VDA, a Method of Choosing a Better Algorithm with Fewer Validations

PubMed Central

Kluger, Yuval

2011-01-01

The multitude of bioinformatics algorithms designed for performing a particular computational task presents end-users with the problem of selecting the most appropriate computational tool for analyzing their biological data. The choice of the best available method is often based on expensive experimental validation of the results. We propose an approach to design validation sets for method comparison and performance assessment that are effective in terms of cost and discrimination power. Validation Discriminant Analysis (VDA) is a method for designing a minimal validation dataset to allow reliable comparisons between the performances of different algorithms. Implementation of our VDA approach achieves this reduction by selecting predictions that maximize the minimum Hamming distance between algorithmic predictions in the validation set. We show that VDA can be used to correctly rank algorithms according to their performances. These results are further supported by simulations and by realistic algorithmic comparisons in silico. VDA is a novel, cost-efficient method for minimizing the number of validation experiments necessary for reliable performance estimation and fair comparison between algorithms. Our VDA software is available at http://sourceforge.net/projects/klugerlab/files/VDA/ PMID:22046256

Center of pressure based segment inertial parameters validation

PubMed Central

Rezzoug, Nasser; Gorce, Philippe; Isableu, Brice; Venture, Gentiane

2017-01-01

By proposing efficient methods for estimating Body Segment Inertial Parameters’ (BSIP) estimation and validating them with a force plate, it is possible to improve the inverse dynamic computations that are necessary in multiple research areas. Until today a variety of studies have been conducted to improve BSIP estimation but to our knowledge a real validation has never been completely successful. In this paper, we propose a validation method using both kinematic and kinetic parameters (contact forces) gathered from optical motion capture system and a force plate respectively. To compare BSIPs, we used the measured contact forces (Force plate) as the ground truth, and reconstructed the displacements of the Center of Pressure (COP) using inverse dynamics from two different estimation techniques. Only minor differences were seen when comparing the estimated segment masses. Their influence on the COP computation however is large and the results show very distinguishable patterns of the COP movements. Improving BSIP techniques is crucial and deviation from the estimations can actually result in large errors. This method could be used as a tool to validate BSIP estimation techniques. An advantage of this approach is that it facilitates the comparison between BSIP estimation methods and more specifically it shows the accuracy of those parameters. PMID:28662090

Experimental validation of the intrinsic spatial efficiency method over a wide range of sizes for cylindrical sources

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

Ortiz-Ramŕez, Pablo, E-mail: rapeitor@ug.uchile.cl; Larroquette, Philippe; Camilla, S.

The intrinsic spatial efficiency method is a new absolute method to determine the efficiency of a gamma spectroscopy system for any extended source. In the original work the method was experimentally demonstrated and validated for homogeneous cylindrical sources containing {sup 137}Cs, whose sizes varied over a small range (29.5 mm radius and 15.0 to 25.9 mm height). In this work we present an extension of the validation over a wide range of sizes. The dimensions of the cylindrical sources vary between 10 to 40 mm height and 8 to 30 mm radius. The cylindrical sources were prepared using the referencemore » material IAEA-372, which had a specific activity of 11320 Bq/kg at july 2006. The obtained results were better for the sources with 29 mm radius showing relative bias lesser than 5% and for the sources with 10 mm height showing relative bias lesser than 6%. In comparison with the obtained results in the work where we present the method, the majority of these results show an excellent agreement.« less

Discriminant Validity Assessment: Use of Fornell & Larcker criterion versus HTMT Criterion

NASA Astrophysics Data System (ADS)

Hamid, M. R. Ab; Sami, W.; Mohmad Sidek, M. H.

2017-09-01

Assessment of discriminant validity is a must in any research that involves latent variables for the prevention of multicollinearity issues. Fornell and Larcker criterion is the most widely used method for this purpose. However, a new method has emerged for establishing the discriminant validity assessment through heterotrait-monotrait (HTMT) ratio of correlations method. Therefore, this article presents the results of discriminant validity assessment using these methods. Data from previous study was used that involved 429 respondents for empirical validation of value-based excellence model in higher education institutions (HEI) in Malaysia. From the analysis, the convergent, divergent and discriminant validity were established and admissible using Fornell and Larcker criterion. However, the discriminant validity is an issue when employing the HTMT criterion. This shows that the latent variables under study faced the issue of multicollinearity and should be looked into for further details. This also implied that the HTMT criterion is a stringent measure that could detect the possible indiscriminant among the latent variables. In conclusion, the instrument which consisted of six latent variables was still lacking in terms of discriminant validity and should be explored further.

Estimation of low back moments from video analysis: a validation study.

PubMed

Coenen, Pieter; Kingma, Idsart; Boot, Cécile R L; Faber, Gert S; Xu, Xu; Bongers, Paulien M; van Dieën, Jaap H

2011-09-02

This study aimed to develop, compare and validate two versions of a video analysis method for assessment of low back moments during occupational lifting tasks since for epidemiological studies and ergonomic practice relatively cheap and easily applicable methods to assess low back loads are needed. Ten healthy subjects participated in a protocol comprising 12 lifting conditions. Low back moments were assessed using two variants of a video analysis method and a lab-based reference method. Repeated measures ANOVAs showed no overall differences in peak moments between the two versions of the video analysis method and the reference method. However, two conditions showed a minor overestimation of one of the video analysis method moments. Standard deviations were considerable suggesting that errors in the video analysis were random. Furthermore, there was a small underestimation of dynamic components and overestimation of the static components of the moments. Intraclass correlations coefficients for peak moments showed high correspondence (>0.85) of the video analyses with the reference method. It is concluded that, when a sufficient number of measurements can be taken, the video analysis method for assessment of low back loads during lifting tasks provides valid estimates of low back moments in ergonomic practice and epidemiological studies for lifts up to a moderate level of asymmetry. Copyright © 2011 Elsevier Ltd. All rights reserved.

[Validity of expired carbon monoxide and urine cotinine using dipstick method to assess smoking status].

PubMed

Park, Su San; Lee, Ju Yul; Cho, Sung-Il

2007-07-01

We investigated the validity of the dipstick method (Mossman Associates Inc. USA) and the expired CO method to distinguish between smokers and nonsmokers. We also elucidated the related factors of the two methods. This study included 244 smokers and 50 ex-smokers, recruited from smoking cessation clinics at 4 local public health centers, who had quit for over 4 weeks. We calculated the sensitivity, specificity and Kappa coefficient of each method for validity. We obtained ROC curve, predictive value and agreement to determine the cutoff of expired air CO method. Finally, we elucidated the related factors and compared their effect powers using the standardized regression coefficient. The dipstick method showed a sensitivity of 92.6%, specificity of 96.0% and Kappa coefficient of 0.79. The best cutoff value to distinguish smokers was 5-6 ppm. At 5 ppm, the expired CO method showed a sensitivity of 94.3%, specificity of 82.0% and Kappa coefficient of 0.73. And at 6 ppm, sensitivity, specificity and Kappa coefficient were 88.5%, 86.0% and 0.64, respectively. Therefore, the dipstick method had higher sensitivity and specificity than the expired CO method. The dipstick and expired CO methods were significantly increased with increasing smoking amount. With longer time since the last smoking, expired CO showed a rapid decrease after 4 hours, whereas the dipstick method showed relatively stable levels for more than 4 hours. The dipstick and expired CO methods were both good indicators for assessing smoking status. However, the former showed higher sensitivity and specificity and stable levels over longer hours after smoking, compared to the expired CO method.

Fractal Clustering and Knowledge-driven Validation Assessment for Gene Expression Profiling.

PubMed

Wang, Lu-Yong; Balasubramanian, Ammaiappan; Chakraborty, Amit; Comaniciu, Dorin

2005-01-01

DNA microarray experiments generate a substantial amount of information about the global gene expression. Gene expression profiles can be represented as points in multi-dimensional space. It is essential to identify relevant groups of genes in biomedical research. Clustering is helpful in pattern recognition in gene expression profiles. A number of clustering techniques have been introduced. However, these traditional methods mainly utilize shape-based assumption or some distance metric to cluster the points in multi-dimension linear Euclidean space. Their results shows poor consistence with the functional annotation of genes in previous validation study. From a novel different perspective, we propose fractal clustering method to cluster genes using intrinsic (fractal) dimension from modern geometry. This method clusters points in such a way that points in the same clusters are more self-affine among themselves than to the points in other clusters. We assess this method using annotation-based validation assessment for gene clusters. It shows that this method is superior in identifying functional related gene groups than other traditional methods.

A statistical approach to selecting and confirming validation targets in -omics experiments

PubMed Central

2012-01-01

Background Genomic technologies are, by their very nature, designed for hypothesis generation. In some cases, the hypotheses that are generated require that genome scientists confirm findings about specific genes or proteins. But one major advantage of high-throughput technology is that global genetic, genomic, transcriptomic, and proteomic behaviors can be observed. Manual confirmation of every statistically significant genomic result is prohibitively expensive. This has led researchers in genomics to adopt the strategy of confirming only a handful of the most statistically significant results, a small subset chosen for biological interest, or a small random subset. But there is no standard approach for selecting and quantitatively evaluating validation targets. Results Here we present a new statistical method and approach for statistically validating lists of significant results based on confirming only a small random sample. We apply our statistical method to show that the usual practice of confirming only the most statistically significant results does not statistically validate result lists. We analyze an extensively validated RNA-sequencing experiment to show that confirming a random subset can statistically validate entire lists of significant results. Finally, we analyze multiple publicly available microarray experiments to show that statistically validating random samples can both (i) provide evidence to confirm long gene lists and (ii) save thousands of dollars and hundreds of hours of labor over manual validation of each significant result. Conclusions For high-throughput -omics studies, statistical validation is a cost-effective and statistically valid approach to confirming lists of significant results. PMID:22738145

AOAC Official MethodSM Matrix Extension Validation Study of Assurance GDSTM for the Detection of Salmonella in Selected Spices.

PubMed

Feldsine, Philip; Kaur, Mandeep; Shah, Khyati; Immerman, Amy; Jucker, Markus; Lienau, Andrew

2015-01-01

Assurance GDSTM for Salmonella Tq has been validated according to the AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces for the detection of selected foods and environmental surfaces (Official Method of AnalysisSM 2009.03, Performance Tested MethodSM No. 050602). The method also completed AFNOR validation (following the ISO 16140 standard) compared to the reference method EN ISO 6579. For AFNOR, GDS was given a scope covering all human food, animal feed stuff, and environmental surfaces (Certificate No. TRA02/12-01/09). Results showed that Assurance GDS for Salmonella (GDS) has high sensitivity and is equivalent to the reference culture methods for the detection of motile and non-motile Salmonella. As part of the aforementioned validations, inclusivity and exclusivity studies, stability, and ruggedness studies were also conducted. Assurance GDS has 100% inclusivity and exclusivity among the 100 Salmonella serovars and 35 non-Salmonella organisms analyzed. To add to the scope of the Assurance GDS for Salmonella method, a matrix extension study was conducted, following the AOAC guidelines, to validate the application of the method for selected spices, specifically curry powder, cumin powder, and chili powder, for the detection of Salmonella.

Use of Bayesian Networks to Probabilistically Model and Improve the Likelihood of Validation of Microarray Findings by RT-PCR

PubMed Central

English, Sangeeta B.; Shih, Shou-Ching; Ramoni, Marco F.; Smith, Lois E.; Butte, Atul J.

2014-01-01

Though genome-wide technologies, such as microarrays, are widely used, data from these methods are considered noisy; there is still varied success in downstream biological validation. We report a method that increases the likelihood of successfully validating microarray findings using real time RT-PCR, including genes at low expression levels and with small differences. We use a Bayesian network to identify the most relevant sources of noise based on the successes and failures in validation for an initial set of selected genes, and then improve our subsequent selection of genes for validation based on eliminating these sources of noise. The network displays the significant sources of noise in an experiment, and scores the likelihood of validation for every gene. We show how the method can significantly increase validation success rates. In conclusion, in this study, we have successfully added a new automated step to determine the contributory sources of noise that determine successful or unsuccessful downstream biological validation. PMID:18790084

Reliability and Validity of the Footprint Assessment Method Using Photoshop CS5 Software.

PubMed

Gutiérrez-Vilahú, Lourdes; Massó-Ortigosa, Núria; Costa-Tutusaus, Lluís; Guerra-Balic, Myriam

2015-05-01

Several sophisticated methods of footprint analysis currently exist. However, it is sometimes useful to apply standard measurement methods of recognized evidence with an easy and quick application. We sought to assess the reliability and validity of a new method of footprint assessment in a healthy population using Photoshop CS5 software (Adobe Systems Inc, San Jose, California). Forty-two footprints, corresponding to 21 healthy individuals (11 men with a mean ± SD age of 20.45 ± 2.16 years and 10 women with a mean ± SD age of 20.00 ± 1.70 years) were analyzed. Footprints were recorded in static bipedal standing position using optical podography and digital photography. Three trials for each participant were performed. The Hernández-Corvo, Chippaux-Smirak, and Staheli indices and the Clarke angle were calculated by manual method and by computerized method using Photoshop CS5 software. Test-retest was used to determine reliability. Validity was obtained by intraclass correlation coefficient (ICC). The reliability test for all of the indices showed high values (ICC, 0.98-0.99). Moreover, the validity test clearly showed no difference between techniques (ICC, 0.99-1). The reliability and validity of a method to measure, assess, and record the podometric indices using Photoshop CS5 software has been demonstrated. This provides a quick and accurate tool useful for the digital recording of morphostatic foot study parameters and their control.

What is the best method for assessing lower limb force-velocity relationship?

PubMed

Giroux, C; Rabita, G; Chollet, D; Guilhem, G

2015-02-01

This study determined the concurrent validity and reliability of force, velocity and power measurements provided by accelerometry, linear position transducer and Samozino's methods, during loaded squat jumps. 17 subjects performed squat jumps on 2 separate occasions in 7 loading conditions (0-60% of the maximal concentric load). Force, velocity and power patterns were averaged over the push-off phase using accelerometry, linear position transducer and a method based on key positions measurements during squat jump, and compared to force plate measurements. Concurrent validity analyses indicated very good agreement with the reference method (CV=6.4-14.5%). Force, velocity and power patterns comparison confirmed the agreement with slight differences for high-velocity movements. The validity of measurements was equivalent for all tested methods (r=0.87-0.98). Bland-Altman plots showed a lower agreement for velocity and power compared to force. Mean force, velocity and power were reliable for all methods (ICC=0.84-0.99), especially for Samozino's method (CV=2.7-8.6%). Our findings showed that present methods are valid and reliable in different loading conditions and permit between-session comparisons and characterization of training-induced effects. While linear position transducer and accelerometer allow for examining the whole time-course of kinetic patterns, Samozino's method benefits from a better reliability and ease of processing. © Georg Thieme Verlag KG Stuttgart · New York.

Development and validation of reversed phase high performance liquid chromatography method for determination of dexpanthenol in pharmaceutical formulations.

PubMed

Kulikov, A U; Zinchenko, A A

2007-02-19

This paper describes the validation of an isocratic HPLC method for the assay of dexpanthenol in aerosol and gel. The method employs the Vydac Proteins C4 column with a mobile phase of aqueous solution of trifluoroacetic acid and UV detection at 206 nm. A linear response (r>0.9999) was observed in the range of 13.0-130 microg mL(-1). The method shows good recoveries and intra and inter-day relative standard deviations were less than 1.0%. Validation parameters as specificity, accuracy and robustness were also determined. The method can be used for dexpanthenol assay of panthenol aerosol and gel with dexpanthenol as the method separates dexpanthenol from aerosol or gel excipients.

Reliability and validity of non-radiographic methods of thoracic kyphosis measurement: a systematic review.

PubMed

Barrett, Eva; McCreesh, Karen; Lewis, Jeremy

2014-02-01

A wide array of instruments are available for non-invasive thoracic kyphosis measurement. Guidelines for selecting outcome measures for use in clinical and research practice recommend that properties such as validity and reliability are considered. This systematic review reports on the reliability and validity of non-invasive methods for measuring thoracic kyphosis. A systematic search of 11 electronic databases located studies assessing reliability and/or validity of non-invasive thoracic kyphosis measurement techniques. Two independent reviewers used a critical appraisal tool to assess the quality of retrieved studies. Data was extracted by the primary reviewer. The results were synthesized qualitatively using a level of evidence approach. 27 studies satisfied the eligibility criteria and were included in the review. The reliability, validity and both reliability and validity were investigated by sixteen, two and nine studies respectively. 17/27 studies were deemed to be of high quality. In total, 15 methods of thoracic kyphosis were evaluated in retrieved studies. All investigated methods showed high (ICC ≥ .7) to very high (ICC ≥ .9) levels of reliability. The validity of the methods ranged from low to very high. The strongest levels of evidence for reliability exists in support of the Debrunner kyphometer, Spinal Mouse and Flexicurve index, and for validity supports the arcometer and Flexicurve index. Further reliability and validity studies are required to strengthen the level of evidence for the remaining methods of measurement. This should be addressed by future research. Copyright © 2013 Elsevier Ltd. All rights reserved.

Support Vector Data Description Model to Map Specific Land Cover with Optimal Parameters Determined from a Window-Based Validation Set.

PubMed

Zhang, Jinshui; Yuan, Zhoumiqi; Shuai, Guanyuan; Pan, Yaozhong; Zhu, Xiufang

2017-04-26

This paper developed an approach, the window-based validation set for support vector data description (WVS-SVDD), to determine optimal parameters for support vector data description (SVDD) model to map specific land cover by integrating training and window-based validation sets. Compared to the conventional approach where the validation set included target and outlier pixels selected visually and randomly, the validation set derived from WVS-SVDD constructed a tightened hypersphere because of the compact constraint by the outlier pixels which were located neighboring to the target class in the spectral feature space. The overall accuracies for wheat and bare land achieved were as high as 89.25% and 83.65%, respectively. However, target class was underestimated because the validation set covers only a small fraction of the heterogeneous spectra of the target class. The different window sizes were then tested to acquire more wheat pixels for validation set. The results showed that classification accuracy increased with the increasing window size and the overall accuracies were higher than 88% at all window size scales. Moreover, WVS-SVDD showed much less sensitivity to the untrained classes than the multi-class support vector machine (SVM) method. Therefore, the developed method showed its merits using the optimal parameters, tradeoff coefficient ( C ) and kernel width ( s ), in mapping homogeneous specific land cover.

Validity and reliability of the Myotest accelerometric system for the assessment of vertical jump height.

PubMed

Casartelli, Nicola; Müller, Roland; Maffiuletti, Nicola A

2010-11-01

The aim of the present study was to verify the validity and reliability of the Myotest accelerometric system (Myotest SA, Sion, Switzerland) for the assessment of vertical jump height. Forty-four male basketball players (age range: 9-25 years) performed series of squat, countermovement and repeated jumps during 2 identical test sessions separated by 2-15 days. Flight height was simultaneously quantified with the Myotest system and validated photoelectric cells (Optojump). Two calculation methods were used to estimate the jump height from Myotest recordings: flight time (Myotest-T) and vertical takeoff velocity (Myotest-V). Concurrent validity was investigated comparing Myotest-T and Myotest-V to the criterion method (Optojump), and test-retest reliability was also examined. As regards validity, Myotest-T overestimated jumping height compared to Optojump (p < 0.001) with a systematic bias of approximately 7 cm, even though random errors were low (2.7 cm) and intraclass correlation coefficients (ICCs) where high (>0.98), that is, excellent validity. Myotest-V overestimated jumping height compared to Optojump (p < 0.001), with high random errors (>12 cm), high limits of agreement ratios (>36%), and low ICCs (<0.75), that is, poor validity. As regards reliability, Myotest-T showed high ICCs (range: 0.92-0.96), whereas Myotest-V showed low ICCs (range: 0.56-0.89), and high random errors (>9 cm). In conclusion, Myotest-T is a valid and reliable method for the assessment of vertical jump height, and its use is legitimate for field-based evaluations, whereas Myotest-V is neither valid nor reliable.

Validation of biological activity testing procedure of recombinant human interleukin-7.

PubMed

Lutsenko, T N; Kovalenko, M V; Galkin, O Yu

2017-01-01

Validation procedure for method of monitoring the biological activity of reсombinant human interleukin-7 has been developed and conducted according to the requirements of national and international recommendations. This method is based on the ability of recombinant human interleukin-7 to induce proliferation of T lymphocytes. It has been shown that to control the biological activity of recombinant human interleukin-7 peripheral blood mononuclear cells (PBMCs) derived from blood or cell lines can be used. Validation charac­teristics that should be determined depend on the method, type of product or object test/measurement and biological test systems used in research. The validation procedure for the method of control of biological activity of recombinant human interleukin-7 in peripheral blood mononuclear cells showed satisfactory results on all parameters tested such as specificity, accuracy, precision and linearity.

[Validation of the nutritional index in Mexican pre-teens with the sensitivity and specificity method].

PubMed

Saucedo-Molina, T J; Gómez-Peresmitré, G

1998-01-01

To determine the diagnostic validity of the nutritional index (NI) in a sample of Mexican preadolescents. A total of 256 preadolescents, between 10 and 12 years old, male and female, students from Mexico City, were used to establish the diagnostic validity of NI using the sensitivity and specificity method. The findings show that the conventional NI cut-off points showed good sensitivity and specificity for the diagnosis of low weight, normality and obesity but not for overweight. When the cut-off points of NI were normalized, the sensitivity, specificity and prediction potency values were more suitable in all categories. When working with preadolescents, it is better to use the new cut-off points of NI, to obtain more reliable diagnosis.

Validation of a Method for Cylindrospermopsin Determination in Vegetables: Application to Real Samples Such as Lettuce (Lactuca sativa L.).

PubMed

Prieto, Ana I; Guzmán-Guillén, Remedios; Díez-Quijada, Leticia; Campos, Alexandre; Vasconcelos, Vitor; Jos, Ángeles; Cameán, Ana M

2018-02-01

Reports on the occurrence of the cyanobacterial toxin cylindrospermopsin (CYN) have increased worldwide because of CYN toxic effects in humans and animals. If contaminated waters are used for plant irrigation, these could represent a possible CYN exposure route for humans. For the first time, a method employing solid phase extraction and quantification by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) of CYN was optimized in vegetables matrices such as lettuce ( Lactuca sativa ). The validated method showed a linear range, from 5 to 500 ng CYN g -1 of fresh weight (f.w.), and detection and quantitation limits (LOD and LOQ) of 0.22 and 0.42 ng CYN g -1 f.w., respectively. The mean recoveries ranged between 85 and 104%, and the intermediate precision from 12.7 to 14.7%. The method showed to be robust for the three different variables tested. Moreover, it was successfully applied to quantify CYN in edible lettuce leaves exposed to CYN-contaminated water (10 µg L -1 ), showing that the tolerable daily intake (TDI) in the case of CYN could be exceeded in elderly high consumers. The validated method showed good results in terms of sensitivity, precision, accuracy, and robustness for CYN determination in leaf vegetables such as lettuce. More studies are needed in order to prevent the risks associated with the consumption of CYN-contaminated vegetables.

The development of thematic materials using project based learning for elementary school

NASA Astrophysics Data System (ADS)

Yuliana, M.; Wiryawan, S. A.; Riyadi

2018-05-01

Teaching materials is one of the important factors in supporting on learning process. This paper discussed about developing thematic materials using project based learning. Thematic materials are designed to make students to be active, creative, cooperative, easy in thinking to solve the problem. The purpose of the research was to develop thematic material using project based learning which used valid variables. The method of research which used in this research was four stages of research and development proposed by Thiagarajan consisting of 4 stages, namely: (1) definition stage, (2) design stage, (3) development stage, and (4) stage of dissemination. The first stage was research and information collection, it was in form of need analysis with questionnaire, observation, interview, and document analysis. Design stage was based on the competencies and indicator. The third was development stage, this stage was used to product validation from expert. The validity of research development involved media validator, material validator, and linguistic validator. The result from the validation of thematic material by expert showed that the overall result had a very good rating which ranged from 1 to 5 likert scale, media validation showed a mean score 4,83, the material validation showed mean score 4,68, and the mean of linguistic validation was e 4,74. It showed that the thematic material using project based learning was valid and feasible to be implemented in the context thematic learning.

Use of the Method of Triads in the Validation of Sodium and Potassium Intake in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil)

PubMed Central

Pereira, Taísa Sabrina Silva; Cade, Nágela Valadão; Mill, José Geraldo; Sichieri, Rosely; Molina, Maria del Carmen Bisi

2016-01-01

Introduction Biomarkers are a good choice to be used in the validation of food frequency questionnaire due to the independence of their random errors. Objective To assess the validity of the potassium and sodium intake estimated using the Food Frequency Questionnaire ELSA-Brasil. Subjects/Methods A subsample of participants in the ELSA-Brasil cohort was included in this study in 2009. Sodium and potassium intake were estimated using three methods: Semi-quantitative food frequency questionnaire, 12-hour nocturnal urinary excretion and three 24-hour food records. Correlation coefficients were calculated between the methods, and the validity coefficient was calculated using the method of triads. The 95% confidence intervals for the validity coefficient were estimated using bootstrap sampling. Exact and adjacent agreement and disagreement of the estimated sodium and potassium intake quintiles were compared among three methods. Results The sample consisted of 246 participants, aged 53±8 years, 52% of women. Validity coefficient for sodium were considered weak (рfood frequency questionnaire actual intake = 0.37 and рbiomarker actual intake = 0.21) and moderate (рfood records actual intake 0.56). The validity coefficient were higher for potassium (рfood frequency questionnaire actual intake = 0.60; рbiomarker actual intake = 0.42; рfood records actual intake = 0.79). Conclusions: The Food Frequency Questionnaire ELSA-Brasil showed good validity in estimating potassium intake in epidemiological studies. For sodium validity was weak, likely due to the non-quantification of the added salt to prepared food. PMID:28030625

Biotransformation of lignan glycoside to its aglycone by Woodfordia fruticosa flowers: quantification of compounds using a validated HPTLC method.

PubMed

Mishra, Shikha; Aeri, Vidhu

2017-12-01

Saraca asoca Linn. (Caesalpiniaceae) is an important traditional remedy for gynaecological disorders and it contains lyoniside, an aryl tetralin lignan glycoside. The aglycone of lyoniside, lyoniresinol possesses structural similarity to enterolignan precursors which are established phytoestrogens. This work illustrates biotransformation of lyoniside to lyoniresinol using Woodfordia fruticosa Kurz. (Lythraceae) flowers and simultaneous quantification of lyoniside and lyoniresinol using a validated HPTLC method. The aqueous extract prepared from S. asoca bark was fermented using W. fruticosa flowers. The substrate and fermented product both were simultaneously analyzed using solvent system:toluene:ethyl acetate:formic acid (4:3:0.4) at 254 nm. The method was validated for specificity, accuracy, precision, linearity, sensitivity and robustness as per ICH guidelines. The substrate showed the presence of lyoniside, however, it decreased as the fermentation proceeded. On 3rd day, lyoniresinol starts appearing in the medium. In 8 days duration most of the lyoniside converted to lyoniresinol. The developed method was specific for lyoniside and lyoniresinol. Lyoniside and lyoniresinol showed linearity in the range of 250-3000 and 500-2500 ng. The method was accurate as resulted in 99.84% and 99.83% recovery, respectively, for lyoniside and lyoniresinol. Aryl tetralin lignan glycoside, lyoniside was successfully transformed into lyoniresinol using W. fruticosa flowers and their contents were simultaneously analyzed using developed validated HPTLC method.

Development and validation of a stability indicating HPLC method for determination of lisinopril, lisinopril degradation product and parabens in the lisinopril extemporaneous formulation.

PubMed

Beasley, Christopher A; Shaw, Jessica; Zhao, Zack; Reed, Robert A

2005-03-09

The purpose of the research described herein was to develop and validate a stability-indicating HPLC method for lisinopril, lisinopril degradation product (DKP), methyl paraben and propyl paraben in a lisinopril extemporaneous formulation. The method developed in this report is selective for the components listed above, in the presence of the complex and chromatographically rich matrix presented by the Bicitra and Ora-Sweet SF formulation diluents. The method was also shown to have adequate sensitivity with a detection limit of 0.0075 microg/mL (0.03% of lisinopril method concentration). The validation elements investigated showed that the method has acceptable specificity, recovery, linearity, solution stability, and method precision. Acceptable robustness indicates that the assay method remains unaffected by small but deliberate variations, which are described in ICH Q2A and Q2B guidelines.

Increased efficacy for in-house validation of real-time PCR GMO detection methods.

PubMed

Scholtens, I M J; Kok, E J; Hougs, L; Molenaar, B; Thissen, J T N M; van der Voet, H

2010-03-01

To improve the efficacy of the in-house validation of GMO detection methods (DNA isolation and real-time PCR, polymerase chain reaction), a study was performed to gain insight in the contribution of the different steps of the GMO detection method to the repeatability and in-house reproducibility. In the present study, 19 methods for (GM) soy, maize canola and potato were validated in-house of which 14 on the basis of an 8-day validation scheme using eight different samples and five on the basis of a more concise validation protocol. In this way, data was obtained with respect to the detection limit, accuracy and precision. Also, decision limits were calculated for declaring non-conformance (>0.9%) with 95% reliability. In order to estimate the contribution of the different steps in the GMO analysis to the total variation variance components were estimated using REML (residual maximum likelihood method). From these components, relative standard deviations for repeatability and reproducibility (RSD(r) and RSD(R)) were calculated. The results showed that not only the PCR reaction but also the factors 'DNA isolation' and 'PCR day' are important factors for the total variance and should therefore be included in the in-house validation. It is proposed to use a statistical model to estimate these factors from a large dataset of initial validations so that for similar GMO methods in the future, only the PCR step needs to be validated. The resulting data are discussed in the light of agreed European criteria for qualified GMO detection methods.

Reliability and Validity of Isometric Knee Extensor Strength Test With Hand-Held Dynamometer Depending on Its Fixation: A Pilot Study

PubMed Central

Kim, Won Kuel; Seo, Kyung Mook; Kang, Si Hyun

2014-01-01

Objective To determine the reliability and validity of hand-held dynamometer (HHD) depending on its fixation in measuring isometric knee extensor strength by comparing the results with an isokinetic dynamometer. Methods Twenty-seven healthy female volunteers participated in this study. The subjects were tested in seated and supine position using three measurement methods: isometric knee extension by isokinetic dynamometer, non-fixed HHD, and fixed HHD. During the measurement, the knee joints of subjects were fixed at a 35° angle from the extended position. The fixed HHD measurement was conducted with the HHD fixed to distal tibia with a Velcro strap; non-fixed HHD was performed with a hand-held method without Velcro fixation. All the measurements were repeated three times and among them, the maximum values of peak torque were used for the analysis. Results The data from the fixed HHD method showed higher validity than the non-fixed method compared with the results of the isokinetic dynamometer. Pearson correlation coefficients (r) between fixed HHD and isokinetic dynamometer method were statistically significant (supine-right: r=0.806, p<0.05; seating-right: r=0.473, p<0.05; supine-left: r=0.524, p<0.05), whereas Pearson correlation coefficients between non-fixed dynamometer and isokinetic dynamometer methods were not statistically significant, except for the result of the supine position of the left leg (r=0.384, p<0.05). Both fixed and non-fixed HHD methods showed excellent inter-rater reliability. However, the fixed HHD method showed a higher reliability than the non-fixed HHD method by considering the intraclass correlation coefficient (fixed HHD, 0.952-0.984; non-fixed HHD, 0.940-0.963). Conclusion Fixation of HHD during measurement in the supine position increases the reliability and validity in measuring the quadriceps strength. PMID:24639931

A new validated method for the simultaneous determination of benzocaine, propylparaben and benzyl alcohol in a bioadhesive gel by HPLC.

PubMed

Pérez-Lozano, P; García-Montoya, E; Orriols, A; Miñarro, M; Ticó, J R; Suñé-Negre, J M

2005-10-04

A new HPLC-RP method has been developed and validated for the simultaneous determination of benzocaine, two preservatives (propylparaben (nipasol) and benzyl alcohol) and degradation products of benzocaine in a semisolid pharmaceutical dosage form (benzocaine gel). The method uses a Nucleosil 120 C18 column and gradient elution. The mobile phase consisted of a mixture of methanol and glacial acetic acid (10%, v/v) at different proportion according to a time-schedule programme, pumped at a flow rate of 2.0 ml min(-1). The DAD detector was set at 258 nm. The validation study was carried out fulfilling the ICH guidelines in order to prove that the new analytical method, meets the reliability characteristics, and these characteristics showed the capacity of analytical method to keep, throughout the time, the fundamental criteria for validation: selectivity, linearity, precision, accuracy and sensitivity. The method was applied during the quality control of benzocaine gel in order to quantify the drug (benzocaine), preservatives and degraded products and proved to be suitable for rapid and reliable quality control method.

The construct validity of session RPE during an intensive camp in young male Karate athletes.

PubMed

Padulo, Johnny; Chaabène, Helmi; Tabben, Montassar; Haddad, Monoem; Gevat, Cecilia; Vando, Stefano; Maurino, Lucio; Chaouachi, Anis; Chamari, Karim

2014-04-01

the aim of this study was to assess the validity of the session rating of perceived exertion (RPE) method and two objective HR-based methods for quantifying karate's training load (TL) in young Karatekas. eleven athletes (age 12.50±1.84 years) participated in this study. The training period/camp was performed on 5 consecutive days with two training session (s) per-day (d). Construct validity of RPE method in young Karate athletes, was studied by correlation analysis between RPE session's training load and both Edwards and Banister's training impulse score' method. significant relationship was found between inter-day (n-11 × d-5 × s-2 = 110) sessions RPE and Edwards (r values from 0.84 to 0.92 p < 0.001) and Banister's (r values from 0.84 to 0.97 p < 0.001), respectively. this study showed that session-RPE can be considered a valid method for quantifying karate's training load in young karate athletes.

Spectroflurimetric estimation of the new antiviral agent ledipasvir in presence of sofosbuvir

NASA Astrophysics Data System (ADS)

Salama, Fathy M.; Attia, Khalid A.; Abouserie, Ahmed A.; El-Olemy, Ahmed; Abolmagd, Ebrahim

2018-02-01

A spectroflurimetric method has been developed and validated for the selective quantitative determination of ledipasvir in presence of sofosbuvir. In this method the native fluorescence of ledipasvir in ethanol at 405 nm was measured after excitation at 340 nm. The proposed method was validated according to ICH guidelines and show high sensitivity, accuracy and precision. Furthermore this method was successfully applied to the analysis of ledipasvir in pharmaceutical dosage form without interference from sofosbuvir and other additives and the results were statistically compared to a reported method and found no significant difference.

Design for validation: An approach to systems validation

NASA Technical Reports Server (NTRS)

Carter, William C.; Dunham, Janet R.; Laprie, Jean-Claude; Williams, Thomas; Howden, William; Smith, Brian; Lewis, Carl M. (Editor)

1989-01-01

Every complex system built is validated in some manner. Computer validation begins with review of the system design. As systems became too complicated for one person to review, validation began to rely on the application of adhoc methods by many individuals. As the cost of the changes mounted and the expense of failure increased, more organized procedures became essential. Attempts at devising and carrying out those procedures showed that validation is indeed a difficult technical problem. The successful transformation of the validation process into a systematic series of formally sound, integrated steps is necessary if the liability inherent in the future digita-system-based avionic and space systems is to be minimized. A suggested framework and timetable for the transformtion are presented. Basic working definitions of two pivotal ideas (validation and system life-cyle) are provided and show how the two concepts interact. Many examples are given of past and present validation activities by NASA and others. A conceptual framework is presented for the validation process. Finally, important areas are listed for ongoing development of the validation process at NASA Langley Research Center.

Dynamic leg length asymmetry during gait is not a valid method for estimating mild anatomic leg length discrepancy.

PubMed

Leporace, Gustavo; Batista, Luiz Alberto; Serra Cruz, Raphael; Zeitoune, Gabriel; Cavalin, Gabriel Armondi; Metsavaht, Leonardo

2018-03-01

The purpose of this study was to test the validity of dynamic leg length discrepancy (DLLD) during gait as a radiation-free screening method for measuring anatomic leg length discrepancy (ALLD). Thirty-three subjects with mild leg length discrepancy walked along a walkway and the dynamic leg length discrepancy (DLLD) was calculated using a motion analysis system. Pearson correlation and paired Student t -tests were applied to calculate the correlation and compare the differences between DLLD and ALLD (α = 0.05). The results of our study showed DLLD is not a valid method to predict ALLD in subjects with mild limb discrepancy.

Evaluation of coarse scale land surface remote sensing albedo product over rugged terrain

NASA Astrophysics Data System (ADS)

Wen, J.; Xinwen, L.; You, D.; Dou, B.

2017-12-01

Satellite derived Land surface albedo is an essential climate variable which controls the earth energy budget and it can be used in applications such as climate change, hydrology, and numerical weather prediction. The accuracy and uncertainty of surface albedo products should be evaluated with a reliable reference truth data prior to applications. And more literatures investigated the validation methods about the albedo validation in a flat or homogenous surface. However, the albedo performance over rugged terrain is still unknow due to the validation method limited. A multi-validation strategy is implemented to give a comprehensive albedo validation, which will involve the high resolution albedo processing, high resolution albedo validation based on in situ albedo, and the method to upscale the high resolution albedo to a coarse scale albedo. Among them, the high resolution albedo generation and the upscale method is the core step for the coarse scale albedo validation. In this paper, the high resolution albedo is generated by Angular Bin algorithm. And a albedo upscale method over rugged terrain is developed to obtain the coarse scale albedo truth. The in situ albedo located 40 sites in mountain area are selected globally to validate the high resolution albedo, and then upscaled to the coarse scale albedo by the upscale method. This paper takes MODIS and GLASS albedo product as a example, and the prelimarily results show the RMSE of MODIS and GLASS albedo product over rugged terrain are 0.047 and 0.057, respectively under the RMSE with 0.036 of high resolution albedo.

A validated UHPLC-tandem mass spectrometry method for quantitative analysis of flavonolignans in milk thistle (Silybum marianum) extracts.

PubMed

Graf, Tyler N; Cech, Nadja B; Polyak, Stephen J; Oberlies, Nicholas H

2016-07-15

Validated methods are needed for the analysis of natural product secondary metabolites. These methods are particularly important to translate in vitro observations to in vivo studies. Herein, a method is reported for the analysis of the key secondary metabolites, a series of flavonolignans and a flavonoid, from an extract prepared from the seeds of milk thistle [Silybum marianum (L.) Gaertn. (Asteraceae)]. This report represents the first UHPLC MS-MS method validated for quantitative analysis of these compounds. The method takes advantage of the excellent resolution achievable with UHPLC to provide a complete analysis in less than 7min. The method is validated using both UV and MS detectors, making it applicable in laboratories with different types of analytical instrumentation available. Lower limits of quantitation achieved with this method range from 0.0400μM to 0.160μM with UV and from 0.0800μM to 0.160μM with MS. The new method is employed to evaluate variability in constituent composition in various commercial S. marianum extracts, and to show that storage of the milk thistle compounds in DMSO leads to degradation. Copyright © 2016 Elsevier B.V. All rights reserved.

Investigation of Content and Face Validity and Reliability of Sociocultural Attitude towards Appearance Questionnaire-3 (SATAQ-3) among Female Adolescents

PubMed Central

Mousazadeh, Somayeh; Rakhshan, Mahnaz; Mohammadi, Fateme

2017-01-01

Objective: This study aimed to determine the psychometric properties of sociocultural attitude towards appearance questionnaire in female adolescents. Method: This was a methodological study. The English version of the questionnaire was translated into Persian, using forward-backward method. Then the face validity, content validity and reliability were checked. To ensure face validity, the questionnaire was given to 25 female adolescents, a psychologist and three nurses, who were required to evaluate the items with respect to problems, ambiguity, relativity, proper terms and grammar, and understandability. For content validity, 15 experts in psychology and nursing, who met the inclusion criteria, were required. They were asked to assess the qualitative of content validity. To determine the quantitative content validity, content validity index and content validity ratio were calculated. At the end, internal consistency of the items was assessed, using Cronbach’s alpha method. Results: According to the expert judgments, content validity ratio was 0.81 and content validity index was 0.91. Besides, the reliability of the questionnaire was confirmed with Cronbach’s alpha = 0.91, and physical and developmental areas showed the highest reliability indices. Conclusion: The aforementioned questionnaire could be used in researches to assess female adolescents’ self-concept. This can be a stepping-stone towards identification of problems and improvement of adolescents’ body image. PMID:28496497

Use of the Method of Triads in the Validation of Sodium and Potassium Intake in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).

PubMed

Pereira, Taísa Sabrina Silva; Cade, Nágela Valadão; Mill, José Geraldo; Sichieri, Rosely; Molina, Maria Del Carmen Bisi

2016-01-01

Biomarkers are a good choice to be used in the validation of food frequency questionnaire due to the independence of their random errors. To assess the validity of the potassium and sodium intake estimated using the Food Frequency Questionnaire ELSA-Brasil. A subsample of participants in the ELSA-Brasil cohort was included in this study in 2009. Sodium and potassium intake were estimated using three methods: Semi-quantitative food frequency questionnaire, 12-hour nocturnal urinary excretion and three 24-hour food records. Correlation coefficients were calculated between the methods, and the validity coefficient was calculated using the method of triads. The 95% confidence intervals for the validity coefficient were estimated using bootstrap sampling. Exact and adjacent agreement and disagreement of the estimated sodium and potassium intake quintiles were compared among three methods. The sample consisted of 246 participants, aged 53±8 years, 52% of women. Validity coefficient for sodium were considered weak (рfood frequency questionnaire actual intake = 0.37 and рbiomarker actual intake = 0.21) and moderate (рfood records actual intake 0.56). The validity coefficient were higher for potassium (рfood frequency questionnaire actual intake = 0.60; рbiomarker actual intake = 0.42; рfood records actual intake = 0.79). Conclusions: The Food Frequency Questionnaire ELSA-Brasil showed good validity in estimating potassium intake in epidemiological studies. For sodium validity was weak, likely due to the non-quantification of the added salt to prepared food.

Validation of a Method for Cylindrospermopsin Determination in Vegetables: Application to Real Samples Such as Lettuce (Lactuca sativa L.)

PubMed Central

Prieto, Ana I.; Díez-Quijada, Leticia; Campos, Alexandre; Vasconcelos, Vitor

2018-01-01

Reports on the occurrence of the cyanobacterial toxin cylindrospermopsin (CYN) have increased worldwide because of CYN toxic effects in humans and animals. If contaminated waters are used for plant irrigation, these could represent a possible CYN exposure route for humans. For the first time, a method employing solid phase extraction and quantification by ultra-performance liquid chromatography–tandem mass spectrometry (UPLC-MS/MS) of CYN was optimized in vegetables matrices such as lettuce (Lactuca sativa). The validated method showed a linear range, from 5 to 500 ng CYN g−1 of fresh weight (f.w.), and detection and quantitation limits (LOD and LOQ) of 0.22 and 0.42 ng CYN g−1 f.w., respectively. The mean recoveries ranged between 85 and 104%, and the intermediate precision from 12.7 to 14.7%. The method showed to be robust for the three different variables tested. Moreover, it was successfully applied to quantify CYN in edible lettuce leaves exposed to CYN-contaminated water (10 µg L−1), showing that the tolerable daily intake (TDI) in the case of CYN could be exceeded in elderly high consumers. The validated method showed good results in terms of sensitivity, precision, accuracy, and robustness for CYN determination in leaf vegetables such as lettuce. More studies are needed in order to prevent the risks associated with the consumption of CYN-contaminated vegetables. PMID:29389882

Causal Interpretations of Psychological Attributes

ERIC Educational Resources Information Center

Kane, Mike

2017-01-01

In the article "Rethinking Traditional Methods of Survey Validation" Andrew Maul describes a minimalist validation methodology for survey instruments, which he suggests is widely used in some areas of psychology and then critiques this methodology empirically and conceptually. He provides a reduction ad absurdum argument by showing that…

Validation of Ion Chromatographic Method for Determination of Standard Inorganic Anions in Treated and Untreated Drinking Water

NASA Astrophysics Data System (ADS)

Ivanova, V.; Surleva, A.; Koleva, B.

2018-06-01

An ion chromatographic method for determination of fluoride, chloride, nitrate and sulphate in untreated and treated drinking waters was described. An automated 850 IC Professional, Metrohm system equipped with conductivity detector and Metrosep A Supp 7-250 (250 x 4 mm) column was used. The validation of the method was performed for simultaneous determination of all studied analytes and the results have showed that the validated method fits the requirements of the current water legislation. The main analytical characteristics were estimated for each of studied analytes: limits of detection, limits of quantification, working and linear ranges, repeatability and intermediate precision, recovery. The trueness of the method was estimated by analysis of certified reference material for soft drinking water. Recovery test was performed on spiked drinking water samples. An uncertainty was estimated. The method was applied for analysis of drinking waters before and after chlorination.

Determination of aliskiren in tablet dosage forms by a validated stability-indicating RP-LC method.

PubMed

Wrasse-Sangoi, M; Sangoi, M S; Oliveira, P R; Secretti, L T; Rolim, C M B

2011-02-01

A reversed-phase liquid chromatography (RP-LC) method is validated for the determination of aliskiren in tablet dosage form. The LC method is carried out on a Waters XBridge C(18) column (150 × 4.6 mm i.d.), maintained at 25°C. The mobile phase consisted of acetonitrile:water (95:5, v/v)/phosphoric acid (25 mM, pH 3.0) (40:60, v/v), run at a flow rate of 1.0 mL/min, with photodiode array detector set at 229 nm. The chromatographic separation is obtained with aliskiren retention time of 3.68 min, and it is linear in the range of 10-300 μg/mL (r = 0.9999). The limits of detection and quantitation are 2.38 and 7.93 μg/mL, respectively. The specificity and stability-indicating capability of the method are proven through degradation studies, which also showed that there is no interference of the formulation excipients, showing that peak is free from any coeluting peak. The method showed adequate precision, with a relative standard deviation (RSD) values lower than 0.92%. Good values of accuracy were also obtained, with a mean value of 99.55%. Experimental design is used during validation to calculate method robustness. The proposed method is applied for the analysis of the tablet dosage forms, contributing to improve the quality control and to assure the therapeutic efficacy.

Uncertainty estimates of purity measurements based on current information: toward a "live validation" of purity methods.

PubMed

Apostol, Izydor; Kelner, Drew; Jiang, Xinzhao Grace; Huang, Gang; Wypych, Jette; Zhang, Xin; Gastwirt, Jessica; Chen, Kenneth; Fodor, Szilan; Hapuarachchi, Suminda; Meriage, Dave; Ye, Frank; Poppe, Leszek; Szpankowski, Wojciech

2012-12-01

To predict precision and other performance characteristics of chromatographic purity methods, which represent the most widely used form of analysis in the biopharmaceutical industry. We have conducted a comprehensive survey of purity methods, and show that all performance characteristics fall within narrow measurement ranges. This observation was used to develop a model called Uncertainty Based on Current Information (UBCI), which expresses these performance characteristics as a function of the signal and noise levels, hardware specifications, and software settings. We applied the UCBI model to assess the uncertainty of purity measurements, and compared the results to those from conventional qualification. We demonstrated that the UBCI model is suitable to dynamically assess method performance characteristics, based on information extracted from individual chromatograms. The model provides an opportunity for streamlining qualification and validation studies by implementing a "live validation" of test results utilizing UBCI as a concurrent assessment of measurement uncertainty. Therefore, UBCI can potentially mitigate the challenges associated with laborious conventional method validation and facilitates the introduction of more advanced analytical technologies during the method lifecycle.

The construct validity of session RPE during an intensive camp in young male Karate athletes

PubMed Central

Padulo, Johnny; Chaabène, Helmi; Tabben, Montassar; Haddad, Monoem; Gevat, Cecilia; Vando, Stefano; Maurino, Lucio; Chaouachi, Anis; Chamari, Karim

2014-01-01

Summary Background: the aim of this study was to assess the validity of the session rating of perceived exertion (RPE) method and two objective HR-based methods for quantifying karate’s training load (TL) in young Karatekas. Methods: eleven athletes (age 12.50±1.84 years) participated in this study. The training period/camp was performed on 5 consecutive days with two training session (s) per-day (d). Construct validity of RPE method in young Karate athletes, was studied by correlation analysis between RPE session’s training load and both Edwards and Banister’s training impulse score’ method. Results: significant relationship was found between inter-day (n-11 × d-5 × s-2 = 110) sessions RPE and Edwards (r values from 0.84 to 0.92 p < 0.001) and Banister’s (r values from 0.84 to 0.97 p < 0.001), respectively Conclusion: this study showed that session-RPE can be considered a valid method for quantifying karate’s training load in young karate athletes. PMID:25332921

Validation and Clinical Evaluation of a Novel Method To Measure Miltefosine in Leishmaniasis Patients Using Dried Blood Spot Sample Collection

PubMed Central

Rosing, H.; Hillebrand, M. J. X.; Blesson, S.; Mengesha, B.; Diro, E.; Hailu, A.; Schellens, J. H. M.; Beijnen, J. H.

2016-01-01

To facilitate future pharmacokinetic studies of combination treatments against leishmaniasis in remote regions in which the disease is endemic, a simple cheap sampling method is required for miltefosine quantification. The aims of this study were to validate a liquid chromatography-tandem mass spectrometry method to quantify miltefosine in dried blood spot (DBS) samples and to validate its use with Ethiopian patients with visceral leishmaniasis (VL). Since hematocrit (Ht) levels are typically severely decreased in VL patients, returning to normal during treatment, the method was evaluated over a range of clinically relevant Ht values. Miltefosine was extracted from DBS samples using a simple method of pretreatment with methanol, resulting in >97% recovery. The method was validated over a calibration range of 10 to 2,000 ng/ml, and accuracy and precision were within ±11.2% and ≤7.0% (≤19.1% at the lower limit of quantification), respectively. The method was accurate and precise for blood spot volumes between 10 and 30 μl and for Ht levels of 20 to 35%, although a linear effect of Ht levels on miltefosine quantification was observed in the bioanalytical validation. DBS samples were stable for at least 162 days at 37°C. Clinical validation of the method using paired DBS and plasma samples from 16 VL patients showed a median observed DBS/plasma miltefosine concentration ratio of 0.99, with good correlation (Pearson's r = 0.946). Correcting for patient-specific Ht levels did not further improve the concordance between the sampling methods. This successfully validated method to quantify miltefosine in DBS samples was demonstrated to be a valid and practical alternative to venous blood sampling that can be applied in future miltefosine pharmacokinetic studies with leishmaniasis patients, without Ht correction. PMID:26787691

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.

A New Green Method for the Quantitative Analysis of Enrofloxacin by Fourier-Transform Infrared Spectroscopy.

PubMed

Rebouças, Camila Tavares; Kogawa, Ana Carolina; Salgado, Hérida Regina Nunes

2018-05-18

Background: A green analytical chemistry method was developed for quantification of enrofloxacin in tablets. The drug, a second-generation fluoroquinolone, was first introduced in veterinary medicine for the treatment of various bacterial species. Objective: This study proposed to develop, validate, and apply a reliable, low-cost, fast, and simple IR spectroscopy method for quantitative routine determination of enrofloxacin in tablets. Methods: The method was completely validated according to the International Conference on Harmonisation guidelines, showing accuracy, precision, selectivity, robustness, and linearity. Results: It was linear over the concentration range of 1.0-3.0 mg with correlation coefficients >0.9999 and LOD and LOQ of 0.12 and 0.36 mg, respectively. Conclusions: Now that this IR method has met performance qualifications, it can be adopted and applied for the analysis of enrofloxacin tablets for production process control. The validated method can also be utilized to quantify enrofloxacin in tablets and thus is an environmentally friendly alternative for the routine analysis of enrofloxacin in quality control. Highlights: A new green method for the quantitative analysis of enrofloxacin by Fourier-Transform Infrared spectroscopy was validated. It is a fast, clean and low-cost alternative for the evaluation of enrofloxacin tablets.

Display format, highlight validity, and highlight method: Their effects on search performance

NASA Technical Reports Server (NTRS)

Donner, Kimberly A.; Mckay, Tim D.; Obrien, Kevin M.; Rudisill, Marianne

1991-01-01

Display format and highlight validity were shown to affect visual display search performance; however, these studies were conducted on small, artificial displays of alphanumeric stimuli. A study manipulating these variables was conducted using realistic, complex Space Shuttle information displays. A 2x2x3 within-subjects analysis of variance found that search times were faster for items in reformatted displays than for current displays. Responses to valid applications of highlight were significantly faster than responses to non or invalidly highlighted applications. The significant format by highlight validity interaction showed that there was little difference in response time to both current and reformatted displays when the highlight validity was applied; however, under the non or invalid highlight conditions, search times were faster with reformatted displays. A separate within-subject analysis of variance of display format, highlight validity, and several highlight methods did not reveal a main effect of highlight method. In addition, observed display search times were compared to search time predicted by Tullis' Display Analysis Program. Benefits of highlighting and reformatting displays to enhance search and the necessity to consider highlight validity and format characteristics in tandem for predicting search performance are discussed.

Hypersensitivity to sound in tinnitus patients: an analysis of a construct based on questionnaire and audiological data.

PubMed

Bläsing, Lena; Goebel, Gerhard; Flötzinger, Uta; Berthold, Anke; Kröner-Herwig, Birgit

2010-07-01

The purpose of this study was to analyse the Questionnaire on Hypersensitivity to Sound (GUF; Nelting & Finlayson, 2004 ) and to improve its validity based on the analysis of intercorrelations (single item level) with other methods of assessing hyperacusis (uncomfortable loudness level, individual loudness function, self-rated severity of hyperacusis). Subjects consisted of 91 inpatients with tinnitus and hyperacusis. The GUF showed a good reliability (alpha = .92). The factorial structure of the questionnaire reported by Nelting et al (2002) was not completely supported by the evidence in this study. The total score and the single items showed small to moderate correlations with the other modes of measuring hyperacusis. Evidence for convergent and discriminant validity were found, but overall the results corroborate the conceptual heterogeneity of the construct hyperacusis and its dependency on the assessment method. Four items of the GUF with particularly low correlations were excluded from the questionnaire. The revised GUF total score showed slightly but not statistically significant higher convergent and discriminant validity.

The use of the FACT-H&N (v4) in clinical settings within a developing country: a mixed method study.

PubMed

Bilal, Sobia; Doss, Jennifer Geraldine; Rogers, Simon N

2014-12-01

In the last decade there has been an increasing awareness about 'quality of life' (QOL) of cancer survivors in developing countries. The study aimed to cross-culturally adapt and validate the FACT-H&N (v4) in Urdu language for Pakistani head and neck cancer patients. In this study the 'same language adaptation method' was used. Cognitive debriefing through in-depth interviews of 25 patients to assess semantic, operational and conceptual equivalence was done. The validation phase included 50 patients to evaluate the psychometric properties. The translated FACT-H&N was easily comprehended (100%). Cronbach's alpha for FACT-G subscales ranged from 0.726 - 0.969. The head and neck subscale and Pakistani questions subscale showed low internal consistency (0.426 and 0.541 respectively). Instrument demonstrated known-group validity in differentiating patients of different clinical stages, treatment status and tumor sites (p < 0.05). Most FACT summary scales correlated strongly with each other (r > 0.75) and showed convergent validity (r > 0.90), with little discriminant validity. Factor analysis revealed 6 factors explaining 85.1% of the total variance with very good (>0.8) Kaiser-Meyer-Olkin and highly significant Bartlett's Test of Sphericity (p < 0.001). The cross-culturally adapted FACT-H&N into Urdu language showed adequate reliability and validity to be incorporated in Pakistani clinical settings for head and neck cancer patients. Copyright © 2014 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Evaluating the statistical performance of less applied algorithms in classification of worldview-3 imagery data in an urbanized landscape

NASA Astrophysics Data System (ADS)

Ranaie, Mehrdad; Soffianian, Alireza; Pourmanafi, Saeid; Mirghaffari, Noorollah; Tarkesh, Mostafa

2018-03-01

In recent decade, analyzing the remotely sensed imagery is considered as one of the most common and widely used procedures in the environmental studies. In this case, supervised image classification techniques play a central role. Hence, taking a high resolution Worldview-3 over a mixed urbanized landscape in Iran, three less applied image classification methods including Bagged CART, Stochastic gradient boosting model and Neural network with feature extraction were tested and compared with two prevalent methods: random forest and support vector machine with linear kernel. To do so, each method was run ten time and three validation techniques was used to estimate the accuracy statistics consist of cross validation, independent validation and validation with total of train data. Moreover, using ANOVA and Tukey test, statistical difference significance between the classification methods was significantly surveyed. In general, the results showed that random forest with marginal difference compared to Bagged CART and stochastic gradient boosting model is the best performing method whilst based on independent validation there was no significant difference between the performances of classification methods. It should be finally noted that neural network with feature extraction and linear support vector machine had better processing speed than other.

What Do You Think You Are Measuring? A Mixed-Methods Procedure for Assessing the Content Validity of Test Items and Theory-Based Scaling

PubMed Central

Koller, Ingrid; Levenson, Michael R.; Glück, Judith

2017-01-01

The valid measurement of latent constructs is crucial for psychological research. Here, we present a mixed-methods procedure for improving the precision of construct definitions, determining the content validity of items, evaluating the representativeness of items for the target construct, generating test items, and analyzing items on a theoretical basis. To illustrate the mixed-methods content-scaling-structure (CSS) procedure, we analyze the Adult Self-Transcendence Inventory, a self-report measure of wisdom (ASTI, Levenson et al., 2005). A content-validity analysis of the ASTI items was used as the basis of psychometric analyses using multidimensional item response models (N = 1215). We found that the new procedure produced important suggestions concerning five subdimensions of the ASTI that were not identifiable using exploratory methods. The study shows that the application of the suggested procedure leads to a deeper understanding of latent constructs. It also demonstrates the advantages of theory-based item analysis. PMID:28270777

Validated spectrofluorometric method for determination of gemfibrozil in self nanoemulsifying drug delivery systems (SNEDDS)

NASA Astrophysics Data System (ADS)

Sierra Villar, Ana M.; Calpena Campmany, Ana C.; Bellowa, Lyda Halbaut; Trenchs, Monserrat Aróztegui; Naveros, Beatriz Clares

2013-09-01

A spectrofluorometric method has been developed and validated for the determination of gemfibrozil. The method is based on the excitation and emission capacities of gemfibrozil with excitation and emission wavelengths of 276 and 304 nm respectively. This method allows de determination of the drug in a self-nanoemulsifying drug delivery system (SNEDDS) for improve its intestinal absorption. Results obtained showed linear relationships with good correlation coefficients (r2 > 0.999) and low limits of detection and quantification (LOD of 0.075 μg mL-1 and LOQ of 0.226 μg mL-1) in the range of 0.2-5 μg mL-1, equally this method showed a good robustness and stability. Thus the amounts of gemfibrozil released from SNEDDS contained in gastro resistant hard gelatine capsules were analysed, and release studies could be performed satisfactorily.

Validated spectrofluorometric method for determination of gemfibrozil in self nanoemulsifying drug delivery systems (SNEDDS).

PubMed

Sierra Villar, Ana M; Calpena Campmany, Ana C; Bellowa, Lyda Halbaut; Trenchs, Monserrat Aróztegui; Naveros, Beatriz Clares

2013-09-01

A spectrofluorometric method has been developed and validated for the determination of gemfibrozil. The method is based on the excitation and emission capacities of gemfibrozil with excitation and emission wavelengths of 276 and 304 nm respectively. This method allows de determination of the drug in a self-nanoemulsifying drug delivery system (SNEDDS) for improve its intestinal absorption. Results obtained showed linear relationships with good correlation coefficients (r(2)>0.999) and low limits of detection and quantification (LOD of 0.075 μg mL(-1) and LOQ of 0.226 μg mL(-1)) in the range of 0.2-5 μg mL(-1), equally this method showed a good robustness and stability. Thus the amounts of gemfibrozil released from SNEDDS contained in gastro resistant hard gelatine capsules were analysed, and release studies could be performed satisfactorily. Copyright © 2013 Elsevier B.V. All rights reserved.

Cumulative query method for influenza surveillance using search engine data.

PubMed

Seo, Dong-Woo; Jo, Min-Woo; Sohn, Chang Hwan; Shin, Soo-Yong; Lee, JaeHo; Yu, Maengsoo; Kim, Won Young; Lim, Kyoung Soo; Lee, Sang-Il

2014-12-16

Internet search queries have become an important data source in syndromic surveillance system. However, there is currently no syndromic surveillance system using Internet search query data in South Korea. The objective of this study was to examine correlations between our cumulative query method and national influenza surveillance data. Our study was based on the local search engine, Daum (approximately 25% market share), and influenza-like illness (ILI) data from the Korea Centers for Disease Control and Prevention. A quota sampling survey was conducted with 200 participants to obtain popular queries. We divided the study period into two sets: Set 1 (the 2009/10 epidemiological year for development set 1 and 2010/11 for validation set 1) and Set 2 (2010/11 for development Set 2 and 2011/12 for validation Set 2). Pearson's correlation coefficients were calculated between the Daum data and the ILI data for the development set. We selected the combined queries for which the correlation coefficients were .7 or higher and listed them in descending order. Then, we created a cumulative query method n representing the number of cumulative combined queries in descending order of the correlation coefficient. In validation set 1, 13 cumulative query methods were applied, and 8 had higher correlation coefficients (min=.916, max=.943) than that of the highest single combined query. Further, 11 of 13 cumulative query methods had an r value of ≥.7, but 4 of 13 combined queries had an r value of ≥.7. In validation set 2, 8 of 15 cumulative query methods showed higher correlation coefficients (min=.975, max=.987) than that of the highest single combined query. All 15 cumulative query methods had an r value of ≥.7, but 6 of 15 combined queries had an r value of ≥.7. Cumulative query method showed relatively higher correlation with national influenza surveillance data than combined queries in the development and validation set.

Culture Training: Validation Evidence for the Culture Assimilator.

ERIC Educational Resources Information Center

Mitchell, Terence R.; And Others

The culture assimilator, a programed self-instructional approach to culture training, is described and a series of laboratory experiments and field studies validating the culture assimilator are reviewed. These studies show that the culture assimilator is an effective method of decreasing some of the stress experienced when one works with people…

Development and Validation of New Discriminative Dissolution Method for Carvedilol Tablets

PubMed Central

Raju, V.; Murthy, K. V. R.

2011-01-01

The objective of the present study was to develop and validate a discriminative dissolution method for evaluation of carvedilol tablets. Different conditions such as type of dissolution medium, volume of dissolution medium and rotation speed of paddle were evaluated. The best in vitro dissolution profile was obtained using Apparatus II (paddle), 50 rpm, 900 ml of pH 6.8 phosphate buffer as dissolution medium. The drug release was evaluated by high-performance liquid chromatographic method. The dissolution method was validated according to current ICH and FDA guidelines using parameters such as the specificity, accuracy, precision and stability were evaluated and obtained results were within the acceptable range. The comparison of the obtained dissolution profiles of three different products were investigated using ANOVA-based, model-dependent and model-independent methods, results showed that there is significant difference between the products. The dissolution test developed and validated was adequate for its higher discriminative capacity in differentiating the release characteristics of the products tested and could be applied for development and quality control of carvedilol tablets. PMID:22923865

Development and Validation of a Safety Climate Scale for Manufacturing Industry

PubMed Central

Ghahramani, Abolfazl; Khalkhali, Hamid R.

2015-01-01

Background This paper describes the development of a scale for measuring safety climate. Methods This study was conducted in six manufacturing companies in Iran. The scale developed through conducting a literature review about the safety climate and constructing a question pool. The number of items was reduced to 71 after performing a screening process. Results The result of content validity analysis showed that 59 items had excellent item content validity index (≥ 0.78) and content validity ratio (> 0.38). The exploratory factor analysis resulted in eight safety climate dimensions. The reliability value for the final 45-item scale was 0.96. The result of confirmatory factor analysis showed that the safety climate model is satisfactory. Conclusion This study produced a valid and reliable scale for measuring safety climate in manufacturing companies. PMID:26106508

A New Method to Cross Calibrate and Validate TOMS, SBUV/2, and SCIAMACHY Measurements

NASA Technical Reports Server (NTRS)

Ahmad, Ziauddin; Hilsenrath, Ernest; Einaudi, Franco (Technical Monitor)

2001-01-01

A unique method to validate back scattered ultraviolet (buv) type satellite data that complements the measurements from existing ground networks is proposed. The method involves comparing the zenith sky radiance measurements from the ground to the nadir radiance measurements taken from space. Since the measurements are compared directly, the proposed method is superior to any other method that involves comparing derived products (for example, ozone), because comparison of derived products involve inversion algorithms which are susceptible to several type of errors. Forward radiative transfer (RT) calculations show that for an aerosol free atmosphere, the ground-based zenith sky radiance measurement and the satellite nadir radiance measurements can be predicted with an accuracy of better than 1 percent. The RT computations also show that for certain values of the solar zenith angles, the radiance comparisons could be better than half a percent. This accuracy is practically independent of ozone amount and aerosols in the atmosphere. Experiences with the Shuttle Solar Backscatter Ultraviolet (SSBUV) program show that the accuracy of the ground-based zenith sky radiance measuring instrument can be maintained at a level of a few tenth of a percent. This implies that the zenith sky radiance measurements can be used to validate Total Ozone Mapping Spectrometer (TOMS), Solar Backscatter Ultraviolet (SBUV/2), and The SCanning Imaging Absorption SpectroMeter for Atmospheric CHartographY (SCIAMACHY) radiance data. Also, this method will help improve the long term precision of the measurements for better trend detection and the accuracy of other BUV products such as tropospheric ozone and aerosols. Finally, in the long term, this method is a good candidate to inter-calibrate and validate long term observations of upcoming operational instruments such as Global Ozone Monitoring Experiment (GOME-2), Ozone Mapping Instrument (OMI), Ozone Dynamics Ultraviolet Spectrometer (ODUS), and Ozone Mapping and Profiler Suite (OMPS).

Automated finite element meshing of the lumbar spine: Verification and validation with 18 specimen-specific models.

PubMed

Campbell, J Q; Coombs, D J; Rao, M; Rullkoetter, P J; Petrella, A J

2016-09-06

The purpose of this study was to seek broad verification and validation of human lumbar spine finite element models created using a previously published automated algorithm. The automated algorithm takes segmented CT scans of lumbar vertebrae, automatically identifies important landmarks and contact surfaces, and creates a finite element model. Mesh convergence was evaluated by examining changes in key output variables in response to mesh density. Semi-direct validation was performed by comparing experimental results for a single specimen to the automated finite element model results for that specimen with calibrated material properties from a prior study. Indirect validation was based on a comparison of results from automated finite element models of 18 individual specimens, all using one set of generalized material properties, to a range of data from the literature. A total of 216 simulations were run and compared to 186 experimental data ranges in all six primary bending modes up to 7.8Nm with follower loads up to 1000N. Mesh convergence results showed less than a 5% difference in key variables when the original mesh density was doubled. The semi-direct validation results showed that the automated method produced results comparable to manual finite element modeling methods. The indirect validation results showed a wide range of outcomes due to variations in the geometry alone. The studies showed that the automated models can be used to reliably evaluate lumbar spine biomechanics, specifically within our intended context of use: in pure bending modes, under relatively low non-injurious simulated in vivo loads, to predict torque rotation response, disc pressures, and facet forces. Copyright © 2016 Elsevier Ltd. All rights reserved.

Simultaneous Validation of Seven Physical Activity Questionnaires Used in Japanese Cohorts for Estimating Energy Expenditure: A Doubly Labeled Water Study.

PubMed

Sasai, Hiroyuki; Nakata, Yoshio; Murakami, Haruka; Kawakami, Ryoko; Nakae, Satoshi; Tanaka, Shigeho; Ishikawa-Takata, Kazuko; Yamada, Yosuke; Miyachi, Motohiko

2018-04-28

Physical activity questionnaires (PAQs) used in large-scale Japanese cohorts have rarely been simultaneously validated against the gold standard doubly labeled water (DLW) method. This study examined the validity of seven PAQs used in Japan for estimating energy expenditure against the DLW method. Twenty healthy Japanese adults (9 men; mean age, 32.4 [standard deviation {SD}, 9.4] years, mainly researchers and students) participated in this study. Fifteen-day daily total energy expenditure (TEE) and basal metabolic rate (BMR) were measured using the DLW method and a metabolic chamber, respectively. Activity energy expenditure (AEE) was calculated as TEE - BMR - 0.1 × TEE. Seven PAQs were self-administered to estimate TEE and AEE. The mean measured values of TEE and AEE were 2,294 (SD, 318) kcal/day and 721 (SD, 161) kcal/day, respectively. All of the PAQs indicated moderate-to-strong correlations with the DLW method in TEE (rho = 0.57-0.84). Two PAQs (Japan Public Health Center Study [JPHC]-PAQ Short and JPHC-PAQ Long) showed significant equivalence in TEE and moderate intra-class correlation coefficients (ICC). None of the PAQs showed significantly equivalent AEE estimates, with differences ranging from -547 to 77 kcal/day. Correlations and ICCs in AEE were mostly weak or fair (rho = 0.02-0.54, and ICC = 0.00-0.44). Only JPHC-PAQ Short provided significant and fair agreement with the DLW method. TEE estimated by the PAQs showed moderate or strong correlations with the results of DLW. Two PAQs showed equivalent TEE and moderate agreement. None of the PAQs showed equivalent AEE estimation to the gold standard, with weak-to-fair correlations and agreements. Further studies with larger sample sizes are needed to confirm these findings.

Development of an Itemwise Efficiency Scoring Method: Concurrent, Convergent, Discriminant, and Neuroimaging-Based Predictive Validity Assessed in a Large Community Sample

PubMed Central

Moore, Tyler M.; Reise, Steven P.; Roalf, David R.; Satterthwaite, Theodore D.; Davatzikos, Christos; Bilker, Warren B.; Port, Allison M.; Jackson, Chad T.; Ruparel, Kosha; Savitt, Adam P.; Baron, Robert B.; Gur, Raquel E.; Gur, Ruben C.

2016-01-01

Traditional “paper-and-pencil” testing is imprecise in measuring speed and hence limited in assessing performance efficiency, but computerized testing permits precision in measuring itemwise response time. We present a method of scoring performance efficiency (combining information from accuracy and speed) at the item level. Using a community sample of 9,498 youths age 8-21, we calculated item-level efficiency scores on four neurocognitive tests, and compared the concurrent, convergent, discriminant, and predictive validity of these scores to simple averaging of standardized speed and accuracy-summed scores. Concurrent validity was measured by the scores' abilities to distinguish men from women and their correlations with age; convergent and discriminant validity were measured by correlations with other scores inside and outside of their neurocognitive domains; predictive validity was measured by correlations with brain volume in regions associated with the specific neurocognitive abilities. Results provide support for the ability of itemwise efficiency scoring to detect signals as strong as those detected by standard efficiency scoring methods. We find no evidence of superior validity of the itemwise scores over traditional scores, but point out several advantages of the former. The itemwise efficiency scoring method shows promise as an alternative to standard efficiency scoring methods, with overall moderate support from tests of four different types of validity. This method allows the use of existing item analysis methods and provides the convenient ability to adjust the overall emphasis of accuracy versus speed in the efficiency score, thus adjusting the scoring to the real-world demands the test is aiming to fulfill. PMID:26866796

Laser ultrasonics for measurements of high-temperature elastic properties and internal temperature distribution

NASA Astrophysics Data System (ADS)

Matsumoto, Takahiro; Nagata, Yasuaki; Nose, Tetsuro; Kawashima, Katsuhiro

2001-06-01

We show two kinds of demonstrations using a laser ultrasonic method. First, we present the results of Young's modulus of ceramics at temperatures above 1600 °C. Second, we introduce the method to determine the internal temperature distribution of a hot steel plate with errors of less than 3%. We compare the results obtained by this laser ultrasonic method with conventional contact techniques to show the validity of this method.

A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error.

PubMed

Yang, Harry; Zhang, Jianchun

2015-01-01

The primary purpose of method validation is to demonstrate that the method is fit for its intended use. Traditionally, an analytical method is deemed valid if its performance characteristics such as accuracy and precision are shown to meet prespecified acceptance criteria. However, these acceptance criteria are not directly related to the method's intended purpose, which is usually a gurantee that a high percentage of the test results of future samples will be close to their true values. Alternate "fit for purpose" acceptance criteria based on the concept of total error have been increasingly used. Such criteria allow for assessing method validity, taking into account the relationship between accuracy and precision. Although several statistical test methods have been proposed in literature to test the "fit for purpose" hypothesis, the majority of the methods are not designed to protect the risk of accepting unsuitable methods, thus having the potential to cause uncontrolled consumer's risk. In this paper, we propose a test method based on generalized pivotal quantity inference. Through simulation studies, the performance of the method is compared to five existing approaches. The results show that both the new method and the method based on β-content tolerance interval with a confidence level of 90%, hereafter referred to as the β-content (0.9) method, control Type I error and thus consumer's risk, while the other existing methods do not. It is further demonstrated that the generalized pivotal quantity method is less conservative than the β-content (0.9) method when the analytical methods are biased, whereas it is more conservative when the analytical methods are unbiased. Therefore, selection of either the generalized pivotal quantity or β-content (0.9) method for an analytical method validation depends on the accuracy of the analytical method. It is also shown that the generalized pivotal quantity method has better asymptotic properties than all of the current methods. Analytical methods are often used to ensure safety, efficacy, and quality of medicinal products. According to government regulations and regulatory guidelines, these methods need to be validated through well-designed studies to minimize the risk of accepting unsuitable methods. This article describes a novel statistical test for analytical method validation, which provides better protection for the risk of accepting unsuitable analytical methods. © PDA, Inc. 2015.

Land surveys show regional variability of historical fire regimes and dry forest structure of the western United States.

PubMed

Baker, William L; Williams, Mark A

2018-03-01

An understanding of how historical fire and structure in dry forests (ponderosa pine, dry mixed conifer) varied across the western United States remains incomplete. Yet, fire strongly affects ecosystem services, and forest restoration programs are underway. We used General Land Office survey reconstructions from the late 1800s across 11 landscapes covering ~1.9 million ha in four states to analyze spatial variation in fire regimes and forest structure. We first synthesized the state of validation of our methods using 20 modern validations, 53 historical cross-validations, and corroborating evidence. These show our method creates accurate reconstructions with low errors. One independent modern test reported high error, but did not replicate our method and made many calculation errors. Using reconstructed parameters of historical fire regimes and forest structure from our validated methods, forests were found to be non-uniform across the 11 landscapes, but grouped together in three geographical areas. Each had a mixture of fire severities, but dominated by low-severity fire and low median tree density in Arizona, mixed-severity fire and intermediate to high median tree density in Oregon-California, and high-severity fire and intermediate median tree density in Colorado. Programs to restore fire and forest structure could benefit from regional frameworks, rather than one size fits all. © 2018 by the Ecological Society of America.

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.

Using digital photography in a clinical setting: a valid, accurate, and applicable method to assess food intake.

PubMed

Winzer, Eva; Luger, Maria; Schindler, Karin

2018-06-01

Regular monitoring of food intake is hardly integrated in clinical routine. Therefore, the aim was to examine the validity, accuracy, and applicability of an appropriate and also quick and easy-to-use tool for recording food intake in a clinical setting. Two digital photography methods, the postMeal method with a picture after the meal, the pre-postMeal method with a picture before and after the meal, and the visual estimation method (plate diagram; PD) were compared against the reference method (weighed food records; WFR). A total of 420 dishes from lunch (7 weeks) were estimated with both photography methods and the visual method. Validity, applicability, accuracy, and precision of the estimation methods, and additionally food waste, macronutrient composition, and energy content were examined. Tests of validity revealed stronger correlations for photography methods (postMeal: r = 0.971, p < 0.001; pre-postMeal: r = 0.995, p < 0.001) compared to the visual estimation method (r = 0.810; p < 0.001). The pre-postMeal method showed smaller variability (bias < 1 g) and also smaller overestimation and underestimation. This method accurately and precisely estimated portion sizes in all food items. Furthermore, the total food waste was 22% for lunch over the study period. The highest food waste was observed in salads and the lowest in desserts. The pre-postMeal digital photography method is valid, accurate, and applicable in monitoring food intake in clinical setting, which enables a quantitative and qualitative dietary assessment. Thus, nutritional care might be initiated earlier. This method might be also advantageous for quantitative and qualitative evaluation of food waste, with a resultantly reduction in costs.

Möglichkeiten und Grenzen der Validierung flächenhaft modellierter Nitrateinträge ins Grundwasser mit der N2/Ar-Methode

NASA Astrophysics Data System (ADS)

Eschenbach, Wolfram; Budziak, Dörte; Elbracht, Jörg; Höper, Heinrich; Krienen, Lisa; Kunkel, Ralf; Meyer, Knut; Well, Reinhard; Wendland, Frank

2018-06-01

Valid models for estimating nitrate emissions from agriculture to groundwater are an indispensable forecasting tool. A major challenge for model validation is the spatial and temporal inconsistency between data from groundwater monitoring points and modelled nitrate inputs into groundwater, and the fact that many existing groundwater monitoring wells cannot be used for validation. With the help of the N2/Ar-method, groundwater monitoring wells in areas with reduced groundwater can now be used for model validation. For this purpose, 484 groundwater monitoring wells were sampled in Lower Saxony. For the first time, modelled potential nitrate concentrations in groundwater recharge (from the DENUZ model) were compared with nitrate input concentrations, which were calculated using the N2/Ar method. The results show a good agreement between both methods for glacial outwash plains and moraine deposits. Although the nitrate degradation processes in groundwater and soil merge seamlessly in areas with a shallow groundwater table, the DENUZ model only calculates denitrification in the soil zone. The DENUZ model thus predicts 27% higher nitrate emissions into the groundwater than the N2/Ar method in such areas. To account for high temporal and spatial variability of nitrate emissions into groundwater, a large number of groundwater monitoring points must be investigated for model validation.

Validating Remotely Sensed Land Surface Evapotranspiration Based on Multi-scale Field Measurements

NASA Astrophysics Data System (ADS)

Jia, Z.; Liu, S.; Ziwei, X.; Liang, S.

2012-12-01

The land surface evapotranspiration plays an important role in the surface energy balance and the water cycle. There have been significant technical and theoretical advances in our knowledge of evapotranspiration over the past two decades. Acquisition of the temporally and spatially continuous distribution of evapotranspiration using remote sensing technology has attracted the widespread attention of researchers and managers. However, remote sensing technology still has many uncertainties coming from model mechanism, model inputs, parameterization schemes, and scaling issue in the regional estimation. Achieving remotely sensed evapotranspiration (RS_ET) with confident certainty is required but difficult. As a result, it is indispensable to develop the validation methods to quantitatively assess the accuracy and error sources of the regional RS_ET estimations. This study proposes an innovative validation method based on multi-scale evapotranspiration acquired from field measurements, with the validation results including the accuracy assessment, error source analysis, and uncertainty analysis of the validation process. It is a potentially useful approach to evaluate the accuracy and analyze the spatio-temporal properties of RS_ET at both the basin and local scales, and is appropriate to validate RS_ET in diverse resolutions at different time-scales. An independent RS_ET validation using this method was presented over the Hai River Basin, China in 2002-2009 as a case study. Validation at the basin scale showed good agreements between the 1 km annual RS_ET and the validation data such as the water balanced evapotranspiration, MODIS evapotranspiration products, precipitation, and landuse types. Validation at the local scale also had good results for monthly, daily RS_ET at 30 m and 1 km resolutions, comparing to the multi-scale evapotranspiration measurements from the EC and LAS, respectively, with the footprint model over three typical landscapes. Although some validation experiments demonstrated that the models yield accurate estimates at flux measurement sites, the question remains whether they are performing well over the broader landscape. Moreover, a large number of RS_ET products have been released in recent years. Thus, we also pay attention to the cross-validation method of RS_ET derived from multi-source models. "The Multi-scale Observation Experiment on Evapotranspiration over Heterogeneous Land Surfaces: Flux Observation Matrix" campaign is carried out at the middle reaches of the Heihe River Basin, China in 2012. Flux measurements from an observation matrix composed of 22 EC and 4 LAS are acquired to investigate the cross-validation of multi-source models over different landscapes. In this case, six remote sensing models, including the empirical statistical model, the one-source and two-source models, the Penman-Monteith equation based model, the Priestley-Taylor equation based model, and the complementary relationship based model, are used to perform an intercomparison. All the results from the two cases of RS_ET validation showed that the proposed validation methods are reasonable and feasible.

A Note on the Incremental Validity of Aggregate Predictors.

ERIC Educational Resources Information Center

Day, H. D.; Marshall, David

Three computer simulations were conducted to show that very high aggregate predictive validity coefficients can occur when the across-case variability in absolute score stability occurring in both the predictor and criterion matrices is quite small. In light of the increase in internal consistency reliability achieved by the method of aggregation…

Ultrasensitive NIR-SERRS Probes with Multiplexed Ratiometric Quantification for In Vivo Antibody Leads Validation.

PubMed

Kang, Homan; Jeong, Sinyoung; Jo, Ahla; Chang, Hyejin; Yang, Jin-Kyoung; Jeong, Cheolhwan; Kyeong, San; Lee, Youn Woo; Samanta, Animesh; Maiti, Kaustabh Kumar; Cha, Myeong Geun; Kim, Taek-Keun; Lee, Sukmook; Jun, Bong-Hyun; Chang, Young-Tae; Chung, Junho; Lee, Ho-Young; Jeong, Dae Hong; Lee, Yoon-Sik

2018-02-01

Immunotargeting ability of antibodies may show significant difference between in vitro and in vivo. To select antibody leads with high affinity and specificity, it is necessary to perform in vivo validation of antibody candidates following in vitro antibody screening. Herein, a robust in vivo validation of anti-tetraspanin-8 antibody candidates against human colon cancer using ratiometric quantification method is reported. The validation is performed on a single mouse and analyzed by multiplexed surface-enhanced Raman scattering using ultrasensitive and near infrared (NIR)-active surface-enhanced resonance Raman scattering nanoprobes (NIR-SERRS dots). The NIR-SERRS dots are composed of NIR-active labels and Au/Ag hollow-shell assembled silica nanospheres. A 93% of NIR-SERRS dots is detectable at a single-particle level and signal intensity is 100-fold stronger than that from nonresonant molecule-labeled spherical Au NPs (80 nm). The result of SERRS-based antibody validation is comparable to that of the conventional method using single-photon-emission computed tomography. The NIR-SERRS-based strategy is an alternate validation method which provides cost-effective and accurate multiplexing measurements for antibody-based drug development. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A methodology for collecting valid software engineering data

NASA Technical Reports Server (NTRS)

Basili, Victor R.; Weiss, David M.

1983-01-01

An effective data collection method for evaluating software development methodologies and for studying the software development process is described. The method uses goal-directed data collection to evaluate methodologies with respect to the claims made for them. Such claims are used as a basis for defining the goals of the data collection, establishing a list of questions of interest to be answered by data analysis, defining a set of data categorization schemes, and designing a data collection form. The data to be collected are based on the changes made to the software during development, and are obtained when the changes are made. To insure accuracy of the data, validation is performed concurrently with software development and data collection. Validation is based on interviews with those people supplying the data. Results from using the methodology show that data validation is a necessary part of change data collection. Without it, as much as 50% of the data may be erroneous. Feasibility of the data collection methodology was demonstrated by applying it to five different projects in two different environments. The application showed that the methodology was both feasible and useful.

Study on evaluation methods for Rayleigh wave dispersion characteristic

USGS Publications Warehouse

Shi, L.; Tao, X.; Kayen, R.; Shi, H.; Yan, S.

2005-01-01

The evaluation of Rayleigh wave dispersion characteristic is the key step for detecting S-wave velocity structure. By comparing the dispersion curves directly with the spectra analysis of surface waves (SASW) method, rather than comparing the S-wave velocity structure, the validity and precision of microtremor-array method (MAM) can be evaluated more objectively. The results from the China - US joint surface wave investigation in 26 sites in Tangshan, China, show that the MAM has the same precision with SASW method in 83% of the 26 sites. The MAM is valid for Rayleigh wave dispersion characteristic testing and has great application potentiality for site S-wave velocity structure detection.

Validated reversed phase LC method for quantitative analysis of polymethoxyflavones in citrus peel extracts.

PubMed

Wang, Zhenyu; Li, Shiming; Ferguson, Stephen; Goodnow, Robert; Ho, Chi-Tang

2008-01-01

Polymethoxyflavones (PMFs), which exist exclusively in the citrus genus, have biological activities including anti-inflammatory, anticarcinogenic, and antiatherogenic properties. A validated RPLC method was developed for quantitative analysis of six major PMFs, namely nobiletin, tangeretin, sinensetin, 5,6,7,4'-tetramethoxyflavone, 3,5,6,7,3',4'-hexamethoxyflavone, and 3,5,6,7,8,3',4'-heptamethoxyflavone. The polar embedded LC stationary phase was able to fully resolve the six analogues. The developed method was fully validated in terms of linearity, accuracy, precision, sensitivity, and system suitability. The LOD of the method was calculated as 0.15 microg/mL and the recovery rate was between 97.0 and 105.1%. This analytical method was successfully applied to quantify the individual PMFs in four commercially available citrus peel extracts (CPEs). Each extract shows significant difference in the PMF composition and concentration. This method may provide a simple, rapid, and reliable tool to help reveal the correlation between the bioactivity of the PMF extracts and the individual PMF content.

Registration of in vivo MR to histology of rodent brains using blockface imaging

NASA Astrophysics Data System (ADS)

Uberti, Mariano; Liu, Yutong; Dou, Huanyu; Mosley, R. Lee; Gendelman, Howard E.; Boska, Michael

2009-02-01

Registration of MRI to histopathological sections can enhance bioimaging validation for use in pathobiologic, diagnostic, and therapeutic evaluations. However, commonly used registration methods fall short of this goal due to tissue shrinkage and tearing after brain extraction and preparation. In attempts to overcome these limitations we developed a software toolbox using 3D blockface imaging as the common space of reference. This toolbox includes a semi-automatic brain extraction technique using constraint level sets (CLS), 3D reconstruction methods for the blockface and MR volume, and a 2D warping technique using thin-plate splines with landmark optimization. Using this toolbox, the rodent brain volume is first extracted from the whole head MRI using CLS. The blockface volume is reconstructed followed by 3D brain MRI registration to the blockface volume to correct the global deformations due to brain extraction and fixation. Finally, registered MRI and histological slices are warped to corresponding blockface images to correct slice specific deformations. The CLS brain extraction technique was validated by comparing manual results showing 94% overlap. The image warping technique was validated by calculating target registration error (TRE). Results showed a registration accuracy of a TRE < 1 pixel. Lastly, the registration method and the software tools developed were used to validate cell migration in murine human immunodeficiency virus type one encephalitis.

Validity of a Simple Method for Measuring Force-Velocity-Power Profile in Countermovement Jump.

PubMed

Jiménez-Reyes, Pedro; Samozino, Pierre; Pareja-Blanco, Fernando; Conceição, Filipe; Cuadrado-Peñafiel, Víctor; González-Badillo, Juan José; Morin, Jean-Benoît

2017-01-01

To analyze the reliability and validity of a simple computation method to evaluate force (F), velocity (v), and power (P) output during a countermovement jump (CMJ) suitable for use in field conditions and to verify the validity of this computation method to compute the CMJ force-velocity (F-v) profile (including unloaded and loaded jumps) in trained athletes. Sixteen high-level male sprinters and jumpers performed maximal CMJs under 6 different load conditions (0-87 kg). A force plate sampling at 1000 Hz was used to record vertical ground-reaction force and derive vertical-displacement data during CMJ trials. For each condition, mean F, v, and P of the push-off phase were determined from both force-plate data (reference method) and simple computation measures based on body mass, jump height (from flight time), and push-off distance and used to establish the linear F-v relationship for each individual. Mean absolute bias values were 0.9% (± 1.6%), 4.7% (± 6.2%), 3.7% (± 4.8%), and 5% (± 6.8%) for F, v, P, and slope of the F-v relationship (S Fv ), respectively. Both methods showed high correlations for F-v-profile-related variables (r = .985-.991). Finally, all variables computed from the simple method showed high reliability, with ICC >.980 and CV <1.0%. These results suggest that the simple method presented here is valid and reliable for computing CMJ force, velocity, power, and F-v profiles in athletes and could be used in practice under field conditions when body mass, push-off distance, and jump height are known.

Application of High-Performance Liquid Chromatography Coupled with Linear Ion Trap Quadrupole Orbitrap Mass Spectrometry for Qualitative and Quantitative Assessment of Shejin-Liyan Granule Supplements.

PubMed

Gu, Jifeng; Wu, Weijun; Huang, Mengwei; Long, Fen; Liu, Xinhua; Zhu, Yizhun

2018-04-11

A method for high-performance liquid chromatography coupled with linear ion trap quadrupole Orbitrap high-resolution mass spectrometry (HPLC-LTQ-Orbitrap MS) was developed and validated for the qualitative and quantitative assessment of Shejin-liyan Granule. According to the fragmentation mechanism and high-resolution MS data, 54 compounds, including fourteen isoflavones, eleven ligands, eight flavonoids, six physalins, six organic acids, four triterpenoid saponins, two xanthones, two alkaloids, and one licorice coumarin, were identified or tentatively characterized. In addition, ten of the representative compounds (matrine, galuteolin, tectoridin, iridin, arctiin, tectorigenin, glycyrrhizic acid, irigenin, arctigenin, and irisflorentin) were quantified using the validated HPLC-LTQ-Orbitrap MS method. The method validation showed a good linearity with coefficients of determination (r²) above 0.9914 for all analytes. The accuracy of the intra- and inter-day variation of the investigated compounds was 95.0-105.0%, and the precision values were less than 4.89%. The mean recoveries and reproducibilities of each analyte were 95.1-104.8%, with relative standard deviations below 4.91%. The method successfully quantified the ten compounds in Shejin-liyan Granule, and the results show that the method is accurate, sensitive, and reliable.

Development and Validation of RP-HPLC Method for the Estimation of Ivabradine Hydrochloride in Tablets

PubMed Central

Seerapu, Sunitha; Srinivasan, B. P.

2010-01-01

A simple, sensitive, precise and robust reverse–phase high-performance liquid chromatographic method for analysis of ivabradine hydrochloride in pharmaceutical formulations was developed and validated as per ICH guidelines. The separation was performed on SS Wakosil C18AR, 250×4.6 mm, 5 μm column with methanol:25 mM phosphate buffer (60:40 v/v), adjusted to pH 6.5 with orthophosphoric acid, added drop wise, as mobile phase. A well defined chromatographic peak of Ivabradine hydrochloride was exhibited with a retention time of 6.55±0.05 min and tailing factor of 1.14 at the flow rate of 0.8 ml/min and at ambient temperature, when monitored at 285 nm. The linear regression analysis data for calibration plots showed good linear relationship with R=0.9998 in the concentration range of 30-210 μg/ml. The method was validated for precision, recovery and robustness. Intra and Inter-day precision (% relative standard deviation) were always less than 2%. The method showed the mean % recovery of 99.00 and 98.55 % for Ivabrad and Inapure tablets, respectively. The proposed method has been successfully applied to the commercial tablets without any interference of excipients. PMID:21695008

Validation of the Five-Phase Method for Simulating Complex Fenestration Systems with Radiance against Field Measurements

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

Geisler-Moroder, David; Lee, Eleanor S.; Ward, Gregory J.

2016-08-29

The Five-Phase Method (5-pm) for simulating complex fenestration systems with Radiance is validated against field measurements. The capability of the method to predict workplane illuminances, vertical sensor illuminances, and glare indices derived from captured and rendered high dynamic range (HDR) images is investigated. To be able to accurately represent the direct sun part of the daylight not only in sensor point simulations, but also in renderings of interior scenes, the 5-pm calculation procedure was extended. The validation shows that the 5-pm is superior to the Three-Phase Method for predicting horizontal and vertical illuminance sensor values as well as glare indicesmore » derived from rendered images. Even with input data from global and diffuse horizontal irradiance measurements only, daylight glare probability (DGP) values can be predicted within 10% error of measured values for most situations.« less

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

PubMed Central

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

2017-01-01

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

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

PubMed

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

2017-01-01

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

Complementary and Alternative Medicine: Italian Validation of a Questionnaire on Nurses' Personal and Professional Use, Knowledge, and Attitudes.

PubMed

Belletti, Giada; Shorofi, Seyed Afshin; Arbon, Paul; Dal Molin, Alberto

2017-08-01

Patients are showing an increasing interest in the use of complementary and alternative medicine (CAM). Most nurses are open to the adoption of CAM into clinical nursing practice, but they may experience a lack of knowledge about the safe and effective use of these therapies. Several studies concerning nurses' knowledge and attitudes toward CAM have been published, but only in one, the authors (Shorofi and Arbon) used a validated questionnaire. In Italy, there are no validated questionnaires to investigate this aspect of nursing practice. To test the psychometric properties of the Italian Shorofi and Arbon questionnaire for use with Italian nurses. A forward-backward translation method was used to translate the questionnaire from English to Italian. Content validity, face validity and reliability were established. This study examined the potential usefulness of the Shorofi and Arbon questionnaire for the evaluation of CAM knowledge of Italian speaking nurses, which showed good content validity and good reliability.

Elaboration and Validation of the Medication Prescription Safety Checklist 1

PubMed Central

Pires, Aline de Oliveira Meireles; Ferreira, Maria Beatriz Guimarães; do Nascimento, Kleiton Gonçalves; Felix, Márcia Marques dos Santos; Pires, Patrícia da Silva; Barbosa, Maria Helena

2017-01-01

ABSTRACT Objective: to elaborate and validate a checklist to identify compliance with the recommendations for the structure of medication prescriptions, based on the Protocol of the Ministry of Health and the Brazilian Health Surveillance Agency. Method: methodological research, conducted through the validation and reliability analysis process, using a sample of 27 electronic prescriptions. Results: the analyses confirmed the content validity and reliability of the tool. The content validity, obtained by expert assessment, was considered satisfactory as it covered items that represent the compliance with the recommendations regarding the structure of the medication prescriptions. The reliability, assessed through interrater agreement, was excellent (ICC=1.00) and showed perfect agreement (K=1.00). Conclusion: the Medication Prescription Safety Checklist showed to be a valid and reliable tool for the group studied. We hope that this study can contribute to the prevention of adverse events, as well as to the improvement of care quality and safety in medication use. PMID:28793128

Method of Analysis by the U.S. Geological Survey California District Sacramento Laboratory?Determination of Trihalomethane Formation Potential, Method Validation, and Quality-Control Practices

USGS Publications Warehouse

Crepeau, Kathryn L.; Fram, Miranda S.; Bush, Noel

2004-01-01

An analytical method for the determination of the trihalomethane formation potential of water samples has been developed. The trihalomethane formation potential is measured by dosing samples with chlorine under specified conditions of pH, temperature, incubation time, darkness, and residual-free chlorine, and then analyzing the resulting trihalomethanes by purge and trap/gas chromatography equipped with an electron capture detector. Detailed explanations of the method and quality-control practices are provided. Method validation experiments showed that the trihalomethane formation potential varies as a function of time between sample collection and analysis, residual-free chlorine concentration, method of sample dilution, and the concentration of bromide in the sample.

Identifying model error in metabolic flux analysis - a generalized least squares approach.

PubMed

Sokolenko, Stanislav; Quattrociocchi, Marco; Aucoin, Marc G

2016-09-13

The estimation of intracellular flux through traditional metabolic flux analysis (MFA) using an overdetermined system of equations is a well established practice in metabolic engineering. Despite the continued evolution of the methodology since its introduction, there has been little focus on validation and identification of poor model fit outside of identifying "gross measurement error". The growing complexity of metabolic models, which are increasingly generated from genome-level data, has necessitated robust validation that can directly assess model fit. In this work, MFA calculation is framed as a generalized least squares (GLS) problem, highlighting the applicability of the common t-test for model validation. To differentiate between measurement and model error, we simulate ideal flux profiles directly from the model, perturb them with estimated measurement error, and compare their validation to real data. Application of this strategy to an established Chinese Hamster Ovary (CHO) cell model shows how fluxes validated by traditional means may be largely non-significant due to a lack of model fit. With further simulation, we explore how t-test significance relates to calculation error and show that fluxes found to be non-significant have 2-4 fold larger error (if measurement uncertainty is in the 5-10 % range). The proposed validation method goes beyond traditional detection of "gross measurement error" to identify lack of fit between model and data. Although the focus of this work is on t-test validation and traditional MFA, the presented framework is readily applicable to other regression analysis methods and MFA formulations.

Validation of GOSAT XCO2 and XCH4 retrieved by PPDF-S method and evaluation of sensitivity of aerosols to gas concentrations

NASA Astrophysics Data System (ADS)

Iwasaki, C.; Imasu, R.; Bril, A.; Yokota, T.; Yoshida, Y.; Morino, I.; Oshchepkov, S.; Rokotyan, N.; Zakharov, V.; Gribanov, K.

2017-12-01

Photon path length probability density function-Simultaneous (PPDF-S) method is one of effective algorithms for retrieving column-averaged concentrations of carbon dioxide (XCO2) and methane (XCH4) from Greenhouse gases Observing SATellite (GOSAT) spectra in Short Wavelength InfraRed (SWIR) [Oshchepkov et al., 2013]. In this study, we validated XCO2 and XCH4 retrieved by the PPDF-S method through comparison with the Total Carbon Column Observing Network (TCCON) data [Wunch et al., 2011] from 26 sites including additional site of the Ural Atmospheric Station at Kourovka [57.038°N and 59.545°E], Russia. Validation results using TCCON data show that bias and its standard deviation of PPDF-S data are respectively 0.48 and 2.10 ppm for XCO2, and -0.73 and 15.77 ppb for XCH4. The results for XCO2 are almost identical with those of Iwasaki et al. [2017] for which the validation data were limited at selected 11 sites. However, the bias of XCH4 shows opposite sign against that of Iwasaki et al. [2017]. Furthermore, the data at Kourouvka showed different features particularly for XCH4. In order to investigate the causes for the differences, we have carried out simulation studies mainly focusing on the effects of aerosols which modify the light path length of solar radiation [O'Brien and Rayner, 2002; Aben et al., 2007; Oshchepkov et al., 2008]. Based on the simulation studies using multiple radiation transfer code based on Discrete Ordinate Method (DOM), Polarization System for Transfer of Atmospheric Radiation3 (Pstar3) [Ota et al., 2010], sensitivity of aerosols to gas concentrations was examined.

Validation of a multi-residue method for the determination of several antibiotic groups in honey by LC-MS/MS.

PubMed

Bohm, Detlef A; Stachel, Carolin S; Gowik, Petra

2012-07-01

The presented multi-method was developed for the confirmation of 37 antibiotic substances from the six antibiotic groups: macrolides, lincosamides, quinolones, tetracyclines, pleuromutilines and diamino-pyrimidine derivatives. All substances were analysed simultaneously in a single analytical run with the same procedure, including an extraction with buffer, a clean-up by solid-phase extraction, and the measurement by liquid chromatography tandem mass spectrometry in ESI+ mode. The method was validated on the basis of an in-house validation concept with factorial design by combination of seven factors to check the robustness in a concentration range of 5-50 μg kg(-1). The honeys used were of different types with regard to colour and origin. The values calculated for the validation parameters-decision limit CCα (range, 7.5-12.9 μg kg(-1)), detection capability CCβ (range, 9.4-19.9 μg kg(-1)), within-laboratory reproducibility RSD(wR) (<20% except for tulathromycin with 23.5% and tylvalosin with 21.4 %), repeatability RSD(r) (<20% except for tylvalosin with 21.1%), and recovery (range, 92-106%)-were acceptable and in agreement with the criteria of Commission Decision 2002/657/EC. The validation results showed that the method was applicable for the residue analysis of antibiotics in honey to substances with and without recommended concentrations, although some changes had been tested during validation to determine the robustness of the method.

Reliability and Validity of the Footprint Assessment Method Using Photoshop CS5 Software in Young People with Down Syndrome.

PubMed

Gutiérrez-Vilahú, Lourdes; Massó-Ortigosa, Núria; Rey-Abella, Ferran; Costa-Tutusaus, Lluís; Guerra-Balic, Myriam

2016-05-01

People with Down syndrome present skeletal abnormalities in their feet that can be analyzed by commonly used gold standard indices (the Hernández-Corvo index, the Chippaux-Smirak index, the Staheli arch index, and the Clarke angle) based on footprint measurements. The use of Photoshop CS5 software (Adobe Systems Software Ireland Ltd, Dublin, Ireland) to measure footprints has been validated in the general population. The present study aimed to assess the reliability and validity of this footprint assessment technique in the population with Down syndrome. Using optical podography and photography, 44 footprints from 22 patients with Down syndrome (11 men [mean ± SD age, 23.82 ± 3.12 years] and 11 women [mean ± SD age, 24.82 ± 6.81 years]) were recorded in a static bipedal standing position. A blinded observer performed the measurements using a validated manual method three times during the 4-month study, with 2 months between measurements. Test-retest was used to check the reliability of the Photoshop CS5 software measurements. Validity and reliability were obtained by intraclass correlation coefficient (ICC). The reliability test for all of the indices showed very good values for the Photoshop CS5 method (ICC, 0.982-0.995). Validity testing also found no differences between the techniques (ICC, 0.988-0.999). The Photoshop CS5 software method is reliable and valid for the study of footprints in young people with Down syndrome.

Cross-validation to select Bayesian hierarchical models in phylogenetics.

PubMed

Duchêne, Sebastián; Duchêne, David A; Di Giallonardo, Francesca; Eden, John-Sebastian; Geoghegan, Jemma L; Holt, Kathryn E; Ho, Simon Y W; Holmes, Edward C

2016-05-26

Recent developments in Bayesian phylogenetic models have increased the range of inferences that can be drawn from molecular sequence data. Accordingly, model selection has become an important component of phylogenetic analysis. Methods of model selection generally consider the likelihood of the data under the model in question. In the context of Bayesian phylogenetics, the most common approach involves estimating the marginal likelihood, which is typically done by integrating the likelihood across model parameters, weighted by the prior. Although this method is accurate, it is sensitive to the presence of improper priors. We explored an alternative approach based on cross-validation that is widely used in evolutionary analysis. This involves comparing models according to their predictive performance. We analysed simulated data and a range of viral and bacterial data sets using a cross-validation approach to compare a variety of molecular clock and demographic models. Our results show that cross-validation can be effective in distinguishing between strict- and relaxed-clock models and in identifying demographic models that allow growth in population size over time. In most of our empirical data analyses, the model selected using cross-validation was able to match that selected using marginal-likelihood estimation. The accuracy of cross-validation appears to improve with longer sequence data, particularly when distinguishing between relaxed-clock models. Cross-validation is a useful method for Bayesian phylogenetic model selection. This method can be readily implemented even when considering complex models where selecting an appropriate prior for all parameters may be difficult.

[Validity and reliability of Korean version of the Family Management Measure (Korean FaMM) for families with children having chronic illness].

PubMed

Kim, Dong Hee; Im, Yeo Jin

2013-02-01

To develop and test the validity and reliability of the Korean version of the Family Management Measure (Korean FaMM) to assess applicability for families with children having chronic illnesses. The Korean FaMM was articulated through forward-backward translation methods. Internal consistency reliability, construct and criterion validity were calculated using PASW WIN (19.0) and AMOS (20.0). Survey data were collected from 341 mothers of children suffering from chronic disease enrolled in a university hospital in Seoul, South Korea. The Korean version of FaMM showed reliable internal consistency with Cronbach's alpha for the total scale of .69-.91. Factor loadings of the 53 items on the six sub-scales ranged from 0.28-0.84. The model of six subscales for the Korean FaMM was validated by expiratory and confirmatory factor analysis (χ²<.001, RMR<.05, GFI, AGFI, NFI, NNFI>.08). Criterion validity compared to the Parental Stress Index (PSI) showed significant correlation. The findings of this study demonstrate that the Korean FaMM showed satisfactory construct and criterion validity and reliability. It is useful to measure Korean family's management style with their children who have a chronic illness.

Validity of a Manual Soft Tissue Profile Prediction Method Following Mandibular Setback Osteotomy

PubMed Central

Kolokitha, Olga-Elpis

2007-01-01

Objectives The aim of this study was to determine the validity of a manual cephalometric method used for predicting the post-operative soft tissue profiles of patients who underwent mandibular setback surgery and compare it to a computerized cephalometric prediction method (Dentofacial Planner). Lateral cephalograms of 18 adults with mandibular prognathism taken at the end of pre-surgical orthodontics and approximately one year after surgery were used. Methods To test the validity of the manual method the prediction tracings were compared to the actual post-operative tracings. The Dentofacial Planner software was used to develop the computerized post-surgical prediction tracings. Both manual and computerized prediction printouts were analyzed by using the cephalometric system PORDIOS. Statistical analysis was performed by means of t-test. Results Comparison between manual prediction tracings and the actual post-operative profile showed that the manual method results in more convex soft tissue profiles; the upper lip was found in a more prominent position, upper lip thickness was increased and, the mandible and lower lip were found in a less posterior position than that of the actual profiles. Comparison between computerized and manual prediction methods showed that in the manual method upper lip thickness was increased, the upper lip was found in a more anterior position and the lower anterior facial height was increased as compared to the computerized prediction method. Conclusions Cephalometric simulation of post-operative soft tissue profile following orthodontic-surgical management of mandibular prognathism imposes certain limitations related to the methods implied. However, both manual and computerized prediction methods remain a useful tool for patient communication. PMID:19212468

Examining Factor Structure and Validating the Persian Version of the Pregnancy’s Worries and Stress Questionnaire for Pregnant Iranian Women

PubMed Central

Navidpour, Fariba; Dolatian, Mahrokh; Yaghmaei, Farideh; Majd, Hamid Alavi; Hashemi, Seyed Saeed

2015-01-01

Background and Objectives: Pregnant women tend to experience anxiety and stress when faced with the changes to their biology, environment and personal relationships. The identification of these factors and the prevention of their side effects are vital for both mother and fetus. The present study was conducted to validate and to examine the factor structure of the Persian version of the Pregnancy’s Worries and Stress Questionnaire. Materials and Methods: The 25-item PWSQ was first translated by specialists into Persian. The questionnaire’s validity was determined using face, content, criterion and construct validity and reliability of questionnaire was examined using Cronbach’s alpha. Confirmatory factor analysis was performed in AMOS and SPSS 21. Participants included healthy Iranian pregnant women (8-39 weeks) who refer to selected hospitals for prenatal care. Hospitals included private, social security and university hospitals and selected through the random cluster sampling method. Findings: The results of validity and reliability assessments of the questionnaire were acceptable. Cronbach’s alpha calculated showed a high internal consistency of 0.89. The confirmatory factor analysis using the χ2, CMIN/DF, IFI, CFI, NFI and NNFI indexes showed the 6-factor model to be the best fitted model for explaining the data. Conclusion: The questionnaire was translated into Persian to examine stress and worry specific to Iranian pregnant women. The psychometric results showed that the questionnaire is suitable for identifying Iranian pregnant women with pregnancy-related stress. PMID:26153186

The Effectiveness of Using Limited Gauge Measurements for Bias Adjustment of Satellite-Based Precipitation Estimation over Saudi Arabia

NASA Astrophysics Data System (ADS)

Alharbi, Raied; Hsu, Kuolin; Sorooshian, Soroosh; Braithwaite, Dan

2018-01-01

Precipitation is a key input variable for hydrological and climate studies. Rain gauges are capable of providing reliable precipitation measurements at point scale. However, the uncertainty of rain measurements increases when the rain gauge network is sparse. Satellite -based precipitation estimations appear to be an alternative source of precipitation measurements, but they are influenced by systematic bias. In this study, a method for removing the bias from the Precipitation Estimation from Remotely Sensed Information using Artificial Neural Networks-Cloud Classification System (PERSIANN-CCS) over a region where the rain gauge is sparse is investigated. The method consists of monthly empirical quantile mapping, climate classification, and inverse-weighted distance method. Daily PERSIANN-CCS is selected to test the capability of the method for removing the bias over Saudi Arabia during the period of 2010 to 2016. The first six years (2010 - 2015) are calibrated years and 2016 is used for validation. The results show that the yearly correlation coefficient was enhanced by 12%, the yearly mean bias was reduced by 93% during validated year. Root mean square error was reduced by 73% during validated year. The correlation coefficient, the mean bias, and the root mean square error show that the proposed method removes the bias on PERSIANN-CCS effectively that the method can be applied to other regions where the rain gauge network is sparse.

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

A Deep Machine Learning Method for Classifying Cyclic Time Series of Biological Signals Using Time-Growing Neural Network.

PubMed

Gharehbaghi, Arash; Linden, Maria

2017-10-12

This paper presents a novel method for learning the cyclic contents of stochastic time series: the deep time-growing neural network (DTGNN). The DTGNN combines supervised and unsupervised methods in different levels of learning for an enhanced performance. It is employed by a multiscale learning structure to classify cyclic time series (CTS), in which the dynamic contents of the time series are preserved in an efficient manner. This paper suggests a systematic procedure for finding the design parameter of the classification method for a one-versus-multiple class application. A novel validation method is also suggested for evaluating the structural risk, both in a quantitative and a qualitative manner. The effect of the DTGNN on the performance of the classifier is statistically validated through the repeated random subsampling using different sets of CTS, from different medical applications. The validation involves four medical databases, comprised of 108 recordings of the electroencephalogram signal, 90 recordings of the electromyogram signal, 130 recordings of the heart sound signal, and 50 recordings of the respiratory sound signal. Results of the statistical validations show that the DTGNN significantly improves the performance of the classification and also exhibits an optimal structural risk.

Measuring landscape esthetics: the scenic beauty estimation method

Treesearch

Terry C. Daniel; Ron S. Boster

1976-01-01

The Scenic Beauty Estimation Method (SBE) provides quantitative measures of esthetic preferences for alternative wildland management systems. Extensive experimentation and testing with user, interest, and professional groups validated the method. SBE shows promise as an efficient and objective means for assessing the scenic beauty of public forests and wildlands, and...

Development and validation of a stability-indicating LC method for the assay of lodenafil carbonate in tablets.

PubMed

Codevilla, Cristiane Franco; Lemos, Alice Machado; Delgado, Leila Schreiner; Rolim, Clarice Madalena Bueno; Adams, Andréa Inês Horn; Bergold, Ana Maria

2011-08-01

A stability-indicating liquid chromatographic method has been developed for the quantitative determination of lodenafil carbonate in tablets. The method employs a Synergi Fusion C18 column (250 × 4.6 mm, i.d., 4 μm particle size), with mobile phase consisting of a mixture of methanol-acetic acid 0.1% pH 4.0 (65:35, v/v) and UV detection at 290 nm, using a photodiode array detector. A linear response (r = 0.9999) was observed in the range of 10-80 μg/mL. The method showed good recoveries (average 100.3%) and also intra and inter-day precision (RSD < 2.0%). Validation parameters as specificity and robustness were also determined. Specificity analysis showed that no impurities or degradation products were co-eluting with the lodenafil carbonate peak. The method was found to be stability-indicating and due to its simplicity and accuracy can be applied for routine quality control analysis of lodenafil carbonate in tablets.

Validation of an in-vivo proton beam range check method in an anthropomorphic pelvic phantom using dose measurements

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

Bentefour, El H., E-mail: hassan.bentefour@iba-group.com; Prieels, Damien; Tang, Shikui

Purpose: In-vivo dosimetry and beam range verification in proton therapy could play significant role in proton treatment validation and improvements. In-vivo beam range verification, in particular, could enable new treatment techniques one of which could be the use of anterior fields for prostate treatment instead of opposed lateral fields as in current practice. This paper reports validation study of an in-vivo range verification method which can reduce the range uncertainty to submillimeter levels and potentially allow for in-vivo dosimetry. Methods: An anthropomorphic pelvic phantom is used to validate the clinical potential of the time-resolved dose method for range verification inmore » the case of prostrate treatment using range modulated anterior proton beams. The method uses a 3 × 4 matrix of 1 mm diodes mounted in water balloon which are read by an ADC system at 100 kHz. The method is first validated against beam range measurements by dose extinction measurements. The validation is first completed in water phantom and then in pelvic phantom for both open field and treatment field configurations. Later, the beam range results are compared with the water equivalent path length (WEPL) values computed from the treatment planning system XIO. Results: Beam range measurements from both time-resolved dose method and the dose extinction method agree with submillimeter precision in water phantom. For the pelvic phantom, when discarding two of the diodes that show sign of significant range mixing, the two methods agree with ±1 mm. Only a dose of 7 mGy is sufficient to achieve this result. The comparison to the computed WEPL by the treatment planning system (XIO) shows that XIO underestimates the protons beam range. Quantifying the exact XIO range underestimation depends on the strategy used to evaluate the WEPL results. To our best evaluation, XIO underestimates the treatment beam range between a minimum of 1.7% and maximum of 4.1%. Conclusions: Time-resolved dose measurement method satisfies the two basic requirements, WEPL accuracy and minimum dose, necessary for clinical use, thus, its potential for in-vivo protons range verification. Further development is needed, namely, devising a workflow that takes into account the limits imposed by proton range mixing and the susceptibility of the comparison of measured and expected WEPLs to errors on the detector positions. The methods may also be used for in-vivo dosimetry and could benefit various proton therapy treatments.« less

UV Spectrophotometric Method for Estimation of Polypeptide-K in Bulk and Tablet Dosage Forms

NASA Astrophysics Data System (ADS)

Kaur, P.; Singh, S. Kumar; Gulati, M.; Vaidya, Y.

2016-01-01

An analytical method for estimation of polypeptide-k using UV spectrophotometry has been developed and validated for bulk as well as tablet dosage form. The developed method was validated for linearity, precision, accuracy, specificity, robustness, detection, and quantitation limits. The method has shown good linearity over the range from 100.0 to 300.0 μg/ml with a correlation coefficient of 0.9943. The percentage recovery of 99.88% showed that the method was highly accurate. The precision demonstrated relative standard deviation of less than 2.0%. The LOD and LOQ of the method were found to be 4.4 and 13.33, respectively. The study established that the proposed method is reliable, specific, reproducible, and cost-effective for the determination of polypeptide-k.

[A method to estimate the short-term fractal dimension of heart rate variability based on wavelet transform].

PubMed

Zhonggang, Liang; Hong, Yan

2006-10-01

A new method of calculating fractal dimension of short-term heart rate variability signals is presented. The method is based on wavelet transform and filter banks. The implementation of the method is: First of all we pick-up the fractal component from HRV signals using wavelet transform. Next, we estimate the power spectrum distribution of fractal component using auto-regressive model, and we estimate parameter 7 using the least square method. Finally according to formula D = 2- (gamma-1)/2 estimate fractal dimension of HRV signal. To validate the stability and reliability of the proposed method, using fractional brown movement simulate 24 fractal signals that fractal value is 1.6 to validate, the result shows that the method has stability and reliability.

Optimization and validation of a minicolumn method for determining aflatoxins in copra meal.

PubMed

Arim, R H; Aguinaldo, A R; Tanaka, T; Yoshizawa, T

1999-01-01

A minicolumn (MC) method for determining aflatoxins in copra meal was optimized and validated. The method uses methanol-4% KCl solution as extractant and CuSO4 solution as clarifying agent. The chloroform extract is applied to an MC that incorporates "lahar," an indigenous material, as substitute for silica gel. The "lahar"-containing MC produces a more distinct and intense blue fluoresence on the Florisil layer than an earlier MC. The method has a detection limit of 15 micrograms total aflatoxins/kg sample. Confirmatory tests using 50% H2SO4 and trifluoroacetic acid in benzene with 25% HNO3 showed that copra meal samples contained aflatoxins and no interfering agents. The MC responses of the copra meal samples were in good agreement with their behavior in thin-layer chromatography. This modified MC method is accurate, giving linearity-valid results; rapid, being done in 15 min; economical, using low-volume reagents; relatively safe, having low-exposure risk of analysts to chemicals; and simple, making its field application feasible.

Imputation of missing data in time series for air pollutants

NASA Astrophysics Data System (ADS)

Junger, W. L.; Ponce de Leon, A.

2015-02-01

Missing data are major concerns in epidemiological studies of the health effects of environmental air pollutants. This article presents an imputation-based method that is suitable for multivariate time series data, which uses the EM algorithm under the assumption of normal distribution. Different approaches are considered for filtering the temporal component. A simulation study was performed to assess validity and performance of proposed method in comparison with some frequently used methods. Simulations showed that when the amount of missing data was as low as 5%, the complete data analysis yielded satisfactory results regardless of the generating mechanism of the missing data, whereas the validity began to degenerate when the proportion of missing values exceeded 10%. The proposed imputation method exhibited good accuracy and precision in different settings with respect to the patterns of missing observations. Most of the imputations obtained valid results, even under missing not at random. The methods proposed in this study are implemented as a package called mtsdi for the statistical software system R.

Development and Validation of an Extractive Spectrophotometric Method for Miconazole Nitrate Assay in Pharmaceutical Formulations.

PubMed

Eticha, Tadele; Kahsay, Getu; Hailu, Teklebrhan; Gebretsadikan, Tesfamichael; Asefa, Fitsum; Gebretsadik, Hailekiros; Thangabalan, Boovizhikannan

2018-01-01

A simple extractive spectrophotometric technique has been developed and validated for the determination of miconazole nitrate in pure and pharmaceutical formulations. The method is based on the formation of a chloroform-soluble ion-pair complex between the drug and bromocresol green (BCG) dye in an acidic medium. The complex showed absorption maxima at 422 nm, and the system obeys Beer's law in the concentration range of 1-30  µ g/mL with molar absorptivity of 2.285 × 10 4  L/mol/cm. The composition of the complex was studied by Job's method of continuous variation, and the results revealed that the mole ratio of drug : BCG is 1 : 1. Full factorial design was used to optimize the effect of variable factors, and the method was validated based on the ICH guidelines. The method was applied for the determination of miconazole nitrate in real samples.

Validated flow-injection method for rapid aluminium determination in anti-perspirants.

PubMed

López-Gonzálvez, A; Ruiz, M A; Barbas, C

2008-09-29

A flow-injection (FI) method for the rapid determination of aluminium in anti-perspirants has been developed. The method is based on the spectrophotometric detection at 535nm of the complex formed between Al ions and the chromogenic reagent eriochrome cyanine R. Both the batch and FI methods were validated by checking the parameters included in the ISO-3543-1 regulation. Variables involved in the FI method were optimized by using appropriate statistical tools. The method does not exhibit interference from other substances present in anti-perspirants and it shows a high precision with a R.S.D. value (n=6) of 0.9%. Moreover, the accuracy of the method was evaluated by comparison with a back complexometric titration method, which is currently used for routine analysis in pharmaceutical laboratories. The Student's t-test showed that the results obtained by both methods were not significantly different for a significance level of 95%. A response time of 12s and a sample analysis time, by performing triplicate injections, of 60s were achieved. The analytical figures of merit make the method highly appropriate to substitute the time-consuming complexometric method for this kind of analysis.

Determination of serum levels of imatinib mesylate in patients with chronic myeloid leukemia: validation and application of a new analytical method to monitor treatment compliance

PubMed Central

Rezende, Vinícius Marcondes; Rivellis, Ariane Julio; Gomes, Melissa Medrano; Dörr, Felipe Augusto; Novaes, Mafalda Megumi Yoshinaga; Nardinelli, Luciana; Costa, Ariel Lais de Lima; Chamone, Dalton de Alencar Fisher; Bendit, Israel

2013-01-01

Objective The goal of this study was to monitor imatinib mesylate therapeutically in the Tumor Biology Laboratory, Department of Hematology and Hemotherapy, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo (USP). A simple and sensitive method to quantify imatinib and its metabolite (CGP74588) in human serum was developed and fully validated in order to monitor treatment compliance. Methods The method used to quantify these compounds in serum included protein precipitation extraction followed by instrumental analysis using high performance liquid chromatography coupled with mass spectrometry. The method was validated for several parameters, including selectivity, precision, accuracy, recovery and linearity. Results The parameters evaluated during the validation stage exhibited satisfactory results based on the Food and Drug Administration and the Brazilian Health Surveillance Agency (ANVISA) guidelines for validating bioanalytical methods. These parameters also showed a linear correlation greater than 0.99 for the concentration range between 0.500 µg/mL and 10.0 µg/mL and a total analysis time of 13 minutes per sample. This study includes results (imatinib serum concentrations) for 308 samples from patients being treated with imatinib mesylate. Conclusion The method developed in this study was successfully validated and is being efficiently used to measure imatinib concentrations in samples from chronic myeloid leukemia patients to check treatment compliance. The imatinib serum levels of patients achieving a major molecular response were significantly higher than those of patients who did not achieve this result. These results are thus consistent with published reports concerning other populations. PMID:23741187

Developmental validation of a Nextera XT mitogenome Illumina MiSeq sequencing method for high-quality samples.

PubMed

Peck, Michelle A; Sturk-Andreaggi, Kimberly; Thomas, Jacqueline T; Oliver, Robert S; Barritt-Ross, Suzanne; Marshall, Charla

2018-05-01

Generating mitochondrial genome (mitogenome) data from reference samples in a rapid and efficient manner is critical to harnessing the greater power of discrimination of the entire mitochondrial DNA (mtDNA) marker. The method of long-range target enrichment, Nextera XT library preparation, and Illumina sequencing on the MiSeq is a well-established technique for generating mitogenome data from high-quality samples. To this end, a validation was conducted for this mitogenome method processing up to 24 samples simultaneously along with analysis in the CLC Genomics Workbench and utilizing the AQME (AFDIL-QIAGEN mtDNA Expert) tool to generate forensic profiles. This validation followed the Federal Bureau of Investigation's Quality Assurance Standards (QAS) for forensic DNA testing laboratories and the Scientific Working Group on DNA Analysis Methods (SWGDAM) validation guidelines. The evaluation of control DNA, non-probative samples, blank controls, mixtures, and nonhuman samples demonstrated the validity of this method. Specifically, the sensitivity was established at ≥25 pg of nuclear DNA input for accurate mitogenome profile generation. Unreproducible low-level variants were observed in samples with low amplicon yields. Further, variant quality was shown to be a useful metric for identifying sequencing error and crosstalk. Success of this method was demonstrated with a variety of reference sample substrates and extract types. These studies further demonstrate the advantages of using NGS techniques by highlighting the quantitative nature of heteroplasmy detection. The results presented herein from more than 175 samples processed in ten sequencing runs, show this mitogenome sequencing method and analysis strategy to be valid for the generation of reference data. Copyright © 2018 Elsevier B.V. All rights reserved.

Validated modified Lycopodium spore method development for standardisation of ingredients of an ayurvedic powdered formulation Shatavaryadi churna.

PubMed

Kumar, Puspendra; Jha, Shivesh; Naved, Tanveer

2013-01-01

Validated modified lycopodium spore method has been developed for simple and rapid quantification of herbal powdered drugs. Lycopodium spore method was performed on ingredients of Shatavaryadi churna, an ayurvedic formulation used as immunomodulator, galactagogue, aphrodisiac and rejuvenator. Estimation of diagnostic characters of each ingredient of Shatavaryadi churna individually was carried out. Microscopic determination, counting of identifying number, measurement of area, length and breadth of identifying characters were performed using Leica DMLS-2 microscope. The method was validated for intraday precision, linearity, specificity, repeatability, accuracy and system suitability, respectively. The method is simple, precise, sensitive, and accurate, and can be used for routine standardisation of raw materials of herbal drugs. This method gives the ratio of individual ingredients in the powdered drug so that any adulteration of genuine drug with its adulterant can be found out. The method shows very good linearity value between 0.988-0.999 for number of identifying character and area of identifying character. Percentage purity of the sample drug can be determined by using the linear equation of standard genuine drug.

Development and validation of a method for the determination of low-ppb levels of macrocyclic lactones in butter, using HPLC-fluorescence.

PubMed

Macedo, Fabio; Marsico, Eliane Teixeira; Conte-Júnior, Carlos Adam; de Resende, Michele Fabri; Brasil, Taila Figueiredo; Pereira Netto, Annibal Duarte

2015-07-15

An analytical method was developed and validated for the simultaneous determination of four macrocyclic lactones (ML) (abamectin, doramectin, ivermectin and moxidectin) in butter, using liquid chromatography with fluorescence detection. The method employed heated liquid-liquid extraction and a mixture of acetonitrile, ethyl acetate and water, with preconcentration and derivatization, to produce stable fluorescent derivatives. The chromatographic run time was <12.5 min, with excellent separation. The method validation followed international guidelines and employed fortified butter samples. The figures of merit obtained, e.g. recovery (72.4-106.5%), repeatability (8.8%), within-laboratory reproducibility (15.7%) and limits of quantification (0.09-0.16 μg kg(-1)) were satisfactory for the desired application. The application of the method to real samples showed that ML residues were present in six of the ten samples evaluated. The method proved to be simple, easy and appropriate for simultaneous determination of ML residues in butter. To our knowledge, this is the first method described for the evaluation of ML in butter. Copyright © 2015. Published by Elsevier Ltd.

Development and Validation of High-performance Thin Layer Chromatographic Method for Ursolic Acid in Malus domestica Peel

PubMed Central

Nikam, P. H.; Kareparamban, J. A.; Jadhav, A. P.; Kadam, V. J.

2013-01-01

Ursolic acid, a pentacyclic triterpenoid possess a wide range of pharmacological activities. It shows hypoglycemic, antiandrogenic, antibacterial, antiinflammatory, antioxidant, diuretic and cynogenic activity. It is commonly present in plants especially coating of leaves and fruits, such as apple fruit, vinca leaves, rosemary leaves, and eucalyptus leaves. A simple high-performance thin layer chromatographic method has been developed for the quantification of ursolic acid from apple peel (Malus domestica). The samples dissolved in methanol and linear ascending development was carried out in twin trough glass chamber. The mobile phase was selected as toluene:ethyl acetate:glacial acetic acid (70:30:2). The linear regression analysis data for the calibration plots showed good linear relationship with r2=0.9982 in the concentration range 0.2-7 μg/spot with respect to peak area. According to the ICH guidelines the method was validated for linearity, accuracy, precision, and robustness. Statistical analysis of the data showed that the method is reproducible and selective for the estimation of ursolic acid. PMID:24302805

Validity of a manual soft tissue profile prediction method following mandibular setback osteotomy.

PubMed

Kolokitha, Olga-Elpis

2007-10-01

The aim of this study was to determine the validity of a manual cephalometric method used for predicting the post-operative soft tissue profiles of patients who underwent mandibular setback surgery and compare it to a computerized cephalometric prediction method (Dentofacial Planner). Lateral cephalograms of 18 adults with mandibular prognathism taken at the end of pre-surgical orthodontics and approximately one year after surgery were used. To test the validity of the manual method the prediction tracings were compared to the actual post-operative tracings. The Dentofacial Planner software was used to develop the computerized post-surgical prediction tracings. Both manual and computerized prediction printouts were analyzed by using the cephalometric system PORDIOS. Statistical analysis was performed by means of t-test. Comparison between manual prediction tracings and the actual post-operative profile showed that the manual method results in more convex soft tissue profiles; the upper lip was found in a more prominent position, upper lip thickness was increased and, the mandible and lower lip were found in a less posterior position than that of the actual profiles. Comparison between computerized and manual prediction methods showed that in the manual method upper lip thickness was increased, the upper lip was found in a more anterior position and the lower anterior facial height was increased as compared to the computerized prediction method. Cephalometric simulation of post-operative soft tissue profile following orthodontic-surgical management of mandibular prognathism imposes certain limitations related to the methods implied. However, both manual and computerized prediction methods remain a useful tool for patient communication.

Simultaneous determination of centchroman and tamoxifen along with their metabolites in rat plasma using LC-MS/MS.

PubMed

Rama Raju, Kanumuri Siva; Taneja, Isha; Singh, Sheelendra Pratap; Tripathi, Amit; Mishra, Durga Prasad; Hussain, K Mahaboob; Gayen, Jiaur Rahman; Singh, Shio Kumar; Wahajuddin, Muhammad

2015-01-01

Tamoxifen and centchroman are two non-steroidal, selective estrogen receptors modulators, intended for long term therapy in the woman. Because of their wide spread use, there is a possibility of co-prescription of these agents. We studied the probable pharmacokinetic interaction between these agents in breast cancer model rats. A simple, sensitive and rapid LC-ESI-MS/MS method was developed and validated for the simultaneous determination of tamoxifen, centchroman and their active metabolites. The method was linear over a range of 0.2-200 ng/ml. All validation parameters met the acceptance criteria according to regulatory guidelines. LC-MS/MS method for determination of tamoxifen, centchroman and their metabolites was developed and validated. Results show the potential of drug-drug interaction upon co-administration these two marketed drugs.

Validation of space-based polarization measurements by use of a single-scattering approximation, with application to the global ozone monitoring experiment.

PubMed

Aben, Ilse; Tanzi, Cristina P; Hartmann, Wouter; Stam, Daphne M; Stammes, Piet

2003-06-20

A method is presented for in-flight validation of space-based polarization measurements based on approximation of the direction of polarization of scattered sunlight by the Rayleigh single-scattering value. This approximation is verified by simulations of radiative transfer calculations for various atmospheric conditions. The simulations show locations along an orbit where the scattering geometries are such that the intensities of the parallel and orthogonal polarization components of the light are equal, regardless of the observed atmosphere and surface. The method can be applied to any space-based instrument that measures the polarization of reflected solar light. We successfully applied the method to validate the Global Ozone Monitoring Experiment (GOME) polarization measurements. The error in the GOME's three broadband polarization measurements appears to be approximately 1%.

A turbulence model for iced airfoils and its validation

NASA Technical Reports Server (NTRS)

Shin, Jaiwon; Chen, Hsun H.; Cebeci, Tuncer

1992-01-01

A turbulence model based on the extension of the algebraic eddy viscosity formulation of Cebeci and Smith developed for two dimensional flows over smooth and rough surfaces is described for iced airfoils and validated for computed ice shapes obtained for a range of total temperatures varying from 28 to -15 F. The validation is made with an interactive boundary layer method which uses a panel method to compute the inviscid flow and an inverse finite difference boundary layer method to compute the viscous flow. The interaction between inviscid and viscous flows is established by the use of the Hilbert integral. The calculated drag coefficients compare well with recent experimental data taken at the NASA-Lewis Icing Research Tunnel (IRT) and show that, in general, the drag increase due to ice accretion can be predicted well and efficiently.

Validation of powder X-ray diffraction following EN ISO/IEC 17025.

PubMed

Eckardt, Regina; Krupicka, Erik; Hofmeister, Wolfgang

2012-05-01

Powder X-ray diffraction (PXRD) is used widely in forensic science laboratories with the main focus of qualitative phase identification. Little is found in literature referring to the topic of validation of PXRD in the field of forensic sciences. According to EN ISO/IEC 17025, the method has to be tested for several parameters. Trueness, specificity, and selectivity of PXRD were tested using certified reference materials or a combination thereof. All three tested parameters showed the secure performance of the method. Sample preparation errors were simulated to evaluate the robustness of the method. These errors were either easily detected by the operator or nonsignificant for phase identification. In case of the detection limit, a statistical evaluation of the signal-to-noise ratio showed that a peak criterion of three sigma is inadequate and recommendations for a more realistic peak criterion are given. Finally, the results of an international proficiency test showed the secure performance of PXRD. © 2012 American Academy of Forensic Sciences.

MRPrimer: a MapReduce-based method for the thorough design of valid and ranked primers for PCR

PubMed Central

Kim, Hyerin; Kang, NaNa; Chon, Kang-Wook; Kim, Seonho; Lee, NaHye; Koo, JaeHyung; Kim, Min-Soo

2015-01-01

Primer design is a fundamental technique that is widely used for polymerase chain reaction (PCR). Although many methods have been proposed for primer design, they require a great deal of manual effort to generate feasible and valid primers, including homology tests on off-target sequences using BLAST-like tools. That approach is inconvenient for many target sequences of quantitative PCR (qPCR) due to considering the same stringent and allele-invariant constraints. To address this issue, we propose an entirely new method called MRPrimer that can design all feasible and valid primer pairs existing in a DNA database at once, while simultaneously checking a multitude of filtering constraints and validating primer specificity. Furthermore, MRPrimer suggests the best primer pair for each target sequence, based on a ranking method. Through qPCR analysis using 343 primer pairs and the corresponding sequencing and comparative analyses, we showed that the primer pairs designed by MRPrimer are very stable and effective for qPCR. In addition, MRPrimer is computationally efficient and scalable and therefore useful for quickly constructing an entire collection of feasible and valid primers for frequently updated databases like RefSeq. Furthermore, we suggest that MRPrimer can be utilized conveniently for experiments requiring primer design, especially real-time qPCR. PMID:26109350

On the analysis of very small samples of Gaussian repeated measurements: an alternative approach.

PubMed

Westgate, Philip M; Burchett, Woodrow W

2017-03-15

The analysis of very small samples of Gaussian repeated measurements can be challenging. First, due to a very small number of independent subjects contributing outcomes over time, statistical power can be quite small. Second, nuisance covariance parameters must be appropriately accounted for in the analysis in order to maintain the nominal test size. However, available statistical strategies that ensure valid statistical inference may lack power, whereas more powerful methods may have the potential for inflated test sizes. Therefore, we explore an alternative approach to the analysis of very small samples of Gaussian repeated measurements, with the goal of maintaining valid inference while also improving statistical power relative to other valid methods. This approach uses generalized estimating equations with a bias-corrected empirical covariance matrix that accounts for all small-sample aspects of nuisance correlation parameter estimation in order to maintain valid inference. Furthermore, the approach utilizes correlation selection strategies with the goal of choosing the working structure that will result in the greatest power. In our study, we show that when accurate modeling of the nuisance correlation structure impacts the efficiency of regression parameter estimation, this method can improve power relative to existing methods that yield valid inference. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Statistical validation of normal tissue complication probability models.

PubMed

Xu, Cheng-Jian; van der Schaaf, Arjen; Van't Veld, Aart A; Langendijk, Johannes A; Schilstra, Cornelis

2012-09-01

To investigate the applicability and value of double cross-validation and permutation tests as established statistical approaches in the validation of normal tissue complication probability (NTCP) models. A penalized regression method, LASSO (least absolute shrinkage and selection operator), was used to build NTCP models for xerostomia after radiation therapy treatment of head-and-neck cancer. Model assessment was based on the likelihood function and the area under the receiver operating characteristic curve. Repeated double cross-validation showed the uncertainty and instability of the NTCP models and indicated that the statistical significance of model performance can be obtained by permutation testing. Repeated double cross-validation and permutation tests are recommended to validate NTCP models before clinical use. Copyright © 2012 Elsevier Inc. All rights reserved.

Quantitative assessment of copper proteinates used as animal feed additives using ATR-FTIR spectroscopy and powder X-ray diffraction (PXRD) analysis.

PubMed

Cantwell, Caoimhe A; Byrne, Laurann A; Connolly, Cathal D; Hynes, Michael J; McArdle, Patrick; Murphy, Richard A

2017-08-01

The aim of the present work was to establish a reliable analytical method to determine the degree of complexation in commercial metal proteinates used as feed additives in the solid state. Two complementary techniques were developed. Firstly, a quantitative attenuated total reflectance Fourier transform infrared (ATR-FTIR) spectroscopic method investigated modifications in vibrational absorption bands of the ligand on complex formation. Secondly, a powder X-ray diffraction (PXRD) method to quantify the amount of crystalline material in the proteinate product was developed. These methods were developed in tandem and cross-validated with each other. Multivariate analysis (MVA) was used to develop validated calibration and prediction models. The FTIR and PXRD calibrations showed excellent linearity (R 2  > 0.99). The diagnostic model parameters showed that the FTIR and PXRD methods were robust with a root mean square error of calibration RMSEC ≤3.39% and a root mean square error of prediction RMSEP ≤7.17% respectively. Comparative statistics show excellent agreement between the MVA packages assessed and between the FTIR and PXRD methods. The methods can be used to determine the degree of complexation in complexes of both protein hydrolysates and pure amino acids.

Reliability and validity of two multidimensional self-reported physical activity questionnaires in people with chronic low back pain.

PubMed

Carvalho, Flávia A; Morelhão, Priscila K; Franco, Marcia R; Maher, Chris G; Smeets, Rob J E M; Oliveira, Crystian B; Freitas Júnior, Ismael F; Pinto, Rafael Z

2017-02-01

Although there is some evidence for reliability and validity of self-report physical activity (PA) questionnaires in the general adult population, it is unclear whether we can assume similar measurement properties in people with chronic low back pain (LBP). To determine the test-retest reliability of the International Physical Activity Questionnaire (IPAQ) long-version and the Baecke Physical Activity Questionnaire (BPAQ) and their criterion-related validity against data derived from accelerometers in patients with chronic LBP. Cross-sectional study. Patients with non-specific chronic LBP were recruited. Each participant attended the clinic twice (one week interval) and completed self-report PA. Accelerometer measures >7 days included time spent in moderate-and-vigorous physical activity, steps/day, counts/minute, and vector magnitude counts/minute. Intraclass Correlation Coefficients (ICC) and Bland and Altman method were used to determine reliability and spearman rho correlation were used for criterion-related validity. A total of 73 patients were included in our analyses. The reliability analyses revealed that the BPAQ and its subscales have moderate to excellent reliability (ICC 2,1 : 0.61 to 0.81), whereas IPAQ and most IPAQ domains (except walking) showed poor reliability (ICC 2,1 : 0.20 to 0.40). The Bland and Altman method revealed larger discrepancies for the IPAQ. For the validity analysis, questionnaire and accelerometer measures showed at best fair correlation (rho < 0.37). Although the BPAQ showed better reliability than the IPAQ long-version, both questionnaires did not demonstrate acceptable validity against accelerometer data. These findings suggest that questionnaire and accelerometer PA measures should not be used interchangeably in this population. Copyright © 2016 Elsevier Ltd. All rights reserved.

Towards Virtual FLS: Development of a Peg Transfer Simulator

PubMed Central

Arikatla, Venkata S; Ahn, Woojin; Sankaranarayanan, Ganesh; De, Suvranu

2014-01-01

Background Peg transfer is one of five tasks in the Fundamentals of Laparoscopic Surgery (FLS), program. We report the development and validation of a Virtual Basic Laparoscopic Skill Trainer-Peg Transfer (VBLaST-PT©) simulator for automatic real-time scoring and objective quantification of performance. Methods We have introduced new techniques in order to allow bi-manual manipulation of pegs and automatic scoring/evaluation while maintaining high quality of simulation. We performed a preliminary face and construct validation study with 22 subjects divided into two groups: experts (PGY 4–5, fellow and practicing surgeons) and novice (PGY 1–3). Results Face validation shows high scores for all the aspects of the simulation. A two-tailed Mann-Whitney U-test scores showed significant difference between the two groups on completion time (p=0.003), FLS score (p=0.002) and the VBLaST-PT© score (p=0.006). Conclusions VBLaST-PT© is a high quality virtual simulator that showed both face and construct validity. PMID:24030904

Cross-validation pitfalls when selecting and assessing regression and classification models.

PubMed

Krstajic, Damjan; Buturovic, Ljubomir J; Leahy, David E; Thomas, Simon

2014-03-29

We address the problem of selecting and assessing classification and regression models using cross-validation. Current state-of-the-art methods can yield models with high variance, rendering them unsuitable for a number of practical applications including QSAR. In this paper we describe and evaluate best practices which improve reliability and increase confidence in selected models. A key operational component of the proposed methods is cloud computing which enables routine use of previously infeasible approaches. We describe in detail an algorithm for repeated grid-search V-fold cross-validation for parameter tuning in classification and regression, and we define a repeated nested cross-validation algorithm for model assessment. As regards variable selection and parameter tuning we define two algorithms (repeated grid-search cross-validation and double cross-validation), and provide arguments for using the repeated grid-search in the general case. We show results of our algorithms on seven QSAR datasets. The variation of the prediction performance, which is the result of choosing different splits of the dataset in V-fold cross-validation, needs to be taken into account when selecting and assessing classification and regression models. We demonstrate the importance of repeating cross-validation when selecting an optimal model, as well as the importance of repeating nested cross-validation when assessing a prediction error.

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.

Simultaneous determination of some cholesterol-lowering drugs in their binary mixture by novel spectrophotometric methods

NASA Astrophysics Data System (ADS)

Lotfy, Hayam Mahmoud; Hegazy, Maha Abdel Monem

2013-09-01

Four simple, specific, accurate and precise spectrophotometric methods manipulating ratio spectra were developed and validated for simultaneous determination of simvastatin (SM) and ezetimibe (EZ) namely; extended ratio subtraction (EXRSM), simultaneous ratio subtraction (SRSM), ratio difference (RDSM) and absorption factor (AFM). The proposed spectrophotometric procedures do not require any preliminary separation step. The accuracy, precision and linearity ranges of the proposed methods were determined, and the methods were validated and the specificity was assessed by analyzing synthetic mixtures containing the cited drugs. The four methods were applied for the determination of the cited drugs in tablets and the obtained results were statistically compared with each other and with those of a reported HPLC method. The comparison showed that there is no significant difference between the proposed methods and the reported method regarding both accuracy and precision.

Evaluation of three different validation procedures regarding the accuracy of template-guided implant placement: an in vitro study.

PubMed

Vasak, Christoph; Strbac, Georg D; Huber, Christian D; Lettner, Stefan; Gahleitner, André; Zechner, Werner

2015-02-01

The study aims to evaluate the accuracy of the NobelGuide™ (Medicim/Nobel Biocare, Göteborg, Sweden) concept maximally reducing the influence of clinical and surgical parameters. Moreover, the study was to compare and validate two validation procedures versus a reference method. Overall, 60 implants were placed in 10 artificial edentulous mandibles according to the NobelGuide™ protocol. For merging the pre- and postoperative DICOM data sets, three different fusion methods (Triple Scan Technique, NobelGuide™ Validation software, and AMIRA® software [VSG - Visualization Sciences Group, Burlington, MA, USA] as reference) were applied. Discrepancies between the virtual and the actual implant positions were measured. The mean deviations measured with AMIRA® were 0.49 mm (implant shoulder), 0.69 mm (implant apex), and 1.98°mm (implant axis). The Triple Scan Technique as well as the NobelGuide™ Validation software revealed similar deviations compared with the reference method. A significant correlation between angular and apical deviations was seen (r = 0.53; p < .001). A greater implant diameter was associated with greater deviations (p = .03). The Triple Scan Technique as a system-independent validation procedure as well as the NobelGuide™ Validation software are in accordance with the AMIRA® software. The NobelGuide™ system showed similar or less spatial and angular deviations compared with others. © 2013 Wiley Periodicals, Inc.

Validity, efficacy and reliability of 3 nutritional screening tools regarding the nutritional assessment in different social and health areas.

PubMed

Castro-Vega, Iciar; Veses Martín, Silvia; Cantero Llorca, Juana; Barrios Marta, Cristina; Bañuls, Celia; Hernández-Mijares, Antonio

2018-03-09

Nutritional screening allows for the detection of nutritional risk. Validated tools should be implemented, and their usefulness should be contrasted with a gold standard. The aim of this study is to discover the validity, efficacy and reliability of 3 nutritional screening tools in relation to complete nutritional assessment. A sub-analysis of a cross-sectional and descriptive study on the prevalence of disease-related malnutrition. The sample was selected from outpatients, hospitalized and institutionalized patients. MUST, MNAsf and MST screening were employed. A nutritional assessment of all the patients was undertaken. The SENPE-SEDOM consensus was used for the diagnosis. In the outpatients, both MUST and MNAsf have a similar validity in relation to the nutritional assessment (AUC 0.871 and 0.883, respectively). In the institutionalized patients, the MUST screening method is the one that shows the greatest validity (AUC 0.815), whereas in the hospitalized patients, the most valid methods are both MUST and MST (AUC 0.868 and 0.853, respectively). It is essential to use nutritional screening to invest the available resources wisely. Based on our results, MUST is the most suitable screening method in hospitalized and institutionalized patients. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Objective assessment based on motion-related metrics and technical performance in laparoscopic suturing.

PubMed

Sánchez-Margallo, Juan A; Sánchez-Margallo, Francisco M; Oropesa, Ignacio; Enciso, Silvia; Gómez, Enrique J

2017-02-01

The aim of this study is to present the construct and concurrent validity of a motion-tracking method of laparoscopic instruments based on an optical pose tracker and determine its feasibility as an objective assessment tool of psychomotor skills during laparoscopic suturing. A group of novice ([Formula: see text] laparoscopic procedures), intermediate (11-100 laparoscopic procedures) and experienced ([Formula: see text] laparoscopic procedures) surgeons performed three intracorporeal sutures on an ex vivo porcine stomach. Motion analysis metrics were recorded using the proposed tracking method, which employs an optical pose tracker to determine the laparoscopic instruments' position. Construct validation was measured for all 10 metrics across the three groups and between pairs of groups. Concurrent validation was measured against a previously validated suturing checklist. Checklists were completed by two independent surgeons over blinded video recordings of the task. Eighteen novices, 15 intermediates and 11 experienced surgeons took part in this study. Execution time and path length travelled by the laparoscopic dissector presented construct validity. Experienced surgeons required significantly less time ([Formula: see text]), travelled less distance using both laparoscopic instruments ([Formula: see text]) and made more efficient use of the work space ([Formula: see text]) compared with novice and intermediate surgeons. Concurrent validation showed strong correlation between both the execution time and path length and the checklist score ([Formula: see text] and [Formula: see text], [Formula: see text]). The suturing performance was successfully assessed by the motion analysis method. Construct and concurrent validity of the motion-based assessment method has been demonstrated for the execution time and path length metrics. This study demonstrates the efficacy of the presented method for objective evaluation of psychomotor skills in laparoscopic suturing. However, this method does not take into account the quality of the suture. Thus, future works will focus on developing new methods combining motion analysis and qualitative outcome evaluation to provide a complete performance assessment to trainees.

Using Lunar Observations to Validate In-Flight Calibrations of Clouds and Earth Radiant Energy System Instruments

NASA Technical Reports Server (NTRS)

Daniels, Janet L.; Smith, G. Louis; Priestley, Kory J.; Thomas, Susan

2014-01-01

The validation of in-orbit instrument performance requires stability in both instrument and calibration source. This paper describes a method of validation using lunar observations scanning near full moon by the Clouds and Earth Radiant Energy System (CERES) instruments. Unlike internal calibrations, the Moon offers an external source whose signal variance is predictable and non-degrading. From 2006 to present, in-orbit observations have become standardized and compiled for the Flight Models-1 and -2 aboard the Terra satellite, for Flight Models-3 and -4 aboard the Aqua satellite, and beginning 2012, for Flight Model-5 aboard Suomi-NPP. Instrument performance parameters which can be gleaned are detector gain, pointing accuracy and static detector point response function validation. Lunar observations are used to examine the stability of all three detectors on each of these instruments from 2006 to present. This validation method has yielded results showing trends per CERES data channel of 1.2% per decade or less.

Prospective validation of pathologic complete response models in rectal cancer: Transferability and reproducibility.

PubMed

van Soest, Johan; Meldolesi, Elisa; van Stiphout, Ruud; Gatta, Roberto; Damiani, Andrea; Valentini, Vincenzo; Lambin, Philippe; Dekker, Andre

2017-09-01

Multiple models have been developed to predict pathologic complete response (pCR) in locally advanced rectal cancer patients. Unfortunately, validation of these models normally omit the implications of cohort differences on prediction model performance. In this work, we will perform a prospective validation of three pCR models, including information whether this validation will target transferability or reproducibility (cohort differences) of the given models. We applied a novel methodology, the cohort differences model, to predict whether a patient belongs to the training or to the validation cohort. If the cohort differences model performs well, it would suggest a large difference in cohort characteristics meaning we would validate the transferability of the model rather than reproducibility. We tested our method in a prospective validation of three existing models for pCR prediction in 154 patients. Our results showed a large difference between training and validation cohort for one of the three tested models [Area under the Receiver Operating Curve (AUC) cohort differences model: 0.85], signaling the validation leans towards transferability. Two out of three models had a lower AUC for validation (0.66 and 0.58), one model showed a higher AUC in the validation cohort (0.70). We have successfully applied a new methodology in the validation of three prediction models, which allows us to indicate if a validation targeted transferability (large differences between training/validation cohort) or reproducibility (small cohort differences). © 2017 American Association of Physicists in Medicine.

A New MI-Based Visualization Aided Validation Index for Mining Big Longitudinal Web Trial Data

PubMed Central

Zhang, Zhaoyang; Fang, Hua; Wang, Honggang

2016-01-01

Web-delivered clinical trials generate big complex data. To help untangle the heterogeneity of treatment effects, unsupervised learning methods have been widely applied. However, identifying valid patterns is a priority but challenging issue for these methods. This paper, built upon our previous research on multiple imputation (MI)-based fuzzy clustering and validation, proposes a new MI-based Visualization-aided validation index (MIVOOS) to determine the optimal number of clusters for big incomplete longitudinal Web-trial data with inflated zeros. Different from a recently developed fuzzy clustering validation index, MIVOOS uses a more suitable overlap and separation measures for Web-trial data but does not depend on the choice of fuzzifiers as the widely used Xie and Beni (XB) index. Through optimizing the view angles of 3-D projections using Sammon mapping, the optimal 2-D projection-guided MIVOOS is obtained to better visualize and verify the patterns in conjunction with trajectory patterns. Compared with XB and VOS, our newly proposed MIVOOS shows its robustness in validating big Web-trial data under different missing data mechanisms using real and simulated Web-trial data. PMID:27482473

A simple validated multi-analyte method for detecting drugs in oral fluid by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS).

PubMed

Zheng, Yufang; Sparve, Erik; Bergström, Mats

2018-06-01

A UPLC-MS/MS method was developed to identify and quantitate 37 commonly abused drugs in oral fluid. Drugs of interest included amphetamines, benzodiazepines, cocaine, opiates, opioids, phencyclidine and tetrahydrocannabinol. Sample preparation and extraction are simple, and analysis times short. Validation showed satisfactory performance at relevant concentrations. The possibility of contaminated samples as well as the interpretation in relation to well-knows matrices, such as urine, will demand further study. Copyright © 2017 John Wiley & Sons, Ltd.

Collaborative study for the validation of alternative in vitro potency assays for human tetanus immunoglobulin.

PubMed

Gross, S; Janssen, S W J; de Vries, B; Terao, E; Daas, A; Buchheit, K-H

2009-10-01

The European Pharmacopoeia (Ph. Eur.) monograph Human tetanus immunoglobulin (0398) gives a clear outline of the in vivo assay to be performed to determine the potency of human tetanus immunoglobulins during their development. Furthermore, it states that an in vitro method shall be validated for the batch potency estimation. Since no further guidance is given on the in vitro assay, every control laboratory concerned is free to design and validate an in-house method. At the moment there is no agreed in vitro method available. The aim of this study was to validate and compare 2 alternative in vitro assays, i.e. an enzyme-linked immunoassay (EIA) and a toxoid inhibition assay (TIA), through an international collaborative study, in view of their eventual inclusion into the Ph. Eur.. The study was run in the framework of the Biological Standardisation Programme (BSP), under the aegis of the European Commission and the Council of Europe. The collaborative study reported here involved 21 laboratories (public and industry) from 15 countries. Initially, 3 samples with low, medium and high potencies were tested by EIA and TIA. Results showed good reproducibility and repeatability of the 2 in vitro methods. The correlation of the data with the in vivo potency assigned by the manufacturers however appeared initially poor for high potency samples. Thorough re-examination of the data showed that the in vivo potencies assigned by the manufacturers had to be corrected: one for potency loss at the time of in vitro testing and one because of a reporting error. After these corrections the values obtained by in vivo and in vitro methods were in close agreement. A supplementary collaborative work was carried out to validate the 2 methods for immunoglobulin products with high potencies. Eight laboratories (public and industry) took part in this additional study to test 3 samples with medium and high potencies by EIA and TIA. Results confirmed that the 2 alternative methods are comparable in terms of assay repeatability, precision and reproducibility. In all laboratories, both methods discriminated between the low, medium and high potency samples. Analysis of the data collected in this study showed a good correlation between EIA and TIA potency estimates as well as a close agreement between values obtained by in vitro and in vivo methods. The study demonstrated that EIA and TIA are suitable quality control methods for polyclonal human tetanus immunoglobulin, which can be standardised in a quality control laboratory using a quality assurance system. Consequently, the Ph. Eur. Group of Experts 6B on Human Blood and Blood products decided in April 2009 to include both methods as examples in the Ph. Eur. monograph 0398 on Human Tetanus immunoglobulin.

Q-Method Extended Kalman Filter

NASA Technical Reports Server (NTRS)

Zanetti, Renato; Ainscough, Thomas; Christian, John; Spanos, Pol D.

2012-01-01

A new algorithm is proposed that smoothly integrates non-linear estimation of the attitude quaternion using Davenport s q-method and estimation of non-attitude states through an extended Kalman filter. The new method is compared to a similar existing algorithm showing its similarities and differences. The validity of the proposed approach is confirmed through numerical simulations.

Development and validation of a matrix solid-phase dispersion method to determine acrylamide in coffee and coffee substitutes.

PubMed

Soares, Cristina M Dias; Alves, Rita C; Casal, Susana; Oliveira, M Beatriz P P; Fernandes, José Oliveira

2010-04-01

The present study describes the development and validation of a new method based on a matrix solid-phase dispersion (MSPD) sample preparation procedure followed by GC-MS for determination of acrylamide levels in coffee (ground coffee and brewed coffee) and coffee substitute samples. Samples were dispersed in C(18) sorbent and the mixture was further packed into a preconditioned custom-made ISOLUTE bilayered SPE column (C(18)/Multimode; 1 g + 1 g). Acrylamide was subsequently eluted with water, and then derivatized with bromine and quantified by GC-MS in SIM mode. The MSPD/GC-MS method presented a LOD of 5 microg/kg and a LOQ of 10 microg/kg. Intra and interday precisions ranged from 2% to 4% and 4% to 10%, respectively. To evaluate the performance of the method, 11 samples of ground and brewed coffee and coffee substitutes were simultaneously analyzed by the developed method and also by a previously validated method based in a liquid-extraction (LE) procedure, and the results were compared showing a high correlation between them.

Development and Validation of Stability Indicating Spectroscopic Method for Content Analysis of Ceftriaxone Sodium in Pharmaceuticals

PubMed Central

Ethiraj, Revathi; Thiruvengadam, Ethiraj; Sampath, Venkattapuram Saravanan; Vahid, Abdul; Raj, Jithin

2014-01-01

A simple, selective, and stability indicating spectroscopic method has been selected and validated for the assay of ceftriaxone sodium in the powder for injection dosage forms. Proposed method is based on the measurement of absorbance of ceftriaxone sodium in aqueous medium at 241 nm. The method obeys Beer's law in the range of 5–50 μg/mL with correlation coefficient of 0.9983. Apparent molar absorptivity and Sandell's sensitivity were found to be 2.046 × 103 L mol−1 cm−1 and 0.02732 μg/cm2/0.001 absorbance units. This study indicated that ceftriaxone sodium was degraded in acid medium and also underwent oxidative degradation. Percent relative standard deviation associated with all the validation parameters was less than 2, showing compliance with acceptance criteria of Q2 (R1), International Conference on Harmonization (2005) guidelines. Then the proposed method was successfully applied to the determination of ceftriaxone sodium in sterile preparation and results were comparable with reported methods. PMID:27355020

Screening for Posttraumatic Stress Disorder among Somali ex-combatants: A validation study

PubMed Central

Odenwald, Michael; Lingenfelder, Birke; Schauer, Maggie; Neuner, Frank; Rockstroh, Brigitte; Hinkel, Harald; Elbert, Thomas

2007-01-01

Background In Somalia, a large number of active and former combatants are affected by psychological problems such as Posttraumatic Stress Disorder (PTSD). This disorder impairs their ability to re-integrate into civilian life. However, many screening instruments for Posttraumatic Stress Disorder used in post-conflict settings have limited validity. Here we report on development and validation of a screening tool for PTSD in Somali language with a sample of ex-combatants. Methods We adapted the Posttraumatic Diagnostic Scale (PDS) to reflect linguistic and cultural differences within the Somali community so that local interviewers could be trained to administer the scale. For validation purposes, a randomly selected group of 135 Somali ex-combatants was screened by trained local interviewers; 64 of them were then re-assessed by trained clinical psychologists using the Composite International Diagnostic Interview (CIDI) and the Self-Report Questionnaire (SRQ-20). Results The screening instrument showed good internal consistency (Cronbach's α = .86), convergent validity with the CIDI (sensitivity = .90; specificity = .90) as well as concurrent validity: positive cases showed higher SRQ-20 scores, higher prevalence of psychotic symptoms, and higher levels of intake of the local stimulant drug khat. Compared to a single cut-off score, the multi-criteria scoring, in keeping with the DSM-IV, produced more diagnostic specificity. Conclusion The results provide evidence that our screening instrument is a reliable and valid method to detect PTSD among Somali ex-combatants. A future Disarmament, Demobilization and Reintegration Program in Somalia is recommended to screen for PTSD in order to identify ex-combatants with special psycho-social needs. PMID:17822562

Developing Enhanced Blood–Brain Barrier Permeability Models: Integrating External Bio-Assay Data in QSAR Modeling

PubMed Central

Wang, Wenyi; Kim, Marlene T.; Sedykh, Alexander

2015-01-01

Purpose Experimental Blood–Brain Barrier (BBB) permeability models for drug molecules are expensive and time-consuming. As alternative methods, several traditional Quantitative Structure-Activity Relationship (QSAR) models have been developed previously. In this study, we aimed to improve the predictivity of traditional QSAR BBB permeability models by employing relevant public bio-assay data in the modeling process. Methods We compiled a BBB permeability database consisting of 439 unique compounds from various resources. The database was split into a modeling set of 341 compounds and a validation set of 98 compounds. Consensus QSAR modeling workflow was employed on the modeling set to develop various QSAR models. A five-fold cross-validation approach was used to validate the developed models, and the resulting models were used to predict the external validation set compounds. Furthermore, we used previously published membrane transporter models to generate relevant transporter profiles for target compounds. The transporter profiles were used as additional biological descriptors to develop hybrid QSAR BBB models. Results The consensus QSAR models have R2=0.638 for fivefold cross-validation and R2=0.504 for external validation. The consensus model developed by pooling chemical and transporter descriptors showed better predictivity (R2=0.646 for five-fold cross-validation and R2=0.526 for external validation). Moreover, several external bio-assays that correlate with BBB permeability were identified using our automatic profiling tool. Conclusions The BBB permeability models developed in this study can be useful for early evaluation of new compounds (e.g., new drug candidates). The combination of chemical and biological descriptors shows a promising direction to improve the current traditional QSAR models. PMID:25862462

In-house validation of a liquid chromatography-tandem mass spectrometry method for the determination of selective androgen receptor modulators (SARMS) in bovine urine.

PubMed

Schmidt, Kathrin S; Mankertz, Joachim

2018-06-01

A sensitive and robust LC-MS/MS method allowing the rapid screening and confirmation of selective androgen receptor modulators in bovine urine was developed and successfully validated according to Commission Decision 2002/657/EC, chapter 3.1.3 'alternative validation', by applying a matrix-comprehensive in-house validation concept. The confirmation of the analytes in the validation samples was achieved both on the basis of the MRM ion ratios as laid down in Commission Decision 2002/657/EC and by comparison of their enhanced product ion (EPI) spectra with a reference mass spectral library by making use of the QTRAP technology. Here, in addition to the MRM survey scan, EPI spectra were generated in a data-dependent way according to an information-dependent acquisition criterion. Moreover, stability studies of the analytes in solution and in matrix according to an isochronous approach proved the stability of the analytes in solution and in matrix for at least the duration of the validation study. To identify factors that have a significant influence on the test method in routine analysis, a factorial effect analysis was performed. To this end, factors considered to be relevant for the method in routine analysis (e.g. operator, storage duration of the extracts before measurement, different cartridge lots and different hydrolysis conditions) were systematically varied on two levels. The examination of the extent to which these factors influence the measurement results of the individual analytes showed that none of the validation factors exerts a significant influence on the measurement results.

Supervised local error estimation for nonlinear image registration using convolutional neural networks

NASA Astrophysics Data System (ADS)

Eppenhof, Koen A. J.; Pluim, Josien P. W.

2017-02-01

Error estimation in medical image registration is valuable when validating, comparing, or combining registration methods. To validate a nonlinear image registration method, ideally the registration error should be known for the entire image domain. We propose a supervised method for the estimation of a registration error map for nonlinear image registration. The method is based on a convolutional neural network that estimates the norm of the residual deformation from patches around each pixel in two registered images. This norm is interpreted as the registration error, and is defined for every pixel in the image domain. The network is trained using a set of artificially deformed images. Each training example is a pair of images: the original image, and a random deformation of that image. No manually labeled ground truth error is required. At test time, only the two registered images are required as input. We train and validate the network on registrations in a set of 2D digital subtraction angiography sequences, such that errors up to eight pixels can be estimated. We show that for this range of errors the convolutional network is able to learn the registration error in pairs of 2D registered images at subpixel precision. Finally, we present a proof of principle for the extension to 3D registration problems in chest CTs, showing that the method has the potential to estimate errors in 3D registration problems.

An entropy-based nonparametric test for the validation of surrogate endpoints.

PubMed

Miao, Xiaopeng; Wang, Yong-Cheng; Gangopadhyay, Ashis

2012-06-30

We present a nonparametric test to validate surrogate endpoints based on measure of divergence and random permutation. This test is a proposal to directly verify the Prentice statistical definition of surrogacy. The test does not impose distributional assumptions on the endpoints, and it is robust to model misspecification. Our simulation study shows that the proposed nonparametric test outperforms the practical test of the Prentice criterion in terms of both robustness of size and power. We also evaluate the performance of three leading methods that attempt to quantify the effect of surrogate endpoints. The proposed method is applied to validate magnetic resonance imaging lesions as the surrogate endpoint for clinical relapses in a multiple sclerosis trial. Copyright © 2012 John Wiley & Sons, Ltd.

Learning to recognize rat social behavior: Novel dataset and cross-dataset application.

PubMed

Lorbach, Malte; Kyriakou, Elisavet I; Poppe, Ronald; van Dam, Elsbeth A; Noldus, Lucas P J J; Veltkamp, Remco C

2018-04-15

Social behavior is an important aspect of rodent models. Automated measuring tools that make use of video analysis and machine learning are an increasingly attractive alternative to manual annotation. Because machine learning-based methods need to be trained, it is important that they are validated using data from different experiment settings. To develop and validate automated measuring tools, there is a need for annotated rodent interaction datasets. Currently, the availability of such datasets is limited to two mouse datasets. We introduce the first, publicly available rat social interaction dataset, RatSI. We demonstrate the practical value of the novel dataset by using it as the training set for a rat interaction recognition method. We show that behavior variations induced by the experiment setting can lead to reduced performance, which illustrates the importance of cross-dataset validation. Consequently, we add a simple adaptation step to our method and improve the recognition performance. Most existing methods are trained and evaluated in one experimental setting, which limits the predictive power of the evaluation to that particular setting. We demonstrate that cross-dataset experiments provide more insight in the performance of classifiers. With our novel, public dataset we encourage the development and validation of automated recognition methods. We are convinced that cross-dataset validation enhances our understanding of rodent interactions and facilitates the development of more sophisticated recognition methods. Combining them with adaptation techniques may enable us to apply automated recognition methods to a variety of animals and experiment settings. Copyright © 2017 Elsevier B.V. All rights reserved.

Assessment of a condition-specific quality-of-life measure for patients with developmentally absent teeth: validity and reliability testing.

PubMed

Akram, A J; Ireland, A J; Postlethwaite, K C; Sandy, J R; Jerreat, A S

2013-11-01

This article describes the process of validity and reliability testing of a condition-specific quality-of-life measure for patients with hypodontia presenting for orthodontic treatment. The development of the instrument is described in a previous article. Royal Devon and Exeter NHS Foundation Trust & Musgrove Park Hospital, Taunton. The child perception questionnaire was used as a standard against which to test criterion validity. The Bland and Altman method was used to check agreement between the two questionnaires. Construct validity was tested using principal component analysis on the four sections of the questionnaire. Test-retest reliability was tested using intraclass correlation coefficient and Bland and Altman method. Cronbach's alpha was used to test internal consistency reliability. Overall the questionnaire showed good reliability, criterion and construct validity. This together with previous evidence of good face and content validity suggests that the instrument may prove useful in clinical practice and further research. This study has demonstrated that the newly developed condition-specific quality-of-life questionnaire is both valid and reliable for use in young patients with hypodontia. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

Development and validation of a rapid capillary zone electrophoresis method for the determination of aconite alkaloids in aconite roots.

PubMed

Song, Jing-Zheng; Han, Quan-Bin; Qiao, Chun-Feng; But, Paul Pui-Hay; Xu, Hong-Xi

2010-01-01

Aconites, with aconite alkaloids as the major therapeutic and toxic components, are used for the treatment of analgesic, antirheumatic and neurological symptoms. Quantification of the aconite alkaloids is important for the quality control of aconite-containing drugs. To establish a validated capillary zone electrophoresis (CZE) method for the simultaneous determination of six major alkaloids, namely aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine and benzoylhypaconine, in crude and processed aconite roots. The CZE method was optimised and validated using a stability-indicating method. The optimised running buffer was a mixture of 200 mm Tris, 150 mm perchloric acid and 40% 1,4-dioxane (pH 7.8) with the capillary thermostated at 25 degrees C. Using the optimised method, six aconite alkaloids were well separated. The established method showed good precision, accuracy and recovery. Contents of these alkaloids in crude and processed aconites were determined and it was observed that the levels of individual alkaloids varied between samples. The developed CZE method was reliable for the quality control of aconites contained in herbal medicines. The method could also be used as an approach for toxicological studies.

Quantification of plasma myo-inositol using gas chromatography-mass spectrometry.

PubMed

Guo, Jin; Shi, Yingfei; Xu, Chengbao; Zhong, Rugang; Zhang, Feng; Zhang, Ting; Niu, Bo; Wang, Jianhua

2016-09-01

Myo-inositol (MI) deficiency is associated with an increased risk for neural tube defects (NTDs), mental disorders and metabolic diseases. We developed a gas chromatography-mass spectrometry (GC-MS) method to detect MI in human plasma, which was accurate, relatively efficient and convenient for clinical application. An external standard method was used for determination of plasma MI. Samples were analyzed by GC-MS after derivatization. The stable-isotope labeled internal standard approach was used to validate the method's accuracy. Alpha fetal protein (AFP) was detected by chemiluminescence immunoassay. The method was validated by determining the linearity, sensitivity and recovery rate. There was a good agreement between the internal standard approach and the present method. The NTD-affected pregnancies showed lower plasma MI (P=0.024) and higher AFP levels (P=0.001) than control. Maternal MI level showed a better discrimination in spina bifida subgroup, while AFP level showed a better discrimination in anencephaly subgroup after stratification analysis. We developed a sensitive and reliable method for the detection of clinical plasma MI, which might be a marker for NTDs screening, and established fundamental knowledge for clinical diagnosis and prevention for the diseases related to disturbed MI metabolism. Copyright © 2016 Elsevier B.V. All rights reserved.

Development and Validation of Liquid Chromatographic Method for Estimation of Naringin in Nanoformulation

PubMed Central

Musmade, Kranti P.; Trilok, M.; Dengale, Swapnil J.; Bhat, Krishnamurthy; Reddy, M. S.; Musmade, Prashant B.; Udupa, N.

2014-01-01

A simple, precise, accurate, rapid, and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method with UV detection has been developed and validated for quantification of naringin (NAR) in novel pharmaceutical formulation. NAR is a polyphenolic flavonoid present in most of the citrus plants having variety of pharmacological activities. Method optimization was carried out by considering the various parameters such as effect of pH and column. The analyte was separated by employing a C18 (250.0 × 4.6 mm, 5 μm) column at ambient temperature in isocratic conditions using phosphate buffer pH 3.5: acetonitrile (75 : 25% v/v) as mobile phase pumped at a flow rate of 1.0 mL/min. UV detection was carried out at 282 nm. The developed method was validated according to ICH guidelines Q2(R1). The method was found to be precise and accurate on statistical evaluation with a linearity range of 0.1 to 20.0 μg/mL for NAR. The intra- and interday precision studies showed good reproducibility with coefficients of variation (CV) less than 1.0%. The mean recovery of NAR was found to be 99.33 ± 0.16%. The proposed method was found to be highly accurate, sensitive, and robust. The proposed liquid chromatographic method was successfully employed for the routine analysis of said compound in developed novel nanopharmaceuticals. The presence of excipients did not show any interference on the determination of NAR, indicating method specificity. PMID:26556205

Fully automated registration of first-pass myocardial perfusion MRI using independent component analysis.

PubMed

Milles, J; van der Geest, R J; Jerosch-Herold, M; Reiber, J H C; Lelieveldt, B P F

2007-01-01

This paper presents a novel method for registration of cardiac perfusion MRI. The presented method successfully corrects for breathing motion without any manual interaction using Independent Component Analysis to extract physiologically relevant features together with their time-intensity behavior. A time-varying reference image mimicking intensity changes in the data of interest is computed based on the results of ICA, and used to compute the displacement caused by breathing for each frame. Qualitative and quantitative validation of the method is carried out using 46 clinical quality, short-axis, perfusion MR datasets comprising 100 images each. Validation experiments showed a reduction of the average LV motion from 1.26+/-0.87 to 0.64+/-0.46 pixels. Time-intensity curves are also improved after registration with an average error reduced from 2.65+/-7.89% to 0.87+/-3.88% between registered data and manual gold standard. We conclude that this fully automatic ICA-based method shows an excellent accuracy, robustness and computation speed, adequate for use in a clinical environment.

Domestic violence on children: development and validation of an instrument to evaluate knowledge of health professionals 1

PubMed Central

Oliveira, Lanuza Borges; Soares, Fernanda Amaral; Silveira, Marise Fagundes; de Pinho, Lucinéia; Caldeira, Antônio Prates; Leite, Maísa Tavares de Souza

2016-01-01

ABSTRACT Objective: to develop and validate an instrument to evaluate the knowledge of health professionals about domestic violence on children. Method: this was a study conducted with 194 physicians, nurses and dentists. A literature review was performed for preparation of the items and identification of the dimensions. Apparent and content validation was performed using analysis of three experts and 27 professors of the pediatric health discipline. For construct validation, Cronbach's alpha was used, and the Kappa test was applied to verify reproducibility. The criterion validation was conducted using the Student's t-test. Results: the final instrument included 56 items; the Cronbach alpha was 0.734, the Kappa test showed a correlation greater than 0.6 for most items, and the Student t-test showed a statistically significant value to the level of 5% for the two selected variables: years of education and using the Family Health Strategy. Conclusion: the instrument is valid and can be used as a promising tool to develop or direct actions in public health and evaluate knowledge about domestic violence on children. PMID:27556878

Relative validity of a semiquantitative food frequency questionnaire designed for schoolchildren in western Greece

PubMed Central

Roumelioti, Maria; Leotsinidis, Michalis

2009-01-01

Background The use of food frequency questionnaires (FFQs) has become increasingly important in epidemiologic studies. During the past few decades, a wide variety of nutritional studies have used the semiquantitative FFQ as a tool for assessing and evaluating dietary intake. One of the main concerns in a dietary analysis is the validity of the collected dietary data. Methods This paper discusses several methodological and statistical issues related to the validation of a semiquantitative FFQ. This questionnaire was used to assess the nutritional habits of schoolchildren in western Greece. For validation purposes, we selected 200 schoolchildren and contacted their respective parents. We evaluated the relative validity of 400 FFQs (200 children's FFQs and 200 parents' FFQs). Results The correlations between the children's and the parents' questionnaire responses showed that the questionnaire we designed was appropriate for fulfilling the purposes of our study and in ranking subjects according to food group intake. Conclusion Our study shows that the semiquantitative FFQ provides a reasonably reliable measure of dietary intake and corroborates the relative validity of our questionnaire. PMID:19196469

Validation of an HPLC method for the quantification of ambroxol hydrochloride and benzoic acid in a syrup as pharmaceutical form stress test for stability evaluation.

PubMed

Heinänen, M; Barbas, C

2001-03-01

A method is described for ambroxol, trans-4-(2-amino-3,5-dibromobenzylamino) cyclohexanol hydrochloride, and benzoic acid separation by HPLC with UV detection at 247 nm in a syrup as pharmaceutical presentation. Optimal conditions were: Column Symmetry Shield RPC8, 5 microm 250 x 4.6 mm, and methanol/(H(3)PO(4) 8.5 mM/triethylamine pH=2.8) 40:60 v/v. Validation was performed using standards and the pharmaceutical preparation which contains the compounds described above. Results from both standards and samples show suitable validation parameters. The pharmaceutical grade substances were tested by factors that could influence the chemical stability. These reaction mixtures were analysed to evaluate the capability of the method to separate degradation products. Degradation products did not interfere with the determination of the substances tested by the assay.

[Study on Accurately Controlling Discharge Energy Method Used in External Defibrillator].

PubMed

Song, Biao; Wang, Jianfei; Jin, Lian; Wu, Xiaomei

2016-01-01

This paper introduces a new method which controls discharge energy accurately. It is achieved by calculating target voltage based on transthoracic impedance and accurately controlling charging voltage and discharge pulse width. A new defibrillator is designed and programmed using this method. The test results show that this method is valid and applicable to all kinds of external defibrillators.

Reduction of the discretization stencil of direct forcing immersed boundary methods on rectangular cells: The ghost node shifting method

NASA Astrophysics Data System (ADS)

Picot, Joris; Glockner, Stéphane

2018-07-01

We present an analytical study of discretization stencils for the Poisson problem and the incompressible Navier-Stokes problem when used with some direct forcing immersed boundary methods. This study uses, but is not limited to, second-order discretization and Ghost-Cell Finite-Difference methods. We show that the stencil size increases with the aspect ratio of rectangular cells, which is undesirable as it breaks assumptions of some linear system solvers. To circumvent this drawback, a modification of the Ghost-Cell Finite-Difference methods is proposed to reduce the size of the discretization stencil to the one observed for square cells, i.e. with an aspect ratio equal to one. Numerical results validate this proposed method in terms of accuracy and convergence, for the Poisson problem and both Dirichlet and Neumann boundary conditions. An improvement on error levels is also observed. In addition, we show that the application of the chosen Ghost-Cell Finite-Difference methods to the Navier-Stokes problem, discretized by a pressure-correction method, requires an additional interpolation step. This extra step is implemented and validated through well known test cases of the Navier-Stokes equations.

Evaluation of passenger health risk assessment of sustainable indoor air quality monitoring in metro systems based on a non-Gaussian dynamic sensor validation method.

PubMed

Kim, MinJeong; Liu, Hongbin; Kim, Jeong Tai; Yoo, ChangKyoo

2014-08-15

Sensor faults in metro systems provide incorrect information to indoor air quality (IAQ) ventilation systems, resulting in the miss-operation of ventilation systems and adverse effects on passenger health. In this study, a new sensor validation method is proposed to (1) detect, identify and repair sensor faults and (2) evaluate the influence of sensor reliability on passenger health risk. To address the dynamic non-Gaussianity problem of IAQ data, dynamic independent component analysis (DICA) is used. To detect and identify sensor faults, the DICA-based squared prediction error and sensor validity index are used, respectively. To restore the faults to normal measurements, a DICA-based iterative reconstruction algorithm is proposed. The comprehensive indoor air-quality index (CIAI) that evaluates the influence of the current IAQ on passenger health is then compared using the faulty and reconstructed IAQ data sets. Experimental results from a metro station showed that the DICA-based method can produce an improved IAQ level in the metro station and reduce passenger health risk since it more accurately validates sensor faults than do conventional methods. Copyright © 2014 Elsevier B.V. All rights reserved.

The Validation of a Case-Based, Cumulative Assessment and Progressions Examination

PubMed Central

Coker, Adeola O.; Copeland, Jeffrey T.; Gottlieb, Helmut B.; Horlen, Cheryl; Smith, Helen E.; Urteaga, Elizabeth M.; Ramsinghani, Sushma; Zertuche, Alejandra; Maize, David

2016-01-01

Objective. To assess content and criterion validity, as well as reliability of an internally developed, case-based, cumulative, high-stakes third-year Annual Student Assessment and Progression Examination (P3 ASAP Exam). Methods. Content validity was assessed through the writing-reviewing process. Criterion validity was assessed by comparing student scores on the P3 ASAP Exam with the nationally validated Pharmacy Curriculum Outcomes Assessment (PCOA). Reliability was assessed with psychometric analysis comparing student performance over four years. Results. The P3 ASAP Exam showed content validity through representation of didactic courses and professional outcomes. Similar scores on the P3 ASAP Exam and PCOA with Pearson correlation coefficient established criterion validity. Consistent student performance using Kuder-Richardson coefficient (KR-20) since 2012 reflected reliability of the examination. Conclusion. Pharmacy schools can implement internally developed, high-stakes, cumulative progression examinations that are valid and reliable using a robust writing-reviewing process and psychometric analyses. PMID:26941435

The development of 'Quality of Life Instrument for Indian Diabetes patients (QOLID): a validation and reliability study in middle and higher income groups.

PubMed

Nagpal, Jitender; Kumar, Arvind; Kakar, Sonia; Bhartia, Abhishek

2010-05-01

To develop a reliable and valid quality of life questionnaire for Indian patients with diabetes. A draft of 75 questions was prepared on the basis of expert opinion, focus group discussions, review of existing literature and detailed semi-structured interviews of patients with diabetes with the intention of including all aspects of diabetes-specific and quality of life considered relevant by patients and care providers to enable constrict validity. A Stage 2 questionnaire was then prepared with 13 domains and 54 items (questions) after expert panel review for obvious irrelevance and duplication of issues. It was administered to 150 participants visiting a diabetes center at New Delhi. Factor analysis was done using principal component method with varimax rotation. Reliability analysis was done by calculating Cronbach's Alpha. For evaluating concordant validity the questionnaire was co-administered with DQL-CTQ to 30 participants. The discriminant validity of the questionnaire was tested using 't' test for metabolic control, co-morbidities, insulin use and gender. Using principal component method 8 domains were identified on the basis of an apriori hypothesis and the scree plot. These 8 domains explained 49.9% of the total variation. 34 items (questions) were selected to represent these domains on the basis of extraction communality, factor loading, inter-item and item-total correlations. The final questionnaire has an Overall Cronbach's Alpha value of 0.894 (subscale- 0.55 to 0.85) showing high internal consistency. The questionnaire showed good concordance (product moment correlation 0.724; p = 0.001; subscale correlation - 0.457 to 0.779) with the DQL-CTQ. The overall standardized questionnaire score showed good responsiveness to metabolic control and co-morbidities establishing discriminant validity. The final version of questionnaire with 8 domains and 34 items is a reliable and valid tool for assessment of quality of life of Indian patients with diabetes.

Bias correction for selecting the minimal-error classifier from many machine learning models.

PubMed

Ding, Ying; Tang, Shaowu; Liao, Serena G; Jia, Jia; Oesterreich, Steffi; Lin, Yan; Tseng, George C

2014-11-15

Supervised machine learning is commonly applied in genomic research to construct a classifier from the training data that is generalizable to predict independent testing data. When test datasets are not available, cross-validation is commonly used to estimate the error rate. Many machine learning methods are available, and it is well known that no universally best method exists in general. It has been a common practice to apply many machine learning methods and report the method that produces the smallest cross-validation error rate. Theoretically, such a procedure produces a selection bias. Consequently, many clinical studies with moderate sample sizes (e.g. n = 30-60) risk reporting a falsely small cross-validation error rate that could not be validated later in independent cohorts. In this article, we illustrated the probabilistic framework of the problem and explored the statistical and asymptotic properties. We proposed a new bias correction method based on learning curve fitting by inverse power law (IPL) and compared it with three existing methods: nested cross-validation, weighted mean correction and Tibshirani-Tibshirani procedure. All methods were compared in simulation datasets, five moderate size real datasets and two large breast cancer datasets. The result showed that IPL outperforms the other methods in bias correction with smaller variance, and it has an additional advantage to extrapolate error estimates for larger sample sizes, a practical feature to recommend whether more samples should be recruited to improve the classifier and accuracy. An R package 'MLbias' and all source files are publicly available. tsenglab.biostat.pitt.edu/software.htm. ctseng@pitt.edu Supplementary data are available at Bioinformatics online. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Validation of asthma recording in electronic health records: a systematic review

PubMed Central

Nissen, Francis; Quint, Jennifer K; Wilkinson, Samantha; Mullerova, Hana; Smeeth, Liam; Douglas, Ian J

2017-01-01

Objective To describe the methods used to validate asthma diagnoses in electronic health records and summarize the results of the validation studies. Background Electronic health records are increasingly being used for research on asthma to inform health services and health policy. Validation of the recording of asthma diagnoses in electronic health records is essential to use these databases for credible epidemiological asthma research. Methods We searched EMBASE and MEDLINE databases for studies that validated asthma diagnoses detected in electronic health records up to October 2016. Two reviewers independently assessed the full text against the predetermined inclusion criteria. Key data including author, year, data source, case definitions, reference standard, and validation statistics (including sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) were summarized in two tables. Results Thirteen studies met the inclusion criteria. Most studies demonstrated a high validity using at least one case definition (PPV >80%). Ten studies used a manual validation as the reference standard; each had at least one case definition with a PPV of at least 63%, up to 100%. We also found two studies using a second independent database to validate asthma diagnoses. The PPVs of the best performing case definitions ranged from 46% to 58%. We found one study which used a questionnaire as the reference standard to validate a database case definition; the PPV of the case definition algorithm in this study was 89%. Conclusion Attaining high PPVs (>80%) is possible using each of the discussed validation methods. Identifying asthma cases in electronic health records is possible with high sensitivity, specificity or PPV, by combining multiple data sources, or by focusing on specific test measures. Studies testing a range of case definitions show wide variation in the validity of each definition, suggesting this may be important for obtaining asthma definitions with optimal validity. PMID:29238227

Quantification of myocardial blood flow using dynamic 320-row multi-detector CT as compared with ¹⁵O-H₂O PET.

PubMed

Kikuchi, Yasuka; Oyama-Manabe, Noriko; Naya, Masanao; Manabe, Osamu; Tomiyama, Yuuki; Sasaki, Tsukasa; Katoh, Chietsugu; Kudo, Kohsuke; Tamaki, Nagara; Shirato, Hiroki

2014-07-01

This study introduces a method to calculate myocardium blood flow (MBF) and coronary flow reserve (CFR) using the relatively low-dose dynamic 320-row multi-detector computed tomography (MDCT), validates the method against (15)O-H₂O positron-emission tomography (PET) and assesses the CFRs of coronary artery disease (CAD) patients. Thirty-two subjects underwent both dynamic CT perfusion (CTP) and PET perfusion imaging at rest and during pharmacological stress. In 12 normal subjects (pilot group), the calculation method for MBF and CFR was established. In the other 13 normal subjects (validation group), MBF and CFR obtained by dynamic CTP and PET were compared. Finally, the CFRs obtained by dynamic CTP and PET were compared between the validation group and CAD patients (n = 7). Correlation between MBF of MDCT and PET was strong (r = 0.95, P < 0.0001). CFR showed good correlation between dynamic CTP and PET (r = 0.67, P = 0.0126). CFRCT in the CAD group (2.3 ± 0.8) was significantly lower than that in the validation group (5.2 ± 1.8) (P = 0.0011). We established a method for measuring MBF and CFR with the relatively low-dose dynamic MDCT. Lower CFR was well demonstrated in CAD patients by dynamic CTP. • MBF and CFR can be calculated using dynamic CTP with 320-row MDCT. • MBF and CFR showed good correlation between dynamic CTP and PET. • Lower CFR was well demonstrated in CAD patients by dynamic CTP.

METAPHOR: Probability density estimation for machine learning based photometric redshifts

NASA Astrophysics Data System (ADS)

Amaro, V.; Cavuoti, S.; Brescia, M.; Vellucci, C.; Tortora, C.; Longo, G.

2017-06-01

We present METAPHOR (Machine-learning Estimation Tool for Accurate PHOtometric Redshifts), a method able to provide a reliable PDF for photometric galaxy redshifts estimated through empirical techniques. METAPHOR is a modular workflow, mainly based on the MLPQNA neural network as internal engine to derive photometric galaxy redshifts, but giving the possibility to easily replace MLPQNA with any other method to predict photo-z's and their PDF. We present here the results about a validation test of the workflow on the galaxies from SDSS-DR9, showing also the universality of the method by replacing MLPQNA with KNN and Random Forest models. The validation test include also a comparison with the PDF's derived from a traditional SED template fitting method (Le Phare).

Ecological content validation of the Information Assessment Method for parents (IAM-parent): A mixed methods study.

PubMed

Bujold, M; El Sherif, R; Bush, P L; Johnson-Lafleur, J; Doray, G; Pluye, P

2018-02-01

This mixed methods study content validated the Information Assessment Method for parents (IAM-parent) that allows users to systematically rate and comment on online parenting information. Quantitative data and results: 22,407 IAM ratings were collected; of the initial 32 items, descriptive statistics showed that 10 had low relevance. Qualitative data and results: IAM-based comments were collected, and 20 IAM users were interviewed (maximum variation sample); the qualitative data analysis assessed the representativeness of IAM items, and identified items with problematic wording. Researchers, the program director, and Web editors integrated quantitative and qualitative results, which led to a shorter and clearer IAM-parent. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Reliability and Validity of Modified Service Quality Instrument (SERVQUAL) in Patients’ Motivation to Adhere to Insulin Therapy

PubMed Central

Jakupovic, Vedran; Solakovic, Suajb; Celebic, Nedim; Kulovic, Dzenan

2018-01-01

Introduction: Diabetes is progressive condition which requires various ways of treatment. Adequate therapy prescribed in the right time helps patient to postpone development of complications. Adherence to complicated therapy is challenge for both patients and HCPs and is subject of research in many disciplines. Improvement in communication between HCP and patients is very important in patient’s adherence to therapy. Aim: Aim of this research was to explore validity and reliability of modified SERVQUAL instrument in attempt to explore ways of motivating diabetic patient to accept prescribed insulin therapy. Material and Methods: We used modified SERVQUAL questionnaire as instrument in the research. It was necessary to check validity and reliability of the new modified instrument. Results: Results show that modified Servqual instrument has excellent reliability (α=0.908), so we could say that it measures precisely Expectations, Perceptions and Motivation at patients. Factor analysis (EFA method) with Varimax rotation extracted 4 factors which together explain 52.902% variance of the results on this subscale. Bifactorial solution could be seen on Scree-plot diagram (break at second factor). Conclusion: Results in this research show that modified Servqual instrument which is created in order to measure expectations and perceptions of the patients is valid and reliable. Reliability and validity are proven indeed in additional dimension which was created originally for this research - motivation to accept insulin therapy. PMID:29670478

Climate change vulnerability for species-Assessing the assessments.

PubMed

Wheatley, Christopher J; Beale, Colin M; Bradbury, Richard B; Pearce-Higgins, James W; Critchlow, Rob; Thomas, Chris D

2017-09-01

Climate change vulnerability assessments are commonly used to identify species at risk from global climate change, but the wide range of methodologies available makes it difficult for end users, such as conservation practitioners or policymakers, to decide which method to use as a basis for decision-making. In this study, we evaluate whether different assessments consistently assign species to the same risk categories and whether any of the existing methodologies perform well at identifying climate-threatened species. We compare the outputs of 12 climate change vulnerability assessment methodologies, using both real and simulated species, and validate the methods using historic data for British birds and butterflies (i.e. using historical data to assign risks and more recent data for validation). Our results show that the different vulnerability assessment methods are not consistent with one another; different risk categories are assigned for both the real and simulated sets of species. Validation of the different vulnerability assessments suggests that methods incorporating historic trend data into the assessment perform best at predicting distribution trends in subsequent time periods. This study demonstrates that climate change vulnerability assessments should not be used interchangeably due to the poor overall agreement between methods when considering the same species. The results of our validation provide more support for the use of trend-based rather than purely trait-based approaches, although further validation will be required as data become available. © 2017 The Authors. Global Change Biology Published by John Wiley & Sons Ltd.

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

MRPrimer: a MapReduce-based method for the thorough design of valid and ranked primers for PCR.

PubMed

Kim, Hyerin; Kang, NaNa; Chon, Kang-Wook; Kim, Seonho; Lee, NaHye; Koo, JaeHyung; Kim, Min-Soo

2015-11-16

Primer design is a fundamental technique that is widely used for polymerase chain reaction (PCR). Although many methods have been proposed for primer design, they require a great deal of manual effort to generate feasible and valid primers, including homology tests on off-target sequences using BLAST-like tools. That approach is inconvenient for many target sequences of quantitative PCR (qPCR) due to considering the same stringent and allele-invariant constraints. To address this issue, we propose an entirely new method called MRPrimer that can design all feasible and valid primer pairs existing in a DNA database at once, while simultaneously checking a multitude of filtering constraints and validating primer specificity. Furthermore, MRPrimer suggests the best primer pair for each target sequence, based on a ranking method. Through qPCR analysis using 343 primer pairs and the corresponding sequencing and comparative analyses, we showed that the primer pairs designed by MRPrimer are very stable and effective for qPCR. In addition, MRPrimer is computationally efficient and scalable and therefore useful for quickly constructing an entire collection of feasible and valid primers for frequently updated databases like RefSeq. Furthermore, we suggest that MRPrimer can be utilized conveniently for experiments requiring primer design, especially real-time qPCR. © The Author(s) 2015. Published by Oxford University Press on behalf of Nucleic Acids Research.

Development and validation of NIR-chemometric methods for chemical and pharmaceutical characterization of meloxicam tablets.

PubMed

Tomuta, Ioan; Iovanov, Rares; Bodoki, Ede; Vonica, Loredana

2014-04-01

Near-Infrared (NIR) spectroscopy is an important component of a Process Analytical Technology (PAT) toolbox and is a key technology for enabling the rapid analysis of pharmaceutical tablets. The aim of this research work was to develop and validate NIR-chemometric methods not only for the determination of active pharmaceutical ingredients content but also pharmaceutical properties (crushing strength, disintegration time) of meloxicam tablets. The development of the method for active content assay was performed on samples corresponding to 80%, 90%, 100%, 110% and 120% of meloxicam content and the development of the methods for pharmaceutical characterization was performed on samples prepared at seven different compression forces (ranging from 7 to 45 kN) using NIR transmission spectra of intact tablets and PLS as a regression method. The results show that the developed methods have good trueness, precision and accuracy and are appropriate for direct active content assay in tablets (ranging from 12 to 18 mg/tablet) and also for predicting crushing strength and disintegration time of intact meloxicam tablets. The comparative data show that the proposed methods are in good agreement with the reference methods currently used for the characterization of meloxicam tablets (HPLC-UV methods for the assay and European Pharmacopeia methods for determining the crushing strength and disintegration time). The results show the possibility to predict both chemical properties (active content) and physical/pharmaceutical properties (crushing strength and disintegration time) directly, without any sample preparation, from the same NIR transmission spectrum of meloxicam tablets.

Development and validation of a stability-indicating capillary zone electrophoretic method for the assessment of entecavir and its correlation with liquid chromatographic methods.

PubMed

Dalmora, Sergio Luiz; Nogueira, Daniele Rubert; D'Avila, Felipe Bianchini; Souto, Ricardo Bizogne; Leal, Diogo Paim

2011-01-01

A stability-indicating capillary zone electrophoresis (CZE) method was validated for the analysis of entecavir in pharmaceutical formulations, using nimesulide as an internal standard. A fused-silica capillary (50 µm i.d.; effective length, 40 cm) was used while being maintained at 25°C; the applied voltage was 25 kV. A background electrolyte solution consisted of a 20 mM sodium tetraborate solution at pH 10. Injections were performed using a pressure mode at 50 mbar for 5 s, with detection at 216 nm. The specificity and stability-indicating capability were proven through forced degradation studies, evaluating also the in vitro cytotoxicity test of the degraded products. The method was linear over the concentration range of 1-200 µg mL(-1) (r(2) = 0.9999), and was applied for the analysis of entecavir in tablet dosage forms. The results were correlated to those of validated conventional and fast LC methods, showing non-significant differences (p > 0.05).

A new analytical method for quantification of olive and palm oil in blends with other vegetable edible oils based on the chromatographic fingerprints from the methyl-transesterified fraction.

PubMed

Jiménez-Carvelo, Ana M; González-Casado, Antonio; Cuadros-Rodríguez, Luis

2017-03-01

A new analytical method for the quantification of olive oil and palm oil in blends with other vegetable edible oils (canola, safflower, corn, peanut, seeds, grapeseed, linseed, sesame and soybean) using normal phase liquid chromatography, and applying chemometric tools was developed. The procedure for obtaining of chromatographic fingerprint from the methyl-transesterified fraction from each blend is described. The multivariate quantification methods used were Partial Least Square-Regression (PLS-R) and Support Vector Regression (SVR). The quantification results were evaluated by several parameters as the Root Mean Square Error of Validation (RMSEV), Mean Absolute Error of Validation (MAEV) and Median Absolute Error of Validation (MdAEV). It has to be highlighted that the new proposed analytical method, the chromatographic analysis takes only eight minutes and the results obtained showed the potential of this method and allowed quantification of mixtures of olive oil and palm oil with other vegetable oils. Copyright © 2016 Elsevier B.V. All rights reserved.

Method validation using weighted linear regression models for quantification of UV filters in water samples.

PubMed

da Silva, Claudia Pereira; Emídio, Elissandro Soares; de Marchi, Mary Rosa Rodrigues

2015-01-01

This paper describes the validation of a method consisting of solid-phase extraction followed by gas chromatography-tandem mass spectrometry for the analysis of the ultraviolet (UV) filters benzophenone-3, ethylhexyl salicylate, ethylhexyl methoxycinnamate and octocrylene. The method validation criteria included evaluation of selectivity, analytical curve, trueness, precision, limits of detection and limits of quantification. The non-weighted linear regression model has traditionally been used for calibration, but it is not necessarily the optimal model in all cases. Because the assumption of homoscedasticity was not met for the analytical data in this work, a weighted least squares linear regression was used for the calibration method. The evaluated analytical parameters were satisfactory for the analytes and showed recoveries at four fortification levels between 62% and 107%, with relative standard deviations less than 14%. The detection limits ranged from 7.6 to 24.1 ng L(-1). The proposed method was used to determine the amount of UV filters in water samples from water treatment plants in Araraquara and Jau in São Paulo, Brazil. Copyright © 2014 Elsevier B.V. All rights reserved.

Multi-body modeling method for rollover using MADYMO

NASA Astrophysics Data System (ADS)

Liu, Changye; Lin, Zhigui; Lv, Juncheng; Luo, Qinyue; Qin, Zhenyao; Zhang, Pu; Chen, Tao

2017-04-01

Rollovers are complex road accidents causing a big deal of fatalities. FE model for rollover study will costtoo much time due to its long duration.A new multi-body modeling method is proposed in this paper which can save a lot of time and has high-fidelity meanwhile. Following works were carried out to validate this new method. First, a small van was tested following the FMVSS 208 protocol for the validation of the proposed modeling method. Second, a MADYMO model of this small van was reconstructed. The vehicle body was divided into two main parts, the deformable upper body and the rigid lower body, modeled by different waysbased on an FE model. The specific method of modeling is offered in this paper. Finally, the trajectories of the vehicle from test and simulation were comparedand the match was very good. Acceleration of left B pillar was taken into consideration, which turned out fitting the test result well in the time of event. The final deformation status of the vehicle in test and simulation showed similar trend. This validated model provides a reliable wayfor further research in occupant injuries during rollovers.

Fully automated motion correction in first-pass myocardial perfusion MR image sequences.

PubMed

Milles, Julien; van der Geest, Rob J; Jerosch-Herold, Michael; Reiber, Johan H C; Lelieveldt, Boudewijn P F

2008-11-01

This paper presents a novel method for registration of cardiac perfusion magnetic resonance imaging (MRI). The presented method is capable of automatically registering perfusion data, using independent component analysis (ICA) to extract physiologically relevant features together with their time-intensity behavior. A time-varying reference image mimicking intensity changes in the data of interest is computed based on the results of that ICA. This reference image is used in a two-pass registration framework. Qualitative and quantitative validation of the method is carried out using 46 clinical quality, short-axis, perfusion MR datasets comprising 100 images each. Despite varying image quality and motion patterns in the evaluation set, validation of the method showed a reduction of the average right ventricle (LV) motion from 1.26+/-0.87 to 0.64+/-0.46 pixels. Time-intensity curves are also improved after registration with an average error reduced from 2.65+/-7.89% to 0.87+/-3.88% between registered data and manual gold standard. Comparison of clinically relevant parameters computed using registered data and the manual gold standard show a good agreement. Additional tests with a simulated free-breathing protocol showed robustness against considerable deviations from a standard breathing protocol. We conclude that this fully automatic ICA-based method shows an accuracy, a robustness and a computation speed adequate for use in a clinical environment.

Validity of two methods for estimation of vertical jump height.

PubMed

Dias, Jonathan Ache; Dal Pupo, Juliano; Reis, Diogo C; Borges, Lucas; Santos, Saray G; Moro, Antônio R P; Borges, Noé G

2011-07-01

The objectives of this study were (a) to determine the concurrent validity of the flight time (FT) and double integration of vertical reaction force (DIF) methods in the estimation of vertical jump height with the video method (VID) as reference; (b) to verify the degree of agreement among the 3 methods; (c) to propose regression equations to predict the jump height using the FT and DIF. Twenty healthy male and female nonathlete college students participated in this study. The experiment involved positioning a contact mat (CTM) on the force platform (FP), with a video camera 3 m from the FP and perpendicular to the sagittal plane of the subject being assessed. Each participant performed 15 countermovement jumps with 60-second intervals between the trials. Significant differences were found between the jump height obtained by VID and the results with FT (p ≤ 0.01) and DIF (p ≤ 0.01), showing that the methods are not valid. Additionally, the DIF showed a greater degree of agreement with the reference method than the FT did, and both presented a systematic error. From the linear regression test was determined the prediction equations with a high degree of linearity between the methods VID vs. DIF (R = 0.988) and VID vs. FT (R = 0.979). Therefore, the prediction equations suggested may allow coaches to measure the vertical jump performance of athletes by the FT and DIF, using a CTM or an FP, which represents more practical and viable approaches in the sports field; comparisons can then be made with the results of other athletes evaluated by VID.

Identification of DNA-Binding Proteins Using Mixed Feature Representation Methods.

PubMed

Qu, Kaiyang; Han, Ke; Wu, Song; Wang, Guohua; Wei, Leyi

2017-09-22

DNA-binding proteins play vital roles in cellular processes, such as DNA packaging, replication, transcription, regulation, and other DNA-associated activities. The current main prediction method is based on machine learning, and its accuracy mainly depends on the features extraction method. Therefore, using an efficient feature representation method is important to enhance the classification accuracy. However, existing feature representation methods cannot efficiently distinguish DNA-binding proteins from non-DNA-binding proteins. In this paper, a multi-feature representation method, which combines three feature representation methods, namely, K-Skip-N-Grams, Information theory, and Sequential and structural features (SSF), is used to represent the protein sequences and improve feature representation ability. In addition, the classifier is a support vector machine. The mixed-feature representation method is evaluated using 10-fold cross-validation and a test set. Feature vectors, which are obtained from a combination of three feature extractions, show the best performance in 10-fold cross-validation both under non-dimensional reduction and dimensional reduction by max-relevance-max-distance. Moreover, the reduced mixed feature method performs better than the non-reduced mixed feature technique. The feature vectors, which are a combination of SSF and K-Skip-N-Grams, show the best performance in the test set. Among these methods, mixed features exhibit superiority over the single features.

[Reliability and validity of the Chinese version on Alcohol Use Disorders Identification Test].

PubMed

Zhang, C; Yang, G P; Li, Z; Li, X N; Li, Y; Hu, J; Zhang, F Y; Zhang, X J

2017-08-10

Objective: To assess the reliability and validity of the Chinese version on Alcohol Use Disorders Identification Test (AUDIT) among medical students in China and to provide correct way of application on the recommended scales. Methods: An E-questionnaire was developed and sent to medical students in five different colleges. Students were all active volunteers to accept the testings. Cronbach's α and split-half reliability were calculated to evaluate the reliability of AUDIT while content, contract, discriminant and convergent validity were performed to measure the validity of the scales. Results: The overall Cronbach's α of AUDIT was 0.782 and the split-half reliability was 0.711. Data showed that the domain Cronbach's α and split-half reliability were 0.796 and 0.794 for hazardous alcohol use, 0.561 and 0.623 for dependence symptoms, and 0.647 and 0.640 for harmful alcohol use. Results also showed that the content validity index on the levels of items I-CVI) were from 0.83 to 1.00, the content validity index of scale level (S-CVI/UA) was 0.90, content validity index of average scale level (S-CVI/Ave) was 0.99 and the content validity ratios (CVR) were from 0.80 to 1.00. The simplified version of AUDIT supported a presupposed three-factor structure which could explain 61.175% of the total variance revealed through exploratory factor analysis. AUDIT semed to have good convergent and discriminant validity, with the success rate of calibration experiment as 100%. Conclusion: AUDIT showed good reliability and validity among medical students in China thus worth for promotion on its use.

Validation for Vegetation Green-up Date Extracted from GIMMS NDVI and NDVI3g Using Variety of Methods

NASA Astrophysics Data System (ADS)

Chang, Q.; Jiao, W.

2017-12-01

Phenology is a sensitive and critical feature of vegetation change that has regarded as a good indicator in climate change studies. So far, variety of remote sensing data sources and phenology extraction methods from satellite datasets have been developed to study the spatial-temporal dynamics of vegetation phenology. However, the differences between vegetation phenology results caused by the varies satellite datasets and phenology extraction methods are not clear, and the reliability for different phenology results extracted from remote sensing datasets is not verified and compared using the ground observation data. Based on three most popular remote sensing phenology extraction methods, this research calculated the Start of the growing season (SOS) for each pixels in the Northern Hemisphere for two kinds of long time series satellite datasets: GIMMS NDVIg (SOSg) and GIMMS NDVI3g (SOS3g). The three methods used in this research are: maximum increase method, dynamic threshold method and midpoint method. Then, this study used SOS calculated from NEE datasets (SOS_NEE) monitored by 48 eddy flux tower sites in global flux website to validate the reliability of six phenology results calculated from remote sensing datasets. Results showed that both SOSg and SOS3g extracted by maximum increase method are not correlated with ground observed phenology metrics. SOSg and SOS3g extracted by the dynamic threshold method and midpoint method are both correlated with SOS_NEE significantly. Compared with SOSg extracted by the dynamic threshold method, SOSg extracted by the midpoint method have a stronger correlation with SOS_NEE. And, the same to SOS3g. Additionally, SOSg showed stronger correlation with SOS_NEE than SOS3g extracted by the same method. SOS extracted by the midpoint method from GIMMS NDVIg datasets seemed to be the most reliable results when validated with SOS_NEE. These results can be used as reference for data and method selection in future's phenology study.

Psychometric and cognitive validation of a social capital measurement tool in Peru and Vietnam.

PubMed

De Silva, Mary J; Harpham, Trudy; Tuan, Tran; Bartolini, Rosario; Penny, Mary E; Huttly, Sharon R

2006-02-01

Social capital is a relatively new concept which has attracted significant attention in recent years. No consensus has yet been reached on how to measure social capital, resulting in a large number of different tools available. While psychometric validation methods such as factor analysis have been used by a few studies to assess the internal validity of some tools, these techniques rely on data already collected by the tool and are therefore not capable of eliciting what the questions are actually measuring. The Young Lives (YL) study includes quantitative measures of caregiver's social capital in four countries (Vietnam, Peru, Ethiopia, and India) using a short version of the Adapted Social Capital Assessment Tool (SASCAT). A range of different psychometric methods including factor analysis were used to evaluate the construct validity of SASCAT in Peru and Vietnam. In addition, qualitative cognitive interviews with 20 respondents from Peru and 24 respondents from Vietnam were conducted to explore what each question is actually measuring. We argue that psychometric validation techniques alone are not sufficient to adequately validate multi-faceted social capital tools for use in different cultural settings. Psychometric techniques show SASCAT to be a valid tool reflecting known constructs and displaying postulated links with other variables. However, results from the cognitive interviews present a more mixed picture with some questions being appropriately interpreted by respondents, and others displaying significant differences between what the researchers intended them to measure and what they actually do. Using evidence from a range of methods of assessing validity has enabled the modification of an existing instrument into a valid and low cost tool designed to measure social capital within larger surveys in Peru and Vietnam, with the potential for use in other developing countries following local piloting and cultural adaptation of the tool.

Validation of RNAi Silencing Efficiency Using Gene Array Data shows 18.5% Failure Rate across 429 Independent Experiments.

PubMed

Munkácsy, Gyöngyi; Sztupinszki, Zsófia; Herman, Péter; Bán, Bence; Pénzváltó, Zsófia; Szarvas, Nóra; Győrffy, Balázs

2016-09-27

No independent cross-validation of success rate for studies utilizing small interfering RNA (siRNA) for gene silencing has been completed before. To assess the influence of experimental parameters like cell line, transfection technique, validation method, and type of control, we have to validate these in a large set of studies. We utilized gene chip data published for siRNA experiments to assess success rate and to compare methods used in these experiments. We searched NCBI GEO for samples with whole transcriptome analysis before and after gene silencing and evaluated the efficiency for the target and off-target genes using the array-based expression data. Wilcoxon signed-rank test was used to assess silencing efficacy and Kruskal-Wallis tests and Spearman rank correlation were used to evaluate study parameters. All together 1,643 samples representing 429 experiments published in 207 studies were evaluated. The fold change (FC) of down-regulation of the target gene was above 0.7 in 18.5% and was above 0.5 in 38.7% of experiments. Silencing efficiency was lowest in MCF7 and highest in SW480 cells (FC = 0.59 and FC = 0.30, respectively, P = 9.3E-06). Studies utilizing Western blot for validation performed better than those with quantitative polymerase chain reaction (qPCR) or microarray (FC = 0.43, FC = 0.47, and FC = 0.55, respectively, P = 2.8E-04). There was no correlation between type of control, transfection method, publication year, and silencing efficiency. Although gene silencing is a robust feature successfully cross-validated in the majority of experiments, efficiency remained insufficient in a significant proportion of studies. Selection of cell line model and validation method had the highest influence on silencing proficiency.

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.

Validity of endothelial cell analysis methods and recommendations for calibration in Topcon SP-2000P specular microscopy.

PubMed

van Schaick, Willem; van Dooren, Bart T H; Mulder, Paul G H; Völker-Dieben, Hennie J M

2005-07-01

To report on the calibration of the Topcon SP-2000P specular microscope and the Endothelial Cell Analysis Module of the IMAGEnet 2000 software, and to establish the validity of the different endothelial cell density (ECD) assessment methods available in these instruments. Using an external microgrid, we calibrated the magnification of the SP-2000P and the IMAGEnet software. In both eyes of 36 volunteers, we validated 4 ECD assessment methods by comparing these methods to the gold standard manual ECD, manual counting of cells on a video print. These methods were: the estimated ECD, estimation of ECD with a reference grid on the camera screen; the SP-2000P ECD, pointing out whole contiguous cells on the camera screen; the uncorrected IMAGEnet ECD, using automatically drawn cell borders, and the corrected IMAGEnet ECD, with manual correction of incorrectly drawn cell borders in the automated analysis. Validity of each method was evaluated by calculating both the mean difference with the manual ECD and the limits of agreement as described by Bland and Altman. Preset factory values of magnification were incorrect, resulting in errors in ECD of up to 9%. All assessments except 1 of the estimated ECDs differed significantly from manual ECDs, with most differences being similar (< or =6.5%), except for uncorrected IMAGEnet ECD (30.2%). Corrected IMAGEnet ECD showed the narrowest limits of agreement (-4.9 to +19.3%). We advise checking the calibration of magnification in any specular microscope or endothelial analysis software as it may be erroneous. Corrected IMAGEnet ECD is the most valid of the investigated methods in the Topcon SP-2000P/IMAGEnet 2000 combination.

Fluid-structure interaction with the entropic lattice Boltzmann method

NASA Astrophysics Data System (ADS)

Dorschner, B.; Chikatamarla, S. S.; Karlin, I. V.

2018-02-01

We propose a fluid-structure interaction (FSI) scheme using the entropic multi-relaxation time lattice Boltzmann (KBC) model for the fluid domain in combination with a nonlinear finite element solver for the structural part. We show the validity of the proposed scheme for various challenging setups by comparison to literature data. Beyond validation, we extend the KBC model to multiphase flows and couple it with a finite element method (FEM) solver. Robustness and viability of the entropic multi-relaxation time model for complex FSI applications is shown by simulations of droplet impact on elastic superhydrophobic surfaces.

Early Prediction of Intensive Care Unit-Acquired Weakness: A Multicenter External Validation Study.

PubMed

Witteveen, Esther; Wieske, Luuk; Sommers, Juultje; Spijkstra, Jan-Jaap; de Waard, Monique C; Endeman, Henrik; Rijkenberg, Saskia; de Ruijter, Wouter; Sleeswijk, Mengalvio; Verhamme, Camiel; Schultz, Marcus J; van Schaik, Ivo N; Horn, Janneke

2018-01-01

An early diagnosis of intensive care unit-acquired weakness (ICU-AW) is often not possible due to impaired consciousness. To avoid a diagnostic delay, we previously developed a prediction model, based on single-center data from 212 patients (development cohort), to predict ICU-AW at 2 days after ICU admission. The objective of this study was to investigate the external validity of the original prediction model in a new, multicenter cohort and, if necessary, to update the model. Newly admitted ICU patients who were mechanically ventilated at 48 hours after ICU admission were included. Predictors were prospectively recorded, and the outcome ICU-AW was defined by an average Medical Research Council score <4. In the validation cohort, consisting of 349 patients, we analyzed performance of the original prediction model by assessment of calibration and discrimination. Additionally, we updated the model in this validation cohort. Finally, we evaluated a new prediction model based on all patients of the development and validation cohort. Of 349 analyzed patients in the validation cohort, 190 (54%) developed ICU-AW. Both model calibration and discrimination of the original model were poor in the validation cohort. The area under the receiver operating characteristics curve (AUC-ROC) was 0.60 (95% confidence interval [CI]: 0.54-0.66). Model updating methods improved calibration but not discrimination. The new prediction model, based on all patients of the development and validation cohort (total of 536 patients) had a fair discrimination, AUC-ROC: 0.70 (95% CI: 0.66-0.75). The previously developed prediction model for ICU-AW showed poor performance in a new independent multicenter validation cohort. Model updating methods improved calibration but not discrimination. The newly derived prediction model showed fair discrimination. This indicates that early prediction of ICU-AW is still challenging and needs further attention.

Validity of worksheet-based guided inquiry and mind mapping for training students’ creative thinking skills

NASA Astrophysics Data System (ADS)

Susanti, L. B.; Poedjiastoeti, S.; Taufikurohmah, T.

2018-04-01

The purpose of this study is to explain the validity of guided inquiry and mind mapping-based worksheet that has been developed in this study. The worksheet implemented the phases of guided inquiry teaching models in order to train students’ creative thinking skills. The creative thinking skills which were trained in this study included fluency, flexibility, originality and elaboration. The types of validity used in this study included content and construct validity. The type of this study is development research with Research and Development (R & D) method. The data of this study were collected using review and validation sheets. Sources of the data were chemistry lecturer and teacher. The data is the analyzed descriptively. The results showed that the worksheet is very valid and could be used as a learning media with the percentage of validity ranged from 82.5%-92.5%.

A method to determine the mammographic regions that show early changes due to the development of breast cancer

NASA Astrophysics Data System (ADS)

Karemore, Gopal; Nielsen, Mads; Karssemeijer, Nico; Brandt, Sami S.

2014-11-01

It is well understood nowadays that changes in the mammographic parenchymal pattern are an indicator of a risk of breast cancer and we have developed a statistical method that estimates the mammogram regions where the parenchymal changes, due to breast cancer, occur. This region of interest is computed from a score map by utilising the anatomical breast coordinate system developed in our previous work. The method also makes an automatic scale selection to avoid overfitting while the region estimates are computed by a nested cross-validation scheme. In this way, it is possible to recover those mammogram regions that show a significant difference in classification scores between the cancer and the control group. Our experiments suggested that the most significant mammogram region is the region behind the nipple and that can be justified by previous findings from other research groups. This result was conducted on the basis of the cross-validation experiments on independent training, validation and testing sets from the case-control study of 490 women, of which 245 women were diagnosed with breast cancer within a period of 2-4 years after the baseline mammograms. We additionally generalised the estimated region to another, mini-MIAS study and showed that the transferred region estimate gives at least a similar classification result when compared to the case where the whole breast region is used. In all, by following our method, one most likely improves both preclinical and follow-up breast cancer screening, but a larger study population will be required to test this hypothesis.

Cross-Cultural Adaptation and Validation of the MPAM-R to Brazilian Portuguese and Proposal of a New Method to Calculate Factor Scores

PubMed Central

Albuquerque, Maicon R.; Lopes, Mariana C.; de Paula, Jonas J.; Faria, Larissa O.; Pereira, Eveline T.; da Costa, Varley T.

2017-01-01

In order to understand the reasons that lead individuals to practice physical activity, researchers developed the Motives for Physical Activity Measure-Revised (MPAM-R) scale. In 2010, a translation of MPAM-R to Portuguese and its validation was performed. However, psychometric measures were not acceptable. In addition, factor scores in some sports psychology scales are calculated by the mean of scores by items of the factor. Nevertheless, it seems appropriate that items with higher factor loadings, extracted by Factor Analysis, have greater weight in the factor score, as items with lower factor loadings have less weight in the factor score. The aims of the present study are to translate, validate the MPAM-R for Portuguese versions, and investigate agreement between two methods used to calculate factor scores. Three hundred volunteers who were involved in physical activity programs for at least 6 months were collected. Confirmatory Factor Analysis of the 30 items indicated that the version did not fit the model. After excluding four items, the final model with 26 items showed acceptable model fit measures by Exploratory Factor Analysis, as well as it conceptually supports the five factors as the original proposal. When two methods are compared to calculate factors scores, our results showed that only “Enjoyment” and “Appearance” factors showed agreement between methods to calculate factor scores. So, the Portuguese version of the MPAM-R can be used in a Brazilian context, and a new proposal for the calculation of the factor score seems to be promising. PMID:28293203

FastaValidator: an open-source Java library to parse and validate FASTA formatted sequences.

PubMed

Waldmann, Jost; Gerken, Jan; Hankeln, Wolfgang; Schweer, Timmy; Glöckner, Frank Oliver

2014-06-14

Advances in sequencing technologies challenge the efficient importing and validation of FASTA formatted sequence data which is still a prerequisite for most bioinformatic tools and pipelines. Comparative analysis of commonly used Bio*-frameworks (BioPerl, BioJava and Biopython) shows that their scalability and accuracy is hampered. FastaValidator represents a platform-independent, standardized, light-weight software library written in the Java programming language. It targets computer scientists and bioinformaticians writing software which needs to parse quickly and accurately large amounts of sequence data. For end-users FastaValidator includes an interactive out-of-the-box validation of FASTA formatted files, as well as a non-interactive mode designed for high-throughput validation in software pipelines. The accuracy and performance of the FastaValidator library qualifies it for large data sets such as those commonly produced by massive parallel (NGS) technologies. It offers scientists a fast, accurate and standardized method for parsing and validating FASTA formatted sequence data.

The validity of using an electrocutaneous device for pain assessment in patients with cervical radiculopathy.

PubMed

Abbott, Allan; Ghasemi-Kafash, Elaheh; Dedering, Åsa

2014-10-01

The purpose of this study was to evaluate the validity and preference for assessing pain magnitude with electrocutaneous testing (ECT) compared to the visual analogue scale (VAS) and Borg CR10 scale in men and women with cervical radiculopathy of varying sensory phenotypes. An additional purpose was to investigate ECT sensory and pain thresholds in men and women with cervical radiculopathy of varying sensory phenotypes. This is a cross-sectional study of 34 patients with cervical radiculopathy. Scatterplots and linear regression were used to investigate bivariate relationships between ECT, VAS and Borg CR10 methods of pain magnitude measurement as well as ECT sensory and pain thresholds. The use of the ECT pain magnitude matching paradigm for patients with cervical radiculopathy with normal sensory phenotype shows good linear association with arm pain VAS (R(2) = 0.39), neck pain VAS (R(2) = 0.38), arm pain Borg CR10 scale (R(2) = 0.50) and neck pain Borg CR10 scale (R(2) = 0.49) suggesting acceptable validity of the procedure. For patients with hypoesthesia and hyperesthesia sensory phenotypes, the ECT pain magnitude matching paradigm does not show adequate linear association with rating scale methods rendering the validity of the procedure as doubtful. ECT for sensory and pain threshold investigation, however, provides a method to objectively assess global sensory function in conjunction with sensory receptor specific bedside examination measures.

Hyperspectral Image Classification for Land Cover Based on an Improved Interval Type-II Fuzzy C-Means Approach

PubMed Central

Li, Zhao-Liang

2018-01-01

Few studies have examined hyperspectral remote-sensing image classification with type-II fuzzy sets. This paper addresses image classification based on a hyperspectral remote-sensing technique using an improved interval type-II fuzzy c-means (IT2FCM*) approach. In this study, in contrast to other traditional fuzzy c-means-based approaches, the IT2FCM* algorithm considers the ranking of interval numbers and the spectral uncertainty. The classification results based on a hyperspectral dataset using the FCM, IT2FCM, and the proposed improved IT2FCM* algorithms show that the IT2FCM* method plays the best performance according to the clustering accuracy. In this paper, in order to validate and demonstrate the separability of the IT2FCM*, four type-I fuzzy validity indexes are employed, and a comparative analysis of these fuzzy validity indexes also applied in FCM and IT2FCM methods are made. These four indexes are also applied into different spatial and spectral resolution datasets to analyze the effects of spectral and spatial scaling factors on the separability of FCM, IT2FCM, and IT2FCM* methods. The results of these validity indexes from the hyperspectral datasets show that the improved IT2FCM* algorithm have the best values among these three algorithms in general. The results demonstrate that the IT2FCM* exhibits good performance in hyperspectral remote-sensing image classification because of its ability to handle hyperspectral uncertainty. PMID:29373548

Validation of an immortalized human (hBMEC) in vitro blood-brain barrier model.

PubMed

Eigenmann, Daniela Elisabeth; Jähne, Evelyn Andrea; Smieško, Martin; Hamburger, Matthias; Oufir, Mouhssin

2016-03-01

We recently established and optimized an immortalized human in vitro blood-brain barrier (BBB) model based on the hBMEC cell line. In the present work, we validated this mono-culture 24-well model with a representative series of drug substances which are known to cross or not to cross the BBB. For each individual compound, a quantitative UHPLC-MS/MS method in Ringer HEPES buffer was developed and validated according to current regulatory guidelines, with respect to selectivity, precision, and reliability. Various biological and analytical challenges were met during method validation, highlighting the importance of careful method development. The positive controls antipyrine, caffeine, diazepam, and propranolol showed mean endothelial permeability coefficients (P e) in the range of 17-70 × 10(-6) cm/s, indicating moderate to high BBB permeability when compared to the barrier integrity marker sodium fluorescein (mean P e 3-5 × 10(-6) cm/s). The negative controls atenolol, cimetidine, and vinblastine showed mean P e values < 10 × 10(-6) cm/s, suggesting low permeability. In silico calculations were in agreement with in vitro data. With the exception of quinidine (P-glycoprotein inhibitor and substrate), BBB permeability of all control compounds was correctly predicted by this new, easy, and fast to set up human in vitro BBB model. Addition of retinoic acid and puromycin did not increase transendothelial electrical resistance (TEER) values of the BBB model.

Measuring physical activity in preschoolers: Reliability and validity of The System for Observing Fitness Instruction Time for Preschoolers (SOFIT-P)

PubMed Central

Sharma, Shreela; Chuang, Ru-Jye; Skala, Katherine; Atteberry, Heather

2012-01-01

The purpose of this study is describe the initial feasibility, reliability, and validity of an instrument to measure physical activity in preschoolers using direct observation. The System for Observing Fitness Instruction Time for Preschoolers was developed and tested among 3- to 6-year-old children over fall 2008 for feasibility and reliability (Phase I, n=67) and in fall 2009 for concurrent validity (Phase II, n=27). Phase I showed that preschoolers spent >75% of their active time at preschool in light physical activity. The mean inter-observer agreements scores were ≥.75 for physical activity level and type. Correlation coefficients, measuring construct validity between the lesson context and physical activity types with and with the activity levels, were moderately strong. Phase II showed moderately strong correlations ranging from .50 to .54 between the System for Observing Fitness Instruction Time for Preschoolers and Actigraph accelerometers for physical activity levels. The System for Observing Fitness Instruction Time for Preschoolers shows promising initial results as a new method for measuring physical activity among preschoolers. PMID:22485071

Remote sensing imagery classification using multi-objective gravitational search algorithm

NASA Astrophysics Data System (ADS)

Zhang, Aizhu; Sun, Genyun; Wang, Zhenjie

2016-10-01

Simultaneous optimization of different validity measures can capture different data characteristics of remote sensing imagery (RSI) and thereby achieving high quality classification results. In this paper, two conflicting cluster validity indices, the Xie-Beni (XB) index and the fuzzy C-means (FCM) (Jm) measure, are integrated with a diversity-enhanced and memory-based multi-objective gravitational search algorithm (DMMOGSA) to present a novel multi-objective optimization based RSI classification method. In this method, the Gabor filter method is firstly implemented to extract texture features of RSI. Then, the texture features are syncretized with the spectral features to construct the spatial-spectral feature space/set of the RSI. Afterwards, cluster of the spectral-spatial feature set is carried out on the basis of the proposed method. To be specific, cluster centers are randomly generated initially. After that, the cluster centers are updated and optimized adaptively by employing the DMMOGSA. Accordingly, a set of non-dominated cluster centers are obtained. Therefore, numbers of image classification results of RSI are produced and users can pick up the most promising one according to their problem requirements. To quantitatively and qualitatively validate the effectiveness of the proposed method, the proposed classification method was applied to classifier two aerial high-resolution remote sensing imageries. The obtained classification results are compared with that produced by two single cluster validity index based and two state-of-the-art multi-objective optimization algorithms based classification results. Comparison results show that the proposed method can achieve more accurate RSI classification.

Process Skill Assessment Instrument: Innovation to measure student’s learning result holistically

NASA Astrophysics Data System (ADS)

Azizah, K. N.; Ibrahim, M.; Widodo, W.

2018-01-01

Science process skills (SPS) are very important skills for students. However, the fact that SPS is not being main concern in the primary school learning is undeniable. This research aimed to develop a valid, practical, and effective assessment instrument to measure student’s SPS. Assessment instruments comprise of worksheet and test. This development research used one group pre-test post-test design. Data were obtained with validation, observation, and test method to investigate validity, practicality, and the effectivenss of the instruments. Results showed that the validity of assessment instruments is very valid, the reliability is categorized as reliable, student SPS activities have a high percentage, and there is significant improvement on student’s SPS score. It can be concluded that assessment instruments of SPS are valid, practical, and effective to be used to measure student’s SPS result.

Theoretical relationship between vibration transmissibility and driving-point response functions of the human body.

PubMed

Dong, Ren G; Welcome, Daniel E; McDowell, Thomas W; Wu, John Z

2013-11-25

The relationship between the vibration transmissibility and driving-point response functions (DPRFs) of the human body is important for understanding vibration exposures of the system and for developing valid models. This study identified their theoretical relationship and demonstrated that the sum of the DPRFs can be expressed as a linear combination of the transmissibility functions of the individual mass elements distributed throughout the system. The relationship is verified using several human vibration models. This study also clarified the requirements for reliably quantifying transmissibility values used as references for calibrating the system models. As an example application, this study used the developed theory to perform a preliminary analysis of the method for calibrating models using both vibration transmissibility and DPRFs. The results of the analysis show that the combined method can theoretically result in a unique and valid solution of the model parameters, at least for linear systems. However, the validation of the method itself does not guarantee the validation of the calibrated model, because the validation of the calibration also depends on the model structure and the reliability and appropriate representation of the reference functions. The basic theory developed in this study is also applicable to the vibration analyses of other structures.

[Validation of three screening tests used for early detection of cervical cancer].

PubMed

Rodriguez-Reyes, Esperanza Rosalba; Cerda-Flores, Ricardo M; Quiñones-Pérez, Juan M; Cortés-Gutiérrez, Elva I

2008-01-01

to evaluate the validity (sensitivity, specificity, and accuracy) of three screening methods used in the early detection of the cervical carcinoma versus the histopathology diagnosis. a selected sample of 107 women attended in the Opportune Detection of Cervicouterine Cancer Program in the Hospital de Zona 46, Instituto Mexicano del Seguro Social in Durango, during the 2003 was included. The application of Papa-nicolaou, acetic acid test, and molecular detection of human papillomavirus, and histopatholgy diagnosis were performed in all the patients at the time of the gynecological exam. The detection and tipification of the human papillomavirus was performed by polymerase chain reaction (PCR) and analysis of polymorphisms of length of restriction fragments (RFLP). Histopathology diagnosis was considered the gold standard. The evaluation of the validity was carried out by the Bayesian method for diagnosis test. the positive cases for acetic acid test, Papanicolaou, and PCR were 47, 22, and 19. The accuracy values were 0.70, 0.80 and 0.99, respectively. since the molecular method showed a greater validity in the early detection of the cervical carcinoma we considered of vital importance its implementation in suitable programs of Opportune Detection of Cervicouterino Cancer Program in Mexico. However, in order to validate this conclusion, cross-sectional studies in different region of country must be carried out.

Statistical Selection of Biological Models for Genome-Wide Association Analyses.

PubMed

Bi, Wenjian; Kang, Guolian; Pounds, Stanley B

2018-05-24

Genome-wide association studies have discovered many biologically important associations of genes with phenotypes. Typically, genome-wide association analyses formally test the association of each genetic feature (SNP, CNV, etc) with the phenotype of interest and summarize the results with multiplicity-adjusted p-values. However, very small p-values only provide evidence against the null hypothesis of no association without indicating which biological model best explains the observed data. Correctly identifying a specific biological model may improve the scientific interpretation and can be used to more effectively select and design a follow-up validation study. Thus, statistical methodology to identify the correct biological model for a particular genotype-phenotype association can be very useful to investigators. Here, we propose a general statistical method to summarize how accurately each of five biological models (null, additive, dominant, recessive, co-dominant) represents the data observed for each variant in a GWAS study. We show that the new method stringently controls the false discovery rate and asymptotically selects the correct biological model. Simulations of two-stage discovery-validation studies show that the new method has these properties and that its validation power is similar to or exceeds that of simple methods that use the same statistical model for all SNPs. Example analyses of three data sets also highlight these advantages of the new method. An R package is freely available at www.stjuderesearch.org/site/depts/biostats/maew. Copyright © 2018. Published by Elsevier 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

Development of a Bayesian model to estimate health care outcomes in the severely wounded

PubMed Central

Stojadinovic, Alexander; Eberhardt, John; Brown, Trevor S; Hawksworth, Jason S; Gage, Frederick; Tadaki, Douglas K; Forsberg, Jonathan A; Davis, Thomas A; Potter, Benjamin K; Dunne, James R; Elster, E A

2010-01-01

Background: Graphical probabilistic models have the ability to provide insights as to how clinical factors are conditionally related. These models can be used to help us understand factors influencing health care outcomes and resource utilization, and to estimate morbidity and clinical outcomes in trauma patient populations. Study design: Thirty-two combat casualties with severe extremity injuries enrolled in a prospective observational study were analyzed using step-wise machine-learned Bayesian belief network (BBN) and step-wise logistic regression (LR). Models were evaluated using 10-fold cross-validation to calculate area-under-the-curve (AUC) from receiver operating characteristics (ROC) curves. Results: Our BBN showed important associations between various factors in our data set that could not be developed using standard regression methods. Cross-validated ROC curve analysis showed that our BBN model was a robust representation of our data domain and that LR models trained on these findings were also robust: hospital-acquired infection (AUC: LR, 0.81; BBN, 0.79), intensive care unit length of stay (AUC: LR, 0.97; BBN, 0.81), and wound healing (AUC: LR, 0.91; BBN, 0.72) showed strong AUC. Conclusions: A BBN model can effectively represent clinical outcomes and biomarkers in patients hospitalized after severe wounding, and is confirmed by 10-fold cross-validation and further confirmed through logistic regression modeling. The method warrants further development and independent validation in other, more diverse patient populations. PMID:21197361

Beyond Corroboration: Strengthening Model Validation by Looking for Unexpected Patterns

PubMed Central

Chérel, Guillaume; Cottineau, Clémentine; Reuillon, Romain

2015-01-01

Models of emergent phenomena are designed to provide an explanation to global-scale phenomena from local-scale processes. Model validation is commonly done by verifying that the model is able to reproduce the patterns to be explained. We argue that robust validation must not only be based on corroboration, but also on attempting to falsify the model, i.e. making sure that the model behaves soundly for any reasonable input and parameter values. We propose an open-ended evolutionary method based on Novelty Search to look for the diverse patterns a model can produce. The Pattern Space Exploration method was tested on a model of collective motion and compared to three common a priori sampling experiment designs. The method successfully discovered all known qualitatively different kinds of collective motion, and performed much better than the a priori sampling methods. The method was then applied to a case study of city system dynamics to explore the model’s predicted values of city hierarchisation and population growth. This case study showed that the method can provide insights on potential predictive scenarios as well as falsifiers of the model when the simulated dynamics are highly unrealistic. PMID:26368917

Development and Validation of Different Ultraviolet-Spectrophotometric Methods for the Estimation of Besifloxacin in Different Simulated Body Fluids.

PubMed

Singh, C L; Singh, A; Kumar, S; Kumar, M; Sharma, P K; Majumdar, D K

2015-01-01

In the present study a simple, accurate, precise, economical and specific UV-spectrophotometric method for estimation of besifloxacin in bulk and in different pharmaceutical formulation has been developed. The drug shows maximum λmax289 nm in distilled water, simulated tears and phosphate buffer saline. The linearity range of developed methods were in the range of 3-30 μg/ml of drug with a correlation coefficient (r(2)) 0.9992, 0.9989 and 0.9984 with respect to distilled water, simulated tears and phosphate buffer saline, respectively. Reproducibility by repeating methods as %RSD were found to be less than 2%. The limit of detection in different media was found to be 0.62, 0.72 and 0.88 μg/ml, respectively. The limit of quantification was found to be 1.88, 2.10, 2.60 μg/ml, respectively. The proposed method was validated statically according to International Conference on Harmonization guidelines with respect to specificity, linearity, range, accuracy, precision and robustness. The proposed methods of validation were found to be accurate and highly specific for the estimation of besifloxacin in different pharmaceutical formulations.

Matrix Effect Evaluation and Method Validation of Azoxystrobin and Difenoconazole Residues in Red Flesh Dragon Fruit (Hylocereus polyrhizus) Matrices Using QuEChERS Sample Preparation Methods Followed by LC-MS/MS Determination.

PubMed

Noegrohati, Sri; Hernadi, Elan; Asviastuti, Syanti

2018-06-01

Production of red flesh dragon fruit (Hylocereus polyrhizus) was hampered by Colletotrichum sp. Pre-harvest application of azoxystrobin and difenoconazole mixture is recommended, therefore, a selective and sensitive multi residues analytical method is required in monitoring and evaluating the commodity's safety. LC-MS/MS is a well-established analytical technique for qualitative and quantitative determination in complex matrices. However, this method is hurdled by co-eluted coextractives interferences. This work evaluated the pH effect of acetate buffered and citrate buffered QuEChERS sample preparation in their effectiveness of matrix effect reduction. Citrate buffered QuEChERS proved to produce clean final extract with relative matrix effect 0.4%-0.7%. Method validation of the selected sample preparation followed by LC-MS/MS for whole dragon fruit, flesh and peel matrices fortified at 0.005, 0.01, 0.1 and 1 g/g showed recoveries 75%-119%, intermediate repeatability 2%-14%. The expanded uncertainties were 7%-48%. Based on the international acceptance criteria, this method is valid.

Moving to Capture Children's Attention: Developing a Methodology for Measuring Visuomotor Attention.

PubMed

Hill, Liam J B; Coats, Rachel O; Mushtaq, Faisal; Williams, Justin H G; Aucott, Lorna S; Mon-Williams, Mark

2016-01-01

Attention underpins many activities integral to a child's development. However, methodological limitations currently make large-scale assessment of children's attentional skill impractical, costly and lacking in ecological validity. Consequently we developed a measure of 'Visual Motor Attention' (VMA)-a construct defined as the ability to sustain and adapt visuomotor behaviour in response to task-relevant visual information. In a series of experiments, we evaluated the capability of our method to measure attentional processes and their contributions in guiding visuomotor behaviour. Experiment 1 established the method's core features (ability to track stimuli moving on a tablet-computer screen with a hand-held stylus) and demonstrated its sensitivity to principled manipulations in adults' attentional load. Experiment 2 standardised a format suitable for use with children and showed construct validity by capturing developmental changes in executive attention processes. Experiment 3 tested the hypothesis that children with and without coordination difficulties would show qualitatively different response patterns, finding an interaction between the cognitive and motor factors underpinning responses. Experiment 4 identified associations between VMA performance and existing standardised attention assessments and thereby confirmed convergent validity. These results establish a novel approach to measuring childhood attention that can produce meaningful functional assessments that capture how attention operates in an ecologically valid context (i.e. attention's specific contribution to visuomanual action).

Validation of Satellite-Based Objective Overshooting Cloud-Top Detection Methods Using CloudSat Cloud Profiling Radar Observations

NASA Technical Reports Server (NTRS)

Bedka, Kristopher M.; Dworak, Richard; Brunner, Jason; Feltz, Wayne

2012-01-01

Two satellite infrared-based overshooting convective cloud-top (OT) detection methods have recently been described in the literature: 1) the 11-mm infrared window channel texture (IRW texture) method, which uses IRW channel brightness temperature (BT) spatial gradients and thresholds, and 2) the water vapor minus IRW BT difference (WV-IRW BTD). While both methods show good performance in published case study examples, it is important to quantitatively validate these methods relative to overshooting top events across the globe. Unfortunately, no overshooting top database currently exists that could be used in such study. This study examines National Aeronautics and Space Administration CloudSat Cloud Profiling Radar data to develop an OT detection validation database that is used to evaluate the IRW-texture and WV-IRW BTD OT detection methods. CloudSat data were manually examined over a 1.5-yr period to identify cases in which the cloud top penetrates above the tropopause height defined by a numerical weather prediction model and the surrounding cirrus anvil cloud top, producing 111 confirmed overshooting top events. When applied to Moderate Resolution Imaging Spectroradiometer (MODIS)-based Geostationary Operational Environmental Satellite-R Series (GOES-R) Advanced Baseline Imager proxy data, the IRW-texture (WV-IRW BTD) method offered a 76% (96%) probability of OT detection (POD) and 16% (81%) false-alarm ratio. Case study examples show that WV-IRW BTD.0 K identifies much of the deep convective cloud top, while the IRW-texture method focuses only on regions with a spatial scale near that of commonly observed OTs. The POD decreases by 20% when IRW-texture is applied to current geostationary imager data, highlighting the importance of imager spatial resolution for observing and detecting OT regions.

Effective and easy to use extraction method shows low numbers of microplastics in offshore planktivorous fish from the northern Baltic Sea.

PubMed

Budimir, Stjepan; Setälä, Outi; Lehtiniemi, Maiju

2018-02-01

Although the presence of microplastics in marine biota has been widely recorded, extraction methods, method validation and approaches to monitoring are not standardized. In this study a method for microplastic extraction from fish guts based on a chemical alkaline digestion is presented. The average particle retrieval rate from spiked fish guts, used for method validation, was 84%. The weight and shape of the test particles (PET, PC, HD-PE) were also analysed with no noticeable changes in any particle shapes and only minor weight change in PET (2.63%). Microplastics were found in 1.8% of herrings (n=164) and in 0.9% of sprat (n=154). None of the three-spined sticklebacks (n=355) contained microplastic particles. Copyright © 2018 Elsevier Ltd. All rights reserved.

Performance analysis of unsupervised optimal fuzzy clustering algorithm for MRI brain tumor segmentation.

PubMed

Blessy, S A Praylin Selva; Sulochana, C Helen

2015-01-01

Segmentation of brain tumor from Magnetic Resonance Imaging (MRI) becomes very complicated due to the structural complexities of human brain and the presence of intensity inhomogeneities. To propose a method that effectively segments brain tumor from MR images and to evaluate the performance of unsupervised optimal fuzzy clustering (UOFC) algorithm for segmentation of brain tumor from MR images. Segmentation is done by preprocessing the MR image to standardize intensity inhomogeneities followed by feature extraction, feature fusion and clustering. Different validation measures are used to evaluate the performance of the proposed method using different clustering algorithms. The proposed method using UOFC algorithm produces high sensitivity (96%) and low specificity (4%) compared to other clustering methods. Validation results clearly show that the proposed method with UOFC algorithm effectively segments brain tumor from MR images.

Development of an LC-MS/MS method for the determination of endogenous cortisol in hair using (13)C3-labeled cortisol as surrogate analyte.

PubMed

Binz, Tina M; Braun, Ueli; Baumgartner, Markus R; Kraemer, Thomas

2016-10-15

Hair cortisol levels are increasingly applied as a measure for stress in humans and mammals. Cortisol is an endogenous compound and is always present within the hair matrix. Therefore, "cortisol-free hair matrix" is a critical point for any analytical method to accurately quantify especially low cortisol levels. The aim of this project was to modify current methods used for hair cortisol analysis to more accurately determine low endogenous cortisol concentrations in hair. For that purpose, (13)C3-labeled cortisol, which is not naturally present in hair (above 13C natural abundance levels), was used for calibration and comparative validation applying cortisol versus (13)C3-labeled cortisol. Cortisol was extracted from 20mg hair (standard sample amount) applying an optimized single step extraction protocol. An LC-MS/MS method was developed for the quantitative analysis of cortisol using either cortisol or (13)C3-cortisol as calibrators and D7-cortisone as internal standard (IS). The two methods (cortisol/(13)C3-labeled cortisol) were validated in a concentration range up to 500pg/mg and showed good linearity for both analytes (cortisol: R(2)=0.9995; (13)C3-cortisol R(2)=0.9992). Slight differences were observed for limit of detection (LOD) (0.2pg/mg/0.1pg/mg) and limit of quantification (LOQ) (1pg/mg/0.5pg/mg). Precision was good with a maximum deviation of 8.8% and 10% for cortisol and (13)C3-cortisol respectively. Accuracy and matrix effects were good for both analytes except for the quality control (QC) low cortisol. QC low (2.5pg/mg) showed matrix effects (126.5%, RSD 35.5%) and accuracy showed a deviation of 26% when using cortisol to spike. These effects are likely to be caused by the unknown amount of endogenous cortisol in the different hair samples used to determine validation parameters like matrix effect, LOQ and accuracy. No matrix effects were observed for the high QC (400pg/mg) samples. Recovery was good with 92.7%/87.3% (RSD 9.9%/6.2%) for QC low and 102.3%/82.1% (RSD 5.8%/11.4%) for QC high. After successful validation the applicability of the method could be proven. The study shows that the method is especially useful for determining low endogenous cortisol concentrations as they occur in cow hair for example. Copyright © 2016 Elsevier B.V. All rights reserved.

Reliability and Validity of the Hip Stability Isometric Test (HipSIT): A New Method to Assess Hip Posterolateral Muscle Strength.

PubMed

Almeida, Gabriel Peixoto Leão; das Neves Rodrigues, Helena Larissa; de Freitas, Bruno Wesley; de Paula Lima, Pedro Olavo

2017-12-01

Study Design Cross-sectional study. Background The Hip Stability Isometric Test (HipSIT) evaluates the strength of the hip posterolateral stabilizers in a position that favors greater activation of the gluteus maximus and gluteus medius and lower activation of the tensor fascia lata. Objectives To check the validity and reliability of the HipSIT and to evaluate the HipSIT in women with patellofemoral pain (PFP). Methods The HipSIT was evaluated with a handheld dynamometer. During testing, the participants were sidelying, with their legs positioned at 45° of hip flexion and 90° of knee flexion. Participants were instructed to raise the knee of the upper leg while keeping the upper and lower heels in contact. To establish reliability and validity, 49 women were tested with the HipSIT by 2 different evaluators on day 1, and then again 7 days later. The strength of the hip extensors, abductors, and external rotators was also evaluated. Twenty women with unilateral PFP were also evaluated. Results The HipSIT has excellent intrarater and interrater reliability. The standard error of measurement was 0.01 kgf/kg, and the minimal detectable change was 0.036 kgf/kg. The HipSIT showed good validity in isolated hip abduction, external rotation, and extension (P<.01). Women with PFP showed a 10% deficit in the HipSIT results for the symptomatic limb (P = .01). Conclusion The HipSIT showed excellent interrater and intrarater reliability, moderate to good validity in women, and was able to identify strength deficits in women with PFP. J Orthop Sports Phys Ther 2017;47(12):906-913. Epub 9 Oct 2017. doi:10.2519/jospt.2017.7274.

Knowledge of Parents of Children with Autism Spectrum Disorder of Behavior Modification Methods and Their Training Needs Accordingly

ERIC Educational Resources Information Center

Deeb, Raid Mousa Al-Shaik

2016-01-01

The study aimed at identifying knowledge of parents of children with autism spectrum disorder of behavior modification methods and their training needs accordingly. The sample of the study consisted of (98) parents in Jordan. A scale of behavior modification methods was constructed, and then validated. The results of the study showed that the…

Recent statistical methods for orientation data

NASA Technical Reports Server (NTRS)

Batschelet, E.

1972-01-01

The application of statistical methods for determining the areas of animal orientation and navigation are discussed. The method employed is limited to the two-dimensional case. Various tests for determining the validity of the statistical analysis are presented. Mathematical models are included to support the theoretical considerations and tables of data are developed to show the value of information obtained by statistical analysis.

Validation of phenol red versus gravimetric method for water reabsorption correction and study of gender differences in Doluisio's absorption technique.

PubMed

Tuğcu-Demiröz, Fatmanur; Gonzalez-Alvarez, Isabel; Gonzalez-Alvarez, Marta; Bermejo, Marival

2014-10-01

The aim of the present study was to develop a method for water flux reabsorption measurement in Doluisio's Perfusion Technique based on the use of phenol red as a non-absorbable marker and to validate it by comparison with gravimetric procedure. The compounds selected for the study were metoprolol, atenolol, cimetidine and cefadroxil in order to include low, intermediate and high permeability drugs absorbed by passive diffusion and by carrier mediated mechanism. The intestinal permeabilities (Peff) of the drugs were obtained in male and female Wistar rats and calculated using both methods of water flux correction. The absorption rate coefficients of all the assayed compounds did not show statistically significant differences between male and female rats consequently all the individual values were combined to compare between reabsorption methods. The absorption rate coefficients and permeability values did not show statistically significant differences between the two strategies of concentration correction. The apparent zero order water absorption coefficients were also similar in both correction procedures. In conclusion gravimetric and phenol red method for water reabsorption correction are accurate and interchangeable for permeability estimation in closed loop perfusion method. Copyright © 2014 Elsevier B.V. All rights reserved.

Robust d -wave pairing symmetry in multiorbital cobalt high-temperature superconductors

NASA Astrophysics Data System (ADS)

Li, Yinxiang; Han, Xinloong; Qin, Shengshan; Le, Congcong; Wang, Qiang-Hua; Hu, Jiangping

2017-07-01

The pairing symmetry of the cobalt high-temperature (high-Tc) superconductors formed by vertex-shared cation-anion tetrahedral complexes is studied by the methods of mean-field, random phase approximation (RPA), and functional renormalization-group (FRG) analyses. The results of all of these methods show that the dx2-y2 pairing symmetry is robustly favored near half filling. The RPA and FRG methods, which are valid in weak-interaction regions, predict that the superconducting state is also strongly orbital selective, namely, the dx2-y2 orbital that has the largest density near half filling among the three t2 g orbitals dominates superconducting pairing. These results suggest that these materials, if synthesized, can provide an indisputable test of the high-Tc pairing mechanism and the validity of different theoretical methods.

A comparative study of the novel spectrophotometric methods versus conventional ones for the simultaneous determination of Esomeprazole magnesium trihydrate and Naproxen in their binary mixture.

PubMed

Lotfy, Hayam M; Amer, Sawsan M; Zaazaa, Hala E; Mostafa, Noha S

2015-01-01

Two novel simple, specific, accurate and precise spectrophotometric methods manipulating ratio spectra are developed and validated for simultaneous determination of Esomeprazole magnesium trihydrate (ESO) and Naproxen (NAP) namely; absorbance subtraction and ratio difference. The results were compared to that of the conventional spectrophotometric methods namely; dual wavelength and isoabsorptive point coupled with first derivative of ratio spectra and derivative ratio. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for determination of ESO and NAP in their laboratory prepared mixtures and pharmaceutical preparation. No preliminary separation steps are required for the proposed spectrophotometeric procedures. The statistical comparison showed that there is no significant difference between the proposed methods and the reported method with respect to both accuracy and precision. Copyright © 2015 Elsevier B.V. All rights reserved.

How to test validity in orthodontic research: a mixed dentition analysis example.

PubMed

Donatelli, Richard E; Lee, Shin-Jae

2015-02-01

The data used to test the validity of a prediction method should be different from the data used to generate the prediction model. In this study, we explored whether an independent data set is mandatory for testing the validity of a new prediction method and how validity can be tested without independent new data. Several validation methods were compared in an example using the data from a mixed dentition analysis with a regression model. The validation errors of real mixed dentition analysis data and simulation data were analyzed for increasingly large data sets. The validation results of both the real and the simulation studies demonstrated that the leave-1-out cross-validation method had the smallest errors. The largest errors occurred in the traditional simple validation method. The differences between the validation methods diminished as the sample size increased. The leave-1-out cross-validation method seems to be an optimal validation method for improving the prediction accuracy in a data set with limited sample sizes. Copyright © 2015 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

Rapid multislice T1 mapping of mouse myocardium: Application to quantification of manganese uptake in α-Dystrobrevin knockout mice.

PubMed

Jiang, Kai; Li, Wen; Li, Wei; Jiao, Sen; Castel, Laurie; Van Wagoner, David R; Yu, Xin

2015-11-01

The aim of this study was to develop a rapid, multislice cardiac T1 mapping method in mice and to apply the method to quantify manganese (Mn(2+)) uptake in a mouse model with altered Ca(2+) channel activity. An electrocardiography-triggered multislice saturation-recovery Look-Locker method was developed and validated both in vitro and in vivo. A two-dose study was performed to investigate the kinetics of T1 shortening, Mn(2+) relaxivity in myocardium, and the impact of Mn(2+) on cardiac function. The sensitivity of Mn(2+)-enhanced MRI in detecting subtle changes in altered Ca(2+) channel activity was evaluated in a mouse model with α-dystrobrevin knockout. Validation studies showed strong agreement between the current method and an established method. High Mn(2+) dose led to significantly accelerated T1 shortening. Heart rate decreased during Mn(2+) infusion, while ejection ratio increased slightly at the end of imaging protocol. No statistical difference in cardiac function was detected between the two dose groups. Mice with α-dystrobrevin knockout showed enhanced Mn(2+) uptake in vivo. In vitro patch-clamp study showed increased Ca(2+) channel activity. The saturation recovery method provides rapid T1 mapping in mouse hearts, which allowed sensitive detection of subtle changes in Mn(2+) uptake in α-dystrobrevin knockout mice. © 2014 Wiley Periodicals, Inc.

Validation of the breast evaluation questionnaire for breast hypertrophy and breast reduction.

PubMed

Lewin, Richard; Elander, Anna; Lundberg, Jonas; Hansson, Emma; Thorarinsson, Andri; Claudelin, Malin; Bladh, Helena; Lidén, Mattias

2018-06-13

There is a lack of published, validated questionnaires for evaluating psychosocial morbidity in patients with breast hypertrophy undergoing breast reduction surgery. To validate the breast evaluation questionnaire (BEQ), originally developed for the assessment of breast augmentation patients, for the assessment of psychosocial morbidity in patients with breast hypertrophy undergoing breast reduction surgery. Validation study Subjects: Women with macromastia Methods: The validation of the BEQ, adapted to breast reduction, was performed in several steps. Content validity, reliability, construct validity and responsiveness were assessed. The original version was adjusted according to the results for content validity and resulted in item reduction and a modified BEQ (mBEQ) that was then assessed for reliability, construct validity and responsiveness. Internal and external validation was performed for the modified BEQ. Convergent validity was tested against Breast-Q (reduction) and discriminate validity was tested against the SF-36. Known-groups validation revealed significant differences between the normal population and patients undergoing breast reduction surgery. The BEQ showed good reliability by test-re-test analysis and high responsiveness. The modified BEQ may be reliable, valid and responsive instrument for assessing women who undergo breast reduction.

[Research on the reliability and validity of postural workload assessment method and the relation to work-related musculoskeletal disorders of workers].

PubMed

Qin, D L; Jin, X N; Wang, S J; Wang, J J; Mamat, N; Wang, F J; Wang, Y; Shen, Z A; Sheng, L G; Forsman, M; Yang, L Y; Wang, S; Zhang, Z B; He, L H

2018-06-18

To form a new assessment method to evaluate postural workload comprehensively analyzing the dynamic and static postural workload for workers during their work process to analyze the reliability and validity, and to study the relation between workers' postural workload and work-related musculoskeletal disorders (WMSDs). In the study, 844 workers from electronic and railway vehicle manufacturing factories were selected as subjects investigated by using the China Musculoskeletal Questionnaire (CMQ) to form the postural workload comprehensive assessment method. The Cronbach's α, cluster analysis and factor analysis were used to assess the reliability and validity of the new assessment method. Non-conditional Logistic regression was used to analyze the relation between workers' postural workload and WMSDs. Reliability of the assessment method for postural workload: internal consistency analysis results showed that Cronbach's α was 0.934 and the results of split-half reliability indicated that Spearman-Brown coefficient was 0.881 and the correlation coefficient between the first part and the second was 0.787. Validity of the assessment method for postural workload: the results of cluster analysis indicated that square Euclidean distance between dynamic and static postural workload assessment in the same part or work posture was the shortest. The results of factor analysis showed that 2 components were extracted and the cumulative percentage of variance achieved 65.604%. The postural workload score of the different occupational workers showed significant difference (P<0.05) by covariance analysis. The results of nonconditional Logistic regression indicated that alcohol intake (OR=2.141, 95%CI 1.337-3.428) and obesity (OR=3.408, 95%CI 1.629-7.130) were risk factors for WMSDs. The risk for WMSDs would rise as workers' postural workload rose (OR=1.035, 95%CI 1.022-1.048). There was significant different risk for WMSDs in the different groups of workers distinguished by work type, gender and age. Female workers exhibited a higher prevalence for WMSDs (OR=2.626, 95%CI 1.414-4.879) and workers between 30-40 years of age (OR=1.909, 95%CI 1.237-2.946) as compared with those under 30. This method for comprehensively assessing postural workload is reliable and effective when used in assembling workers, and there is certain relation between the postural workload and WMSDs.

Reliability, Validity, and Cross-Cultural Adaptation of the Turkish Version of the Bournemouth Questionnaire.

PubMed

Gunaydin, Gurkan; Citaker, Seyit; Meray, Jale; Cobanoglu, Gamze; Gunaydin, Ozge Ece; Hazar Kanik, Zeynep

2016-11-01

Validation of a self-report questionnaire. The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Bournemouth Questionnaire. Low back pain is one of the most frequent disorders leading to activity limitation. This pain affects most of people in their lives. The most important point to evaluate patient's functional abilities and to decide a successful therapy procedure is to manage the assessment questionnaires precisely. One hundred ten patients with chronic low back pain were included in present study. To assess reliability, test-retest and internal consistency analyses were applied. The results of test-retest analysis were assessed by using Intraclass Correlation Coefficient method (95% confidence interval). For internal consistency, Cronbach alpha value was calculated. Validity of the questionnaire was assessed in terms of construct validity. For construct validity, factor analysis and convergent validity were tested. For convergent validity, total points of the Bournemouth Questionnaire were assessed with the total points of Quebec Back Pain Disability Scale and Roland Morris Disability Questionnaire by using Pearson correlation coefficient analysis. Cronbach alpha value was found 0.914, showing that this questionnaire has high internal consistency. The results of test-retest analysis were varying between 0.851 and 0.927, which shows that test-retest results are highly correlated. Factor analysis test indicated that this questionnaire had one factor. Pearson correlation coefficient of the Bournemouth Questionnaire with Roland Morris Disability Questionnaire was calculated 0.703 and it was found with Quebec Back Pain Disability Scale is 0.659. These results showed that the Bournemouth Questionnaire is very good correlated with Roland Morris Disability Questionnaire and Quebec Back Pain Disability Scale. The Turkish version of the Bournemouth Questionnaire is valid and reliable. 3.

Reliability and Validity of a New Method for Isometric Back Extensor Strength Evaluation Using A Hand-Held Dynamometer.

PubMed

Park, Hee-Won; Baek, Sora; Kim, Hong Young; Park, Jung-Gyoo; Kang, Eun Kyoung

2017-10-01

To investigate the reliability and validity of a new method for isometric back extensor strength measurement using a portable dynamometer. A chair equipped with a small portable dynamometer was designed (Power Track II Commander Muscle Tester). A total of 15 men (mean age, 34.8±7.5 years) and 15 women (mean age, 33.1±5.5 years) with no current back problems or previous history of back surgery were recruited. Subjects were asked to push the back of the chair while seated, and their isometric back extensor strength was measured by the portable dynamometer. Test-retest reliability was assessed with intraclass correlation coefficient (ICC). For the validity assessment, isometric back extensor strength of all subjects was measured by a widely used physical performance evaluation instrument, BTE PrimusRS system. The limit of agreement (LoA) from the Bland-Altman plot was evaluated between two methods. The test-retest reliability was excellent (ICC=0.82; 95% confidence interval, 0.65-0.91). The Bland-Altman plots demonstrated acceptable agreement between the two methods: the lower 95% LoA was -63.1 N and the upper 95% LoA was 61.1 N. This study shows that isometric back extensor strength measurement using a portable dynamometer has good reliability and validity.

Development and validation of an ionic chromatography method for the determination of nitrate, nitrite and chloride in meat.

PubMed

Lopez-Moreno, Cristina; Perez, Isabel Viera; Urbano, Ana M

2016-03-01

The purpose of this study is to develop the validation of a method for the analysis of certain preservatives in meat and to obtain a suitable Certified Reference Material (CRM) to achieve this task. The preservatives studied were NO3(-), NO2(-) and Cl(-) as they serve as important antimicrobial agents in meat to inhibit the growth of bacteria spoilage. The meat samples were prepared using a treatment that allowed the production of a known CRM concentration that is highly homogeneous and stable in time. The matrix effects were also studied to evaluate the influence on the analytical signal for the ions of interest, showing that the matrix influence does not affect the final result. An assessment of the signal variation in time was carried out for the ions. In this regard, although the chloride and nitrate signal remained stable for the duration of the study, the nitrite signal decreased appreciably with time. A mathematical treatment of the data gave a stable nitrite signal, obtaining a method suitable for the validation of these anions in meat. A statistical study was needed for the validation of the method, where the precision, accuracy, uncertainty and other mathematical parameters were evaluated obtaining satisfactory results. Copyright © 2015 Elsevier Ltd. All rights reserved.

Application of qualitative biospeckle methods for the identification of scar region in a green orange

NASA Astrophysics Data System (ADS)

Retheesh, R.; Ansari, Md. Zaheer; Radhakrishnan, P.; Mujeeb, A.

2018-03-01

This study demonstrates the feasibility of a view-based method, the motion history image (MHI) to map biospeckle activity around the scar region in a green orange fruit. The comparison of MHI with the routine intensity-based methods validated the effectiveness of the proposed method. The results show that MHI can be implementated as an alternative online image processing tool in the biospeckle analysis.

Validation of energy intake estimated from a food frequency questionnaire: a doubly labelled water study.

PubMed

Andersen, L Frost; Tomten, H; Haggarty, P; Løvø, A; Hustvedt, B-E

2003-02-01

The validation of dietary assessment methods is critical in the evaluation of the relation between dietary intake and health. The aim of this study was to assess the validity of a food frequency questionnaire by comparing energy intake with energy expenditure measured with the doubly labelled water method. Total energy expenditure was measured with the doubly labelled water (DLW) method during a 10 day period. Furthermore, the subjects filled in the food frequency questionnaire about 18-35 days after the DLW phase of the study was completed. Twenty-one healthy, non-pregnant females volunteered to participate in the study; only 17 subjects completed the study. The group energy intake was on average 10% lower than the energy expenditure, but the difference was not statistically significant. However, there was a wide range in reporting accuracy: seven subjects were identified as acceptable reporters, eight as under-reporters and two were identified as over-reporters. The width of the 95% confidence limits of agreement in a Bland and Altman plot for energy intake and energy expenditure varied from -5 to 3 MJ. The data showed that there was substantial variability in the accuracy of the food frequency questionnaire at the individual level. Furthermore, the results showed that the questionnaire was more accurate for groups than individuals.

Reliability and Validity of a New Method for Isometric Back Extensor Strength Evaluation Using A Hand-Held Dynamometer

PubMed Central

2017-01-01

Objective To investigate the reliability and validity of a new method for isometric back extensor strength measurement using a portable dynamometer. Methods A chair equipped with a small portable dynamometer was designed (Power Track II Commander Muscle Tester). A total of 15 men (mean age, 34.8±7.5 years) and 15 women (mean age, 33.1±5.5 years) with no current back problems or previous history of back surgery were recruited. Subjects were asked to push the back of the chair while seated, and their isometric back extensor strength was measured by the portable dynamometer. Test-retest reliability was assessed with intraclass correlation coefficient (ICC). For the validity assessment, isometric back extensor strength of all subjects was measured by a widely used physical performance evaluation instrument, BTE PrimusRS system. The limit of agreement (LoA) from the Bland-Altman plot was evaluated between two methods. Results The test-retest reliability was excellent (ICC=0.82; 95% confidence interval, 0.65–0.91). The Bland-Altman plots demonstrated acceptable agreement between the two methods: the lower 95% LoA was −63.1 N and the upper 95% LoA was 61.1 N. Conclusion This study shows that isometric back extensor strength measurement using a portable dynamometer has good reliability and validity. PMID:29201818

Validation of a RP-HPLC-DAD Method for Chamomile (Matricaria recutita) Preparations and Assessment of the Marker, Apigenin-7-glucoside, Safety and Anti-Inflammatory Effect

PubMed Central

Miguel, Felipe Galeti; Spinola, Nathália Favaretto; Ribeiro, Diego Luis; Barcelos, Gustavo Rafael Mazzaron; Antunes, Lusânia Maria Greggi; Hori, Juliana Issa; Marquele-Oliveira, Franciane; Rocha, Bruno Alves; Berretta, Andresa Aparecida

2015-01-01

Chamomile is a medicinal plant, which presents several biological effects, especially the anti-inflammatory effect. One of the compounds related to this effect is apigenin, a flavonoid that is mostly found in its glycosylated form, apigenin-7-glucoside (APG), in natural sources. However, the affectivity and safety of this glycoside have not been well explored for topical application. In this context, the aim of this work was to develop and validate a reversed-phase high-performance liquid chromatography (RP-HPLC-DAD) method to quantify APG in chamomile preparations. Additionally, the safety and the anti-inflammatory potential of this flavonoid were verified. The RP-HPLC-DAD method was developed and validated with linearity at 24.0–36.0 μg/mL range (r = 0.9994). Intra- and interday precision (RSD) were 0.27–2.66% and accuracy was 98.27–101.21%. The validated method was applied in the analysis of chamomile flower heads, glycolic extract, and Kamillen cream, supporting the method application in the quality control of chamomile preparations. Furthermore, the APG safety was assessed by MTT cytotoxicity assay and mutagenic protocols and the anti-inflammatory activity was confirmed by a diminished TNF-α production showed by mice macrophages treated with APG following LPS treatment. PMID:26421053

Design and validation of general biology learning program based on scientific inquiry skills

NASA Astrophysics Data System (ADS)

Cahyani, R.; Mardiana, D.; Noviantoro, N.

2018-03-01

Scientific inquiry is highly recommended to teach science. The reality in the schools and colleges is that many educators still have not implemented inquiry learning because of their lack of understanding. The study aims to1) analyze students’ difficulties in learning General Biology, 2) design General Biology learning program based on multimedia-assisted scientific inquiry learning, and 3) validate the proposed design. The method used was Research and Development. The subjects of the study were 27 pre-service students of general elementary school/Islamic elementary schools. The workflow of program design includes identifying learning difficulties of General Biology, designing course programs, and designing instruments and assessment rubrics. The program design is made for four lecture sessions. Validation of all learning tools were performed by expert judge. The results showed that: 1) there are some problems identified in General Biology lectures; 2) the designed products include learning programs, multimedia characteristics, worksheet characteristics, and, scientific attitudes; and 3) expert validation shows that all program designs are valid and can be used with minor revisions. The first section in your paper.

Development and validation of the Hospitality Axiological Scale for Humanization of Nursing Care

PubMed Central

Galán González-Serna, José María; Ferreras-Mencia, Soledad; Arribas-Marín, Juan Manuel

2017-01-01

ABSTRACT Objective: to develop and validate a scale to evaluate nursing attitudes in relation to hospitality for the humanization of nursing care. Participants: the sample consisted of 499 nursing professionals and undergraduate students of the final two years of the Bachelor of Science in Nursing program. Method: the instrument has been developed and validated to evaluate the ethical values related to hospitality using a methodological approach. Subsequently, a model was developed to measure the dimensions forming the construct hospitality. Results: the Axiological Hospitality Scale showed a high internal consistency, with Cronbach’s Alpha=0.901. The validation of the measuring instrument was performed using factorial, exploratory and confirmatory analysis techniques with high goodness of fit measures. Conclusions: the developed instrument showed an adequate validity and a high internal consistency. Based on the consistency of its psychometric properties, it is possible to affirm that the scale provides a reliable measurement of the hospitality. It was also possible to determine the dimensions or sources that embrace it: respect, responsibility, quality and transpersonal care. PMID:28793127

Development of models for classification of action between heat-clearing herbs and blood-activating stasis-resolving herbs based on theory of traditional Chinese medicine.

PubMed

Chen, Zhao; Cao, Yanfeng; He, Shuaibing; Qiao, Yanjiang

2018-01-01

Action (" gongxiao " in Chinese) of traditional Chinese medicine (TCM) is the high recapitulation for therapeutic and health-preserving effects under the guidance of TCM theory. TCM-defined herbal properties (" yaoxing " in Chinese) had been used in this research. TCM herbal property (TCM-HP) is the high generalization and summary for actions, both of which come from long-term effective clinical practice in two thousands of years in China. However, the specific relationship between TCM-HP and action of TCM is complex and unclear from a scientific perspective. The research about this is conducive to expound the connotation of TCM-HP theory and is of important significance for the development of the TCM-HP theory. One hundred and thirty-three herbs including 88 heat-clearing herbs (HCHs) and 45 blood-activating stasis-resolving herbs (BAHRHs) were collected from reputable TCM literatures, and their corresponding TCM-HPs/actions information were collected from Chinese pharmacopoeia (2015 edition). The Kennard-Stone (K-S) algorithm was used to split 133 herbs into 100 calibration samples and 33 validation samples. Then, machine learning methods including supported vector machine (SVM), k-nearest neighbor (kNN) and deep learning methods including deep belief network (DBN), convolutional neutral network (CNN) were adopted to develop action classification models based on TCM-HP theory, respectively. In order to ensure robustness, these four classification methods were evaluated by using the method of tenfold cross validation and 20 external validation samples for prediction. As results, 72.7-100% of 33 validation samples including 17 HCHs and 16 BASRHs were correctly predicted by these four types of methods. Both of the DBN and CNN methods gave out the best results and their sensitivity, specificity, precision, accuracy were all 100.00%. Especially, the predicted results of external validation set showed that the performance of deep learning methods (DBN, CNN) were better than traditional machine learning methods (kNN, SVM) in terms of their sensitivity, specificity, precision, accuracy. Moreover, the distribution patterns of TCM-HPs of HCHs and BASRHs were also analyzed to detect the featured TCM-HPs of these two types of herbs. The result showed that the featured TCM-HPs of HCHs were cold, bitter, liver and stomach meridians entered, while those of BASRHs were warm, bitter and pungent, liver meridian entered. The performance on validation set and external validation set of deep learning methods (DBN, CNN) were better than machine learning models (kNN, SVM) in sensitivity, specificity, precision, accuracy when predicting the actions of heat-clearing and blood-activating stasis-resolving based on TCM-HP theory. The deep learning classification methods owned better generalization ability and accuracy when predicting the actions of heat-clearing and blood-activating stasis-resolving based on TCM-HP theory. Besides, the methods of deep learning would help us to improve our understanding about the relationship between herbal property and action, as well as to enrich and develop the theory of TCM-HP scientifically.

Evaluation of methyl methanesulfonate, 2,6-diaminotoluene and 5-fluorouracil: Part of the Japanese center for the validation of alternative methods (JaCVAM) international validation study of the in vivo rat alkaline comet assay.

PubMed

Plappert-Helbig, Ulla; Junker-Walker, Ursula; Martus, Hans-Joerg

2015-07-01

As a part of the Japanese Center for the Validation of Alternative Methods (JaCVAM)-initiative international validation study of the in vivo rat alkaline comet assay (comet assay), we examined methyl methanesulfonate, 2,6-diaminotoluene, and 5-fluorouracil under coded test conditions. Rats were treated orally with the maximum tolerated dose (MTD) and two additional descending doses of the respective compounds. In the MMS treated groups liver and stomach showed significantly elevated DNA damage at each dose level and a significant dose-response relationship. 2,6-diaminotoluene induced significantly elevated DNA damage in the liver at each dose and a statistically significant dose-response relationship whereas no DNA damage was obtained in the stomach. 5-fluorouracil did not induce DNA damage in either liver or stomach. Copyright © 2015 Elsevier B.V. All rights reserved.

Validating Machine Learning Algorithms for Twitter Data Against Established Measures of Suicidality

PubMed Central

2016-01-01

Background One of the leading causes of death in the United States (US) is suicide and new methods of assessment are needed to track its risk in real time. Objective Our objective is to validate the use of machine learning algorithms for Twitter data against empirically validated measures of suicidality in the US population. Methods Using a machine learning algorithm, the Twitter feeds of 135 Mechanical Turk (MTurk) participants were compared with validated, self-report measures of suicide risk. Results Our findings show that people who are at high suicidal risk can be easily differentiated from those who are not by machine learning algorithms, which accurately identify the clinically significant suicidal rate in 92% of cases (sensitivity: 53%, specificity: 97%, positive predictive value: 75%, negative predictive value: 93%). Conclusions Machine learning algorithms are efficient in differentiating people who are at a suicidal risk from those who are not. Evidence for suicidality can be measured in nonclinical populations using social media data. PMID:27185366

Translation and validation of the Self-care of Heart Failure Index into Persian.

PubMed

Siabani, Soraya; Leeder, Stephen R; Davidson, Patricia M; Najafi, Farid; Hamzeh, Behrooz; Solimani, Akram; Siahbani, Sara; Driscoll, Tim

2014-01-01

Chronic heart failure (CHF) is a common burdensome health problem worldwide. Self-care improves outcomes in patients with CHF. The Self-care of Heart Failure Index (SCHFI) is a well-known scale for assessing self-care. A reliable, valid, and culturally acceptable instrument is needed to develop and test self-care interventions in Iran. We sought to translate and validate the Persian version of SCHFI v 6.2 (pSCHFI). We translated the SCHFI into Persian (pSCHFI) using standardized methods. The reliability was evaluated by assessing Cronbach's α coefficient. Expert opinion, discussion with patients, and confirmatory factor analysis were used to assess face validity, content validity, and construct validity, respectively. The analysis, using 184 participants, showed acceptable internal consistency and construct validity for the 3 subscales of pSCHFI-self-care maintenance, self-care management, and self-care self-confidence. The pSCHFI is a valid instrument with an acceptable reliability for evaluating self-care in Persian patients with heart failure.

[Validity of three methods for inmuno-diagnostic of neurocysticercosis: systematic review of the literature with meta-analysis 1960-2014].

PubMed

Cardona-Arias, Jaiberth Antonio; Carrasquilla-Agudelo, Yoneida Elena; Restrepo-Posada, Deisy Cristina

2017-02-01

The screening of neurocysticercosis is complex and immunological methods have varying validity. To evaluate the validity of ELISA for antigen and antibody, and EITB for antibody in the screening of neurocysticercosis. Meta-analysis of diagnostic tests with an ex-ante protocol implemented in five databases with 15 search strategies, ensuring reproducibility in the selection and extraction of information. Sensitivity, specificity, likelihood ratios (LR), diagnostic odds ratio and ROC curve were estimated in MetaDiSc, and predictive values, and Youden index were estimated in Epidat. EITB presented sensitivity of 85.7% (95% CI 83.5-87.7), specificity 93.9% (95% CI = 92.7-95.0), PLR 19.6 (95% CI = 8,6-44.6), NLR 0.16 (95% CI = 0.12-0.21), OR diagnostic 136.2 (95% CI = 54.7-342.6) and area under the curve 0.926. In ELISA for antibody sensitivity was 87.5% (95% CI = 86.1-88.8), specificity 92.2% (95% CI = 91.4-93.0), PLR 11.3 (95% CI = 8.45-15.11), NLR 0.15 (95% CI = 0.13-0.18), diagnostic OR 87.4 (95% CI = 60.1-127.1) and area under the curve 0.950. ELISA for antigen showed low diagnostic validity. No differences were found in these parameters by sample, antigen or antibody type. ELISA for antibodies and EITB have a similar diagnostic value, detection of serum and CSF showed a similar validity.

A meta-analysis of the validity of FFQ targeted to adolescents.

PubMed

Tabacchi, Garden; Filippi, Anna Rita; Amodio, Emanuele; Jemni, Monèm; Bianco, Antonino; Firenze, Alberto; Mammina, Caterina

2016-05-01

The present work is aimed at meta-analysing validity studies of FFQ for adolescents, to investigate their overall accuracy and variables that can affect it negatively. A meta-analysis of sixteen original articles was performed within the ASSO Project (Adolescents and Surveillance System in the Obesity prevention). The articles assessed the validity of FFQ for adolescents, compared with food records or 24 h recalls, with regard to energy and nutrient intakes. Pearson's or Spearman's correlation coefficients, means/standard deviations, kappa agreement, percentiles and mean differences/limits of agreement (Bland-Altman method) were extracted. Pooled estimates were calculated and heterogeneity tested for correlation coefficients and means/standard deviations. A subgroup analysis assessed variables influencing FFQ accuracy. An overall fair/high correlation between FFQ and reference method was found; a good agreement, measured through the intake mean comparison for all nutrients except sugar, carotene and K, was observed. Kappa values showed fair/moderate agreement; an overall good ability to rank adolescents according to energy and nutrient intakes was evidenced by data of percentiles; absolute validity was not confirmed by mean differences/limits of agreement. Interviewer administration mode, consumption interval of the previous year/6 months and high number of food items are major contributors to heterogeneity and thus can reduce FFQ accuracy. The meta-analysis shows that FFQ are accurate tools for collecting data and could be used for ranking adolescents in terms of energy and nutrient intakes. It suggests how the design and the validation of a new FFQ should be addressed.

Validating fatty acid intake as estimated by an FFQ: how does the 24 h recall perform as reference method compared with the duplicate portion?

PubMed

Trijsburg, Laura; de Vries, Jeanne Hm; Hollman, Peter Ch; Hulshof, Paul Jm; van 't Veer, Pieter; Boshuizen, Hendriek C; Geelen, Anouk

2018-05-08

To compare the performance of the commonly used 24 h recall (24hR) with the more distinct duplicate portion (DP) as reference method for validation of fatty acid intake estimated with an FFQ. Intakes of SFA, MUFA, n-3 fatty acids and linoleic acid (LA) were estimated by chemical analysis of two DP and by on average five 24hR and two FFQ. Plasma n-3 fatty acids and LA were used to objectively compare ranking of individuals based on DP and 24hR. Multivariate measurement error models were used to estimate validity coefficients and attenuation factors for the FFQ with the DP and 24hR as reference methods. Wageningen, the Netherlands. Ninety-two men and 106 women (aged 20-70 years). Validity coefficients for the fatty acid estimates by the FFQ tended to be lower when using the DP as reference method compared with the 24hR. Attenuation factors for the FFQ tended to be slightly higher based on the DP than those based on the 24hR as reference method. Furthermore, when using plasma fatty acids as reference, the DP showed comparable to slightly better ranking of participants according to their intake of n-3 fatty acids (0·33) and n-3:LA (0·34) than the 24hR (0·22 and 0·24, respectively). The 24hR gives only slightly different results compared with the distinctive but less feasible DP, therefore use of the 24hR seems appropriate as the reference method for FFQ validation of fatty acid intake.

Patenting Marketing Methods: A Missing Topic in the Classroom

ERIC Educational Resources Information Center

Christ, Paul

2005-01-01

Since the 1998 landmark case that validated the patenting of business methods as intellectual property, a plethora of patents has emerged. Patents for marketing-related processes have been particularly abundant, especially when new marketing processes are tied to a technology component. A review of the marketing literature and textbooks shows an…

On using sample selection methods in estimating the price elasticity of firms' demand for insurance.

PubMed

Marquis, M Susan; Louis, Thomas A

2002-01-01

We evaluate a technique based on sample selection models that has been used by health economists to estimate the price elasticity of firms' demand for insurance. We demonstrate that, this technique produces inflated estimates of the price elasticity. We show that alternative methods lead to valid estimates.

Rapid determination of flavonoids and phenolic acids in grape juices and wines by RP-HPLC/DAD: Method validation and characterization of commercial products of the new Brazilian varieties of grape.

PubMed

Padilha, Carla Valéria da Silva; Miskinis, Gabriela Aquino; de Souza, Marcelo Eduardo Alves Olinda; Pereira, Giuliano Elias; de Oliveira, Débora; Bordignon-Luiz, Marilde Terezinha; Lima, Marcos Dos Santos

2017-08-01

A method for rapid determination of phenolic compounds by reversed-phase high-performance liquid chromatography (RP-HPLC), using a new column of faster resolution was validated and used to characterize commercial products produced with new grape Brazilian varieties of Northeast of Brazil. The in vitro antioxidant activity was also measured. The method showed linearity (R>0.9995), good precision (CV%<2.78), recovery (91.8-105.1%) and limits of detection (0.04-0.85mgL -1 ) and quantification (0.04-1.41mgL -1 ) according to other methods previously published with the difference of a run time of only 25min. The results obtained in the characterization of the samples differed for juices and wines from other world regions, mainly because of the high values of (-)-epigallocatechin and trans-caftaric acid. The products analyzed showed high antioxidant activity, especially the wine samples with values higher than those from wines of different regions of the world. Copyright © 2017 Elsevier Ltd. All rights reserved.

Revealed and stated preference valuation and transfer: A within-sample comparison of water quality improvement values

NASA Astrophysics Data System (ADS)

Ferrini, Silvia; Schaafsma, Marije; Bateman, Ian

2014-06-01

Benefit transfer (BT) methods are becoming increasingly important for environmental policy, but the empirical findings regarding transfer validity are mixed. A novel valuation survey was designed to obtain both stated preference (SP) and revealed preference (RP) data concerning river water quality values from a large sample of households. Both dichotomous choice and payment card contingent valuation (CV) and travel cost (TC) data were collected. Resulting valuations were directly compared and used for BT analyses using both unit value and function transfer approaches. WTP estimates are found to pass the convergence validity test. BT results show that the CV data produce lower transfer errors, below 20% for both unit value and function transfer, than TC data especially when using function transfer. Further, comparison of WTP estimates suggests that in all cases, differences between methods are larger than differences between study areas. Results show that when multiple studies are available, using welfare estimates from the same area but based on a different method consistently results in larger errors than transfers across space keeping the method constant.

Testing and Validation of the Dynamic Inertia Measurement Method

NASA Technical Reports Server (NTRS)

Chin, Alexander W.; Herrera, Claudia Y.; Spivey, Natalie D.; Fladung, William A.; Cloutier, David

2015-01-01

The Dynamic Inertia Measurement (DIM) method uses a ground vibration test setup to determine the mass properties of an object using information from frequency response functions. Most conventional mass properties testing involves using spin tables or pendulum-based swing tests, which for large aerospace vehicles becomes increasingly difficult and time-consuming, and therefore expensive, to perform. The DIM method has been validated on small test articles but has not been successfully proven on large aerospace vehicles. In response, the National Aeronautics and Space Administration Armstrong Flight Research Center (Edwards, California) conducted mass properties testing on an "iron bird" test article that is comparable in mass and scale to a fighter-type aircraft. The simple two-I-beam design of the "iron bird" was selected to ensure accurate analytical mass properties. Traditional swing testing was also performed to compare the level of effort, amount of resources, and quality of data with the DIM method. The DIM test showed favorable results for the center of gravity and moments of inertia; however, the products of inertia showed disagreement with analytical predictions.

Land Surface Temperature Measurements from EOS MODIS Data

NASA Technical Reports Server (NTRS)

Wan, Zhengming

1997-01-01

We applied the multi-method strategy of land-surface temperature (LST) and emissivity measurements in two field campaigns this year for validating the MODIS LST algorithm. The first field campaign was conducted in Death Valley, CA, on March 3rd and the second one in Railroad Valley, NV, on June 23-27. ER2 MODIS Airborne Simulator (MAS) data were acquired in morning and evening for these two field campaigns. TIR spectrometer, radiometer, and thermistor data were also collected in the field campaigns. The LST values retrieved from MAS data with the day/night LST algorithm agree with those obtained from ground-based measurements within 1 C and show close correlations with topographic maps. The band emissivities retrieved from MAS data show close correlations with geological maps in the Death Valley field campaign. The comparison of measurement data in the latest Railroad Valley field campaign indicates that we are approaching the goals of the LST validation: LST uncertainty less than 0.5 C, and emissivity uncertainty less than 0.005 in the 10-13 spectral range. Measurement data show that the spatial variation in LST is the major uncertainty in the LST validation. In order to reduce this uncertainty, a new component of the multi-method strategy has been identified.

Assessment of Free Dye in Solutions of Dual-Labeled Antibody Conjugates for In Vivo Molecular Imaging

PubMed Central

Aldrich, Melissa B.; Wang, XueJuan; Hart, Amy; Sampath, Lakshmi; Marshall, Milton V.; Sevick-Muraca, Eva M.

2017-01-01

PURPOSE Recent preclinical and clinical studies show dyes that excite and fluoresce in the near infrared range may be used for tracking and detecting disease targets in vivo. A method for quantifying free dye molecules in antibody conjugate preparations is required for agent batch release and for translation into the clinic. PROCEDURES Herein, we developed and validated a SDS-PAGE method to determine the percentage of free IRDye 800CW in (DTPA)n-trastuzumab—(IRDye 800)m conjugate sample preparations in which HPLC assessment of free dye was not possible. RESULTS The SDS-PAGE assay was accurate and valid for free IRDye 800CW amounts between 38 and 4 molar percent of total dye. Gel sample preparation reagent affected the specificity of the assay, and lower and upper limits of quantitation and detection were determined. CONCLUSION This method may be applicable to other near infrared dye-conjugated antibody-based imaging agents in which HPLC assessment of purity is not feasible. This validated method for quality assurance will facilitate the translation of dual-labeled antibody conjugates for nuclear and optical imaging. PMID:20458634

Method validation for simultaneous determination of chromium, molybdenum and selenium in infant formulas by ICP-OES and ICP-MS.

PubMed

Khan, Naeem; Jeong, In Seon; Hwang, In Min; Kim, Jae Sung; Choi, Sung Hwa; Nho, Eun Yeong; Choi, Ji Yeon; Kwak, Byung-Man; Ahn, Jang-Hyuk; Yoon, Taehyung; Kim, Kyong Su

2013-12-15

This study aimed to validate the analytical method for simultaneous determination of chromium (Cr), molybdenum (Mo), and selenium (Se) in infant formulas available in South Korea. Various digestion methods of dry-ashing, wet-digestion and microwave were evaluated for samples preparation and both inductively coupled plasma optical emission spectrometry (ICP-OES) and inductively coupled plasma mass spectrometry (ICP-MS) were compared for analysis. The analytical techniques were validated by detection limits, precision, accuracy and recovery experiments. Results showed that wet-digestion and microwave methods were giving satisfactory results for sample preparation, while ICP-MS was found more sensitive and effective technique than ICP-OES. The recovery (%) of Se, Mo and Cr by ICP-OES were 40.9, 109.4 and 0, compared to 99.1, 98.7 and 98.4, respectively by ICP-MS. The contents of Cr, Mo and Se in infant formulas by ICP-MS were found in good nutritional values in accordance to nutrient standards for infant formulas CODEX values. Copyright © 2013 Elsevier Ltd. All rights reserved.

Dynamic measurement of speed of sound in n-Heptane by ultrasonics during fuel injections.

PubMed

Minnetti, Elisa; Pandarese, Giuseppe; Evangelisti, Piersavio; Verdugo, Francisco Rodriguez; Ungaro, Carmine; Bastari, Alessandro; Paone, Nicola

2017-11-01

The paper presents a technique to measure the speed of sound in fuels based on pulse-echo ultrasound. The method is applied inside the test chamber of a Zeuch-type instrument used for indirect measurement of the injection rate (Mexus). The paper outlines the pulse-echo method, considering probe installation, ultrasound beam propagation inside the test chamber, typical signals obtained, as well as different processing algorithms. The method is validated in static conditions by comparing the experimental results to the NIST database both for water and n-Heptane. The ultrasonic system is synchronized to the injector so that time resolved samples of speed of sound can be successfully acquired during a series of injections. Results at different operating conditions in n-Heptane are shown. An uncertainty analysis supports the analysis of results and allows to validate the method. Experimental results show that the speed of sound variation during an injection event is less than 1%, so the Mexus model assumption to consider it constant during the injection is valid. Copyright © 2017 Elsevier B.V. All rights reserved.

Development and Validation of a Multiplexed Protein Quantitation Assay for the Determination of Three Recombinant Proteins in Soybean Tissues by Liquid Chromatography with Tandem Mass Spectrometry.

PubMed

Hill, Ryan C; Oman, Trent J; Shan, Guomin; Schafer, Barry; Eble, Julie; Chen, Cynthia

2015-08-26

Currently, traditional immunochemistry technologies such as enzyme-linked immunosorbent assays (ELISA) are the predominant analytical tool used to measure levels of recombinant proteins expressed in genetically engineered (GE) plants. Recent advances in agricultural biotechnology have created a need to develop methods capable of selectively detecting and quantifying multiple proteins in complex matrices because of increasing numbers of transgenic proteins being coexpressed or "stacked" to achieve tolerance to multiple herbicides or to provide multiple modes of action for insect control. A multiplexing analytical method utilizing liquid chromatography with tandem mass spectrometry (LC-MS/MS) has been developed and validated to quantify three herbicide-tolerant proteins in soybean tissues: aryloxyalkanoate dioxygenase (AAD-12), 5-enol-pyruvylshikimate-3-phosphate synthase (2mEPSPS), and phosphinothricin acetyltransferase (PAT). Results from the validation showed high recovery and precision over multiple analysts and laboratories. Results from this method were comparable to those obtained with ELISA with respect to protein quantitation, and the described method was demonstrated to be suitable for multiplex quantitation of transgenic proteins in GE crops.

Assessment and risk classification protocol for patients in emergency units1

PubMed Central

Silva, Michele de Freitas Neves; Oliveira, Gabriela Novelli; Pergola-Marconato, Aline Maino; Marconato, Rafael Silva; Bargas, Eliete Boaventura; Araujo, Izilda Esmenia Muglia

2014-01-01

Objective to develop, validate the contents and verify the reliability of a risk classification protocol for an Emergency Unit. Method the content validation was developed in a University Hospital in a country town located in the state of Sao Paulo and was carried out in two stages: the first with the individual assessment of specialists and the second with the meeting between the researchers and the specialists. The use of the protocol followed a specific guide. Concerning reliability, the concordance or equivalent method among observers was used. Results the protocol developed showed to have content validity and, after the suggested changes were made, there were excellent results concerning reliability. Conclusion the assistance flow chart was shown to be easy to use, and facilitate the search for the complaint in each assistance priority. PMID:26107828

Gold-standard evaluation of a folksonomy-based ontology learning model

NASA Astrophysics Data System (ADS)

Djuana, E.

2018-03-01

Folksonomy, as one result of collaborative tagging process, has been acknowledged for its potential in improving categorization and searching of web resources. However, folksonomy contains ambiguities such as synonymy and polysemy as well as different abstractions or generality problem. To maximize its potential, some methods for associating tags of folksonomy with semantics and structural relationships have been proposed such as using ontology learning method. This paper evaluates our previous work in ontology learning according to gold-standard evaluation approach in comparison to a notable state-of-the-art work and several baselines. The results show that our method is comparable to the state-of the art work which further validate our approach as has been previously validated using task-based evaluation approach.

Validation of the activity expansion method with ultrahigh pressure shock equations of state

NASA Astrophysics Data System (ADS)

Rogers, Forrest J.; Young, David A.

1997-11-01

Laser shock experiments have recently been used to measure the equation of state (EOS) of matter in the ultrahigh pressure region between condensed matter and a weakly coupled plasma. Some ultrahigh pressure data from nuclear-generated shocks are also available. Matter at these conditions has proven very difficult to treat theoretically. The many-body activity expansion method (ACTEX) has been used for some time to calculate EOS and opacity data in this region, for use in modeling inertial confinement fusion and stellar interior plasmas. In the present work, we carry out a detailed comparison with the available experimental data in order to validate the method. The agreement is good, showing that ACTEX adequately describes strongly shocked matter.

Verification and validation of a Work Domain Analysis with turing machine task analysis.

PubMed

Rechard, J; Bignon, A; Berruet, P; Morineau, T

2015-03-01

While the use of Work Domain Analysis as a methodological framework in cognitive engineering is increasing rapidly, verification and validation of work domain models produced by this method are becoming a significant issue. In this article, we propose the use of a method based on Turing machine formalism named "Turing Machine Task Analysis" to verify and validate work domain models. The application of this method on two work domain analyses, one of car driving which is an "intentional" domain, and the other of a ship water system which is a "causal domain" showed the possibility of highlighting improvements needed by these models. More precisely, the step by step analysis of a degraded task scenario in each work domain model pointed out unsatisfactory aspects in the first modelling, like overspecification, underspecification, omission of work domain affordances, or unsuitable inclusion of objects in the work domain model. Copyright © 2014 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Teaching learning methods of an entrepreneurship curriculum.

PubMed

Esmi, Keramat; Marzoughi, Rahmatallah; Torkzadeh, Jafar

2015-10-01

One of the most significant elements of entrepreneurship curriculum design is teaching-learning methods, which plays a key role in studies and researches related to such a curriculum. It is the teaching method, and systematic, organized and logical ways of providing lessons that should be consistent with entrepreneurship goals and contents, and should also be developed according to the learners' needs. Therefore, the current study aimed to introduce appropriate, modern, and effective methods of teaching entrepreneurship and their validation. This is a mixed method research of a sequential exploratory kind conducted through two stages: a) developing teaching methods of entrepreneurship curriculum, and b) validating developed framework. Data were collected through "triangulation" (study of documents, investigating theoretical basics and the literature, and semi-structured interviews with key experts). Since the literature on this topic is very rich, and views of the key experts are vast, directed and summative content analysis was used. In the second stage, qualitative credibility of research findings was obtained using qualitative validation criteria (credibility, confirmability, and transferability), and applying various techniques. Moreover, in order to make sure that the qualitative part is reliable, reliability test was used. Moreover, quantitative validation of the developed framework was conducted utilizing exploratory and confirmatory factor analysis methods and Cronbach's alpha. The data were gathered through distributing a three-aspect questionnaire (direct presentation teaching methods, interactive, and practical-operational aspects) with 29 items among 90 curriculum scholars. Target population was selected by means of purposive sampling and representative sample. Results obtained from exploratory factor analysis showed that a three factor structure is an appropriate method for describing elements of teaching-learning methods of entrepreneurship curriculum. Moreover, the value for Kaiser Meyer Olkin measure of sampling adequacy equaled 0.72 and the value for Bartlett's test of variances homogeneity was significant at the 0.0001 level. Except for internship element, the rest had a factor load of higher than 0.3. Also, the results of confirmatory factor analysis showed the model appropriateness, and the criteria for qualitative accreditation were acceptable. Developed model can help instructors in selecting an appropriate method of entrepreneurship teaching, and it can also make sure that the teaching is on the right path. Moreover, the model is comprehensive and includes all the effective teaching methods in entrepreneurship education. It is also based on qualities, conditions, and requirements of Higher Education Institutions in Iranian cultural environment.

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.

Evaluation of methods for calculating maximum allowable standing height in amputees competing in Paralympic athletics.

PubMed

Connick, M J; Beckman, E; Ibusuki, T; Malone, L; Tweedy, S M

2016-11-01

The International Paralympic Committee has a maximum allowable standing height (MASH) rule that limits stature to a pre-trauma estimation. The MASH rule reduces the probability that bilateral lower limb amputees use disproportionately long prostheses in competition. Although there are several methods for estimating stature, the validity of these methods has not been compared. To identify the most appropriate method for the MASH rule, this study aimed to compare the criterion validity of estimations resulting from the current method, the Contini method, and four Canda methods (Canda-1, Canda-2, Canda-3, and Canda-4). Stature, ulna length, demispan, sitting height, thigh length, upper arm length, and forearm length measurements in 31 males and 30 females were used to calculate the respective estimation for each method. Results showed that Canda-1 (based on four anthropometric variables) produced the smallest error and best fitted the data in males and females. The current method was associated with the largest error of those tests because it increasingly overestimated height in people with smaller stature. The results suggest that the set of Canda equations provide a more valid MASH estimation in people with a range of upper limb and bilateral lower limb amputations compared with the current method. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Evaluation of PDA Technical Report No 33. Statistical Testing Recommendations for a Rapid Microbiological Method Case Study.

PubMed

Murphy, Thomas; Schwedock, Julie; Nguyen, Kham; Mills, Anna; Jones, David

2015-01-01

New recommendations for the validation of rapid microbiological methods have been included in the revised Technical Report 33 release from the PDA. The changes include a more comprehensive review of the statistical methods to be used to analyze data obtained during validation. This case study applies those statistical methods to accuracy, precision, ruggedness, and equivalence data obtained using a rapid microbiological methods system being evaluated for water bioburden testing. Results presented demonstrate that the statistical methods described in the PDA Technical Report 33 chapter can all be successfully applied to the rapid microbiological method data sets and gave the same interpretation for equivalence to the standard method. The rapid microbiological method was in general able to pass the requirements of PDA Technical Report 33, though the study shows that there can be occasional outlying results and that caution should be used when applying statistical methods to low average colony-forming unit values. Prior to use in a quality-controlled environment, any new method or technology has to be shown to work as designed by the manufacturer for the purpose required. For new rapid microbiological methods that detect and enumerate contaminating microorganisms, additional recommendations have been provided in the revised PDA Technical Report No. 33. The changes include a more comprehensive review of the statistical methods to be used to analyze data obtained during validation. This paper applies those statistical methods to analyze accuracy, precision, ruggedness, and equivalence data obtained using a rapid microbiological method system being validated for water bioburden testing. The case study demonstrates that the statistical methods described in the PDA Technical Report No. 33 chapter can be successfully applied to rapid microbiological method data sets and give the same comparability results for similarity or difference as the standard method. © PDA, Inc. 2015.

Establishing glucose- and ABA-regulated transcription networks in Arabidopsis by microarray analysis and promoter classification using a Relevance Vector Machine.

PubMed

Li, Yunhai; Lee, Kee Khoon; Walsh, Sean; Smith, Caroline; Hadingham, Sophie; Sorefan, Karim; Cawley, Gavin; Bevan, Michael W

2006-03-01

Establishing transcriptional regulatory networks by analysis of gene expression data and promoter sequences shows great promise. We developed a novel promoter classification method using a Relevance Vector Machine (RVM) and Bayesian statistical principles to identify discriminatory features in the promoter sequences of genes that can correctly classify transcriptional responses. The method was applied to microarray data obtained from Arabidopsis seedlings treated with glucose or abscisic acid (ABA). Of those genes showing >2.5-fold changes in expression level, approximately 70% were correctly predicted as being up- or down-regulated (under 10-fold cross-validation), based on the presence or absence of a small set of discriminative promoter motifs. Many of these motifs have known regulatory functions in sugar- and ABA-mediated gene expression. One promoter motif that was not known to be involved in glucose-responsive gene expression was identified as the strongest classifier of glucose-up-regulated gene expression. We show it confers glucose-responsive gene expression in conjunction with another promoter motif, thus validating the classification method. We were able to establish a detailed model of glucose and ABA transcriptional regulatory networks and their interactions, which will help us to understand the mechanisms linking metabolism with growth in Arabidopsis. This study shows that machine learning strategies coupled to Bayesian statistical methods hold significant promise for identifying functionally significant promoter sequences.

Experiences using IAEA Code of practice for radiation sterilization of tissue allografts: Validation and routine control

NASA Astrophysics Data System (ADS)

Hilmy, N.; Febrida, A.; Basril, A.

2007-11-01

Problems of tissue allografts in using International Standard (ISO) 11137 for validation of radiation sterilization dose (RSD) are limited and low numbers of uniform samples per production batch, those are products obtained from one donor. Allograft is a graft transplanted between two different individuals of the same species. The minimum number of uniform samples needed for verification dose (VD) experiment at the selected sterility assurance level (SAL) per production batch according to the IAEA Code is 20, i.e., 10 for bio-burden determination and the remaining 10 for sterilization test. Three methods of the IAEA Code have been used for validation of RSD, i.e., method A1 that is a modification of method 1 of ISO 11137:1995, method B (ISO 13409:1996), and method C (AAMI TIR 27:2001). This paper describes VD experiments using uniform products obtained from one cadaver donor, i.e., cancellous bones, demineralized bone powders and amnion grafts from one life donor. Results of the verification dose experiments show that RSD is 15.4 kGy for cancellous and demineralized bone grafts and 19.2 kGy for amnion grafts according to method A1 and 25 kGy according to methods B and C.

Capsule Typing of Haemophilus influenzae by Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry.

PubMed

Månsson, Viktor; Gilsdorf, Janet R; Kahlmeter, Gunnar; Kilian, Mogens; Kroll, J Simon; Riesbeck, Kristian; Resman, Fredrik

2018-03-01

Encapsulated Haemophilus influenzae strains belong to type-specific genetic lineages. Reliable capsule typing requires PCR, but a more efficient method would be useful. We evaluated capsule typing by using matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry. Isolates of all capsule types (a-f and nontypeable; n = 258) and isogenic capsule transformants (types a-d) were investigated. Principal component and biomarker analyses of mass spectra showed clustering, and mass peaks correlated with capsule type-specific genetic lineages. We used 31 selected isolates to construct a capsule typing database. Validation with the remaining isolates (n = 227) showed 100% sensitivity and 92.2% specificity for encapsulated strains (a-f; n = 61). Blinded validation of a supplemented database (n = 50) using clinical isolates (n = 126) showed 100% sensitivity and 100% specificity for encapsulated strains (b, e, and f; n = 28). MALDI-TOF mass spectrometry is an accurate method for capsule typing of H. influenzae.

Development and Validity of Western University's On-Road Assessment.

PubMed

Classen, Sherrilene; Krasniuk, Sarah; Alvarez, Liliana; Monahan, Miriam; Morrow, Sarah A; Danter, Tim

2017-01-01

Although used across North America, many on-road studies do not explicitly document the content and metrics of on-road courses and accompanying assessments. This article discusses the development of the University of Western Ontario's on-road course, and elucidates the validity of its accompanying on-road assessment. We identified main components for developing an on-road course and used measurement theory to establish face, content, and initial construct validity. Five adult volunteer drivers and 30 drivers with multiple sclerosis participated in the study. The road course had face and content validity, representing 100% of roadway components determined through a content validity matrix and index. The known-groups method showed that debilitated drivers (vs. not debilitated), made more driving errors ( W = 463.50, p = .03), and failed the on-road course, indicating preliminary construct validity of the on-road assessment. This research guides and empirically supports a process for developing a road course and its assessment.

Development and Validation of Videotaped Scenarios

PubMed Central

Noel, Nora E.; Maisto, Stephen A.; Johnson, James D.; Jackson, Lee A.; Goings, Christopher D.; Hagman, Brett T.

2013-01-01

Researchers using scenarios often neglect to validate perceived content and salience of embedded stimuli specifically with intended participants, even when such meaning is integral to the study. For example, sex and aggression stimuli are heavily influenced by culture, so participants may not perceive what researchers intended in sexual aggression scenarios. Using four studies, the authors describe the method of scenario validation to produce two videos assessing alcohol-related sexual aggression. Both videos are identical except for the presence in one video of antiforce cues that are extremely salient to the young heterosexual men. Focus groups and questionnaires validate these men's perceptions that (a) the woman was sexually interested, (b) the sexual cues were salient, (c) the antiforce cues were salient (antiaggression video only), and (e) these antiforce cues inhibited acceptance of forced sex. Results show the value of carefully selecting and validating content when assessing socially volatile variables and provide a useful template for developing culturally valid scenarios. PMID:18252938

[Development and validation of a questionnaire about the main variables affecting the individual investor's behavior in the Stock Exchange].

PubMed

Pascual-Ezama, David; San Martín Castellanos, Rafael; Gil-Gómez de Liaño, Beatriz; Scandroglio, Bárbara

2010-11-01

Development and validation of a questionnaire about the main variables affecting the individual investor's behavior in the Stock Exchange. There is a considerable lack of information about the methodology usually used in most of the studies about individual investor's behavior. The studies reviewed do not show the method used in the selection of the items or the psychometric properties of the questionnaires. Because of the importance of investment in the Stock Exchange nowadays, it seems relevant to obtain a reliable instrument to understand individual investor's behavior in the Stock Exchange. Therefore, the goal of the present work is to validate a questionnaire about the main variables involved in individual investors' behavior in the Stock Exchange. Based on previous studies, we elaborated a questionnaire using the Delphi methodology with a group of experts. The internal consistency (Cronbach alpha=.934) and validity evidence of the questionnaire show that it may be an effective instrument and can be applied with some assurance.

Temperature field simulation and phantom validation of a Two-armed Spiral Antenna for microwave thermotherapy.

PubMed

Du, Yongxing; Zhang, Lingze; Sang, Lulu; Wu, Daocheng

2016-04-29

In this paper, an Archimedean planar spiral antenna for the application of thermotherapy was designed. This type of antenna was chosen for its compact structure, flexible application and wide heating area. The temperature field generated by the use of this Two-armed Spiral Antenna in a muscle-equivalent phantom was simulated and subsequently validated by experimentation. First, the specific absorption rate (SAR) of the field was calculated using the Finite Element Method (FEM) by Ansoft's High Frequency Structure Simulation (HFSS). Then, the temperature elevation in the phantom was simulated by an explicit finite difference approximation of the bioheat equation (BHE). The temperature distribution was then validated by a phantom heating experiment. The results showed that this antenna had a good heating ability and a wide heating area. A comparison between the calculation and the measurement showed a fair agreement in the temperature elevation. The validated model could be applied for the analysis of electromagnetic-temperature distribution in phantoms during the process of antenna design or thermotherapy experimentation.

Accelerated solvent extraction by using an 'in-line' clean-up approach for multiresidue analysis of pesticides in organic honey.

PubMed

Chiesa, Luca Maria; Labella, Giuseppe Federico; Panseri, Sara; Britti, Domenico; Galbiati, Fabrizio; Villa, Roberto; Arioli, Francesco

2017-05-01

The worldwide loss of honeybee colonies may be due to their exposure to several contaminants (i.e., pesticides); such contamination may also have impacts on consumers' health. Therefore, it is essential to develop quick and new methods to detect several pesticide residues in honey samples. In this study, the effectiveness of accelerated solvent extraction (ASE) was compared with QuEChERS methods for the analysis of 53 pesticides in organic honey by gas chromatography-triple quadrupole mass spectrometry. Two simple and rapid ASE methods with 'in-line' clean-up were optimised and then compared with QuEChERS. Hexane-ethyl acetate (Hex:EtAc) and Florisil were chosen as extraction solvent and retainer for the first ASE method respectively; acetonitrile and a primary-secondary amine phase (ACN-PSA) were selected for the second ASE method. The methods were validated according to the European Union SANTE/11945/2015 guidelines. The validation parameters showed that QuEChERS and ASE with PSA as retainer had better repeatability than ASE with Hex:EtAc and Florisil. In particular, QuEChERS and ASE (ACN-PSA) showed good recovery, according to the SANTE criteria, for the majority of investigated pesticides. Conversely, when ASE with Hex:EtAc and Florisil was used as the retainer, several compounds showed recoveries lower than the acceptable value of 70%. The ASE in-line method was finally applied to evaluate pesticide concentration in organic honey samples.

Determination of proline in honey: comparison between official methods, optimization and validation of the analytical methodology.

PubMed

Truzzi, Cristina; Annibaldi, Anna; Illuminati, Silvia; Finale, Carolina; Scarponi, Giuseppe

2014-05-01

The study compares official spectrophotometric methods for the determination of proline content in honey - those of the International Honey Commission (IHC) and the Association of Official Analytical Chemists (AOAC) - with the original Ough method. Results show that the extra time-consuming treatment stages added by the IHC method with respect to the Ough method are pointless. We demonstrate that the AOACs method proves to be the best in terms of accuracy and time saving. The optimized waiting time for the absorbance recording is set at 35min from the removal of reaction tubes from the boiling bath used in the sample treatment. The optimized method was validated in the matrix: linearity up to 1800mgL(-1), limit of detection 20mgL(-1), limit of quantification 61mgL(-1). The method was applied to 43 unifloral honey samples from the Marche region, Italy. Copyright © 2013 Elsevier Ltd. All rights reserved.

Quantitative analysis of γ-oryzanol content in cold pressed rice bran oil by TLC-image analysis method

PubMed Central

Sakunpak, Apirak; Suksaeree, Jirapornchai; Monton, Chaowalit; Pathompak, Pathamaporn; Kraisintu, Krisana

2014-01-01

Objective To develop and validate an image analysis method for quantitative analysis of γ-oryzanol in cold pressed rice bran oil. Methods TLC-densitometric and TLC-image analysis methods were developed, validated, and used for quantitative analysis of γ-oryzanol in cold pressed rice bran oil. The results obtained by these two different quantification methods were compared by paired t-test. Results Both assays provided good linearity, accuracy, reproducibility and selectivity for determination of γ-oryzanol. Conclusions The TLC-densitometric and TLC-image analysis methods provided a similar reproducibility, accuracy and selectivity for the quantitative determination of γ-oryzanol in cold pressed rice bran oil. A statistical comparison of the quantitative determinations of γ-oryzanol in samples did not show any statistically significant difference between TLC-densitometric and TLC-image analysis methods. As both methods were found to be equal, they therefore can be used for the determination of γ-oryzanol in cold pressed rice bran oil. PMID:25182282

Development and Validation of a HPTLC Method for Simultaneous Estimation of L-Glutamic Acid and γ-Aminobutyric Acid in Mice Brain

PubMed Central

Sancheti, J. S.; Shaikh, M. F.; Khatwani, P. F.; Kulkarni, Savita R.; Sathaye, Sadhana

2013-01-01

A new robust, simple and economic high performance thin layer chromatographic method was developed for simultaneous estimation of L-glutamic acid and γ-amino butyric acid in brain homogenate. The high performance thin layer chromatographic separation of these amino acid was achieved using n-butanol:glacial acetic acid:water (22:3:5 v/v/v) as mobile phase and ninhydrin as a derivatising agent. Quantitation of the method was achieved by densitometric method at 550 nm over the concentration range of 10-100 ng/spot. This method showed good separation of amino acids in the brain homogenate with Rf value of L-glutamic acid and γ-amino butyric acid as 21.67±0.58 and 33.67±0.58, respectively. The limit of detection and limit of quantification for L-glutamic acid was found to be 10 and 20 ng and for γ-amino butyric acid it was 4 and 10 ng, respectively. The method was also validated in terms of accuracy, precision and repeatability. The developed method was found to be precise and accurate with good reproducibility and shows promising applicability for studying pathological status of disease and therapeutic significance of drug treatment. PMID:24591747

Development and Validation of a HPTLC Method for Simultaneous Estimation of L-Glutamic Acid and γ-Aminobutyric Acid in Mice Brain.

PubMed

Sancheti, J S; Shaikh, M F; Khatwani, P F; Kulkarni, Savita R; Sathaye, Sadhana

2013-11-01

A new robust, simple and economic high performance thin layer chromatographic method was developed for simultaneous estimation of L-glutamic acid and γ-amino butyric acid in brain homogenate. The high performance thin layer chromatographic separation of these amino acid was achieved using n-butanol:glacial acetic acid:water (22:3:5 v/v/v) as mobile phase and ninhydrin as a derivatising agent. Quantitation of the method was achieved by densitometric method at 550 nm over the concentration range of 10-100 ng/spot. This method showed good separation of amino acids in the brain homogenate with Rf value of L-glutamic acid and γ-amino butyric acid as 21.67±0.58 and 33.67±0.58, respectively. The limit of detection and limit of quantification for L-glutamic acid was found to be 10 and 20 ng and for γ-amino butyric acid it was 4 and 10 ng, respectively. The method was also validated in terms of accuracy, precision and repeatability. The developed method was found to be precise and accurate with good reproducibility and shows promising applicability for studying pathological status of disease and therapeutic significance of drug treatment.

A novel method for automated tracking and quantification of adult zebrafish behaviour during anxiety.

PubMed

Nema, Shubham; Hasan, Whidul; Bhargava, Anamika; Bhargava, Yogesh

2016-09-15

Behavioural neuroscience relies on software driven methods for behavioural assessment, but the field lacks cost-effective, robust, open source software for behavioural analysis. Here we propose a novel method which we called as ZebraTrack. It includes cost-effective imaging setup for distraction-free behavioural acquisition, automated tracking using open-source ImageJ software and workflow for extraction of behavioural endpoints. Our ImageJ algorithm is capable of providing control to users at key steps while maintaining automation in tracking without the need for the installation of external plugins. We have validated this method by testing novelty induced anxiety behaviour in adult zebrafish. Our results, in agreement with established findings, showed that during state-anxiety, zebrafish showed reduced distance travelled, increased thigmotaxis and freezing events. Furthermore, we proposed a method to represent both spatial and temporal distribution of choice-based behaviour which is currently not possible to represent using simple videograms. ZebraTrack method is simple and economical, yet robust enough to give results comparable with those obtained from costly proprietary software like Ethovision XT. We have developed and validated a novel cost-effective method for behavioural analysis of adult zebrafish using open-source ImageJ software. Copyright © 2016 Elsevier B.V. All rights reserved.

A simple method for measurement of maximal downstroke power on friction-loaded cycle ergometer.

PubMed

Morin, Jean-Benoît; Belli, Alain

2004-01-01

The aim of this study was to propose and validate a post-hoc correction method to obtain maximal power values taking into account inertia of the flywheel during sprints on friction-loaded cycle ergometers. This correction method was obtained from a basic postulate of linear deceleration-time evolution during the initial phase (until maximal power) of a sprint and included simple parameters as flywheel inertia, maximal velocity, time to reach maximal velocity and friction force. The validity of this model was tested by comparing measured and calculated maximal power values for 19 sprint bouts performed by five subjects against 0.6-1 N kg(-1) friction loads. Non-significant differences between measured and calculated maximal power (1151+/-169 vs. 1148+/-170 W) and a mean error index of 1.31+/-1.20% (ranging from 0.09% to 4.20%) showed the validity of this method. Furthermore, the differences between measured maximal power and power neglecting inertia (20.4+/-7.6%, ranging from 9.5% to 33.2%) emphasized the usefulness of power correcting in studies about anaerobic power which do not include inertia, and also the interest of this simple post-hoc method.

Development and validation of an automated enzyme assay for paracetamol (acetaminophen).

PubMed

Morris, H C; Overton, P D; Ramsay, J R; Campbell, R S; Hammond, P M; Atkinson, T; Price, C P

1990-02-28

A rapid, enzymatic assay for serum or plasma paracetamol has been developed with the potential for adaptation to a wide range of clinical analysers. The method involves the action of an amidase enzyme to produce 4-aminophenol from paracetamol, which in turn reacts with 8-hydroxyquinoline in the presence of manganese ions to form a blue dye. Two stable reagents are used and excellent precision is achieved over the drug concentration range 0-2.5 mmol/l. The method, which is complete within 6 min, has been validated using a Monarch centrifugal analyser and shows no significant interference from endogenous serum compounds, drugs or paracetamol metabolites.

Transcriptomic SNP discovery for custom genotyping arrays: impacts of sequence data, SNP calling method and genotyping technology on the probability of validation success.

PubMed

Humble, Emily; Thorne, Michael A S; Forcada, Jaume; Hoffman, Joseph I

2016-08-26

Single nucleotide polymorphism (SNP) discovery is an important goal of many studies. However, the number of 'putative' SNPs discovered from a sequence resource may not provide a reliable indication of the number that will successfully validate with a given genotyping technology. For this it may be necessary to account for factors such as the method used for SNP discovery and the type of sequence data from which it originates, suitability of the SNP flanking sequences for probe design, and genomic context. To explore the relative importance of these and other factors, we used Illumina sequencing to augment an existing Roche 454 transcriptome assembly for the Antarctic fur seal (Arctocephalus gazella). We then mapped the raw Illumina reads to the new hybrid transcriptome using BWA and BOWTIE2 before calling SNPs with GATK. The resulting markers were pooled with two existing sets of SNPs called from the original 454 assembly using NEWBLER and SWAP454. Finally, we explored the extent to which SNPs discovered using these four methods overlapped and predicted the corresponding validation outcomes for both Illumina Infinium iSelect HD and Affymetrix Axiom arrays. Collating markers across all discovery methods resulted in a global list of 34,718 SNPs. However, concordance between the methods was surprisingly poor, with only 51.0 % of SNPs being discovered by more than one method and 13.5 % being called from both the 454 and Illumina datasets. Using a predictive modeling approach, we could also show that SNPs called from the Illumina data were on average more likely to successfully validate, as were SNPs called by more than one method. Above and beyond this pattern, predicted validation outcomes were also consistently better for Affymetrix Axiom arrays. Our results suggest that focusing on SNPs called by more than one method could potentially improve validation outcomes. They also highlight possible differences between alternative genotyping technologies that could be explored in future studies of non-model organisms.

3D inversion of full gravity gradient tensor data in spherical coordinate system using local north-oriented frame

NASA Astrophysics Data System (ADS)

Zhang, Yi; Wu, Yulong; Yan, Jianguo; Wang, Haoran; Rodriguez, J. Alexis P.; Qiu, Yue

2018-04-01

In this paper, we propose an inverse method for full gravity gradient tensor data in the spherical coordinate system. As opposed to the traditional gravity inversion in the Cartesian coordinate system, our proposed method takes the curvature of the Earth, the Moon, or other planets into account, using tesseroid bodies to produce gravity gradient effects in forward modeling. We used both synthetic and observed datasets to test the stability and validity of the proposed method. Our results using synthetic gravity data show that our new method predicts the depth of the density anomalous body efficiently and accurately. Using observed gravity data for the Mare Smythii area on the moon, the density distribution of the crust in this area reveals its geological structure. These results validate the proposed method and potential application for large area data inversion of planetary geological structures.[Figure not available: see fulltext.

Validation of the concentration profiles obtained from the near infrared/multivariate curve resolution monitoring of reactions of epoxy resins using high performance liquid chromatography as a reference method.

PubMed

Garrido, M; Larrechi, M S; Rius, F X

2007-03-07

This paper reports the validation of the results obtained by combining near infrared spectroscopy and multivariate curve resolution-alternating least squares (MCR-ALS) and using high performance liquid chromatography as a reference method, for the model reaction of phenylglycidylether (PGE) and aniline. The results are obtained as concentration profiles over the reaction time. The trueness of the proposed method has been evaluated in terms of lack of bias. The joint test for the intercept and the slope showed that there were no significant differences between the profiles calculated spectroscopically and the ones obtained experimentally by means of the chromatographic reference method at an overall level of confidence of 5%. The uncertainty of the results was estimated by using information derived from the process of assessment of trueness. Such operational aspects as the cost and availability of instrumentation and the length and cost of the analysis were evaluated. The method proposed is a good way of monitoring the reactions of epoxy resins, and it adequately shows how the species concentration varies over time.

Clinical application of the basic definition of malnutrition proposed by the European Society for Clinical Nutrition and Metabolism (ESPEN): Comparison with classical tools in geriatric care.

PubMed

Sánchez-Rodríguez, Dolores; Annweiler, Cédric; Ronquillo-Moreno, Natalia; Tortosa-Rodríguez, Andrea; Guillén-Solà, Anna; Vázquez-Ibar, Olga; Escalada, Ferran; Muniesa, Josep M; Marco, Ester

Malnutrition is a prevalent condition related to adverse outcomes in older people. Our aim was to compare the diagnostic capacity of the malnutrition criteria of the European Society of Parenteral and Enteral Nutrition (ESPEN) with other classical diagnostic tools. Cohort study of 102 consecutive in-patients ≥70 years admitted for postacute rehabilitation. Patients were considered malnourished if their Mini-Nutritional Assessment-Short Form (MNA-SF) score was ≤11 and serum albumin <3 mg/dL or MNA-SF ≤ 11, serum albumin <3 mg/dL, and usual clinical signs and symptoms of malnutrition. Sensitivity, specificity, positive and negative predictive values, accuracy likelihood ratios, and kappa values were calculated for both methods: and compared with ESPEN consensus. Of 102 eligible in-patients, 88 fulfilled inclusion criteria and were identified as "at risk" by MNA-SF. Malnutrition diagnosis was confirmed in 11.6% and 10.5% of the patients using classical methods,whereas 19.3% were malnourished according to the ESPEN criteria. Combined with low albumin levels, the diagnosis showed 57.9% sensitivity, 64.5% specificity, 85.9% negative predictive value,0.63 accuracy (fair validity, low range), and kappa index of 0.163 (poor ESPEN agreement). The combination of MNA-SF, low albumin, and clinical malnutrition showed 52.6% sensitivity, 88.3% specificity, 88.3%negative predictive value, and 0.82 accuracy (fair validity, low range), and kappa index of 0.43 (fair ESPEN agreement). Malnutrition was almost twice as prevalent when diagnosed by the ESPEN consensus, compared to classical assessment methods: Classical methods: showed fair validity and poor agreement with the ESPEN consensus in assessing malnutrition in geriatric postacute care. Copyright © 2018 Elsevier B.V. All rights reserved.

A computational continuum model of poroelastic beds

PubMed Central

Zampogna, G. A.

2017-01-01

Despite the ubiquity of fluid flows interacting with porous and elastic materials, we lack a validated non-empirical macroscale method for characterizing the flow over and through a poroelastic medium. We propose a computational tool to describe such configurations by deriving and validating a continuum model for the poroelastic bed and its interface with the above free fluid. We show that, using stress continuity condition and slip velocity condition at the interface, the effective model captures the effects of small changes in the microstructure anisotropy correctly and predicts the overall behaviour in a physically consistent and controllable manner. Moreover, we show that the performance of the effective model is accurate by validating with fully microscopic resolved simulations. The proposed computational tool can be used in investigations in a wide range of fields, including mechanical engineering, bio-engineering and geophysics. PMID:28413355

Mathematic models for a ray tracing method and its applications in wireless optical communications.

PubMed

Zhang, Minglun; Zhang, Yangan; Yuan, Xueguang; Zhang, Jinnan

2010-08-16

This paper presents a new ray tracing method, which contains a whole set of mathematic models, and its validity is verified by simulations. In addition, both theoretical analysis and simulation results show that the computational complexity of the method is much lower than that of previous ones. Therefore, the method can be used to rapidly calculate the impulse response of wireless optical channels for complicated systems.

Evaluation of the performance of a micromethod for measuring urinary iodine by using six sigma quality metrics.

PubMed

Hussain, Husniza; Khalid, Norhayati Mustafa; Selamat, Rusidah; Wan Nazaimoon, Wan Mohamud

2013-09-01

The urinary iodine micromethod (UIMM) is a modification of the conventional method and its performance needs evaluation. UIMM performance was evaluated using the method validation and 2008 Iodine Deficiency Disorders survey data obtained from four urinary iodine (UI) laboratories. Method acceptability tests and Sigma quality metrics were determined using total allowable errors (TEas) set by two external quality assurance (EQA) providers. UIMM obeyed various method acceptability test criteria with some discrepancies at low concentrations. Method validation data calculated against the UI Quality Program (TUIQP) TEas showed that the Sigma metrics were at 2.75, 1.80, and 3.80 for 51±15.50 µg/L, 108±32.40 µg/L, and 149±38.60 µg/L UI, respectively. External quality control (EQC) data showed that the performance of the laboratories was within Sigma metrics of 0.85-1.12, 1.57-4.36, and 1.46-4.98 at 46.91±7.05 µg/L, 135.14±13.53 µg/L, and 238.58±17.90 µg/L, respectively. No laboratory showed a calculated total error (TEcalc)

Validated chromatographic and spectrophotometric methods for analysis of some amoebicide drugs in their combined pharmaceutical preparation.

PubMed

Abdelaleem, Eglal Adelhamid; Abdelwahab, Nada Sayed

2013-01-01

This work is concerned with development and validation of chromatographic and spectrophotometric methods for analysis of mebeverine HCl (MEH), diloxanide furoate (DF) and metronidazole (MET) in Dimetrol® tablets - spectrophotometric and RP-HPLC methods using UV detection. The developed spectrophotometric methods depend on determination of MEH and DF in the combined dosage form using the successive derivative ratio spectra method which depends on derivatization of the obtained ratio spectra in two steps using methanol as a solvent and measuring MEH at 226.4-232.2 nm (peak to peak) and DF at 260.6-264.8 nm (peak to peak). While MET concentrations were determined using first derivative (1D) at λ = 327 nm using the same solvent. The chromatographic method depends on HPLC separation on ODS column and elution with a mobile phase consisting water: methanol: triethylamine (25: 75: 0.5, by volume, orthophosphoric acid to pH =4). Pumping the mobile phase at 0.7 ml min-1 with UV at 230 nm. Factors affecting the developed methods were studied and optimized, moreover, they have been validated as per ICH guideline and the results demonstrated that the suggested methods are reproducible, reliable and can be applied for routine use with short time of analysis. Statistical analysis of the two developed methods with each other using F and student's-t tests showed no significant difference.

A validated Fourier transform infrared spectroscopy method for quantification of total lactones in Inula racemosa and Andrographis paniculata.

PubMed

Shivali, Garg; Praful, Lahorkar; Vijay, Gadgil

2012-01-01

Fourier transform infrared (FT-IR) spectroscopy is a technique widely used for detection and quantification of various chemical moieties. This paper describes the use of the FT-IR spectroscopy technique for the quantification of total lactones present in Inula racemosa and Andrographis paniculata. To validate the FT-IR spectroscopy method for quantification of total lactones in I. racemosa and A. paniculata. Dried and powdered I. racemosa roots and A. paniculata plant were extracted with ethanol and dried to remove ethanol completely. The ethanol extract was analysed in a KBr pellet by FT-IR spectroscopy. The FT-IR spectroscopy method was validated and compared with a known spectrophotometric method for quantification of lactones in A. paniculata. By FT-IR spectroscopy, the amount of total lactones was found to be 2.12 ± 0.47% (n = 3) in I. racemosa and 8.65 ± 0.51% (n = 3) in A. paniculata. The method showed comparable results with a known spectrophotometric method used for quantification of such lactones: 8.42 ± 0.36% (n = 3) in A. paniculata. Limits of detection and quantification for isoallantolactone were 1 µg and 10 µg respectively; for andrographolide they were 1.5 µg and 15 µg respectively. Recoveries were over 98%, with good intra- and interday repeatability: RSD ≤ 2%. The FT-IR spectroscopy method proved linear, accurate, precise and specific, with low limits of detection and quantification, for estimation of total lactones, and is less tedious than the UV spectrophotometric method for the compounds tested. This validated FT-IR spectroscopy method is readily applicable for the quality control of I. racemosa and A. paniculata. Copyright © 2011 John Wiley & Sons, Ltd.

Development and Bioanalytical Validation of a Liquid Chromatographic-Tandem Mass Spectrometric (LC-MS/MS) Method for the Quantification of the CCR5 Antagonist Maraviroc in Human Plasma

PubMed Central

Emory, Joshua F.; Seserko, Lauren A.; Marzinke, Mark A.

2014-01-01

Background Maraviroc is a CCR5 antagonist that has been utilized as a viral entry inhibitor in the management of HIV-1. Current clinical trials are pursuing maraviroc drug efficacy in both oral and topical formulations. Therefore, in order to fully understand drug pharmacokinetics, a sensitive method is required to quantify plasma drug concentrations. Methods Maraviroc-spiked plasma was combined with acetonitrile containing an isotopically-labeled internal standard, and following protein precipitation, samples were evaporated to dryness and reconstituted for liquid chromatographic-tandem mass spectrometric (LC-MS/MS) analysis. Chromatographic separation was achieved on a Waters BEH C8, 50 × 2.1 mm UPLC column, with a 1.7 μm particle size and the eluent was analyzed using an API 4000 mass analyzer in selected reaction monitoring mode. The method was validated as per FDA Bioanalytical Method Validation guidelines. Results The analytical measuring range of the LC-MS/MS method is 0.5-1000 ng/ml. Calibration curves were generated using weighted 1/x2 quadratic regression. Inter-and intra-assay precision was ≤ 5.38% and ≤ 5.98%, respectively; inter-and intra-assay accuracy (%DEV) was ≤ 10.2% and ≤ 8.44%, respectively. Additional studies illustrated similar matrix effects between maraviroc and its internal standard, and that maraviroc is stable under a variety of conditions. Method comparison studies with a reference LC-MS/MS method show a slope of 0.948 with a Spearman coefficient of 0.98. Conclusions Based on the validation metrics, we have generated a sensitive and automated LC-MS/MS method for maraviroc quantification in human plasma. PMID:24561264

Cross-validation and Peeling Strategies for Survival Bump Hunting using Recursive Peeling Methods

PubMed Central

Dazard, Jean-Eudes; Choe, Michael; LeBlanc, Michael; Rao, J. Sunil

2015-01-01

We introduce a framework to build a survival/risk bump hunting model with a censored time-to-event response. Our Survival Bump Hunting (SBH) method is based on a recursive peeling procedure that uses a specific survival peeling criterion derived from non/semi-parametric statistics such as the hazards-ratio, the log-rank test or the Nelson--Aalen estimator. To optimize the tuning parameter of the model and validate it, we introduce an objective function based on survival or prediction-error statistics, such as the log-rank test and the concordance error rate. We also describe two alternative cross-validation techniques adapted to the joint task of decision-rule making by recursive peeling and survival estimation. Numerical analyses show the importance of replicated cross-validation and the differences between criteria and techniques in both low and high-dimensional settings. Although several non-parametric survival models exist, none addresses the problem of directly identifying local extrema. We show how SBH efficiently estimates extreme survival/risk subgroups unlike other models. This provides an insight into the behavior of commonly used models and suggests alternatives to be adopted in practice. Finally, our SBH framework was applied to a clinical dataset. In it, we identified subsets of patients characterized by clinical and demographic covariates with a distinct extreme survival outcome, for which tailored medical interventions could be made. An R package PRIMsrc (Patient Rule Induction Method in Survival, Regression and Classification settings) is available on CRAN (Comprehensive R Archive Network) and GitHub. PMID:27034730

Primary central nervous system lymphoma and glioblastoma differentiation based on conventional magnetic resonance imaging by high-throughput SIFT features.

PubMed

Chen, Yinsheng; Li, Zeju; Wu, Guoqing; Yu, Jinhua; Wang, Yuanyuan; Lv, Xiaofei; Ju, Xue; Chen, Zhongping

2018-07-01

Due to the totally different therapeutic regimens needed for primary central nervous system lymphoma (PCNSL) and glioblastoma (GBM), accurate differentiation of the two diseases by noninvasive imaging techniques is important for clinical decision-making. Thirty cases of PCNSL and 66 cases of GBM with conventional T1-contrast magnetic resonance imaging (MRI) were analyzed in this study. Convolutional neural networks was used to segment tumor automatically. A modified scale invariant feature transform (SIFT) method was utilized to extract three-dimensional local voxel arrangement information from segmented tumors. Fisher vector was proposed to normalize the dimension of SIFT features. An improved genetic algorithm (GA) was used to extract SIFT features with PCNSL and GBM discrimination ability. The data-set was divided into a cross-validation cohort and an independent validation cohort by the ratio of 2:1. Support vector machine with the leave-one-out cross-validation based on 20 cases of PCNSL and 44 cases of GBM was employed to build and validate the differentiation model. Among 16,384 high-throughput features, 1356 features show significant differences between PCNSL and GBM with p < 0.05 and 420 features with p < 0.001. A total of 496 features were finally chosen by improved GA algorithm. The proposed method produces PCNSL vs. GBM differentiation with an area under the curve (AUC) curve of 99.1% (98.2%), accuracy 95.3% (90.6%), sensitivity 85.0% (80.0%) and specificity 100% (95.5%) on the cross-validation cohort (and independent validation cohort). Since the local voxel arrangement characterization provided by SIFT features, proposed method produced more competitive PCNSL and GBM differentiation performance by using conventional MRI than methods based on advanced MRI.

Ultrasound-Assisted Extraction of Stilbenes from Grape Canes.

PubMed

Piñeiro, Zulema; Marrufo-Curtido, Almudena; Serrano, Maria Jose; Palma, Miguel

2016-06-16

An analytical ultrasound-assisted extraction (UAE) method has been optimized and validated for the rapid extraction of stilbenes from grape canes. The influence of sample pre-treatment (oven or freeze-drying) and several extraction variables (solvent, sample-solvent ratio and extraction time between others) on the extraction process were analyzed. The new method allowed the main stilbenes in grape canes to be extracted in just 10 min, with an extraction temperature of 75 °C and 60% ethanol in water as the extraction solvent. Validation of the extraction method was based on analytical properties. The resulting RSDs (n = 5) for interday/intraday precision were less than 10%. Furthermore, the method was successfully applied in the analysis of 20 different grape cane samples. The result showed that grape cane byproducts are potentially sources of bioactive compounds of interest for pharmaceutical and food industries.

Validated ¹H and 13C Nuclear Magnetic Resonance Methods for the Quantitative Determination of Glycerol in Drug Injections.

PubMed

Lu, Jiaxi; Wang, Pengli; Wang, Qiuying; Wang, Yanan; Jiang, Miaomiao

2018-05-15

In the current study, we employed high-resolution proton and carbon nuclear magnetic resonance spectroscopy (¹H and 13 C NMR) for quantitative analysis of glycerol in drug injections without any complex pre-treatment or derivatization on samples. The established methods were validated with good specificity, linearity, accuracy, precision, stability, and repeatability. Our results revealed that the contents of glycerol were convenient to calculate directly via the integration ratios of peak areas with an internal standard in ¹H NMR spectra, while the integration of peak heights were proper for 13 C NMR in combination with an external calibration of glycerol. The developed methods were both successfully applied in drug injections. Quantitative NMR methods showed an extensive prospect for glycerol determination in various liquid samples.

[A Simultaneous Determination Method with Acetonitrile-n-Hexane Partitioning and Solid-Phase Extraction for Pesticide Residues in Livestock and Marine Products by GC-MS].

PubMed

Yoshizaki, Mayuko; Kobayashi, Yukari; Shimizu, Masanori; Maruyama, Kouichi

2015-01-01

A simultaneous determination method was examined for 312 pesticides (including isomers) in muscle of livestock and marine products by GC-MS. The pesticide residues extracted from samples with acetone and n-hexane were purified by acetonitrile-n-hexane partitioning, and C18 and SAX/PSA solid-phase extraction without using GPC. Matrix components such as cholesterol were effectively removed. In recovery tests performed by this method using pork, beef, chicken and shrimp, 237-257 pesticides showed recoveries within the range of 70-120% in each sample. Validity was confirmed for 214 of the target pesticides by means of a validation test using pork. In comparison with the Japanese official method using GPC, the treatment time of samples and the quantity of solvent were reduced substantially.

Uncovering Specific Electrostatic Interactions in the Denatured States of Proteins

PubMed Central

Shen, Jana K.

2010-01-01

The stability and folding of proteins are modulated by energetically significant interactions in the denatured state that is in equilibrium with the native state. These interactions remain largely invisible to current experimental techniques, however, due to the sparse population and conformational heterogeneity of the denatured-state ensemble under folding conditions. Molecular dynamics simulations using physics-based force fields can in principle offer atomistic details of the denatured state. However, practical applications are plagued with the lack of rigorous means to validate microscopic information and deficiencies in force fields and solvent models. This study presents a method based on coupled titration and molecular dynamics sampling of the denatured state starting from the extended sequence under native conditions. The resulting denatured-state pKas allow for the prediction of experimental observables such as pH- and mutation-induced stability changes. I show the capability and use of the method by investigating the electrostatic interactions in the denatured states of wild-type and K12M mutant of NTL9 protein. This study shows that the major errors in electrostatics can be identified by validating the titration properties of the fragment peptides derived from the sequence of the intact protein. Consistent with experimental evidence, our simulations show a significantly depressed pKa for Asp8 in the denatured state of wild-type, which is due to a nonnative interaction between Asp8 and Lys12. Interestingly, the simulation also shows a nonnative interaction between Asp8 and Glu48 in the denatured state of the mutant. I believe the presented method is general and can be applied to extract and validate microscopic electrostatics of the entire folding energy landscape. PMID:20682271

Transient signal isotope analysis: validation of the method for isotope signal synchronization with the determination of amplifier first-order time constants.

PubMed

Gourgiotis, Alkiviadis; Manhès, Gérard; Louvat, Pascale; Moureau, Julien; Gaillardet, Jérôme

2015-09-30

During transient signal acquisition by Multi-Collection Inductively Coupled Plasma Mass Spectrometry (MC-ICPMS), an isotope ratio increase or decrease (isotopic drift hereafter) is often observed which is related to the different time responses of the amplifiers involved in multi-collection. This isotopic drift affects the quality of the isotopic data and, in a recent study, a method of internal amplifier signal synchronization for isotope drift correction was proposed. In this work the determination of the amplifier time constants was investigated in order to validate the method of internal amplifier signal synchronization for isotope ratio drift correction. Two different MC-ICPMS instruments, the Neptune and the Neptune Plus, were used, and both the lead transient signals and the signal decay curves of the amplifiers were investigated. Our results show that the first part of the amplifier signal decay curve is characterized by a pure exponential decay. This part of the signal decay was used for the effective calculation of the amplifier first-order time constants. The small differences between these time constants were compared with time lag values obtained from the method of isotope signal synchronization and were found to be in good agreement. This work proposes a way of determining amplifier first-order time constants. We show that isotopic drift is directly related to the amplifier first-order time constants and the method of internal amplifier signal synchronization for isotope ratio drift correction is validated. Copyright © 2015 John Wiley & Sons, Ltd.

Validation of alternative methods for toxicity testing.

PubMed Central

Bruner, L H; Carr, G J; Curren, R D; Chamberlain, M

1998-01-01

Before nonanimal toxicity tests may be officially accepted by regulatory agencies, it is generally agreed that the validity of the new methods must be demonstrated in an independent, scientifically sound validation program. Validation has been defined as the demonstration of the reliability and relevance of a test method for a particular purpose. This paper provides a brief review of the development of the theoretical aspects of the validation process and updates current thinking about objectively testing the performance of an alternative method in a validation study. Validation of alternative methods for eye irritation testing is a specific example illustrating important concepts. Although discussion focuses on the validation of alternative methods intended to replace current in vivo toxicity tests, the procedures can be used to assess the performance of alternative methods intended for other uses. Images Figure 1 PMID:9599695

Reproducibility and validity of a semi-quantitative FFQ for trace elements.

PubMed

Lee, Yujin; Park, Kyong

2016-09-01

The aim of this study was to test the reproducibility and validity of a self-administered FFQ for the Trace Element Study of Korean Adults in the Yeungnam area (SELEN). Study subjects were recruited from the SELEN cohort selected from rural and urban areas in Yeungnam, Korea. A semi-quantitative FFQ with 146 items was developed considering the dietary characteristics of cohorts in the study area. In a validation study, seventeen men and forty-eight women aged 38-62 years completed 3-d dietary records (DR) and two FFQ over a 3-month period. The validity was examined with the FFQ and DR, and the reproducibility was estimated using partial correlation coefficients, the Bland-Altman method and cross-classification. There were no significant differences between the mean intakes of selected nutrients as estimated from FFQ1, FFQ2 and DR. The median correlation coefficients for all nutrients were 0·47 and 0·56 in the reproducibility and validity tests, respectively. Bland-Altman's index and cross-classification showed acceptable agreement between FFQ1 and FFQ2 and between FFQ2 and DR. Ultimately, 78 % of the subjects were classified into the same and adjacent quartiles for most nutrients. In addition, the weighted κ value indicated that the two methods agreed fairly. In conclusion, this newly developed FFQ was a suitable dietary assessment method for the SELEN cohort study.

Reliability and validity of the adolescent health profile-types.

PubMed

Riley, A W; Forrest, C B; Starfield, B; Green, B; Kang, M; Ensminger, M

1998-08-01

The purpose of this study was to demonstrate the preliminary reliability and validity of a set 13 profiles of adolescent health that describe distinct patterns of health and health service requirements on four domains of health. Reliability and validity were tested in four ethnically diverse population samples of urban and rural youths aged 11 to 17-years-old in public schools (N = 4,066). The reliability of the classification procedure and construct validity were examined in terms of the predicted and actual distributions of age, gender, race, socioeconomic status, and family type. School achievement, medical conditions, and the proportion of youths with a psychiatric disorder also were examined as tests of construct validity. The classification method was shown to produce consistent results across the four populations in terms of proportions of youths assigned with specific sociodemographic characteristics. Variations in health described by specific profiles showed expected relations to sociodemographic characteristics, family structure, school achievement, medical disorders, and psychiatric disorders. This taxonomy of health profile-types appears to effectively describe a set of patterns that characterize adolescent health. The profile-types provide a unique and practical method for identifying subgroups having distinct needs for health services, with potential utility for health policy and planning. Such integrative reporting methods are critical for more effective utilization of health status instruments in health resource planning and policy development.

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

PubMed

MacNeil, James D

2012-08-01

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

Serbian translation of the 20-item Toronto Alexithymia Scale: psychometric properties and the new methodological approach in translating scales.

PubMed

Trajanović, Nikola N; Djurić, Vladimir; Latas, Milan; Milovanović, Srdjan; Jovanović, Aleksandar A; Djurić, Dusan

2013-01-01

Since inception of the alexithymia construct in 1970's, there has been a continuous effort to improve both its theoretical postulates and the clinical utility through development, standardization and validation of assessment scales. The aim of this study was to validate the Serbian translation of the 20-item Toronto Alexithymia Scale (TAS-20) and to propose a new method of translation of scales with a property of temporal stability. The scale was expertly translated by bilingual medical professionals and a linguist, and given to a sample of bilingual participants from the general population who completed both the English and the Serbian version of the scale one week apart. The findings showed that the Serbian version of the TAS-20 had a good internal consistency reliability regarding total scale (alpha=0.86), and acceptable reliability of the three factors (alpha=0.71-0.79). The analysis confirmed the validity and consistency of the Serbian translation of the scale, with observed weakness of the factorial structure consistent with studies in other languages. The results also showed that the method of utilizing a self-control bilingual subject is a useful alternative to the back-translation method, particularly in cases of linguistically and structurally sensitive scales, or in cases where a larger sample is not available. This method, dubbed as 'forth-translation' could be used to translate psychometric scales measuring properties which have temporal stability over the period of at least several weeks.

Direct Analysis of Low-Volatile Molecular Marker Extract from Airborne Particulate Matter Using Sensitivity Correction Method

PubMed Central

Irei, Satoshi

2016-01-01

Molecular marker analysis of environmental samples often requires time consuming preseparation steps. Here, analysis of low-volatile nonpolar molecular markers (5-6 ring polycyclic aromatic hydrocarbons or PAHs, hopanoids, and n-alkanes) without the preseparation procedure is presented. Analysis of artificial sample extracts was directly conducted by gas chromatography-mass spectrometry (GC-MS). After every sample injection, a standard mixture was also analyzed to make a correction on the variation of instrumental sensitivity caused by the unfavorable matrix contained in the extract. The method was further validated for the PAHs using the NIST standard reference materials (SRMs) and then applied to airborne particulate matter samples. Tests with the SRMs showed that overall our methodology was validated with the uncertainty of ~30%. The measurement results of airborne particulate matter (PM) filter samples showed a strong correlation between the PAHs, implying the contributions from the same emission source. Analysis of size-segregated PM filter samples showed that their size distributions were found to be in the PM smaller than 0.4 μm aerodynamic diameter. The observations were consistent with our expectation of their possible sources. Thus, the method was found to be useful for molecular marker studies. PMID:27127511

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.

Validated spectrofluorimetric method for the determination of tamsulosin in spiked human urine, pure and pharmaceutical preparations.

PubMed

Karasakal, A; Ulu, S T

2014-05-01

A novel, sensitive and selective spectrofluorimetric method was developed for the determination of tamsulosin in spiked human urine and pharmaceutical preparations. The proposed method is based on the reaction of tamsulosin with 1-dimethylaminonaphthalene-5-sulfonyl chloride in carbonate buffer pH 10.5 to yield a highly fluorescent derivative. The described method was validated and the analytical parameters of linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision, recovery and robustness were evaluated. The proposed method showed a linear dependence of the fluorescence intensity on drug concentration over the range 1.22 × 10(-7) to 7.35 × 10(-6)  M. LOD and LOQ were calculated as 1.07 × 10(-7) and 3.23 × 10(-7)  M, respectively. The proposed method was successfully applied for the determination of tamsulosin in pharmaceutical preparations and the obtained results were in good agreement with those obtained using the reference method. Copyright © 2013 John Wiley & Sons, Ltd.

Selection of regularization parameter in total variation image restoration.

PubMed

Liao, Haiyong; Li, Fang; Ng, Michael K

2009-11-01

We consider and study total variation (TV) image restoration. In the literature there are several regularization parameter selection methods for Tikhonov regularization problems (e.g., the discrepancy principle and the generalized cross-validation method). However, to our knowledge, these selection methods have not been applied to TV regularization problems. The main aim of this paper is to develop a fast TV image restoration method with an automatic selection of the regularization parameter scheme to restore blurred and noisy images. The method exploits the generalized cross-validation (GCV) technique to determine inexpensively how much regularization to use in each restoration step. By updating the regularization parameter in each iteration, the restored image can be obtained. Our experimental results for testing different kinds of noise show that the visual quality and SNRs of images restored by the proposed method is promising. We also demonstrate that the method is efficient, as it can restore images of size 256 x 256 in approximately 20 s in the MATLAB computing environment.

Quantitative analysis of γ-oryzanol content in cold pressed rice bran oil by TLC-image analysis method.

PubMed

Sakunpak, Apirak; Suksaeree, Jirapornchai; Monton, Chaowalit; Pathompak, Pathamaporn; Kraisintu, Krisana

2014-02-01

To develop and validate an image analysis method for quantitative analysis of γ-oryzanol in cold pressed rice bran oil. TLC-densitometric and TLC-image analysis methods were developed, validated, and used for quantitative analysis of γ-oryzanol in cold pressed rice bran oil. The results obtained by these two different quantification methods were compared by paired t-test. Both assays provided good linearity, accuracy, reproducibility and selectivity for determination of γ-oryzanol. The TLC-densitometric and TLC-image analysis methods provided a similar reproducibility, accuracy and selectivity for the quantitative determination of γ-oryzanol in cold pressed rice bran oil. A statistical comparison of the quantitative determinations of γ-oryzanol in samples did not show any statistically significant difference between TLC-densitometric and TLC-image analysis methods. As both methods were found to be equal, they therefore can be used for the determination of γ-oryzanol in cold pressed rice bran oil.

A mathematical definition of the financial bubbles and crashes

NASA Astrophysics Data System (ADS)

Watanabe, Kota; Takayasu, Hideki; Takayasu, Misako

2007-09-01

We check the validity of the mathematical method of detecting financial bubbles or crashes, which is based on a data fitting with an exponential function. We show that the period of a bubble can be determined nearly uniquely independent of the precision of data. The method is widely applicable for stock market data such as the Internet bubble.

Application of a Method of Estimating DIF for Polytomous Test Items.

ERIC Educational Resources Information Center

Camilli, Gregory; Congdon, Peter

1999-01-01

Demonstrates a method for studying differential item functioning (DIF) that can be used with dichotomous or polytomous items and that is valid for data that follow a partial credit Item Response Theory model. A simulation study shows that positively biased Type I error rates are in accord with results from previous studies. (SLD)

Mathematical Induction and Recursive Definition in Teaching Training

ERIC Educational Resources Information Center

Vármonostory, Endre

2009-01-01

The method of proof by mathematical induction follows from Peano axiom 5. We give three properties which are often used in the proofs by mathematical induction. We show that these are equivalent. Supposing the well-ordering property we prove the validity of this method without using Peano axiom 5. Finally, we introduce the simplest form of…

Test procedure for validation of automated distress data : project summary.

DOT National Transportation Integrated Search

2017-01-01

For distress surveys of asphalt pavements, the automated results from two vendors compared reasonably closely in ratings to the manual methods. In addition, automated ratings for jointed concrete pavement show much greater inconsistency between diffe...

Feasibility study on inverse four-dimensional dose reconstruction using the continuous dose-image of EPID

PubMed Central

Yeo, Inhwan Jason; Jung, Jae Won; Yi, Byong Yong; Kim, Jong Oh

2013-01-01

Purpose: When an intensity-modulated radiation beam is delivered to a moving target, the interplay effect between dynamic beam delivery and the target motion due to miss-synchronization can cause unpredictable dose delivery. The portal dose image in electronic portal imaging device (EPID) represents radiation attenuated and scattered through target media. Thus, it may possess information about delivered radiation to the target. Using a continuous scan (cine) mode of EPID, which provides temporal dose images related to target and beam movements, the authors’ goal is to perform four-dimensional (4D) dose reconstruction. Methods: To evaluate this hypothesis, first, the authors have derived and subsequently validated a fast method of dose reconstruction based on virtual beamlet calculations of dose responses using a test intensity-modulated beam. This method was necessary for processing a large number of EPID images pertinent for four-dimensional reconstruction. Second, cine mode acquisition after summation over all images was validated through comparison with integration mode acquisition on EPID (IAS3 and aS1000) for the test beam. This was to confirm the agreement of the cine mode with the integrated mode, specifically for the test beam, which is an accepted mode of image acquisition for dosimetry with EPID. Third, in-phantom film and exit EPID dosimetry was performed on a moving platform using the same beam. Heterogeneous as well as homogeneous phantoms were used. The cine images were temporally sorted at 10% interval. The authors have performed dose reconstruction to the in-phantom plane from the sorted cine images using the above validated method of dose reconstruction. The reconstructed dose from each cine image was summed to compose a total reconstructed dose from the test beam delivery, and was compared with film measurements. Results: The new method of dose reconstruction was validated showing greater than 95.3% pass rates of the gamma test with the criteria of dose difference of 3% and distance to agreement of 3 mm. The dose comparison of the reconstructed dose with the measured dose for the two phantoms showed pass rates higher than 96.4% given the same criteria. Conclusions: Feasibility of 4D dose reconstruction was successfully demonstrated in this study. The 4D dose reconstruction demonstrated in this study can be a promising dose validation method for radiation delivery on moving organs. PMID:23635250

Temporally diffeomorphic cardiac motion estimation from three-dimensional echocardiography by minimization of intensity consistency error.

PubMed

Zhang, Zhijun; Ashraf, Muhammad; Sahn, David J; Song, Xubo

2014-05-01

Quantitative analysis of cardiac motion is important for evaluation of heart function. Three dimensional (3D) echocardiography is among the most frequently used imaging modalities for motion estimation because it is convenient, real-time, low-cost, and nonionizing. However, motion estimation from 3D echocardiographic sequences is still a challenging problem due to low image quality and image corruption by noise and artifacts. The authors have developed a temporally diffeomorphic motion estimation approach in which the velocity field instead of the displacement field was optimized. The optimal velocity field optimizes a novel similarity function, which we call the intensity consistency error, defined as multiple consecutive frames evolving to each time point. The optimization problem is solved by using the steepest descent method. Experiments with simulated datasets, images of anex vivo rabbit phantom, images of in vivo open-chest pig hearts, and healthy human images were used to validate the authors' method. Simulated and real cardiac sequences tests showed that results in the authors' method are more accurate than other competing temporal diffeomorphic methods. Tests with sonomicrometry showed that the tracked crystal positions have good agreement with ground truth and the authors' method has higher accuracy than the temporal diffeomorphic free-form deformation (TDFFD) method. Validation with an open-access human cardiac dataset showed that the authors' method has smaller feature tracking errors than both TDFFD and frame-to-frame methods. The authors proposed a diffeomorphic motion estimation method with temporal smoothness by constraining the velocity field to have maximum local intensity consistency within multiple consecutive frames. The estimated motion using the authors' method has good temporal consistency and is more accurate than other temporally diffeomorphic motion estimation methods.

Bibliometrics for Social Validation.

PubMed

Hicks, Daniel J

2016-01-01

This paper introduces a bibliometric, citation network-based method for assessing the social validation of novel research, and applies this method to the development of high-throughput toxicology research at the US Environmental Protection Agency. Social validation refers to the acceptance of novel research methods by a relevant scientific community; it is formally independent of the technical validation of methods, and is frequently studied in history, philosophy, and social studies of science using qualitative methods. The quantitative methods introduced here find that high-throughput toxicology methods are spread throughout a large and well-connected research community, which suggests high social validation. Further assessment of social validation involving mixed qualitative and quantitative methods are discussed in the conclusion.

Bibliometrics for Social Validation

PubMed Central

2016-01-01

This paper introduces a bibliometric, citation network-based method for assessing the social validation of novel research, and applies this method to the development of high-throughput toxicology research at the US Environmental Protection Agency. Social validation refers to the acceptance of novel research methods by a relevant scientific community; it is formally independent of the technical validation of methods, and is frequently studied in history, philosophy, and social studies of science using qualitative methods. The quantitative methods introduced here find that high-throughput toxicology methods are spread throughout a large and well-connected research community, which suggests high social validation. Further assessment of social validation involving mixed qualitative and quantitative methods are discussed in the conclusion. PMID:28005974

Validity and Reliability of the Italian Version of the Functioning Assessment Short Test (FAST) in Bipolar Disorder

PubMed Central

Moro, Maria Francesca; Colom, Francesc; Floris, Francesca; Pintus, Elisa; Pintus, Mirra; Contini, Francesca; Carta, Mauro Giovanni

2012-01-01

Background: Functioning Assessment Short Test (FAST) is a brief instrument designed to assess the main functioning problems experienced by psychiatric patients, specifically bipolar patients. It includes 24 items assessing impairment or disability in six domains of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time. The aim of this study is to measure the validity and reliability of the Italian version of this instrument. Methods: Twenty-four patients with DSM-IV TR bipolar disorder and 20 healthy controls were recruited and evaluated in three private clinics in Cagliari (Sardinia, Italy). The psychometric properties of FAST (feasibility, internal consistency, concurrent validity, discriminant validity (patients vs controls and eutimic patients vs manic and depressed), and test-retest reliability were analyzed. Results: The internal consistency obtained was very high with a Cronbach's alpha of 0.955. A highly significant negative correlation with GAF was obtained (r = -0.9; p < 0.001) pointing to a reasonable degree of concurrent validity. FAST show a good test-retest reliability between two independent evaluation differing of one week (mean K =0.73). The total FAST scores were lower in controls as compared with Bipolar Patients and in Euthimic patients compared with Depressed or Manic. Conclusion: The Italian version of the FAST showed similar psychometrics properties as far as regard internal consistency and discriminant validity of the original version and show a good test retest reliability measure by means of K statistics. PMID:22905035

Development and validation of an HPLC–MS/MS method to determine clopidogrel in human plasma

PubMed Central

Liu, Gangyi; Dong, Chunxia; Shen, Weiwei; Lu, Xiaopei; Zhang, Mengqi; Gui, Yuzhou; Zhou, Qinyi; Yu, Chen

2015-01-01

A quantitative method for clopidogrel using online-SPE tandem LC–MS/MS was developed and fully validated according to the well-established FDA guidelines. The method achieves adequate sensitivity for pharmacokinetic studies, with lower limit of quantifications (LLOQs) as low as 10 pg/mL. Chromatographic separations were performed on reversed phase columns Kromasil Eternity-2.5-C18-UHPLC for both methods. Positive electrospray ionization in multiple reaction monitoring (MRM) mode was employed for signal detection and a deuterated analogue (clopidogrel-d4) was used as internal standard (IS). Adjustments in sample preparation, including introduction of an online-SPE system proved to be the most effective method to solve the analyte back-conversion in clinical samples. Pooled clinical samples (two levels) were prepared and successfully used as real-sample quality control (QC) in the validation of back-conversion testing under different conditions. The result showed that the real samples were stable in room temperature for 24 h. Linearity, precision, extraction recovery, matrix effect on spiked QC samples and stability tests on both spiked QCs and real sample QCs stored in different conditions met the acceptance criteria. This online-SPE method was successfully applied to a bioequivalence study of 75 mg single dose clopidogrel tablets in 48 healthy male subjects. PMID:26904399

Quantification of Rifaximin in Tablets by Spectrophotometric Method Ecofriendly in Ultraviolet Region

PubMed Central

2016-01-01

Rifaximin is an oral nonabsorbable antibiotic that acts locally in the gastrointestinal tract with minimal systemic adverse effects. It does not have spectrophotometric method ecofriendly in the ultraviolet region described in official compendiums and literature. The analytical techniques for determination of rifaximin reported in the literature require large amount of time to release results and are significantly onerous. Furthermore, they use toxic reagents both for the operator and environment and, therefore, cannot be considered environmentally friendly analytical techniques. The objective of this study was to develop and validate an ecofriendly spectrophotometric method in the ultraviolet region to quantify rifaximin in tablets. The method was validated, showing linearity, selectivity, precision, accuracy, and robustness. It was linear over the concentration range of 10–30 mg L−1 with correlation coefficients greater than 0.9999 and limits of detection and quantification of 1.39 and 4.22 mg L−1, respectively. The validated method is useful and applied for the routine quality control of rifaximin, since it is simple with inexpensive conditions and fast in the release of results, optimizes analysts and equipment, and uses environmentally friendly solvents, being considered a green method, which does not prejudice either the operator or the environment. PMID:27429835

Validation of a new ELISA method for in vitro potency testing of hepatitis A vaccines.

PubMed

Morgeaux, S; Variot, P; Daas, A; Costanzo, A

2013-01-01

The goal of the project was to standardise a new in vitro method in replacement of the existing standard method for the determination of hepatitis A virus antigen content in hepatitis A vaccines (HAV) marketed in Europe. This became necessary due to issues with the method used previously, requiring the use of commercial test kits. The selected candidate method, not based on commercial kits, had already been used for many years by an Official Medicines Control Laboratory (OMCL) for routine testing and batch release of HAV. After a pre-qualification phase (Phase 1) that showed the suitability of the commercially available critical ELISA reagents for the determination of antigen content in marketed HAV present on the European market, an international collaborative study (Phase 2) was carried out in order to fully validate the method. Eleven laboratories took part in the collaborative study. They performed assays with the candidate standard method and, in parallel, for comparison purposes, with their own in-house validated methods where these were available. The study demonstrated that the new assay provides a more reliable and reproducible method when compared to the existing standard method. A good correlation of the candidate standard method with the in vivo immunogenicity assay in mice was shown previously for both potent and sub-potent (stressed) vaccines. Thus, the new standard method validated during the collaborative study may be implemented readily by manufacturers and OMCLs for routine batch release but also for in-process control or consistency testing. The new method was approved in October 2012 by Group of Experts 15 of the European Pharmacopoeia (Ph. Eur.) as the standard method for in vitro potency testing of HAV. The relevant texts will be revised accordingly. Critical reagents such as coating reagent and detection antibodies have been adopted by the Ph. Eur. Commission and are available from the EDQM as Ph. Eur. Biological Reference Reagents (BRRs).

Simultaneous determination of eperisone hydrochloride and paracetamol in mouse plasma by high performance liquid chromatography-photodiode array detector.

PubMed

Locatelli, Marcello; Cifelli, Roberta; Di Legge, Cristina; Barbacane, Renato Carmine; Costa, Nicola; Fresta, Massimo; Celia, Christian; Capolupo, Carlo; Di Marzio, Luisa

2015-04-03

This paper reports the validation of a quantitative high performance liquid chromatography-photodiode array (HPLC-PDA) method for the simultaneous analysis, in mouse plasma, of eperisone hydrochloride and paracetamol by protein precipitation using zinc sulphate-methanol-acetonitrile. The analytes were resolved on a Gemini C18 column (4.6 mm × 250 mm; 5 μm particle size) using a gradient elution mode with a run time of 15 min, comprising re-equilibration, at 60°C (± 1°C). The method was validated over the concentration range from 0.5 to 25 μg/mL for eperisone hydrochloride and paracetamol, in mouse plasma. Ciprofloxacin was used as Internal Standard. Results from assay validations show that the method is selective, sensitive and robust. The limit of quantification of the method was 0.5 μg/mL for eperisone hydrochloride and paracetamol, and matrix-matched standard curves showed a good linearity, up to 25 μg/mL with correlation coefficients (r(2))≥ 0.9891. In the entire analytical range the intra and inter-day precision (RSD%) values were ≤ 1.15% and ≤ 1.46% for eperisone hydrochloride, and ≤ 0.35% and ≤ 1.65% for paracetamol. For both analytes the intra and inter-day trueness (bias%) values ranged, respectively, from -5.33% to 4.00% and from -11.4% to -4.00%. The method was successfully tested in pharmacokinetic studies after oral administration in mouse. Furthermore, the application of this method results in a significant reduction in terms of animal number, dosage, and improvement in speed, rate of analysis, and quality of pharmacokinetic parameters related to serial blood sampling. Copyright © 2015 Elsevier B.V. All rights reserved.

Rapid analysis of aminoglycoside antibiotics in bovine tissues using disposable pipette extraction and ultrahigh performance liquid chromatography-tandem mass spectrometry.

PubMed

Lehotay, Steven J; Mastovska, Katerina; Lightfield, Alan R; Nuñez, Alberto; Dutko, Terry; Ng, Chilton; Bluhm, Louis

2013-10-25

A high-throughput qualitative screening and identification method for 9 aminoglycosides of regulatory interest has been developed, validated, and implemented for bovine kidney, liver, and muscle tissues. The method involves extraction at previously validated conditions, cleanup using disposable pipette extraction, and analysis by a 3 min ultrahigh-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method. The drug analytes include neomycin, streptomycin, dihydrosptreptomycin, and spectinomycin, which have residue tolerances in bovine in the US, and kanamicin, gentamicin, apramycin, amikacin, and hygromycin, which do not have US tolerances established in bovine tissues. Tobramycin was used as an internal standard. An additional drug, paromomycin also was validated in the method, but it was dropped during implementation due to conversion of neomycin into paromomycin. Proposed fragmentation patterns for the monitored ions of each analyte were elucidated with the aid of high resolution MS using a quadrupole-time-of-flight instrument. Recoveries from spiking experiments at regulatory levels of concern showed that all analytes averaged 70-120% recoveries in all tissues, except hygromycin averaged 61% recovery. Lowest calibrated levels were as low as 0.005 μg/g in matrix extracts, which approximately corresponded to the limit of detection for screening purposes. Drug identifications at levels <0.05 μg/g were made in spiked and/or real samples for all analytes and tissues tested. Analyses of 60 samples from 20 slaughtered cattle previously screened positive for aminoglycosides showed that this method worked well in practice. The UHPLC-MS/MS method has several advantages compared to the previous microbial inhibition screening assay, especially for distinguishing individual drugs from a mixture and improving identification of gentamicin in tissue samples. Published by Elsevier B.V.

Validating e-learning in continuing pharmacy education: user acceptance and knowledge change

PubMed Central

2014-01-01

Background Continuing pharmacy education is becoming mandatory in most countries in order to keep the professional license valid. Increasing number of pharmacists are now using e-learning as part of their continuing education. Consequently, the increasing popularity of this method of education calls for standardization and validation practices. The conducted research explored validation aspects of e-learning in terms of knowledge increase and user acceptance. Methods Two e-courses were conducted as e-based continuing pharmacy education for graduated pharmacists. Knowledge increase and user acceptance were the two outcome measured. The change of knowledge in the first e-course was measured by a pre- and post-test and results analysed by the Wilcoxon signed–rank test. The acceptance of e-learning in the second e-course was investigated by a questionnaire and the results analysed using descriptive statistics. Results Results showed that knowledge increased significantly (p < 0.001) by 16 pp after participation in the first e-course. Among the participants who responded to the survey in the second course, 92% stated that e-courses were effective and 91% stated that they enjoyed the course. Conclusions The study shows that e-learning is a viable medium of conducting continuing pharmacy education; e-learning is effective in increasing knowledge and highly accepted by pharmacists from various working environments such as community and hospital pharmacies, faculties of pharmacy or wholesales. PMID:24528547

Validating Analytical Protocols to Determine Selected Pesticides and PCBs Using Routine Samples.

PubMed

Pindado Jiménez, Oscar; García Alonso, Susana; Pérez Pastor, Rosa María

2017-01-01

This study aims at providing recommendations concerning the validation of analytical protocols by using routine samples. It is intended to provide a case-study on how to validate the analytical methods in different environmental matrices. In order to analyze the selected compounds (pesticides and polychlorinated biphenyls) in two different environmental matrices, the current work has performed and validated two analytical procedures by GC-MS. A description is given of the validation of the two protocols by the analysis of more than 30 samples of water and sediments collected along nine months. The present work also scopes the uncertainty associated with both analytical protocols. In detail, uncertainty of water sample was performed through a conventional approach. However, for the sediments matrices, the estimation of proportional/constant bias is also included due to its inhomogeneity. Results for the sediment matrix are reliable, showing a range 25-35% of analytical variability associated with intermediate conditions. The analytical methodology for the water matrix determines the selected compounds with acceptable recoveries and the combined uncertainty ranges between 20 and 30%. Analyzing routine samples is rarely applied to assess trueness of novel analytical methods and up to now this methodology was not focused on organochlorine compounds in environmental matrices.

Degrees of separation as a statistical tool for evaluating candidate genes.

PubMed

Nelson, Ronald M; Pettersson, Mats E

2014-12-01

Selection of candidate genes is an important step in the exploration of complex genetic architecture. The number of gene networks available is increasing and these can provide information to help with candidate gene selection. It is currently common to use the degree of connectedness in gene networks as validation in Genome Wide Association (GWA) and Quantitative Trait Locus (QTL) mapping studies. However, it can cause misleading results if not validated properly. Here we present a method and tool for validating the gene pairs from GWA studies given the context of the network they co-occur in. It ensures that proposed interactions and gene associations are not statistical artefacts inherent to the specific gene network architecture. The CandidateBacon package provides an easy and efficient method to calculate the average degree of separation (DoS) between pairs of genes to currently available gene networks. We show how these empirical estimates of average connectedness are used to validate candidate gene pairs. Validation of interacting genes by comparing their connectedness with the average connectedness in the gene network will provide support for said interactions by utilising the growing amount of gene network information available. Copyright © 2014 Elsevier Ltd. All rights reserved.

Considerations regarding the validation of chromatographic mass spectrometric methods for the quantification of endogenous substances in forensics.

PubMed

Hess, Cornelius; Sydow, Konrad; Kueting, Theresa; Kraemer, Michael; Maas, Alexandra

2018-02-01

The requirement for correct evaluation of forensic toxicological results in daily routine work and scientific studies is reliable analytical data based on validated methods. Validation of a method gives the analyst tools to estimate the efficacy and reliability of the analytical method. Without validation, data might be contested in court and lead to unjustified legal consequences for a defendant. Therefore, new analytical methods to be used in forensic toxicology require careful method development and validation of the final method. Until now, there are no publications on the validation of chromatographic mass spectrometric methods for the detection of endogenous substances although endogenous analytes can be important in Forensic Toxicology (alcohol consumption marker, congener alcohols, gamma hydroxy butyric acid, human insulin and C-peptide, creatinine, postmortal clinical parameters). For these analytes, conventional validation instructions cannot be followed completely. In this paper, important practical considerations in analytical method validation for endogenous substances will be discussed which may be used as guidance for scientists wishing to develop and validate analytical methods for analytes produced naturally in the human body. Especially the validation parameters calibration model, analytical limits, accuracy (bias and precision) and matrix effects and recovery have to be approached differently. Highest attention should be paid to selectivity experiments. Copyright © 2017 Elsevier B.V. All rights reserved.

Tropical Tropospheric Ozone (TTO) Maps from Nimbus 7 and Earth-Probe TOMS by the Modified-Residual Method. 1; Validation, Evaluation and Trends based on Atlantic Regional Time Series

NASA Technical Reports Server (NTRS)

Thompson, Anne M.; Hudson, Robert D.

1998-01-01

The well-known wave-one pattern seen in tropical total ozone [Shiotani, 1992; Ziemke et al., 1996, 1998] has been used to develop a modified-residual (MR) method for retrieving time-averaged stratospheric ozone and tropospheric ozone column amount from TOMS (Total Ozone Mapping Spectrometer) over the 14 complete calendar years of Nimbus 7 observations (1979-1992) and from TOMS on the Earth-Probe (1996-present) and ADEOS platforms (1996- 1997). Nine- to sixteen-day averaged tropical tropospheric ozone (TTO) maps, validated with ozonesondes, show a seasonality expected from dynamical and chemical influences. The maps may be viewed on a homepage: http://metosrv2.umd.edu/tropo. Stratospheric column ozone, which is also derived by the modified-residual method, compares well with sondes (to within 6-7 DU) and with stratospheric ozone column derived from other satellites (within 8-10 DU). Validation of the TTO time-series is presently limited to ozonesonde comparisons with Atlantic stations and sites on the adjacent continents (Ascension Island, Natal, Brazil; Brazzaville); for the sounding periods, TTO at all locations agrees with the sonde record to +/-7 DU. TTO time-series and the magnitude of the wave-one pattern show ENSO signals in the strongest El Nifio periods from 1979-1998. From 12degN and 12degS, zonally averaged tropospheric ozone shows no significant trend from 1980-1990. Trends are also not significant during this period in localized regions, e.g. from just west of South America across to southern Africa. This is consistent with the ozonesonde record at Natal, Brazil (the only tropical ozone data publicly available for the 1980's), which shows a not statistically significant increase. The lack of trend in tropospheric ozone agrees with a statistical analysis based on another method for deriving TTO from TOMS, the so-called Convective-Cloud-Differential approach of Ziemke et al. [1998].

Validation of Regression-Based Myogenic Correction Techniques for Scalp and Source-Localized EEG

PubMed Central

McMenamin, Brenton W.; Shackman, Alexander J.; Maxwell, Jeffrey S.; Greischar, Lawrence L.; Davidson, Richard J.

2008-01-01

EEG and EEG source-estimation are susceptible to electromyographic artifacts (EMG) generated by the cranial muscles. EMG can mask genuine effects or masquerade as a legitimate effect - even in low frequencies, such as alpha (8–13Hz). Although regression-based correction has been used previously, only cursory attempts at validation exist and the utility for source-localized data is unknown. To address this, EEG was recorded from 17 participants while neurogenic and myogenic activity were factorially varied. We assessed the sensitivity and specificity of four regression-based techniques: between-subjects, between-subjects using difference-scores, within-subjects condition-wise, and within-subject epoch-wise on the scalp and in data modeled using the LORETA algorithm. Although within-subject epoch-wise showed superior performance on the scalp, no technique succeeded in the source-space. Aside from validating the novel epoch-wise methods on the scalp, we highlight methods requiring further development. PMID:19298626

A closer look at cross-validation for assessing the accuracy of gene regulatory networks and models.

PubMed

Tabe-Bordbar, Shayan; Emad, Amin; Zhao, Sihai Dave; Sinha, Saurabh

2018-04-26

Cross-validation (CV) is a technique to assess the generalizability of a model to unseen data. This technique relies on assumptions that may not be satisfied when studying genomics datasets. For example, random CV (RCV) assumes that a randomly selected set of samples, the test set, well represents unseen data. This assumption doesn't hold true where samples are obtained from different experimental conditions, and the goal is to learn regulatory relationships among the genes that generalize beyond the observed conditions. In this study, we investigated how the CV procedure affects the assessment of supervised learning methods used to learn gene regulatory networks (or in other applications). We compared the performance of a regression-based method for gene expression prediction estimated using RCV with that estimated using a clustering-based CV (CCV) procedure. Our analysis illustrates that RCV can produce over-optimistic estimates of the model's generalizability compared to CCV. Next, we defined the 'distinctness' of test set from training set and showed that this measure is predictive of performance of the regression method. Finally, we introduced a simulated annealing method to construct partitions with gradually increasing distinctness and showed that performance of different gene expression prediction methods can be better evaluated using this method.

Physiotherapy for patients with soft tissue shoulder disorders: a systematic review of randomised clinical trials.

PubMed Central

van der Heijden, G. J.; van der Windt, D. A.; de Winter, A. F.

1997-01-01

OBJECTIVE: To assess the effectiveness of physiotherapy for patients with soft tissue shoulder disorders. DESIGN: A systematic computerised literature search of Medline and Embase, supplemented with citation tracking, for relevant trials with random allocation published before 1996. SUBJECTS: Patients treated with physiotherapy for disorders of soft tissue of the shoulder. MAIN OUTCOME MEASURES: Success rates, mobility, pain, functional status. RESULTS: Six of the 20 assessed trials satisfied at least five of eight validity criteria. Assessment of methods was often hampered by insufficient information on various validity criteria, and trials were often flawed by lack of blinding, high proportions of withdrawals from treatment, and high proportions of missing values. Trial sizes were small: only six trials included intervention groups of more than 25 patients. Ultrasound therapy, evaluated in six trials, was not shown to be effective. Four other trials favoured physiotherapy (laser therapy or manipulation), but the validity of their methods was unsatisfactory. CONCLUSIONS: There is evidence that ultrasound therapy is ineffective in the treatment of soft tissue shoulder disorders. Due to small trial sizes and unsatisfactory methods, evidence for the effectiveness of other methods of physiotherapy is inconclusive. For all methods of treatment, trials were too heterogeneous with respect to included patients, index and reference treatments, and follow up to merit valid statistical pooling. Future studies should show whether physiotherapy is superior to treatment with drugs, steroid injections, or a wait and see policy. PMID:9233322

Characterization of nine polyphenols in fruits of Malus pumila Mill by high-performance liquid chromatography.

PubMed

Bai, Lu; Guo, Sen; Liu, Qingchao; Cui, Xueqin; Zhang, Xinxin; Zhang, Li; Yang, Xinwen; Hou, Manwei; Ho, Chi-Tang; Bai, Naisheng

2016-04-01

Polyphenols are important bioactive substances in apple. To explore the profiles of the nine representative polyphenols in this fruit, a high-performance liquid chromatography method has been established and validated. The validated method was successfully applied for the simultaneous characterization and quantification of these nine apple polyphenols in 11 apple extracts, which were obtained from six cultivars from Shaanxi Province, China. The results showed that only abscission of the Fuji apple sample was rich in the nine apple polyphenols, and the polyphenol contents of other samples varied. Although all the samples were collected in the same region, the contents of nine polyphenols were different. The proposed method could serve as a prerequisite for quality control of Malus products. Copyright © 2015. Published by Elsevier B.V.

Thermodynamics of Gas Turbine Cycles with Analytic Derivatives in OpenMDAO

NASA Technical Reports Server (NTRS)

Gray, Justin; Chin, Jeffrey; Hearn, Tristan; Hendricks, Eric; Lavelle, Thomas; Martins, Joaquim R. R. A.

2016-01-01

A new equilibrium thermodynamics analysis tool was built based on the CEA method using the OpenMDAO framework. The new tool provides forward and adjoint analytic derivatives for use with gradient based optimization algorithms. The new tool was validated against the original CEA code to ensure an accurate analysis and the analytic derivatives were validated against finite-difference approximations. Performance comparisons between analytic and finite difference methods showed a significant speed advantage for the analytic methods. To further test the new analysis tool, a sample optimization was performed to find the optimal air-fuel equivalence ratio, , maximizing combustion temperature for a range of different pressures. Collectively, the results demonstrate the viability of the new tool to serve as the thermodynamic backbone for future work on a full propulsion modeling tool.

High-throughput method for the quantitation of metabolites and co-factors from homocysteine-methionine cycle for nutritional status assessment.

PubMed

Da Silva, Laeticia; Collino, Sebastiano; Cominetti, Ornella; Martin, Francois-Pierre; Montoliu, Ivan; Moreno, Sergio Oller; Corthesy, John; Kaput, Jim; Kussmann, Martin; Monteiro, Jacqueline Pontes; Guiraud, Seu Ping

2016-09-01

There is increasing interest in the profiling and quantitation of methionine pathway metabolites for health management research. Currently, several analytical approaches are required to cover metabolites and co-factors. We report the development and the validation of a method for the simultaneous detection and quantitation of 13 metabolites in red blood cells. The method, validated in a cohort of healthy human volunteers, shows a high level of accuracy and reproducibility. This high-throughput protocol provides a robust coverage of central metabolites and co-factors in one single analysis and in a high-throughput fashion. In large-scale clinical settings, the use of such an approach will significantly advance the field of nutritional research in health and disease.

Development and validation of a sensitive and fast UPLC-MS/MS method for simultaneous determination of seven bioactive compounds in rat plasma after oral administration of Guizhi-gancao decoction.

PubMed

Ji, Bin; Zhuo, Limeng; Yang, Bin; Wang, Yang; Li, Lin; Yu, Miao; Zhao, Yunli; Yu, Zhiguo

2017-04-15

Rapid, sensitive, selective and accurate UPLC-MS/MS method was developed and fully validated for simultaneous determination of cinnamaldehyde, cinnamic acid, 2-methoxy cinnamic acid, glycyrrhizic acid, glycyrrhetinic acid, liquiritigenin and isoliquiritin in rat plasma after oral administration of Guizhi-gancao decoction. Plasma samples were processed with a simple protein precipitation technique using acetonitrile, followed by chromatographic separation using a Thermo Hypersil GOLD C 18 column. A 11.0min linear gradient elution was used at a flow rate of 0.2mL/min with a mobile phase of 0.1% acetic acid containing 0.2mM ammonium acetate in water and acetonitrile. The analytes and internal standard, schisandrin, were detected using both positive and negative ion electrospray ionization in multiple reaction monitoring mode. The developed method was validated for intra-day and inter-day accuracy and precision whose values fell in the acceptable limits. Matrix effect was found to be minimal. Recovery efficiency of all the analytes was found to be >60%. Stability results showed that the analytes were stable at all the conditions. This validated method was successfully used to study the pharmacokinetics of multiple compounds in rat plasma after oral administration of Guizhi-gancao decoction. Copyright © 2017 Elsevier B.V. All rights reserved.

Comparison of scoring approaches for the NEI VFQ-25 in low vision.

PubMed

Dougherty, Bradley E; Bullimore, Mark A

2010-08-01

The aim of this study was to evaluate different approaches to scoring the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) in patients with low vision including scoring by the standard method, by Rasch analysis, and by use of an algorithm created by Massof to approximate Rasch person measure. Subscale validity and use of a 7-item short form instrument proposed by Ryan et al. were also investigated. NEI VFQ-25 data from 50 patients with low vision were analyzed using the standard method of summing Likert-type scores and calculating an overall average, Rasch analysis using Winsteps software, and the Massof algorithm in Excel. Correlations between scores were calculated. Rasch person separation reliability and other indicators were calculated to determine the validity of the subscales and of the 7-item instrument. Scores calculated using all three methods were highly correlated, but evidence of floor and ceiling effects was found with the standard scoring method. None of the subscales investigated proved valid. The 7-item instrument showed acceptable person separation reliability and good targeting and item performance. Although standard scores and Rasch scores are highly correlated, Rasch analysis has the advantages of eliminating floor and ceiling effects and producing interval-scaled data. The Massof algorithm for approximation of the Rasch person measure performed well in this group of low-vision patients. The validity of the subscales VFQ-25 should be reconsidered.

Development and Validation of a Questionnaire on Breastfeeding Intentions, Attitudes and Knowledge of a Sample of Croatian Secondary-School Students

PubMed Central

Marković, Martina; Grgurić, Josip

2018-01-01

Background: Validating a questionnaire/instrument before proceeding to the field for data collection is important. Methods: An 18-item breastfeeding intention, 39-item attitude and 44-item knowledge questionnaire was validated in a Croatian sample of secondary-school students (N = 277). Results: For the intentions, principal component analysis (PCA) yielded a four-factor solution with 8 items explaining 68.3% of the total variance. Cronbach’s alpha (0.71) indicated satisfactory internal consistency. For the attitudes, PCA showed a seven-factor structure with 33 items explaining 58.41% of total variance. Cronbach’s alpha (0.87) indicated good internal consistency. There were 13 knowledge questions that were retained after item analysis, showing good internal consistency (KR20 = 0.83). In terms of criterion validity, the questionnaire differentiated between students who received breastfeeding education compared to students who were not educated in breastfeeding. Correlations between intentions and attitudes (r = 0.49), intentions and knowledge (r = 0.29), and attitudes and knowledge (r = 0.38) confirmed concurrent validity. Conclusions: The final instrument is reliable and valid for data collection on breastfeeding. Therefore, the instrument is recommended for evaluation of breastfeeding education programs aimed at upper-grade elementary and secondary school students. PMID:29702616

Validation to Portuguese of the Scale of Student Satisfaction and Self-Confidence in Learning1

PubMed Central

Almeida, Rodrigo Guimarães dos Santos; Mazzo, Alessandra; Martins, José Carlos Amado; Baptista, Rui Carlos Negrão; Girão, Fernanda Berchelli; Mendes, Isabel Amélia Costa

2015-01-01

Objective: translate and validate to Portuguese the Scale of Student Satisfaction and Self-Confidence in Learning. Material and Methods: methodological translation and validation study of a research tool. After following all steps of the translation process, for the validation process, the event III Workshop Brazil - Portugal: Care Delivery to Critical Patients was created, promoted by one Brazilian and another Portuguese teaching institution. Results: 103 nurses participated. As to the validity and reliability of the scale, the correlation pattern between the variables, the sampling adequacy test (Kaiser-Meyer-Olkin) and the sphericity test (Bartlett) showed good results. In the exploratory factorial analysis (Varimax), item 9 behaved better in factor 1 (Satisfaction) than in factor 2 (Self-confidence in learning). The internal consistency (Cronbach's alpha) showed coefficients of 0.86 in factor 1 with six items and 0.77 for factor 2 with 07 items. Conclusion: in Portuguese this tool was called: Escala de Satisfação de Estudantes e Autoconfiança na Aprendizagem. The results found good psychometric properties and a good potential use. The sampling size and specificity are limitations of this study, but future studies will contribute to consolidate the validity of the scale and strengthen its potential use. PMID:26625990

Validation of a Measure of Family Resilience among Iraq and Afghanistan Veterans.

PubMed

Finley, Erin P; Pugh, Mary Jo; Palmer, Raymond F

2016-01-01

Although interactions within veterans' families may support or inhibit resilient coping to stress and trauma across the deployment cycle, research on family resilience has been hampered by the lack of a brief assessment. Using a three-stage mixed-method study, we developed and conducted preliminary validation of a measure of family resilience tailored for Iraq and Afghanistan veterans (IAV), the Family Resilience Scale for Veterans (FRS-V) , which was field-tested using a survey of 151 IAV. Our findings indicate the resulting 6-item measure shows strong initial reliability and validity and support the application of existing models of family resilience in this population.

Validation of a Measure of Family Resilience among Iraq and Afghanistan Veterans

PubMed Central

Finley, Erin P.; Pugh, Mary Jo; Palmer, Raymond F.

2016-01-01

Although interactions within veterans’ families may support or inhibit resilient coping to stress and trauma across the deployment cycle, research on family resilience has been hampered by the lack of a brief assessment. Using a three-stage mixed-method study, we developed and conducted preliminary validation of a measure of family resilience tailored for Iraq and Afghanistan veterans (IAV), the Family Resilience Scale for Veterans (FRS-V), which was field-tested using a survey of 151 IAV. Our findings indicate the resulting 6-item measure shows strong initial reliability and validity and support the application of existing models of family resilience in this population. PMID:28168094

Why Does a Method That Fails Continue To Be Used: The Answer

PubMed Central

Templeton, Alan R.

2009-01-01

It has been claimed that hundreds of researchers use nested clade phylogeographic analysis (NCPA) based on what the method promises rather than requiring objective validation of the method. The supposed failure of NCPA is based upon the argument that validating it by using positive controls ignored type I error, and that computer simulations have shown a high type I error. The first argument is factually incorrect: the previously published validation analysis fully accounted for both type I and type II errors. The simulations that indicate a 75% type I error rate have serious flaws and only evaluate outdated versions of NCPA. These outdated type I error rates fall precipitously when the 2003 version of single locus NCPA is used or when the 2002 multi-locus version of NCPA is used. It is shown that the treewise type I errors in single-locus NCPA can be corrected to the desired nominal level by a simple statistical procedure, and that multilocus NCPA reconstructs a simulated scenario used to discredit NCPA with 100% accuracy. Hence, NCPA is a not a failed method at all, but rather has been validated both by actual data and by simulated data in a manner that satisfies the published criteria given by its critics. The critics have come to different conclusions because they have focused on the pre-2002 versions of NCPA and have failed to take into account the extensive developments in NCPA since 2002. Hence, researchers can choose to use NCPA based upon objective critical validation that shows that NCPA delivers what it promises. PMID:19335340

78 FR 56718 - Draft Guidance for Industry on Bioanalytical Method Validation; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-13

...] Draft Guidance for Industry on Bioanalytical Method Validation; Availability AGENCY: Food and Drug... availability of a draft guidance for industry entitled ``Bioanalytical Method Validation.'' The draft guidance is intended to provide recommendations regarding analytical method development and validation for the...

Probability machines: consistent probability estimation using nonparametric learning machines.

PubMed

Malley, J D; Kruppa, J; Dasgupta, A; Malley, K G; Ziegler, A

2012-01-01

Most machine learning approaches only provide a classification for binary responses. However, probabilities are required for risk estimation using individual patient characteristics. It has been shown recently that every statistical learning machine known to be consistent for a nonparametric regression problem is a probability machine that is provably consistent for this estimation problem. The aim of this paper is to show how random forests and nearest neighbors can be used for consistent estimation of individual probabilities. Two random forest algorithms and two nearest neighbor algorithms are described in detail for estimation of individual probabilities. We discuss the consistency of random forests, nearest neighbors and other learning machines in detail. We conduct a simulation study to illustrate the validity of the methods. We exemplify the algorithms by analyzing two well-known data sets on the diagnosis of appendicitis and the diagnosis of diabetes in Pima Indians. Simulations demonstrate the validity of the method. With the real data application, we show the accuracy and practicality of this approach. We provide sample code from R packages in which the probability estimation is already available. This means that all calculations can be performed using existing software. Random forest algorithms as well as nearest neighbor approaches are valid machine learning methods for estimating individual probabilities for binary responses. Freely available implementations are available in R and may be used for applications.

Nifedipine-loaded polymeric nanocapsules: validation of a stability-indicating HPLC method to evaluate the drug entrapment efficiency and in vitro release profiles.

PubMed

Granada, Andréa; Tagliari, Monika Piazzon; Soldi, Valdir; Silva, Marcos António Segatto; Zanetti-Ramos, Betina Ghiel; Fernandes, Daniel; Stulzer, Hellen Karine

2013-01-01

A simple stability-indicating analytical method was developed and validated to quantify nifedipine in polymeric nanocapsule suspensions; an in vitro drug release study was then carried out. The analysis was performed using an RP C18 column, UV-Vis detection at 262 nm, and methanol-water (70 + 30, v/v) mobile phase at a flow rate of 1.2 mL/min. The method was validated in terms of specificity, linearity and range, LOQ, accuracy, precision, and robustness. The results obtained were within the acceptable ranges. The nanocapsules, made of poly(epsilon-caprolactone), were prepared by the solvent displacement technique and showed high entrapment efficiency. The entrapment efficiency was 97.6 and 98.2% for the nifedipine-loaded polymeric nanocapsules prepared from polyvinyl alcohol (PVA) and Pluronic F68 (PF68), respectively. The particle size and zeta potential of nanocapsules were found to be influenced by the nature of the stabilizer used. The mean diameter and zeta potential for nanocapsules with PVA and PF68 were 290.9 and 179.9 nm, and -17.7 mV and -32.7 mV, respectively. The two formulations prepared showed a drug release of up to 70% over 4 days. This behavior indicates the viability of this drug delivery system for use as a controlled-release system.

Quantitative analysis of boeravinones in the roots of Boerhaavia Diffusa by UPLC/PDA.

PubMed

Bairwa, Khemraj; Srivastava, Amit; Jachak, Sanjay Madhukar

2014-01-01

Boerhaavia diffusa is a perennial herb belonging to Nyctaginaceae. Various classes of chemical constituents such as phenolics (boeravinones), terpenoids and organic acids have been reported in B. diffusa roots. As boeravinones have been proposed as putative active constituents for the anti-cancer, spasmolytic and anti-inflammatory activities exhibited by B. diffusa extracts, it is worthwhile developing and validating an ultra-performance liquid chromatography (UPLC) method for analysis of boeravinones in B. diffusa roots. To develop and validate a simple, accurate, robust and rapid UPLC analytical method for quality control of B. diffusa roots. Samples for analysis were prepared by refluxing powdered root material with methanol for 2 h. The extracts were concentrated, dried and stored at -20°C until their use. A UPLC with photodiode array (PDA) method was developed and validated for the quantification of boeravinones in the roots of B. diffusa. The separation of boeravinones was achieved using a BEH Shield C18 -column (2.1 × 100 mm, 1.7 µm) with gradient elution of methanol and water (0.1% acetic acid), at a flow rate of 0.4 mL/min and detection was carried out at λmax 273 nm. The UPLC method developed showed good linearity (r(2)  ≥ 0.9999), accuracy and precision. The UPLC method developed provided a selective, sensitive and rapid analytical method for the quantification of boeravinones in B. diffusa roots. All the validation parameters were found to be within the permissible limits as per International Conference on Harmonisation guidelines. Copyright © 2014 John Wiley & Sons, Ltd.

Development and Psychometric Validation of HIPER-Q to Assess Knowledge of Hypertensive Patients in Cardiac Rehabilitation.

PubMed

Santos, Rafaella Zulianello Dos; Bonin, Christiani Decker Batista; Martins, Eliara Ten Caten; Pereira Junior, Moacir; Ghisi, Gabriela Lima de Melo; Macedo, Kassia Rosangela Paz de; Benetti, Magnus

2018-01-01

The absence of instruments capable of measuring the level of knowledge of hypertensive patients in cardiac rehabilitation programs about their disease reflects the lack of specific recommendations for these patients. To develop and validate a questionnaire to evaluate the knowledge of hypertensive patients in cardiac rehabilitation programs about their disease. A total of 184 hypertensive patients (mean age 60.5 ± 10 years, 66.8% men) were evaluated. Reproducibility was assessed by calculation of the intraclass correlation coefficient using the test-retest method. Internal consistency was assessed by the Cronbach's alpha and the construct validity by the exploratory factorial analysis. The final version of the instrument had 17 questions organized in areas considered important for patient education. The instrument proposed showed a clarity index of 8.7 (0.25). The intraclass correlation coefficient was 0.804 and the Cronbach's correlation coefficient was 0.648. Factor analysis revealed five factors associated with knowledge areas. Regarding the criterion validity, patients with higher education level and higher family income showed greater knowledge about hypertension. The instrument has a satisfactory clarity index and adequate validity, and can be used to evaluate the knowledge of hypertensive participants in cardiac rehabilitation programs.

Validation of a Monte Carlo code system for grid evaluation with interference effect on Rayleigh scattering

NASA Astrophysics Data System (ADS)

Zhou, Abel; White, Graeme L.; Davidson, Rob

2018-02-01

Anti-scatter grids are commonly used in x-ray imaging systems to reduce scatter radiation reaching the image receptor. Anti-scatter grid performance and validation can be simulated through use of Monte Carlo (MC) methods. Our recently reported work has modified existing MC codes resulting in improved performance when simulating x-ray imaging. The aim of this work is to validate the transmission of x-ray photons in grids from the recently reported new MC codes against experimental results and results previously reported in other literature. The results of this work show that the scatter-to-primary ratio (SPR), the transmissions of primary (T p), scatter (T s), and total (T t) radiation determined using this new MC code system have strong agreement with the experimental results and the results reported in the literature. T p, T s, T t, and SPR determined in this new MC simulation code system are valid. These results also show that the interference effect on Rayleigh scattering should not be neglected in both mammographic and general grids’ evaluation. Our new MC simulation code system has been shown to be valid and can be used for analysing and evaluating the designs of grids.

Development and Validation of a Job Exposure Matrix for Physical Risk Factors in Low Back Pain

PubMed Central

Solovieva, Svetlana; Pehkonen, Irmeli; Kausto, Johanna; Miranda, Helena; Shiri, Rahman; Kauppinen, Timo; Heliövaara, Markku; Burdorf, Alex; Husgafvel-Pursiainen, Kirsti; Viikari-Juntura, Eira

2012-01-01

Objectives The aim was to construct and validate a gender-specific job exposure matrix (JEM) for physical exposures to be used in epidemiological studies of low back pain (LBP). Materials and Methods We utilized two large Finnish population surveys, one to construct the JEM and another to test matrix validity. The exposure axis of the matrix included exposures relevant to LBP (heavy physical work, heavy lifting, awkward trunk posture and whole body vibration) and exposures that increase the biomechanical load on the low back (arm elevation) or those that in combination with other known risk factors could be related to LBP (kneeling or squatting). Job titles with similar work tasks and exposures were grouped. Exposure information was based on face-to-face interviews. Validity of the matrix was explored by comparing the JEM (group-based) binary measures with individual-based measures. The predictive validity of the matrix against LBP was evaluated by comparing the associations of the group-based (JEM) exposures with those of individual-based exposures. Results The matrix includes 348 job titles, representing 81% of all Finnish job titles in the early 2000s. The specificity of the constructed matrix was good, especially in women. The validity measured with kappa-statistic ranged from good to poor, being fair for most exposures. In men, all group-based (JEM) exposures were statistically significantly associated with one-month prevalence of LBP. In women, four out of six group-based exposures showed an association with LBP. Conclusions The gender-specific JEM for physical exposures showed relatively high specificity without compromising sensitivity. The matrix can therefore be considered as a valid instrument for exposure assessment in large-scale epidemiological studies, when more precise but more labour-intensive methods are not feasible. Although the matrix was based on Finnish data we foresee that it could be applicable, with some modifications, in other countries with a similar level of technology. PMID:23152793

Examining Factor Structure and Validating the Persian Version of the Pregnancy's Worries and Stress Questionnaire for Pregnant Iranian Women.

PubMed

Navidpour, Fariba; Dolatian, Mahrokh; Yaghmaei, Farideh; Majd, Hamid Alavi; Hashemi, Seyed Saeed

2015-04-23

Pregnant women tend to experience anxiety and stress when faced with the changes to their biology, environment and personal relationships. The identification of these factors and the prevention of their side effects are vital for both mother and fetus. The present study was conducted to validate and to examine the factor structure of the Persian version of the Pregnancy's Worries and Stress Questionnaire. The 25-item PWSQ was first translated by specialists into Persian. The questionnaire's validity was determined using face, content, criterion and construct validity and reliability of questionnaire was examined using Cronbach's alpha. Confirmatory factor analysis was performed in AMOS and SPSS 21. Participants included healthy Iranian pregnant women (8-39 weeks) who refer to selected hospitals for prenatal care. Hospitals included private, social security and university hospitals and selected through the random cluster sampling method. The results of validity and reliability assessments of the questionnaire were acceptable. Cronbach's alpha calculated showed a high internal consistency of 0.89. The confirmatory factor analysis using the c2, CMIN/DF, IFI, CFI, NFI and NNFI indexes showed the 6-factor model to be the best fitted model for explaining the data. The questionnaire was translated into Persian to examine stress and worry specific to Iranian pregnant women. The psychometric results showed that the questionnaire is suitable for identifying Iranian pregnant women with pregnancy-related stress.

[Reliability and validity of the Chinese version on Comprehensive Scores for Financial Toxicity based on the patient-reported outcome measures].

PubMed

Yu, H H; Bi, X; Liu, Y Y

2017-08-10

Objective: To evaluate the reliability and validity of the Chinese version on comprehensive scores for financial toxicity (COST), based on the patient-reported outcome measures. Methods: A total of 118 cancer patients were face-to-face interviewed by well-trained investigators. Cronbach's α and Pearson correlation coefficient were used to evaluate reliability. Content validity index (CVI) and exploratory factor analysis (EFA) were used to evaluate the content validity and construct validity, respectively. Results: The Cronbach's α coefficient appeared as 0.889 for the whole questionnaire, with the results of test-retest were between 0.77 and 0.98. Scale-content validity index (S-CVI) appeared as 0.82, with item-content validity index (I-CVI) between 0.83 and 1.00. Two components were extracted from the Exploratory factor analysis, with cumulative rate as 68.04% and loading>0.60 on every item. Conclusion: The Chinese version of COST scale showed high reliability and good validity, thus can be applied to assess the financial situation in cancer patients.

Student mathematical imagination instruments: construction, cultural adaptation and validity

NASA Astrophysics Data System (ADS)

Dwijayanti, I.; Budayasa, I. K.; Siswono, T. Y. E.

2018-03-01

Imagination has an important role as the center of sensorimotor activity of the students. The purpose of this research is to construct the instrument of students’ mathematical imagination in understanding concept of algebraic expression. The researcher performs validity using questionnaire and test technique and data analysis using descriptive method. Stages performed include: 1) the construction of the embodiment of the imagination; 2) determine the learning style questionnaire; 3) construct instruments; 4) translate to Indonesian as well as adaptation of learning style questionnaire content to student culture; 5) perform content validation. The results stated that the constructed instrument is valid by content validation and empirical validation so that it can be used with revisions. Content validation involves Indonesian linguists, english linguists and mathematics material experts. Empirical validation is done through a legibility test (10 students) and shows that in general the language used can be understood. In addition, a questionnaire test (86 students) was analyzed using a biserial point correlation technique resulting in 16 valid items with a reliability test using KR 20 with medium reability criteria. While the test instrument test (32 students) to find all items are valid and reliability test using KR 21 with reability is 0,62.

Noninvasive and fast measurement of blood glucose in vivo by near infrared (NIR) spectroscopy

NASA Astrophysics Data System (ADS)

Jintao, Xue; Liming, Ye; Yufei, Liu; Chunyan, Li; Han, Chen

2017-05-01

This research was to develop a method for noninvasive and fast blood glucose assay in vivo. Near-infrared (NIR) spectroscopy, a more promising technique compared to other methods, was investigated in rats with diabetes and normal rats. Calibration models are generated by two different multivariate strategies: partial least squares (PLS) as linear regression method and artificial neural networks (ANN) as non-linear regression method. The PLS model was optimized individually by considering spectral range, spectral pretreatment methods and number of model factors, while the ANN model was studied individually by selecting spectral pretreatment methods, parameters of network topology, number of hidden neurons, and times of epoch. The results of the validation showed the two models were robust, accurate and repeatable. Compared to the ANN model, the performance of the PLS model was much better, with lower root mean square error of validation (RMSEP) of 0.419 and higher correlation coefficients (R) of 96.22%.

Sampling Frequency Optimisation and Nonlinear Distortion Mitigation in Subsampling Receiver

NASA Astrophysics Data System (ADS)

Castanheira, Pedro Xavier Melo Fernandes

Subsampling receivers utilise the subsampling method to down convert signals from radio frequency (RF) to a lower frequency location. Multiple signals can also be down converted using the subsampling receiver, but using the incorrect subsampling frequency could result in signals aliasing one another after down conversion. The existing method for subsampling multiband signals focused on down converting all the signals without any aliasing between the signals. The case considered initially was a dual band signal, and then it was further extended to a more general multiband case. In this thesis, a new method is proposed with the assumption that only one signal is needed to not overlap the other multiband signals that are down converted at the same time. The proposed method will introduce unique formulas using the said assumption to calculate the valid subsampling frequencies, ensuring that the target signal is not aliased by the other signals. Simulation results show that the proposed method will provide lower valid subsampling frequencies for down conversion compared to the existing methods.

Multi-criteria decision making development of ion chromatographic method for determination of inorganic anions in oilfield waters based on artificial neural networks retention model.

PubMed

Stefanović, Stefica Cerjan; Bolanča, Tomislav; Luša, Melita; Ukić, Sime; Rogošić, Marko

2012-02-24

This paper describes the development of ad hoc methodology for determination of inorganic anions in oilfield water, since their composition often significantly differs from the average (concentration of components and/or matrix). Therefore, fast and reliable method development has to be performed in order to ensure the monitoring of desired properties under new conditions. The method development was based on computer assisted multi-criteria decision making strategy. The used criteria were: maximal value of objective functions used, maximal robustness of the separation method, minimal analysis time, and maximal retention distance between two nearest components. Artificial neural networks were used for modeling of anion retention. The reliability of developed method was extensively tested by the validation of performance characteristics. Based on validation results, the developed method shows satisfactory performance characteristics, proving the successful application of computer assisted methodology in the described case study. Copyright © 2011 Elsevier B.V. All rights reserved.

Optimized, Fast-Throughput UHPLC-DAD Based Method for Carotenoid Quantification in Spinach, Serum, Chylomicrons, and Feces.

PubMed

Eriksen, Jane N; Madsen, Pia L; Dragsted, Lars O; Arrigoni, Eva

2017-02-01

An improved UHPLC-DAD-based method was developed and validated for quantification of major carotenoids present in spinach, serum, chylomicrons, and feces. Separation was achieved with gradient elution within 12.5 min for six dietary carotenoids and the internal standard, echinenone. The proposed method provides, for all standard components, resolution > 1.1, linearity covering the target range (R > 0.99), LOQ < 0.035 mg/L, and intraday and interday RSDs < 2 and 10%, respectively. Suitability of the method was tested on biological matrices. Method precision (RSD%) for carotenoid quantification in serum, chylomicrons, and feces was below 10% for intra- and interday analysis, except for lycopene. Method accuracy was consistent with mean recoveries ranging from 78.8 to 96.9% and from 57.2 to 96.9% for all carotenoids, except for lycopene, in serum and feces, respectively. Additionally, an interlaboratory validation study on spinach at two institutions showed no significant differences in lutein or β-carotene content, when evaluated on four occasions.

Development and validation of a food photography manual, as a tool for estimation of food portion size in epidemiological dietary surveys in Tunisia

PubMed Central

Bouchoucha, Mongia; Akrout, Mouna; Bellali, Hédia; Bouchoucha, Rim; Tarhouni, Fadwa; Mansour, Abderraouf Ben; Zouari, Béchir

2016-01-01

Background Estimation of food portion sizes has always been a challenge in dietary studies on free-living individuals. The aim of this work was to develop and validate a food photography manual to improve the accuracy of the estimated size of consumed food portions. Methods A manual was compiled from digital photos of foods commonly consumed by the Tunisian population. The food was cooked and weighed before taking digital photographs of three portion sizes. The manual was validated by comparing the method of 24-hour recall (using photos) to the reference method [food weighing (FW)]. In both the methods, the comparison focused on food intake amounts as well as nutritional issues. Validity was assessed by Bland–Altman limits of agreement. In total, 31 male and female volunteers aged 9–89 participated in the study. Results We focused on eight food categories and compared their estimated amounts (using the 24-hour recall method) to those actually consumed (using FW). Animal products and sweets were underestimated, whereas pasta, bread, vegetables, fruits, and dairy products were overestimated. However, the difference between the two methods is not statistically significant except for pasta (p<0.05) and dairy products (p<0.05). The coefficient of correlation between the two methods is highly significant, ranging from 0.876 for pasta to 0.989 for dairy products. Nutrient intake calculated for both methods showed insignificant differences except for fat (p<0.001) and dietary fiber (p<0.05). A highly significant correlation was observed between the two methods for all micronutrients. The test agreement highlights the lack of difference between the two methods. Conclusion The difference between the 24-hour recall method using digital photos and the weighing method is acceptable. Our findings indicate that the food photography manual can be a useful tool for quantifying food portion sizes in epidemiological dietary surveys. PMID:27585631

Development and validation of a food photography manual, as a tool for estimation of food portion size in epidemiological dietary surveys in Tunisia.

PubMed

Bouchoucha, Mongia; Akrout, Mouna; Bellali, Hédia; Bouchoucha, Rim; Tarhouni, Fadwa; Mansour, Abderraouf Ben; Zouari, Béchir

2016-01-01

Background Estimation of food portion sizes has always been a challenge in dietary studies on free-living individuals. The aim of this work was to develop and validate a food photography manual to improve the accuracy of the estimated size of consumed food portions. Methods A manual was compiled from digital photos of foods commonly consumed by the Tunisian population. The food was cooked and weighed before taking digital photographs of three portion sizes. The manual was validated by comparing the method of 24-hour recall (using photos) to the reference method [food weighing (FW)]. In both the methods, the comparison focused on food intake amounts as well as nutritional issues. Validity was assessed by Bland-Altman limits of agreement. In total, 31 male and female volunteers aged 9-89 participated in the study. Results We focused on eight food categories and compared their estimated amounts (using the 24-hour recall method) to those actually consumed (using FW). Animal products and sweets were underestimated, whereas pasta, bread, vegetables, fruits, and dairy products were overestimated. However, the difference between the two methods is not statistically significant except for pasta (p<0.05) and dairy products (p<0.05). The coefficient of correlation between the two methods is highly significant, ranging from 0.876 for pasta to 0.989 for dairy products. Nutrient intake calculated for both methods showed insignificant differences except for fat (p<0.001) and dietary fiber (p<0.05). A highly significant correlation was observed between the two methods for all micronutrients. The test agreement highlights the lack of difference between the two methods. Conclusion The difference between the 24-hour recall method using digital photos and the weighing method is acceptable. Our findings indicate that the food photography manual can be a useful tool for quantifying food portion sizes in epidemiological dietary surveys.

State of the art in the validation of screening methods for the control of antibiotic residues: is there a need for further development?

PubMed

Gaudin, Valérie

2017-09-01

Screening methods are used as a first-line approach to detect the presence of antibiotic residues in food of animal origin. The validation process guarantees that the method is fit-for-purpose, suited to regulatory requirements, and provides evidence of its performance. This article is focused on intra-laboratory validation. The first step in validation is characterisation of performance, and the second step is the validation itself with regard to pre-established criteria. The validation approaches can be absolute (a single method) or relative (comparison of methods), overall (combination of several characteristics in one) or criterion-by-criterion. Various approaches to validation, in the form of regulations, guidelines or standards, are presented and discussed to draw conclusions on their potential application for different residue screening methods, and to determine whether or not they reach the same conclusions. The approach by comparison of methods is not suitable for screening methods for antibiotic residues. The overall approaches, such as probability of detection (POD) and accuracy profile, are increasingly used in other fields of application. They may be of interest for screening methods for antibiotic residues. Finally, the criterion-by-criterion approach (Decision 2002/657/EC and of European guideline for the validation of screening methods), usually applied to the screening methods for antibiotic residues, introduced a major characteristic and an improvement in the validation, i.e. the detection capability (CCβ). In conclusion, screening methods are constantly evolving, thanks to the development of new biosensors or liquid chromatography coupled to tandem-mass spectrometry (LC-MS/MS) methods. There have been clear changes in validation approaches these last 20 years. Continued progress is required and perspectives for future development of guidelines, regulations and standards for validation are presented here.

Relations between inductive reasoning and deductive reasoning.

PubMed

Heit, Evan; Rotello, Caren M

2010-05-01

One of the most important open questions in reasoning research is how inductive reasoning and deductive reasoning are related. In an effort to address this question, we applied methods and concepts from memory research. We used 2 experiments to examine the effects of logical validity and premise-conclusion similarity on evaluation of arguments. Experiment 1 showed 2 dissociations: For a common set of arguments, deduction judgments were more affected by validity, and induction judgments were more affected by similarity. Moreover, Experiment 2 showed that fast deduction judgments were like induction judgments-in terms of being more influenced by similarity and less influenced by validity, compared with slow deduction judgments. These novel results pose challenges for a 1-process account of reasoning and are interpreted in terms of a 2-process account of reasoning, which was implemented as a multidimensional signal detection model and applied to receiver operating characteristic data. PsycINFO Database Record (c) 2010 APA, all rights reserved.

Teaching learning methods of an entrepreneurship curriculum

PubMed Central

ESMI, KERAMAT; MARZOUGHI, RAHMATALLAH; TORKZADEH, JAFAR

2015-01-01

Introduction One of the most significant elements of entrepreneurship curriculum design is teaching-learning methods, which plays a key role in studies and researches related to such a curriculum. It is the teaching method, and systematic, organized and logical ways of providing lessons that should be consistent with entrepreneurship goals and contents, and should also be developed according to the learners’ needs. Therefore, the current study aimed to introduce appropriate, modern, and effective methods of teaching entrepreneurship and their validation Methods This is a mixed method research of a sequential exploratory kind conducted through two stages: a) developing teaching methods of entrepreneurship curriculum, and b) validating developed framework. Data were collected through “triangulation” (study of documents, investigating theoretical basics and the literature, and semi-structured interviews with key experts). Since the literature on this topic is very rich, and views of the key experts are vast, directed and summative content analysis was used. In the second stage, qualitative credibility of research findings was obtained using qualitative validation criteria (credibility, confirmability, and transferability), and applying various techniques. Moreover, in order to make sure that the qualitative part is reliable, reliability test was used. Moreover, quantitative validation of the developed framework was conducted utilizing exploratory and confirmatory factor analysis methods and Cronbach’s alpha. The data were gathered through distributing a three-aspect questionnaire (direct presentation teaching methods, interactive, and practical-operational aspects) with 29 items among 90 curriculum scholars. Target population was selected by means of purposive sampling and representative sample. Results Results obtained from exploratory factor analysis showed that a three factor structure is an appropriate method for describing elements of teaching-learning methods of entrepreneurship curriculum. Moreover, the value for Kaiser Meyer Olkin measure of sampling adequacy equaled 0.72 and the value for Bartlett’s test of variances homogeneity was significant at the 0.0001 level. Except for internship element, the rest had a factor load of higher than 0.3. Also, the results of confirmatory factor analysis showed the model appropriateness, and the criteria for qualitative accreditation were acceptable. Conclusion Developed model can help instructors in selecting an appropriate method of entrepreneurship teaching, and it can also make sure that the teaching is on the right path. Moreover, the model is comprehensive and includes all the effective teaching methods in entrepreneurship education. It is also based on qualities, conditions, and requirements of Higher Education Institutions in Iranian cultural environment. PMID:26457314

Quantitative determination of additive Chlorantraniliprole in Abamectin preparation: Investigation of bootstrapping soft shrinkage approach by mid-infrared spectroscopy

NASA Astrophysics Data System (ADS)

Yan, Hong; Song, Xiangzhong; Tian, Kuangda; Chen, Yilin; Xiong, Yanmei; Min, Shungeng

2018-02-01

A novel method, mid-infrared (MIR) spectroscopy, which enables the determination of Chlorantraniliprole in Abamectin within minutes, is proposed. We further evaluate the prediction ability of four wavelength selection methods, including bootstrapping soft shrinkage approach (BOSS), Monte Carlo uninformative variable elimination (MCUVE), genetic algorithm partial least squares (GA-PLS) and competitive adaptive reweighted sampling (CARS) respectively. The results showed that BOSS method obtained the lowest root mean squared error of cross validation (RMSECV) (0.0245) and root mean squared error of prediction (RMSEP) (0.0271), as well as the highest coefficient of determination of cross-validation (Qcv2) (0.9998) and the coefficient of determination of test set (Q2test) (0.9989), which demonstrated that the mid infrared spectroscopy can be used to detect Chlorantraniliprole in Abamectin conveniently. Meanwhile, a suitable wavelength selection method (BOSS) is essential to conducting a component spectral analysis.

Discrimination of whisky brands and counterfeit identification by UV-Vis spectroscopy and multivariate data analysis.

PubMed

Martins, Angélica Rocha; Talhavini, Márcio; Vieira, Maurício Leite; Zacca, Jorge Jardim; Braga, Jez Willian Batista

2017-08-15

The discrimination of whisky brands and counterfeit identification were performed by UV-Vis spectroscopy combined with partial least squares for discriminant analysis (PLS-DA). In the proposed method all spectra were obtained with no sample preparation. The discrimination models were built with the employment of seven whisky brands: Red Label, Black Label, White Horse, Chivas Regal (12years), Ballantine's Finest, Old Parr and Natu Nobilis. The method was validated with an independent test set of authentic samples belonging to the seven selected brands and another eleven brands not included in the training samples. Furthermore, seventy-three counterfeit samples were also used to validate the method. Results showed correct classification rates for genuine and false samples over 98.6% and 93.1%, respectively, indicating that the method can be helpful for the forensic analysis of whisky samples. Copyright © 2017 Elsevier Ltd. All rights reserved.

Genomic validation of PB 260 clone of rubber (Hevea brasiliensis) at Cikumpay Plantation by SSR marker

NASA Astrophysics Data System (ADS)

Royani, J. I.; Safarrida, A.; Rachmawati, I.; Khairiyah, H.; Mustika, I. P.; Suyono, A.; Rudiyana, Y.; Kubil; Nurjaya; Arianto, A.

2017-05-01

Rubber from Hevea brasiliensis is the only commercial natural rubber in the world. Propagation of rubber trees usually done by grafting and seed germination. BPPT had been producing rubber tree by in vitro technique with embryo somatic methods. Validation of mother plant for in vitro propagation is important to compare between mother plant and propagated plants. The aim for this research was to validation of PB 260 clone that planted at Cikumpay Plantation by SSR marker. Sampling of 10 rubber leaves were done at Cikumpay Plantation based on GPS position from the area of PB 260 clone. Rubber leaves were isolated with CTAB modification method to obtained DNA. Four of SSR primers from rubber, i.e.: hmac 4, hmac 5, hmct 1, and hmct 5, were used as primers to amplification of rubber DNA. The result showed that no band that different from 10 rubber of PB 260 clone at Cikumpay Plantation. This research will continue to compare genomic validation between mother plant and propagated plants that had been produced from BPPT.

Fecal glucocorticoid metabolites and assay validation: Stress response evaluation in captive brown howler monkeys (Alouatta clamitans).

PubMed

Eleonora Madeira Buti, Thais; Kugelmeier, Tatiana; Sobral, Gisela; Viau Furtado, Priscila; do Valle Dutra de Andrade Neves, Dafne; Alvarenga de Oliveira, Claudio

2018-04-25

The advent of non-invasive methods provides a powerful alternative to stress studies as the use of stressful handling techniques is no longer needed. However, many factors influence hormone metabolism such as sex, diet, and metabolic rate. Thus, validation should be species- and matrix-specific. To assess stress response in brown howler monkeys Alouatta clamitans, we adopted an ACTH challenge test and parallelism to provide physiological and laboratorial validation. Radioimmunoassay was used to measure fecal levels of corticosterone. All challenged animals presented a peak in fecal glucocorticoids levels the day after the treatment, while control animals did not. There were no significant sex differences, but females with infants had higher levels of corticosterone. Corticosterone levels showed parallelism to the standard curve of the diagnostics kit. Collectively, the data suggest that the method was validated and is useful for monitoring stress, thereby helping in conservation programs both in captivity and in the wild. Transit time information may be coupled with travel distance in seed dispersal studies. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Precision of dehydroascorbic acid quantitation with the use of the subtraction method--validation of HPLC-DAD method for determination of total vitamin C in food.

PubMed

Mazurek, Artur; Jamroz, Jerzy

2015-04-15

In food analysis, a method for determination of vitamin C should enable measuring of total content of ascorbic acid (AA) and dehydroascorbic acid (DHAA) because both chemical forms exhibit biological activity. The aim of the work was to confirm applicability of HPLC-DAD method for analysis of total content of vitamin C (TC) and ascorbic acid in various types of food by determination of validation parameters such as: selectivity, precision, accuracy, linearity and limits of detection and quantitation. The results showed that the method applied for determination of TC and AA was selective, linear and precise. Precision of DHAA determination by the subtraction method was also evaluated. It was revealed that the results of DHAA determination obtained by the subtraction method were not precise which resulted directly from the assumption of this method and the principles of uncertainty propagation. The proposed chromatographic method should be recommended for routine determinations of total vitamin C in various food. Copyright © 2014 Elsevier Ltd. All rights reserved.

Development and validation of an ultra-performance convergence chromatography method for the quality control of Angelica gigas Nakai.

PubMed

Kim, Hyo Seon; Chun, Jin Mi; Kwon, Bo-In; Lee, A-Reum; Kim, Ho Kyoung; Lee, A Yeong

2016-10-01

Ultra-performance convergence chromatography, which integrates the advantages of supercritical fluid chromatography and ultra high performance liquid chromatography technologies, is an environmentally friendly analytical method that uses dramatically reduced amounts of organic solvents. An ultra-performance convergence chromatography method was developed and validated for the quantification of decursinol angelate and decursin in Angelica gigas using a CSH Fluoro-Phenyl column (2.1 mm × 150 mm, 1.7 μm) with a run time of 4 min. The method had an improved resolution and a shorter analysis time in comparison to the conventional high-performance liquid chromatography method. This method was validated in terms of linearity, precision, and accuracy. The limits of detection were 0.005 and 0.004 μg/mL for decursinol angelate and decursin, respectively, while the limits of quantitation were 0.014 and 0.012 μg/mL, respectively. The two components showed good regression (correlation coefficient (r 2 ) > 0.999), excellent precision (RSD < 2.28%), and acceptable recoveries (99.75-102.62%). The proposed method can be used to efficiently separate, characterize, and quantify decursinol angelate and decursin in Angelica gigas and its related medicinal materials or preparations, with the advantages of a shorter analysis time, greater sensitivity, and better environmental compatibility. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Development and Validation of UV-Visible Spectrophotometric Method for Simultaneous Determination of Eperisone and Paracetamol in Solid Dosage Form.

PubMed

Khanage, Shantaram Gajanan; Mohite, Popat Baban; Jadhav, Sandeep

2013-01-01

Eperisone Hydrochloride (EPE) is a potent new generation antispasmodic drug which is used in the treatment of moderate to severe pain in combination with Paracetamol (PAR). Both drugs are available in tablet dosage form in combination with a dose of 50 mg for EPE and 325 mg PAR respectively. The method is based upon Q-absorption ratio method for the simultaneous determination of the EPE and PAR. Absorption ratio method is used for the ratio of the absorption at two selected wavelength one of which is the iso-absorptive point and other being the λmax of one of the two components. EPE and PAR shows their iso-absorptive point at 260 nm in methanol, the second wavelength used is 249 nm which is the λmax of PAR in methanol. The linearity was obtained in the concentration range of 5-25 μg/mL for EPE and 2-10 μg/mL for PAR. The proposed method was effectively applied to tablet dosage form for estimation of both drugs. The accuracy and reproducibility results are close to 100% with 2% RSD. RESULTS of the analysis were validated statistically and found to be satisfactory. The results of proposed method have been validated as per ICH guidelines. A simple, precise and economical spectrophotometric method has been developed for the estimation of EPE and PAR in pharmaceutical formulation.

Risk-Based Prioritization Method for the Classification of Groundwater Pollution from Hazardous Waste Landfills.

PubMed

Yang, Yu; Jiang, Yong-Hai; Lian, Xin-Ying; Xi, Bei-Dou; Ma, Zhi-Fei; Xu, Xiang-Jian; An, Da

2016-12-01

Hazardous waste landfill sites are a significant source of groundwater pollution. To ensure that these landfills with a significantly high risk of groundwater contamination are properly managed, a risk-based ranking method related to groundwater contamination is needed. In this research, a risk-based prioritization method for the classification of groundwater pollution from hazardous waste landfills was established. The method encompasses five phases, including risk pre-screening, indicator selection, characterization, classification and, lastly, validation. In the risk ranking index system employed here, 14 indicators involving hazardous waste landfills and migration in the vadose zone as well as aquifer were selected. The boundary of each indicator was determined by K-means cluster analysis and the weight of each indicator was calculated by principal component analysis. These methods were applied to 37 hazardous waste landfills in China. The result showed that the risk for groundwater contamination from hazardous waste landfills could be ranked into three classes from low to high risk. In all, 62.2 % of the hazardous waste landfill sites were classified in the low and medium risk classes. The process simulation method and standardized anomalies were used to validate the result of risk ranking; the results were consistent with the simulated results related to the characteristics of contamination. The risk ranking method was feasible, valid and can provide reference data related to risk management for groundwater contamination at hazardous waste landfill sites.

In silico prediction of Tetrahymena pyriformis toxicity for diverse industrial chemicals with substructure pattern recognition and machine learning methods.

PubMed

Cheng, Feixiong; Shen, Jie; Yu, Yue; Li, Weihua; Liu, Guixia; Lee, Philip W; Tang, Yun

2011-03-01

There is an increasing need for the rapid safety assessment of chemicals by both industries and regulatory agencies throughout the world. In silico techniques are practical alternatives in the environmental hazard assessment. It is especially true to address the persistence, bioaccumulative and toxicity potentials of organic chemicals. Tetrahymena pyriformis toxicity is often used as a toxic endpoint. In this study, 1571 diverse unique chemicals were collected from the literature and composed of the largest diverse data set for T. pyriformis toxicity. Classification predictive models of T. pyriformis toxicity were developed by substructure pattern recognition and different machine learning methods, including support vector machine (SVM), C4.5 decision tree, k-nearest neighbors and random forest. The results of a 5-fold cross-validation showed that the SVM method performed better than other algorithms. The overall predictive accuracies of the SVM classification model with radial basis functions kernel was 92.2% for the 5-fold cross-validation and 92.6% for the external validation set, respectively. Furthermore, several representative substructure patterns for characterizing T. pyriformis toxicity were also identified via the information gain analysis methods. Copyright © 2010 Elsevier Ltd. All rights reserved.

Validation of an Empathy Scale in Pharmacy and Nursing Students

PubMed Central

Chen, Aleda M. H.; Yehle, Karen S.; Plake, Kimberly S.

2013-01-01

Objective. To validate an empathy scale to measure empathy in pharmacy and nursing students. Methods. A 15-item instrument comprised of the cognitive and affective empathy domains, was created. Each item was rated using a 7-point Likert scale, ranging from strongly disagree to strongly agree. Concurrent validity was demonstrated with the Jefferson Scale of Empathy – Health Professional Students (JSE-HPS). Results. Reliability analysis of data from 216 students (pharmacy, N=158; nursing, N=58) showed that scores on the empathy scale were positively associated with JSE-HPS scores (p<0.001). Factor analysis confirmed that 14 of the 15 items were significantly associated with their respective domain, but the overall instrument had limited goodness of fit. Conclusions. Results of this study demonstrate the reliability and validity of a new scale for evaluating student empathy. Further testing of the scale at other universities is needed to establish validity. PMID:23788805

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 4 2013-10-01 2013-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures...

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 4 2012-10-01 2012-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures...

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 4 2014-10-01 2014-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures...

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 4 2011-10-01 2011-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a) The Administrator will periodically validate showings submitted under § 456.654. Validation procedures...

Multivariate optimization and validation of an analytical methodology by RP-HPLC for the determination of losartan potassium in capsules.

PubMed

Bonfilio, Rudy; Tarley, César Ricardo Teixeira; Pereira, Gislaine Ribeiro; Salgado, Hérida Regina Nunes; de Araújo, Magali Benjamim

2009-11-15

This paper describes the optimization and validation of an analytical methodology for the determination of losartan potassium in capsules by HPLC using 2(5-1) fractional factorial and Doehlert designs. This multivariate approach allows a considerable improvement in chromatographic performance using fewer experiments, without additional cost for columns or other equipment. The HPLC method utilized potassium phosphate buffer (pH 6.2; 58 mmol L(-1))-acetonitrile (65:35, v/v) as the mobile phase, pumped at a flow rate of 1.0 mL min(-1). An octylsilane column (100 mm x 4.6mm i.d., 5 microm) maintained at 35 degrees C was used as the stationary phase. UV detection was performed at 254 nm. The method was validated according to the ICH guidelines, showing accuracy, precision (intra-day relative standard deviation (R.S.D.) and inter-day R.S.D values <2.0%), selectivity, robustness and linearity (r=0.9998) over a concentration range from 30 to 70 mg L(-1) of losartan potassium. The limits of detection and quantification were 0.114 and 0.420 mg L(-1), respectively. The validated method may be used to quantify losartan potassium in capsules and to determine the stability of this drug.

Double regions growing algorithm for automated satellite image mosaicking

NASA Astrophysics Data System (ADS)

Tan, Yihua; Chen, Chen; Tian, Jinwen

2011-12-01

Feathering is a most widely used method in seamless satellite image mosaicking. A simple but effective algorithm - double regions growing (DRG) algorithm, which utilizes the shape content of images' valid regions, is proposed for generating robust feathering-line before feathering. It works without any human intervention, and experiment on real satellite images shows the advantages of the proposed method.

History and Development of the Schmidt-Hunter Meta-Analysis Methods

ERIC Educational Resources Information Center

Schmidt, Frank L.

2015-01-01

In this article, I provide answers to the questions posed by Will Shadish about the history and development of the Schmidt-Hunter methods of meta-analysis. In the 1970s, I headed a research program on personnel selection at the US Office of Personnel Management (OPM). After our research showed that validity studies have low statistical power, OPM…

Solid phase microextraction and gas chromatography-mass spectrometry methods for residual solvent assessment in seized cocaine and heroin.

PubMed

Cabarcos, Pamela; Herbello-Hermelo, Paloma; Álvarez-Freire, Iván; Moreda-Piñeiro, Antonio; Tabernero, María Jesús; Bermejo, Ana María; Bermejo-Barrera, Pilar

2016-09-01

A simple sample pre-treatment method based on solid phase microextraction (SPME) and gas chromatography-mass spectrometry (GC-MS) has been optimized and validated for the assessment of 15 residual solvents (2-propanol, 2-methylpentane, 3-methylpentane, acetone, ethyl acetate, benzene, hexane, methylcyclohexane, methylcyclopentane, m-xylene, propyl acetate, toluene, 1,2,4-trimethylbenzene, dichloromethane, and ethylbenzene) in seized illicit cocaine and heroin. DMSO and DMF as sample diluents were found to offer the best residual solvent transference to the head space for further adsorption onto the SPME fiber, and the developed method therefore showed high sensitivity and analytical recovery. Variables affecting SPME were fully evaluated by applying an experimental design approach. Best conditions were found when using an equilibration time of 5 min at 70 °C and headspace sampling of residual solvents at the same temperature for 15 min. Method validation, performed within the requirements of international guidelines, showed excellent sensitivity, as well as intra- and inter-day precision and accuracy. The proposed methodology was applied to 96 cocaine samples and 14 heroin samples seized in Galicia (northwestern Spain) within 2013 and 2014.

[Respondent-Driven Sampling: a new sampling method to study visible and hidden populations].

PubMed

Mantecón, Alejandro; Juan, Montse; Calafat, Amador; Becoña, Elisardo; Román, Encarna

2008-01-01

The paper introduces a variant of chain-referral sampling: respondent-driven sampling (RDS). This sampling method shows that methods based on network analysis can be combined with the statistical validity of standard probability sampling methods. In this sense, RDS appears to be a mathematical improvement of snowball sampling oriented to the study of hidden populations. However, we try to prove its validity with populations that are not within a sampling frame but can nonetheless be contacted without difficulty. The basics of RDS are explained through our research on young people (aged 14 to 25) who go clubbing, consume alcohol and other drugs, and have sex. Fieldwork was carried out between May and July 2007 in three Spanish regions: Baleares, Galicia and Comunidad Valenciana. The presentation of the study shows the utility of this type of sampling when the population is accessible but there is a difficulty deriving from the lack of a sampling frame. However, the sample obtained is not a random representative one in statistical terms of the target population. It must be acknowledged that the final sample is representative of a 'pseudo-population' that approximates to the target population but is not identical to it.

Determination of total arsenic in fish by hydride-generation atomic absorption spectrometry: method validation, traceability and uncertainty evaluation

NASA Astrophysics Data System (ADS)

Nugraha, W. C.; Elishian, C.; Ketrin, R.

2017-03-01

Fish containing arsenic compound is one of the important indicators of arsenic contamination in water monitoring. The high level of arsenic in fish is due to absorption through food chain and accumulated in their habitat. Hydride generation (HG) coupled with atomic absorption spectrometric (AAS) detection is one of the most popular techniques employed for arsenic determination in a variety of matrices including fish. This study aimed to develop a method for the determination of total arsenic in fish by HG-AAS. The method for sample preparation from American of Analytical Chemistry (AOAC) Method 999.10-2005 was adopted for acid digestion using microwave digestion system and AOAC Method 986.15 - 2005 for dry ashing. The method was developed and validated using Certified Reference Material DORM 3 Fish Protein for trace metals for ensuring the accuracy and the traceability of the results. The sources of uncertainty of the method were also evaluated. By using the method, it was found that the total arsenic concentration in the fish was 45.6 ± 1.22 mg.Kg-1 with a coverage factor of equal to 2 at 95% of confidence level. Evaluation of uncertainty was highly influenced by the calibration curve. This result was also traceable to International Standard System through analysis of Certified Reference Material DORM 3 with 97.5% of recovery. In summary, it showed that method of preparation and HG-AAS technique for total arsenic determination in fish were valid and reliable.

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

PubMed Central

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

2014-01-01

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

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

PubMed

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

2014-01-01

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

Development and validation of a food photography manual, as a tool for estimation of food portion size in epidemiological dietary surveys in Tunisia.

PubMed

Bouchoucha, Mongia; Akrout, Mouna; Bellali, Hédia; Bouchoucha, Rim; Tarhouni, Fadwa; Mansour, Abderraouf Ben; Zouari, Béchir

2016-01-01

Estimation of food portion sizes has always been a challenge in dietary studies on free-living individuals. The aim of this work was to develop and validate a food photography manual to improve the accuracy of the estimated size of consumed food portions. A manual was compiled from digital photos of foods commonly consumed by the Tunisian population. The food was cooked and weighed before taking digital photographs of three portion sizes. The manual was validated by comparing the method of 24-hour recall (using photos) to the reference method [food weighing (FW)]. In both the methods, the comparison focused on food intake amounts as well as nutritional issues. Validity was assessed by Bland-Altman limits of agreement. In total, 31 male and female volunteers aged 9-89 participated in the study. We focused on eight food categories and compared their estimated amounts (using the 24-hour recall method) to those actually consumed (using FW). Animal products and sweets were underestimated, whereas pasta, bread, vegetables, fruits, and dairy products were overestimated. However, the difference between the two methods is not statistically significant except for pasta (p<0.05) and dairy products (p<0.05). The coefficient of correlation between the two methods is highly significant, ranging from 0.876 for pasta to 0.989 for dairy products. Nutrient intake calculated for both methods showed insignificant differences except for fat (p<0.001) and dietary fiber (p<0.05). A highly significant correlation was observed between the two methods for all micronutrients. The test agreement highlights the lack of difference between the two methods. The difference between the 24-hour recall method using digital photos and the weighing method is acceptable. Our findings indicate that the food photography manual can be a useful tool for quantifying food portion sizes in epidemiological dietary surveys.

Online geometric calibration of cone-beam computed tomography for arbitrary imaging objects.

PubMed

Meng, Yuanzheng; Gong, Hui; Yang, Xiaoquan

2013-02-01

A novel online method based on the symmetry property of the sum of projections (SOP) is proposed to obtain the geometric parameters in cone-beam computed tomography (CBCT). This method requires no calibration phantom and can be used in circular trajectory CBCT with arbitrary cone angles. An objective function is deduced to illustrate the dependence of the symmetry of SOP on geometric parameters, which will converge to its minimum when the geometric parameters achieve their true values. Thus, by minimizing the objective function, we can obtain the geometric parameters for image reconstruction. To validate this method, numerical phantom studies with different noise levels are simulated. The results show that our method is insensitive to the noise and can determine the skew (in-plane rotation angle of the detector), the roll (rotation angle around the projection of the rotation axis on the detector), and the rotation axis with high accuracy, while the mid-plane and source-to-detector distance will be obtained with slightly lower accuracy. However, our simulation studies validate that the errors of the latter two parameters brought by our method will hardly degrade the quality of reconstructed images. The small animal studies show that our method is able to deal with arbitrary imaging objects. In addition, the results of the reconstructed images in different slices demonstrate that we have achieved comparable image quality in the reconstructions as some offline methods.

Validity of the t-plot method to assess microporosity in hierarchical micro/mesoporous materials.

PubMed

Galarneau, Anne; Villemot, François; Rodriguez, Jeremy; Fajula, François; Coasne, Benoit

2014-11-11

The t-plot method is a well-known technique which allows determining the micro- and/or mesoporous volumes and the specific surface area of a sample by comparison with a reference adsorption isotherm of a nonporous material having the same surface chemistry. In this paper, the validity of the t-plot method is discussed in the case of hierarchical porous materials exhibiting both micro- and mesoporosities. Different hierarchical zeolites with MCM-41 type ordered mesoporosity are prepared using pseudomorphic transformation. For comparison, we also consider simple mechanical mixtures of microporous and mesoporous materials. We first show an intrinsic failure of the t-plot method; this method does not describe the fact that, for a given surface chemistry and pressure, the thickness of the film adsorbed in micropores or small mesopores (< 10σ, σ being the diameter of the adsorbate) increases with decreasing the pore size (curvature effect). We further show that such an effect, which arises from the fact that the surface area and, hence, the free energy of the curved gas/liquid interface decreases with increasing the film thickness, is captured using the simple thermodynamical model by Derjaguin. The effect of such a drawback on the ability of the t-plot method to estimate the micro- and mesoporous volumes of hierarchical samples is then discussed, and an abacus is given to correct the underestimated microporous volume by the t-plot method.

Methods for Evaluating Flammability Characteristics of Shipboard Materials

DTIC Science & Technology

1994-02-28

E 23 • smoke optical properties; and • (toxic) gas production rates. In general, the prediction of these full-scale burning characteristics requires ...Method. The ASTM Room/Corner Test Method can be used to calculate the heat release rate of a material based upon oxygen depletion calorimetry. As can be...Clearly, more validation is required for the theoretical calculations . All are consistent in the use of calorimeter and UFT-type property data, all show

Exploring the construct validity of the social cognition and object relations scale in a clinical sample.

PubMed

Stein, Michelle B; Slavin-Mulford, Jenelle; Sinclair, S Justin; Siefert, Caleb J; Blais, Mark A

2012-01-01

The Social Cognition and Object Relations Scale-Global rating method (SCORS-G; Stein, Hilsenroth, Slavin-Mulford, & Pinsker, 2011; Westen, 1995) measures the quality of object relations in narrative material. This study employed a multimethod approach to explore the structure and construct validity of the SCORS-G. The Thematic Apperception Test (TAT; Murray, 1943) was administered to 59 patients referred for psychological assessment at a large Northeastern U.S. hospital. The resulting 301 TAT narratives were rated using the SCORS-G method. The 8 SCORS variables were found to have high interrater reliability and good internal consistency. Principal components analysis revealed a 3-component solution with components tapping emotions/affect regulation in relationships, self-image, and aspects of cognition. Next, the construct validity of the SCORS-G components was explored using measures of intellectual and executive functioning, psychopathology, and normal personality. The 3 SCORS-G components showed unique and theoretically meaningful relationships across these broad and diverse psychological measures. This study demonstrates the value of using a standardized scoring method, like the SCORS-G, to reveal the rich and complex nature of narrative material.

[Validation of an improved Demons deformable registration algorithm and its application in re-contouring in 4D-CT].

PubMed

Zhen, Xin; Zhou, Ling-hong; Lu, Wen-ting; Zhang, Shu-xu; Zhou, Lu

2010-12-01

To validate the efficiency and accuracy of an improved Demons deformable registration algorithm and evaluate its application in contour recontouring in 4D-CT. To increase the additional Demons force and reallocate the bilateral forces to accelerate convergent speed, we propose a novel energy function as the similarity measure, and utilize a BFGS method for optimization to avoid specifying the numbers of iteration. Mathematical transformed deformable CT images and home-made deformable phantom were used to validate the accuracy of the improved algorithm, and its effectiveness for contour recontouring was tested. The improved algorithm showed a relatively high registration accuracy and speed when compared with the classic Demons algorithm and optical flow based method. Visual inspection of the positions and shapes of the deformed contours agreed well with the physician-drawn contours. Deformable registration is a key technique in 4D-CT, and this improved Demons algorithm for contour recontouring can significantly reduce the workload of the physicians. The registration accuracy of this method proves to be sufficient for clinical needs.

Validation of a liquid chromatography-electrospray ionization tandem mass spectrometric method to determine six polyether ionophores in raw, UHT, pasteurized and powdered milk.

PubMed

Pereira, Mararlene Ulberg; Spisso, Bernardete Ferraz; Jacob, Silvana do Couto; Monteiro, Mychelle Alves; Ferreira, Rosana Gomes; Carlos, Betânia de Souza; da Nóbrega, Armi Wanderley

2016-04-01

This study aimed to validate a method developed for the determination of six antibiotics from the polyether ionophore class (lasalocid, maduramicin, monensin, narasin, salinomycin and semduramicin) at residue levels in raw, UHT, pasteurized and powdered milk using QuEChERS extraction and high performance liquid chromatography coupled to tandem mass spectrometry (HPLC-MS/MS). The validation was conducted under an in-house laboratory protocol that is primarily based on 2002/657/EC Decision, but takes in account the variability of matrix sources. Overall recoveries between 93% and 113% with relative standard deviations up to 16% were obtained under intermediate precision conditions. CCα calculated values did not exceed 20% the Maximum Residue Limit for monensin and 25% the Maximum Levels for all other substances. The method showed to be simple, fast and suitable for verifying the compliance of raw and processed milk samples regarding the limits recommended by Codex Alimentarius and those adopted in European Community for polyether ionophores. Copyright © 2015 Elsevier Ltd. All rights reserved.

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.

The reliability and validity of the Japanese version of the Temperament and Personality Questionnaire for patients with non-melancholic depression.

PubMed

Kudo, Yuka; Nakagawa, Atsuo; Tamura, Noriko; Kato, Noriko; Williams, Aya; Aida, Nobuo; Mimura, Masaru

2016-07-01

Parker et al. (2006) proposed a new approach to classify specific sub-types of non-melancholic depression caused by various stress factors and premorbid personality styles: the Temperament and Personality Questionnaire (T&P). The current study aim was to develop the Japanese version of the T&P and evaluate its reliability and validity. We studied 114 patients with non-melancholic depression. Reliability was assessed using the test-retest method. Convergent validity of the T&P was compared with the clinician ratings of each patient for the eight personality traits. We also assessed the impact of depressive state on the T&P. The test-retest intraclass correlation coefficients among eight constructs of the T&P ranged from 0.77 to 0.89, indicating good-to-excellent reliability. Anxious Worrying (rho=0.29), Perfectionism (rho=0.17), Personal Reserve (rho=0.18), Irritability (rho=0.38), and Social Avoidance (rho=0.32) showed adequate levels of convergent validity; Rejection Sensitivity (rho=0.16), Self-criticism (rho=-0.02), and Self-focus (rho=0.07) showed relatively weak convergent validity. Perfectionism (rho=-0.06), Social Avoidance (rho=0.17), Anxious Worrying (rho=0.40), Personal Reserve (rho=0.30), Irritability (rho=0.28), Rejection Sensitivity (rho=0.35), Self-criticism (rho=0.49), and Self-focus (rho=0.24) showed minimal sensitivity to mood state effects. Only one site was used. While a Likert scale was used, the clinician-rated personality trait measure had not been validated. The J-T&P is a reliable and valid measure for assessing temperament and personality in Japanese patients with non-melancholic depression. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Patient-specific lean body mass can be estimated from limited-coverage computed tomography images.

PubMed

Devriese, Joke; Beels, Laurence; Maes, Alex; van de Wiele, Christophe; Pottel, Hans

2018-06-01

In PET/CT, quantitative evaluation of tumour metabolic activity is possible through standardized uptake values, usually normalized for body weight (BW) or lean body mass (LBM). Patient-specific LBM can be estimated from whole-body (WB) CT images. As most clinical indications only warrant PET/CT examinations covering head to midthigh, the aim of this study was to develop a simple and reliable method to estimate LBM from limited-coverage (LC) CT images and test its validity. Head-to-toe PET/CT examinations were retrospectively retrieved and semiautomatically segmented into tissue types based on thresholding of CT Hounsfield units. LC was obtained by omitting image slices. Image segmentation was validated on the WB CT examinations by comparing CT-estimated BW with actual BW, and LBM estimated from LC images were compared with LBM estimated from WB images. A direct method and an indirect method were developed and validated on an independent data set. Comparing LBM estimated from LC examinations with estimates from WB examinations (LBMWB) showed a significant but limited bias of 1.2 kg (direct method) and nonsignificant bias of 0.05 kg (indirect method). This study demonstrates that LBM can be estimated from LC CT images with no significant difference from LBMWB.

In vivo measurement of aerodynamic weight support in freely flying birds

NASA Astrophysics Data System (ADS)

Lentink, David; Haselsteiner, Andreas; Ingersoll, Rivers

2014-11-01

Birds dynamically change the shape of their wing during the stroke to support their body weight aerodynamically. The wing is partially folded during the upstroke, which suggests that the upstroke of birds might not actively contribute to aerodynamic force production. This hypothesis is supported by the significant mass difference between the large pectoralis muscle that powers the down-stroke and the much smaller supracoracoideus that drives the upstroke. Previous works used indirect or incomplete techniques to measure the total force generated by bird wings ranging from muscle force, airflow, wing surface pressure, to detailed kinematics measurements coupled with bird mass-distribution models to derive net force through second derivatives. We have validated a new method that measures aerodynamic force in vivo time-resolved directly in freely flying birds which can resolve this question. The validation of the method, using independent force measurements on a quadcopter with pulsating thrust, show the aerodynamic force and impulse are measured within 2% accuracy and time-resolved. We demonstrate results for quad-copters and birds of similar weight and size. The method is scalable and can be applied to both engineered and natural flyers across taxa. The first author invented the method, the second and third authors validated the method and present results for quadcopters and birds.

Monitoring of platinum surface contamination in seven Dutch hospital pharmacies using inductively coupled plasma mass spectrometry

PubMed Central

Huitema, A. D. R.; Bakker, E. N.; Douma, J. W.; Schimmel, K. J. M.; van Weringh, G.; de Wolf, P. J.; Schellens, J. H. M.; Beijnen, J. H.

2007-01-01

Objective: To develop, validate, and apply a method for the determination of platinum contamination, originating from cisplatinum, oxaliplatinum, and carboplatinum. Methods: Inductively coupled plasma mass spectrometry (ICP-MS) was used to determine platinum in wipe samples. The sampling procedure and the analytical conditions were optimised and the assay was validated. The method was applied to measure surface contamination in seven Dutch hospital pharmacies. Results: The developed method allowed reproducible quantification of 0.50 ng l−1 platinum (5 pg/wipe sample). Recoveries for stainless steel and linoleum surfaces ranged between 50.4 and 81.4% for the different platinum compounds tested. Platinum contamination was reported in 88% of the wipe samples. Although a substantial variation in surface contamination of the pharmacies was noticed, in most pharmacies, the laminar-airflow (LAF) hoods, the floor in front of the LAF hoods, door handles, and handles of service hatches showed positive results. This demonstrates that contamination is spread throughout the preparation rooms. Conclusion: We developed and validated an ultra sensitive and reliable ICP-MS method for the determination of platinum in surface samples. Surface contamination with platinum was observed in all hospital pharmacies sampled. The interpretation of these results is, however, complicated. PMID:17377802

Total Arsenic, Cadmium, and Lead Determination in Brazilian Rice Samples Using ICP-MS

PubMed Central

Buzzo, Márcia Liane; de Arauz, Luciana Juncioni; Carvalho, Maria de Fátima Henriques; Arakaki, Edna Emy Kumagai; Matsuzaki, Richard; Tiglea, Paulo

2016-01-01

This study is aimed at investigating a suitable method for rice sample preparation as well as validating and applying the method for monitoring the concentration of total arsenic, cadmium, and lead in rice by using Inductively Coupled Plasma Mass Spectrometry (ICP-MS). Various rice sample preparation procedures were evaluated. The analytical method was validated by measuring several parameters including limit of detection (LOD), limit of quantification (LOQ), linearity, relative bias, and repeatability. Regarding the sample preparation, recoveries of spiked samples were within the acceptable range from 89.3 to 98.2% for muffle furnace, 94.2 to 103.3% for heating block, 81.0 to 115.0% for hot plate, and 92.8 to 108.2% for microwave. Validation parameters showed that the method fits for its purpose, being the total arsenic, cadmium, and lead within the Brazilian Legislation limits. The method was applied for analyzing 37 rice samples (including polished, brown, and parboiled), consumed by the Brazilian population. The total arsenic, cadmium, and lead contents were lower than the established legislative values, except for total arsenic in one brown rice sample. This study indicated the need to establish monitoring programs for emphasizing the study on this type of cereal, aiming at promoting the Public Health. PMID:27766178

Volumetric adsorptive microsampling-liquid chromatography tandem mass spectrometry assay for the simultaneous quantification of four antibiotics in human blood: Method development, validation and comparison with dried blood spot.

PubMed

Barco, Sebastiano; Castagnola, Elio; Moscatelli, Andrea; Rudge, James; Tripodi, Gino; Cangemi, Giuliana

2017-10-25

In this paper we show the development and validation of a volumetric absorptive microsampling (VAMS™)-LC-MS/MS method for the simultaneous quantification of four antibiotics: piperacillin-tazobactam, meropenem, linezolid and ceftazidime in 10μL human blood. The novel VAMS-LC-MS/MS method has been compared with a dried blood spot (DBS)-based method in terms of impact of hematocrit (HCT) on accuracy, reproducibility, recovery and matrix effect. Antibiotics were extracted from VAMS and DBS by protein precipitation with methanol after a re-hydration step at 37°C for 10min. LC-MS/MS was carried out on a Thermo Scientific™ TSQ Quantum™ Access MAX triple quadrupole coupled to an Accela ™UHPLC system. The VAMS-LC-MS/MS method is selective, precise and reproducible. In contrast to DBS, it allows an accurate quantification without any HCT influence. It has been applied to samples derived from pediatric patients under therapy. VAMS is a valid alternative sampling strategy for the quantification of antibiotics and is valuable in support of clinical PK/PD studies and consequently therapeutic drug monitoring (TDM) in pediatrics. Copyright © 2017 Elsevier B.V. All rights reserved.

Validation of Field Methods to Assess Body Fat Percentage in Elite Youth Soccer Players.

PubMed

Munguia-Izquierdo, Diego; Suarez-Arrones, Luis; Di Salvo, Valter; Paredes-Hernandez, Victor; Alcazar, Julian; Ara, Ignacio; Kreider, Richard; Mendez-Villanueva, Alberto

2018-05-01

This study determined the most effective field method for quantifying body fat percentage in male elite youth soccer players and developed prediction equations based on anthropometric variables. Forty-four male elite-standard youth soccer players aged 16.3-18.0 years underwent body fat percentage assessments, including bioelectrical impedance analysis and the calculation of various skinfold-based prediction equations. Dual X-ray absorptiometry provided a criterion measure of body fat percentage. Correlation coefficients, bias, limits of agreement, and differences were used as validity measures, and regression analyses were used to develop soccer-specific prediction equations. The equations from Sarria et al. (1998) and Durnin & Rahaman (1967) reached very large correlations and the lowest biases, and they reached neither the practically worthwhile difference nor the substantial difference between methods. The new youth soccer-specific skinfold equation included a combination of triceps and supraspinale skinfolds. None of the practical methods compared in this study are adequate for estimating body fat percentage in male elite youth soccer players, except for the equations from Sarria et al. (1998) and Durnin & Rahaman (1967). The new youth soccer-specific equation calculated in this investigation is the only field method specifically developed and validated in elite male players, and it shows potentially good predictive power. © Georg Thieme Verlag KG Stuttgart · New York.

A trace map comparison algorithm for the discrete fracture network models of rock masses

NASA Astrophysics Data System (ADS)

Han, Shuai; Wang, Gang; Li, Mingchao

2018-06-01

Discrete fracture networks (DFN) are widely used to build refined geological models. However, validating whether a refined model can match to reality is a crucial problem, concerning whether the model can be used for analysis. The current validation methods include numerical validation and graphical validation. However, the graphical validation, aiming at estimating the similarity between a simulated trace map and the real trace map by visual observation, is subjective. In this paper, an algorithm for the graphical validation of DFN is set up. Four main indicators, including total gray, gray grade curve, characteristic direction and gray density distribution curve, are presented to assess the similarity between two trace maps. A modified Radon transform and loop cosine similarity are presented based on Radon transform and cosine similarity respectively. Besides, how to use Bézier curve to reduce the edge effect is described. Finally, a case study shows that the new algorithm can effectively distinguish which simulated trace map is more similar to the real trace map.

The convergence study of the homotopy analysis method for solving nonlinear Volterra-Fredholm integrodifferential equations.

PubMed

Ghanbari, Behzad

2014-01-01

We aim to study the convergence of the homotopy analysis method (HAM in short) for solving special nonlinear Volterra-Fredholm integrodifferential equations. The sufficient condition for the convergence of the method is briefly addressed. Some illustrative examples are also presented to demonstrate the validity and applicability of the technique. Comparison of the obtained results HAM with exact solution shows that the method is reliable and capable of providing analytic treatment for solving such equations.

Reliability and validity of television food advertising questionnaire in Malaysia.

PubMed

Zalma, Abdul Razak; Safiah, Md Yusof; Ajau, Danis; Khairil Anuar, Md Isa

2015-09-01

Interventions to counter the influence of television food advertising amongst children are important. Thus, reliable and valid instrument to assess its effect is needed. The objective of this study was to determine the reliability and validity of such a questionnaire. The questionnaire was administered twice on 32 primary schoolchildren aged 10-11 years in Selangor, Malaysia. The interval between the first and second administration was 2 weeks. Test-retest method was used to examine the reliability of the questionnaire. Intra-rater reliability was determined by kappa coefficient and internal consistency by Cronbach's alpha coefficient. Construct validity was evaluated using factor analysis. The test-retest correlation showed moderate-to-high reliability for all scores (r = 0.40*, p = 0.02 to r = 0.95**, p = 0.00), with one exception, consumption of fast foods (r = 0.24, p = 0.20). Kappa coefficient showed acceptable-to-strong intra-rater reliability (K = 0.40-0.92), except for two items under knowledge on television food advertising (K = 0.26 and K = 0.21) and one item under preference for healthier foods (K = 0.33). Cronbach's alpha coefficient indicated acceptable internal consistency for all scores (0.45-0.60). After deleting two items under Consumption of Commonly Advertised Food, the items showed moderate-to-high loading (0.52, 0.84, 0.42 and 0.42) with the Scree plot showing that there was only one factor. The Kaiser-Meyer-Olkin was 0.60, showing that the sample was adequate for factor analysis. The questionnaire on television food advertising is reliable and valid to assess the effect of media literacy education on television food advertising on schoolchildren. © The Author (2013). Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Mechanical energy estimation during walking: validity and sensitivity in typical gait and in children with cerebral palsy.

PubMed

Van de Walle, P; Hallemans, A; Schwartz, M; Truijen, S; Gosselink, R; Desloovere, K

2012-02-01

Gait efficiency in children with cerebral palsy is usually quantified by metabolic energy expenditure. Mechanical energy estimations, however, can be a valuable supplement as they can be assessed during gait analysis and plotted over the gait cycle, thus revealing information on timing and sources of increases in energy expenditure. Unfortunately, little information on validity and sensitivity exists. Three mechanical estimation approaches: (1) centre of mass (CoM) approach, (2) sum of segmental energies (SSE) approach and (3) integrated joint power approach, were validated against oxygen consumption and each other. Sensitivity was assessed in typical gait and in children with diplegia. CoM approach underestimated total energy expenditure and showed poor sensitivity. SSE approach overestimated energy expenditure and showed acceptable sensitivity. Validity and sensitivity were best in the integrated joint power approach. This method is therefore preferred for mechanical energy estimation in children with diplegia. However, mechanical energy should supplement, not replace metabolic energy, as total energy expended is not captured in any mechanical approach. Copyright © 2011 Elsevier B.V. All rights reserved.

[Kriging analysis of vegetation index depression in peak cluster karst area].

PubMed

Yang, Qi-Yong; Jiang, Zhong-Cheng; Ma, Zu-Lu; Cao, Jian-Hua; Luo, Wei-Qun; Li, Wen-Jun; Duan, Xiao-Fang

2012-04-01

In order to master the spatial variability of the normal different vegetation index (NDVI) of the peak cluster karst area, taking into account the problem of the mountain shadow "missing" information of remote sensing images existing in the karst area, NDVI of the non-shaded area were extracted in Guohua Ecological Experimental Area, in Pingguo County, Guangxi applying image processing software, ENVI. The spatial variability of NDVI was analyzed applying geostatistical method, and the NDVI of the mountain shadow areas was predicted and validated. The results indicated that the NDVI of the study area showed strong spatial variability and spatial autocorrelation resulting from the impact of intrinsic factors, and the range was 300 m. The spatial distribution maps of the NDVI interpolated by Kriging interpolation method showed that the mean of NDVI was 0.196, apparently strip and block. The higher NDVI values distributed in the area where the slope was greater than 25 degrees of the peak cluster area, while the lower values distributed in the area such as foot of the peak cluster and depression, where slope was less than 25 degrees. Kriging method validation results show that interpolation has a very high prediction accuracy and could predict the NDVI of the shadow area, which provides a new idea and method for monitoring and evaluation of the karst rocky desertification.

Preliminary Face and Construct Validation Study of a Virtual Basic Laparoscopic Skill Trainer

PubMed Central

Sankaranarayanan, Ganesh; Lin, Henry; Arikatla, Venkata S.; Mulcare, Maureen; Zhang, Likun; Derevianko, Alexandre; Lim, Robert; Fobert, David; Cao, Caroline; Schwaitzberg, Steven D.; Jones, Daniel B.

2010-01-01

Abstract Background The Virtual Basic Laparoscopic Skill Trainer (VBLaST™) is a developing virtual-reality–based surgical skill training system that incorporates several of the tasks of the Fundamentals of Laparoscopic Surgery (FLS) training system. This study aimed to evaluate the face and construct validity of the VBLaST™ system. Materials and Methods Thirty-nine subjects were voluntarily recruited at the Beth Israel Deaconess Medical Center (Boston, MA) and classified into two groups: experts (PGY 5, fellow and practicing surgeons) and novice (PGY 1–4). They were then asked to perform three FLS tasks, consisting of peg transfer, pattern cutting, and endoloop, on both the VBLaST and FLS systems. The VBLaST performance scores were automatically computed, while the FLS scores were rated by a trained evaluator. Face validity was assessed using a 5-point Likert scale, varying from not realistic/useful (1) to very realistic/useful (5). Results Face-validity scores showed that the VBLaST system was significantly realistic in portraying the three FLS tasks (3.95 ± 0.909), as well as the reality in trocar placement and tool movements (3.67 ± 0.874). Construct-validity results show that VBLaST was able to differentiate between the expert and novice group (P = 0.015). However, of the two tasks used for evaluating VBLaST, only the peg-transfer task showed a significant difference between the expert and novice groups (P = 0.003). Spearman correlation coefficient analysis between the two scores showed significant correlation for the peg-transfer task (Spearman coefficient 0.364; P = 0.023). Conclusions VBLaST demonstrated significant face and construct validity. A further set of studies, involving improvement to the current VBLaST system, is needed to thoroughly demonstrate face and construct validity for all the tasks. PMID:20201683

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%.

Application of a novel liquid chromatography/tandem mass spectrometry method for the determination of antazoline in human plasma: Result of ELEPHANT-I [ELEctrophysiological, pharmacokinetic and hemodynamic effects of PHenazolinum (ANTazoline mesylate)] human pharmacokinetic study.

PubMed

Giebułtowicz, Joanna; Piotrowski, Roman; Baran, Jakub; Kułakowski, Piotr; Wroczyński, Piotr

2016-05-10

Antazoline is a first-generation antihistaminic agent with antiarrhythmic quinidine-like properties. In some countries, it is widely used for termination of cardiac arrhythmias, especially atrial fibrillation (AF). However, no human pharmacokinetic studies have been conducted with intravenous antazoline. The aim of our study was to develop and validate a novel liquid chromatography/tandem mass spectrometry (LC-MS/MS) method for the determination of antazoline in human plasma: the ELEPHANT-I [ELEctrophysiological, pharmacokinetic and hemodynamic effects of PHenazolinum (ANTazoline mesylate)] human pharmacokinetic study. Antazoline was extracted from plasma using liquid-liquid extraction. The concentration of the analyte was measured by LC-MS/MS with xylometazoline as an internal standard. The method was validated for linearity, precision, accuracy, stability (freeze/thaw stability, stability in autosampler, short and long term stability), dilution integrity and matrix effect. The analyzed validation criteria were fulfilled. The method was applied to a pharmacokinetic study involving 10 healthy volunteers. Following a single intravenous dose of antazoline mesylate (100 mg), the plasma concentration profile showed a relative fast elimination with a terminal elimination half-life of 2.29 h. A relatively high volume of distribution was observed (Vss=315 L). The values of mean residence time (MRT∞), area under the curve (AUC∞) and clearance were 3.45 h, 0.91 mg h L(-1) and 80.5 L h(-1), respectively. One volunteer showed significant differences in pharmacokinetic parameters. In conclusion, the proposed new LC-MS/MS method was successfully used for the first time for the determination of antazoline in human plasma. Copyright © 2016 Elsevier B.V. All rights reserved.

Cytokeratin 8 in Association with sdLDL and ELISA Development

PubMed Central

Ashmaig, Mohmed

2015-01-01

Background: Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality worldwide. Cytokeratins (CKs) which may also be expressed in vascular smooth muscle cells (SMCs) are generally considered to be markers for the differentiation of epithelial cells. Small, dense, low-density lipoprotein (sdLDL) particles, also termed LDL-IV, independently predict risk of CVD. Aims: The aims of this study were to develop an analytical method, apart from ultracentrifugation capable of isolating sdLDL in order to study any associated proteins. Materials and Methods: Using modified gradient gel electrophoresis (GGE), de-identified sdLDL-enriched plasma was used to physically elute and isolate sdLDL particles. To validate the finding, additional plasma from 77 normal and 48 higher risk subjects were used to measure sdLDL particles and CK8. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) and immunoblotting method were used to identify the characteristics of proteins associated with sdLDL. An enzyme-linked immunosorbent assay (ELISA) method was developed and validated for the measurement of CK8 in plasma. Results: The validation of the CK8 ELISA method showed good analytical performance. The isolated sdLDL particles were verified with nondenaturing GGE with the apolipoprotein B component confirmed by Western immunoblotting. Confirmed by SDS-PAGE and Western immunoblotting, CK8 was associated with sdLDL. Two-tailed statistical analysis showed that CK8 and sdLDL particles were significantly higher in the high-risk CVD group compared to control group (P < 0.01 and P < 0.01, respectively). Conclusion: This study reports a novel association between CK8 and sdLDL in individuals with CVD who have a predominance of sdLDL. PMID:26713292

Evaluation of storage and evaporation in the removal efficiency of D-norgestrel and progesterone in human urine.

PubMed

Zanchetta, Priscilla Garozi; Heringer, Otávio; Scherer, Rodrigo; Pacheco, Henrique Poltronieri; Gonçalves, Ricardo; Pena, Angelina

2015-10-01

Pharmaceuticals are emerging contaminants and it must be noted that approximately 70 % of them are excreted via urine. Therefore, urine usage implies the risk of transfer of pharmaceutical residues to agricultural fields and environment contamination. Thus, this study aimed on the development and validation of a LC-MS/MS method for D-norgestrel (D-NOR) and progesterone (PRO) determination in human urine, as well as the evaluation of the removal efficiency of two methods (storage and evaporation), and the effects of acidification with sulfuric acid. The storage process was evaluated for 6 weeks, while the evaporation was assessed at three different temperatures (50, 75, and 100 °C). All experiments were done with normal urine (pH = 6.0) and acidified urine (pH = 2.0, with sulfuric acid). The results of validation showed good method efficiency. In the second week of storage, higher hormone degradation was observed. In the evaporation method, both D-NOR and PRO were almost completely degraded when the volume was reduced to the lowermost level. Results also indicate that acidification did not affect degradation. Overall, the results showed that combination of two methods can be employed for more efficient hormone removal in urine.

Detection of proximal caries using quantitative light-induced fluorescence-digital and laser fluorescence: a comparative study.

PubMed

Yoon, Hyung-In; Yoo, Min-Jeong; Park, Eun-Jin

2017-12-01

The purpose of this study was to evaluate the in vitro validity of quantitative light-induced fluorescence-digital (QLF-D) and laser fluorescence (DIAGNOdent) for assessing proximal caries in extracted premolars, using digital radiography as reference method. A total of 102 extracted premolars with similar lengths and shapes were used. A single operator conducted all the examinations using three different detection methods (bitewing radiography, QLF-D, and DIAGNOdent). The bitewing x-ray scale, QLF-D fluorescence loss (ΔF), and DIAGNOdent peak readings were compared and statistically analyzed. Each method showed an excellent reliability. The correlation coefficient between bitewing radiography and QLF-D, DIAGNOdent were -0.644 and 0.448, respectively, while the value between QLF-D and DIAGNOdent was -0.382. The kappa statistics for bitewing radiography and QLF-D had a higher diagnosis consensus than those for bitewing radiography and DIAGNOdent. The QLF-D was moderately to highly accurate (AUC = 0.753 - 0.908), while DIAGNOdent was moderately to less accurate (AUC = 0.622 - 0.784). All detection methods showed statistically significant correlation and high correlation between the bitewing radiography and QLF-D. QLF-D was found to be a valid and reliable alternative diagnostic method to digital bitewing radiography for in vitro detection of proximal caries.

Life history of the lake herring (Leucichthys artedi Le Sueur) of Lake Huron as revealed by its scales, with a critique of the scale method

USGS Publications Warehouse

Van Oosten, John

1928-01-01

This study shows that the structural characters of the scales of the coregonid fishes of Lake Huron are so clearly recognizable as to permit their use by the scale method. It shows, further, that the fundamental assumptions underlying the scale method are warranted in so far as they apply to the lake herring (Leucichthys artedi Le Sueur). The scale method is therefore valid when applied in a study fo the life history of the lake herring. The life history of the lake herring that occur in Lake Huron is described in detail in this paper for the first time.

A calibration method of infrared LVF based spectroradiometer

NASA Astrophysics Data System (ADS)

Liu, Jiaqing; Han, Shunli; Liu, Lei; Hu, Dexin

2017-10-01

In this paper, a calibration method of LVF-based spectroradiometer is summarize, including spectral calibration and radiometric calibration. The spectral calibration process as follow: first, the relationship between stepping motor's step number and transmission wavelength is derivative by theoretical calculation, including a non-linearity correction of LVF;second, a line-to-line method was used to corrected the theoretical wavelength; Finally, the 3.39 μm and 10.69 μm laser is used for spectral calibration validation, show the sought 0.1% accuracy or better is achieved.A new sub-region multi-point calibration method is used for radiometric calibration to improving accuracy, results show the sought 1% accuracy or better is achieved.

Effect of nonlinearity in hybrid kinetic Monte Carlo-continuum models.

PubMed

Balter, Ariel; Lin, Guang; Tartakovsky, Alexandre M

2012-01-01

Recently there has been interest in developing efficient ways to model heterogeneous surface reactions with hybrid computational models that couple a kinetic Monte Carlo (KMC) model for a surface to a finite-difference model for bulk diffusion in a continuous domain. We consider two representative problems that validate a hybrid method and show that this method captures the combined effects of nonlinearity and stochasticity. We first validate a simple deposition-dissolution model with a linear rate showing that the KMC-continuum hybrid agrees with both a fully deterministic model and its analytical solution. We then study a deposition-dissolution model including competitive adsorption, which leads to a nonlinear rate, and show that in this case the KMC-continuum hybrid and fully deterministic simulations do not agree. However, we are able to identify the difference as a natural result of the stochasticity coming from the KMC surface process. Because KMC captures inherent fluctuations, we consider it to be more realistic than a purely deterministic model. Therefore, we consider the KMC-continuum hybrid to be more representative of a real system.

Effect of Nonlinearity in Hybrid Kinetic Monte Carlo-Continuum Models

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

Balter, Ariel I.; Lin, Guang; Tartakovsky, Alexandre M.

2012-04-23

Recently there has been interest in developing efficient ways to model heterogeneous surface reactions with hybrid computational models that couple a KMC model for a surface to a finite difference model for bulk diffusion in a continuous domain. We consider two representative problems that validate a hybrid method and also show that this method captures the combined effects of nonlinearity and stochasticity. We first validate a simple deposition/dissolution model with a linear rate showing that the KMC-continuum hybrid agrees with both a fully deterministic model and its analytical solution. We then study a deposition/dissolution model including competitive adsorption, which leadsmore » to a nonlinear rate, and show that, in this case, the KMC-continuum hybrid and fully deterministic simulations do not agree. However, we are able to identify the difference as a natural result of the stochasticity coming from the KMC surface process. Because KMC captures inherent fluctuations, we consider it to be more realistic than a purely deterministic model. Therefore, we consider the KMC-continuum hybrid to be more representative of a real system.« less

Numerical Predictions of Wind Turbine Power and Aerodynamic Loads for the NREL Phase II and IV Combined Experiment Rotor

NASA Technical Reports Server (NTRS)

Duque, Earl P. N.; Johnson, Wayne; vanDam, C. P.; Chao, David D.; Cortes, Regina; Yee, Karen

1999-01-01

Accurate, reliable and robust numerical predictions of wind turbine rotor power remain a challenge to the wind energy industry. The literature reports various methods that compare predictions to experiments. The methods vary from Blade Element Momentum Theory (BEM), Vortex Lattice (VL), to variants of Reynolds-averaged Navier-Stokes (RaNS). The BEM and VL methods consistently show discrepancies in predicting rotor power at higher wind speeds mainly due to inadequacies with inboard stall and stall delay models. The RaNS methodologies show promise in predicting blade stall. However, inaccurate rotor vortex wake convection, boundary layer turbulence modeling and grid resolution has limited their accuracy. In addition, the inherently unsteady stalled flow conditions become computationally expensive for even the best endowed research labs. Although numerical power predictions have been compared to experiment. The availability of good wind turbine data sufficient for code validation experimental data that has been extracted from the IEA Annex XIV download site for the NREL Combined Experiment phase II and phase IV rotor. In addition, the comparisons will show data that has been further reduced into steady wind and zero yaw conditions suitable for comparisons to "steady wind" rotor power predictions. In summary, the paper will present and discuss the capabilities and limitations of the three numerical methods and make available a database of experimental data suitable to help other numerical methods practitioners validate their own work.

Liquid chromatography tandem-mass spectrometry (LC-MS/MS) and dried blood spot sampling applied to pharmacokinetics studies in animals: Correlation of classic and block design.

PubMed

Baldo, Matías N; Angeli, Emmanuel; Gareis, Natalia C; Hunzicker, Gabriel A; Murguía, Marcelo C; Ortega, Hugo H; Hein, Gustavo J

2018-04-01

A relative bioavailability study (RBA) of two phenytoin (PHT) formulations was conducted in rabbits, in order to compare the results obtained from different matrices (plasma and blood from dried blood spot (DBS) sampling) and different experimental designs (classic and block). The method was developed by liquid chromatography tandem-mass spectrometry (LC-MS/MS) in plasma and blood samples. The different sample preparation techniques, plasma protein precipitation and DBS, were validated according to international requirements. The analytical method was validated with ranges 0.20-50.80 and 0.12-20.32 µg ml -1 , r > 0.999 for plasma and blood, respectively. Accuracy and precision were within acceptance criteria for bioanalytical assay validation (< 15 for bias and CV% and < 20 for limit of quantification (LOQ)). PHT showed long-term stability, both for plasma and blood, and under refrigerated and room temperature conditions. Haematocrit values were measured during the validation process and RBA study. Finally, the pharmacokinetic parameters (C max , T max and AUC 0-t ) obtained from the RBA study were tested. Results were highly comparable for matrices and experimental designs. A matrix correlation higher than 0.975 and a ratio of (PHT blood) = 1.158 (PHT plasma) were obtained. The results obtained herein show that the use of classic experimental design and DBS sampling for animal pharmacokinetic studies should be encouraged as they could help to prevent the use of a large number of animals and also animal euthanasia. Finally, the combination of DBS sampling with LC-MS/MS technology showed to be an excellent tool not only for therapeutic drug monitoring but also for RBA studies.

A comparative investigation of seven indirect attitude measures.

PubMed

Bar-Anan, Yoav; Nosek, Brian A

2014-09-01

We compared the psychometric qualities of seven indirect attitude measures across three attitude domains (race, politics, and self-esteem) with a large sample (N = 23,413). We compared the measures on internal consistency, sensitivity to known effects, relationships with indirect and direct measures of the same topic, the reliability and validity of single-category attitude measurement, their ability to detect meaningful variance among people with nonextreme attitudes, and their robustness to the exclusion of misbehaving or well-behaving participants. All seven indirect measures correlated with each other and with direct measures of the same topic. These relations were always weak for self-esteem, moderate for race, and strong for politics. This pattern suggests that some of the sources of variation in the reliability and predictive validity of the indirect measures is a function of the concepts rather than the methods. The Implicit Association Test (IAT) and Brief IAT (BIAT) showed the best overall psychometric quality, followed by the Go–No-Go association task, Single-Target IAT (ST-IAT), Affective Misattribution Procedure (AMP), Sorting Paired Features task, and Evaluative Priming. The AMP showed a steep decline in its psychometric qualities when people with extreme attitude scores were removed. Single-category attitude scores computed for the IAT and BIAT showed good relationships with other attitude measures but no evidence of discriminant validity between paired categories. The other measures, especially the AMP and ST-IAT, showed better evidence for discriminant validity. These results inform us on the validity of the measures as attitude assessments, but do not speak to the implicitness of the measured constructs.

Construct Validity of Fresh Frozen Human Cadaver as a Training Model in Minimal Access Surgery

PubMed Central

Macafee, David; Pranesh, Nagarajan; Horgan, Alan F.

2012-01-01

Background: The construct validity of fresh human cadaver as a training tool has not been established previously. The aims of this study were to investigate the construct validity of fresh frozen human cadaver as a method of training in minimal access surgery and determine if novices can be rapidly trained using this model to a safe level of performance. Methods: Junior surgical trainees, novices (<3 laparoscopic procedure performed) in laparoscopic surgery, performed 10 repetitions of a set of structured laparoscopic tasks on fresh frozen cadavers. Expert laparoscopists (>100 laparoscopic procedures) performed 3 repetitions of identical tasks. Performances were scored using a validated, objective Global Operative Assessment of Laparoscopic Skills scale. Scores for 3 consecutive repetitions were compared between experts and novices to determine construct validity. Furthermore, to determine if the novices reached a safe level, a trimmed mean of the experts score was used to define a benchmark. Mann-Whitney U test was used for construct validity analysis and 1-sample t test to compare performances of the novice group with the benchmark safe score. Results: Ten novices and 2 experts were recruited. Four out of 5 tasks (nondominant to dominant hand transfer; simulated appendicectomy; intracorporeal and extracorporeal knot tying) showed construct validity. Novices’ scores became comparable to benchmark scores between the eighth and tenth repetition. Conclusion: Minimal access surgical training using fresh frozen human cadavers appears to have construct validity. The laparoscopic skills of novices can be accelerated through to a safe level within 8 to 10 repetitions. PMID:23318058

The reliability and validity of a short food frequency questionnaire among 9–11-year olds: a multinational study on three middle-income and high-income countries

PubMed Central

Saloheimo, T; González, S A; Erkkola, M; Milauskas, D M; Meisel, J D; Champagne, C M; Tudor-Locke, C; Sarmiento, O; Katzmarzyk, P T; Fogelholm, M

2015-01-01

Objective: The main aim of this study was to assess the reliability and validity of a food frequency questionnaire with 23 food groups (I-FFQ) among a sample of 9–11-year-old children from three different countries that differ on economical development and income distribution, and to assess differences between country sites. Furthermore, we assessed factors associated with I-FFQ's performance. Methods: This was an ancillary study of the International Study of Childhood Obesity, Lifestyle and the Environment. Reliability (n=321) and validity (n=282) components of this study had the same participants. Participation rates were 95% and 70%, respectively. Participants completed two I-FFQs with a mean interval of 4.9 weeks to assess reliability. A 3-day pre-coded food diary (PFD) was used as the reference method in the validity analyses. Wilcoxon signed-rank tests, intraclass correlation coefficients and cross-classifications were used to assess the reliability of I-FFQ. Spearman correlation coefficients, percentage difference and cross-classifications were used to assess the validity of I-FFQ. A logistic regression model was used to assess the relation of selected variables with the estimate of validity. Analyses based on information in the PFDs were performed to assess how participants interpreted food groups. Results: Reliability correlation coefficients ranged from 0.37 to 0.78 and gross misclassification for all food groups was <5%. Validity correlation coefficients were below 0.5 for 22/23 food groups, and they differed among country sites. For validity, gross misclassification was <5% for 22/23 food groups. Over- or underestimation did not appear for 19/23 food groups. Logistic regression showed that country of participation and parental education were associated (P⩽0.05) with the validity of I-FFQ. Analyses of children's interpretation of food groups suggested that the meaning of most food groups was understood by the children. Conclusion: I-FFQ is a moderately reliable method and its validity ranged from low to moderate, depending on food group and country site. PMID:27152180

Analysis of nifedipine in human plasma and amniotic fluid by liquid chromatography-tandem mass spectrometry and its application to clinical pharmacokinetics in hypertensive pregnant women.

PubMed

Filgueira, Gabriela Campos de Oliveira; Filgueira, Osmany Alberto Silva; Carvalho, Daniela Miarelli; Marques, Maria Paula; Moisés, Elaine Christine Dantas; Duarte, Geraldo; Lanchote, Vera Lucia; Cavalli, Ricardo Carvalho

2015-07-01

Nifedipine is a dihydropyridine calcium channel blocker used for the treatment of hypertension in pregnant women. A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed and validated for analysis of nifedipine in human plasma and amniotic fluid. Separation of nifedipine and nitrendipine (IS) was performed using a LiChroCART(®) RP-Select B column and a mixture of water:acetonitrile:glacial acetic acid (30:70:0.5 v/v) as the mobile phase. Aliquots of 500μL of biological samples were extracted at pH 13 using dichloromethane:n-pentane (3:7 v/v). The validated method was applied to a study of the pharmacokinetics of nifedipine in human plasma and amniotic fluid samples collected up to 12h after administration of the last slow-release nifedipine (20mg/12h) dose to 12 hypertensive pregnant women. The estimated pharmacokinetic parameters of nifedipine showed a mean AUC(0-12) of 250.2ngh/mL, ClT/F of 89.2L/h, Vd/F of 600.0L and t1/2 5.1h. The mean amniotic fluid/plasma concentration ratio was 0.05. The methods proved to be highly sensitive by showing a lower quantification limit of 0.1ng/mL for both matrices. And this study reports for the first time the complete development and validation of the method to quantify nifedipine in amniotic fluid using LC-MS-MS. Copyright © 2015 Elsevier B.V. All rights reserved.

Identifying outliers of non-Gaussian groundwater state data based on ensemble estimation for long-term trends

NASA Astrophysics Data System (ADS)

Jeong, Jina; Park, Eungyu; Han, Weon Shik; Kim, Kueyoung; Choung, Sungwook; Chung, Il Moon

2017-05-01

A hydrogeological dataset often includes substantial deviations that need to be inspected. In the present study, three outlier identification methods - the three sigma rule (3σ), inter quantile range (IQR), and median absolute deviation (MAD) - that take advantage of the ensemble regression method are proposed by considering non-Gaussian characteristics of groundwater data. For validation purposes, the performance of the methods is compared using simulated and actual groundwater data with a few hypothetical conditions. In the validations using simulated data, all of the proposed methods reasonably identify outliers at a 5% outlier level; whereas, only the IQR method performs well for identifying outliers at a 30% outlier level. When applying the methods to real groundwater data, the outlier identification performance of the IQR method is found to be superior to the other two methods. However, the IQR method shows limitation by identifying excessive false outliers, which may be overcome by its joint application with other methods (for example, the 3σ rule and MAD methods). The proposed methods can be also applied as potential tools for the detection of future anomalies by model training based on currently available data.

Development and validation of reverse phase high performance liquid chromatography for citral analysis from essential oils.

PubMed

Gaonkar, Roopa; Yallappa, S; Dhananjaya, B L; Hegde, Gurumurthy

2016-11-15

Citral is a widely used monoterpene aldehyde in aromatherapy, food and pesticide industries. A new validated reverse phase high performance liquid chromatography (RP - HPLC) procedure for the detection and quantification of cis-trans isomers of citral was developed. The RP-HPLC analysis was carried out using Enable C - 18G column (250×4.6mm, 5μ), with acetonitrile and water (70: 30) mobile phase in isocratic mode at 1mL/min flow. A photodiode array (PDA) detector was set at 233nm for the detection of citral. The method showed linearity, selectivity and accuracy for citral in the range of 3-100μg/mL. In order to compare the new RP-HPLC method with the available methods, one of the commercially available essential oil from Cymbopogon flexuosus was analyzed using new RP-HPLC method and the same was analyzed using GC-MS for the comparison of the method for the detection of citral. The GC-MS analysis was done using mass selective detector (MSD) showed citral content to be of 72.76%; wherein the new method showed to contain that same at 74.98%. To prove the application of the new method, essential oils were extracted from lemongrass, lemon leaves and mosambi peels by steam distillation. The citral content present in the essential and also in the condensate was analyzed. The method was found to be suitable for the analysis of citral in essential oils and water based citral formulations with a very good resolution of its components geranial and neral. Copyright © 2016 Elsevier B.V. All rights reserved.

WEIGHING GALAXY CLUSTERS WITH GAS. I. ON THE METHODS OF COMPUTING HYDROSTATIC MASS BIAS

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

Lau, Erwin T.; Nagai, Daisuke; Nelson, Kaylea, E-mail: erwin.lau@yale.edu

2013-11-10

Mass estimates of galaxy clusters from X-ray and Sunyeav-Zel'dovich observations assume the intracluster gas is in hydrostatic equilibrium with their gravitational potential. However, since galaxy clusters are dynamically active objects whose dynamical states can deviate significantly from the equilibrium configuration, the departure from the hydrostatic equilibrium assumption is one of the largest sources of systematic uncertainties in cluster cosmology. In the literature there have been two methods for computing the hydrostatic mass bias based on the Euler and the modified Jeans equations, respectively, and there has been some confusion about the validity of these two methods. The word 'Jeans' wasmore » a misnomer, which incorrectly implies that the gas is collisionless. To avoid further confusion, we instead refer these methods as 'summation' and 'averaging' methods respectively. In this work, we show that these two methods for computing the hydrostatic mass bias are equivalent by demonstrating that the equation used in the second method can be derived from taking spatial averages of the Euler equation. Specifically, we identify the correspondences of individual terms in these two methods mathematically and show that these correspondences are valid to within a few percent level using hydrodynamical simulations of galaxy cluster formation. In addition, we compute the mass bias associated with the acceleration of gas and show that its contribution is small in the virialized regions in the interior of galaxy clusters, but becomes non-negligible in the outskirts of massive galaxy clusters. We discuss future prospects of understanding and characterizing biases in the mass estimate of galaxy clusters using both hydrodynamical simulations and observations and their implications for cluster cosmology.« less

Weighing Galaxy Clusters with Gas. I. On the Methods of Computing Hydrostatic Mass Bias

NASA Astrophysics Data System (ADS)

Lau, Erwin T.; Nagai, Daisuke; Nelson, Kaylea

2013-11-01

Mass estimates of galaxy clusters from X-ray and Sunyeav-Zel'dovich observations assume the intracluster gas is in hydrostatic equilibrium with their gravitational potential. However, since galaxy clusters are dynamically active objects whose dynamical states can deviate significantly from the equilibrium configuration, the departure from the hydrostatic equilibrium assumption is one of the largest sources of systematic uncertainties in cluster cosmology. In the literature there have been two methods for computing the hydrostatic mass bias based on the Euler and the modified Jeans equations, respectively, and there has been some confusion about the validity of these two methods. The word "Jeans" was a misnomer, which incorrectly implies that the gas is collisionless. To avoid further confusion, we instead refer these methods as "summation" and "averaging" methods respectively. In this work, we show that these two methods for computing the hydrostatic mass bias are equivalent by demonstrating that the equation used in the second method can be derived from taking spatial averages of the Euler equation. Specifically, we identify the correspondences of individual terms in these two methods mathematically and show that these correspondences are valid to within a few percent level using hydrodynamical simulations of galaxy cluster formation. In addition, we compute the mass bias associated with the acceleration of gas and show that its contribution is small in the virialized regions in the interior of galaxy clusters, but becomes non-negligible in the outskirts of massive galaxy clusters. We discuss future prospects of understanding and characterizing biases in the mass estimate of galaxy clusters using both hydrodynamical simulations and observations and their implications for cluster cosmology.

Development and validation of LC-HRMS and GC-NICI-MS methods for stereoselective determination of MDMA and its phase I and II metabolites in human urine

PubMed Central

Schwaninger, Andrea E.; Meyer, Markus R.; Huestis, Marilyn A.; Maurer, Hans H.

2013-01-01

3,4-Methylenedioxymethamphetamine (MDMA) is a racemic drug of abuse and its R- and S-enantiomers are known to differ in their dose-response curve. The S-enantiomer was shown to be eliminated at a higher rate than the R-enantiomer most likely explained by stereoselective metabolism that was observed in various in vitro experiments. The aim of this work was the development and validation of methods for evaluating the stereoselective elimination of phase I and particularly phase II metabolites of MDMA in human urine. Urine samples were divided into three different methods. Method A allowed stereoselective determination of the 4-hydroxy-3-methoxymethamphetamine (HMMA) glucuronides and only achiral determination of the intact sulfate conjugates of HMMA and 3,4-dihydroxymethamphetamine (DHMA) after C18 solid-phase extraction by liquid chromatography–high-resolution mass spectrometry with electrospray ionization. Method B allowed the determination of the enantiomer ratios of DHMA and HMMA sulfate conjugates after selective enzymatic cleavage and chiral analysis of the corresponding deconjugated metabolites after chiral derivatization with S-heptafluorobutyrylprolyl chloride using gas chromatography–mass spectrometry with negativeion chemical ionization. Method C allowed the chiral determination of MDMA and its unconjugated metabolites using method B without sulfate cleavage. The validation process including specificity, recovery, matrix effects, process efficiency, accuracy and precision, stabilities and limits of quantification and detection showed that all methods were selective, sensitive, accurate and precise for all tested analytes. PMID:21656610

A Comparison of Three Different Scoring Methods for Self-Report Measures of Psychological Aggression in a Sample of College Females

PubMed Central

Shorey, Ryan C.; Brasfield, Hope; Febres, Jeniimarie; Cornelius, Tara L.; Stuart, Gregory L.

2012-01-01

Psychological aggression in females’ dating relationships has received increased empirical attention in recent years. However, researchers have used numerous measures of psychological aggression, and various scoring methods with these measures, making it difficult to compare across studies on psychological aggression. In addition, research has yet to examine whether different scoring methods for psychological aggression measures may affect the psychometric properties of these instruments. The current study examined three self-report measures of psychological aggression within a sample of female college students (N = 108), including their psychometric properties when scored using frequency, sum, and variety scores. Results showed that the Revised Conflict Tactics Scales (CTS2) had variable internal consistency depending on the scoring method used and good validity; the Multidimensional Measure of Emotional Abuse (MMEA) and the Follingstad Psychological Aggression Scale (FPAS) both had good internal consistency and validity across scoring methods. Implications of these findings for the assessment of psychological aggression and future research are discussed. PMID:23393957

A comparison of three different scoring methods for self-report measures of psychological aggression in a sample of college females.

PubMed

Shorey, Ryan C; Brasfield, Hope; Febres, Jeniimarie; Cornelius, Tara L; Stuart, Gregory L

2012-01-01

Psychological aggression in females' dating relationships has received increased empirical attention in recent years. However, researchers' have used numerous measures of psychological aggression and various scoring methods with these measures, making it difficult to compare across studies on psychological aggression. In addition, research has yet to examine whether different scoring methods for psychological aggression measures may affect the psychometric properties of these instruments. This study examined three self-report measures of psychological aggression within a sample of female college students (N = 108), including their psychometric properties when scored using frequency, sum, and variety scores. Results showed that the Revised Conflict Tactics Scales (CTS2) had variable internal consistency depending on the scoring method used and good validity; the Multidimensional Measure of Emotional Abuse (MMEA) and the Follingstad Psychological Aggression Scale (FPAS) both had good internal consistency and validity across scoring methods. Implications of these findings for the assessment of psychological aggression and future research are discussed.

Fracture toughness testing of Linde 1092 reactor vessel welds in the transition range using Charpy-sized specimens

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

Pavinich, W.A.; Yoon, K.K.; Hour, K.Y.

1999-10-01

The present reference toughness method for predicting the change in fracture toughness can provide over estimates of these values because of uncertainties in initial RT{sub NDT} and shift correlations. It would be preferable to directly measure fracture toughness. However, until recently, no standard method was available to characterize fracture toughness in the transition range. ASTM E08 has developed a draft standard that shows promise for providing lower bound transition range fracture toughness using the master curve approach. This method has been successfully implemented using 1T compact fracture specimens. Combustion Engineering reactor vessel surveillance programs do not have compact fracture specimens.more » Therefore, the CE Owners Group developed a program to validate the master curve method for Charpy-sized and reconstituted Charpy-sized specimens for future application on irradiated specimens. This method was validated for Linde 1092 welds using unirradiated Charpy-sized and reconstituted Charpy-sized specimens by comparison of results with those from compact fracture specimens.« less

Verification and Validation in a Rapid Software Development Process

NASA Technical Reports Server (NTRS)

Callahan, John R.; Easterbrook, Steve M.

1997-01-01

The high cost of software production is driving development organizations to adopt more automated design and analysis methods such as rapid prototyping, computer-aided software engineering (CASE) tools, and high-level code generators. Even developers of safety-critical software system have adopted many of these new methods while striving to achieve high levels Of quality and reliability. While these new methods may enhance productivity and quality in many cases, we examine some of the risks involved in the use of new methods in safety-critical contexts. We examine a case study involving the use of a CASE tool that automatically generates code from high-level system designs. We show that while high-level testing on the system structure is highly desirable, significant risks exist in the automatically generated code and in re-validating releases of the generated code after subsequent design changes. We identify these risks and suggest process improvements that retain the advantages of rapid, automated development methods within the quality and reliability contexts of safety-critical projects.

An enhanced multi-view vertical line locus matching algorithm of object space ground primitives based on positioning consistency for aerial and space images

NASA Astrophysics Data System (ADS)

Zhang, Ka; Sheng, Yehua; Wang, Meizhen; Fu, Suxia

2018-05-01

The traditional multi-view vertical line locus (TMVLL) matching method is an object-space-based method that is commonly used to directly acquire spatial 3D coordinates of ground objects in photogrammetry. However, the TMVLL method can only obtain one elevation and lacks an accurate means of validating the matching results. In this paper, we propose an enhanced multi-view vertical line locus (EMVLL) matching algorithm based on positioning consistency for aerial or space images. The algorithm involves three components: confirming candidate pixels of the ground primitive in the base image, multi-view image matching based on the object space constraints for all candidate pixels, and validating the consistency of the object space coordinates with the multi-view matching result. The proposed algorithm was tested using actual aerial images and space images. Experimental results show that the EMVLL method successfully solves the problems associated with the TMVLL method, and has greater reliability, accuracy and computing efficiency.

Estimation of Monthly Near Surface Air Temperature Using Geographically Weighted Regression in China

NASA Astrophysics Data System (ADS)

Wang, M. M.; He, G. J.; Zhang, Z. M.; Zhang, Z. J.; Liu, X. G.

2018-04-01

Near surface air temperature (NSAT) is a primary descriptor of terrestrial environment conditions. The availability of NSAT with high spatial resolution is deemed necessary for several applications such as hydrology, meteorology and ecology. In this study, a regression-based NSAT mapping method is proposed. This method is combined remote sensing variables with geographical variables, and uses geographically weighted regression to estimate NSAT. The altitude was selected as geographical variable; and the remote sensing variables include land surface temperature (LST) and Normalized Difference vegetation index (NDVI). The performance of the proposed method was assessed by predict monthly minimum, mean, and maximum NSAT from point station measurements in China, a domain with a large area, complex topography, and highly variable station density, and the NSAT maps were validated against the meteorology observations. Validation results with meteorological data show the proposed method achieved an accuracy of 1.58 °C. It is concluded that the proposed method for mapping NSAT is very operational and has good precision.

Extended Finite Element Method with Simplified Spherical Harmonics Approximation for the Forward Model of Optical Molecular Imaging

PubMed Central

Li, Wei; Yi, Huangjian; Zhang, Qitan; Chen, Duofang; Liang, Jimin

2012-01-01

An extended finite element method (XFEM) for the forward model of 3D optical molecular imaging is developed with simplified spherical harmonics approximation (SPN). In XFEM scheme of SPN equations, the signed distance function is employed to accurately represent the internal tissue boundary, and then it is used to construct the enriched basis function of the finite element scheme. Therefore, the finite element calculation can be carried out without the time-consuming internal boundary mesh generation. Moreover, the required overly fine mesh conforming to the complex tissue boundary which leads to excess time cost can be avoided. XFEM conveniences its application to tissues with complex internal structure and improves the computational efficiency. Phantom and digital mouse experiments were carried out to validate the efficiency of the proposed method. Compared with standard finite element method and classical Monte Carlo (MC) method, the validation results show the merits and potential of the XFEM for optical imaging. PMID:23227108

Extended finite element method with simplified spherical harmonics approximation for the forward model of optical molecular imaging.

PubMed

Li, Wei; Yi, Huangjian; Zhang, Qitan; Chen, Duofang; Liang, Jimin

2012-01-01

An extended finite element method (XFEM) for the forward model of 3D optical molecular imaging is developed with simplified spherical harmonics approximation (SP(N)). In XFEM scheme of SP(N) equations, the signed distance function is employed to accurately represent the internal tissue boundary, and then it is used to construct the enriched basis function of the finite element scheme. Therefore, the finite element calculation can be carried out without the time-consuming internal boundary mesh generation. Moreover, the required overly fine mesh conforming to the complex tissue boundary which leads to excess time cost can be avoided. XFEM conveniences its application to tissues with complex internal structure and improves the computational efficiency. Phantom and digital mouse experiments were carried out to validate the efficiency of the proposed method. Compared with standard finite element method and classical Monte Carlo (MC) method, the validation results show the merits and potential of the XFEM for optical imaging.

The Importance of Method Selection in Determining Product Integrity for Nutrition Research1234

PubMed Central

Mudge, Elizabeth M; Brown, Paula N

2016-01-01

The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application. PMID:26980823

The Importance of Method Selection in Determining Product Integrity for Nutrition Research.

PubMed

Mudge, Elizabeth M; Betz, Joseph M; Brown, Paula N

2016-03-01

The American Herbal Products Association estimates that there as many as 3000 plant species in commerce. The FDA estimates that there are about 85,000 dietary supplement products in the marketplace. The pace of product innovation far exceeds that of analytical methods development and validation, with new ingredients, matrixes, and combinations resulting in an analytical community that has been unable to keep up. This has led to a lack of validated analytical methods for dietary supplements and to inappropriate method selection where methods do exist. Only after rigorous validation procedures to ensure that methods are fit for purpose should they be used in a routine setting to verify product authenticity and quality. By following systematic procedures and establishing performance requirements for analytical methods before method development and validation, methods can be developed that are both valid and fit for purpose. This review summarizes advances in method selection, development, and validation regarding herbal supplement analysis and provides several documented examples of inappropriate method selection and application. © 2016 American Society for Nutrition.

Development and validation of a simple and sensitive method for quantification of levodopa and carbidopa in rat and monkey plasma using derivatization and UPLC-MS/MS.

PubMed

Junnotula, Venkatraman; Licea-Perez, Hermes

2013-05-01

A simple, selective, and sensitive quantitative method has been developed for the simultaneous determination of levodopa and carbidopa in rat and monkey plasma by protein precipitation using acetonitrile containing the derivatizing reagent, flourescamine. Derivatized products of levodopa and carbidopa were separated on a BEH C18 column (2.1 mm × 50 mm; 1.7 μm particle size) using ultra high performance liquid chromatography (UHPLC) without any further purification. Tandem mass spectrometry (MS/MS) was used for detection. The method was validated over the concentration range of 5-5000 ng/mL and 3-3000 ng/mL for levodopa and carbidopa, respectively in rat and monkey plasma. Due to the poor stability of the investigated analytes in biological matrices, a mixture of sodium metabisulfite and hydrazine dihydrochloride was used as a stabilizer. This method was successfully utilized to support pharmacokinetic studies in both species. The results from assay validations and incurred samples re-analysis show that the method is selective, sensitive and robust. To our knowledge, this is the first UHPLC-MS/MS based method that utilizes derivatization with fluorescamine and provides adequate sensitivity for both levodopa and carbidopa with 50 μL of sample and a run time of 3.5 min. Copyright © 2013 Elsevier B.V. All rights reserved.

Psychometric Arabic Sino-Nasal Outcome Test-22: validation and translation in chronic rhinosinusitis patients.

PubMed

Alanazy, Fatma; Dousary, Surayie Al; Albosaily, Ahmed; Aldriweesh, Turki; Alsaleh, Saad; Aldrees, Turki

2018-01-01

The Sino-Nasal Outcome Test (SNOT)-22 has multiple items that reflect how nasal disease affects quality of life. Currently, no validated Arabic version of the SNOT-22 is available. . To develop an Arabic-validated version of SNOT-22. Prospective. Tertiary care center. This single-center validation study was conducted between 2015 and 2017 at King Abdul-Aziz University Hospital, Riyadh, Saudi Arabia. The SNOT-22 English version was translated into Arabic by the forward and backward method. The test and retest reliability, internal consistency, responsiveness to surgical treatment, discriminant validity, sensitivity and specificity all were tested. Validated Arabic version of the SNOT-22. Of 265 individuals, 171 were healthy volunteers and 94 were chronic rhinosinusitis patients. The Arabic version showed high internal consistency (Cronbach's of 0.94), and the ability to differentiate between diseased and healthy volunteers (P < .001). The translated versions demonstrated the ability to detect the change scores significantly in response to intervention (P < .001). This is the first validated Arabic version of SNOT-22. The instrument can be used among the Arabic population. No subjects from other Arab countries.

Analysis of an ABE Scheme with Verifiable Outsourced Decryption.

PubMed

Liao, Yongjian; He, Yichuan; Li, Fagen; Jiang, Shaoquan; Zhou, Shijie

2018-01-10

Attribute-based encryption (ABE) is a popular cryptographic technology to protect the security of users' data in cloud computing. In order to reduce its decryption cost, outsourcing the decryption of ciphertexts is an available method, which enables users to outsource a large number of decryption operations to the cloud service provider. To guarantee the correctness of transformed ciphertexts computed by the cloud server via the outsourced decryption, it is necessary to check the correctness of the outsourced decryption to ensure security for the data of users. Recently, Li et al. proposed a full verifiability of the outsourced decryption of ABE scheme (ABE-VOD) for the authorized users and unauthorized users, which can simultaneously check the correctness of the transformed ciphertext for both them. However, in this paper we show that their ABE-VOD scheme cannot obtain the results which they had shown, such as finding out all invalid ciphertexts, and checking the correctness of the transformed ciphertext for the authorized user via checking it for the unauthorized user. We first construct some invalid ciphertexts which can pass the validity checking in the decryption algorithm. That means their "verify-then-decrypt" skill is unavailable. Next, we show that the method to check the validity of the outsourced decryption for the authorized users via checking it for the unauthorized users is not always correct. That is to say, there exist some invalid ciphertexts which can pass the validity checking for the unauthorized user, but cannot pass the validity checking for the authorized user.

Analysis of an ABE Scheme with Verifiable Outsourced Decryption

PubMed Central

He, Yichuan; Li, Fagen; Jiang, Shaoquan; Zhou, Shijie

2018-01-01

Attribute-based encryption (ABE) is a popular cryptographic technology to protect the security of users’ data in cloud computing. In order to reduce its decryption cost, outsourcing the decryption of ciphertexts is an available method, which enables users to outsource a large number of decryption operations to the cloud service provider. To guarantee the correctness of transformed ciphertexts computed by the cloud server via the outsourced decryption, it is necessary to check the correctness of the outsourced decryption to ensure security for the data of users. Recently, Li et al. proposed a full verifiability of the outsourced decryption of ABE scheme (ABE-VOD) for the authorized users and unauthorized users, which can simultaneously check the correctness of the transformed ciphertext for both them. However, in this paper we show that their ABE-VOD scheme cannot obtain the results which they had shown, such as finding out all invalid ciphertexts, and checking the correctness of the transformed ciphertext for the authorized user via checking it for the unauthorized user. We first construct some invalid ciphertexts which can pass the validity checking in the decryption algorithm. That means their “verify-then-decrypt” skill is unavailable. Next, we show that the method to check the validity of the outsourced decryption for the authorized users via checking it for the unauthorized users is not always correct. That is to say, there exist some invalid ciphertexts which can pass the validity checking for the unauthorized user, but cannot pass the validity checking for the authorized user. PMID:29320418

The validation of the visual analogue scale for patient satisfaction after total hip arthroplasty.

PubMed

Brokelman, Roy B G; Haverkamp, Daniel; van Loon, Corné; Hol, Annemiek; van Kampen, Albert; Veth, Rene

2012-06-01

INTRODUCTION: Patient satisfaction becomes more important in our modern health care system. The assessment of satisfaction is difficult because it is a multifactorial item for which no golden standard exists. One of the potential methods of measuring satisfaction is by using the well-known visual analogue scale (VAS). In this study, we validated VAS for satisfaction. PATIENT AND METHODS: In this prospective study, we studied 147 patients (153 hips). The construct validity was measured using the Spearman correlation test that compares the satisfaction VAS with the Harris hip score, pain VAS at rest and during activity, Oxford hip score, Short Form 36 and Western Ontario McMaster Universities Osteoarthritis Index. The reliability was tested using the intra-class coefficient. RESULTS: The Pearson correlation test showed correlations in the range of 0.40-0.80. The satisfaction VAS had a high correlation between the pain VAS and Oxford hip score, which could mean that pain is one of the most important factors in patient satisfaction. The intra-class coefficient was 0.95. CONCLUSIONS: There is a moderate to mark degree of correlation between the satisfaction VAS and the currently available subjective and objective scoring systems. The intra-class coefficient of 0.95 indicates an excellent test-retest reliability. The VAS satisfaction is a simple instrument to quantify the satisfaction of a patient after total hip arthroplasty. In this study, we showed that the satisfaction VAS has a good validity and reliability.

Validation of selected analytical methods using accuracy profiles to assess the impact of a Tobacco Heating System on indoor air quality.

PubMed

Mottier, Nicolas; Tharin, Manuel; Cluse, Camille; Crudo, Jean-René; Lueso, María Gómez; Goujon-Ginglinger, Catherine G; Jaquier, Anne; Mitova, Maya I; Rouget, Emmanuel G R; Schaller, Mathieu; Solioz, Jennifer

2016-09-01

Studies in environmentally controlled rooms have been used over the years to assess the impact of environmental tobacco smoke on indoor air quality. As new tobacco products are developed, it is important to determine their impact on air quality when used indoors. Before such an assessment can take place it is essential that the analytical methods used to assess indoor air quality are validated and shown to be fit for their intended purpose. Consequently, for this assessment, an environmentally controlled room was built and seven analytical methods, representing eighteen analytes, were validated. The validations were carried out with smoking machines using a matrix-based approach applying the accuracy profile procedure. The performances of the methods were compared for all three matrices under investigation: background air samples, the environmental aerosol of Tobacco Heating System THS 2.2, a heat-not-burn tobacco product developed by Philip Morris International, and the environmental tobacco smoke of a cigarette. The environmental aerosol generated by the THS 2.2 device did not have any appreciable impact on the performances of the methods. The comparison between the background and THS 2.2 environmental aerosol samples generated by smoking machines showed that only five compounds were higher when THS 2.2 was used in the environmentally controlled room. Regarding environmental tobacco smoke from cigarettes, the yields of all analytes were clearly above those obtained with the other two air sample types. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

Application of the Modular Approach to an In-House Validation Study of Real-Time PCR Methods for the Detection and Serogroup Determination of Verocytotoxigenic Escherichia coli ▿ †

PubMed Central

Kagkli, Dafni-Maria; Weber, Thomas P.; Van den Bulcke, Marc; Folloni, Silvia; Tozzoli, Rosangela; Morabito, Stefano; Ermolli, Monica; Gribaldo, Laura; Van den Eede, Guy

2011-01-01

European Commission regulation 2073/2005 on the microbiological criteria for food requires that Escherichia coli is monitored as an indicator of hygienic conditions. Since verocytotoxigenic E. coli (VTEC) strains often cause food-borne infections by the consumption of raw food, the Biological Hazards (BIOHAZ) panel of the European Food Safety Authority (EFSA) recommended their monitoring in food as well. In particular, VTEC strains belonging to serogroups such as O26, O103, O111, O145, and O157 are known causative agents of several human outbreaks. Eight real-time PCR methods for the detection of E. coli toxin genes and their variants (stx1, stx2), the intimin gene (eae), and five serogroup-specific genes have been proposed by the European Reference Laboratory for VTEC (EURL-VTEC) as a technical specification to the European Normalization Committee (CEN TC275/WG6). Here we applied a “modular approach” to the in-house validation of these PCR methods. The modular approach subdivides an analytical process into separate parts called “modules,” which are independently validated based on method performance criteria for a limited set of critical parameters. For the VTEC real-time PCR module, the following parameters are being assessed: specificity, dynamic range, PCR efficiency, and limit of detection (LOD). This study describes the modular approach for the validation of PCR methods to be used in food microbiology, using single-target plasmids as positive controls and showing their applicability with food matrices. PMID:21856838

Validation of Bayesian analysis of compartmental kinetic models in medical imaging.

PubMed

Sitek, Arkadiusz; Li, Quanzheng; El Fakhri, Georges; Alpert, Nathaniel M

2016-10-01

Kinetic compartmental analysis is frequently used to compute physiologically relevant quantitative values from time series of images. In this paper, a new approach based on Bayesian analysis to obtain information about these parameters is presented and validated. The closed-form of the posterior distribution of kinetic parameters is derived with a hierarchical prior to model the standard deviation of normally distributed noise. Markov chain Monte Carlo methods are used for numerical estimation of the posterior distribution. Computer simulations of the kinetics of F18-fluorodeoxyglucose (FDG) are used to demonstrate drawing statistical inferences about kinetic parameters and to validate the theory and implementation. Additionally, point estimates of kinetic parameters and covariance of those estimates are determined using the classical non-linear least squares approach. Posteriors obtained using methods proposed in this work are accurate as no significant deviation from the expected shape of the posterior was found (one-sided P>0.08). It is demonstrated that the results obtained by the standard non-linear least-square methods fail to provide accurate estimation of uncertainty for the same data set (P<0.0001). The results of this work validate new methods for a computer simulations of FDG kinetics. Results show that in situations where the classical approach fails in accurate estimation of uncertainty, Bayesian estimation provides an accurate information about the uncertainties in the parameters. Although a particular example of FDG kinetics was used in the paper, the methods can be extended for different pharmaceuticals and imaging modalities. Copyright © 2016 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Quantitative Method for Simultaneous Analysis of Acetaminophen and 6 Metabolites.

PubMed

Lammers, Laureen A; Achterbergh, Roos; Pistorius, Marcel C M; Romijn, Johannes A; Mathôt, Ron A A

2017-04-01

Hepatotoxicity after ingestion of high-dose acetaminophen [N-acetyl-para-aminophenol (APAP)] is caused by the metabolites of the drug. To gain more insight into factors influencing susceptibility to APAP hepatotoxicity, quantification of APAP and metabolites is important. A few methods have been developed to simultaneously quantify APAP and its most important metabolites. However, these methods require a comprehensive sample preparation and long run times. The aim of this study was to develop and validate a simplified, but sensitive method for the simultaneous quantification of acetaminophen, the main metabolites acetaminophen glucuronide and acetaminophen sulfate, and 4 Cytochrome P450-mediated metabolites by using liquid chromatography with mass spectrometric (LC-MS) detection. The method was developed and validated for the human plasma, and it entailed a single method for sample preparation, enabling quick processing of the samples followed by an LC-MS method with a chromatographic run time of 9 minutes. The method was validated for selectivity, linearity, accuracy, imprecision, dilution integrity, recovery, process efficiency, ionization efficiency, and carryover effect. The method showed good selectivity without matrix interferences. For all analytes, the mean process efficiency was >86%, and the mean ionization efficiency was >94%. Furthermore, the accuracy was between 90.3% and 112% for all analytes, and the within- and between-run imprecision were <20% for the lower limit of quantification and <14.3% for the middle level and upper limit of quantification. The method presented here enables the simultaneous quantification of APAP and 6 of its metabolites. It is less time consuming than previously reported methods because it requires only a single and simple method for the sample preparation followed by an LC-MS method with a short run time. Therefore, this analytical method provides a useful method for both clinical and research purposes.

Method validation for chemical composition determination by electron microprobe with wavelength dispersive spectrometer

NASA Astrophysics Data System (ADS)

Herrera-Basurto, R.; Mercader-Trejo, F.; Muñoz-Madrigal, N.; Juárez-García, J. M.; Rodriguez-López, A.; Manzano-Ramírez, A.

2016-07-01

The main goal of method validation is to demonstrate that the method is suitable for its intended purpose. One of the advantages of analytical method validation is translated into a level of confidence about the measurement results reported to satisfy a specific objective. Elemental composition determination by wavelength dispersive spectrometer (WDS) microanalysis has been used over extremely wide areas, mainly in the field of materials science, impurity determinations in geological, biological and food samples. However, little information is reported about the validation of the applied methods. Herein, results of the in-house method validation for elemental composition determination by WDS are shown. SRM 482, a binary alloy Cu-Au of different compositions, was used during the validation protocol following the recommendations for method validation proposed by Eurachem. This paper can be taken as a reference for the evaluation of the validation parameters more frequently requested to get the accreditation under the requirements of the ISO/IEC 17025 standard: selectivity, limit of detection, linear interval, sensitivity, precision, trueness and uncertainty. A model for uncertainty estimation was proposed including systematic and random errors. In addition, parameters evaluated during the validation process were also considered as part of the uncertainty model.

Computer simulation of Cerebral Arteriovenous Malformation-validation analysis of hemodynamics parameters.

PubMed

Kumar, Y Kiran; Mehta, Shashi Bhushan; Ramachandra, Manjunath

2017-01-01

The purpose of this work is to provide some validation methods for evaluating the hemodynamic assessment of Cerebral Arteriovenous Malformation (CAVM). This article emphasizes the importance of validating noninvasive measurements for CAVM patients, which are designed using lumped models for complex vessel structure. The validation of the hemodynamics assessment is based on invasive clinical measurements and cross-validation techniques with the Philips proprietary validated software's Qflow and 2D Perfursion. The modeling results are validated for 30 CAVM patients for 150 vessel locations. Mean flow, diameter, and pressure were compared between modeling results and with clinical/cross validation measurements, using an independent two-tailed Student t test. Exponential regression analysis was used to assess the relationship between blood flow, vessel diameter, and pressure between them. Univariate analysis is used to assess the relationship between vessel diameter, vessel cross-sectional area, AVM volume, AVM pressure, and AVM flow results were performed with linear or exponential regression. Modeling results were compared with clinical measurements from vessel locations of cerebral regions. Also, the model is cross validated with Philips proprietary validated software's Qflow and 2D Perfursion. Our results shows that modeling results and clinical results are nearly matching with a small deviation. In this article, we have validated our modeling results with clinical measurements. The new approach for cross-validation is proposed by demonstrating the accuracy of our results with a validated product in a clinical environment.

Identification and validation of loss of function variants in clinical contexts.

PubMed

Lescai, Francesco; Marasco, Elena; Bacchelli, Chiara; Stanier, Philip; Mantovani, Vilma; Beales, Philip

2014-01-01

The choice of an appropriate variant calling pipeline for exome sequencing data is becoming increasingly more important in translational medicine projects and clinical contexts. Within GOSgene, which facilitates genetic analysis as part of a joint effort of the University College London and the Great Ormond Street Hospital, we aimed to optimize a variant calling pipeline suitable for our clinical context. We implemented the GATK/Queue framework and evaluated the performance of its two callers: the classical UnifiedGenotyper and the new variant discovery tool HaplotypeCaller. We performed an experimental validation of the loss-of-function (LoF) variants called by the two methods using Sequenom technology. UnifiedGenotyper showed a total validation rate of 97.6% for LoF single-nucleotide polymorphisms (SNPs) and 92.0% for insertions or deletions (INDELs), whereas HaplotypeCaller was 91.7% for SNPs and 55.9% for INDELs. We confirm that GATK/Queue is a reliable pipeline in translational medicine and clinical context. We conclude that in our working environment, UnifiedGenotyper is the caller of choice, being an accurate method, with a high validation rate of error-prone calls like LoF variants. We finally highlight the importance of experimental validation, especially for INDELs, as part of a standard pipeline in clinical environments.

Questionnaire to assess patient satisfaction with pharmaceutical care in Spanish language.

PubMed

Traverso, María Luz; Salamano, Mercedes; Botta, Carina; Colautti, Marisel; Palchik, Valeria; Pérez, Beatriz

2007-08-01

To develop and validate a questionnaire, in Spanish, for assessing patient satisfaction with pharmaceutical care received in community pharmacies. Selection and translation of questionnaire's items; definition of response scale and demographic questions. Evaluation of face and content validity, feasibility, factor structure, reliability and construct validity. Forty-one community pharmacies of the province of Santa Fe. Argentina. Questionnaire administered to patients receiving pharmaceutical care or traditional pharmacy services. Pilot test to assess feasibility. Factor analysis used principal components and varimax rotation. Reliability established using internal consistency with Cronbach's alpha. Construct validity determined with extreme group method. A self-administered questionnaire with 27 items, 5-point Likert response scale and demographic questions was designed considering multidimensional structure of patient satisfaction. Questionnaire evaluates cumulative experience of patients with comprehensive pharmaceutical care practice in community pharmacies. Two hundred and seventy-four complete questionnaires were obtained. Factor analysis resulted in three factors: Managing therapy, Interpersonal relationship and General satisfaction, with a cumulative variance of 62.51%. Cronbach's alpha for the whole questionnaire was 0.96, and 0.95, 0.88 and 0.76 for the three factors, respectively. Mann-Whitney test for construct validity did not showed significant differences between pharmacies that provide pharmaceutical care and those that do not, however, 23 items showed significant differences between the two groups of pharmacies. The questionnaire developed can be a reliable and valid instrument to assess patient satisfaction with pharmaceutical care in community pharmacies in Spanish. Further research is needed to deepen the validation process.

OWL-based reasoning methods for validating archetypes.

PubMed

Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás

2013-04-01

Some modern Electronic Healthcare Record (EHR) architectures and standards are based on the dual model-based architecture, which defines two conceptual levels: reference model and archetype model. Such architectures represent EHR domain knowledge by means of archetypes, which are considered by many researchers to play a fundamental role for the achievement of semantic interoperability in healthcare. Consequently, formal methods for validating archetypes are necessary. In recent years, there has been an increasing interest in exploring how semantic web technologies in general, and ontologies in particular, can facilitate the representation and management of archetypes, including binding to terminologies, but no solution based on such technologies has been provided to date to validate archetypes. Our approach represents archetypes by means of OWL ontologies. This permits to combine the two levels of the dual model-based architecture in one modeling framework which can also integrate terminologies available in OWL format. The validation method consists of reasoning on those ontologies to find modeling errors in archetypes: incorrect restrictions over the reference model, non-conformant archetype specializations and inconsistent terminological bindings. The archetypes available in the repositories supported by the openEHR Foundation and the NHS Connecting for Health Program, which are the two largest publicly available ones, have been analyzed with our validation method. For such purpose, we have implemented a software tool called Archeck. Our results show that around 1/5 of archetype specializations contain modeling errors, the most common mistakes being related to coded terms and terminological bindings. The analysis of each repository reveals that different patterns of errors are found in both repositories. This result reinforces the need for making serious efforts in improving archetype design processes. Copyright © 2012 Elsevier Inc. All rights reserved.

Development and validation of a food frequency questionnaire for dietary intake assessment among multi-ethnic primary school-aged children

PubMed Central

Fatihah, Fadil; Ng, Boon Koon; Hazwanie, Husin; Norimah, A Karim; Shanita, Safii Nik; Ruzita, Abd Talib; Poh, Bee Koon

2015-01-01

INTRODUCTION This study aimed to develop and validate a food frequency questionnaire (FFQ) to assess habitual diets of multi-ethnic Malaysian children aged 7–12 years. METHODS A total of 236 primary school children participated in the development of the FFQ and 209 subjects participated in the validation study, with a subsample of 30 subjects participating in the reproducibility study. The FFQ, consisting of 94 food items from 12 food groups, was compared with a three-day dietary record (3DR) as the reference method. The reproducibility of the FFQ was assessed through repeat administration (FFQ2), seven days after the first administration (FFQ1). RESULTS The results of the validation study demonstrated good acceptance of the FFQ. Mean intake of macronutrients in FFQ1 and 3DR correlated well, although the FFQ intake data tended to be higher. Cross-classification of nutrient intake between the two methods showed that < 7% of subjects were grossly misclassified. Moderate correlations noted between the two methods ranged from r = 0.310 (p < 0.001) for fat to r = 0.497 (p < 0.001) for energy. The reproducibility of the FFQ, as assessed by Cronbach’s alpha, ranged from 0.61 (protein) to 0.70 (energy, carbohydrates and fat). Spearman’s correlations between FFQ1 and FFQ2 ranged from rho = 0.333 (p = 0.072) for protein to rho = 0.479 (p < 0.01) for fat. CONCLUSION These findings indicate that the FFQ is valid and reliable for measuring the average intake of energy and macronutrients in a population of multi-ethnic children aged 7–12 years in Malaysia. PMID:26702165

Development and validation of a Food Frequency Questionnaire (FFQ) for assessing sugar consumption among adults in Klang Valley, Malaysia.

PubMed

Shanita, Nik S; Norimah, A K; Abu Hanifah, S

2012-12-01

The aim of this study was to develop and validate a semiquantitative food frequency questionnaire (FFQ) for assessing habitual added sugar consumption of adults in the Klang Valley. In the development phase, a 24-hour dietary recall (24-hr DR) was used to determine food items to be included into the FFQ among adults from three major ethnicities (n = 51). In the validation phase, the FFQ was further validated against a reference method which was a multiple-pass 24-hr DR among 125 adults in Klang Valley. The response rate for the latter phase was 96.1%. The semi-quantitative FFQ consisting of 64 food items was categorised into 10 food groups. The mean added sugar intake determined by the reference method was 44.2 +/- 20.2 g/day while that from the FFQ was 49.4 +/- 21.4 g/day. The difference in mean intake between the two methods was 5.2 g (95% CI = 2.6-7.9; SD = 14.9, p < 0.05) or 11.8%. Pearson correlation was r = 0.74 (p < 0.001) for the two methods while Spearman rank correlations for the various food groups ranged between 0.11 (cake and related foods) to 0.61 (self-prepared drinks), with most groups correlating significantly (p < 0.05). Cross-classification of subjects into quintiles of intake showed 47.2% of the subjects correctly classifying into the same quintile, 34.4% into adjacent quintiles while none were grossly misclassified. The Bland-Altman plot was concentrated in the y-axis range (-24.14 g to 34.8 g) with a mean of 5.22 g. This semi-quantitative FFQ provides a validated tool for estimating habitual intake of added sugar in the adult population of the Klang Valley.

Validity and power of association testing in family-based sampling designs: evidence for and against the common wisdom.

PubMed

Knight, Stacey; Camp, Nicola J

2011-04-01

Current common wisdom posits that association analyses using family-based designs have inflated type 1 error rates (if relationships are ignored) and independent controls are more powerful than familial controls. We explore these suppositions. We show theoretically that family-based designs can have deflated type-error rates. Through simulation, we examine the validity and power of family designs for several scenarios: cases from randomly or selectively ascertained pedigrees; and familial or independent controls. Family structures considered are as follows: sibships, nuclear families, moderate-sized and extended pedigrees. Three methods were considered with the χ(2) test for trend: variance correction (VC), weighted (weights assigned to account for genetic similarity), and naïve (ignoring relatedness) as well as the Modified Quasi-likelihood Score (MQLS) test. Selectively ascertained pedigrees had similar levels of disease enrichment; random ascertainment had no such restriction. Data for 1,000 cases and 1,000 controls were created under the null and alternate models. The VC and MQLS methods were always valid. The naïve method was anti-conservative if independent controls were used and valid or conservative in designs with familial controls. The weighted association method was generally valid for independent controls, and was conservative for familial controls. With regard to power, independent controls were more powerful for small-to-moderate selectively ascertained pedigrees, but familial and independent controls were equivalent in the extended pedigrees and familial controls were consistently more powerful for all randomly ascertained pedigrees. These results suggest a more complex situation than previously assumed, which has important implications for study design and analysis. © 2011 Wiley-Liss, Inc.

Zig-zag tape influence in NREL Phase VI wind turbine

NASA Astrophysics Data System (ADS)

Gomez-Iradi, Sugoi; Munduate, Xabier

2014-06-01

Two bladed 10 metre diameter wind turbine was tested in the 24.4m × 36.6m NASA-Ames wind tunnel (Phase VI). These experiments have been extensively used for validation purposes for CFD and other engineering tools. The free transition case (S), has been, and is, the most employed one for validation purposes, and consist in a 3° pitch case with a rotational speed of 72rpm upwind configuration with and without yaw misalignment. However, there is another less visited case (M) where identical configuration was tested but with the inclusion of a zig-zag tape. This was called transition fixed sequence. This paper shows the differences between the free and the fix transition cases, that should be more appropriate for comparison with fully turbulent simulations. Steady k-ω SST fully turbulent computations performed with WMB CFD method are compared with the experiments showing, better predictions in the attached flow region when it is compared with the transition fixed experiments. This work wants to prove the utility of M case (transition fixed) and show its differences respect the S case (free transition) for validation purposes.

Consortium on Methods Evaluating Tobacco: Research Tools to Inform FDA Regulation of Snus.

PubMed

Berman, Micah L; Bickel, Warren K; Harris, Andrew C; LeSage, Mark G; O'Connor, Richard J; Stepanov, Irina; Shields, Peter G; Hatsukami, Dorothy K

2017-10-04

The U.S. Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this paper is to describe these assessment methods using a U.S. manufactured "snus" as the test product. In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This paper integrates COMET's findings over the last 4 years. Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine. Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit. This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, and consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm. © The Author 2017. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Meeting Report: Validation of Toxicogenomics-Based Test Systems: ECVAM–ICCVAM/NICEATM Considerations for Regulatory Use

PubMed Central

Corvi, Raffaella; Ahr, Hans-Jürgen; Albertini, Silvio; Blakey, David H.; Clerici, Libero; Coecke, Sandra; Douglas, George R.; Gribaldo, Laura; Groten, John P.; Haase, Bernd; Hamernik, Karen; Hartung, Thomas; Inoue, Tohru; Indans, Ian; Maurici, Daniela; Orphanides, George; Rembges, Diana; Sansone, Susanna-Assunta; Snape, Jason R.; Toda, Eisaku; Tong, Weida; van Delft, Joost H.; Weis, Brenda; Schechtman, Leonard M.

2006-01-01

This is the report of the first workshop “Validation of Toxicogenomics-Based Test Systems” held 11–12 December 2003 in Ispra, Italy. The workshop was hosted by the European Centre for the Validation of Alternative Methods (ECVAM) and organized jointly by ECVAM, the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). The primary aim of the workshop was for participants to discuss and define principles applicable to the validation of toxicogenomics platforms as well as validation of specific toxicologic test methods that incorporate toxicogenomics technologies. The workshop was viewed as an opportunity for initiating a dialogue between technologic experts, regulators, and the principal validation bodies and for identifying those factors to which the validation process would be applicable. It was felt that to do so now, as the technology is evolving and associated challenges are identified, would be a basis for the future validation of the technology when it reaches the appropriate stage. Because of the complexity of the issue, different aspects of the validation of toxicogenomics-based test methods were covered. The three focus areas include a) biologic validation of toxicogenomics-based test methods for regulatory decision making, b) technical and bioinformatics aspects related to validation, and c) validation issues as they relate to regulatory acceptance and use of toxicogenomics-based test methods. In this report we summarize the discussions and describe in detail the recommendations for future direction and priorities. PMID:16507466

Meeting report: Validation of toxicogenomics-based test systems: ECVAM-ICCVAM/NICEATM considerations for regulatory use.

PubMed

Corvi, Raffaella; Ahr, Hans-Jürgen; Albertini, Silvio; Blakey, David H; Clerici, Libero; Coecke, Sandra; Douglas, George R; Gribaldo, Laura; Groten, John P; Haase, Bernd; Hamernik, Karen; Hartung, Thomas; Inoue, Tohru; Indans, Ian; Maurici, Daniela; Orphanides, George; Rembges, Diana; Sansone, Susanna-Assunta; Snape, Jason R; Toda, Eisaku; Tong, Weida; van Delft, Joost H; Weis, Brenda; Schechtman, Leonard M

2006-03-01

This is the report of the first workshop "Validation of Toxicogenomics-Based Test Systems" held 11-12 December 2003 in Ispra, Italy. The workshop was hosted by the European Centre for the Validation of Alternative Methods (ECVAM) and organized jointly by ECVAM, the U.S. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). The primary aim of the workshop was for participants to discuss and define principles applicable to the validation of toxicogenomics platforms as well as validation of specific toxicologic test methods that incorporate toxicogenomics technologies. The workshop was viewed as an opportunity for initiating a dialogue between technologic experts, regulators, and the principal validation bodies and for identifying those factors to which the validation process would be applicable. It was felt that to do so now, as the technology is evolving and associated challenges are identified, would be a basis for the future validation of the technology when it reaches the appropriate stage. Because of the complexity of the issue, different aspects of the validation of toxicogenomics-based test methods were covered. The three focus areas include a) biologic validation of toxicogenomics-based test methods for regulatory decision making, b) technical and bioinformatics aspects related to validation, and c) validation issues as they relate to regulatory acceptance and use of toxicogenomics-based test methods. In this report we summarize the discussions and describe in detail the recommendations for future direction and priorities.

Content validation: clarity/relevance, reliability and internal consistency of enunciative signs of language acquisition.

PubMed

Crestani, Anelise Henrich; Moraes, Anaelena Bragança de; Souza, Ana Paula Ramos de

2017-08-10

To analyze the results of the validation of building enunciative signs of language acquisition for children aged 3 to 12 months. The signs were built based on mechanisms of language acquisition in an enunciative perspective and on clinical experience with language disorders. The signs were submitted to judgment of clarity and relevance by a sample of six experts, doctors in linguistic in with knowledge of psycholinguistics and language clinic. In the validation of reliability, two judges/evaluators helped to implement the instruments in videos of 20% of the total sample of mother-infant dyads using the inter-evaluator method. The method known as internal consistency was applied to the total sample, which consisted of 94 mother-infant dyads to the contents of the Phase 1 (3-6 months) and 61 mother-infant dyads to the contents of Phase 2 (7 to 12 months). The data were collected through the analysis of mother-infant interaction based on filming of dyads and application of the parameters to be validated according to the child's age. Data were organized in a spreadsheet and then converted to computer applications for statistical analysis. The judgments of clarity/relevance indicated no modifications to be made in the instruments. The reliability test showed an almost perfect agreement between judges (0.8 ≤ Kappa ≥ 1.0); only the item 2 of Phase 1 showed substantial agreement (0.6 ≤ Kappa ≥ 0.79). The internal consistency for Phase 1 had alpha = 0.84, and Phase 2, alpha = 0.74. This demonstrates the reliability of the instruments. The results suggest adequacy as to content validity of the instruments created for both age groups, demonstrating the relevance of the content of enunciative signs of language acquisition.

Injection Drug User Quality of Life Scale (IDUQOL): Findings from a content validation study

PubMed Central

Hubley, Anita M; Palepu, Anita

2007-01-01

Background Quality of life studies among injection drug users have primarily focused on health-related measures. The chaotic life-style of many injection drug users (IDUs), however, extends far beyond their health, and impacts upon social relationships, employment opportunities, housing, and day to day survival. Most current quality of life instruments do not capture the realities of people living with addictions. The Injection Drug Users' Quality of Life Scale (IDUQOL) was developed to reflect the life areas of relevance to IDUs. The present study examined the content validity of the IDUQOL using judgmental methods based on subject matter experts' (SMEs) ratings of various elements of this measure (e.g., appropriateness of life areas or items, names and descriptions of life areas, instructions for administration and scoring). Methods Six SMEs were provided with a copy of the IDUQOL and its administration and scoring manual and a detailed content validation questionnaire. Two commonly used judgmental measures of inter-rater agreement, the Content Validity Index (CVI) and the Average Deviation Mean Index (ADM), were used to evaluate SMEs' agreement on ratings of IDUQOL elements. Results A total of 75 elements of the IDUQOL were examined. The CVI results showed that all elements were endorsed by the required number of SMEs or more. The ADM results showed that acceptable agreement (i.e., practical significance) was obtained for all elements but statistically significant agreement was missed for nine elements. For these elements, SMEs' feedback was examined for ways to improve the elements. Open-ended feedback also provided suggestions for other revisions to the IDUQOL. Conclusion The results of the study provided strong evidence in support of the content validity of the IDUQOL and direction for the revision of some IDUQOL elements. PMID:17663783

Clinical assessment of the physical activity pattern of chronic fatigue syndrome patients: a validation of three methods.

PubMed

Scheeres, Korine; Knoop, Hans; Meer, van der Jos; Bleijenberg, Gijs

2009-04-01

Effective treatment of chronic fatigue syndrome (CFS) with cognitive behavioural therapy (CBT) relies on a correct classification of so called 'fluctuating active' versus 'passive' patients. For successful treatment with CBT is it especially important to recognise the passive patients and give them a tailored treatment protocol. In the present study it was evaluated whether CFS patient's physical activity pattern can be assessed most accurately with the 'Activity Pattern Interview' (API), the International Physical Activity Questionnaire (IPAQ) or the CFS-Activity Questionnaire (CFS-AQ). The three instruments were validated compared to actometers. Actometers are until now the best and most objective instrument to measure physical activity, but they are too expensive and time consuming for most clinical practice settings. In total 226 CFS patients enrolled for CBT therapy answered the API at intake and filled in the two questionnaires. Directly after intake they wore the actometer for two weeks. Based on receiver operating characteristic (ROC) curves the validity of the three methods were assessed and compared. Both the API and the two questionnaires had an acceptable validity (0.64 to 0.71). None of the three instruments was significantly better than the others. The proportion of false predictions was rather high for all three instrument. The IPAQ had the highest proportion of correct passive predictions (sensitivity 70.1%). The validity of all three instruments appeared to be fair, and all showed rather high proportions of false classifications. Hence in fact none of the tested instruments could really be called satisfactory. Because the IPAQ showed to be the best in correctly predicting 'passive' CFS patients, which is most essentially related to treatment results, it was concluded that the IPAQ is the preferable alternative for an actometer when treating CFS patients in clinical practice.

The validity of a web-based FFQ assessed by doubly labelled water and multiple 24-h recalls.

PubMed

Medin, Anine C; Carlsen, Monica H; Hambly, Catherine; Speakman, John R; Strohmaier, Susanne; Andersen, Lene F

2017-12-01

The aim of this study was to validate the estimated habitual dietary intake from a newly developed web-based FFQ (WebFFQ), for use in an adult population in Norway. In total, ninety-two individuals were recruited. Total energy expenditure (TEE) measured by doubly labelled water was used as the reference method for energy intake (EI) in a subsample of twenty-nine women, and multiple 24-h recalls (24HR) were used as the reference method for the relative validation of macronutrients and food groups in the entire sample. Absolute differences, ratios, crude and deattenuated correlations, cross-classifications, Bland-Altman plot and plots between misreporting of EI (EI-TEE) and the relative misreporting of food groups (WebFFQ-24HR) were used to assess the validity. Results showed that EI on group level was not significantly different from TEE measured by doubly labelled water (0·7 MJ/d), but ranking abilities were poor (r -0·18). The relative validation showed an overestimation for the majority of the variables using absolute intakes, especially for the food groups 'vegetables' and 'fish and shellfish', but an improved agreement between the test and reference tool was observed for energy adjusted intakes. Deattenuated correlation coefficients were between 0·22 and 0·89, and low levels of grossly misclassified individuals (0-3 %) were observed for the majority of the energy adjusted variables for macronutrients and food groups. In conclusion, energy estimates from the WebFFQ should be used with caution, but the estimated absolute intakes on group level and ranking abilities seem acceptable for macronutrients and most food groups.

Random sampling and validation of covariance matrices of resonance parameters

NASA Astrophysics Data System (ADS)

Plevnik, Lucijan; Zerovnik, Gašper

2017-09-01

Analytically exact methods for random sampling of arbitrary correlated parameters are presented. Emphasis is given on one hand on the possible inconsistencies in the covariance data, concentrating on the positive semi-definiteness and consistent sampling of correlated inherently positive parameters, and on the other hand on optimization of the implementation of the methods itself. The methods have been applied in the program ENDSAM, written in the Fortran language, which from a file from a nuclear data library of a chosen isotope in ENDF-6 format produces an arbitrary number of new files in ENDF-6 format which contain values of random samples of resonance parameters (in accordance with corresponding covariance matrices) in places of original values. The source code for the program ENDSAM is available from the OECD/NEA Data Bank. The program works in the following steps: reads resonance parameters and their covariance data from nuclear data library, checks whether the covariance data is consistent, and produces random samples of resonance parameters. The code has been validated with both realistic and artificial data to show that the produced samples are statistically consistent. Additionally, the code was used to validate covariance data in existing nuclear data libraries. A list of inconsistencies, observed in covariance data of resonance parameters in ENDF-VII.1, JEFF-3.2 and JENDL-4.0 is presented. For now, the work has been limited to resonance parameters, however the methods presented are general and can in principle be extended to sampling and validation of any nuclear data.

Development and validation of sensitive LC/MS/MS method for quantitative bioanalysis of levonorgestrel in rat plasma and application to pharmacokinetics study.

PubMed

Ananthula, Suryatheja; Janagam, Dileep R; Jamalapuram, Seshulatha; Johnson, James R; Mandrell, Timothy D; Lowe, Tao L

2015-10-15

Rapid, sensitive, selective and accurate LC/MS/MS method was developed for quantitative determination of levonorgestrel (LNG) in rat plasma and further validated for specificity, linearity, accuracy, precision, sensitivity, matrix effect, recovery efficiency and stability. Liquid-liquid extraction procedure using hexane:ethyl acetate mixture at 80:20 v:v ratio was employed to efficiently extract LNG from rat plasma. Reversed phase Luna column C18(2) (50×2.0mm i.d., 3μM) installed on a AB SCIEX Triple Quad™ 4500 LC/MS/MS system was used to perform chromatographic separation. LNG was identified within 2min with high specificity. Linear calibration curve was drawn within 0.5-50ng·mL(-1) concentration range. The developed method was validated for intra-day and inter-day accuracy and precision whose values fell in the acceptable limits. Matrix effect was found to be minimal. Recovery efficiency at three quality control (QC) concentrations 0.5 (low), 5 (medium) and 50 (high) ng·mL(-1) was found to be >90%. Stability of LNG at various stages of experiment including storage, extraction and analysis was evaluated using QC samples, and the results showed that LNG was stable at all the conditions. This validated method was successfully used to study the pharmacokinetics of LNG in rats after SubQ injection, providing its applicability in relevant preclinical studies. Copyright © 2015 Elsevier B.V. All rights reserved.

Novel spectrophotometric methods for simultaneous determination of timolol and dorzolamide in their binary mixture.

PubMed

Lotfy, Hayam Mahmoud; Hegazy, Maha A; Rezk, Mamdouh R; Omran, Yasmin Rostom

2014-05-21

Two smart and novel spectrophotometric methods namely; absorbance subtraction (AS) and amplitude modulation (AM) were developed and validated for the determination of a binary mixture of timolol maleate (TIM) and dorzolamide hydrochloride (DOR) in presence of benzalkonium chloride without prior separation, using unified regression equation. Additionally, simple, specific, accurate and precise spectrophotometric methods manipulating ratio spectra were developed and validated for simultaneous determination of the binary mixture namely; simultaneous ratio subtraction (SRS), ratio difference (RD), ratio subtraction (RS) coupled with extended ratio subtraction (EXRS), constant multiplication method (CM) and mean centering of ratio spectra (MCR). The proposed spectrophotometric procedures do not require any separation steps. Accuracy, precision and linearity ranges of the proposed methods were determined and the specificity was assessed by analyzing synthetic mixtures of both drugs. They were applied to their pharmaceutical formulation and the results obtained were statistically compared to that of a reported spectrophotometric method. The statistical comparison showed that there is no significant difference between the proposed methods and the reported one regarding both accuracy and precision. Copyright © 2014 Elsevier B.V. All rights reserved.

Development and validation of a ultra high performance liquid chromatography-tandem mass spectrometric method for the direct detection of formoterol in human urine.

PubMed

Sardela, V F; Deventer, K; Pereira, H M G; de Aquino Neto, F R; Van Eenoo, P

2012-11-01

Formoterol is a long acting β(2)-agonist and has proven to be a very effective bronchodilating agent. Hence it is frequently applied therapeutically for the treatment of asthma. Because β(2)-agonists might be misused in sports for the stimulatory effects and for growth-promoting action their use is restricted. Since January 2012, formoterol is prohibited in urinary concentrations higher than 30 ng/mL. The objective of this study was to develop and validate a simple and robust ultra high performance liquid chromatographic-tandem mass spectrometric (UHPLC-MS/MS) method for the direct quantification of formoterol in urine. Sample preparation was limited to an enzymatic hydrolysis step after which 2 μL was injected in the chromatographic system. Chromatography was performed on a C(8)-column using gradient conditions. The mobile phase consisted of water/methanol (H(2)O/MeOH) both containing 0.1% acetic acid (HOAc) and 1mM ammonium acetate (NH(4)OAc). Calibration curve were constructed between 15 and 60 ng/mL. Validation data showed bias of 1.3% and imprecision of 5.4% at the threshold. Ion suppression/enhancement never exceeded 7%. Calculating measurement uncertainty showed proof of applicability of the method. Stability of formoterol was also investigated at 56 °C (accelerated stability test) at pH 1.0/5.2/7.0 and 9.5. At the physiological pH values of 5.2 and 7.0, formoterol showed good stability. At pH 1.0 and 9.5 significant degradation was observed. Copyright © 2012 Elsevier B.V. All rights reserved.

Translation and validation of the Malay version of Shiffman-Jarvik withdrawal scale and cessation self-efficacy questionnaire: a review of psychometric properties.

PubMed

Teo, Eng Wah; Lee, Yuin Yi; Khoo, Selina; Morris, Tony

2015-04-09

Smoking tobacco is a major concern in Malaysia, with 23.1% of Malaysian adults smoking tobacco in 2012. Withdrawal symptoms and self-efficacy to quit smoking have been shown to have significant effects on the outcomes of smoking cessation. The Shiffman-Jarvik Withdrawal Scale (Psychopharmacology, 50: 35-39, 1976) and the Cessation Self-Efficacy Questionnaire (Cognitive Ther Res 5: 175-187, 1981) are two questionnaires that have been widely used in various smoking cessation research. The short SJWS consists of 15 items with five subscales: physical symptoms, psychological symptoms, stimulation/sedation, appetite, and cravings. The CSEQ is a 12-item questionnaire that assesses participant's self-efficacy to avoid smoking in various situations described in each item. The aim of this study was to translate and validate the Malay language version of the SJWS and the CSEQ. The SJWS and CSEQ were translated into the Malay language based on the back translation method. A total of 146 participants (25.08 ± 5.19 years) answered the translated questionnaires. Psychometrics properties such as reliability (internal consistency and test-retest) and validity (content validity, construct validity and face validity) were examined. Both questionnaires showed acceptable internal consistency; SJWS-M (α = 0.66) and CSEQ-M (α = 0.90) and good test-retest reliability; SJWS-M (r = 0.76) and the CSEQ-M (r = 0.80). SJWS-M (χ(2) = 15.964, GFI = 0.979, CFI = 1.000, RMSEA = 0.000, ChiSq/df = 0.939, AGFI = 0.933, TLI = 1.004, and NPI = 0.978) and CSEQ-M (of χ(2) = 35.16, GFI = 0.960, CFI = 0.999, RMSEA = 0.015, ChiSq/df = 1.034, AGFI = 0.908, TLI = 0.999, and NPI = 0.979) also showed good construct validity. Both questionnaires showed sufficient item to item convergent validity and item discriminant validity. Content validity was established (reassess) by experts in the field of psychology, culture and language whereas face validity was confirmed by smokers. The translated Malay version of the CSEQ-M and the SJWS-M showed great reliability and validity evidences therefore is an adequate and useful instrument to evaluate Malaysian smokers. Future studies could investigate differences in self-esteem between long-term and short-term smokers and evaluate the usability of these questionnaires in local smoking research and other Malay speaking countries (Brunei and Indonesia).

A general time-dependent stochastic method for solving Parker's transport equation in spherical coordinates

NASA Astrophysics Data System (ADS)

Pei, C.; Bieber, J. W.; Burger, R. A.; Clem, J.

2010-12-01

We present a detailed description of our newly developed stochastic approach for solving Parker's transport equation, which we believe is the first attempt to solve it with time dependence in 3-D, evolving from our 3-D steady state stochastic approach. Our formulation of this method is general and is valid for any type of heliospheric magnetic field, although we choose the standard Parker field as an example to illustrate the steps to calculate the transport of galactic cosmic rays. Our 3-D stochastic method is different from other stochastic approaches in the literature in several ways. For example, we employ spherical coordinates to integrate directly, which makes the code much more efficient by reducing coordinate transformations. What is more, the equivalence between our stochastic differential equations and Parker's transport equation is guaranteed by Ito's theorem in contrast to some other approaches. We generalize the technique for calculating particle flux based on the pseudoparticle trajectories for steady state solutions and for time-dependent solutions in 3-D. To validate our code, first we show that good agreement exists between solutions obtained by our steady state stochastic method and a traditional finite difference method. Then we show that good agreement also exists for our time-dependent method for an idealized and simplified heliosphere which has a Parker magnetic field and a simple initial condition for two different inner boundary conditions.

Stir bar sorptive extraction of diclofenac from liquid formulations: a proof of concept study.

PubMed

Kole, Prashant Laxman; Millership, Jeff; McElnay, James C

2011-03-25

A new stir bar sorptive extraction (SBSE) technique coupled with HPLC-UV method for quantification of diclofenac in pharmaceutical formulations has been developed and validated as a proof of concept study. Commercially available polydimethylsiloxane stir bars (Twister™) were used for method development and SBSE extraction (pH, phase ratio, stirring speed, temperature, ionic strength and time) and liquid desorption (solvents, desorption method, stirring time etc) procedures were optimised. The method was validated as per ICH guidelines and was successfully applied for the estimation of diclofenac from three liquid formulations viz. Voltarol(®) Optha single dose eye drops, Voltarol(®) Ophtha multidose eye drops and Voltarol(®) ampoules. The developed method was found to be linear (r=0.9999) over 100-2000ng/ml concentration range with acceptable accuracy and precision (tested over three QC concentrations). The SBSE extraction recovery of the diclofenac was found to be 70% and the LOD and LOQ of the validated method were found to be 16.06 and 48.68ng/ml, respectively. Furthermore, a forced degradation study of a diclofenac formulation leading to the formation of structurally similar cyclic impurity (indolinone) was carried out. The developed extraction method showed comparable results to that of the reference method, i.e. method was capable of selectively extracting the indolinone and diclofenac from the liquid matrix. Data on inter and intra stir bar accuracy and precision further confirmed robustness of the method, supporting the multiple re-use of the stir bars. Copyright © 2010 Elsevier B.V. All rights reserved.

Validated spectrophotometric methods for determination of sodium valproate based on charge transfer complexation reactions.

PubMed

Belal, Tarek S; El-Kafrawy, Dina S; Mahrous, Mohamed S; Abdel-Khalek, Magdi M; Abo-Gharam, Amira H

2016-02-15

This work presents the development, validation and application of four simple and direct spectrophotometric methods for determination of sodium valproate (VP) through charge transfer complexation reactions. The first method is based on the reaction of the drug with p-chloranilic acid (p-CA) in acetone to give a purple colored product with maximum absorbance at 524nm. The second method depends on the reaction of VP with dichlone (DC) in dimethylformamide forming a reddish orange product measured at 490nm. The third method is based upon the interaction of VP and picric acid (PA) in chloroform resulting in the formation of a yellow complex measured at 415nm. The fourth method involves the formation of a yellow complex peaking at 361nm upon the reaction of the drug with iodine in chloroform. Experimental conditions affecting the color development were studied and optimized. Stoichiometry of the reactions was determined. The proposed spectrophotometric procedures were effectively validated with respect to linearity, ranges, precision, accuracy, specificity, robustness, detection and quantification limits. Calibration curves of the formed color products with p-CA, DC, PA and iodine showed good linear relationships over the concentration ranges 24-144, 40-200, 2-20 and 1-8μg/mL respectively. The proposed methods were successfully applied to the assay of sodium valproate in tablets and oral solution dosage forms with good accuracy and precision. Assay results were statistically compared to a reference pharmacopoeial HPLC method where no significant differences were observed between the proposed methods and reference method. Copyright © 2015 Elsevier B.V. All rights reserved.

Validated spectrophotometric methods for determination of sodium valproate based on charge transfer complexation reactions

NASA Astrophysics Data System (ADS)

Belal, Tarek S.; El-Kafrawy, Dina S.; Mahrous, Mohamed S.; Abdel-Khalek, Magdi M.; Abo-Gharam, Amira H.

2016-02-01

This work presents the development, validation and application of four simple and direct spectrophotometric methods for determination of sodium valproate (VP) through charge transfer complexation reactions. The first method is based on the reaction of the drug with p-chloranilic acid (p-CA) in acetone to give a purple colored product with maximum absorbance at 524 nm. The second method depends on the reaction of VP with dichlone (DC) in dimethylformamide forming a reddish orange product measured at 490 nm. The third method is based upon the interaction of VP and picric acid (PA) in chloroform resulting in the formation of a yellow complex measured at 415 nm. The fourth method involves the formation of a yellow complex peaking at 361 nm upon the reaction of the drug with iodine in chloroform. Experimental conditions affecting the color development were studied and optimized. Stoichiometry of the reactions was determined. The proposed spectrophotometric procedures were effectively validated with respect to linearity, ranges, precision, accuracy, specificity, robustness, detection and quantification limits. Calibration curves of the formed color products with p-CA, DC, PA and iodine showed good linear relationships over the concentration ranges 24-144, 40-200, 2-20 and 1-8 μg/mL respectively. The proposed methods were successfully applied to the assay of sodium valproate in tablets and oral solution dosage forms with good accuracy and precision. Assay results were statistically compared to a reference pharmacopoeial HPLC method where no significant differences were observed between the proposed methods and reference method.

Development and validation spectroscopic methods for the determination of lomefloxacin in bulk and pharmaceutical formulations

NASA Astrophysics Data System (ADS)

El-Didamony, A. M.; Hafeez, S. M.

2016-01-01

Four simple, sensitive spectrophotometric and spectrofluorimetric methods (A-D) for the determination of antibacterial drug lomefloxacin (LMFX) in pharmaceutical formulations have been developed. Method A is based on formation of ternary complex between Pd(II), eosin and LMFX in the presence of methyl cellulose as surfactant and acetate-HCl buffer pH 4.0. Spectrophotometrically, under the optimum conditions, the ternary complex showed absorption maximum at 530 nm. Methods B and C are based on redox reaction between LMFX and KMnO4 in acid and alkaline media. In indirect spectrophotometry method B the drug solution is treated with a known excess of KMnO4 in H2SO4 medium and subsequent determination of unreacted oxidant by reacting it with safronine O in the same medium at λmax = 520 nm. Direct spectrophotometry method C involves treating the alkaline solution of LMFX with KMnO4 and measuring the bluish green product at 604 nm. Method D is based on the chelation of LMFX with Zr(IV) to produce fluorescent chelate. At the optimum reaction conditions, the drug-metal chelate showed excitation maxima at 280 nm and emission maxima at 443 nm. The optimum experimental parameters for the reactions have been studied. The validity of the described procedures was assessed. Statistical analysis of the results has been carried out revealing high accuracy and good precision. The proposed methods were successfully applied for the determination of the selected drug in pharmaceutical preparations with good recoveries.

Quantitative analysis of benzodiazepines in vitreous humor by high-performance liquid chromatography

PubMed Central

Bazmi, Elham; Behnoush, Behnam; Akhgari, Maryam; Bahmanabadi, Leila

2016-01-01

Objective: Benzodiazepines are frequently screened drugs in emergency toxicology, drugs of abuse testing, and in forensic cases. As the variations of benzodiazepines concentrations in biological samples during bleeding, postmortem changes, and redistribution could be biasing forensic medicine examinations, hence selecting a suitable sample and a validated accurate method is essential for the quantitative analysis of these main drug categories. The aim of this study was to develop a valid method for the determination of four benzodiazepines (flurazepam, lorazepam, alprazolam, and diazepam) in vitreous humor using liquid–liquid extraction and high-performance liquid chromatography. Methods: Sample preparation was carried out using liquid–liquid extraction with n-hexane: ethyl acetate and subsequent detection by high-performance liquid chromatography method coupled to diode array detector. This method was applied to quantify benzodiazepines in 21 authentic vitreous humor samples. Linear curve for each drug was obtained within the range of 30–3000 ng/mL with coefficient of correlation higher than 0.99. Results: The limit of detection and quantitation were 30 and 100 ng/mL respectively for four drugs. The method showed an appropriate intra- and inter-day precision (coefficient of variation < 10%). Benzodiazepines recoveries were estimated to be over 80%. The method showed high selectivity; no additional peak due to interfering substances in samples was observed. Conclusion: The present method was selective, sensitive, accurate, and precise for the quantitative analysis of benzodiazepines in vitreous humor samples in forensic toxicology laboratory. PMID:27635251

Experimental Validation of Model Updating and Damage Detection via Eigenvalue Sensitivity Methods with Artificial Boundary Conditions

DTIC Science & Technology

2017-09-01

VALIDATION OF MODEL UPDATING AND DAMAGE DETECTION VIA EIGENVALUE SENSITIVITY METHODS WITH ARTIFICIAL BOUNDARY CONDITIONS by Matthew D. Bouwense...VALIDATION OF MODEL UPDATING AND DAMAGE DETECTION VIA EIGENVALUE SENSITIVITY METHODS WITH ARTIFICIAL BOUNDARY CONDITIONS 5. FUNDING NUMBERS 6. AUTHOR...unlimited. EXPERIMENTAL VALIDATION OF MODEL UPDATING AND DAMAGE DETECTION VIA EIGENVALUE SENSITIVITY METHODS WITH ARTIFICIAL BOUNDARY

Brazilian Center for the Validation of Alternative Methods (BraCVAM) and the process of validation in Brazil.

PubMed

Presgrave, Octavio; Moura, Wlamir; Caldeira, Cristiane; Pereira, Elisabete; Bôas, Maria H Villas; Eskes, Chantra

2016-03-01

The need for the creation of a Brazilian centre for the validation of alternative methods was recognised in 2008, and members of academia, industry and existing international validation centres immediately engaged with the idea. In 2012, co-operation between the Oswaldo Cruz Foundation (FIOCRUZ) and the Brazilian Health Surveillance Agency (ANVISA) instigated the establishment of the Brazilian Center for the Validation of Alternative Methods (BraCVAM), which was officially launched in 2013. The Brazilian validation process follows OECD Guidance Document No. 34, where BraCVAM functions as the focal point to identify and/or receive requests from parties interested in submitting tests for validation. BraCVAM then informs the Brazilian National Network on Alternative Methods (RENaMA) of promising assays, which helps with prioritisation and contributes to the validation studies of selected assays. A Validation Management Group supervises the validation study, and the results obtained are peer-reviewed by an ad hoc Scientific Review Committee, organised under the auspices of BraCVAM. Based on the peer-review outcome, BraCVAM will prepare recommendations on the validated test method, which will be sent to the National Council for the Control of Animal Experimentation (CONCEA). CONCEA is in charge of the regulatory adoption of all validated test methods in Brazil, following an open public consultation. 2016 FRAME.

Searching for transcription factor binding sites in vector spaces

PubMed Central

2012-01-01

Background Computational approaches to transcription factor binding site identification have been actively researched in the past decade. Learning from known binding sites, new binding sites of a transcription factor in unannotated sequences can be identified. A number of search methods have been introduced over the years. However, one can rarely find one single method that performs the best on all the transcription factors. Instead, to identify the best method for a particular transcription factor, one usually has to compare a handful of methods. Hence, it is highly desirable for a method to perform automatic optimization for individual transcription factors. Results We proposed to search for transcription factor binding sites in vector spaces. This framework allows us to identify the best method for each individual transcription factor. We further introduced two novel methods, the negative-to-positive vector (NPV) and optimal discriminating vector (ODV) methods, to construct query vectors to search for binding sites in vector spaces. Extensive cross-validation experiments showed that the proposed methods significantly outperformed the ungapped likelihood under positional background method, a state-of-the-art method, and the widely-used position-specific scoring matrix method. We further demonstrated that motif subtypes of a TF can be readily identified in this framework and two variants called the k NPV and k ODV methods benefited significantly from motif subtype identification. Finally, independent validation on ChIP-seq data showed that the ODV and NPV methods significantly outperformed the other compared methods. Conclusions We conclude that the proposed framework is highly flexible. It enables the two novel methods to automatically identify a TF-specific subspace to search for binding sites. Implementations are available as source code at: http://biogrid.engr.uconn.edu/tfbs_search/. PMID:23244338

Validity and reliability of sleep time questionnaires in children and adolescents: A systematic review and meta-analysis.

PubMed

Nascimento-Ferreira, Marcus V; Collese, Tatiana S; de Moraes, Augusto César F; Rendo-Urteaga, Tara; Moreno, Luis A; Carvalho, Heráclito B

2016-12-01

Sleep duration has been associated with several health outcomes in children and adolescents. As an extensive number of questionnaires are currently used to investigate sleep schedule or sleep time, we performed a systematic review of criterion validation of sleep time questionnaires for children and adolescents, considering accelerometers as the reference method. We found a strong correlation between questionnaires and accelerometers for weeknights and a moderate correlation for weekend nights. When considering only studies performing a reliability assessment of the used questionnaires, a significant increase in the correlations for both weeknights and weekend nights was observed. In conclusion, moderate to strong criterion validity of sleep time questionnaires was observed; however, the reliability assessment of the questionnaires showed strong validation performance. Copyright © 2015 Elsevier Ltd. All rights reserved.

Training situational awareness to reduce surgical errors in the operating room.

PubMed

Graafland, M; Schraagen, J M C; Boermeester, M A; Bemelman, W A; Schijven, M P

2015-01-01

Surgical errors result from faulty decision-making, misperceptions and the application of suboptimal problem-solving strategies, just as often as they result from technical failure. To date, surgical training curricula have focused mainly on the acquisition of technical skills. The aim of this review was to assess the validity of methods for improving situational awareness in the surgical theatre. A search was conducted in PubMed, Embase, the Cochrane Library and PsycINFO using predefined inclusion criteria, up to June 2014. All study types were considered eligible. The primary endpoint was validity for improving situational awareness in the surgical theatre at individual or team level. Nine articles were considered eligible. These evaluated surgical team crisis training in simulated environments for minimally invasive surgery (4) and open surgery (3), and training courses focused at training non-technical skills (2). Two studies showed that simulation-based surgical team crisis training has construct validity for assessing situational awareness in surgical trainees in minimally invasive surgery. None of the studies showed effectiveness of surgical crisis training on situational awareness in open surgery, whereas one showed face validity of a 2-day non-technical skills training course. To improve safety in the operating theatre, more attention to situational awareness is needed in surgical training. Few structured curricula have been developed and validation research remains limited. Strategies to improve situational awareness can be adopted from other industries. © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd.

Development and Validation of a New Questionnaire Assessing Quality of Life in Adults with Hypopituitarism: Adult Hypopituitarism Questionnaire (AHQ)

PubMed Central

Ishii, Hitoshi; Shimatsu, Akira; Okimura, Yasuhiko; Tanaka, Toshiaki; Hizuka, Naomi; Kaji, Hidesuke; Hanew, Kunihiko; Oki, Yutaka; Yamashiro, Sayuri; Takano, Koji; Chihara, Kazuo

2012-01-01

Objective To develop and validate the Adult Hypopituitarism Questionnaire (AHQ) as a disease-specific, self-administered questionnaire for evaluation of quality of life (QOL) in adult patients with hypopituitarism. Methods We developed and validated this new questionnaire, using a standardized procedure which included item development, pilot-testing and psychometric validation. Of the patients who participated in psychometric validation, those whose clinical conditions were judged to be stable were asked to answer the survey questionnaire twice, in order to assess test-retest reliability. Results Content validity of the initial questionnaire was evaluated via two pilot tests. After these tests, we made minor revisions and finalized the initial version of the questionnaire. The questionnaire was constructed with two domains, one psycho-social and the other physical. For psychometric assessment, analyses were performed on the responses of 192 adult patients with various types of hypopituitarism. The intraclass correlations of the respective domains were 0.91 and 0.95, and the Cronbach’s alpha coefficients were 0.96 and 0.95, indicating adequate test-retest reliability and internal consistency for each domain. For known-group validity, patients with hypopituitarism due to hypothalamic disorder showed significantly lower scores in 11 out of 13 sub-domains compared to those who had hypopituitarism due to pituitary disorder. Regarding construct validity, the domain structure was found to be almost the same as that initially hypothesized. Exploratory factor analysis (n = 228) demonstrated that each domain consisted of six and seven sub-domains. Conclusion The AHQ showed good reliability and validity for evaluating QOL in adult patients with hypopituitarism. PMID:22984490

The reliability and validity of Chinese version of SF36 v2 in aging patients with chronic heart failure.

PubMed

Dong, Aishu; Chen, Sisi; Zhu, Lianlian; Shi, Lingmin; Cai, Yueli; Zeng, Jingni; Guo, Wenjian

2017-08-01

Chronic heart failure (CHF), a major public health problem worldwide, seriously limits health-related quality of life (HRQOL). How to evaluate HRQOL in older patients with CHF remains a problem. To evaluate the reliability and validity of the Chinese version of the Medical Outcomes Study Short Form version 2 (SF-36v2) in CHF patients. From September 2012 to June 2014, we assessed QOL using the SF-36v2 in 171 aging participants with CHF in four cardiology departments. Convergent and discriminant validity, factorial validity, sensitivity among different NYHA classes and between different age groups, and reliability were determined using standard measurement methods. A total of 150 participants completed a structured questionnaire including general information and the Chinese SF-36v2; 132 questionnaires were considered valid, while 21 patients refused to take part. 25 of the 50 participants invited to complete the 2-week test-retest questionnaires returned completed questionnaires. The internal consistency reliability (Cronbach's α) of the total SF-36v2 was 0.92 (range 0.74-0.93). All hypothesized item-subscale correlations showed satisfactory convergent and discriminant validity. Sensitivity was measured in different NYHA classes and age groups. Comparison of different NYHA classes showed statistical significance, but there was no significant difference between age groups. We confirmed the SF-36v2 as a valid instrument for evaluating HRQOL Chinese CHF patients. Both reliability and validity were strongly satisfactory, but there was divergence in understanding subscales such as "social functioning" because of differing cultural background. The reliability, validity, and sensitivity of SF-36v2 in aging patients with CHF were acceptable.

The Smartphone Addiction Scale: Development and Validation of a Short Version for Adolescents

PubMed Central

Kwon, Min; Kim, Dai-Jin; Cho, Hyun; Yang, Soo

2013-01-01

Objective This study was designed to investigate the revised and short version of the smartphone addiction scale and the proof of its validity in adolescents. In addition, it suggested cutting off the values by gender in order to determine smartphone addiction and elaborate the characteristics of smartphone usage in adolescents. Method A set of questionnaires were provided to a total of 540 selected participants from April to May of 2013. The participants consisted of 343 boys and 197 girls, and their average age was 14.5 years old. The content validity was performed on a selection of shortened items, while an internal-consistency test was conducted for the verification of its reliability. The concurrent validity was confirmed using SAS, SAPS and KS-scale. Receiver operating characteristics analysis was conducted to suggest cut-off. Results The 10 final questions were selected using content validity. The internal consistency and concurrent validity of SAS were verified with a Cronbach's alpha of 0.911. The SAS-SV was significantly correlated with the SAS, SAPS and KS-scale. The SAS-SV scores of gender (p<.001) and self-evaluation of smartphone addiction (p<.001) showed significant difference. The ROC analysis results showed an area under a curve (AUC) value of 0.963(0.888–1.000), a cut-off value of 31, sensitivity value of 0.867 and specificity value of 0.893 in boys while an AUC value of 0.947(0.887–1.000), a cut-off value of 33, sensitivity value of 0.875, and a specificity value of 0.886 in girls. Conclusions The SAS-SV showed good reliability and validity for the assessment of smartphone addiction. The smartphone addiction scale short version, which was developed and validated in this study, could be used efficiently for the evaluation of smartphone addiction in community and research areas. PMID:24391787

Comparing ordinary kriging and inverse distance weighting for soil as pollution in Beijing.

PubMed

Qiao, Pengwei; Lei, Mei; Yang, Sucai; Yang, Jun; Guo, Guanghui; Zhou, Xiaoyong

2018-06-01

Spatial interpolation method is the basis of soil heavy metal pollution assessment and remediation. The existing evaluation index for interpolation accuracy did not combine with actual situation. The selection of interpolation methods needs to be based on specific research purposes and research object characteristics. In this paper, As pollution in soils of Beijing was taken as an example. The prediction accuracy of ordinary kriging (OK) and inverse distance weighted (IDW) were evaluated based on the cross validation results and spatial distribution characteristics of influencing factors. The results showed that, under the condition of specific spatial correlation, the cross validation results of OK and IDW for every soil point and the prediction accuracy of spatial distribution trend are similar. But the prediction accuracy of OK for the maximum and minimum is less than IDW, while the number of high pollution areas identified by OK are less than IDW. It is difficult to identify the high pollution areas fully by OK, which shows that the smoothing effect of OK is obvious. In addition, with increasing of the spatial correlation of As concentration, the cross validation error of OK and IDW decreases, and the high pollution area identified by OK is approaching the result of IDW, which can identify the high pollution areas more comprehensively. However, because the semivariogram constructed by OK interpolation method is more subjective and requires larger number of soil samples, IDW is more suitable for spatial prediction of heavy metal pollution in soils.

A simple mass-conserved level set method for simulation of multiphase flows

NASA Astrophysics Data System (ADS)

Yuan, H.-Z.; Shu, C.; Wang, Y.; Shu, S.

2018-04-01

In this paper, a modified level set method is proposed for simulation of multiphase flows with large density ratio and high Reynolds number. The present method simply introduces a source or sink term into the level set equation to compensate the mass loss or offset the mass increase. The source or sink term is derived analytically by applying the mass conservation principle with the level set equation and the continuity equation of flow field. Since only a source term is introduced, the application of the present method is as simple as the original level set method, but it can guarantee the overall mass conservation. To validate the present method, the vortex flow problem is first considered. The simulation results are compared with those from the original level set method, which demonstrates that the modified level set method has the capability of accurately capturing the interface and keeping the mass conservation. Then, the proposed method is further validated by simulating the Laplace law, the merging of two bubbles, a bubble rising with high density ratio, and Rayleigh-Taylor instability with high Reynolds number. Numerical results show that the mass is a well-conserved by the present method.

Analysis of amide compounds in different parts of Piper ovatum Vahl by high-performance liquid chromatographic

PubMed Central

Silva, Daniel R.; Brenzan, Mislaine A.; Kambara, Lauro M.; Cortez, Lucia E. R.; Cortez, Diógenes A. G.

2013-01-01

Background: Piper ovatum (Piperaceae) has been used in traditional medicine for the treatment of inflammations and as an analgesic. Previous studies have showed important biological activities of the extracts and amides from P. ovatum leaves. Objective: In this study, a high-performance liquid chromatographic (HPLC) method was developed and validated for quantitative determination of the amides in different parts of Piper ovatum. Materials and Methods: The analysis was carried out on a Metasil ODS column (150 × 4.6 mm, 5μm) at room temperature. HPLC conditions were as follows: acetonitrile (A), and water (B), 1.0% acetic acid. The gradient elution used was 0–30 min, 0-60% A; 30–40 min, 60% A. Flow rate used was 1.0mL/min, and detection at 280nm. Results: The validation using piperlonguminine, as the standard, demonstrated that the method shows linearity (linear correlation coefficient = 0.998), precision (relative standard deviation <5%) and accuracy (mean recovery = 103.78%) in the concentration range 31.25 – 500μg/mL. The limit of detection and quantification were 1.21 and 4.03μg/mL, respectively. This method allowed the identification and quantification of piperlonguminine and piperovatine in the hydroethanolic extracts of P. ovatum obtained from the leaves, stems and roots. All the extracts showed the same chromatographic profile. The leaves and roots contained the highest concentrations of piperlonguminine and the stems and leaves showed the most concentrations of piperovatine. Conclusion: This HPLC method is suitable for routine quantitative analysis of amides in extracts of Piper ovatum and phytopharmaceuticals containing this herb. PMID:24174818

Vision-based system identification technique for building structures using a motion capture system

NASA Astrophysics Data System (ADS)

Oh, Byung Kwan; Hwang, Jin Woo; Kim, Yousok; Cho, Tongjun; Park, Hyo Seon

2015-11-01

This paper presents a new vision-based system identification (SI) technique for building structures by using a motion capture system (MCS). The MCS with outstanding capabilities for dynamic response measurements can provide gage-free measurements of vibrations through the convenient installation of multiple markers. In this technique, from the dynamic displacement responses measured by MCS, the dynamic characteristics (natural frequency, mode shape, and damping ratio) of building structures are extracted after the processes of converting the displacement from MCS to acceleration and conducting SI by frequency domain decomposition. A free vibration experiment on a three-story shear frame was conducted to validate the proposed technique. The SI results from the conventional accelerometer-based method were compared with those from the proposed technique and showed good agreement, which confirms the validity and applicability of the proposed vision-based SI technique for building structures. Furthermore, SI directly employing MCS measured displacements to FDD was performed and showed identical results to those of conventional SI method.

FUN-LDA: A Latent Dirichlet Allocation Model for Predicting Tissue-Specific Functional Effects of Noncoding Variation: Methods and Applications.

PubMed

Backenroth, Daniel; He, Zihuai; Kiryluk, Krzysztof; Boeva, Valentina; Pethukova, Lynn; Khurana, Ekta; Christiano, Angela; Buxbaum, Joseph D; Ionita-Laza, Iuliana

2018-05-03

We describe a method based on a latent Dirichlet allocation model for predicting functional effects of noncoding genetic variants in a cell-type- and/or tissue-specific way (FUN-LDA). Using this unsupervised approach, we predict tissue-specific functional effects for every position in the human genome in 127 different tissues and cell types. We demonstrate the usefulness of our predictions by using several validation experiments. Using eQTL data from several sources, including the GTEx project, Geuvadis project, and TwinsUK cohort, we show that eQTLs in specific tissues tend to be most enriched among the predicted functional variants in relevant tissues in Roadmap. We further show how these integrated functional scores can be used for (1) deriving the most likely cell or tissue type causally implicated for a complex trait by using summary statistics from genome-wide association studies and (2) estimating a tissue-based correlation matrix of various complex traits. We found large enrichment of heritability in functional components of relevant tissues for various complex traits, and FUN-LDA yielded higher enrichment estimates than existing methods. Finally, using experimentally validated functional variants from the literature and variants possibly implicated in disease by previous studies, we rigorously compare FUN-LDA with state-of-the-art functional annotation methods and show that FUN-LDA has better prediction accuracy and higher resolution than these methods. In particular, our results suggest that tissue- and cell-type-specific functional prediction methods tend to have substantially better prediction accuracy than organism-level prediction methods. Scores for each position in the human genome and for each ENCODE and Roadmap tissue are available online (see Web Resources). Copyright © 2018 American Society of Human Genetics. Published by Elsevier Inc. All rights reserved.

Methods of Measurement in epidemiology: Sedentary Behaviour

PubMed Central

Atkin, Andrew J; Gorely, Trish; Clemes, Stacy A; Yates, Thomas; Edwardson, Charlotte; Brage, Soren; Salmon, Jo; Marshall, Simon J; Biddle, Stuart JH

2012-01-01

Background Research examining sedentary behaviour as a potentially independent risk factor for chronic disease morbidity and mortality has expanded rapidly in recent years. Methods We present a narrative overview of the sedentary behaviour measurement literature. Subjective and objective methods of measuring sedentary behaviour suitable for use in population-based research with children and adults are examined. The validity and reliability of each method is considered, gaps in the literature specific to each method identified and potential future directions discussed. Results To date, subjective approaches to sedentary behaviour measurement, e.g. questionnaires, have focused predominantly on TV viewing or other screen-based behaviours. Typically, such measures demonstrate moderate reliability but slight to moderate validity. Accelerometry is increasingly being used for sedentary behaviour assessments; this approach overcomes some of the limitations of subjective methods, but detection of specific postures and postural changes by this method is somewhat limited. Instruments developed specifically for the assessment of body posture have demonstrated good reliability and validity in the limited research conducted to date. Miniaturization of monitoring devices, interoperability between measurement and communication technologies and advanced analytical approaches are potential avenues for future developments in this field. Conclusions High-quality measurement is essential in all elements of sedentary behaviour epidemiology, from determining associations with health outcomes to the development and evaluation of behaviour change interventions. Sedentary behaviour measurement remains relatively under-developed, although new instruments, both objective and subjective, show considerable promise and warrant further testing. PMID:23045206

A risk-model for hospital mortality among patients with severe sepsis or septic shock based on German national administrative claims data

PubMed Central

Fleischmann-Struzek, Carolin; Rüddel, Hendrik; Reinhart, Konrad; Thomas-Rüddel, Daniel O.

2018-01-01

Background Sepsis is a major cause of preventable deaths in hospitals. Feasible and valid methods for comparing quality of sepsis care between hospitals are needed. The aim of this study was to develop a risk-adjustment model suitable for comparing sepsis-related mortality between German hospitals. Methods We developed a risk-model using national German claims data. Since these data are available with a time-lag of 1.5 years only, the stability of the model across time was investigated. The model was derived from inpatient cases with severe sepsis or septic shock treated in 2013 using logistic regression with backward selection and generalized estimating equations to correct for clustering. It was validated among cases treated in 2015. Finally, the model development was repeated in 2015. To investigate secular changes, the risk-adjusted trajectory of mortality across the years 2010–2015 was analyzed. Results The 2013 deviation sample consisted of 113,750 cases; the 2015 validation sample consisted of 134,851 cases. The model developed in 2013 showed good validity regarding discrimination (AUC = 0.74), calibration (observed mortality in 1st and 10th risk-decile: 11%-78%), and fit (R2 = 0.16). Validity remained stable when the model was applied to 2015 (AUC = 0.74, 1st and 10th risk-decile: 10%-77%, R2 = 0.17). There was no indication of overfitting of the model. The final model developed in year 2015 contained 40 risk-factors. Between 2010 and 2015 hospital mortality in sepsis decreased from 48% to 42%. Adjusted for risk-factors the trajectory of decrease was still significant. Conclusions The risk-model shows good predictive validity and stability across time. The model is suitable to be used as an external algorithm for comparing risk-adjusted sepsis mortality among German hospitals or regions based on administrative claims data, but secular changes need to be taken into account when interpreting risk-adjusted mortality. PMID:29558486

Comparing the validity of the payment card and structured haggling willingness to pay methods: The case of a diabetes prevention program in rural Kenya.

PubMed

Kangethe, Anne; Franic, Duska M; Corso, Phaedra S

2016-11-01

The objective of this study was to compare the theoretical validity of two willingness-to-pay (WTP) methods, the commonly used payment card (PC) and the recently developed structured haggling (SH), for estimating the potential benefits of a diabetes prevention program in rural Kenya. A convenience sample of adult residents from a rural county in Kenya (Kiambu), with no history of diabetes, was randomly assigned to one of two WTP methods, PC or SH, using structured face-to-face interviews from December 2011 to February 2012. A total of 376 respondents completed the interviews using PC (n = 185) or SH (n = 191). More than 95% of respondents were willing to pay something for program access. The study showed that both methods were feasible in rural Kenya. SH resulted in a higher annual mean WTP than PC, Ksh504.05 (US$7.25) versus Ksh619.95 (US$5.90), respectively (p < 0.01). Based on theory, it was hypothesized that certain predisposing factors would result in greater WTP. Greater socio-economic status (measured using income proxies) resulted in greater unconditional WTP for both the PC and SH groups (t-tests and bivariate correlations) and conditional WTP (GLM models). GLM for PC showed being male, employed and having distant relatives with diabetes were significant predictors for WTP, while for SH being educated, employed and owning a vehicle were significant predictors. Both PC and SH showed theoretical validity in rural Kenya. However, the use of SH over PC in rural Kenya may be the better choice given that SH more closely mirrors marketplace transactions in this setting and the use of SH resulted in more significant variables in the GLM models. Copyright © 2016 Elsevier Ltd. All rights reserved.

Design and validation of a method for evaluation of interocular interaction.

PubMed

Lai, Xin Jie Angela; Alexander, Jack; Ho, Arthur; Yang, Zhikuan; He, Mingguang; Suttle, Catherine

2012-02-01

To design a simple viewing system allowing dichoptic masking, and to validate this system in adults and children with normal vision. A Trial Frame Apparatus (TFA) was designed to evaluate interocular interaction. This device consists of a trial frame, a 1 mm pinhole in front of the tested eye and a full or partial occluder in front of the non-tested eye. The difference in visual function in one eye between the full- and partial-occlusion conditions was termed the Interaction Index. In experiment 1, low-contrast acuity was measured in six adults using five types of partial occluder. Interaction Index was compared between these five, and the occluder showing the highest Index was used in experiment 2. In experiment 2, low-contrast acuity, contrast sensitivity, and alignment sensitivity were measured in the non-dominant eye of 45 subjects (15 older adults, 15 young adults, and 15 children), using the TFA and an existing well-validated device (shutter goggles) with full and partial occlusion of the dominant eye. These measurements were repeated on 11 subjects of each group using TFA in the partial-occlusion condition only. Repeatability of visual function measurements using TFA was assessed using the Bland-Altman method and agreement between TFA and goggles in terms of visual functions and interactions was assessed using the Bland-Altman method and t-test. In all three subject groups, the TFA showed a high level of repeatability in all visual function measurements. Contrast sensitivity was significantly poorer when measured using TFA than using goggles (p < 0.05). However, Interaction Index of all three visual functions showed acceptable agreement between TFA and goggles (p > 0.05). The TFA may provide an acceptable method for the study of some forms of dichoptic masking in populations where more complex devices (e.g., shutter goggles) cannot be used.

3-D surface profilometry based on modulation measurement by applying wavelet transform method

NASA Astrophysics Data System (ADS)

Zhong, Min; Chen, Feng; Xiao, Chao; Wei, Yongchao

2017-01-01

A new analysis of 3-D surface profilometry based on modulation measurement technique by the application of Wavelet Transform method is proposed. As a tool excelling for its multi-resolution and localization in the time and frequency domains, Wavelet Transform method with good localized time-frequency analysis ability and effective de-noizing capacity can extract the modulation distribution more accurately than Fourier Transform method. Especially for the analysis of complex object, more details of the measured object can be well remained. In this paper, the theoretical derivation of Wavelet Transform method that obtains the modulation values from a captured fringe pattern is given. Both computer simulation and elementary experiment are used to show the validity of the proposed method by making a comparison with the results of Fourier Transform method. The results show that the Wavelet Transform method has a better performance than the Fourier Transform method in modulation values retrieval.

Likelihood ratio data to report the validation of a forensic fingerprint evaluation method.

PubMed

Ramos, Daniel; Haraksim, Rudolf; Meuwly, Didier

2017-02-01

Data to which the authors refer to throughout this article are likelihood ratios (LR) computed from the comparison of 5-12 minutiae fingermarks with fingerprints. These LRs data are used for the validation of a likelihood ratio (LR) method in forensic evidence evaluation. These data present a necessary asset for conducting validation experiments when validating LR methods used in forensic evidence evaluation and set up validation reports. These data can be also used as a baseline for comparing the fingermark evidence in the same minutiae configuration as presented in (D. Meuwly, D. Ramos, R. Haraksim,) [1], although the reader should keep in mind that different feature extraction algorithms and different AFIS systems used may produce different LRs values. Moreover, these data may serve as a reproducibility exercise, in order to train the generation of validation reports of forensic methods, according to [1]. Alongside the data, a justification and motivation for the use of methods is given. These methods calculate LRs from the fingerprint/mark data and are subject to a validation procedure. The choice of using real forensic fingerprint in the validation and simulated data in the development is described and justified. Validation criteria are set for the purpose of validation of the LR methods, which are used to calculate the LR values from the data and the validation report. For privacy and data protection reasons, the original fingerprint/mark images cannot be shared. But these images do not constitute the core data for the validation, contrarily to the LRs that are shared.

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

PubMed

Wiegers, Ann L

2003-07-01

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

A validation framework for brain tumor segmentation.

PubMed

Archip, Neculai; Jolesz, Ferenc A; Warfield, Simon K

2007-10-01

We introduce a validation framework for the segmentation of brain tumors from magnetic resonance (MR) images. A novel unsupervised semiautomatic brain tumor segmentation algorithm is also presented. The proposed framework consists of 1) T1-weighted MR images of patients with brain tumors, 2) segmentation of brain tumors performed by four independent experts, 3) segmentation of brain tumors generated by a semiautomatic algorithm, and 4) a software tool that estimates the performance of segmentation algorithms. We demonstrate the validation of the novel segmentation algorithm within the proposed framework. We show its performance and compare it with existent segmentation. The image datasets and software are available at http://www.brain-tumor-repository.org/. We present an Internet resource that provides access to MR brain tumor image data and segmentation that can be openly used by the research community. Its purpose is to encourage the development and evaluation of segmentation methods by providing raw test and image data, human expert segmentation results, and methods for comparing segmentation results.

Design and landing dynamic analysis of reusable landing leg for a near-space manned capsule

NASA Astrophysics Data System (ADS)

Yue, Shuai; Nie, Hong; Zhang, Ming; Wei, Xiaohui; Gan, Shengyong

2018-06-01

To improve the landing performance of a near-space manned capsule under various landing conditions, a novel landing system is designed that employs double chamber and single chamber dampers in the primary and auxiliary struts, respectively. A dynamic model of the landing system is established, and the damper parameters are determined by employing the design method. A single-leg drop test with different initial pitch angles is then conducted to compare and validate the simulation model. Based on the validated simulation model, seven critical landing conditions regarding nine crucial landing responses are found by combining the radial basis function (RBF) surrogate model and adaptive simulated annealing (ASA) optimization method. Subsequently, the adaptability of the landing system under critical landing conditions is analyzed. The results show that the simulation effectively results match the test results, which validates the accuracy of the dynamic model. In addition, all of the crucial responses under their corresponding critical landing conditions satisfy the design specifications, demonstrating the feasibility of the landing system.

Scaling field data to calibrate and validate moderate spatial resolution remote sensing models

USGS Publications Warehouse

Baccini, A.; Friedl, M.A.; Woodcock, C.E.; Zhu, Z.

2007-01-01

Validation and calibration are essential components of nearly all remote sensing-based studies. In both cases, ground measurements are collected and then related to the remote sensing observations or model results. In many situations, and particularly in studies that use moderate resolution remote sensing, a mismatch exists between the sensor's field of view and the scale at which in situ measurements are collected. The use of in situ measurements for model calibration and validation, therefore, requires a robust and defensible method to spatially aggregate ground measurements to the scale at which the remotely sensed data are acquired. This paper examines this challenge and specifically considers two different approaches for aggregating field measurements to match the spatial resolution of moderate spatial resolution remote sensing data: (a) landscape stratification; and (b) averaging of fine spatial resolution maps. The results show that an empirically estimated stratification based on a regression tree method provides a statistically defensible and operational basis for performing this type of procedure. 

Validation of the Use of Dried Blood Spot (DBS) Method to Assess Vitamin A Status

PubMed Central

Fallah, Elham; Peighambardoust, Seyed Hadi

2012-01-01

Background: Vitamin A deficiency is an important dietary deficiency in the world. Thus, the ne¬cessity of screening for deficient populations is obvious. This paper introduces a fast, cheap and relatively reliable method called “dried blood spot” (DBS) method in screening the deficient populations. The validity of this method for retinol measurement was investigated. Method: The “precision” and “agreement” criteria of the DBS method were assessed. The preci¬sion was calculated and compared with those of plasma using F-test. The agreement was eva¬luated using Bland-Altman plot. Results: The imprecision of retinol measurements in dried spots was not significantly different from those of the control (plasma). A good correlation coefficient (r2=0.78) was obtained for dried spots’ retinol measurements versus plasma’s retinol analysis (P < 0.01). Paired t-test showed no significant difference between the DBS and retinol methods on a group level. Imprecision of DBS measurement was acceptable, compared to that of the plasma method. The difference be¬tween these two methods was not statistically significant on a group level. Conclusion: Application of DBS standard samples, in which a part of the plasma was replaced with the artificial plasma, was shown to be a reliable calibration mean for retinol measurements in DBS samples. Retinol in dried spots was stable for 90 days. Overall, the DBS method provided a precise measurement of retinol, showing results that were comparable with the measurement of retinol in plasma. PMID:24688932

Evaluation of the Predictive Validity of Thermography in Identifying Extravasation With Intravenous Chemotherapy Infusions.

PubMed

Matsui, Yuko; Murayama, Ryoko; Tanabe, Hidenori; Oe, Makoto; Motoo, Yoshiharu; Wagatsuma, Takanori; Michibuchi, Michiko; Kinoshita, Sachiko; Sakai, Keiko; Konya, Chizuko; Sugama, Junko; Sanada, Hiromi

Early detection of extravasation is important, but conventional methods of detection lack objectivity and reliability. This study evaluated the predictive validity of thermography for identifying extravasation during intravenous antineoplastic therapy. Of 257 patients who received chemotherapy through peripheral veins, extravasation was identified in 26. Thermography was performed every 15 to 30 minutes during the infusions. Sensitivity, specificity, positive predictive value, and negative predictive value using thermography were 84.6%, 94.8%, 64.7%, and 98.2%, respectively. This study showed that thermography offers an accurate prediction of extravasation.

42 CFR 456.655 - Validation of showings.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Administrator will not find an agency's showing satisfactory if the information obtained through his validation... 42 Public Health 4 2010-10-01 2010-10-01 false Validation of showings. 456.655 Section 456.655... Showing of an Effective Institutional Utilization Control Program § 456.655 Validation of showings. (a...

Quantitative impurity analysis of monoclonal antibody size heterogeneity by CE-LIF: example of development and validation through a quality-by-design framework.

PubMed

Michels, David A; Parker, Monica; Salas-Solano, Oscar

2012-03-01

This paper describes the framework of quality by design applied to the development, optimization and validation of a sensitive capillary electrophoresis-sodium dodecyl sulfate (CE-SDS) assay for monitoring impurities that potentially impact drug efficacy or patient safety produced in the manufacture of therapeutic MAb products. Drug substance or drug product samples are derivatized with fluorogenic 3-(2-furoyl)quinoline-2-carboxaldehyde and nucleophilic cyanide before separation by CE-SDS coupled to LIF detection. Three design-of-experiments enabled critical labeling parameters to meet method requirements for detecting minor impurities while building precision and robustness into the assay during development. The screening design predicted optimal conditions to control labeling artifacts while two full factorial designs demonstrated method robustness through control of temperature and cyanide parameters within the normal operating range. Subsequent validation according to the guidelines of the International Committee of Harmonization showed the CE-SDS/LIF assay was specific, accurate, and precise (RSD ≤ 0.8%) for relative peak distribution and linear (R > 0.997) between the range of 0.5-1.5 mg/mL with LOD and LOQ of 10 ng/mL and 35 ng/mL, respectively. Validation confirmed the system suitability criteria used as a level of control to ensure reliable method performance. © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Detrended fluctuation analysis for major depressive disorder.

PubMed

Mumtaz, Wajid; Malik, Aamir Saeed; Ali, Syed Saad Azhar; Yasin, Mohd Azhar Mohd; Amin, Hafeezullah

2015-01-01

Clinical utility of Electroencephalography (EEG) based diagnostic studies is less clear for major depressive disorder (MDD). In this paper, a novel machine learning (ML) scheme was presented to discriminate the MDD patients and healthy controls. The proposed method inherently involved feature extraction, selection, classification and validation. The EEG data acquisition involved eyes closed (EC) and eyes open (EO) conditions. At feature extraction stage, the de-trended fluctuation analysis (DFA) was performed, based on the EEG data, to achieve scaling exponents. The DFA was performed to analyzes the presence or absence of long-range temporal correlations (LRTC) in the recorded EEG data. The scaling exponents were used as input features to our proposed system. At feature selection stage, 3 different techniques were used for comparison purposes. Logistic regression (LR) classifier was employed. The method was validated by a 10-fold cross-validation. As results, we have observed that the effect of 3 different reference montages on the computed features. The proposed method employed 3 different types of feature selection techniques for comparison purposes as well. The results show that the DFA analysis performed better in LE data compared with the IR and AR data. In addition, during Wilcoxon ranking, the AR performed better than LE and IR. Based on the results, it was concluded that the DFA provided useful information to discriminate the MDD patients and with further validation can be employed in clinics for diagnosis of MDD.

Development and validation of an extraction method for the analysis of perfluoroalkyl substances in human hair.

PubMed

Kim, Da-Hye; Oh, Jeong-Eun

2017-05-01

Human hair has many advantages as a non-invasive sample; however, analytical methods for detecting perfluoroalkyl substances (PFASs) in human hair are still in the development stage. Therefore, the aim of this study was to develop and validate a method for monitoring 11 PFASs in human hair. Solid-phase extraction (SPE), ion-pairing extraction (IPE), a combined method (SPE+IPE) and solvent extraction with ENVI-carb clean-up were compared to develop an optimal extraction method using two types of hair sample (powder and piece forms). Analysis of PFASs was performed using liquid chromatography and tandem mass spectrometry. Among the four different extraction procedures, the SPE method using powdered hair showed the best extraction efficiency and recoveries ranged from 85.8 to 102%. The method detection limits for the SPE method were 0.114-0.796 ng/g and good precision (below 10%) and accuracy (66.4-110%) were obtained. In light of these results, SPE is considered the optimal method for PFAS extraction from hair. It was also successfully used to detect PFASs in human hair samples. Copyright © 2017 Elsevier Ltd. All rights reserved.

Measurement properties of gingival biotype evaluation methods.

PubMed

Alves, Patrick Henry Machado; Alves, Thereza Cristina Lira Pacheco; Pegoraro, Thiago Amadei; Costa, Yuri Martins; Bonfante, Estevam Augusto; de Almeida, Ana Lúcia Pompéia Fraga

2018-06-01

There are numerous methods to measure the dimensions of the gingival tissue, but few have compared the effectiveness of one method over another. This study aimed to describe a new method and to estimate the validity of gingival biotype assessment with the aid of computed tomography scanning (CTS). In each patient different methods of evaluation of the gingival thickness were used: transparency of periodontal probe, transgingival, photography, and a new method of CTS). Intrarater and interrater reliability considering the categorical classification of the gingival biotype were estimated with Cohen's kappa coefficient, intraclass correlation coefficient (ICC), and ANOVA (P < .05). The criterion validity of the CTS was determined using the transgingival method as the reference standard. Sensitivity and specificity values were computed along with theirs 95% CI. Twelve patients were subjected to assessment of their gingival thickness. The highest agreement was found between transgingival and CTS (86.1%). The comparison between the categorical classifications of CTS and the transgingival method (reference standard) showed high specificity (94.92%) and low sensitivity (53.85%) for definition of a thin biotype. The new method of CTS assessment to classify gingival tissue thickness can be considered reliable and clinically useful to diagnose thick biotype. © 2018 Wiley Periodicals, Inc.

Development of a multiresidue method for the determination of endocrine disrupters in fish fillet using gas chromatography-triple quadrupole tandem mass spectrometry.

PubMed

Munaretto, Juliana S; Ferronato, Giovana; Ribeiro, Lucila C; Martins, Manoel L; Adaime, Martha B; Zanella, Renato

2013-11-15

Endocrine Disrupter Compounds (EDCs) are responsible for alterations in the endocrine system functions. Aquatic organisms are able to accumulate EDCs residues, being the major source of contamination for top predators and human consumers. This study aimed to develop and validate a method for the determination of 40 EDCs in fish fillet using modified QuEChERS and Gas Chromatography coupled with Mass Spectrometry in tandem (GC-MS/MS). A factorial design was used to optimize the extraction procedure. Method validation presented recoveries from 70.1% to 120.0% with RSD<20% and method limit of detection ranged from 0.3 to 7.5 µg kg(-1), showing good accuracy and precision. This method was successfully applied to the analysis of fish fillet from different species and residues of bisphenol A, chlorpyrifos and bifenthrin were detected. The proposed method proved to be effective for the determination of EDCs in fish fillet at very low concentration levels. © 2013 Elsevier B.V. All rights reserved.

Fractal propagation method enables realistic optical microscopy simulations in biological tissues

PubMed Central

Glaser, Adam K.; Chen, Ye; Liu, Jonathan T.C.

2017-01-01

Current simulation methods for light transport in biological media have limited efficiency and realism when applied to three-dimensional microscopic light transport in biological tissues with refractive heterogeneities. We describe here a technique which combines a beam propagation method valid for modeling light transport in media with weak variations in refractive index, with a fractal model of refractive index turbulence. In contrast to standard simulation methods, this fractal propagation method (FPM) is able to accurately and efficiently simulate the diffraction effects of focused beams, as well as the microscopic heterogeneities present in tissue that result in scattering, refractive beam steering, and the aberration of beam foci. We validate the technique and the relationship between the FPM model parameters and conventional optical parameters used to describe tissues, and also demonstrate the method’s flexibility and robustness by examining the steering and distortion of Gaussian and Bessel beams in tissue with comparison to experimental data. We show that the FPM has utility for the accurate investigation and optimization of optical microscopy methods such as light-sheet, confocal, and nonlinear microscopy. PMID:28983499

Validation of an association rule mining-based method to infer associations between medications and problems.

PubMed

Wright, A; McCoy, A; Henkin, S; Flaherty, M; Sittig, D

2013-01-01

In a prior study, we developed methods for automatically identifying associations between medications and problems using association rule mining on a large clinical data warehouse and validated these methods at a single site which used a self-developed electronic health record. To demonstrate the generalizability of these methods by validating them at an external site. We received data on medications and problems for 263,597 patients from the University of Texas Health Science Center at Houston Faculty Practice, an ambulatory practice that uses the Allscripts Enterprise commercial electronic health record product. We then conducted association rule mining to identify associated pairs of medications and problems and characterized these associations with five measures of interestingness: support, confidence, chi-square, interest and conviction and compared the top-ranked pairs to a gold standard. 25,088 medication-problem pairs were identified that exceeded our confidence and support thresholds. An analysis of the top 500 pairs according to each measure of interestingness showed a high degree of accuracy for highly-ranked pairs. The same technique was successfully employed at the University of Texas and accuracy was comparable to our previous results. Top associations included many medications that are highly specific for a particular problem as well as a large number of common, accurate medication-problem pairs that reflect practice patterns.

Determination of Ochratoxin A in Rye and Rye-Based Products by Fluorescence Polarization Immunoassay

PubMed Central

Lippolis, Vincenzo; Porricelli, Anna C. R.; Cortese, Marina; Zanardi, Sandro; Pascale, Michelangelo

2017-01-01

A rapid fluorescence polarization immunoassay (FPIA) was optimized and validated for the determination of ochratoxin A (OTA) in rye and rye crispbread. Samples were extracted with a mixture of acetonitrile/water (60:40, v/v) and purified by SPE-aminopropyl column clean-up before performing the FPIA. Overall mean recoveries were 86 and 95% for spiked rye and rye crispbread with relative standard deviations lower than 6%. Limits of detection (LOD) of the optimized FPIA was 0.6 μg/kg for rye and rye crispbread, respectively. Good correlations (r > 0.977) were observed between OTA contents in contaminated samples obtained by FPIA and high-performance liquid chromatography (HPLC) with immunoaffinity cleanup used as reference method. Furthermore, single laboratory validation and small-scale collaborative trials were carried out for the determination of OTA in rye according to Regulation 519/2014/EU laying down procedures for the validation of screening methods. The precision profile of the method, cut-off level and rate of false suspect results confirm the satisfactory analytical performances of assay as a screening method. These findings show that the optimized FPIA is suitable for high-throughput screening, and permits reliable quantitative determination of OTA in rye and rye crispbread at levels that fall below the EU regulatory limits. PMID:28954398

Determining skeletal muscle architecture with Laplacian simulations: a comparison with diffusion tensor imaging.

PubMed

Handsfield, Geoffrey G; Bolsterlee, Bart; Inouye, Joshua M; Herbert, Robert D; Besier, Thor F; Fernandez, Justin W

2017-12-01

Determination of skeletal muscle architecture is important for accurately modeling muscle behavior. Current methods for 3D muscle architecture determination can be costly and time-consuming, making them prohibitive for clinical or modeling applications. Computational approaches such as Laplacian flow simulations can estimate muscle fascicle orientation based on muscle shape and aponeurosis location. The accuracy of this approach is unknown, however, since it has not been validated against other standards for muscle architecture determination. In this study, muscle architectures from the Laplacian approach were compared to those determined from diffusion tensor imaging in eight adult medial gastrocnemius muscles. The datasets were subdivided into training and validation sets, and computational fluid dynamics software was used to conduct Laplacian simulations. In training sets, inputs of muscle geometry, aponeurosis location, and geometric flow guides resulted in good agreement between methods. Application of the method to validation sets showed no significant differences in pennation angle (mean difference [Formula: see text] or fascicle length (mean difference 0.9 mm). Laplacian simulation was thus effective at predicting gastrocnemius muscle architectures in healthy volunteers using imaging-derived muscle shape and aponeurosis locations. This method may serve as a tool for determining muscle architecture in silico and as a complement to other approaches.

A Stability-Indicating HPLC-DAD Method for Determination of Stiripentol: Development, Validation, Kinetics, Structure Elucidation and Application to Commercial Dosage Form

PubMed Central

Darwish, Hany W.; Abdelhameed, Ali S.; Bakheit, Ahmed H.; Khalil, Nasr Y.; Al-Majed, Abdulrahman A.

2014-01-01

A rapid, simple, sensitive, and accurate isocratic reversed-phase stability-indicating high performance liquid chromatography method has been developed and validated for the determination of stiripentol and its degradation product in its bulk form and pharmaceutical dosage form. Chromatographic separation was achieved on a Symmetry C18 column and quantification was achieved using photodiode array detector (DAD). The method was validated in accordance with the ICH requirements showing specificity, linearity (r 2 = 0.9996, range of 1–25 μg/mL), precision (relative standard deviation lower than 2%), accuracy (mean recovery 100.08 ± 1.73), limits of detection and quantitation (LOD = 0.024 and LOQ = 0.081 μg/mL), and robustness. Stiripentol was subjected to various stress conditions and it has shown marked stability under alkaline hydrolytic stress conditions, thermal, oxidative, and photolytic conditions. Stiripentol degraded only under acidic conditions, forming a single degradation product which was well resolved from the pure drug with significantly different retention time values. This degradation product was characterized by 1H-NMR and 13C-NMR spectroscopy as well as ion trap mass spectrometry. The results demonstrated that the method would have a great value when applied in quality control and stability studies for stiripentol. PMID:25371844

Validation of a HLA-A2 tetramer flow cytometric method, IFNgamma real time RT-PCR, and IFNgamma ELISPOT for detection of immunologic response to gp100 and MelanA/MART-1 in melanoma patients

PubMed Central

Xu, Yuanxin; Theobald, Valerie; Sung, Crystal; DePalma, Kathleen; Atwater, Laura; Seiger, Keirsten; Perricone, Michael A; Richards, Susan M

2008-01-01

Background HLA-A2 tetramer flow cytometry, IFNγ real time RT-PCR and IFNγ ELISPOT assays are commonly used as surrogate immunological endpoints for cancer immunotherapy. While these are often used as research assays to assess patient's immunologic response, assay validation is necessary to ensure reliable and reproducible results and enable more accurate data interpretation. Here we describe a rigorous validation approach for each of these assays prior to their use for clinical sample analysis. Methods Standard operating procedures for each assay were established. HLA-A2 (A*0201) tetramer assay specific for gp100209(210M) and MART-126–35(27L), IFNγ real time RT-PCR and ELISPOT methods were validated using tumor infiltrating lymphocyte cell lines (TIL) isolated from HLA-A2 melanoma patients. TIL cells, specific for gp100 (TIL 1520) or MART-1 (TIL 1143 and TIL1235), were used alone or spiked into cryopreserved HLA-A2 PBMC from healthy subjects. TIL/PBMC were stimulated with peptides (gp100209, gp100pool, MART-127–35, or influenza-M1 and negative control peptide HIV) to further assess assay performance characteristics for real time RT-PCR and ELISPOT methods. Validation parameters included specificity, accuracy, precision, linearity of dilution, limit of detection (LOD) and limit of quantification (LOQ). In addition, distribution was established in normal HLA-A2 PBMC samples. Reference ranges for assay controls were established. Results The validation process demonstrated that the HLA-A2 tetramer, IFNγ real time RT-PCR, and IFNγ ELISPOT were highly specific for each antigen, with minimal cross-reactivity between gp100 and MelanA/MART-1. The assays were sensitive; detection could be achieved at as few as 1/4545–1/6667 cells by tetramer analysis, 1/50,000 cells by real time RT-PCR, and 1/10,000–1/20,000 by ELISPOT. The assays met criteria for precision with %CV < 20% (except ELISPOT using high PBMC numbers with %CV < 25%) although flow cytometric assays and cell based functional assays are known to have high assay variability. Most importantly, assays were demonstrated to be effective for their intended use. A positive IFNγ response (by RT-PCR and ELISPOT) to gp100 was demonstrated in PBMC from 3 melanoma patients. Another patient showed a positive MART-1 response measured by all 3 validated methods. Conclusion Our results demonstrated the tetramer flow cytometry assay, IFNγ real-time RT-PCR, and INFγ ELISPOT met validation criteria. Validation approaches provide a guide for others in the field to validate these and other similar assays for assessment of patient T cell response. These methods can be applied not only to cancer vaccines but to other therapeutic proteins as part of immunogenicity and safety analyses. PMID:18945350