myriophyllum aquaticum has been developed by the German Federal Institute of Hydrology and standardized within the International Organization for Standardization (ISO; ISO 16191). An international ring-test was performed to evaluate the precision of the test method. Four sediments (artificial, natural) were tested. Test duration was 10 d, and test endpoint was inhibition of growth rate (r) based on fresh weight data. Eighteen of 21 laboratories met the validity criterion of r ≥ 0.09 d(-1) in the control. Results from 4 tests that did not conform to test-performance criteria were excluded from statistical evaluation. The inter-laboratory variability of growth rates (20.6%-25.0%) and inhibition (26.6%-39.9%) was comparable with the variability of other standardized bioassays. The mean test-internal variability of the controls was low (7% [control], 9.7% [solvent control]), yielding a high discriminatory power of the given test design (median minimum detectable differences [MDD] 13% to 15%). To ensure these MDDs, an additional validity criterion of CV ≤ 15% of the growth rate in the controls was recommended. As a positive control, 90 mg 3,5-dichlorophenol/kg sediment dry mass was tested. The range of the expected growth inhibition was proposed to be 35 ± 15%. The ring test results demonstrated the reliability of the ISO 16191 toxicity test and its suitability as a tool to assess the toxicity of sediment and dredged material. © 2013 SETAC.

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

PubMed

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

2015-12-02

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.

Dating of fossil human teeth and shells from Toca do Enoque site at Serra das Confusões National Park, Brazil.

PubMed

Kinoshita, Angela; Sullasi, Henry L; Asfora, Viviane K; Azevedo, Renata L; Guzzo, Pedro; Guidon, Niede; Figueiredo, Ana Maria G; Khoury, Helen; Pessis, Anne-Marie; Baffa, Oswaldo

2016-06-07

This work reports the dating of a fossil human tooth and shell found at the archaeological site Toca do Enoque located in Serra das Confusões National Park (Piauí, Brazil). Many prehistoric paintings have been found at this site. An archaeological excavation unearthed three sepulchers with human skeletons and some shells. Two Brazilian laboratories, in Ribeirão Preto (USP) and Recife (UFPE), independently performed Electron Spin Resonance (ESR) measurements to date the tooth and the shell and obtain the equivalent dose received by each sample. The laboratories determined similar ages for the tooth and the shell (~4.8 kyBP). The results agreed with C-14 dating of the shell and other samples (charcoal) collected in the same sepulcher. Therefore, this work provides a valid inter-comparison of results by two independent ESR-dating laboratories and between two dating methods; i.e., C-14 and ESR, showing the validity of ESR dating for this range of ages.

A multi-segment foot model based on anatomically registered technical coordinate systems: method repeatability in pediatric feet.

PubMed

Saraswat, Prabhav; MacWilliams, Bruce A; Davis, Roy B

2012-04-01

Several multi-segment foot models to measure the motion of intrinsic joints of the foot have been reported. Use of these models in clinical decision making is limited due to lack of rigorous validation including inter-clinician, and inter-lab variability measures. A model with thoroughly quantified variability may significantly improve the confidence in the results of such foot models. This study proposes a new clinical foot model with the underlying strategy of using separate anatomic and technical marker configurations and coordinate systems. Anatomical landmark and coordinate system identification is determined during a static subject calibration. Technical markers are located at optimal sites for dynamic motion tracking. The model is comprised of the tibia and three foot segments (hindfoot, forefoot and hallux) and inter-segmental joint angles are computed in three planes. Data collection was carried out on pediatric subjects at two sites (Site 1: n=10 subjects by two clinicians and Site 2: five subjects by one clinician). A plaster mold method was used to quantify static intra-clinician and inter-clinician marker placement variability by allowing direct comparisons of marker data between sessions for each subject. Intra-clinician and inter-clinician joint angle variability were less than 4°. For dynamic walking kinematics, intra-clinician, inter-clinician and inter-laboratory variability were less than 6° for the ankle and forefoot, but slightly higher for the hallux. Inter-trial variability accounted for 2-4° of the total dynamic variability. Results indicate the proposed foot model reduces the effects of marker placement variability on computed foot kinematics during walking compared to similar measures in previous models. Copyright © 2011 Elsevier B.V. All rights reserved.

NREL Spectrum of Clean Energy Innovation (Brochure)

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

Not Available

2011-09-01

This brochure describes the NREL Spectrum of Clean Energy Innovation, which includes analysis and decision support, fundamental science, market relevant research, systems integration, testing and validation, commercialization and deployment. Through deep technical expertise and an unmatched breadth of capabilities, the National Renewable Energy Laboratory (NREL) leads an integrated approach across the spectrum of renewable energy innovation. From scientific discovery to accelerating market deployment, NREL works in partnership with private industry to drive the transformation of our nation's energy systems. NREL integrates the entire spectrum of innovation, including fundamental science, market relevant research, systems integration, testing and validation, commercialization, and deployment.more » Our world-class analysis and decision support informs every point on the spectrum. The innovation process at NREL is inter-dependent and iterative. Many scientific breakthroughs begin in our own laboratories, but new ideas and technologies may come to NREL at any point along the innovation spectrum to be validated and refined for commercial use.« less

Validity and Reliability of a Digital Inclinometer to Assess Knee Joint Position Sense in an Open Kinetic Chain.

PubMed

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.

Organizational readiness for implementing change: a psychometric assessment of a new measure.

PubMed

Shea, Christopher M; Jacobs, Sara R; Esserman, Denise A; Bruce, Kerry; Weiner, Bryan J

2014-01-10

Organizational readiness for change in healthcare settings is an important factor in successful implementation of new policies, programs, and practices. However, research on the topic is hindered by the absence of a brief, reliable, and valid measure. Until such a measure is developed, we cannot advance scientific knowledge about readiness or provide evidence-based guidance to organizational leaders about how to increase readiness. This article presents results of a psychometric assessment of a new measure called Organizational Readiness for Implementing Change (ORIC), which we developed based on Weiner's theory of organizational readiness for change. We conducted four studies to assess the psychometric properties of ORIC. In study one, we assessed the content adequacy of the new measure using quantitative methods. In study two, we examined the measure's factor structure and reliability in a laboratory simulation. In study three, we assessed the reliability and validity of an organization-level measure of readiness based on aggregated individual-level data from study two. In study four, we conducted a small field study utilizing the same analytic methods as in study three. Content adequacy assessment indicated that the items developed to measure change commitment and change efficacy reflected the theoretical content of these two facets of organizational readiness and distinguished the facets from hypothesized determinants of readiness. Exploratory and confirmatory factor analysis in the lab and field studies revealed two correlated factors, as expected, with good model fit and high item loadings. Reliability analysis in the lab and field studies showed high inter-item consistency for the resulting individual-level scales for change commitment and change efficacy. Inter-rater reliability and inter-rater agreement statistics supported the aggregation of individual level readiness perceptions to the organizational level of analysis. This article provides evidence in support of the ORIC measure. We believe this measure will enable testing of theories about determinants and consequences of organizational readiness and, ultimately, assist healthcare leaders to reduce the number of health organization change efforts that do not achieve desired benefits. Although ORIC shows promise, further assessment is needed to test for convergent, discriminant, and predictive validity.

Organizational readiness for implementing change: a psychometric assessment of a new measure

PubMed Central

2014-01-01

Background Organizational readiness for change in healthcare settings is an important factor in successful implementation of new policies, programs, and practices. However, research on the topic is hindered by the absence of a brief, reliable, and valid measure. Until such a measure is developed, we cannot advance scientific knowledge about readiness or provide evidence-based guidance to organizational leaders about how to increase readiness. This article presents results of a psychometric assessment of a new measure called Organizational Readiness for Implementing Change (ORIC), which we developed based on Weiner’s theory of organizational readiness for change. Methods We conducted four studies to assess the psychometric properties of ORIC. In study one, we assessed the content adequacy of the new measure using quantitative methods. In study two, we examined the measure’s factor structure and reliability in a laboratory simulation. In study three, we assessed the reliability and validity of an organization-level measure of readiness based on aggregated individual-level data from study two. In study four, we conducted a small field study utilizing the same analytic methods as in study three. Results Content adequacy assessment indicated that the items developed to measure change commitment and change efficacy reflected the theoretical content of these two facets of organizational readiness and distinguished the facets from hypothesized determinants of readiness. Exploratory and confirmatory factor analysis in the lab and field studies revealed two correlated factors, as expected, with good model fit and high item loadings. Reliability analysis in the lab and field studies showed high inter-item consistency for the resulting individual-level scales for change commitment and change efficacy. Inter-rater reliability and inter-rater agreement statistics supported the aggregation of individual level readiness perceptions to the organizational level of analysis. Conclusions This article provides evidence in support of the ORIC measure. We believe this measure will enable testing of theories about determinants and consequences of organizational readiness and, ultimately, assist healthcare leaders to reduce the number of health organization change efforts that do not achieve desired benefits. Although ORIC shows promise, further assessment is needed to test for convergent, discriminant, and predictive validity. PMID:24410955

International round-robin inter-comparison of dye-sensitized and crystalline silicon solar cells

NASA Astrophysics Data System (ADS)

Chen, Chia-Yuan; Ahn, Seung Kyu; Aoki, Dasiuke; Kokubo, Junichi; Yoon, Kyung Hoon; Saito, Hidenori; Lee, Kyung Sik; Magaino, Shinichi; Takagi, Katsuhiko; Lin, Ling-Chuan; Lee, Kun-Mu; Wu, Chun-Guey; Zhou, Hong; Igari, Sanekazu

2017-02-01

An international round-robin inter-comparison of the spectral responsivity (SR) and current-voltage (I-V) characteristics for dye-sensitized solar cells (DSCs) and crystalline silicon solar cells is reported for the first time. The crystalline silicon cells with various spectral responsivities were also calibrated by AIST to validate this round-robin activity. On the basis of the remarkable consistency in Pmax (within ±1.4% among participants) and Isc (within ±1.2% compared to the primary calibration of AIST) of the silicon specimens, the discrepancy in the SR and photovoltaic parameters of five DSCs among three national laboratories can be verified and diagnosed. Recommendations about sample packages, SR and I-V measurement methods as well as the inter-comparison protocol for improving the performance characterization of the mesoscopic DSCs are presented according to the consolidated data and the experience of the participants.

A Follow-Up of the Multicenter Collaborative Study on HIV-1 Drug Resistance and Tropism Testing Using 454 Ultra Deep Pyrosequencing

PubMed Central

St. John, Elizabeth P.; Simen, Birgitte B.; Turenchalk, Gregory S.; Braverman, Michael S.; Abbate, Isabella; Aerssens, Jeroen; Bouchez, Olivier; Gabriel, Christian; Izopet, Jacques; Meixenberger, Karolin; Di Giallonardo, Francesca; Schlapbach, Ralph; Paredes, Roger; Sakwa, James; Schmitz-Agheguian, Gudrun G.; Thielen, Alexander; Victor, Martin

2016-01-01

Background Ultra deep sequencing is of increasing use not only in research but also in diagnostics. For implementation of ultra deep sequencing assays in clinical laboratories for routine diagnostics, intra- and inter-laboratory testing are of the utmost importance. Methods A multicenter study was conducted to validate an updated assay design for 454 Life Sciences’ GS FLX Titanium system targeting protease/reverse transcriptase (RTP) and env (V3) regions to identify HIV-1 drug-resistance mutations and determine co-receptor use with high sensitivity. The study included 30 HIV-1 subtype B and 6 subtype non-B samples with viral titers (VT) of 3,940–447,400 copies/mL, two dilution series (52,129–1,340 and 25,130–734 copies/mL), and triplicate samples. Amplicons spanning PR codons 10–99, RT codons 1–251 and the entire V3 region were generated using barcoded primers. Analysis was performed using the GS Amplicon Variant Analyzer and geno2pheno for tropism. For comparison, population sequencing was performed using the ViroSeq HIV-1 genotyping system. Results The median sequencing depth across the 11 sites was 1,829 reads per position for RTP (IQR 592–3,488) and 2,410 for V3 (IQR 786–3,695). 10 preselected drug resistant variants were measured across sites and showed high inter-laboratory correlation across all sites with data (P<0.001). The triplicate samples of a plasmid mixture confirmed the high inter-laboratory consistency (mean% ± stdev: 4.6 ±0.5, 4.8 ±0.4, 4.9 ±0.3) and revealed good intra-laboratory consistency (mean% range ± stdev range: 4.2–5.2 ± 0.04–0.65). In the two dilutions series, no variants >20% were missed, variants 2–10% were detected at most sites (even at low VT), and variants 1–2% were detected by some sites. All mutations detected by population sequencing were also detected by UDS. Conclusions This assay design results in an accurate and reproducible approach to analyze HIV-1 mutant spectra, even at variant frequencies well below those routinely detectable by population sequencing. PMID:26756901

Braden scale (ALB) for assessing pressure ulcer risk in hospital patients: A validity and reliability study.

PubMed

Chen, Hong-Lin; Cao, Ying-Juan; Zhang, Wei; Wang, Jing; Huai, Bao-Sha

2017-02-01

The inter-rater reliability of Braden Scale is not so good. We modified the Braden(ALB) scale by defining nutrition subscale based on serum albumin, then assessed it's the validity and reliability in hospital patients. We designed a retrospective study for validity analysis, and a prospective study for reliability analysis. Receiver operating curve (ROC) and area under the curve (AUC) were used to evaluate the predictive validity. Intra-class correlation coefficient (ICC) was used to investigate the inter-rater reliability. Two thousand five hundred twenty-five patients were included for validity analysis, 76 patients (3.0%) developed pressure ulcer. Positive correlation was found between serum albumin and nutrition score in Braden scale (Spearman's coefficient 0.2203, P<0.0001). The AUCs for Braden scale and Braden(ALB) scale predicting pressure ulcer risk were 0.813 (95% CI 0.797-0.828; P<0.0001), and 0.859 (95% CI 0.845-0.872; P<0.0001), respectively. The Braden(ALB) scale was even more valid than the Braden scale (z=1.860, P=0.0628). In different age subgroups, the Braden(ALB) scale seems also more valid than the original Braden scale, but no statistically significant differences were found (P>0.05). The inter-rater reliability study showed the ICC-value for nutrition increased 45.9%, and increased 4.3% for total score. The Braden(ALB) scale has similar validity compared with the original Braden scale for in hospital patients. However, the inter-rater reliability was significantly increased. Copyright © 2016 Elsevier Inc. All rights reserved.

Forensic analysis of explosives using isotope ratio mass spectrometry (IRMS)--part 2: forensic inter-laboratory trial: bulk carbon and nitrogen stable isotopes in a range of chemical compounds (Australia and New Zealand).

PubMed

Benson, Sarah J; Lennard, Christopher J; Maynard, Philip; Hill, David M; Andrew, Anita S; Neal, Ken; Stuart-Williams, Hilary; Hope, Janet; Walker, G Stewart; Roux, Claude

2010-01-01

Comparability of data over time and between laboratories is a key issue for consideration in the development of global databases, and more broadly for quality assurance in general. One mechanism that can be utilized for evaluating traceability is an inter-laboratory trial. This paper addresses an inter-laboratory trial conducted across a number of Australian and New Zealand isotope ratio mass spectrometry (IRMS) laboratories. The main objective of this trial was to determine whether IRMS laboratories in these countries would record comparable values for the distributed samples. Four carbon containing and four nitrogen containing compounds were distributed to seven laboratories in Australia and one in New Zealand. The laboratories were requested to analyze the samples using their standard procedures. The data from each laboratory was evaluated collectively using International Standard ISO 13528 (Statistical methods for use in proficiency testing by inter-laboratory comparisons). "Warning signals" were raised against one participant in this trial. "Action signals" requiring corrective action were raised against four participants. These participants reviewed the data and possible sources for the discrepancies. This inter-laboratory trial was successful in providing an initial snapshot of the potential for traceability between the participating laboratories. The statistical methods described in this article could be used as a model for others needing to evaluate stable isotope results derived from multiple laboratories, e.g., inter-laboratory trials/proficiency testing. Ongoing trials will be conducted to improve traceability across the Australian and New Zealand IRMS community.

[Radium in pharmacy! Second Part: Pharmaceutical used of radium during the inter-war years].

PubMed

Raynal, Cécile; Lefebvre, Thierry

2012-05-01

This article presents the raise of patent medicines composed of radium during the inter-war years. Because of a lack of regulation, this production was getting anarchistic. It is studied throught many documents from pharmaceutical laboratories wich are kept by the Curie' museum. Those laboratories would obtain certificates from Curie Institute, to show them in their advertisements.

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

PubMed

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.

[Inter-rater reliability and validity of the OPD-CA axes structure and conflict].

PubMed

Benecke, Cord; Bock, Astrid; Wieser, Elke; Tschiesner, Reinhard; Lochmann, Martha; Küspert, Felicia; Schorn, Robert; Viertler, Bernhard; Steinmayr-Gensluckner, Maria

2011-01-01

The manual of the Operationalized Psychodynamic Diagnostics in childhood and adolescence (OPD-CA) is an instrument meanwhile widespread in the clinical practice to assess psychodynamic dimensions. Publications of inter-rater agreement and validity are still outstanding. This study assessed the interrater-reliability and validity for the axis structure and the axis conflict. 60 adolescents between 14 and 17 years, with and without psychic disorders, were diagnosed with the Operationalized Psychodynamic Diagnostics in childhood and adolescence (Arbeitskreis OPD-KJ, 2007) and SCID-II-interviews and questionnaires. A partial sample of 36 OPD-CA-interviews was the data basis for the assessment of inter-rater agreement. Calculations of validity for axis structure and axis conflict were made with the whole sample. Inter-rater agreement for the axis structure and the axis conflict showed good to very good weighted Kappa coefficients among the trained raters. Validity of the axis structure showed good results. The Operationalized Psychodynamic Diagnostics in childhood and adolescence (OPD-CA) allows a reliable diagnostic of axis structure and axis conflict, if the ratings are done on the basis of semistructured videotaped interviews by trained raters. The axis structure shows validity, while the results concerning the validity of the axis conflict remain unclear.

Book Order/Inter Library Loan Documentation

DTIC Science & Technology

1992-04-20

BORROWER: SCOTT DAVID OFFICE: DPRA ARTICLE TITLE: LABORATORY STUDY OF THE RELEASE OF PESTICIDES AND PCB MATERIALS TO THE WATER COLUMN DURING... ARTICLE...TECHNICAL INFORMATION CENTER PAGE NO. INTER LIBARY LOAN REPORT BORROWER: SCOTT DAVID OFFICE: DPRA ARTICLE TITLE: LABORATORY STUDY OF THE RELEASE OF...FROM A USER THAT REQUIRES FEWER THAN 15 MINUTES OF A STAFF MEMBER’S TIME TO ANSWER. MAY INCLUDE A RTIC CATALOG SEARCH, VERIFICATION OF INFORMATION IN A

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

PubMed Central

2011-01-01

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. PMID:21477356

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

PubMed

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.

Bias from two analytical laboratories involved in a long-term air monitoring program measuring organic pollutants in the Arctic: a quality assurance/quality control assessment.

PubMed

Su, Yushan; Hung, Hayley; Stern, Gary; Sverko, Ed; Lao, Randy; Barresi, Enzo; Rosenberg, Bruno; Fellin, Phil; Li, Henrik; Xiao, Hang

2011-11-01

Initiated in 1992, air monitoring of organic pollutants in the Canadian Arctic provided spatial and temporal trends in support of Canada's participation in the Stockholm Convention of Persistent Organic Pollutants. The specific analytical laboratory charged with this task was changed in 2002 while field sampling protocols remained unchanged. Three rounds of intensive comparison studies were conducted in 2004, 2005, and 2008 to assess data comparability between the two laboratories. Analysis was compared for organochlorine pesticides (OCPs), polychlorinated biphenyls (PCBs) and polycyclic aromatic hydrocarbons (PAHs) in standards, blind samples of mixed standards and extracts of real air samples. Good measurement accuracy was achieved for both laboratories when standards were analyzed. Variation of measurement accuracy over time was found for some OCPs and PCBs in standards on a random and non-systematic manner. Relatively low accuracy in analyzing blind samples was likely related to the process of sample purification. Inter-laboratory measurement differences for standards (<30%) and samples (<70%) were generally less than or comparable to those reported in a previous inter-laboratory study with 21 participating laboratories. Regression analysis showed inconsistent data comparability between the two laboratories during the initial stages of the study. These inter-laboratory differences can complicate abilities to discern long-term trends of pollutants in a given sampling site. It is advisable to maintain long-term measurements with minimal changes in sample analysis.

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

NASA Astrophysics Data System (ADS)

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.

Reproducibility of up-flow column percolation tests for contaminated soils

PubMed Central

Naka, Angelica; Sakanakura, Hirofumi; Kurosawa, Akihiko; Inui, Toru; Takeo, Miyuki; Inoba, Seiji; Watanabe, Yasutaka; Fujikawa, Takuro; Miura, Toshihiko; Miyaguchi, Shinji; Nakajou, Kunihide; Sumikura, Mitsuhiro; Ito, Kenichi; Tamoto, Shuichi; Tatsuhara, Takeshi; Chida, Tomoyuki; Hirata, Kei; Ohori, Ken; Someya, Masayuki; Katoh, Masahiko; Umino, Madoka; Negishi, Masanori; Ito, Keijiro; Kojima, Junichi; Ogawa, Shohei

2017-01-01

Up-flow column percolation tests are used at laboratory scale to assess the leaching behavior of hazardous substance from contaminated soils in a specific condition as a function of time. Monitoring the quality of these test results inter or within laboratory is crucial, especially if used for Environment-related legal policy or for routine testing purposes. We tested three different sandy loam type soils (Soils I, II and III) to determine the reproducibility (variability inter laboratory) of test results and to evaluate the difference in the test results within laboratory. Up-flow column percolation tests were performed following the procedure described in the ISO/TS 21268–3. This procedure consists of percolating solution (calcium chloride 1 mM) from bottom to top at a flow rate of 12 mL/h through softly compacted soil contained in a column of 5 cm diameter and 30 ± 5 cm height. Eluate samples were collected at liquid-to-solid ratio of 0.1, 0.2, 0.5, 1, 2, 5 and 10 L/kg and analyzed for quantification of the target elements (Cu, As, Se, Cl, Ca, F, Mg, DOC and B in this research). For Soil I, 17 institutions in Japan joined this validation test. The up-flow column experiments were conducted in duplicate, after 48 h of equilibration time and at a flow rate of 12 mL/h. Column percolation test results from Soils II and III were used to evaluate the difference in test results from the experiments conducted in duplicate in a single laboratory, after 16 h of equilibration time and at a flow rate of 36 mL/h. Overall results showed good reproducibility (expressed in terms of the coefficient of variation, CV, calculated by dividing the standard deviation by the mean), as the CV was lower than 30% in more than 90% of the test results associated with Soil I. Moreover, low variability (expressed in terms of difference between the two test results divided by the mean) was observed in the test results related to Soils II and III, with a variability lower than 30% in more than 88% of the cases for Soil II and in more than 96% of the cases for Soil III. We also discussed the possible factors that affect the reproducibility and variability in the test results from the up-flow column percolation tests. The low variability inter and within laboratory obtained in this research indicates that the ISO/TS 21268–3 can be successfully upgraded to a fully validated ISO standard. PMID:28582458

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

PubMed

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.

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

PubMed

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.

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

PubMed

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.

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

PubMed

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 effects (p=0.008) in renal transplant recipients receiving tacrolimus and mycophenolic acid compared to the cyclosporine regimen. This finding demonstrated construct validity. Intra-class correlation was 0.81 (95% confidence interval: 0.65-0.90) and Kappa statistic of 0.68 ± 0.25 for all 18 adverse effects and verified substantial inter-rater reliability. This immunosuppressive adverse effects scoring system in stable renal transplant recipients was evaluated and substantiated face, content and construct validity with inter-rater reliability. The scoring system may facilitate prospective, standardized clinical monitoring of immunosuppressive adverse drug effects in stable renal transplant recipients and improve medication adherence.

Global Inter-Laboratory Fecal Source Identification Methods Comparison Study

EPA Science Inventory

Source tracking is key to identifying sources of fecal contamination for remediation as well as risk assessment. Previous intra- and inter-lab studies have investigated the performance of human and cow-associated source tracking markers, as well as library-dependent fecal source ...

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

PubMed

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.

Validation of biomarkers of food intake-critical assessment of candidate biomarkers.

PubMed

Dragsted, L O; Gao, Q; Scalbert, A; Vergères, G; Kolehmainen, M; Manach, C; Brennan, L; Afman, L A; Wishart, D S; Andres Lacueva, C; Garcia-Aloy, M; Verhagen, H; Feskens, E J M; Praticò, G

2018-01-01

Biomarkers of food intake (BFIs) are a promising tool for limiting misclassification in nutrition research where more subjective dietary assessment instruments are used. They may also be used to assess compliance to dietary guidelines or to a dietary intervention. Biomarkers therefore hold promise for direct and objective measurement of food intake. However, the number of comprehensively validated biomarkers of food intake is limited to just a few. Many new candidate biomarkers emerge from metabolic profiling studies and from advances in food chemistry. Furthermore, candidate food intake biomarkers may also be identified based on extensive literature reviews such as described in the guidelines for Biomarker of Food Intake Reviews (BFIRev). To systematically and critically assess the validity of candidate biomarkers of food intake, it is necessary to outline and streamline an optimal and reproducible validation process. A consensus-based procedure was used to provide and evaluate a set of the most important criteria for systematic validation of BFIs. As a result, a validation procedure was developed including eight criteria, plausibility, dose-response, time-response, robustness, reliability, stability, analytical performance, and inter-laboratory reproducibility. The validation has a dual purpose: (1) to estimate the current level of validation of candidate biomarkers of food intake based on an objective and systematic approach and (2) to pinpoint which additional studies are needed to provide full validation of each candidate biomarker of food intake. This position paper on biomarker of food intake validation outlines the second step of the BFIRev procedure but may also be used as such for validation of new candidate biomarkers identified, e.g., in food metabolomic studies.

Anatomical landmark position--can we trust what we see? Results from an online reliability and validity study of osteopaths.

PubMed

Pattyn, Elise; Rajendran, Dévan

2014-04-01

Practitioners traditionally use observation to classify the position of patients' anatomical landmarks. This information may contribute to diagnosis and patient management. To calculate a) Inter-rater reliability of categorising the sagittal plane position of four anatomical landmarks (lateral femoral epicondyle, greater trochanter, mastoid process and acromion) on side-view photographs (with landmarks highlighted and not-highlighted) of anonymised subjects; b) Intra-rater reliability; c) Individual landmark inter-rater reliability; d) Validity against a 'gold standard' photograph. Online inter- and intra-rater reliability study. Photographed subjects: convenience sample of asymptomatic students; raters: randomly selected UK registered osteopaths. 40 photographs of 30 subjects were used, a priori clinically acceptable reliability was ≥0.4. Inter-rater arm: 20 photographs without landmark highlights plus 10 with highlights; Intra-rater arm: 10 duplicate photographs (non-highlighted landmarks). Validity arm: highlighted landmark scores versus 'gold standard' photographs with vertical line. Research ethics approval obtained. Osteopaths (n = 48) categorised landmark position relative to imagined vertical-line; Gwet's Agreement Coefficient 1 (AC1) calculated and chance-corrected coefficient benchmarked against Landis and Koch's scale; Validity calculation used Kendall's tau-B. Inter-rater reliability was 'fair' (AC1 = 0.342; 95% confidence interval (CI) = 0.279-0.404) for non-highlighted landmarks and 'moderate' (AC1 = 0.700; 95% CI = 0.596-0.805) for highlighted landmarks. Intra-rater reliability was 'fair' (AC1 = 0.522); range was 'poor' (AC1 = 0.160) to 'substantial' (AC1 = 0.896). No differences were found between individual landmarks. Validity was 'low' (TB = 0.327; p = 0.104). Both inter- and intra-rater reliability was 'fair' but below clinically acceptable levels, validity was 'low'. Together these results challenge the clinical practice of using observation to categorise anterio-posterior landmark position. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

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

Weaver, Robert P.; Miller, Paul; Howley, Kirsten

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, includingmore » 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.« less

Sources of Variability in Chlorophyll Analysis by Fluorometry and High-Performance Liquid Chromatography in a SIMBIOS Inter-Calibration Exercise

NASA Technical Reports Server (NTRS)

VanHeukelem, Laurie; Thomas, Crystal S.; Gilbert, Patricia M.; Fargion, Giulietta S. (Editor); McClain, Charles R. (Editor)

2002-01-01

The purpose of this technical report is to provide current documentation of the Sensor Intercomparison and Merger for Biological and Interdisciplinary Oceanic Studies (SIMBIOS) Project activities, NASA Research Announcement (NRA) research status, satellite data processing, data product validation, and field calibration. This documentation is necessary to ensure that critical information is related to the scientific community and NASA management. This critical information includes the technical difficulties and challenges of validating and combining ocean color data from an array of independent satellite systems to form consistent and accurate global bio-optical time series products. This technical report is not meant as a substitute for scientific literature. Instead, it will provide a ready and responsive vehicle for the multitude of technical reports issued by an operational project. This particular document focus on the variability in chlorophyll pigment measurements resulting from differences in methodologies and laboratories conducting the pigment analysis.

Validation of the 3D Skin Comet assay using full thickness skin models: Transferability and reproducibility.

PubMed

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 continue by testing an additional 22 chemicals. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Measuring the effect of inter-study variability on estimating prediction error.

PubMed

Ma, Shuyi; Sung, Jaeyun; Magis, Andrew T; Wang, Yuliang; Geman, Donald; Price, Nathan D

2014-01-01

The biomarker discovery field is replete with molecular signatures that have not translated into the clinic despite ostensibly promising performance in predicting disease phenotypes. One widely cited reason is lack of classification consistency, largely due to failure to maintain performance from study to study. This failure is widely attributed to variability in data collected for the same phenotype among disparate studies, due to technical factors unrelated to phenotypes (e.g., laboratory settings resulting in "batch-effects") and non-phenotype-associated biological variation in the underlying populations. These sources of variability persist in new data collection technologies. Here we quantify the impact of these combined "study-effects" on a disease signature's predictive performance by comparing two types of validation methods: ordinary randomized cross-validation (RCV), which extracts random subsets of samples for testing, and inter-study validation (ISV), which excludes an entire study for testing. Whereas RCV hardwires an assumption of training and testing on identically distributed data, this key property is lost in ISV, yielding systematic decreases in performance estimates relative to RCV. Measuring the RCV-ISV difference as a function of number of studies quantifies influence of study-effects on performance. As a case study, we gathered publicly available gene expression data from 1,470 microarray samples of 6 lung phenotypes from 26 independent experimental studies and 769 RNA-seq samples of 2 lung phenotypes from 4 independent studies. We find that the RCV-ISV performance discrepancy is greater in phenotypes with few studies, and that the ISV performance converges toward RCV performance as data from additional studies are incorporated into classification. We show that by examining how fast ISV performance approaches RCV as the number of studies is increased, one can estimate when "sufficient" diversity has been achieved for learning a molecular signature likely to translate without significant loss of accuracy to new clinical settings.

An inter-laboratory comparison study of the ANSI/BIFMA standard test method M7.1 for furniture

EPA Science Inventory

Five laboratories using five different test chambers participated in the study to quantify within- and between-laboratory variability in the measurement of emissions of volatile organic compounds (VOCs) from new commercial furniture test items following ANSI/BIFMA M7.1. Test item...

Technical aspects and inter-laboratory variability in native peptide profiling: the CE-MS experience.

PubMed

Mischak, Harald; Vlahou, Antonia; Ioannidis, John P A

2013-04-01

Mass spectrometry platforms have attracted a lot of interest in the last 2 decades as profiling tools for native peptides and proteins with clinical potential. However, limitations associated with reproducibility and analytical robustness, especially pronounced with the initial SELDI systems, hindered the application of such platforms in biomarker qualification and clinical implementation. The scope of this article is to give a short overview on data available on performance and on analytical robustness of the different platforms for peptide profiling. Using the CE-MS platform as a paradigm, data on analytical performance are described including reproducibility (short-term and intermediate repeatability), stability, interference, quantification capabilities (limits of detection), and inter-laboratory variability. We discuss these issues by using as an example our experience with the development of a 273-peptide marker for chronic kidney disease. Finally, we discuss pros and cons and means for improvement and emphasize the need to test in terms of comparative clinical performance and impact, different platforms that pass reasonably well analytical validation tests. Copyright © 2012 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Inter-laboratory consistency and variability in the buccal micronucleus cytome assay depends on biomarker scored and laboratory experience: results from the HUMNxl international inter-laboratory scoring exercise.

PubMed

Bolognesi, Claudia; Knasmueller, Siegfried; Nersesyan, Armen; Roggieri, Paola; Ceppi, Marcello; Bruzzone, Marco; Blaszczyk, Ewa; Mielzynska-Svach, Danuta; Milic, Mirta; Bonassi, Stefano; Benedetti, Danieli; Da Silva, Juliana; Toledo, Raphael; Salvadori, Daisy Maria Fávero; Groot de Restrepo, Helena; Filipic, Metka; Hercog, Klara; Aktas, Ayça; Burgaz, Sema; Kundi, Michael; Grummt, Tamara; Thomas, Philip; Hor, Maryam; Escudero-Fung, Maria; Holland, Nina; Fenech, Michael

2017-03-01

The buccal micronucleus cytome (BMNcyt) assay in uncultured exfoliated epithelial cells from oral mucosa is widely applied in biomonitoring human exposures to genotoxic agents and is also proposed as a suitable test for prescreening and follow-up of precancerous oral lesions. The main limitation of the assay is the large variability observed in the baseline values of micronuclei (MNi) and other nuclear anomalies mainly related to different scoring criteria. The aim of this international collaborative study, involving laboratories with different level of experience, was to evaluate the inter- and intra-laboratory variations in the BMNcyt parameters, using recently implemented guidelines, in scoring cells from the same pooled samples obtained from healthy subjects (control group) and from cancer patients undergoing radiotherapy (treated group). The results indicate that all laboratories correctly discriminated samples from the two groups by a significant increase of micronucleus (MN) and nuclear bud (NBUD) frequencies and differentiated binucleated (BN) cells, associated with the exposure to ionizing radiation. The experience of the laboratories was shown to play an important role in the identification of the different cell types and nuclear anomalies. MN frequency in differentiated mononucleated (MONO) and BN cells showed the greatest consistency among the laboratories and low variability was also detected in the frequencies of MONO and BN cells. A larger variability was observed in classifying the different cell types, indicating the subjectivity in the interpretation of some of the scoring criteria while reproducibility of the results between scoring sessions was very good. An inter-laboratory calibration exercise is strongly recommended before starting studies with BMNcyt assay involving multiple research centers. © The Author 2016. Published by Oxford University Press on behalf of the UK Environmental Mutagen Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Validation of a single-platform method for hematopoietic CD34+ stem cells enumeration according to accreditation procedure.

PubMed

Massin, Frédéric; Huili, Cai; Decot, Véronique; Stoltz, Jean-François; Bensoussan, Danièle; Latger-Cannard, Véronique

2015-01-01

Stem cells for autologous and allogenic transplantation are obtained from several sources including bone marrow, peripheral blood or cord blood. Accurate enumeration of viable CD34+ hematopoietic stem cells (HSC) is routinely used in clinical settings, especially to monitor progenitor cell mobilization and apheresis. The number of viable CD34+ HSC has also been shown to be the most critical factor in haematopoietic engraftment. The International Society for Cellular Therapy actually recommends the use of single-platform flow cytometry system using 7-AAD as a viability dye. In a way to move routine analysis from a BD FACSCaliburTM instrument to a BD FACSCantoTM II, according to ISO 15189 standard guidelines, we define laboratory performance data of the BDTM Stem Cell Enumeration (SCE) kit on a CE-IVD system including a BD FACSCanto II flow cytometer and the BD FACSCantoTM Clinical Software. InterQCTM software, a real time internet laboratory QC management system developed by VitroTM and distributed by Becton DickinsonTM, was also tested to monitor daily QC data, to define the internal laboratory statistics and to compare them to external laboratories. Precision was evaluated with BDTM Stem Cell Control (high and low) results and the InterQC software, an internet laboratory QC management system by Vitro. This last one drew Levey-Jennings curves and generated numeral statistical parameters allowing detection of potential changes in the system performances as well as interlaboratory comparisons. Repeatability, linearity and lower limits of detection were obtained with routine samples from different origins. Agreement evaluation between BD FACSCanto II system versus BD FACSCalibur system was tested on fresh peripheral blood, freeze-thawed apheresis, fresh bone marrow and fresh cord blood samples. Instrument's measure and staining repeatability clearly evidenced acceptable variability on the different samples tested. Intra- and inter-laboratory CV in CD34+ cell absolute count are consistent and reproducible. Linearity analysis, established between 2 and 329 cells/μl showed a linear relation between expected counts and measured counts (R2=0.97). Linear regression and Bland-Altman representations showed an excellent correlation on samples from different sources between the two systems and allowed the transfer of routine analysis from BD FACSCalibur to BD FACSCanto II. The BD SCE kit provides an accurate measure of the CD34 HSC, and can be used in daily routine to optimize the enumeration of hematopoietic CD34+ stem cells by flow cytometry. Moreover, the InterQC system seems to be a very useful tool for laboratory daily quality monitoring and thus for accreditation.

Urinary biomarkers of smokers’ exposure to tobacco smoke constituents in tobacco products assessment: a fit for purpose approach

PubMed Central

Gregg, Evan O.; Minet, Emmanuel

2013-01-01

There are established guidelines for bioanalytical assay validation and qualification of biomarkers. In this review, they were applied to a panel of urinary biomarkers of tobacco smoke exposure as part of a “fit for purpose” approach to the assessment of smoke constituents exposure in groups of tobacco product smokers. Clinical studies have allowed the identification of a group of tobacco exposure biomarkers demonstrating a good doseresponse relationship whilst others such as dihydroxybutyl mercapturic acid and 2-carboxy-1-methylethylmercapturic acid – did not reproducibly discriminate smokers and non-smokers. Furthermore, there are currently no agreed common reference standards to measure absolute concentrations and few inter-laboratory trials have been performed to establish consensus values for interim standards. Thus, we also discuss in this review additional requirements for the generation of robust data on urinary biomarkers, including toxicant metabolism and disposition, method validation and qualification for use in tobacco products comparison studies. PMID:23902266

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

NASA Astrophysics Data System (ADS)

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.

Inter-rater reliability for movement pattern analysis (MPA): measuring patterning of behaviors versus discrete behavior counts as indicators of decision-making style

PubMed Central

Connors, Brenda L.; Rende, Richard; Colton, Timothy J.

2014-01-01

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 = 0.89). 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 patterning versus discrete behavioral counts 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. PMID:24999336

Inter-rater reliability for movement pattern analysis (MPA): measuring patterning of behaviors versus discrete behavior counts as indicators of decision-making style.

PubMed

Connors, Brenda L; Rende, Richard; Colton, Timothy J

2014-01-01

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 = 0.89). 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 patterning versus discrete behavioral counts 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.

Single-laboratory validation of a GC/MS method for the determination of 27 polycyclic aromatic hydrocarbons (PAHs) in oils and fats.

PubMed

Rose, M; White, S; Macarthur, R; Petch, R G; Holland, J; Damant, A P

2007-06-01

A protocol for the measurement of 27 polycyclic aromatic hydrocarbons (PAHs) in vegetable oils by GC/MS has undergone single-laboratory validation. PAHs were measured in three oils (olive pomace, sunflower and coconut oil). Five samples of each oil (one unfortified, and four fortified at concentrations between 2 and 50 microg kg(-1)) were analysed in replicate (four times in separate runs). Two samples (one unfortified and one fortified at 2 microg kg(-1)) of five oils (virgin olive oil, grapeseed oil, toasted sesame oil, olive margarine and palm oil) were also analysed. The validation included an assessment of measurement bias from the results of 120 measurements of a certified reference material (coconut oil BCR CRM458 certified for six PAHs). The method is capable of reliably detecting 26 out of 27 PAHs, at concentration <2 microg kg(-1) which is the European Union maximum limit for benzo[a]pyrene, in vegetable oils, olive pomace oil, sunflower oil and coconut oil. Quantitative results were obtained that are fit for purpose for concentrations from <2 to 50 microg kg(-1) for 24 out of 27 PAHs in olive pomace oil, sunflower oil and coconut oil. The reliable detection of 2 microg kg(-1) of PAHs in five additional oils (virgin olive oil, grapeseed oil, toasted sesame oil, olive margarine and palm oil) has been demonstrated. The method failed to produce fit-for-purpose results for the measurement of dibenzo[a,h]pyrene, anthanthrene and cyclopenta[c,d]pyrene. The reason for the failure was the large variation in results. The likely cause was the lack of availability of (13)C isotope internal standards for these PAHs at the time of the study. The protocol has been shown to be fit-for-purpose and is suitable for formal validation by inter-laboratory collaborative study.

Validity evidence for the Fundamentals of Laparoscopic Surgery (FLS) program as an assessment tool: a systematic review.

PubMed

Zendejas, Benjamin; Ruparel, Raaj K; Cook, David A

2016-02-01

The Fundamentals of Laparoscopic Surgery (FLS) program uses five simulation stations (peg transfer, precision cutting, loop ligation, and suturing with extracorporeal and intracorporeal knot tying) to teach and assess laparoscopic surgery skills. We sought to summarize evidence regarding the validity of scores from the FLS assessment. We systematically searched for studies evaluating the FLS as an assessment tool (last search update February 26, 2013). We classified validity evidence using the currently standard validity framework (content, response process, internal structure, relations with other variables, and consequences). From a pool of 11,628 studies, we identified 23 studies reporting validity evidence for FLS scores. Studies involved residents (n = 19), practicing physicians (n = 17), and medical students (n = 8), in specialties of general (n = 17), gynecologic (n = 4), urologic (n = 1), and veterinary (n = 1) surgery. Evidence was most common in the form of relations with other variables (n = 22, most often expert-novice differences). Only three studies reported internal structure evidence (inter-rater or inter-station reliability), two studies reported content evidence (i.e., derivation of assessment elements), and three studies reported consequences evidence (definition of pass/fail thresholds). Evidence nearly always supported the validity of FLS total scores. However, the loop ligation task lacks discriminatory ability. Validity evidence confirms expected relations with other variables and acceptable inter-rater reliability, but other validity evidence is sparse. Given the high-stakes use of this assessment (required for board eligibility), we suggest that more validity evidence is required, especially to support its content (selection of tasks and scoring rubric) and the consequences (favorable and unfavorable impact) of assessment.

The development of an instrument to match individuals with disabilities and service animals.

PubMed

Zapf, S A; Rough, R B

There has been an increase in the use of service animals assisting persons with disabilities in the past decade. However many of the service dog agencies do not utilize an assessment that is designed to match the person to the animal in the rehabilitation and psycho-social domains. The purpose of this study was to develop the Service Animal Adaptive Intervention Assessment (SAAIA) and to measure the content validity, inter-rater reliability and clinical utility of the assessment. Two subject groups were used. Subject group one had 43 subjects who measured the content validity and clinical utility of the SAAIA Survey. Subject group two had 12 subjects who measured the inter-rater reliability by completing the SAAIA using information obtained through a video-taped client case scenario. Content validity results indicated a good to high percentage of agreement and a fair percentage of agreement for clinical utility. Inter-rater reliability results indicate good to high agreement on six of the eight variables of the SAAIA. However, the Kappa score indicates low inter-rater reliability. Results indicate the SAAIA has good content validity and inter-rater reliability and fair clinical utility based on percent agreement. However, further research is needed on the reliability of the SAAIA.

Evaluation of Cardiac Toxicity Biomarkers in Rats from Different Laboratories

PubMed Central

Kim, Kyuri; Chini, Naseem; Fairchild, David G.; Engle, Steven K.; Reagan, William J.; Summers, Sandra D.; Mirsalis, Jon C.

2016-01-01

There is a great need for improved diagnostic and prognostic accuracy of potential cardiac toxicity in drug development. This study reports the evaluation of several commercially available biomarker kits by three institutions (SRI, Eli Lilly and Pfizer) for the discrimination between myocardial degeneration/necrosis and cardiac hypertrophy as well as the assessment of the inter-laboratory and inter-platform variation in results. Serum concentrations of natriuretic peptides (NT-proANP, NT-proBNP), cardiac and skeletal troponins (cTnI, cTnT, sTnI), myosin light chain 3 (Myl3) and fatty acid binding protein 3 (FABP3) were assessed in rats treated with minoxidil and isoproterenol. Minoxidil caused increased heart-to-body weight ratios and prominent elevations in NT-proANP and NT-proBNP concentrations detected at 24 hr postdose without elevation in troponins, Myl3 or FABP3 and with no abnormal histopathological findings. Isoproterenol caused ventricular leukocyte infiltration, myocyte fibrosis and necrosis with increased concentrations of the natriuretic peptides, cardiac troponins and Myl3. These results reinforce the advantages of a multi-marker strategy in elucidating the underlying cause of cardiac insult and detecting myocardial tissue damage at 24 hr post-treatment. The inter-laboratory and inter-platform comparison analyses also showed that the data obtained from different laboratories and platforms are highly correlated and reproducible, making these biomarkers widely applicable in preclinical studies. PMID:27638646

Development and inter-laboratory validation study of an improved new real-time PCR assay with internal control for detection and laboratory diagnosis of African swine fever virus.

PubMed

Tignon, Marylène; Gallardo, Carmina; Iscaro, Carmen; Hutet, Evelyne; Van der Stede, Yves; Kolbasov, Denis; De Mia, Gian Mario; Le Potier, Marie-Frédérique; Bishop, Richard P; Arias, Marisa; Koenen, Frank

2011-12-01

A real-time polymerase chain reaction (PCR) assay for the rapid detection of African swine fever virus (ASFV), multiplexed for simultaneous detection of swine beta-actin as an endogenous control, has been developed and validated by four National Reference Laboratories of the European Union for African swine fever (ASF) including the European Union Reference Laboratory. Primers and a TaqMan(®) probe specific for ASFV were selected from conserved regions of the p72 gene. The limit of detection of the new real-time PCR assay is 5.7-57 copies of the ASFV genome. High accuracy, reproducibility and robustness of the PCR assay (CV ranging from 0.7 to 5.4%) were demonstrated both within and between laboratories using different real-time PCR equipments. The specificity of virus detection was validated using a panel of 44 isolates collected over many years in various geographical locations in Europe, Africa and America, including recent isolates from the Caucasus region, Sardinia, East and West Africa. Compared to the OIE-prescribed conventional and real-time PCR assays, the sensitivity of the new assay with internal control was improved, as demonstrated by testing 281 field samples collected in recent outbreaks and surveillance areas in Europe and Africa (170 samples) together with samples obtained through experimental infections (111 samples). This is particularly evident in the early days following experimental infection and during the course of the disease in pigs sub-clinically infected with strains of low virulence (from 35 up to 70dpi). The specificity of the assay was also confirmed on 150 samples from uninfected pigs and wild boar from ASF-free areas. Measured on the total of 431 tested samples, the positive deviation of the new assay reaches 21% or 26% compared to PCR and real-time PCR methods recommended by OIE. This improved and rigorously validated real-time PCR assay with internal control will provide a rapid, sensitive and reliable molecular tool for ASFV detection in pigs in newly infected areas, control in endemic areas and surveillance in ASF-free areas. Copyright © 2011 Elsevier B.V. All rights reserved.

Immunoassays for the measurement of IGF-II, IGFBP-2 and -3, and ICTP as indirect biomarkers of recombinant human growth hormone misuse in sport. Values in selected population of athletes.

PubMed

Abellan, Rosario; Ventura, Rosa; Palmi, Ilaria; di Carlo, Simonetta; Bacosi, Antonella; Bellver, Montse; Olive, Ramon; Pascual, Jose Antonio; Pacifici, Roberta; Segura, Jordi; Zuccaro, Piergiorgio; Pichini, Simona

2008-11-04

Insulin-like growth factor-II (IGF-II), insulin-like growth factor binding proteins (IGFBPs) -2 and -3 and C-terminal telopeptide of type I collagen (ICTP) have been proposed, among others, as indirect biomarkers of the recombinant human growth hormone misuse in sport. An extended intra- and inter-laboratory validation of commercially available immunoassays for biomarkers detection was performed. ELISA assays for total IGF-II, IGFBP-2 and IGFBP-3 (IGF-II/ELISA1: DSLabs, IGFBP-2/ELISA2: Biosource, and IGFBP-3/ELISA3: BioSource) and an EIA assay for ICTP (ICTP/EIA: Orion Diagnostica) were evaluated. The inter- and intra-laboratory precision values were acceptable for all evaluated assays (maximum imprecision of 30% and 66% were found only for the lowest quality control samples of IGF-II and IGFBP-3). Correct accuracy was obtained for all inter-laboratory immunoassays and for IGFBP-2 intra-laboratory immunoassay. The range of concentrations found in serum samples under investigation was always covered by the calibration curves of the studied immunoassays. However, 11% and 15% of the samples felt below the estimated LOQ for IGF-II and ICTP, respectively, in the zone where lower precision was obtained. Although the majority of evaluated assays showed an overall reliability not always suitable for antidoping control analysis, relatively high concordances between laboratory results were obtained for all assays. Evaluated immunoassays were used to measure serum concentrations of IGF-II, IGFBP-2 and -3 and ICTP in elite athletes of various sport disciplines at different moments of the training season; in recreational athletes at baseline conditions and finally in sedentary individuals. Serum IGF-II was statistically higher both in recreational and elite athletes compared to sedentary individuals. Elite athletes showed lower IGFBP-2 and higher IGFBP-3 concentration with respect to recreational athletes and sedentary people. Among elite athletes, serum IGFBP-3 (synchronized swimming), and ICTP (rhythmic gymnastics) concentrations were sport-dependent. Over the training season, within athlete variability was observed for IGFBP-2 in case of taekwondo and IGFBP-2 and -3 in case of weightlifting. Variations due to those aspects should be taken in careful consideration in the hypothesis of setting reference concentration ranges for doping detection.

Obstructive apnea hypopnea index estimation by analysis of nocturnal snoring signals in adults.

PubMed

Ben-Israel, Nir; Tarasiuk, Ariel; Zigel, Yaniv

2012-09-01

To develop a whole-night snore sounds analysis algorithm enabling estimation of obstructive apnea hypopnea index (AHI(EST)) among adult subjects. Snore sounds were recorded using a directional condenser microphone placed 1 m above the bed. Acoustic features exploring intra-(mel- cepstability, pitch density) and inter-(running variance, apnea phase ratio, inter-event silence) snore properties were extracted and integrated to assess AHI(EST). University-affiliated sleep-wake disorder center and biomedical signal processing laboratory. Ninety subjects (age 53 ± 13 years, BMI 31 ± 5 kg/m(2)) referred for polysomnography (PSG) diagnosis of OSA were prospectively and consecutively recruited. The system was trained and tested on 60 subjects. Validation was blindly performed on the additional 30 consecutive subjects. AHI(EST) correlated with AHI (AHI(PSG); r(2) = 0.81, P < 0.001). Area under the receiver operating characteristic curve of 85% and 92% for thresholds of 10 and 20 events/h, respectively, were obtained for OSA detection. Both Altman-Bland analysis and diagnostic agreement criteria revealed 80% and 83% agreements of AHI(EST) with AHI(PSG), respectively. Acoustic analysis based on intra- and inter-snore properties can differentiate subjects according to AHI. An acoustic-based screening system may address the growing needs for reliable OSA screening tool. Further studies are needed to support these findings.

33 CFR 209.340 - Laboratory investigations and materials testing.

Code of Federal Regulations, 2010 CFR

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...

33 CFR 209.340 - Laboratory investigations and materials testing.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 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...

Validity and reliability of the Diagnostic Adaptive Behaviour Scale.

PubMed

Tassé, M J; Schalock, R L; Balboni, G; Spreat, S; Navas, P

2016-01-01

The Diagnostic Adaptive Behaviour Scale (DABS) is a new standardised adaptive behaviour measure that provides information for evaluating limitations in adaptive behaviour for the purpose of determining a diagnosis of intellectual disability. This article presents validity evidence and reliability data for the DABS. Validity evidence was based on comparing DABS scores with scores obtained on the Vineland Adaptive Behaviour Scale, second edition. The stability of the test scores was measured using a test and retest, and inter-rater reliability was assessed by computing the inter-respondent concordance. The DABS convergent validity coefficients ranged from 0.70 to 0.84, while the test-retest reliability coefficients ranged from 0.78 to 0.95, and the inter-rater concordance as measured by intraclass correlation coefficients ranged from 0.61 to 0.87. All obtained validity and reliability indicators were strong and comparable with the validity and reliability coefficients of the most commonly used adaptive behaviour instruments. These results and the advantages of the DABS for clinician and researcher use are discussed. © 2015 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

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

PubMed

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.

Validity and Reliability of the Clinical Competency Evaluation Instrument for Use among Physiotherapy Students: Pilot study.

PubMed

Muhamad, Zailani; Ramli, Ayiesah; Amat, Salleh

2015-05-01

The aim of this study was to determine the content validity, internal consistency, test-retest reliability and inter-rater reliability of the Clinical Competency Evaluation Instrument (CCEVI) in assessing the clinical performance of physiotherapy students. This study was carried out between June and September 2013 at University Kebangsaan Malaysia (UKM), Kuala Lumpur, Malaysia. A panel of 10 experts were identified to establish content validity by evaluating and rating each of the items used in the CCEVI with regards to their relevance in measuring students' clinical competency. A total of 50 UKM undergraduate physiotherapy students were assessed throughout their clinical placement to determine the construct validity of these items. The instrument's reliability was determined through a cross-sectional study involving a clinical performance assessment of 14 final-year undergraduate physiotherapy students. The content validity index of the entire CCEVI was 0.91, while the proportion of agreement on the content validity indices ranged from 0.83-1.00. The CCEVI construct validity was established with factor loading of ≥0.6, while internal consistency (Cronbach's alpha) overall was 0.97. Test-retest reliability of the CCEVI was confirmed with a Pearson's correlation range of 0.91-0.97 and an intraclass coefficient correlation range of 0.95-0.98. Inter-rater reliability of the CCEVI domains ranged from 0.59 to 0.97 on initial and subsequent assessments. This pilot study confirmed the content validity of the CCEVI. It showed high internal consistency, thereby providing evidence that the CCEVI has moderate to excellent inter-rater reliability. However, additional refinement in the wording of the CCEVI items, particularly in the domains of safety and documentation, is recommended to further improve the validity and reliability of the instrument.

Reliability and criterion validity of two applications of the iPhone™ to measure cervical range of motion in healthy participants

PubMed Central

2013-01-01

Summary of background data Recent smartphones, such as the iPhone, are often equipped with an accelerometer and magnetometer, which, through software applications, can perform various inclinometric functions. Although these applications are intended for recreational use, they have the potential to measure and quantify range of motion. The purpose of this study was to estimate the intra and inter-rater reliability as well as the criterion validity of the clinometer and compass applications of the iPhone in the assessment cervical range of motion in healthy participants. Methods The sample consisted of 28 healthy participants. Two examiners measured cervical range of motion of each participant twice using the iPhone (for the estimation of intra and inter-reliability) and once with the CROM (for the estimation of criterion validity). Estimates of reliability and validity were then established using the intraclass correlation coefficient (ICC). Results We observed a moderate intra-rater reliability for each movement (ICC = 0.65-0.85) but a poor inter-rater reliability (ICC < 0.60). For the criterion validity, the ICCs are moderate (>0.50) to good (>0.65) for movements of flexion, extension, lateral flexions and right rotation, but poor (<0.50) for the movement left rotation. Conclusion We found good intra-rater reliability and lower inter-rater reliability. When compared to the gold standard, these applications showed moderate to good validity. However, before using the iPhone as an outcome measure in clinical settings, studies should be done on patients presenting with cervical problems. PMID:23829201

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

PubMed Central

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. Gait and Posture require improved sensitivity, and Palpation should be interpreted cautiously, in diagnosing feline OA. PMID:26633524

A comparison of the analytical performance of five commercially available assays for neutrophil gelatinase-associated lipocalin using urine.

PubMed

Kift, Rebecca L; Messenger, Michael P; Wind, Tobias C; Hepburn, Sophie; Wilson, Michelle; Thompson, Douglas; Smith, Matthew Welberry; Sturgeon, Catharine; Lewington, Andrew J; Selby, Peter J; Banks, Rosamonde E

2013-05-01

Neutrophil gelatinase-associated lipocalin (NGAL) is a promising biomarker for acute kidney injury that is beginning to be used in clinical practice in addition to research studies. The current study describes an independent validation and comparison of five commercially available NGAL assays, focusing on urine samples. This is an essential step in the translation of this marker to clinical use in terms of allowing valid inter-study comparison and generation of robust results. Two CE (Conformité Européenne)-marked assays, the NGAL Test (BioPorto) on Siemens ADVIA(®) 1800 and the ARCHITECT Urine NGAL assay on i2000SR (Abbott Laboratories), and three research-use-only (RUO) ELISAs (R&D Systems, Hycult and BioPorto) were evaluated. Imprecision, parallelism, recovery, selectivity, limit of quantitation (LOQ), vulnerability to interference and hook effect were assessed and inter-assay agreement was determined using 68 urine samples from patients with various renal diseases and healthy controls. The Abbott and R&D Systems assays demonstrated satisfactory performance for all parameters tested. However for the other three assays evaluated, problems were identified with LOQ (BioPorto/ADVIA(®)), parallelism (BioPorto ELISA) or several parameters (Hycult). Between-method agreement varied with the Hycult assay in particular being markedly different and highlighting issues with standardization and form of NGAL measured. Variability exists between the five NGAL assays in terms of their performance and this should be taken into account when interpreting results from the various clinical or research studies measuring urinary NGAL.

Analysis of 161Tb by radiochemical separation and liquid scintillation counting

DOE PAGES

Jiang, J.; Davies, A.; Arrigo, L.; ...

2015-12-05

The determination of 161Tb activity is problematic due to its very low fission yield, short half-life, and the complication of its gamma spectrum. At AWE, radiochemically purified 161Tb solution was measured on a PerkinElmer 1220 Quantulus TM Liquid Scintillation Spectrometer. Since there was no 161Tb certified standard solution available commercially, the counting efficiency was determined by the CIEMAT/NIST Efficiency Tracing method. The method was validated during a recent inter-laboratory comparison exercise involving the analysis of a uranium sample irradiated with thermal neutrons. Lastly, the measured 161Tb result was in excellent agreement with the result using gamma spectrometry and the resultmore » obtained by Pacific Northwest National Laboratory.« less

Reliability and Validity of the Dutch Physical Activity Questionnaires for Children (PAQ-C) and Adolescents (PAQ-A).

PubMed

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.

Development and validation of a new assessment tool for suturing skills in medical students.

PubMed

Sundhagen, Henriette Pisani; Almeland, Stian Kreken; Hansson, Emma

2018-01-01

In recent years, emphasis has been put on that medical student should demonstrate pre-practice/pre-registration core procedural skills to ensure patient safety. Nonetheless, the formal teaching and training of basic suturing skills to medical students have received relatively little attention and there is no standard for what should be tested and how. The aim of this study was to develop and validate, using scientific methods, a tool for assessment of medical students' suturing skills, measuring both micro- and macrosurgical qualities. A tool was constructed and content, construct, concurrent validity, and inter-rater, inter-item, inter-test reliability were tested. Three groups were included: students with no training in suturing skills, students who have had training, plastic surgery. The results show promising reliability and validity when assessing novice medical students' suturing skills. Further studies are needed on implementation of the instrument. Moreover, how the instrument can be used to give formative feedback, evaluate if a required standard is met and for curriculum development needs further investigation.Level of Evidence: Not ratable.

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

PubMed

Schnakers, Caroline; Majerus, Steve; Giacino, Joseph; Vanhaudenhuyse, Audrey; Bruno, Marie-Aurelie; Boly, Melanie; Moonen, Gustave; Damas, Pierre; Lambermont, Bernard; Lamy, Maurice; Damas, Francois; Ventura, Manfredi; Laureys, Steven

2008-09-01

The aim of the present study was to explore the concurrent validity, inter-rater agreement and diagnostic sensitivity of a French adaptation of the Coma Recovery Scale-Revised (CRS-R) as compared to other coma scales such as the Glasgow Coma Scale (GCS), the Full Outline of UnResponsiveness scale (FOUR) and the Wessex Head Injury Matrix (WHIM). Multi-centric prospective study. To test concurrent validity and diagnostic sensitivity, the four behavioural scales were administered in a randomized order in 77 vegetative and minimally conscious patients. Twenty-four clinicians with different professional backgrounds, levels of expertise and CRS-R experience were recruited to assess inter-rater agreement. Good concurrent validity was obtained between the CRS-R and the three other standardized behavioural scales. Inter-rater reliability for the CRS-R total score and sub-scores was good, indicating that the scale yields reproducible findings across examiners and does not appear to be systematically biased by profession, level of expertise or CRS-R experience. Finally, the CRS-R demonstrated a significantly higher sensitivity to detect MCS patients, as compared to the GCS, the FOUR and the WHIM. The results show that the French version of the CRS-R is a valid and sensitive scale which can be used in severely brain damaged patients by all members of the medical staff.

Descriptive analysis of the verbal behavior of a therapist: a known-group validity analysis of the putative behavioral functions involved in clinical interaction.

PubMed

Virues-Ortega, Javier; Montaño-Fidalgo, Montserrat; Froján-Parga, María Xesús; Calero-Elvira, Ana

2011-12-01

This study analyzes the interobserver agreement and hypothesis-based known-group validity of the Therapist's Verbal Behavior Category System (SISC-INTER). The SISC-INTER is a behavioral observation protocol comprised of a set of verbal categories representing putative behavioral functions of the in-session verbal behavior of a therapist (e.g., discriminative, reinforcing, punishing, and motivational operations). The complete therapeutic process of a clinical case of an individual with marital problems was recorded (10 sessions, 8 hours), and data were arranged in a temporal sequence using 10-min periods. Hypotheses based on the expected performance of the putative behavioral functions portrayed by the SISC-INTER codes across prevalent clinical activities (i.e., assessing, explaining, Socratic method, providing clinical guidance) were tested using autoregressive integrated moving average (ARIMA) models. Known-group validity analyses provided support to all hypotheses. The SISC-INTER may be a useful tool to describe therapist-client interaction in operant terms. The utility of reliable and valid protocols for the descriptive analysis of clinical practice in terms of verbal behavior is discussed. Copyright © 2011. Published by Elsevier Ltd.

Analytical validation of a new point-of-care assay for serum amyloid A in horses.

PubMed

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 POC test and the TIA is not recommended. © 2018 EVJ Ltd.

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.

PubMed

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/non-allergen, especially using THP-1 cells. These results suggest that our method, human Cell Line Activation Test (h-CLAT), using human cell lines THP-1 and U-937, but especially THP-1 cells at 24h treatment, may be a useful in vitro skin sensitization model to predict various contact allergens.

Towards a standardization of biomethane potential tests.

PubMed

Holliger, Christof; Alves, Madalena; Andrade, Diana; Angelidaki, Irini; Astals, Sergi; Baier, Urs; Bougrier, Claire; Buffière, Pierre; Carballa, Marta; de Wilde, Vinnie; Ebertseder, Florian; Fernández, Belén; Ficara, Elena; Fotidis, Ioannis; Frigon, Jean-Claude; de Laclos, Hélène Fruteau; Ghasimi, Dara S M; Hack, Gabrielle; Hartel, Mathias; Heerenklage, Joern; Horvath, Ilona Sarvari; Jenicek, Pavel; Koch, Konrad; Krautwald, Judith; Lizasoain, Javier; Liu, Jing; Mosberger, Lona; Nistor, Mihaela; Oechsner, Hans; Oliveira, João Vítor; Paterson, Mark; Pauss, André; Pommier, Sébastien; Porqueddu, Isabella; Raposo, Francisco; Ribeiro, Thierry; Rüsch Pfund, Florian; Strömberg, Sten; Torrijos, Michel; van Eekert, Miriam; van Lier, Jules; Wedwitschka, Harald; Wierinck, Isabella

2016-12-01

Production of biogas from different organic materials is a most interesting source of renewable energy. The biomethane potential (BMP) of these materials has to be determined to get insight in design parameters for anaerobic digesters. Although several norms and guidelines for BMP tests exist, inter-laboratory tests regularly show high variability of BMPs for the same substrate. A workshop was held in June 2015, in Leysin, Switzerland, with over 40 attendees from 30 laboratories around the world, to agree on common solutions to the conundrum of inconsistent BMP test results. This paper presents the consensus of the intense roundtable discussions and cross-comparison of methodologies used in respective laboratories. Compulsory elements for the validation of BMP results were defined. They include the minimal number of replicates, the request to carry out blank and positive control assays, a criterion for the test duration, details on BMP calculation, and last but not least criteria for rejection of the BMP tests. Finally, recommendations on items that strongly influence the outcome of BMP tests such as inoculum characteristics, substrate preparation, test setup, and data analysis are presented to increase the probability of obtaining validated and reproducible results.

The admissions process of a bachelor of science in nursing program: initial reliability and validity of the personal interview.

PubMed

Carpio, B; Brown, B

1993-01-01

The undergraduate nursing degree program (B.Sc.N.) at McMaster University School of Nursing uses small groups, and is learner-centered and problem-based. A study was conducted during the 1991 admissions cycle to determine the initial reliability and validity of the semi-structured personal interview which constitutes the final component of candidate selection for this program. During the interview, three-member teams assess applicant suitability to the program based on six dimensions: applicant motivation, awareness of the program, problem-solving abilities, ability to relate to others, self-appraisal skills, and career goals. Each interviewer assigns the applicant a global rating using a seven-point scale. For the purposes of this study four interviewer teams were randomly selected from the pool of 31 teams to interview four simulated (preprogrammed) applicants. Using two-factor repeated-measures ANOVA to analyze interview ratings, inter-rater and inter-team intraclass correlation coefficients (ICC) were calculated. Inter-team reliability ranged from .64 to .97 for the individual dimensions, and .66 to .89 on global ratings. Inter-rater ICC for the six dimensions ranged from .81 to .99, and .96 to .99 for the global ratings. The item-to-total correlation coefficients between individual dimensions and global ratings ranged from .8 to 1.0. Pearson correlations between items ranged from .77 to 1.0. The ICC were then calculated for the interview scores of 108 actual applicants to the program. Inter-rater reliability based on global ratings was .79 for the single (1 rater) observation, and .91 for the multiple (3 rater) observation. These findings support the continued use of the interview as a reliable instrument with face validity. Studies of predictive validity will be undertaken.

Reliability and validity of a nutrition and physical activity environmental self-assessment for child care

PubMed Central

Benjamin, Sara E; Neelon, Brian; Ball, Sarah C; Bangdiwala, Shrikant I; Ammerman, Alice S; Ward, Dianne S

2007-01-01

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 Child Care (NAP SACC) instrument to researchers and practitioners interested in conducting healthy weight intervention in child care. However, a more robust, less subjective measure would be more appropriate for researchers seeking an outcome measure to assess intervention impact. PMID:17615078

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

PubMed

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.

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

PubMed Central

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 < .01) and handball tests (ICC = 0.89, p < .01) demonstrated strong reliability and acceptable levels of absolute agreement. Content validity was determined by examining the test scores sensitivity to laterality and distance. Concurrent validity was assessed by comparing coaches’ perceptions of skill to actual test outcomes. Multivariate analysis of variance (MANOVA) examined the main effect of laterality, with scores on the dominant hand (p = .04) and foot (p < .01) significantly higher compared to the non-dominant side. Follow-up univariate analysis reported significant differences at every distance in the kicking test. A poor correlation was found between coaches’ perceptions of skill and testing outcomes. The results of this study demonstrate both skill tests demonstrate acceptable inter-rater reliable. Partial content validity was confirmed for the kicking test, however further research is required to confirm validity of the 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

Inter-laboratory comparison of X-ray fluorescence analyses of eruptive products of El Chichón Volcano, Chiapas, Mexico

USGS Publications Warehouse

Tilling, Robert I.; Bornhorst, Theodore J.; Taggart, Joseph E.; Rose, William I.; McGee, James J.

1987-01-01

An inter-laboratory comparison has been made of X-ray fluorescence analyses of 10 samples of lava and pumices from El Chichón Volcano, Chiapas, Mexico. Some determinations of major-element constituents agree within analytical uncertainty, whereas others exchibit significant bias. Analyses carried out at the Michigan Technological University (MTU) laboratory are systematically lower in MgO (26–48%), Fetotal(5–18%), CaO (4–15%) and higher in K2O (0–15%) than analyses made at the U.S. Geological Survey (USGS) Denver laboratory. These differences are ascribed in part to a complex combination of calibration assumptionsand mineralogical and particle-size effects inherent in the use of pressed rock-powder pellets in the analytical procedure of the MTU laboratory. Other, but as yet unknown, differences in sample preparation and/or analytical technique may also be important; effects related to natural sample inhomogeneityare believed to be insignificant. The inter-laboratory differences in the analytical data complicated accurate assessment of whether El Chichón magmas have changed composition during the past 300 000 a. Knowledge of such change is needed for understanding petrogenetic history and for such related studies as evaluation of volcanic hazards.

Tackling reliability and construct validity: the systematic development of a qualitative protocol for skill and incident analysis.

PubMed

Savage, Trevor Nicholas; McIntosh, Andrew Stuart

2017-03-01

It is important to understand factors contributing to and directly causing sports injuries to improve the effectiveness and safety of sports skills. The characteristics of injury events must be evaluated and described meaningfully and reliably. However, many complex skills cannot be effectively investigated quantitatively because of ethical, technological and validity considerations. Increasingly, qualitative methods are being used to investigate human movement for research purposes, but there are concerns about reliability and measurement bias of such methods. Using the tackle in Rugby union as an example, we outline a systematic approach for developing a skill analysis protocol with a focus on improving objectivity, validity and reliability. Characteristics for analysis were selected using qualitative analysis and biomechanical theoretical models and epidemiological and coaching literature. An expert panel comprising subject matter experts provided feedback and the inter-rater reliability of the protocol was assessed using ten trained raters. The inter-rater reliability results were reviewed by the expert panel and the protocol was revised and assessed in a second inter-rater reliability study. Mean agreement in the second study improved and was comparable (52-90% agreement and ICC between 0.6 and 0.9) with other studies that have reported inter-rater reliability of qualitative analysis of human movement.

Intra- and inter-tester reliability and validity of normal finger size measurement using the Japanese ring gauge system.

PubMed

Suzuki, T; Sato, Y; Sotome, S; Arai, H; Arai, A; Yoshida, H

2017-06-01

This study was designed to investigate the reliability and validity of measurements of finger diameters with a ring gauge. A reliability study enrolled two independent samples (50 participants and seven examiners in Study I; 26 participants and 26 examiners in Study II). The sizes of each participant's little fingers were measured twice with a ring gauge by each examiner. To investigate the validity of the measurements, five hand therapists compared the finger size and hand volume of 30 participants with the ring gauge and with a figure-of-eight technique (Study III). The intra-class correlation coefficient for intra-observer reliability ranged from 0.97 to 0.99 in Study I, and 0.90 to 0.97 in Study II. The intra-class correlation coefficient for inter-observer reliability was 0.95 in Study I and 0.94 in Study II. The validity study showed a Pearson product moment correlation coefficient of 0.75. The ring gauge showed high reliability and validity for measurement of finger size. III, diagnostic.

An ultraviolet-spectrophotometric method for the determination of glimepiride in solid dosage forms.

PubMed

Afieroho, Ozadheoghene E; Okorie, Ogbonna; Okonkwo, Tochukwu J N

2011-06-01

Considering the cost of acquiring a liquid chromatographic instrument in underdeveloped economies, the rising incidence of diabetes mellitus, the need to evaluate the quality performance of glimepiride generics, and the need for less toxic processes, this research is an imperative. The method was validated for linearity, recovery accuracy, intra- and inter-day precision, specificity in the presence of excipients, and inter-day stability under laboratory conditions. Student's t test at the 95% confidence limit was used for statistics. Using 96% ethanol as solvent, a less toxic and cost-effective spectrophotometric method for the determination of glimepiride in solid dosage forms was developed and validated. The results of the validated parameters showed a λ(max) of 231 nm, linearity range of 0.5-22 μg/mL, precision with relative SD of <1.0%, recovery accuracy of 100.8%, regression equation of y = 45.741x + 0.0202, R(2) = 0.999, limit of detection of 0.35 μg/mL, and negligible interference from common excipients and colorants. The method was found to be accurate at the 95% confidence limit compared with the standard liquid chromatographic method with comparable reproducibility when used to assay the formulated products Amaryl(®) (sanofi-aventis, Paris, France) and Mepyril(®) (May & Baker Nigeria PLC, Ikeja, Nigeria). The results obtained for the validated parameters were within allowable limits. This method is recommended for routine quality control analysis.

Demonstrating the feasibility of large-scale development of standardized assays to quantify human proteins

PubMed Central

Kennedy, Jacob J.; Abbatiello, Susan E.; Kim, Kyunggon; Yan, Ping; Whiteaker, Jeffrey R.; Lin, Chenwei; Kim, Jun Seok; Zhang, Yuzheng; Wang, Xianlong; Ivey, Richard G.; Zhao, Lei; Min, Hophil; Lee, Youngju; Yu, Myeong-Hee; Yang, Eun Gyeong; Lee, Cheolju; Wang, Pei; Rodriguez, Henry; Kim, Youngsoo; Carr, Steven A.; Paulovich, Amanda G.

2014-01-01

The successful application of MRM in biological specimens raises the exciting possibility that assays can be configured to measure all human proteins, resulting in an assay resource that would promote advances in biomedical research. We report the results of a pilot study designed to test the feasibility of a large-scale, international effort in MRM assay generation. We have configured, validated across three laboratories, and made publicly available as a resource to the community 645 novel MRM assays representing 319 proteins expressed in human breast cancer. Assays were multiplexed in groups of >150 peptides and deployed to quantify endogenous analyte in a panel of breast cancer-related cell lines. Median assay precision was 5.4%, with high inter-laboratory correlation (R2 >0.96). Peptide measurements in breast cancer cell lines were able to discriminate amongst molecular subtypes and identify genome-driven changes in the cancer proteome. These results establish the feasibility of a scaled, international effort. PMID:24317253

Validity and reliability of a low-cost digital dynamometer for measuring isometric strength of lower limb.

PubMed

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.

Performance of Proximity Loggers in Recording Intra- and Inter-Species Interactions: A Laboratory and Field-Based Validation Study

PubMed Central

Carter, Stephen P.; Bearhop, Stuart; Harrison, Xavier A.; Dall, Sasha R. X.; McDonald, Robbie A.; Delahay, Richard J.

2012-01-01

Knowledge of the way in which animals interact through social networks can help to address questions surrounding the ecological and evolutionary consequences of social organisation, and to understand and manage the spread of infectious diseases. Automated proximity loggers are increasingly being used to record interactions between animals, but the accuracy and reliability of the collected data remain largely un-assessed. Here we use laboratory and observational field data to assess the performance of these devices fitted to a herd of 32 beef cattle (Bos taurus) and nine groups of badgers (Meles meles, n  = 77) living in the surrounding woods. The distances at which loggers detected each other were found to decrease over time, potentially related to diminishing battery power that may be a function of temperature. Loggers were highly accurate in recording the identification of contacted conspecifics, but less reliable at determining contact duration. There was a tendency for extended interactions to be recorded as a series of shorter contacts. We show how data can be manipulated to correct this discrepancy and accurately reflect observed interaction patterns by combining records between any two loggers that occur within a 1 to 2 minute amalgamation window, and then removing any remaining 1 second records. We make universally applicable recommendations for the effective use of proximity loggers, to improve the validity of data arising from future studies. PMID:22745704

Implementation of a National Reference Laboratory for Buruli Ulcer Disease in Togo

PubMed Central

Badziklou, Kossi; Halatoko, Wemboo Afiwa; Maman, Issaka; Vogel, Felix; Bidjada, Bawimodom; Awoussi, Koffi Somenou; Piten, Ebekalisai; Helfrich, Kerstin; Mengele, Carolin; Nitschke, Jörg; Amekuse, Komi; Wiedemann, Franz Xaver; Diefenhardt, Adolf; Kobara, Basile; Herbinger, Karl–Heinz; Kere, Abiba Banla; Prince-David, Mireille; Löscher, Thomas; Bretzel, Gisela

2013-01-01

Background In a previous study PCR analysis of clinical samples from suspected cases of Buruli ulcer disease (BUD) from Togo and external quality assurance (EQA) for local microscopy were conducted at an external reference laboratory in Germany. The relatively poor performance of local microscopy as well as effort and time associated with shipment of PCR samples necessitated the implementation of stringent EQA measures and availability of local laboratory capacity. This study describes the approach to implementation of a national BUD reference laboratory in Togo. Methodology Large scale outreach activities accompanied by regular training programs for health care professionals were conducted in the regions “Maritime” and “Central,” standard operating procedures defined all processes in participating laboratories (regional, national and external reference laboratories) as well as the interaction between laboratories and partners in the field. Microscopy was conducted at regional level and slides were subjected to EQA at national and external reference laboratories. For PCR analysis, sample pairs were collected and subjected to a dry-reagent-based IS2404-PCR (DRB-PCR) at national level and standard IS2404 PCR followed by IS2404 qPCR analysis of negative samples at the external reference laboratory. Principal Findings The inter-laboratory concordance rates for microscopy ranged from 89% to 94%; overall, microscopy confirmed 50% of all suspected BUD cases. The inter-laboratory concordance rate for PCR was 96% with an overall PCR case confirmation rate of 78%. Compared to a previous study, the rate of BUD patients with non-ulcerative lesions increased from 37% to 50%, the mean duration of disease before clinical diagnosis decreased significantly from 182.6 to 82.1 days among patients with ulcerative lesions, and the percentage of category III lesions decreased from 30.3% to 19.2%. Conclusions High inter-laboratory concordance rates as well as case confirmation rates of 50% (microscopy), 71% (PCR at national level), and 78% (including qPCR confirmation at external reference laboratory) suggest high standards of BUD diagnostics. The increase of non-ulcerative lesions, as well as the decrease in diagnostic delay and category III lesions, prove the effect of comprehensive EQA and training measures involving also procedures outside the laboratory. PMID:23359828

Implementation of a national reference laboratory for Buruli ulcer disease in Togo.

PubMed

Beissner, Marcus; Huber, Kristina Lydia; Badziklou, Kossi; Halatoko, Wemboo Afiwa; Maman, Issaka; Vogel, Felix; Bidjada, Bawimodom; Awoussi, Koffi Somenou; Piten, Ebekalisai; Helfrich, Kerstin; Mengele, Carolin; Nitschke, Jörg; Amekuse, Komi; Wiedemann, Franz Xaver; Diefenhardt, Adolf; Kobara, Basile; Herbinger, Karl-Heinz; Kere, Abiba Banla; Prince-David, Mireille; Löscher, Thomas; Bretzel, Gisela

2013-01-01

In a previous study PCR analysis of clinical samples from suspected cases of Buruli ulcer disease (BUD) from Togo and external quality assurance (EQA) for local microscopy were conducted at an external reference laboratory in Germany. The relatively poor performance of local microscopy as well as effort and time associated with shipment of PCR samples necessitated the implementation of stringent EQA measures and availability of local laboratory capacity. This study describes the approach to implementation of a national BUD reference laboratory in Togo. Large scale outreach activities accompanied by regular training programs for health care professionals were conducted in the regions "Maritime" and "Central," standard operating procedures defined all processes in participating laboratories (regional, national and external reference laboratories) as well as the interaction between laboratories and partners in the field. Microscopy was conducted at regional level and slides were subjected to EQA at national and external reference laboratories. For PCR analysis, sample pairs were collected and subjected to a dry-reagent-based IS2404-PCR (DRB-PCR) at national level and standard IS2404 PCR followed by IS2404 qPCR analysis of negative samples at the external reference laboratory. The inter-laboratory concordance rates for microscopy ranged from 89% to 94%; overall, microscopy confirmed 50% of all suspected BUD cases. The inter-laboratory concordance rate for PCR was 96% with an overall PCR case confirmation rate of 78%. Compared to a previous study, the rate of BUD patients with non-ulcerative lesions increased from 37% to 50%, the mean duration of disease before clinical diagnosis decreased significantly from 182.6 to 82.1 days among patients with ulcerative lesions, and the percentage of category III lesions decreased from 30.3% to 19.2%. High inter-laboratory concordance rates as well as case confirmation rates of 50% (microscopy), 71% (PCR at national level), and 78% (including qPCR confirmation at external reference laboratory) suggest high standards of BUD diagnostics. The increase of non-ulcerative lesions, as well as the decrease in diagnostic delay and category III lesions, prove the effect of comprehensive EQA and training measures involving also procedures outside the laboratory.

Validity and inter-observer reliability of subjective hand-arm vibration assessments.

PubMed

Coenen, Pieter; Formanoy, Margriet; Douwes, Marjolein; Bosch, Tim; de Kraker, Heleen

2014-07-01

Exposure to mechanical vibrations at work (e.g., due to handling powered tools) is a potential occupational risk as it may cause upper extremity complaints. However, reliable and valid assessment methods for vibration exposure at work are lacking. Measuring hand-arm vibration objectively is often difficult and expensive, while often used information provided by manufacturers lacks detail. Therefore, a subjective hand-arm vibration assessment method was tested on validity and inter-observer reliability. In an experimental protocol, sixteen tasks handling powered tools were executed by two workers. Hand-arm vibration was assessed subjectively by 16 observers according to the proposed subjective assessment method. As a gold standard reference, hand-arm vibration was measured objectively using a vibration measurement device. Weighted κ's were calculated to assess validity, intra-class-correlation coefficients (ICCs) were calculated to assess inter-observer reliability. Inter-observer reliability of the subjective assessments depicting the agreement among observers can be expressed by an ICC of 0.708 (0.511-0.873). The validity of the subjective assessments as compared to the gold-standard reference can be expressed by a weighted κ of 0.535 (0.285-0.785). Besides, the percentage of exact agreement of the subjective assessment compared to the objective measurement was relatively low (i.e., 52% of all tasks). This study shows that subjectively assessed hand-arm vibrations are fairly reliable among observers and moderately valid. This assessment method is a first attempt to use subjective risk assessments of hand-arm vibration. Although, this assessment method can benefit from some future improvement, it can be of use in future studies and in field-based ergonomic assessments. Copyright © 2014 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Proposed minimal panel of antibodies for cost-effectiveness and accuracy in acute leukemias immunophenotyping: Prospective study at a tertiary care center.

PubMed

Singh, Neha; Pati, Hara Prasad P; Tyagi, Seema; Deka, Roopam; Sharma, Rahul; Saxena, Renu

2016-07-01

Flowcytometry has an essential role in the diagnosis and classification of acute leukemias. However, there exists a great degree of inter-laboratory variability on issues like panel selection, antibody combinations, gating strategies, fluorochromes, and clonal selection. The primary aim of this study was to derive a minimal panel of antibodies and evaluate its diagnostic usefulness in acute leukemias by flowcytometry by using the detailed immune-phenotype of different lineage-specific or non-specific markers. This prospective observational study involved 400 newly diagnosed cases of acute leukemias. Bone marrow aspirate samples were subjected to morphological evaluation, cytogenetics and flow cytometric immunophenotyping. A minimal panel of eight antibodies comprising of CD45/CD34/CD19/MPO/cytoCD3/CD64/CD117/CD79a was derived by applying different permutations and combinations with a diagnostic yield of 97.5%. The minimal panel was further validated by testing in an independent cohort of patients with similar demographic characteristics, where it showed a high diagnostic yield of 98% in comparison with the screening panels proposed by other recently published studies. It may be concluded that the diagnostic performance of the eight antibody panel is better than most other panels used across the different laboratories in terms of yield, number of antibodies used and the scientific approach used to derive and validate the results and so henceforth may be applied in any setting with limited resources for better diagnostic accuracy.

Hierarchical Clustering on the Basis of Inter-Job Similarity as a Tool in Validity Generalization

ERIC Educational Resources Information Center

Mobley, William H.; Ramsay, Robert S.

1973-01-01

The present research was stimulated by three related problems frequently faced in validation research: viable procedures for combining similar jobs in order to assess the validity of various predictors, for assessing groups of jobs represented in previous validity studies, and for assessing the applicability of validity findings between units.…

Evaluation of the National Solar Radiation Database (NSRDB) Using Ground-Based Measurements

NASA Astrophysics Data System (ADS)

Xie, Y.; Sengupta, M.; Habte, A.; Lopez, A.

2017-12-01

Solar resource is essential for a wide spectrum of applications including renewable energy, climate studies, and solar forecasting. Solar resource information can be obtained from ground-based measurement stations and/or from modeled data sets. While measurements provide data for the development and validation of solar resource models and other applications modeled data expands the ability to address the needs for increased accuracy and spatial and temporal resolution. The National Renewable Energy Laboratory (NREL) has developed and regular updates modeled solar resource through the National Solar Radiation Database (NSRDB). The recent NSRDB dataset was developed using the physics-based Physical Solar Model (PSM) and provides gridded solar irradiance (global horizontal irradiance (GHI), direct normal irradiance (DNI), and diffuse horizontal irradiance) at a 4-km by 4-km spatial and half-hourly temporal resolution covering 18 years from 1998-2015. A comprehensive validation of the performance of the NSRDB (1998-2015) was conducted to quantify the accuracy of the spatial and temporal variability of the solar radiation data. Further, the study assessed the ability of NSRDB (1998-2015) to accurately capture inter-annual variability, which is essential information for solar energy conversion projects and grid integration studies. Comparisons of the NSRDB (1998-2015) with nine selected ground-measured data were conducted under both clear- and cloudy-sky conditions. These locations provide a high quality data covering a variety of geographical locations and climates. The comparison of the NSRDB to the ground-based data demonstrated that biases were within +/- 5% for GHI and +/-10% for DNI. A comprehensive uncertainty estimation methodology was established to analyze the performance of the gridded NSRDB and includes all sources of uncertainty at various time-averaged periods, a method that is not often used in model evaluation. Further, the study analyzed the inter-annual and mean-anomaly of the 18 years of solar radiation data. This presentation will outline the validation methodology and provide detailed results of the comparison.

Inter-laboratory comparison of multi-locus variable-number tandem repeat analysis (MLVA) for verocytotoxin-producing Escherichia coli O157 to facilitate data sharing.

PubMed

Holmes, A; Perry, N; Willshaw, G; Hanson, M; Allison, L

2015-01-01

Multi-locus variable number tandem repeat analysis (MLVA) is used in clinical and reference laboratories for subtyping verocytotoxin-producing Escherichia coli O157 (VTEC O157). However, as yet there is no common allelic or profile nomenclature to enable laboratories to easily compare data. In this study, we carried out an inter-laboratory comparison of an eight-loci MLVA scheme using a set of 67 isolates of VTEC O157. We found all but two isolates were identical in profile in the two laboratories, and repeat units were homogeneous in size but some were incomplete. A subset of the isolates (n = 17) were sequenced to determine the actual copy number of representative alleles, thereby enabling alleles to be named according to international consensus guidelines. This work has enabled us to realize the potential of MLVA as a portable, highly discriminatory and convenient subtyping method.

Urdu translation of the Hamilton Rating Scale for Depression: Results of a validation study

PubMed Central

Hashmi, Ali M.; Naz, Shahana; Asif, Aftab; Khawaja, Imran S.

2016-01-01

Objective: To develop a standardized validated version of the Hamilton Rating Scale for Depression (HAM-D) in Urdu. Methods: After translation of the HAM-D into the Urdu language following standard guidelines, the final Urdu version (HAM-D-U) was administered to 160 depressed outpatients. Inter-item correlation was assessed by calculating Cronbach alpha. Correlation between HAM-D-U scores at baseline and after a 2-week interval was evaluated for test-retest reliability. Moreover, scores of two clinicians on HAM-D-U were compared for inter-rater reliability. For establishing concurrent validity, scores of HAM-D-U and BDI-U were compared by using Spearman correlation coefficient. The study was conducted at Mayo Hospital, Lahore, from May to December 2014. Results: The Cronbach alpha for HAM-D-U was 0.71. Composite scores for HAM-D-U at baseline and after a 2-week interval were also highly correlated with each other (Spearman correlation coefficient 0.83, p-value < 0.01) indicating good test-retest reliability. Composite scores for HAM-D-U and BDI-U were positively correlated with each other (Spearman correlation coefficient 0.85, p < 0.01) indicating good concurrent validity. Scores of two clinicians for HAM-D-U were also positively correlated (Spearman correlation coefficient 0.82, p-value < 0.01) indicated good inter-rater reliability. Conclusion: The HAM-D-U is a valid and reliable instrument for the assessment of Depression. It shows good inter-rater and test-retest reliability. The HAM-D-U can be a tool either for clinical management or research. PMID:28083049

Urdu translation of the Hamilton Rating Scale for Depression: Results of a validation study.

PubMed

Hashmi, Ali M; Naz, Shahana; Asif, Aftab; Khawaja, Imran S

2016-01-01

To develop a standardized validated version of the Hamilton Rating Scale for Depression (HAM-D) in Urdu. After translation of the HAM-D into the Urdu language following standard guidelines, the final Urdu version (HAM-D-U) was administered to 160 depressed outpatients. Inter-item correlation was assessed by calculating Cronbach alpha. Correlation between HAM-D-U scores at baseline and after a 2-week interval was evaluated for test-retest reliability. Moreover, scores of two clinicians on HAM-D-U were compared for inter-rater reliability. For establishing concurrent validity, scores of HAM-D-U and BDI-U were compared by using Spearman correlation coefficient. The study was conducted at Mayo Hospital, Lahore, from May to December 2014. The Cronbach alpha for HAM-D-U was 0.71. Composite scores for HAM-D-U at baseline and after a 2-week interval were also highly correlated with each other (Spearman correlation coefficient 0.83, p-value < 0.01) indicating good test-retest reliability. Composite scores for HAM-D-U and BDI-U were positively correlated with each other (Spearman correlation coefficient 0.85, p < 0.01) indicating good concurrent validity. Scores of two clinicians for HAM-D-U were also positively correlated (Spearman correlation coefficient 0.82, p-value < 0.01) indicated good inter-rater reliability. The HAM-D-U is a valid and reliable instrument for the assessment of Depression. It shows good inter-rater and test-retest reliability. The HAM-D-U can be a tool either for clinical management or research.

Development and applicability of a ready-to-use PCR system for GMO screening.

PubMed

Rosa, Sabrina F; Gatto, Francesco; Angers-Loustau, Alexandre; Petrillo, Mauro; Kreysa, Joachim; Querci, Maddalena

2016-06-15

With the growing number of GMOs introduced to the market, testing laboratories have seen their workload increase significantly. Ready-to-use multi-target PCR-based detection systems, such as pre-spotted plates (PSP), reduce analysis time while increasing capacity. This paper describes the development and applicability to GMO testing of a screening strategy involving a PSP and its associated web-based Decision Support System. The screening PSP was developed to detect all GMOs authorized in the EU in one single PCR experiment, through the combination of 16 validated assays. The screening strategy was successfully challenged in a wide inter-laboratory study on real-life food/feed samples. The positive outcome of this study could result in the adoption of a PSP screening strategy across the EU; a step that would increase harmonization and quality of GMO testing in the EU. Furthermore, this system could represent a model for other official control areas where high-throughput DNA-based detection systems are needed. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The reliability and validity of the Turkish version of Fullerton Advanced Balance (FAB-T) scale.

PubMed

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.

Analytical performance of a bronchial genomic classifier.

PubMed

Hu, Zhanzhi; Whitney, Duncan; Anderson, Jessica R; Cao, Manqiu; Ho, Christine; Choi, Yoonha; Huang, Jing; Frink, Robert; Smith, Kate Porta; Monroe, Robert; Kennedy, Giulia C; Walsh, P Sean

2016-02-26

The current standard practice of lung lesion diagnosis often leads to inconclusive results, requiring additional diagnostic follow up procedures that are invasive and often unnecessary due to the high benign rate in such lesions (Chest 143:e78S-e92, 2013). The Percepta bronchial genomic classifier was developed and clinically validated to provide more accurate classification of lung nodules and lesions that are inconclusive by bronchoscopy, using bronchial brushing specimens (N Engl J Med 373:243-51, 2015, BMC Med Genomics 8:18, 2015). The analytical performance of the Percepta test is reported here. Analytical performance studies were designed to characterize the stability of RNA in bronchial brushing specimens during collection and shipment; analytical sensitivity defined as input RNA mass; analytical specificity (i.e. potentially interfering substances) as tested on blood and genomic DNA; and assay performance studies including intra-run, inter-run, and inter-laboratory reproducibility. RNA content within bronchial brushing specimens preserved in RNAprotect is stable for up to 20 days at 4 °C with no changes in RNA yield or integrity. Analytical sensitivity studies demonstrated tolerance to variation in RNA input (157 ng to 243 ng). Analytical specificity studies utilizing cancer positive and cancer negative samples mixed with either blood (up to 10 % input mass) or genomic DNA (up to 10 % input mass) demonstrated no assay interference. The test is reproducible from RNA extraction through to Percepta test result, including variation across operators, runs, reagent lots, and laboratories (standard deviation of 0.26 for scores on > 6 unit scale). Analytical sensitivity, analytical specificity and robustness of the Percepta test were successfully verified, supporting its suitability for clinical use.

Validation and transferability study of a method based on near-infrared hyperspectral imaging for the detection and quantification of ergot bodies in cereals.

PubMed

Vermeulen, Ph; Fernández Pierna, J A; van Egmond, H P; Zegers, J; Dardenne, P; Baeten, V

2013-09-01

In recent years, near-infrared (NIR) hyperspectral imaging has proved its suitability for quality and safety control in the cereal sector by allowing spectroscopic images to be collected at single-kernel level, which is of great interest to cereal control laboratories. Contaminants in cereals include, inter alia, impurities such as straw, grains from other crops, and insects, as well as undesirable substances such as ergot (sclerotium of Claviceps purpurea). For the cereal sector, the presence of ergot creates a high toxicity risk for animals and humans because of its alkaloid content. A study was undertaken, in which a complete procedure for detecting ergot bodies in cereals was developed, based on their NIR spectral characteristics. These were used to build relevant decision rules based on chemometric tools and on the morphological information obtained from the NIR images. The study sought to transfer this procedure from a pilot online NIR hyperspectral imaging system at laboratory level to a NIR hyperspectral imaging system at industrial level and to validate the latter. All the analyses performed showed that the results obtained using both NIR hyperspectral imaging cameras were quite stable and repeatable. In addition, a correlation higher than 0.94 was obtained between the predicted values obtained by NIR hyperspectral imaging and those supplied by the stereo-microscopic method which is the reference method. The validation of the transferred protocol on blind samples showed that the method could identify and quantify ergot contamination, demonstrating the transferability of the method. These results were obtained on samples with an ergot concentration of 0.02% which is less than the EC limit for cereals (intervention grains) destined for humans fixed at 0.05%.

The development and validation of a custom built device for assessing frontal knee joint laxity.

PubMed

Ismail, Shiek Abdullah; Simic, Milena; Clarke, Jillian L; Lopes, Thiago Jambo Alves; Pappas, Evangelos

2017-12-01

This study reports the development and validation of a quantitative technique of assessing frontal knee joint laxity through a custom built device named KLICP. The objectives of this study were to determine: (i) the intra- and inter-rater reliability and (ii) the validity of the device when compared to real time ultrasound. Twenty-five participants had their frontal knee joint laxity assessed by the KLICP, by manual varus/valgus tests and by ultrasound. Two raters independently assessed laxity manually by three repeated measurements, repeated at least 48h later. Results were validated by comparing them to the medial and lateral joint space opening measured by the ultrasound. Intraclass correlation coefficients and standard error of measurement reliability were calculated. Pearson's correlation coefficients were calculated to determine the correlation between the KLICP and the joint space. Intra-rater reliability (intra-session) for each rater was good on both sessions (0.91-0.98), intra-rater reliability (inter-sessions) was moderate to good (0.62-0.87), and inter-rater reliability (intra-session) was good (0.75-0.80). There is low agreement for intra-rater (inter-session) and for inter-rater (intra-session) reliability. The KLICP measurement has a significant positive fair to moderate correlation to the ultrasound measurement at the left (r: 0.61, p: 0.01) and right (r: 0.48, p: 0.02) knee in the valgus direction and at the left (r: 0.51, p: 0.01) and right (r: 0.39, p: 0.05) knee in the varus direction. There is low agreement between the KLICP and the RTU. Reliability and agreement was good only when measured for intra-rater, within session. Copyright © 2017 Elsevier B.V. All rights reserved.

Validity and reliability of Internet-based physiotherapy assessment for musculoskeletal disorders: a systematic review.

PubMed

Mani, Suresh; Sharma, Shobha; Omar, Baharudin; Paungmali, Aatit; Joseph, Leonard

2017-04-01

Purpose The purpose of this review is to systematically explore and summarise the validity and reliability of telerehabilitation (TR)-based physiotherapy assessment for musculoskeletal disorders. Method A comprehensive systematic literature review was conducted using a number of electronic databases: PubMed, EMBASE, PsycINFO, Cochrane Library and CINAHL, published between January 2000 and May 2015. The studies examined the validity, inter- and intra-rater reliabilities of TR-based physiotherapy assessment for musculoskeletal conditions were included. Two independent reviewers used the Quality Appraisal Tool for studies of diagnostic Reliability (QAREL) and the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool to assess the methodological quality of reliability and validity studies respectively. Results A total of 898 hits were achieved, of which 11 articles based on inclusion criteria were reviewed. Nine studies explored the concurrent validity, inter- and intra-rater reliabilities, while two studies examined only the concurrent validity. Reviewed studies were moderate to good in methodological quality. The physiotherapy assessments such as pain, swelling, range of motion, muscle strength, balance, gait and functional assessment demonstrated good concurrent validity. However, the reported concurrent validity of lumbar spine posture, special orthopaedic tests, neurodynamic tests and scar assessments ranged from low to moderate. Conclusion TR-based physiotherapy assessment was technically feasible with overall good concurrent validity and excellent reliability, except for lumbar spine posture, orthopaedic special tests, neurodynamic testa and scar assessment.

New Sentinel-2 radiometric validation approaches (SEOM program)

NASA Astrophysics Data System (ADS)

Bruniquel, Véronique; Lamquin, Nicolas; Ferron, Stéphane; Govaerts, Yves; Woolliams, Emma; Dilo, Arta; Gascon, Ferran

2016-04-01

SEOM is an ESA program element whose one of the objectives aims at launching state-of-the-art studies for the scientific exploitation of operational missions. In the frame of this program, ESA awarded ACRI-ST and its partners Rayference and National Physical Laboratory (NPL) early 2016 for a R&D study on the development and intercomparison of algorithms for validating the Sentinel-2 radiometric L1 data products beyond the baseline algorithms used operationally in the frame of the S2 Mission Performance Centre. In this context, several algorithms have been proposed and are currently in development: The first one is based on the exploitation of Deep Convective Cloud (DCC) observations over ocean. This method allows an inter-band radiometry validation from the blue to the NIR (typically from B1 to B8a) from a reference band already validated for example with the well-known Rayleigh method. Due to their physical properties, DCCs appear from the remote sensing point of view to have bright and cold tops and they can be used as invariant targets to monitor the radiometric response degradation of reflective solar bands. The DCC approach is statistical i.e. the method shall be applied on a large number of measurements to derive reliable statistics and decrease the impact of the perturbing contributors. The second radiometric validation method is based on the exploitation of matchups combining both concomitant in-situ measurements and Sentinel-2 observations. The in-situ measurements which are used here correspond to measurements acquired in the frame of the RadCalNet networks. The validation is performed for the Sentinel-2 bands similar to the bands of the instruments equipping the validation site. The measurements from the Cimel CE 318 12-filters BRDF Sun Photometer installed recently in the Gobabeb site near the Namib desert are used for this method. A comprehensive verification of the calibration requires an analysis of MSI radiances over the full dynamic range, including low radiances, as extreme values are more subject to instrument response non-linearity. The third method developed in the frame of this project aims to address this point. It is based on a comparison of Sentinel-2 observations over coastal waters which have low radiometry and corresponding Radiative Transfer (RT) simulations using AERONET-OC measurements. Finally, a last method is developed using RadCalNet measurements and Sentinel-2 observations to validate the radiometry of mid/low resolution sensors such as Sentinel-3/OLCI. The RadCalNet measurements are transferred from the RadCalNet sites to Pseudo Invariant Calibration Sites (PICS) using Sentinel-2, and then these larger sites are used to validate mid- and low-resolution sensors to the RadCalNet reference. For all the developed methods, an uncertainty budget is derived following QA4EO guidelines. A last step of this ESA project is dedicated to an Inter-comparison Workshop open to entities involved in Sentinel-2 radiometric validation activities. Blind inter-comparison tests over a series of images will be proposed and the results will be discussed during the workshop.

Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials.

PubMed

Coecke, Sandra; Bernasconi, Camilla; Bowe, Gerard; Bostroem, Ann-Charlotte; Burton, Julien; Cole, Thomas; Fortaner, Salvador; Gouliarmou, Varvara; Gray, Andrew; Griesinger, Claudius; Louhimies, Susanna; Gyves, Emilio Mendoza-de; Joossens, Elisabeth; Prinz, Maurits-Jan; Milcamps, Anne; Parissis, Nicholaos; Wilk-Zasadna, Iwona; Barroso, João; Desprez, Bertrand; Langezaal, Ingrid; Liska, Roman; Morath, Siegfried; Reina, Vittorio; Zorzoli, Chiara; Zuang, Valérie

This chapter focuses on practical aspects of conducting prospective in vitro validation studies, and in particular, by laboratories that are members of the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) that is coordinated by the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM). Prospective validation studies involving EU-NETVAL, comprising a multi-study trial involving several laboratories or "test facilities", typically consist of two main steps: (1) the design of the validation study by EURL ECVAM and (2) the execution of the multi-study trial by a number of qualified laboratories within EU-NETVAL, coordinated and supported by EURL ECVAM. The approach adopted in the conduct of these validation studies adheres to the principles described in the OECD Guidance Document on the Validation and International Acceptance of new or updated test methods for Hazard Assessment No. 34 (OECD 2005). The context and scope of conducting prospective in vitro validation studies is dealt with in Chap. 4 . Here we focus mainly on the processes followed to carry out a prospective validation of in vitro methods involving different laboratories with the ultimate aim of generating a dataset that can support a decision in relation to the possible development of an international test guideline (e.g. by the OECD) or the establishment of performance standards.

Uncertainty evaluation in the chloroquine phosphate potentiometric titration: application of three different approaches.

PubMed

Rodomonte, Andrea Luca; Montinaro, Annalisa; Bartolomei, Monica

2006-09-11

A measurement result cannot be properly interpreted if not accompanied by its uncertainty. Several methods to estimate uncertainty have been developed. From those methods three in particular were chosen in this work to estimate the uncertainty of the Eu. Ph. chloroquine phosphate assay, a potentiometric titration commonly used in medicinal control laboratories. The famous error-budget approach (also called bottom-up or step-by-step) described by the ISO Guide to the expression of Uncertainty in Measurement (GUM) was the first method chosen. It is based on the combination of uncertainty contributions that have to be directly derived from the measurement process. The second method employed was the Analytical Method Committee top-down which estimates uncertainty through reproducibility obtained during inter-laboratory studies. Data for its application were collected in a proficiency testing study carried out by over 50 laboratories throughout Europe. The last method chosen was the one proposed by Barwick and Ellison. It uses a combination of precision, trueness and ruggedness data to estimate uncertainty. These data were collected from a validation process specifically designed for uncertainty estimation. All the three approaches presented a distinctive set of advantages and drawbacks in their implementation. An expanded uncertainty of about 1% was assessed for the assay investigated.

Reliability and validity of the de Morton Mobility Index in individuals with sub-acute stroke.

PubMed

Braun, Tobias; Marks, Detlef; Thiel, Christian; Grüneberg, Christian

2018-02-04

To establish the validity and reliability of the de Morton Mobility Index (DEMMI) in patients with sub-acute stroke. This cross-sectional study was performed in a neurological rehabilitation hospital. We assessed unidimensionality, construct validity, internal consistency reliability, inter-rater reliability, minimal detectable change and possible floor and ceiling effects of the DEMMI in adult patients with sub-acute stroke. The study included a total sample of 121 patients with sub-acute stroke. We analysed validity (n = 109) and reliability (n = 51) in two sub-samples. Rasch analysis indicated unidimensionality with an overall fit to the model (chi-square = 12.37, p = 0.577). All hypotheses on construct validity were confirmed. Internal consistency reliability (Cronbach's alpha = 0.94) and inter-rater reliability (intraclass correlation coefficient = 0.95; 95% confidence interval: 0.92-0.97) were excellent. The minimal detectable change with 90% confidence was 13 points. No floor or ceiling effects were evident. These results indicate unidimensionality, sufficient internal consistency reliability, inter-rater reliability, and construct validity of the DEMMI in patients with a sub-acute stroke. Advantages of the DEMMI in clinical application are the short administration time, no need for special equipment and interval level data. The de Morton Mobility Index, therefore, may be a useful performance-based bedside test to measure mobility in individuals with a sub-acute stroke across the whole mobility spectrum. Implications for Rehabilitation The de Morton Mobility Index (DEMMI) is an unidimensional measurement instrument of mobility in individuals with sub-acute stroke. The DEMMI has excellent internal consistency and inter-rater reliability, and sufficient construct validity. The minimal detectable change of the DEMMI with 90% confidence in stroke rehabilitation is 13 points. The lack of any floor or ceiling effects on hospital admission indicates applicability across the whole mobility spectrum of patients with sub-acute stroke.

Standards Performance Continuum: Development and Validation of a Measure of Effective Pedagogy.

ERIC Educational Resources Information Center

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…

Amino acid racemization dating of fossil bones, I. inter-laboratory comparison of racemization measurements

USGS Publications Warehouse

Bada, J.L.; Hoopes, E.; Darling, D.; Dungworth, G.; Kessels, H.J.; Kvenvolden, K.A.; Blunt, D.J.

1979-01-01

Enantiomeric measurements for aspartic acid, glutamic acid, and alanine in twenty-one different fossil bone samples have been carried out by three different laboratories using different analytical methods. These inter-laboratory comparisons demonstrate that D/L aspartic acid measurements are highly reproducible, whereas the enantiomeric measurements for the other amino acids show a wide variation between the three laboratories. At present, aspartic acid measurements are the most suitable for racemization dating of bone because of their superior analytical precision. ?? 1979.

The consumer quality index anthroposophic healthcare: a construction and validation study.

PubMed

Koster, Evi B; Ong, Rob R S; Heybroek, Rachel; Delnoij, Diana M J; Baars, Erik W

2014-04-02

Accounting for the patients' perspective on quality of care has become increasingly important in the development of Evidence Based Medicine as well as in governmental policies. In the Netherlands the Consumer Quality (CQ) Index has been developed to measure the quality of care from the patients' perspective in different healthcare sectors in a standardized manner. Although the scientific accountability of anthroposophic healthcare as a form of integrative medicine is growing, patient experiences with anthroposophic healthcare have not been measured systematically. In addition, the specific anthroposophic aspects are not measured by means of existing CQ Indexes. To enable accountability of quality of the anthroposophic healthcare from the patients' perspective the aim of this study is the construction and validation of a CQ Index for anthroposophic healthcare. Construction in three phases: Phase 1. Determining anthroposophic quality aspects: literature study and focus groups. Phase 2. Adding new questions and validating the new questionnaire. Research population: random sample from 7910 patients of 22 anthroposophic GPs. survey, mixed mode by means of the Dillman method. Measuring instrument: experience questionnaire: CQ Index General Practice (56 items), added with 27 new anthroposophic items added and an item-importance questionnaire (anthroposophic items only). Factor analysis, scale construction, internal consistency (Chronbach's Alpha), inter-item-correlation, discriminative ability (Intra Class Correlation) and inter-factor-correlations. Phase 3. Modulation and selection of new questions based on results. Criteria of retaining items: general: a limited amount of items, statistical: part of a reliable scale and inter-item-correlation <0,7, and theoretical. Phase 1. 27 anthroposophic items. Phase 2. Two new anthroposophic scales: Scale AntroposophicTreatmentGP: seven items, Alpha=0,832, ICC=4,2 Inter-factor-correlation with existing GP-scales range from r=0,24 (Accessibility) to r=0,56 (TailoredCare). Scale InteractionalStyleGP: five items, Alpha=0,810, ICC=5,8, Inter-factor-correlation with existing GP-scales range from r=0,32 (Accessibility) to r=0,76 (TailoredCare). Inter-factor-correlation between new scales: r=0,50. Phase 3: Adding both scales and four single items. Removing eleven items and reformulating two items. The CQ Index Anthroposophic Healthcare measures patient experiences with anthroposophic GP's validly and reliably. Regarding the inter-factor-correlations anthroposophic quality aspects from the patients' perspective are mostly associated with individually tailored care and patient centeredness.

Harmonisation of seven common enzyme results through EQA.

PubMed

Weykamp, Cas; Franck, Paul; Gunnewiek, Jacqueline Klein; de Jonge, Robert; Kuypers, Aldy; van Loon, Douwe; Steigstra, Herman; Cobbaert, Christa

2014-11-01

Equivalent results between different laboratories enable optimal patient care and can be achieved with harmonisation. We report on EQA-initiated national harmonisation of seven enzymes using commutable samples. EQA samples were prepared from human serum spiked with human recombinant enzymes. Target values were assigned with the IFCC Reference Measurement Procedures. The same samples were included at four occasions in the EQA programmes of 2012 and 2013. Laboratories were encouraged to report IFCC traceable results. A parallel study was done to confirm commutability of the samples. Of the 223 participating laboratories, 95% reported IFCC traceable results, ranging from 98% (ASAT) to 87% (amylase). Users of Roche and Siemens (97%) more frequently reported in IFCC traceable results than users of Abbott (91%), Beckman (90%), and Olympus (87%). The success of harmonisation, expressed as the recovery of assigned values and the inter-laboratory CV was: ALAT (recovery 100%; inter-lab CV 4%), ASAT (102%; 4%), LD (98%; 3%), CK (101%; 5%), GGT (98%; 4%), AP (96%; 6%), amylase (99%; 4%). There were no significant differences between the manufacturers. Commutability was demonstrated in the parallel study. Equal results in the same sample in the 2012 and 2013 EQA programmes demonstrated stability of the samples. The EQA-initiated national harmonisation of seven enzymes, using stable, commutable human serum samples, spiked with human recombinant enzymes, and targeted with the IFCC Reference Measurement Procedures, was successful in terms of implementation of IFCC traceable results (95%), recovery of the target (99%), and inter-laboratory CV (4%).

Inter-laboratory comparison of the in vivo comet assay including three image analysis systems.

PubMed

Plappert-Helbig, Ulla; Guérard, Melanie

2015-12-01

To compare the extent of potential inter-laboratory variability and the influence of different comet image analysis systems, in vivo comet experiments were conducted using the genotoxicants ethyl methanesulfonate and methyl methanesulfonate. Tissue samples from the same animals were processed and analyzed-including independent slide evaluation by image analysis-in two laboratories with extensive experience in performing the comet assay. The analysis revealed low inter-laboratory experimental variability. Neither the use of different image analysis systems, nor the staining procedure of DNA (propidium iodide vs. SYBR® Gold), considerably impacted the results or sensitivity of the assay. In addition, relatively high stability of the staining intensity of propidium iodide-stained slides was found in slides that were refrigerated for over 3 months. In conclusion, following a thoroughly defined protocol and standardized routine procedures ensures that the comet assay is robust and generates comparable results between different laboratories. © 2015 Wiley Periodicals, Inc.

Analysis of tacrolimus and creatinine from a single dried blood spot using liquid chromatography tandem mass spectrometry.

PubMed

Koop, Dennis R; Bleyle, Lisa A; Munar, Myrna; Cherala, Ganesh; Al-Uzri, Amira

2013-05-01

Long term therapeutic drug monitoring and assessment of renal function are required in renal transplant recipients on immunosuppressant therapy such as tacrolimus. Dry blood spots (DBS) have been used successfully in the clinic for many years and offers a convenient, simple and non-invasive method for repeated blood tests. We developed and performed a preliminary validation of a method for the analysis of tacrolimus and creatinine from a single DBS using liquid chromatography-tandem mass spectrometric (LC-MS/MS). Tacrolimus and creatinine were extracted from a 6mm punch with a mixture of methanol/acetonitrile containing ascomycin and deuterated creatinine as internal standards. A 10 μl aliquot of the extract was analyzed directly after dilution for creatinine with normal phase high performance liquid chromatography and multiple reaction monitoring. The remainder of the extract was processed and analyzed for tacrolimus. The lower limit of quantification for tacrolimus was 1 ng/ml with accuracy of 0.34% bias and precision (CV) of 11.1%. The precision ranged from 1.33% to 7.68% and accuracy from -4.44% to 11.6% bias for the intra- and inter-day analysis. The lower limit of quantification of creatinine was 0.01 mg/dL with precision of 7.94%. Accuracy was based on recovery of additional creatinine spiked into whole blood samples and ranged from -2.45% bias at 5 mg/dL to 3.75% bias at 0.5 mg/dL. Intra- and inter-day precision was from 3.48 to 4.11%. The assay was further validated with DBS prepared from pediatric renal transplant recipients. There was excellent correlation between the levels of tacrolimus and creatinine obtained from the clinical laboratory and the DBS method developed. After additional validation, this assay may have a significant impact on compliance with medication intake as well as potentially lowering the cost associated with intravenous blood draws in clinical laboratories. Copyright © 2013 Elsevier B.V. All rights reserved.

Optoelectronic devices product assurance guideline for space application

NASA Astrophysics Data System (ADS)

Bensoussan, A.; Vanzi, M.

2017-11-01

New opportunities are emerging for the implementation of hardware sub-systems based on OptoElectronic Devices (OED) for space application. Since the end of this decade the main players for space systems namely designers and users including Industries, Agencies, Manufacturers and Laboratories are strongly demanding of adequate strategies to qualify and validate new optoelectronics products and sub-systems [1]. The long term space application mission will require to address either inter-satellite link (free space communication, positioning systems, tracking) or intra-satellite connectivity/flexibility/reconfigurability or high volume of data transfer between equipment installed into payload.

Convergent Validity, Concurrent Validity, and Diagnostic Accuracy of the interRAI Depression Rating Scale.

PubMed

Penny, Katherine; Barron, Alex; Higgins, Ann-Marie; Gee, Susan; Croucher, Matthew; Cheung, Gary

2016-09-19

Depression Rating Scale (DRS) is one of the clinical outcome measures of the International Resident Assessment Instrument (interRAI) assessment. The primary aim of this study is to investigate the diagnostic accuracy and concurrent validity of the 3-day assessment window version of the DRS. The performance of DRS was compared with a gold standard clinical diagnosis of depression in 92 patients (age ≥65) who had interRAI version 9.1 Home Care assessment completed within 30 days of discharge from psychogeriatric inpatient care or memory clinic assessment. The DRS had poor diagnostic accuracy for depression diagnosis with an area under the curve of 0.68 (95% confidence interval [CI] = 0.57-0.77). The DRS score had a poor to moderate correlation with the Health of the Nation Outcome Scale 65+ depression item score (r s = 0.30, 95% CI = 0.09-0.48, P = .006). This study and the existing literature raise concerns that the DRS is not an adequate measure of depression. © The Author(s) 2016.

Schedule for personality assessment from notes and documents (SPAN-DOC): Preliminary validation, links to the ICD-11 classification of personality disorder, and use in eating disorders.

PubMed

Kim, Youl-Ri; Tyrer, Peter; Lee, Hong-Seock; Kim, Sung-Gon; Connan, Frances; Kinnaird, Emma; Olajide, Kike; Crawford, Mike

2016-05-01

The underlying core of personality is insufficiently assessed by any single instrument. This has led to the development of instruments adapted for written records in the assessment of personality disorder. To test the construct validity and inter-rater reliability of a new personality assessment method. This study (four parts) assessed the construct validity of the Schedule for Personality Assessment from Notes and Documents (SPAN-DOC), a dimensional assessment from clinical records. We examined inter-rater reliability using case vignettes (Part 1) and convergent validity in three ways: by comparison with NEO Five-Factor Inventory in 130 Korean patients (Part 2), with agreed ICD-11 personality severity levels in two populations (Part 3) and determining its use in assessing the personality status in 90 British patients with eating disorders (Part 4). Internal consistency (alpha = .90) and inter-rater reliability (intraclass correlation coefficient ≥ .88) were satisfactory. Each factor in the five-factor model of personality was correlated with conceptually valid SPAN-DOC variables. The SPAN-DOC domain traits in those with eating disorders were categorized into 3 clusters: self-aggrandisement, emotionally unstable, and anxious/dependent. This study provides preliminary support for the usefulness of SPAN-DOC in the assessment of personality disorder. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Reliability and Concurrent Validity of Dynamic Rotator Stability Test-A Cross Sectional study.

PubMed

Binoy Mathew, K V; Eapen, Charu; Kumar, P Senthil

2012-01-01

To find intra rater and inter rater reliability of Dynamic Rotator Stability Test (DRST) and to find concurrent validity of Dynamic Rotator Stability Test (DRST) with University of Pennsylvania Shoulder Score (PENN) Scale. 40 subjects of either gender between the age group of 18-70 with painful shoulder conditions of musculoskeletal origin was selected through convenient sampling. Tester 1 and tester 2 administered DRST and PENN scale randomly. In a subgroup of 20 subjects DRST was administered by both the testers to find the inter rater reliability. 180° Standard Universal Goniometer was used to take measurements. For intra-rater reliability, all the test variables were showing highly significant correlation (p=.94 - 1). For inter -rater, with tester 2, test variables like position, ROM, force, direction of abnormal translation, pain during the test, compensatory movement during test were found to be significant (p=.71-1).only some variables of DRST showed significant correlation with PENN scale (P=.320-.450). Dynamic Rotator Stability Test has good intra rater and moderate inter rater reliability. Concurrent validity of Dynamic Rotator Stability Test was found to be poor when compared to PENN Shoulder Score.

Modern modeling techniques had limited external validity in predicting mortality from traumatic brain injury.

PubMed

van der Ploeg, Tjeerd; Nieboer, Daan; Steyerberg, Ewout W

2016-10-01

Prediction of medical outcomes may potentially benefit from using modern statistical modeling techniques. We aimed to externally validate modeling strategies for prediction of 6-month mortality of patients suffering from traumatic brain injury (TBI) with predictor sets of increasing complexity. We analyzed individual patient data from 15 different studies including 11,026 TBI patients. We consecutively considered a core set of predictors (age, motor score, and pupillary reactivity), an extended set with computed tomography scan characteristics, and a further extension with two laboratory measurements (glucose and hemoglobin). With each of these sets, we predicted 6-month mortality using default settings with five statistical modeling techniques: logistic regression (LR), classification and regression trees, random forests (RFs), support vector machines (SVM) and neural nets. For external validation, a model developed on one of the 15 data sets was applied to each of the 14 remaining sets. This process was repeated 15 times for a total of 630 validations. The area under the receiver operating characteristic curve (AUC) was used to assess the discriminative ability of the models. For the most complex predictor set, the LR models performed best (median validated AUC value, 0.757), followed by RF and support vector machine models (median validated AUC value, 0.735 and 0.732, respectively). With each predictor set, the classification and regression trees models showed poor performance (median validated AUC value, <0.7). The variability in performance across the studies was smallest for the RF- and LR-based models (inter quartile range for validated AUC values from 0.07 to 0.10). In the area of predicting mortality from TBI, nonlinear and nonadditive effects are not pronounced enough to make modern prediction methods beneficial. Copyright © 2016 Elsevier Inc. All rights reserved.

Inter-calibration and validation of observations from SAPHIR and ATMS instruments

NASA Astrophysics Data System (ADS)

Moradi, I.; Ferraro, R. R.

2015-12-01

We present the results of evaluating observations from microwave instruments aboard the Suomi National Polar-orbiting Partnership (NPP, ATMS instrument) and Megha-Tropiques (SAPHIR instrument) satellites. The study includes inter-comparison and inter-calibration of observations of similar channels from the two instruments, evaluation of the satellite data using high-quality radiosonde data from Atmospheric Radiation Measurement Program and GPS Radio Occultaion Observations from COSMIC mission, as well as geolocation error correction. The results of this study are valuable for generating climate data records from these instruments as well as for extending current climate data records from similar instruments such as AMSU-B and MHS to the ATMS and SAPHIR instruments. Reference: Moradi et al., Intercalibration and Validation of Observations From ATMS and SAPHIR Microwave Sounders. IEEE Transactions on Geoscience and Remote Sensing. 01/2015; DOI: 10.1109/TGRS.2015.2427165

The Factor Replicability of the Litwin and Stringer Organizational Climate Questionnaire: An Inter- and Intra-Organizational Assessment.

ERIC Educational Resources Information Center

Rogers, Evan D.; And Others

1980-01-01

Four recent factor analytic studies of the Litwin and Stringer Organizational Climate Questionnaire (LSOCQ) are compared. Although there is somewhat more intra- than inter-organizational replicability of factors, both comparisons raise considerable doubt about the validity of the Litwin and Stringer instrument. (Author)

Results of an inter and intra laboratory exercise on the assessment of complex autosomal DNA profiles.

PubMed

Benschop, Corina C G; Connolly, Edward; Ansell, Ricky; Kokshoorn, Bas

2017-01-01

The interpretation of complex DNA profiles may differ between laboratories and reporting officers, which can lead to discrepancies in the final reports. In this study, we assessed the intra and inter laboratory variation in DNA mixture interpretation for three European ISO17025-accredited laboratories. To this aim, 26 reporting officers analyzed five sets of DNA profiles. Three main aspects were considered: 1) whether the mixed DNA profiles met the criteria for comparison to a reference profile, 2) the actual result of the comparison between references and DNA profiling data and 3) whether the weight of the DNA evidence could be assessed. Similarity in answers depended mostly on the complexity of the tasks. This study showed less variation within laboratories than between laboratories which could be the result of differences between internal laboratory guidelines and methods and tools available. Results show the profile types for which the three laboratories report differently, which informs indirectly on the complexity threshold the laboratories employ. Largest differences between laboratories were caused by the methods available to assess the weight of the DNA evidence. This exercise aids in training forensic scientists, refining laboratory guidelines and explaining differences between laboratories in court. Undertaking more collaborative exercises in future may stimulate dialog and consensus regarding interpretation. For training purposes, DNA profiles of the mixed stains and questioned references are made available. Copyright © 2016 The Chartered Society of Forensic Sciences. Published by Elsevier Ireland Ltd. All rights reserved.

Development of the Therapist Empathy Scale.

PubMed

Decker, Suzanne E; Nich, Charla; Carroll, Kathleen M; Martino, Steve

2014-05-01

Few measures exist to examine therapist empathy as it occurs in session. A 9-item observer rating scale, called the Therapist Empathy Scale (TES), was developed based on Watson's (1999) work to assess affective, cognitive, attitudinal, and attunement aspects of therapist empathy. The aim of this study was to evaluate the inter-rater reliability, internal consistency, and construct and criterion validity of the TES. Raters evaluated therapist empathy in 315 client sessions conducted by 91 therapists, using data from a multi-site therapist training trial (Martino et al., 2010) in Motivational Interviewing (MI). Inter-rater reliability (ICC = .87 to .91) and internal consistency (Cronbach's alpha = .94) were high. Confirmatory factor analyses indicated some support for single-factor fit. Convergent validity was supported by correlations between TES scores and MI fundamental adherence (r range .50 to .67) and competence scores (r range .56 to .69). Discriminant validity was indicated by negative or nonsignificant correlations between TES and MI-inconsistent behavior (r range .05 to -.33). The TES demonstrates excellent inter-rater reliability and internal consistency. RESULTS indicate some support for a single-factor solution and convergent and discriminant validity. Future studies should examine the use of the TES to evaluate therapist empathy in different psychotherapy approaches and to determine the impact of therapist empathy on client outcome.

Effect of cryopreservation of peripheral blood mononuclear cells (PBMCs) on the variability of an antigen-specific memory B cell ELISpot.

PubMed

Trück, Johannes; Mitchell, Ruth; Thompson, Amber J; Morales-Aza, Begonia; Clutterbuck, Elizabeth A; Kelly, Dominic F; Finn, Adam; Pollard, Andrew J

2014-01-01

The ELISpot assay is used in vaccine studies for the quantification of antigen-specific memory B cells (B(MEM)), and can be performed using cryopreserved samples. The effects of cryopreservation on B(MEM) detection and the consistency of cultured ELISpot assays when performed by different operators or laboratories are unknown. In this study, blood was taken from healthy volunteers, and a cultured ELISpot assay was used to count B(MEM) specific for 2 routine vaccine antigens (diphtheria and tetanus toxoid). Results were assessed for intra- and inter-operator variation, and the effects of cryopreservation. Cryopreserved samples were shipped to a second laboratory in order to assess inter-laboratory variation. B(MEM) frequencies were very strongly correlated when comparing fresh and frozen samples processed by the same operator, and were also very strongly correlated when comparing 2 operators in the same laboratory. Results were slightly less consistent when samples were processed in different laboratories but correlation between the 2 measurements was still very strong. Although cell viability was reduced in some cryopreserved samples due to higher temperatures during transportation, B(MEM) could still be quantified. These results demonstrate the reproducibility of the ELISpot assay across operators and laboratories, and support the use of cryopreserved samples in future B(MEM) studies.

The Italian external quality assessment for RAS testing in colorectal carcinoma identifies methods-related inter-laboratory differences.

PubMed

Normanno, Nicola; Pinto, Carmine; Castiglione, Francesca; Fenizia, Francesca; Barberis, Massimo; Marchetti, Antonio; Fontanini, Gabriella; De Rosa, Gaetano; Taddei, Gian Luigi

2015-09-03

In 2014 the European Medicines Agency included exon 2, 3 and 4 KRAS and NRAS testing for the selection of metastatic colorectal cancer (mCRC) patients eligible for the therapy with anti-EGFR monoclonal antibodies. The Italian Association of Medical Oncology (AIOM) and the Italian Society of Pathology and Cytology (SIAPEC) organized an external quality assessment (EQA) scheme for CRC to evaluate inter-laboratory consistency and to ensure standardization of the results in the transition from KRAS to all-RAS testing. Ten formalin fixed paraffin embedded specimens including KRAS/NRAS (exons 2, 3, 4) and BRAF (codon 600) mutations were validated by three referral laboratories and sent to 88 participant centers. Molecular pathology sample reports were also requested to each laboratory. A board of assessors from AIOM and SIAPEC evaluated the results according to a predefined scoring system. The scheme was composed of two rounds. In the first round 36% of the 88 participants failed, with 23 centers having at least one false positive or false negative while 9 centers did not meet the deadline. The genotyping error rate was higher when Sanger sequencing was employed for testing as compared with pyrosequencing (3 vs 1.3%; p = 0.01; Pearson Chi Square test). In the second round, the laboratories improved their performance, with 23/32 laboratories passing the round. Overall, 79/88 participants passed the RAS EQA scheme. Standardized Human Genome Variation Society nomenclature was incorrectly used to describe the mutations identified and relevant variations were noticed in the genotype specification. The results of the Italian RAS EQA scheme indicate that the mutational analyses are performed with good quality in many Italian centers, although significant differences in the methods used were highlighted. The relatively high number of centers failing the first round underlines the fundamental role in continued education covered by EQA schemes.

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

Treesearch

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...

Inter-agency communication and operations capabilities during a hospital functional exercise: reliability and validity of a measurement tool.

PubMed

Savoia, Elena; Biddinger, Paul D; Burstein, Jon; Stoto, Michael A

2010-01-01

As proxies for actual emergencies, drills and exercises can raise awareness, stimulate improvements in planning and training, and provide an opportunity to examine how different components of the public health system would combine to respond to a challenge. Despite these benefits, there remains a substantial need for widely accepted and prospectively validated tools to evaluate agencies' and hospitals' performance during such events. Unfortunately, to date, few studies have focused on addressing this need. The purpose of this study was to assess the validity and reliability of a qualitative performance assessment tool designed to measure hospitals' communication and operational capabilities during a functional exercise. The study population included 154 hospital personnel representing nine hospitals that participated in a functional exercise in Massachusetts in June 2008. A 25-item questionnaire was developed to assess the following three hospital functional capabilities: (1) inter-agency communication; (2) communication with the public; and (3) disaster operations. Analyses were conducted to examine internal consistency, associations among scales, the empirical structure of the items, and inter-rater agreement. Twenty-two questions were retained in the final instrument, which demonstrated reliability with alpha coefficients of 0.83 or higher for all scales. A three-factor solution from the principal components analysis accounted for 57% of the total variance, and the factor structure was consistent with the original hypothesized domains. Inter-rater agreement between participants' self reported scores and external evaluators' scores ranged from moderate to good. The resulting 22-item performance measurement tool reliably measured hospital capabilities in a functional exercise setting, with preliminary evidence of concurrent and criterion-related validity.

Norwegian version of the rating anxiety in dementia scale (RAID-N): a validity and reliability study.

PubMed

Goyal, Alka R; Bergh, Sverre; Engedal, Knut; Kirkevold, Marit; Kirkevold, Øyvind

2017-12-01

Dementia-specific anxiety scales in the Norwegian language are lacking; the aim of this study was to investigate the validity and inter-rater reliability of a Norwegian version of the Rating Anxiety in Dementia (RAID-N) scale. The validity of the RAID-N was tested in a sample of 101 patients with dementia from seven Norwegian nursing homes. One psychogeriatrician (n = 50) or a physician with long experience with nursing home patients (n = 51) 'blind' to the RAID-N score diagnosed anxiety according to DSM-5 criteria of generalised anxiety disorder (GAD). A receiver operating characteristic (ROC) analysis assessed the best cut-off point for the RAID-N, and the area under the curve (AUC) was calculated. Inter-rater reliability was tested in a subgroup of 53 patients by intraclass correlation (ICC) and Cohen's kappa. Twenty-eight of 101 (27.7%) met the GAD criteria. The mean RAID-N score for patients with GAD was 16.1 (SD 6.3) and without GAD, 8.8 (SD 6.5) (p < 0.001). A cut-off score of ≥12 on the RAID-N gave a sensitivity of 82.1%, specificity of 70.0%, and 73.3% accuracy in identifying clinically significant GAD in patients with dementia. Inter-rater reliability on overall RAID-N items was good (ICC = 0.82), Cohen's kappa was 0.58 for total RAID-N score, with satisfactory internal consistency (Cronbach's alpha = 0.81). The RAID-N has fairly good validity and inter-rater reliability, and could be useful to assess GAD in patients with dementia. Further studies should investigate the optimal RAID-N cut-off score in different settings.

Psychometric evaluation of a motor control test battery of the craniofacial region.

PubMed

von Piekartz, H; Stotz, E; Both, A; Bahn, G; Armijo-Olivo, S; Ballenberger, N

2017-12-01

The primary objective of this study was to determine the structural and known-group validity as well as the inter-rater reliability of a test battery to evaluate the motor control of the craniofacial region. Seventy volunteers without TMD and 25 subjects with TMD (Axes I) per the DC/TMD were asked to execute a test battery consisting of eight tests. The tests were video-taped in the same sequence in a standardised manner. Two experienced physical therapists participated in this study as blinded assessors. We used exploratory factor analysis to identify the underlying component structure of the eight tests. Internal consistency (Cronbach's α), inter-rater reliability (intra-class correlation coefficient) and construct validity (ie, hypothesis testing-known-group validity) (receiver operating curves) were also explored for the test battery. The structural validity showed the presence of one factor underlying the construct of the test battery. The internal consistency was excellent (0.90) as well as the inter-rater reliability. All values of reliability were close to 0.9 or above indicating very high inter-rater reliability. The area under the curve (AUC) was 0.93 for rater 1 and 0.94 for rater two, respectively, indicating excellent discrimination between subjects with TMD and healthy controls. The results of the present study support the psychometric properties of test battery to measure motor control of the craniofacial region when evaluated through videotaping. This test battery could be used to differentiate between healthy subjects and subjects with musculoskeletal impairments in the cervical and oro-facial regions. In addition, this test battery could be used to assess the effectiveness of management strategies in the craniofacial region. © 2017 John Wiley & Sons Ltd.

Comparison of Hepatic 2D Sandwich Cultures and 3D Spheroids for Long-term Toxicity Applications: A Multicenter Study

PubMed Central

Bell, Catherine C; Dankers, Anita C A; Sison-Young, Rowena; Jenkins, Roz; Rowe, Cliff; Goldring, Chris E; Park, Kevin; Regan, Sophie L; Walker, Tracy; Schofield, Chris; Baze, Audrey; Foster, Alison J; Williams, Dominic P; van de Ven, Amy W M; Jacobs, Frank; van Houdt, Jos; Lähteenmäki, Tuula; Snoeys, Jan; Juhila, Satu; Richert, Lysiane; Ingelman-Sundberg, Magnus

2018-01-01

Abstract Primary human hepatocytes (PHHs) are commonly used for in vitro studies of drug-induced liver injury. However, when cultured as 2D monolayers, PHH lose crucial hepatic functions within hours. This dedifferentiation can be ameliorated when PHHs are cultured in sandwich configuration (2Dsw), particularly when cultures are regularly re-overlaid with extracellular matrix, or as 3D spheroids. In this study, the 6 participating laboratories evaluated the robustness of these 2 model systems made from cryopreserved PHH from the same donors considering both inter-donor and inter-laboratory variability and compared their suitability for use in repeated-dose toxicity studies using 5 different hepatotoxins with different toxicity mechanisms. We found that expression levels of proteins involved in drug absorption, distribution, metabolism, and excretion, as well as catalytic activities of 5 different CYPs, were significantly higher in 3D spheroid cultures, potentially affecting the exposure of the cells to drugs and their metabolites. Furthermore, global proteomic analyses revealed that PHH in 3D spheroid configuration were temporally stable whereas proteomes from the same donors in 2Dsw cultures showed substantial alterations in protein expression patterns over the 14 days in culture. Overall, spheroid cultures were more sensitive to the hepatotoxic compounds investigated, particularly upon long-term exposures, across testing sites with little inter-laboratory or inter-donor variability. The data presented here suggest that repeated-dosing regimens improve the predictivity of in vitro toxicity assays, and that PHH spheroids provide a sensitive and robust system for long-term mechanistic studies of drug-induced hepatotoxicity, whereas the 2Dsw system has a more dedifferentiated phenotype and lower sensitivity to detect hepatotoxicity. PMID:29329425

Validation of different pediatric triage systems in the emergency department

PubMed Central

Aeimchanbanjong, Kanokwan; Pandee, Uthen

2017-01-01

BACKGROUND: Triage system in children seems to be more challenging compared to adults because of their different response to physiological and psychosocial stressors. This study aimed to determine the best triage system in the pediatric emergency department. METHODS: This was a prospective observational study. This study was divided into two phases. The first phase determined the inter-rater reliability of five triage systems: Manchester Triage System (MTS), Emergency Severity Index (ESI) version 4, Pediatric Canadian Triage and Acuity Scale (CTAS), Australasian Triage Scale (ATS), and Ramathibodi Triage System (RTS) by triage nurses and pediatric residents. In the second phase, to analyze the validity of each triage system, patients were categorized as two groups, i.e., high acuity patients (triage level 1, 2) and low acuity patients (triage level 3, 4, and 5). Then we compared the triage acuity with actual admission. RESULTS: In phase I, RTS illustrated almost perfect inter-rater reliability with kappa of 1.0 (P<0.01). ESI and CTAS illustrated good inter-rater reliability with kappa of 0.8–0.9 (P<0.01). Meanwhile, ATS and MTS illustrated moderate to good inter-rater reliability with kappa of 0.5–0.7 (P<0.01). In phase II, we included 1 041 participants with average age of 4.7±4.2 years, of which 55% were male and 45% were female. In addition 32% of the participants had underlying diseases, and 123 (11.8%) patients were admitted. We found that ESI illustrated the most appropriate predicting ability for admission with sensitivity of 52%, specificity of 81%, and AUC 0.78 (95%CI 0.74–0.81). CONCLUSION: RTS illustrated almost perfect inter-rater reliability. Meanwhile, ESI and CTAS illustrated good inter-rater reliability. Finally, ESI illustrated the appropriate validity for triage system. PMID:28680520

Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study

PubMed Central

Perraton, Luke G.; Bower, Kelly J.; Adair, Brooke; Pua, Yong-Hao; Williams, Gavin P.; McGaw, Rebekah

2015-01-01

Introduction Hand-held dynamometry (HHD) has never previously been used to examine isometric muscle power. Rate of force development (RFD) is often used for muscle power assessment, however no consensus currently exists on the most appropriate method of calculation. The aim of this study was to examine the reliability of different algorithms for RFD calculation and to examine the intra-rater, inter-rater, and inter-device reliability of HHD as well as the concurrent validity of HHD for the assessment of isometric lower limb muscle strength and power. Methods 30 healthy young adults (age: 23±5yrs, male: 15) were assessed on two sessions. Isometric muscle strength and power were measured using peak force and RFD respectively using two HHDs (Lafayette Model-01165 and Hoggan microFET2) and a criterion-reference KinCom dynamometer. Statistical analysis of reliability and validity comprised intraclass correlation coefficients (ICC), Pearson correlations, concordance correlations, standard error of measurement, and minimal detectable change. Results Comparison of RFD methods revealed that a peak 200ms moving window algorithm provided optimal reliability results. Intra-rater, inter-rater, and inter-device reliability analysis of peak force and RFD revealed mostly good to excellent reliability (coefficients ≥ 0.70) for all muscle groups. Concurrent validity analysis showed moderate to excellent relationships between HHD and fixed dynamometry for the hip and knee (ICCs ≥ 0.70) for both peak force and RFD, with mostly poor to good results shown for the ankle muscles (ICCs = 0.31–0.79). Conclusions Hand-held dynamometry has good to excellent reliability and validity for most measures of isometric lower limb strength and power in a healthy population, particularly for proximal muscle groups. To aid implementation we have created freely available software to extract these variables from data stored on the Lafayette device. Future research should examine the reliability and validity of these variables in clinical populations. PMID:26509265

Review Over a 3-Year Period of European Union Proficiency Tests for Detection of Staphylococcal Enterotoxins in Food Matrices.

PubMed

Nia, Yacine; Mutel, Isabelle; Assere, Adrien; Lombard, Bertrand; Auvray, Frederic; Hennekinne, Jacques-Antoine

2016-04-13

Staphylococcal food poisoning outbreaks are a major cause of foodborne illnesses in Europe and their notifications have been mandatory since 2005. Even though the European regulation on microbiological criteria for food defines a criterion on staphylococcal enterotoxin (SE) only in cheese and dairy products, European Food Safety Authority (EFSA) data reported that various types of food matrices are involved in staphylococcal food poisoning outbreaks. The European Screening Method (ESM) of European Union Reference Laboratory for Coagulase Positive Staphylococci (EURL CPS) was validated in 2011 for SE detection in food matrices and is currently the official method used for screening purposes in Europe. In this context, EURLCPS is annually organizing Inter-Laboratory Proficiency Testing Trials (ILPT) to evaluate the competency of the European countries' National Reference Laboratories (NRLs) to analyse SE content in food matrices. A total of 31 NRLs representing 93% of European countries participated in these ILPTs. Eight food matrices were used for ILPT over the period 2013-2015, including cheese, freeze-dried cheese, tuna, mackerel, roasted chicken, ready-to-eat food, milk, and pastry. Food samples were spiked with four SE types (i.e., SEA, SEC, SED, and SEE) at various concentrations. Homogeneity and stability studies showed that ILPT samples were both homogeneous and stable. The analysis of results obtained by participants for a total of 155 blank and 620 contaminated samples allowed for evaluation of trueness (>98%) and specificity (100%) of ESM. Further to the validation study of ESM carried out in 2011, these three ILPTs allowed for the assessment of the proficiency of the NRL network and the performance of ESM on a large variety of food matrices and samples. The ILPT design presented here will be helpful for the organization of ILPT on SE detection by NRLs or other expert laboratories.

Trueness and precision of the real-time RT-PCR method for quantifying the chronic bee paralysis virus genome in bee homogenates evaluated by a comparative inter-laboratory study.

PubMed

Schurr, Frank; Cougoule, Nicolas; Rivière, Marie-Pierre; Ribière-Chabert, Magali; Achour, Hamid; Ádám, Dán; Castillo, Carlos; de Graaf, Dirk C; Forsgren, Eva; Granato, Anna; Heinikainen, Sirpa; Jurovčíková, Júlia; Kryger, Per; Manson, Christine; Ménard, Marie-Françoise; Perennes, Stéphane; Schäfer, Marc O; Ibañez, Elena San Miguel; Silva, João; Gajger, Ivana Tlak; Tomkies, Victoria; Toplak, Ivan; Viry, Alain; Zdańska, Dagmara; Dubois, Eric

2017-10-01

The Chronic bee paralysis virus (CBPV) is the aetiological agent of chronic bee paralysis, a contagious disease associated with nervous disorders in adult honeybees leading to massive mortalities in front of the hives. Some of the clinical signs frequently reported, such as trembling, may be confused with intoxication syndromes. Therefore, laboratory diagnosis using real-time PCR to quantify CBPV loads is used to confirm disease. Clinical signs of chronic paralysis are usually associated with viral loads higher than 10 8 copies of CBPV genome copies per bee (8 log 10 CBPV/bee). This threshold is used by the European Union Reference Laboratory for Bee Health to diagnose the disease. In 2015, the accuracy of measurements of three CBPV loads (5, 8 and 9 log 10 CBPV/bee) was assessed through an inter-laboratory study. Twenty-one participants, including 16 European National Reference Laboratories, received 13 homogenates of CBPV-infected bees adjusted to the three loads. Participants were requested to use the method usually employed for routine diagnosis. The quantitative results (n=270) were analysed according to international standards NF ISO 13528 (2015) and NF ISO 5725-2 (1994). The standard deviations of measurement reproducibility (S R ) were 0.83, 1.06 and 1.16 at viral loads 5, 8 and 9 log 10 CBPV/bee, respectively. The inter-laboratory confidence of viral quantification (+/- 1.96S R ) at the diagnostic threshold (8 log 10 CBPV/bee) was+/- 2.08 log 10 CBPV/bee. These results highlight the need to take into account the confidence of measurements in epidemiological studies using results from different laboratories. Considering this confidence, viral loads over 6 log 10 CBPV/bee may be considered to indicate probable cases of chronic paralysis. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

Inter-laboratory exercise on antibiotic drugs analysis in aqueous samples.

PubMed

Roig, B; Brogat, M; Mompelat, S; Leveque, J; Cadiere, A; Thomas, O

2012-08-30

An inter-laboratory exercise was organized under the PHARMAS EU project, by the Advanced School of Public Health (EHESP), in order to evaluate the performances of analytical methods for the measurement of antibiotics in waters (surface and tap). This is the first time such an exercise on antibiotics has been organized in Europe, using different kinds of analytical methods and devices. In this exercise thirteen laboratories from five countries (Canada, France, Italy, the Netherlands and Portugal) participated, and a total number of 78 samples were distributed. During the exercise, 2 testing samples (3 bottles of each) prepared from tap water and river water, respectively, spiked with antibiotics, were sent to participants and analyzed over a period of one month. A final number of 77 (98.7%) testing samples were considered. Depending on substances studied by each participant, 305 values in duplicate were collected, with the results for each sample being expressed as the target concentration. A statistical study was initiated using 611 results. The mean value, standard deviation, coefficient of variation, standard uncertainty of the mean, median, the minimum and maximum values of each series as well as the 95% confidence interval were obtained from each participant laboratory. In this exercise, 36 results (6% of accounted values) were outliers according to the distribution over the median (box plot). The outlier results were excluded. In order to establish the stability of testing samples in the course of the exercise, differences between variances obtained for every type of sample at different intervals were evaluated. The results showed no representative variations and it can be considered that all samples were stable during the exercise. The goals of this inter-laboratory study were to assess results variability when analysis is conducted by different laboratories, to evaluate the influence of different matrix samples, and to determine the rate at which participating laboratories successfully completed the tests initiated. Copyright © 2012 Elsevier B.V. All rights reserved.

How consistent are we? Inter-laboratory comparison for male fathead minnows exposed to 17α-ethinylestradiol

EPA Science Inventory

Transcriptomic approaches are widely used to examine effects of aquatic contaminants in both laboratory and field studies. Fundamental questions remain however for defining the limits of the technology and how it may be used in environmental monitoring programs. Uncertainties exi...

Additional Evidence for the Reliability and Validity of the Student Risk Screening Scale at the High School Level: A Replication and Extension

ERIC Educational Resources Information Center

Lane, Kathleen Lynne; Oakes, Wendy P.; Ennis, Robin Parks; Cox, Meredith Lucille; Schatschneider, Christopher; Lambert, Warren

2013-01-01

This study reports findings from a validation study of the Student Risk Screening Scale for use with 9th- through 12th-grade students (N = 1854) attending a rural fringe school. Results indicated high internal consistency, test-retest stability, and inter-rater reliability. Predictive validity was established across two academic years, with Spring…

Population Pharmacokinetics of Intravenous Methotrexate in Patients with Hematological Malignancies: Utilization of Routine Clinical Monitoring Parameters.

PubMed

Nader, Ahmed; Zahran, Noran; Alshammaa, Aya; Altaweel, Heba; Kassem, Nancy; Wilby, Kyle John

2017-04-01

Clinical response to methotrexate in cancer is variable and depends on several factors including serum drug exposure. This study aimed to develop a population pharmacokinetic model describing methotrexate disposition in cancer patients using retrospective chart review data available from routine clinical practice. A retrospective review of medical records was conducted for cancer patients in Qatar. Relevant data (methotrexate dosing/concentrations from multiple occasions, patient history, and laboratory values) were extracted and analyzed using NONMEM VII ® . A population pharmacokinetic model was developed and used to estimate inter-individual and inter-occasion variability terms on methotrexate pharmacokinetic parameters, as well as patient factors affecting methotrexate pharmacokinetics. Methotrexate disposition was described by a two-compartment model with clearance (CL) of 15.7 L/h and central volume of distribution (V c ) of 79.2 L. Patient weight and hematocrit levels were significant covariates on methotrexate V c and CL, respectively. Methotrexate CL changed by 50 % with changes in hematocrit levels from 23 to 50 %. Inter-occasion variability in methotrexate CL was estimated for patients administered the drug on multiple occasions (48 and 31 % for 2nd and 3rd visits, respectively). Therapeutic drug monitoring data collected during routine clinical practice can provide a useful tool for understanding factors affecting methotrexate pharmacokinetics. Patient weight and hematocrit levels may play a clinically important role in determining methotrexate serum exposure and dosing requirements. Future prospective studies are needed to validate results of the developed model and evaluate its usefulness to predict methotrexate exposure and optimize dosing regimens.

A multi-site comparison of in vivo safety pharmacology studies conducted to support ICH S7A & B regulatory submissions.

PubMed

Ewart, Lorna; Milne, Aileen; Adkins, Debbie; Benjamin, Amanda; Bialecki, Russell; Chen, Yafei; Ericsson, Ann-Christin; Gardner, Stacey; Grant, Claire; Lengel, David; Lindgren, Silvana; Lowing, Sarah; Marks, Louise; Moors, Jackie; Oldman, Karen; Pietras, Mark; Prior, Helen; Punton, James; Redfern, Will S; Salmond, Ross; Skinner, Matt; Some, Margareta; Stanton, Andrea; Swedberg, Michael; Finch, John; Valentin, Jean-Pierre

2013-01-01

Parts A and B of the ICH S7 guidelines on safety pharmacology describe the in vivo studies that must be conducted prior to first time in man administration of any new pharmaceutical. ICH S7A requires a consideration of the sensitivity and reproducibility of the test systems used. This could encompass maintaining a dataset of historical pre-dose values, power analyses, as well as a demonstration of acceptable model sensitivity and robust pharmacological validation. During the process of outsourcing safety pharmacology studies to Charles River Laboratories, AstraZeneca set out to ensure that models were performed identically in each facility and saw this as an opportunity to review the inter-laboratory variability of these essential models. The five in vivo studies outsourced were the conscious dog telemetry model for cardiovascular assessment, the rat whole body plethysmography model for respiratory assessment, the rat modified Irwin screen for central nervous system assessment, the rat charcoal meal study for gastrointestinal assessment and the rat metabolic cage study for assessment of renal function. Each study was validated with known reference compounds and data were compared across facilities. Statistical power was also calculated for each model. The results obtained indicated that each of the studies could be performed with comparable statistical power and could achieve a similar outcome, independent of facility. The consistency of results obtained from these models across multiple facilities was high thus providing confidence that the models can be run in different facilities and maintain compliance with ICH S7A and B. Copyright © 2013 Elsevier Inc. All rights reserved.

Chemometric and biological validation of a capillary electrophoresis metabolomic experiment of Schistosoma mansoni infection in mice.

PubMed

Garcia-Perez, Isabel; Angulo, Santiago; Utzinger, Jürg; Holmes, Elaine; Legido-Quigley, Cristina; Barbas, Coral

2010-07-01

Metabonomic and metabolomic studies are increasingly utilized for biomarker identification in different fields, including biology of infection. The confluence of improved analytical platforms and the availability of powerful multivariate analysis software have rendered the multiparameter profiles generated by these omics platforms a user-friendly alternative to the established analysis methods where the quality and practice of a procedure is well defined. However, unlike traditional assays, validation methods for these new multivariate profiling tools have yet to be established. We propose a validation for models obtained by CE fingerprinting of urine from mice infected with the blood fluke Schistosoma mansoni. We have analysed urine samples from two sets of mice infected in an inter-laboratory experiment where different infection methods and animal husbandry procedures were employed in order to establish the core biological response to a S. mansoni infection. CE data were analysed using principal component analysis. Validation of the scores consisted of permutation scrambling (100 repetitions) and a manual validation method, using a third of the samples (not included in the model) as a test or prediction set. The validation yielded 100% specificity and 100% sensitivity, demonstrating the robustness of these models with respect to deciphering metabolic perturbations in the mouse due to a S. mansoni infection. A total of 20 metabolites across the two experiments were identified that significantly discriminated between S. mansoni-infected and noninfected control samples. Only one of these metabolites, allantoin, was identified as manifesting different behaviour in the two experiments. This study shows the reproducibility of CE-based metabolic profiling methods for disease characterization and screening and highlights the importance of much needed validation strategies in the emerging field of metabolomics.

The Technical and Biological Reproducibility of Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) Based Typing: Employment of Bioinformatics in a Multicenter Study.

PubMed

Oberle, Michael; Wohlwend, Nadia; Jonas, Daniel; Maurer, Florian P; Jost, Geraldine; Tschudin-Sutter, Sarah; Vranckx, Katleen; Egli, Adrian

2016-01-01

The technical, biological, and inter-center reproducibility of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI TOF MS) typing data has not yet been explored. The aim of this study is to compare typing data from multiple centers employing bioinformatics using bacterial strains from two past outbreaks and non-related strains. Participants received twelve extended spectrum betalactamase-producing E. coli isolates and followed the same standard operating procedure (SOP) including a full-protein extraction protocol. All laboratories provided visually read spectra via flexAnalysis (Bruker, Germany). Raw data from each laboratory allowed calculating the technical and biological reproducibility between centers using BioNumerics (Applied Maths NV, Belgium). Technical and biological reproducibility ranged between 96.8-99.4% and 47.6-94.4%, respectively. The inter-center reproducibility showed a comparable clustering among identical isolates. Principal component analysis indicated a higher tendency to cluster within the same center. Therefore, we used a discriminant analysis, which completely separated the clusters. Next, we defined a reference center and performed a statistical analysis to identify specific peaks to identify the outbreak clusters. Finally, we used a classifier algorithm and a linear support vector machine on the determined peaks as classifier. A validation showed that within the set of the reference center, the identification of the cluster was 100% correct with a large contrast between the score with the correct cluster and the next best scoring cluster. Based on the sufficient technical and biological reproducibility of MALDI-TOF MS based spectra, detection of specific clusters is possible from spectra obtained from different centers. However, we believe that a shared SOP and a bioinformatics approach are required to make the analysis robust and reliable.

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

PubMed

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).

Inter-rater agreement of comorbid DSM-IV personality disorders in substance abusers.

PubMed

Hesse, Morten; Thylstrup, Birgitte

2008-05-17

Little is known about the inter-rater agreement of personality disorders in clinical settings. 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. 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. 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.

Assessing the environmental characteristics of cycling routes to school: a study on the reliability and validity of a Google Street View-based audit.

PubMed

Vanwolleghem, Griet; Van Dyck, Delfien; Ducheyne, Fabian; De Bourdeaudhuij, Ilse; Cardon, Greet

2014-06-10

Google Street View provides a valuable and efficient alternative to observe the physical environment compared to on-site fieldwork. However, studies on the use, reliability and validity of Google Street View in a cycling-to-school context are lacking. We aimed to study the intra-, inter-rater reliability and criterion validity of EGA-Cycling (Environmental Google Street View Based Audit - Cycling to school), a newly developed audit using Google Street View to assess the physical environment along cycling routes to school. Parents (n = 52) of 11-to-12-year old Flemish children, who mostly cycled to school, completed a questionnaire and identified their child's cycling route to school on a street map. Fifty cycling routes of 11-to-12-year olds were identified and physical environmental characteristics along the identified routes were rated with EGA-Cycling (5 subscales; 37 items), based on Google Street View. To assess reliability, two researchers performed the audit. Criterion validity of the audit was examined by comparing the ratings based on Google Street View with ratings through on-site assessments. Intra-rater reliability was high (kappa range 0.47-1.00). Large variations in the inter-rater reliability (kappa range -0.03-1.00) and criterion validity scores (kappa range -0.06-1.00) were reported, with acceptable inter-rater reliability values for 43% of all items and acceptable criterion validity for 54% of all items. EGA-Cycling can be used to assess physical environmental characteristics along cycling routes to school. However, to assess the micro-environment specifically related to cycling, on-site assessments have to be added.

Development and Validation of Targeted Next-Generation Sequencing Panels for Detection of Germline Variants in Inherited Diseases.

PubMed

Santani, Avni; Murrell, Jill; Funke, Birgit; Yu, Zhenming; Hegde, Madhuri; Mao, Rong; Ferreira-Gonzalez, Andrea; Voelkerding, Karl V; Weck, Karen E

2017-06-01

- The number of targeted next-generation sequencing (NGS) panels for genetic diseases offered by clinical laboratories is rapidly increasing. Before an NGS-based test is implemented in a clinical laboratory, appropriate validation studies are needed to determine the performance characteristics of the test. - To provide examples of assay design and validation of targeted NGS gene panels for the detection of germline variants associated with inherited disorders. - The approaches used by 2 clinical laboratories for the development and validation of targeted NGS gene panels are described. Important design and validation considerations are examined. - Clinical laboratories must validate performance specifications of each test prior to implementation. Test design specifications and validation data are provided, outlining important steps in validation of targeted NGS panels by clinical diagnostic laboratories.

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

PubMed

Reus, Astrid A; Reisinger, Kerstin; Downs, Thomas R; Carr, Gregory J; Zeller, Andreas; Corvi, Raffaella; Krul, Cyrille A M; Pfuhler, Stefan

2013-11-01

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 < 0.05) in DNA damage in every experiment. For the genotoxic carcinogen, 2,4-diaminotoluene, the overall result from all laboratories showed a smaller, but significant genotoxic response (P < 0.05). For cyclohexanone (CHN) (non-genotoxic in vitro and in vivo, and non-carcinogenic), an increase compared to the solvent control acetone was observed only in one laboratory. However, the response was not dose related and CHN was judged negative overall, as was p-nitrophenol (p-NP) (genotoxic in vitro but not in vivo and non-carcinogenic), which was the only compound showing clear cytotoxic effects. For p-NP, significant DNA damage generally occurred only at doses that were substantially cytotoxic (>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.

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

PubMed Central

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 < 0.05) in DNA damage in every experiment. For the genotoxic carcinogen, 2,4-diaminotoluene, the overall result from all laboratories showed a smaller, but significant genotoxic response (P < 0.05). For cyclohexanone (CHN) (non-genotoxic in vitro and in vivo, and non-carcinogenic), an increase compared to the solvent control acetone was observed only in one laboratory. However, the response was not dose related and CHN was judged negative overall, as was p-nitrophenol (p-NP) (genotoxic in vitro but not in vivo and non-carcinogenic), which was the only compound showing clear cytotoxic effects. For p-NP, significant DNA damage generally occurred only at doses that were substantially cytotoxic (>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

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

EPA Science Inventory

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...

A New Proxy Measurement Algorithm with Application to the Estimation of Vertical Ground Reaction Forces Using Wearable Sensors

PubMed Central

Billings, Stephen A.; Pavic, Aleksandar; Guo, Ling-Zhong

2017-01-01

Measurement of the ground reaction forces (GRF) during walking is typically limited to laboratory settings, and only short observations using wearable pressure insoles have been reported so far. In this study, a new proxy measurement method is proposed to estimate the vertical component of the GRF (vGRF) from wearable accelerometer signals. The accelerations are used as the proxy variable. An orthogonal forward regression algorithm (OFR) is employed to identify the dynamic relationships between the proxy variables and the measured vGRF using pressure-sensing insoles. The obtained model, which represents the connection between the proxy variable and the vGRF, is then used to predict the latter. The results have been validated using pressure insoles data collected from nine healthy individuals under two outdoor walking tasks in non-laboratory settings. The results show that the vGRFs can be reconstructed with high accuracy (with an average prediction error of less than 5.0%) using only one wearable sensor mounted at the waist (L5, fifth lumbar vertebra). Proxy measures with different sensor positions are also discussed. Results show that the waist acceleration-based proxy measurement is more stable with less inter-task and inter-subject variability than the proxy measures based on forehead level accelerations. The proposed proxy measure provides a promising low-cost method for monitoring ground reaction forces in real-life settings and introduces a novel generic approach for replacing the direct determination of difficult to measure variables in many applications. PMID:28937593

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

PubMed

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 (<5.56% on 1 H-MRS) in linear regression analysis. The 2.0 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.

A method to classify schizophrenia using inter-task spatial correlations of functional brain images.

PubMed

Michael, Andrew M; Calhoun, Vince D; Andreasen, Nancy C; Baum, Stefi A

2008-01-01

The clinical heterogeneity of schizophrenia (scz) and the overlap of self reported and observed symptoms with other mental disorders makes its diagnosis a difficult task. At present no laboratory-based or image-based diagnostic tool for scz exists and such tools are desired to support existing methods for more precise diagnosis. Functional magnetic resonance imaging (fMRI) is currently employed to identify and correlate cognitive processes related to scz and its symptoms. Fusion of multiple fMRI tasks that probe different cognitive processes may help to better understand hidden networks of this complex disorder. In this paper we utilize three different fMRI tasks and introduce an approach to classify subjects based on inter-task spatial correlations of brain activation. The technique was applied to groups of patients and controls and its validity was checked with the leave-one-out method. We show that the classification rate increases when information from multiple tasks are combined.

Multicentre evaluation of a direct agglutination test prototype kit (DAT-LPC) for diagnosis of visceral leishmaniasis.

PubMed

Oliveira, E; Oliveira, D; Cardoso, F A; Barbosa, J R; Marcelino, A P; Dutra, T; Araujo, T; Fernandes, L; Duque, D; Rabello, A

2017-12-01

In this study, we assessed the sensitivity, specificity, and diagnostic accuracy of a previously developed direct agglutination test (DAT) using a freeze-dried antigen derived from Leishmania infantum promastigotes and composed in a prototype kit for visceral leishmaniasis (VL) diagnosis, named DAT-LPC. To evaluate DAT-LPC reproducibility, the kit was used to analyse 207 serum samples from VL patients and 80 serum samples from patients with other parasitic infections or healthy subjects in four laboratories from different public health institutions in Brazil. DAT-LPC showed sensitivity between 96·2 and 99·5% (P = 0·14), specificity ranging from 96·2 to 97·5% (P = 0·95), and diagnostic accuracy ranging from 96·5 to 99% (P = 0·34). The inter-laboratory reproducibility of qualitative results was classified as excellent (κ index: 0·94-0·97). The reproducibility of the end-titre results in relation to the reference laboratory, ranged from 31 to 85%. These results demonstrate an excellent performance of the DAT-LPC, and validate it for the diagnosis of VL that could replace the immunofluorescent antibody test as the routine diagnostic test in the Brazilian public health system.

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

PubMed

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.

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI): Revision for Clinical Use, Content Validation, and Inter-rater Reliability.

PubMed

Rosenson, Robert S; Miller, Kate; Bayliss, Martha; Sanchez, Robert J; Baccara-Dinet, Marie T; Chibedi-De-Roche, Daniela; Taylor, Beth; Khan, Irfan; Manvelian, Garen; White, Michelle; Jacobson, Terry A

2017-04-01

The Statin-Associated Muscle Symptom Clinical Index (SAMS-CI) is a method for assessing the likelihood that a patient's muscle symptoms (e.g., myalgia or myopathy) were caused or worsened by statin use. The objectives of this study were to prepare the SAMS-CI for clinical use, estimate its inter-rater reliability, and collect feedback from physicians on its practical application. For content validity, we conducted structured in-depth interviews with its original authors as well as with a panel of independent physicians. Estimation of inter-rater reliability involved an analysis of 30 written clinical cases which were scored by a sample of physicians. A separate group of physicians provided feedback on the clinical use of the SAMS-CI and its potential utility in practice. Qualitative interviews with providers supported the content validity of the SAMS-CI. Feedback on the clinical use of the SAMS-CI included several perceived benefits (such as brevity, clear wording, and simple scoring process) and some possible concerns (workflow issues and applicability in primary care). The inter-rater reliability of the SAMS-CI was estimated to be 0.77 (confidence interval 0.66-0.85), indicating high concordance between raters. With additional provider feedback, a revised SAMS-CI instrument was created suitable for further testing, both in the clinical setting and in prospective validation studies. With standardized questions, vetted language, easily interpreted scores, and demonstrated reliability, the SAMS aims to estimate the likelihood that a patient's muscle symptoms were attributable to statins. The SAMS-CI may support better detection of statin-associated muscle symptoms in clinical practice, optimize treatment for patients experiencing muscle symptoms, and provide a useful tool for further clinical research.

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

PubMed

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.

The Assessment of Minor Neurological Dysfunction in Infancy Using the Touwen Infant Neurological Examination: Strengths and Limitations

ERIC Educational Resources Information Center

Hadders-Algra, Mijna; Heineman, Kirsten R.; Bos, Arend F.; Middelburg, Karin J.

2010-01-01

Aim: Little is known of minor neurological dysfunction (MND) in infancy. This study aimed to evaluate the inter-assessor reliability of the assessment of MND with the Touwen Infant Neurological Examination (TINE) and the construct and predictive validity of MND in infancy. Method: Inter-assessor agreement was determined in a sample of 40 infants…

Validation of a digital audio recording method for the objective assessment of cough in the horse.

PubMed

Duz, M; Whittaker, A G; Love, S; Parkin, T D H; Hughes, K J

2010-10-01

To validate the use of digital audio recording and analysis for quantification of coughing in horses. Part A: Nine simultaneous digital audio and video recordings were collected individually from seven stabled horses over a 1 h period using a digital audio recorder attached to the halter. Audio files were analysed using audio analysis software. Video and audio recordings were analysed for cough count and timing by two blinded operators on two occasions using a randomised study design for determination of intra-operator and inter-operator agreement. Part B: Seventy-eight hours of audio recordings obtained from nine horses were analysed once by two blinded operators to assess inter-operator repeatability on a larger sample. Part A: There was complete agreement between audio and video analyses and inter- and intra-operator analyses. Part B: There was >97% agreement between operators on number and timing of 727 coughs recorded over 78 h. The results of this study suggest that the cough monitor methodology used has excellent sensitivity and specificity for the objective assessment of cough in horses and intra- and inter-operator variability of recorded coughs is minimal. Crown Copyright 2010. Published by Elsevier India Pvt Ltd. All rights reserved.

INTER LABORATORY COMBAT HELMET BLUNT IMPACT TEST METHOD COMPARISON

DTIC Science & Technology

2018-03-26

HELMET BLUNT IMPACT TEST METHOD COMPARISON by Tony J. Kayhart Charles A. Hewitt and Jonathan Cyganik March 2018 Final...Report March 2016 – August 2017 Approved for public release; distribution is unlimited U.S. Army Natick Soldier Research ...INTER-LABORATORY COMBAT HELMET BLUNT IMPACT TEST METHOD COMPARISON 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR

RELIABILITY AND VALIDITY OF SUBJECTIVE ASSESSMENT OF LUMBAR LORDOSIS IN CONVENTIONAL RADIOGRAPHY.

PubMed

Ruhinda, E; Byanyima, R K; Mugerwa, H

2014-10-01

Reliability and validity studies of different lumbar curvature analysis and measurement techniques have been documented however there is limited literature on the reliability and validity of subjective visual analysis. Radiological assessment of lumbar lordotic curve aids in early diagnosis of conditions even before neurologic changes set in. To ascertain the level of reliability and validity of subjective assessment of lumbar lordosis in conventional radiography. A blinded, repeated-measures diagnostic test was carried out on lumbar spine x-ray radiographs. Radiology Department at Joint Clinical Research Centre (JCRC), Mengo-Kampala-Uganda. Seventy (70) lateral lumbar x-ray films were used for this study and were obtained from the archive of JCRC radiology department at Butikiro house, Mengo-Kampala. Poor observer agreement, both inter- and intra-observer, with kappa values of 0.16 was found. Inter-observer agreement was poorer than intra-observer agreement. Kappa values significantly rose when the lumbar lordosis was clustered into four categories without grading each abnormality. The results confirm that subjective assessment of lumbar lordosis has low reliability and validity. Film quality has limited influence on the observer reliability. This study further shows that fewer scale categories of lordosis abnormalities produce better observer reliability.

MCMEG: Simulations of both PDD and TPR for 6 MV LINAC photon beam using different MC codes

NASA Astrophysics Data System (ADS)

Fonseca, T. C. F.; Mendes, B. M.; Lacerda, M. A. S.; Silva, L. A. C.; Paixão, L.; Bastos, F. M.; Ramirez, J. V.; Junior, J. P. R.

2017-11-01

The Monte Carlo Modelling Expert Group (MCMEG) is an expert network specializing in Monte Carlo radiation transport and the modelling and simulation applied to the radiation protection and dosimetry research field. For the first inter-comparison task the group launched an exercise to model and simulate a 6 MV LINAC photon beam using the Monte Carlo codes available within their laboratories and validate their simulated results by comparing them with experimental measurements carried out in the National Cancer Institute (INCA) in Rio de Janeiro, Brazil. The experimental measurements were performed using an ionization chamber with calibration traceable to a Secondary Standard Dosimetry Laboratory (SSDL). The detector was immersed in a water phantom at different depths and was irradiated with a radiation field size of 10×10 cm2. This exposure setup was used to determine the dosimetric parameters Percentage Depth Dose (PDD) and Tissue Phantom Ratio (TPR). The validation process compares the MC calculated results to the experimental measured PDD20,10 and TPR20,10. Simulations were performed reproducing the experimental TPR20,10 quality index which provides a satisfactory description of both the PDD curve and the transverse profiles at the two depths measured. This paper reports in detail the modelling process using MCNPx, MCNP6, EGSnrc and Penelope Monte Carlo codes, the source and tally descriptions, the validation processes and the results.

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

PubMed Central

Clavijo, Alfonso; Freire de Carvalho, Mary H.; Orciari, Lillian A.; Velasco-Villa, Andres; Ellison, James A.; Greenberg, Lauren; Yager, Pamela A.; Green, Douglas B.; Vigilato, Marco A.; Cosivi, Ottorino; Del Rio-Vilas, Victor J.

2017-01-01

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. PMID:28369139

Emotional and Behavioral Screener: Test-Retest Reliability, Inter-Rater Reliability, and Convergent Validity

ERIC Educational Resources Information Center

Nordness, Philip D.; Epstein, Michael H.; Cullinan, Douglas; Pierce, Corey D.

2014-01-01

The Emotional and Behavioral Screener (EBS) is a universal screening instrument designed to identify students whose excessive problem behaviors put them at risk of the education disability category of emotional disturbance (ED). This article reports findings from three studies that address the reliability and validity of the EBS. Studies 1 and 2…

Validation of a multiplex electrochemiluminescent immunoassay platform in human and mouse samples

PubMed Central

Bastarache, J.A.; Koyama, T.; Wickersham, N.E; Ware, L.B.

2014-01-01

Despite the widespread use of multiplex immunoassays, there are very few scientific reports that test the accuracy and reliability of a platform prior to publication of experimental data. Our laboratory has previously demonstrated the need for new assay platform validation prior to use of biologic samples from large studies in order to optimize sample handling and assay performance. In this study, our goal was to test the accuracy and reproducibility of an electrochemiluminescent multiplex immunoassay platform (Meso Scale Discovery, MSD®) and compare this platform to validated, singleplex immunoassays (R&D Systems®) using actual study subject (human plasma and mouse bronchoalveolar lavage fluid (BALF) and plasma) samples. We found that the MSD platform performed well on intra- and inter-assay comparisons, spike and recovery and cross-platform comparisons. The mean intra-assay CV% and range for MSD was 3.49 (0.0-10.4) for IL-6 and 2.04 (0.1-7.9) for IL-8. The correlation between values for identical samples measured on both MSD and R&D was R=0.97 for both analytes. The mouse MSD assay had a broader range of CV% with means ranging from 9.5-28.5 depending on the analyte. The range of mean CV% was similar for single plex ELISAs at 4.3-23.7 depending on the analyte. Regardless of species or sample type, CV% was more variable at lower protein concentrations. In conclusion, we validated a multiplex electrochemiluminscent assay system and found that it has superior test characteristics in human plasma compared to mouse BALF and plasma. Both human and MSD assays compared favorably to well-validated singleplex ELISA's PMID:24768796

Intact cell mass spectrometry (ICMS) used to type methicillin-resistant Staphylococcus aureus: media effects and inter-laboratory reproducibility.

PubMed

Walker, J; Fox, A J; Edwards-Jones, V; Gordon, D B

2002-02-01

Intact cell mass spectrometry (ICMS) rapidly analyses the surface composition of microorganisms providing rapid, discriminatory fingerprints for identification and subtyping of important nosocomial pathogens such as methicillin resistant Staphylocccus aureus (MRSA). In this study, ICMS using matrix-assisted laser desorption ionisation time-of-flight mass spectrometry (MALDI TOF/MS) was assessed for the identification and subtyping of MRSA. An intra- and inter-laboratory reproducibility study was carried out and the effects of culture media (an important source of variation for ICMS) were also studied. Several media used for the cultural identification of MRSA were examined using a panel of well-characterised staphylococcal isolates (n=26). Six MRSA isolates were analysed over a 1-month period for intra-laboratory reproducibility on the same instrument and three different culture media. Spectra were consistent for each isolate between the four experiments on the same culture medium. Individual isolates produced different spectral profiles on different culture media. Spectra from organisms grown on Columbia blood agar contained more peaks (approximately 120) compared to Columbia agar (approximately 50) and methicillin mannitol salt agar (approximately 25). All 26 staphylococcal isolates were subjected to an inter-laboratory study on two MALDI instruments. For each isolate, the overall spectral profile was the same for each of the two instruments but the baseline threshold values was adjusted due to instrument differences in detector sensitivities. Differences between certain regions of the spectra reproducibly identified isolates belonging to the two major MRSA strains (EMRSA phage group 15 and 16). These results demonstrate ICMS with appropriate media selection is a rapid and reproducible technique for identification and discrimination of MRSA.

Do you see what I see? Mobile eye-tracker contextual analysis and inter-rater reliability.

PubMed

Stuart, S; Hunt, D; Nell, J; Godfrey, A; Hausdorff, J M; Rochester, L; Alcock, L

2018-02-01

Mobile eye-trackers are currently used during real-world tasks (e.g. gait) to monitor visual and cognitive processes, particularly in ageing and Parkinson's disease (PD). However, contextual analysis involving fixation locations during such tasks is rarely performed due to its complexity. This study adapted a validated algorithm and developed a classification method to semi-automate contextual analysis of mobile eye-tracking data. We further assessed inter-rater reliability of the proposed classification method. A mobile eye-tracker recorded eye-movements during walking in five healthy older adult controls (HC) and five people with PD. Fixations were identified using a previously validated algorithm, which was adapted to provide still images of fixation locations (n = 116). The fixation location was manually identified by two raters (DH, JN), who classified the locations. Cohen's kappa correlation coefficients determined the inter-rater reliability. The algorithm successfully provided still images for each fixation, allowing manual contextual analysis to be performed. The inter-rater reliability for classifying the fixation location was high for both PD (kappa = 0.80, 95% agreement) and HC groups (kappa = 0.80, 91% agreement), which indicated a reliable classification method. This study developed a reliable semi-automated contextual analysis method for gait studies in HC and PD. Future studies could adapt this methodology for various gait-related eye-tracking studies.

An international inter-laboratory ring trial to evaluate a real-time PCR assay for the detection of bovine herpesvirus 1 in extended bovine semen.

PubMed

Wang, Jianning; O'Keefe, Joseph; Orr, Della; Loth, Leo; Banks, Malcolm; Wakeley, Philip; West, Donna; Card, Roderick; Ibata, Georgina; Van Maanen, Kees; Thoren, Peter; Isaksson, Mats; Kerkhofs, Pierre

2008-01-01

Six laboratories participated in a ring trial to evaluate the reliability of a real-time PCR assay for the detection of bovine herpesvirus 1 (BoHV-1) from extended bovine semen. Sets of coded samples were prepared and distributed to each of the laboratories. The sample panel contained semen from naturally and artificially infected bulls, serial dilutions of positive semen with negative semen, semen from uninfected seronegative bulls, negative semen spiked with virus, as well as serial dilutions of reference virus. The samples were tested using a previously validated real-time PCR assay for the detection of BoHV-1 in each participating laboratory. The PCR tests were conducted with four different real-time PCR amplification platforms, including RotorGene 3000, Stratagene MX 3000/4000, ABI 7900, and Roche LightCycler 2.0. Virus isolation using one set of samples was performed in one laboratory. The results of the laboratories were compared with one another, and with those of virus isolation. It was found that the sensitivity and specificity of the real-time PCR test was greater than those of virus isolation (82.7% versus 53.6% and 93.6% versus 84.6%, respectively). A high level of agreement on PCR testing results between the laboratories was achieved (kappa value 0.59-0.95). The results of this study indicate that the real-time PCR assay is suitable for the detection of BoHV-1 in extended semen, and would be a good substitute for the slow and laborious virus isolation, for the screening testing at artificial insemination centres and for international trade.

Measuring the needs of mental health patients in Greece: reliability and validity of the Greek version of the Camberwell assessment of need.

PubMed

Stefanatou, Pentagiotissa; Giannouli, Eleni; Konstantakopoulos, George; Vitoratou, Silia; Mavreas, Venetsanos

2014-11-01

Evaluation of mental health services based on patients' needs assessments has never taken place in Greece, although it is a crucial factor for the efficient use of their limited resources. To examine the inter-rater and test-retest reliability and the concurrent/convergent validity of the Greek research version of the Camberwell Assessment of Need-Research (CAN-R). A total of 53 schizophrenic patient-staff pairs were interviewed twice to test the inter-rater and test-retest reliability of the Greek version of the CAN-R. The World Health Organization Quality of Life-Brief Form (WHOQOL-BREF) and World Health Organization Disability Assessment Schedule-2.0 (WHODAS-2.0) were administered to the patients to examine concurrent validity. The inter-rater and test-retest reliability of patient and staff interviews for the 22 individual items and the eight summary scores of the instrument's four sections were good to excellent. Significant correlations emerged between CAN scores and the WHOQOL-BREF and WHODAS-2.0 domains for both patient and staff ratings, indicating good concurrent validity. Our results suggest that the Greek version of the CAN-R is a reliable instrument for assessing mental health patients' needs. Moreover, it is the first CAN-R validity study with satisfactory results using WHOQOL-BREF and WHODAS-2.0 as criterion variables. © The Author(s) 2013.

Estimation of absorbed dose in clinical radiotherapy linear accelerator beams: Effect of ion chamber calibration and long-term stability

PubMed Central

Ravichandran, Ramamoorthy; Binukumar, Johnson Pichy; Davis, Cheriyathmanjiyil Antony

2013-01-01

The measured dose in water at reference point in phantom is a primary parameter for planning the treatment monitor units (MU); both in conventional and intensity modulated/image guided treatments. Traceability of dose accuracy therefore still depends mainly on the calibration factor of the ion chamber/dosimeter provided by the accredited Secondary Standard Dosimetry Laboratories (SSDLs), under International Atomic Energy Agency (IAEA) network of laboratories. The data related to Nd,water calibrations, thermoluminescent dosimetry (TLD) postal dose validation, inter-comparison of different dosimeter/electrometers, and validity of Nd,water calibrations obtained from different calibration laboratories were analyzed to find out the extent of accuracy achievable. Nd,w factors in Gray/Coulomb calibrated at IBA, GmBH, Germany showed a mean variation of about 0.2% increase per year in three Farmer chambers, in three subsequent calibrations. Another ion chamber calibrated in different accredited laboratory (PTW, Germany) showed consistent Nd,w for 9 years period. The Strontium-90 beta check source response indicated long-term stability of the ion chambers within 1% for three chambers. Results of IAEA postal TL “dose intercomparison” for three photon beams, 6 MV (two) and 15 MV (one), agreed well within our reported doses, with mean deviation of 0.03% (SD 0.87%) (n = 9). All the chamber/electrometer calibrated by a single SSDL realized absorbed doses in water within 0.13% standard deviations. However, about 1-2% differences in absorbed dose estimates observed when dosimeters calibrated from different calibration laboratories are compared in solid phantoms. Our data therefore imply that the dosimetry level maintained for clinical use of linear accelerator photon beams are within recommended levels of accuracy, and uncertainties are within reported values. PMID:24672156

Application of probabilistic modelling for the uncertainty evaluation of alignment measurements of large accelerator magnets assemblies

NASA Astrophysics Data System (ADS)

Doytchinov, I.; Tonnellier, X.; Shore, P.; Nicquevert, B.; Modena, M.; Mainaud Durand, H.

2018-05-01

Micrometric assembly and alignment requirements for future particle accelerators, and especially large assemblies, create the need for accurate uncertainty budgeting of alignment measurements. Measurements and uncertainties have to be accurately stated and traceable, to international standards, for metre-long sized assemblies, in the range of tens of µm. Indeed, these hundreds of assemblies will be produced and measured by several suppliers around the world, and will have to be integrated into a single machine. As part of the PACMAN project at CERN, we proposed and studied a practical application of probabilistic modelling of task-specific alignment uncertainty by applying a simulation by constraints calibration method. Using this method, we calibrated our measurement model using available data from ISO standardised tests (10360 series) for the metrology equipment. We combined this model with reference measurements and analysis of the measured data to quantify the actual specific uncertainty of each alignment measurement procedure. Our methodology was successfully validated against a calibrated and traceable 3D artefact as part of an international inter-laboratory study. The validated models were used to study the expected alignment uncertainty and important sensitivity factors in measuring the shortest and longest of the compact linear collider study assemblies, 0.54 m and 2.1 m respectively. In both cases, the laboratory alignment uncertainty was within the targeted uncertainty budget of 12 µm (68% confidence level). It was found that the remaining uncertainty budget for any additional alignment error compensations, such as the thermal drift error due to variation in machine operation heat load conditions, must be within 8.9 µm and 9.8 µm (68% confidence level) respectively.

Application of multi-factorial design of experiments to successfully optimize immunoassays for robust measurements of therapeutic proteins.

PubMed

Ray, Chad A; Patel, Vimal; Shih, Judy; Macaraeg, Chris; Wu, Yuling; Thway, Theingi; Ma, Mark; Lee, Jean W; Desilva, Binodh

2009-02-20

Developing a process that generates robust immunoassays that can be used to support studies with tight timelines is a common challenge for bioanalytical laboratories. Design of experiments (DOEs) is a tool that has been used by many industries for the purpose of optimizing processes. The approach is capable of identifying critical factors and their interactions with a minimal number of experiments. The challenge for implementing this tool in the bioanalytical laboratory is to develop a user-friendly approach that scientists can understand and apply. We have successfully addressed these challenges by eliminating the screening design, introducing automation, and applying a simple mathematical approach for the output parameter. A modified central composite design (CCD) was applied to three ligand binding assays. The intra-plate factors selected were coating, detection antibody concentration, and streptavidin-HRP concentrations. The inter-plate factors included incubation times for each step. The objective was to maximize the logS/B (S/B) of the low standard to the blank. The maximum desirable conditions were determined using JMP 7.0. To verify the validity of the predictions, the logS/B prediction was compared against the observed logS/B during pre-study validation experiments. The three assays were optimized using the multi-factorial DOE. The total error for all three methods was less than 20% which indicated method robustness. DOE identified interactions in one of the methods. The model predictions for logS/B were within 25% of the observed pre-study validation values for all methods tested. The comparison between the CCD and hybrid screening design yielded comparable parameter estimates. The user-friendly design enables effective application of multi-factorial DOE to optimize ligand binding assays for therapeutic proteins. The approach allows for identification of interactions between factors, consistency in optimal parameter determination, and reduced method development time.

Integrated primary care, the collaboration imperative inter-organizational cooperation in the integrated primary care field: a theoretical framework

PubMed Central

Valentijn, Pim P; Bruijnzeels, Marc A; de Leeuw, Rob J; Schrijvers, Guus J.P

2012-01-01

Purpose Capacity problems and political pressures have led to a rapid change in the organization of primary care from mono disciplinary small business to complex inter-organizational relationships. It is assumed that inter-organizational collaboration is the driving force to achieve integrated (primary) care. Despite the importance of collaboration and integration of services in primary care, there is no unambiguous definition for both concepts. The purpose of this study is to examine and link the conceptualisation and validation of the terms inter-organizational collaboration and integrated primary care using a theoretical framework. Theory The theoretical framework is based on the complex collaboration process of negotiation among multiple stakeholder groups in primary care. Methods A literature review of health sciences and business databases, and targeted grey literature sources. Based on the literature review we operationalized the constructs of inter-organizational collaboration and integrated primary care in a theoretical framework. The framework is being validated in an explorative study of 80 primary care projects in the Netherlands. Results and conclusions Integrated primary care is considered as a multidimensional construct based on a continuum of integration, extending from segregation to integration. The synthesis of the current theories and concepts of inter-organizational collaboration is insufficient to deal with the complexity of collaborative issues in primary care. One coherent and integrated theoretical framework was found that could make the complex collaboration process in primary care transparent. This study presented theoretical framework is a first step to understand the patterns of successful collaboration and integration in primary care services. These patterns can give insights in the organization forms needed to create a good working integrated (primary) care system that fits the local needs of a population. Preliminary data of the patterns of collaboration and integration will be presented.

Comparison of a New Cobinamide-Based Method to a Standard Laboratory Method for Measuring Cyanide in Human Blood

PubMed Central

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

Reliability and criterion validity of an observation protocol for working technique assessments in cash register work.

PubMed

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.

Reliability of laser Doppler flowmetry curve reading for measurement of toe and ankle pressures: intra- and inter-observer variation.

PubMed

Høyer, C; Paludan, J P D; Pavar, S; Biurrun Manresa, J A; Petersen, L J

2014-03-01

To assess the intra- and inter-observer variation in laser Doppler flowmetry curve reading for measurement of toe and ankle pressures. A prospective single blinded diagnostic accuracy study was conducted on 200 patients with known or suspected peripheral arterial disease (PAD), with a total of 760 curve sets produced. The first curve reading for this study was performed by laboratory technologists blinded to clinical clues and previous readings at least 3 months after the primary data sampling. The pressure curves were later reassessed following another period of at least 3 months. Observer agreement in diagnostic classification according to TASC-II criteria was quantified using Cohen's kappa. Reliability was quantified using intra-class correlation coefficients, coefficients of variance, and Bland-Altman analysis. The overall agreement in diagnostic classification (PAD/not PAD) was 173/200 (87%) for intra-observer (κ = .858) and 175/200 (88%) for inter-observer data (κ = .787). Reliability analysis confirmed excellent correlation for both intra- and inter-observer data (ICC all ≥.931). The coefficients of variance ranged from 2.27% to 6.44% for intra-observer and 2.39% to 8.42% for inter-observer data. Subgroup analysis showed lower observer-variation for reading of toe pressures in patients with diabetes and/or chronic kidney disease than patients not diagnosed with these conditions. Bland-Altman plots showed higher variation in toe pressure readings than ankle pressure readings. This study shows substantial intra- and inter-observer agreement in diagnostic classification and reading of absolute pressures when using laboratory technologists as observers. The study emphasises that observer variation for curve reading is an important factor concerning the overall reproducibility of the method. Our data suggest diabetes and chronic kidney disease have an influence on toe pressure reproducibility. Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

An automated genotyping tool for enteroviruses and noroviruses.

PubMed

Kroneman, A; Vennema, H; Deforche, K; v d Avoort, H; Peñaranda, S; Oberste, M S; Vinjé, J; Koopmans, M

2011-06-01

Molecular techniques are established as routine in virological laboratories and virus typing through (partial) sequence analysis is increasingly common. Quality assurance for the use of typing data requires harmonization of genotype nomenclature, and agreement on target genes, depending on the level of resolution required, and robustness of methods. To develop and validate web-based open-access typing-tools for enteroviruses and noroviruses. An automated web-based typing algorithm was developed, starting with BLAST analysis of the query sequence against a reference set of sequences from viruses in the family Picornaviridae or Caliciviridae. The second step is phylogenetic analysis of the query sequence and a sub-set of the reference sequences, to assign the enterovirus type or norovirus genotype and/or variant, with profile alignment, construction of phylogenetic trees and bootstrap validation. Typing is performed on VP1 sequences of Human enterovirus A to D, and ORF1 and ORF2 sequences of genogroup I and II noroviruses. For validation, we used the tools to automatically type sequences in the RIVM and CDC enterovirus databases and the FBVE norovirus database. Using the typing-tools, 785(99%) of 795 Enterovirus VP1 sequences, and 8154(98.5%) of 8342 norovirus sequences were typed in accordance with previously used methods. Subtyping into variants was achieved for 4439(78.4%) of 5838 NoV GII.4 sequences. The online typing-tools reliably assign genotypes for enteroviruses and noroviruses. The use of phylogenetic methods makes these tools robust to ongoing evolution. This should facilitate standardized genotyping and nomenclature in clinical and public health laboratories, thus supporting inter-laboratory comparisons. Copyright © 2011 Elsevier B.V. All rights reserved.

Validity and reliability of a Malay version of the Lawton instrumental activities of daily living scale among the Malay speaking elderly in Malaysia.

PubMed

Kadar, Masne; Ibrahim, Suhaili; Razaob, Nor Afifi; Chai, Siaw Chui; Harun, Dzalani

2018-02-01

The Lawton Instrumental Activities of Daily Living Scale is a tool often used to assess independence among elderly at home. Its suitability to be used with the elderly population in Malaysia has not been validated. This current study aimed to assess the validity and reliability of the Lawton Instrumental Activities of Daily Living Scale - Malay Version to Malay speaking elderly in Malaysia. This study was divided into three phases: (1) translation and linguistic validity involving both forward and backward translations; (2) establishment of face validity and content validity; and (3) establishment of reliability involving inter-rater, test-retest and internal consistency analyses. Data used for these analyses were obtained by interviewing 65 elderly respondents. Percentages of Content Validity Index for 4 criteria were from 88.89 to 100.0. The Cronbach α coefficient for internal consistency was 0.838. Intra-class Correlation Coefficient of inter-rater reliability and test-retest reliability was 0.957 and 0.950 respectively. The result shows that the Lawton Instrumental Activities of Daily Living Scale - Malay Version has excellent reliability and validity for use with the Malay speaking elderly people in Malaysia. This scale could be used by professionals to assess functional ability of elderly who live independently in community. © 2018 Occupational Therapy Australia.

Heart rate variability indicates emotional value during pro-social economic laboratory decisions with large external validity.

PubMed

Fooken, Jonas

2017-03-10

The present study investigates the external validity of emotional value measured in economic laboratory experiments by using a physiological indicator of stress, heart rate variability (HRV). While there is ample evidence supporting the external validity of economic experiments, there is little evidence comparing the magnitude of internal levels of emotional stress during decision making with external stress. The current study addresses this gap by comparing the magnitudes of decision stress experienced in the laboratory with the stress from outside the laboratory. To quantify a large change in HRV, measures observed in the laboratory during decision-making are compared to the difference between HRV during a university exam and other mental activity for the same individuals in and outside of the laboratory. The results outside the laboratory inform about the relevance of laboratory findings in terms of their relative magnitude. Results show that psychologically induced HRV changes observed in the laboratory, particularly in connection with social preferences, correspond to large effects outside. This underscores the external validity of laboratory findings and shows the magnitude of emotional value connected to pro-social economic decisions in the laboratory.

Particle atlas of World Trade Center dust

USGS Publications Warehouse

Lowers, Heather; Meeker, Gregory P.

2005-01-01

The United States Environmental Protection Agency (EPA) has begun a reassessment of the presence of World Trade Center (WTC) dust in residences, public buildings, and office spaces in New York City, New York. Background dust samples collected from residences, public buildings, and office spaces will be analyzed by multiple laboratories for the presence of WTC dust. Other laboratories are currently studying WTC dust for other purposes, such as health effects studies. To assist in inter-laboratory consistency for identification of WTC dust components, this particle atlas of phases in WTC dust has been compiled.

Assessing movement quality in persons with severe mental illness - Reliability and validity of the Body Awareness Scale Movement Quality and Experience.

PubMed

Hedlund, Lena; Gyllensten, Amanda Lundvik; Waldegren, Tomas; Hansson, Lars

2016-05-01

Motor disturbances and disturbed self-recognition are common features that affect mobility in persons with schizophrenia spectrum disorder and bipolar disorder. Physiotherapists in Scandinavia assess and treat movement difficulties in persons with severe mental illness. The Body Awareness Scale Movement Quality and Experience (BAS MQ-E) is a new and shortened version of the commonly used Body Awareness Scale-Health (BAS-H). The purpose of this study was to investigate the inter-rater reliability and the concurrent validity of BAS MQ-E in persons with severe mental illness. The concurrent validity was examined by investigating the relationships between neurological soft signs, alexithymia, fatigue, anxiety, and mastery. Sixty-two persons with severe mental illness participated in the study. The results showed a satisfactory inter-rater reliability (n = 53) and a concurrent validity (n = 62) with neurological soft signs, especially cognitive and perceptual based signs. There was also a concurrent validity linked to physical fatigue and aspects of alexithymia. The scores of BAS MQ-E were in general higher for persons with schizophrenia compared to persons with other diagnoses within the schizophrenia spectrum disorders and bipolar disorder. The clinical implications are presented in the discussion.

Bayesian Local Contamination Models for Multivariate Outliers

PubMed Central

Page, Garritt L.; Dunson, David B.

2013-01-01

In studies where data are generated from multiple locations or sources it is common for there to exist observations that are quite unlike the majority. Motivated by the application of establishing a reference value in an inter-laboratory setting when outlying labs are present, we propose a local contamination model that is able to accommodate unusual multivariate realizations in a flexible way. The proposed method models the process level of a hierarchical model using a mixture with a parametric component and a possibly nonparametric contamination. Much of the flexibility in the methodology is achieved by allowing varying random subsets of the elements in the lab-specific mean vectors to be allocated to the contamination component. Computational methods are developed and the methodology is compared to three other possible approaches using a simulation study. We apply the proposed method to a NIST/NOAA sponsored inter-laboratory study which motivated the methodological development. PMID:24363465

Psychometrics and Validation of a Brief Rating Measure of Parent-Infant Interaction: Manchester Assessment of Caregiver-Infant Interaction

ERIC Educational Resources Information Center

Wan, Ming Wai; Brooks, Ami; Green, Jonathan; Abel, Kathryn; Elmadih, Alya

2017-01-01

This study investigated the psychometrics of a recently developed global rating measure of videotaped parent-infant interaction, the "Manchester Assessment of Caregiver-Infant Interaction" (MACI), in a normative sample. Inter-rater reliability, stability over time, and convergent and discriminant validity were tested. Six-minute play…

Mothers and Children as Informants of Bullying Victimization: Results from an Epidemiological Cohort of Children

ERIC Educational Resources Information Center

Shakoor, Sania; Jaffee, Sara R.; Andreou, Penelope; Bowes, Lucy; Ambler, Antony P.; Caspi, Avshalom; Moffitt, Terrie E.; Arseneault, Louise

2011-01-01

Stressful events early in life can affect children's mental health problems. Collecting valid and reliable information about children's bad experiences is important for research and clinical purposes. This study aimed to (1) investigate whether mothers and children provide valid reports of bullying victimization, (2) examine the inter-rater…

Validity and reliability of a novel measure of activity performance and participation.

PubMed

Murgatroyd, Phil; Karimi, Leila

2016-01-01

To develop and evaluate an innovative clinician-rated measure, which produces global numerical ratings of activity performance and participation. Repeated measures study with 48 community-dwelling participants investigating clinical sensibility, comprehensiveness, practicality, inter-rater reliability, responsiveness, sensitivity and concurrent validity with Barthel Index. Important clinimetric characteristics including comprehensiveness and ease of use were rated >8/10 by clinicians. Inter-rater reliability was excellent on the summary scores (intraclass correlation of 0.95-0.98). There was good evidence that the new outcome measure distinguished between known high and low functional scoring groups, including both responsiveness to change and sensitivity at the same time point in numerous tests. Concurrent validity with the Barthel Index was fair to high (Spearman Rank Order Correlation 0.32-0.85, p > 0.05). The new measure's summary scores were nearly twice as responsive to change compared with the Barthel Index. Other more detailed data could also be generated by the new measure. The Activity Performance Measure is an innovative outcome instrument that showed good clinimetric qualities in this initial study. Some of the results were strong, given the sample size, and further trial and evaluation is appropriate. Implications for Rehabilitation The Activity Performance Measure is an innovative outcome measure covering activity performance and participation. In an initial evaluation, it showed good clinimetric qualities including responsiveness to change, sensitivity, practicality, clinical sensibility, item coverage, inter-rater reliability and concurrent validity with the Barthel Index. Further trial and evaluation is appropriate.

Inter-hemispheric interaction facilitates face processing.

PubMed

Compton, Rebecca J

2002-01-01

Many recent studies have revealed that interaction between the left and right cerebral hemispheres can aid in task performance, but these studies have tended to examine perception of simple stimuli such as letters, digits or simple shapes, which may have limited naturalistic validity. The present study extends these prior findings to a more naturalistic face perception task. Matching tasks required subjects to indicate when a target face matched one of two probe faces. Matches could be either across-field, requiring inter-hemispheric interaction, or within-field, not requiring inter-hemispheric interaction. Subjects indicated when faces matched in emotional expression (Experiment 1; n=32) or in character identity (Experiment 2; n=32). In both experiments, across-field performance was significantly better than within-field performance, supporting the primary hypothesis. Further, this advantage was greater for the more difficult character identity task. Results offer qualified support for the hypothesis that inter-hemispheric interaction is especially advantageous as task demands increase.

Validity and reliability of the robotic objective structured assessment of technical skills

PubMed Central

Siddiqui, Nazema Y.; Galloway, Michael L.; Geller, Elizabeth J.; Green, Isabel C.; Hur, Hye-Chun; Langston, Kyle; Pitter, Michael C.; Tarr, Megan E.; Martino, Martin A.

2015-01-01

Objective Objective structured assessments of technical skills (OSATS) have been developed to measure the skill of surgical trainees. Our aim was to develop an OSATS specifically for trainees learning robotic surgery. Study Design This is a multi-institutional study in eight academic training programs. We created an assessment form to evaluate robotic surgical skill through five inanimate exercises. Obstetrics/gynecology, general surgery, and urology residents, fellows, and faculty completed five robotic exercises on a standard training model. Study sessions were recorded and randomly assigned to three blinded judges who scored performance using the assessment form. Construct validity was evaluated by comparing scores between participants with different levels of surgical experience; inter- and intra-rater reliability were also assessed. Results We evaluated 83 residents, 9 fellows, and 13 faculty, totaling 105 participants; 88 (84%) were from obstetrics/gynecology. Our assessment form demonstrated construct validity, with faculty and fellows performing significantly better than residents (mean scores: 89 ± 8 faculty; 74 ± 17 fellows; 59 ± 22 residents, p<0.01). In addition, participants with more robotic console experience scored significantly higher than those with fewer prior console surgeries (p<0.01). R-OSATS demonstrated good inter-rater reliability across all five drills (mean Cronbach's α: 0.79 ± 0.02). Intra-rater reliability was also high (mean Spearman's correlation: 0.91 ± 0.11). Conclusions We developed an assessment form for robotic surgical skill that demonstrates construct validity, inter- and intra-rater reliability. When paired with standardized robotic skill drills this form may be useful to distinguish between levels of trainee performance. PMID:24807319

BiofOmics: a Web platform for the systematic and standardized collection of high-throughput biofilm data.

PubMed

Lourenço, Anália; Ferreira, Andreia; Veiga, Nuno; Machado, Idalina; Pereira, Maria Olivia; Azevedo, Nuno F

2012-01-01

Consortia of microorganisms, commonly known as biofilms, are attracting much attention from the scientific community due to their impact in human activity. As biofilm research grows to be a data-intensive discipline, the need for suitable bioinformatics approaches becomes compelling to manage and validate individual experiments, and also execute inter-laboratory large-scale comparisons. However, biofilm data is widespread across ad hoc, non-standardized individual files and, thus, data interchange among researchers, or any attempt of cross-laboratory experimentation or analysis, is hardly possible or even attempted. This paper presents BiofOmics, the first publicly accessible Web platform specialized in the management and analysis of data derived from biofilm high-throughput studies. The aim is to promote data interchange across laboratories, implementing collaborative experiments, and enable the development of bioinformatics tools in support of the processing and analysis of the increasing volumes of experimental biofilm data that are being generated. BiofOmics' data deposition facility enforces data structuring and standardization, supported by controlled vocabulary. Researchers are responsible for the description of the experiments, their results and conclusions. BiofOmics' curators interact with submitters only to enforce data structuring and the use of controlled vocabulary. Then, BiofOmics' search facility makes publicly available the profile and data associated with a submitted study so that any researcher can profit from these standardization efforts to compare similar studies, generate new hypotheses to be tested or even extend the conditions experimented in the study. BiofOmics' novelty lies in its support to standardized data deposition, the availability of computerizable data files and the free-of-charge dissemination of biofilm studies across the community. Hopefully, this will open promising research possibilities, namely the comparison of results between different laboratories, the reproducibility of methods within and between laboratories, and the development of guidelines and standardized protocols for biofilm formation operating procedures and analytical methods.

Inter-laboratory comparison measurements of radiochemical laboratories in Slovakia.

PubMed

Meresová, J; Belanová, A; Vrsková, M

2010-01-01

The first inter-laboratory comparison organized by the radiochemistry laboratory of Water Research Institute (WRI) in Bratislava was carried out in 1993 and since then is it realized on an annual basis and about 10 radiochemical laboratories from all over Slovakia are participating. The gross alpha and gross beta activities, and the activity concentrations of (222)Rn, tritium, and (226)Ra, and U(nat) concentration in synthetic water samples are compared. The distributed samples are covering the concentration range prevailing in potable and surface waters and are prepared by dilution of certified reference materials. Over the course of the years 1993-2008, we observed the improvement in the quality of results for most of the laboratories. However, the success rate of the gross alpha determination activity is not improving as much as the other parameters. Copyright 2009 Elsevier Ltd. All rights reserved.

Digital image analysis of Ki67 proliferation index in breast cancer using virtual dual staining on whole tissue sections: clinical validation and inter-platform agreement.

PubMed

Koopman, Timco; Buikema, Henk J; Hollema, Harry; de Bock, Geertruida H; van der Vegt, Bert

2018-05-01

The Ki67 proliferation index is a prognostic and predictive marker in breast cancer. Manual scoring is prone to inter- and intra-observer variability. The aims of this study were to clinically validate digital image analysis (DIA) of Ki67 using virtual dual staining (VDS) on whole tissue sections and to assess inter-platform agreement between two independent DIA platforms. Serial whole tissue sections of 154 consecutive invasive breast carcinomas were stained for Ki67 and cytokeratin 8/18 with immunohistochemistry in a clinical setting. Ki67 proliferation index was determined using two independent DIA platforms, implementing VDS to identify tumor tissue. Manual Ki67 score was determined using a standardized manual counting protocol. Inter-observer agreement between manual and DIA scores and inter-platform agreement between both DIA platforms were determined and calculated using Spearman's correlation coefficients. Correlations and agreement were assessed with scatterplots and Bland-Altman plots. Spearman's correlation coefficients were 0.94 (p < 0.001) for inter-observer agreement between manual counting and platform A, 0.93 (p < 0.001) between manual counting and platform B, and 0.96 (p < 0.001) for inter-platform agreement. Scatterplots and Bland-Altman plots revealed no skewness within specific data ranges. In the few cases with ≥ 10% difference between manual counting and DIA, results by both platforms were similar. DIA using VDS is an accurate method to determine the Ki67 proliferation index in breast cancer, as an alternative to manual scoring of whole sections in clinical practice. Inter-platform agreement between two different DIA platforms was excellent, suggesting vendor-independent clinical implementability.

Evaluation of molecular typing of foodborne pathogens in European reference laboratories from 2012 to 2013

PubMed Central

Schjørring, Susanne; Niskanen, Taina; Torpdahl, Mia; Björkman, Jonas T; Nielsen, Eva Møller

2016-01-01

In 2012, the European Centre for Disease Prevention and Control (ECDC) initiated external quality assessment (EQA) schemes for molecular typing including the National Public Health Reference Laboratories in Europe. The overall aim for these EQA schemes was to enhance the European surveillance of food-borne pathogens by evaluating and improving the quality and comparability of molecular typing. The EQAs were organised by Statens Serum Institut (SSI) and included Salmonella enterica subsp. enterica, verocytotoxin-producing Escherichia coli (VTEC) and Listeria monocytogenes. Inter-laboratory comparable pulsed-field gel electrophoresis (PFGE) images were obtained from 10 of 17 of the participating laboratories for Listeria, 15 of 25 for Salmonella, but only nine of 20 for VTEC. Most problems were related to PFGE running conditions and/or incorrect use of image acquisition. Analysis of the gels was done in good accordance with the provided guidelines. Furthermore, we assessed the multilocus variable-number tandem repeat analysis (MLVA) scheme for S. Typhimurium. Of 15 laboratories, nine submitted correct results for all analysed strains, and four had difficulties with one strain only. In conclusion, both PFGE and MLVA are prone to variation in quality, and there is therefore a continuous need for standardisation and validation of laboratory performance for molecular typing methods of food-borne pathogens in the human public health sector. PMID:28006653

Evaluation of resolution-precision relationships when using Structure-from-Motion to measure low intensity erosion processes, within a laboratory setting.

NASA Astrophysics Data System (ADS)

Benaud, Pia; Anderson, Karen; Quine, Timothy; James, Mike; Quinton, John; Brazier, Richard E.

2017-04-01

The accessibility of Structure-from-Motion Multi-Stereo View (SfM) and the potential for multi-temporal applications, offers an exciting opportunity to quantify soil erosion spatially. Accordingly, published research provides examples of the successful quantification of large erosion features and events, to centimetre accuracy. Through rigorous control of the camera and image network geometry, the centimetre accuracy achievable at the field scale, can translate to sub-millimetre accuracies within a laboratory environment. The broad aim of this study, therefore, was to understand how ultra-high-resolution spatial information on soil surface topography, derived from SfM, can be utilised to develop a spatially explicit, mechanistic understanding of rill and inter-rill erosion, under experimental conditions. A rainfall simulator was used to create three soil surface conditions; compaction and rainsplash erosion, inter-rill erosion, and rill erosion. Total sediment capture was the primary validation for the experiments, allowing the comparison between structurally and volumetrically derived change, and true soil loss. A Terrestrial Laser Scanner (resolution of ca. 0.8mm) was employed to assess spatial discrepancies within the SfM datasets and to provide an alternative measure of volumetric change. The body of work will present the workflow that has been developed for the laboratory-scale studies and provide information on the importance of DTM resolution for volumetric calculations of soil loss, under different soil surface conditions. To-date, using the methodology presented, point clouds with ca. 3.38 x 107 points per m2, and RMSE values of 0.17 to 0.43 mm (relative precision 1:2023-5117), were constructed. Preliminary results suggest a decrease in DTM resolution from 0.5 to 10 mm does not result in a significant change in volumetric calculations (p = 0.088), while affording a 24-fold decrease in processing times, but may impact negatively on mechanistic understanding of patterns of erosion. It is argued that the approach can be an invaluable tool for the spatially-explicit evaluation of soil erosion models.

A Comparative Reference Study for the Validation of HLA-Matching Algorithms in the Search for Allogeneic Hematopoietic Stem Cell Donors and Cord Blood Units

DTIC Science & Technology

2016-08-15

HLA ISSN 2059-2302 A comparative reference study for the validation of HLA-matching algorithms in the search for allogeneic hematopoietic stem cell...from different inter- national donor registries by challenging them with simulated input data and subse- quently comparing the output. This experiment...original work is properly cited, the use is non-commercial and no modifications or adaptations are made. Comparative reference validation of HLA

Is laser speckle contrast analysis (LASCA) the new kid on the block in systemic sclerosis? A systematic literature review and pilot study to evaluate reliability of LASCA to measure peripheral blood perfusion in scleroderma patients.

PubMed

Cutolo, Maurizio; Vanhaecke, Amber; Ruaro, Barbara; Deschepper, Ellen; Ickinger, Claudia; Melsens, Karin; Piette, Yves; Trombetta, Amelia Chiara; De Keyser, Filip; Smith, Vanessa

2018-06-06

A reliable tool to evaluate flow is paramount in systemic sclerosis (SSc). We describe herein on the one hand a systematic literature review on the reliability of laser speckle contrast analysis (LASCA) to measure the peripheral blood perfusion (PBP) in SSc and perform an additional pilot study, investigating the intra- and inter-rater reliability of LASCA. A systematic search was performed in 3 electronic databases, according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the pilot study, 30 SSc patients and 30 healthy subjects (HS) underwent LASCA assessment. Intra-rater reliability was assessed by having a first anchor rater performing the measurements at 2 time-points and inter-rater reliability by having the anchor rater and a team of second raters performing the measurements in 15 SSc and 30 HS. The measurements were repeated with a second anchor rater in the other 15 SSc patients, as external validation. Only 1 of the 14 records of interest identified through the systematic search was included in the final analysis. In the additional pilot study: intra-class correlation coefficient (ICC) for intra-rater reliability of the first anchor rater was 0.95 in SSc and 0.93 in HS, the ICC for inter-rater reliability was 0.97 in SSc and 0.93 in HS. Intra- and inter-rater reliability of the second anchor rater was 0.78 and 0.87. The identified literature regarding the reliability of LASCA measurements reports good to excellent inter-rater agreement. This very pilot study could confirm the reliability of LASCA measurements with good to excellent inter-rater agreement and found additionally good to excellent intra-rater reliability. Furthermore, similar results were found in the external validation. Copyright © 2018. Published by Elsevier B.V.

Radiological findings for hip dysplasia at skeletal maturity. Validation of digital and manual measurement techniques.

PubMed

Engesæter, Ingvild Øvstebø; Laborie, Lene Bjerke; Lehmann, Trude Gundersen; Sera, Francesco; Fevang, Jonas; Pedersen, Douglas; Morcuende, José; Lie, Stein Atle; Engesæter, Lars Birger; Rosendahl, Karen

2012-07-01

To report on intra-observer, inter-observer, and inter-method reliability and agreement for radiological measurements used in the diagnosis of hip dysplasia at skeletal maturity, as obtained by a manual and a digital measurement technique. Pelvic radiographs from 95 participants (56 females) in a follow-up hip study of 18- to 19-year-old patients were included. Eleven radiological measurements relevant for hip dysplasia (Sharp's, Wiberg's, and Ogata's angles; acetabular roof angle of Tönnis; articulo-trochanteric distance; acetabular depth-width ratio; femoral head extrusion index; maximum teardrop width; and the joint space width in three different locations) were validated. Three observers measured the radiographs using both a digital measurement program and manually in AgfaWeb1000. Inter-method and inter- and intra-observer agreement were analyzed using the mean differences between the readings/readers, establishing the 95% limits of agreement. We also calculated the minimum detectable change and the intra-class correlation coefficient. Large variations among different radiological measurements were demonstrated. However, the variation was not related to the use of either the manual or digital measurement technique. For measurements with greater absolute values (Sharp's angle, femoral head extrusion index, and acetabular depth-width ratio) the inter- and intra-observer and inter-method agreements were better as compared to measurements with lower absolute values (acetabular roof angle, teardrop and joint space width). The inter- and intra-observer variation differs notably across different radiological measurements relevant for hip dysplasia at skeletal maturity, a fact that should be taken into account in clinical practice. The agreement between the manual and digital methods is good.

Refinement of the Montreal Instrument for Cat Arthritis Testing, for Use by Veterinarians: detection of naturally occurring osteoarthritis in laboratory cats.

PubMed

Klinck, Mary P; Monteiro, Beatriz P; Lussier, Bertrand; Guillot, Martin; Moreau, Maxim; Otis, Colombe; Steagall, Paulo Vm; Frank, Diane; Martel-Pelletier, Johanne; Pelletier, Jean-Pierre; Del Castillo, Jérôme Re; Troncy, Eric

2017-09-01

Objectives Feline osteoarthritis causes pain and disability. Detection and measurement is challenging, relying heavily on owner report. This study describes refinement of the Montreal Instrument for Cat Arthritis Testing, for Use by Veterinarians. Methods A video analysis of osteoarthritic (n = 6) and non-osteoarthritic (n = 4) cats facilitated expansion of scale items. Three successive therapeutic trials (using gabapentin, tramadol and oral transmucosal meloxicam spray) in laboratory cats with and without natural osteoarthritis (n = 12-20), permitted construct validation (assessments of disease status sensitivity and therapeutic responsiveness) and further scale refinements based on performance. Results Scale osteoarthritic sensitivity improved from phase I to phase III; phase III scale total score ( P = 0.0001) and 4/5 subcategories - body posture ( P = 0.0006), gait ( P = 0.0031), jumping (0.0824) and global distance examination ( P = 0.0001) - detected osteoarthritic cats. Total score inter-rater (intra-class correlation coefficients [ICC] = 0.64-0.75), intra-rater (ICC = 0.90-0.91) and overall internal consistency (Cronbach's alpha = 0.85) reliability were good to excellent. von Frey anesthesiometer-induced paw withdrawal threshold increased with gabapentin in phase I, in osteoarthritic cats ( P <0.001) but not in non-osteoarthritic cats ( P = 0.075). Night-time activity increased during gabapentin treatment. Objective measures also detected tramadol and/or meloxicam treatment effects in osteoarthritic cats in phases II and III. There was some treatment responsiveness: in phase I, 3/10 subcategory scores improved ( P <0.09) in treated osteoarthritic cats; in phase II, 3/8 subcategories; and in phase III, 1/5 subcategories improved ( P <0.096). Conclusions and relevance The revised scale detected naturally occurring osteoarthritis, but not treatment effects, in laboratory cats, suggesting future potential for screening of at-risk cats. Further study is needed to confirm reliability, validity (disease sensitivity and treatment responsiveness) and clinical feasibility, as well as cut-off scores for osteoarthritic vs non-osteoarthritic status, in client-owned cats.

Spanish translation, cross-cultural adaptation, and validation of the Questionnaire for Diabetes-Related Foot Disease (Q-DFD)

PubMed Central

Castillo-Tandazo, Wilson; Flores-Fortty, Adolfo; Feraud, Lourdes; Tettamanti, Daniel

2013-01-01

Purpose To translate, cross-culturally adapt, and validate the Questionnaire for Diabetes-Related Foot Disease (Q-DFD), originally created and validated in Australia, for its use in Spanish-speaking patients with diabetes mellitus. Patients and methods The translation and cross-cultural adaptation were based on international guidelines. The Spanish version of the survey was applied to a community-based (sample A) and a hospital clinic-based sample (samples B and C). Samples A and B were used to determine criterion and construct validity comparing the survey findings with clinical evaluation and medical records, respectively; while sample C was used to determine intra- and inter-rater reliability. Results After completing the rigorous translation process, only four items were considered problematic and required a new translation. In total, 127 patients were included in the validation study: 76 to determine criterion and construct validity and 41 to establish intra- and inter-rater reliability. For an overall diagnosis of diabetes-related foot disease, a substantial level of agreement was obtained when we compared the Q-DFD with the clinical assessment (kappa 0.77, sensitivity 80.4%, specificity 91.5%, positive likelihood ratio [LR+] 9.46, negative likelihood ratio [LR−] 0.21); while an almost perfect level of agreement was obtained when it was compared with medical records (kappa 0.88, sensitivity 87%, specificity 97%, LR+ 29.0, LR− 0.13). Survey reliability showed substantial levels of agreement, with kappa scores of 0.63 and 0.73 for intra- and inter-rater reliability, respectively. Conclusion The translated and cross-culturally adapted Q-DFD showed good psychometric properties (validity, reproducibility, and reliability) that allow its use in Spanish-speaking diabetic populations. PMID:24039434

Reliability and Validity of Objective Measures of Physical Activity in Youth With Cerebral Palsy Who Are Ambulatory.

PubMed

O'Neil, Margaret E; Fragala-Pinkham, Maria; Lennon, Nancy; George, Ameeka; Forman, Jeffrey; Trost, Stewart G

2016-01-01

Physical therapy for youth with cerebral palsy (CP) who are ambulatory includes interventions to increase functional mobility and participation in physical activity (PA). Thus, reliable and valid measures are needed to document PA in youth with CP. The purpose of this study was to evaluate the inter-instrument reliability and concurrent validity of 3 accelerometer-based motion sensors with indirect calorimetry as the criterion for measuring PA intensity in youth with CP. Fifty-seven youth with CP (mean age=12.5 years, SD=3.3; 51% female; 49.1% with spastic hemiplegia) participated. Inclusion criteria were: aged 6 to 20 years, ambulatory, Gross Motor Function Classification System (GMFCS) levels I through III, able to follow directions, and able to complete the full PA protocol. Protocol activities included standardized activity trials with increasing PA intensity (resting, writing, household chores, active video games, and walking at 3 self-selected speeds), as measured by weight-relative oxygen uptake (in mL/kg/min). During each trial, participants wore bilateral accelerometers on the upper arms, waist/hip, and ankle and a portable indirect calorimeter. Intraclass coefficient correlations (ICCs) were calculated to evaluate inter-instrument reliability (left-to-right accelerometer placement). Spearman correlations were used to examine concurrent validity between accelerometer output (activity and step counts) and indirect calorimetry. Friedman analyses of variance with post hoc pair-wise analyses were conducted to examine the validity of accelerometers to discriminate PA intensity across activity trials. All accelerometers exhibited excellent inter-instrument reliability (ICC=.94-.99) and good concurrent validity (rho=.70-.85). All accelerometers discriminated PA intensity across most activity trials. This PA protocol consisted of controlled activity trials. Accelerometers provide valid and reliable measures of PA intensity among youth with CP. © 2016 American Physical Therapy Association.

Prevalidation of the ex-vivo model PCLS for prediction of respiratory toxicity.

PubMed

Hess, A; Wang-Lauenstein, L; Braun, A; Kolle, S N; Landsiedel, R; Liebsch, M; Ma-Hock, L; Pirow, R; Schneider, X; Steinfath, M; Vogel, S; Martin, C; Sewald, K

2016-04-01

In acute inhalation toxicity studies, animals inhale substances at given concentrations. Without additional information, however, appropriate starting concentrations for in-vivo inhalation studies are difficult to estimate. The goal of this project was the prevalidation of precision-cut lung slices (PCLS) as an ex-vivo alternative to reduce the number of animals used in inhalation toxicity studies. According to internationally agreed principles for Prevalidation Studies, the project was conducted in three independent laboratories. The German BfR provided consultancy in validation principles and independent support with biostatistics. In all laboratories, rat PCLS were prepared and exposed to 5 concentrations of 20 industrial chemicals under submerged culture conditions for 1h. After 23 h post-incubation, toxicity was assessed by measurement of released lactate dehydrogenase and mitochondrial activity. In addition, protein content and pro-inflammatory cytokine IL-1α were measured. For all endpoints IC50 values were calculated if feasible. For each endpoint test acceptance criteria were established. This report provides the final results for all 20 chemicals. More than 900 concentration-response curves were analyzed. Log10[IC50 (μM)], obtained for all assay endpoints, showed best intra- and inter-laboratory consistency for the data obtained by WST-1 and BCA assays. While WST-1 and LDH indicated toxic effects for the majority of substances, only some of the substances induced an increase in extracellular IL-1α. Two prediction models (two-group classification model, prediction of LC50 by IC50) were developed and showed promising results. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Development and validation of the Bush-Francis Catatonia Rating Scale - Brazilian version.

PubMed

Nunes, Ana Letícia Santos; Filgueiras, Alberto; Nicolato, Rodrigo; Alvarenga, Jussara Mendonça; Silveira, Luciana Angélica Silva; Silva, Rafael Assis da; Cheniaux, Elie

2017-01-01

This article aims to describe the adaptation and translation process of the Bush-Francis Catatonia Rating Scale (BFCRS) and its reduced version, the Bush-Francis Catatonia Screening Instrument (BFCSI) for Brazilian Portuguese, as well as its validation. Semantic equivalence processes included four steps: translation, back translation, evaluation of semantic equivalence and a pilot-study. Validation consisted of simultaneous applications of the instrument in Portuguese by two examiners in 30 catatonic and 30 non-catatonic patients. Total scores averaged 20.07 for the complete scale and 7.80 for its reduced version among catatonic patients, compared with 0.47 and 0.20 among non-catatonic patients, respectively. Overall values of inter-rater reliability of the instruments were 0.97 for the BFCSI and 0.96 for the BFCRS. The scale's version in Portuguese proved to be valid and was able to distinguish between catatonic and non-catatonic patients. It was also reliable, with inter-evaluator reliability indexes as high as those of the original instrument.

Extra-analytical quality indicators and laboratory performances.

PubMed

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.

Round-robin 230Th– 234U age dating of bulk uranium for nuclear forensics

DOE PAGES

Gaffney, Amy M.; Hubert, Amélie; Kinman, William S.; ...

2015-07-30

We report that in an inter-laboratory measurement comparison study, four laboratories determined 230Th– 234U model ages of uranium certified reference material NBL U050 using isotope dilution mass spectrometry. The model dates determined by the participating laboratories range from 9 March 1956 to 19 October 1957, and are indistinguishable given the associated measurement uncertainties. These model ages are concordant with to slightly older than the known production age of NBL U050.

Round-robin 230Th– 234U age dating of bulk uranium for nuclear forensics

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

Gaffney, Amy M.; Hubert, Amélie; Kinman, William S.

We report that in an inter-laboratory measurement comparison study, four laboratories determined 230Th– 234U model ages of uranium certified reference material NBL U050 using isotope dilution mass spectrometry. The model dates determined by the participating laboratories range from 9 March 1956 to 19 October 1957, and are indistinguishable given the associated measurement uncertainties. These model ages are concordant with to slightly older than the known production age of NBL U050.

High accuracy measurements of dry mole fractions of carbon dioxide and methane in humid air

NASA Astrophysics Data System (ADS)

Rella, C. W.; Chen, H.; Andrews, A. E.; Filges, A.; Gerbig, C.; Hatakka, J.; Karion, A.; Miles, N. L.; Richardson, S. J.; Steinbacher, M.; Sweeney, C.; Wastine, B.; Zellweger, C.

2012-08-01

Traditional techniques for measuring the mole fractions of greenhouse gas in the well-mixed atmosphere have required extremely dry sample gas streams (dew point < -25 °C) to achieve the inter-laboratory compatibility goals set forth by the Global Atmospheric Watch program of the World Meteorological Organization (WMO/GAW) for carbon dioxide (±0.1 ppm) and methane (±2 ppb). Drying the sample gas to low levels of water vapor can be expensive, time-consuming, and/or problematic, especially at remote sites where access is difficult. Recent advances in optical measurement techniques, in particular Cavity Ring Down Spectroscopy (CRDS), have led to the development of highly stable and precise greenhouse gas analyzers capable of highly accurate measurements of carbon dioxide, methane, and water vapor. Unlike many older technologies, which can suffer from significant uncorrected interference from water vapor, these instruments permit for the first time accurate and precise greenhouse gas measurements that can meet the WMO/GAW inter-laboratory compatibility goals without drying the sample gas. In this paper, we present laboratory methodology for empirically deriving the water vapor correction factors, and we summarize a series of in-situ validation experiments comparing the measurements in humid gas streams to well-characterized dry-gas measurements. By using the manufacturer-supplied correction factors, the dry-mole fraction measurements have been demonstrated to be well within the GAW compatibility goals up to at least 1% water vapor. By determining the correction factors for individual instruments once at the start of life, this range can be extended to at least 2% over the life of the instrument, and if the correction factors are determined periodically over time, the evidence suggests that this range can be extended above 4%.

Variability in baseline laboratory measurements of the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).

PubMed

Ladwig, R; Vigo, A; Fedeli, L M G; Chambless, L E; Bensenor, I; Schmidt, M I; Vidigal, P G; Castilhos, C D; Duncan, B B

2016-08-01

Multi-center epidemiological studies must ascertain that their measurements are accurate and reliable. For laboratory measurements, reliability can be assessed through investigation of reproducibility of measurements in the same individual. In this paper, we present results from the quality control analysis of the baseline laboratory measurements from the ELSA-Brasil study. The study enrolled 15,105 civil servants at 6 research centers in 3 regions of Brazil between 2008-2010, with multiple biochemical analytes being measured at a central laboratory. Quality control was ascertained through standard laboratory evaluation of intra- and inter-assay variability and test-retest analysis in a subset of randomly chosen participants. An additional sample of urine or blood was collected from these participants, and these samples were handled in the same manner as the original ones, locally and at the central laboratory. Reliability was assessed with the intraclass correlation coefficient (ICC), estimated through a random effects model. Coefficients of variation (CV) and Bland-Altman plots were additionally used to assess measurement variability. Laboratory intra and inter-assay CVs varied from 0.86% to 7.77%. From test-retest analyses, the ICCs were high for the majority of the analytes. Notably lower ICCs were observed for serum sodium (ICC=0.50; 95%CI=0.31-0.65) and serum potassium (ICC=0.73; 95%CI=0.60-0.83), due to the small biological range of these analytes. The CVs ranged from 1 to 14%. The Bland-Altman plots confirmed these results. The quality control analyses showed that the collection, processing and measurement protocols utilized in the ELSA-Brasil produced reliable biochemical measurements.

Validation of a fast and accurate chromatographic method for detailed quantification of vitamin E in green leafy vegetables.

PubMed

Cruz, Rebeca; Casal, Susana

2013-11-15

Vitamin E analysis in green vegetables is performed by an array of different methods, making it difficult to compare published data or choosing the adequate one for a particular sample. Aiming to achieve a consistent method with wide applicability, the current study reports the development and validation of a fast micro-method for quantification of vitamin E in green leafy vegetables. The methodology uses solid-liquid extraction based on the Folch method, with tocol as internal standard, and normal-phase HPLC with fluorescence detection. A large linear working range was confirmed, being highly reproducible, with inter-day precisions below 5% (RSD). Method sensitivity was established (below 0.02 μg/g fresh weight), and accuracy was assessed by recovery tests (>96%). The method was tested in different green leafy vegetables, evidencing diverse tocochromanol profiles, with variable ratios and amounts of α- and γ-tocopherol, and other minor compounds. The methodology is adequate for routine analyses, with a reduced chromatographic run (<7 min) and organic solvent consumption, and requires only standard chromatographic equipment available in most laboratories. Copyright © 2013 Elsevier Ltd. All rights reserved.

The Brief Negative Symptom Scale (BNSS): Independent validation in a large sample of Italian patients with schizophrenia.

PubMed

Mucci, A; Galderisi, S; Merlotti, E; Rossi, A; Rocca, P; Bucci, P; Piegari, G; Chieffi, M; Vignapiano, A; Maj, M

2015-07-01

The Brief Negative Symptom Scale (BNSS) was developed to address the main limitations of the existing scales for the assessment of negative symptoms of schizophrenia. The initial validation of the scale by the group involved in its development demonstrated good convergent and discriminant validity, and a factor structure confirming the two domains of negative symptoms (reduced emotional/verbal expression and anhedonia/asociality/avolition). However, only relatively small samples of patients with schizophrenia were investigated. Further independent validation in large clinical samples might be instrumental to the broad diffusion of the scale in clinical research. The present study aimed to examine the BNSS inter-rater reliability, convergent/discriminant validity and factor structure in a large Italian sample of outpatients with schizophrenia. Our results confirmed the excellent inter-rater reliability of the BNSS (the intraclass correlation coefficient ranged from 0.81 to 0.98 for individual items and was 0.98 for the total score). The convergent validity measures had r values from 0.62 to 0.77, while the divergent validity measures had r values from 0.20 to 0.28 in the main sample (n=912) and in a subsample without clinically significant levels of depression and extrapyramidal symptoms (n=496). The BNSS factor structure was supported in both groups. The study confirms that the BNSS is a promising measure for quantifying negative symptoms of schizophrenia in large multicenter clinical studies. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Assessing the validity and reliability of the Pool Activity Level (PAL) Checklist for use with older people with dementia.

PubMed

Wenborn, Jennifer; Challis, David; Pool, Jackie; Burgess, Jane; Elliott, Nicola; Orrell, Martin

2008-03-01

Activity is key to maintaining physical and mental health and well-being. However, as dementia affects the ability to engage in activity, care-givers can find it difficult to provide appropriate activities. The Pool Activity Level (PAL) Checklist guides the selection of appropriate, personally meaningful activities. The aim of this study was to assess the reliability and validity of the PAL Checklist when used with older people with dementia. A postal questionnaire sent to activity providers assessed content validity. Validity and reliability were measured in a sample of 60 older people with dementia. The questionnaire response rate was 83% (102/122). Most respondents felt no important items were missing. Seven of the nine activities were ranked as 'very important' or 'essential' by at least 77% of the sample, indicating very good content validity. Correlation with measures of cognition, severity of dementia and activity performance demonstrated strong concurrent validity. Inter-item correlation indicated strong construct validity. Cronbach's alpha coefficient measured internal consistency as excellent (0.95). All items achieved acceptable test-retest reliability, and the majority demonstrated acceptable inter-rater reliability. We conclude that the PAL Checklist demonstrates adequate validity and reliability when used with older people with dementia and appears a useful tool for a variety of care settings.

A Validation of the Ski Hi Language Development Scale.

ERIC Educational Resources Information Center

Tonelson, Stephen W.

The purpose of the study was to assess the reliability and the validity of the Ski Hi Language Development Scale which was designed to determine the receptive and the expressive language levels of hearing impaired children from birth to age 5. The reliability of the instrument was estimated through: (1) internal consistency, (2) inter-rater…

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

PubMed

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. To address the issues arising from inter-laboratory comparisons, we devise a novel measure we term the Minimum Meaningful Difference (MMD), and demonstrate its application.

Quantifying Inter-Laboratory Variability in Stable Isotope Analysis of Ancient Skeletal Remains

PubMed Central

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. To address the issues arising from inter-laboratory comparisons, we devise a novel measure we term the Minimum Meaningful Difference (MMD), and demonstrate its application. PMID:25061843

Toward Improvements in Inter-laboratory Calibration of Argon Isotope Measurements

NASA Astrophysics Data System (ADS)

Hemming, S. R.; Deino, A. L.; Heizler, M. T.; Hodges, K. V.; McIntosh, W. C.; Renne, P. R.; Swisher, C. C., III; Turrin, B. D.; Van Soest, M. C.

2015-12-01

It is important to continue to develop strategies to improve our ability to compare results between laboratories chronometers. The U-Pb community has significantly reduced inter-laboratory biases with the application of a community tracer solution and the distribution of synthetic zircon solutions. Inevitably sample selection and processing and even biases in interpretations will still lead to some disagreements in the assignment of ages. Accordingly natural samples that are shared will be important for achievement of the highest levels of agreement. Analogous improvements in quality and inter-laboratory agreement of analytical aspects of Ar-Ar can be achieved through development of synthetic age standards in gas canisters with multiple pipettes to deliver various controlled amounts of argon to the mass spectrometer. A preliminary proof-of concept comes from the inter-laboratory calibration experiment for the 40Ar/39Ar community. This portable Argon Pipette Intercalibration System (APIS) consists of three 2.7 L canisters each equipped with three pipettes of 0.1, 0.2 and 0.4 cc volumes. The currently traveling APIS has the three canisters filled with air and 40Ar*/39Ar of 1.73 and canister 2 has a 40Ar*/39Ar of 40.98 (~ Alder Creek and Fish Canyon in the same irradiation). With these pipettes it is possible to combine them to provide 0.1, 0.2, 0.3 (0.1+0.2), 0.4, 0.5 (0.1+0.4), 0.6 (0.2+0.4), and 0.7 (0.1+0.2+0.4) cc. The configuration allows a simple test for inter-laboratory biases and for volume/pressure dependent mass fractionation on the measured ratios for a gas with a single argon isotope composition. Although not yet tested, it is also possible to mix gas from any one of the three canisters in proportions of these increments, allowing even more tightly controlled calibration of measurements. We suggest that ultimately each EARTHTIME lab should be equipped with such a system permanently, with a community plan for a traveling system to periodically repeat the inter-calibration tests. The composition(s) of such systems may not be the same for each lab, depending on the requirements of equipment and main age ranges targeted. But with a relatively small number of end member compositions it should be possible to greatly improve the calibration capability of the community.

Analyzing Movements Development and Evaluation of the Body Awareness Scale Movement Quality (BAS MQ).

PubMed

Sundén, A; Ekdahl, C; Horstman, V; Gyllensten, A L

2016-06-01

Limitations in everyday movements, physical activities are/or pain are the main reasons for seeking help from a physiotherapist. The purpose of this study was to investigate the psychometric properties of the Body Awareness Scale Movement Quality (BAS MQ) focusing on factor structure, validity and reliability and to explore whether BAS MQ could discriminate between healthy individuals and patients. BAS MQ assesses both limitations and resources concerning functional ability and quality of movements. The total sample in the study (n = 172) consisted of individuals with hip osteoarthritis (OA) (n = 132), individuals with psychiatric disorders (n = 33) and healthy individuals (n = 7). A factor analysis of the BAS MQ was performed for the total group. Inter-rater reliability was tested in a group of individuals with hip OA (n = 24). Concurrent validity was tested in a group of individuals with hip OA (n = 89). The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), the 6-Minute Walk Test (6MWT) and the Hip Osteoarthritis Outcome Score (HOOS) were chosen in the validation process. The factor analysis revealed three factors that together explained 60.8% of the total variance of BAS MQ. The inter-rater reliability was considered good or very good with a kappa value of 0.61. Significant correlations between BAS MQ and SF-36, HOOS and 6MWT in the subjects with hip OA confirmed the validity. The BAS MQ was able to discriminate between healthy individuals and individuals with physical and psychiatric limitations. Results of the study revealed that BAS MQ has a satisfactory factor structure. The inter-rater reliability and validity were acceptable in a group of individuals with hip OA. BAS MQ could be a useful assessment tool for physiotherapists when evaluating the quality of everyday movements in different patient groups. Copyright © 2014 John Wiley & Sons, Ltd. Copyright © 2014 John Wiley & Sons, Ltd.

An in-house assay for BK polyomavirus quantification using the Abbott m2000 RealTime system.

PubMed

Muldrew, Kenneth L; Lovett, Jennie L

2013-11-01

BK polyomavirus (BKPyV) quantification is useful for monitoring renal transplant patient response to therapy. The Abbott m2000 RealTime System employed by some clinical laboratories to perform US Food and Drug Administration-approved assays can also be used to develop in-house assays such as the one presented here. This study aimed to validate an in-house quantitative real-time PCR assay targeting the BKPyV major capsid VP1 gene for assessment of viral load using the Abbott m2000 RealTime System. BKPyV load was measured in 95 urine and plasma samples previously tested for BKPyV by one of three laboratories (46 BKPyV-positive samples consisting of 35 plasma and 11 urine samples; 49 samples negative for BKPyV consisting of 47 plasma and two urine samples). Two additional plasma specimens from the College of American Pathologists proficiency testing survey were also analysed. Precision studies were performed by diluting a high-viral-titre patient sample into BKPyV-negative pooled plasma to create high-positive (6.16 log10 copies ml(-1)) and low-positive (3.16 log10 copies ml(-1)) samples. For precision studies of inter-assay variability, a high-positive (7.0 log10 copies ml(-1)) and a low-positive (3.0 log10 copies ml(-1)) sample were measured in 20 separate runs. The assay's limit of quantification and limit of detection were 2.70 and 2.25 log10 copies ml(-1), respectively. The assay was linear from 2.70 to 9.26 log10 copies ml(-1). Of the 48 known positives, 43 were detected as positive, with three reported by the reference laboratory as values lower than the limit of detection. Two known positives at 3.27 and 3.80 log10 copies ml(-1) tested negative by the m2000 BKPyV assay. Of the 49 known negative samples, 48 were negative by the m2000 BKPyV load assay, with one sample confirmed positive by a reference laboratory. Qualitative analysis prior to discrepancy testing demonstrated a sensitivity of 89.58 % and a specificity of 97.96 %. Precision studies demonstrated inter-assay coefficients of variation of 0.63 % (high positive) and 4.38 % (low positive). Genotyping was performed on 22 patient samples, of which 21 (95.45 %) were type I and one (4.55 %) was type II. In conclusion, the m2000 BKPyV viral load assay sensitivity, specificity, linear range, precision and cost effectiveness make it an attractive methodology for clinical laboratories using the Abbott m2000 RealTime System.

Assessing physiotherapists' communication skills for promoting patient autonomy for self-management: reliability and validity of the communication evaluation in rehabilitation tool.

PubMed

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 comprehensive user manual to assess how well health care providers use autonomy-supportive communication strategies in real world-clinical settings. This tool has demonstrated good inter-rater reliability and concurrent validity in its initial testing phase. The Communication Evaluation in Rehabilitation Tool can be used in future studies to assess autonomy-supportive communication and undergo further measurement property testing as per our recommendations.

The development and testing of a qualitative instrument designed to assess critical thinking

NASA Astrophysics Data System (ADS)

Clauson, Cynthia Louisa

This study examined a qualitative approach to assess critical thinking. An instrument was developed that incorporates an assessment process based on Dewey's (1933) concepts of self-reflection and critical thinking as problem solving. The study was designed to pilot test the critical thinking assessment process with writing samples collected from a heterogeneous group of students. The pilot test included two phases. Phase 1 was designed to determine the validity and inter-rater reliability of the instrument using two experts in critical thinking, problem solving, and literacy development. Validity of the instrument was addressed by requesting both experts to respond to ten questions in an interview. The inter-rater reliability was assessed by analyzing the consistency of the two experts' scorings of the 20 writing samples to each other, as well as to my scoring of the same 20 writing samples. Statistical analyses included the Spearman Rho and the Kuder-Richardson (Formula 20). Phase 2 was designed to determine the validity and reliability of the critical thinking assessment process with seven science teachers. Validity was addressed by requesting the teachers to respond to ten questions in a survey and interview. Inter-rater reliability was addressed by comparing the seven teachers' scoring of five writing samples with my scoring of the same five writing samples. Again, the Spearman Rho and the Kuder-Richardson (Formula 20) were used to determine the inter-rater reliability. The validity results suggest that the instrument is helpful as a guide for instruction and provides a systematic method to teach and assess critical thinking while problem solving with students in the classroom. The reliability results show the critical thinking assessment instrument to possess fairly high reliability when used by the experts, but weak reliability when used by classroom teachers. A major conclusion was drawn that teachers, as well as students, would need to receive instruction in critical thinking and in how to use the assessment process in order to gain more consistent interpretations of the six problem-solving steps. Specific changes needing to be made in the instrument to improve the quality are included.

Analytic Validation of Immunohistochemical Assays: A Comparison of Laboratory Practices Before and After Introduction of an Evidence-Based Guideline.

PubMed

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

2017-09-01

- Laboratories must demonstrate analytic validity before any test can be used clinically, but studies have shown inconsistent practices in immunohistochemical assay validation. - To assess changes in immunohistochemistry analytic validation practices after publication of an evidence-based laboratory practice guideline. - A survey on current immunohistochemistry assay validation practices and on the awareness and adoption of a recently published guideline was sent to subscribers enrolled in one of 3 relevant College of American Pathologists proficiency testing programs and to additional nonsubscribing laboratories that perform immunohistochemical testing. The results were compared with an earlier survey of validation practices. - Analysis was based on responses from 1085 laboratories that perform immunohistochemical staining. Of 1057 responses, 65.4% (691) were aware of the guideline recommendations before this survey was sent and 79.9% (550 of 688) of those have already adopted some or all of the recommendations. Compared with the 2010 survey, a significant number of laboratories now have written validation procedures for both predictive and nonpredictive marker assays and specifications for the minimum numbers of cases needed for validation. There was also significant improvement in compliance with validation requirements, with 99% (100 of 102) having validated their most recently introduced predictive marker assay, compared with 74.9% (326 of 435) in 2010. The difficulty in finding validation cases for rare antigens and resource limitations were cited as the biggest challenges in implementing the guideline. - Dissemination of the 2014 evidence-based guideline validation practices had a positive impact on laboratory performance; some or all of the recommendations have been adopted by nearly 80% of respondents.

Instrumental and statistical methods for the comparison of class evidence

NASA Astrophysics Data System (ADS)

Liszewski, Elisa Anne

Trace evidence is a major field within forensic science. Association of trace evidence samples can be problematic due to sample heterogeneity and a lack of quantitative criteria for comparing spectra or chromatograms. The aim of this study is to evaluate different types of instrumentation for their ability to discriminate among samples of various types of trace evidence. Chemometric analysis, including techniques such as Agglomerative Hierarchical Clustering, Principal Components Analysis, and Discriminant Analysis, was employed to evaluate instrumental data. First, automotive clear coats were analyzed by using microspectrophotometry to collect UV absorption data. In total, 71 samples were analyzed with classification accuracy of 91.61%. An external validation was performed, resulting in a prediction accuracy of 81.11%. Next, fiber dyes were analyzed using UV-Visible microspectrophotometry. While several physical characteristics of cotton fiber can be identified and compared, fiber color is considered to be an excellent source of variation, and thus was examined in this study. Twelve dyes were employed, some being visually indistinguishable. Several different analyses and comparisons were done, including an inter-laboratory comparison and external validations. Lastly, common plastic samples and other polymers were analyzed using pyrolysis-gas chromatography/mass spectrometry, and their pyrolysis products were then analyzed using multivariate statistics. The classification accuracy varied dependent upon the number of classes chosen, but the plastics were grouped based on composition. The polymers were used as an external validation and misclassifications occurred with chlorinated samples all being placed into the category containing PVC.

Preliminary appraisal of the reliability and validity of the Colorado State University Feline Acute Pain Scale.

PubMed

Shipley, Hilary; Guedes, Alonso; Graham, Lynelle; Goudie-DeAngelis, Elizabeth; Wendt-Hornickle, Erin

2018-05-01

Objectives The objective of this study was to determine the inter-rater reliability and convergent validity of the Colorado State University Feline Acute Pain Scale (CSU-FAPS) in a preliminary appraisal of its performance in a clinical teaching setting. Methods Sixty-eight female cats were assessed for pain after ovariohysterectomy. A cohort of 21 cats was examined independently by four raters (two board-certified anesthesiologists and two anesthesia residents) with the CSU-FAPS, and intra-class correlation coefficient (ICC) was used to determine inter-rater reliability. Weighted Cohen's kappa was used to determine inter-rater reliability centered on the 'need to reassess analgesic plan' (dichotomous scale). A separate cohort of 47 cats was evaluated independently by two raters (one board-certified anesthesiologist and one veterinary small animal rotating intern) using the CSU-FAPS and the Glasgow Composite Measure Pain Scale (CMPS-Feline), and Spearman rank-order correlation was determined to assess convergent validity. Reliability was interpreted using Altman's classification as very good, good, moderate, fair and poor. Validity was considered adequate if correlation coefficients were between 0.4 and 0.8. Results The ICC was 0.61 for anesthesiologists and 0.67 for residents, indicating good reliability. Weighted Cohen's kappa was 0.79 for anesthesiologists and 0.44 for residents, indicating moderate to good reliability. The Spearman rank correlation indicated a statistically significant ( P = 0.0003) positive correlation (0.31; 95% confidence interval 0.14-0.46) between the CSU-FAPS and the CMPS-Feline. Conclusions and relevance The CSU-FAPS showed moderate-to-good inter-rater reliability when used by veterinarians to assess pain level or need to reassess analgesic plan after ovariohysterectomy in cats. The validity fell short of current guidelines for correlation coefficients and further refinement and testing are warranted to improve its performance.

Inferior turbinate classification system, grades 1 to 4: development and validation study.

PubMed

Camacho, Macario; Zaghi, Soroush; Certal, Victor; Abdullatif, Jose; Means, Casey; Acevedo, Jason; Liu, Stanley; Brietzke, Scott E; Kushida, Clete A; Capasso, Robson

2015-02-01

To develop a validated inferior turbinate grading scale. Development and validation study. Phase 1 development (alpha test) consisted of a proposal of 10 different inferior turbinate grading scales (>1,000 clinic patients). Phase 2 validation (beta test) utilized 10 providers grading 27 standardized endoscopic photos of inferior turbinates using two different classification systems. Phase 3 validation (pilot study) consisted of 100 live consecutive clinic patients (n = 200 inferior turbinates) who were each prospectively graded by 18 different combinations of two independent raters, and grading was repeated by each of the same two raters, two separate times for each patient. In the development phase, 25% (grades 1-4) and 33% (grades 1-4) were the most useful systems. In the validation phase, the 25% classification system was found to be the best balance between potential clinical utility and ability to grade; the photo grading demonstrated a Cohen's kappa (κ) = 0.4671 ± 0.0082 (moderate inter-rater agreement). Live-patient grading with the 25% classification system demonstrated an overall inter-rater reliability of 71.5% (95% confidence interval [CI]: 64.8-77.3), with overall substantial agreement (κ = 0.704 ± 0.028). Intrarater reliability was 91.5% (95% CI: 88.7-94.3). Distribution for the 200 inferior turbinates was as follows: 25% quartile = grade 1, 50% quartile (median) = grade 2, 75% quartile = grade 3, and 90% quartile = grade 4. Mean turbinate size was 2.22 (95% CI: 2.07-2.34; standard deviation 1.02). Categorical κ was as follows: grade 1, 0.8541 ± 0.0289; grade 2, 0.7310 ± 0.0289; grade 3, 0.6997 ± 0.0289, and grade 4, 0.7760 ± 0.0289. The 25% (grades 1-4) inferior turbinate classification system is a validated grading scale with high intrarater and inter-rater reliability. This system can facilitate future research by tracking the effect of interventions on inferior turbinates. 2c. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Measurement of patient safety: a systematic review of the reliability and validity of adverse event detection with record review

PubMed Central

Hanskamp-Sebregts, Mirelle; Zegers, Marieke; Vincent, Charles; van Gurp, Petra J; de Vet, Henrica C W; Wollersheim, Hub

2016-01-01

Objectives Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review. Design A systematic review of the literature. Methods We searched PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library and from their inception through February 2015. We included all studies that aimed to describe the reliability and/or validity of record review. Two reviewers conducted data extraction. We pooled κ values (κ) and analysed the differences in subgroups according to number of reviewers, reviewer experience and training level, adjusted for the prevalence of adverse events. Results In 25 studies, the psychometric data of the Global Trigger Tool (GTT) and the Harvard Medical Practice Study (HMPS) were reported and 24 studies were included for statistical pooling. The inter-rater reliability of the GTT and HMPS showed a pooled κ of 0.65 and 0.55, respectively. The inter-rater agreement was statistically significantly higher when the group of reviewers within a study consisted of a maximum five reviewers. We found no studies reporting on the validity of the GTT and HMPS. Conclusions The reliability of record review is moderate to substantial and improved when a small group of reviewers carried out record review. The validity of the record review method has never been evaluated, while clinical data registries, autopsy or direct observations of patient care are potential reference methods that can be used to test concurrent validity. PMID:27550650

Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories.

PubMed

Ćwiklińska, Agnieszka; Dąbrowska, Hanna; Kowalski, Robert; Kuchta, Agnieszka; Kortas-Stempak, Barbara; Fijałkowska, Aleksandra; Bednarczuk, Gabriela; Jankowski, Maciej

2018-05-11

The ratio of albumin to creatinine (ACR) is an important parameter used for detection of albuminuria in patients with early kidney damage. The aim of the study was to evaluate the harmonization of ACR results among Polish participants in an international external quality assessment (EQA) program, and to evaluate the impact of albumin and creatinine analytical performance on the harmonization of ACR results. We analyzed 182 results of albumin, 202 of creatinine, and 180 of ACR obtained from Polish laboratories in an EQA program organized by Labquality. The dispersion of the results in surveys and percentage differences between the results and target values were calculated. Moreover, differences between method groups were assessed. The inter-laboratory coefficient of variation (CV) for ACR was 36%. Only 74% of results of Polish laboratories were within the target limits; for 11% of the results, an incorrect albuminuria category would have been reported. The inter-laboratory CV for albumin was 20%, 2.6-fold higher than for creatinine. Significant differences between method groups for albumin determination have been observed, even when the same measurement technique was used. The greatest difference between two groups was 23%, 2.5-fold greater in comparison to creatinine. There is an insufficient harmonization of ACR values among Polish laboratories, caused mainly by urine albumin analytical performance. Given the important role of ACR in the classification, monitoring and treatment of kidney damage, the harmonization of albumin measurements is crucial and urgently needed.

Children's cortisol responses to a social evaluative laboratory stressor from early to middle childhood.

PubMed

Leppert, Katherine A; Kushner, Marissa; Smith, Victoria C; Lemay, Edward P; Dougherty, Lea R

2016-12-01

This study examined the stability of children's cortisol responses to a social evaluative laboratory stressor from early to middle childhood. Ninety-six children (51 males) completed stress-inducing laboratory tasks and provided five salivary cortisol samples in early (W1) and middle (W2) childhood. Although W1 cortisol responses did not predict W2 cortisol responses, children's cortisol responses demonstrated change: compared to their W1 cortisol responses, children's W2 cortisol responses demonstrated an increased slope and more negative quadratic curvature. Furthermore, child psychiatric symptoms at W1 moderated the stability of children's cortisol responses. Children with fewer preschool psychiatric symptoms demonstrated greater inter-individual and intra-individual stability, whereas children with higher preschool psychiatric symptoms and comorbidity demonstrated systematic inter-individual and intra-individual instability in cortisol responses over time. Findings suggest a developmental shift toward increasing cortisol stress responses from early to middle childhood and highlight preschool psychopathology as a moderator of stability in children's cortisol responses over time. © 2016 Wiley Periodicals, Inc.

Simultaneous analysis of Alternaria toxins and citrinin in tomato: an optimised method using liquid chromatography-tandem mass spectrometry

PubMed Central

Tölgyesi, Ádám; Stroka, Joerg; Tamosiunas, Vytautas; Zwickel, Theresa

2015-01-01

Alternaria toxins and citrinin are mycotoxins produced by fungi growing on different raw materials and agricultural commodities. Maximum levels of these toxins in foods are currently under consideration by the European Commission as a risk management measure. In this study, a new quantitative method is described for the determination of five Alternaria toxins and citrinin in tomato and tomato juice samples based on LC-MS/MS detection. Samples were extracted with pure methanol, followed by a derivatisation step with 2,4-dinitrophenylhydrazine to improve the determination of tenuazonic acid and to decrease the wide polarity difference between the compounds of interest. Samples were purified on hydrophilic-modified styrene polymer solid-phase extraction cartridges. High-performance liquid chromatographic columns packed with different core–shell materials were tested for the separation of toxins and a C-18 phase was in the final method applied to achieve sufficient separation of all relevant analytes. A key element of this approach was to prove successful transferability of the method to three different triple quadrupole mass spectrometers. A full single laboratory method validation was performed on two LC-MS/MS systems and performance characteristics met the predefined requirements. Moreover, the method was used in an international proficiency test and the satisfactory z-scores obtained (−0.1 to 0.8 in tomato juice samples) demonstrated the reliability of the approach described. The method will be validated in an inter-laboratory collaborative study and if the criteria for method precision are met, the method will be proposed as a new Work Item to the European Committee for Standardisation. PMID:26212568

QNOTE: an instrument for measuring the quality of EHR clinical notes.

PubMed

Burke, Harry B; Hoang, Albert; Becher, Dorothy; Fontelo, Paul; Liu, Fang; Stephens, Mark; Pangaro, Louis N; Sessums, Laura L; O'Malley, Patrick; Baxi, Nancy S; Bunt, Christopher W; Capaldi, Vincent F; Chen, Julie M; Cooper, Barbara A; Djuric, David A; Hodge, Joshua A; Kane, Shawn; Magee, Charles; Makary, Zizette R; Mallory, Renee M; Miller, Thomas; Saperstein, Adam; Servey, Jessica; Gimbel, Ronald W

2014-01-01

The outpatient clinical note documents the clinician's information collection, problem assessment, and patient management, yet there is currently no validated instrument to measure the quality of the electronic clinical note. This study evaluated the validity of the QNOTE instrument, which assesses 12 elements in the clinical note, for measuring the quality of clinical notes. It also compared its performance with a global instrument that assesses the clinical note as a whole. Retrospective multicenter blinded study of the clinical notes of 100 outpatients with type 2 diabetes mellitus who had been seen in clinic on at least three occasions. The 300 notes were rated by eight general internal medicine and eight family medicine practicing physicians. The QNOTE instrument scored the quality of the note as the sum of a set of 12 note element scores, and its inter-rater agreement was measured by the intraclass correlation coefficient. The Global instrument scored the note in its entirety, and its inter-rater agreement was measured by the Fleiss κ. The overall QNOTE inter-rater agreement was 0.82 (CI 0.80 to 0.84), and its note quality score was 65 (CI 64 to 66). The Global inter-rater agreement was 0.24 (CI 0.19 to 0.29), and its note quality score was 52 (CI 49 to 55). The QNOTE quality scores were consistent, and the overall QNOTE score was significantly higher than the overall Global score (p=0.04). We found the QNOTE to be a valid instrument for evaluating the quality of electronic clinical notes, and its performance was superior to that of the Global instrument. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Analysis of Carbamate Pesticides: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS666

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

Owens, J; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for analysis of aldicarb, bromadiolone, carbofuran, oxamyl, and methomyl in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS666. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures described in MS666 for analysis of carbamatemore » pesticides in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS666 can be determined.« less

Analysis of Ethanolamines: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS888

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

Owens, J; Vu, A; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method titled 'Analysis of Diethanolamine, Triethanolamine, n-Methyldiethanolamine, and n-Ethyldiethanolamine in Water by Single Reaction Monitoring Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS): EPA Method MS888'. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures described in 'EPA Method MS888' for analysis of themore » listed ethanolamines in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of 'EPA Method MS888' can be determined.« less

The reliability and validity of the Complex Task Performance Assessment: A performance-based assessment of executive function.

PubMed

Wolf, Timothy J; Dahl, Abigail; Auen, Colleen; Doherty, Meghan

2017-07-01

The objective of this study was to evaluate the inter-rater reliability, test-retest reliability, concurrent validity, and discriminant validity of the Complex Task Performance Assessment (CTPA): an ecologically valid performance-based assessment of executive function. Community control participants (n = 20) and individuals with mild stroke (n = 14) participated in this study. All participants completed the CTPA and a battery of cognitive assessments at initial testing. The control participants completed the CTPA at two different times one week apart. The intra-class correlation coefficient (ICC) for inter-rater reliability for the total score on the CTPA was .991. The ICCs for all of the sub-scores of the CTPA were also high (.889-.977). The CTPA total score was significantly correlated to Condition 4 of the DKEFS Color-Word Interference Test (p = -.425), and the Wechsler Test of Adult Reading (p  = -.493). Finally, there were significant differences between control subjects and individuals with mild stroke on the total score of the CTPA (p = .007) and all sub-scores except interpretation failures and total items incorrect. These results are also consistent with other current executive function performance-based assessments and indicate that the CTPA is a reliable and valid performance-based measure of executive function.

Psychometric evaluation of the Work Readiness Questionnaire in schizophrenia.

PubMed

Potkin, Steven G; Bugarski-Kirola, Dragana; Edgar, Chris J; Soliman, Sherif; Le Scouiller, Stephanie; Kunovac, Jelena; Miguel Velasco, Eugenio; Garibaldi, George M

2016-04-01

Unemployment can negatively impact quality of life among patients with schizophrenia. Employment status depends on ability, opportunity, education, and cultural influences. A clinician-rated scale of work readiness, independent of current work status, can be a valuable assessment tool. A series of studies were conducted to create and validate a Work Readiness Questionnaire (WoRQ) for clinicians to assess patient ability to engage in socially useful activity, independent of work availability. Content validity, test-retest and inter-rater reliability, and construct validity were evaluated in three separate studies. Content validity was supported. Cronbach's α was 0.91, in the excellent range. Clinicians endorsed WoRQ concepts, including treatment adherence, physical appearance, social competence, and symptom control. The final readiness decision showed good test-retest reliability and moderate inter-rater reliability. Work readiness was associated with higher function and lower levels of negative symptoms. Low positive and high negative predictive values confirmed the concept validity. The WoRQ has suitable psychometric properties for use in a clinical trial for patients with a broad range of symptom severity. The scale may be applicable to assess therapeutic interventions. It is not intended to assess eligibility for supported work interventions. The WoRQ is suitable for use in schizophrenia clinical trials to assess patient work functional potential.

The Technical and Biological Reproducibility of Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry (MALDI-TOF MS) Based Typing: Employment of Bioinformatics in a Multicenter Study

PubMed Central

Oberle, Michael; Wohlwend, Nadia; Jonas, Daniel; Maurer, Florian P.; Jost, Geraldine; Tschudin-Sutter, Sarah; Vranckx, Katleen; Egli, Adrian

2016-01-01

Background The technical, biological, and inter-center reproducibility of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI TOF MS) typing data has not yet been explored. The aim of this study is to compare typing data from multiple centers employing bioinformatics using bacterial strains from two past outbreaks and non-related strains. Material/Methods Participants received twelve extended spectrum betalactamase-producing E. coli isolates and followed the same standard operating procedure (SOP) including a full-protein extraction protocol. All laboratories provided visually read spectra via flexAnalysis (Bruker, Germany). Raw data from each laboratory allowed calculating the technical and biological reproducibility between centers using BioNumerics (Applied Maths NV, Belgium). Results Technical and biological reproducibility ranged between 96.8–99.4% and 47.6–94.4%, respectively. The inter-center reproducibility showed a comparable clustering among identical isolates. Principal component analysis indicated a higher tendency to cluster within the same center. Therefore, we used a discriminant analysis, which completely separated the clusters. Next, we defined a reference center and performed a statistical analysis to identify specific peaks to identify the outbreak clusters. Finally, we used a classifier algorithm and a linear support vector machine on the determined peaks as classifier. A validation showed that within the set of the reference center, the identification of the cluster was 100% correct with a large contrast between the score with the correct cluster and the next best scoring cluster. Conclusions Based on the sufficient technical and biological reproducibility of MALDI-TOF MS based spectra, detection of specific clusters is possible from spectra obtained from different centers. However, we believe that a shared SOP and a bioinformatics approach are required to make the analysis robust and reliable. PMID:27798637

Gait assessment using the Microsoft Xbox One Kinect: Concurrent validity and inter-day reliability of spatiotemporal and kinematic variables.

PubMed

Mentiplay, Benjamin F; Perraton, Luke G; Bower, Kelly J; Pua, Yong-Hao; McGaw, Rebekah; Heywood, Sophie; Clark, Ross A

2015-07-16

The revised Xbox One Kinect, also known as the Microsoft Kinect V2 for Windows, includes enhanced hardware which may improve its utility as a gait assessment tool. This study examined the concurrent validity and inter-day reliability of spatiotemporal and kinematic gait parameters estimated using the Kinect V2 automated body tracking system and a criterion reference three-dimensional motion analysis (3DMA) marker-based camera system. Thirty healthy adults performed two testing sessions consisting of comfortable and fast paced walking trials. Spatiotemporal outcome measures related to gait speed, speed variability, step length, width and time, foot swing velocity and medial-lateral and vertical pelvis displacement were examined. Kinematic outcome measures including ankle flexion, knee flexion and adduction and hip flexion were examined. To assess the agreement between Kinect and 3DMA systems, Bland-Altman plots, relative agreement (Pearson's correlation) and overall agreement (concordance correlation coefficients) were determined. Reliability was assessed using intraclass correlation coefficients, Cronbach's alpha and standard error of measurement. The spatiotemporal measurements had consistently excellent (r≥0.75) concurrent validity, with the exception of modest validity for medial-lateral pelvis sway (r=0.45-0.46) and fast paced gait speed variability (r=0.73). In contrast kinematic validity was consistently poor to modest, with all associations between the systems weak (r<0.50). In those measures with acceptable validity, the inter-day reliability was similar between systems. In conclusion, while the Kinect V2 body tracking may not accurately obtain lower body kinematic data, it shows great potential as a tool for measuring spatiotemporal aspects of gait. Copyright © 2015 Elsevier Ltd. All rights reserved.

Developing Guided Inquiry-Based Student Lab Worksheet for Laboratory Knowledge Course

NASA Astrophysics Data System (ADS)

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.

Reliability and Validity of the Psychoeducational Profile-Third Edition Caregiver Report in Children with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Fu, Chung-Pei; Chen, Kuan-Lin; Tseng, Mei-Hui; Chiang, Fu-Mei; Hsieh, Ching-Lin

2012-01-01

The aim of this study was to examine the internal consistency, inter-respondent reliability, and convergent and divergent validity of the Psychoeducational Profile-third edition Caregiver Report (PEP3-CR) in children with Autism Spectrum Disorders (ASD). We examined the internal consistency on 66 mothers of children with ASD who completed the…

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.

PubMed

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 < 0.001). A correlation was found between the "6-clicks" and length of stay (r= -0.408, p = 0.001), but not between the "6-clicks" and age (r= -0.180, p = 0.528). To determine the inter-rater reliability, an additional 50 patients were assessed by pairs of physiotherapists who independently scored the patients. Intraclass Correlation Coefficients of 0.920 (95%CI: 0.828-0.964) were found. The Kappa Coefficients for the individual items ranged from 0.649 (walking stairs) to 0.841 (sit-to-stand). The 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.

Results of an inter-laboratory study of glass formulation for the immobilization of excess plutonium

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

Peeler, D.K.

1999-12-08

The primary focus of the current study is to determine allowable loadings of feed streams containing different ratios of plutonium, uranium, and minor components into the LaBS glass and to evaluate thermal stability with respect to the DWPF pour.

Testing fine motor coordination via telehealth: effects of video characteristics on reliability and validity.

PubMed

Hoenig, Helen M; Amis, Kristopher; Edmonds, Carol; Morgan, Michelle S; Landerman, Lawrence; Caves, Kevin

2017-01-01

Background There is limited research about the effects of video quality on the accuracy of assessments of physical function. Methods A repeated measures study design was used to assess reliability and validity of the finger-nose test (FNT) and the finger-tapping test (FTT) carried out with 50 veterans who had impairment in gross and/or fine motor coordination. Videos were scored by expert raters under eight differing conditions, including in-person, high definition video with slow motion review and standard speed videos with varying bit rates and frame rates. Results FTT inter-rater reliability was excellent with slow motion video (ICC 0.98-0.99) and good (ICC 0.59) under the normal speed conditions. Inter-rater reliability for FNT 'attempts' was excellent (ICC 0.97-0.99) for all viewing conditions; for FNT 'misses' it was good to excellent (ICC 0.89) with slow motion review but substantially worse (ICC 0.44) on the normal speed videos. FTT criterion validity (i.e. compared to slow motion review) was excellent (β = 0.94) for the in-person rater and good ( β = 0.77) on normal speed videos. Criterion validity for FNT 'attempts' was excellent under all conditions ( r ≥ 0.97) and for FNT 'misses' it was good to excellent under all conditions ( β = 0.61-0.81). Conclusions In general, the inter-rater reliability and validity of the FNT and FTT assessed via video technology is similar to standard clinical practices, but is enhanced with slow motion review and/or higher bit rate.

Assessing peristomal skin changes in ostomy patients: validation of the Ostomy Skin Tool.

PubMed

Jemec, G B; Martins, L; Claessens, I; Ayello, E A; Hansen, A S; Poulsen, L H; Sibbald, R G

2011-02-01

Peristomal skin problems are common and are treated by a variety of health professionals. Clear and consistent communication among these professionals is therefore particularly important. The Ostomy Skin Tool (OST) is a new assessment instrument for the extent and severity of peristomal skin conditions. Formal tests of reliability and validity are necessary for its use in clinical practice, research, and education. To estimate inter- and intra nurse assessment variability of the OST and validity by comparison to a 'gold standard' (GS) defined by an expert panel. Thirty photographs of peristomal skin were presented twice to 20 ostomy care nurses--10 from Denmark (DK) and 10 from Spain (ES)--to determine intra- and inter nurse assessment variability. The same photographs were presented to an international group of experts (dermatologist and ostomy care nurses), to establish a GS for comparison and validation of the results. A high intra-nurse assessment agreement, κ=0·84, was found with no differences in the intra-nurse assessments from the two groups of nurses (DK and ES). The inter-nurse assessment agreement was 'moderate to good', κ=0·54, with the agreement between the experts higher, κ=0·70. A high correlation between the scores from the nurses and the GS were seen in the lower part of the two scales [Discoloration, Erosion, Tissue overgrowth (DET) score<7)]. The study supported the validity of the OST. It is suggested that a categorical scale can be used to illustrate the severity of the DET scores. © 2011 The Authors. BJD © 2011 British Association of Dermatologists.

The Reliability and Validity of the Thoracolumbar Injury Classification System in Pediatric Spine Trauma.

PubMed

Savage, Jason W; Moore, Timothy A; Arnold, Paul M; Thakur, Nikhil; Hsu, Wellington K; Patel, Alpesh A; McCarthy, Kathryn; Schroeder, Gregory D; Vaccaro, Alexander R; Dimar, John R; Anderson, Paul A

2015-09-15

The thoracolumbar injury classification system (TLICS) was evaluated in 20 consecutive pediatric spine trauma cases. The purpose of this study was to determine the reliability and validity of the TLICS in pediatric spine trauma. The TLICS was developed to improve the categorization and management of thoracolumbar trauma. TLICS has been shown to have good reliability and validity in the adult population. The clinical and radiographical findings of 20 pediatric thoracolumbar fractures were prospectively presented to 20 surgeons with disparate levels of training and experience with spinal trauma. These injuries were consecutively scored using the TLICS. Cohen unweighted κ coefficients and Spearman rank order correlation values were calculated for the key parameters (injury morphology, status of posterior ligamentous complex, neurological status, TLICS total score, and proposed management) to assess the inter-rater reliabilities. Five surgeons scored the same cases 3 months later to assess the intra-rater reliability. The actual management of each case was then compared with the treatment recommended by the TLICS algorithm to assess validity. The inter-rater κ statistics of all subgroups (injury morphology, status of the posterior ligamentous complex, neurological status, TLICS total score, and proposed treatment) were within the range of moderate to substantial reproducibility (0.524-0.958). All subgroups had excellent intra-rater reliability (0.748-1.000). The various indices for validity were calculated (80.3% correct, 0.836 sensitivity, 0.785 specificity, 0.676 positive predictive value, 0.899 negative predictive value). Overall, TLICS demonstrated good validity. The TLICS has good reliability and validity when used in the pediatric population. The inter-rater reliability of predicting management and indices for validity are lower than those in adults with thoracolumbar fractures, which is likely due to differences in the way children are treated for certain types of injuries. TLICS can be used to reliably categorize thoracolumbar injuries in the pediatric population; however, modifications may be needed to better guide treatment in this specific patient population. 4.

Cortisol stress resonance in the laboratory is associated with inter-couple diurnal cortisol covariation in daily life.

PubMed

Engert, Veronika; Ragsdale, Amy M; Singer, Tania

2018-02-01

In laboratory environments individuals may display empathic cortisol stress responses merely from observing another experience psychosocial stress. Moreover, within couples, women synchronize their own to their partners' stress-induced cortisol release. We investigated whether a woman's tendency to experience such cortisol stress resonance in a controlled laboratory task is associated with the degree to which her and her partner's diurnal cortisol levels covary in a naturalistic environment. Such habitual cortisol covariation may be a pathway via which close relationships influence health outcomes. Forty-four men completed the Trier Social Stress Test while their female partners observed the situation, either via "real-life" (one-way mirror) or "virtual" (video) observation modality. Later, the couples collected diurnal cortisol samples over two weekdays. Hierarchical linear modeling indicated that the degree to which couples covaried in their daily cortisol secretion was associated with the female partner's cortisol stress resonance in the laboratory, and that this association was stronger if stress resonance was assessed in the "real-life" observation condition. Specifically, women with higher cortisol stress resonance were more closely linked to their partner's diurnal cortisol secretion. Neither momentary partner presence during sampling nor relationship duration or quality accounted for the association. By showing that covariation in the laboratory has ecological validity in naturalistic conditions, these results make an important methodological contribution to the study of dyadic processes. Given that close relationships exert immense influence over individual health outcomes, understanding the association between acute and chronic physiological linkage may provide important insight into the mechanisms by which close relationships impact well-being. Copyright © 2018 Elsevier Inc. All rights reserved.

Stroke and aphasia quality-of-life scale-39: Reliability and validity of the Turkish version.

PubMed

Noyan-ErbaŞ, AyŞin; Toğram, Bülent

2016-10-01

The aim of this study was to adapt the stroke and aphasia quality-of-life scale-39 (SAQoL-39) to the Turkish language and carry out a reliability and validity study of the instrument in a group of patients with aphasia. The study was a descriptive study and contained three phases: adaptation of the SAQoL-39 to the Turkish language, administration of the scale to 30 aphasia patients and reliability and validity studies of the scale. Internal consistency was assessed with Cronbach's alpha and test-re-test reliability was explored (n = 14). The adaptation process was completed based on inter-rater agreement on the translated items and within the scope of final editing by the authors of the study. The SAQoL-39 in Turkish exhibited high test-re-test reliability (ICC =0.97) as well as acceptability with minimal missing data (0-1.4). This instrument exhibited high internal consistency (Cronbach's α = 0.70-0.97), domain-total correlations (r = 0.76-0.85) and inter-domain correlations (r = 0.40-0.68). The analysis shows that the Turkish version of SAQoL-39 is a scale that is highly acceptable, valid and reliable and can be easily used in evaluating the quality-of-life of Turkish people with aphasia.

Paediatric Automatic Phonological Analysis Tools (APAT).

PubMed

Saraiva, Daniela; Lousada, Marisa; Hall, Andreia; Jesus, Luis M T

2017-12-01

To develop the pediatric Automatic Phonological Analysis Tools (APAT) and to estimate inter and intrajudge reliability, content validity, and concurrent validity. The APAT were constructed using Excel spreadsheets with formulas. The tools were presented to an expert panel for content validation. The corpus used in the Portuguese standardized test Teste Fonético-Fonológico - ALPE produced by 24 children with phonological delay or phonological disorder was recorded, transcribed, and then inserted into the APAT. Reliability and validity of APAT were analyzed. The APAT present strong inter- and intrajudge reliability (>97%). The content validity was also analyzed (ICC = 0.71), and concurrent validity revealed strong correlations between computerized and manual (traditional) methods. The development of these tools contributes to fill existing gaps in clinical practice and research, since previously there were no valid and reliable tools/instruments for automatic phonological analysis, which allowed the analysis of different corpora.

Intraguild predation may reinforce a species-environment gradient

NASA Astrophysics Data System (ADS)

MacNeil, Calum; Dick, Jaimie T. A.

2012-05-01

Species-environment gradients are ubiquitous in nature, with studies often partially explaining the replacement of species along such gradients by autecological factors such as differential physiological tolerances. However, lacking direct evidence, the majority of studies only infer some form of inter-specific interaction, often competition, as reinforcing these gradients. There is usually the further implication that environmental factors mediate asymmetries in the interaction. Recognising the lack of explicit experimental considerations of how key inter-specific interactions are modified by the environment, we chose a study system where we were able to bring the species in question into the laboratory and conduct experiments to test hypotheses about gradient-induced asymmetries in an inter-specific interaction. To this end, we tested the hypothesis that a species-salinity gradient may be reinforced by changes in the asymmetry of intraguild predation between two species of amphipod crustaceans with wide salinity tolerances. River and estuary surveys showed that Gammarus duebeni and Gammarus zaddachi have overlapping distributions, with both surviving and reproducing in salinities ranging from freshwater to fully marine. However, the former species is relatively more abundant in low salinities and the latter in higher salinities. In the laboratory, survival of both species was high in all salinities and cannibalism occurred at low frequencies. However, intraguild predation by males on moulted females was asymmetric in favour of G. duebeni at low salinities, this asymmetry completely reversing to favour G. zaddachi at higher salinities. Thus, we provide evidence that this species-environment gradient occurs due to overlapping physiological tolerances and salinity-driven shifts in the asymmetry of a key inter-specific interaction, intraguild predation.

A point of application study to determine the accuracy, precision and reliability of a low-cost balance plate for center of pressure measurement.

PubMed

Goble, Daniel J; Khan, Ehran; Baweja, Harsimran S; O'Connor, Shawn M

2018-04-11

Changes in postural sway measured via force plate center of pressure have been associated with many aspects of human motor ability. A previous study validated the accuracy and precision of a relatively new, low-cost and portable force plate called the Balance Tracking System (BTrackS). This work compared a laboratory-grade force plate versus BTrackS during human-like dynamic sway conditions generated by an inverted pendulum device. The present study sought to extend previous validation attempts for BTrackS using a more traditional point of application (POA) approach. Computer numerical control (CNC) guided application of ∼155 N of force was applied five times to each of 21 points on five different BTrackS Balance Plate (BBP) devices with a hex-nose plunger. Results showed excellent agreement (ICC > 0.999) between the POAs and measured COP by the BBP devices, as well as high accuracy (<1% average percent error) and precision (<0.1 cm average standard deviation of residuals). The ICC between BBP devices was exceptionally high (ICC > 0.999) providing evidence of almost perfect inter-device reliability. Taken together, these results provide an important, static corollary to the previously obtained dynamic COP results from inverted pendulum testing of the BBP. Copyright © 2018 Elsevier Ltd. All rights reserved.

Validity and reliability of the de Morton Mobility Index in the subacute hospital setting in a geriatric evaluation and management population.

PubMed

de Morton, Natalie A; Lane, Kylie

2010-11-01

To investigate the clinimetric properties of the de Morton Mobility Index (DEMMI) in a Geriatric Evaluation and Management (GEM) population. A longitudinal validation study (n = 100) and inter-rater reliability study (n = 29) in a GEM population. Consecutive patients admitted to a GEM rehabilitation ward were eligible for inclusion. At hospital admission and discharge, a physical therapist assessed patients with physical performance instruments that included the 6-metre walk test, step test, Clinical Test of Sensory Organization and Balance, Timed Up and Go test, 6-minute walk test and the DEMMI. Consecutively eligible patients were included in an inter-rater reliability study between physical therapists. DEMMI admission scores were normally distributed (mean 30.2, standard deviation 16.7) and other activity limitation instruments had either a floor or a ceiling effect. Evidence of convergent, discriminant and known groups validity for the DEMMI were obtained. The minimal detectable change with 90% confidence was 10.5 (95% confidence interval 6.1-17.9) points and the minimally clinically important difference was 8.4 points on the 100-point interval DEMMI scale. The DEMMI provides clinicians with an accurate and valid method of measuring mobility for geriatric patients in the subacute hospital setting.

Comparison of PIXE and XRF analysis of airborne particulate matter samples collected on Teflon and quartz fibre filters

NASA Astrophysics Data System (ADS)

Chiari, M.; Yubero, E.; Calzolai, G.; Lucarelli, F.; Crespo, J.; Galindo, N.; Nicolás, J. F.; Giannoni, M.; Nava, S.

2018-02-01

Within the framework of research projects focusing on the sampling and analysis of airborne particulate matter, Particle Induced X-ray Emission (PIXE) and Energy Dispersive X-ray Fluorescence (ED-XRF) techniques are routinely used in many laboratories throughout the world to determine the elemental concentration of the particulate matter samples. In this work an inter-laboratory comparison of the results obtained from analysing several samples (collected on both Teflon and quartz fibre filters) using both techniques is presented. The samples were analysed by PIXE (in Florence, at the 3 MV Tandetron accelerator of INFN-LABEC laboratory) and by XRF (in Elche, using the ARL Quant'X EDXRF spectrometer with specific conditions optimized for specific groups of elements). The results from the two sets of measurements are in good agreement for all the analysed samples, thus validating the use of the ARL Quant'X EDXRF spectrometer and the selected measurement protocol for the analysis of aerosol samples. Moreover, thanks to the comparison of PIXE and XRF results on Teflon and quartz fibre filters, possible self-absorption effects due to the penetration of the aerosol particles inside the quartz fibre-filters were quantified.

Creation of 0.10-cm-1 resolution quantitative infrared spectral libraries for gas samples

NASA Astrophysics Data System (ADS)

Sharpe, Steven W.; Sams, Robert L.; Johnson, Timothy J.; Chu, Pamela M.; Rhoderick, George C.; Guenther, Franklin R.

2002-02-01

The National Institute of Standards and Technology (NIST) and the Pacific Northwest National Laboratory (PNNL) are independently creating quantitative, approximately 0.10 cm-1 resolution, infrared spectral libraries of vapor phase compounds. The NIST library will consist of approximately 100 vapor phase spectra of volatile hazardous air pollutants (HAPs) and suspected greenhouse gases. The PNNL library will consist of approximately 400 vapor phase spectra associated with DOE's remediation mission. A critical part of creating and validating any quantitative work involves independent verification based on inter-laboratory comparisons. The two laboratories use significantly different sample preparation and handling techniques. NIST uses gravimetric dilution and a continuous flowing sample while PNNL uses partial pressure dilution and a static sample. Agreement is generally found to be within the statistical uncertainties of the Beer's law fit and less than 3 percent of the total integrated band areas for the 4 chemicals used in this comparison. There does appear to be a small systematic difference between the PNNL and NIST data, however. Possible sources of the systematic difference will be discussed as well as technical details concerning the sample preparation and the procedures for overcoming instrumental artifacts.

Web based scoring is useful for validation and harmonisation of scoring criteria within RENEB.

PubMed

Romm, Horst; Ainsbury, Elizabeth A; Barquinero, Joan Francesc; Barrios, Leonardo; Beinke, Christina; Cucu, Alexandra; Domene, Mercedes Moreno; Filippi, Silvia; Monteiro Gil, Octávia; Gregoire, Eric; Hadjidekova, Valeria; Hatzi, Vasia; Lindholm, Carita; M Kacher, Radhia; Montoro, Alegria; Moquet, Jayne; Noditi, Mihaela; Oestreicher, Ursula; Palitti, Fabrizio; Pantelias, Gabriel; Prieto, María Jesús; Popescu, Irina; Rothkamm, Kai; Sebastià, Natividad; Sommer, Sylwester; Terzoudi, Georgia; Testa, Antonella; Wojcik, Andrzej

2017-01-01

To establish a training data set of digital images and to investigate the scoring criteria and dose assessment of the dicentric assay within the European network of biodosimetry (RENEB), a web based scoring inter-comparison was undertaken by 17 RENEB partners. Two sets of 50 high resolution images were uploaded onto the RENEB website. One set included metaphases after a moderate exposure (1.3 Gy) and the other set consisted of metaphases after a high dose exposure (3.5 Gy). The laboratories used their own calibration curves for estimating doses based on observed aberration frequencies. The dose estimations and 95% confidence limits were compared to the actual doses and the corresponding z-values were satisfactory for the majority; only the dose estimations from two laboratories were too low or too high. The coefficients of variation were 17.6% for the moderate and 11.2% for the high dose. Metaphases with controversial results could be identified for training purposes. Overall, the web based scoring of the two galleries by the 17 laboratories produced very good results. Application of web based scoring for the dicentric assay may therefore be a relevant strategy for an operational biodosimetry assistance network.

Interlaboratory study of a liquid chromatography method for erythromycin: determination of uncertainty.

PubMed

Dehouck, P; Vander Heyden, Y; Smeyers-Verbeke, J; Massart, D L; Marini, R D; Chiap, P; Hubert, Ph; Crommen, J; Van de Wauw, W; De Beer, J; Cox, R; Mathieu, G; Reepmeyer, J C; Voigt, B; Estevenon, O; Nicolas, A; Van Schepdael, A; Adams, E; Hoogmartens, J

2003-08-22

Erythromycin is a mixture of macrolide antibiotics produced by Saccharopolyspora erythreas during fermentation. A new method for the analysis of erythromycin by liquid chromatography has previously been developed. It makes use of an Astec C18 polymeric column. After validation in one laboratory, the method was now validated in an interlaboratory study. Validation studies are commonly used to test the fitness of the analytical method prior to its use for routine quality testing. The data derived in the interlaboratory study can be used to make an uncertainty statement as well. The relationship between validation and uncertainty statement is not clear for many analysts and there is a need to show how the existing data, derived during validation, can be used in practice. Eight laboratories participated in this interlaboratory study. The set-up allowed the determination of the repeatability variance, s(2)r and the between-laboratory variance, s(2)L. Combination of s(2)r and s(2)L results in the reproducibility variance s(2)R. It has been shown how these data can be used in future by a single laboratory that wants to make an uncertainty statement concerning the same analysis.

Validation of the one pass measure for motivational interviewing competence.

PubMed

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.

[Desing and validation of a scale to measure caregiving dedication in caregivers of dependent older people].

PubMed

Serrano-Ortega, Natalia; Frías-Osuna, Antonio; Recio-Gómez, Juan M; Del-Pino-Casado, Rafael

2015-11-01

To develop and validate a scale to measure caregiving dedication regarding activities of daily living in caregivers of dependent older people. Cross-sectional study. Primary Health Care (Andalusia, Spain). a probabilistic sample of 200 caregivers of older relatives from Córdoba, Spain. Content validation by experts, construct validity (by exploratory factor analysis), divergent validity and reliability (internal consistency, test-retest reliability and inter-observers reliability). Cronbach's alpha was 0.86. Intraclass Correlation Coefficient was 0.96 for test-retest reliability and 0.88 for inter-observers reliability. When the sample was divided in two groups according to perceived burden level (presence and absence), the perceived burden was significantly different in each group (P=.001). The factor analysis revealed one only factor that explained 64% of the variance. The scale allows a suitable measure of caregiving dedication regarding activities of daily living in caregivers of older people, because this scale allows a quickly, easy administration, is well accepted by caregivers, has acceptable psychometric results and includes the frequency of caregiving, the kind of attended need and the dependence level in each need. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Laboratory Study of Homogeneous and Isotropic Turbulence at High Reynolds Number

NASA Astrophysics Data System (ADS)

Pecenak, Zachary; Dou, Zhongwang; Yang, Fan; Cao, Lujie; Liang, Zach; Meng, Hui

2013-11-01

To study particle dynamics modified by isotropic turbulence at high Reynolds numbers and provide experimental data for DNS validation, we have developed a soccer-ball-shaped truncated icosahedron turbulence chamber with 20 adjoining hexagon surfaces, 12 pentagon surfaces and twenty symettrically displaced fans, which form an enclosed chamber of 1m diameter. We use Particle Image Velocimetry (PIV) technique to characterize the base turbulent flow, using different PIV set ups to capture various characteristic scales of turbulence. Results show that the stationary isotropic turbulence field is a spherical domain with diameter of 40 mm with quasi-zero mean velocities. The maximum rms velocity is ~1.5 m/s, corresponding to a Taylor microscale Re of 450. We extract from the PIV velocity field the whole set of turbulent flow parameters including: turbulent kinetic energy, turbulent intensity, kinetic energy dissipation rate, large eddy length and time scales, the Kolmogorov length, time and velocity scales, Taylor microscale and Re, which are critical to the study of inter-particle statistics modified by turbulence. This research is funded by an NSF grant CBET-0967407.

[Interest of the study of a not identified peak on a hemoglobin chromatogram: delta variant or inter-sample contaminations?].

PubMed

Desmons, Aurore; Jaisson, Stéphane; Gillery, Philippe; Guillard, Emmanuelle

2013-01-01

D-10(®) (Bio-Rad) analyzer using cationic exchange high performance chromatography (HPLC) allows the detection of the main hemoglobin variants. This observation shows the presence of a peak on chromatogram with a low intensity and no quantifiable which can lead to different diagnosis. Inter-sample contaminations can be confused with the presence of an hemoglobin variant. This case highlights the importance of the knowledge of technicals limits for validation and clinical use of results.

The reliability and validity of the SF-8 with a conflict-affected population in northern Uganda.

PubMed

Roberts, Bayard; Browne, John; Ocaka, Kaducu Felix; Oyok, Thomas; Sondorp, Egbert

2008-12-02

The SF-8 is a health-related quality of life instrument that could provide a useful means of assessing general physical and mental health amongst populations affected by conflict. The purpose of this study was to test the validity and reliability of the SF-8 with a conflict-affected population in northern Uganda. A cross-sectional multi-staged, random cluster survey was conducted with 1206 adults in camps for internally displaced persons in Gulu and Amuru districts of northern Uganda. Data quality was assessed by analysing the number of incomplete responses to SF-8 items. Response distribution was analysed using aggregate endorsement frequency. Test-retest reliability was assessed in a separate smaller survey using the intraclass correlation test. Construct validity was measured using principal component analysis, and the Pearson Correlation test for item-summary score correlation and inter-instrument correlations. Known groups validity was assessed using a two sample t-test to evaluates the ability of the SF-8 to discriminate between groups known to have, and not have, physical and mental health problems. The SF-8 showed excellent data quality. It showed acceptable item response distribution based upon analysis of aggregate endorsement frequencies. Test-retest showed a good intraclass correlation of 0.61 for PCS and 0.68 for MCS. The principal component analysis indicated strong construct validity and concurred with the results of the validity tests by the SF-8 developers. The SF-8 also showed strong construct validity between the 8 items and PCS and MCS summary score, moderate inter-instrument validity, and strong known groups validity. This study provides evidence on the reliability and validity of the SF-8 amongst IDPs in northern Uganda.

The reliability and validity of the SF-8 with a conflict-affected population in northern Uganda

PubMed Central

Roberts, Bayard; Browne, John; Ocaka, Kaducu Felix; Oyok, Thomas; Sondorp, Egbert

2008-01-01

Background The SF-8 is a health-related quality of life instrument that could provide a useful means of assessing general physical and mental health amongst populations affected by conflict. The purpose of this study was to test the validity and reliability of the SF-8 with a conflict-affected population in northern Uganda. Methods A cross-sectional multi-staged, random cluster survey was conducted with 1206 adults in camps for internally displaced persons in Gulu and Amuru districts of northern Uganda. Data quality was assessed by analysing the number of incomplete responses to SF-8 items. Response distribution was analysed using aggregate endorsement frequency. Test-retest reliability was assessed in a separate smaller survey using the intraclass correlation test. Construct validity was measured using principal component analysis, and the Pearson Correlation test for item-summary score correlation and inter-instrument correlations. Known groups validity was assessed using a two sample t-test to evaluates the ability of the SF-8 to discriminate between groups known to have, and not have, physical and mental health problems. Results The SF-8 showed excellent data quality. It showed acceptable item response distribution based upon analysis of aggregate endorsement frequencies. Test-retest showed a good intraclass correlation of 0.61 for PCS and 0.68 for MCS. The principal component analysis indicated strong construct validity and concurred with the results of the validity tests by the SF-8 developers. The SF-8 also showed strong construct validity between the 8 items and PCS and MCS summary score, moderate inter-instrument validity, and strong known groups validity. Conclusion This study provides evidence on the reliability and validity of the SF-8 amongst IDPs in northern Uganda. PMID:19055716

The Arthroscopic Surgical Skill Evaluation Tool (ASSET)

PubMed Central

Koehler, Ryan J.; Amsdell, Simon; Arendt, Elizabeth A; Bisson, Leslie J; Braman, Jonathan P; Butler, Aaron; Cosgarea, Andrew J; Harner, Christopher D; Garrett, William E; Olson, Tyson; Warme, Winston J.; Nicandri, Gregg T.

2014-01-01

Background Surgeries employing arthroscopic techniques are among the most commonly performed in orthopaedic clinical practice however, valid and reliable methods of assessing the arthroscopic skill of orthopaedic surgeons are lacking. Hypothesis The Arthroscopic Surgery Skill Evaluation Tool (ASSET) will demonstrate content validity, concurrent criterion-oriented validity, and reliability, when used to assess the technical ability of surgeons performing diagnostic knee arthroscopy on cadaveric specimens. Study Design Cross-sectional study; Level of evidence, 3 Methods Content validity was determined by a group of seven experts using a Delphi process. Intra-articular performance of a right and left diagnostic knee arthroscopy was recorded for twenty-eight residents and two sports medicine fellowship trained attending surgeons. Subject performance was assessed by two blinded raters using the ASSET. Concurrent criterion-oriented validity, inter-rater reliability, and test-retest reliability were evaluated. Results Content validity: The content development group identified 8 arthroscopic skill domains to evaluate using the ASSET. Concurrent criterion-oriented validity: Significant differences in total ASSET score (p<0.05) between novice, intermediate, and advanced experience groups were identified. Inter-rater reliability: The ASSET scores assigned by each rater were strongly correlated (r=0.91, p <0.01) and the intra-class correlation coefficient between raters for the total ASSET score was 0.90. Test-retest reliability: there was a significant correlation between ASSET scores for both procedures attempted by each individual (r = 0.79, p<0.01). Conclusion The ASSET appears to be a useful, valid, and reliable method for assessing surgeon performance of diagnostic knee arthroscopy in cadaveric specimens. Studies are ongoing to determine its generalizability to other procedures as well as to the live OR and other simulated environments. PMID:23548808

An initial reliability and validity study of the Interaction, Communication, and Literacy Skills Audit.

PubMed

El-Choueifati, Nisrine; Purcell, Alison; McCabe, Patricia; Heard, Robert; Munro, Natalie

2014-06-01

Early childhood educators (ECEs) have an important role in promoting positive outcomes for children's language and literacy development. This paper reports the development of a new tool, The Interaction Communication and Literacy (ICL) Skills Audit, and pilots its reliability and validity. Intra- and inter-rater reliability was examined by three speech-language pathologists (SLPs). Five skill areas relating to ECE language and literacy practice were rated. The face and content validity of the ICL Skills Audit was examined by expert SLPs (n = 8) and expert ECEs (n = 4) via questionnaire. The overall intra-rater reliability for the ICL Skills Audit was excellent with percentage close agreement (PCA) of 91-94. Inter-rater agreement was PCA 68-80. Expert SLPs and ECEs agreed that the content was comprehensive and practical. Based on this preliminary study, the ICL Skills Audit appears to be a promising tool that can be used by SLPs and ECEs in collaboration to measure the skills of ECEs in the areas of language and literacy support. Future psychometric and outcome research on the revised ICL Skills Audit is warranted.

Analysis of Phosphonic Acids: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS999

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

Owens, J; Vu, A; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method titled Analysis of Diisopropyl Methylphosphonate, Ethyl Hydrogen Dimethylamidophosphate, Isopropyl Methylphosphonic Acid, Methylphosphonic Acid, and Pinacolyl Methylphosphonic Acid in Water by Multiple Reaction Monitoring Liquid Chromatography/Tandem Mass Spectrometry: EPA Version MS999. This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to validate and verify the analytical procedures describedmore » in EPA Method MS999 for analysis of the listed phosphonic acids and surrogates in aqueous samples. The gathered data from this validation study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of EPA Method MS999 can be determined.« less

Cryogenic insulation standard data and methodologies

NASA Astrophysics Data System (ADS)

Demko, J. A.; Fesmire, J. E.; Johnson, W. L.; Swanger, A. M.

2014-01-01

Although some standards exist for thermal insulation, few address the sub-ambient temperature range and cold-side temperatures below 100 K. Standards for cryogenic insulation systems require cryostat testing and data analysis that will allow the development of the tools needed by design engineers and thermal analysts for the design of practical cryogenic systems. Thus, this critically important information can provide reliable data and methodologies for industrial efficiency and energy conservation. Two Task Groups have been established in the area of cryogenic insulation systems Under ASTM International's Committee C16 on Thermal Insulation. These are WK29609 - New Standard for Thermal Performance Testing of Cryogenic Insulation Systems and WK29608 - Standard Practice for Multilayer Insulation in Cryogenic Service. The Cryogenics Test Laboratory of NASA Kennedy Space Center and the Thermal Energy Laboratory of LeTourneau University are conducting Inter-Laboratory Study (ILS) of selected insulation materials. Each lab carries out the measurements of thermal properties of these materials using identical flat-plate boil-off calorimeter instruments. Parallel testing will provide the comparisons necessary to validate the measurements and methodologies. Here we discuss test methods, some initial data in relation to the experimental approach, and the manner reporting the thermal performance data. This initial study of insulation materials for sub-ambient temperature applications is aimed at paving the way for further ILS comparative efforts that will produce standard data sets for several commercial materials. Discrepancies found between measurements will be used to improve the testing and data reduction techniques being developed as part of the future ASTM International standards.

Can we have an overall osteoarthritis severity score for the patellofemoral joint using magnetic resonance imaging? Reliability and validity.

PubMed

Kobayashi, Sarah; Peduto, Anthony; Simic, Milena; Fransen, Marlene; Refshauge, Kathryn; Mah, Jean; Pappas, Evangelos

2018-04-01

This work aimed to assess inter-rater reliability and agreement of a magnetic resonance imaging (MRI)-based Kellgren and Lawrence (K&L) grading for patellofemoral joint osteoarthritis (OA) and to validate it against the MRI Osteoarthritis Knee Score (MOAKS). MRI scans from people aged 45 to 75 years with chronic knee pain participating in a randomised clinical trial evaluating dietary supplements were utilised. Fifty participants were randomly selected and scored using the MRI-based K&L grading using axial and sagittal MRI scans. Raters conducted inter-rater reliability, blinded to clinical information, radiology reports and other rater results. Intra- and inter-rater reliability and agreement were evaluated using the intra-class correlation coefficient (ICC) and Cohen's weighted kappa. There was a 2-week interval between the first and second readings for intra-rater reliability. Validity was assessed using the MOAKS and evaluated using Spearman's correlation coefficient. Intra-rater reliability of the K&L system was excellent: ICC 0.91 (95% CI 0.82-0.95); weighted kappa (ĸ = 0.69). Inter-rater reliability was high (ICC 0.88; 95% CI 0.79-0.93), while agreement between raters was moderate (ĸ = 0.49-0.57). Validity analysis demonstrated a strong correlation between the total MOAKS features score and the K&L grading system (ρ = 0.62-0.67) but weak correlations when compared with individual MOAKS features (ρ = 0.19-0.61). The high reliability and good agreement show consistency in grading the severity of patellofemoral OA with the MRI-based K&L score. Our validity results suggest that the scale may be useful, particularly in the clinical environment. Future research should validate this method against clinical findings.

Construct Validity and Reliability of the SARA Gait and Posture Sub-scale in Early Onset Ataxia

PubMed Central

Lawerman, Tjitske F.; Brandsma, Rick; Verbeek, Renate J.; van der Hoeven, Johannes H.; Lunsing, Roelineke J.; Kremer, Hubertus P. H.; Sival, Deborah A.

2017-01-01

Aim: In children, gait and posture assessment provides a crucial marker for the early characterization, surveillance and treatment evaluation of early onset ataxia (EOA). For reliable data entry of studies targeting at gait and posture improvement, uniform quantitative biomarkers are necessary. Until now, the pediatric test construct of gait and posture scores of the Scale for Assessment and Rating of Ataxia sub-scale (SARA) is still unclear. In the present study, we aimed to validate the construct validity and reliability of the pediatric (SARAGAIT/POSTURE) sub-scale. Methods: We included 28 EOA patients [15.5 (6–34) years; median (range)]. For inter-observer reliability, we determined the ICC on EOA SARAGAIT/POSTURE sub-scores by three independent pediatric neurologists. For convergent validity, we associated SARAGAIT/POSTURE sub-scores with: (1) Ataxic gait Severity Measurement by Klockgether (ASMK; dynamic balance), (2) Pediatric Balance Scale (PBS; static balance), (3) Gross Motor Function Classification Scale -extended and revised version (GMFCS-E&R), (4) SARA-kinetic scores (SARAKINETIC; kinetic function of the upper and lower limbs), (5) Archimedes Spiral (AS; kinetic function of the upper limbs), and (6) total SARA scores (SARATOTAL; i.e., summed SARAGAIT/POSTURE, SARAKINETIC, and SARASPEECH sub-scores). For discriminant validity, we investigated whether EOA co-morbidity factors (myopathy and myoclonus) could influence SARAGAIT/POSTURE sub-scores. Results: The inter-observer agreement (ICC) on EOA SARAGAIT/POSTURE sub-scores was high (0.97). SARAGAIT/POSTURE was strongly correlated with the other ataxia and functional scales [ASMK (rs = -0.819; p < 0.001); PBS (rs = -0.943; p < 0.001); GMFCS-E&R (rs = -0.862; p < 0.001); SARAKINETIC (rs = 0.726; p < 0.001); AS (rs = 0.609; p = 0.002); and SARATOTAL (rs = 0.935; p < 0.001)]. Comorbid myopathy influenced SARAGAIT/POSTURE scores by concurrent muscle weakness, whereas comorbid myoclonus predominantly influenced SARAKINETIC scores. Conclusion: In young EOA patients, separate SARAGAIT/POSTURE parameters reveal a good inter-observer agreement and convergent validity, implicating the reliability of the scale. In perspective of incomplete discriminant validity, it is advisable to interpret SARAGAIT/POSTURE scores for comorbid muscle weakness. PMID:29326569

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

ERIC Educational Resources Information Center

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,…

Psychometric Evaluation of the D-Catch, an Instrument to Measure the Accuracy of Nursing Documentation.

PubMed

D'Agostino, Fabio; Barbaranelli, Claudio; Paans, Wolter; Belsito, Romina; Juarez Vela, Raul; Alvaro, Rosaria; Vellone, Ercole

2017-07-01

To evaluate the psychometric properties of the D-Catch instrument. A cross-sectional methodological study. Validity and reliability were estimated with confirmatory factor analysis (CFA) and internal consistency and inter-rater reliability, respectively. A sample of 250 nursing documentations was selected. CFA showed the adequacy of a 1-factor model (chronologically descriptive accuracy) with an outlier item (nursing diagnosis accuracy). Internal consistency and inter-rater reliability were adequate. The D-Catch is a valid and reliable instrument for measuring the accuracy of nursing documentation. Caution is needed when measuring diagnostic accuracy since only one item measures this dimension. The D-Catch can be used as an indicator of the accuracy of nursing documentation and the quality of nursing care. © 2015 NANDA International, Inc.

A Danish diabetes risk score for targeted screening: the Inter99 study.

PubMed

Glümer, Charlotte; Carstensen, Bendix; Sandbaek, Annelli; Lauritzen, Torsten; Jørgensen, Torben; Borch-Johnsen, Knut

2004-03-01

To develop a simple self-administered questionnaire identifying individuals with undiagnosed diabetes with a sensitivity of 75% and minimizing the high-risk group needing subsequent testing. A population-based sample (Inter99 study) of 6,784 individuals aged 30-60 years completed a questionnaire on diabetes-related symptoms and risk factors. The participants underwent an oral glucose tolerance test. The risk score was derived from the first half and validated on the second half of the study population. External validation was performed based on the Danish Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care (ADDITION) pilot study. The risk score was developed by stepwise backward multiple logistic regression. The final risk score included age, sex, BMI, known hypertension, physical activity at leisure time, and family history of diabetes, items independently and significantly (P<0.05) associated with the presence of previously undiagnosed diabetes. The area under the receiver operating curve was 0.804 (95% CI 0.765-0.838) for the first half of the Inter99 population, 0.761 (0.720-0.803) for the second half of the Inter99 population, and 0.803 (0.721-0.876) for the ADDITION pilot study. The sensitivity, specificity, and percentage that needed subsequent testing were 76, 72, and 29%, respectively. The false-negative individuals in the risk score had a lower absolute risk of ischemic heart disease compared with the true-positive individuals (11.3 vs. 20.4%; P<0.0001). We developed a questionnaire to be used in a stepwise screening strategy for type 2 diabetes, decreasing the numbers of subsequent tests and thereby possibly minimizing the economical and personal costs of the screening strategy.

Crowd-sourced assessment of technical skills: an adjunct to urology resident surgical simulation training.

PubMed

Holst, Daniel; Kowalewski, Timothy M; White, Lee W; Brand, Timothy C; Harper, Jonathan D; Sorenson, Mathew D; Kirsch, Sarah; Lendvay, Thomas S

2015-05-01

Crowdsourcing is the practice of obtaining services from a large group of people, typically an online community. Validated methods of evaluating surgical video are time-intensive, expensive, and involve participation of multiple expert surgeons. We sought to obtain valid performance scores of urologic trainees and faculty on a dry-laboratory robotic surgery task module by using crowdsourcing through a web-based grading tool called Crowd Sourced Assessment of Technical Skill (CSATS). IRB approval was granted to test the technical skills grading accuracy of Amazon.com Mechanical Turk™ crowd-workers compared to three expert faculty surgeon graders. The two groups assessed dry-laboratory robotic surgical suturing performances of three urology residents (PGY-2, -4, -5) and two faculty using three performance domains from the validated Global Evaluative Assessment of Robotic Skills assessment tool. After an average of 2 hours 50 minutes, each of the five videos received 50 crowd-worker assessments. The inter-rater reliability (IRR) between the surgeons and crowd was 0.91 using Cronbach's alpha statistic (confidence intervals=0.20-0.92), indicating an agreement level between the two groups of "excellent." The crowds were able to discriminate the surgical level, and both the crowds and the expert faculty surgeon graders scored one senior trainee's performance above a faculty's performance. Surgery-naive crowd-workers can rapidly assess varying levels of surgical skill accurately relative to a panel of faculty raters. The crowds provided rapid feedback and were inexpensive. CSATS may be a valuable adjunct to surgical simulation training as requirements for more granular and iterative performance tracking of trainees become mandated and commonplace.

Empirical solvent-mediated potentials hold for both intra-molecular and inter-molecular inter-residue interactions.

PubMed Central

Keskin, O.; Bahar, I.; Badretdinov, A. Y.; Ptitsyn, O. B.; Jernigan, R. L.

1998-01-01

Whether knowledge-based intra-molecular inter-residue potentials are valid to represent inter-molecular interactions taking place at protein-protein interfaces has been questioned in several studies. Differences in the chain connectivity effect and in residue packing geometry between interfaces and single chain monomers have been pointed out as possible sources of distinct energetics for the two cases. In the present study, the interfacial regions of protein-protein complexes are examined to extract inter-molecular inter-residue potentials, using the same statistical methods as those previously adopted for intra-molecular residue pairs. Two sets of energy parameters are derived, corresponding to solvent-mediation and "average residue" mediation. The former set is shown to be highly correlated (correlation coefficient 0.89) with that previously obtained for inter-residue interactions within single chain monomers, while the latter exhibits a weaker correlation (0.69) with its intra-molecular counterpart. In addition to the close similarity of intra- and inter-molecular solvent-mediated potentials, they are shown to be significantly more residue-specific and thereby discriminative compared to the residue-mediated ones, indicating that solvent-mediation plays a major role in controlling the effective inter-residue interactions, either at interfaces, or within single monomers. Based on this observation, a reduced set of energy parameters comprising 20 one-body and 3 two-body terms is proposed (as opposed to the 20 x 20 tables of inter-residue potentials), which reproduces the conventional 20 x 20 tables with a correlation coefficient of 0.99. PMID:9865952

Rater reliability and concurrent validity of the Keyboard Personal Computer Style instrument (K-PeCS).

PubMed

Baker, Nancy A; Cook, James R; Redfern, Mark S

2009-01-01

This paper describes the inter-rater and intra-rater reliability, and the concurrent validity of an observational instrument, the Keyboard Personal Computer Style instrument (K-PeCS), which assesses stereotypical postures and movements associated with computer keyboard use. Three trained raters independently rated the video clips of 45 computer keyboard users to ascertain inter-rater reliability, and then re-rated a sub-sample of 15 video clips to ascertain intra-rater reliability. Concurrent validity was assessed by comparing the ratings obtained using the K-PeCS to scores developed from a 3D motion analysis system. The overall K-PeCS had excellent reliability [inter-rater: intra-class correlation coefficients (ICC)=.90; intra-rater: ICC=.92]. Most individual items on the K-PeCS had from good to excellent reliability, although six items fell below ICC=.75. Those K-PeCS items that were assessed for concurrent validity compared favorably to the motion analysis data for all but two items. These results suggest that most items on the K-PeCS can be used to reliably document computer keyboarding style.

Validated UV-spectrophotometric method for the evaluation of the efficacy of makeup remover.

PubMed

Charoennit, P; Lourith, N

2012-04-01

A UV-spectrophotometric method for the analysis of makeup remover was developed and validated according to ICH guidelines. Three makeup removers for which the main ingredients consisted of vegetable oil (A), mineral oil and silicone (B) and mineral oil and water (C) were sampled in this study. Ethanol was the optimal solvent because it did not interfere with the maximum absorbance of the liquid foundation at 250 nm. The linearity was determined over a range of makeup concentrations from 0.540 to 1.412 mg mL⁻¹ (R² = 0.9977). The accuracy of this method was determined by analysing low, intermediate and high concentrations of the liquid foundation and gave 78.59-91.57% recoveries with a relative standard deviation of <2% (0.56-1.45%). This result demonstrates the validity and reliability of this method. The reproducibilities were 97.32 ± 1.79, 88.34 ± 2.69 and 95.63 ± 2.94 for preparations A, B and C respectively, which are within the acceptable limits set forth by the ASEAN analytical validation guidelines, which ensure the precision of the method under the same operating conditions over a short time interval and the inter-assay precision within the laboratory. The proposed method is therefore a simple, rapid, accurate, precise and inexpensive technique for the routine analysis of makeup remover efficacy. © 2011 The Authors. ICS © 2011 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

Satellite Derived Volcanic Ash Product Inter-Comparison in Support to SCOPE-Nowcasting

NASA Astrophysics Data System (ADS)

Siddans, Richard; Thomas, Gareth; Pavolonis, Mike; Bojinski, Stephan

2016-04-01

In support of aeronautical meteorological services, WMO organized a satellite-based volcanic ash retrieval algorithm inter-comparison activity, to improve the consistency of quantitative volcanic ash products from satellites, under the Sustained, Coordinated Processing of Environmental Satellite Data for Nowcasting (SCOPEe Nowcasting) initiative (http:/ jwww.wmo.int/pagesjprogjsatjscopee nowcasting_en.php). The aims of the intercomparison were as follows: 1. Select cases (Sarychev Peak 2009, Eyjafyallajökull 2010, Grimsvötn 2011, Puyehue-Cordón Caulle 2011, Kirishimayama 2011, Kelut 2014), and quantify the differences between satellite-derived volcanic ash cloud properties derived from different techniques and sensors; 2. Establish a basic validation protocol for satellite-derived volcanic ash cloud properties; 3. Document the strengths and weaknesses of different remote sensing approaches as a function of satellite sensor; 4. Standardize the units and quality flags associated with volcanic cloud geophysical parameters; 5. Provide recommendations to Volcanic Ash Advisory Centers (VAACs) and other users on how to best to utilize quantitative satellite products in operations; 6. Create a "road map" for future volcanic ash related scientific developments and inter-comparison/validation activities that can also be applied to SO2 clouds and emergent volcanic clouds. Volcanic ash satellite remote sensing experts from operational and research organizations were encouraged to participate in the inter-comparison activity, to establish the plans for the inter-comparison and to submit data sets. RAL was contracted by EUMETSAT to perform a systematic inter-comparison of all submitted datasets and results were reported at the WMO International Volcanic Ash Inter-comparison Meeting to held on 29 June - 2 July 2015 in Madison, WI, USA (http:/ /cimss.ssec.wisc.edujmeetings/vol_ash14). 26 different data sets were submitted, from a range of passive imagers and spectrometers and these were inter-compared against each other and against validation data such as CALIPSO lidar, ground-based lidar and aircraft observations. Results of the comparison exercise will be presented together with the conclusions and recommendations arising from the activity.

The inter and intra rater reliability of the Netball Movement Screening Tool.

PubMed

Reid, Duncan A; Vanweerd, Rebecca J; Larmer, Peter J; Kingstone, Rachel

2015-05-01

To establish the inter- and intra-rater reliability of the Netball Movement Screening Tool, for screening adolescent female netball players. Inter- and intra-rater reliability study. Forty secondary school netball players were recruited to take part in the study. Twenty subjects were screened simultaneously and independently by two raters to ascertain inter-rater agreement. Twenty subjects were scored by rater one on two occasions, separated by a week, to ascertain intra-rater agreement. Inter and intra-rater agreement was assessed utilising the two-way mixed inter class correlation coefficient and weighted kappa statistics. No significant demographic differences were found between the inter and intra-rater groups of subjects. Inter class correlation coefficients' demonstrated excellent inter-rater (two-way mixed inter class correlation coefficients 0.84, standard error of measurement 0.25) and intra-rater (two-way mixed inter class correlation coefficients 0.96, standard error of measurement 0.13) reliability for the overall Netball Movement Screening Tool score and substantial-excellent (two-way mixed inter class correlation coefficients 1.0-0.65) inter-rater and substantial-excellent intra-rater (two-way mixed inter class correlation coefficients 0.96-0.79) reliability for the component scores of the Netball Movement Screening Tool. Kappa statistic showed substantial to poor inter-rater (k=0.75-0.32) and intra-rater (k=0.77-0.27) agreement for individual tests of the NMST. The Netball Movement Screening Tool may be a reliable screening tool for adolescent netball players; however the individual test scores have low reliability. The screening tool can be administered reliably by raters with similar levels of training in the tool but variable clinical experience. On-going research needs to be undertaken to ascertain whether the Netball Movement Screening Tool is a valid tool in ascertaining increased injury risk for netball players. Copyright © 2014 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

The Imperial Paediatric Emergency Training Toolkit (IPETT) for use in paediatric emergency training: development and evaluation of feasibility and validity.

PubMed

Lambden, Simon; DeMunter, Claudine; Dowson, Anne; Cooper, Mehrengise; Gautama, Sanjay; Sevdalis, Nick

2013-06-01

To develop and test the feasibility, reliability, and validity of a practical toolkit for the assessment and feedback of skills required to manage paediatric emergencies in critical care settings. The Imperial Paediatric Emergency Training Toolkit (IPETT) was developed based on current evidence-base and expert input. IPETT assesses both technical and non-technical skills. The technical component covers skills in the areas of clinical assessment, airway and breathing, cardiovascular, and drugs. The non-technical component is based on the validated NOTECHS tool and covers communication and interaction, cooperation and team skills, leadership and managerial skills, and decision-making. The reliability (internal consistency), content validity (inter-correlations between different skills) and concurrent validity (correlations between global technical and non-technical scores) of IPETT were prospectively evaluated in 45 simulated paediatric crises carried out in a PICU with anaesthetic and paediatric trainees (N=52). Non-parametric analyses were carried out. Significance was set at P<0.05. Cronbach alpha reliability coefficients were overall acceptable for the technical (alpha range=0.638-0.810) and good for the non-technical (alpha range=0.701-0.899) component of IPETT. The median inter-skill correlation was rho=0.564 and rho=0.549 for the technical and non-technical components, respectively. These indicate good content validity, as the skills were inter-related but not redundant. We also demonstrate a correlation between the global technical and non-technical scores (rho=0.471) - all Ps<0.05 during the assessments. IPETT offers a psychometrically viable and feasible to use tool in the context of paediatric emergencies training. This study shows that assessment of technical and non-technical skills in combination may offer a more clinically relevant model for training in paediatric emergencies. Further validation should aim to demonstrate skill retention over time and skill transfer from simulation-based training to real emergencies. Copyright © 2013. Published by Elsevier Ireland Ltd.

Development and validation of a tool to evaluate the quality of medical education websites in pathology.

PubMed

Alyusuf, Raja H; Prasad, Kameshwar; Abdel Satir, Ali M; Abalkhail, Ali A; Arora, Roopa K

2013-01-01

The exponential use of the internet as a learning resource coupled with varied quality of many websites, lead to a need to identify suitable websites for teaching purposes. The aim of this study is to develop and to validate a tool, which evaluates the quality of undergraduate medical educational websites; and apply it to the field of pathology. A tool was devised through several steps of item generation, reduction, weightage, pilot testing, post-pilot modification of the tool and validating the tool. Tool validation included measurement of inter-observer reliability; and generation of criterion related, construct related and content related validity. The validated tool was subsequently tested by applying it to a population of pathology websites. Reliability testing showed a high internal consistency reliability (Cronbach's alpha = 0.92), high inter-observer reliability (Pearson's correlation r = 0.88), intraclass correlation coefficient = 0.85 and κ =0.75. It showed high criterion related, construct related and content related validity. The tool showed moderately high concordance with the gold standard (κ =0.61); 92.2% sensitivity, 67.8% specificity, 75.6% positive predictive value and 88.9% negative predictive value. The validated tool was applied to 278 websites; 29.9% were rated as recommended, 41.0% as recommended with caution and 29.1% as not recommended. A systematic tool was devised to evaluate the quality of websites for medical educational purposes. The tool was shown to yield reliable and valid inferences through its application to pathology websites.

Restoration in Its Natural Context: How Ecological Momentary Assessment Can Advance Restoration Research

PubMed Central

Beute, Femke; de Kort, Yvonne; IJsselsteijn, Wijnand

2016-01-01

More and more people use self-tracking technologies to track their psychological states, physiology, and behaviors to gain a better understanding of themselves or to achieve a certain goal. Ecological Momentary Assessment (EMA) also offers an excellent opportunity for restorative environments research, which examines how our physical environment (especially nature) can positively influence health and wellbeing. It enables investigating restorative health effects in everyday life, providing not only high ecological validity but also opportunities to study in more detail the dynamic processes playing out over time on recovery, thereby bridging the gap between laboratory (i.e., short-term effects) and epidemiological (long-term effects) research. We have identified four main areas in which self-tracking could help advance restoration research: (1) capturing a rich set of environment types and restorative characteristics; (2) distinguishing intra-individual from inter-individual effects; (3) bridging the gap between laboratory and epidemiological research; and (4) advancing theoretical insights by measuring a more broad range of effects in everyday life. This paper briefly introduces restorative environments research, then reviews the state of the art of self-tracking technologies and methodologies, discusses how these can be implemented to advance restoration research, and presents some examples of pioneering work in this area. PMID:27089352

In-Depth Analysis of Simulation Engine Codes for Comparison with DOE s Roof Savings Calculator and Measured Data

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

New, Joshua Ryan; Levinson, Ronnen; Huang, Yu

The Roof Savings Calculator (RSC) was developed through collaborations among Oak Ridge National Laboratory (ORNL), White Box Technologies, Lawrence Berkeley National Laboratory (LBNL), and the Environmental Protection Agency in the context of a California Energy Commission Public Interest Energy Research project to make cool-color roofing materials a market reality. The RSC website and a simulation engine validated against demonstration homes were developed to replace the liberal DOE Cool Roof Calculator and the conservative EPA Energy Star Roofing Calculator, which reported different roof savings estimates. A preliminary analysis arrived at a tentative explanation for why RSC results differed from previous LBNLmore » studies and provided guidance for future analysis in the comparison of four simulation programs (doe2attic, DOE-2.1E, EnergyPlus, and MicroPas), including heat exchange between the attic surfaces (principally the roof and ceiling) and the resulting heat flows through the ceiling to the building below. The results were consolidated in an ORNL technical report, ORNL/TM-2013/501. This report is an in-depth inter-comparison of four programs with detailed measured data from an experimental facility operated by ORNL in South Carolina in which different segments of the attic had different roof and attic systems.« less

Validity and Reliability of Field-Based Measures for Assessing Movement Skill Competency in Lifelong Physical Activities: A Systematic Review.

PubMed

Hulteen, Ryan M; Lander, Natalie J; Morgan, Philip J; Barnett, Lisa M; Robertson, Samuel J; Lubans, David R

2015-10-01

It has been suggested that young people should develop competence in a variety of 'lifelong physical activities' to ensure that they can be active across the lifespan. The primary aim of this systematic review is to report the methodological properties, validity, reliability, and test duration of field-based measures that assess movement skill competency in lifelong physical activities. A secondary aim was to clearly define those characteristics unique to lifelong physical activities. A search of four electronic databases (Scopus, SPORTDiscus, ProQuest, and PubMed) was conducted between June 2014 and April 2015 with no date restrictions. Studies addressing the validity and/or reliability of lifelong physical activity tests were reviewed. Included articles were required to assess lifelong physical activities using process-oriented measures, as well as report either one type of validity or reliability. Assessment criteria for methodological quality were adapted from a checklist used in a previous review of sport skill outcome assessments. Movement skill assessments for eight different lifelong physical activities (badminton, cycling, dance, golf, racquetball, resistance training, swimming, and tennis) in 17 studies were identified for inclusion. Methodological quality, validity, reliability, and test duration (time to assess a single participant), for each article were assessed. Moderate to excellent reliability results were found in 16 of 17 studies, with 71% reporting inter-rater reliability and 41% reporting intra-rater reliability. Only four studies in this review reported test-retest reliability. Ten studies reported validity results; content validity was cited in 41% of these studies. Construct validity was reported in 24% of studies, while criterion validity was only reported in 12% of studies. Numerous assessments for lifelong physical activities may exist, yet only assessments for eight lifelong physical activities were included in this review. Generalizability of results may be more applicable if more heterogeneous samples are used in future research. Moderate to excellent levels of inter- and intra-rater reliability were reported in the majority of studies. However, future work should look to establish test-retest reliability. Validity was less commonly reported than reliability, and further types of validity other than content validity need to be established in future research. Specifically, predictive validity of 'lifelong physical activity' movement skill competency is needed to support the assertion that such activities provide the foundation for a lifetime of activity.

Objective structured clinical examination for pharmacy students in Qatar: cultural and contextual barriers to assessment.

PubMed

Wilby, K J; Black, E K; Austin, Z; Mukhalalati, B; Aboulsoud, S; Khalifa, S I

2016-07-10

This study aimed to evaluate the feasibility and psychometric defensibility of implementing a comprehensive objective structured clinical examination (OSCE) on the complete pharmacy programme for pharmacy students in a Middle Eastern context, and to identify facilitators and barriers to implementation within new settings. Eight cases were developed, validated, and had standards set according to a blueprint, and were assessed with graduating pharmacy students. Assessor reliability was evaluated using inter-class coefficients (ICCs). Concurrent validity was evaluated by comparing OSCE results to professional skills course grades. Field notes were maintained to generate recommendations for implementation in other contexts. The examination pass mark was 424 points out of 700 (60.6%). All 23 participants passed. Mean performance was 74.6%. Low to moderate inter-rater reliability was obtained for analytical and global components (average ICC 0.77 and 0.48, respectively). In conclusion, OSCE was feasible in Qatar but context-related validity and reliability concerns must be addressed prior to future iterations in Qatar and elsewhere.

Mass spectrometric characterization of the hypoxia-inducible factor (HIF) stabilizer drug candidate BAY 85-3934 (molidustat) and its glucuronidated metabolite BAY-348, and their implementation into routine doping controls.

PubMed

Dib, Josef; Mongongu, Cynthia; Buisson, Corinne; Molina, Adeline; Schänzer, Wilhelm; Thuss, Uwe; Thevis, Mario

2017-01-01

The development of new therapeutics potentially exhibiting performance-enhancing properties implicates the risk of their misuse by athletes in amateur and elite sports. Such drugs necessitate preventive anti-doping research for consideration in sports drug testing programmes. Hypoxia-inducible factor (HIF) stabilizers represent an emerging class of therapeutics that allows for increasing erythropoiesis in patients. BAY 85-3934 is a novel HIF stabilizer, which is currently undergoing phase-2 clinical trials. Consequently, the comprehensive characterization of BAY 85-3934 and human urinary metabolites as well as the implementation of these analytes into routine doping controls is of great importance. The mass spectrometric behaviour of the HIF stabilizer drug candidate BAY 85-3934 and a glucuronidated metabolite (BAY-348) were characterized by electrospray ionization-(tandem) mass spectrometry (ESI-MS(/MS)) and multiple-stage mass spectrometry (MS n ). Subsequently, two different laboratories established different analytical approaches (one each) enabling urine sample analyses by employing either direct urine injection or solid-phase extraction. The methods were cross-validated for the metabolite BAY-348 that is expected to represent an appropriate target analyte for human urine analysis. Two test methods allowing for the detection of BAY-348 in human urine were applied and cross-validated concerning the validation parameters specificity, linearity, lower limit of detection (LLOD; 1-5 ng/mL), ion suppression/enhancement (up to 78%), intra- and inter-day precision (3-21%), recovery (29-48%), and carryover. By means of ten spiked test urine samples sent blinded to one of the participating laboratories, the fitness-for-purpose of both assays was provided as all specimens were correctly identified applying both testing methods. As no post-administration study samples were available, analyses of authentic urine specimens remain desirable. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Further Development of the PCRTM Model and RT Model Inter Comparison

NASA Technical Reports Server (NTRS)

Yang, Qiguang; Liu, Xu; Wu, Wan; Kizer, Susan

2015-01-01

New results for the development of the PCRTM model will be presented. The new results were used for IASI retrieval validation inter comparison and better results were obtained compare to other fast radiative transfer models.

A tool to assess sex-gender when selecting health research projects.

PubMed

Tomás, Concepción; Yago, Teresa; Eguiluz, Mercedes; Samitier, M A Luisa; Oliveros, Teresa; Palacios, Gemma

2015-04-01

To validate the questionnaire "Gender Perspective in Health Research" (GPIHR) to assess the inclusion of gender perspective in research projects. Validation study in two stages. Feasibility was analysed in the first, and reliability, internal consistence and validity in the second. Aragón Institute of Health Science, Aragón, Spain. GPIHR was applied to 118 research projects funded in national and international competitive tenders from 2003 to 2012. Analysis of inter- and intra-observer reliability with Kappa index and internal consistency with Cronbach's alpha. Content validity analysed through literature review and construct validity with an exploratory factor analysis. Validated GPIHR has 10 questions: 3 in the introduction, 1 for objectives, 3 for methodology and 3 for research purpose. Average time of application was 13min Inter-observer reliability (Kappa) varied between 0.35 and 0.94 and intra-observer between 0.40 and 0.94. Theoretical construct is supported in the literature. Factor analysis identifies three levels of GP inclusion: "difference by sex", "gender sensitive" and "feminist research" with an internal consistency of 0.64, 0.87 and 0.81, respectively, which explain 74.78% of variance. GPIHR questionnaire is a valid tool to assess GP and useful for those researchers who would like to include GP in their projects. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Workgroup for Hydraulic laboratory Testing and Verification of Hydroacoustic Instrumentation

USGS Publications Warehouse

Fulford, Janice M.; Armstrong, Brandy N.; Thibodeaux, Kirk G.

2015-01-01

An international workgroup was recently formed for hydraulic laboratory testing and verification of hydroacoustic instrumentation used for water velocity measurements. The activities of the workgroup have included one face to face meeting, conference calls and an inter-laboratory exchange of two acoustic meters among participating laboratories. Good agreement was found among four laboratories at higher tow speeds and poorer agreement at the lowest tow speed.

A validation study of the Keyboard Personal Computer Style instrument (K-PeCS) for use with children.

PubMed

Green, Dido; Meroz, Anat; Margalit, Adi Edit; Ratzon, Navah Z

2012-11-01

This study examines a potential instrument for measurement of typing postures of children. This paper describes inter-rater, test-retest reliability and concurrent validity of the Keyboard Personal Computer Style instrument (K-PeCS), an observational measurement of postures and movements during keyboarding, for use with children. Two trained raters independently rated videos of 24 children (aged 7-10 years). Six children returned one week later for identifying test-retest reliability. Concurrent validity was assessed by comparing ratings obtained using the K-PECS to scores from a 3D motion analysis system. Inter-rater reliability was moderate to high for 12 out of 16 items (Kappa: 0.46 to 1.00; correlation coefficients: 0.77-0.95) and test-retest reliability varied across items (Kappa: 0.25 to 0.67; correlation coefficients: r = 0.20 to r = 0.95). Concurrent validity compared favourably across arm pathlength, wrist extension and ulnar deviation. In light of the limitations of other tools the K-PeCS offers a fairly affordable, reliable and valid instrument to address the gap for measurement of typing styles of children, despite the shortcomings of some items. However further research is required to refine the instrument for use in evaluating typing among children. Copyright © 2012 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Validation of the Spanish adaptation of the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V).

PubMed

Núñez-Batalla, Faustino; Morato-Galán, Marta; García-López, Isabel; Ávila-Menéndez, Arántzazu

2015-01-01

The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) was developed.to promote a standardised approach to evaluating and documenting auditory perceptual judgments of vocal quality. This tool was originally developed in English language and its Spanish version is still inexistent. The aim of this study was to develop a Spanish adaptation of CAPE-V and to examine the reliability and empirical validity of this Spanish version. To adapt the CAPE-V protocol to the Spanish language, we proposed 6 phrases phonetically designed according to the CAPE-V requirements. Prospective instrument validation was performed. The validity of the Spanish version of the CAPE-V was examined in 4 ways: intra-rater reliability, inter-rater reliability and CAPE-V versus GRABS judgments. Inter-rater reliability coefficients for the CAPE-V ranged from 0.93 for overall severity to 0.54 for intensity; intra-rater reliability ranged from 0.98 for overall severity to 0.85 for intensity. The comparison of judgments between GRABS and CAPE-V ranged from 0.86 for overall severity to 0.61 for breathiness. The present study supports the use of the Spanish version of CAPE-V because of its validity and reliability. Copyright © 2014 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

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

NASA Astrophysics Data System (ADS)

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.

Validity and reliability of three definitions of hip osteoarthritis: cross sectional and longitudinal approach.

PubMed

Reijman, M; Hazes, J M W; Pols, H A P; Bernsen, R M D; Koes, B W; Bierma-Zeinstra, S M A

2004-11-01

To compare the reliability and validity in a large open population of three frequently used radiological definitions of hip osteoarthritis (OA): Kellgren and Lawrence grade, minimal joint space (MJS), and Croft grade; and to investigate whether the validity of the three definitions of hip OA is sex dependent. from the Rotterdam study (aged > or= 55 years, n = 3585) were evaluated. The inter-rater reliability was tested in a random set of 148 x rays. The validity was expressed as the ability to identify patients who show clinical symptoms of hip OA (construct validity) and as the ability to predict total hip replacement (THR) at follow up (predictive validity). Inter-rater reliability was similar for the Kellgren and Lawrence grade and MJS (kappa statistics 0.68 and 0.62, respectively) but lower for Croft's grade (kappa statistic, 0.51). The Kellgren and Lawrence grade and MJS showed the strongest associations with clinical symptoms of hip OA. Sex appeared to be an effect modifier for Kellgren and Lawrence and MJS definitions, women showing a stronger association between grading and symptoms than men. However, the sex dependency was attributed to differences in height between women and men. The Kellgren and Lawrence grade showed the highest predictive value for THR at follow up. Based on these findings, Kellgren and Lawrence still appears to be a useful OA definition for epidemiological studies focusing on the presence of hip OA.

The inter-rater reliability of the incontinence-associated dermatitis intervention tool-D (IADIT-D) between two independent registered nurses of nursing home residents in long-term care facilities.

PubMed

Braunschmidt, Brigitte; Müller, Gerhard; Jukic-Puntigam, Margareta; Steininger, Alfred

2013-01-01

Incontinence-associated dermatitis (IAD) is the clinical manifestation of moisture related skin damage (Beeckman, Woodward, & Gray, 2011). Valid assessment instruments are needed for risk assessment and classification of IAD. Aim of the quantitative-descriptive cross-sectional study was to determine the inter-rater reliability of the item scores of the German Incontinence Associated Dermatitis Intervention Tool (IADIT-D) between two independent assessors of nursing home residents (n = 381) in long-term care facilities. The 19 pairs of assessors consisted of registered nurses. The data analysis was computed first with the calculation of the total percentage of agreement. Because this value is not randomly adjusted, the calculation of the Kappa-coefficients and AC1-Statistic was done as well. The total percentage of the inter-rater agreement was 84% (n = 319). In a second step of analysis, the calculation of all items determined high (kappa = .70) and very high agreement (AC1 = .83) levels, respectively. For the risk assessment (kappa = .82; AC1 = .94), the values amounted to very high agreement levels and for the classification (kappa(w) = .70; AC1 = .76) to high agreement levels. The high to very high agreement values of IADIT-D demonstrate that the items can be regarded as stable in regards to the inter-rater reliability for the use in long-term care facilities. In addition, further validation studies are needed.

Puffing Topography and Nicotine Intake of Electronic Cigarette Users

PubMed Central

Behar, Rachel Z.; Hua, My; Talbot, Prue

2015-01-01

Background Prior electronic cigarette (EC) topography data are based on two video analyses with limited parameters. Alternate methods for measuring topography are needed to understand EC use and nicotine intake. Objectives This study evaluated EC topography with a CReSS Pocket device and quantified nicotine intake. Methods Validation tests on pressure drop, flow rate, and volume confirmed reliable performance of the CReSS Pocket device. Twenty participants used Blu Cigs and V2 Cigs for 10 minute intervals with a 10–15 minute break between brands. Brand order was reversed and repeated within 7 days Data were analyzed to determine puff duration, puff count, volume, flow rate, peak flow, and inter-puff interval. Nicotine intake was estimated from cartomizer fluid consumption and topography data. Results Nine patterns of EC use were identified. The average puff count and inter-puff interval were 32 puffs and 17.9 seconds. All participants, except one, took more than 20 puffs/10 minutes. The averages for puff duration (2.65 seconds/puff), volume/puff (51ml/puff), total puff volume (1,579 ml), EC fluid consumption (79.6 mg), flow rate (20 ml/s), and peak flow rate (27 ml/s) were determined for 10-minute sessions. All parameters except total puff count were significantly different for Blu versus V2 EC. Total volume for Blu versus V2 was four-times higher than for conventional cigarettes. Average nicotine intake for Blu and V2 across both sessions was 1.2 ± 0.5 mg and 1.4 ± 0.7 mg, respectively, which is similar to conventional smokers. Conclusions EC puffing topography was variable among participants in the study, but often similar within an individual between brands or days. Puff duration, inter-puff interval, and puff volume varied from conventional cigarette standards. Data on total puff volume and nicotine intake are consistent with compensatory usage of EC. These data can contribute to the development of a standard protocol for laboratory testing of EC products. PMID:25664463

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

PubMed

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.

Validity and reliability of criterion based clinical audit to assess obstetrical quality of care in West Africa.

PubMed

Pirkle, Catherine M; Dumont, Alexandre; Traore, Mamadou; Zunzunegui, Maria-Victoria

2012-10-29

In Mali and Senegal, over 1% of women die giving birth in hospital. At some hospitals, over a third of infants are stillborn. Many deaths are due to substandard medical practices. Criterion-based clinical audits (CBCA) are increasingly used to measure and improve obstetrical care in resource-limited settings, but their measurement properties have not been formally evaluated. In 2011, we published a systematic review of obstetrical CBCA highlighting insufficient considerations of validity and reliability. The objective of this study is to develop an obstetrical CBCA adapted to the West African context and assess its reliability and validity. This work was conducted as a sub-study within a cluster randomized trial known as QUARITE. Criteria were selected based on extensive literature review and expert opinion. Early 2010, two auditors applied the CBCA to identical samples at 8 sites in Mali and Senegal (n = 185) to evaluate inter-rater reliability. In 2010-11, we conducted CBCA at 32 hospitals to assess construct validity (n = 633 patients). We correlated hospital characteristics (resource availability, facility perinatal and maternal mortality) with mean hospital CBCA scores. We used generalized estimating equations to assess whether patient CBCA scores were associated with perinatal mortality. Results demonstrate substantial (ICC = 0.67, 95% CI 0.54; 0.76) to elevated inter-rater reliability (ICC = 0.84, 95% CI 0.77; 0.89) in Senegal and Mali, respectively. Resource availability positively correlated with mean hospital CBCA scores and maternal and perinatal mortality were inversely correlated with hospital CBCA scores. Poor CBCA scores, adjusted for hospital and patient characteristics, were significantly associated with perinatal mortality (OR 1.84, 95% CI 1.01-3.34). Our CBCA has substantial inter-rater reliability and there is compelling evidence of its validity as the tool performs according to theory. Current Controlled Trials ISRCTN46950658.

Collaborative analysis of wheat endosperm compressive material properties

USDA-ARS?s Scientific Manuscript database

The objective measurement of cereal endosperm texture, for wheat (Triticum L.) in particular, is relevant to the milling, processing and utilization of grain. The objective of this study was to evaluate the inter-laboratory results of compression failure testing of wheat endosperm specimens of defi...

Validation conform ISO-15189 of assays in the field of autoimmunity: Joint efforts in The Netherlands.

PubMed

Mulder, Leontine; van der Molen, Renate; Koelman, Carin; van Leeuwen, Ester; Roos, Anja; Damoiseaux, Jan

2018-05-01

ISO 15189:2012 requires validation of methods used in the medical laboratory, and lists a series of performance parameters for consideration to include. Although these performance parameters are feasible for clinical chemistry analytes, application in the validation of autoimmunity tests is a challenge. Lack of gold standards or reference methods in combination with the scarcity of well-defined diagnostic samples of patients with rare diseases make validation of new assays difficult. The present manuscript describes the initiative of Dutch medical immunology laboratory specialists to combine efforts and perform multi-center validation studies of new assays in the field of autoimmunity. Validation data and reports are made available to interested Dutch laboratory specialists. Copyright © 2018 Elsevier B.V. All rights reserved.

Determination of perfluorinated alkyl acid concentrations in biological standard reference materials.

PubMed

Reiner, Jessica L; O'Connell, Steven G; Butt, Craig M; Mabury, Scott A; Small, Jeff M; De Silva, Amila O; Muir, Derek C G; Delinsky, Amy D; Strynar, Mark J; Lindstrom, Andrew B; Reagen, William K; Malinsky, Michelle; Schäfer, Sandra; Kwadijk, Christiaan J A F; Schantz, Michele M; Keller, Jennifer M

2012-11-01

Standard reference materials (SRMs) are homogeneous, well-characterized materials used to validate measurements and improve the quality of analytical data. The National Institute of Standards and Technology (NIST) has a wide range of SRMs that have mass fraction values assigned for legacy pollutants. These SRMs can also serve as test materials for method development, method validation, and measurement for contaminants of emerging concern. Because inter-laboratory comparison studies have revealed substantial variability of measurements of perfluoroalkyl acids (PFAAs), future analytical measurements will benefit from determination of consensus values for PFAAs in SRMs to provide a means to demonstrate method-specific performance. To that end, NIST, in collaboration with other groups, has been measuring concentrations of PFAAs in a variety of SRMs. Here we report levels of PFAAs and perfluorooctane sulfonamide (PFOSA) determined in four biological SRMs: fish tissue (SRM 1946 Lake Superior Fish Tissue, SRM 1947 Lake Michigan Fish Tissue), bovine liver (SRM 1577c), and mussel tissue (SRM 2974a). We also report concentrations for three in-house quality-control materials: beluga whale liver, pygmy sperm whale liver, and white-sided dolphin liver. Measurements in SRMs show an array of PFAAs, with perfluorooctane sulfonate (PFOS) being the most frequently detected. Reference and information values are reported for PFAAs measured in these biological SRMs.

Infant polysomnography: reliability and validity of infant arousal assessment.

PubMed

Crowell, David H; Kulp, Thomas D; Kapuniai, Linda E; Hunt, Carl E; Brooks, Lee J; Weese-Mayer, Debra E; Silvestri, Jean; Ward, Sally Davidson; Corwin, Michael; Tinsley, Larry; Peucker, Mark

2002-10-01

Infant arousal scoring based on the Atlas Task Force definition of transient EEG arousal was evaluated to determine (1). whether transient arousals can be identified and assessed reliably in infants and (2). whether arousal and no-arousal epochs scored previously by trained raters can be validated reliably by independent sleep experts. Phase I for inter- and intrarater reliability scoring was based on two datasets of sleep epochs selected randomly from nocturnal polysomnograms of healthy full-term, preterm, idiopathic apparent life-threatening event cases, and siblings of Sudden Infant Death Syndrome infants of 35 to 64 weeks postconceptional age. After training, test set 1 reliability was assessed and discrepancies identified. After retraining, test set 2 was scored by the same raters to determine interrater reliability. Later, three raters from the trained group rescored test set 2 to assess inter- and intrarater reliabilities. Interrater and intrarater reliability kappa's, with 95% confidence intervals, ranged from substantial to almost perfect levels of agreement. Interrater reliabilities for spontaneous arousals were initially moderate and then substantial. During the validation phase, 315 previously scored epochs were presented to four sleep experts to rate as containing arousal or no-arousal events. Interrater expert agreements were diverse and considered as noninterpretable. Concordance in sleep experts' agreements, based on identification of the previously sampled arousal and no-arousal epochs, was used as a secondary evaluative technique. Results showed agreement by two or more experts on 86% of the Collaborative Home Infant Monitoring Evaluation Study arousal scored events. Conversely, only 1% of the Collaborative Home Infant Monitoring Evaluation Study-scored no-arousal epochs were rated as an arousal. In summary, this study presents an empirically tested model with procedures and criteria for attaining improved reliability in transient EEG arousal assessments in infants using the modified Atlas Task Force standards. With training based on specific criteria, substantial inter- and intrarater agreement in identifying infant arousals was demonstrated. Corroborative validation results were too disparate for meaningful interpretation. Alternate evaluation based on concordance agreements supports reliance on infant EEG criteria for assessment. Results mandate additional confirmatory validation studies with specific training on infant EEG arousal assessment criteria.

Validations of a portable home sleep study with twelve-lead polysomnography: comparisons and insights into a variable gold standard.

PubMed

Michaelson, Peter G; Allan, Patrick; Chaney, John; Mair, Eric A

2006-11-01

Accurate and timely diagnosis for patients with obstructive sleep apnea (OSA) is imperative. Unfortunately, growing interest in this diagnosis has resulted in increased requests and waiting times for polysomnography (PSG), as well as a potential delay in diagnosis and treatment. This study evaluated the accuracy and viability of utilizing SNAP (SNAP Laboratories, LLC, Wheeling, Illinois), a portable home sleep test, as an alternative to traditional PSG in diagnosing OSA. This prospective clinical trial included 59 patients evaluated at our institution's sleep laboratory. Concurrent PSG and SNAP testing was performed for 1 night on each patient. Independent, blinded readers at our institution and at an outside-accredited institution read the PSG data, and 2 independent, blinded readers interpreted the SNAP data at SNAP laboratories. The apnea-hypopnea index (AHI) was used to compare the 2 testing modalities. The correlation coefficient, receiver operating characteristic curve analysis, and the Bland-Altman curves, as well as sensitivity, specificity, inter-reader variability, positive predictive value, and negative predictive value, were used to compare SNAP and PSG. There is a definitive, statistically sound correlation between the AHIs determined from both PSG and SNAP. This relationship holds true for all measures of comparison, while displaying a concerning, weaker correlation between the different PSG interpretations. There is a convincing correlation between the study-determined AHIs of both PSG and SNAP. This finding supports SNAP as a suitable alternative to PSG in identifying OSA, while accentuating the inherent variation present in a PSG-derived AHI. This test expands the diagnostic and therapeutic prowess of the practicing otolaryngologist by offering an alternative OSA testing modality that is associated with not only less expense, decreased waiting time, and increased convenience, but also statistically proven accuracy.

A highly sensitive and specific method for the screening detection of genetically modified organisms based on digital PCR without pretreatment

PubMed Central

Fu, Wei; Zhu, Pengyu; Wang, Chenguang; Huang, Kunlun; Du, Zhixin; Tian, Wenying; Wang, Qin; Wang, Huiyu; Xu, Wentao; Zhu, Shuifang

2015-01-01

Digital PCR has developed rapidly since it was first reported in the 1990s. It was recently reported that an improved method facilitated the detection of genetically modified organisms (GMOs). However, to use this improved method, the samples must be pretreated, which could introduce inaccuracy into the results. In our study, we explored a pretreatment-free digital PCR detection method for the screening for GMOs. We chose the CaMV35s promoter and the NOS terminator as the templates in our assay. To determine the specificity of our method, 9 events of GMOs were collected, including MON810, MON863, TC1507, MIR604, MIR162, GA21, T25, NK603 and Bt176. Moreover, the sensitivity, intra-laboratory and inter-laboratory reproducibility of our detection method were assessed. The results showed that the limit of detection of our method was 0.1%, which was lower than the labeling threshold level of the EU. The specificity and stability among the 9 events were consistent, respectively. The intra-laboratory and inter-laboratory reproducibility were both good. Finally, the perfect fitness for the detection of eight double-blind samples indicated the good practicability of our method. In conclusion, the method in our study would allow more sensitive, specific and stable screening detection of the GMO content of international trading products. PMID:26239916

A highly sensitive and specific method for the screening detection of genetically modified organisms based on digital PCR without pretreatment.

PubMed

Fu, Wei; Zhu, Pengyu; Wang, Chenguang; Huang, Kunlun; Du, Zhixin; Tian, Wenying; Wang, Qin; Wang, Huiyu; Xu, Wentao; Zhu, Shuifang

2015-08-04

Digital PCR has developed rapidly since it was first reported in the 1990 s. It was recently reported that an improved method facilitated the detection of genetically modified organisms (GMOs). However, to use this improved method, the samples must be pretreated, which could introduce inaccuracy into the results. In our study, we explored a pretreatment-free digital PCR detection method for the screening for GMOs. We chose the CaMV35s promoter and the NOS terminator as the templates in our assay. To determine the specificity of our method, 9 events of GMOs were collected, including MON810, MON863, TC1507, MIR604, MIR162, GA21, T25, NK603 and Bt176. Moreover, the sensitivity, intra-laboratory and inter-laboratory reproducibility of our detection method were assessed. The results showed that the limit of detection of our method was 0.1%, which was lower than the labeling threshold level of the EU. The specificity and stability among the 9 events were consistent, respectively. The intra-laboratory and inter-laboratory reproducibility were both good. Finally, the perfect fitness for the detection of eight double-blind samples indicated the good practicability of our method. In conclusion, the method in our study would allow more sensitive, specific and stable screening detection of the GMO content of international trading products.

An Italian multicentre validation study of the coma recovery scale-revised.

PubMed

Estraneo, A; Moretta, P; De Tanti, A; Gatta, G; Giacino, J T; Trojano, L

2015-10-01

Rate of misdiagnosis of disorders of consciousness (DoC) can be reduced by employing validated clinical diagnostic tools, such as the Coma Recovery Scale-Revised (CRS-R). An Italian version of the CRS-R has been recently developed, but its applicability across different clinical settings, and its concurrent validity and diagnostic sensitivity have not been estimated yet. To perform a multicentre validation study of the Italian version of the Coma Recovery Scale-Revised (CRS-R). Analysis of inter-rater reliability, concurrent validity and diagnostic sensitivity of the scale. One Intensive Care Unit, 8 Post-acute rehabilitation centres and 2 Long-term facilities Twenty-seven professionals (physicians, N.=11; psychologists, N.=5; physiotherapists, N.=3; speech therapists, N.=6; nurses, N.=2) from 11 Italian Centres. CRS-R and Disability Rating Scale (DRS) applied to 122 patients with clinical diagnosis of Vegetative State (VS) or Minimally Conscious State (MCS). CRS-R has good-to-excellent inter-rater reliability for all subscales, particularly for the communication subscale. The Italian version of the CRS-R showed a high sensitivity and specificity in detecting MCS with reference to clinical consensus diagnosis. The CRS-R showed good concurrent validity with the Disability Rating Scale, which had very low specificity with reference to clinical consensus diagnosis. The Italian version of the CRS-R is a valid scale for use from the sub-acute to chronic stages of DoC. It can be administered reliably by all members of the rehabilitation team with different specialties, levels of experience and settings. The present study promote use of the Italian version of the CRS-R to improve diagnosis of DoC patients, and plan tailored rehabilitation treatment.

Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component

PubMed Central

Perez, Concepcion; Galvez, Rafael; Huelbes, Silvia; Insausti, Joaquin; Bouhassira, Didier; Diaz, Silvia; Rejas, Javier

2007-01-01

Background This study assesses the validity and reliability of the Spanish version of DN4 questionnaire as a tool for differential diagnosis of pain syndromes associated to a neuropathic (NP) or somatic component (non-neuropathic pain, NNP). Methods A study was conducted consisting of two phases: cultural adaptation into the Spanish language by means of conceptual equivalence, including forward and backward translations in duplicate and cognitive debriefing, and testing of psychometric properties in patients with NP (peripheral, central and mixed) and NNP. The analysis of psychometric properties included reliability (internal consistency, inter-rater agreement and test-retest reliability) and validity (ROC curve analysis, agreement with the reference diagnosis and determination of sensitivity, specificity, and positive and negative predictive values in different subsamples according to type of NP). Results A sample of 164 subjects (99 women, 60.4%; age: 60.4 ± 16.0 years), 94 (57.3%) with NP (36 with peripheral, 32 with central, and 26 with mixed pain) and 70 with NNP was enrolled. The questionnaire was reliable [Cronbach's alpha coefficient: 0.71, inter-rater agreement coefficient: 0.80 (0.71–0.89), and test-retest intra-class correlation coefficient: 0.95 (0.92–0.97)] and valid for a cut-off value ≥ 4 points, which was the best value to discriminate between NP and NNP subjects. Discussion This study, representing the first validation of the DN4 questionnaire into another language different than the original, not only supported its high discriminatory value for identification of neuropathic pain, but also provided supplemental psychometric validation (i.e. test-retest reliability, influence of educational level and pain intensity) and showed its validity in mixed pain syndromes. PMID:18053212

Results of a European interlaboratory comparison on CO2 sorption on activated carbon and coals

NASA Astrophysics Data System (ADS)

Gensterblum, Yves; Busch, Andreas; Krooss, Bernhard; de Weireld, Guy; Billemont, Pierre; van Hemert, Patrick; Wolf, Karl-Heinz

2013-04-01

For the assessment of CO2 storage in coal seams or enhanced coalbed methane production (ECBM), the sorption properties of natural coals are important parameters. Since more and more laboratories worldwide are concerned with measurements of gas sorption on coal it is indispensable to establish quality standards for such experiments. The first two interlaboratory studies on CO2 sorption on coal (Goodman et al. 2004, 2007) revealed a poor agreement of sorption isotherms among the participating laboratories, particularly in the high-pressure range. During the MOVECBM (http://www.movecbm.eu/) project funded by the European Commission (6th framework), an interlaboratory comparison of CO2 sorption on selected coals and activated carbon was initiated. Measurements were performed on dry samples at 45° C using the manometric and the gravimetric method. up to a final pressure of 15 MPa. The first set of high-pressure sorption measurements was performed on a Filtrasorb 400 activated carbon sample in order to minimise heterogeneity effects and to optimize the experimental procedures for the individual (manometric or gravimetric) methods (Gensterblum et al. 2009). Since comparability for the activated carbon was excellent, the measurements were continued using natural coals of various rank (anthracite, bituminous coal and lignite) to study the influence of heterogeneities and varying starting conditions on the CO2 sorption properties (Gensterblum et al. 2010). Compared to the poor reproducibility observed in previous interlaboratory studies (Goodman et al., 2004, 2007) this European study showed excellent agreement (<5 % deviation) among the participating laboratories with good repeatability. The sorption data and technical information on the different experimental setups have been used to investigate errors and potential pitfalls in the assessment of high-pressure CO2 sorption isotherms. References Gensterblum Y., P. van Hemert, P. Billemont, A. Busch, B.M. Krooss, G. de Weireld, D. Prinz , K.-H.A.A. Wolf, "European inter-laboratory comparison of high pressure CO2 sorption isotherms. II: natural coals" IJCG, 2010, 84, 115-124 Gensterblum Y., P. van Hemert, P. Billemont, A. Busch, D. Charriére, D. Li, B.M. Krooss, G. de Weireld, D. Prinz , K.-H.A.A. Wolf, "European inter-laboratory comparison of high pressure CO2 sorption isotherms. I: Activated carbon" Carbon 47 ( 2009 ) 2958 -2969 Goodman, A.L., Busch, A., Duffy, G., Fitzgerald, J.E., Gasem, K.A.M., Gensterblum, Y., Krooss, B.M., Levy, J., Ozdemir, E., Pan, Z., Robinson, Jr., R.L., Schroeder, K., Sudibandriyo, M., White, C. (2004). An Inter-laboratory Comparison of CO2 Isotherms Measured on Argonne Premium Coal Samples. Energy and Fuels 18, 1175-1182. Goodman, A.L., Busch, A., Day, S., Duffy, G.J., Fitzgerald, J.E., Gasem, K.A.M., Gensterblum, Y., Hartman, C., Krooss, B.M., Pan, Z., Pratt, T., Robinson, Jr., R.L., Romanov, V., Sakurovs, R., Schroeder, K., Sudibandriyo, M., White, C.M. (2007) "Inter-laboratory Comparison II: CO2 Isotherms Measured on Moisture-Equilibrated Argonne Premium Coals at 55oC and 15 MPa", International Journal of Coal Geology 72, 153-164.

Development and implementation of an international proficiency testing program for a neutralizing antibody assay for HIV-1 in TZM-bl cells.

PubMed

Todd, Christopher A; Greene, Kelli M; Yu, Xuesong; Ozaki, Daniel A; Gao, Hongmei; Huang, Yunda; Wang, Maggie; Li, Gary; Brown, Ronald; Wood, Blake; D'Souza, M Patricia; Gilbert, Peter; Montefiori, David C; Sarzotti-Kelsoe, Marcella

2012-01-31

Recent advances in assay technology have led to major improvements in how HIV-1 neutralizing antibodies are measured. A luciferase reporter gene assay performed in TZM-bl (JC53bl-13) cells has been optimized and validated. Because this assay has been adopted by multiple laboratories worldwide, an external proficiency testing program was developed to ensure data equivalency across laboratories performing this neutralizing antibody assay for HIV/AIDS vaccine clinical trials. The program was optimized by conducting three independent rounds of testing, with an increased level of stringency from the first to third round. Results from the participating domestic and international laboratories improved each round as factors that contributed to inter-assay variability were identified and minimized. Key contributors to increased agreement were experience among laboratories and standardization of reagents. A statistical qualification rule was developed using a simulation procedure based on the three optimization rounds of testing, where a laboratory qualifies if at least 25 of the 30 ID50 values lie within the acceptance ranges. This ensures no more than a 20% risk that a participating laboratory fails to qualify when it should, as defined by the simulation procedure. Five experienced reference laboratories were identified and tested a series of standardized reagents to derive the acceptance ranges for pass-fail criteria. This Standardized Proficiency Testing Program is the first available for the evaluation and documentation of assay equivalency for laboratories performing HIV-1 neutralizing antibody assays and may provide guidance for the development of future proficiency testing programs for other assay platforms. Copyright © 2011 Elsevier B.V. All rights reserved.

Studying Sexual Aggression: A Review of the Evolution and Validity of Laboratory Paradigms

PubMed Central

Davis, Kelly Cue; George, William H.; Nagayama Hall, Gordon C.; Parrott, Dominic J.; Tharp, Andra Teten; Stappenbeck, Cynthia A.

2018-01-01

Objective Researchers have endeavored for decades to develop and implement experimental assessments of sexual aggression and its precursors to capitalize on the many scientific advantages offered by laboratory experiments, such as rigorous control of key variables and identification of causal relationships. The purpose of this review is to provide an overview of and commentary on the evolution of these laboratory-based methods. Conclusions To date, two primary types of sexual aggression laboratory studies have been developed: those that involve behavioral analogues of sexual aggression and those that assess postulated precursors to sexually aggressive behavior. Although the study of sexual aggression in the laboratory is fraught with methodological challenges, validity concerns, and ethical considerations, advances in the field have resulted in greater methodological rigor, more precise dependent measures, and improved experimental validity, reliability, and realism. Because highly effective sexual aggression prevention strategies remain elusive, continued laboratory-based investigation of sexual aggression coupled with translation of critical findings to the development and modification of sexual aggression prevention programs remains an important task for the field. PMID:29675289

Inter-annual Variations in Snow/Firn Density over the Greenland Ice Sheet by Combining GRACE gravimetry and Envisat Altimetry

NASA Astrophysics Data System (ADS)

Su, X.; Shum, C. K.; Guo, J.; Howat, I.; Jezek, K. C.; Luo, Z.; Zhou, Z.

2017-12-01

Satellite altimetry has been used to monitor elevation and volume change of polar ice sheets since the 1990s. In order to derive mass change from the measured volume change, different density assumptions are commonly used in the research community, which may cause discrepancies on accurately estimating ice sheets mass balance. In this study, we investigate the inter-annual anomalies of mass change from GRACE gravimetry and elevation change from Envisat altimetry during years 2003-2009, with the objective of determining inter-annual variations of snow/firn density over the Greenland ice sheet (GrIS). High positive correlations (0.6 or higher) between these two inter-annual anomalies at are found over 93% of the GrIS, which suggests that both techniques detect the same geophysical process at the inter-annual timescale. Interpreting the two anomalies in terms of near surface density variations, over 80% of the GrIS, the inter-annual variation in average density is between the densities of snow and pure ice. In particular, at the Summit of Central Greenland, we validate the satellite data estimated density with the in situ data available from 75 snow pits and 9 ice cores. This study provides constraints on the currently applied density assumptions for the GrIS.

Inter-layer synchronization in non-identical multi-layer networks

NASA Astrophysics Data System (ADS)

Leyva, I.; Sevilla-Escoboza, R.; Sendiña-Nadal, I.; Gutiérrez, R.; Buldú, J. M.; Boccaletti, S.

2017-04-01

Inter-layer synchronization is a dynamical process occurring in multi-layer networks composed of identical nodes. This process emerges when all layers are synchronized, while nodes in each layer do not necessarily evolve in unison. So far, the study of such inter-layer synchronization has been restricted to the case in which all layers have an identical connectivity structure. When layers are not identical, the inter-layer synchronous state is no longer a stable solution of the system. Nevertheless, when layers differ in just a few links, an approximate treatment is still feasible, and allows one to gather information on whether and how the system may wander around an inter-layer synchronous configuration. We report the details of an approximate analytical treatment for a two-layer multiplex, which results in the introduction of an extra inertial term accounting for structural differences. Numerical validation of the predictions highlights the usefulness of our approach, especially for small or moderate topological differences in the intra-layer coupling. Moreover, we identify a non-trivial relationship connecting the betweenness centrality of the missing links and the intra-layer coupling strength. Finally, by the use of multiplexed layers of electronic circuits, we study the inter-layer synchronization as a function of the removed links.

[Domestic and international trends concerning allowable limits of error in external quality assessment scheme].

PubMed

Hosogaya, Shigemi; Ozaki, Yukio

2005-06-01

Many external quality assessment schemes (EQAS) are performed to support quality improvement of the services provided by participating laboratories for the benefits of patients. The EQAS organizer shall be responsible for ensuring that the method of evaluation is appropriate for maintenance of the credibility of the schemes. Procedures to evaluate each participating laboratory are gradually being standardized. In most cases of EQAS, the peer group mean is used as a target of accuracy, and the peer group standard deviation is used as a criterion for inter-laboratory variation. On the other hand, Fraser CG, et al. proposed desirable quality specifications for any imprecision and inaccuracies, which were derived from inter- and intra-biologic variations. We also proposed allowable limits of analytical error, being less than one-half of the average intra-individual variation for evaluation of imprecision, and less than one-quarter of the inter- plus intra-individual variation for evaluation of inaccuracy. When expressed in coefficient of variation terms, these allowable limits may be applied at a wide range of levels of quantity.

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

NASA Astrophysics Data System (ADS)

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.

Are we closer to the vision? A proposed framework for incorporating omics into environmental assessments.

PubMed

Martyniuk, Christopher J

2018-04-01

Environmental science has benefited a great deal from omics-based technologies. High-throughput toxicology has defined adverse outcome pathways (AOPs), prioritized chemicals of concern, and identified novel actions of environmental chemicals. While many of these approaches are conducted under rigorous laboratory conditions, a significant challenge has been the interpretation of omics data in "real-world" exposure scenarios. Clarity in the interpretation of these data limits their use in environmental monitoring programs. In recent years, one overarching objective of many has been to address fundamental questions concerning experimental design and the robustness of data collected under the broad umbrella of environmental genomics. These questions include: (1) the likelihood that molecular profiles return to a predefined baseline level following remediation efforts, (2) how reference site selection in an urban environment influences interpretation of omics data and (3) what is the most appropriate species to monitor in the environment from an omics point of view. In addition, inter-genomics studies have been conducted to assess transcriptome reproducibility in toxicology studies. One lesson learned from inter-genomics studies is that there are core molecular networks that can be identified by multiple laboratories using the same platform. This supports the idea that "omics-networks" defined a priori may be a viable approach moving forward for evaluating environmental impacts over time. Both spatial and temporal variability in ecosystem structure is expected to influence molecular responses to environmental stressors, and it is important to recognize how these variables, as well as individual factor (i.e. sex, age, maturation), may confound interpretation of network responses to chemicals. This mini-review synthesizes the progress made towards adopting these tools into environmental monitoring and identifies future challenges to be addressed, as we move into the next era of high throughput sequencing. A conceptual framework for validating and incorporating molecular networks into environmental monitoring programs is proposed. As AOPs become more defined and their potential in environmental monitoring assessments becomes more recognized, the AOP framework may prove to be the conduit between omics and penultimate ecological responses for environmental risk assessments. Copyright © 2018 Elsevier B.V. All rights reserved.

Validating and calibrating the Nintendo Wii balance board to derive reliable center of pressure measures.

PubMed

Leach, Julia M; Mancini, Martina; Peterka, Robert J; Hayes, Tamara L; Horak, Fay B

2014-09-29

The Nintendo Wii balance board (WBB) has generated significant interest in its application as a postural control measurement device in both the clinical and (basic, clinical, and rehabilitation) research domains. Although the WBB has been proposed as an alternative to the "gold standard" laboratory-grade force plate, additional research is necessary before the WBB can be considered a valid and reliable center of pressure (CoP) measurement device. In this study, we used the WBB and a laboratory-grade AMTI force plate (AFP) to simultaneously measure the CoP displacement of a controlled dynamic load, which has not been done before. A one-dimensional inverted pendulum was displaced at several different displacement angles and load heights to simulate a variety of postural sway amplitudes and frequencies (<1 Hz). Twelve WBBs were tested to address the issue of inter-device variability. There was a significant effect of sway amplitude, frequency, and direction on the WBB's CoP measurement error, with an increase in error as both sway amplitude and frequency increased and a significantly greater error in the mediolateral (ML) (compared to the anteroposterior (AP)) sway direction. There was no difference in error across the 12 WBB's, supporting low inter-device variability. A linear calibration procedure was then implemented to correct the WBB's CoP signals and reduce measurement error. There was a significant effect of calibration on the WBB's CoP signal accuracy, with a significant reduction in CoP measurement error (quantified by root-mean-squared error) from 2-6 mm (before calibration) to 0.5-2 mm (after calibration). WBB-based CoP signal calibration also significantly reduced the percent error in derived (time-domain) CoP sway measures, from -10.5% (before calibration) to -0.05% (after calibration) (percent errors averaged across all sway measures and in both sway directions). In this study, we characterized the WBB's CoP measurement error under controlled, dynamic conditions and implemented a linear calibration procedure for WBB CoP signals that is recommended to reduce CoP measurement error and provide more reliable estimates of time-domain CoP measures. Despite our promising results, additional work is necessary to understand how our findings translate to the clinical and rehabilitation research domains. Once the WBB's CoP measurement error is fully characterized in human postural sway (which differs from our simulated postural sway in both amplitude and frequency content), it may be used to measure CoP displacement in situations where lower accuracy and precision is acceptable.

Validating and Calibrating the Nintendo Wii Balance Board to Derive Reliable Center of Pressure Measures

PubMed Central

Leach, Julia M.; Mancini, Martina; Peterka, Robert J.; Hayes, Tamara L.; Horak, Fay B.

2014-01-01

The Nintendo Wii balance board (WBB) has generated significant interest in its application as a postural control measurement device in both the clinical and (basic, clinical, and rehabilitation) research domains. Although the WBB has been proposed as an alternative to the “gold standard” laboratory-grade force plate, additional research is necessary before the WBB can be considered a valid and reliable center of pressure (CoP) measurement device. In this study, we used the WBB and a laboratory-grade AMTI force plate (AFP) to simultaneously measure the CoP displacement of a controlled dynamic load, which has not been done before. A one-dimensional inverted pendulum was displaced at several different displacement angles and load heights to simulate a variety of postural sway amplitudes and frequencies (<1 Hz). Twelve WBBs were tested to address the issue of inter-device variability. There was a significant effect of sway amplitude, frequency, and direction on the WBB's CoP measurement error, with an increase in error as both sway amplitude and frequency increased and a significantly greater error in the mediolateral (ML) (compared to the anteroposterior (AP)) sway direction. There was no difference in error across the 12 WBB's, supporting low inter-device variability. A linear calibration procedure was then implemented to correct the WBB's CoP signals and reduce measurement error. There was a significant effect of calibration on the WBB's CoP signal accuracy, with a significant reduction in CoP measurement error (quantified by root-mean-squared error) from 2–6 mm (before calibration) to 0.5–2 mm (after calibration). WBB-based CoP signal calibration also significantly reduced the percent error in derived (time-domain) CoP sway measures, from −10.5% (before calibration) to −0.05% (after calibration) (percent errors averaged across all sway measures and in both sway directions). In this study, we characterized the WBB's CoP measurement error under controlled, dynamic conditions and implemented a linear calibration procedure for WBB CoP signals that is recommended to reduce CoP measurement error and provide more reliable estimates of time-domain CoP measures. Despite our promising results, additional work is necessary to understand how our findings translate to the clinical and rehabilitation research domains. Once the WBB's CoP measurement error is fully characterized in human postural sway (which differs from our simulated postural sway in both amplitude and frequency content), it may be used to measure CoP displacement in situations where lower accuracy and precision is acceptable. PMID:25268919

Development and validation of a rapid and sensitive UPLC-MS/MS method for determination of uracil and dihydrouracil in human plasma.

PubMed

Jacobs, Bart A W; Rosing, Hilde; de Vries, Niels; Meulendijks, Didier; Henricks, Linda M; Schellens, Jan H M; Beijnen, Jos H

2016-07-15

Quantification of the endogenous dihydropyrimidine dehydrogenase (DPD) substrate uracil (U) and the reaction product dihydrouracil (UH2) in plasma might be suitable for identification of patients at risk of fluoropyrimidine-induced toxicity as a result of DPD deficiency. In this paper, we describe the development and validation of a rapid and sensitive ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) assay for quantification of U and UH2 in human plasma. Analytes were extracted by protein precipitation, chromatographically separated on an Acquity UPLC(®) HSS T3 column with gradient elution and analyzed with a tandem mass spectrometer equipped with an electrospray ionization source. U was quantified in the negative ion mode and UH2 in the positive ion mode. Stable isotopes for U and UH2 were used as internal standards. Total chromatographic run time was 5min. Validated concentration ranges for U and UH2 were from 1 to 100ng/mL and 10 to 1000ng/mL, respectively. Inter-assay bias and inter-assay precision for U were within ±2.8% and ≤12.4%. For UH2, inter-assay bias and inter-assay precision were within ±2.9% and ≤7.2%. Adequate stability of U and UH2 in dry extract, final extract, stock solution and plasma was demonstrated. Stability of U and UH2 in whole blood was only satisfactory when stored up to 4hours at 2-8°C, but not at ambient temperatures. An accurate, precise and sensitive UPLC-MS/MS assay for quantification of U and UH2 in plasma was developed. This assay is now applied to support clinical studies with fluoropyrimidine drugs. Copyright © 2016 Elsevier B.V. All rights reserved.

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

PubMed Central

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

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

PubMed

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

2011-08-01

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. 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. 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. 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. © 2010 Blackwell Publishing Ltd.

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.

PubMed

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.

42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 5 2010-10-01 2010-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 5 2012-10-01 2012-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 5 2011-10-01 2011-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 5 2013-10-01 2013-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

42 CFR 493.565 - Selection for validation inspection-laboratory responsibilities.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 5 2014-10-01 2014-10-01 false Selection for validation inspection-laboratory... Program § 493.565 Selection for validation inspection—laboratory responsibilities. A laboratory selected for a validation inspection must do the following: (a) Authorize its accreditation organization or...

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

PubMed

Ishibashi, Midori

2015-01-01

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

Rater reliability and construct validity of a mobile application for posture analysis

PubMed Central

Szucs, Kimberly A.; Brown, Elena V. Donoso

2018-01-01

[Purpose] Measurement of posture is important for those with a clinical diagnosis as well as researchers aiming to understand the impact of faulty postures on the development of musculoskeletal disorders. A reliable, cost-effective and low tech posture measure may be beneficial for research and clinical applications. The purpose of this study was to determine rater reliability and construct validity of a posture screening mobile application in healthy young adults. [Subjects and Methods] Pictures of subjects were taken in three standing positions. Two raters independently digitized the static standing posture image twice. The app calculated posture variables, including sagittal and coronal plane translations and angulations. Intra- and inter-rater reliability were calculated using the appropriate ICC models for complete agreement. Construct validity was determined through comparison of known groups using repeated measures ANOVA. [Results] Intra-rater reliability ranged from 0.71 to 0.99. Inter-rater reliability was good to excellent for all translations. ICCs were stronger for translations versus angulations. The construct validity analysis found that the app was able to detect the change in the four variables selected. [Conclusion] The posture mobile application has demonstrated strong rater reliability and preliminary evidence of construct validity. This application may have utility in clinical and research settings. PMID:29410561

Validation of the secretion severity rating scale.

PubMed

Pluschinski, Petra; Zaretsky, Eugen; Stöver, Timo; Murray, Joseph; Sader, Robert; Hey, Christiane

2016-10-01

Accumulation of secretions within the hypopharynx, aditus laryngis, and trachea is one characteristic of severe dysphagia and is of high clinical and therapeutic relevance. For the graduation of the secretion severity level, a secretion scale was provided by Murray et al. in 1996. The purpose of the study presented here is the validation of this scale by analyzing the intra-rater and inter-rater reliability as well as concurrent validity. For examination of reliability and validity, a reference standard was defined by two expert clinicians who reviewed 40 video recordings of fiberendoscopic swallowing evaluations, with 10 videos for each severity grade. These videos were rated and rerated independently and blinded by 4 ENT-residents with an interval of 4 weeks. Both the intra-rater (Kendall's τ > 0.847***) and inter-rater reliability (Kendall's W > 0.951***) were highly significant and can be considered good or very good. Correlation of the median of all ratings with the reference standard was close to the highest possible value 1 (τ = 0.984***). The scale was proved to be a reliable and valid instrument for graduation of one of the principal symptoms of oropharyngeal dysphagia and is recommended as an evidence-based instrument for standardized fiberoptic endoscopic evaluation of swallowing.

[Overal cognitive assessment in Basque-speaking people with advanced dementia. Validation to the Basque language of the Severe Mini-Mental State Examination SMMSE (SMMSE-eus)].

PubMed

Buiza, Cristina; Yanguas, Javier; Zulaica, Amaia; Antón, Iván; Arriola, Enrique; García, Alvaro

2018-04-13

Adaptation and validation to the Basque language of tests to assess advanced cognitive impairment is a not covered need for Basque-speaking people. The present work shows the validation of the Basque version of the Severe Mini Mental State Examination (SMMSE). A total of 109 people with advanced dementia (MEC<15) took part in the validation study, and were classified as GDS 5-7 on the Geriatric Depression Scale (GDS). All participants were Spanish-Basque bilingual. It was shown that SMMSE-eus has a high internal consistency (alpha=0.92), a good test-retest reliability (r=0.88; P<.01), and a high inter-rater reliability (CCI=0.99; P<.00) for the overall score, as well as for each item. Both the high internal consistency and inter-rater reliability, and to a lesser extent, test-retest reliability, made the SMMSE-eus a valid test for the brief assessment of cognitive status in people with advanced dementia in Basque-speaking people. For this reason, the SMMSE-eus is a usable and reliable alternative for assessing Basque-speaking people in their mother-tongue, or preferred language. Copyright © 2017 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

Rater reliability and construct validity of a mobile application for posture analysis.

PubMed

Szucs, Kimberly A; Brown, Elena V Donoso

2018-01-01

[Purpose] Measurement of posture is important for those with a clinical diagnosis as well as researchers aiming to understand the impact of faulty postures on the development of musculoskeletal disorders. A reliable, cost-effective and low tech posture measure may be beneficial for research and clinical applications. The purpose of this study was to determine rater reliability and construct validity of a posture screening mobile application in healthy young adults. [Subjects and Methods] Pictures of subjects were taken in three standing positions. Two raters independently digitized the static standing posture image twice. The app calculated posture variables, including sagittal and coronal plane translations and angulations. Intra- and inter-rater reliability were calculated using the appropriate ICC models for complete agreement. Construct validity was determined through comparison of known groups using repeated measures ANOVA. [Results] Intra-rater reliability ranged from 0.71 to 0.99. Inter-rater reliability was good to excellent for all translations. ICCs were stronger for translations versus angulations. The construct validity analysis found that the app was able to detect the change in the four variables selected. [Conclusion] The posture mobile application has demonstrated strong rater reliability and preliminary evidence of construct validity. This application may have utility in clinical and research settings.

Publishing nutrition research: validity, reliability, and diagnostic test assessment in nutrition-related research.

PubMed

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.

Analytical validation of a flow cytometric protocol for quantification of platelet microparticles in dogs.

PubMed

Cremer, Signe E; Krogh, Anne K H; Hedström, Matilda E K; Christiansen, Liselotte B; Tarnow, Inge; Kristensen, Annemarie T

2018-06-01

Platelet microparticles (PMPs) are subcellular procoagulant vesicles released upon platelet activation. In people with clinical diseases, alterations in PMP concentrations have been extensively investigated, but few canine studies exist. This study aims to validate a canine flow cytometric protocol for PMP quantification and to assess the influence of calcium on PMP concentrations. Microparticles (MP) were quantified in citrated whole blood (WB) and platelet-poor plasma (PPP) using flow cytometry. Anti-CD61 antibody and Annexin V (AnV) were used to detect platelets and phosphatidylserine, respectively. In 13 healthy dogs, CD61 + /AnV - concentrations were analyzed with/without a calcium buffer. CD61 + /AnV - , CD61 + /AnV + , and CD61 - /AnV + MP quantification were validated in 10 healthy dogs. The coefficient of variation (CV) for duplicate (intra-assay) and parallel (inter-assay) analyses and detection limits (DLs) were calculated. CD61 + /AnV - concentrations were higher in calcium buffer; 841,800 MP/μL (526,000-1,666,200) vs without; 474,200 MP/μL (278,800-997,500), P < .05. In WB, PMP were above DLs and demonstrated acceptable (<20%) intra-assay and inter-assay CVs in 9/10 dogs: 1.7% (0.5-8.9) and 9.0% (0.9-11.9), respectively, for CD61 + /AnV - and 2.4% (0.2-8.7) and 7.8% (0.0-12.8), respectively, for CD61 + /AnV + . Acceptable CVs were not seen for the CD61 - /AnV + MP. In PPP, quantifications were challenged by high inter-assay CV, overlapping DLs and hemolysis and lipemia interfered with quantification in 5/10 dogs. Calcium induced higher in vitro PMP concentrations, likely due to platelet activation. PMP concentrations were reliably quantified in WB, indicating the potential for clinical applications. PPP analyses were unreliable due to high inter-CV and DL overlap, and not obtainable due to hemolysis and lipemia interference. © 2018 American Society for Veterinary Clinical Pathology.

Reliability, validity and factorial structure of the Arabic version of the international suicide prevention trial (InterSePT) scale for suicidal thinking in schizophrenia patients in Doha, Qatar.

PubMed

Hammoudeh, Samer; Ghuloum, Suhaila; Mahfoud, Ziyad; Opler, Mark; Khan, Anzalee; Yehya, Arij; Abdulhakam, Abdulmoneim; Al-Mujalli, Azza; Hani, Yahya; Elsherbiny, Reem; Al-Amin, Hassen

2016-12-07

Patients with schizophrenia are known to have higher rates of mortality and morbidity when compared to the general population. Suicidality is a major contributor to increased mortality. The International Suicide Prevention Trial (InterSePT) Scale for Suicidal Thinking (ISST) is a validated tool to assess current suicidal ideation in patients with schizophrenia. The aims of the study were to culturally adapt the Arabic translation of ISST and to examine the psychometric characteristics of the Arabic version of the ISST among patients with schizophrenia in Qatar. ISST was translated and adapted into formal Arabic using the back translation method. Patients diagnosed with schizophrenia were randomly recruited from the department of Psychiatry, Rumailah Hospital, Doha, Qatar. Healthy controls were randomly recruited from two primary health care centers in Doha, Qatar. The Arabic version of Module B for suicidality in Mini International Neuropsychiatric Interview was used as the gold standard to which the Arabic ISST was compared. The study sample (n = 199) was composed of 100 patients diagnosed with schizophrenia (age 35.30 ± 10.04 years; M/F is 2/1) and 99 controls (age 33.98 ± 8.33 years; M/F is 2/3). The mean score on the ISST was 3.03 ± 4.75 vs. 0.47 ± 1.44 for the schizophrenia and control groups, respectively. Inter-rater reliability coefficient was 0.95, p > 0.001. The overall Cronbach's alpha was 0.92. Principal Component Analysis produced 3 factors explaining a total of 73.8% of variance. This is the first study in the Arab countries to validate the Arabic version of the ISST. The psychometric properties indicate that the Arabic ISST is a valid tool to assess the severity of suicidal ideation in Arabic patients with schizophrenia.

Bronchiolitis Score of Sant Joan de Déu: BROSJOD Score, validation and usefulness.

PubMed

Balaguer, Mònica; Alejandre, Carme; Vila, David; Esteban, Elisabeth; Carrasco, Josep L; Cambra, Francisco José; Jordan, Iolanda

2017-04-01

To validate the bronchiolitis score of Sant Joan de Déu (BROSJOD) and to examine the previously defined scoring cutoff. Prospective, observational study. BROSJOD scoring was done by two independent physicians (at admission, 24 and 48 hr). Internal consistency of the score was assessed using Cronbach's α. To determine inter-rater reliability, the concordance correlation coefficient estimated as an intraclass correlation coefficient (CCC) and limits of agreement estimated as the 90% total deviation index (TDI) were estimated. An expert opinion was used to classify patients according to clinical severity. A validity analysis was conducted comparing the 3-level classification score to that expert opinion. Volume under the surface (VUS), predictive values, and probability of correct classification (PCC) were measured to assess discriminant validity. About 112 patients were recruited, 62 of them (55.4%) males. Median age: 52.5 days (IQR: 32.75-115.25). The admission Cronbach's α was 0.77 (CI95%: 0.71; 0.82) and at 24 hr it was 0.65 (CI95%: 0.48; 0.7). The inter-rater reliability analysis was: CCC at admission 0.96 (95%CI 0.94-0.97), at 24 h 0.77 (95%CI 0.65-0.86), and at 48 hr 0.94 (95%CI 0.94-0.97); TDI 90%: 1.6, 2.9, and 1.57, respectively. The discriminant validity at admission: VUS of 0.8 (95%CI 0.70-0.90), at 24 h 0.92 (95%CI 0.85-0.99), and at 48 hr 0.93 (95%CI 0.87-0.99). The predictive values and PCC values were within 38-100% depending on the level of clinical severity. There is a high inter-rater reliability, showing the BROSJOD score to be reliable and valid, even when different observers apply it. Pediatr Pulmonol. 2017;52:533-539. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Reliability and Validity of the Italian Version of the Protocol of Orofacial Myofunctional Evaluation with Scores (I-OMES).

PubMed

Scarponi, Letizia; de Felicio, Claudia Maria; Sforza, Chiarella; Pimenta Ferreira, Claudia Lucia; Ginocchio, Daniela; Pizzorni, Nicole; Barozzi, Stefania; Mozzanica, Francesco; Schindler, Antonio

2018-05-30

To evaluate the reliability, validity, and responsiveness of the Italian OMES (I-OMES). The study consisted of 3 phases: (1) internal consistency and reliability, (2) validity, and (3) responsiveness analysis. The recruited population included 27 patients with orofacial myofunctional disorders (OMD) and 174 healthy volunteers. Forty-seven subjects, 18 healthy and all recruited patients with OMD were assessed for inter-rater and test-retest reliability analysis. I-OMES and Nordic Orofacial Test - Screening (NOT-S) scores of the patients were correlated for concurrent validity analysis. I-OMES scores from 27 patients with OMD and 27 age- and gender-matched healthy subjects were compared to investigate construct validity. I-OMES scores before and after successful swallowing rehabilitation in patients were compared for responsiveness analysis. Adequate internal consistency (Cronbach α = 0.71) and strong inter-rater and test-retest reliability (intraclass coefficient correlation = 0.97 and 0.98, respectively) were found. I-OMES and NOT-S scores significantly and inversely correlated (r = -0.38). A statistical significance (p < 0.001) was found between the pathological group and the control group for the total I-OMES score. The mean I-OMES score improved from 90 (78-102) to 99 (89-103) after myofunctional rehabilitation (p < 0.001). The I-OMES is a reliable and valid tool to evaluate OMD. © 2018 S. Karger AG, Basel.

RELIABILITY AND VALIDITY OF A BIOMECHANICALLY BASED ANALYSIS METHOD FOR THE TENNIS SERVE

PubMed Central

Kibler, W. Ben; Lamborn, Leah; Smith, Belinda J.; English, Tony; Jacobs, Cale; Uhl, Tim L.

2017-01-01

Background An observational tennis serve analysis (OTSA) tool was developed using previously established body positions from three-dimensional kinematic motion analysis studies. These positions, defined as nodes, have been associated with efficient force production and minimal joint loading. However, the tool has yet to be examined scientifically. Purpose The primary purpose of this investigation was to determine the inter-observer reliability for each node between two health care professionals (HCPs) that developed the OTSA, and secondarily to investigate the validity of the OTSA. Methods Two separate studies were performed to meet these objectives. An inter-observer reliability study preceded the validity study by examining 28 videos of players serving. Two HCPs graded each video and scored the presence or absence of obtaining each node. Discriminant validity was determined in 33 tennis players using video taped records of three first serves. Serve mechanics were graded using the OSTA and categorized players into those with good ( ≥ 5) and poor ( ≤ 4) mechanics. Participants performed a series of field tests to evaluate trunk flexibility, lower extremity and trunk power, and dynamic balance. Results The group with good mechanics demonstrated greater backward trunk flexibility (p=0.02), greater rotational power (p=0.02), and higher single leg countermovement jump (p=0.05). Reliability of the OTSA ranged from K = 0.36-1.0, with the majority of all the nodes displaying substantial reliability (K>0.61). Conclusion This study provides HCPs with a valid and reliable field tool used to assess serve mechanics. Physical characteristics of trunk mobility and power appear to discriminate serve mechanics between players. Future intervention studies are needed to determine if improvement in physical function contribute to improved serve mechanics. Level of Evidence 3 PMID:28593098

Diagnosing paratonia in the demented elderly: reliability and validity of the Paratonia Assessment Instrument (PAI).

PubMed

Hobbelen, Johannes S M; Koopmans, Raymond T C M; Verhey, Frans R J; Habraken, Kitty M; de Bie, Rob A

2008-08-01

Paratonia is one of the associated movement disorders characteristic of dementia. The aim of this study was to develop an assessment tool (the Paratonia Assessment Instrument, PAI), based on the new consensus definition of paratonia. An additional aim was to investigate the reliability and validity of the PAI. A three-phase cross-sectional survey was conducted. In the first two phases, the PAI was developed and validated. In the third phase, the inter-observer reliability and feasibility of the instrument was tested. The original PAI consisted of five criteria that all needed to be met in order to make the diagnosis. On the basis of a qualitative analysis, one criterion was reformulated and another was removed. Following this, inter-observer reliability between the two assessors resulted in an improvement of Cohen's kappa from 0.532 in the initial phase to 0.677 in the second phase. This improvement was substantiated in the third phase by two independent assessors with Cohen's kappa ranging from 0.625 to 1. The PAI is a reliable and valid assessment tool for diagnosing paratonia in elderly people with dementia that can be applied easily in daily practice.

Cross-cultural validation of the St. Louis Inventory of Community Living Skills for Chinese patients with schizophrenia in Hong Kong.

PubMed

Au, Raymond Wing Cheong; Tam, Peter Wai Chung; Tam, Gladys Wai Chi; Ungvari, Gabor Sander

2005-01-01

The study validated a culturally sensitive community living skills rating scale for Chinese patients by adapting the St. Louis Inventory of Community Living Skills (SLICLS). The Chinese version (SLICLS-C) was produced by forward and backward translation. An expert panel evaluated its content validity. Its internal consistency, inter-rater reliability, construct and concurrent validity were tested on 80 DSM-IV schizophrenia inpatients in a long-term facility. For predictive validity, the above sample was extended to ensure at least 20 subjects discharged to each of three levels of community care were included in the study sample. The SLICLS-C was psychometrically sound and could be used for predicting level of community care, program evaluation and measuring outcome.

A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus.

PubMed

Golden, Allison; Stevens, Eric J; Yokobe, Lindsay; Faulx, Dunia; Kalnoky, Michael; Peck, Roger; Valdez, Melissa; Steel, Cathy; Karabou, Potochoziou; Banla, Méba; Soboslay, Peter T; Adade, Kangi; Tekle, Afework H; Cama, Vitaliano A; Fischer, Peter U; Nutman, Thomas B; Unnasch, Thomas R; de los Santos, Tala; Domingo, Gonzalo J

2016-01-01

Serological assays for human IgG4 to the Onchocerca volvulus antigen Ov16 have been used to confirm elimination of onchocerciasis in much of the Americas and parts of Africa. A standardized source of positive control antibody (human anti-Ov16 IgG4) will ensure the quality of surveillance data using these tests. A recombinant human IgG4 antibody to Ov16 was identified by screening against a synthetic human Fab phage display library and converted into human IgG4. This antibody was developed into different positive control formulations for enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT) platforms. Variation in ELISA results and utility as a positive control of the antibody were assessed from multiple laboratories. Temperature and humidity conditions were collected across seven surveillance activities from 2011-2014 to inform stability requirements for RDTs and positive controls. The feasibility of the dried positive control for RDT was evaluated during onchocerciasis surveillance activity in Togo, in 2014. When the anti-Ov16 IgG4 antibody was used as a standard dilution in horseradish peroxidase (HRP) and alkaline phosphatase (AP) ELISAs, the detection limits were approximately 1ng/mL by HRP ELISA and 10ng/mL by AP ELISA. Positive control dilutions and spiked dried blood spots (DBS) produced similar ELISA results. Used as a simple plate normalization control, the positive control antibody may improve ELISA data comparison in the context of inter-laboratory variation. The aggregate temperature and humidity monitor data informed temperature parameters under which the dried positive control was tested and are applicable inputs for testing of diagnostics tools intended for sub-Saharan Africa. As a packaged positive control for Ov16 RDTs, stability of the antibody was demonstrated for over six months at relevant temperatures in the laboratory and for over 15 weeks under field conditions. The recombinant human anti-Ov16 IgG4 antibody-based positive control will benefit inter-laboratory validation of ELISA assays and serve as quality control (QC) reagents for Ov16 RDTs at different points of the supply chain from manufacturer to field use.

Validation of a method to detect cocaine and its metabolites in nails by gas chromatography-mass spectrometry.

PubMed

Valente-Campos, Simone; Yonamine, Mauricio; de Moraes Moreau, Regina Lucia; Silva, Ovandir Alves

2006-06-02

The objective of the present work was to compare previously published methods and provide validation data to detect simultaneously cocaine (COC), benzoylecgonine (BE) and norcocaine (NCOC) in nail. Finger and toenail samples (5mg) were cut in very small pieces and submitted to an initial procedure for external decontamination. Methanol (3 ml) was used to release analytes from the matrix. A cleanup step was performed simultaneously by solid-phase extraction (SPE) and the residue was derivatized with pentafluoropropionic anhydride/pentafluoropropanol (PFPA/PFP). Gas chromatography-mass spectrometry (GC-MS) was used to detect the analytes in selected ion monitoring mode (SIM). Confidence parameters of validation of the method were: recovery, intra- and inter-assay precision, as well as limit of detection (LOD) of the analytes. The limits of detection were: 3.5 ng/mg for NCOC and 3.0 ng/mg for COC and BE. Good intra-assay precision was observed for all detected substances (coefficient of variation (CV)<11%). The inter-assay precision for norcocaine and benzoylecgonine were <4%. For intra- and inter-assay precision deuterated internal standards were used. Toenail and fingernail samples from eight declared cocaine users were submitted to the validated method.

High accuracy measurements of dry mole fractions of carbon dioxide and methane in humid air

NASA Astrophysics Data System (ADS)

Rella, C. W.; Chen, H.; Andrews, A. E.; Filges, A.; Gerbig, C.; Hatakka, J.; Karion, A.; Miles, N. L.; Richardson, S. J.; Steinbacher, M.; Sweeney, C.; Wastine, B.; Zellweger, C.

2013-03-01

Traditional techniques for measuring the mole fractions of greenhouse gases in the well-mixed atmosphere have required dry sample gas streams (dew point < -25 °C) to achieve the inter-laboratory compatibility goals set forth by the Global Atmosphere Watch programme of the World Meteorological Organisation (WMO/GAW) for carbon dioxide (±0.1 ppm in the Northern Hemisphere and ±0.05 ppm in the Southern Hemisphere) and methane (±2 ppb). Drying the sample gas to low levels of water vapour can be expensive, time-consuming, and/or problematic, especially at remote sites where access is difficult. Recent advances in optical measurement techniques, in particular cavity ring down spectroscopy, have led to the development of greenhouse gas analysers capable of simultaneous measurements of carbon dioxide, methane and water vapour. Unlike many older technologies, which can suffer from significant uncorrected interference from water vapour, these instruments permit accurate and precise greenhouse gas measurements that can meet the WMO/GAW inter-laboratory compatibility goals (WMO, 2011a) without drying the sample gas. In this paper, we present laboratory methodology for empirically deriving the water vapour correction factors, and we summarise a series of in-situ validation experiments comparing the measurements in humid gas streams to well-characterised dry-gas measurements. By using the manufacturer-supplied correction factors, the dry-mole fraction measurements have been demonstrated to be well within the GAW compatibility goals up to a water vapour concentration of at least 1%. By determining the correction factors for individual instruments once at the start of life, this water vapour concentration range can be extended to at least 2% over the life of the instrument, and if the correction factors are determined periodically over time, the evidence suggests that this range can be extended up to and even above 4% water vapour concentrations.

Development and psychometric properties rating scale of “clinical competency evaluation in mental health nurses”: Exploratory factor analysis

PubMed Central

Moskoei, Sara; Mohtashami, Jamileh; Ghalenoeei, Mahdie; Nasiri, Maliheh; Tafreshi, Mansoreh Zaghari

2017-01-01

Introduction Evaluation of clinical competency in nurses has a distinct importance in healthcare due to its significant impact on improving the quality of patient care and creation of opportunities for professional promotion. This is a psychometric study for development of the “Clinical Competency of Mental Health Nursing”(CCMHN) rating scale. Methods In this methodological research that was conducted in 2015, in Tehran, Iran, the main items were developed after literature review and the validity and reliability of the tool were identified. The face, content (content validity ratio and content validity index) and construct validities were calculated. For face and content validity, experts’ comments were used. Exploratory factor analysis was used to determine the construct validity. The reliability of scale was determined by the internal consistency and inter-rater correlation. The collected data were analyzed by SPSS version 16, using descriptive statistical analysis. Results A scale with 45 items in two parts including Emotional/Moral and Specific Care competencies was developed. Content validity ratio and content validity index were 0.88, 0.97 respectively. Exploratory factor analysis indicated two factors: The first factor with 23.93 eigenvalue and second factor with eigenvalue 2.58. Cronbach’s alpha coefficient for determination of internal consistency was 0.98 and the ICC for confirmation inter-rater correlation was 0.98. Conclusion A scale with 45 items and two areas was developed with appropriate validity and reliability. This scale can be used to assess the clinical competency in nursing students and mental health nurses. PMID:28607650

Development and validation of a tool to evaluate the quality of medical education websites in pathology

PubMed Central

Alyusuf, Raja H.; Prasad, Kameshwar; Abdel Satir, Ali M.; Abalkhail, Ali A.; Arora, Roopa K.

2013-01-01

Background: The exponential use of the internet as a learning resource coupled with varied quality of many websites, lead to a need to identify suitable websites for teaching purposes. Aim: The aim of this study is to develop and to validate a tool, which evaluates the quality of undergraduate medical educational websites; and apply it to the field of pathology. Methods: A tool was devised through several steps of item generation, reduction, weightage, pilot testing, post-pilot modification of the tool and validating the tool. Tool validation included measurement of inter-observer reliability; and generation of criterion related, construct related and content related validity. The validated tool was subsequently tested by applying it to a population of pathology websites. Results and Discussion: Reliability testing showed a high internal consistency reliability (Cronbach's alpha = 0.92), high inter-observer reliability (Pearson's correlation r = 0.88), intraclass correlation coefficient = 0.85 and κ =0.75. It showed high criterion related, construct related and content related validity. The tool showed moderately high concordance with the gold standard (κ =0.61); 92.2% sensitivity, 67.8% specificity, 75.6% positive predictive value and 88.9% negative predictive value. The validated tool was applied to 278 websites; 29.9% were rated as recommended, 41.0% as recommended with caution and 29.1% as not recommended. Conclusion: A systematic tool was devised to evaluate the quality of websites for medical educational purposes. The tool was shown to yield reliable and valid inferences through its application to pathology websites. PMID:24392243

Reliability and validity of job content questionnaire for university research laboratory staff in Malaysia.

PubMed

Nehzat, F; Huda, B Z; Tajuddin, S H Syed

2014-03-01

Job Content Questionnaire (JCQ) has been proven a reliable and valid instrument to assess job stress in many countries and among various occupations. In Malaysia, both English and Malay versions of the JCQ have been administered to automotive workers, schoolteachers, and office workers. This study assessed the reliability and validity of the instrument with research laboratory staff in a university. A cross sectional study was conducted among 258 research laboratory staff in Universiti Putra Malaysia (UPM). Malaysian laboratory staff who have worked for at least one year were randomly selected from nine faculties and institutes in the university that have research laboratory. A self-administered English and Malay version of Job Content Questionnaire (JCQ) was used. Three major scales of JCQ: decision latitude, psychological job demands, and social support were assessed. Cronbach's alpha coefficients of two scales were acceptable, decision latitude and psychological job demands (0.70 and 0.72, respectively), while Cronbach's alpha coefficient for social support (0.86) was good. Exploratory factor analysis showed five factors that correspond closely to the theoretical construct of the questionnaire. The results of this research suggest that the JCQ is reliable and valid for examining psychosocial work situations and job strain among research laboratory staff. Further studies should be done for confirmative results, and further evaluation is needed on the decision authority subscale for this occupation.

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

PubMed Central

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

2012-01-01

Introduction 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. Materials and methods: 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 (%). Results: The accuracy of data transfer from laboratory analyzers to LIS was 99.5% and of that from LIS to HIS 100%. Conclusion: We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose. PMID:22384522

Some case studies of skewed (and other ab-normal) data distributions arising in low-level environmental research.

PubMed

Currie, L A

2001-07-01

Three general classes of skewed data distributions have been encountered in research on background radiation, chemical and radiochemical blanks, and low levels of 85Kr and 14C in the atmosphere and the cryosphere. The first class of skewed data can be considered to be theoretically, or fundamentally skewed. It is typified by the exponential distribution of inter-arrival times for nuclear counting events for a Poisson process. As part of a study of the nature of low-level (anti-coincidence) Geiger-Muller counter background radiation, tests were performed on the Poisson distribution of counts, the uniform distribution of arrival times, and the exponential distribution of inter-arrival times. The real laboratory system, of course, failed the (inter-arrival time) test--for very interesting reasons, linked to the physics of the measurement process. The second, computationally skewed, class relates to skewness induced by non-linear transformations. It is illustrated by non-linear concentration estimates from inverse calibration, and bivariate blank corrections for low-level 14C-12C aerosol data that led to highly asymmetric uncertainty intervals for the biomass carbon contribution to urban "soot". The third, environmentally, skewed, data class relates to a universal problem for the detection of excursions above blank or baseline levels: namely, the widespread occurrence of ab-normal distributions of environmental and laboratory blanks. This is illustrated by the search for fundamental factors that lurk behind skewed frequency distributions of sulfur laboratory blanks and 85Kr environmental baselines, and the application of robust statistical procedures for reliable detection decisions in the face of skewed isotopic carbon procedural blanks with few degrees of freedom.

Systematic behavioural observation of executive performance after brain injury.

PubMed

Lewis, Mark W; Babbage, Duncan R; Leathem, Janet M

2017-01-01

To develop an ecologically valid measure of executive functioning (i.e. Planning and Organization, Executive Memory, Initiation, Cognitive Shifting, Impulsivity, Sustained and Directed Attention, Error Detection, Error Correction and Time Management) during a functional chocolate brownie cooking task. In Study 1, the inter-rater reliability of a novel behavioural observation assessment method was assessed with 10 people with traumatic brain injury (TBI). In Study 2, 27 people with TBI and 16 healthy controls completed the functional task along with other measures of executive functioning to assess validity. Intraclass correlation coefficients for six of the nine aspects of executive functioning ranged from .54 to 1.00. Percentage agreements for the remaining aspects ranged from 70% to 90%. Significant and non-significant, moderate, correlations were found between the functional cooking task and standard neuropsychological measures. The healthy control group performed better than the TBI group in six areas (d = 0.56 to 1.23). In this initial trial of a novel assessment method, adequate inter-rater reliability was found. The measure was associated with standard neuropsychological measures, and our healthy control group performed better than the TBI group. The measure appears to be an ecologically valid measure of executive functioning.

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

PubMed

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.

Oil mist and vapour concentrations from drilling fluids: inter- and intra-laboratory comparison of chemical analyses.

PubMed

Galea, Karen S; Searl, Alison; Sánchez-Jiménez, Araceli; Woldbæk, Torill; Halgard, Kristin; Thorud, Syvert; Steinsvåg, Kjersti; Krüger, Kirsti; Maccalman, Laura; Cherrie, John W; van Tongeren, Martie

2012-01-01

There are no recognized analytical methods for measuring oil mist and vapours arising from drilling fluids used in offshore petroleum drilling industry. To inform the future development of improved methods of analysis for oil mist and vapours this study assessed the inter- and intra-laboratory variability in oil mist and vapour analysis. In addition, sample losses during transportation and storage were assessed. Replicate samples for oil mist and vapour were collected using the 37-mm Millipore closed cassette and charcoal tube assembly. Sampling was conducted in a simulated shale shaker room, similar to that found offshore for processing drilling fluids. Samples were analysed at two different laboratories, one in Norway and one in the UK. Oil mist samples were analysed using Fourier transform infrared spectroscopy (FTIR), while oil vapour samples were analysed by gas chromatography (GC). The comparison of replicate samples showed substantial within- and between-laboratory variability in reported oil mist concentrations. The variability in oil vapour results was considerably reduced compared to oil mist, provided that a common method of calibration and quantification was adopted. The study also showed that losses can occur during transportation and storage of samples. There is a need to develop a harmonized method for the quantification of oil mist on filter and oil vapour on charcoal supported by a suitable proficiency testing scheme for laboratories involved in the analysis of occupational hygiene samples for the petroleum industry. The uncertainties in oil mist and vapour measurement have substantial implications in relation to compliance with occupational exposure limits and also in the reliability of any exposure-response information reported in epidemiological studies.

Microbiological methods for the water recovery systems test, revision 1.1

NASA Technical Reports Server (NTRS)

Rhoads, Tim; Kilgore, M. V., Jr.; Mikell, A. T., Jr.

1990-01-01

Current microbiological parameters specified to verify microbiological quality of Space Station Freedom water quality include the enumeration of total bacteria, anaerobes, aerobes, yeasts and molds, enteric bacteria, gram positives, gram negatives, and E. coli. In addition, other parameters have been identified as necessary to support the Water Recovery Test activities to be conducted at the NASA/MSFC later this year. These other parameters include aerotolerant eutrophic mesophiles, legionellae, and an additional method for heterotrophic bacteria. If inter-laboratory data are to be compared to evaluate quality, analytical methods must be eliminated as a variable. Therefore, each participating laboratory must utilize the same analytical methods and procedures. Without this standardization, data can be neither compared nor validated between laboratories. Multiple laboratory participation represents a conservative approach to insure quality and completeness of data. Invariably, sample loss will occur in transport and analyses. Natural variance is a reality on any test of this magnitude and is further enhanced because biological entities, capable of growth and death, are specific parameters of interest. The large variation due to the participation of human test subjects has been noted with previous testing. The resultant data might be dismissed as 'out of control' unless intra-laboratory control is included as part of the method or if participating laboratories are not available for verification. The purpose of this document is to provide standardized laboratory procedures for the enumeration of certain microorganisms in water and wastewater specific to the water recovery systems test. The document consists of ten separate cultural methods and one direct count procedure. It is not intended nor is it implied to be a complete microbiological methods manual.

Producing standard damaged DNA samples by heating: pitfalls and suggestions.

PubMed

Fattorini, Paolo; Marrubini, Giorgio; Bonin, Serena; Bertoglio, Barbara; Grignani, Pierangela; Recchia, Elisa; Pitacco, Paola; Procopio, Francesca; Cantoni, Carolina; Pajnič, Irena Zupanič; Sorçaburu-Cigliero, Solange; Previderè, Carlo

2018-05-15

Heat-mediated hydrolysis of DNA is a simple and inexpensive method for producing damaged samples in vitro. Despite heat-mediated DNA hydrolysis is being widely used in forensic and clinical validation procedures, the lack of standardized procedures makes it impossible to compare the intra and inter-laboratory outcomes of the damaging treatments. In this work, a systematic approach to heat induced DNA hydrolysis was performed at 70 °C for 0-18 h to test the role both of the hydrolysis buffer and of the experimental conditions. Specifically, a trial DNA sample, resuspended in three different media (ultrapure water, 0.1% DEPC-water and, respectively, TE) was treated both in Eppendorf tubes ("Protocol P") and in Eppendorf tubes provided with screwcaps ("Protocol S"). The results of these comparative tests were assessed by normalization of the qPCR results. DEPC-water increased the degradation of the samples up to about 100 times when compared to the ultrapure water. Conversely, the TE protected the DNA from degradation whose level was about 1700 times lower than in samples treated in ultrapure water. Even the employment of the "Protocol S" affected the level of degradation, by consistently increasing it (up to about 180 times in DEPC-water). Thus, this comparative approach showed that even seemingly apparently trivial and often underestimated parameters modify the degradation level up to 2-3 orders of magnitude. The chemical-physical reasons of these findings are discussed together with the role of potential factors such as enhanced reactivity of CO 2 , ROS, NO x and pressure, which are likely to be involved. Since the intra and inter-laboratory comparison of the outcomes of the hydrolytic procedure is the first step toward its standardization, the normalization of the qPCR data by the UV/qPCR ratio seems to be the simplest and most reliable way to allow this. Finally, the supplying (provided with the commercial qPCR kits) of a DNA sample whose degree of degradation is well documented could be helpful in ISO/IEC 17025 validation procedures and in proficiency testing. Copyright © 2018 Elsevier Inc. All rights reserved.

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

PubMed

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.

Quantitative measurement of salivary testosterone in Korean adults by stable isotope-dilution liquid chromatographyelectrospray-tandem mass spectrometry.

PubMed

Lee, Sanghoo; Kwon, Soonho; Shin, Hye-Jin; Park, Jimyeong; Lim, Hwan-Sub; Lee, Kyoung-Ryul; Kim, Young-Jin

2010-11-01

Salivary testosterone levels in Korean adults were quantitatively measured for the first time by liquid chromatography-electrospray-tandem mass spectrometry (LC ESI MS/MS). Salivary testosterone was separated on a multiple reaction monitoring (MRM) chromatogram within 7 min. The LC ESI MS/MS assay was validated over the linearity range of 0.01-2.00 ng/ml (r=0.99987) using testosterone-d(3) as an internal standard. The lower limit of quantification (LOQ) was 0.01 ng/ml. The intra- and inter-assay precisions were 1.54% to 4.09% and 0.96% to 4.29%, respectively. The mean recovery was 93.32% (range 88.43-98.05%). The validated assay was then applied to measure the salivary testosterone levels of Korean adults. In men, the salivary testosterone level collected between 9:00-11:00 am was approximately 2.8 times higher than that in women (P < 0.0001). Salivary testosterone levels in both sexes negatively correlated with age. The present assay would also be useful in measuring salivary testosterone levels in clinical laboratories.

Developing the Person-Environment Apathy Rating for persons with dementia.

PubMed

Jao, Ying-Ling; Algase, Donna L; Specht, Janet K; Williams, Kristine

2016-08-01

To develop the Person-Environment Apathy Rating (PEAR) scale that measures environmental stimulation and apathy in persons with dementia and to evaluate its psychometrics. The PEAR scale consists of the PEAR-Environment subscale and PEAR-Apathy subscales. The items were developed via literature review, field testing, expert review, and pilot testing. The construct validity and reliability were examined through video observation. The parent study enrolled 185 institutionalized residents with dementia. For this study, 96 videos were selected from 24 participants. The PEAR-Environment subscale was validated using the Ambiance Scale and the Crowding Index. The PEAR-Apathy subscale was validated using the Neuropsychiatric Inventory (NPI)-Apathy, Passivity in Dementia Scale (PDS), and NPI-Depression. The PEAR-Environment subscale and PEAR-Apathy subscales each consists of six items rated on a 1-4 scale. For validity, the Crowding Index slightly, yet significantly, correlated with the PEAR-Environment subscale total score and three of the individual scores. Ambiance Scale scores, both engaging and soothing, did not correlate with the PEAR-Environment subscale. The PEAR-Apathy highly correlated with the PDS and NPI-Apathy and moderately correlated with the NPI-Depression, suggesting good convergent validity and moderate discriminant validity. For reliability, both environment and apathy subscales demonstrated excellent internal consistency. Although facial expression and eye contact showed moderate inter-rater reliability, all other items showed good to excellent inter-rater and intra-rater reliability. This study has successfully developed the PEAR scale and established its psychometrics based on the compatible scales available. The PEAR scale is the first scale that concurrently assesses apathy and environmental stimulation, and is recommended for use in persons with dementia.

Virtual and remote robotic laboratory using EJS, MATLAB and LabVIEW.

PubMed

Chaos, Dictino; Chacón, Jesús; Lopez-Orozco, Jose Antonio; Dormido, Sebastián

2013-02-21

This paper describes the design and implementation of a virtual and remote laboratory based on Easy Java Simulations (EJS) and LabVIEW. The main application of this laboratory is to improve the study of sensors in Mobile Robotics, dealing with the problems that arise on the real world experiments. This laboratory allows the user to work from their homes, tele-operating a real robot that takes measurements from its sensors in order to obtain a map of its environment. In addition, the application allows interacting with a robot simulation (virtual laboratory) or with a real robot (remote laboratory), with the same simple and intuitive graphical user interface in EJS. Thus, students can develop signal processing and control algorithms for the robot in simulation and then deploy them on the real robot for testing purposes. Practical examples of application of the laboratory on the inter-University Master of Systems Engineering and Automatic Control are presented.

Virtual and Remote Robotic Laboratory Using EJS, MATLAB and Lab VIEW

PubMed Central

Chaos, Dictino; Chacón, Jesús; Lopez-Orozco, Jose Antonio; Dormido, Sebastián

2013-01-01

This paper describes the design and implementation of a virtual and remote laboratory based on Easy Java Simulations (EJS) and LabVIEW. The main application of this laboratory is to improve the study of sensors in Mobile Robotics, dealing with the problems that arise on the real world experiments. This laboratory allows the user to work from their homes, tele-operating a real robot that takes measurements from its sensors in order to obtain a map of its environment. In addition, the application allows interacting with a robot simulation (virtual laboratory) or with a real robot (remote laboratory), with the same simple and intuitive graphical user interface in EJS. Thus, students can develop signal processing and control algorithms for the robot in simulation and then deploy them on the real robot for testing purposes. Practical examples of application of the laboratory on the inter-University Master of Systems Engineering and Automatic Control are presented. PMID:23429578

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2013 CFR

2013-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2013-10-01 2013-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2011 CFR

2011-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2011-10-01 2011-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2010 CFR

2010-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2010-10-01 2010-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2012 CFR

2012-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2012-10-01 2012-10-01 false What is validity testing, and are laboratories...

49 CFR 40.89 - What is validity testing, and are laboratories required to conduct it?

Code of Federal Regulations, 2014 CFR

2014-10-01

... PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Drug Testing Laboratories § 40.89 What is validity testing, and are laboratories required to conduct it? (a) Specimen validity testing is... 49 Transportation 1 2014-10-01 2014-10-01 false What is validity testing, and are laboratories...

Is Ultrasound a Valid and Reliable Imaging Modality for Airway Evaluation?: An Observational Computed Tomographic Validation Study Using Submandibular Scanning of the Mouth and Oropharynx.

PubMed

Abdallah, Faraj W; Yu, Eugene; Cholvisudhi, Phantila; Niazi, Ahtsham U; Chin, Ki J; Abbas, Sherif; Chan, Vincent W

2017-01-01

Ultrasound (US) imaging of the airway may be useful in predicting difficulty of airway management (DAM); but its use is limited by lack of proof of its validity and reliability. We sought to validate US imaging of the airway by comparison to CT-scan, and to assess its inter- and intra-observer reliability. We used submandibular sonographic imaging of the mouth and oropharynx to examine how well the ratio of tongue thickness to oral cavity height correlates with the ratio of tongue volume to oral cavity volume, an established tomographic measure of DAM. A cohort of 34 patients undergoing CT-scan was recruited. Study standardized assessments included CT-measured ratios of tongue volume to oropharyngeal cavity volume; tongue thickness to oral cavity height; and US-measured ratio of tongue thickness to oral cavity height. Two sonographers independently performed US imaging of the airway before and after CT-scan. Our findings indicate that the US-measured ratio of tongue thickness to oral cavity height highly correlates with the CT-measured ratio of tongue volume to oral cavity volume. US measurements also demonstrated strong inter- and intra-observer reliability. This study suggests that US is a valid and reliable tool for imaging the oral and oropharyngeal parts of the airway, as well as for measuring the volumetric relationship between the tongue and oral cavity, and may therefore be a useful predictor of DAM. © 2016 by the American Institute of Ultrasound in Medicine.

Comparing the nine-item Shared Decision-Making Questionnaire to the OPTION Scale - an attempt to establish convergent validity.

PubMed

Scholl, Isabelle; Kriston, Levente; Dirmaier, Jörg; Härter, Martin

2015-02-01

While there has been a clear move towards shared decision-making (SDM) in the last few years, the measurement of SDM-related constructs remains challenging. There has been a call for further psychometric testing of known scales, especially regarding validity aspects. To test convergent validity of the nine-item Shared Decision-Making Questionnaire (SDM-Q-9) by comparing it to the OPTION Scale. Cross-sectional study. Data were collected in outpatient care practices. Patients suffering from chronic diseases and facing a medical decision were included in the study. Consultations were evaluated using the OPTION Scale. Patients completed the SDM-Q-9 after the consultation. First, the internal consistency of both scales and the inter-rater reliability of the OPTION Scale were calculated. To analyse the convergent validity of the SDM-Q-9, correlation between the patient (SDM-Q-9) and expert ratings (OPTION Scale) was calculated. A total of 21 physicians provided analysable data of consultations with 63 patients. Analyses revealed good internal consistency of the SDM-Q-9 and limited internal consistency of the OPTION Scale. Inter-rater reliability of the latter was less than optimal. Association between the total scores of both instruments was weak with a Spearman correlation of r = 0.19 and did not reach statistical significance. By the use of the OPTION Scale convergent validity of the SDM-Q-9 could not be established. Several possible explanations for this result are discussed. This study shows that the measurement of SDM remains challenging. © 2012 John Wiley & Sons Ltd.

A new scale for the assessment of performance and capacity of hand function in children with hemiplegic cerebral palsy: reliability and validity studies.

PubMed

Rosa-Rizzotto, M; Visonà Dalla Pozza, L; Corlatti, A; Luparia, A; Marchi, A; Molteni, F; Facchin, P; Pagliano, E; Fedrizzi, E

2014-10-01

In hemiplegic children, the recognition of the activity limitation pattern and the possibility of grading its severity are relevant for clinicians while planning interventions, monitoring results, predicting outcomes. Aim of the study is to examine the reliability and validity of Besta Scale, an instrument used to measure in hemiplegic children from 18 months to 12 years of age both grasp on request (capacity) and spontaneous use of upper limb (performance) in bimanual play activities and in ADL. Psychometric analysis of reliability and of validity of the Besta scale was performed. Outpatient study sample Reliability study: A sample of 39 patients was enrolled. The administration of Besta scale was video-recorded in a standardized manner. All videos were scored by 20 independent raters on subsequent viewing. 3 raters randomly selected from the 20-raters group rescored the same video two years later for intra-rater reliability. Intra and inter-rater reliability were calculated using Intraclass Correlation Coefficient (ICC) and Kendall's coefficient (K), respectively. Internal consistency reliability was assessed using Alpha's Chronbach coefficient. Validity study: a sample of 105 children was assessed 5 times (at t0 and 2, 3, 6 and 12 months later) by 20 independent raters. Each patient underwent at the same time to QUEST and Besta scale administration and assessment. Criterion validity was calculated using rho-Pearson coefficient. Reliability study: The inter-rater reliability calculated with Kendall's coefficient resulted moderate K=0.47. The intra-rater (or test-retest) reliability for 3 raters was excellent (ICC=0.927). The Cronbach's alpha for internal consistency was 0.972. Validity study: Besta scale showed a good criterion validity compared to QUEST increasing by age and severity of impairment. Rho Pearson's correlation coefficient r was 0.81 (P<0.0001). Limitations. Besta scales in infants finds hard to distinguish between mild to moderately impaired hand function. Besta scale scoring system is a valid and reliable tool, utilizable in a clinical setting to monitor evolution of unimanual and bimanual manipulation and to distinguish hand's capacity from performance.

Test Assembly Implications for Providing Reliable and Valid Subscores

ERIC Educational Resources Information Center

Lee, Minji K.; Sweeney, Kevin; Melican, Gerald J.

2017-01-01

This study investigates the relationships among factor correlations, inter-item correlations, and the reliability estimates of subscores, providing a guideline with respect to psychometric properties of useful subscores. In addition, it compares subscore estimation methods with respect to reliability and distinctness. The subscore estimation…

Exploring students' perceptions on the use of significant event analysis, as part of a portfolio assessment process in general practice, as a tool for learning how to use reflection in learning

PubMed Central

Grant, Andrew J; Vermunt, Jan D; Kinnersley, Paul; Houston, Helen

2007-01-01

Background Portfolio learning enables students to collect evidence of their learning. Component tasks making up a portfolio can be devised that relate directly to intended learning outcomes. Reflective tasks can stimulate students to recognise their own learning needs. Assessment of portfolios using a rating scale relating to intended learning outcomes offers high content validity. This study evaluated a reflective portfolio used during a final-year attachment in general practice (family medicine). Students were asked to evaluate the portfolio (which used significant event analysis as a basis for reflection) as a learning tool. The validity and reliability of the portfolio as an assessment tool were also measured. Methods 81 final-year medical students completed reflective significant event analyses as part of a portfolio created during a three-week attachment (clerkship) in general practice (family medicine). As well as two reflective significant event analyses each portfolio contained an audit and a health needs assessment. Portfolios were marked three times; by the student's GP teacher, the course organiser and by another teacher in the university department of general practice. Inter-rater reliability between pairs of markers was calculated. A questionnaire enabled the students' experience of portfolio learning to be determined. Results Benefits to learning from reflective learning were limited. Students said that they thought more about the patients they wrote up in significant event analyses but information as to the nature and effect of this was not forthcoming. Moderate inter-rater reliability (Spearman's Rho .65) was found between pairs of departmental raters dealing with larger numbers (20 – 60) of portfolios. Inter-rater reliability of marking involving GP tutors who only marked 1 – 3 portfolios was very low. Students rated highly their mentoring relationship with their GP teacher but found the portfolio tasks time-consuming. Conclusion The inter-rater reliability observed in this study should be viewed alongside the high validity afforded by the authenticity of the learning tasks (compared with a sample of a student's learning taken by an exam question). Validity is enhanced by the rating scale which directly connects the grade given with intended learning outcomes. The moderate inter-rater reliability may be increased if a portfolio is completed over a longer period of time and contains more component pieces of work. The questionnaire used in this study only accessed limited information about the effect of reflection on students' learning. Qualitative methods of evaluation would determine the students experience in greater depth. It would be useful to evaluate the effects of reflective learning after students have had more time to get used to this unfamiliar method of learning and to overcome any problems in understanding the task. PMID:17397544

Exploring students' perceptions on the use of significant event analysis, as part of a portfolio assessment process in general practice, as a tool for learning how to use reflection in learning.

PubMed

Grant, Andrew J; Vermunt, Jan D; Kinnersley, Paul; Houston, Helen

2007-03-30

Portfolio learning enables students to collect evidence of their learning. Component tasks making up a portfolio can be devised that relate directly to intended learning outcomes. Reflective tasks can stimulate students to recognise their own learning needs. Assessment of portfolios using a rating scale relating to intended learning outcomes offers high content validity. This study evaluated a reflective portfolio used during a final-year attachment in general practice (family medicine). Students were asked to evaluate the portfolio (which used significant event analysis as a basis for reflection) as a learning tool. The validity and reliability of the portfolio as an assessment tool were also measured. 81 final-year medical students completed reflective significant event analyses as part of a portfolio created during a three-week attachment (clerkship) in general practice (family medicine). As well as two reflective significant event analyses each portfolio contained an audit and a health needs assessment. Portfolios were marked three times; by the student's GP teacher, the course organiser and by another teacher in the university department of general practice. Inter-rater reliability between pairs of markers was calculated. A questionnaire enabled the students' experience of portfolio learning to be determined. Benefits to learning from reflective learning were limited. Students said that they thought more about the patients they wrote up in significant event analyses but information as to the nature and effect of this was not forthcoming. Moderate inter-rater reliability (Spearman's Rho .65) was found between pairs of departmental raters dealing with larger numbers (20-60) of portfolios. Inter-rater reliability of marking involving GP tutors who only marked 1-3 portfolios was very low. Students rated highly their mentoring relationship with their GP teacher but found the portfolio tasks time-consuming. The inter-rater reliability observed in this study should be viewed alongside the high validity afforded by the authenticity of the learning tasks (compared with a sample of a student's learning taken by an exam question). Validity is enhanced by the rating scale which directly connects the grade given with intended learning outcomes. The moderate inter-rater reliability may be increased if a portfolio is completed over a longer period of time and contains more component pieces of work. The questionnaire used in this study only accessed limited information about the effect of reflection on students' learning. Qualitative methods of evaluation would determine the students experience in greater depth. It would be useful to evaluate the effects of reflective learning after students have had more time to get used to this unfamiliar method of learning and to overcome any problems in understanding the task.

Computational Fluid Dynamics Modeling of Bubbling in a Viscous Fluid for Validation of Waste Glass Melter Modeling

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

Abboud, Alexander William; Guillen, Donna Post

2016-01-01

At the Hanford site, radioactive waste stored in underground tanks is slated for vitrification for final disposal. A comprehensive knowledge of the glass batch melting process will be useful in optimizing the process, which could potentially reduce the cost and duration of this multi-billion dollar cleanup effort. We are developing a high-fidelity heat transfer model of a Joule-heated ceramic lined melter to improve the understanding of the complex, inter-related processes occurring with the melter. The glass conversion rates in the cold cap layer are dependent on promoting efficient heat transfer. In practice, heat transfer is augmented by inserting air bubblersmore » into the molten glass. However, the computational simulations must be validated to provide confidence in the solutions. As part of a larger validation procedure, it is beneficial to split the physics of the melter into smaller systems to validate individually. The substitution of molten glass for a simulant liquid with similar density and viscosity at room temperature provides a way to study mixing through bubbling as an isolated effect without considering the heat transfer dynamics. The simulation results are compared to experimental data obtained by the Vitreous State Laboratory at the Catholic University of America using bubblers placed within a large acrylic tank that is similar in scale to a pilot glass waste melter. Comparisons are made for surface area of the rising air bubbles between experiments and CFD simulations for a variety of air flow rates and bubble injection depths. Also, computed bubble rise velocity is compared to a well-accepted expression for bubble terminal velocity.« less

The reliability of a maximal isometric hip strength and simultaneous surface EMG screening protocol in elite, junior rugby league athletes.

PubMed

Charlton, Paula C; Mentiplay, Benjamin F; Grimaldi, Alison; Pua, Yong-Hao; Clark, Ross A

2017-02-01

Firstly to describe the reliability of assessing maximal isometric strength of the hip abductor and adductor musculature using a hand held dynamometry (HHD) protocol with simultaneous wireless surface electromyographic (sEMG) evaluation of the gluteus medius (GM) and adductor longus (AL). Secondly, to describe the correlation between isometric strength recorded with the HHD protocol and a laboratory standard isokinetic device. Reliability and correlational study. A sample of 24 elite, male, junior, rugby league athletes, age 16-20 years participated in repeated HHD and isometric Kin-Com (KC) strength testing with simultaneous sEMG assessment, on average (range) 6 (5-7) days apart by a single assessor. Strength tests included; unilateral hip abduction (ABD) and adduction (ADD) and bilateral ADD assessed with squeeze (SQ) tests in 0 and 45° of hip flexion. HHD demonstrated good to excellent inter-session reliability for all outcome measures (ICC (2,1) =0.76-0.91) and good to excellent association with the laboratory reference KC (ICC (2,1) =0.80-0.88). Whilst intra-session, inter-trial reliability of EMG activation and co-activation outcome measures ranged from moderate to excellent (ICC (2,1) =0.70-0.94), inter-session reliability was poor (all ICC (2,1) <0.50). Isometric strength testing of the hip ABD and ADD musculature using HHD may be measured reliably in elite, junior rugby league athletes. Due to the poor inter-session reliability of sEMG measures, it is not recommended for athlete screening purposes if using the techniques implemented in this study. Copyright © 2016 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

[Inter-rater reliability and construct validity of the OPD-CA axis structure: first study results regarding the integration of OPD-CA into clinical practice].

PubMed

Cropp, Carola; Salzer, Simone; Häusser, Leonard F; Streeck-Fischer, Annette

2013-01-01

The axis structure of the Operationalized Psychodynamic Diagnostics in childhood and adolescence (OPD-CA) has proven to be a reliable and valid diagnostic tool under research conditions. However, corresponding data regarding the integration of OPD-CA axis structure into clinical practice is still lacking. Hence, this aspect was examined as part of a randomized controlled clinical trial realized at Asklepios Fachklinikum Tiefenbrunn. Here, the OPD-CA axis structure has been applied to assess the structural level of 42 adolescent patients (15-19 years). In contrast to previous studies, the assessment was not carried out by independent raters using a videotaped OPD-CA interview, but the rating was part of clinical routine procedures. Also under these conditions, inter-rater reliability was high, in particular regarding the four subscales of the OPD-CA axis structure. With respect to construct validity, the results of our study supported a two-factor solution, which is in accordance with the findings of two previous works. One factor corresponded to the dimension "self-regulation" while the other factor included both the dimension "self-perception and object perception" as well as the dimension "communication skills". Implications of the findings for research and practice are discussed.

Inter-rater Reliability of Real-Time Ultrasound to Measure Acromiohumeral Distance.

PubMed

Mackenzie, Tanya Anne; Bdaiwi, Alya H; Herrington, Lee; Cools, Ann

2016-07-01

Real-time ultrasound (RTUS) has been suggested as a reliable measure of acromiohumeral distance. However, to date, no vigorous assessment and reporting of inter-rater reliability of this method has been performed with the shoulder in a neutral position or with active and passive arm abduction. To assess intrasession inter-rater reliability of using RTUS to measure acromiohumeral distance with the shoulder in a neutral position and with 60° active and passive abduction. Inter-rater intrasession reliability of repeated measures. Human performance laboratory. Twenty persons (12 male and 8 female) with an average age of 29.86 years (standard deviation, 7.8). In an inter-rater, intrasession study, RTUS was used to measure the acromiohumeral distance with the shoulder in a neutral position and with 60° of both active and passive abduction. Acromiohumeral distance. Intraclass correlation coefficient (ICC)2.1 scores ranged between 0.65-0.88 (standard error of the mean = 0.81-1.2 mm and minimal detectable differences with 95% confidence = 2.2-2.3 mm) for inter-rater intrasession reliability. RTUS was found to have fair to good inter-rater reliability as a tool to measure acromiohumeral distance with the shoulder in a neutral position and with 60° of both active and passive arm abduction. Copyright © 2016 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Inter-rater reliability of output measures for a posture matching assessment approach: a pilot study with food service workers.

PubMed

Cann, A P; Connolly, M; Ruuska, R; MacNeil, M; Birmingham, T B; Vandervoort, A A; Callaghan, J P

2008-04-01

Despite the ongoing health problem of repetitive strain injuries, there are few tools currently available for ergonomic applications evaluating cumulative loading that have well-documented evidence of reliability and validity. The purpose of this study was to determine the inter-rater reliability of a posture matching based analysis tool (3DMatch, University of Waterloo) for predicting cumulative and peak spinal loads. A total of 30 food service workers were each videotaped for a 1-h period while performing typical work activities and a single work task was randomly selected from each for analysis by two raters. Inter-rater reliability was determined using intraclass correlation coefficients (ICC) model 2,1 and standard errors of measurement for cumulative and peak spinal and shoulder loading variables across all subjects. Overall, 85.5% of variables had moderate to excellent inter-rater reliability, with ICCs ranging from 0.30-0.99 for all cumulative and peak loading variables. 3DMatch was found to be a reliable ergonomic tool when more than one rater is involved.

Development and validation of an LC-MS method for determination of Karanjin in rat plasma: application to preclinical pharmacokinetics.

PubMed

Yi, Deliang; Wang, Zhihua; Yi, Longzhi

2015-04-01

A selective and sensitive liquid chromatography-mass spectrometry (MS) method was developed and validated for the determination of karanjin in rat plasma. The target analyte, together with the internal standard (warfarin), was extracted from rat plasma by liquid-liquid extraction with ethyl acetate. Chromatographic separation was performed on a ZORBAX SB-C18 column using a mixture of acetonitrile and 0.1% aqueous formic acid as the mobile phase with linear gradient elution. MS detection was performed on a single quadrupole MS by selected ion monitoring mode via a positive electrospray ionization source. The assay exhibited a linear dynamic range of 2.50-3,000 ng/mL for karanjin. The intra- and inter-day precision was <10.8%, and the intra- and inter-day accuracy was <9.2%. The validated method has been applied to the preclinical pharmacokinetic studies of karanjin following oral administration of 5, 10 and 20 mg/kg karanjin to rats. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Validation of a confirmatory method for the determination of residues of four nitrofurans in egg by liquid chromatography-tandem mass spectrometry with the software InterVal.

PubMed

Bock, C; Stachel, C; Gowik, P

2007-03-14

A method for the detection and determination of nitrofuran derivatives in egg by liquid chromatography-tandem mass spectrometry (LC-MS/MS) was validated with the software InterVal and can be applied for the confirmation of nitrofuran metabolites in fresh or lyophilised eggs. The validation study comprises variations in operator, storage condition, breeding, equipment and duration of sample preparation. A comprehensive overview of the robustness of the method is obtained by analysing eight samples at six concentration levels. First results of short- and medium-term investigations for stability of analytes in solution show that standard solutions of nitrofuran metabolites are stable for at least 1 year when stored at +4 degrees C in the dark. The decision limit CCalpha expressed for the underivatised metabolite is 0.05 microg kg(-1) for 3-amino-5-methyl-morpholino-2-oxazolidinone, 0.03 microg kg(-1) for 3-amino-2-oxazolidinone, 0.20 microg kg(-1) for semicarbazide and 0.22 microg kg(-1) for 1-amino-hydantoin.

Assessing the Validity and Reliability of the Peristomal Skin Lesion Assessment Instrument Adapted for Use in Turkey.

PubMed

Ay, Ali; Bulut, Hulya

2015-08-01

Many ostomy patients experience peristomal skin lesions. A descriptive study was conducted to assess the validity, usability, and reliability of the Peristomal Skin Lesions Assessment instrument (SACS instrument) adapted to Turkish from English. The SACS Instrument consists of 2 main assessments: lesion type (utilizing definitions and photographs) and lesion area by location around the ostomy. The study was performed in 2 stages: 1) the SACS language was changed and its content validity established; and 2) the instrument\\'92s content validity and inter-observer agreement (consistency) were determined among pairs of nurses who used the tool to assess peristomal skin lesions. Patients (included if they were >18 years old and receiving treatment/observation at 1 of the 4 participating stomatherapy units) and 8 stomatherapy nurses also completed appropriate sociodemographic questionnaires. Of the 393 patients screened during the 7-month study, 100 (average age 56.74 \\'b1 14.03 years, 55 men) participated; most (79) had a planned operation. A little more than half (59) of the patients had colorectal cancer and 28 had their stoma site marked preoperatively by a stomatherapy nurse. The most common peristomal skin lesion risk factors were having an ileostomy and unplanned surgery. The content validity index of the entire Turkish SACS instrument was 1, and the inter-observer agreement Kappa statistic was very good (K = 0.90, 95% CI 0.80- 0.99). Individual SACS item K values ranged from K = 0.84 (95% CI 0.63\\'961) to K = 1 (95% CI 1). Most (62.5%) nurses found the terms and pictures used in the SACS classification adequate and suitable, and 50% believed the Turkish version of the SACS instrument was a valid and suitable assessment tool for use by Turkish stomatherapy nurses. Validity and reliability studies involving larger and more diverse patient and nurse samples are warranted.

Quantitative determination of tilmicosin in canine serum by high performance liquid chromatography-tandem mass spectrometry.

PubMed

Herrera, Michael; Ding, Haiqing; McClanahan, Robert; Owens, Jane G; Hunter, Robert P

2007-09-15

A highly sensitive and quantitative LC/MS/MS assay for the determination of tilmicosin in serum has been developed and validated. For sample preparation, 0.2 mL of canine serum was extracted with 3 mL of methyl tert-butyl ether. The organic layer was transferred to a new vessel and dried under nitrogen. The sample was then reconstituted for analysis by high performance liquid chromatography-tandem mass spectrometry. A Phenomenex Luna C8(2) analytical column was used for the chromatographic separation. The eluent was subsequently introduced to the mass spectrometer by electrospray ionization. A single range was validated for 50-5000 ng/mL for support of toxicokinetic studies. The inter-day relative error (inaccuracy) for the LLOQ samples ranged from -5.5% to 0.3%. The inter-day relative standard deviations (imprecision) at the respective LLOQ levels were < or =10.1%.

Intra- and Inter-Fractional Variation Prediction of Lung Tumors Using Fuzzy Deep Learning

PubMed Central

Park, Seonyeong; Lee, Suk Jin; Weiss, Elisabeth

2016-01-01

Tumor movements should be accurately predicted to improve delivery accuracy and reduce unnecessary radiation exposure to healthy tissue during radiotherapy. The tumor movements pertaining to respiration are divided into intra-fractional variation occurring in a single treatment session and inter-fractional variation arising between different sessions. Most studies of patients’ respiration movements deal with intra-fractional variation. Previous studies on inter-fractional variation are hardly mathematized and cannot predict movements well due to inconstant variation. Moreover, the computation time of the prediction should be reduced. To overcome these limitations, we propose a new predictor for intra- and inter-fractional data variation, called intra- and inter-fraction fuzzy deep learning (IIFDL), where FDL, equipped with breathing clustering, predicts the movement accurately and decreases the computation time. Through the experimental results, we validated that the IIFDL improved root-mean-square error (RMSE) by 29.98% and prediction overshoot by 70.93%, compared with existing methods. The results also showed that the IIFDL enhanced the average RMSE and overshoot by 59.73% and 83.27%, respectively. In addition, the average computation time of IIFDL was 1.54 ms for both intra- and inter-fractional variation, which was much smaller than the existing methods. Therefore, the proposed IIFDL might achieve real-time estimation as well as better tracking techniques in radiotherapy. PMID:27170914

Translation, adaptation and validation of the American short form Patient Activation Measure (PAM13) in a Danish version.

PubMed

Maindal, Helle Terkildsen; Sokolowski, Ineta; Vedsted, Peter

2009-06-29

The Patient Activation Measure (PAM) is a measure that assesses patient knowledge, skill, and confidence for self-management. This study validates the Danish translation of the 13-item Patient Activation Measure (PAM13) in a Danish population with dysglycaemia. 358 people with screen-detected dysglycaemia participating in a primary care health education study responded to PAM13. The PAM13 was translated into Danish by a standardised forward-backward translation. Data quality was assessed by mean, median, item response, missing values, floor and ceiling effects, internal consistency (Cronbach's alpha and average inter-item correlation) and item-rest correlations. Scale properties were assessed by Rasch Rating Scale models. The item response was high with a small number of missing values (0.8-4.2%). Floor effect was small (range 0.6-3.6%), but the ceiling effect was above 15% for all items (range 18.6-62.7%). The alpha-coefficient was 0.89 and the average inter-item correlation 0.38. The Danish version formed a unidimensional, probabilistic Guttman-like scale explaining 43.2% of the variance. We did however, find a different item sequence compared to the original scale. A Danish version of PAM13 with acceptable validity and reliability is now available. Further development should focus on single items, response categories in relation to ceiling effects and further validation of reproducibility and responsiveness.

A novel optimised and validated method for analysis of multi-residues of pesticides in fruits and vegetables by microwave-assisted extraction (MAE)-dispersive solid-phase extraction (d-SPE)-retention time locked (RTL)-gas chromatography-mass spectrometry with Deconvolution reporting software (DRS).

PubMed

Satpathy, Gouri; Tyagi, Yogesh Kumar; Gupta, Rajinder Kumar

2011-08-01

A rapid, effective and ecofriendly method for sensitive screening and quantification of 72 pesticides residue in fruits and vegetables, by microwave-assisted extraction (MAE) followed by dispersive solid-phase extraction (d-SPE), retention time locked (RTL) capillary gas-chromatographic separation in trace ion mode mass spectrometric determination has been validated as per ISO/IEC: 17025:2005. Identification and reporting with total and extracted ion chromatograms were facilitated to a great extent by Deconvolution reporting software (DRS). For all compounds LOD were 0.002-0.02mg/kg and LOQ were 0.025-0.100mg/kg. Correlation coefficients of the calibration curves in the range of 0.025-0.50mg/kg were >0.993. To validate matrix effects repeatability, reproducibility, recovery and overall uncertainty were calculated for the 35 matrices at 0.025, 0.050 and 0.100mg/kg. Recovery ranged between 72% and 114% with RSD of <20% for repeatability and intermediate precision. The reproducibility of the method was evaluated by an inter laboratory participation and Z score obtained within ±2. Copyright © 2011 Elsevier Ltd. All rights reserved.

Developmental validation of an X-Insertion/Deletion polymorphism panel and application in HAN population of China.

PubMed

Zhang, Suhua; Sun, Kuan; Bian, Yingnan; Zhao, Qi; Wang, Zheng; Ji, Chaoneng; Li, Chengtao

2015-12-14

InDels are short-length polymorphisms characterized by low mutation rates, high inter-population diversity, short amplicon strategy and simplicity of laboratory analysis. This work describes the developmental validation of an X-InDels panel amplifying 18 bi-allelic markers and Amelogenin in one single PCR system. Developmental validation indicated that this novel panel was reproducible, accurate, sensitive and robust for forensic application. Sensitivity testing of the panel was such that a full profile was obtainable even with 125 pg of human DNA with intra-locus balance above 70%. Specificity testing was demonstrated by the lack of cross-reactivity with a variety of commonly encountered animal species and microorganisms. For the stability testing in cases of PCR inhibition, full profiles have been obtained with hematin (≤1000 μM) and humic acid (≤150 ng/μL). For the forensic investigation of the 18 X-InDels in the HAN population of China, no locus deviated from the Hardy-Weinberg equilibrium and linkage disequilibrium. Since they are independent from each other, the CDPfemale was 0.999999726 and CDPmale was 0.999934223. The forensic parameters suggested that this X-Indel panel is polymorphic and informative, which provides valuable X-linked information for deficient relationship cases where autosomal markers are uninformative.

Impact of pH on the stability and the cross-reactivity of ochratoxin A and citrinin.

PubMed

Bazin, Ingrid; Faucet-Marquis, Virginie; Monje, Marie-Carmen; El Khoury, Micheline; Marty, Jean-Louis; Pfohl-Leszkowicz, Annie

2013-11-28

Mycotoxins are secondary metabolites produced by several fungi contaminating crops. In several countries, the maximum permitted levels of mycotoxins are found in foodstuffs and feedstuffs. The common strategy of mycotoxin analysis involves extraction, clean-up and quantification by chromatography. In this paper, we analyzed the reasons of underestimation of ochratoxin A (OTA) content in wine, and overestimation of OTA in wheat, depending on the pH of the clean-up step and the simultaneous presence of citrinin (CIT). We demonstrated that the increase of pH by adding polyethylene glycol (PEG) to wine led to an underestimation of OTA by conversion of OTA into open ring ochratoxin A OP-OA. In comparing three methods of extraction and clean-up for the determination of OTA and CIT in wheat--(i) an inter-laboratory validated method for OTA in cereals using immunoaffinity column clean-up (IAC) and extraction by acetonitrile/water; (ii) a validated method using IAC and extraction with 1% bicarbonate Na; and (iii) an in-house validated method based on acid liquid/liquid extraction--we observed an overestimation of OTA after immunoaffinity clean-up when CIT is also present in the sample, whereas an underestimation was observed when OTA was alone. Under neutral and alkaline conditions, CIT was partially recognized by OTA antibodies.

Developmental validation of an X-Insertion/Deletion polymorphism panel and application in HAN population of China

PubMed Central

Zhang, Suhua; Sun, Kuan; Bian, Yingnan; Zhao, Qi; Wang, Zheng; Ji, Chaoneng; Li, Chengtao

2015-01-01

InDels are short-length polymorphisms characterized by low mutation rates, high inter-population diversity, short amplicon strategy and simplicity of laboratory analysis. This work describes the developmental validation of an X-InDels panel amplifying 18 bi-allelic markers and Amelogenin in one single PCR system. Developmental validation indicated that this novel panel was reproducible, accurate, sensitive and robust for forensic application. Sensitivity testing of the panel was such that a full profile was obtainable even with 125 pg of human DNA with intra-locus balance above 70%. Specificity testing was demonstrated by the lack of cross-reactivity with a variety of commonly encountered animal species and microorganisms. For the stability testing in cases of PCR inhibition, full profiles have been obtained with hematin (≤1000 μM) and humic acid (≤150 ng/μL). For the forensic investigation of the 18 X-InDels in the HAN population of China, no locus deviated from the Hardy–Weinberg equilibrium and linkage disequilibrium. Since they are independent from each other, the CDPfemale was 0.999999726 and CDPmale was 0.999934223. The forensic parameters suggested that this X-Indel panel is polymorphic and informative, which provides valuable X-linked information for deficient relationship cases where autosomal markers are uninformative. PMID:26655948

Impact of pH on the Stability and the Cross-Reactivity of Ochratoxin A and Citrinin

PubMed Central

Bazin, Ingrid; Faucet-Marquis, Virginie; Monje, Marie-Carmen; El Khoury, Micheline; Marty, Jean-Louis; Pfohl-Leszkowicz, Annie

2013-01-01

Mycotoxins are secondary metabolites produced by several fungi contaminating crops. In several countries, the maximum permitted levels of mycotoxins are found in foodstuffs and feedstuffs. The common strategy of mycotoxin analysis involves extraction, clean-up and quantification by chromatography. In this paper, we analyzed the reasons of underestimation of ochratoxin A (OTA) content in wine, and overestimation of OTA in wheat, depending on the pH of the clean-up step and the simultaneous presence of citrinin (CIT). We demonstrated that the increase of pH by adding polyethylene glycol (PEG) to wine led to an underestimation of OTA by conversion of OTA into open ring ochratoxin A OP-OA. In comparing three methods of extraction and clean-up for the determination of OTA and CIT in wheat—(i) an inter-laboratory validated method for OTA in cereals using immunoaffinity column clean-up (IAC) and extraction by acetonitrile/water; (ii) a validated method using IAC and extraction with 1% bicarbonate Na; and (iii) an in-house validated method based on acid liquid/liquid extraction—we observed an overestimation of OTA after immunoaffinity clean-up when CIT is also present in the sample, whereas an underestimation was observed when OTA was alone. Under neutral and alkaline conditions, CIT was partially recognized by OTA antibodies. PMID:24287570

The evaluation of lumbar multifidus muscle function via palpation: reliability and validity of a new clinical test.

PubMed

Hebert, Jeffrey J; Koppenhaver, Shane L; Teyhen, Deydre S; Walker, Bruce F; Fritz, Julie M

2015-06-01

The lumbar multifidus muscle provides an important contribution to lumbar spine stability, and the restoration of lumbar multifidus function is a frequent goal of rehabilitation. Currently, there are no reliable and valid physical examination procedures available to assess lumbar multifidus function among patients with low back pain. To examine the inter-rater reliability and concurrent validity of the multifidus lift test (MLT) to identify lumbar multifidus dysfunction among patients with low back pain. A cross-sectional analysis of reliability and concurrent validity performed in a university outpatient research facility. Thirty-two persons aged 18 to 60 years with current low back pain and a minimum modified Oswestry disability score of 20%. Study participants were excluded if they reported a history of lumbar spine surgery, lumbar radiculopathy, medical red flags, osteoporosis, or had recently been treated with spinal manipulation or trunk stabilization exercises. Concurrent measures of lumbar multifidus muscle function at the L4-L5 and L5-S1 levels were obtained with the MLT (index test) and real-time ultrasound imaging (reference standard). The inter-rater reliability of the MLT was examined by measuring the level of agreement between two blinded examiners. Concurrent validity of the MLT was investigated by comparing clinicians' judgments with real-time ultrasound imaging measures of lumbar multifidus function. Inter-rater reliability of the MLT was substantial to excellent (κ=0.75 to 0.81, p≤.01) and free from errors of bias and prevalence. When performed at L4-L5 or L5-S1, the MLT demonstrated evidence of concurrent validity through its relationship with the reference standard results at L4-L5 (rbis=0.59-0.73, p≤.01). The MLT generally failed to demonstrate a relationship with the reference standard results from the L5-S1 level. Our results provide preliminary evidence supporting the reliability and validity of the MLT to assess lumbar multifidus function at the L4-L5 spinal level. Additional research examining the measurement properties and utility of this test should be undertaken before confident implementation with patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Probability of Detection (POD) as a statistical model for the validation of qualitative methods.

PubMed

Wehling, Paul; LaBudde, Robert A; Brunelle, Sharon L; Nelson, Maria T

2011-01-01

A statistical model is presented for use in validation of qualitative methods. This model, termed Probability of Detection (POD), harmonizes the statistical concepts and parameters between quantitative and qualitative method validation. POD characterizes method response with respect to concentration as a continuous variable. The POD model provides a tool for graphical representation of response curves for qualitative methods. In addition, the model allows comparisons between candidate and reference methods, and provides calculations of repeatability, reproducibility, and laboratory effects from collaborative study data. Single laboratory study and collaborative study examples are given.

Comparative analysis of four commercial on-farm culture methods to identify bacteria associated with clinical mastitis in dairy cattle.

PubMed

Ferreira, Jair C; Gomes, Marilia S; Bonsaglia, Erika C R; Canisso, Igor F; Garrett, Edgar F; Stewart, Jamie L; Zhou, Ziyao; Lima, Fabio S

2018-01-01

Several multiple-media culture systems have become commercially available for on-farm identification of mastitis-associated pathogens. However, the accuracy of these systems has not been thoroughly and independently validated against microbiological evaluations performed by referral laboratories. Therefore, the purpose of the present study was to evaluate the performance of commercially available culture plates (Accumast, Minnesota Easy System, SSGN and SSGNC Quad plates) to identify pathogens associated with clinical mastitis in dairy cows. Milk samples from the affected quarter with clinical mastitis were aerobically cultured with the on-farm culture systems and by two additional reference laboratories. Agreeing results from both standard laboratories were denoted as the reference standard (RS). Accuracy (Ac), sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV and NPV, respectively) and Cohen's kappa coefficient (k) of on-farm plates were determined based on the RS culture of 211 milk samples. All four plate-systems correctly identified ≥ 84.9% of milk samples with no bacterial growth. Accumast had greater values for all overall predictive factors (Ac, Se, Sp, PPV and NPV) and a substantial agreement (k = 0.79) with RS. The inter-rater agreements of Minnesota, SSGN, and SSGNC with RS were moderate (0.45 ≤ k ≤ 0.55). The effectiveness to categorize bacterial colonies at the genus and species was numerically different amongst the commercial plates. Our findings suggest that Accumast was the most accurate on-farm culture system for identification of mastitis-associated pathogens of the four systems included in the analysis.

Comparative analysis of four commercial on-farm culture methods to identify bacteria associated with clinical mastitis in dairy cattle

PubMed Central

Ferreira, Jair C.; Gomes, Marilia S.; Bonsaglia, Erika C. R.; Canisso, Igor F.; Garrett, Edgar F.; Stewart, Jamie L.; Zhou, Ziyao

2018-01-01

Several multiple-media culture systems have become commercially available for on-farm identification of mastitis-associated pathogens. However, the accuracy of these systems has not been thoroughly and independently validated against microbiological evaluations performed by referral laboratories. Therefore, the purpose of the present study was to evaluate the performance of commercially available culture plates (Accumast, Minnesota Easy System, SSGN and SSGNC Quad plates) to identify pathogens associated with clinical mastitis in dairy cows. Milk samples from the affected quarter with clinical mastitis were aerobically cultured with the on-farm culture systems and by two additional reference laboratories. Agreeing results from both standard laboratories were denoted as the reference standard (RS). Accuracy (Ac), sensitivity (Se), specificity (Sp), positive and negative predictive values (PPV and NPV, respectively) and Cohen’s kappa coefficient (k) of on-farm plates were determined based on the RS culture of 211 milk samples. All four plate-systems correctly identified ≥ 84.9% of milk samples with no bacterial growth. Accumast had greater values for all overall predictive factors (Ac, Se, Sp, PPV and NPV) and a substantial agreement (k = 0.79) with RS. The inter-rater agreements of Minnesota, SSGN, and SSGNC with RS were moderate (0.45 ≤ k ≤ 0.55). The effectiveness to categorize bacterial colonies at the genus and species was numerically different amongst the commercial plates. Our findings suggest that Accumast was the most accurate on-farm culture system for identification of mastitis-associated pathogens of the four systems included in the analysis. PMID:29543852

Neurobehavioural assessment and diagnosis in disorders of consciousness: a preliminary study of the Sensory Tool to Assess Responsiveness (STAR).

PubMed

Stokes, Verity; Gunn, Sarah; Schouwenaars, Katie; Badwan, Derar

2018-09-01

The Sensory Tool to Assess Responsiveness (STAR) is an interdisciplinary neurobehavioural diagnostic tool for individuals with prolonged disorders of consciousness. It utilises current diagnostic criteria and is intended to improve upon the high misdiagnosis rate in this population. This study assesses the inter-rater reliability of the STAR and its diagnostic validity in comparison with the Coma Recovery Scale-Revised (CRS-R) and the Wessex Head Injury Matrix (WHIM). Participants were patients with severe acquired brain injury resulting in a disorder of consciousness, who were admitted to the Royal Leamington Spa Rehabilitation Hospital between 1999 and 2009. Patients underwent sensory stimulation sessions during their period of admission, which were recorded on video. Using this footage, patients were re-assessed for this study using the STAR, WHIM and CRS-R criteria. The STAR demonstrated "moderate" inter-rater reliability, "substantial" diagnostic agreement with the CRS-R, and "moderate" agreement with the WHIM. There were no significant differences between diagnoses assigned by the different assessments. The STAR demonstrated a good degree of inter-rater reliability in identification of diagnoses for patients with disorders of consciousness. The diagnostic outcomes of the STAR agreed at a good level with the CRS-R, moderately with the WHIM, and did not significantly differ from either. This demonstrates the reliability and validity of the STAR, showing its appropriateness for clinical use. Future longitudinal studies and research into the STAR's applicability in long-stay rehabilitation are indicated.

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2010 CFR

2010-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2012 CFR

2012-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2011 CFR

2011-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2014 CFR

2014-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

42 CFR 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a...

Code of Federal Regulations, 2013 CFR

2013-10-01

... laboratories or laboratories requesting or issued a certificate of accreditation. (a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA-exempt laboratory at... requirements of this part. (c) Noncompliance determination. If a validation or complaint inspection results in...

Predictive performance and inter-laboratory reproducibility in assessing eye irritation potential of water- and oil-soluble mixtures using the Short Time Exposure test method.

PubMed

Abo, Takayuki; Hilberer, Allison; Behle-Wagner, Christine; Watanabe, Mika; Cameron, David; Kirst, Annette; Nukada, Yuko; Yuki, Takuo; Araki, Daisuke; Sakaguchi, Hitoshi; Itagaki, Hiroshi

2018-04-01

The Short Time Exposure (STE) test method is an alternative method for assessing eye irritation potential using Statens Seruminstitut Rabbit Cornea cells and has been adopted as test guideline 491 by the Organisation for Economic Co-operation and Development. Its good predictive performance in identifying the Globally Harmonized System (GHS) No Category (NC) or Irritant Category has been demonstrated in evaluations of water-soluble substances, oil-soluble substances, and water-soluble mixtures. However, the predictive performance for oil-soluble mixtures was not evaluated. Twenty-four oil-soluble mixtures were evaluated using the STE test method. The GHS NC or Irritant Category of 22 oil-soluble mixtures were consistent with that of a Reconstructed human Cornea-like Epithelium (RhCE) test method. Inter-laboratory reproducibility was then confirmed using 20 water- and oil-soluble mixtures blind-coded. The concordance in GHS NC or Irritant Category among four laboratories was 90%-100%. In conclusion, the concordance in comparison with the results of RhCE test method using 24 oil-soluble mixtures and inter-laboratory reproducibility using 20 water- and oil-soluble mixtures blind-coded were good, indicating that the STE test method is a suitable alternative for predicting the eye irritation potential of both substances and mixtures. Copyright © 2018 Elsevier Ltd. All rights reserved.

Development, reliability and validation of an infant mammalian penetration-aspiration scale

PubMed Central

Holman, Shaina Devi; Campbell-Malone, Regina; Ding, Peng; Gierbolini-Norat, Estela M.; Griffioen, Anne M.; Inokuchi, Haruhi; Lukasik, Stacey L.; German, Rebecca Z.

2012-01-01

A penetration-aspiration scale exists for assessing airway protection in adult videofluoroscopy and fiberoptic endoscopic swallowing studies, however no such scale exists for animal models. The aim of this study was threefold to 1) develop a Penetration-Aspiration Scale (PAS) for infant mammals, 2) test the scale’s intra- and inter-rater reliability, and 3) to validate the use of the scale for distinguishing between abnormal and normal animals. After discussion and reviewing many videos, the result was a 7-Point Infant Mammal PAS. Reliability was tested by having 5 judges score 90 swallows recorded with videofluoroscopy across two time points. In these videos, the frame rate was either 30 or 60 frames per second and the animals were either normal, had a unilateral superior laryngeal nerve (SLN) lesion, or had hard palate local anesthesia. The scale was validated by having one judge score videos of both normal and SLN lesioned pigs and testing the difference using a t-test. Raters had a high intra-rater (average kappa of 0.82, intraclass correlation coefficient (ICC)= 0.92) and high inter-rater reliability (average kappa of 0.68, ICC= 0.66). There was a significant difference in reliability for videos captured at 30 and 60 frames per second for scores of 3 and 7 (p<0.001). The scale was also validated for distinguishing between normal and abnormal pigs (p<0.001). Given the increasing number of animal studies using videofluoroscopy to study dysphagia, this scale provides a valid and reliable measure of airway protection during swallowing in infant pigs that will give these animal models increased translational significance. PMID:23129423

The reliability and validity of the Saliba Postural Classification System

PubMed Central

Collins, Cristiana Kahl; Johnson, Vicky Saliba; Godwin, Ellen M.; Pappas, Evangelos

2016-01-01

Objectives To determine the reliability and validity of the Saliba Postural Classification System (SPCS). Methods Two physical therapists classified pictures of 100 volunteer participants standing in their habitual posture for inter and intra-tester reliability. For validity, 54 participants stood on a force plate in a habitual and a corrected posture, while a vertical force was applied through the shoulders until the clinician felt a postural give. Data were extracted at the time the give was felt and at a time in the corrected posture that matched the peak vertical ground reaction force (VGRF) in the habitual posture. Results Inter-tester reliability demonstrated 75% agreement with a Kappa = 0.64 (95% CI = 0.524–0.756, SE = 0.059). Intra-tester reliability demonstrated 87% agreement with a Kappa = 0.8, (95% CI = 0.702–0.898, SE = 0.05) and 80% agreement with a Kappa = 0.706, (95% CI = 0.594–0818, SE = 0.057). The examiner applied a significantly higher (p < 0.001) peak vertical force in the corrected posture prior to a postural give when compared to the habitual posture. Within the corrected posture, the %VGRF was higher when the test was ongoing vs. when a postural give was felt (p < 0.001). The %VGRF was not different between the two postures when comparing the peaks (p = 0.214). Discussion The SPCS has substantial agreement for inter- and intra-tester reliability and is largely a valid postural classification system as determined by the larger vertical forces in the corrected postures. Further studies on the correlation between the SPCS and diagnostic classifications are indicated. PMID:27559288

The reliability and validity of the Saliba Postural Classification System.

PubMed

Collins, Cristiana Kahl; Johnson, Vicky Saliba; Godwin, Ellen M; Pappas, Evangelos

2016-07-01

To determine the reliability and validity of the Saliba Postural Classification System (SPCS). Two physical therapists classified pictures of 100 volunteer participants standing in their habitual posture for inter and intra-tester reliability. For validity, 54 participants stood on a force plate in a habitual and a corrected posture, while a vertical force was applied through the shoulders until the clinician felt a postural give. Data were extracted at the time the give was felt and at a time in the corrected posture that matched the peak vertical ground reaction force (VGRF) in the habitual posture. Inter-tester reliability demonstrated 75% agreement with a Kappa = 0.64 (95% CI = 0.524-0.756, SE = 0.059). Intra-tester reliability demonstrated 87% agreement with a Kappa = 0.8, (95% CI = 0.702-0.898, SE = 0.05) and 80% agreement with a Kappa = 0.706, (95% CI = 0.594-0818, SE = 0.057). The examiner applied a significantly higher (p < 0.001) peak vertical force in the corrected posture prior to a postural give when compared to the habitual posture. Within the corrected posture, the %VGRF was higher when the test was ongoing vs. when a postural give was felt (p < 0.001). The %VGRF was not different between the two postures when comparing the peaks (p = 0.214). The SPCS has substantial agreement for inter- and intra-tester reliability and is largely a valid postural classification system as determined by the larger vertical forces in the corrected postures. Further studies on the correlation between the SPCS and diagnostic classifications are indicated.

Quality of pathology reporting is crucial for cancer care and registration: a baseline assessment for breast cancers diagnosed in Belgium in 2008.

PubMed

De Schutter, H; Van Damme, N; Colpaert, C; Galant, C; Lambein, K; Cornelis, A; Neven, P; Van Eycken, E

2015-04-01

Given the crucial role of pathology reporting in the management of breast cancers, we aimed to investigate the quality and variability of breast cancer pathology reporting in Belgium. Detailed information on non-molecular and molecular parameters was retrieved from the pathology protocols available at the Belgian Cancer Registry for 10,007 breast cancers diagnosed in Belgium in 2008. Substantial underreporting was shown for several clinically relevant non-molecular parameters, such as lymphovascular invasion. High-volume laboratories performed only slightly better than others, and analyses at the individual laboratory level showed clear inter-laboratory variability in reporting for all volume categories. Information on ER/PR and HER2 IHC was mentioned in respectively 91.7% and 90.8% of evaluative cases. HER2 ISH data were available for 78.5% of the cases judged to be 2+ for HER2 IHC. For cases with different specimens analysed, discordance between these specimens was highest for HER2, followed by PR. For HER2, results obtained from different laboratories were even less concordant. In addition, inter-laboratory differences were noted in the used ER/PR scoring systems, the proportion of ER-/PR+ cases, and the relation between histological grade and ER/PR positivity. Data on Ki67 were only available for 43.8% of the investigated cases, and showed inconsistent use of cut-off values. Breast pathology reporting in Belgium in 2008 was suboptimal and showed considerable inter-laboratory variability. Synoptic reporting has been proposed as a facilitator towards increased reporting quality and harmonization, but the lack of aligned informatics remains a major hurdle in its concrete implementation. Copyright © 2014 Elsevier Ltd. All rights reserved.

21 CFR 58.202 - Grounds for disqualification.

Code of Federal Regulations, 2011 CFR

2011-04-01

....202 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing Facilities § 58.202... adversely affected the validity of the nonclinical laboratory studies; and (c) Other lesser regulatory...

21 CFR 58.202 - Grounds for disqualification.

Code of Federal Regulations, 2010 CFR

2010-04-01

....202 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES Disqualification of Testing Facilities § 58.202... adversely affected the validity of the nonclinical laboratory studies; and (c) Other lesser regulatory...

Reliability and validity of a novel tool to comprehensively assess food and beverage marketing in recreational sport settings.

PubMed

Prowse, Rachel J L; Naylor, Patti-Jean; Olstad, Dana Lee; Carson, Valerie; Mâsse, Louise C; Storey, Kate; Kirk, Sara F L; Raine, Kim D

2018-05-31

Current methods for evaluating food marketing to children often study a single marketing channel or approach. As the World Health Organization urges the removal of unhealthy food marketing in children's settings, methods that comprehensively explore the exposure and power of food marketing within a setting from multiple marketing channels and approaches are needed. The purpose of this study was to test the inter-rater reliability and the validity of a novel settings-based food marketing audit tool. The Food and beverage Marketing Assessment Tool for Settings (FoodMATS) was developed and its psychometric properties evaluated in five public recreation and sport facilities (sites) and subsequently used in 51 sites across Canada for a cross-sectional analysis of food marketing. Raters recorded the count of food marketing occasions, presence of child-targeted and sports-related marketing techniques, and the physical size of marketing occasions. Marketing occasions were classified by healthfulness. Inter-rater reliability was tested using Cohen's kappa (κ) and intra-class correlations (ICC). FoodMATS scores for each site were calculated using an algorithm that represented the theoretical impact of the marketing environment on food preferences, purchases, and consumption. Higher FoodMATS scores represented sites with higher exposure to, and more powerful (unhealthy, child-targeted, sports-related, large) food marketing. Validity of the scoring algorithm was tested through (1) Pearson's correlations between FoodMATS scores and facility sponsorship dollars, and (2) sequential multiple regression for predicting "Least Healthy" food sales from FoodMATS scores. Inter-rater reliability was very good to excellent (κ = 0.88-1.00, p < 0.001; ICC = 0.97, p < 0.001). There was a strong positive correlation between FoodMATS scores and food sponsorship dollars, after controlling for facility size (r = 0.86, p < 0.001). The FoodMATS score explained 14% of the variability in "Least Healthy" concession sales (p = 0.012) and 24% of the variability total concession and vending "Least Healthy" food sales (p = 0.003). FoodMATS has high inter-rater reliability and good validity. As the first validated tool to evaluate the exposure and power of food marketing in recreation facilities, the FoodMATS provides a novel means to comprehensively track changes in food marketing environments that can assist in developing and monitoring the impact of policies and interventions.

Measuring hunger and satiety in primary school children. Validation of a new picture rating scale.

PubMed

Bennett, Carmel; Blissett, Jackie

2014-07-01

Measuring hunger and satiety in children is essential to many studies of childhood eating behaviour. Few validated measures currently exist that allow children to make accurate and reliable ratings of hunger/satiety. Three studies aimed to validate the use of a new categorical rating scale in the context of estimated and real eating episodes. Forty-seven 6- to 8-year-olds participated in Study 1, which used a between-participant design. Results indicated that the majority of children were able to make estimated hunger/satiety ratings for a story character using the scale. No significant differences in the ratings of hunger/satiety of children measured before and after lunch were observed and likely causes are discussed. To account for inter-individual differences in hunger/satiety perceptions Study 2 employed a within-participant design. Fifty-four 5- to 7-year-olds participated and made estimated hunger/satiety ratings for a story character and real hunger/satiety ratings before and after lunch. The results indicated that the majority of children were able to use the scale to make estimated and real hunger and satiety ratings. Children were found to be significantly hungrier before compared to after lunch. As it was not possible to establish the types and quantities of food children ate for lunch a third study was carried out in a controlled laboratory environment. Thirty-six 6- to 9-year-olds participated in Study 3 and made hunger/satiety ratings before and after ingesting an ad libitum snack of known composition and quantity. Results indicated that children felt hungrier before than after the snack and that pre-snack hunger/satiety, and changes in hunger/satiety, were associated with snack intake. Overall, the studies indicate that the scale has potential for use with primary school children. Implications of the findings are discussed. Copyright © 2014 Elsevier Ltd. All rights reserved.

Rapid measurement of methyl cellulose precipitable tannins using ultraviolet spectroscopy with chemometrics: application to red wine and inter-laboratory calibration transfer.

PubMed

Dambergs, Robert G; Mercurio, Meagan D; Kassara, Stella; Cozzolino, Daniel; Smith, Paul A

2012-06-01

Information relating to tannin concentration in grapes and wine is not currently available simply and rapidly enough to inform decision-making by grape growers, winemakers, and wine researchers. Spectroscopy and chemometrics have been implemented for the analysis of critical grape and wine parameters and offer a possible solution for rapid tannin analysis. We report here the development and validation of an ultraviolet (UV) spectral calibration for the prediction of tannin concentration in red wines. Such spectral calibrations reduce the time and resource requirements involved in measuring tannins. A diverse calibration set (n = 204) was prepared with samples of Australian wines of five varieties (Cabernet Sauvignon, Shiraz, Merlot, Pinot Noir, and Durif), from regions spanning the wine grape growing areas of Australia, with varying climate and soils, and with vintages ranging from 1991 to 2007. The relationship between tannin measured by the methyl cellulose precipitation (MCP) reference method at 280 nm and tannin predicted with a multiple linear regression (MLR) calibration, using ultraviolet (UV) absorbance at 250, 270, 280, 290, and 315 nm, was strong (r(2)val = 0.92; SECV = 0.20 g/L). An independent validation set (n = 85) was predicted using the MLR algorithm developed with the calibration set and gave confidence in the ability to predict new samples, independent of the samples used to prepare the calibration (r(2)val = 0.94; SEP = 0.18 g/L). The MLR algorithm could also predict tannin in fermenting wines (r(2)val = 0.76; SEP = 0.18 g/L), but worked best from the second day of ferment on. This study also explored instrument-to-instrument transfer of a spectral calibration for MCP tannin. After slope and bias adjustments of the calibration, efficient calibration transfer to other laboratories was clearly demonstrated, with all instruments in the study effectively giving identical results on a transfer set.

Equilibrium sampling informs tissue residue and sediment remediation for pyrethroid insecticides in mariculture: A laboratory demonstration.

PubMed

Li, Juan-Ying; Shi, Wenxuan; Li, Zhenhua; Chen, Yiqin; Shao, Liu; Jin, Ling

2018-03-01

Mariculture product safety in relation to sediment quality has attracted increasing attention because of the accumulation of potentially hazardous chemicals, including pyrethroid insecticides, in sediment. Passive sampling has been widely used to assess the bioavailability of sediment-associated hydrophobic organic contaminants and predict their body residue in benthic organisms. Therefore, in this study, we introduced polydimethylsiloxane (PDMS) polymer as a biomimetic "chemometer" for freely-dissolved concentrations (C free ) to assess the efficacy of different carbon sorbents in reducing the bioavailability of pyrethroids in the process of sediment remediation. Black carbon (BC)-based materials (e.g., charcoal, biochar, and activated carbon) showed the advantageous sorption capacity over humic substance-based peat soil based on both C free and tissue residue in exposed clams. Of the tested BC-type materials, biochar appeared to be an ideal one in the remediation of pyrethroid-contaminated sediment. The predictive value of the PDMS chemometer approach to informing tissue residue was confirmed by a good agreement between the measured lipid-normalized concentrations of pyrethroids in clams and the lipid-based equilibrium concentrations calculated from C free via lipid-water partition coefficients. The quantitative inter-compartmental relationship underlying the laboratory system of sediment-pore water-PDMS-biota was also cross-validated by a mechanistically-based bioaccumulation model, thus confirming the validity of C free as a predictive intermediate to alert for tissue residue and guide sediment remediation. The present study revealed a great promise of sensing C free by polymer-based equilibrium sampling in predicting tissue residue of chemicals applied in mariculture against regulatory guidelines, and, in turn, informing remediation measures when needs arise. In situ demonstration is warranted in the future to ascertain the field applicability of this approach in real mariculture systems. Copyright © 2017 Elsevier B.V. All rights reserved.

Rheology measurements of a biomass slurry : an inter-laboratory study

Treesearch

Jonathan J. Stickel; Jeffrey S. Knutsen; Matthew W. Liberatore; Wing Luu; Douglas W. Bousfield; Daniel J. Klingenberg; Tim Scott; Thatcher W. Root; Max R. Ehrhardt; Thomas O. Monz

2009-01-01

The conversion of biomass, specifically lignocellulosic biomass, into fuels and chemicals has recently gained national attention as an alternative to the use of fossil fuels. Increasing the concentration of the biomass solids during biochemical conversion has a large potential to reduce production costs. These concentrated biomass slurries have highly viscous, non-...

Interactions of Neuromodulators with Cells of the Immune System

DTIC Science & Technology

1988-08-05

neuromodulators on non-neuronal cells. During the past year significant progress has been made in four inter-related areas: 1) The affects 4f ".orepinephrine on...of neuromodulators on non-neuronal cells. This laboratory is well equipped to undertake such studies since we also are involved in a large research

DNA Commission of the International Society for Forensic Genetics: Recommendations on the validation of software programs performing biostatistical calculations for forensic genetics applications.

PubMed

Coble, M D; Buckleton, J; Butler, J M; Egeland, T; Fimmers, R; Gill, P; Gusmão, L; Guttman, B; Krawczak, M; Morling, N; Parson, W; Pinto, N; Schneider, P M; Sherry, S T; Willuweit, S; Prinz, M

2016-11-01

The use of biostatistical software programs to assist in data interpretation and calculate likelihood ratios is essential to forensic geneticists and part of the daily case work flow for both kinship and DNA identification laboratories. Previous recommendations issued by the DNA Commission of the International Society for Forensic Genetics (ISFG) covered the application of bio-statistical evaluations for STR typing results in identification and kinship cases, and this is now being expanded to provide best practices regarding validation and verification of the software required for these calculations. With larger multiplexes, more complex mixtures, and increasing requests for extended family testing, laboratories are relying more than ever on specific software solutions and sufficient validation, training and extensive documentation are of upmost importance. Here, we present recommendations for the minimum requirements to validate bio-statistical software to be used in forensic genetics. We distinguish between developmental validation and the responsibilities of the software developer or provider, and the internal validation studies to be performed by the end user. Recommendations for the software provider address, for example, the documentation of the underlying models used by the software, validation data expectations, version control, implementation and training support, as well as continuity and user notifications. For the internal validations the recommendations include: creating a validation plan, requirements for the range of samples to be tested, Standard Operating Procedure development, and internal laboratory training and education. To ensure that all laboratories have access to a wide range of samples for validation and training purposes the ISFG DNA commission encourages collaborative studies and public repositories of STR typing results. Published by Elsevier Ireland Ltd.

Reliability and diagnostic validity of the slump knee bend neurodynamic test for upper/mid lumbar nerve root compression: a pilot study.

PubMed

Trainor, Kate; Pinnington, Mark A

2011-03-01

It has been proposed that neurodynamic examination can assist differential diagnosis of upper/mid lumbar nerve root compression; however, the diagnostic validity of many of these tests has yet to be established. This pilot study aimed to establish the diagnostic validity of the slump knee bend neurodynamic test for upper/mid lumbar nerve root compression in subjects with suspected lumbosacral radicular pain. Two independent examiners performed the slump knee bend test on subjects with radicular leg pain. Inter-tester reliability was calculated using the kappa coefficient. Slump knee bend test results were compared with magnetic resonance imaging findings, and diagnostic accuracy measures were calculated including sensitivity, specificity, predictive values and likelihood ratios. Orthopaedic spinal clinic, secondary care. Sixteen patients with radicular leg pain. All four subjects with mid lumbar nerve root compression on magnetic resonance imaging were correctly identified with the slump knee bend test; however, it was falsely positive in two individuals without the condition. Inter-tester reliability for the slump knee bend test using the kappa coefficient was 0.71 (95% confidence interval 0.33 to 1.0). Diagnostic validity calculations for the slump knee bend test (95% confidence intervals) were: sensitivity, 100% (40 to 100%); specificity, 83% (52 to 98%); positive predictive value, 67% (22 to 96%); negative predictive value, 100% (69 to 100%); positive likelihood ratio, 6.0 (1.58 to 19.4); and negative likelihood ratio, 0 (0 to 0.6). Results indicate good inter-tester reliability and suggest that the slump knee bend test has potential to be a useful clinical test for identifying patients with mid lumbar nerve root compression. Further investigation is needed on larger numbers of patients to confirm these findings. Copyright © 2010 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

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

PubMed Central

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

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 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. PMID:29434059

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

PubMed

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.

Inter-laboratory variation in the chemical analysis of acidic forest soil reference samples from eastern North America

Treesearch

D.S. Ross; S.W. Bailey; R.D. Briggs; J. Curry; I.J. Fernandez; G. Fredriksen; C.L. Goodale; P.W. Hazlett; P.R. Heine; C.E. Johnson; J.T. Larson; G.B. Lawrence; R.K. Kolka; R. Ouimet; D. Pare; D. deB Richter; C.D. Schirmer; R.A. Warby

2015-01-01

Long-term forest soil monitoring and research often requires a comparison of laboratory data generated at different times and in different laboratories. Quantifying the uncertainty associated with these analyses is necessary to assess temporal changes in soil properties. Forest soil chemical properties, and methods to measure these properties, often differ from...

Validation of an In Vitro Sun Protection Factor (SPF) method in blinded ring-testing.

PubMed

Pissavini, M; Tricaud, C; Wiener, G; Lauer, A; Contier, M; Kolbe, L; Trullás Cabanas, C; Boyer, F; Nollent, V; Meredith, E; Dietrich, E; Matts, P J

2018-04-20

The objective of this work was to investigate the utility of a new in vitro SPF test method in blinded ring-testing, against new ISO acceptance criteria. 24 blinded, commercial, emulsion-type, primary sunscreen products, covering the full range of labelled SPF in Europe (SPF6 - 50+), were tested by 3 test institutes using the current ISO24444:2010 In Vivo SPF Test Method and simultaneously by 3 separate test laboratories using a new candidate in vitro SPF test method, developed under the leadership of Cosmetics Europe (CE). The resulting relationship between in vitro SPF and in vivo SPF values was then compared with acceptance criteria developed recently by the International Standards (ISO) TC217 / WG7 Sun Protection Test Methods Working Group. Analysis of the mean inter-laboratory in vitro and mean inter-institute in vivo SPF values revealed a strong correlation between in vitro and in vivo values, with a Pearson correlation coefficient of r 2 =0.88 (p<0.0001), a slope of 1.01 and a non-significant intercept (-1.48; p=0.62). When these data were compared to the new ISO WG7 acceptance criteria, method bias was found to be extremely low and over 95% of the coupled data lay within the model "funnel" (defined by upper and lower confidence intervals). In conclusion, the results of blinded ring testing and comparison to new ISO WG7 acceptance criteria indicate that a new in vitro SPF test method meets (and exceeds) these minimum criteria and is an interesting candidate for possible deployment as an industry test methodology. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Psychometric validation of the Chinese version of the Johns Hopkins Fall Risk Assessment Tool for older Chinese inpatients.

PubMed

Zhang, Junhong; Wang, Min; Liu, Yu

2016-10-01

To culturally adapt and evaluate the reliability and validity of the Chinese version of the Johns Hopkins Fall Risk Assessment Tool among older inpatients in the mainland of China. Patient falls are an important safety consideration within hospitals among older inpatients. Nurses need specific risk assessment tools for older inpatients to reliably identify at-risk populations and guide interventions that highlight fixable risk factors for falls and consequent injuries. In China, a few tools have been developed to measure fall risk. However, they lack the solid psychometric development necessary to establish their validity and reliability, and they are not widely used for elderly inpatients. A cross-sectional study. A convenient sampling was used to recruit 201 older inpatients from two tertiary-level hospitals in Beijing and Xiamen, China. The Johns Hopkins Fall Risk Assessment Tool was translated using forward and backward translation procedures and was administered to these 201 older inpatients. Reliability of the tool was calculated by inter-rater reliability and Cronbach's alpha. Validity was analysed through content validity index and construct validity. The Inter-rater reliability of Chinese version of Johns Hopkins Fall Risk Assessment Tool was 97·14% agreement with Cohen's Kappa of 0·903. Cronbach's α was 0·703. Content of Validity Index was 0·833. Two factors represented intrinsic and extrinsic risk factors were explored that together explained 58·89% of the variance. This study provided evidence that Johns Hopkins Fall Risk Assessment Tool is an acceptable, valid and reliable tool to identify older inpatients at risk of falls and falls with injury. Further psychometric testing on criterion validity and evaluation of its advanced utility in geriatric clinical settings are warranted. The Chinese version of Johns Hopkins Fall Risk Assessment Tool may be useful for health care personnel to identify older Chinese inpatients at risk of falls and falls with injury. © 2016 John Wiley & Sons Ltd.

Development and initial evaluation of a reconstituted water formulation that better represents natural waters(poster)

EPA Science Inventory

The use of reconstituted waters is deeply entrenched in many standardized aquatic toxicity testing protocols The primary appeal of reconstituted waters is inter-laboratory comparability, such that experiments performed in different laboratories can be conducted in (nominally) id...

Development and Initial Evaluation of a Reconstituted Water Formulation that Better Represents Natural Waters

EPA Science Inventory

The use of reconstituted waters is deeply entrenched in many standardized aquatic toxicity testing protocols. The primary appeal of reconstituted waters is inter-laboratory comparability, such that experiments performed in different laboratories can be conducted in (nominally) id...

Measurement of cervical flexor endurance following whiplash.

PubMed

Kumbhare, Dinesh A; Balsor, Brad; Parkinson, William L; Harding Bsckin, Peter; Bedard, Michel; Papaioannou, Alexandra; Adachi, Jonathan D

2005-07-22

To investigate measurement properties of a practical test of cervical flexor endurance (CFE) in whiplash patients including inter-rater reliability, sensitivity to clinical change, criterion related validity against the Neck Disability Index (NDI), and discriminant validity for injured versus uninjured populations. Two samples were recruited, 81 whiplash patients, and a convenience sample of 160 subjects who were not seeking treatment and met criteria for normal pain and range of motion. CFE was measured using a stopwatch while the subject, in crook lying, held their head against gravity to fatigue. Inter-rater reliability in whiplash patients was in a range considered 'almost perfect' (Intraclass Correlation=0.96). CFE had greater inter-subject variability than the NDI or range of motion in any of three planes. However, the effect size for improvement in CFE over treatment was as large as the effect sizes for all of those measures. In multivariate regression, CFE changes accounted for changes on the NDI better than the three ranges of motion. CFE discriminated whiplash patients who were within six months of injury (n=71) from age and gender matched normals with high effect size (ES=1.5). These findings provide evidence of reliability and validity for CFE measurement, and demonstrate that CFE detects clinical improvements. Variance on CFE emphasizes the need to consider inter-, and intra-subject standard deviations to interpret scores.

Refinement and partial validation of the UNESP-Botucatu multidimensional composite pain scale for assessing postoperative pain in horses.

PubMed

Taffarel, Marilda Onghero; Luna, Stelio Pacca Loureiro; de Oliveira, Flavia Augusta; Cardoso, Guilherme Schiess; Alonso, Juliana de Moura; Pantoja, Jose Carlos; Brondani, Juliana Tabarelli; Love, Emma; Taylor, Polly; White, Kate; Murrell, Joanna C

2015-04-01

Quantification of pain plays a vital role in the diagnosis and management of pain in animals. In order to refine and validate an acute pain scale for horses a prospective, randomized, blinded study was conducted. Twenty-four client owned adult horses were recruited and allocated to one of four following groups: anaesthesia only (GA); pre-emptive analgesia and anaesthesia (GAA,); anaesthesia, castration and postoperative analgesia (GC); or pre-emptive analgesia, anaesthesia and castration (GCA). One investigator, unaware of the treatment group, assessed all horses at time-points before and after intervention and completed the pain scale. Videos were also obtained at these time-points and were evaluated by a further four blinded evaluators who also completed the scale. The data were used to investigate the relevance, specificity, criterion validity and inter- and intra-observer reliability of each item on the pain scale, and to evaluate construct validity and responsiveness of the scale. Construct validity was demonstrated by the observed differences in scores between the groups, four hours after anaesthetic recovery and before administration of systemic analgesia in the GC group. Inter- and intra-observer reliability for the items was only satisfactory. Subsequently the pain scale was refined, based on results for relevance, specificity and total item correlation. Scale refinement and exclusion of items that did not meet predefined requirements generated a selection of relevant pain behaviours in horses. After further validation for reliability, these may be used to evaluate pain under clinical and experimental conditions.

Motivational Interviewing Skills in Health Care Encounters (MISHCE): Development and psychometric testing of an assessment tool.

PubMed

Petrova, Tatjana; Kavookjian, Jan; Madson, Michael B; Dagley, John; Shannon, David; McDonough, Sharon K

2015-01-01

Motivational interviewing (MI) has demonstrated a significant impact as an intervention strategy for addiction management, change in lifestyle behaviors, and adherence to prescribed medication and other treatments. Key elements to studying MI include training in MI of professionals who will use it, assessment of skills acquisition in trainees, and the use of a validated skills assessment tool. The purpose of this research project was to develop a psychometrically valid and reliable tool that has been designed to assess MI skills competence in health care provider trainees. The goal was to develop an assessment tool that would evaluate the acquisition and use of specific MI skills and principles, as well as the quality of the patient-provider therapeutic alliance in brief health care encounters. To address this purpose, specific steps were followed, beginning with a literature review. This review contributed to the development of relevant conceptual and operational definitions, selecting a scaling technique and response format, and methods for analyzing validity and reliability. Internal consistency reliability was established on 88 video recorded interactions. The inter-rater and test-retest reliability were established using randomly selected 18 from the 88 interactions. The assessment tool Motivational Interviewing Skills for Health Care Encounters (MISHCE) and a manual for use of the tool were developed. Validity and reliability of MISHCE were examined. Face and content validity were supported with well-defined conceptual and operational definitions and feedback from an expert panel. Reliability was established through internal consistency, inter-rater reliability, and test-retest reliability. The overall internal consistency reliability (Cronbach's alpha) for all fifteen items was 0.75. MISHCE demonstrated good inter-rater reliability and good to excellent test-retest reliability. MISHCE assesses the health provider's level of knowledge and skills in brief disease management encounters. MISHCE also evaluates quality of the patient-provider therapeutic alliance, i.e., the "flow" of the interaction. Copyright © 2015 Elsevier Inc. All rights reserved.

The German Version of the Manchester Triage System and Its Quality Criteria – First Assessment of Validity and Reliability

PubMed Central

Gräff, Ingo; Goldschmidt, Bernd; Glien, Procula; Bogdanow, Manuela; Fimmers, Rolf; Hoeft, Andreas; Kim, Se-Chan; Grigutsch, Daniel

2014-01-01

Background The German Version of the Manchester Triage System (MTS) has found widespread use in EDs across German-speaking Europe. Studies about the quality criteria validity and reliability of the MTS currently only exist for the English-language version. Most importantly, the content of the German version differs from the English version with respect to presentation diagrams and change indicators, which have a significant impact on the category assigned. This investigation offers a preliminary assessment in terms of validity and inter-rater reliability of the German MTS. Methods Construct validity of assigned MTS level was assessed based on comparisons to hospitalization (general / intensive care), mortality, ED and hospital length of stay, level of prehospital care and number of invasive diagnostics. A sample of 45,469 patients was used. Inter-rater agreement between an expert and triage nurses (reliability) was calculated separately for a subset group of 167 emergency patients. Results For general hospital admission the area under the curve (AUC) of the receiver operating characteristic was 0.749; for admission to ICU it was 0.871. An examination of MTS-level and number of deceased patients showed that the higher the priority derived from MTS, the higher the number of deaths (p<0.0001 / χ2 Test). There was a substantial difference in the 30-day survival among the 5 MTS categories (p<0.0001 / log-rank test).The AUC for the predict 30-day mortality was 0.613. Categories orange and red had the highest numbers of heart catheter and endoscopy. Category red and orange were mostly accompanied by an emergency physician, whereas categories blue and green were walk-in patients. Inter-rater agreement between expert triage nurses was almost perfect (κ = 0.954). Conclusion The German version of the MTS is a reliable and valid instrument for a first assessment of emergency patients in the emergency department. PMID:24586477

Development of the lunar gravity field model GrazLGM300b in the framework of project GRAZIL

NASA Astrophysics Data System (ADS)

Krauss, Sandro; Klinger, Beate; Wirnsberger, Harald; Baur, Oliver; Mayer-Gürr, Torsten

2015-04-01

The objective of project GRAZIL is to compile a high-accurate gravity field model of the Moon based on measurements provided by the Gravity Recovery And Interior Laboratory (GRAIL) mission. In order to reach this goal we perform dynamic precise orbit determination from radio science observations (Doppler range-rates) in combination with the analysis of inter-satellite ranging observations. We present an updated version of the lunar gravity field models GrazLGM200a (Klinger et al. 2014; doi: 10.1016/j.pss.2013.12.001) and GrazLGM300a (prepared for the 2014 AGU Fall Meeting) derived from inter-satellite Ka-band ranging (KBR) observations collected by GRAIL during the primary mission phase (March 1 to May 29, 2012). We exploit the KBR data by an integral equation approach using short orbital arcs. The basic idea behind this technique is to reformulate Newton's equation of motion as a boundary value problem. In this contribution particular attention is paid to processing details associated with the error structure of the observations and the incorporation of non-gravitational accelerations (with emphasis on solar radiation pressure, lunar albedo and self-shadowing). We validate our results against recent GRAIL models computed at NASA-GSFC and NASA-JPL.

GaMin’11 – an international inter-laboratory comparison for geochemical CO₂ - saline fluid - mineral interaction experiments

DOE PAGES

Ostertag-Henning, C.; Risse, A.; Thomas, B.; ...

2014-12-31

Due to the strong interest in geochemical CO₂-fluid-rock interaction in the context of geological storage of CO₂ a growing number of research groups have used a variety of different experimental ways to identify important geochemical dissolution or precipitation reactions and – if possible – quantify the rates and extent of mineral or rock alteration. In this inter-laboratory comparison the gas-fluid-mineral reactions of three samples of rock-forming minerals have been investigated by 11 experimental labs. The reported results point to robust identification of the major processes in the experiments by most groups. The dissolution rates derived from the changes in compositionmore » of the aqueous phase are consistent overall, but the variation could be reduced by using similar corrections for changing parameters in the reaction cells over time. The comparison of experimental setups and procedures as well as of data corrections identified potential improvements for future gas-fluid-rock studies.« less

Validation on milk and sprouts of EN ISO 16654:2001 - Microbiology of food and animal feeding stuffs - Horizontal method for the detection of Escherichia coli O157.

PubMed

Tozzoli, Rosangela; Maugliani, Antonella; Michelacci, Valeria; Minelli, Fabio; Caprioli, Alfredo; Morabito, Stefano

2018-05-08

In 2006, the European Committee for standardisation (CEN)/Technical Committee 275 - Food analysis - Horizontal methods/Working Group 6 - Microbiology of the food chain (TC275/WG6), launched the project of validating the method ISO 16654:2001 for the detection of Escherichia coli O157 in foodstuff by the evaluation of its performance, in terms of sensitivity and specificity, through collaborative studies. Previously, a validation study had been conducted to assess the performance of the Method No 164 developed by the Nordic Committee for Food Analysis (NMKL), which aims at detecting E. coli O157 in food as well, and is based on a procedure equivalent to that of the ISO 16654:2001 standard. Therefore, CEN established that the validation data obtained for the NMKL Method 164 could be exploited for the ISO 16654:2001 validation project, integrated with new data obtained through two additional interlaboratory studies on milk and sprouts, run in the framework of the CEN mandate No. M381. The ISO 16654:2001 validation project was led by the European Union Reference Laboratory for Escherichia coli including VTEC (EURL-VTEC), which organized the collaborative validation study on milk in 2012 with 15 participating laboratories and that on sprouts in 2014, with 14 participating laboratories. In both studies, a total of 24 samples were tested by each laboratory. Test materials were spiked with different concentration of E. coli O157 and the 24 samples corresponded to eight replicates of three levels of contamination: zero, low and high spiking level. The results submitted by the participating laboratories were analyzed to evaluate the sensitivity and specificity of the ISO 16654:2001 method when applied to milk and sprouts. The performance characteristics calculated on the data of the collaborative validation studies run under the CEN mandate No. M381 returned sensitivity and specificity of 100% and 94.4%, respectively for the milk study. As for sprouts matrix, the sensitivity resulted in 75.9% in the low level of contamination samples and 96.4% in samples spiked with high level of E. coli O157 and specificity was calculated as 99.1%. Copyright © 2018 Elsevier B.V. All rights reserved.

National and international veterinary reference laboratories for infectious diseases.

PubMed

Edwards, S; Alexander, D

1998-08-01

Reference laboratories play an increasingly important role in the harmonisation of laboratory diagnostic tests and the standardisation of veterinary vaccines. This is particularly important in building confidence between international trading partners. The authors review aspects of the organisation, designation and support of reference laboratories for infectious diseases of animals and discuss the principal activities which such laboratories would normally perform. These activities include advice and consultancy, publications and communication, training, research, disease surveillance, maintenance of culture collections, evaluation of reference methods, preparation of reference materials and organisation of inter-laboratory comparisons.

All Together Now: Measuring Staff Cohesion in Special Education Classrooms

ERIC Educational Resources Information Center

Kratz, Hilary E.; Locke, Jill; Piotrowski, Zinnia; Ouellette, Rachel R.; Xie, Ming; Stahmer, Aubyn C.; Mandell, David S.

2015-01-01

This study sought to validate a new measure, the Classroom Cohesion Survey (CCS), designed to examine the relationship between teachers and classroom assistants in autism support classrooms. Teachers, classroom assistants, and external observers showed good inter-rater agreement on the CCS and good internal consistency for all scales. Simple…

All Together Now: Measuring Staff Cohesion in Special Education Classrooms

ERIC Educational Resources Information Center

Kratz, Hilary E.; Locke, Jill; Piotrowski, Zinnia; Ouellette, Rachel R.; Xie, Ming; Stahmer, Aubyn C.; Mandell, David S.

2014-01-01

This study sought to validate a new measure, the Classroom Cohesion Survey (CCS), designed to examine the relationship between teachers and classroom assistants in autism support classrooms. Teachers, classroom assistants, and external observers showed good inter-rater agreement on the CCS and good internal consistency for all scales. Simple…

Collaborative study for the standardisation of the histamine sensitizing test in mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines.

PubMed

Xing, D; Maes, A; Behr-Gross, M-E; Costanzo, A; Daas, A; Buchheit, K-H

2010-04-01

The European Pharmacopoeia (Ph. Eur.) and the World Health Organisation (WHO) require the performance of extensive quality and safety control testing before the release on the market of vaccine products for human use. Safety testing with regard to residual pertussis toxin (PT) in acellular pertussis combination vaccines is performed through assessment of fatal sensitisation of mice to histamine challenge by the vaccine product under test. Currently, use of different in-house procedures and no requirement for the inclusion of a standard reference in each assay render comparisons of results obtained for identical vaccine batches between different control laboratories very difficult. At the initiative of the European Directorate for the Quality of Medicines and HealthCare (EDQM), an international collaborative study was organised for the standardization of the Histamine Sensitizing Test (HIST) in mice and the Chinese Hamster Ovary (CHO)-cell-based assay (performed at the bulk product level) for the residual toxicity testing of acellular pertussis vaccines or acellular pertussis-based combination vaccines. The study was run under the aegis of the Biological Standardisation Programme, jointly supported by the Council of Europe and the European Commission under the project code BSP076. Ten (10) laboratories participated in the study and were requested to perform 3 independent Histamine Sensitizing Tests in mice and to report results of the lethal end-point measurement as prescribed by the Ph. Eur. monographs. Some of them also reported data from an in-house validated CHO-cell-based assay. In addition, some of the laboratories reported concomitantly data obtained by measurement of the drop in temperature induced after the histamine challenge, a method currently under investigation to be added as an alternative end-point for the HIST in the Ph. Eur. monographs for acellular pertussis-based combination vaccines in order to alleviate animal suffering (in application of the 3Rs principle). Based on the results of the collaborative study, a potency of 7500 IU/vial (International Units per vial) was assigned to the current Ph. Eur. Biological Reference Preparation (BRP) for PT. The results of the study also show that 1) intra- and inter-laboratory variations can be improved by the use of a validated standard operating procedure; 2) inclusion in each assay of a standard reference sample, calibrated in IU, can increase comparability of results among laboratories and thus help to reduce repeat testing; 3) a correlation between mortality data and temperature data was observed although, due to the limited number of data sets and the lack of a common method for the temperature end-point, further investigation of this point is required; 4) the CHO-cell-based assay did not yield comparable results and further standardisation of the assay procedure may be investigated in a follow-up project.

Validity of Using Tri-Axial Accelerometers to Measure Human Movement – Part II: Step Counts at a Wide Range of Gait Velocities

PubMed Central

Fortune, Emma; Lugade, Vipul; Morrow, Melissa; Kaufman, Kenton

2014-01-01

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 m/s to 4.8 m/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. PMID:24656871

Validity of using tri-axial accelerometers to measure human movement - Part II: Step counts at a wide range of gait velocities.

PubMed

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 reliability and validity of measurements of human dental casts made by an intra-oral 3D scanner, with conventional hand-held digital callipers as the comparison measure.

PubMed

Rajshekar, Mithun; Julian, Roberta; Williams, Anne-Marie; Tennant, Marc; Forrest, Alex; Walsh, Laurence J; Wilson, Gary; Blizzard, Leigh

2017-09-01

Intra-oral 3D scanning of dentitions has the potential to provide a fast, accurate and non-invasive method of recording dental information. The aim of this study was to assess the reliability of measurements of human dental casts made using a portable intra-oral 3D scanner appropriate for field use. Two examiners each measured 84 tooth and 26 arch features of 50 sets of upper and lower human dental casts using digital hand-held callipers, and secondly using the measuring tool provided with the Zfx IntraScan intraoral 3D scanner applied to the virtual dental casts. The measurements were repeated at least one week later. Reliability and validity were quantified concurrently by calculation of intra-class correlation coefficients (ICC) and standard errors of measurement (SEM). The measurements of the 110 landmark features of human dental casts made using the intra-oral 3D scanner were virtually indistinguishable from measurements of the same features made using conventional hand-held callipers. The difference of means as a percentage of the average of the measurements by each method ranged between 0.030% and 1.134%. The intermethod SEMs ranged between 0.037% and 0.535%, and the inter-method ICCs ranged between 0.904 and 0.999, for both the upper and the lower arches. The inter-rater SEMs were one-half and the intra-method/rater SEMs were one-third of the inter-method values. This study demonstrates that the Zfx IntraScan intra-oral 3D scanner with its virtual on-screen measuring tool is a reliable and valid method for measuring the key features of dental casts. Copyright © 2017 Elsevier B.V. All rights reserved.

The ICI classification for calcaneal injuries: a validation study.

PubMed

Frima, Herman; Eshuis, Rienk; Mulder, Paul; Leenen, Luke

2012-06-01

The integral classification of injuries (ICI), by Zwipp et al. has been developed as a classification system for injuries of the bones, joints, cartilage and ligaments of the foot. It follows the principles of the comprehensive classification of fractures by Müller et al. The ICI was developed for 'everyday use' and scientific purposes. Our aim was to perform a validation study for this classification system applied to the calcaneal injuries. A panel of five experienced trauma and orthopaedic surgeons evaluated the ICI score in 20 calcaneal injuries. After 2 months, a second classification was performed in a different order. Inter- and intra-observer variability were evaluated by kappa statistics. Panel members were not able to evaluate capsule and ligamental injuries based on X-ray and computed tomography (CT) films. Two injuries were excluded for logistical reasons. The inter-observer agreement based on 18 injuries of bone and joints was slight; kappa 0.14 (90% confidence interval (CI): 0.05-0.22). The intra-observer agreement was fair; kappa 0.31 (90% CI: 0.22-0.41). Overall, the panel rated the system as very complicated and not practical. The ICI is a complicated classification system with slight to fair inter- and intra-observer variabilities. It might not be a practical classification system for calcaneal injuries in 'everyday use' or scientific purposes. Copyright © 2011 Elsevier Ltd. All rights reserved.

Reliability and concurrent validity of a new iPhone® goniometric application for measuring active wrist range of motion: a cross-sectional study in asymptomatic subjects.

PubMed

Pourahmadi, Mohammad Reza; Ebrahimi Takamjani, Ismail; Sarrafzadeh, Javad; Bahramian, Mehrdad; Mohseni-Bandpei, Mohammad Ali; Rajabzadeh, Fatemeh; Taghipour, Morteza

2017-03-01

Measurement of wrist range of motion (ROM) is often considered to be an essential component of wrist physical examination. The measurement can be carried out through various instruments such as goniometers and inclinometers. Recent smartphones have been equipped with accelerometers and magnetometers, which, through specific software applications (apps) can be used for goniometric functions. This study, for the first time, aimed to evaluate the reliability and concurrent validity of a new smartphone goniometric app (Goniometer Pro©) for measuring active wrist ROM. In all, 120 wrists of 70 asymptomatic adults (38 men and 32 women; aged 18-40 years) were assessed in a physiotherapy clinic located at the School of Rehabilitation Sciences, Iran University of Medical Science and Health Services, Tehran, Iran. Following the recruitment process, active wrist ROM was measured using a universal goniometer and iPhone ® 5 app. Two blinded examiners each utilized the universal goniometer and iPhone ® to measure active wrist ROM using a volar/dorsal alignment technique in the following sequences: flexion, extension, radial deviation, and ulnar deviation. The second (2 h later) and third (48 h later) sessions were carried out in the same manner as the first session. All the measurements were conducted three times and the mean value of three repetitions for each measurement was used for analysis. Intraclass correlation coefficient (ICC) models (3, k) and (2, k) were used to determine the intra-rater and inter-rater reliability, respectively. The Pearson correlation coefficients were used to establish concurrent validity of the iPhone ® app. Good to excellent intra-rater and inter-rater reliability was demonstrated for the goniometer with ICC values of ≥ 0.82 and ≥ 0.73 and the iPhone ® app with ICC values of ≥ 0.83 and ≥ 0.79, respectively. Minimum detectable change at the 95% confidence level (MDC 95 ) was computed as 1.96 × standard error of measurement × √2. The MDC 95 ranged from 1.66° to 5.35° for the intra-rater analysis and from 1.97° to 6.15° for the inter-rater analysis. The concurrent validity between the two instruments was high, with r values of ≥ 0.80. From the results of this cross-sectional study, it can be concluded that the iPhone ® app possesses good to excellent intra-rater and inter-rater reliability and concurrent validity. It seems that this app can be used for the measurement of wrist ROM. However, further research is needed to evaluate symptomatic subjects using this app. © 2016 Anatomical Society.

Reliability and validity of the Korean version of the community balance and mobility scale in patients with hemiplegia after stroke

PubMed Central

Lee, Kyoung-bo; Lee, Paul; Yoo, Sang-won; Kim, Young-dong

2016-01-01

[Purpose] The aim of this study was to translate and adapt the Community Balance and Mobility Scale (CB&M) into Korean (K-CB&M) and to verify the reliability and validity of scores obtained with Korean patients. [Subjects and Methods] A total of 16 subjects were recruited from St. Vincent’s Hospital in South Korea. At each testing session, subjects completed the K-CB&M, Berg balance scale (BBS), timed up and go test (TUG), and functional reaching test. All tests were administered by a physical therapist, and subjects completed the tests in an identical standardized order during all testing sessions. [Results] The inter- and intra-rater reliability coefficients were high for most subscores, while moderate inter-rater reliability was observed for the items “walking and looking” and “walk, look, and carry”, and moderate intra-rater reliability was observed for “forward to backward walking”. There was a positive correlation between the K-CB&M and BBS and a negative correlation between the K-CB&M and TUG in the convergent validity assessments. [Conclusion] The reliability and validity of the K-CB&M was high, suggesting that clinical practitioners treating Korean patients with hemiplegia can use this material for assessing static and dynamic balance. PMID:27630420

Inter-rater and intra-rater reliability of a movement control test in shoulder.

PubMed

Rajasekar, S; Bangera, Rakshith K; Sekaran, Padmanaban

2017-07-01

Movement faults are commonly observed in patients with musculoskeletal pain. The Kinetic Medial Rotation Test (KMRT) is a movement control test used to identify movement faults of the scapula and gleno-humeral joints during arm movement. Objective tests such as the KMRT need to be reliable and valid for the results to be applied across different clinical settings and patient populations. The primary objective of the present study was to determine the intra-rater and inter-rater reliability of KMRT in subjects with and without shoulder pain. Sixty subjects were included in this study based on specific inclusion and exclusion criteria. Two musculoskeletal physiotherapists with different levels of clinical experience performed the tests. The intra-rater reliability was tested in twenty asymptomatic subjects by a single assessor at two week intervals. An equal number of subjects with and without shoulder pain were tested by both the assessors to determine the inter-rater reliability. Both components of the KMRT, the Gleno- Humeral Anterior Translation (GHAT) and the Scapular Forward Tilt (SCFT) were tested. The Kappa values for inter-rater reliability of the GHAT and SCFT were K = 0.68 & K = 0.65 respectively in subjects with shoulder pain. In asymptomatic subjects, the inter-rater reliability of GHAT was K = 0.61 and SCFT was K = 0.85. Intra-rater reliability ranged from K = 0.66 for GHAT to K = 0.87 for SCFT. Our study found substantial agreement in inter-rater reliability of KMRT in subjects with shoulder pain, whereas substantial to near perfect agreement was found in intra-rater and inter-rater reliability of KMRT in subjects without shoulder pain. Copyright © 2017 Elsevier Ltd. All rights reserved.

Inter-arm blood pressure difference in type 2 diabetes: a barrier to effective management?

PubMed Central

Clark, Christopher E; Greaves, Colin J; Evans, Philip H; Dickens, Andy; Campbell, John L

2009-01-01

Background Previous studies have identified a substantial prevalence of a blood pressure difference between arms in various populations, but not patients with type 2 diabetes. Recognition of such a difference would be important as a potential cause of underestimation of blood pressure. Aim To measure prevalence of an inter-arm blood pressure difference in patients with type 2 diabetes, and to estimate how frequently blood pressure measurements could be erroneously underestimated if an inter-arm difference is unrecognised. Design of study Cross-sectional study. Setting Five surgeries covered by three general practices, Devon, England. Method Patients with type 2 diabetes underwent bilateral simultaneous blood pressure measurements using a validated protocol. Mean blood pressures were calculated for each arm to derive mean systolic and diastolic differences, and to estimate point prevalence of predefined magnitudes of difference. Results A total of 101 participants were recruited. Mean age was 66 years (standard deviation [SD] = 13.9 years); 59% were male, and mean blood pressure was 138/79 mmHg (SD = 15/10 mmHg). Ten participants (10%; 95% confidence interval [CI] = 4 to 16) had a systolic inter-arm difference ≥10 mmHg; 29 (29%; 95% CI = 20 to 38) had a diastolic difference ≥5 mmHg; and three (3%; 95% CI = 0 to 6) a diastolic difference ≥10 mmHg. No confounding variable was observed to account for the magnitude of an inter-arm difference. Conclusion A systolic inter-arm difference ≥10 mmHg was observed in 10% of patients with diabetes. Failure to recognise this would misclassify half of these as normotensive rather than hypertensive using the lower-reading arm. New patients with type 2 diabetes should be screened for an inter-arm blood pressure difference. PMID:19520026

Architectural Specialization for Inter-Iteration Loop Dependence Patterns

DTIC Science & Technology

2015-10-01

Architectural Specialization for Inter-Iteration Loop Dependence Patterns Christopher Batten Computer Systems Laboratory School of Electrical and...Trends in Computer Architecture Transistors (Thousands) Frequency (MHz) Typical Power (W) MIPS R2K Intel P4 DEC Alpha 21264 Data collected by M...T as ks p er Jo ule ) Simple Processor Design Power Constraint High-Performance Architectures Embedded Architectures Design Performance

Validation of an ELISA Synthetic Cannabinoids Urine Assay

PubMed Central

Barnes, Allan J.; Spinelli, Eliani; Young, Sheena; Martin, Thomas M.; Klette, Kevin L.; Huestis, Marilyn A.

2015-01-01

Background Synthetic cannabinoids are touted as legal alternatives to cannabis, at least when first released, and routine urine cannabinoid screening methods do not detect these novel psychoactive substances. Synthetic cannabinoids are widely available, are a major public health and safety problem, and a difficult challenge for drug testing laboratories. We evaluated performance of the NMS JWH-018 direct ELISA kit to sensitively, selectively, and rapidly screen urinary synthetic cannabinoids. Materials/ Methods The NMS ELISA kit targeting the JWH-018 N-(5-hydroxypentyl) metabolite was utilized to screen 2492 urine samples with 5 and 10µg/L cutoffs. A fully validated LC-MS/MS method for 29 synthetic cannabinoids markers confirmed all presumptive positive and negative results. Performance challenges at ±25 and ±50% of cutoffs determined intra- and inter-plate imprecision around proposed cutoffs. Result The immunoassay was linear from 1–500µg/L with intra- and inter-plate imprecision of ≤8.2% and <14.0%, respectively. No interferences were present from 93 common drugs of abuse, metabolites, co-administered drugs, over-the-counter medications or structurally similar compounds, and 19 of 73 individual, synthetic cannabinoids (26%) exhibited moderate to high cross-reactivity to JWH-018 N-(5-hydroxypentyl) metabolite. Sensitivity, specificity, and efficiency results were 83.7%, 99.4% and 97.6% and 71.6%, 99.7% and 96.4%, with the 5 and 10µg/L urine cutoffs, respectively. Conclusion This high throughput immunoassay exhibited good diagnostic efficiency and documented that the NMS JWH-018 direct ELISA is a viable method for screening synthetic cannabinoids in urine targeting the JWH-018 N-(5-hydroxypentyl) and related analytes. Optimal performance was achieved with a matrix-matched 5µg/L urine cutoff. PMID:25706046

Inter-lab proteomics: data mining in collaborative projects on the basis of the HUPO brain proteome project's pilot studies.

PubMed

Hamacher, Michael; Gröttrup, Bernd; Eisenacher, Martin; Marcus, Katrin; Park, Young Mok; Meyer, Helmut E; Kwon, Kyung-Hoon; Stephan, Christian

2011-01-01

Several projects were initiated by the Human Proteome Organisation (HUPO) focusing on the proteome analysis of distinct human organs. The initiative dedicated to the brain, its development and correlated diseases is the HUPO Brain Proteome Project (HUPO BPP). An objective data submission, storage, and reprocessing strategy have been established with the help of the results gained in a pilot study phase and within subsequent studies. The bioinformatic relevance of the data is drawn from the inter-laboratory comparisons as well as from the recalculation of all data sets submitted by the different groups. In the following, results of the single groups as well as the centralised reprocessing effort are summarised, demonstrating the added-value of this concerted work.

Validation of the Hindi version of National Institute of Health Stroke Scale.

PubMed

Prasad, Kameshwar; Dash, Deepa; Kumar, Amit

2012-01-01

To determine the reliability and validity of the National Institute of Health Stroke Scale (NIHSS) with the Hindi and Indian adaptation of items 9 and 10. NIHSS items 9 and 10 were modified and culturally adapted at All India Institute of Medical Sciences (AIIMS) and the resulting version was termed as Hindi version (HV-NIHSS). HV-NIHSS was applied by two independent investigators on 107 patients with stroke. Inter-observer agreement and intra-class correlation coefficients were calculated. The predictive validity of the HV-NIHSS was calculated using functional outcome after three months in the form of modified Rankin Scale (mRS) and Barthel Index (BI). The study included 107 patients of stroke recruited from a tertiary referral hospital at Delhi between November 1, 2009, and October 1, 2010; the mean age of these patients was 56.26±13.84 years and 65.4% of them had suffered ischemic stroke. Inter-rater reliability was high between the two examiners, with Pearson's r ranging from 0.72 to 0.99 for the 15 items on the Scale. Intra-class correlation coefficient for the total score was 0.995 (95% CI-0.993-0.997). Concurrent construct validity was established between HV-NIHSS and baseline Glasgow Coma Scale, with a high correlation (Spearman coefficient = -0.863, P<.001). Predictive validity was also established with BI at three months (Spearman's rho: -0.829, P<.001) and with mRS at three months (Spearman's rho: 0.851, P<0.001). This study shows that a Hindi language version of the NIHSS developed at AIIMS appears reliable and valid when applied to a Hindi-speaking population.

Reliability and validity of the Turkish version of the Berg Balance Scale.

PubMed

Sahin, Fusun; Yilmaz, Figen; Ozmaden, Asli; Kotevolu, Nurdan; Sahin, Tulay; Kuran, Banu

2008-01-01

The purpose of this study was to develop a Turkish version of the Berg Balance Scale (BBS) and assess its reliability and validity. Sixty healthy volunteers older than 65 years were included in to the study. Subjects who had lower extremity amputation, or were armchair or bedridden were excluded. After translation process, the Turkish version of the scale was administered to each participant twice with an interval of 2 weeks. The intraclass correlation coefficient (ICC) was calculated to assess intra- and inter-observer reliability. Chronbach alpha was calculated to evaluate internal consistency of the total BBS score. Interclass correlation coefficient was calcuated to examine test-retest reliability. Convergent validity was assessed by correlating the scale with Modified Barthel Index (MBI) and Timed Up and Go Test (TUG). Construct validity was assessed with factor analysis. The mean age in years of the participants were 77.00+/-5.67 (range: 67-92 yrs). The ICC for intra- and inter- observer reliability was 0.98 (p<0.0001) and 0.97 (p<0.0001), respectively. Chronbach alpha of the Turkish version of the BBS was 0.98. The test-retest reliability (ICC) of the Turkish version of the BBS was determined as 0.98 for the total score, and ranged from 0.86-0.99 for individual items. In terms of validity, the Turkish version of the BBS was correlated with the MBI (in positive direction) and TUG (in negative direction) (r=0.67 p<0.0001; r=-0.75 p<0.0001, respectively). The Turkish version of the BBS is a reliable and valid scale to be used in balance assessment of Turkish older adults.

[Reliability and Validity of the Behavioral Check List for Preschool Children to Measure Attention Deficit Hyperactivity Behaviors].

PubMed

Tsuno, Kanami; Yoshimasu, Kouichi; Hayashi, Takashi; Tatsuta, Nozomi; Ito, Yuki; Kamijima, Michihiro; Nakai, Kunihiko

2018-01-01

Nowadays, attention deficit hyperactivity (ADH) problems are observed commonly among school-age children. However, questionnaires specific to ADH behaviors among preschool children are very few. The aim of this study was to investigate the reliability and validity of the 25-item Behavioral Check List (BCL), which was developed from interviews of parents with children who were diagnosed as having Attention-deficit/hyperactivity disorder (ADHD) and measures ADH behaviors in preschool age. We recruited 22 teachers from 10 nurseries/kindergartens in Miyagi Prefecture, Japan. A total of 138 preschool children were assessed using the BCL. To investigate inter-rater reliability, two teachers from each facility assess seven to twenty children in their class, and intraclass correlation coefficients (ICCs) were calculated. The teachers additionally answered questions in the 1/5-5 Caregiver-Teacher Report Form (C-TRF) to investigate the criterion validity of the BCL. To investigate structural validity, exploratory factor analysis with promax rotation and confirmatory factor analysis were performed. The internal consistency reliability of the BCL was good (α = 0.92) and correlation analyses also confirmed its excellent criterion validity. Although exploratory factor analysis for the BCL yielded a five-factor model that consisted of a factor structure different from that of the original one, the results were similar to the original six factors. The ICCs of the BCL were 0.38-0.99 and it was not high enough for inter-rater reliability in some facilities. However, there is a possibility to improve it by giving raters adequate explanations when using BCL. The present study showed acceptable levels of reliability and validity of the BCL among Japanese preschool children.

Analysis of Thiodiglycol: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS777

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

Owens, J; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for the analysis of thiodiglycol, the breakdown product of the sulfur mustard HD, in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS777 (hereafter referred to as EPA CRL SOP MS777). This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to verifymore » the analytical procedures described in MS777 for analysis of thiodiglycol in aqueous samples. The gathered data from this study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS777 can be determined.« less

Development and assessment of a digital X-ray software tool to determine vertebral rotation in adolescent idiopathic scoliosis.

PubMed

Eijgenraam, Susanne M; Boselie, Toon F M; Sieben, Judith M; Bastiaenen, Caroline H G; Willems, Paul C; Arts, Jacobus J; Lataster, Arno

2017-02-01

The amount of vertebral rotation in the axial plane is of key importance in the prognosis and treatment of adolescent idiopathic scoliosis (AIS). Current methods to determine vertebral rotation are either designed for use in analogue plain radiographs and not useful in digital images, or lack measurement precision and are therefore less suitable for the follow-up of rotation in AIS patients. This study aimed to develop a digital X-ray software tool with high measurement precision to determine vertebral rotation in AIS, and to assess its (concurrent) validity and reliability. In this study a combination of basic science and reliability methodology applied in both laboratory and clinical settings was used. Software was developed using the algorithm of the Perdriolle torsion meter for analogue AP plain radiographs of the spine. Software was then assessed for (1) concurrent validity and (2) intra- and interobserver reliability. Plain radiographs of both human cadaver vertebrae and outpatient AIS patients were used. Concurrent validity was measured by two independent observers, both experienced in the assessment of plain radiographs. Reliability-measurements were performed by three independent spine surgeons. Pearson correlation of the software compared with the analogue Perdriolle torsion meter for mid-thoracic vertebrae was 0.98, for low-thoracic vertebrae 0.97 and for lumbar vertebrae 0.97. Measurement exactness of the software was within 5° in 62% of cases and within 10° in 97% of cases. Intraclass correlation coefficient (ICC) for inter-observer reliability was 0.92 (0.91-0.95), ICC for intra-observer reliability was 0.96 (0.94-0.97). We developed a digital X-ray software tool to determine vertebral rotation in AIS with a substantial concurrent validity and reliability, which may be useful for the follow-up of vertebral rotation in AIS patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Good Laboratory Practice. Part 1. An Introduction

ERIC Educational Resources Information Center

Wedlich, Richard C.; Libera, Agata E.; Pires, Amanda; Therrien, Matthew T.

2013-01-01

The Good Laboratory Practice (GLP) regulations were put into place in 1978. They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the U.S. Food and Drug Administration (FDA) are valid and that the study report accurately reflects the conduct of the study. While the GLP regulations promulgate…

The TiltMeter app is a novel and accurate measurement tool for the weight bearing lunge test.

PubMed

Williams, Cylie M; Caserta, Antoni J; Haines, Terry P

2013-09-01

The weight bearing lunge test is increasing being used by health care clinicians who treat lower limb and foot pathology. This measure is commonly established accurately and reliably with the use of expensive equipment. This study aims to compare the digital inclinometer with a free app, TiltMeter on an Apple iPhone. This was an intra-rater and inter-rater reliability study. Two raters (novice and experienced) conducted the measurements in both a bent knee and straight leg position to determine the intra-rater and inter-rater reliability. Concurrent validity was also established. Allied health practitioners were recruited as participants from the workplace. A preconditioning stretch was conducted and the ankle range of motion was established with the weight bearing lunge test position with firstly the leg straight and secondly with the knee bent. The measurement device and each participant were randomised during measurement. The intra-rater reliability and inter-rater reliability for the devices and in both positions were all over ICC 0.8 except for one intra-rater measure (Digital inclinometer, novice, ICC 0.65). The inter-rater reliability between the digital inclinometer and the tilmeter was near perfect, ICC 0.96 (CI: 0.898-0.983); Concurrent validity ICC between the two devices was 0.83 (CI: -0.740 to 0.445). The use of the Tiltmeter app on the iPhone is a reliable and inexpensive tool to measure the available ankle range of motion. Health practitioners should use caution in applying these findings to other smart phone equipment if surface areas are not comparable. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

[Inter-laboratory reproducibility of pulsed-field electrophoresis for the study of 12 types of Pseudomonas aeruginosa].

PubMed

Foissaud, V; Puyhardy, J M; Chapalain, J C; Salord, H; Depina, J J; Morillon, M; Nicolas, P; Perrier-Gros-Claude, J D

1999-12-01

The increasing hospital-to-hospital transmission of multiple drug-resistant bacteria is a major concern for bacteriology laboratories involved in nosocomial infection control. The interlaboratory reproducibility of pulsed-field gel electrophoresis (PFGE) for Pseudomonas aeruginosa typing was evaluated by asking four hospital laboratories (two in Lyon, one in Brest, and one in Marseille) to study 11 P. aeruginosa isolates, some of which were epidemiologically related, and the reference strain ATCC 27853. Two laboratories used the Genepath system, one the Chef DR II, system, and one the Chef Mapper system, Bio-Rad, restriction/Spe I. Profiles were read visually and by computerized comparison of restriction band molecular weights (Taxotron, software, PAD Grimont, Pasteur Institute, Paris, France). These two methods led to similar epidemiological conclusions. However, centralization of the data showed poor center-to-center reproducibility due to inadequate standardization of the procedure.

[Validation of the Montgomery-Åsberg Depression Rating Scale (MADRS) in Colombia].

PubMed

Cano, Juan Fernando; Gomez Restrepo, Carlos; Rondón, Martín

2016-01-01

To adapt and to validate the Montgomery-Åsberg Depression Rating Scale (MADRS) in Colombia. Observational study for scale validation. Validity criteria were used to determine the severity cut-off points of the tool. Taking into account sensitivity and specificity values, those cut points were contrasted with ICD-10 criteria for depression severity. A a factor analysis was performed. The internal consistencY was determined with the same sample of patients used for the validity criteria. Inter-rater reliability was assessed by evaluating the 22 records of the patients that consented to a video interview. Sensitivity to change was established through a second application of the scale in 28 subjects after a lapse of 14 to 28 days. The study was performed in Bogotá, the tool was applied in 150 patients suffering from major depressive disorder. The cut-off point for moderate depression was 20 (sensitivity, 98%; specificity, 96%), and the cut-off point for severe depression was 34 (sensitivity, 98%; specificity, 92%). The tool appears as a unidimensional scale, which possesses a good internal consistency with (α=.9168). The findings of inter-rater reliability evaluation showed the scale as highly reliable (intraclass correlation coefficient=.9833). The instrument has a good sensitivity to change. The Colombian version of the Montgomery-Åsberg Depression Rating Scale has good psychometric properties and can be used in clinical practice and in clinical research in the field of depressive disorder. Copyright © 2015 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study.

PubMed

Corner, E J; Wood, H; Englebretsen, C; Thomas, A; Grant, R L; Nikoletou, D; Soni, N

2013-03-01

To develop a scoring system to measure physical morbidity in critical care - the Chelsea Critical Care Physical Assessment Tool (CPAx). The development process was iterative involving content validity indices (CVI), a focus group and an observational study of 33 patients to test construct validity against the Medical Research Council score for muscle strength, peak cough flow, Australian Therapy Outcome Measures score, Glasgow Coma Scale score, Bloomsbury sedation score, Sequential Organ Failure Assessment score, Short Form 36 (SF-36) score, days of mechanical ventilation and inter-rater reliability. Trauma and general critical care patients from two London teaching hospitals. Users of the CPAx felt that it possessed content validity, giving a final CVI of 1.00 (P<0.05). Construct validation data showed moderate to strong significant correlations between the CPAx score and all secondary measures, apart from the mental component of the SF-36 which demonstrated weak correlation with the CPAx score (r=0.024, P=0.720). Reliability testing showed internal consistency of α=0.798 and inter-rater reliability of κ=0.988 (95% confidence interval 0.791 to 1.000) between five raters. This pilot work supports proof of concept of the CPAx as a measure of physical morbidity in the critical care population, and is a cogent argument for further investigation of the scoring system. Copyright © 2012 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

How can we reduce costs of solid-phase multiplex-bead assays used to determine anti-HLA antibodies?

PubMed

Kamburova, E G; Wisse, B W; Joosten, I; Allebes, W A; van der Meer, A; Hilbrands, L B; Baas, M C; Spierings, E; Hack, C E; van Reekum, F E; van Zuilen, A D; Verhaar, M; Bots, M L; Drop, A C A D; Plaisier, L; Seelen, M A J; Sanders, J S F; Hepkema, B G; Lambeck, A J; Bungener, L B; Roozendaal, C; Tilanus, M G J; Vanderlocht, J; Voorter, C E; Wieten, L; van Duijnhoven, E M; Gelens, M; Christiaans, M H L; van Ittersum, F J; Nurmohamed, A; Lardy, N M; Swelsen, W; van der Pant, K A; van der Weerd, N C; Ten Berge, I J M; Bemelman, F J; Hoitsma, A; van der Boog, P J M; de Fijter, J W; Betjes, M G H; Heidt, S; Roelen, D L; Claas, F H; Otten, H G

2016-09-01

Solid-phase multiplex-bead assays are widely used in transplantation to detect anti-human leukocyte antigen (HLA) antibodies. These assays enable high resolution detection of low levels of HLA antibodies. However, multiplex-bead assays are costly and yield variable measurements that limit the comparison of results between laboratories. In the context of a Dutch national Consortium study we aimed to determine the inter-assay and inter-machine variability of multiplex-bead assays, and we assessed how to reduce the assay reagents costs. Fifteen sera containing a variety of HLA antibodies were used yielding in total 7092 median fluorescence intensities (MFI) values. The inter-assay and inter-machine mean absolute relative differences (MARD) of the screening assay were 12% and 13%, respectively. The single antigen bead (SAB) inter-assay MARD was comparable, but showed a higher lot-to-lot variability. Reduction of screening assay reagents to 50% or 40% of manufacturers' recommendations resulted in MFI values comparable to 100% of the reagents, with an MARD of 12% or 14%, respectively. The MARD of the 50% and 40% SAB assay reagent reductions were 11% and 22%, respectively. From this study, we conclude that the reagents can be reliably reduced at least to 50% of manufacturers' recommendations with virtually no differences in HLA antibody assignments. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Inter-laboratory quality control for hormone-dependent gene expression in human breast tumors using real-time reverse transcription-polymerase chain reaction.

PubMed

de Cremoux, P; Bieche, I; Tran-Perennou, C; Vignaud, S; Boudou, E; Asselain, B; Lidereau, R; Magdelénat, H; Becette, V; Sigal-Zafrani, B; Spyratos, F

2004-09-01

Quantitative reverse transcription-polymerase chain reaction (RT-PCR) used to detect minor changes in specific mRNA concentrations may be associated with poor reproducibility. Stringent quality control is therefore essential at each step of the protocol, including the PCR procedure. We performed inter-laboratory quality control of quantitative PCR between two independent laboratories, using in-house RT-PCR assays on a series of hormone-related target genes in a retrospective consecutive series of 79 breast tumors. Total RNA was reverse transcribed in a single center. Calibration curves were performed for five target genes (estrogen receptor (ER)alpha, ERbeta, progesterone receptor (PR), CYP19 (aromatase) and Ki 67) and for two reference genes (human acidic ribosomal phosphoprotein PO (RPLPO) and TATA box-binding protein (TBP)). Amplification efficiencies of the calibrator were determined for each run and used to calculate mRNA expression. Correlation coefficients were evaluated for each target and each reference gene. A good correlation was observed for all target and reference genes in both centers using their own protocols and kits (P < 0.0001). The correlation coefficients ranged from 0.90 to 0.98 for the various target genes in the two centers. A good correlation was observed between the level of expression of the ERalpha and the PR transcripts (P < 0.001). A weak inverse correlation was observed in both centers between ERalpha and ERbeta levels, but only when TBP was the reference gene. No other correlation was observed with other parameters. Real-time PCR assays allow convenient quantification of target mRNA transcripts and quantification of target-derived nucleic acids in clinical specimens. This study addresses the importance of inter-laboratory quality controls for the use of a panel of real-time PCR assays devoted to clinical samples and protocols and to ensure their appropriate accuracy. This can also facilitate exchanges and multicenter comparison of data.

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

PubMed

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.

An inter-laboratory study on the variability in measured concentrations of 17Beta-estradiol, testosterone and 11-ketotestosterone in white sucker: implications and recommendations

EPA Science Inventory

Endocrine-disrupting chemicals (EDCs) are exogenous substances that can lead to impacts on the reproduction of fish sometimes by altering circulating concentrations of 17â-estradiol (E2), testosterone (T) and 11-ketotestosterone (11-KT). Common methods to measure steroids in pla...

Inter-lab testing of Hyalella azteca water and sediment methods: 1 Summary of 10- to 42-d data from 25 laboratories

EPA Science Inventory

Over the past four years, USEPA Duluth, USGS Columbia, the Illinois Natural History Survey, and Environment Canada have been conducting studies to refine the USEPA and ASTM International methods for conducting 10- to 42-d water or sediment toxicity exposures with the amphipod Hya...

The Consequences of Failing to Imitate.

ERIC Educational Resources Information Center

Richman, Charles L.; And Others

This demonstration study examines the affective reactions of infants when they imitate or fail to imitate play behavior modeled by an adult. Subjects were twenty-four 18-month-old and twenty-four 24-month-old male and female infants. Each infant visited the laboratory twice with an inter-session interval of 48 hours. At each session, the infant…

Evaluation of cross-connected waveguides as transfer standards of transmission at high millimetre-wave frequencies

NASA Astrophysics Data System (ADS)

Ridler, Nick; Clarke, Roland; Huang, Hui; Zinal, Sherko

2016-08-01

At the present time, transfer and verification standards of transmission coefficient (or, equivalently, transmission loss) are not readily available at high millimetre-wave frequencies (i.e. at frequencies ranging typically from 100 GHz to 300 GHz). In recent years, cross-connected waveguide devices have been proposed to provide calculable standards of transmission loss at these frequencies. This paper investigates the viability of these cross-connected waveguides as transfer standards of transmission for inter-laboratory measurement comparison exercises. This relates to their potential use in activities such as international key comparison exercises and measurement audit programmes. A trial inter-laboratory comparison involving four laboratories using two cross-connected waveguides in the WR-05 waveguide size (covering frequencies from 140 GHz to 220 GHz) is described and includes an analysis of the measurement results obtained during the comparison exercise.

Transfer Standard Uncertainty Can Cause Inconclusive Inter-Laboratory Comparisons

PubMed Central

Wright, John; Toman, Blaza; Mickan, Bodo; Wübbeler, Gerd; Bodnar, Olha; Elster, Clemens

2016-01-01

Inter-laboratory comparisons use the best available transfer standards to check the participants’ uncertainty analyses, identify underestimated uncertainty claims or unknown measurement biases, and improve the global measurement system. For some measurands, instability of the transfer standard can lead to an inconclusive comparison result. If the transfer standard uncertainty is large relative to a participating laboratory’s uncertainty, the commonly used standardized degree of equivalence ≤ 1 criterion does not always correctly assess whether a participant is working within their uncertainty claims. We show comparison results that demonstrate this issue and propose several criteria for assessing a comparison result as passing, failing, or inconclusive. We investigate the behavior of the standardized degree of equivalence and alternative comparison measures for a range of values of the transfer standard uncertainty relative to the individual laboratory uncertainty values. The proposed alternative criteria successfully discerned between passing, failing, and inconclusive comparison results for the cases we examined. PMID:28090123

Evaluation of Methods for Analysis of Lead in Air Particulates: An Intra-Laboratory and Inter-Laboratory Comparison

EPA Science Inventory

In 2008, the United States Environmental Protection Agency (USEPA) set a new National Ambient Air Quality Standard (NAAQS) for lead (Pb) in total suspended particulate matter (Pb-TSP) which called for significant decreases in the allowable limits. The Federal Reference Method (FR...

Touryan Elected Chairman

Science.gov Websites

Touryan Elected Chairman of Proliferation Prevention Advisory Board For information contact: e:mail ) National Renewable Energy Laboratory (NREL) was elected chairman of the Inter-Laboratory Advisory Board for opportunities and a means of rapid commercialization of defense technologies. It creates a win-win situation for

Validation of an indirect ELISA to detect antibodies against BoHV-1 in bovine and guinea-pig serum samples using ISO/IEC 17025 standards.

PubMed

Parreño, Viviana; Romera, S Alejandra; Makek, Lucia; Rodriguez, Daniela; Malacari, Darío; Maidana, Silvina; Compaired, Diego; Combessies, Gustavo; Vena, María Marta; Garaicoechea, Lorena; Wigdorovitz, Andrés; Marangunich, Laura; Fernandez, Fernando

2010-10-01

Two ELISAs to quantify antibodies to BoHV-1 in the sera of cattle and immunized guinea pigs were developed and validated using ISO/IEC 17025 standards. The cut-off value of the assay was established at 20% positivity of a high positive control for screening of cattle. Using this threshold, the assay properly classified the OIE bovine reference sera EU1, EU2 and EU3. For vaccine potency testing, a cut-off of 40% was selected for both species. The reliability of the assays, given by their diagnostic sensitivity and specificity, using the threshold of 40% was 89.7% and 100%, respectively, for bovines and 94.9% and 100% for guinea pigs, respectively. There was almost perfect agreement between the ELISA and virus neutralization results. In addition, after vaccination, there was a good correlation between the neutralizing and ELISA antibody titers of the serum from the same bovine or guinea pig, sampled at 60 and 30 days post-vaccination, respectively (R(bovine)=0.88, R(guinea pig)=0.92; p<0.0001). A similar correlation was observed when analyzing the mean antibody titers of groups of vaccinated animals (R(bovine)=0.95 and R(guinea pig)=0.97; p<0.0001), indicating the relevance of the ELISAs for batch to batch vaccine potency testing in the target species and in the laboratory animal model. The intermediate precision of the assays expressed as the relative coefficient of variation (CV) of the positive control assayed over a 3-year period in the same laboratory was 22.2% for bovines and 23.1% for guinea pigs. The reproducibility of both techniques obtained in inter-laboratory assays was CV=12.4% for bovines and CV approximately 0 for guinea pigs, which met the requirements of the OIE (CV<30%). The validated ELISAs represent important methods for vaccine potency testing and for controlling BoHV-1 infections. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Montreal Archive of Sleep Studies: an open-access resource for instrument benchmarking and exploratory research.

PubMed

O'Reilly, Christian; Gosselin, Nadia; Carrier, Julie; Nielsen, Tore

2014-12-01

Manual processing of sleep recordings is extremely time-consuming. Efforts to automate this process have shown promising results, but automatic systems are generally evaluated on private databases, not allowing accurate cross-validation with other systems. In lacking a common benchmark, the relative performances of different systems are not compared easily and advances are compromised. To address this fundamental methodological impediment to sleep study, we propose an open-access database of polysomnographic biosignals. To build this database, whole-night recordings from 200 participants [97 males (aged 42.9 ± 19.8 years) and 103 females (aged 38.3 ± 18.9 years); age range: 18-76 years] were pooled from eight different research protocols performed in three different hospital-based sleep laboratories. All recordings feature a sampling frequency of 256 Hz and an electroencephalography (EEG) montage of 4-20 channels plus standard electro-oculography (EOG), electromyography (EMG), electrocardiography (ECG) and respiratory signals. Access to the database can be obtained through the Montreal Archive of Sleep Studies (MASS) website (http://www.ceams-carsm.ca/en/MASS), and requires only affiliation with a research institution and prior approval by the applicant's local ethical review board. Providing the research community with access to this free and open sleep database is expected to facilitate the development and cross-validation of sleep analysis automation systems. It is also expected that such a shared resource will be a catalyst for cross-centre collaborations on difficult topics such as improving inter-rater agreement on sleep stage scoring. © 2014 European Sleep Research Society.

An internationally standardized species identification test for use on suspected seized rhinoceros horn in the illegal wildlife trade.

PubMed

Ewart, Kyle M; Frankham, Greta J; McEwing, Ross; Webster, Lucy M I; Ciavaglia, Sherryn A; Linacre, Adrian M T; The, Dang Tat; Ovouthan, Kanitia; Johnson, Rebecca N

2018-01-01

Rhinoceros (rhino) numbers have dwindled substantially over the past century. As a result, three of the five species are now considered to be critically endangered, one species is vulnerable and one species is near-threatened. Poaching has increased dramatically over the past decade due to a growing demand for rhino horn products, primarily in Asia. Improved wildlife forensic techniques, such as validated tests for species identification of seized horns, are critical to aid current enforcement and prosecution efforts and provide a deterrent to future rhino horn trafficking. Here, we present an internationally standardized species identification test based on a 230 base pair cytochrome-b region. This test improves on previous nested PCR protocols and can be used for the discrimination of samples with <20pg of template DNA, thus suitable for DNA extracted from horn products. The assay was designed to amplify water buffalo samples, a common 'rhino horn' substitute, but to exclude human DNA, a common contaminant. Phylogenetic analyses using this partial cytochrome-b region resolved the five extant rhino species. Testing successfully returned a sequence and correct identification for all of the known rhino horn samples and vouchered rhino samples from museum and zoo collections, and provided species level identification for 47 out of 52 unknown samples from seizures. Validation and standardization was carried out across five different laboratories, in four different countries, demonstrating it to be an effective and reproducible test, robust to inter laboratory variation in equipment and consumables (such as PCR reagents). This is one of the first species identification tests to be internationally standardized to produce data for evidential proceedings and the first published validated test for rhinos, one of the flagship species groups of the illegal wildlife trade and for which forensic tools are urgently required. This study serves as a model for how species identification tests should be standardized and disseminated for wildlife forensic testing. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

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

USGS Publications Warehouse

Raimondo, Sandy; Lilavois, Crystal R.; Lee, Larisa; Augspurger, Tom; Wang, Ning; Ingersoll, Christopher G.; Bauer, Candice R.; Hammer, Edward J.; Barron, Mace G.

2016-01-01

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 sensitivity among commonly tested mussels (Lampsilis siliquoidea, Utterbackia imbecillis, Villosa iris), commonly tested cladocerans (Daphnia magna, Ceriodaphnia dubia) and fish (Oncorhynchus mykiss, Pimephales promelas, Lepomis macrochirus). The results of these analyses indicate intra-laboratory variability for median effect concentrations (EC50) averaged about 2 fold for both life stages, while inter-laboratory variability averaged 3.6 fold for juvenile mussels and 6.3 fold for glochidia. The EC50s for juveniles and glochidia were within a factor of 2 of each other for 50% of paired records across chemicals, with juveniles more sensitive than glochidia by more than 2 fold for 33% of the comparisons made between life stages. There was a high concurrence of the sensitivity of commonly tested L. siliquoidea, U. imbecillis, and V. iris to that of other mussels. However, this concurrence decreases as the taxonomic distance of the commonly tested cladocerans and fish to mussels increases. The compiled mussel database and determination of data variability will advance risk assessments by including more robust species sensitivity distributions, interspecies correlation estimates, and availability of taxon-specific empirically derived application factors for risk assessment.

Species identification in forensic samples using the SPInDel approach: A GHEP-ISFG inter-laboratory collaborative exercise.

PubMed

Alves, Cíntia; Pereira, Rui; Prieto, Lourdes; Aler, Mercedes; Amaral, Cesar R L; Arévalo, Cristina; Berardi, Gabriela; Di Rocco, Florencia; Caputo, Mariela; Carmona, Cristian Hernandez; Catelli, Laura; Costa, Heloísa Afonso; Coufalova, Pavla; Furfuro, Sandra; García, Óscar; Gaviria, Anibal; Goios, Ana; Gómez, Juan José Builes; Hernández, Alexis; Hernández, Eva Del Carmen Betancor; Miranda, Luís; Parra, David; Pedrosa, Susana; Porto, Maria João Anjos; Rebelo, Maria de Lurdes; Spirito, Matteo; Torres, María Del Carmen Villalobos; Amorim, António; Pereira, Filipe

2017-05-01

DNA is a powerful tool available for forensic investigations requiring identification of species. However, it is necessary to develop and validate methods able to produce results in degraded and or low quality DNA samples with the high standards obligatory in forensic research. Here, we describe a voluntary collaborative exercise to test the recently developed Species Identification by Insertions/Deletions (SPInDel) method. The SPInDel kit allows the identification of species by the generation of numeric profiles combining the lengths of six mitochondrial ribosomal RNA (rRNA) gene regions amplified in a single reaction followed by capillary electrophoresis. The exercise was organized during 2014 by a Working Commission of the Spanish and Portuguese-Speaking Working Group of the International Society for Forensic Genetics (GHEP-ISFG), created in 2013. The 24 participating laboratories from 10 countries were asked to identify the species in 11 DNA samples from previous GHEP-ISFG proficiency tests using a SPInDel primer mix and control samples of the 10 target species. A computer software was also provided to the participants to assist the analyses of the results. All samples were correctly identified by 22 of the 24 laboratories, including samples with low amounts of DNA (hair shafts) and mixtures of saliva and blood. Correct species identifications were obtained in 238 of the 241 (98.8%) reported SPInDel profiles. Two laboratories were responsible for the three cases of misclassifications. The SPInDel was efficient in the identification of species in mixtures considering that only a single laboratory failed to detect a mixture in one sample. This result suggests that SPInDel is a valid method for mixture analyses without the need for DNA sequencing, with the advantage of identifying more than one species in a single reaction. The low frequency of wrong (5.0%) and missing (2.1%) alleles did not interfere with the correct species identification, which demonstrated the advantage of using a method based on the analysis of multiple loci. Overall, the SPInDel method was easily implemented by laboratories using different genotyping platforms, the interpretation of results was straightforward and the SPInDel software was used without any problems. The results of this collaborative exercise indicate that the SPInDel method can be applied successfully in forensic casework investigations. Copyright © 2017 Elsevier B.V. All rights reserved.

A Bootstrap Algorithm for Mixture Models and Interval Data in Inter-Comparisons

DTIC Science & Technology

2001-07-01

parametric bootstrap. The present algorithm will be applied to a thermometric inter-comparison, where data cannot be assumed to be normally distributed. 2 Data...experimental methods, used in each laboratory) often imply that the statistical assumptions are not satisfied, as for example in several thermometric ...triangular). Indeed, in thermometric experiments these three probabilistic models can represent several common stochastic variabilities for

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

ERIC Educational Resources Information Center

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…

Reliability and validity of a Chinese version of the Diagnostic Interview for Borderlines-Revised.

PubMed

Wang, Lanlan; Yuan, Chenmei; Qiu, Jianying; Gunderson, John; Zhang, Min; Jiang, Kaida; Leung, Freedom; Zhong, Jie; Xiao, Zeping

2014-09-01

Borderline personality disorder (BPD) is the most studied of the axis II disorders. One of the most widely used diagnostic instruments is the Diagnostic Interview for Borderline Patients-Revised (DIB-R). The aim of this study was to test the reliability and validity of DIB-R for use in the Chinese culture. The reliability and validity of the DIB-R Chinese version were assessed in a sample of 236 outpatients with a probable BPD diagnosis. The Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II) was used as a standard. Test-retest reliability was tested six months later with 20 patients, and inter-rater reliability was tested on 32 patients. The Chinese version of the DIB-R showed good internal global consistency (Cronbach's α of 0.916), good test-retest reliability (Pearson correlation of 0.704), good inter-rater reliability (intra-class correlation coefficient of 0.892 and kappa of 0.861). When compared with the DSM-IV diagnosis as measured by the SCID-II, the DIB-R showed relatively good sensitivity (0.768) and specificity (0.891) at the cutoff of 7, moderate diagnostic convergence (kappa of 0.631), as well as good discriminating validity. The Chinese version of the DIB-R has good psychometric properties, which renders it a valuable method for examining the presence, the severity, and component phenotypes of BPD in Chinese samples. © 2013 Wiley Publishing Asia Pty Ltd.

Reliability of 3D laser-based anthropometry and comparison with classical anthropometry.

PubMed

Kuehnapfel, Andreas; Ahnert, Peter; Loeffler, Markus; Broda, Anja; Scholz, Markus

2016-05-26

Anthropometric quantities are widely used in epidemiologic research as possible confounders, risk factors, or outcomes. 3D laser-based body scans (BS) allow evaluation of dozens of quantities in short time with minimal physical contact between observers and probands. The aim of this study was to compare BS with classical manual anthropometric (CA) assessments with respect to feasibility, reliability, and validity. We performed a study on 108 individuals with multiple measurements of BS and CA to estimate intra- and inter-rater reliabilities for both. We suggested BS equivalents of CA measurements and determined validity of BS considering CA the gold standard. Throughout the study, the overall concordance correlation coefficient (OCCC) was chosen as indicator of agreement. BS was slightly more time consuming but better accepted than CA. For CA, OCCCs for intra- and inter-rater reliability were greater than 0.8 for all nine quantities studied. For BS, 9 of 154 quantities showed reliabilities below 0.7. BS proxies for CA measurements showed good agreement (minimum OCCC > 0.77) after offset correction. Thigh length showed higher reliability in BS while upper arm length showed higher reliability in CA. Except for these issues, reliabilities of CA measurements and their BS equivalents were comparable.

Validation of two commercial real-time RT-PCR kits for rapid and specific diagnosis of classical swine fever virus.

PubMed

Le Dimna, M; Vrancken, R; Koenen, F; Bougeard, S; Mesplède, A; Hutet, E; Kuntz-Simon, G; Le Potier, M F

2008-01-01

Two real-time RT-PCR kits, developed by LSI (TaqVet CSF) and ADIAGENE (Adiavet CSF), obtained an agreement to be commercialised in France, subject to conditions, defined by the French Classical Swine Fever (CSF) National Reference Laboratory. The producers were asked to introduce an internal control to check the RNA extraction efficacy. The different criteria assessed were sensitivity, "pestivirus specificity", reproducibility and ease of handling, using 189 different samples. These samples were either CSFV inactivated strains or blood/serum/organs collected from CSFV experimentally infected pigs or naturally infected wild boars. The reproducibility of the assays was confirmed by the analysis of a batch-to-batch panel control that was used for inter-laboratory tests involving nine laboratories. The two kits were also tested for the use in mass diagnostics and the results proved the kits to be suited using pools of blood, serum and tonsils. Moreover, a field evaluation, carried out on spleen samples collected from the CSF surveillance of wild boars in an area known to be infected and from domestic pigs at a slaughterhouse, confirmed the high sensitivity and specificity of the two kits. This step-by-step evaluation procedure confirmed that the two commercial CSF real-time RT-PCR kits have a higher predictive value than the current diagnostic standard, Virus Isolation.

Development and testing of the cancer multidisciplinary team meeting observational tool (MDT-MOT)

PubMed Central

Harris, Jenny; Taylor, Cath; Sevdalis, Nick; Jalil, Rozh; Green, James S.A.

2016-01-01

Abstract Objective To develop a tool for independent observational assessment of cancer multidisciplinary team meetings (MDMs), and test criterion validity, inter-rater reliability/agreement and describe performance. Design Clinicians and experts in teamwork used a mixed-methods approach to develop and refine the tool. Study 1 observers rated pre-determined optimal/sub-optimal MDM film excerpts and Study 2 observers independently rated video-recordings of 10 MDMs. Setting Study 2 included 10 cancer MDMs in England. Participants Testing was undertaken by 13 health service staff and a clinical and non-clinical observer. Intervention None. Main Outcome Measures Tool development, validity, reliability/agreement and variability in MDT performance. Results Study 1: Observers were able to discriminate between optimal and sub-optimal MDM performance (P ≤ 0.05). Study 2: Inter-rater reliability was good for 3/10 domains. Percentage of absolute agreement was high (≥80%) for 4/10 domains and percentage agreement within 1 point was high for 9/10 domains. Four MDTs performed well (scored 3+ in at least 8/10 domains), 5 MDTs performed well in 6–7 domains and 1 MDT performed well in only 4 domains. Leadership and chairing of the meeting, the organization and administration of the meeting, and clinical decision-making processes all varied significantly between MDMs (P ≤ 0.01). Conclusions MDT-MOT demonstrated good criterion validity. Agreement between clinical and non-clinical observers (within one point on the scale) was high but this was inconsistent with reliability coefficients and warrants further investigation. If further validated MDT-MOT might provide a useful mechanism for the routine assessment of MDMs by the local workforce to drive improvements in MDT performance. PMID:27084499

Development and testing of the cancer multidisciplinary team meeting observational tool (MDT-MOT).

PubMed

Harris, Jenny; Taylor, Cath; Sevdalis, Nick; Jalil, Rozh; Green, James S A

2016-06-01

To develop a tool for independent observational assessment of cancer multidisciplinary team meetings (MDMs), and test criterion validity, inter-rater reliability/agreement and describe performance. Clinicians and experts in teamwork used a mixed-methods approach to develop and refine the tool. Study 1 observers rated pre-determined optimal/sub-optimal MDM film excerpts and Study 2 observers independently rated video-recordings of 10 MDMs. Study 2 included 10 cancer MDMs in England. Testing was undertaken by 13 health service staff and a clinical and non-clinical observer. None. Tool development, validity, reliability/agreement and variability in MDT performance. Study 1: Observers were able to discriminate between optimal and sub-optimal MDM performance (P ≤ 0.05). Study 2: Inter-rater reliability was good for 3/10 domains. Percentage of absolute agreement was high (≥80%) for 4/10 domains and percentage agreement within 1 point was high for 9/10 domains. Four MDTs performed well (scored 3+ in at least 8/10 domains), 5 MDTs performed well in 6-7 domains and 1 MDT performed well in only 4 domains. Leadership and chairing of the meeting, the organization and administration of the meeting, and clinical decision-making processes all varied significantly between MDMs (P ≤ 0.01). MDT-MOT demonstrated good criterion validity. Agreement between clinical and non-clinical observers (within one point on the scale) was high but this was inconsistent with reliability coefficients and warrants further investigation. If further validated MDT-MOT might provide a useful mechanism for the routine assessment of MDMs by the local workforce to drive improvements in MDT performance. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

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

PubMed

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.

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

PubMed

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.

How reliable are efficiency measurements of perovskite solar cells? The first inter-comparison, between two accredited and eight non-accredited laboratories

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

Dunbar, Ricky B.; Duck, Benjamin C.; Moriarty, Tom E.

Perovskite materials have generated significant interest from academia and industry as a potential component in next-generation, high-efficiency, low-cost, photovoltaic (PV) devices. The record efficiency reported for perovskite solar cells has risen rapidly, and is now more than 22%. However, due to their complex dynamic behaviour, the process of measuring the efficiency of perovskite solar cells appears to be much more complicated than for other technologies. It has long been acknowledged that this is likely to greatly reduce the reliability of reported efficiency measurements, but the quantitative extent to which this occurs has not been determined. To investigate this, we conductmore » the first major inter-comparison of this PV technology. The participants included two labs accredited for PV performance measurement (CSIRO and NREL) and eight PV research laboratories. We find that the inter-laboratory measurement variability can be almost ten times larger for a slowly responding perovskite cell than for a control silicon cell. We show that for such a cell, the choice of measurement method, far more so than measurement hardware, is the single-greatest cause for this undesirably large variability. We provide recommendations for identifying the most appropriate method for a given cell, depending on its stabilization and degradation behaviour. Moreover, the results of this study suggest that identifying a consensus technique for accurate and meaningful efficiency measurements of perovskite solar cells will lead to an immediate improvement in reliability. This, in turn, should assist device researchers to correctly evaluate promising new materials and fabrication methods, and further boost the development of this technology.« less

How reliable are efficiency measurements of perovskite solar cells? The first inter-comparison, between two accredited and eight non-accredited laboratories

DOE PAGES

Dunbar, Ricky B.; Duck, Benjamin C.; Moriarty, Tom E.; ...

2017-10-24

Perovskite materials have generated significant interest from academia and industry as a potential component in next-generation, high-efficiency, low-cost, photovoltaic (PV) devices. The record efficiency reported for perovskite solar cells has risen rapidly, and is now more than 22%. However, due to their complex dynamic behaviour, the process of measuring the efficiency of perovskite solar cells appears to be much more complicated than for other technologies. It has long been acknowledged that this is likely to greatly reduce the reliability of reported efficiency measurements, but the quantitative extent to which this occurs has not been determined. To investigate this, we conductmore » the first major inter-comparison of this PV technology. The participants included two labs accredited for PV performance measurement (CSIRO and NREL) and eight PV research laboratories. We find that the inter-laboratory measurement variability can be almost ten times larger for a slowly responding perovskite cell than for a control silicon cell. We show that for such a cell, the choice of measurement method, far more so than measurement hardware, is the single-greatest cause for this undesirably large variability. We provide recommendations for identifying the most appropriate method for a given cell, depending on its stabilization and degradation behaviour. Moreover, the results of this study suggest that identifying a consensus technique for accurate and meaningful efficiency measurements of perovskite solar cells will lead to an immediate improvement in reliability. This, in turn, should assist device researchers to correctly evaluate promising new materials and fabrication methods, and further boost the development of this technology.« less