Evaluation and Validation of Reference Genes for qRT-PCR Normalization in Frankliniella occidentalis (Thysanoptera:Thripidae)

PubMed Central

Zheng, Yu-Tao; Li, Hong-Bo; Lu, Ming-Xing; Du, Yu-Zhou

2014-01-01

Quantitative real time PCR (qRT-PCR) has emerged as a reliable and reproducible technique for studying gene expression analysis. For accurate results, the normalization of data with reference genes is particularly essential. Once the transcriptome sequencing of Frankliniella occidentalis was completed, numerous unigenes were identified and annotated. Unfortunately, there are no studies on the stability of reference genes used in F. occidentalis. In this work, seven candidate reference genes, including actin, 18S rRNA, H3, tubulin, GAPDH, EF-1 and RPL32, were evaluated for their suitability as normalization genes under different experimental conditions using the statistical software programs BestKeeper, geNorm, Normfinder and the comparative ΔCt method. Because the rankings of the reference genes provided by each of the four programs were different, we chose a user-friendly web-based comprehensive tool RefFinder to get the final ranking. The result demonstrated that EF-1 and RPL32 displayed the most stable expression in different developmental stages; RPL32 and GAPDH showed the most stable expression at high temperatures, while 18S and EF-1 exhibited the most stable expression at low temperatures. In this study, we validated the suitable reference genes in F. occidentalis for gene expression profiling under different experimental conditions. The choice of internal standard is very important in the normalization of the target gene expression levels, thus validating and selecting the best genes will help improve the quality of gene expression data of F. occidentalis. What is more, these validated reference genes could serve as the basis for the selection of candidate reference genes in other insects. PMID:25356721

Evaluation and validation of reference genes for qRT-PCR normalization in Frankliniella occidentalis (Thysanoptera: Thripidae).

PubMed

Zheng, Yu-Tao; Li, Hong-Bo; Lu, Ming-Xing; Du, Yu-Zhou

2014-01-01

Quantitative real time PCR (qRT-PCR) has emerged as a reliable and reproducible technique for studying gene expression analysis. For accurate results, the normalization of data with reference genes is particularly essential. Once the transcriptome sequencing of Frankliniella occidentalis was completed, numerous unigenes were identified and annotated. Unfortunately, there are no studies on the stability of reference genes used in F. occidentalis. In this work, seven candidate reference genes, including actin, 18S rRNA, H3, tubulin, GAPDH, EF-1 and RPL32, were evaluated for their suitability as normalization genes under different experimental conditions using the statistical software programs BestKeeper, geNorm, Normfinder and the comparative ΔCt method. Because the rankings of the reference genes provided by each of the four programs were different, we chose a user-friendly web-based comprehensive tool RefFinder to get the final ranking. The result demonstrated that EF-1 and RPL32 displayed the most stable expression in different developmental stages; RPL32 and GAPDH showed the most stable expression at high temperatures, while 18S and EF-1 exhibited the most stable expression at low temperatures. In this study, we validated the suitable reference genes in F. occidentalis for gene expression profiling under different experimental conditions. The choice of internal standard is very important in the normalization of the target gene expression levels, thus validating and selecting the best genes will help improve the quality of gene expression data of F. occidentalis. What is more, these validated reference genes could serve as the basis for the selection of candidate reference genes in other insects.

Validation of endogenous reference genes for qRT-PCR analysis of human visceral adipose samples

PubMed Central

2010-01-01

Background Given the epidemic proportions of obesity worldwide and the concurrent prevalence of metabolic syndrome, there is an urgent need for better understanding the underlying mechanisms of metabolic syndrome, in particular, the gene expression differences which may participate in obesity, insulin resistance and the associated series of chronic liver conditions. Real-time PCR (qRT-PCR) is the standard method for studying changes in relative gene expression in different tissues and experimental conditions. However, variations in amount of starting material, enzymatic efficiency and presence of inhibitors can lead to quantification errors. Hence the need for accurate data normalization is vital. Among several known strategies for data normalization, the use of reference genes as an internal control is the most common approach. Recent studies have shown that both obesity and presence of insulin resistance influence an expression of commonly used reference genes in omental fat. In this study we validated candidate reference genes suitable for qRT-PCR profiling experiments using visceral adipose samples from obese and lean individuals. Results Cross-validation of expression stability of eight selected reference genes using three popular algorithms, GeNorm, NormFinder and BestKeeper found ACTB and RPII as most stable reference genes. Conclusions We recommend ACTB and RPII as stable reference genes most suitable for gene expression studies of human visceral adipose tissue. The use of these genes as a reference pair may further enhance the robustness of qRT-PCR in this model system. PMID:20492695

Validation of endogenous reference genes for qRT-PCR analysis of human visceral adipose samples.

PubMed

Mehta, Rohini; Birerdinc, Aybike; Hossain, Noreen; Afendy, Arian; Chandhoke, Vikas; Younossi, Zobair; Baranova, Ancha

2010-05-21

Given the epidemic proportions of obesity worldwide and the concurrent prevalence of metabolic syndrome, there is an urgent need for better understanding the underlying mechanisms of metabolic syndrome, in particular, the gene expression differences which may participate in obesity, insulin resistance and the associated series of chronic liver conditions. Real-time PCR (qRT-PCR) is the standard method for studying changes in relative gene expression in different tissues and experimental conditions. However, variations in amount of starting material, enzymatic efficiency and presence of inhibitors can lead to quantification errors. Hence the need for accurate data normalization is vital. Among several known strategies for data normalization, the use of reference genes as an internal control is the most common approach. Recent studies have shown that both obesity and presence of insulin resistance influence an expression of commonly used reference genes in omental fat. In this study we validated candidate reference genes suitable for qRT-PCR profiling experiments using visceral adipose samples from obese and lean individuals. Cross-validation of expression stability of eight selected reference genes using three popular algorithms, GeNorm, NormFinder and BestKeeper found ACTB and RPII as most stable reference genes. We recommend ACTB and RPII as stable reference genes most suitable for gene expression studies of human visceral adipose tissue. The use of these genes as a reference pair may further enhance the robustness of qRT-PCR in this model system.

Optimal Reference Gene Selection for Expression Studies in Human Reticulocytes.

PubMed

Aggarwal, Anu; Jamwal, Manu; Viswanathan, Ganesh K; Sharma, Prashant; Sachdeva, ManUpdesh S; Bansal, Deepak; Malhotra, Pankaj; Das, Reena

2018-05-01

Reference genes are indispensable for normalizing mRNA levels across samples in real-time quantitative PCR. Their expression levels vary under different experimental conditions and because of several inherent characteristics. Appropriate reference gene selection is thus critical for gene-expression studies. This study aimed at selecting optimal reference genes for gene-expression analysis of reticulocytes and at validating them in hereditary spherocytosis (HS) and β-thalassemia intermedia (βTI) patients. Seven reference genes (PGK1, MPP1, HPRT1, ACTB, GAPDH, RN18S1, and SDHA) were selected because of published reports. Real-time quantitative PCR was performed on reticulocytes in 20 healthy volunteers, 15 HS patients, and 10 βTI patients. Threshold cycle values were compared with fold-change method and RefFinder software. The stable reference genes recommended by RefFinder were validated with SLC4A1 and flow cytometric eosin-5'-maleimide binding assay values in HS patients and HBG2 and high performance liquid chromatography-derived percentage of hemoglobin F in βTI. Comprehensive ranking predicted MPP1 and GAPDH as optimal reference genes for reticulocytes that were not affected in HS and βTI. This was further confirmed on validation with eosin-5'-maleimide results and percentage of hemoglobin F in HS and βTI patients, respectively. Hence, MPP1 and GAPDH are good reference genes for reticulocyte expression studies compared with ACTB and RN18S1, the two most commonly used reference genes. Copyright © 2018 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Psychometric testing of the short version of the world health organization quality of life (WHOQOL-BREF) questionnaire among pulmonary tuberculosis patients in Taiwan

PubMed Central

2012-01-01

Background Studies on the effects of tuberculosis on a patient’s quality of life (QOL) are scant. The objective of this study was to evaluate the psychometric properties of the Taiwan short version of the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire using patients with tuberculosis in Taiwan and healthy referents. Methods The Taiwanese short version of the WHOQOL-BREF was administered to patients with tuberculosis undergoing treatment and healthy referents from March 2007 to July 2007. Patients with tuberculosis (n = 140) and healthy referents (n = 130), matched by age, sex, and ethnicity, agreed to an interview. All participants lived in eastern Taiwan. Reliability assessments included internal consistency, whereas validity assessments included construct validity, convergent validity, and discriminant validity. Results More than half of these patients and referents were men (70.7% and 66.2%, respectively), and their average ages were 50.1 and 47.9 years, respectively. Approximately 60% of patients and referents were aboriginal Taiwanese (60.7% and 61.1%, respectively). The proportion with low socioeconomic status was greater for these patients. The internal consistency reliability coefficients were .92 and .93 for the patients and healthy referents, respectively. Exploratory factor analysis on the healthy referents displayed a 4-domain model, which was compatible with the original WHOQOL-BREF 4-domain model. However, for the TB patient group, after deleting 3 items, both exploratory and confirmatory factor analysis revealed a 6-domain model. Conclusion Psychometric evaluation of the Taiwan short version of the WHOQOL-BREF indicates that it has adequate reliability for use in research with TB patients in Taiwan. However, the factor structure generated from this TB patient sample differed from the WHO’s original 4-factor model, which raised a validity concern to apply the Taiwan short version of the WHOQOL-BREF to Taiwanese TB patients. Future research recruiting another sample to revisit this validity issue must be conducted to determine the validity of the WHOQOL-BREF TW in patients with TB. PMID:22877305

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.

CLSI-based transference of the CALIPER database of pediatric reference intervals from Abbott to Beckman, Ortho, Roche and Siemens Clinical Chemistry Assays: direct validation using reference samples from the CALIPER cohort.

PubMed

Estey, Mathew P; Cohen, Ashley H; Colantonio, David A; Chan, Man Khun; Marvasti, Tina Binesh; Randell, Edward; Delvin, Edgard; Cousineau, Jocelyne; Grey, Vijaylaxmi; Greenway, Donald; Meng, Qing H; Jung, Benjamin; Bhuiyan, Jalaluddin; Seccombe, David; Adeli, Khosrow

2013-09-01

The CALIPER program recently established a comprehensive database of age- and sex-stratified pediatric reference intervals for 40 biochemical markers. However, this database was only directly applicable for Abbott ARCHITECT assays. We therefore sought to expand the scope of this database to biochemical assays from other major manufacturers, allowing for a much wider application of the CALIPER database. Based on CLSI C28-A3 and EP9-A2 guidelines, CALIPER reference intervals were transferred (using specific statistical criteria) to assays performed on four other commonly used clinical chemistry platforms including Beckman Coulter DxC800, Ortho Vitros 5600, Roche Cobas 6000, and Siemens Vista 1500. The resulting reference intervals were subjected to a thorough validation using 100 reference specimens (healthy community children and adolescents) from the CALIPER bio-bank, and all testing centers participated in an external quality assessment (EQA) evaluation. In general, the transferred pediatric reference intervals were similar to those established in our previous study. However, assay-specific differences in reference limits were observed for many analytes, and in some instances were considerable. The results of the EQA evaluation generally mimicked the similarities and differences in reference limits among the five manufacturers' assays. In addition, the majority of transferred reference intervals were validated through the analysis of CALIPER reference samples. This study greatly extends the utility of the CALIPER reference interval database which is now directly applicable for assays performed on five major analytical platforms in clinical use, and should permit the worldwide application of CALIPER pediatric reference intervals. Copyright © 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Validation of reference genes for gene expression studies in soybean aphid, Aphis glycines Matsumura

USDA-ARS?s Scientific Manuscript database

Quantitative real-time PCR (qRT-PCR) is a common tool for quantifying mRNA transcripts. To normalize results, a reference gene is mandatory. Aphis glycines is a significant soybean pest, yet gene expression and functional genomics studies are hindered by a lack of stable reference genes. We evalu...

First Definition of Reference Intervals of Liver Function Tests in China: A Large-Population-Based Multi-Center Study about Healthy Adults

PubMed Central

Zhang, Chuanbao; Guo, Wei; Huang, Hengjian; Ma, Yueyun; Zhuang, Junhua; Zhang, Jie

2013-01-01

Background Reference intervals of Liver function tests are very important for the screening, diagnosis, treatment, and monitoring of liver diseases. We aim to establish common reference intervals of liver function tests specifically for the Chinese adult population. Methods A total of 3210 individuals (20–79 years) were enrolled in six representative geographical regions in China. Analytes of ALT, AST, GGT, ALP, total protein, albumin and total bilirubin were measured using three analytical systems mainly used in China. The newly established reference intervals were based on the results of traceability or multiple systems, and then validated in 21 large hospitals located nationwide qualified by the National External Quality Assessment (EQA) of China. Results We had been established reference intervals of the seven liver function tests for the Chinese adult population and found there were apparent variances of reference values for the variables for partitioning analysis such as gender(ALT, GGT, total bilirubin), age(ALP, albumin) and region(total protein). More than 86% of the 21 laboratories passed the validation in all subgroup of reference intervals and overall about 95.3% to 98.8% of the 1220 validation results fell within the range of the new reference interval for all liver function tests. In comparison with the currently recommended reference intervals in China, the single side observed proportions of out of range of reference values from our study for most of the tests deviated significantly from the nominal 2.5% such as total bilirubin (15.2%), ALP (0.2%), albumin (0.0%). Most of reference intervals in our study were obviously different from that of other races. Conclusion These used reference intervals are no longer applicable for the current Chinese population. We have established common reference intervals of liver function tests that are defined specifically for Chinese population and can be universally used among EQA-approved laboratories located all over China. PMID:24058449

Gene expression studies of reference genes for quantitative real-time PCR: an overview in insects.

PubMed

Shakeel, Muhammad; Rodriguez, Alicia; Tahir, Urfa Bin; Jin, Fengliang

2018-02-01

Whenever gene expression is being examined, it is essential that a normalization process is carried out to eliminate non-biological variations. The use of reference genes, such as glyceraldehyde-3-phosphate dehydrogenase, actin, and ribosomal protein genes, is the usual method of choice for normalizing gene expression. Although reference genes are used to normalize target gene expression, a major problem is that the stability of these genes differs among tissues, developmental stages, species, and responses to abiotic factors. Therefore, the use and validation of multiple reference genes are required. This review discusses the reasons that why RT-qPCR has become the preferred method for validating results of gene expression profiles, the use of specific and non-specific dyes and the importance of use of primers and probes for qPCR as well as to discuss several statistical algorithms developed to help the validation of potential reference genes. The conflicts arising in the use of classical reference genes in gene normalization and their replacement with novel references are also discussed by citing the high stability and low stability of classical and novel reference genes under various biotic and abiotic experimental conditions by employing various methods applied for the reference genes amplification.

Evaluation of New Reference Genes in Papaya for Accurate Transcript Normalization under Different Experimental Conditions

PubMed Central

Chen, Weixin; Chen, Jianye; Lu, Wangjin; Chen, Lei; Fu, Danwen

2012-01-01

Real-time reverse transcription PCR (RT-qPCR) is a preferred method for rapid and accurate quantification of gene expression studies. Appropriate application of RT-qPCR requires accurate normalization though the use of reference genes. As no single reference gene is universally suitable for all experiments, thus reference gene(s) validation under different experimental conditions is crucial for RT-qPCR analysis. To date, only a few studies on reference genes have been done in other plants but none in papaya. In the present work, we selected 21 candidate reference genes, and evaluated their expression stability in 246 papaya fruit samples using three algorithms, geNorm, NormFinder and RefFinder. The samples consisted of 13 sets collected under different experimental conditions, including various tissues, different storage temperatures, different cultivars, developmental stages, postharvest ripening, modified atmosphere packaging, 1-methylcyclopropene (1-MCP) treatment, hot water treatment, biotic stress and hormone treatment. Our results demonstrated that expression stability varied greatly between reference genes and that different suitable reference gene(s) or combination of reference genes for normalization should be validated according to the experimental conditions. In general, the internal reference genes EIF (Eukaryotic initiation factor 4A), TBP1 (TATA binding protein 1) and TBP2 (TATA binding protein 2) genes had a good performance under most experimental conditions, whereas the most widely present used reference genes, ACTIN (Actin 2), 18S rRNA (18S ribosomal RNA) and GAPDH (Glyceraldehyde-3-phosphate dehydrogenase) were not suitable in many experimental conditions. In addition, two commonly used programs, geNorm and Normfinder, were proved sufficient for the validation. This work provides the first systematic analysis for the selection of superior reference genes for accurate transcript normalization in papaya under different experimental conditions. PMID:22952972

Using the Wisconsin-Ohio Reference Evaluation Program (WOREP) to Improve Training and Reference Services

ERIC Educational Resources Information Center

Novotny, Eric; Rimland, Emily

2007-01-01

This article discusses a service quality study conducted in the Pennsylvania State University Libraries. The Wisconsin-Ohio Reference Evaluation Program survey was selected as a valid, standardized instrument. We present our results, highlighting the impact on reference training. A second survey a year later demonstrated that focusing on…

Transcriptome-wide selection of a reliable set of reference genes for gene expression studies in potato cyst nematodes (Globodera spp.).

PubMed

Sabeh, Michael; Duceppe, Marc-Olivier; St-Arnaud, Marc; Mimee, Benjamin

2018-01-01

Relative gene expression analyses by qRT-PCR (quantitative reverse transcription PCR) require an internal control to normalize the expression data of genes of interest and eliminate the unwanted variation introduced by sample preparation. A perfect reference gene should have a constant expression level under all the experimental conditions. However, the same few housekeeping genes selected from the literature or successfully used in previous unrelated experiments are often routinely used in new conditions without proper validation of their stability across treatments. The advent of RNA-Seq and the availability of public datasets for numerous organisms are opening the way to finding better reference genes for expression studies. Globodera rostochiensis is a plant-parasitic nematode that is particularly yield-limiting for potato. The aim of our study was to identify a reliable set of reference genes to study G. rostochiensis gene expression. Gene expression levels from an RNA-Seq database were used to identify putative reference genes and were validated with qRT-PCR analysis. Three genes, GR, PMP-3, and aaRS, were found to be very stable within the experimental conditions of this study and are proposed as reference genes for future work.

Validation of psychoanalytic theories: towards a conceptualization of references.

PubMed

Zachrisson, Anders; Zachrisson, Henrik Daae

2005-10-01

The authors discuss criteria for the validation of psychoanalytic theories and develop a heuristic and normative model of the references needed for this. Their core question in this paper is: can psychoanalytic theories be validated exclusively from within psychoanalytic theory (internal validation), or are references to sources of knowledge other than psychoanalysis also necessary (external validation)? They discuss aspects of the classic truth criteria correspondence and coherence, both from the point of view of contemporary psychoanalysis and of contemporary philosophy of science. The authors present arguments for both external and internal validation. Internal validation has to deal with the problems of subjectivity of observations and circularity of reasoning, external validation with the problem of relevance. They recommend a critical attitude towards psychoanalytic theories, which, by carefully scrutinizing weak points and invalidating observations in the theories, reduces the risk of wishful thinking. The authors conclude by sketching a heuristic model of validation. This model combines correspondence and coherence with internal and external validation into a four-leaf model for references for the process of validating psychoanalytic theories.

Validation of Reference Genes in mRNA Expression Analysis Applied to the Study of Asthma.

PubMed

Segundo-Val, Ignacio San; Sanz-Lozano, Catalina S

2016-01-01

The quantitative Polymerase Chain Reaction is the most used technique for the study of gene expression. To correct putative experimental errors of this technique is necessary normalizing the expression results of the gene of interest with the obtained for reference genes. Here, we describe an example of the process to select reference genes. In this particular case, we select reference genes for expression studies in the peripheral blood mononuclear cells of asthmatic patients.

Validation of Suitable Reference Genes for Expression Normalization in Echinococcus spp. Larval Stages

PubMed Central

Espínola, Sergio Martin; Ferreira, Henrique Bunselmeyer; Zaha, Arnaldo

2014-01-01

In recent years, a significant amount of sequence data (both genomic and transcriptomic) for Echinococcus spp. has been published, thereby facilitating the analysis of genes expressed during a specific stage or involved in parasite development. To perform a suitable gene expression quantification analysis, the use of validated reference genes is strongly recommended. Thus, the aim of this work was to identify suitable reference genes to allow reliable expression normalization for genes of interest in Echinococcus granulosus sensu stricto (s.s.) (G1) and Echinococcus ortleppi upon induction of the early pre-adult development. Untreated protoscoleces (PS) and pepsin-treated protoscoleces (PSP) from E. granulosus s.s. (G1) and E. ortleppi metacestode were used. The gene expression stability of eleven candidate reference genes (βTUB, NDUFV2, RPL13, TBP, CYP-1, RPII, EF-1α, βACT-1, GAPDH, ETIF4A-III and MAPK3) was assessed using geNorm, Normfinder, and RefFinder. Our qPCR data showed a good correlation with the recently published RNA-seq data. Regarding expression stability, EF-1α and TBP were the most stable genes for both species. Interestingly, βACT-1 (the most commonly used reference gene), and GAPDH and ETIF4A-III (previously identified as housekeeping genes) did not behave stably in our assay conditions. We propose the use of EF-1α as a reference gene for studies involving gene expression analysis in both PS and PSP experimental conditions for E. granulosus s.s. and E. ortleppi. To demonstrate its applicability, EF-1α was used as a normalizer gene in the relative quantification of transcripts from genes coding for antigen B subunits. The same EF-1α reference gene may be used in studies with other Echinococcus sensu lato species. This report validates suitable reference genes for species of class Cestoda, phylum Platyhelminthes, thus providing a foundation for further validation in other epidemiologically important cestode species, such as those from the Taenia genus. PMID:25014071

Validation of suitable reference genes for expression normalization in Echinococcus spp. larval stages.

PubMed

Espínola, Sergio Martin; Ferreira, Henrique Bunselmeyer; Zaha, Arnaldo

2014-01-01

In recent years, a significant amount of sequence data (both genomic and transcriptomic) for Echinococcus spp. has been published, thereby facilitating the analysis of genes expressed during a specific stage or involved in parasite development. To perform a suitable gene expression quantification analysis, the use of validated reference genes is strongly recommended. Thus, the aim of this work was to identify suitable reference genes to allow reliable expression normalization for genes of interest in Echinococcus granulosus sensu stricto (s.s.) (G1) and Echinococcus ortleppi upon induction of the early pre-adult development. Untreated protoscoleces (PS) and pepsin-treated protoscoleces (PSP) from E. granulosus s.s. (G1) and E. ortleppi metacestode were used. The gene expression stability of eleven candidate reference genes (βTUB, NDUFV2, RPL13, TBP, CYP-1, RPII, EF-1α, βACT-1, GAPDH, ETIF4A-III and MAPK3) was assessed using geNorm, Normfinder, and RefFinder. Our qPCR data showed a good correlation with the recently published RNA-seq data. Regarding expression stability, EF-1α and TBP were the most stable genes for both species. Interestingly, βACT-1 (the most commonly used reference gene), and GAPDH and ETIF4A-III (previously identified as housekeeping genes) did not behave stably in our assay conditions. We propose the use of EF-1α as a reference gene for studies involving gene expression analysis in both PS and PSP experimental conditions for E. granulosus s.s. and E. ortleppi. To demonstrate its applicability, EF-1α was used as a normalizer gene in the relative quantification of transcripts from genes coding for antigen B subunits. The same EF-1α reference gene may be used in studies with other Echinococcus sensu lato species. This report validates suitable reference genes for species of class Cestoda, phylum Platyhelminthes, thus providing a foundation for further validation in other epidemiologically important cestode species, such as those from the Taenia genus.

Fecal electrolyte testing for evaluation of unexplained diarrhea: Validation of body fluid test accuracy in the absence of a reference method.

PubMed

Voskoboev, Nikolay V; Cambern, Sarah J; Hanley, Matthew M; Giesen, Callen D; Schilling, Jason J; Jannetto, Paul J; Lieske, John C; Block, Darci R

2015-11-01

Validation of tests performed on body fluids other than blood or urine can be challenging due to the lack of a reference method to confirm accuracy. The aim of this study was to evaluate alternate assessments of accuracy that laboratories can rely on to validate body fluid tests in the absence of a reference method using the example of sodium (Na(+)), potassium (K(+)), and magnesium (Mg(2+)) testing in stool fluid. Validations of fecal Na(+), K(+), and Mg(2+) were performed on the Roche cobas 6000 c501 (Roche Diagnostics) using residual stool specimens submitted for clinical testing. Spiked recovery, mixing studies, and serial dilutions were performed and % recovery of each analyte was calculated to assess accuracy. Results were confirmed by comparison to a reference method (ICP-OES, PerkinElmer). Mean recoveries for fecal electrolytes were Na(+) upon spiking=92%, mixing=104%, and dilution=105%; K(+) upon spiking=94%, mixing=96%, and dilution=100%; and Mg(2+) upon spiking=93%, mixing=98%, and dilution=100%. When autoanalyzer results were compared to reference ICP-OES results, Na(+) had a slope=0.94, intercept=4.1, and R(2)=0.99; K(+) had a slope=0.99, intercept=0.7, and R(2)=0.99; and Mg(2+) had a slope=0.91, intercept=-4.6, and R(2)=0.91. Calculated osmotic gap using both methods were highly correlated with slope=0.95, intercept=4.5, and R(2)=0.97. Acid pretreatment increased magnesium recovery from a subset of clinical specimens. A combination of mixing, spiking, and dilution recovery experiments are an acceptable surrogate for assessing accuracy in body fluid validations in the absence of a reference method. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

The establishment of tocopherol reference intervals for Hungarian adult population using a validated HPLC method.

PubMed

Veres, Gábor; Szpisjak, László; Bajtai, Attila; Siska, Andrea; Klivényi, Péter; Ilisz, István; Földesi, Imre; Vécsei, László; Zádori, Dénes

2017-09-01

Evidence suggests that decreased α-tocopherol (the most biologically active substance in the vitamin E group) level can cause neurological symptoms, most likely ataxia. The aim of the current study was to first provide reference intervals for serum tocopherols in the adult Hungarian population with appropriate sample size, recruiting healthy control subjects and neurological patients suffering from conditions without symptoms of ataxia, myopathy or cognitive deficiency. A validated HPLC method applying a diode array detector and rac-tocol as internal standard was utilized for that purpose. Furthermore, serum cholesterol levels were determined as well for data normalization. The calculated 2.5-97.5% reference intervals for α-, β/γ- and δ-tocopherols were 24.62-54.67, 0.81-3.69 and 0.29-1.07 μm, respectively, whereas the tocopherol/cholesterol ratios were 5.11-11.27, 0.14-0.72 and 0.06-0.22 μmol/mmol, respectively. The establishment of these reference intervals may improve the diagnostic accuracy of tocopherol measurements in certain neurological conditions with decreased tocopherol levels. Moreover, the current study draws special attention to the possible pitfalls in the complex process of the determination of reference intervals as well, including the selection of study population, the application of internal standard and method validation and the calculation of tocopherol/cholesterol ratios. Copyright © 2017 John Wiley & Sons, Ltd.

Reference genes for quantitative real-time PCR analysis in symbiont Entomomyces delphacidicola of Nilaparvata lugens (Stål)

PubMed Central

Wan, Pin-Jun; Tang, Yao-Hua; Yuan, San-Yue; He, Jia-Chun; Wang, Wei-Xia; Lai, Feng-Xiang; Fu, Qiang

2017-01-01

Nilaparvata lugens (Stål) (Hemiptera: Delphacidae) is a major rice pest that harbors an endosymbiont ascomycete fungus, Entomomyces delphacidicola str. NLU (also known as yeast-like symbiont, YLS). Driving by demand of novel population management tactics (e.g. RNAi), the importance of YLS has been studied and revealed, which greatly boosts the interest of molecular level studies related to YLS. The current study focuses on reference genes for RT-qPCR studies related to YLS. Eight previously unreported YLS genes were cloned, and their expressions were evaluated for N. lugens samples of different developmental stages and sexes, and under different nutritional conditions and temperatures. Expression stabilities were analyzed by BestKeeper, geNorm, NormFinder, ΔCt method and RefFinder. Furthermore, the selected reference genes for RT-qPCR of YLS genes were validated using targeted YLS genes that respond to different nutritional conditions (amino acid deprivation) and RNAi. The results suggest that ylsRPS15p/ylsACT are the most suitable reference genes for temporal gene expression profiling, while ylsTUB/ylsACT and ylsRPS15e/ylsGADPH are the most suitable reference gene choices for evaluating nutrition and temperature effects. Validation studies demonstrated the advantage of using endogenous YLS reference genes for YLS studies. PMID:28198810

POTENTIAL RADIOACTIVE POLLUTANTS RESULTING FROM EXPANDED ENERGY PROGRAMS

EPA Science Inventory

An effective environmental monitoring program must have a quality assurance component to assure the production of valid data. Quality assurance has many components: calibration standards, standard reference materials, standard reference methods, interlaboratory comparison studies...

Identification and validation of reference genes for normalization of gene expression analysis using qRT-PCR in Helicoverpa armigera (Lepidoptera: Noctuidae).

PubMed

Zhang, Songdou; An, Shiheng; Li, Zhen; Wu, Fengming; Yang, Qingpo; Liu, Yichen; Cao, Jinjun; Zhang, Huaijiang; Zhang, Qingwen; Liu, Xiaoxia

2015-01-25

Recent studies have focused on determining functional genes and microRNAs in the pest Helicoverpa armigera (Lepidoptera: Noctuidae). Most of these studies used quantitative real-time PCR (qRT-PCR). Suitable reference genes are necessary to normalize gene expression data of qRT-PCR. However, a comprehensive study on the reference genes in H. armigera remains lacking. Twelve candidate reference genes of H. armigera were selected and evaluated for their expression stability under different biotic and abiotic conditions. The comprehensive stability ranking of candidate reference genes was recommended by RefFinder and the optimal number of reference genes was calculated by geNorm. Two target genes, thioredoxin (TRX) and Cu/Zn superoxide dismutase (SOD), were used to validate the selection of reference genes. Results showed that the most suitable candidate combinations of reference genes were as follows: 28S and RPS15 for developmental stages; RPS15 and RPL13 for larvae tissues; EF and RPL27 for adult tissues; GAPDH, RPL27, and β-TUB for nuclear polyhedrosis virus infection; RPS15 and RPL32 for insecticide treatment; RPS15 and RPL27 for temperature treatment; and RPL32, RPS15, and RPL27 for all samples. This study not only establishes an accurate method for normalizing qRT-PCR data in H. armigera but also serve as a reference for further study on gene transcription in H. armigera and other insects. Copyright © 2014 Elsevier B.V. All rights reserved.

Development and co-validation of porcine insulin certified reference material by high-performance liquid chromatography-isotope dilution mass spectrometry.

PubMed

Wu, Liqing; Takatsu, Akiko; Park, Sang-Ryoul; Yang, Bin; Yang, Huaxin; Kinumi, Tomoya; Wang, Jing; Bi, Jiaming; Wang, Yang

2015-04-01

This article concerns the development and co-validation of a porcine insulin (pINS) certified reference material (CRM) produced by the National Institute of Metrology, People's Republic of China. Each CRM unit contained about 15 mg of purified solid pINS. The moisture content, amount of ignition residue, molecular mass, and purity of the pINS were measured. Both high-performance liquid chromatography-isotope dilution mass spectrometry and a purity deduction method were used to determine the mass fraction of the pINS. Fifteen units were selected to study the between-bottle homogeneity, and no inhomogeneity was observed. A stability study concluded that the CRM was stable for at least 12 months at -20 °C. The certified value of the CRM was (0.892 ± 0.036) g/g. A co-validation of the CRM was performed among Chinese, Japanese, and Korean laboratories under the framework of the Asian Collaboration on Reference Materials. The co-validation results agreed well with the certified value of the CRM. Consequently, the pINS CRM may be used as a calibration material or as a validation standard for pharmaceutical purposes to improve the quality of pharmaceutical products.

Handwriting assessment of Franco-Quebec primary school-age students

PubMed

Couture, Mélanie; Morin, Marie-France; Coallier, Mélissa; Lavigne, Audrey; Archambault, Patricia; Bolduc, Émilie; Chartier, Émilie; Liard, Karolane; Jasmin, Emmanuelle

2016-12-01

Reasons for referring school-age children to occupational therapy mainly relate to handwriting problems. However, there are no validated tools or reference values for assessing handwriting in francophone children in Canada. This study aimed to adapt and validate the writing tasks described in an English Canadian handwriting assessment protocol and to develop reference values for handwriting speed for francophone children. Three writing tasks from the Handwriting Assessment Protocol-2nd Edition (near-point and far-point copying and dictation) were adapted for Québec French children and administered to 141 Grade 1 ( n = 73) and Grade 2 ( n = 68) students. Reference values for handwriting speed were obtained for near point and far point copying tasks. This adapted protocol and these reference values for speed will improve occupational therapy handwriting assessments for the target population.

Standard Specimen Reference Set: Colon — EDRN Public Portal

Cancer.gov

The Early Detection Research Network, Great Lakes-New England Clinical, Epidemiological and Validation Center (GLNE CVC) announces the availability of serum, plasma and urine samples for the early detection for colon cancer and validation studies.

Selection and validation of reference genes for gene expression analysis in apomictic and sexual Cenchrus ciliaris

PubMed Central

2013-01-01

Background Apomixis is a naturally occurring asexual mode of seed reproduction resulting in offspring genetically identical to the maternal plant. Identifying differential gene expression patterns between apomictic and sexual plants is valuable to help deconstruct the trait. Quantitative RT-PCR (qRT-PCR) is a popular method for analyzing gene expression. Normalizing gene expression data using proper reference genes which show stable expression under investigated conditions is critical in qRT-PCR analysis. We used qRT-PCR to validate expression and stability of six potential reference genes (EF1alpha, EIF4A, UBCE, GAPDH, ACT2 and TUBA) in vegetative and reproductive tissues of B-2S and B-12-9 accessions of C. ciliaris. Findings Among tissue types evaluated, EF1alpha showed the highest level of expression while TUBA showed the lowest. When all tissue types were evaluated and compared between genotypes, EIF4A was the most stable reference gene. Gene expression stability for specific ovary stages of B-2S and B-12-9 was also determined. Except for TUBA, all other tested reference genes could be used for any stage-specific ovary tissue normalization, irrespective of the mode of reproduction. Conclusion Our gene expression stability assay using six reference genes, in sexual and apomictic accessions of C. ciliaris, suggests that EIF4A is the most stable gene across all tissue types analyzed. All other tested reference genes, with the exception of TUBA, could be used for gene expression comparison studies between sexual and apomictic ovaries over multiple developmental stages. This reference gene validation data in C. ciliaris will serve as an important base for future apomixis-related transcriptome data validation. PMID:24083672

Guideline for translation and national validation of the Quality of Life in Hand Eczema Questionnaire (QOLHEQ).

PubMed

Oosterhaven, Jart A F; Schuttelaar, Marie L A; Apfelbacher, Christian; Diepgen, Thomas L; Ofenloch, Robert F

2017-08-01

There is a need for well-developed and validated questionnaires to measure patient reported outcomes. The Quality of Life in Hand Eczema Questionnaire (QOLHEQ) is such a validated instrument measuring disease-specific health-related quality of life in hand eczema patients. A re-validation of measurement properties is required before an instrument is used in a new population. With the objective of arriving at a guideline for translation and national validation of the QOLHEQ, we have developed the design of a reference study on how to adequately assess measurement properties of the QOLHEQ based on interdisciplinary discussions and current standards. We present a step-by-step guideline to assess translation (including cross-cultural adaptation), scale structure, validity, reproducibility, responsiveness, and interpretability. We describe which outcomes should be reported for each measurement property, and give advice on how to calculate these. It is also specified which sample size is needed, how to deal with missing data, and which cutoff values should be applied for the measurement properties assessed during the validation process. In conclusion, this guideline, presenting a reference validation study for the QOLHEQ, creates the possibility to harmonize the national validation of the various language versions of the QOLHEQ. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Simulation verification techniques study. Subsystem simulation validation techniques

NASA Technical Reports Server (NTRS)

Duncan, L. M.; Reddell, J. P.; Schoonmaker, P. B.

1974-01-01

Techniques for validation of software modules which simulate spacecraft onboard systems are discussed. An overview of the simulation software hierarchy for a shuttle mission simulator is provided. A set of guidelines for the identification of subsystem/module performance parameters and critical performance parameters are presented. Various sources of reference data to serve as standards of performance for simulation validation are identified. Environment, crew station, vehicle configuration, and vehicle dynamics simulation software are briefly discussed from the point of view of their interfaces with subsystem simulation modules. A detailed presentation of results in the area of vehicle subsystems simulation modules is included. A list of references, conclusions and recommendations are also given.

Reverse transcription quantitative real-time polymerase chain reaction reference genes in the spared nerve injury model of neuropathic pain: validation and literature search.

PubMed

Piller, Nicolas; Decosterd, Isabelle; Suter, Marc R

2013-07-10

The reverse transcription quantitative real-time polymerase chain reaction (RT-qPCR) is a widely used, highly sensitive laboratory technique to rapidly and easily detect, identify and quantify gene expression. Reliable RT-qPCR data necessitates accurate normalization with validated control genes (reference genes) whose expression is constant in all studied conditions. This stability has to be demonstrated.We performed a literature search for studies using quantitative or semi-quantitative PCR in the rat spared nerve injury (SNI) model of neuropathic pain to verify whether any reference genes had previously been validated. We then analyzed the stability over time of 7 commonly used reference genes in the nervous system - specifically in the spinal cord dorsal horn and the dorsal root ganglion (DRG). These were: Actin beta (Actb), Glyceraldehyde-3-phosphate dehydrogenase (GAPDH), ribosomal proteins 18S (18S), L13a (RPL13a) and L29 (RPL29), hypoxanthine phosphoribosyltransferase 1 (HPRT1) and hydroxymethylbilane synthase (HMBS). We compared the candidate genes and established a stability ranking using the geNorm algorithm. Finally, we assessed the number of reference genes necessary for accurate normalization in this neuropathic pain model. We found GAPDH, HMBS, Actb, HPRT1 and 18S cited as reference genes in literature on studies using the SNI model. Only HPRT1 and 18S had been once previously demonstrated as stable in RT-qPCR arrays. All the genes tested in this study, using the geNorm algorithm, presented gene stability values (M-value) acceptable enough for them to qualify as potential reference genes in both DRG and spinal cord. Using the coefficient of variation, 18S failed the 50% cut-off with a value of 61% in the DRG. The two most stable genes in the dorsal horn were RPL29 and RPL13a; in the DRG they were HPRT1 and Actb. Using a 0.15 cut-off for pairwise variations we found that any pair of stable reference gene was sufficient for the normalization process. In the rat SNI model, we validated and ranked Actb, RPL29, RPL13a, HMBS, GAPDH, HPRT1 and 18S as good reference genes in the spinal cord. In the DRG, 18S did not fulfill stability criteria. The combination of any two stable reference genes was sufficient to provide an accurate normalization.

Characterization of reference genes for qPCR analysis in various tissues of the Fujian oyster Crassostrea angulata

NASA Astrophysics Data System (ADS)

Pu, Fei; Yang, Bingye; Ke, Caihuan

2015-07-01

Accurate quantification of transcripts using quantitative real-time polymerase chain reaction (qPCR) depends on the identification of reliable reference genes for normalization. This study aimed to identify and validate seven reference genes, including actin-2 ( ACT-2), elongation factor 1 alpha ( EF-1α), elongation factor 1 beta ( EF-1β), glyceraldehyde-3-phosphate dehydrogenase ( GAPDH), ubiquitin ( UBQ), β-tubulin ( β-TUB), and 18S ribosomal RNA, from Crassostrea angulata, a valuable marine bivalve cultured worldwide. Transcript levels of the candidate reference genes were examined using qPCR analysis and showed differential expression patterns in the mantle, gill, adductor muscle, labial palp, visceral mass, hemolymph and gonad tissues. Quantitative data were analyzed using the geNorm software to assess the expression stability of the candidate reference genes, revealing that β-TUB and UBQ were the most stable genes. The commonly used GAPDH and 18S rRNA showed low stability, making them unsuitable candidates in this system. The expression pattern of the G protein β-subunit gene ( Gβ) across tissue types was also examined and normalized to the expression of each or both of UBQ and β-TUB as internal controls. This revealed consistent trends with all three normalization approaches, thus validating the reliability of UBQ and β-TUB as optimal internal controls. The study provides the first validated reference genes for accurate data normalization in transcript profiling in Crassostrea angulata, which will be indispensable for further functional genomics studies in this economically valuable marine bivalve.

Sensitivity of regression calibration to non-perfect validation data with application to the Norwegian Women and Cancer Study.

PubMed

Buonaccorsi, John P; Dalen, Ingvild; Laake, Petter; Hjartåker, Anette; Engeset, Dagrun; Thoresen, Magne

2015-04-15

Measurement error occurs when we observe error-prone surrogates, rather than true values. It is common in observational studies and especially so in epidemiology, in nutritional epidemiology in particular. Correcting for measurement error has become common, and regression calibration is the most popular way to account for measurement error in continuous covariates. We consider its use in the context where there are validation data, which are used to calibrate the true values given the observed covariates. We allow for the case that the true value itself may not be observed in the validation data, but instead, a so-called reference measure is observed. The regression calibration method relies on certain assumptions.This paper examines possible biases in regression calibration estimators when some of these assumptions are violated. More specifically, we allow for the fact that (i) the reference measure may not necessarily be an 'alloyed gold standard' (i.e., unbiased) for the true value; (ii) there may be correlated random subject effects contributing to the surrogate and reference measures in the validation data; and (iii) the calibration model itself may not be the same in the validation study as in the main study; that is, it is not transportable. We expand on previous work to provide a general result, which characterizes potential bias in the regression calibration estimators as a result of any combination of the violations aforementioned. We then illustrate some of the general results with data from the Norwegian Women and Cancer Study. Copyright © 2015 John Wiley & Sons, Ltd.

Validation of Reference Genes for RT-qPCR Studies of Gene Expression in Preharvest and Postharvest Longan Fruits under Different Experimental Conditions

PubMed Central

Wu, Jianyang; Zhang, Hongna; Liu, Liqin; Li, Weicai; Wei, Yongzan; Shi, Shengyou

2016-01-01

Reverse transcription quantitative PCR (RT-qPCR) as the accurate and sensitive method is use for gene expression analysis, but the veracity and reliability result depends on whether select appropriate reference gene or not. To date, several reliable reference gene validations have been reported in fruits trees, but none have been done on preharvest and postharvest longan fruits. In this study, 12 candidate reference genes, namely, CYP, RPL, GAPDH, TUA, TUB, Fe-SOD, Mn-SOD, Cu/Zn-SOD, 18SrRNA, Actin, Histone H3, and EF-1a, were selected. Expression stability of these genes in 150 longan samples was evaluated and analyzed using geNorm and NormFinder algorithms. Preharvest samples consisted of seven experimental sets, including different developmental stages, organs, hormone stimuli (NAA, 2,4-D, and ethephon) and abiotic stresses (bagging and girdling with defoliation). Postharvest samples consisted of different temperature treatments (4 and 22°C) and varieties. Our findings indicate that appropriate reference gene(s) should be picked for each experimental condition. Our data further showed that the commonly used reference gene Actin does not exhibit stable expression across experimental conditions in longan. Expression levels of the DlACO gene, which is a key gene involved in regulating fruit abscission under girdling with defoliation treatment, was evaluated to validate our findings. In conclusion, our data provide a useful framework for choice of suitable reference genes across different experimental conditions for RT-qPCR analysis of preharvest and postharvest longan fruits. PMID:27375640

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.

Sea Temperature Fiducial Reference Measurements for the Validation and Data Gap Bridging of Satellite SST Data Products

NASA Astrophysics Data System (ADS)

Wimmer, Werenfrid

2016-08-01

The Infrared Sea surface temperature Autonomous Radiometer (ISAR) was developed to provide reference data for the validation of satellite Sea Surface Temperature at the Skin interface (SSTskin) temperature data products, particularly the Advanced Along Track Scanning Radiometer (AATSR). Since March 2004 ISAR instruments have been deployed nearly continuously on ferries crossing the English Channel and the Bay of Biscay, between Portsmouth (UK) and Bilbao/Santander (Spain). The resulting twelve years of ISAR data, including an individual uncertainty estimate for each SST record, are calibrated with traceability to national standards (National Institute of Standards and Technology, USA (NIST) and National Physical Laboratory, Teddigton, UK (NPL), Fiducial Reference Measurements for satellite derived surface temperature product validation (FRM4STS)). They provide a unique independent in situ reference dataset against which to validate satellite derived products. We present results of the AATSR validation, and show the use of ISAR fiducial reference measurements as a common traceable validation data source for both AATSR and Sea and Land Surface Temperature Radiometer (SLSTR). ISAR data were also used to review performance of the Operational Sea Surface Temperature and Sea Ice Analysis (OSTIA) Sea Surface Temperature (SST) analysis before and after the demise of ESA Environmental Satellite (Envisat) when AATSR inputs ceased This demonstrates use of the ISAR reference data set for validating the SST climatologies that will bridge the data gap between AATSR and SLSTR.

Selection and validation of suitable reference genes for miRNA expression normalization by quantitative RT-PCR in citrus somatic embryogenic and adult tissues.

PubMed

Kou, Shu-Jun; Wu, Xiao-Meng; Liu, Zheng; Liu, Yuan-Long; Xu, Qiang; Guo, Wen-Wu

2012-12-01

miRNAs have recently been reported to modulate somatic embryogenesis (SE), a key pathway of plant regeneration in vitro. For expression level detection and subsequent function dissection of miRNAs in certain biological processes, qRT-PCR is one of the most effective and sensitive techniques, for which suitable reference gene selection is a prerequisite. In this study, three miRNAs and eight non-coding RNAs (ncRNA) were selected as reference candidates, and their expression stability was inspected in developing citrus SE tissues cultured at 20, 25, and 30 °C. Stability of the eight non-miRNA ncRNAs was further validated in five adult tissues without temperature treatment. The best single reference gene for SE tissues was snoR14 or snoRD25, while for the adult tissues the best one was U4; although they were not as stable as the optimal multiple references snoR14 + U6 for SE tissues and snoR14 + U5 for adult tissues. For expression normalization of less abundant miRNAs in SE tissues, miR3954 was assessed as a viable reference. Single reference gene snoR14 outperformed multiple references for the overall SE and adult tissues. As one of the pioneer systematic studies on reference gene identification for plant miRNA normalization, this study benefits future exploration on miRNA function in citrus and provides valuable information for similar studies in other higher plants. Three miRNAs and eight non-coding RNAs were tested as reference candidates on developing citrus SE tissues. Best single references snoR14 or snoRD25 and optimal multiple references snoR14 + U6, snoR14 + U5 were identified.

Evaluation of the methodological quality of studies of the performance of diagnostic tests for bovine tuberculosis using QUADAS.

PubMed

Downs, Sara H; More, Simon J; Goodchild, Anthony V; Whelan, Adam O; Abernethy, Darrell A; Broughan, Jennifer M; Cameron, Angus; Cook, Alasdair J; Ricardo de la Rua-Domenech, R; Greiner, Matthias; Gunn, Jane; Nuñez-Garcia, Javier; Rhodes, Shelley; Rolfe, Simon; Sharp, Michael; Upton, Paul; Watson, Eamon; Welsh, Michael; Woolliams, John A; Clifton-Hadley, Richard S; Parry, Jessica E

2018-05-01

There has been little assessment of the methodological quality of studies measuring the performance (sensitivity and/or specificity) of diagnostic tests for animal diseases. In a systematic review, 190 studies of tests for bovine tuberculosis (bTB) in cattle (published 1934-2009) were assessed by at least one of 18 reviewers using the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) checklist adapted for animal disease tests. VETQUADAS (VQ) included items measuring clarity in reporting (n = 3), internal validity (n = 9) and external validity (n = 2). A similar pattern for compliance was observed in studies of different diagnostic test types. Compliance significantly improved with year of publication for all items measuring clarity in reporting and external validity but only improved in four of the nine items measuring internal validity (p < 0.05). 107 references, of which 83 had performance data eligible for inclusion in a meta-analysis were reviewed by two reviewers. In these references, agreement between reviewers' responses was 71% for compliance, 32% for unsure and 29% for non-compliance. Mean compliance with reporting items was 2, 5.2 for internal validity and 1.5 for external validity. The index test result was described in sufficient detail in 80.1% of studies and was interpreted without knowledge of the reference standard test result in only 33.1%. Loss to follow-up was adequately explained in only 31.1% of studies. The prevalence of deficiencies observed may be due to inadequate reporting but may also reflect lack of attention to methodological issues that could bias the results of diagnostic test performance estimates. QUADAS was a useful tool for assessing and comparing the quality of studies measuring the performance of diagnostic tests but might be improved further by including explicit assessment of population sampling strategy. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

Interlaboratory Reproducibility of Droplet Digital Polymerase Chain Reaction Using a New DNA Reference Material Format.

PubMed

Pinheiro, Leonardo B; O'Brien, Helen; Druce, Julian; Do, Hongdo; Kay, Pippa; Daniels, Marissa; You, Jingjing; Burke, Daniel; Griffiths, Kate; Emslie, Kerry R

2017-11-07

Use of droplet digital PCR technology (ddPCR) is expanding rapidly in the diversity of applications and number of users around the world. Access to relatively simple and affordable commercial ddPCR technology has attracted wide interest in use of this technology as a molecular diagnostic tool. For ddPCR to effectively transition to a molecular diagnostic setting requires processes for method validation and verification and demonstration of reproducible instrument performance. In this study, we describe the development and characterization of a DNA reference material (NMI NA008 High GC reference material) comprising a challenging methylated GC-rich DNA template under a novel 96-well microplate format. A scalable process using high precision acoustic dispensing technology was validated to produce the DNA reference material with a certified reference value expressed in amount of DNA molecules per well. An interlaboratory study, conducted using blinded NA008 High GC reference material to assess reproducibility among seven independent laboratories demonstrated less than 4.5% reproducibility relative standard deviation. With the exclusion of one laboratory, laboratories had appropriate technical competency, fully functional instrumentation, and suitable reagents to perform accurate ddPCR based DNA quantification measurements at the time of the study. The study results confirmed that NA008 High GC reference material is fit for the purpose of being used for quality control of ddPCR systems, consumables, instrumentation, and workflow.

Identification of TMEM208 and PQLC2 as reference genes for normalizing mRNA expression in colorectal cancer treated with aspirin

PubMed Central

Zhu, Yuanyuan; Yang, Chao; Weng, Mingjiao; Zhang, Yan; Yang, Chunhui; Jin, Yinji; Yang, Weiwei; He, Yan; Wu, Yiqi; Zhang, Yuhua; Wang, Guangyu; RajkumarEzakiel Redpath, Riju James; Zhang, Lei; Jin, Xiaoming; Liu, Ying; Sun, Yuchun; Ning, Ning; Qiao, Yu; Zhang, Fengmin; Li, Zhiwei; Wang, Tianzhen; Zhang, Yanqiao; Li, Xiaobo

2017-01-01

Numerous evidences indicate that aspirin usage causes a significant reduction in colorectal cancer. However, the molecular mechanisms about aspirin preventing colon cancer are largely unknown. Quantitative reverse transcription polymerase chain reaction (qRT-PCR) is a most frequently used method to identify the target molecules regulated by certain compound. However, this method needs stable internal reference genes to analyze the expression change of the targets. In this study, the transcriptional stabilities of several traditional reference genes were evaluated in colon cancer cells treated with aspirin, and also, the suitable internal reference genes were screened by using a microarray and were further identified by using the geNorm and NormFinder softwares, and then were validated in more cell lines and xenografts. We have showed that three traditional internal reference genes, β-actin, GAPDH and α-tubulin, are not suitable for studying gene transcription in colon cancer cells treated with aspirin, and we have identified and validated TMEM208 and PQLC2 as the ideal internal reference genes for detecting the molecular targets of aspirin in colon cancer in vitro and in vivo. This study reveals stable internal reference genes for studying the target genes of aspirin in colon cancer, which will contribute to identify the molecular mechanism behind aspirin preventing colon cancer. PMID:28184026

Identification of TMEM208 and PQLC2 as reference genes for normalizing mRNA expression in colorectal cancer treated with aspirin.

PubMed

Zhu, Yuanyuan; Yang, Chao; Weng, Mingjiao; Zhang, Yan; Yang, Chunhui; Jin, Yinji; Yang, Weiwei; He, Yan; Wu, Yiqi; Zhang, Yuhua; Wang, Guangyu; RajkumarEzakiel Redpath, Riju James; Zhang, Lei; Jin, Xiaoming; Liu, Ying; Sun, Yuchun; Ning, Ning; Qiao, Yu; Zhang, Fengmin; Li, Zhiwei; Wang, Tianzhen; Zhang, Yanqiao; Li, Xiaobo

2017-04-04

Numerous evidences indicate that aspirin usage causes a significant reduction in colorectal cancer. However, the molecular mechanisms about aspirin preventing colon cancer are largely unknown. Quantitative reverse transcription polymerase chain reaction (qRT-PCR) is a most frequently used method to identify the target molecules regulated by certain compound. However, this method needs stable internal reference genes to analyze the expression change of the targets. In this study, the transcriptional stabilities of several traditional reference genes were evaluated in colon cancer cells treated with aspirin, and also, the suitable internal reference genes were screened by using a microarray and were further identified by using the geNorm and NormFinder softwares, and then were validated in more cell lines and xenografts. We have showed that three traditional internal reference genes, β-actin, GAPDH and α-tubulin, are not suitable for studying gene transcription in colon cancer cells treated with aspirin, and we have identified and validated TMEM208 and PQLC2 as the ideal internal reference genes for detecting the molecular targets of aspirin in colon cancer in vitro and in vivo. This study reveals stable internal reference genes for studying the target genes of aspirin in colon cancer, which will contribute to identify the molecular mechanism behind aspirin preventing colon cancer.

Validation of Student and Parent Reported Data on the Basic Grant Application Form, 1978-79 Comprehensive Validation Guide. Procedural Manual for: Validation of Cases Referred by Institutions; Validation of Cases Referred by the Office of Education; Recovery of Overpayments.

ERIC Educational Resources Information Center

Smith, Karen; And Others

Procedures for validating data reported by students and parents on an application for Basic Educational Opportunity Grants were developed in 1978 for the U.S. Office of Education (OE). Validation activities include: validation of flagged Student Eligibility Reports (SERs) for students whose schools are part of the Alternate Disbursement System;…

Selection and Validation of Appropriate Reference Genes for qRT-PCR Analysis in Isatis indigotica Fort.

PubMed Central

Li, Tao; Wang, Jing; Lu, Miao; Zhang, Tianyi; Qu, Xinyun; Wang, Zhezhi

2017-01-01

Due to its sensitivity and specificity, real-time quantitative PCR (qRT-PCR) is a popular technique for investigating gene expression levels in plants. Based on the Minimum Information for Publication of Real-Time Quantitative PCR Experiments (MIQE) guidelines, it is necessary to select and validate putative appropriate reference genes for qRT-PCR normalization. In the current study, three algorithms, geNorm, NormFinder, and BestKeeper, were applied to assess the expression stability of 10 candidate reference genes across five different tissues and three different abiotic stresses in Isatis indigotica Fort. Additionally, the IiYUC6 gene associated with IAA biosynthesis was applied to validate the candidate reference genes. The analysis results of the geNorm, NormFinder, and BestKeeper algorithms indicated certain differences for the different sample sets and different experiment conditions. Considering all of the algorithms, PP2A-4 and TUB4 were recommended as the most stable reference genes for total and different tissue samples, respectively. Moreover, RPL15 and PP2A-4 were considered to be the most suitable reference genes for abiotic stress treatments. The obtained experimental results might contribute to improved accuracy and credibility for the expression levels of target genes by qRT-PCR normalization in I. indigotica. PMID:28702046

Effect of cow reference group on validation reliability of genomic evaluation.

PubMed

Koivula, M; Strandén, I; Aamand, G P; Mäntysaari, E A

2016-06-01

We studied the effect of including genomic data for cows in the reference population of single-step evaluations. Deregressed individual cow genetic evaluations (DRP) from milk production evaluations of Nordic Red Dairy cattle were used to estimate the single-step breeding values. Validation reliability and bias of the evaluations were calculated with four data sets including different amount of DRP record information from genotyped cows in the reference population. The gain in reliability was from 2% to 4% units for the production traits, depending on the used DRP data and the amount of genomic data. Moreover, inclusion of genotyped bull dams and their genotyped daughters seemed to create some bias in the single-step evaluation. Still, genotyping cows and their inclusion in the reference population is advantageous and should be encouraged.

Cross-cultural adaptation of the German version of the spinal stenosis measure.

PubMed

Wertli, Maria M; Steurer, Johann; Wildi, Lukas M; Held, Ulrike

2014-06-01

To validate the German version of the spinal stenosis measure (SSM), a disease-specific questionnaire assessing symptom severity, physical function, and satisfaction with treatment in patients with lumbar spinal stenosis. After translation, cross-cultural adaptation, and pilot testing, we assessed internal consistency, test-retest reliability, construct validity, and responsiveness of the SSM subscales. Data from a large Swiss multi-center prospective cohort study were used. Reference scales for the assessment of construct validity and responsiveness were the numeric rating scale, pain thermometer, and the Roland Morris Disability Questionnaire. One hundred and eight consecutive patients were included in this validation study, recruited from five different centers. Cronbach's alpha was above 0.8 for all three subscales of the SSM. The objectivity of the SSM was assessed using a partial credit approach. The model showed a good global fit to the data. Of the 108 patients 78 participated in the test-retest procedure. The ICC values were above 0.8 for all three subscales of the SSM. Correlations with reference scales were above 0.7 for the symptom and function subscales. For satisfaction subscale, it was 0.66 or above. Clinically meaningful changes of the reference scales over time were associated with significantly more improvement in all three SSM subscales (p < 0.001). Conclusion: The proposed version of the SSM showed very good measurement properties and can be considered validated for use in the German language.

Pooled results from 5 validation studies of dietary self-report instruments using recovery biomarkers for energy and protein intake

USDA-ARS?s Scientific Manuscript database

We pooled data from 5 large validation studies of dietary self-report instruments that used recovery biomarkers as references to clarify the measurement properties of food frequency questionnaires (FFQs) and 24-hour recalls. The studies were conducted in widely differing U.S. adult populations from...

Content validity of manual spinal palpatory exams - A systematic review

PubMed Central

Najm, Wadie I; Seffinger, Michael A; Mishra, Shiraz I; Dickerson, Vivian M; Adams, Alan; Reinsch, Sibylle; Murphy, Linda S; Goodman, Arnold F

2003-01-01

Background Many health care professionals use spinal palpatory exams as a primary and well-accepted part of the evaluation of spinal pathology. However, few studies have explored the validity of spinal palpatory exams. To evaluate the status of the current scientific evidence, we conducted a systematic review to assess the content validity of spinal palpatory tests used to identify spinal neuro-musculoskeletal dysfunction. Methods Review of eleven databases and a hand search of peer-reviewed literature, published between 1965–2002, was undertaken. Two blinded reviewers abstracted pertinent data from the retrieved papers, using a specially developed quality-scoring instrument. Five papers met the inclusion/exclusion criteria. Results Three of the five papers included in the review explored the content validity of motion tests. Two of these papers focused on identifying the level of fixation (decreased mobility) and one focused on range of motion. All three studies used a mechanical model as a reference standard. Two of the five papers included in the review explored the validity of pain assessment using the visual analogue scale or the subjects' own report as reference standards. Overall the sensitivity of studies looking at range of motion tests and pain varied greatly. Poor sensitivity was reported for range of motion studies regardless of the examiner's experience. A slightly better sensitivity (82%) was reported in one study that examined cervical pain. Conclusions The lack of acceptable reference standards may have contributed to the weak sensitivity findings. Given the importance of spinal palpatory tests as part of the spinal evaluation and treatment plan, effort is required by all involved disciplines to create well-designed and implemented studies in this area. PMID:12734016

Construct Validity of the WISC-IV[superscript UK] with a Large Referred Irish Sample

ERIC Educational Resources Information Center

Watkins, Marley W.; Canivez, Gary L.; James, Trevor; James, Kate; Good, Rebecca

2013-01-01

Irish educational psychologists frequently use the Wechsler Intelligence Scale for Children-Fourth U.K. Edition (WISC-IV[superscript UK]) in clinical assessments of children with learning difficulties. Unfortunately, reliability and validity studies of the WISC-IV[superscript UK] have not yet been reported. This study examined the construct…

Selection of appropriate reference genes for RT-qPCR analysis in a streptozotocin-induced Alzheimer's disease model of cynomolgus monkeys (Macaca fascicularis).

PubMed

Park, Sang-Je; Kim, Young-Hyun; Lee, Youngjeon; Kim, Kyoung-Min; Kim, Heui-Soo; Lee, Sang-Rae; Kim, Sun-Uk; Kim, Sang-Hyun; Kim, Ji-Su; Jeong, Kang-Jin; Lee, Kyoung-Min; Huh, Jae-Won; Chang, Kyu-Tae

2013-01-01

Reverse transcription quantitative real-time polymerase chain reaction (RT-qPCR) has been widely used to quantify relative gene expression because of the specificity, sensitivity, and accuracy of this technique. In order to obtain reliable gene expression data from RT-qPCR experiments, it is important to utilize optimal reference genes for the normalization of target gene expression under varied experimental conditions. Previously, we developed and validated a novel icv-STZ cynomolgus monkey model for Alzheimer's disease (AD) research. However, in order to enhance the reliability of this disease model, appropriate reference genes must be selected to allow meaningful analysis of the gene expression levels in the icv-STZ cynomolgus monkey brain. In this study, we assessed the expression stability of 9 candidate reference genes in 2 matched-pair brain samples (5 regions) of control cynomolgus monkeys and those who had received intracerebroventricular injection of streptozotocin (icv-STZ). Three well-known analytical programs geNorm, NormFinder, and BestKeeper were used to choose the suitable reference genes from the total sample group, control group, and icv-STZ group. Combination analysis of the 3 different programs clearly indicated that the ideal reference genes are RPS19 and YWHAZ in the total sample group, GAPDH and RPS19 in the control group, and ACTB and GAPDH in the icv-STZ group. Additionally, we validated the normalization accuracy of the most appropriate reference genes (RPS19 and YWHAZ) by comparison with the least stable gene (TBP) using quantification of the APP and MAPT genes in the total sample group. To the best of our knowledge, this research is the first study to identify and validate the appropriate reference genes in cynomolgus monkey brains. These findings provide useful information for future studies involving the expression of target genes in the cynomolgus monkey.

Obstetric care providers are able to assess psychosocial risks, identify and refer high-risk pregnant women: validation of a short assessment tool - the KINDEX Greek version.

PubMed

Spyridou, Andria; Schauer, Maggie; Ruf-Leuschner, Martina

2015-02-21

Prenatal assessment for psychosocial risk factors and prevention and intervention is scarce and, in most cases, nonexistent in obstetrical care. In this study we aimed to evaluate if the KINDEX, a short instrument developed in Germany, is a useful tool in the hands of non-trained medical staff, in order to identify and refer women in psychosocial risk to the adequate mental health and social services. We also examined the criterion-related concurrent validity of the tool through a validation interview carried out by an expert clinical psychologist. Our final objective was to achieve the cultural adaptation of the KINDEX Greek Version and to offer a valid tool for the psychosocial risk assessment to the obstetric care providers. Two obstetricians and five midwives carried out 93 KINDEX interviews (duration 20 minutes) with pregnant women to assess psychosocial risk factors present during pregnancy. Afterwards they referred women who they identified having two or more psychosocial risk factors to the mental health attention unit of the hospital. During the validation procedure an expert clinical psychologist carried out diagnostic interviews with a randomized subsample of 50 pregnant women based on established diagnostic instruments for stress and psychopathology, like the PSS-14, ESI, PDS, HSCL-25. Significant correlations between the results obtained through the assessment using the KINDEX and the risk areas of stress, psychopathology and trauma load assessed in the validation interview demonstrate the criterion-related concurrent validity of the KINDEX. The referral accuracy of the medical staff is confirmed through comparisons between pregnant women who have and have not been referred to the mental health attention unit. Prenatal screenings for psychosocial risks like the KINDEX are feasible in public health settings in Greece. In addition, validity was confirmed in high correlations between the KINDEX results and the results of the validation interviews. The KINDEX Greek version can be considered a valid tool, which can be used by non-trained medical staff providing obstetrical care to identify high-risk women and refer them to adequate mental health and social services. These kind of assessments are indispensable for the promotion of a healthy family environment and child development.

Automatic Generation of Validated Specific Epitope Sets.

PubMed

Carrasco Pro, Sebastian; Sidney, John; Paul, Sinu; Lindestam Arlehamn, Cecilia; Weiskopf, Daniela; Peters, Bjoern; Sette, Alessandro

2015-01-01

Accurate measurement of B and T cell responses is a valuable tool to study autoimmunity, allergies, immunity to pathogens, and host-pathogen interactions and assist in the design and evaluation of T cell vaccines and immunotherapies. In this context, it is desirable to elucidate a method to select validated reference sets of epitopes to allow detection of T and B cells. However, the ever-growing information contained in the Immune Epitope Database (IEDB) and the differences in quality and subjects studied between epitope assays make this task complicated. In this study, we develop a novel method to automatically select reference epitope sets according to a categorization system employed by the IEDB. From the sets generated, three epitope sets (EBV, mycobacteria and dengue) were experimentally validated by detection of T cell reactivity ex vivo from human donors. Furthermore, a web application that will potentially be implemented in the IEDB was created to allow users the capacity to generate customized epitope sets.

Development and validation of RAYDOSE: a Geant4-based application for molecular radiotherapy

NASA Astrophysics Data System (ADS)

Marcatili, S.; Pettinato, C.; Daniels, S.; Lewis, G.; Edwards, P.; Fanti, S.; Spezi, E.

2013-04-01

We developed and validated a Monte-Carlo-based application (RAYDOSE) to generate patient-specific 3D dose maps on the basis of pre-treatment imaging studies. A CT DICOM image is used to model patient geometry, while repeated PET scans are employed to assess radionuclide kinetics and distribution at the voxel level. In this work, we describe the structure of this application and present the tests performed to validate it against reference data and experiments. We used the spheres of a NEMA phantom to calculate S values and total doses. The comparison with reference data from OLINDA/EXM showed an agreement within 2% for a sphere size above 2.8 cm diameter. A custom heterogeneous phantom composed of several layers of Perspex and lung equivalent material was used to compare TLD measurements of gamma radiation from 131I to Monte Carlo simulations. An agreement within 5% was found. RAYDOSE has been validated against reference data and experimental measurements and can be a useful multi-modality platform for treatment planning and research in MRT.

Identification and validation of reference genes for quantitative real-time PCR studies in long yellow daylily, Hemerocallis citrina Borani

USDA-ARS?s Scientific Manuscript database

Gene expression analysis requires the use of reference genes in the target species. The long yellow daylily is rich in beneficial secondary metabolites and is considered as a functional vegetable. It is widely cultivated and consumed in East Asia. However, reference genes for use in RT-qPCR in this ...

Incremental Validity of WISC-IV[superscript UK] Factor Index Scores with a Referred Irish Sample: Predicting Performance on the WIAT-II[superscript UK

ERIC Educational Resources Information Center

Canivez, Gary L.; Watkins, Marley W.; James, Trevor; Good, Rebecca; James, Kate

2014-01-01

Background: Subtest and factor scores have typically provided little incremental predictive validity beyond the omnibus IQ score. Aims: This study examined the incremental validity of Wechsler Intelligence Scale for Children-Fourth UK Edition (WISC-IV[superscript UK]; Wechsler, 2004a, "Wechsler Intelligence Scale for Children-Fourth UK…

Validation of reference genes for real-time quantitative PCR normalization in soybean developmental and germinating seeds.

PubMed

Li, Qing; Fan, Cheng-Ming; Zhang, Xiao-Mei; Fu, Yong-Fu

2012-10-01

Most of traditional reference genes chosen for real-time quantitative PCR normalization were assumed to be ubiquitously and constitutively expressed in vegetative tissues. However, seeds show distinct transcriptomes compared with the vegetative tissues. Therefore, there is a need for re-validation of reference genes in samples of seed development and germination, especially for soybean seeds. In this study, we aimed at identifying reference genes suitable for the quantification of gene expression level in soybean seeds. In order to identify the best reference genes for soybean seeds, 18 putative reference genes were tested with various methods in different seed samples. We combined the outputs of both geNorm and NormFinder to assess the expression stability of these genes. The reference genes identified as optimums for seed development were TUA5 and UKN2, whereas for seed germination they were novel reference genes Glyma05g37470 and Glyma08g28550. Furthermore, for total seed samples it was necessary to combine four genes of Glyma05g37470, Glyma08g28550, Glyma18g04130 and UKN2 [corrected] for normalization. Key message We identified several reference genes that stably expressed in soybean seed developmental and germinating processes.

Evaluation of stability and validation of reference genes for RT-qPCR expression studies in rice plants under water deficit.

PubMed

Auler, Priscila Ariane; Benitez, Letícia Carvalho; do Amaral, Marcelo Nogueira; Vighi, Isabel Lopes; Dos Santos Rodrigues, Gabriela; da Maia, Luciano Carlos; Braga, Eugenia Jacira Bolacel

2017-05-01

Many studies use strategies that allow for the identification of a large number of genes expressed in response to different stress conditions to which the plant is subjected throughout its cycle. In order to obtain accurate and reliable results in gene expression studies, it is necessary to use reference genes, which must have uniform expression in the majority of cells in the organism studied. RNA isolation of leaves and expression analysis in real-time quantitative polymerase chain reaction (RT-qPCR) were carried out. In this study, nine candidate reference genes were tested, actin 11 (ACT11), ubiquitin conjugated to E2 enzyme (UBC-E2), glyceraldehyde-3-phosphate dehydrogenase (GAPDH), beta tubulin (β-tubulin), eukaryotic initiation factor 4α (eIF-4α), ubiquitin 10 (UBQ10), ubiquitin 5 (UBQ5), aquaporin TIP41 (TIP41-Like) and cyclophilin, in two genotypes of rice, AN Cambará and BRS Querência, with different levels of soil moisture (20%, 10% and recovery) in the vegetative (V5) and reproductive stages (period preceding flowering). Currently, there are different softwares that perform stability analyses and define the most suitable reference genes for a particular study. In this study, we used five different methods: geNorm, BestKeeper, ΔCt method, NormFinder and RefFinder. The results indicate that UBC-E2 and UBQ5 can be used as reference genes in all samples and softwares evaluated. The genes β-tubulin and eIF-4α, traditionally used as reference genes, along with GAPDH, presented lower stability values. The gene expression of basic leucine zipper (bZIP23 and bZIP72) was used to validate the selected reference genes, demonstrating that the use of an inappropriate reference can induce erroneous results.

A novel adaptive scoring system for segmentation validation with multiple reference masks

NASA Astrophysics Data System (ADS)

Moltz, Jan H.; Rühaak, Jan; Hahn, Horst K.; Peitgen, Heinz-Otto

2011-03-01

The development of segmentation algorithms for different anatomical structures and imaging protocols is an important task in medical image processing. The validation of these methods, however, is often treated as a subordinate task. Since manual delineations, which are widely used as a surrogate for the ground truth, exhibit an inherent uncertainty, it is preferable to use multiple reference segmentations for an objective validation. This requires a consistent framework that should fulfill three criteria: 1) it should treat all reference masks equally a priori and not demand consensus between the experts; 2) it should evaluate the algorithmic performance in relation to the inter-reference variability, i.e., be more tolerant where the experts disagree about the true segmentation; 3) it should produce results that are comparable for different test data. We show why current state-of-the-art frameworks as the one used at several MICCAI segmentation challenges do not fulfill these criteria and propose a new validation methodology. A score is computed in an adaptive way for each individual segmentation problem, using a combination of volume- and surface-based comparison metrics. These are transformed into the score by relating them to the variability between the reference masks which can be measured by comparing the masks with each other or with an estimated ground truth. We present examples from a study on liver tumor segmentation in CT scans where our score shows a more adequate assessment of the segmentation results than the MICCAI framework.

Validation and Test-Retest Reliability of New Thermographic Technique Called Thermovision Technique of Dry Needling for Gluteus Minimus Trigger Points in Sciatica Subjects and TrPs-Negative Healthy Volunteers

PubMed Central

Rychlik, Michał; Samborski, Włodzimierz

2015-01-01

The aim of this study was to assess the validity and test-retest reliability of Thermovision Technique of Dry Needling (TTDN) for the gluteus minimus muscle. TTDN is a new thermography approach used to support trigger points (TrPs) diagnostic criteria by presence of short-term vasomotor reactions occurring in the area where TrPs refer pain. Method. Thirty chronic sciatica patients (n=15 TrP-positive and n=15 TrPs-negative) and 15 healthy volunteers were evaluated by TTDN three times during two consecutive days based on TrPs of the gluteus minimus muscle confirmed additionally by referred pain presence. TTDN employs average temperature (T avr), maximum temperature (T max), low/high isothermal-area, and autonomic referred pain phenomenon (AURP) that reflects vasodilatation/vasoconstriction. Validity and test-retest reliability were assessed concurrently. Results. Two components of TTDN validity and reliability, T avr and AURP, had almost perfect agreement according to κ (e.g., thigh: 0.880 and 0.938; calf: 0.902 and 0.956, resp.). The sensitivity for T avr, T max, AURP, and high isothermal-area was 100% for everyone, but specificity of 100% was for T avr and AURP only. Conclusion. TTDN is a valid and reliable method for T avr and AURP measurement to support TrPs diagnostic criteria for the gluteus minimus muscle when digitally evoked referred pain pattern is present. PMID:26137486

Pooled results from five validation studies of dietary self-report instruments using recovery biomarkers for potassium and sodium intake

USDA-ARS?s Scientific Manuscript database

We have pooled data from five large validation studies of dietary self-report instruments that used recovery biomarkers as referents to assess food frequency questionnaires (FFQs) and 24-hour recalls. We reported on total potassium and sodium intakes, their densities, and their ratio. Results were...

Selection and Validation of Reference Genes for Quantitative Real-Time Polymerase Chain Reaction Studies in Mossy Maze Polypore, Cerrena unicolor (Higher Basidiomycetes).

PubMed

Yang, Jie; Lin, Qi; Lin, Juan; Ye, Xiuyun

2016-01-01

With its ability to produce ligninolytic enzymes such as laccases, white-rot basidiomycete Cerrena unicolor, a medicinal mushroom, has great potential in biotechnology. Elucidation of the expression profiles of genes encoding ligninolytic enzymes are important for increasing their production. Quantitative real-time polymerase chain reaction (qPCR) is a powerful tool to study transcriptional regulation of genes of interest. To ensure accuracy and reliability of qPCR analysis of C. unicolor, expression levels of seven candidate reference genes were studied at different growth phases, under various induction conditions, and with a range of carbon/nitrogen ratios and carbon and nitrogen sources. The stability of the genes were analyzed with five statistical approaches, namely geNorm, NormFinder, BestKeeper, the ΔCt method, and RefFinder. Our results indicated that the selection of reference genes varied with sample sets. A combination of four reference genes (Cyt-c, ATP6, TEF1, and β-tubulin) were recommended for normalizing gene expression at different growth phases. GAPDH and Cyt-c were the appropriate reference genes under different induction conditions. ATP6 and TEF1 were most stable in fermentation media with various carbon/nitrogen ratios. In the fermentation media with various carbon or nitrogen sources, 18S rRNA and GAPDH were the references of choice. The present study represents the first validation analysis of reference genes in C. unicolor and serves as a foundation for its qPCR analysis.

Optimal SVM parameter selection for non-separable and unbalanced datasets.

PubMed

Jiang, Peng; Missoum, Samy; Chen, Zhao

2014-10-01

This article presents a study of three validation metrics used for the selection of optimal parameters of a support vector machine (SVM) classifier in the case of non-separable and unbalanced datasets. This situation is often encountered when the data is obtained experimentally or clinically. The three metrics selected in this work are the area under the ROC curve (AUC), accuracy, and balanced accuracy. These validation metrics are tested using computational data only, which enables the creation of fully separable sets of data. This way, non-separable datasets, representative of a real-world problem, can be created by projection onto a lower dimensional sub-space. The knowledge of the separable dataset, unknown in real-world problems, provides a reference to compare the three validation metrics using a quantity referred to as the "weighted likelihood". As an application example, the study investigates a classification model for hip fracture prediction. The data is obtained from a parameterized finite element model of a femur. The performance of the various validation metrics is studied for several levels of separability, ratios of unbalance, and training set sizes.

A de novo transcriptome and valid reference genes for quantitative real-time PCR in Colaphellus bowringi.

PubMed

Tan, Qian-Qian; Zhu, Li; Li, Yi; Liu, Wen; Ma, Wei-Hua; Lei, Chao-Liang; Wang, Xiao-Ping

2015-01-01

The cabbage beetle Colaphellus bowringi Baly is a serious insect pest of crucifers and undergoes reproductive diapause in soil. An understanding of the molecular mechanisms of diapause regulation, insecticide resistance, and other physiological processes is helpful for developing new management strategies for this beetle. However, the lack of genomic information and valid reference genes limits knowledge on the molecular bases of these physiological processes in this species. Using Illumina sequencing, we obtained more than 57 million sequence reads derived from C. bowringi, which were assembled into 39,390 unique sequences. A Clusters of Orthologous Groups classification was obtained for 9,048 of these sequences, covering 25 categories, and 16,951 were assigned to 255 Kyoto Encyclopedia of Genes and Genomes pathways. Eleven candidate reference gene sequences from the transcriptome were then identified through reverse transcriptase polymerase chain reaction. Among these candidate genes, EF1α, ACT1, and RPL19 proved to be the most stable reference genes for different reverse transcriptase quantitative polymerase chain reaction experiments in C. bowringi. Conversely, aTUB and GAPDH were the least stable reference genes. The abundant putative C. bowringi transcript sequences reported enrich the genomic resources of this beetle. Importantly, the larger number of gene sequences and valid reference genes provide a valuable platform for future gene expression studies, especially with regard to exploring the molecular mechanisms of different physiological processes in this species.

Performance Validation Approach for the GTX Air-Breathing Launch Vehicle

NASA Technical Reports Server (NTRS)

Trefny, Charles J.; Roche, Joseph M.

2002-01-01

The primary objective of the GTX effort is to determine whether or not air-breathing propulsion can enable a launch vehicle to achieve orbit in a single stage. Structural weight, vehicle aerodynamics, and propulsion performance must be accurately known over the entire flight trajectory in order to make a credible assessment. Structural, aerodynamic, and propulsion parameters are strongly interdependent, which necessitates a system approach to design, evaluation, and optimization of a single-stage-to-orbit concept. The GTX reference vehicle serves this purpose, by allowing design, development, and validation of components and subsystems in a system context. The reference vehicle configuration (including propulsion) was carefully chosen so as to provide high potential for structural and volumetric efficiency, and to allow the high specific impulse of air-breathing propulsion cycles to be exploited. Minor evolution of the configuration has occurred as analytical and experimental results have become available. With this development process comes increasing validation of the weight and performance levels used in system performance determination. This paper presents an overview of the GTX reference vehicle and the approach to its performance validation. Subscale test rigs and numerical studies used to develop and validate component performance levels and unit structural weights are outlined. The sensitivity of the equivalent, effective specific impulse to key propulsion component efficiencies is presented. The role of flight demonstration in development and validation is discussed.

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.

Validating Reference Equations for Impulse Oscillometry in Healthy Mexican Children.

PubMed

Gochicoa-Rangel, Laura; Del Río-Hidalgo, Rodrigo; Hernández-Ruiz, Juana; Rodríguez-Moreno, Luis; Martínez-Briseño, David; Mora-Romero, Uri; Cid-Juárez, Silvia; García-Sancho, Cecilia; Torre-Bouscoulet, Luis

2017-09-01

The impulse oscillometry system (IOS) measures the impedance (Z) of the respiratory system, but proper interpretation of its results requires adequate reference values. The objectives of this work were: (1) to validate the reference equations for the IOS published previously by our group and (2) to compare the adjustment of new available reference equations for the IOS from different countries in a sample of healthy children. Subjects were healthy 4-15-y-old children from the metropolitan area of Mexico City, who performed an IOS test. The functional IOS parameters obtained were compared with the predicted values from 12 reference equations determined in studies of different ethnic groups. The validation methods applied were: analysis of the differences between measured and predicted values for each reference equation; correlation and concordance coefficients; adjustment by Z-score values; percentage of predicted value; and the percentage of patients below the lower limit of normality or above the upper limit of normality. Of the 224 participants, 117 (52.3%) were girls, and the mean age was 8.6 ± 2.3 y. The equations that showed the best adjustment for the different parameters were those from the studies by Nowowiejska et al (2008) and Gochicoa et al (2015). The equations proposed by Frei et al (2005), Hellinckx et al (1998), Kalhoff et al (2011), Klug and Bisgaard (1998), de Assumpção et al (2016), and Dencker et al (2006) overestimated the airway resistance of the children in our sample, whereas the equation of Amra et al (2008) underestimated it. In the analysis of the lower and upper limits of normality, Gochicoa et al equation was the closest, since 5% of subjects were below or above percentiles 5 and 95, respectively. The study found that, in general, all of the equations showed greater error at the extremes of the age distribution. Because of the robust adjustment of the present study reference equations for the IOS, it can be recommended for both clinical and research purposes in our population. The differential adjustment of other equations underlines the need to obtain local reference values. Copyright © 2017 by Daedalus Enterprises.

Identification of Suitable Reference Genes for Gene Expression Normalization in qRT-PCR Analysis in Watermelon

PubMed Central

Gao, Lingyun; Zhao, Shuang; Jiang, Wei; Huang, Yuan; Bie, Zhilong

2014-01-01

Watermelon is one of the major Cucurbitaceae crops and the recent availability of genome sequence greatly facilitates the fundamental researches on it. Quantitative real-time reverse transcriptase PCR (qRT–PCR) is the preferred method for gene expression analyses, and using validated reference genes for normalization is crucial to ensure the accuracy of this method. However, a systematic validation of reference genes has not been conducted on watermelon. In this study, transcripts of 15 candidate reference genes were quantified in watermelon using qRT–PCR, and the stability of these genes was compared using geNorm and NormFinder. geNorm identified ClTUA and ClACT, ClEF1α and ClACT, and ClCAC and ClTUA as the best pairs of reference genes in watermelon organs and tissues under normal growth conditions, abiotic stress, and biotic stress, respectively. NormFinder identified ClYLS8, ClUBCP, and ClCAC as the best single reference genes under the above experimental conditions, respectively. ClYLS8 and ClPP2A were identified as the best reference genes across all samples. Two to nine reference genes were required for more reliable normalization depending on the experimental conditions. The widely used watermelon reference gene 18SrRNA was less stable than the other reference genes under the experimental conditions. Catalase family genes were identified in watermelon genome, and used to validate the reliability of the identified reference genes. ClCAT1and ClCAT2 were induced and upregulated in the first 24 h, whereas ClCAT3 was downregulated in the leaves under low temperature stress. However, the expression levels of these genes were significantly overestimated and misinterpreted when 18SrRNA was used as a reference gene. These results provide a good starting point for reference gene selection in qRT–PCR analyses involving watermelon. PMID:24587403

Identification of suitable reference genes for gene expression normalization in qRT-PCR analysis in watermelon.

PubMed

Kong, Qiusheng; Yuan, Jingxian; Gao, Lingyun; Zhao, Shuang; Jiang, Wei; Huang, Yuan; Bie, Zhilong

2014-01-01

Watermelon is one of the major Cucurbitaceae crops and the recent availability of genome sequence greatly facilitates the fundamental researches on it. Quantitative real-time reverse transcriptase PCR (qRT-PCR) is the preferred method for gene expression analyses, and using validated reference genes for normalization is crucial to ensure the accuracy of this method. However, a systematic validation of reference genes has not been conducted on watermelon. In this study, transcripts of 15 candidate reference genes were quantified in watermelon using qRT-PCR, and the stability of these genes was compared using geNorm and NormFinder. geNorm identified ClTUA and ClACT, ClEF1α and ClACT, and ClCAC and ClTUA as the best pairs of reference genes in watermelon organs and tissues under normal growth conditions, abiotic stress, and biotic stress, respectively. NormFinder identified ClYLS8, ClUBCP, and ClCAC as the best single reference genes under the above experimental conditions, respectively. ClYLS8 and ClPP2A were identified as the best reference genes across all samples. Two to nine reference genes were required for more reliable normalization depending on the experimental conditions. The widely used watermelon reference gene 18SrRNA was less stable than the other reference genes under the experimental conditions. Catalase family genes were identified in watermelon genome, and used to validate the reliability of the identified reference genes. ClCAT1and ClCAT2 were induced and upregulated in the first 24 h, whereas ClCAT3 was downregulated in the leaves under low temperature stress. However, the expression levels of these genes were significantly overestimated and misinterpreted when 18SrRNA was used as a reference gene. These results provide a good starting point for reference gene selection in qRT-PCR analyses involving watermelon.

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

Evaluation of the 24-Hour Recall as a Reference Instrument for Calibrating Other Self-Report Instruments in Nutritional Cohort Studies: Evidence From the Validation Studies Pooling Project.

PubMed

Freedman, Laurence S; Commins, John M; Willett, Walter; Tinker, Lesley F; Spiegelman, Donna; Rhodes, Donna; Potischman, Nancy; Neuhouser, Marian L; Moshfegh, Alanna J; Kipnis, Victor; Baer, David J; Arab, Lenore; Prentice, Ross L; Subar, Amy F

2017-07-01

Calibrating dietary self-report instruments is recommended as a way to adjust for measurement error when estimating diet-disease associations. Because biomarkers available for calibration are limited, most investigators use self-reports (e.g., 24-hour recalls (24HRs)) as the reference instrument. We evaluated the performance of 24HRs as reference instruments for calibrating food frequency questionnaires (FFQs), using data from the Validation Studies Pooling Project, comprising 5 large validation studies using recovery biomarkers. Using 24HRs as reference instruments, we estimated attenuation factors, correlations with truth, and calibration equations for FFQ-reported intakes of energy and for protein, potassium, and sodium and their densities, and we compared them with values derived using biomarkers. Based on 24HRs, FFQ attenuation factors were substantially overestimated for energy and sodium intakes, less for protein and potassium, and minimally for nutrient densities. FFQ correlations with truth, based on 24HRs, were substantially overestimated for all dietary components. Calibration equations did not capture dependencies on body mass index. We also compared predicted bias in estimated relative risks adjusted using 24HRs as reference instruments with bias when making no adjustment. In disease models with energy and 1 or more nutrient intakes, predicted bias in estimated nutrient relative risks was reduced on average, but bias in the energy risk coefficient was unchanged. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.

[Validation of BREV: comparison with reference battery in 173 children with learning disorders].

PubMed

Billard, C; Ducot, B; Pinton, F; Coste-Zeitoun, D; Picard, S; Warszawski, J

2006-01-01

The BREV battery (Battery for rapid evaluation of cognitive functions) is a tool which can be used for the rapid neuropsychological evaluation of children aged between 4 and 9 years. After standardization (700 unaffected children) and validation by comparison with a reference battery (202 children with epilepsy), the aim of this study was further validation in 173 children with learning disorders. The study protocol included administration of the BREV, precise neuropsychological examination and evaluation of oral and written language. Statistical analysis was used to compare the findings of the BREV with those of the reference method, and the recommendations indicated by the BREV with the final diagnoses, and to define the sensitivity and the specificity of the BREV battery. All the correlations between BREV tests and reference tests were significant. Recommendations after the BREV were in agreement with the conclusions of the reference evaluation in 168/172 children for language, 145/173 for the psychometric evaluation. For only 4 chidren, the results of the BREV were false negative. Diagnoses corresponded in 168/173 children for oral language, in 102/110 for written language, 166/173 for praxis disorders and 157/173 for intellectual deficit. The most predictive subtests of the BREV and sensitivity and specificity of verbal and non-verbal scores were calculated. The BREV is a reliable examination, in learning disorders, to determine the most complementary investigations both in terms of language disorders and for non-verbal or global learning disabilities.

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.

Validating the weight gain of preterm infants between the reference growth curve of the fetus and the term infant

PubMed Central

2013-01-01

Background Current fetal-infant growth references have an obvious growth disjuncture around 40 week gestation overlapping where the fetal and infant growth references are combined. Graphical smoothening of the disjuncture to connect the matching percentile curves has never been validated. This study was designed to compare weight gain patterns of contemporary preterm infants with a fetal-infant growth reference (derived from a meta-analysis) to validate the previous smoothening assumptions and inform the revision of the Fenton chart. Methods Growth and descriptive data of preterm infants (23 to 31 weeks) from birth through 10 weeks post term age were collected in three cities in Canada and the USA between 2001 and 2010 (n = 977). Preterm infants were grouped by gestational age into 23–25, 26–28, and 29–31 weeks. Comparisons were made between the weight data of the preterm cohort and the fetal-infant growth reference. Results Median weight gain curves of the three preterm gestational age groups were almost identical and remained between the 3rd and the 50th percentiles of the fetal-infant-growth-reference from birth through 10 weeks post term. The growth velocity of the preterm infants decreased in a pattern similar to the decreased velocity of the fetus and term infant estimates, from a high of 17–18 g/kg/day between 31–34 weeks to rates of 4–5 g/kg/day by 50 weeks in each gestational age group. The greatest discrepancy in weight gain velocity between the preterm infants and the fetal estimate was between 37 and 40 weeks; preterm infants grew more rapidly than the fetus. The infants in this study regained their birthweight earlier compared to those in the 1999 National Institute of Child Health and Human Development report. Conclusion The weight gain velocity of preterm infants through the period of growth data disjuncture between 37 and 50 weeks gestation is consistent with and thus validates the smoothening assumptions made between preterm and post-term growth references. PMID:23758808

Validating the weight gain of preterm infants between the reference growth curve of the fetus and the term infant.

PubMed

Fenton, Tanis R; Nasser, Roseann; Eliasziw, Misha; Kim, Jae H; Bilan, Denise; Sauve, Reg

2013-06-11

Current fetal-infant growth references have an obvious growth disjuncture around 40 week gestation overlapping where the fetal and infant growth references are combined. Graphical smoothening of the disjuncture to connect the matching percentile curves has never been validated. This study was designed to compare weight gain patterns of contemporary preterm infants with a fetal-infant growth reference (derived from a meta-analysis) to validate the previous smoothening assumptions and inform the revision of the Fenton chart. Growth and descriptive data of preterm infants (23 to 31 weeks) from birth through 10 weeks post term age were collected in three cities in Canada and the USA between 2001 and 2010 (n = 977). Preterm infants were grouped by gestational age into 23-25, 26-28, and 29-31 weeks. Comparisons were made between the weight data of the preterm cohort and the fetal-infant growth reference. Median weight gain curves of the three preterm gestational age groups were almost identical and remained between the 3rd and the 50th percentiles of the fetal-infant-growth-reference from birth through 10 weeks post term. The growth velocity of the preterm infants decreased in a pattern similar to the decreased velocity of the fetus and term infant estimates, from a high of 17-18 g/kg/day between 31-34 weeks to rates of 4-5 g/kg/day by 50 weeks in each gestational age group. The greatest discrepancy in weight gain velocity between the preterm infants and the fetal estimate was between 37 and 40 weeks; preterm infants grew more rapidly than the fetus. The infants in this study regained their birthweight earlier compared to those in the 1999 National Institute of Child Health and Human Development report. The weight gain velocity of preterm infants through the period of growth data disjuncture between 37 and 50 weeks gestation is consistent with and thus validates the smoothening assumptions made between preterm and post-term growth references.

An extended protocol for usability validation of medical devices: Research design and reference model.

PubMed

Schmettow, Martin; Schnittker, Raphaela; Schraagen, Jan Maarten

2017-05-01

This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences and derive performance measures. Secondly, a prevailing focus on cross-sectional validation studies, ignoring the issues of learnability and training. The U.S. Federal Drug and Food Administration's recent proposal for a validation testing protocol for medical devices is then extended to address these shortcomings: (1) a novel process measure 'normative path deviations' is introduced that is useful for both quantitative and qualitative usability studies and (2) a longitudinal, completely within-subject study design is presented that assesses learnability, training effects and allows analysis of diversity of users. A reference regression model is introduced to analyze data from this and similar studies, drawing upon generalized linear mixed-effects models and a Bayesian estimation approach. The extended protocol is implemented and demonstrated in a study comparing a novel syringe infusion pump prototype to an existing design with a sample of 25 healthcare professionals. Strong performance differences between designs were observed with a variety of usability measures, as well as varying training-on-the-job effects. We discuss our findings with regard to validation testing guidelines, reflect on the extensions and discuss the perspectives they add to the validation process. Copyright © 2017 Elsevier Inc. All rights reserved.

Validation studies of Karl Fisher reference method for moisture in cotton

USDA-ARS?s Scientific Manuscript database

With current international standard oven drying (SOD) techniques lacking precision and accuracy statements, a new standard reference method is needed. Volumetric Karl Fischer Titration (KFT) is a widely used measure of moisture content. The method is used in many ASTM methods, 14 NIST SRMs, and te...

Validation of a simplified food frequency questionnaire for the assessment of dietary habits in Iranian adults: Isfahan Healthy Heart Program, Iran.

PubMed

Mohammadifard, Noushin; Sajjadi, Firouzeh; Maghroun, Maryam; Alikhasi, Hassan; Nilforoushzadeh, Farzaneh; Sarrafzadegan, Nizal

2015-03-01

Dietary assessment is the first step of dietary modification in community-based interventional programs. This study was performed to validate a simple food frequency questionnaire (SFFQ) for assessment of selected food items in epidemiological studies with a large sample size as well as community trails. This validation study was carried out on 264 healthy adults aged ≥ 41 years old living in 3 district central of Iran, including Isfahan, Najafabad, and Arak. Selected food intakes were assessed using a 48-item food frequency questionnaire (FFQ). The FFQ was interviewer-administered, which was completed twice; at the beginning of the study and 2 weeks thereafter. The validity of this SFFQ was examined compared to estimated amount by single 24 h dietary recall and 2 days dietary record. Validation of the FFQ was determined using Spearman correlation coefficients between daily frequency consumption of food groups as assessed by the FFQ and the qualitative amount of daily food groups intake accessed by dietary reference method was applied to evaluate validity. Intraclass correlation coefficients (ICC) were used to determine the reproducibility. Spearman correlation coefficient between the estimated amount of food groups intake by examined and reference methods ranged from 0.105 (P = 0.378) in pickles to 0.48 (P < 0.001) in plant protein. ICC for reproducibility of FFQ were between 0.47-0.69 in different food groups (P < 0.001). The designed SFFQ has a good relative validity and reproducibility for assessment of selected food groups intake. Thus, it can serve as a valid tool in epidemiological studies and clinical trial with large participants.

Evolution of an Implementation-Ready Interprofessional Pain Assessment Reference Model

PubMed Central

Collins, Sarah A; Bavuso, Karen; Swenson, Mary; Suchecki, Christine; Mar, Perry; Rocha, Roberto A.

2017-01-01

Standards to increase consistency of comprehensive pain assessments are important for safety, quality, and analytics activities, including meeting Joint Commission requirements and learning the best management strategies and interventions for the current prescription Opioid epidemic. In this study we describe the development and validation of a Pain Assessment Reference Model ready for implementation on EHR forms and flowsheets. Our process resulted in 5 successive revisions of the reference model, which more than doubled the number of data elements to 47. The organization of the model evolved during validation sessions with panels totaling 48 subject matter experts (SMEs) to include 9 sets of data elements, with one set recommended as a minimal data set. The reference model also evolved when implemented into EHR forms and flowsheets, indicating specifications such as cascading logic that are important to inform secondary use of data. PMID:29854125

Reference datasets for 2-treatment, 2-sequence, 2-period bioequivalence studies.

PubMed

Schütz, Helmut; Labes, Detlew; Fuglsang, Anders

2014-11-01

It is difficult to validate statistical software used to assess bioequivalence since very few datasets with known results are in the public domain, and the few that are published are of moderate size and balanced. The purpose of this paper is therefore to introduce reference datasets of varying complexity in terms of dataset size and characteristics (balance, range, outlier presence, residual error distribution) for 2-treatment, 2-period, 2-sequence bioequivalence studies and to report their point estimates and 90% confidence intervals which companies can use to validate their installations. The results for these datasets were calculated using the commercial packages EquivTest, Kinetica, SAS and WinNonlin, and the non-commercial package R. The results of three of these packages mostly agree, but imbalance between sequences seems to provoke questionable results with one package, which illustrates well the need for proper software validation.

Simulation verification techniques study: Simulation performance validation techniques document. [for the space shuttle system

NASA Technical Reports Server (NTRS)

Duncan, L. M.; Reddell, J. P.; Schoonmaker, P. B.

1975-01-01

Techniques and support software for the efficient performance of simulation validation are discussed. Overall validation software structure, the performance of validation at various levels of simulation integration, guidelines for check case formulation, methods for real time acquisition and formatting of data from an all up operational simulator, and methods and criteria for comparison and evaluation of simulation data are included. Vehicle subsystems modules, module integration, special test requirements, and reference data formats are also described.

The medline UK filter: development and validation of a geographic search filter to retrieve research about the UK from OVID medline.

PubMed

Ayiku, Lynda; Levay, Paul; Hudson, Tom; Craven, Jenny; Barrett, Elizabeth; Finnegan, Amy; Adams, Rachel

2017-07-13

A validated geographic search filter for the retrieval of research about the United Kingdom (UK) from bibliographic databases had not previously been published. To develop and validate a geographic search filter to retrieve research about the UK from OVID medline with high recall and precision. Three gold standard sets of references were generated using the relative recall method. The sets contained references to studies about the UK which had informed National Institute for Health and Care Excellence (NICE) guidance. The first and second sets were used to develop and refine the medline UK filter. The third set was used to validate the filter. Recall, precision and number-needed-to-read (NNR) were calculated using a case study. The validated medline UK filter demonstrated 87.6% relative recall against the third gold standard set. In the case study, the medline UK filter demonstrated 100% recall, 11.4% precision and a NNR of nine. A validated geographic search filter to retrieve research about the UK with high recall and precision has been developed. The medline UK filter can be applied to systematic literature searches in OVID medline for topics with a UK focus. © 2017 Crown copyright. Health Information and Libraries Journal © 2017 Health Libraries GroupThis article is published with the permission of the Controller of HMSO and the Queen's Printer for Scotland.

Standard Specimen Reference Set: Pancreatic — EDRN Public Portal

Cancer.gov

The primary objective of the EDRN Pancreatic Cancer Working Group Proposal is to create a reference set consisting of well-characterized serum/plasma specimens to use as a resource for the development of biomarkers for the early detection of pancreatic adenocarcinoma. The testing of biomarkers on the same sample set permits direct comparison among them; thereby, allowing the development of a biomarker panel that can be evaluated in a future validation study. Additionally, the establishment of an infrastructure with core data elements and standardized operating procedures for specimen collection, processing and storage, will provide the necessary preparatory platform for larger validation studies when the appropriate marker/panel for pancreatic adenocarcinoma has been identified.

Validation of the Artsana CSI 610 automated blood pressure monitor in adults according to the International Protocol of the European Society of Hypertension.

PubMed

Pini, Claudio; Pastori, Marco; Baccheschi, Jordan; Omboni, Stefano; Parati, Gianfranco

2007-06-01

There is evidence that blood pressure measurement outside the doctor's office can provide valuable information for the diagnostic evaluation of hypertensive patients and for monitoring their response to treatment. Home blood pressure monitoring devices have a major role in this setting, provided that their accuracy in measuring blood pressure is demonstrated by validation studies. This study aimed at verifying whether the automatic electronic oscillometric blood pressure measuring device Artsana CSI 610 complied with the standard of accuracy indicated by the ESH International Protocol. Sequential measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). A standard adult cuff was always employed during the study. According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants). The Artsana CSI 610 device successfully passed phase 1 of study validation with the number of absolute differences between test and reference device never <35 within 5 mmHg and never <40 within 10 and 15 mmHg. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -1.4+/-4.8 mmHg for systolic and -0.9+/-3.5 mmHg for diastolic blood pressure. According to the results of the validation study on the basis of the ESH International Protocol, the Artsana CSI 610 can be recommended for clinical use in adults.

The validity of upper-limb neurodynamic tests for detecting peripheral neuropathic pain.

PubMed

Nee, Robert J; Jull, Gwendolen A; Vicenzino, Bill; Coppieters, Michel W

2012-05-01

The validity of upper-limb neurodynamic tests (ULNTs) for detecting peripheral neuropathic pain (PNP) was assessed by reviewing the evidence on plausibility, the definition of a positive test, reliability, and concurrent validity. Evidence was identified by a structured search for peer-reviewed articles published in English before May 2011. The quality of concurrent validity studies was assessed with the Quality Assessment of Diagnostic Accuracy Studies tool, where appropriate. Biomechanical and experimental pain data support the plausibility of ULNTs. Evidence suggests that a positive ULNT should at least partially reproduce the patient's symptoms and that structural differentiation should change these symptoms. Data indicate that this definition of a positive ULNT is reliable when used clinically. Limited evidence suggests that the median nerve test, but not the radial nerve test, helps determine whether a patient has cervical radiculopathy. The median nerve test does not help diagnose carpal tunnel syndrome. These findings should be interpreted cautiously, because diagnostic accuracy might have been distorted by the investigators' definitions of a positive ULNT. Furthermore, patients with PNP who presented with increased nerve mechanosensitivity rather than conduction loss might have been incorrectly classified by electrophysiological reference standards as not having PNP. The only evidence for concurrent validity of the ulnar nerve test was a case study on cubital tunnel syndrome. We recommend that researchers develop more comprehensive reference standards for PNP to accurately assess the concurrent validity of ULNTs and continue investigating the predictive validity of ULNTs for prognosis or treatment response.

Construct validity of posture as a measure of physical function in elderly individuals: Use of a digitalized inclinometer to assess trunk inclination.

PubMed

Suzuki, Yoshikazu; Kawai, Hisashi; Kojima, Motonaga; Shiba, Yoshitaka; Yoshida, Hideyo; Hirano, Hirohiko; Fujiwara, Yoshinori; Ihara, Kazushige; Obuchi, Shuichi

2016-09-01

The first aim of the present study was to determine the construct validity of evaluating posture as a measure of physical function in elderly individuals. The second aim was to determine reference values for sternum inclination in elderly individuals when measured using a digitalized inclinometer. We included 834 community-dwelling elderly individuals (350 men and 484 women) in this study. We used a digital inclinometer for measuring sternum inclination angle. We evaluated physical functions, including muscle strength, static balance, gait ability and the functional mobility of our study participants. To assess the construct validity of sternum inclination in elderly people, Pearson's correlation coefficient between sternum inclination and participant characteristics was calculated. To determine a reference value of sternum inclination by age, P for trend was calculated. In men, the sternum inclination angle and sternum inclination index were significantly associated with all anthropometric measures, except static balance. In women, the sternum inclination index was significantly associated with all measures, whereas the sternum inclination angle was associated with all measures except for balance and the Timed Up and Go test. Trend of sternum inclination index by age was significant. Our results show that the sternum inclination as a measure of physical function in elderly men and women has construct validity. We determined reference values for sternum inclination of which trend by age was considered. Geriatr Gerontol Int 2016; 16: 1068-1073. © 2015 Japan Geriatrics Society.

Validation of reference genes aiming accurate normalization of qRT-PCR data in Dendrocalamus latiflorus Munro.

PubMed

Liu, Mingying; Jiang, Jing; Han, Xiaojiao; Qiao, Guirong; Zhuo, Renying

2014-01-01

Dendrocalamus latiflorus Munro distributes widely in subtropical areas and plays vital roles as valuable natural resources. The transcriptome sequencing for D. latiflorus Munro has been performed and numerous genes especially those predicted to be unique to D. latiflorus Munro were revealed. qRT-PCR has become a feasible approach to uncover gene expression profiling, and the accuracy and reliability of the results obtained depends upon the proper selection of stable reference genes for accurate normalization. Therefore, a set of suitable internal controls should be validated for D. latiflorus Munro. In this report, twelve candidate reference genes were selected and the assessment of gene expression stability was performed in ten tissue samples and four leaf samples from seedlings and anther-regenerated plants of different ploidy. The PCR amplification efficiency was estimated, and the candidate genes were ranked according to their expression stability using three software packages: geNorm, NormFinder and Bestkeeper. GAPDH and EF1α were characterized to be the most stable genes among different tissues or in all the sample pools, while CYP showed low expression stability. RPL3 had the optimal performance among four leaf samples. The application of verified reference genes was illustrated by analyzing ferritin and laccase expression profiles among different experimental sets. The analysis revealed the biological variation in ferritin and laccase transcript expression among the tissues studied and the individual plants. geNorm, NormFinder, and BestKeeper analyses recommended different suitable reference gene(s) for normalization according to the experimental sets. GAPDH and EF1α had the highest expression stability across different tissues and RPL3 for the other sample set. This study emphasizes the importance of validating superior reference genes for qRT-PCR analysis to accurately normalize gene expression of D. latiflorus Munro.

Defining suitable reference genes for RT-qPCR analysis on human sertoli cells after 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD) exposure.

PubMed

Ribeiro, Mariana Antunes; dos Reis, Mariana Bisarro; de Moraes, Leonardo Nazário; Briton-Jones, Christine; Rainho, Cláudia Aparecida; Scarano, Wellerson Rodrigo

2014-11-01

Quantitative real-time RT-PCR (qPCR) has proven to be a valuable molecular technique to quantify gene expression. There are few studies in the literature that describe suitable reference genes to normalize gene expression data. Studies of transcriptionally disruptive toxins, like tetrachlorodibenzo-p-dioxin (TCDD), require careful consideration of reference genes. The present study was designed to validate potential reference genes in human Sertoli cells after exposure to TCDD. 32 candidate reference genes were analyzed to determine their applicability. geNorm and NormFinder softwares were used to obtain an estimation of the expression stability of the 32 genes and to identify the most suitable genes for qPCR data normalization.

Work ability of workers in western China: reference data.

PubMed

Lin, Sihao; Wang, Zhiming; Wang, Mianzhen

2006-03-01

The Work Ability Index (WAI) is a validated and widely used research tool. Reference data for Chinese workers by age, gender and work content are poorly documented or lacking. To provide reference data for work ability among workers in western China. A random sample of 10 218 workers (including manual, professional, clerical and semi-skilled workers) in western China, aged 16-69 years, was taken from several studies and the WAI questionnaire was administered. All the WAI scores were distributed continuously and nearly normally. The WAI for female workers was significantly higher than for males (P < 0.01) and the 'poor' WAI category only accounted for 3% of females, against 6% of males. WAI scores declined with age and changed variably among workers according to work content and age. Mean WAI scores of manual workers declined rapidly beyond the age of 35 years, and beyond age 45 years for professional and clerical workers. WAI scores were distributed differently according to work content and age group (P < 0.01). WAI categories differed by work content and age group both for male and female workers. WAI is validated in Chinese occupational practices. Some reference data are different from Finnish data. This study provides gender, age and work-content-specific WAI reference values that will help enable comparison and intervention evaluation in further studies.

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

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

Owens, J; Koester, C

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

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

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

Owens, J; Vu, A; Koester, C

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

The Construction and Validation of the Heat Vulnerability Index, a Review

PubMed Central

Bao, Junzhe; Li, Xudong; Yu, Chuanhua

2015-01-01

The occurrence of extreme heat and its adverse effects will be exacerbated with the trend of global warming. An increasing number of researchers have been working on aggregating multiple heat-related indicators to create composite indices for heat vulnerability assessments and have visualized the vulnerability through geographic information systems to provide references for reducing the adverse effects of extreme heat more effectively. This review includes 15 studies concerning heat vulnerability assessment. We have studied the indicators utilized and the methods adopted in these studies for the construction of the heat vulnerability index (HVI) and then further reviewed some of the studies that validated the HVI. We concluded that the HVI is useful for targeting the intervention of heat risk, and that heat-related health outcomes could be used to validate and optimize the HVI. In the future, more studies should be conducted to provide references for the selection of heat-related indicators and the determination of weight values of these indicators in the development of the HVI. Studies concerning the application of the HVI are also needed. PMID:26132476

Evaluation of Suitable Reference Genes for Normalization of qPCR Gene Expression Studies in Brinjal (Solanum melongena L.) During Fruit Developmental Stages.

PubMed

Kanakachari, Mogilicherla; Solanke, Amolkumar U; Prabhakaran, Narayanasamy; Ahmad, Israr; Dhandapani, Gurusamy; Jayabalan, Narayanasamy; Kumar, Polumetla Ananda

2016-02-01

Brinjal/eggplant/aubergine is one of the major solanaceous vegetable crops. Recent availability of genome information greatly facilitates the fundamental research on brinjal. Gene expression patterns during different stages of fruit development can provide clues towards the understanding of its biological functions. Quantitative real-time PCR (qPCR) has become one of the most widely used methods for rapid and accurate quantification of gene expression. However, its success depends on the use of a suitable reference gene for data normalization. For qPCR analysis, a single reference gene is not universally suitable for all experiments. Therefore, reference gene validation is a crucial step. Suitable reference genes for qPCR analysis of brinjal fruit development have not been investigated so far. In this study, we have selected 21 candidate reference genes from the Brinjal (Solanum melongena) Plant Gene Indices database (compbio.dfci.harvard.edu/tgi/plant.html) and studied their expression profiles by qPCR during six different fruit developmental stages (0, 5, 10, 20, 30, and 50 days post anthesis) along with leaf samples of the Pusa Purple Long (PPL) variety. To evaluate the stability of gene expression, geNorm and NormFinder analytical softwares were used. geNorm identified SAND (SAND family protein) and TBP (TATA binding protein) as the best pairs of reference genes in brinjal fruit development. The results showed that for brinjal fruit development, individual or a combination of reference genes should be selected for data normalization. NormFinder identified Expressed gene (expressed sequence) as the best single reference gene in brinjal fruit development. In this study, we have identified and validated for the first time reference genes to provide accurate transcript normalization and quantification at various fruit developmental stages of brinjal which can also be useful for gene expression studies in other Solanaceae plant species.

International collaborative study of the endogenous reference gene, sucrose phosphate synthase (SPS), used for qualitative and quantitative analysis of genetically modified rice.

PubMed

Jiang, Lingxi; Yang, Litao; Zhang, Haibo; Guo, Jinchao; Mazzara, Marco; Van den Eede, Guy; Zhang, Dabing

2009-05-13

One rice ( Oryza sativa ) gene, sucrose phosphate synthase (SPS), has been proven to be a suitable endogenous reference gene for genetically modified (GM) rice detection in a previous study. Herein are the reported results of an international collaborative ring trial for validation of the SPS gene as an endogenous reference gene and its optimized qualitative and quantitative polymerase chain reaction (PCR) systems. A total of 12 genetically modified organism (GMO) detection laboratories from seven countries participated in the ring trial and returned their results. The validated results confirmed the species specificity of the method through testing 10 plant genomic DNAs, low heterogeneity, and a stable single-copy number of the rice SPS gene among 7 indica varieties and 5 japonica varieties. The SPS qualitative PCR assay was validated with a limit of detection (LOD) of 0.1%, which corresponded to about 230 copies of haploid rice genomic DNA, while the limit of quantification (LOQ) for the quantitative PCR system was about 23 copies of haploid rice genomic DNA, with acceptable PCR efficiency and linearity. Furthermore, the bias between the test and true values of eight blind samples ranged from 5.22 to 26.53%. Thus, we believe that the SPS gene is suitable for use as an endogenous reference gene for the identification and quantification of GM rice and its derivates.

Optimal Reference Genes for Gene Expression Normalization in Trichomonas vaginalis.

PubMed

dos Santos, Odelta; de Vargas Rigo, Graziela; Frasson, Amanda Piccoli; Macedo, Alexandre José; Tasca, Tiana

2015-01-01

Trichomonas vaginalis is the etiologic agent of trichomonosis, the most common non-viral sexually transmitted disease worldwide. This infection is associated with several health consequences, including cervical and prostate cancers and HIV acquisition. Gene expression analysis has been facilitated because of available genome sequences and large-scale transcriptomes in T. vaginalis, particularly using quantitative real-time polymerase chain reaction (qRT-PCR), one of the most used methods for molecular studies. Reference genes for normalization are crucial to ensure the accuracy of this method. However, to the best of our knowledge, a systematic validation of reference genes has not been performed for T. vaginalis. In this study, the transcripts of nine candidate reference genes were quantified using qRT-PCR under different cultivation conditions, and the stability of these genes was compared using the geNorm and NormFinder algorithms. The most stable reference genes were α-tubulin, actin and DNATopII, and, conversely, the widely used T. vaginalis reference genes GAPDH and β-tubulin were less stable. The PFOR gene was used to validate the reliability of the use of these candidate reference genes. As expected, the PFOR gene was upregulated when the trophozoites were cultivated with ferrous ammonium sulfate when the DNATopII, α-tubulin and actin genes were used as normalizing gene. By contrast, the PFOR gene was downregulated when the GAPDH gene was used as an internal control, leading to misinterpretation of the data. These results provide an important starting point for reference gene selection and gene expression analysis with qRT-PCR studies of T. vaginalis.

Optimal Reference Genes for Gene Expression Normalization in Trichomonas vaginalis

PubMed Central

dos Santos, Odelta; de Vargas Rigo, Graziela; Frasson, Amanda Piccoli; Macedo, Alexandre José; Tasca, Tiana

2015-01-01

Trichomonas vaginalis is the etiologic agent of trichomonosis, the most common non-viral sexually transmitted disease worldwide. This infection is associated with several health consequences, including cervical and prostate cancers and HIV acquisition. Gene expression analysis has been facilitated because of available genome sequences and large-scale transcriptomes in T. vaginalis, particularly using quantitative real-time polymerase chain reaction (qRT-PCR), one of the most used methods for molecular studies. Reference genes for normalization are crucial to ensure the accuracy of this method. However, to the best of our knowledge, a systematic validation of reference genes has not been performed for T. vaginalis. In this study, the transcripts of nine candidate reference genes were quantified using qRT-PCR under different cultivation conditions, and the stability of these genes was compared using the geNorm and NormFinder algorithms. The most stable reference genes were α-tubulin, actin and DNATopII, and, conversely, the widely used T. vaginalis reference genes GAPDH and β-tubulin were less stable. The PFOR gene was used to validate the reliability of the use of these candidate reference genes. As expected, the PFOR gene was upregulated when the trophozoites were cultivated with ferrous ammonium sulfate when the DNATopII, α-tubulin and actin genes were used as normalizing gene. By contrast, the PFOR gene was downregulated when the GAPDH gene was used as an internal control, leading to misinterpretation of the data. These results provide an important starting point for reference gene selection and gene expression analysis with qRT-PCR studies of T. vaginalis. PMID:26393928

Identification and Validation of Reference Genes and Their Impact on Normalized Gene Expression Studies across Cultivated and Wild Cicer Species

PubMed Central

Reddy, Palakolanu Sudhakar; Sri Cindhuri, Katamreddy; Sivaji Ganesh, Adusumalli; Sharma, Kiran Kumar

2016-01-01

Quantitative Real-Time PCR (qPCR) is a preferred and reliable method for accurate quantification of gene expression to understand precise gene functions. A total of 25 candidate reference genes including traditional and new generation reference genes were selected and evaluated in a diverse set of chickpea samples. The samples used in this study included nine chickpea genotypes (Cicer spp.) comprising of cultivated and wild species, six abiotic stress treatments (drought, salinity, high vapor pressure deficit, abscisic acid, cold and heat shock), and five diverse tissues (leaf, root, flower, seedlings and seed). The geNorm, NormFinder and RefFinder algorithms used to identify stably expressed genes in four sample sets revealed stable expression of UCP and G6PD genes across genotypes, while TIP41 and CAC were highly stable under abiotic stress conditions. While PP2A and ABCT genes were ranked as best for different tissues, ABCT, UCP and CAC were most stable across all samples. This study demonstrated the usefulness of new generation reference genes for more accurate qPCR based gene expression quantification in cultivated as well as wild chickpea species. Validation of the best reference genes was carried out by studying their impact on normalization of aquaporin genes PIP1;4 and TIP3;1, in three contrasting chickpea genotypes under high vapor pressure deficit (VPD) treatment. The chickpea TIP3;1 gene got significantly up regulated under high VPD conditions with higher relative expression in the drought susceptible genotype, confirming the suitability of the selected reference genes for expression analysis. This is the first comprehensive study on the stability of the new generation reference genes for qPCR studies in chickpea across species, different tissues and abiotic stresses. PMID:26863232

Identification and Validation of Reference Genes and Their Impact on Normalized Gene Expression Studies across Cultivated and Wild Cicer Species.

PubMed

Reddy, Dumbala Srinivas; Bhatnagar-Mathur, Pooja; Reddy, Palakolanu Sudhakar; Sri Cindhuri, Katamreddy; Sivaji Ganesh, Adusumalli; Sharma, Kiran Kumar

2016-01-01

Quantitative Real-Time PCR (qPCR) is a preferred and reliable method for accurate quantification of gene expression to understand precise gene functions. A total of 25 candidate reference genes including traditional and new generation reference genes were selected and evaluated in a diverse set of chickpea samples. The samples used in this study included nine chickpea genotypes (Cicer spp.) comprising of cultivated and wild species, six abiotic stress treatments (drought, salinity, high vapor pressure deficit, abscisic acid, cold and heat shock), and five diverse tissues (leaf, root, flower, seedlings and seed). The geNorm, NormFinder and RefFinder algorithms used to identify stably expressed genes in four sample sets revealed stable expression of UCP and G6PD genes across genotypes, while TIP41 and CAC were highly stable under abiotic stress conditions. While PP2A and ABCT genes were ranked as best for different tissues, ABCT, UCP and CAC were most stable across all samples. This study demonstrated the usefulness of new generation reference genes for more accurate qPCR based gene expression quantification in cultivated as well as wild chickpea species. Validation of the best reference genes was carried out by studying their impact on normalization of aquaporin genes PIP1;4 and TIP3;1, in three contrasting chickpea genotypes under high vapor pressure deficit (VPD) treatment. The chickpea TIP3;1 gene got significantly up regulated under high VPD conditions with higher relative expression in the drought susceptible genotype, confirming the suitability of the selected reference genes for expression analysis. This is the first comprehensive study on the stability of the new generation reference genes for qPCR studies in chickpea across species, different tissues and abiotic stresses.

The Stroop test as a measure of performance validity in adults clinically referred for neuropsychological assessment.

PubMed

Erdodi, Laszlo A; Sagar, Sanya; Seke, Kristian; Zuccato, Brandon G; Schwartz, Eben S; Roth, Robert M

2018-06-01

This study was designed to develop performance validity indicators embedded within the Delis-Kaplan Executive Function Systems (D-KEFS) version of the Stroop task. Archival data from a mixed clinical sample of 132 patients (50% male; M Age = 43.4; M Education = 14.1) clinically referred for neuropsychological assessment were analyzed. Criterion measures included the Warrington Recognition Memory Test-Words and 2 composites based on several independent validity indicators. An age-corrected scaled score ≤6 on any of the 4 trials reliably differentiated psychometrically defined credible and noncredible response sets with high specificity (.87-.94) and variable sensitivity (.34-.71). An inverted Stroop effect was less sensitive (.14-.29), but comparably specific (.85-90) to invalid performance. Aggregating the newly developed D-KEFS Stroop validity indicators further improved classification accuracy. Failing the validity cutoffs was unrelated to self-reported depression or anxiety. However, it was associated with elevated somatic symptom report. In addition to processing speed and executive function, the D-KEFS version of the Stroop task can function as a measure of performance validity. A multivariate approach to performance validity assessment is generally superior to univariate models. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Validity and reproducibility of a food frequency questionnaire for assessment of fruit and vegetable intake in Iranian adults*

PubMed Central

Mohammadifard, Noushin; Omidvar, Nasrin; Houshiarrad, Anahita; Neyestani, Tirang; Naderi, Gholam-Ali; Soleymani, Bahram

2011-01-01

BACKGROUND: This study's aim was to design and validate a semi-quantitative food frequency questionnaire (FFQ) for assessment of fruits and vegetables (FV) consumption in adults of Isfahan by comparing the FFQ with dietary reference method and blood plasma levels of beta-carotene, vitamin C, and retinol. METHODS: This validation study was performed on 123 healthy adults of Isfahan. FV intake was assessed using a 110-item FFQ. Data collection was performed during two different time periods to control for seasonal effects, fall/winter (cold season) and spring/summer (warm season). In each phase a FFQ and 1 day recall, and 2 days of food records as the dietary reference method were completed and plasma vitamin C, beta-carotene and retinol were measured. Data was analyzed by Pearson or Spearman and intraclass correlations. RESULTS: Serum Lipids, sex, age, body mass index (BMI) and educational level adjusted Pearson correlation coefficient of FV with plasma vitamin C, beta-carotene and retinol were 0.55, 0.47 and 0.28 in the cold season (p < 0.05) and 0.52, 0.45 and 0.35 in the warm season (p < 0.001), respectively. Energy and fat intake, sex, age, BMI and educational level adjusted Pearson correlation coefficient for FV with dietary reference method in the cold and warm seasons were 0.62 and 0.60, respectively (p < 0.001). Intraclass correlation for reproducibility of FFQ in FV was 0.65 (p<0.001). CONCLUSIONS: The designed FFQ had a good criterion validity and reproducibility for assessment of FV intake. Thus, it can serve as a valid tool in epidemiological studies to assess fruit and vegetable intake. PMID:22973322

Validation of integrated water vapor from OMI satellite instrument against reference GPS data at the Iberian Peninsula.

PubMed

Vaquero-Martínez, Javier; Antón, Manuel; Ortiz de Galisteo, José Pablo; Cachorro, Victoria E; Wang, Huiqun; González Abad, Gonzalo; Román, Roberto; Costa, Maria João

2017-02-15

This paper shows the validation of integrated water vapor (IWV) measurements retrieved from the Ozone Monitoring Instrument (OMI), using as reference nine ground-based GPS stations in the Iberian Peninsula. The study period covers from 2007 to 2009. The influence of two factors, - solar zenith angle (SZA) and IWV -, on OMI-GPS differences was studied in detail, as well as the seasonal dependence. The pseudomedian of the relative differences is -1 ± 1% and the inter-quartile range (IQR) is 41%. Linear regressions calculated over each station show an acceptable agreement (R 2 up to 0.77). The OMI-GPS differences display a clear dependence on IWV values. Hence, OMI substantially overestimates the lower IWV data recorded by GPS (∼ 40%), while underestimates the higher IWV reference values (∼ 20%). In connection to this IWV dependence, the relative differences also show an evident SZA dependence when the whole range of IWV values are analyzed (OMI overestimates for high SZA values while underestimates for low values). Finally, the seasonal variation of the OMI-GPS differences is also associated with the strong IWV dependence found in this validation exercise. Copyright © 2016 Elsevier B.V. All rights reserved.

Analysis of Thiodiglycol: Validation of Semi-Volatile Analysis by HPLC-MS/MS by EPA Method MS777

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

Owens, J; Koester, C

The Environmental Protection Agency's (EPA) Region 5 Chicago Regional Laboratory (CRL) developed a method for the analysis of thiodiglycol, the breakdown product of the sulfur mustard HD, in water by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS), titled Method EPA MS777 (hereafter referred to as EPA CRL SOP MS777). This draft standard operating procedure (SOP) was distributed to multiple EPA laboratories and to Lawrence Livermore National Laboratory, which was tasked to serve as a reference laboratory for EPA's Environmental Reference Laboratory Network (ERLN) and to develop and validate analytical procedures. The primary objective of this study was to verifymore » the analytical procedures described in MS777 for analysis of thiodiglycol in aqueous samples. The gathered data from this study will be used to: (1) demonstrate analytical method performance; (2) generate quality control acceptance criteria; and (3) revise the SOP to provide a validated method that would be available for use during a homeland security event. The data contained in this report will be compiled, by EPA CRL, with data generated by other EPA Regional laboratories so that performance metrics of Method EPA MS777 can be determined.« less

Reference method for detection of Pgp mediated multidrug resistance in human hematological malignancies: a method validated by the laboratories of the French Drug Resistance Network.

PubMed

Huet, S; Marie, J P; Gualde, N; Robert, J

1998-12-15

Multidrug resistance (MDR) associated with overexpression of the MDR1 gene and of its product, P-glycoprotein (Pgp), plays an important role in limiting cancer treatment efficacy. Many studies have investigated Pgp expression in clinical samples of hematological malignancies but failed to give definitive conclusion on its usefulness. One convenient method for fluorescent detection of Pgp in malignant cells is flow cytometry which however gives variable results from a laboratory to another one, partly due to the lack of a reference method rigorously tested. The purpose of this technical note is to describe each step of a reference flow cytometric method. The guidelines for sample handling, staining and analysis have been established both for Pgp detection with monoclonal antibodies directed against extracellular epitopes (MRK16, UIC2 and 4E3), and for Pgp functional activity measurement with Rhodamine 123 as a fluorescent probe. Both methods have been validated on cultured cell lines and clinical samples by 12 laboratories of the French Drug Resistance Network. This cross-validated multicentric study points out crucial steps for the accuracy and reproducibility of the results, like cell viability, data analysis and expression.

Validation of Student and Parent Reported Data on the Basic Grant Application Form: Institution/OE Referral Study, Pre-Established and ACT Criteria Study, Overpayment Recovery. Final Report, Volume 2.

ERIC Educational Resources Information Center

Walters, Pamela Barnhouse; And Others

The validity of information provided in applications to the Basic Educational Opportunity Grant (BEOG) program was studied, along with procedures used in recovering overpayments. The objective was to investigate misreporting and misuse of the BEOG program. A 1977-1978 study reviewed cases referred to the U.S. Office of Education by educational…

Londrina Activities of Daily Living Protocol: Reproducibility, Validity, and Reference Values in Physically Independent Adults Age 50 Years and Older.

PubMed

Paes, Thaís; Belo, Letícia Fernandes; da Silva, Diego Rodrigues; Morita, Andrea Akemi; Donária, Leila; Furlanetto, Karina Couto; Sant'Anna, Thaís; Pitta, Fabio; Hernandes, Nidia Aparecida

2017-03-01

It is important to assess activities of daily living (ADL) in older adults due to impairment of independence and quality of life. However, there is no objective and standardized protocol available to assess this outcome. Thus, the aim of this study was to verify the reproducibility and validity of a new protocol for ADL assessment applied in physically independent adults age ≥50 y, the Londrina ADL protocol, and to establish an equation to predict reference values of the Londrina ADL protocol. Ninety-three physically independent adults age ≥50 y had their performance in ADL evaluated by registering the time spent to conclude the protocol. The protocol was performed twice. The 6-min walk test, which assesses functional exercise capacity, was used as a validation criterion. A multiple linear regression model was applied, including anthropometric and demographic variables that correlated with the protocol, to establish an equation to predict the protocol's reference values. In general, the protocol was reproducible (intraclass correlation coefficient 0.91). The average difference between the first and second protocol was 5.3%. The new protocol was valid to assess ADL performance in the studied subjects, presenting a moderate correlation with the 6-min walk test (r = -0.53). The time spent to perform the protocol correlated significantly with age (r = 0.45) but neither with weight (r = -0.17) nor with height (r = -0.17). A model of stepwise multiple regression including sex and age showed that age was the only determinant factor to the Londrina ADL protocol, explaining 21% ( P < .001) of its variability. The derived reference equation was: Londrina ADL protocol pred (s) = 135.618 + (3.102 × age [y]). The Londrina ADL protocol was reproducible and valid in physically independent adults age ≥50 y. A reference equation for the protocol was established including only age as an independent variable (r 2 = 0.21), allowing a better interpretation of the protocol's results in clinical practice. Copyright © 2017 by Daedalus Enterprises.

Determination of reference ranges for elements in human scalp hair.

PubMed

Druyan, M E; Bass, D; Puchyr, R; Urek, K; Quig, D; Harmon, E; Marquardt, W

1998-06-01

Expected values, reference ranges, or reference limits are necessary to enable clinicians to apply analytical chemical data in the delivery of health care. Determination of references ranges is not straightforward in terms of either selecting a reference population or performing statistical analysis. In light of logistical, scientific, and economic obstacles, it is understandable that clinical laboratories often combine approaches in developing health associated reference values. A laboratory may choose to: 1. Validate either reference ranges of other laboratories or published data from clinical research or both, through comparison of patients test data. 2. Base the laboratory's reference values on statistical analysis of results from specimens assayed by the clinical reference laboratory itself. 3. Adopt standards or recommendations of regulatory agencies and governmental bodies. 4. Initiate population studies to validate transferred reference ranges or to determine them anew. Effects of external contamination and anecdotal information from clinicians may be considered. The clinical utility of hair analysis is well accepted for some elements. For others, it remains in the realm of clinical investigation. This article elucidates an approach for establishment of reference ranges for elements in human scalp hair. Observed levels of analytes from hair specimens from both our laboratory's total patient population and from a physician-defined healthy American population have been evaluated. Examination of levels of elements often associated with toxicity serves to exemplify the process of determining reference ranges in hair. In addition the approach serves as a model for setting reference ranges for analytes in a variety of matrices.

Development of a reference material for routine performance monitoring of methods measuring polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans and dioxin-like polychlorinated biphenyls.

PubMed

Selliah, S S; Cussion, S; MacPherson, K A; Reiner, E J; Toner, D

2001-06-01

Matrix-matched environmental certified reference materials (CRMs) are one of the most useful tools to validate analytical methods, assess analytical laboratory performance and to assist in the resolution of data conflicts between laboratories. This paper describes the development of a lake sediment as a CRM for polychorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and dioxin-like polychlorinated biphenyls (DLPCBs). The presence of DLPCBs in the environment is of increased concern and analytical methods are being developed internationally for monitoring DLPCBs in the environment. This paper also reports the results of an international interlaboratory study involving thirty-five laboratories from seventeen countries, conducted to characterize and validate levels of a sediment reference material for PCDDs, PCDFs and DLPCBs.

Nasal potential difference measurements in diagnosis of cystic fibrosis: an international survey.

PubMed

Naehrlich, Lutz; Ballmann, Manfred; Davies, Jane; Derichs, Nico; Gonska, Tanja; Hjelte, Lena; van Konigsbruggen-Rietschel, Silke; Leal, Teresinha; Melotti, Paola; Middleton, Peter; Tümmler, Burkhard; Vermeulen, Francois; Wilschanski, Michael

2014-01-01

The role of nasal potential difference (NPD) measurement as a diagnostic test for cystic fibrosis (CF) is a subject of global controversy because of the lack of validation studies, clear reference values, and standardized protocols for diagnostic NPD. To determine diagnostic NPD frequency, protocols, interpretation, and rater agreement, we surveyed the 18 NPD centres of the European Cystic Fibrosis Society Diagnostic Network Working Group. Fifteen centres reported performing 373 diagnostic NPDs in 2012. Most use the CFF-TDN-SOP (67%) and the chloride-free + isoproterenol response of the side with the largest response (47%) as diagnostic criteria and use centre-specific reference ranges. Rater agreement for five NPD tracings - in general - was good, but poor in tracings with different responses between the two nostrils. NPD is frequently used as a diagnostic and research tool for CF. Performance is highly standardized, centre-specific reference ranges are established, and rater agreement - in general - is good. Centre-independent diagnostic criteria and reference ranges must be defined by multicentre validation studies to improve standardized interpretation for diagnostic use. © 2013.

Identification and validation of superior reference gene for gene expression normalization via RT-qPCR in staminate and pistillate flowers of Jatropha curcas - A biodiesel plant.

PubMed

Karuppaiya, Palaniyandi; Yan, Xiao-Xue; Liao, Wang; Wu, Jun; Chen, Fang; Tang, Lin

2017-01-01

Physic nut (Jatropha curcas L) seed oil is a natural resource for the alternative production of fossil fuel. Seed oil production is mainly depended on seed yield, which was restricted by the low ratio of staminate flowers to pistillate flowers. Further, the mechanism of physic nut flower sex differentiation has not been fully understood yet. Quantitative Real Time-Polymerase Chain Reaction is a reliable and widely used technique to quantify the gene expression pattern in biological samples. However, for accuracy of qRT-PCR, appropriate reference gene is highly desirable to quantify the target gene level. Hence, the present study was aimed to identify the stable reference genes in staminate and pistillate flowers of J. curcas. In this study, 10 candidate reference genes were selected and evaluated for their expression stability in staminate and pistillate flowers, and their stability was validated by five different algorithms (ΔCt, BestKeeper, NormFinder, GeNorm and RefFinder). Resulting, TUB and EF found to be the two most stably expressed reference for staminate flower; while GAPDH1 and EF found to be the most stably expressed reference gene for pistillate flowers. Finally, RT-qPCR assays of target gene AGAMOUS using the identified most stable reference genes confirmed the reliability of selected reference genes in different stages of flower development. AGAMOUS gene expression levels at different stages were further proved by gene copy number analysis. Therefore, the present study provides guidance for selecting appropriate reference genes for analyzing the expression pattern of floral developmental genes in staminate and pistillate flowers of J. curcas.

Identification and validation of superior reference gene for gene expression normalization via RT-qPCR in staminate and pistillate flowers of Jatropha curcas – A biodiesel plant

PubMed Central

Karuppaiya, Palaniyandi; Yan, Xiao-Xue; Liao, Wang; Chen, Fang; Tang, Lin

2017-01-01

Physic nut (Jatropha curcas L) seed oil is a natural resource for the alternative production of fossil fuel. Seed oil production is mainly depended on seed yield, which was restricted by the low ratio of staminate flowers to pistillate flowers. Further, the mechanism of physic nut flower sex differentiation has not been fully understood yet. Quantitative Real Time—Polymerase Chain Reaction is a reliable and widely used technique to quantify the gene expression pattern in biological samples. However, for accuracy of qRT-PCR, appropriate reference gene is highly desirable to quantify the target gene level. Hence, the present study was aimed to identify the stable reference genes in staminate and pistillate flowers of J. curcas. In this study, 10 candidate reference genes were selected and evaluated for their expression stability in staminate and pistillate flowers, and their stability was validated by five different algorithms (ΔCt, BestKeeper, NormFinder, GeNorm and RefFinder). Resulting, TUB and EF found to be the two most stably expressed reference for staminate flower; while GAPDH1 and EF found to be the most stably expressed reference gene for pistillate flowers. Finally, RT-qPCR assays of target gene AGAMOUS using the identified most stable reference genes confirmed the reliability of selected reference genes in different stages of flower development. AGAMOUS gene expression levels at different stages were further proved by gene copy number analysis. Therefore, the present study provides guidance for selecting appropriate reference genes for analyzing the expression pattern of floral developmental genes in staminate and pistillate flowers of J. curcas. PMID:28234941

Development and Validation of Rapid Assessment Indices for Condition of Coastal Wetlands in Southern New England USA

EPA Science Inventory

The goals of this study were to develop and validate a Rapid Assessment Method (RAM) for assessing the condition of coastal wetlands in New England, USA. Eighty-one coastal wetland sites were assessed; nested within these were ten reference sites which were previously assessed us...

Evaluation Instruments for Quality of Life Related to Melasma: An Integrative Review.

PubMed

Pollo, Camila Fernandes; Meneguin, Silmara; Miot, Helio Amante

2018-05-21

The aim of this study was to analyze scientific production concerning the validation and cultural adaptation of quality of life evaluation instruments for patients with melasma and to offer a critical reflection on these methods. A literature review was performed based on a search of the Web of Science, Bireme, PubMed, Elsevier Scopus, and Google Scholar databases. All published articles from indexed periodicals in these electronic databases up to December 2015 were included. Eight articles were identified, of which only one (12.5%) referred to the development and validation of a specific instrument for evaluation of the quality of life of melasma patients. An additional six articles (75%) referred to transcultural adjustment and validation of the same instrument in other languages, and another (12.5%) article reported the development of a generic instrument for evaluation of quality of life in patients with pigment disorders. This review revealed only one specific instrument developed and validated in different cultures. Despite being widely used, this instrument did not follow the classic construction steps for psychometric instruments, which paves the way for future studies to develop novel instruments.

Evaluation Instruments for Quality of Life Related to Melasma: An Integrative Review

PubMed Central

Pollo, Camila Fernandes; Meneguin, Silmara; Miot, Helio Amante

2018-01-01

The aim of this study was to analyze scientific production concerning the validation and cultural adaptation of quality of life evaluation instruments for patients with melasma and to offer a critical reflection on these methods. A literature review was performed based on a search of the Web of Science, Bireme, PubMed, Elsevier Scopus, and Google Scholar databases. All published articles from indexed periodicals in these electronic databases up to December 2015 were included. Eight articles were identified, of which only one (12.5%) referred to the development and validation of a specific instrument for evaluation of the quality of life of melasma patients. An additional six articles (75%) referred to transcultural adjustment and validation of the same instrument in other languages, and another (12.5%) article reported the development of a generic instrument for evaluation of quality of life in patients with pigment disorders. This review revealed only one specific instrument developed and validated in different cultures. Despite being widely used, this instrument did not follow the classic construction steps for psychometric instruments, which paves the way for future studies to develop novel instruments. PMID:29791603

Definitive Characterization of CA 19-9 in Resectable Pancreatic Cancer Using a Reference Set of Serum and Plasma Specimens.

PubMed

Haab, Brian B; Huang, Ying; Balasenthil, Seetharaman; Partyka, Katie; Tang, Huiyuan; Anderson, Michelle; Allen, Peter; Sasson, Aaron; Zeh, Herbert; Kaul, Karen; Kletter, Doron; Ge, Shaokui; Bern, Marshall; Kwon, Richard; Blasutig, Ivan; Srivastava, Sudhir; Frazier, Marsha L; Sen, Subrata; Hollingsworth, Michael A; Rinaudo, Jo Ann; Killary, Ann M; Brand, Randall E

2015-01-01

The validation of candidate biomarkers often is hampered by the lack of a reliable means of assessing and comparing performance. We present here a reference set of serum and plasma samples to facilitate the validation of biomarkers for resectable pancreatic cancer. The reference set includes a large cohort of stage I-II pancreatic cancer patients, recruited from 5 different institutions, and relevant control groups. We characterized the performance of the current best serological biomarker for pancreatic cancer, CA 19-9, using plasma samples from the reference set to provide a benchmark for future biomarker studies and to further our knowledge of CA 19-9 in early-stage pancreatic cancer and the control groups. CA 19-9 distinguished pancreatic cancers from the healthy and chronic pancreatitis groups with an average sensitivity and specificity of 70-74%, similar to previous studies using all stages of pancreatic cancer. Chronic pancreatitis patients did not show CA 19-9 elevations, but patients with benign biliary obstruction had elevations nearly as high as the cancer patients. We gained additional information about the biomarker by comparing two distinct assays. The two CA 9-9 assays agreed well in overall performance but diverged in measurements of individual samples, potentially due to subtle differences in antibody specificity as revealed by glycan array analysis. Thus, the reference set promises be a valuable resource for biomarker validation and comparison, and the CA 19-9 data presented here will be useful for benchmarking and for exploring relationships to CA 19-9.

Definitive Characterization of CA 19-9 in Resectable Pancreatic Cancer Using a Reference Set of Serum and Plasma Specimens

PubMed Central

Haab, Brian B.; Huang, Ying; Balasenthil, Seetharaman; Partyka, Katie; Tang, Huiyuan; Anderson, Michelle; Allen, Peter; Sasson, Aaron; Zeh, Herbert; Kaul, Karen; Kletter, Doron; Ge, Shaokui; Bern, Marshall; Kwon, Richard; Blasutig, Ivan; Srivastava, Sudhir; Frazier, Marsha L.; Sen, Subrata; Hollingsworth, Michael A.; Rinaudo, Jo Ann; Killary, Ann M.; Brand, Randall E.

2015-01-01

The validation of candidate biomarkers often is hampered by the lack of a reliable means of assessing and comparing performance. We present here a reference set of serum and plasma samples to facilitate the validation of biomarkers for resectable pancreatic cancer. The reference set includes a large cohort of stage I-II pancreatic cancer patients, recruited from 5 different institutions, and relevant control groups. We characterized the performance of the current best serological biomarker for pancreatic cancer, CA 19–9, using plasma samples from the reference set to provide a benchmark for future biomarker studies and to further our knowledge of CA 19–9 in early-stage pancreatic cancer and the control groups. CA 19–9 distinguished pancreatic cancers from the healthy and chronic pancreatitis groups with an average sensitivity and specificity of 70–74%, similar to previous studies using all stages of pancreatic cancer. Chronic pancreatitis patients did not show CA 19–9 elevations, but patients with benign biliary obstruction had elevations nearly as high as the cancer patients. We gained additional information about the biomarker by comparing two distinct assays. The two CA 9–9 assays agreed well in overall performance but diverged in measurements of individual samples, potentially due to subtle differences in antibody specificity as revealed by glycan array analysis. Thus, the reference set promises be a valuable resource for biomarker validation and comparison, and the CA 19–9 data presented here will be useful for benchmarking and for exploring relationships to CA 19–9. PMID:26431551

Evaluation of CASL boiling model for DNB performance in full scale 5x5 fuel bundle with spacer grids

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

Kim, Seung Jun

As one of main tasks for FY17 CASL-THM activity, Evaluation study on applicability of the CASL baseline boiling model for 5x5 DNB application is conducted and the predictive capability of the DNB analysis is reported here. While the baseline CASL-boiling model (GEN- 1A) approach has been successfully implemented and validated with a single pipe application in the previous year’s task, the extended DNB validation for realistic sub-channels with detailed spacer grid configurations are tasked in FY17. The focus area of the current study is to demonstrate the robustness and feasibility of the CASL baseline boiling model for DNB performance inmore » a full 5x5 fuel bundle application. A quantitative evaluation of the DNB predictive capability is performed by comparing with corresponding experimental measurements (i.e. reference for the model validation). The reference data are provided from the Westinghouse Electricity Company (WEC). Two different grid configurations tested here include Non-Mixing Vane Grid (NMVG), and Mixing Vane Grid (MVG). Thorough validation studies with two sub-channel configurations are performed at a wide range of realistic PWR operational conditions.« less

Selection of Reference Genes for Expression Studies in Diaphorina citri (Hemiptera: Liviidae).

PubMed

Bassan, Meire Menezes; Angelotti-Mendonc A, Je Ssika; Alves, Gustavo Rodrigues; Yamamoto, Pedro Takao; Moura O Filho, Francisco de Assis Alves

2017-12-05

The Asian citrus psyllid, Diaphorina citri Kuwayama (Hemiptera: Liviidae), is considered the main vector of the bacteria associated with huanglongbing, a very serious disease that has threatened the world citrus industry. The absence of efficient control management protocols, including a lack of resistant cultivars, has led to the development of different approaches to study this pathosystem. The production of resistant genotypes relies on D. citri gene expression analyses by RT-qPCR to assess control of the vector population. High-quality, reliable RT-qPCR analyses depend upon proper reference gene selection and validation. However, adequate D. citri reference genes have not yet been identified. In the present study, we evaluated the genes EF 1-α, ACT, GAPDH, RPL7, RPL17, and TUB as candidate reference genes for this insect. Gene expression stability was evaluated using the mathematical algorithms deltaCt, NormFinder, BestKeeper, and geNorm, at five insect developmental stages, grown on two different plant hosts [Citrus sinensis (L.) Osbeck (Sapindales: Rutaceae) and Murraya paniculata (L.) Jack (Sapindales: Rutaceae)]. The final gene ranking was calculated using RefFinder software, and the V-ATPase-A gene was selected for validation. According to our results, two reference genes are recommended when different plant hosts and developmental stages are considered. Considering gene expression studies in D. citri grown on M. paniculata, regardless of the insect developmental stage, GAPDH and RPL7 have the best fit as reference genes in RT-qPCR analyses, whereas GAPDH and EF 1-α are recommended as reference genes in insect studies using C. sinensis. © The Author(s) 2017. Published by Oxford University Press on behalf of Entomological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Validating internal controls for quantitative plant gene expression studies.

PubMed

Brunner, Amy M; Yakovlev, Igor A; Strauss, Steven H

2004-08-18

Real-time reverse transcription PCR (RT-PCR) has greatly improved the ease and sensitivity of quantitative gene expression studies. However, accurate measurement of gene expression with this method relies on the choice of a valid reference for data normalization. Studies rarely verify that gene expression levels for reference genes are adequately consistent among the samples used, nor compare alternative genes to assess which are most reliable for the experimental conditions analyzed. Using real-time RT-PCR to study the expression of 10 poplar (genus Populus) housekeeping genes, we demonstrate a simple method for determining the degree of stability of gene expression over a set of experimental conditions. Based on a traditional method for analyzing the stability of varieties in plant breeding, it defines measures of gene expression stability from analysis of variance (ANOVA) and linear regression. We found that the potential internal control genes differed widely in their expression stability over the different tissues, developmental stages and environmental conditions studied. Our results support that quantitative comparisons of candidate reference genes are an important part of real-time RT-PCR studies that seek to precisely evaluate variation in gene expression. The method we demonstrated facilitates statistical and graphical evaluation of gene expression stability. Selection of the best reference gene for a given set of experimental conditions should enable detection of biologically significant changes in gene expression that are too small to be revealed by less precise methods, or when highly variable reference genes are unknowingly used in real-time RT-PCR experiments.

Serum free light chain reference values: a critical approach.

PubMed

Altinier, Sara; Seguso, Mara; Zaninotto, Martina; Varagnolo, Mariacristina; Adami, Fausto; Angeli, Paolo; Plebani, Mario

2013-05-01

The clinical usefulness of serum free light chain (FLC) measurement in the management of patients with plasma cell proliferative disorders has been reported in several papers, and most clinical studies use the reference ranges declared by the manufacturer. The aim of the present study was to evaluate the reproducibility of FLCs immunoassay and to validate the reference range, before introducing it in routine setting. Internal quality control materials and a pool of fresh serum samples were used to evaluate imprecision; 162 fresh sera from healthy blood donors were analyzed to evaluate the reference range for FLCs. In order to verify the κ/λ FLC ratio, 43 sera from patients with polyclonal hypergammaglobulinemia were tested. The FLC immunoassay was performed using a nephelometer with the Freelite reagents. The imprecision studies performed using a serum pool tested with two different lots of reagents showed a mean CV of 16.09% for κFLC and of 16.72% for λFLC. Lower CV%s and different mean values were found by calculating the results from each specific lot separately, while different results were obtained using the control materials provided by the manufacturer. In reference subjects, the 2.5-97.5th percentiles were found to be 4.52-22.33 and 4.84-21.88mg/L for κFLC and λFLC, respectively. The range for κ/λ ratio (0.65-2.36) was validated with the values obtained from subjects with polyclonal hypergammaglobulinemia. In retesting 15 samples from blood donor subjects with a different lot of reagents, mean bias percentages of 17.60 for κFLC and 15.26 for λFLC were obtained. These findings confirm the lot-to-lot variability of the FLC assays also in the measurement of polyclonal light chains, as well as the need to carefully validate the reference values. Published by Elsevier Inc.

Internal validation of the GlobalFiler™ Express PCR Amplification Kit for the direct amplification of reference DNA samples on a high-throughput automated workflow.

PubMed

Flores, Shahida; Sun, Jie; King, Jonathan; Budowle, Bruce

2014-05-01

The GlobalFiler™ Express PCR Amplification Kit uses 6-dye fluorescent chemistry to enable multiplexing of 21 autosomal STRs, 1 Y-STR, 1 Y-indel and the sex-determining marker amelogenin. The kit is specifically designed for processing reference DNA samples in a high throughput manner. Validation studies were conducted to assess the performance and define the limitations of this direct amplification kit for typing blood and buccal reference DNA samples on various punchable collection media. Studies included thermal cycling sensitivity, reproducibility, precision, sensitivity of detection, minimum detection threshold, system contamination, stochastic threshold and concordance. Results showed that optimal amplification and injection parameters for a 1.2mm punch from blood and buccal samples were 27 and 28 cycles, respectively, combined with a 12s injection on an ABI 3500xL Genetic Analyzer. Minimum detection thresholds were set at 100 and 120RFUs for 27 and 28 cycles, respectively, and it was suggested that data from positive amplification controls provided a better threshold representation. Stochastic thresholds were set at 250 and 400RFUs for 27 and 28 cycles, respectively, as stochastic effects increased with cycle number. The minimum amount of input DNA resulting in a full profile was 0.5ng, however, the optimum range determined was 2.5-10ng. Profile quality from the GlobalFiler™ Express Kit and the previously validated AmpFlSTR(®) Identifiler(®) Direct Kit was comparable. The validation data support that reliable DNA typing results from reference DNA samples can be obtained using the GlobalFiler™ Express PCR Amplification Kit. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A reference equation for maximal aerobic power for treadmill and cycle ergometer exercise testing: Analysis from the FRIEND registry.

PubMed

de Souza E Silva, Christina G; Kaminsky, Leonard A; Arena, Ross; Christle, Jeffrey W; Araújo, Claudio Gil S; Lima, Ricardo M; Ashley, Euan A; Myers, Jonathan

2018-05-01

Background Maximal oxygen uptake (VO 2 max) is a powerful predictor of health outcomes. Valid and portable reference values are integral to interpreting measured VO 2 max; however, available reference standards lack validation and are specific to exercise mode. This study was undertaken to develop and validate a single equation for normal standards for VO 2 max for the treadmill or cycle ergometer in men and women. Methods Healthy individuals ( N = 10,881; 67.8% men, 20-85 years) who performed a maximal cardiopulmonary exercise test on either a treadmill or a cycle ergometer were studied. Of these, 7617 and 3264 individuals were randomly selected for development and validation of the equation, respectively. A Brazilian sample (1619 individuals) constituted a second validation cohort. The prediction equation was determined using multiple regression analysis, and comparisons were made with the widely-used Wasserman and European equations. Results Age, sex, weight, height and exercise mode were significant predictors of VO 2 max. The regression equation was: VO 2 max (ml kg -1  min -1 ) = 45.2 - 0.35*Age - 10.9*Sex (male = 1; female = 2) - 0.15*Weight (pounds) + 0.68*Height (inches) - 0.46*Exercise Mode (treadmill = 1; bike = 2) ( R = 0.79, R 2  = 0.62, standard error of the estimate = 6.6 ml kg -1  min -1 ). Percentage predicted VO 2 max for the US and Brazilian validation cohorts were 102.8% and 95.8%, respectively. The new equation performed better than traditional equations, particularly among women and individuals ≥60 years old. Conclusion A combined equation was developed for normal standards for VO 2 max for different exercise modes derived from a US national registry. The equation provided a lower average error between measured and predicted VO 2 max than traditional equations even when applied to an independent cohort. Additional studies are needed to determine its portability.

Probability of Detection (POD) as a statistical model for the validation of qualitative methods.

PubMed

Wehling, Paul; LaBudde, Robert A; Brunelle, Sharon L; Nelson, Maria T

2011-01-01

A statistical model is presented for use in validation of qualitative methods. This model, termed Probability of Detection (POD), harmonizes the statistical concepts and parameters between quantitative and qualitative method validation. POD characterizes method response with respect to concentration as a continuous variable. The POD model provides a tool for graphical representation of response curves for qualitative methods. In addition, the model allows comparisons between candidate and reference methods, and provides calculations of repeatability, reproducibility, and laboratory effects from collaborative study data. Single laboratory study and collaborative study examples are given.

Selection and validation of reference genes for qRT-PCR analysis during biological invasions: The thermal adaptability of Bemisia tabaci MED.

PubMed

Dai, Tian-Mei; Lü, Zhi-Chuang; Liu, Wan-Xue; Wan, Fang-Hao

2017-01-01

The Bemisia tabaci Mediterranean (MED) cryptic species has been rapidly invading to most parts of the world owing to its strong ecological adaptability, which is considered as a model insect for stress tolerance studies under rapidly changing environments. Selection of a suitable reference gene for quantitative stress-responsive gene expression analysis based on qRT-PCR is critical for elaborating the molecular mechanisms of thermotolerance. To obtain accurate and reliable normalization data in MED, eight candidate reference genes (β-act, GAPDH, β-tub, EF1-α, GST, 18S, RPL13A and α-tub) were examined under various thermal stresses for varied time periods by using geNorm, NormFinder and BestKeeper algorithms, respectively. Our results revealed that β-tub and EF1-α were the best reference genes across all sample sets. On the other hand, 18S and GADPH showed the least stability for all the samples studied. β-act was proved to be highly stable only in case of short-term thermal stresses. To our knowledge this was the first comprehensive report on validation of reference genes under varying temperature stresses in MED. The study could expedite particular discovery of thermotolerance genes in MED. Further, the present results can form the basis of further research on suitable reference genes in this invasive insect and will facilitate transcript profiling in other invasive insects.

A Comparative Study of Different EEG Reference Choices for Diagnosing Unipolar Depression.

PubMed

Mumtaz, Wajid; Malik, Aamir Saeed

2018-06-02

The choice of an electroencephalogram (EEG) reference has fundamental importance and could be critical during clinical decision-making because an impure EEG reference could falsify the clinical measurements and subsequent inferences. In this research, the suitability of three EEG references was compared while classifying depressed and healthy brains using a machine-learning (ML)-based validation method. In this research, the EEG data of 30 unipolar depressed subjects and 30 age-matched healthy controls were recorded. The EEG data were analyzed in three different EEG references, the link-ear reference (LE), average reference (AR), and reference electrode standardization technique (REST). The EEG-based functional connectivity (FC) was computed. Also, the graph-based measures, such as the distances between nodes, minimum spanning tree, and maximum flow between the nodes for each channel pair, were calculated. An ML scheme provided a mechanism to compare the performances of the extracted features that involved a general framework such as the feature extraction (graph-based theoretic measures), feature selection, classification, and validation. For comparison purposes, the performance metrics such as the classification accuracies, sensitivities, specificities, and F scores were computed. When comparing the three references, the diagnostic accuracy showed better performances during the REST, while the LE and AR showed less discrimination between the two groups. Based on the results, it can be concluded that the choice of appropriate reference is critical during the clinical scenario. The REST reference is recommended for future applications of EEG-based diagnosis of mental illnesses.

Identification of optimal reference genes for RT-qPCR in the rat hypothalamus and intestine for the study of obesity.

PubMed

Li, B; Matter, E K; Hoppert, H T; Grayson, B E; Seeley, R J; Sandoval, D A

2014-02-01

Obesity has a complicated metabolic pathology, and defining the underlying mechanisms of obesity requires integrative studies with molecular end points. Real-time quantitative PCR (RT-qPCR) is a powerful tool that has been widely utilized. However, the importance of using carefully validated reference genes in RT-qPCR seems to have been overlooked in obesity-related research. The objective of this study was to select a set of reference genes with stable expressions to be used for RT-qPCR normalization in rats under fasted vs re-fed and chow vs high-fat diet (HFD) conditions. Male long-Evans rats were treated under four conditions: chow/fasted, chow/re-fed, HFD/fasted and HFD/re-fed. Expression stabilities of 13 candidate reference genes were evaluated in the rat hypothalamus, duodenum, jejunum and ileum using the ReFinder software program. The optimal number of reference genes needed for RT-qPCR analyses was determined using geNorm. Using geNorm analysis, we found that it was sufficient to use the two most stably expressed genes as references in RT-qPCR analyses for each tissue under specific experimental conditions. B2M and RPLP0 in the hypothalamus, RPS18 and HMBS in the duodenum, RPLP2 and RPLP0 in the jejunum and RPS18 and YWHAZ in the ileum were the most suitable pairs for a normalization study when the four aforementioned experimental conditions were considered. Our study demonstrates that gene expression levels of reference genes commonly used in obesity-related studies, such as ACTB or RPS18, are altered by changes in acute or chronic energy status. These findings underline the importance of using reference genes that are stable in expression across experimental conditions when studying the rat hypothalamus and intestine, because these tissues have an integral role in the regulation of energy homeostasis. It is our hope that this study will raise awareness among obesity researchers on the essential need for reference gene validation in gene expression studies.

Validation of SMAP Root Zone Soil Moisture Estimates with Improved Cosmic-Ray Neutron Probe Observations

NASA Astrophysics Data System (ADS)

Babaeian, E.; Tuller, M.; Sadeghi, M.; Franz, T.; Jones, S. B.

2017-12-01

Soil Moisture Active Passive (SMAP) soil moisture products are commonly validated based on point-scale reference measurements, despite the exorbitant spatial scale disparity. The difference between the measurement depth of point-scale sensors and the penetration depth of SMAP further complicates evaluation efforts. Cosmic-ray neutron probes (CRNP) with an approximately 500-m radius footprint provide an appealing alternative for SMAP validation. This study is focused on the validation of SMAP level-4 root zone soil moisture products with 9-km spatial resolution based on CRNP observations at twenty U.S. reference sites with climatic conditions ranging from semiarid to humid. The CRNP measurements are often biased by additional hydrogen sources such as surface water, atmospheric vapor, or mineral lattice water, which sometimes yield unrealistic moisture values in excess of the soil water storage capacity. These effects were removed during CRNP data analysis. Comparison of SMAP data with corrected CRNP observations revealed a very high correlation for most of the investigated sites, which opens new avenues for validation of current and future satellite soil moisture products.

Evidence for validity of five secondary data sources for enumerating retail food outlets in seven American Indian communities in North Carolina.

PubMed

Fleischhacker, Sheila E; Rodriguez, Daniel A; Evenson, Kelly R; Henley, Amanda; Gizlice, Ziya; Soto, Dolly; Ramachandran, Gowri

2012-11-22

Most studies on the local food environment have used secondary sources to describe the food environment, such as government food registries or commercial listings (e.g., Reference USA). Most of the studies exploring evidence for validity of secondary retail food data have used on-site verification and have not conducted analysis by data source (e.g., sensitivity of Reference USA) or by food outlet type (e.g., sensitivity of Reference USA for convenience stores). Few studies have explored the food environment in American Indian communities. To advance the science on measuring the food environment, we conducted direct, on-site observations of a wide range of food outlets in multiple American Indian communities, without a list guiding the field observations, and then compared our findings to several types of secondary data. Food outlets located within seven State Designated Tribal Statistical Areas in North Carolina (NC) were gathered from online Yellow Pages, Reference USA, Dun & Bradstreet, local health departments, and the NC Department of Agriculture and Consumer Services. All TIGER/Line 2009 roads (>1,500 miles) were driven in six of the more rural tribal areas and, for the largest tribe, all roads in two of its cities were driven. Sensitivity, positive predictive value, concordance, and kappa statistics were calculated to compare secondary data sources to primary data. 699 food outlets were identified during primary data collection. Match rate for primary data and secondary data differed by type of food outlet observed, with the highest match rates found for grocery stores (97%), general merchandise stores (96%), and restaurants (91%). Reference USA exhibited almost perfect sensitivity (0.89). Local health department data had substantial sensitivity (0.66) and was almost perfect when focusing only on restaurants (0.91). Positive predictive value was substantial for Reference USA (0.67) and moderate for local health department data (0.49). Evidence for validity was comparatively lower for Dun & Bradstreet, online Yellow Pages, and the NC Department of Agriculture. Secondary data sources both over- and under-represented the food environment; they were particularly problematic for identifying convenience stores and specialty markets. More attention is needed to improve the validity of existing data sources, especially for rural local food environments.

Evidence for validity of five secondary data sources for enumerating retail food outlets in seven American Indian Communities in North Carolina

PubMed Central

2012-01-01

Background Most studies on the local food environment have used secondary sources to describe the food environment, such as government food registries or commercial listings (e.g., Reference USA). Most of the studies exploring evidence for validity of secondary retail food data have used on-site verification and have not conducted analysis by data source (e.g., sensitivity of Reference USA) or by food outlet type (e.g., sensitivity of Reference USA for convenience stores). Few studies have explored the food environment in American Indian communities. To advance the science on measuring the food environment, we conducted direct, on-site observations of a wide range of food outlets in multiple American Indian communities, without a list guiding the field observations, and then compared our findings to several types of secondary data. Methods Food outlets located within seven State Designated Tribal Statistical Areas in North Carolina (NC) were gathered from online Yellow Pages, Reference USA, Dun & Bradstreet, local health departments, and the NC Department of Agriculture and Consumer Services. All TIGER/Line 2009 roads (>1,500 miles) were driven in six of the more rural tribal areas and, for the largest tribe, all roads in two of its cities were driven. Sensitivity, positive predictive value, concordance, and kappa statistics were calculated to compare secondary data sources to primary data. Results 699 food outlets were identified during primary data collection. Match rate for primary data and secondary data differed by type of food outlet observed, with the highest match rates found for grocery stores (97%), general merchandise stores (96%), and restaurants (91%). Reference USA exhibited almost perfect sensitivity (0.89). Local health department data had substantial sensitivity (0.66) and was almost perfect when focusing only on restaurants (0.91). Positive predictive value was substantial for Reference USA (0.67) and moderate for local health department data (0.49). Evidence for validity was comparatively lower for Dun & Bradstreet, online Yellow Pages, and the NC Department of Agriculture. Conclusions Secondary data sources both over- and under-represented the food environment; they were particularly problematic for identifying convenience stores and specialty markets. More attention is needed to improve the validity of existing data sources, especially for rural local food environments. PMID:23173781

Construct Validity of the WISC-IV with a Referred Sample: Direct versus Indirect Hierarchical Structures

ERIC Educational Resources Information Center

Canivez, Gary L.

2014-01-01

The Wechsler Intelligence Scale for Children--Fourth Edition (WISC-IV) is one of the most frequently used intelligence tests in clinical assessments of children with learning difficulties. Construct validity studies of the WISC-IV have generally supported the higher order structure with four correlated first-order factors and one higher-order…

Prevalence Estimation and Validation of New Instruments in Psychiatric Research: An Application of Latent Class Analysis and Sensitivity Analysis

ERIC Educational Resources Information Center

Pence, Brian Wells; Miller, William C.; Gaynes, Bradley N.

2009-01-01

Prevalence and validation studies rely on imperfect reference standard (RS) diagnostic instruments that can bias prevalence and test characteristic estimates. The authors illustrate 2 methods to account for RS misclassification. Latent class analysis (LCA) combines information from multiple imperfect measures of an unmeasurable latent condition to…

Validity Study of a Jump Mat Compared to the Reference Standard Force Plate.

PubMed

Rogan, Slavko; Radlinger, Lorenz; Imhasly, Caroline; Kneubuehler, Andrea; Hilfiker, Roger

2015-12-01

In the field of vertical jump diagnostics, force plates (FP) are the reference standard. Recently, despite a lack of evidence, jump mats have been used increasingly. Important factors in favor of jumping mats are their low cost and portability. This validity study compared the Haynl-Elektronik jump mat (HE jump mat) with the reference standard force plate. Ten healthy volunteers participated and each participant completed three series of five drop jumps (DJ). The parameters ground contact time (GCT) and vertical jump height (VJH) from the HE jump mat and the FP were used to evaluate the concurrent validity. The following statistical calculations were performed: Pearson's correlation (r), Bland-Altman plots (standard and for adjusted trend), and regression equations. The Bland-Altman plots suggest that the HE jump mat measures shorter contact times and higher jump heights than the FP. The trend-adjusted Bland-Altman plot shows higher mean differences and wider wing-spreads of confidence limits during longer GCT. During the VJH the mean differences and the wing-spreads of the confidence limits throughout the range present as relatively constant. The following regression equations were created, as close as possible to the true value: GCT = 5.920385 + 1.072293 × [value HE jump mat] and VJH = -1.73777 + 1.011156 × [value HE jump mat]. The HE jump mat can be recommended in relation to the validity of constraints. In this study, only a part of the quality criteria were examined. For the final recommendation it is advised to examine the HE jump mat on the other quality criteria (test-retest reliability, sensitivity change).

Validation assessment of shoreline extraction on medium resolution satellite image

NASA Astrophysics Data System (ADS)

Manaf, Syaifulnizam Abd; Mustapha, Norwati; Sulaiman, Md Nasir; Husin, Nor Azura; Shafri, Helmi Zulhaidi Mohd

2017-10-01

Monitoring coastal zones helps provide information about the conditions of the coastal zones, such as erosion or accretion. Moreover, monitoring the shorelines can help measure the severity of such conditions. Such measurement can be performed accurately by using Earth observation satellite images rather than by using traditional ground survey. To date, shorelines can be extracted from satellite images with a high degree of accuracy by using satellite image classification techniques based on machine learning to identify the land and water classes of the shorelines. In this study, the researchers validated the results of extracted shorelines of 11 classifiers using a reference shoreline provided by the local authority. Specifically, the validation assessment was performed to examine the difference between the extracted shorelines and the reference shorelines. The research findings showed that the SVM Linear was the most effective image classification technique, as evidenced from the lowest mean distance between the extracted shoreline and the reference shoreline. Furthermore, the findings showed that the accuracy of the extracted shoreline was not directly proportional to the accuracy of the image classification.

A validation method for near-infrared spectroscopy based tissue oximeters for cerebral and somatic tissue oxygen saturation measurements.

PubMed

Benni, Paul B; MacLeod, David; Ikeda, Keita; Lin, Hung-Mo

2018-04-01

We describe the validation methodology for the NIRS based FORE-SIGHT ELITE ® (CAS Medical Systems, Inc., Branford, CT, USA) tissue oximeter for cerebral and somatic tissue oxygen saturation (StO 2 ) measurements for adult subjects submitted to the United States Food and Drug Administration (FDA) to obtain clearance for clinical use. This validation methodology evolved from a history of NIRS validations in the literature and FDA recommended use of Deming regression and bootstrapping statistical validation methods. For cerebral validation, forehead cerebral StO 2 measurements were compared to a weighted 70:30 reference (REF CX B ) of co-oximeter internal jugular venous and arterial blood saturation of healthy adult subjects during a controlled hypoxia sequence, with a sensor placed on the forehead. For somatic validation, somatic StO 2 measurements were compared to a weighted 70:30 reference (REF CX S ) of co-oximetry central venous and arterial saturation values following a similar protocol, with sensors place on the flank, quadriceps muscle, and calf muscle. With informed consent, 25 subjects successfully completed the cerebral validation study. The bias and precision (1 SD) of cerebral StO 2 compared to REF CX B was -0.14 ± 3.07%. With informed consent, 24 subjects successfully completed the somatic validation study. The bias and precision of somatic StO 2 compared to REF CX S was 0.04 ± 4.22% from the average of flank, quadriceps, and calf StO 2 measurements to best represent the global whole body REF CX S . The NIRS validation methods presented potentially provide a reliable means to test NIRS monitors and qualify them for clinical use.

Validation of reference genes for quantitative RT-PCR studies of gene expression in perennial ryegrass (Lolium perenne L.)

PubMed Central

2010-01-01

Background Perennial ryegrass (Lolium perenne L.) is an important pasture and turf crop. Biotechniques such as gene expression studies are being employed to improve traits in this temperate grass. Quantitative reverse transcription-polymerase chain reaction (qRT-PCR) is among the best methods available for determining changes in gene expression. Before analysis of target gene expression, it is essential to select an appropriate normalisation strategy to control for non-specific variation between samples. Reference genes that have stable expression at different biological and physiological states can be effectively used for normalisation; however, their expression stability must be validated before use. Results Existing Serial Analysis of Gene Expression data were queried to identify six moderately expressed genes that had relatively stable gene expression throughout the year. These six candidate reference genes (eukaryotic elongation factor 1 alpha, eEF1A; TAT-binding protein homolog 1, TBP-1; eukaryotic translation initiation factor 4 alpha, eIF4A; YT521-B-like protein family protein, YT521-B; histone 3, H3; ubiquitin-conjugating enzyme, E2) were validated for qRT-PCR normalisation in 442 diverse perennial ryegrass (Lolium perenne L.) samples sourced from field- and laboratory-grown plants under a wide range of experimental conditions. Eukaryotic EF1A is encoded by members of a multigene family exhibiting differential expression and necessitated the expression analysis of different eEF1A encoding genes; a highly expressed eEF1A (h), a moderately, but stably expressed eEF1A (s), and combined expression of multigene eEF1A (m). NormFinder identified eEF1A (s) and YT521-B as the best combination of two genes for normalisation of gene expression data in perennial ryegrass following different defoliation management in the field. Conclusions This study is unique in the magnitude of samples tested with the inclusion of numerous field-grown samples, helping pave the way to conduct gene expression studies in perennial biomass crops under field-conditions. From our study several stably expressed reference genes have been validated. This provides useful candidates for reference gene selection in perennial ryegrass under conditions other than those tested here. PMID:20089196

Poor symptom and performance validity in regularly referred Hospital outpatients: Link with standard clinical measures, and role of incentives.

PubMed

Dandachi-FitzGerald, Brechje; van Twillert, Björn; van de Sande, Peter; van Os, Yindee; Ponds, Rudolf W H M

2016-05-30

We investigated the frequency of symptom validity test (SVT) failure and its clinical correlates in a large, heterogeneous sample of hospital outpatients referred for psychological assessment for clinical purposes. We studied patients (N=469), who were regularly referred for assessment to the psychology departments of five hospitals. Background characteristics, including information about incentives, were obtained with a checklist completed by the clinician. As a measure of over-reporting, the Structured Inventory of Malingered Symptomatology (SIMS) was administered to all patients. The Amsterdam Short-Term Memory test (ASTM), a cognitive underperformance measure, was only administered to patients who were referred for a neuropsychological assessment. Symptom over-reporting occurred in a minority of patients, ranging from 12% to 19% in the main diagnostic patient groups. Patients with morbid obesity had a low rate of over-reporting (1%). The SIMS was positively associated with levels of self-reported psychological symptoms. Cognitive underperformance occurred in 29.3% of the neuropsychological assessments. The ASTM was negatively associated with memory test performance. We found no association between SVT failure and financial incentives. Our results support the recommendation to routinely evaluate symptom validity in clinical assessments of hospital patients. The dynamics behind invalid symptom reporting need to be further elucidated. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Validity of administrative data claim-based methods for identifying individuals with diabetes at a population level.

PubMed

Southern, Danielle A; Roberts, Barbara; Edwards, Alun; Dean, Stafford; Norton, Peter; Svenson, Lawrence W; Larsen, Erik; Sargious, Peter; Lau, David C W; Ghali, William A

2010-01-01

This study assessed the validity of a widely-accepted administrative data surveillance methodology for identifying individuals with diabetes relative to three laboratory data reference standard definitions for diabetes. We used a combination of linked regional data (hospital discharge abstracts and physician data) and laboratory data to test the validity of administrative data surveillance definitions for diabetes relative to a laboratory data reference standard. The administrative discharge data methodology includes two definitions for diabetes: a strict administrative data definition of one hospitalization code or two physician claims indicating diabetes; and a more liberal definition of one hospitalization code or a single physician claim. The laboratory data, meanwhile, produced three reference standard definitions based on glucose levels +/- HbA1c levels. Sensitivities ranged from 68.4% to 86.9% for the administrative data definitions tested relative to the three laboratory data reference standards. Sensitivities were higher for the more liberal administrative data definition. Positive predictive values (PPV), meanwhile, ranged from 53.0% to 88.3%, with the liberal administrative data definition producing lower PPVs. These findings demonstrate the trade-offs of sensitivity and PPV for selecting diabetes surveillance definitions. Centralized laboratory data may be of value to future surveillance initiatives that use combined data sources to optimize case detection.

Development and validation of a method for mercury determination in seawater for the process control of a candidate certified reference material.

PubMed

Sánchez, Raquel; Snell, James; Held, Andrea; Emons, Hendrik

2015-08-01

A simple, robust and reliable method for mercury determination in seawater matrices based on the combination of cold vapour generation and inductively coupled plasma mass spectrometry (CV-ICP-MS) and its complete in-house validation are described. The method validation covers parameters such as linearity, limit of detection (LOD), limit of quantification (LOQ), trueness, repeatability, intermediate precision and robustness. A calibration curve covering the whole working range was achieved with coefficients of determination typically higher than 0.9992. The repeatability of the method (RSDrep) was 0.5 %, and the intermediate precision was 2.3 % at the target mass fraction of 20 ng/kg. Moreover, the method was robust with respect to the salinity of the seawater. The limit of quantification was 2.7 ng/kg, which corresponds to 13.5 % of the target mass fraction in the future certified reference material (20 ng/kg). An uncertainty budget for the measurement of mercury in seawater has been established. The relative expanded (k = 2) combined uncertainty is 6 %. The performance of the validated method was demonstrated by generating results for process control and a homogeneity study for the production of a candidate certified reference material.

Validity and reliability of self-reported diabetes in the Atherosclerosis Risk in Communities Study.

PubMed

Schneider, Andrea L C; Pankow, James S; Heiss, Gerardo; Selvin, Elizabeth

2012-10-15

The objective of this study was to assess the validity of prevalent and incident self-reported diabetes compared with multiple reference definitions and to assess the reliability (repeatability) of a self-reported diagnosis of diabetes. Data from 10,321 participants in the Atherosclerosis Risk in Communities (ARIC) Study who attended visit 4 (1996-1998) were analyzed. Prevalent self-reported diabetes was compared with reference definitions defined by fasting glucose and medication use obtained at visit 4. Incident self-reported diabetes was assessed during annual follow-up telephone calls and was compared with reference definitions defined by fasting glucose, hemoglobin A1c, and medication use obtained during an in-person visit attended by a subsample of participants (n = 1,738) in 2004-2005. The sensitivity of prevalent self-reported diabetes ranged from 58.5% to 70.8%, and specificity ranged from 95.6% to 96.8%, depending on the reference definition. Similarly, the sensitivity of incident self-reported diabetes ranged from 55.9% to 80.4%, and specificity ranged from 84.5% to 90.6%. Percent positive agreement of self-reported diabetes during 9 years of repeat assessments ranged from 92.7% to 95.4%. Both prevalent self-reported diabetes and incident self-reported diabetes were 84%-97% specific and 55%-80% sensitive as compared with reference definitions using glucose and medication criteria. Self-reported diabetes was >92% reliable over time.

Pediatric reference intervals for general clinical chemistry components - merging of studies from Denmark and Sweden.

PubMed

Ridefelt, Peter; Hilsted, Linda; Juul, Anders; Hellberg, Dan; Rustad, Pål

2018-05-28

Reference intervals are crucial tools aiding clinicians when making medical decisions. However, for children such values often are lacking or incomplete. The present study combines data from separate pediatric reference interval studies of Denmark and Sweden in order to increase sample size and to include also pre-school children who were lacking in the Danish study. Results from two separate studies including 1988 healthy children and adolescents aged 6 months to 18 years of age were merged and recalculated. Eighteen general clinical chemistry components were measured on Abbott and Roche platforms. To facilitate commutability, the NFKK Reference Serum X was used. Age- and gender-specific pediatric reference intervals were defined by calculating 2.5 and 97.5 percentiles. The data generated are primarily applicable to a Nordic population, but could be used by any laboratory if validated for the local patient population.

Validation of reference genes for normalization of qPCR gene expression data from Coffea spp. hypocotyls inoculated with Colletotrichum kahawae

PubMed Central

2013-01-01

Background Coffee production in Africa represents a significant share of the total export revenues and influences the lives of millions of people, yet severe socio-economic repercussions are annually felt in result of the overall losses caused by the coffee berry disease (CBD). This quarantine disease is caused by the fungus Colletotrichum kahawae Waller and Bridge, which remains one of the most devastating threats to Coffea arabica production in Africa at high altitude, and its dispersal to Latin America and Asia represents a serious concern. Understanding the molecular genetic basis of coffee resistance to this disease is of high priority to support breeding strategies. Selection and validation of suitable reference genes presenting stable expression in the system studied is the first step to engage studies of gene expression profiling. Results In this study, a set of ten genes (S24, 14-3-3, RPL7, GAPDH, UBQ9, VATP16, SAND, UQCC, IDE and β-Tub9) was evaluated to identify reference genes during the first hours of interaction (12, 48 and 72 hpi) between resistant and susceptible coffee genotypes and C. kahawae. Three analyses were done for the selection of these genes considering the entire dataset and the two genotypes (resistant and susceptible), separately. The three statistical methods applied GeNorm, NormFinder, and BestKeeper, allowed identifying IDE as one of the most stable genes for all datasets analysed, and in contrast GADPH and UBQ9 as the least stable ones. In addition, the expression of two defense-related transcripts, encoding for a receptor like kinase and a pathogenesis related protein 10, were used to validate the reference genes selected. Conclusion Taken together, our results provide guidelines for reference gene(s) selection towards a more accurate and widespread use of qPCR to study the interaction between Coffea spp. and C. kahawae. PMID:24073624

Epigenetic discrimination of identical twins from blood under the forensic scenario.

PubMed

Vidaki, Athina; Díez López, Celia; Carnero-Montoro, Elena; Ralf, Arwin; Ward, Kirsten; Spector, Timothy; Bell, Jordana T; Kayser, Manfred

2017-11-01

Monozygotic (MZ) twins share the same STR profile, demonstrating a practical problem in forensic casework. DNA methylation has provided a suitable resource for MZ twin differentiation; however, studies addressing the forensic feasibility are lacking. Here, we investigated epigenetic MZ twin differentiation from blood under the forensic scenario comprising i) the discovery of candidate markers in reference-type blood DNA via genome-wide analysis, ii) the technical validation of candidate markers in reference-type blood DNA using a suitable targeted method, and iii) the analysis of the validated markers in trace-type DNA. Genome-wide methylation analysis in blood DNA from 10 MZ twin pairs resulted in 19-111 twin-differentially methylated sites (tDMSs) per pair with >0.3 twin-to-twin differences. Considering all top three candidate tDMSs across all pairs in the technical validation based on methylation-specific qPCR, 67.85% generated >0.1 twin-to-twin differences. Of the validated tDMSs, 68.4% showed >0.1 twin-to-twin differences with qPCR in trace-type DNA across 8 pairs. Using an updated marker selection strategy, 8 additional candidate tDMSs were obtained for an example MZ pair, of which 7 showed >0.1 twin-to-twin differences in both reference- and trace-type DNA. Lastly, we introduce a high-resolution melting curve analysis of the entire fragment that can complement the proposed approach. Overall, our study demonstrates the general feasibility of epigenetic twin differentiation in the forensic context and highlights that the number of informative tDMSs in the final trace DNA analysis is crucial, as some candidate markers identified in reference DNA were shown not informative in the trace DNA due to various, including technical, reasons. Future studies will need to address the optimal number of epigenetic markers required for reliable identification of MZ twin individuals including statistical considerations. Copyright © 2017 Elsevier B.V. All rights reserved.

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

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

Owens, J; Vu, A; Koester, C

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

Validation of Living Donor Nephrectomy Codes

PubMed Central

Lam, Ngan N.; Lentine, Krista L.; Klarenbach, Scott; Sood, Manish M.; Kuwornu, Paul J.; Naylor, Kyla L.; Knoll, Gregory A.; Kim, S. Joseph; Young, Ann; Garg, Amit X.

2018-01-01

Background: Use of administrative data for outcomes assessment in living kidney donors is increasing given the rarity of complications and challenges with loss to follow-up. Objective: To assess the validity of living donor nephrectomy in health care administrative databases compared with the reference standard of manual chart review. Design: Retrospective cohort study. Setting: 5 major transplant centers in Ontario, Canada. Patients: Living kidney donors between 2003 and 2010. Measurements: Sensitivity and positive predictive value (PPV). Methods: Using administrative databases, we conducted a retrospective study to determine the validity of diagnostic and procedural codes for living donor nephrectomies. The reference standard was living donor nephrectomies identified through the province’s tissue and organ procurement agency, with verification by manual chart review. Operating characteristics (sensitivity and PPV) of various algorithms using diagnostic, procedural, and physician billing codes were calculated. Results: During the study period, there were a total of 1199 living donor nephrectomies. Overall, the best algorithm for identifying living kidney donors was the presence of 1 diagnostic code for kidney donor (ICD-10 Z52.4) and 1 procedural code for kidney procurement/excision (1PC58, 1PC89, 1PC91). Compared with the reference standard, this algorithm had a sensitivity of 97% and a PPV of 90%. The diagnostic and procedural codes performed better than the physician billing codes (sensitivity 60%, PPV 78%). Limitations: The donor chart review and validation study was performed in Ontario and may not be generalizable to other regions. Conclusions: An algorithm consisting of 1 diagnostic and 1 procedural code can be reliably used to conduct health services research that requires the accurate determination of living kidney donors at the population level. PMID:29662679

Screening tests for aphasia in patients with stroke: a systematic review.

PubMed

El Hachioui, Hanane; Visch-Brink, Evy G; de Lau, Lonneke M L; van de Sandt-Koenderman, Mieke W M E; Nouwens, Femke; Koudstaal, Peter J; Dippel, Diederik W J

2017-02-01

Aphasia has a large impact on the quality of life and adds significantly to the costs of stroke care. Early recognition of aphasia in stroke patients is important for prognostication and well-timed treatment planning. We aimed to identify available screening tests for differentiating between aphasic and non-aphasic stroke patients, and to evaluate test accuracy, reliability, and feasibility. We searched PubMed, EMbase, Web of Science, and PsycINFO for published studies on screening tests aimed at assessing aphasia in stroke patients. The reference lists of the selected articles were scanned, and several experts were contacted to detect additional references. Of each screening test, we estimated the sensitivity, specificity, likelihood ratio of a positive test, likelihood ratio of a negative test, and diagnostic odds ratio (DOR), and rated the degree of bias of the validation method. We included ten studies evaluating eight screening tests. There was a large variation across studies regarding sample size, patient characteristics, and reference tests used for validation. Many papers failed to report on the consecutiveness of patient inclusion, time between aphasia onset and administration of the screening test, and blinding. Of the three studies that were rated as having an intermediate or low risk of bias, the DOR was highest for the Language Screening Test and ScreeLing. Several screening tools for aphasia in stroke are available, but many tests have not been verified properly. Methodologically sound validation studies of aphasia screening tests are needed to determine their usefulness in clinical practice.

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

PubMed

Hall, Emily A; Docherty, Carrie L

2017-07-01

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

Concurrent validity and clinical usefulness of several individually administered tests of children's social-emotional cognition.

PubMed

McKown, Clark

2007-03-01

In this study, the validity of 5 tests of children's social-emotional cognition, defined as their encoding, memory, and interpretation of social information, was tested. Participants were 126 clinic-referred children between the ages of 5 and 17. All 5 tests were evaluated in terms of their (a) concurrent validity, (b) incremental validity, and (c) clinical usefulness in predicting social functioning. Tests included measures of nonverbal sensitivity, social language, and social problem solving. Criterion measures included parent and teacher report of social functioning. Analyses support the concurrent validity of all measures, and the incremental validity and clinical usefulness of tests of pragmatic language and problem solving.

[Design and validation of a questionnaire for psychosocial nursing diagnosis in Primary Care].

PubMed

Brito-Brito, Pedro Ruymán; Rodríguez-Álvarez, Cristobalina; Sierra-López, Antonio; Rodríguez-Gómez, José Ángel; Aguirre-Jaime, Armando

2012-01-01

To develop a valid, reliable and easy-to-use questionnaire for a psychosocial nursing diagnosis. The study was performed in two phases: first phase, questionnaire design and construction; second phase, validity and reliability tests. A bank of items was constructed using the NANDA classification as a theoretical framework. Each item was assigned a Likert scale or dichotomous response. The combination of responses to the items constituted the diagnostic rules to assign up to 28 labels. A group of experts carried out the validity test for content. Other validated scales were used as reference standards for the criterion validity tests. Forty-five nurses provided the questionnaire to the patients on three separate occasions over a period of three weeks, and the other validated scales only once to 188 randomly selected patients in Primary Care centres in Tenerife (Spain). Validity tests for construct confirmed the six dimensions of the questionnaire with 91% of total variance explained. Validity tests for criterion showed a specificity of 66%-100%, and showed high correlations with the reference scales when the questionnaire was assigning nursing diagnoses. Reliability tests showed agreement of 56%-91% (P<.001), and a 93% internal consistency. The Questionnaire for Psychosocial Nursing Diagnosis was called CdePS, and included 61 items. The CdePS is a valid, reliable and easy-to-use tool in Primary Care centres to improve the assigning of a psychosocial nursing diagnosis. Copyright © 2011 Elsevier España, S.L. All rights reserved.

Identification of reference genes for RT-qPCR analysis in peach genotypes with contrasting chilling requirements.

PubMed

Marini, N; Bevilacqua, C B; Büttow, M V; Raseira, M C B; Bonow, S

2017-05-25

Selecting and validating reference genes are the first steps in studying gene expression by reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR). The present study aimed to evaluate the stability of five reference genes for the purpose of normalization when studying gene expression in various cultivars of Prunus persica with different chilling requirements. Flower bud tissues of nine peach genotypes from Embrapa's peach breeding program with different chilling requirements were used, and five candidate reference genes based on the RT-qPCR that were useful for studying the relative quantitative gene expression and stability were evaluated using geNorm, NormFinder, and bestKeeper software packages. The results indicated that among the genes tested, the most stable genes to be used as reference genes are Act and UBQ10. This study is the first survey of the stability of reference genes in peaches under chilling stress and provides guidelines for more accurate RT-qPCR results.

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.

Lung Reference Set A Application: LaszloTakacs - Biosystems (2010) — EDRN Public Portal

Cancer.gov

We would like to access the NCI lung cancer Combined Pre-Validation Reference Set A in order to further validate a lung cancer diagnostic test candidate. Our test is based on a panel of antibodies which have been tested on 4 different cohorts (see below, paragraph “Preliminary Data and Methods”). This Reference Set A, whose clinical setting is “Diagnosis of lung cancer”, will be used to validate the panel of monoclonal antibodies which have been demonstrated by extensive data analysis to provide the best discrimination between controls and Lung Cancer patient plasma samples, sensitivity and specificity values from ROC analyses are superior than 85 %.

Validation studies and proficiency testing.

PubMed

Ankilam, Elke; Heinze, Petra; Kay, Simon; Van den Eede, Guy; Popping, Bert

2002-01-01

Genetically modified organisms (GMOs) entered the European food market in 1996. Current legislation demands the labeling of food products if they contain <1% GMO, as assessed for each ingredient of the product. To create confidence in the testing methods and to complement enforcement requirements, there is an urgent need for internationally validated methods, which could serve as reference methods. To date, several methods have been submitted to validation trials at an international level; approaches now exist that can be used in different circumstances and for different food matrixes. Moreover, the requirement for the formal validation of methods is clearly accepted; several national and international bodies are active in organizing studies. Further validation studies, especially on the quantitative polymerase chain reaction methods, need to be performed to cover the rising demand for new extraction methods and other background matrixes, as well as for novel GMO constructs.

Validating internal controls for quantitative plant gene expression studies

PubMed Central

Brunner, Amy M; Yakovlev, Igor A; Strauss, Steven H

2004-01-01

Background Real-time reverse transcription PCR (RT-PCR) has greatly improved the ease and sensitivity of quantitative gene expression studies. However, accurate measurement of gene expression with this method relies on the choice of a valid reference for data normalization. Studies rarely verify that gene expression levels for reference genes are adequately consistent among the samples used, nor compare alternative genes to assess which are most reliable for the experimental conditions analyzed. Results Using real-time RT-PCR to study the expression of 10 poplar (genus Populus) housekeeping genes, we demonstrate a simple method for determining the degree of stability of gene expression over a set of experimental conditions. Based on a traditional method for analyzing the stability of varieties in plant breeding, it defines measures of gene expression stability from analysis of variance (ANOVA) and linear regression. We found that the potential internal control genes differed widely in their expression stability over the different tissues, developmental stages and environmental conditions studied. Conclusion Our results support that quantitative comparisons of candidate reference genes are an important part of real-time RT-PCR studies that seek to precisely evaluate variation in gene expression. The method we demonstrated facilitates statistical and graphical evaluation of gene expression stability. Selection of the best reference gene for a given set of experimental conditions should enable detection of biologically significant changes in gene expression that are too small to be revealed by less precise methods, or when highly variable reference genes are unknowingly used in real-time RT-PCR experiments. PMID:15317655

The Role of Anchor Stations in the Validation of Earth Observation Satellite Data and Products. The Valencia and the Alacant Anchor Stations

NASA Astrophysics Data System (ADS)

Lopez-Baeza, Ernesto; Geraldo Ferreira, A.; Saleh-Contell, Kauzar

Space technology facilitates humanity and science with a global revolutionary view of the Earth through the acquisition of Earth Observation satellite data. Satellites capture information over different spatial and temporal scales and assist in understanding natural climate processes and in detecting and explaining climate change. Accurate Earth Observation data is needed to describe climate processes by improving the parameterisations of different climate elements. Algorithms to produce geophysical parameters from raw satellite observations should go through selection processes or participate in inter-comparison programmes to ensure performance reliability. Geophysical parameter datasets, obtained from satellite observations, should pass a quality control before they are accepted in global databases for impact, diagnostic or sensitivity studies. Calibration and Validation, or simply "Cal/Val", is the activity that endeavours to ensure that remote sensing products are highly consistent and reproducible. This is an evolving scientific activity that is becoming increasingly important as more long-term studies on global change are undertaken, and new satellite missions are launched. Calibration is the process of quantitatively defining the system responses to known, controlled signal inputs. Validation refers to the process of assessing, by independent means, the quality of the data products derived from the system outputs. These definitions are generally accepted and most often used in the remote sensing context to refer specifically and respectively to sensor radiometric calibration and geophysical parameter validation. Anchor Stations are carefully selected locations at which instruments measure quantities that are needed to run, calibrate or validate models and algorithms. These are needed to quanti-tatively evaluate satellite data and convert it into geophysical information. The instruments collect measurements of basic quantities over a long timescale. Measurements are made of meteorological and hydrological background data, and of quantities not readily assessed at operational stations. Anchor Stations also offer infrastructure to undertake validation experi-ments. These are more detailed measurements over shorter intensive observation periods. The Valencia Anchor Station is showing its capabilities and conditions as a reference validation site in the framework of low spatial resolution remote sensing missions such as CERES, GERB and SMOS. The Alacant Anchor Station is a reference site in studies on the interactions between desertification and climate. This paper presents the activities so far carried out at both Anchor Stations, the precise and detailed ground and aircraft experiments carefully designed to develop a specific methodology to validate low spatial resolution satellite data and products, and the knowledge exchange currently being exercised between the University of Valencia, Spain, and FUNCEME, Brazil, in common objectives of mutual interest.

In-house validation study of the DuPont Qualicon BAX system Q7 instrument with the BAX system PCR Assay for Salmonella (modification of AOAC Official Method 2003.09 and AOAC Research Institute Performance-Tested Method 100201).

PubMed

Tice, George; Andaloro, Bridget; White, H Kirk; Bolton, Lance; Wang, Siqun; Davis, Eugene; Wallace, Morgan

2009-01-01

In 2006, DuPont Qualicon introduced the BAX system Q7 instrument for use with its assays. To demonstrate the equivalence of the new and old instruments, a validation study was conducted using the BAX system PCR Assay for Salmonella, AOAC Official Method 2003.09, on three food types. The foods were simultaneously analyzed with the BAX system Q7 instrument and either the U.S. Food and Drug Administration Bacteriological Analytical Manual or the U.S. Department of Agriculture-Food Safety and Inspection Service Microbiology Laboratory Guidebook reference method for detecting Salmonella. Comparable performance between the BAX system and the reference methods was observed. Of the 75 paired samples analyzed, 39 samples were positive by both the BAX system and reference methods, and 36 samples were negative by both the BAX system and reference methods, demonstrating 100% correlation. Inclusivity and exclusivity for the BAX system Q7 instrument were also established by testing 50 Salmonella strains and 20 non-Salmonella isolates. All Salmonella strains returned positive results, and all non-Salmonella isolates returned a negative response.

A mixture approach to the acoustic properties of a macroscopically inhomogeneous porous aluminum in the equivalent fluid approximation.

PubMed

Sacristan, C J; Dupont, T; Sicot, O; Leclaire, P; Verdière, K; Panneton, R; Gong, X L

2016-10-01

The acoustic properties of an air-saturated macroscopically inhomogeneous aluminum foam in the equivalent fluid approximation are studied. A reference sample built by forcing a highly compressible melamine foam with conical shape inside a constant diameter rigid tube is studied first. In this process, a radial compression varying with depth is applied. With the help of an assumption on the compressed pore geometry, properties of the reference sample can be modelled everywhere in the thickness and it is possible to use the classical transfer matrix method as theoretical reference. In the mixture approach, the material is viewed as a mixture of two known materials placed in a patchwork configuration and with proportions of each varying with depth. The properties are derived from the use of a mixing law. For the reference sample, the classical transfer matrix method is used to validate the experimental results. These results are used to validate the mixture approach. The mixture approach is then used to characterize a porous aluminium for which only the properties of the external faces are known. A porosity profile is needed and is obtained from the simulated annealing optimization process.

Differential DNA Methylation Analysis without a Reference Genome.

PubMed

Klughammer, Johanna; Datlinger, Paul; Printz, Dieter; Sheffield, Nathan C; Farlik, Matthias; Hadler, Johanna; Fritsch, Gerhard; Bock, Christoph

2015-12-22

Genome-wide DNA methylation mapping uncovers epigenetic changes associated with animal development, environmental adaptation, and species evolution. To address the lack of high-throughput methods for DNA methylation analysis in non-model organisms, we developed an integrated approach for studying DNA methylation differences independent of a reference genome. Experimentally, our method relies on an optimized 96-well protocol for reduced representation bisulfite sequencing (RRBS), which we have validated in nine species (human, mouse, rat, cow, dog, chicken, carp, sea bass, and zebrafish). Bioinformatically, we developed the RefFreeDMA software to deduce ad hoc genomes directly from RRBS reads and to pinpoint differentially methylated regions between samples or groups of individuals (http://RefFreeDMA.computational-epigenetics.org). The identified regions are interpreted using motif enrichment analysis and/or cross-mapping to annotated genomes. We validated our method by reference-free analysis of cell-type-specific DNA methylation in the blood of human, cow, and carp. In summary, we present a cost-effective method for epigenome analysis in ecology and evolution, which enables epigenome-wide association studies in natural populations and species without a reference genome. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Validating a Theory-Based Survey to Evaluate Teaching Effectiveness in Higher Education

ERIC Educational Resources Information Center

Amrein-Beardsley, A.; Haladyna, T.

2012-01-01

Surveys to evaluate instructor effectiveness are commonly used in higher education. Yet the survey items included are often drawn from other surveys without reference to a theory of adult learning. The authors present the results from a validation study of such a theory-based survey. They evidence that an evaluation survey based on a theory that…

Accreditation or Validation of Prior Experiential Learning: Knowledge and "Savoirs" in France-A Different Perspective?

ERIC Educational Resources Information Center

Pouget, Mireille; Osborne, Michael

2004-01-01

This article stems from the study of the process and application of Accreditation of Prior Experiential Learning (APEL) in the French higher education system, in France referred to as VAP (Validation des Acquis Professionnels ). The paper seeks to review not only the context in which the concepts underpinning VAP in France have developed, but also…

Effect of genotyped cows in the reference population on the genomic evaluation of Holstein cattle.

PubMed

Uemoto, Y; Osawa, T; Saburi, J

2017-03-01

This study evaluated the dependence of reliability and prediction bias on the prediction method, the contribution of including animals (bulls or cows), and the genetic relatedness, when including genotyped cows in the progeny-tested bull reference population. We performed genomic evaluation using a Japanese Holstein population, and assessed the accuracy of genomic enhanced breeding value (GEBV) for three production traits and 13 linear conformation traits. A total of 4564 animals for production traits and 4172 animals for conformation traits were genotyped using Illumina BovineSNP50 array. Single- and multi-step methods were compared for predicting GEBV in genotyped bull-only and genotyped bull-cow reference populations. No large differences in realized reliability and regression coefficient were found between the two reference populations; however, a slight difference was found between the two methods for production traits. The accuracy of GEBV determined by single-step method increased slightly when genotyped cows were included in the bull reference population, but decreased slightly by multi-step method. A validation study was used to evaluate the accuracy of GEBV when 800 additional genotyped bulls (POPbull) or cows (POPcow) were included in the base reference population composed of 2000 genotyped bulls. The realized reliabilities of POPbull were higher than those of POPcow for all traits. For the gain of realized reliability over the base reference population, the average ratios of POPbull gain to POPcow gain for production traits and conformation traits were 2.6 and 7.2, respectively, and the ratios depended on heritabilities of the traits. For regression coefficient, no large differences were found between the results for POPbull and POPcow. Another validation study was performed to investigate the effect of genetic relatedness between cows and bulls in the reference and test populations. The effect of genetic relationship among bulls in the reference population was also assessed. The results showed that it is important to account for relatedness among bulls in the reference population. Our studies indicate that the prediction method, the contribution ratio of including animals, and genetic relatedness could affect the prediction accuracy in genomic evaluation of Holstein cattle, when including genotyped cows in the reference population.

Identification of Reference Genes for RT-qPCR Data Normalization in Cannabis sativa Stem Tissues.

PubMed

Mangeot-Peter, Lauralie; Legay, Sylvain; Hausman, Jean-Francois; Esposito, Sergio; Guerriero, Gea

2016-09-15

Gene expression profiling via quantitative real-time PCR is a robust technique widely used in the life sciences to compare gene expression patterns in, e.g., different tissues, growth conditions, or after specific treatments. In the field of plant science, real-time PCR is the gold standard to study the dynamics of gene expression and is used to validate the results generated with high throughput techniques, e.g., RNA-Seq. An accurate relative quantification of gene expression relies on the identification of appropriate reference genes, that need to be determined for each experimental set-up used and plant tissue studied. Here, we identify suitable reference genes for expression profiling in stems of textile hemp (Cannabis sativa L.), whose tissues (isolated bast fibres and core) are characterized by remarkable differences in cell wall composition. We additionally validate the reference genes by analysing the expression of putative candidates involved in the non-oxidative phase of the pentose phosphate pathway and in the first step of the shikimate pathway. The goal is to describe the possible regulation pattern of some genes involved in the provision of the precursors needed for lignin biosynthesis in the different hemp stem tissues. The results here shown are useful to design future studies focused on gene expression analyses in hemp.

Validation approach for a fast and simple targeted screening method for 75 antibiotics in meat and aquaculture products using LC-MS/MS.

PubMed

Dubreil, Estelle; Gautier, Sophie; Fourmond, Marie-Pierre; Bessiral, Mélaine; Gaugain, Murielle; Verdon, Eric; Pessel, Dominique

2017-04-01

An approach is described to validate a fast and simple targeted screening method for antibiotic analysis in meat and aquaculture products by LC-MS/MS. The strategy of validation was applied for a panel of 75 antibiotics belonging to different families, i.e., penicillins, cephalosporins, sulfonamides, macrolides, quinolones and phenicols. The samples were extracted once with acetonitrile, concentrated by evaporation and injected into the LC-MS/MS system. The approach chosen for the validation was based on the Community Reference Laboratory (CRL) guidelines for the validation of screening qualitative methods. The aim of the validation was to prove sufficient sensitivity of the method to detect all the targeted antibiotics at the level of interest, generally the maximum residue limit (MRL). A robustness study was also performed to test the influence of different factors. The validation showed that the method is valid to detect and identify 73 antibiotics of the 75 antibiotics studied in meat and aquaculture products at the validation levels.

Validity of the Catapult ClearSky T6 Local Positioning System for Team Sports Specific Drills, in Indoor Conditions

PubMed Central

Luteberget, Live S.; Spencer, Matt; Gilgien, Matthias

2018-01-01

Aim: The aim of the present study was to determine the validity of position, distance traveled and instantaneous speed of team sport players as measured by a commercially available local positioning system (LPS) during indoor use. In addition, the study investigated how the placement of the field of play relative to the anchor nodes and walls of the building affected the validity of the system. Method: The LPS (Catapult ClearSky T6, Catapult Sports, Australia) and the reference system [Qualisys Oqus, Qualisys AB, Sweden, (infra-red camera system)] were installed around the field of play to capture the athletes' motion. Athletes completed five tasks, all designed to imitate team-sports movements. The same protocol was completed in two sessions, one with an assumed optimal geometrical setup of the LPS (optimal condition), and once with a sub-optimal geometrical setup of the LPS (sub-optimal condition). Raw two-dimensional position data were extracted from both the LPS and the reference system for accuracy assessment. Position, distance and speed were compared. Results: The mean difference between the LPS and reference system for all position estimations was 0.21 ± 0.13 m (n = 30,166) in the optimal setup, and 1.79 ± 7.61 m (n = 22,799) in the sub-optimal setup. The average difference in distance was below 2% for all tasks in the optimal condition, while it was below 30% in the sub-optimal condition. Instantaneous speed showed the largest differences between the LPS and reference system of all variables, both in the optimal (≥35%) and sub-optimal condition (≥74%). The differences between the LPS and reference system in instantaneous speed were speed dependent, showing increased differences with increasing speed. Discussion: Measures of position, distance, and average speed from the LPS show low errors, and can be used confidently in time-motion analyses for indoor team sports. The calculation of instantaneous speed from LPS raw data is not valid. To enhance instantaneous speed calculation the application of appropriate filtering techniques to enhance the validity of such data should be investigated. For all measures, the placement of anchor nodes and the field of play relative to the walls of the building influence LPS output to a large degree. PMID:29670530

Validation of the Thermo Scientific SureTect Escherichia coli O157:H7 Real-Time PCR Assay for Raw Beef and Produce Matrixes.

PubMed

Cloke, Jonathan; Crowley, Erin; Bird, Patrick; Bastin, Ben; Flannery, Jonathan; Agin, James; Goins, David; Clark, Dorn; Radcliff, Roy; Wickstrand, Nina; Kauppinen, Mikko

2015-01-01

The Thermo Scientific™ SureTect™ Escherichia coli O157:H7 Assay is a new real-time PCR assay which has been validated through the AOAC Research Institute (RI) Performance Tested Methods(SM) program for raw beef and produce matrixes. This validation study specifically validated the assay with 375 g 1:4 and 1:5 ratios of raw ground beef and raw beef trim in comparison to the U.S. Department of Agriculture, Food Safety Inspection Service, Microbiology Laboratory Guidebook (USDS-FSIS/MLG) reference method and 25 g bagged spinach and fresh apple juice at a ratio of 1:10, in comparison to the reference method detailed in the International Organization for Standardization 16654:2001 reference method. For raw beef matrixes, the validation of both 1:4 and 1:5 allows user flexibility with the enrichment protocol, although which of these two ratios chosen by the laboratory should be based on specific test requirements. All matrixes were analyzed by Thermo Fisher Scientific, Microbiology Division, Vantaa, Finland, and Q Laboratories Inc, Cincinnati, Ohio, in the method developer study. Two of the matrixes (raw ground beef at both 1:4 and 1:5 ratios) and bagged spinach were additionally analyzed in the AOAC-RI controlled independent laboratory study, which was conducted by Marshfield Food Safety, Marshfield, Wisconsin. Using probability of detection statistical analysis, no significant difference was demonstrated by the SureTect kit in comparison to the USDA FSIS reference method for raw beef matrixes, or with the ISO reference method for matrixes of bagged spinach and apple juice. Inclusivity and exclusivity testing was conducted with 58 E. coli O157:H7 and 54 non-E. coli O157:H7 isolates, respectively, which demonstrated that the SureTect assay was able to detect all isolates of E. coli O157:H7 analyzed. In addition, all but one of the nontarget isolates were correctly interpreted as negative by the SureTect Software. The single isolate giving a positive result was an E. coli O157:NM isolate. Nonmotile isolates of E. coli O157 have been demonstrated to still contain the H7 gene; therefore, this result is not unexpected. Robustness testing was conducted to evaluate the performance of the SureTect assay with specific deviations to the assay protocol, which were outside the recommended parameters and which are open to variation. This study demonstrated that the SureTect assay gave reliable performance. A final study to verify the shelf life of the product, under accelerated conditions was also conducted.

The NIH analytical methods and reference materials program for dietary supplements.

PubMed

Betz, Joseph M; Fisher, Kenneth D; Saldanha, Leila G; Coates, Paul M

2007-09-01

Quality of botanical products is a great uncertainty that consumers, clinicians, regulators, and researchers face. Definitions of quality abound, and include specifications for sanitation, adventitious agents (pesticides, metals, weeds), and content of natural chemicals. Because dietary supplements (DS) are often complex mixtures, they pose analytical challenges and method validation may be difficult. In response to product quality concerns and the need for validated and publicly available methods for DS analysis, the US Congress directed the Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) to accelerate an ongoing methods validation process, and the Dietary Supplements Methods and Reference Materials Program was created. The program was constructed from stakeholder input and incorporates several federal procurement and granting mechanisms in a coordinated and interlocking framework. The framework facilitates validation of analytical methods, analytical standards, and reference materials.

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

PubMed

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

2015-10-01

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

Current Status of Simulation-based Training Tools in Orthopedic Surgery: A Systematic Review.

PubMed

Morgan, Michael; Aydin, Abdullatif; Salih, Alan; Robati, Shibby; Ahmed, Kamran

To conduct a systematic review of orthopedic training and assessment simulators with reference to their level of evidence (LoE) and level of recommendation. Medline and EMBASE library databases were searched for English language articles published between 1980 and 2016, describing orthopedic simulators or validation studies of these models. All studies were assessed for LoE, and each model was subsequently awarded a level of recommendation using a modified Oxford Centre for Evidence-Based Medicine classification, adapted for education. A total of 76 articles describing orthopedic simulators met the inclusion criteria, 47 of which described at least 1 validation study. The most commonly identified models (n = 34) and validation studies (n = 26) were for knee arthroscopy. Construct validation was the most frequent validation study attempted by authors. In all, 62% (47 of 76) of the simulator studies described arthroscopy simulators, which also contained validation studies with the highest LoE. Orthopedic simulators are increasingly being subjected to validation studies, although the LoE of such studies generally remain low. There remains a lack of focus on nontechnical skills and on cost analyses of orthopedic simulators. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Nutrition screening tools: does one size fit all? A systematic review of screening tools for the hospital setting.

PubMed

van Bokhorst-de van der Schueren, Marian A E; Guaitoli, Patrícia Realino; Jansma, Elise P; de Vet, Henrica C W

2014-02-01

Numerous nutrition screening tools for the hospital setting have been developed. The aim of this systematic review is to study construct or criterion validity and predictive validity of nutrition screening tools for the general hospital setting. A systematic review of English, French, German, Spanish, Portuguese and Dutch articles identified via MEDLINE, Cinahl and EMBASE (from inception to the 2nd of February 2012). Additional studies were identified by checking reference lists of identified manuscripts. Search terms included key words for malnutrition, screening or assessment instruments, and terms for hospital setting and adults. Data were extracted independently by 2 authors. Only studies expressing the (construct, criterion or predictive) validity of a tool were included. 83 studies (32 screening tools) were identified: 42 studies on construct or criterion validity versus a reference method and 51 studies on predictive validity on outcome (i.e. length of stay, mortality or complications). None of the tools performed consistently well to establish the patients' nutritional status. For the elderly, MNA performed fair to good, for the adults MUST performed fair to good. SGA, NRS-2002 and MUST performed well in predicting outcome in approximately half of the studies reviewed in adults, but not in older patients. Not one single screening or assessment tool is capable of adequate nutrition screening as well as predicting poor nutrition related outcome. Development of new tools seems redundant and will most probably not lead to new insights. New studies comparing different tools within one patient population are required. Copyright © 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Validation of diabetes mellitus and hypertension diagnosis in computerized medical records in primary health care

PubMed Central

2011-01-01

Background Computerized Clinical Records, which are incorporated in primary health care practice, have great potential for research. In order to use this information, data quality and reliability must be assessed to prevent compromising the validity of the results. The aim of this study is to validate the diagnosis of hypertension and diabetes mellitus in the computerized clinical records of primary health care, taking the diagnosis criteria established in the most prominently used clinical guidelines as the gold standard against which what measure the sensitivity, specificity, and determine the predictive values. The gold standard for diabetes mellitus was the diagnostic criteria established in 2003 American Diabetes Association Consensus Statement for diabetic subjects. The gold standard for hypertension was the diagnostic criteria established in the Joint National Committee published in 2003. Methods A cross-sectional multicentre validation study of diabetes mellitus and hypertension diagnoses in computerized clinical records of primary health care was carried out. Diagnostic criteria from the most prominently clinical practice guidelines were considered for standard reference. Sensitivity, specificity, positive and negative predictive values, and global agreement (with kappa index), were calculated. Results were shown overall and stratified by sex and age groups. Results The agreement for diabetes mellitus with the reference standard as determined by the guideline was almost perfect (κ = 0.990), with a sensitivity of 99.53%, a specificity of 99.49%, a positive predictive value of 91.23% and a negative predictive value of 99.98%. Hypertension diagnosis showed substantial agreement with the reference standard as determined by the guideline (κ = 0.778), the sensitivity was 85.22%, the specificity 96.95%, the positive predictive value 85.24%, and the negative predictive value was 96.95%. Sensitivity results were worse in patients who also had diabetes and in those aged 70 years or over. Conclusions Our results substantiate the validity of using diagnoses of diabetes and hypertension found within the computerized clinical records for epidemiologic studies. PMID:22035202

Unremarked or Unperformed? Systematic Review on Reporting of Validation Efforts of Health Economic Decision Models in Seasonal Influenza and Early Breast Cancer.

PubMed

de Boer, Pieter T; Frederix, Geert W J; Feenstra, Talitha L; Vemer, Pepijn

2016-09-01

Transparent reporting of validation efforts of health economic models give stakeholders better insight into the credibility of model outcomes. In this study we reviewed recently published studies on seasonal influenza and early breast cancer in order to gain insight into the reporting of model validation efforts in the overall health economic literature. A literature search was performed in Pubmed and Embase to retrieve health economic modelling studies published between 2008 and 2014. Reporting on model validation was evaluated by checking for the word validation, and by using AdViSHE (Assessment of the Validation Status of Health Economic decision models), a tool containing a structured list of relevant items for validation. Additionally, we contacted corresponding authors to ask whether more validation efforts were performed other than those reported in the manuscripts. A total of 53 studies on seasonal influenza and 41 studies on early breast cancer were included in our review. The word validation was used in 16 studies (30 %) on seasonal influenza and 23 studies (56 %) on early breast cancer; however, in a minority of studies, this referred to a model validation technique. Fifty-seven percent of seasonal influenza studies and 71 % of early breast cancer studies reported one or more validation techniques. Cross-validation of study outcomes was found most often. A limited number of studies reported on model validation efforts, although good examples were identified. Author comments indicated that more validation techniques were performed than those reported in the manuscripts. Although validation is deemed important by many researchers, this is not reflected in the reporting habits of health economic modelling studies. Systematic reporting of validation efforts would be desirable to further enhance decision makers' confidence in health economic models and their outcomes.

Selection of reference genes for microRNA analysis associated to early stress response to handling and confinement in Salmo salar.

PubMed

Zavala, Eduardo; Reyes, Daniela; Deerenberg, Robert; Vidal, Rodrigo

2017-05-11

MicroRNAs are key non-coding RNA molecules that play a relevant role in the regulation of gene expression through translational repression and/or transcript cleavage during normal development and physiological adaptation processes like stress. Quantitative reverse transcription polymerase chain reaction (RT-qPCR) has become the approach normally used to determine the levels of microRNAs. However, this approach needs the use of endogenous reference. An improper selection of endogenous references can result in confusing interpretation of data. The aim of this study was to identify and validate appropriate endogenous reference miRNA genes for normalizing RT-qPCR survey of miRNAs expression in four different tissues of Atlantic salmon, under handling and confinement stress conditions associated to early or primary stress response. Nine candidate reference normalizers, including microRNAs and nuclear genes, normally used in vertebrate microRNA expression studies were selected from literature, validated by RT-qPCR and analyzed by the algorithms geNorm and NormFinder. The results revealed that the ssa-miR-99-5p gene was the most stable overall and that ssa-miR-99-5p and ssa-miR-23a-5p genes were the best combination. Moreover, the suitability of ssa-miR-99-5p and ssa-miR-23a-5p as endogeneuos reference genes was demostrated by the expression analysis of ssa-miR-193-5p gene.

Health surveillance under adverse ergonomics conditions--validity of a screening method adapted for the occupational health service.

PubMed

Jonker, Dirk; Gustafsson, Ewa; Rolander, Bo; Arvidsson, Inger; Nordander, Catarina

2015-01-01

A new health surveillance protocol for work-related upper-extremity musculoskeletal disorders has been validated by comparing the results with a reference protocol. The studied protocol, Health Surveillance in Adverse Ergonomics Conditions (HECO), is a new version of the reference protocol modified for application in the Occupational Health Service (OHS). The HECO protocol contains both a screening part and a diagnosing part. Sixty-three employees were examined. The screening in HECO did not miss any diagnosis found when using the reference protocol, but in comparison to the reference protocol considerable time savings could be achieved. Fair to good agreement between the protocols was obtained for one or more diagnoses in neck/shoulders (86%, k = 0.62) and elbow/hands (84%, k = 0.49). Therefore, the results obtained using the HECO protocol can be compared with a reference material collected with the reference protocol, and thus provide information of the magnitude of disorders in an examined work group. Practitioner Summary: The HECO protocol is a relatively simple physical examination protocol for identification of musculoskeletal disorders in the neck and upper extremities. The protocol is a reliable and cost-effective tool for the OHS to use for occupational health surveillance in order to detect workplaces at high risk for developing musculoskeletal disorders.

A simple method for HPLC retention time prediction: linear calibration using two reference substances.

PubMed

Sun, Lei; Jin, Hong-Yu; Tian, Run-Tao; Wang, Ming-Juan; Liu, Li-Na; Ye, Liu-Ping; Zuo, Tian-Tian; Ma, Shuang-Cheng

2017-01-01

Analysis of related substances in pharmaceutical chemicals and multi-components in traditional Chinese medicines needs bulk of reference substances to identify the chromatographic peaks accurately. But the reference substances are costly. Thus, the relative retention (RR) method has been widely adopted in pharmacopoeias and literatures for characterizing HPLC behaviors of those reference substances unavailable. The problem is it is difficult to reproduce the RR on different columns due to the error between measured retention time (t R ) and predicted t R in some cases. Therefore, it is useful to develop an alternative and simple method for prediction of t R accurately. In the present study, based on the thermodynamic theory of HPLC, a method named linear calibration using two reference substances (LCTRS) was proposed. The method includes three steps, procedure of two points prediction, procedure of validation by multiple points regression and sequential matching. The t R of compounds on a HPLC column can be calculated by standard retention time and linear relationship. The method was validated in two medicines on 30 columns. It was demonstrated that, LCTRS method is simple, but more accurate and more robust on different HPLC columns than RR method. Hence quality standards using LCTRS method are easy to reproduce in different laboratories with lower cost of reference substances.

Identification of suitable internal control genes for expression studies in Coffea arabica under different experimental conditions

PubMed Central

Barsalobres-Cavallari, Carla F; Severino, Fábio E; Maluf, Mirian P; Maia, Ivan G

2009-01-01

Background Quantitative data from gene expression experiments are often normalized by transcription levels of reference or housekeeping genes. An inherent assumption for their use is that the expression of these genes is highly uniform in living organisms during various phases of development, in different cell types and under diverse environmental conditions. To date, the validation of reference genes in plants has received very little attention and suitable reference genes have not been defined for a great number of crop species including Coffea arabica. The aim of the research reported herein was to compare the relative expression of a set of potential reference genes across different types of tissue/organ samples of coffee. We also validated the expression profiles of the selected reference genes at various stages of development and under a specific biotic stress. Results The expression levels of five frequently used housekeeping genes (reference genes), namely alcohol dehydrogenase (adh), 14-3-3, polyubiquitin (poly), β-actin (actin) and glyceraldehyde-3-phosphate dehydrogenase (gapdh) was assessed by quantitative real-time RT-PCR over a set of five tissue/organ samples (root, stem, leaf, flower, and fruits) of Coffea arabica plants. In addition to these commonly used internal controls, three other genes encoding a cysteine proteinase (cys), a caffeine synthase (ccs) and the 60S ribosomal protein L7 (rpl7) were also tested. Their stability and suitability as reference genes were validated by geNorm, NormFinder and BestKeeper programs. The obtained results revealed significantly variable expression levels of all reference genes analyzed, with the exception of gapdh, which showed no significant changes in expression among the investigated experimental conditions. Conclusion Our data suggests that the expression of housekeeping genes is not completely stable in coffee. Based on our results, gapdh, followed by 14-3-3 and rpl7 were found to be homogeneously expressed and are therefore adequate for normalization purposes, showing equivalent transcript levels in different tissue/organ samples. Gapdh is therefore the recommended reference gene for measuring gene expression in Coffea arabica. Its use will enable more accurate and reliable normalization of tissue/organ-specific gene expression studies in this important cherry crop plant. PMID:19126214

Establishment and validation of analytical reference panels for the standardization of quantitative BCR-ABL1 measurements on the international scale.

PubMed

White, Helen E; Hedges, John; Bendit, Israel; Branford, Susan; Colomer, Dolors; Hochhaus, Andreas; Hughes, Timothy; Kamel-Reid, Suzanne; Kim, Dong-Wook; Modur, Vijay; Müller, Martin C; Pagnano, Katia B; Pane, Fabrizio; Radich, Jerry; Cross, Nicholas C P; Labourier, Emmanuel

2013-06-01

Current guidelines for managing Philadelphia-positive chronic myeloid leukemia include monitoring the expression of the BCR-ABL1 (breakpoint cluster region/c-abl oncogene 1, non-receptor tyrosine kinase) fusion gene by quantitative reverse-transcription PCR (RT-qPCR). Our goal was to establish and validate reference panels to mitigate the interlaboratory imprecision of quantitative BCR-ABL1 measurements and to facilitate global standardization on the international scale (IS). Four-level secondary reference panels were manufactured under controlled and validated processes with synthetic Armored RNA Quant molecules (Asuragen) calibrated to reference standards from the WHO and the NIST. Performance was evaluated in IS reference laboratories and with non-IS-standardized RT-qPCR methods. For most methods, percent ratios for BCR-ABL1 e13a2 and e14a2 relative to ABL1 or BCR were robust at 4 different levels and linear over 3 logarithms, from 10% to 0.01% on the IS. The intraassay and interassay imprecision was <2-fold overall. Performance was stable across 3 consecutive lots, in multiple laboratories, and over a period of 18 months to date. International field trials demonstrated the commutability of the reagents and their accurate alignment to the IS within the intra- and interlaboratory imprecision of IS-standardized methods. The synthetic calibrator panels are robust, reproducibly manufactured, analytically calibrated to the WHO primary standards, and compatible with most BCR-ABL1 RT-qPCR assay designs. The broad availability of secondary reference reagents will further facilitate interlaboratory comparative studies and independent quality assessment programs, which are of paramount importance for worldwide standardization of BCR-ABL1 monitoring results and the optimization of current and new therapeutic approaches for chronic myeloid leukemia. © 2013 American Association for Clinical Chemistry.

Validation of Reference Genes for Quantitative Expression Analysis by Real-Time RT-PCR in Four Lepidopteran Insects

PubMed Central

Teng, Xiaolu; Zhang, Zan; He, Guiling; Yang, Liwen; Li, Fei

2012-01-01

Quantitative real-time polymerase chain reaction (qPCR) is an efficient and widely used technique to monitor gene expression. Housekeeping genes (HKGs) are often empirically selected as the reference genes for data normalization. However, the suitability of HKGs used as the reference genes has been seldom validated. Here, six HKGs were chosen (actin A3, actin A1, GAPDH, G3PDH, E2F, rp49) in four lepidopteran insects Bombyx mori L. (Lepidoptera: Bombycidae), Plutella xylostella L. (Plutellidae), Chilo suppressalis Walker (Crambidae), and Spodoptera exigua Hübner (Noctuidae) to study their expression stability. The algorithms of geNorm, NormFinder, stability index, and ΔCt analysis were used to evaluate these HKGs. Across different developmental stages, actin A1 was the most stable in P. xylostella and C. suppressalis, but it was the least stable in B. mori and S. exigua. Rp49 and GAPDH were the most stable in B. mori and S. exigua, respectively. In different tissues, GAPDH, E2F, and Rp49 were the most stable in B. mori, S. exigua, and C. suppressalis, respectively. The relative abundances of Siwi genes estimated by 2-ΔΔCt method were tested with different HKGs as the reference gene, proving the importance of internal controls in qPCR data analysis. The results not only presented a list of suitable reference genes in four lepidopteran insects, but also proved that the expression stabilities of HKGs were different among evolutionarily close species. There was no single universal reference gene that could be used in all situations. It is indispensable to validate the expression of HKGs before using them as the internal control in qPCR. PMID:22938136

Validation of reference genes for quantitative expression analysis by real-time rt-PCR in four lepidopteran insects.

PubMed

Teng, Xiaolu; Zhang, Zan; He, Guiling; Yang, Liwen; Li, Fei

2012-01-01

Quantitative real-time polymerase chain reaction (qPCR) is an efficient and widely used technique to monitor gene expression. Housekeeping genes (HKGs) are often empirically selected as the reference genes for data normalization. However, the suitability of HKGs used as the reference genes has been seldom validated. Here, six HKGs were chosen (actin A3, actin A1, GAPDH, G3PDH, E2F, rp49) in four lepidopteran insects Bombyx mori L. (Lepidoptera: Bombycidae), Plutella xylostella L. (Plutellidae), Chilo suppressalis Walker (Crambidae), and Spodoptera exigua Hübner (Noctuidae) to study their expression stability. The algorithms of geNorm, NormFinder, stability index, and ΔCt analysis were used to evaluate these HKGs. Across different developmental stages, actin A1 was the most stable in P. xylostella and C. suppressalis, but it was the least stable in B. mori and S. exigua. Rp49 and GAPDH were the most stable in B. mori and S. exigua, respectively. In different tissues, GAPDH, E2F, and Rp49 were the most stable in B. mori, S. exigua, and C. suppressalis, respectively. The relative abundances of Siwi genes estimated by 2(-ΔΔCt) method were tested with different HKGs as the reference gene, proving the importance of internal controls in qPCR data analysis. The results not only presented a list of suitable reference genes in four lepidopteran insects, but also proved that the expression stabilities of HKGs were different among evolutionarily close species. There was no single universal reference gene that could be used in all situations. It is indispensable to validate the expression of HKGs before using them as the internal control in qPCR.

Validity and Reliability of a Glucometer Against Industry Reference Standards.

PubMed

Salacinski, Amanda J; Alford, Micah; Drevets, Kathryn; Hart, Sarah; Hunt, Brian E

2014-01-01

As an appealing alternative to reference glucose analyzers, portable glucometers are recommended for self-monitoring at home, in the field, and in research settings. The purpose was to characterize the accuracy and precision, and bias of glucometers in biomedical research. Fifteen young (20-36 years; mean = 24.5), moderately to highly active men (n = 10) and women (n = 5), defined by exercising 2 to 3 times a week for the past 6 months, were given an oral glucose tolerance test (OGTT) after an overnight fast. Participants ingested 50, 75, or 150 grams of glucose over a 5-minute period. The glucometer was compared to a reference instrument. The glucometer had 39% of values within 15% of measurements made using the reference instrument ranging from 45.05 to 169.37 mg/dl. There was both a proportional (-0.45 to -0.39) and small fixed (5.06 and 0.90 mg/dl) bias. Results of the present study suggest that the glucometer provided poor validity and reliability results compared to the results provided by the reference laboratory analyzer. The portable glucometers should be used for patient management, but not for diagnosis, treatment, or research purposes. © 2014 Diabetes Technology Society.

[Drug-promoting advertisements in the Dutch Journal of Medicine and Pharmaceutical Weekly: not always evidence based].

PubMed

van Eeden, Annelies E; Roach, Rachel E J; Halbesma, Nynke; Dekker, Friedo W

2012-01-01

To determine and compare the foundation of claims in drug-promoting advertisements in a Dutch journal for physicians and a Dutch journal for pharmacists. A cross-sectional study. We included all the drug-promoting advertisements referring to a randomized controlled trial (RCT) we could find on Medline from 2 volumes of the Dutch Journal of Medicine (Nederlands Tijdschrift voor Geneeskunde; NTvG) and the (also Dutch) Pharmaceutical Weekly (Pharmaceutisch Weekblad; PW). The validity of the advertisements (n = 54) and the methodological quality of the referenced RCTs (n = 150) were independently scored by 250 medical students using 2 standardised questionnaires. The advertisements' sources were concealed from the students. Per journal, the percentage of drug-promoting advertisements having a valid claim and the percentage of high-quality RCT references were determined. Average scores on quality and validity were compared between the 2 journals. On a scale of 0-18 points, the mean quality scores of the RCTs differed 0.3 (95% CI: -0.1-0.7) between the NTvG (score: 14.8; SD: 2.2) and the PW (score: 14.5; SD: 2.6). The difference between the validity scores of drug-promoting advertisements in the NTvG (score: 5.8; SD: 3.3) and the PW (score: 5.6; SD: 3.6) was 0.3 (95% CI: -0.3-0.9) on a scale of 0-10 points. For both journals, an average of 15% of drug-promoting advertisements was valid (defined as a validity score of > 8 points); 35% of the RCTs referred to was of good methodological quality (defined as a quality score of > 16 points). The substantiation of many claims in drug-promoting advertisements in the NTvG and the PW was mediocre. There was no difference between the 2 journals.

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.

[Validity of AUDIT test for detection of disorders related with alcohol consumption in women].

PubMed

Pérula-de Torres, Luis Angel; Fernández-García, José Angel; Arias-Vega, Raquel; Muriel-Palomino, María; Márquez-Rebollo, Encarnación; Ruiz-Moral, Roger

2005-11-26

Early detection of patients with alcohol problems is important in clinical practice. The AUDIT (Alcohol Use Disorders Identification Test) questionnaire is a valid tool for this aim, especially in the male population. The objective of this study was to validate how useful is this questionnaire in females patients and to assess their test cut-off point for the diagnosis of alcohol problems in women. 414 woman were recruited in 2 health center and specialized center for addiction treatment. The AUDIT test and a semistructured interview (SCAN as gold standard) were performed to all patients. Internal consistency and criteria validity was assessed. Cronbach alpha was 0.93 (95% confidence interval [CI], 0.921-0.941). When the DSM-IV was taken as reference the most useful cut-off point was 6 points, with 89.6% (95% CI, 76.11-96.02) sensitivity and 95.07% (95% CI, 92.18-96.97) specificity. When CIE-10 was taken as reference the sensitivity was 89.58% (95% CI, 76.56-96.10) and the specificity was 95.33% (95% CI, 92.48-97.17). AUDIT is a questionnaire with good psychometrics properties and is valid for detecting dependence and risk alcohol consumption in women.

Accurate reconstruction of 3D cardiac geometry from coarsely-sliced MRI.

PubMed

Ringenberg, Jordan; Deo, Makarand; Devabhaktuni, Vijay; Berenfeld, Omer; Snyder, Brett; Boyers, Pamela; Gold, Jeffrey

2014-02-01

We present a comprehensive validation analysis to assess the geometric impact of using coarsely-sliced short-axis images to reconstruct patient-specific cardiac geometry. The methods utilize high-resolution diffusion tensor MRI (DTMRI) datasets as reference geometries from which synthesized coarsely-sliced datasets simulating in vivo MRI were produced. 3D models are reconstructed from the coarse data using variational implicit surfaces through a commonly used modeling tool, CardioViz3D. The resulting geometries were then compared to the reference DTMRI models from which they were derived to analyze how well the synthesized geometries approximate the reference anatomy. Averaged over seven hearts, 95% spatial overlap, less than 3% volume variability, and normal-to-surface distance of 0.32 mm was observed between the synthesized myocardial geometries reconstructed from 8 mm sliced images and the reference data. The results provide strong supportive evidence to validate the hypothesis that coarsely-sliced MRI may be used to accurately reconstruct geometric ventricular models. Furthermore, the use of DTMRI for validation of in vivo MRI presents a novel benchmark procedure for studies which aim to substantiate their modeling and simulation methods using coarsely-sliced cardiac data. In addition, the paper outlines a suggested original procedure for deriving image-based ventricular models using the CardioViz3D software. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The Iranian Version of the Exercise Self-Efficacy Scale (ESES): Factor Structure, Internal Consistency and Construct Validity

ERIC Educational Resources Information Center

Noroozi, Azita; Ghofranipour, Fazlollah; Heydarnia, Ali Reza; Nabipour, Iraj; Tahmasebi, Rahim; Tavafian, Sedighe Sadat

2011-01-01

Purpose: The exercise self-efficacy scale (ESES) is largely used among diabetic patients to enhance exercise behaviour. However, the Iranian version of ESES was not available. The aim of this study was to validate ESES in this country. Method: Data were collected from 348 women who referred to a diabetes institute in Iran through convenience…

Validity, Reliability, and the Questionable Role of Psychometrics in Plastic Surgery

PubMed Central

2014-01-01

Summary: This report examines the meaning of validity and reliability and the role of psychometrics in plastic surgery. Study titles increasingly include the word “valid” to support the authors’ claims. Studies by other investigators may be labeled “not validated.” Validity simply refers to the ability of a device to measure what it intends to measure. Validity is not an intrinsic test property. It is a relative term most credibly assigned by the independent user. Similarly, the word “reliable” is subject to interpretation. In psychometrics, its meaning is synonymous with “reproducible.” The definitions of valid and reliable are analogous to accuracy and precision. Reliability (both the reliability of the data and the consistency of measurements) is a prerequisite for validity. Outcome measures in plastic surgery are intended to be surveys, not tests. The role of psychometric modeling in plastic surgery is unclear, and this discipline introduces difficult jargon that can discourage investigators. Standard statistical tests suffice. The unambiguous term “reproducible” is preferred when discussing data consistency. Study design and methodology are essential considerations when assessing a study’s validity. PMID:25289354

Reference source data for GCNP noise model validation study

DOT National Transportation Integrated Search

2000-05-30

The U.S. Department of the Interior (DOI), National Park Service (NPS), and the U.S. Department : of Transportation (DOT), Federal Aviation Administration (FAA) are jointly sponsoring a study to : examine the accuracy of existing models used for pred...

3D-CAM: Derivation and Validation of a 3-Minute Diagnostic Interview for CAM-defined Delirium

PubMed Central

Marcantonio, Edward R.; Ngo, Long H.; O’Connor, Margaret; Jones, Richard N.; Crane, Paul K.; Metzger, Eran D.; Inouye, Sharon K.

2015-01-01

Background Delirium is common, morbid, and costly, yet remains often unrecognized in most clinical settings. The Confusion Assessment Method (CAM) is the most widely used diagnostic algorithm, and operationalizing its features would represent a substantial advance for clinical care. Objective To derive the 3D-CAM, a new 3-minute diagnostic assessment for CAM-defined delirium, and to validate it against a clinical reference standard. Design Diagnostic test study Setting 4 general medicine units in an academic medical center Participants 201 inpatients aged ≥ 75 years old Measurements We identified 20 items that best operationalized the 4 CAM diagnostic features to create the 3D-CAM. For prospective validation, 3D-CAM assessments were administered by trained research assistants. Independently, clinicians performed an extensive assessment that included patient interviews, family interviews, and review of the medical record. These data were considered by an expert panel to determine the presence or absence of delirium and dementia (reference standard). We compared the 3D-CAM delirium determination to the reference standard in all patients and in subgroups with and without dementia. Results The 201 participants in the prospective validation study had mean age (SD) of 84 (5.5) years, and 27% had dementia. The expert panel identified delirium in 21%. Median administration time for 3D-CAM was 3 minutes (inter-quartile range: 2–5 minutes). The sensitivity [95% CI] of 3D-CAM was 95% [84%, 99%] and the specificity was 94% [90%, 97%]. The 3D-CAM performed well in patients both with dementia (sensitivity=96% [82%, 100%], specificity=86% [67%, 96%]) and without dementia (sensitivity=93% [66%, 100%], specificity=96% [91%,99%]). Limitations Limited to single center, cross-sectional, and medicine patients only Conclusion The 3D-CAM operationalizes the CAM algorithm using a 3-minute structured assessment with high sensitivity and specificity relative to a reference standard and could be an important tool for improving recognition of delirium. PMID:25329203

Self-reported quality of life measure is reliable and valid in adult patients suffering from schizophrenia with executive impairment.

PubMed

Baumstarck, Karine; Boyer, Laurent; Boucekine, Mohamed; Aghababian, Valérie; Parola, Nathalie; Lançon, Christophe; Auquier, Pascal

2013-06-01

Impaired executive functions are among the most widely observed in patients suffering from schizophrenia. The use of self-reported outcomes for evaluating treatment and managing care of these patients has been questioned. The aim of this study was to provide new evidence about the suitability of self-reported outcome for use in this specific population by exploring the internal structure, reliability and external validity of a specific quality of life (QoL) instrument, the Schizophrenia Quality of Life questionnaire (SQoL18). cross-sectional study. age over 18 years, diagnosis of schizophrenia according to the DSM-IV criteria. sociodemographic (age, gender, and education level) and clinical data (duration of illness, Positive and Negative Syndrome Scale, Calgary Depression Scale for Schizophrenia); QoL (SQoL18); and executive performance (Stroop test, lexical and verbal fluency, and trail-making test). Non-impaired and impaired populations were defined for each of the three tests. For the six groups, psychometric properties were compared to those reported from the reference population assessed in the validation study. One hundred and thirteen consecutive patients were enrolled. The factor analysis performed in the impaired groups showed that the questionnaire structure adequately matched the initial structure of the SQoL18. The unidimensionality of the dimensions was preserved, and the internal/external validity indices were close to those of the non-impaired groups and the reference population. Our study suggests that executive dysfunction did not compromise the reliability or validity of self-reported disease-specific QoL questionnaire. Copyright © 2013 Elsevier B.V. All rights reserved.

Validating hierarchical verbal autopsy expert algorithms in a large data set with known causes of death.

PubMed

Kalter, Henry D; Perin, Jamie; Black, Robert E

2016-06-01

Physician assessment historically has been the most common method of analyzing verbal autopsy (VA) data. Recently, the World Health Organization endorsed two automated methods, Tariff 2.0 and InterVA-4, which promise greater objectivity and lower cost. A disadvantage of the Tariff method is that it requires a training data set from a prior validation study, while InterVA relies on clinically specified conditional probabilities. We undertook to validate the hierarchical expert algorithm analysis of VA data, an automated, intuitive, deterministic method that does not require a training data set. Using Population Health Metrics Research Consortium study hospital source data, we compared the primary causes of 1629 neonatal and 1456 1-59 month-old child deaths from VA expert algorithms arranged in a hierarchy to their reference standard causes. The expert algorithms were held constant, while five prior and one new "compromise" neonatal hierarchy, and three former child hierarchies were tested. For each comparison, the reference standard data were resampled 1000 times within the range of cause-specific mortality fractions (CSMF) for one of three approximated community scenarios in the 2013 WHO global causes of death, plus one random mortality cause proportions scenario. We utilized CSMF accuracy to assess overall population-level validity, and the absolute difference between VA and reference standard CSMFs to examine particular causes. Chance-corrected concordance (CCC) and Cohen's kappa were used to evaluate individual-level cause assignment. Overall CSMF accuracy for the best-performing expert algorithm hierarchy was 0.80 (range 0.57-0.96) for neonatal deaths and 0.76 (0.50-0.97) for child deaths. Performance for particular causes of death varied, with fairly flat estimated CSMF over a range of reference values for several causes. Performance at the individual diagnosis level was also less favorable than that for overall CSMF (neonatal: best CCC = 0.23, range 0.16-0.33; best kappa = 0.29, 0.23-0.35; child: best CCC = 0.40, 0.19-0.45; best kappa = 0.29, 0.07-0.35). Expert algorithms in a hierarchy offer an accessible, automated method for assigning VA causes of death. Overall population-level accuracy is similar to that of more complex machine learning methods, but without need for a training data set from a prior validation study.

Certified reference materials (GBW09170 and 09171) of creatinine in human serum.

PubMed

Dai, Xinhua; Fang, Xiang; Shao, Mingwu; Li, Ming; Huang, Zejian; Li, Hongmei; Jiang, You; Song, Dewei; He, Yajuan

2011-02-15

Creatinine is the most widely used clinical marker for assessing renal function. Concentrations of creatinine in human serum need to be carefully checked in order to ensure accurate diagnosis of renal function. Therefore, development of certified reference materials (CRMs) of creatinine in serum is of increasing importance. In this study, two new CRMs (Nos. GBW09170 and 09171) for creatinine in human serum have been developed. They were prepared with mixtures of several dozens of healthy people's and kidney disease patient's serum, respectively. The certified values of 8.10, 34.1 mg/kg for these two CRMs have been assigned by liquid chromatography-isotope dilution mass spectrometry (LC-IDMS) method which was validated by using standard reference material (SRM) of SRM909b (a reference material obtained from National Institute of Standards and Technology, NIST). The expanded uncertainties of certified values for low and high concentrations were estimated to be 1.2 and 1.1%, respectively. The certified values were further confirmed by an international intercomparison for the determination of creatinine in human serum (Consultative Committee for Amount of Substance, CCQM) of K80 (CCQM-K80). These new CRMs of creatinine in human serum pool are totally native without additional creatinine spiked for enrichment. These new CRMs are capable of validating routine clinical methods for ensuring accuracy, reliability and comparability of analytical results from different clinical laboratories. They can also be used for instrument validation, development of secondary reference materials, and evaluating the accuracy of high order clinical methods for the determination of creatinine in human serum. Copyright © 2011 Elsevier B.V. All rights reserved.

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

PubMed Central

Laslett, Mark; McDonald, Barry; Tropp, Hans; Aprill, Charles N; Öberg, Birgitta

2005-01-01

Background The tissue origin of low back pain (LBP) or referred lower extremity symptoms (LES) may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC) statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216) with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement (PCC) was estimated at 13%. "Exact" agreement between clinical and reference standard diagnoses was 32% and "clinical agreement" 51%. For six pathoanatomic categories (disc, facet joint, sacroiliac joint, hip joint, nerve root and spinal stenosis), PCC was 33% with actual agreement 56%. There was no overlap of 95% confidence intervals on any comparison. Diagnostic agreement on the six most common patho-anatomic categories produced a kappa of 0.31. Conclusion Clinical diagnoses agree with reference standards diagnoses more often than chance. Using available reference standards, most patients can have a tissue source of pain identified. PMID:15943873

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

PubMed

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

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

The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12): validation of the Dutch version.

PubMed

't Hoen, Lisette A; Utomo, Elaine; Steensma, Anneke B; Blok, Bertil F M; Korfage, Ida J

2015-09-01

To establish the reliability and validity of the Dutch version of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) in women with pelvic floor dysfunction. The PISQ-12 was translated into Dutch following a standardized translation process. A group of 124 women involved in a heterosexual relationship who had had symptoms of urinary incontinence, fecal incontinence and/or pelvic organ prolapse for at least 3 months were eligible for inclusion. A reference group was used for assessment of discriminative ability. Data were analyzed for internal consistency, reproducibility, construct validity, responsiveness, and interpretability. An alteration was made to item 12 and was corrected for during the analysis. The patient group comprised 70 of the 124 eligible women, and the reference group comprised 208 women from a panel representative of the Dutch female population. The Dutch PISQ-12 showed an adequate internal consistency with a Cronbach's alpha of 0.57 - 0.69, increasing with correction for item 12 to 0.69 - 0.75, for the reference and patient group, respectively. Scores in the patient group were lower (32.6 ± 6.9) than in the reference group (36.3 ± 4.8; p = 0.0001), indicating a lower sexual function in the patient group and good discriminative ability. Reproducibility was excellent with an intraclass correlation coefficient for agreement of 0.93 (0.88 - 0.96). A positive correlation was found with the Short Form-12 Health Survey (SF-12) measure representing good criterion validity. Due to the small number of patients who had received treatment at the 6-month follow-up, no significant responsiveness could be established. This study showed that the Dutch version of the PISQ-12 has good validity and reliability. The PISQ-12 will enable Dutch physicians to evaluate sexual dysfunction in women with pelvic floor disorders.

Identification of appropriate reference genes for human mesenchymal stem cell analysis by quantitative real-time PCR.

PubMed

Li, Xiuying; Yang, Qiwei; Bai, Jinping; Xuan, Yali; Wang, Yimin

2015-01-01

Normalization to a reference gene is the method of choice for quantitative reverse transcription-PCR (RT-qPCR) analysis. The stability of reference genes is critical for accurate experimental results and conclusions. We have evaluated the expression stability of eight commonly used reference genes found in four different human mesenchymal stem cells (MSC). Using geNorm, NormFinder and BestKeeper algorithms, we show that beta-2-microglobulin and peptidyl-prolylisomerase A were the optimal reference genes for normalizing RT-qPCR data obtained from MSC, whereas the TATA box binding protein was not suitable due to its extensive variability in expression. Our findings emphasize the significance of validating reference genes for qPCR analyses. We offer a short list of reference genes to use for normalization and recommend some commercially-available software programs as a rapid approach to validate reference genes. We also demonstrate that the two reference genes, β-actin and glyceraldehyde-3-phosphate dehydrogenase, are frequently used are not always successful in many cases.

Study on the Rationality and Validity of Probit Models of Domino Effect to Chemical Process Equipment caused by Overpressure

NASA Astrophysics Data System (ADS)

Sun, Dongliang; Huang, Guangtuan; Jiang, Juncheng; Zhang, Mingguang; Wang, Zhirong

2013-04-01

Overpressure is one important cause of domino effect in accidents of chemical process equipments. Some models considering propagation probability and threshold values of the domino effect caused by overpressure have been proposed in previous study. In order to prove the rationality and validity of the models reported in the reference, two boundary values of three damage degrees reported were considered as random variables respectively in the interval [0, 100%]. Based on the overpressure data for damage to the equipment and the damage state, and the calculation method reported in the references, the mean square errors of the four categories of damage probability models of overpressure were calculated with random boundary values, and then a relationship of mean square error vs. the two boundary value was obtained, the minimum of mean square error was obtained, compared with the result of the present work, mean square error decreases by about 3%. Therefore, the error was in the acceptable range of engineering applications, the models reported can be considered reasonable and valid.

Creation and Initial Validation of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale

PubMed Central

Steele, Catriona M.; Namasivayam-MacDonald, Ashwini M.; Guida, Brittany T.; Cichero, Julie A.; Duivestein, Janice; MRSc; Hanson, Ben; Lam, Peter; Riquelme, Luis F.

2018-01-01

Objective To assess consensual validity, interrater reliability, and criterion validity of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale, a new functional outcome scale intended to capture the severity of oropharyngeal dysphagia, as represented by the degree of diet texture restriction recommended for the patient. Design Participants assigned International Dysphagia Diet Standardisation Initiative Functional Diet Scale scores to 16 clinical cases. Consensual validity was measured against reference scores determined by an author reference panel. Interrater reliability was measured overall and across quartile subsets of the dataset. Criterion validity was evaluated versus Functional Oral Intake Scale (FOIS) scores assigned by survey respondents to the same case scenarios. Feedback was requested regarding ease and likelihood of use. Setting Web-based survey. Participants Respondents (NZ170) from 29 countries. Interventions Not applicable. Main Outcome Measures Consensual validity (percent agreement and Kendall t), criterion validity (Spearman rank correlation), and interrater reliability (Kendall concordance and intraclass coefficients). Results The International Dysphagia Diet Standardisation Initiative Functional Diet Scale showed strong consensual validity, criterion validity, and interrater reliability. Scenarios involving liquid-only diets, transition from nonoral feeding, or trial diet advances in therapy showed the poorest consensus, indicating a need for clear instructions on how to score these situations. The International Dysphagia Diet Standardisation Initiative Functional Diet Scale showed greater sensitivity than the FOIS to specific changes in diet. Most (>70%) respondents indicated enthusiasm for implementing the International Dysphagia Diet Standardisation Initiative Functional Diet Scale. Conclusions This initial validation study suggests that the International Dysphagia Diet Standardisation Initiative Functional Diet Scale has strong consensual and criterion validity and can be used reliably by clinicians to capture diet texture restriction and progression in people with dysphagia. PMID:29428348

Creation and Initial Validation of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale.

PubMed

Steele, Catriona M; Namasivayam-MacDonald, Ashwini M; Guida, Brittany T; Cichero, Julie A; Duivestein, Janice; Hanson, Ben; Lam, Peter; Riquelme, Luis F

2018-05-01

To assess consensual validity, interrater reliability, and criterion validity of the International Dysphagia Diet Standardisation Initiative Functional Diet Scale, a new functional outcome scale intended to capture the severity of oropharyngeal dysphagia, as represented by the degree of diet texture restriction recommended for the patient. Participants assigned International Dysphagia Diet Standardisation Initiative Functional Diet Scale scores to 16 clinical cases. Consensual validity was measured against reference scores determined by an author reference panel. Interrater reliability was measured overall and across quartile subsets of the dataset. Criterion validity was evaluated versus Functional Oral Intake Scale (FOIS) scores assigned by survey respondents to the same case scenarios. Feedback was requested regarding ease and likelihood of use. Web-based survey. Respondents (N=170) from 29 countries. Not applicable. Consensual validity (percent agreement and Kendall τ), criterion validity (Spearman rank correlation), and interrater reliability (Kendall concordance and intraclass coefficients). The International Dysphagia Diet Standardisation Initiative Functional Diet Scale showed strong consensual validity, criterion validity, and interrater reliability. Scenarios involving liquid-only diets, transition from nonoral feeding, or trial diet advances in therapy showed the poorest consensus, indicating a need for clear instructions on how to score these situations. The International Dysphagia Diet Standardisation Initiative Functional Diet Scale showed greater sensitivity than the FOIS to specific changes in diet. Most (>70%) respondents indicated enthusiasm for implementing the International Dysphagia Diet Standardisation Initiative Functional Diet Scale. This initial validation study suggests that the International Dysphagia Diet Standardisation Initiative Functional Diet Scale has strong consensual and criterion validity and can be used reliably by clinicians to capture diet texture restriction and progression in people with dysphagia. Copyright © 2018 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Development of “OQALE” Based Reference Module for School Geometry Subject and Analysis of Mathematical Creative Thinking Skills

NASA Astrophysics Data System (ADS)

Wulandari, N. A. D.; Sukestiyarno, Y. L.

2017-04-01

This research aims to develop an OQALE based reference module for school geometry subject that meets the criteria of a valid and practical. OQALE approach is learning by of O = observation, Q = question, A = Analyze, L = Logic, E = Express. Geometry subject presented in the module are a triangle, the Pythagorean theorem, and rectangular. Mathematical skills of creative thinking shown from four aspects: fluency, flexibility, originality and elaboration. Research procedures in the development of reference module using a strategy of the investigation and development described by [2], which is limited to the sixth stage is leading field testing. The focus of this research is to develop a reference module that is valid, practical and able to increase the mathematical creative thinking skills of students. The testing is limited to three teachers, nine students and two mathematic readers using purposive sampling technique. The data validity, practicality, and creative thinking skills upgrading collected through questionnaires, observations, and interviews and analysed with a valid test, practical test, gain test and qualitative descriptive. The results were obtained (1) the validity of the module = 4.52, which is 4.20 ≤ Vm< 5.00 included in the category of very valid; (2) the results of the questionnaire responses of teachers = 4.53, which is 4.20 ≤ Rg< 5.00 included in the category of very good; (3) the results of the survey responses of students = 3.13, which is 2.80 ≤ Rpd< 3.40 included in the category of good with an average percentage of 78%; and (4) increasing skills of creative thinking mathematically nine students through the test of the gain included in the high and medium category. The conclusions of this research are the generated OQALE based reference module for school geometry subjectis valid and practical.

Validation of reference genes for accurate normalization of gene expression for real time-quantitative PCR in strawberry fruits using different cultivars and osmotic stresses.

PubMed

Galli, Vanessa; Borowski, Joyce Moura; Perin, Ellen Cristina; Messias, Rafael da Silva; Labonde, Julia; Pereira, Ivan dos Santos; Silva, Sérgio Delmar Dos Anjos; Rombaldi, Cesar Valmor

2015-01-10

The increasing demand of strawberry (Fragaria×ananassa Duch) fruits is associated mainly with their sensorial characteristics and the content of antioxidant compounds. Nevertheless, the strawberry production has been hampered due to its sensitivity to abiotic stresses. Therefore, to understand the molecular mechanisms highlighting stress response is of great importance to enable genetic engineering approaches aiming to improve strawberry tolerance. However, the study of expression of genes in strawberry requires the use of suitable reference genes. In the present study, seven traditional and novel candidate reference genes were evaluated for transcript normalization in fruits of ten strawberry cultivars and two abiotic stresses, using RefFinder, which integrates the four major currently available software programs: geNorm, NormFinder, BestKeeper and the comparative delta-Ct method. The results indicate that the expression stability is dependent on the experimental conditions. The candidate reference gene DBP (DNA binding protein) was considered the most suitable to normalize expression data in samples of strawberry cultivars and under drought stress condition, and the candidate reference gene HISTH4 (histone H4) was the most stable under osmotic stresses and salt stress. The traditional genes GAPDH (glyceraldehyde-3-phosphate dehydrogenase) and 18S (18S ribosomal RNA) were considered the most unstable genes in all conditions. The expression of phenylalanine ammonia lyase (PAL) and 9-cis epoxycarotenoid dioxygenase (NCED1) genes were used to further confirm the validated candidate reference genes, showing that the use of an inappropriate reference gene may induce erroneous results. This study is the first survey on the stability of reference genes in strawberry cultivars and osmotic stresses and provides guidelines to obtain more accurate RT-qPCR results for future breeding efforts. Copyright © 2014 Elsevier B.V. All rights reserved.

Validity and Reliability of Published Comprehensive Theory of Mind Tests for Normal Preschool Children: A Systematic Review.

PubMed

Ziatabar Ahmadi, Seyyede Zohreh; Jalaie, Shohreh; Ashayeri, Hassan

2015-09-01

Theory of mind (ToM) or mindreading is an aspect of social cognition that evaluates mental states and beliefs of oneself and others. Validity and reliability are very important criteria when evaluating standard tests; and without them, these tests are not usable. The aim of this study was to systematically review the validity and reliability of published English comprehensive ToM tests developed for normal preschool children. We searched MEDLINE (PubMed interface), Web of Science, Science direct, PsycINFO, and also evidence base Medicine (The Cochrane Library) databases from 1990 to June 2015. Search strategy was Latin transcription of 'Theory of Mind' AND test AND children. Also, we manually studied the reference lists of all final searched articles and carried out a search of their references. Inclusion criteria were as follows: Valid and reliable diagnostic ToM tests published from 1990 to June 2015 for normal preschool children; and exclusion criteria were as follows: the studies that only used ToM tests and single tasks (false belief tasks) for ToM assessment and/or had no description about structure, validity or reliability of their tests. METHODological quality of the selected articles was assessed using the Critical Appraisal Skills Programme (CASP). In primary searching, we found 1237 articles in total databases. After removing duplicates and applying all inclusion and exclusion criteria, we selected 11 tests for this systematic review. There were a few valid, reliable and comprehensive ToM tests for normal preschool children. However, we had limitations concerning the included articles. The defined ToM tests were different in populations, tasks, mode of presentations, scoring, mode of responses, times and other variables. Also, they had various validities and reliabilities. Therefore, it is recommended that the researchers and clinicians select the ToM tests according to their psychometric characteristics, validity and reliability.

Validity and Reliability of Published Comprehensive Theory of Mind Tests for Normal Preschool Children: A Systematic Review

PubMed Central

Ziatabar Ahmadi, Seyyede Zohreh; Jalaie, Shohreh; Ashayeri, Hassan

2015-01-01

Objective: Theory of mind (ToM) or mindreading is an aspect of social cognition that evaluates mental states and beliefs of oneself and others. Validity and reliability are very important criteria when evaluating standard tests; and without them, these tests are not usable. The aim of this study was to systematically review the validity and reliability of published English comprehensive ToM tests developed for normal preschool children. Method: We searched MEDLINE (PubMed interface), Web of Science, Science direct, PsycINFO, and also evidence base Medicine (The Cochrane Library) databases from 1990 to June 2015. Search strategy was Latin transcription of ‘Theory of Mind’ AND test AND children. Also, we manually studied the reference lists of all final searched articles and carried out a search of their references. Inclusion criteria were as follows: Valid and reliable diagnostic ToM tests published from 1990 to June 2015 for normal preschool children; and exclusion criteria were as follows: the studies that only used ToM tests and single tasks (false belief tasks) for ToM assessment and/or had no description about structure, validity or reliability of their tests. Methodological quality of the selected articles was assessed using the Critical Appraisal Skills Programme (CASP). Result: In primary searching, we found 1237 articles in total databases. After removing duplicates and applying all inclusion and exclusion criteria, we selected 11 tests for this systematic review. Conclusion: There were a few valid, reliable and comprehensive ToM tests for normal preschool children. However, we had limitations concerning the included articles. The defined ToM tests were different in populations, tasks, mode of presentations, scoring, mode of responses, times and other variables. Also, they had various validities and reliabilities. Therefore, it is recommended that the researchers and clinicians select the ToM tests according to their psychometric characteristics, validity and reliability. PMID:27006666

Application of quantitative 1H NMR for the calibration of protoberberine alkaloid reference standards.

PubMed

Wu, Yan; He, Yi; He, Wenyi; Zhang, Yumei; Lu, Jing; Dai, Zhong; Ma, Shuangcheng; Lin, Ruichao

2014-03-01

Quantitative nuclear magnetic resonance spectroscopy (qNMR) has been developed into an important tool in the drug analysis, biomacromolecule detection, and metabolism study. Compared with mass balance method, qNMR method bears some advantages in the calibration of reference standard (RS): it determines the absolute amount of a sample; other chemical compound and its certified reference material (CRM) can be used as internal standard (IS) to obtain the purity of the sample. Protoberberine alkaloids have many biological activities and have been used as reference standards for the control of many herbal drugs. In present study, the qNMR methods were developed for the calibration of berberine hydrochloride, palmatine hydrochloride, tetrahydropalmatine, and phellodendrine hydrochloride with potassium hydrogen phthalate as IS. Method validation was carried out according to the guidelines for the method validation of Chinese Pharmacopoeia. The results of qNMR were compared with those of mass balance method and the differences between the results of two methods were acceptable based on the analysis of estimated measurement uncertainties. Therefore, qNMR is an effective and reliable analysis method for the calibration of RS and can be used as a good complementarity to the mass balance method. Copyright © 2013 Elsevier B.V. All rights reserved.

Kerlinger's Criterial Referents Theory Revisited.

ERIC Educational Resources Information Center

Zak, Itai; Birenbaum, Menucha

1980-01-01

Kerlinger's criterial referents theory of attitudes was tested cross-culturally by administering an education attitude referents summated-rating scale to 713 individuals in Israel. The response pattern to criterial and noncriterial referents was examined. Results indicated empirical cross-cultural validity of theory, but questioned measuring…

[Development of a Japanese version of a short form of the Profile of Emotional Competence].

PubMed

Nozaki, Yuki; Koyasu, Masuo

2015-06-01

Emotional competence refers to individual differences in the ability to appropriately identity, understand, express, regulate, and utilize one's own emotions and those of others. This study developed a Japanese version of a short form of the Profile of Emotional Competence, a measure that allows the comprehensive assessment of intra- and interpersonal emotional competence with shorter items, and investigated its reliability and validity. In Study 1, we selected items for a short version and compared it with the full scale in terms of scores, internal consistency, and validity. In Study 2, we examined the short form's test-retest reliability. Results supported the original two-factor model and the measure had adequate reliability and validity. We discuss the construct validity and practical applicability of the short form of the Profile of Emotional Competence.

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

PubMed

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

2018-05-01

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

Generation, Validation, and Application of Abundance Map Reference Data for Spectral Unmixing

NASA Astrophysics Data System (ADS)

Williams, McKay D.

Reference data ("ground truth") maps traditionally have been used to assess the accuracy of imaging spectrometer classification algorithms. However, these reference data can be prohibitively expensive to produce, often do not include sub-pixel abundance estimates necessary to assess spectral unmixing algorithms, and lack published validation reports. Our research proposes methodologies to efficiently generate, validate, and apply abundance map reference data (AMRD) to airborne remote sensing scenes. We generated scene-wide AMRD for three different remote sensing scenes using our remotely sensed reference data (RSRD) technique, which spatially aggregates unmixing results from fine scale imagery (e.g., 1-m Ground Sample Distance (GSD)) to co-located coarse scale imagery (e.g., 10-m GSD or larger). We validated the accuracy of this methodology by estimating AMRD in 51 randomly-selected 10 m x 10 m plots, using seven independent methods and observers, including field surveys by two observers, imagery analysis by two observers, and RSRD using three algorithms. Results indicated statistically-significant differences between all versions of AMRD, suggesting that all forms of reference data need to be validated. Given these significant differences between the independent versions of AMRD, we proposed that the mean of all (MOA) versions of reference data for each plot and class were most likely to represent true abundances. We then compared each version of AMRD to MOA. Best case accuracy was achieved by a version of imagery analysis, which had a mean coverage area error of 2.0%, with a standard deviation of 5.6%. One of the RSRD algorithms was nearly as accurate, achieving a mean error of 3.0%, with a standard deviation of 6.3%, showing the potential of RSRD-based AMRD generation. Application of validated AMRD to specific coarse scale imagery involved three main parts: 1) spatial alignment of coarse and fine scale imagery, 2) aggregation of fine scale abundances to produce coarse scale imagery-specific AMRD, and 3) demonstration of comparisons between coarse scale unmixing abundances and AMRD. Spatial alignment was performed using our scene-wide spectral comparison (SWSC) algorithm, which aligned imagery with accuracy approaching the distance of a single fine scale pixel. We compared simple rectangular aggregation to coarse sensor point spread function (PSF) aggregation, and found that the PSF approach returned lower error, but that rectangular aggregation more accurately estimated true abundances at ground level. We demonstrated various metrics for comparing unmixing results to AMRD, including mean absolute error (MAE) and linear regression (LR). We additionally introduced reference data mean adjusted MAE (MA-MAE), and reference data confidence interval adjusted MAE (CIA-MAE), which account for known error in the reference data itself. MA-MAE analysis indicated that fully constrained linear unmixing of coarse scale imagery across all three scenes returned an error of 10.83% per class and pixel, with regression analysis yielding a slope = 0.85, intercept = 0.04, and R2 = 0.81. Our reference data research has demonstrated a viable methodology to efficiently generate, validate, and apply AMRD to specific examples of airborne remote sensing imagery, thereby enabling direct quantitative assessment of spectral unmixing performance.

Identification and validation of quantitative real-time reverse transcription PCR reference genes for gene expression analysis in teak (Tectona grandis L.f.)

PubMed Central

2014-01-01

Background Teak (Tectona grandis L.f.) is currently the preferred choice of the timber trade for fabrication of woody products due to its extraordinary qualities and is widely grown around the world. Gene expression studies are essential to explore wood formation of vascular plants, and quantitative real-time reverse transcription PCR (qRT-PCR) is a sensitive technique employed for quantifying gene expression levels. One or more appropriate reference genes are crucial to accurately compare mRNA transcripts through different tissues/organs and experimental conditions. Despite being the focus of some genetic studies, a lack of molecular information has hindered genetic exploration of teak. To date, qRT-PCR reference genes have not been identified and validated for teak. Results Identification and cloning of nine commonly used qRT-PCR reference genes from teak, including ribosomal protein 60s (rp60s), clathrin adaptor complexes medium subunit family (Cac), actin (Act), histone 3 (His3), sand family (Sand), β-Tubulin (Β-Tub), ubiquitin (Ubq), elongation factor 1-α (Ef-1α), and glyceraldehyde-3-phosphate dehydrogenase (GAPDH). Expression profiles of these genes were evaluated by qRT-PCR in six tissue and organ samples (leaf, flower, seedling, root, stem and branch secondary xylem) of teak. Appropriate gene cloning and sequencing, primer specificity and amplification efficiency was verified for each gene. Their stability as reference genes was validated by NormFinder, BestKeeper, geNorm and Delta Ct programs. Results obtained from all programs showed that TgUbq and TgEf-1α are the most stable genes to use as qRT-PCR reference genes and TgAct is the most unstable gene in teak. The relative expression of the teak cinnamyl alcohol dehydrogenase (TgCAD) gene in lignified tissues at different ages was assessed by qRT-PCR, using TgUbq and TgEf-1α as internal controls. These analyses exposed a consistent expression pattern with both reference genes. Conclusion This study proposes a first broad collection of teak tissue and organ mRNA expression data for nine selected candidate qRT-PCR reference genes. NormFinder, Bestkeeper, geNorm and Delta Ct analyses suggested that TgUbq and TgEf-1α have the highest expression stability and provided similar results when evaluating TgCAD gene expression, while the commonly used Act should be avoided. PMID:25048176

A content validity study of signs, symptoms and diseases/health problems expressed in LIBRAS1

PubMed Central

Aragão, Jamilly da Silva; de França, Inacia Sátiro Xavier; Coura, Alexsandro Silva; de Sousa, Francisco Stélio; Batista, Joana D'arc Lyra; Magalhães, Isabella Medeiros de Oliveira

2015-01-01

Objectives: to validate the content of signs, symptoms and diseases/health problems expressed in LIBRAS for people with deafness Method: methodological development study, which involved 36 people with deafness and three LIBRAS specialists. The study was conducted in three stages: investigation of the signs, symptoms and diseases/health problems, referred to by people with deafness, reported in a questionnaire; video recordings of how people with deafness express, through LIBRA, the signs, symptoms and diseases/health problems; and validation of the contents of the recordings of the expressions by LIBRAS specialists. Data were processed in a spreadsheet and analyzed using univariate tables, with absolute frequencies and percentages. The validation results were analyzed using the Content Validity Index (CVI). Results: 33 expressions in LIBRAS, of signs, symptoms and diseases/health problems were evaluated, and 28 expressions obtained a satisfactory CVI (1.00). Conclusions: the signs, symptoms and diseases/health problems expressed in LIBRAS presented validity, in the study region, for health professionals, especially nurses, for use in the clinical anamnesis of the nursing consultation for people with deafness. PMID:26625991

A content validity study of signs, symptoms and diseases/health problems expressed in LIBRAS.

PubMed

Aragão, Jamilly da Silva; de França, Inacia Sátiro Xavier; Coura, Alexsandro Silva; de Sousa, Francisco Stélio; Batista, Joana D'arc Lyra; Magalhães, Isabella Medeiros de Oliveira

2015-01-01

To validate the content of signs, symptoms and diseases/health problems expressed in LIBRAS for people with deafness. Method: Methodological development study, which involved 36 people with deafness and three LIBRAS specialists. The study was conducted in three stages: investigation of the signs, symptoms and diseases/health problems, referred to by people with deafness, reported in a questionnaire; video recordings of how people with deafness express, through LIBRA, the signs, symptoms and diseases/health problems; and validation of the contents of the recordings of the expressions by LIBRAS specialists. Data were processed in a spreadsheet and analyzed using univariate tables, with absolute frequencies and percentages. The validation results were analyzed using the Content Validity Index (CVI). 33 expressions in LIBRAS, of signs, symptoms and diseases/health problems were evaluated, and 28 expressions obtained a satisfactory CVI (1.00). The signs, symptoms and diseases/health problems expressed in LIBRAS presented validity, in the study region, for health professionals, especially nurses, for use in the clinical anamnesis of the nursing consultation for people with deafness.

Seizures in the elderly: development and validation of a diagnostic algorithm.

PubMed

Dupont, Sophie; Verny, Marc; Harston, Sandrine; Cartz-Piver, Leslie; Schück, Stéphane; Martin, Jennifer; Puisieux, François; Alecu, Cosmin; Vespignani, Hervé; Marchal, Cécile; Derambure, Philippe

2010-05-01

Seizures are frequent in the elderly, but their diagnosis can be challenging. The objective of this work was to develop and validate an expert-based algorithm for the diagnosis of seizures in elderly people. A multidisciplinary group of neurologists and geriatricians developed a diagnostic algorithm using a combination of selected clinical, electroencephalographical and radiological criteria. The algorithm was validated by multicentre retrospective analysis of data of patients referred for specific symptoms and classified by the experts as epileptic patients or not. The algorithm was applied to all the patients, and the diagnosis provided by the algorithm was compared to the clinical diagnosis of the experts. Twenty-nine clinical, electroencephalographical and radiological criteria were selected for the algorithm. According to criteria combination, seizures were classified in four levels of diagnosis: certain, highly probable, possible or improbable. To validate the algorithm, the medical records of 269 elderly patients were analyzed (138 with epileptic seizures, 131 with non-epileptic manifestations). Patients were mainly referred for a transient focal deficit (40%), confusion (38%), unconsciousness (27%). The algorithm best classified certain and probable seizures versus possible and improbable seizures, with 86.2% sensitivity and 67.2% specificity. Using logistical regression, 2 simplified models were developed, the first with 13 criteria (Se 85.5%, Sp 90.1%), and the second with 7 criteria only (Se 84.8%, Sp 88.6%). In conclusion, the present study validated the use of a revised diagnostic algorithm to help diagnosis epileptic seizures in the elderly. A prospective study is planned to further validate this algorithm. Copyright 2010 Elsevier B.V. All rights reserved.

Uncertainty Analysis in the Creation of a Fine-Resolution Leaf Area Index (LAI) Reference Map for Validation of Moderate Resolution LAI Products

EPA Science Inventory

The validation process for a moderate resolution leaf area index (LAI) product (i.e., MODIS) involves the creation of a high spatial resolution LAI reference map (Lai-RM), which when scaled to the moderate LAI resolution (i.e., >1 km) allows for comparison and analysis with this ...

Resource Conservation and Recovery Act, Part B Permit Application [for the Waste Isolation Pilot Plant (WIPP)]. Volume 5, Chapter D, Appendix D1 (conclusion), Revision 3

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

Cook, Neville G.W.; Heuze, Francois E.; Miller, Hamish D.S.

1993-03-01

The reference design for the underground facilities at the Waste Isolation Pilot Plant was developed using the best criteria available at initiation of the detailed design effort. These design criteria are contained in the US Department of Energy document titled Design Criteria, Waste Isolation Pilot Plant (WIPP). Revised Mission Concept-IIA (RMC-IIA), Rev. 4, dated February 1984. The validation process described in the Design Validation Final Report has resulted in validation of the reference design of the underground openings based on these criteria. Future changes may necessitate modification of the Design Criteria document and/or the reference design. Validation of the referencemore » design as presented in this report permits the consideration of future design or design criteria modifications necessitated by these changes or by experience gained at the WIPP. Any future modifications to the design criteria and/or the reference design will be governed by a DOE Standard Operation Procedure (SOP) covering underground design changes. This procedure will explain the process to be followed in describing, evaluating and approving the change.« less

Validity of a traffic air pollutant dispersion model to assess exposure to fine particles.

PubMed

Kostrzewa, Aude; Reungoat, Patrice; Raherison, Chantal

2009-08-01

Fine particles (PM(2.5)) are an important component of air pollution. Epidemiological studies have shown health effects due to ambient air particles, particularly allergies in children. Since the main difficulty is to determine exposure to such pollution, traffic air pollutant (TAP) dispersions models have been developed to improve the estimation of individual exposure levels. One such model, the ExTra index, has been validated for nitrogen oxide concentrations but not for other pollutants. The purpose of this study was to assess the validity of the ExTra index to assess PM(2.5) exposure. We compared PM(2.5) concentrations calculated by the ExTra index to reference measures (passive samplers situated under the covered part of the playground), in 15 schools in Bordeaux, in 2000. First, we collected the input data required by the ExTra index: background and local pollution depending on traffic, meteorology and topography. Second, the ExTra index was calculated for each school. Statistical analysis consisted of a graphic description; then, we calculated an intraclass correlation coefficient. Concentrations calculated with the ExTra index and the reference method were similar. The ExTra index underestimated exposure by 2.2 microg m(-3) on average compared to the reference method. The intraclass correlation coefficient was 0.85 and its 95% confidence interval was [0.62; 0.95]. The results suggest that the ExTra index provides an assessment of PM(2.5) exposure similar to that of the reference method. Although caution is required in interpreting these results owing to the small number of sites, the ExTra index could be a useful epidemiological tool for reconstructing individual exposure, an important challenge in epidemiology.

A Validation Study of the Rank-Preserving Structural Failure Time Model: Confidence Intervals and Unique, Multiple, and Erroneous Solutions.

PubMed

Ouwens, Mario; Hauch, Ole; Franzén, Stefan

2018-05-01

The rank-preserving structural failure time model (RPSFTM) is used for health technology assessment submissions to adjust for switching patients from reference to investigational treatment in cancer trials. It uses counterfactual survival (survival when only reference treatment would have been used) and assumes that, at randomization, the counterfactual survival distribution for the investigational and reference arms is identical. Previous validation reports have assumed that patients in the investigational treatment arm stay on therapy throughout the study period. To evaluate the validity of the RPSFTM at various levels of crossover in situations in which patients are taken off the investigational drug in the investigational arm. The RPSFTM was applied to simulated datasets differing in percentage of patients switching, time of switching, underlying acceleration factor, and number of patients, using exponential distributions for the time on investigational and reference treatment. There were multiple scenarios in which two solutions were found: one corresponding to identical counterfactual distributions, and the other to two different crossing counterfactual distributions. The same was found for the hazard ratio (HR). Unique solutions were observed only when switching patients were on investigational treatment for <40% of the time that patients in the investigational arm were on treatment. Distributions other than exponential could have been used for time on treatment. An HR equal to 1 is a necessary but not always sufficient condition to indicate acceleration factors associated with equal counterfactual survival. Further assessment to distinguish crossing counterfactual curves from equal counterfactual curves is especially needed when the time that switchers stay on investigational treatment is relatively long compared to the time direct starters stay on investigational treatment.

Health surveillance under adverse ergonomics conditions – validity of a screening method adapted for the occupational health service

PubMed Central

Jonker, Dirk; Gustafsson, Ewa; Rolander, Bo; Arvidsson, Inger; Nordander, Catarina

2015-01-01

A new health surveillance protocol for work-related upper-extremity musculoskeletal disorders has been validated by comparing the results with a reference protocol. The studied protocol, Health Surveillance in Adverse Ergonomics Conditions (HECO), is a new version of the reference protocol modified for application in the Occupational Health Service (OHS). The HECO protocol contains both a screening part and a diagnosing part. Sixty-three employees were examined. The screening in HECO did not miss any diagnosis found when using the reference protocol, but in comparison to the reference protocol considerable time savings could be achieved. Fair to good agreement between the protocols was obtained for one or more diagnoses in neck/shoulders (86%, k = 0.62) and elbow/hands (84%, k = 0.49). Therefore, the results obtained using the HECO protocol can be compared with a reference material collected with the reference protocol, and thus provide information of the magnitude of disorders in an examined work group. Practitioner Summary: The HECO protocol is a relatively simple physical examination protocol for identification of musculoskeletal disorders in the neck and upper extremities. The protocol is a reliable and cost-effective tool for the OHS to use for occupational health surveillance in order to detect workplaces at high risk for developing musculoskeletal disorders. PMID:25761380

Biophysical characterization and structure of the Fab fragment from the NIST reference antibody, RM 8671.

PubMed

Karageorgos, Ioannis; Gallagher, Elyssia S; Galvin, Connor; Gallagher, D Travis; Hudgens, Jeffrey W

2017-11-01

Monoclonal antibody pharmaceuticals are the fastest-growing class of therapeutics, with a wide range of clinical applications. To assure their safety, these protein drugs must demonstrate highly consistent purity and stability. Key to these objectives is higher order structure measurements validated by calibration to reference materials. We describe preparation, characterization, and crystal structure of the Fab fragment prepared from the NIST Reference Antibody RM 8671 (NISTmAb). NISTmAb is a humanized IgG1κ antibody, produced in murine cell culture and purified by standard biopharmaceutical production methods, developed at the National Institute of Standards and Technology (NIST) to serve as a reference material. The Fab fragment was derived from NISTmAb through papain cleavage followed by protein A based purification. The purified Fab fragment was characterized by SDS-PAGE, capillary gel electrophoresis, multi-angle light scattering, size exclusion chromatography, mass spectrometry, and x-ray crystallography. The crystal structure at 0.2 nm resolution includes four independent Fab molecules with complete light chains and heavy chains through Cys 223, enabling assessment of conformational variability and providing a well-characterized reference structure for research and engineering applications. This nonproprietary, publically available reference material of known higher-order structure can support metrology in biopharmaceutical applications, and it is a suitable platform for validation of molecular modeling studies. Published by Elsevier Ltd.

The 2006 Cape Canaveral Air Force Station Range Reference Atmosphere Model Validation Study and Sensitivity Analysis to the National Aeronautics and Space Administration's Space Shuttle

NASA Technical Reports Server (NTRS)

Burns, Lee; Merry, Carl; Decker, Ryan; Harrington, Brian

2008-01-01

The 2006 Cape Canaveral Air Force Station (CCAFS) Range Reference Atmosphere (RRA) is a statistical model summarizing the wind and thermodynamic atmospheric variability from surface to 70 kin. Launches of the National Aeronautics and Space Administration's (NASA) Space Shuttle from Kennedy Space Center utilize CCAFS RRA data to evaluate environmental constraints on various aspects of the vehicle during ascent. An update to the CCAFS RRA was recently completed. As part of the update, a validation study on the 2006 version was conducted as well as a comparison analysis of the 2006 version to the existing CCAFS RRA database version 1983. Assessments to the Space Shuttle vehicle ascent profile characteristics were performed to determine impacts of the updated model to the vehicle performance. Details on the model updates and the vehicle sensitivity analyses with the update model are presented.

Development and validation of the RapidHIT™ 200 utilising NGMSElect™ Express for the processing of buccal swabs.

PubMed

Shackleton, David; Pagram, Jenny; Ives, Lesley; Vanhinsbergh, Des

2018-06-02

The RapidHIT™ 200 System is a fully automated sample-to-DNA profile system designed to produce high quality DNA profiles within 2h. The use of RapidHIT™ 200 System within the United Kingdom Criminal Justice System (UKCJS) has required extensive development and validation of methods with a focus on AmpFℓSTR ® NGMSElect™ Express PCR kit to comply with specific regulations for loading to the UK National DNA Database (NDNAD). These studies have been carried out using single source reference samples to simulate live reference samples taken from arrestees and victims for elimination. The studies have shown that the system is capable of generating high quality profile and has achieved the accreditations necessary to load to the NDNAD; a first for the UK. Copyright © 2018 Elsevier B.V. All rights reserved.

Validation of the secretion severity rating scale.

PubMed

Pluschinski, Petra; Zaretsky, Eugen; Stöver, Timo; Murray, Joseph; Sader, Robert; Hey, Christiane

2016-10-01

Accumulation of secretions within the hypopharynx, aditus laryngis, and trachea is one characteristic of severe dysphagia and is of high clinical and therapeutic relevance. For the graduation of the secretion severity level, a secretion scale was provided by Murray et al. in 1996. The purpose of the study presented here is the validation of this scale by analyzing the intra-rater and inter-rater reliability as well as concurrent validity. For examination of reliability and validity, a reference standard was defined by two expert clinicians who reviewed 40 video recordings of fiberendoscopic swallowing evaluations, with 10 videos for each severity grade. These videos were rated and rerated independently and blinded by 4 ENT-residents with an interval of 4 weeks. Both the intra-rater (Kendall's τ > 0.847***) and inter-rater reliability (Kendall's W > 0.951***) were highly significant and can be considered good or very good. Correlation of the median of all ratings with the reference standard was close to the highest possible value 1 (τ = 0.984***). The scale was proved to be a reliable and valid instrument for graduation of one of the principal symptoms of oropharyngeal dysphagia and is recommended as an evidence-based instrument for standardized fiberoptic endoscopic evaluation of swallowing.

An examination of the MASC Social Anxiety Scale in a non-referred sample of adolescents.

PubMed

Anderson, Emily R; Jordan, Judith A; Smith, Ashley J; Inderbitzen-Nolan, Heidi M

2009-12-01

Social phobia is prevalent during adolescence and is associated with negative outcomes. Two self-report instruments are empirically validated to specifically assess social phobia symptomatology in youth: the Social Phobia and Anxiety Inventory for Children and the Social Anxiety Scale for Adolescents. The Multidimensional Anxiety Scale for Children is a broad-band measure of anxiety containing a scale assessing the social phobia construct. The present study investigated the MASC Social Anxiety Scale in relation to other well-established measures of social phobia and depression in a non-referred sample of adolescents. Results support the convergent validity of the MASC Social Anxiety Scale and provide some support for its discriminant validity, suggesting its utility in the initial assessment of social phobia. Receiver Operating Characteristics (ROCs) calculated the sensitivity and specificity of the MASC Social Anxiety Scale. Binary logistic regression analyses determined the predictive utility of the MASC Social Anxiety Scale. Implications for assessment are discussed.

Simulation verification techniques study

NASA Technical Reports Server (NTRS)

Schoonmaker, P. B.; Wenglinski, T. H.

1975-01-01

Results are summarized of the simulation verification techniques study which consisted of two tasks: to develop techniques for simulator hardware checkout and to develop techniques for simulation performance verification (validation). The hardware verification task involved definition of simulation hardware (hardware units and integrated simulator configurations), survey of current hardware self-test techniques, and definition of hardware and software techniques for checkout of simulator subsystems. The performance verification task included definition of simulation performance parameters (and critical performance parameters), definition of methods for establishing standards of performance (sources of reference data or validation), and definition of methods for validating performance. Both major tasks included definition of verification software and assessment of verification data base impact. An annotated bibliography of all documents generated during this study is provided.

The internal validity of arthroscopic simulators and their effectiveness in arthroscopic education.

PubMed

Slade Shantz, Jesse Alan; Leiter, Jeff R S; Gottschalk, Tania; MacDonald, Peter Benjamin

2014-01-01

The purpose of this systematic review was to identify standard procedures for the validation of arthroscopic simulators and determine whether simulators improve the surgical skills of users. Arthroscopic simulator validation studies and randomized trials assessing the effectiveness of arthroscopic simulators in education were identified from online databases, as well as, grey literature and reference lists. Only validation studies and randomized trials were included for review. Study heterogeneity was calculated and where appropriate, study results were combined employing a random effects model. Four hundred and thirteen studies were reviewed. Thirteen studies met the inclusion criteria assessing the construct validity of simulators. A pooled analysis of internal validation studies determined that simulators could discriminate between novice and experts, but not between novice and intermediate trainees on time of completion of a simulated task. Only one study assessed the utility of a knee simulator in training arthroscopic skills directly and demonstrated that the skill level of simulator-trained residents was greater than non-simulator-trained residents. Excessive heterogeneity exists in the literature to determine the internal and transfer validity of arthroscopic simulators currently available. Evidence suggests that simulators can discriminate between novice and expert users, but discrimination between novice and intermediate trainees in surgical education should be paramount. International standards for the assessment of arthroscopic simulator validity should be developed to increase the use and effectiveness of simulators in orthopedic surgery.

Uncovering Suitable Reference Proteins for Expression Studies in Human Adipose Tissue with Relevance to Obesity

PubMed Central

Pérez-Pérez, Rafael; López, Juan A.; García-Santos, Eva; Camafeita, Emilio; Gómez-Serrano, María; Ortega-Delgado, Francisco J.; Ricart, Wifredo; Fernández-Real, José M.; Peral, Belén

2012-01-01

Background Protein expression studies based on the two major intra-abdominal human fat depots, the subcutaneous and the omental fat, can shed light into the mechanisms involved in obesity and its co-morbidities. Here we address, for the first time, the identification and validation of reference proteins for data standardization, which are essential for accurate comparison of protein levels in expression studies based on fat from obese and non-obese individuals. Methodology and Findings To uncover adipose tissue proteins equally expressed either in omental and subcutaneous fat depots (study 1) or in omental fat from non-obese and obese individuals (study 2), we have reanalyzed our previously published data based on two-dimensional fluorescence difference gel electrophoresis. Twenty-four proteins (12 in study 1 and 12 in study 2) with similar expression levels in all conditions tested were selected and identified by mass spectrometry. Immunoblotting analysis was used to confirm in adipose tissue the expression pattern of the potential reference proteins and three proteins were validated: PARK7, ENOA and FAA. Western Blot analysis was also used to test customary loading control proteins. ENOA, PARK7 and the customary loading control protein Beta-actin showed steady expression profiles in fat from non-obese and obese individuals, whilst FAA maintained steady expression levels across paired omental and subcutaneous fat samples. Conclusions ENOA, PARK7 and Beta-actin are proper reference standards in obesity studies based on omental fat, whilst FAA is the best loading control for the comparative analysis of omental and subcutaneous adipose tissues either in obese and non-obese subjects. Neither customary loading control proteins GAPDH and TBB5 nor CALX are adequate standards in differential expression studies on adipose tissue. The use of the proposed reference proteins will facilitate the adequate analysis of proteins differentially expressed in the context of obesity, an aim difficult to achieve before this study. PMID:22272336

Inappropriate Use of Homeostasis Model Assessment Cutoff Values for Diagnosing Insulin Resistance in Pediatric Studies.

PubMed

Fox, Carrie; Bernardino, Lourdes; Cochran, Jill; Essig, Mary; Bridges, Kristie Grove

2017-11-01

Assessing pediatric patients for insulin resistance is one way to identify those who are at a high risk of developing type 2 diabetes mellitus. The homoeostasis model assessment (HOMA) is a measure of insulin resistance based on fasting blood glucose and insulin levels. Although this measure is widely used in research, cutoff values for pediatric populations have not been established. To assess the validity of HOMA cutoff values used in pediatric studies published in peer-reviewed journals. Studies published from January 2010 to December 2015 were identified through MEDLINE. Initial screening of abstracts was done to select studies that were conducted in pediatric populations and used HOMA to assess insulin resistance. Subsequent full-text review narrowed the list to only those studies that used a specific HOMA score to diagnose insulin resistance. Each study was classified as using a predetermined fixed HOMA cutoff value or a cutoff that was a percentile specific to that population. For studies that used a predetermined cutoff value, the references cited to provide evidence in support of that cutoff were evaluated. In the 298 articles analyzed, 51 different HOMA cutoff values were used to classify patients as having insulin resistance. Two hundred fifty-five studies (85.6%) used a predetermined fixed cutoff value, but only 72 (28.2%) of those studies provided a reference that supported its use. One hundred ten studies (43%) that used a fixed cutoff either cited a study that did not mention HOMA or provided no reference at all. Tracing of citation history indicated that the most commonly used cutoff values were ultimately based on studies that did not validate their use for defining insulin resistance. Little evidence exists to support HOMA cutoff values commonly used to define insulin resistance in pediatric studies. These findings highlight the importance of validating study design elements when training medical students and novice investigators. Using available data to generate population ranges for HOMA would improve its clinical utility.

Creating an open access cal/val repository via the LACO-Wiki online validation platform

NASA Astrophysics Data System (ADS)

Perger, Christoph; See, Linda; Dresel, Christopher; Weichselbaum, Juergen; Fritz, Steffen

2017-04-01

There is a major gap in the amount of in-situ data available on land cover and land use, either as field-based ground truth information or from image interpretation, both of which are used for the calibration and validation (cal/val) of products derived from Earth Observation. Although map producers generally publish their confusion matrices and the accuracy measures associated with their land cover and land use products, the cal/val data (also referred to as reference data) are rarely shared in an open manner. Although there have been efforts in compiling existing reference datasets and making them openly available, e.g. through the GOFC/GOLD (Global Observation for Forest Cover and Land Dynamics) portal or the European Commission's Copernicus Reference Data Access (CORDA), this represents a tiny fraction of the reference data collected and stored locally around the world. Moreover, the validation of land cover and land use maps is usually undertaken with tools and procedures specific to a particular institute or organization due to the lack of standardized validation procedures; thus, there are currently no incentives to share the reference data more broadly with the land cover and land use community. In an effort to provide a set of standardized, online validation tools and to build an open repository of cal/val data, the LACO-Wiki online validation portal has been developed, which will be presented in this paper. The portal contains transparent, documented and reproducible validation procedures that can be applied to local as well as global products. LACO-Wiki was developed through a user consultation process that resulted in a 4-step wizard-based workflow, which supports the user from uploading the map product for validation, through to the sampling process and the validation of these samples, until the results are processed and a final report is created that includes a range of commonly reported accuracy measures. One of the design goals of LACO-Wiki has been to simplify the workflows as much as possible so that the tool can be used both professionally and in an educational or non-expert context. By using the tool for validation, the user agrees to share their validation samples and therefore contribute to an open access cal/val repository. Interest in the use of LACO-Wiki for validation of national land cover or related products has already been expressed, e.g. by national stakeholders under the umbrella of the European Environment Agency (EEA), and for global products by GOFC/GOLD and the Group on Earth Observation (GEO). Thus, LACO-Wiki has the potential to become the focal point around which an international land cover validation community could be built, and could significantly advance the state-of-the-art in land cover cal/val, particularly given recent developments in opening up of the Landsat archive and the open availability of Sentinel imagery. The platform will also offer open access to crowdsourced in-situ data, for example, from the recently developed LACO-Wiki mobile smartphone app, which can be used to collect additional validation information in the field, as well as to validation data collected via its partner platform, Geo-Wiki, where an already established community of citizen scientists collect land cover and land use data for different research applications.

Validity of a physical activity questionnaire among African-American Seventh-day Adventists.

PubMed

Singh, P N; Fraser, G E; Knutsen, S F; Lindsted, K D; Bennett, H W

2001-03-01

Physical activity has been identified as an important predictor of chronic disease risk in numerous studies in which activity levels were measured by questionnaire. Although the validity of physical activity questionnaires has been documented in a number of studies of U.S. adults, few have included a validation analysis among blacks. We have examined the validity and reliability of a physical activity questionnaire that was administered to 165 black Seventh-day Adventists from Southern California. Subjects completed a self-administered physical activity questionnaire and then "reference" measures of activity (7-d activity recalls, pedometer readings) and fitness (treadmill test) were completed in subsets of this population. The authors found that 7-d recall activity levels correlated well with the corresponding questionnaire indices among women (total activity, r = 0.65; vigorous, r = 0.85; moderate, r = 0.44; inactivity, r = 0.59; sleep duration, r = 0.52) and men (total activity, r = 0.51; vigorous, r = 0.65; moderate, r = 0.53; inactivity, r = 0.69; sleep duration, r = 0.39). Vigorous activity from 7-d recalls was best measured by gender-specific indices that included only recreational activities among men and emphasized nonrecreational activities among women. Correlations between questionnaire data and the other "reference" measures were lower. Test-retest correlations of questionnaire items over a 6-wk interval were high (r = 0.4-0.9). Simple questions can measure activities of different intensity with good validity and reliability among black Adventist men and women.

Dried blood spot testing for seven steroids using liquid chromatography-tandem mass spectrometry with reference interval determination in the Korean population.

PubMed

Kim, Borahm; Lee, Mi Na; Park, Hyung Doo; Kim, Jong Won; Chang, Yun Sil; Park, Won Soon; Lee, Soo Youn

2015-11-01

Conventional screening for congenital adrenal hyperplasia (CAH) using immunoassays generates a large number of false-positive results. A more specific liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been introduced to minimize unnecessary follow-ups. However, because of limited data on its use in the Korean population, LC-MS/MS has not yet been incorporated into newborn screening programs in this region. The present study aims to develop and validate an LC-MS/MS method for the simultaneous determination of seven steroids in dried blood spots (DBS) for CAH screening, and to define age-specific reference intervals in the Korean population. We developed and validated an LC-MS/MS method to determine the reference intervals of cortisol, 17-hydroxyprogesterone, 11-deoxycortisol, 21-deoxycortisol, androstenedione, corticosterone, and 11-deoxycorticosterone simultaneously in 453 DBS samples. The samples were from Korean subjects stratified by age group (78 full-term neonates, 76 premature neonates, 89 children, and 100 adults). The accuracy, precision, matrix effects, and extraction recovery were satisfactory for all the steroids at three concentrations; values of intra- and inter-day precision coefficients of variance, bias, and recovery were 0.7-7.7%, -1.5-9.8%, and 49.3-97.5%, respectively. The linearity range was 1-100 ng/mL for cortisol and 0.5-50 ng/mL for other steroids (R²>0.99). The reference intervals were in agreement with the previous reports. This LC-MS/MS method and the reference intervals validated in the Korean population can be successfully applied to analyze seven steroids in DBS for the diagnosis of CAH.

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.

Validation of a questionnaire method for estimating extent of menstrual blood loss in young adult women.

PubMed

Heath, A L; Skeaff, C M; Gibson, R S

1999-04-01

The objective of this study was to validate two indirect methods for estimating the extent of menstrual blood loss against a reference method to determine which method would be most appropriate for use in a population of young adult women. Thirty-two women aged 18 to 29 years (mean +/- SD; 22.4 +/- 2.8) were recruited by poster in Dunedin (New Zealand). Data are presented for 29 women. A recall method and a record method for estimating extent of menstrual loss were validated against a weighed reference method. Spearman rank correlation coefficients between blood loss assessed by Weighed Menstrual Loss and Menstrual Record was rs = 0.47 (p = 0.012), and between Weighed Menstrual Loss and Menstrual Recall, was rs = 0.61 (p = 0.001). The Record method correctly classified 66% of participants into the same tertile, grossly misclassifying 14%. The Recall method correctly classified 59% of participants, grossly misclassifying 7%. Reference method menstrual loss calculated for surrogate categories demonstrated a significant difference between the second and third tertiles for the Record method, and between the first and third tertiles for the Recall method. The Menstrual Recall method can differentiate between low and high levels of menstrual blood loss in young adult women, is quick to complete and analyse, and has a low participant burden.

Field validation of secondary data sources for enumerating retail tobacco outlets in a state without tobacco outlet licensing.

PubMed

D'Angelo, Heather; Fleischhacker, Sheila; Rose, Shyanika W; Ribisl, Kurt M

2014-07-01

Identifying tobacco retail outlets for U.S. FDA compliance checks or calculating tobacco outlet density is difficult in the 13 States without tobacco retail licensing or where licensing lists are unavailable for research. This study uses primary data collection to identify tobacco outlets in three counties in a non-licensing state and validate two commercial secondary data sources. We calculated sensitivity and positive predictive values (PPV) to examine the evidence of validity for two secondary data sources, and conducted a geospatial analysis to determine correct allocation to census tract. ReferenceUSA had almost perfect sensitivity (0.82) while Dun & Bradstreet (D&B) had substantial sensitivity (0.69) for identifying tobacco outlets; combined, sensitivity improved to 0.89. D&B identified fewer "false positives" with a PPV of 0.82 compared to 0.71 for ReferenceUSA. More than 90% of the outlets identified by ReferenceUSA were geocoded to the correct census tract. Combining two commercial data sources resulted in enumeration of nearly 90% of tobacco outlets in a three county area. Commercial databases appear to provide a reasonably accurate way to identify tobacco outlets for enforcement operations and density estimation. Copyright © 2014 Elsevier Ltd. All rights reserved.

Selection and validation of reference genes for miRNA expression studies during porcine pregnancy.

PubMed

Wessels, Jocelyn M; Edwards, Andrew K; Zettler, Candace; Tayade, Chandrakant

2011-01-01

MicroRNAs comprise a family of small non-coding RNAs that modulate several developmental and physiological processes including pregnancy. Their ubiquitous presence is confirmed in mammals, worms, flies and plants. Although rapid advances have been made in microRNA research, information on stable reference genes for validation of microRNA expression is still lacking. Real time PCR is a widely used tool to quantify gene transcripts. An appropriate reference gene must be chosen to minimize experimental error in this system. A small difference in miRNA levels between experimental samples can be biologically meaningful as these entities can affect multiple targets in a pathway. This study examined the suitability of six commercially available reference genes (RNU1A, RNU5A, RNU6B, SNORD25, SCARNA17, and SNORA73A) in maternal-fetal tissues from healthy and spontaneously arresting/dying conceptuses from sows were separately analyzed at gestation day 20. Comparisons were also made with non-pregnant endometrial tissues from sows. Spontaneous fetal loss is a prime concern to the commercial pork industry. Our laboratory has previously identified deficits in vasculature development at maternal-fetal interface as one of the major participating causes of fetal loss. Using this well-established model, we have extended our studies to identify suitable microRNA reference genes. A methodical approach to assessing suitability was adopted using standard curve and melting curve analysis, PCR product sequencing, real time PCR expression in a panel of gestational tissues, and geNorm and NormFinder analysis. Our quantitative real time PCR analysis confirmed expression of all 6 reference genes in maternal and fetal tissues. All genes were uniformly expressed in tissues from healthy and spontaneously arresting conceptus attachment sites. Comparisons between tissue types (maternal/fetal/non-pregnant) revealed significant differences for RNU5A, RNU6B, SCARNA17, and SNORA73A expression. Based on our methodical assessment of all 6 reference genes, results suggest that RNU1A is the most stable reference gene for porcine pregnancy studies.

Validating EHR documents: automatic schematron generation using archetypes.

PubMed

Pfeiffer, Klaus; Duftschmid, Georg; Rinner, Christoph

2014-01-01

The goal of this study was to examine whether Schematron schemas can be generated from archetypes. The openEHR Java reference API was used to transform an archetype into an object model, which was then extended with context elements. The model was processed and the constraints were transformed into corresponding Schematron assertions. A prototype of the generator for the reference model HL7 v3 CDA R2 was developed and successfully tested. Preconditions for its reusability with other reference models were set. Our results indicate that an automated generation of Schematron schemas is possible with some limitations.

A semi-automatic method for left ventricle volume estimate: an in vivo validation study

NASA Technical Reports Server (NTRS)

Corsi, C.; Lamberti, C.; Sarti, A.; Saracino, G.; Shiota, T.; Thomas, J. D.

2001-01-01

This study aims to the validation of the left ventricular (LV) volume estimates obtained by processing volumetric data utilizing a segmentation model based on level set technique. The validation has been performed by comparing real-time volumetric echo data (RT3DE) and magnetic resonance (MRI) data. A validation protocol has been defined. The validation protocol was applied to twenty-four estimates (range 61-467 ml) obtained from normal and pathologic subjects, which underwent both RT3DE and MRI. A statistical analysis was performed on each estimate and on clinical parameters as stroke volume (SV) and ejection fraction (EF). Assuming MRI estimates (x) as a reference, an excellent correlation was found with volume measured by utilizing the segmentation procedure (y) (y=0.89x + 13.78, r=0.98). The mean error on SV was 8 ml and the mean error on EF was 2%. This study demonstrated that the segmentation technique is reliably applicable on human hearts in clinical practice.

Validity for What? The Peril of Overclarifying

ERIC Educational Resources Information Center

Murphy, Kevin R.

2012-01-01

As Paul Newton so ably demonstrates, the concept of validity is both important and problematic. Over the last several decades, a consensus definition of validity has emerged; the current edition of "Standards for Educational and Psychological Testing" notes, "Validity refers to the degree to which evidence and theory support the interpretations of…

On the Validity of Useless Tests

ERIC Educational Resources Information Center

Sireci, Stephen G.

2016-01-01

A misconception exists that validity may refer only to the "interpretation" of test scores and not to the "uses" of those scores. The development and evolution of validity theory illustrate test score interpretation was a primary focus in the earliest days of modern testing, and that validating interpretations derived from test…

40 CFR 1065.514 - Cycle-validation criteria for operation over specified duty cycles.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 34 2012-07-01 2012-07-01 false Cycle-validation criteria for... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...-validation criteria. You must compare the original reference duty cycle points generated as described in...

40 CFR 1065.514 - Cycle-validation criteria for operation over specified duty cycles.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 34 2013-07-01 2013-07-01 false Cycle-validation criteria for... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...-validation criteria. You must compare the original reference duty cycle points generated as described in...

40 CFR 1065.514 - Cycle-validation criteria for operation over specified duty cycles.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 33 2011-07-01 2011-07-01 false Cycle-validation criteria for... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...-validation criteria. You must compare the original reference duty cycle points generated as described in...

40 CFR 1065.514 - Cycle-validation criteria for operation over specified duty cycles.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 33 2014-07-01 2014-07-01 false Cycle-validation criteria for... Over Specified Duty Cycles § 1065.514 Cycle-validation criteria for operation over specified duty...-validation criteria. You must compare the original reference duty cycle points generated as described in...

Validity Issues in Clinical Assessment.

ERIC Educational Resources Information Center

Foster, Sharon L.; Cone, John D.

1995-01-01

Validation issues that arise with measures of constructs and behavior are addressed with reference to general reasons for using assessment procedures in clinical psychology. A distinction is made between the representational phase of validity assessment and the elaborative validity phase in which the meaning and utility of scores are examined.…

Quantitative Imaging Biomarkers: A Review of Statistical Methods for Computer Algorithm Comparisons

PubMed Central

2014-01-01

Quantitative biomarkers from medical images are becoming important tools for clinical diagnosis, staging, monitoring, treatment planning, and development of new therapies. While there is a rich history of the development of quantitative imaging biomarker (QIB) techniques, little attention has been paid to the validation and comparison of the computer algorithms that implement the QIB measurements. In this paper we provide a framework for QIB algorithm comparisons. We first review and compare various study designs, including designs with the true value (e.g. phantoms, digital reference images, and zero-change studies), designs with a reference standard (e.g. studies testing equivalence with a reference standard), and designs without a reference standard (e.g. agreement studies and studies of algorithm precision). The statistical methods for comparing QIB algorithms are then presented for various study types using both aggregate and disaggregate approaches. We propose a series of steps for establishing the performance of a QIB algorithm, identify limitations in the current statistical literature, and suggest future directions for research. PMID:24919829

Rediscovery rate estimation for assessing the validation of significant findings in high-throughput studies.

PubMed

Ganna, Andrea; Lee, Donghwan; Ingelsson, Erik; Pawitan, Yudi

2015-07-01

It is common and advised practice in biomedical research to validate experimental or observational findings in a population different from the one where the findings were initially assessed. This practice increases the generalizability of the results and decreases the likelihood of reporting false-positive findings. Validation becomes critical when dealing with high-throughput experiments, where the large number of tests increases the chance to observe false-positive results. In this article, we review common approaches to determine statistical thresholds for validation and describe the factors influencing the proportion of significant findings from a 'training' sample that are replicated in a 'validation' sample. We refer to this proportion as rediscovery rate (RDR). In high-throughput studies, the RDR is a function of false-positive rate and power in both the training and validation samples. We illustrate the application of the RDR using simulated data and real data examples from metabolomics experiments. We further describe an online tool to calculate the RDR using t-statistics. We foresee two main applications. First, if the validation study has not yet been collected, the RDR can be used to decide the optimal combination between the proportion of findings taken to validation and the size of the validation study. Secondly, if a validation study has already been done, the RDR estimated using the training data can be compared with the observed RDR from the validation data; hence, the success of the validation study can be assessed. © The Author 2014. Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

AFNOR validation of Premi Test, a microbiological-based screening tube-test for the detection of antimicrobial residues in animal muscle tissue.

PubMed

Gaudin, Valerie; Juhel-Gaugain, Murielle; Morétain, Jean-Pierre; Sanders, Pascal

2008-12-01

Premi Test contains viable spores of a strain of Bacillus stearothermophilus which is sensitive to antimicrobial residues, such as beta-lactams, tetracyclines, macrolides and sulphonamides. The growth of the strain is inhibited by the presence of antimicrobial residues in muscle tissue samples. Premi Test was validated according to AFNOR rules (French Association for Normalisation). The AFNOR validation was based on the comparison of reference methods (French Official method, i.e. four plate test (FPT) and the STAR protocol (five plate test)) with the alternative method (Premi Test). A preliminary study was conducted in an expert laboratory (Community Reference Laboratory, CRL) on both spiked and incurred samples (field samples). Several method performance criteria (sensitivity, specificity, relative accuracy) were estimated and are discussed, in addition to detection capabilities. Adequate agreement was found between the alternative method and the reference methods. However, Premi Test was more sensitive to beta-lactams and sulphonamides than the FPT. Subsequently, a collaborative study with 11 laboratories was organised by the CRL. Blank and spiked meat juice samples were sent to participants. The expert laboratory (CRL) statistically analysed the results. It was concluded that Premi Test could be used for the routine determination of antimicrobial residues in muscle of different animal origin with acceptable analytical performance. The detection capabilities of Premi Test for beta-lactams (amoxicillin, ceftiofur), one macrolide (tylosin) and tetracycline were at the level of the respective maximum residue limits (MRL) in muscle samples or even lower.

Identification and validation of reference genes for quantitative real-time PCR normalization and its applications in lycium.

PubMed

Zeng, Shaohua; Liu, Yongliang; Wu, Min; Liu, Xiaomin; Shen, Xiaofei; Liu, Chunzhao; Wang, Ying

2014-01-01

Lycium barbarum and L. ruthenicum are extensively used as traditional Chinese medicinal plants. Next generation sequencing technology provides a powerful tool for analyzing transcriptomic profiles of gene expression in non-model species. Such gene expression can then be confirmed with quantitative real-time polymerase chain reaction (qRT-PCR). Therefore, use of systematically identified suitable reference genes is a prerequisite for obtaining reliable gene expression data. Here, we calculated the expression stability of 18 candidate reference genes across samples from different tissues and grown under salt stress using geNorm and NormFinder procedures. The geNorm-determined rank of reference genes was similar to those defined by NormFinder with some differences. Both procedures confirmed that the single most stable reference gene was ACNTIN1 for L. barbarum fruits, H2B1 for L. barbarum roots, and EF1α for L. ruthenicum fruits. PGK3, H2B2, and PGK3 were identified as the best stable reference genes for salt-treated L. ruthenicum leaves, roots, and stems, respectively. H2B1 and GAPDH1+PGK1 for L. ruthenicum and SAMDC2+H2B1 for L. barbarum were the best single and/or combined reference genes across all samples. Finally, expression of salt-responsive gene NAC, fruit ripening candidate gene LrPG, and anthocyanin genes were investigated to confirm the validity of the selected reference genes. Suitable reference genes identified in this study provide a foundation for accurately assessing gene expression and further better understanding of novel gene function to elucidate molecular mechanisms behind particular biological/physiological processes in Lycium.

Spectroscopic characterization and quantitative determination of atorvastatin calcium impurities by novel HPLC method

NASA Astrophysics Data System (ADS)

Gupta, Lokesh Kumar

2012-11-01

Seven process related impurities were identified by LC-MS in the atorvastatin calcium drug substance. These impurities were identified by LC-MS. The structure of impurities was confirmed by modern spectroscopic techniques like 1H NMR and IR and physicochemical studies conducted by using synthesized authentic reference compounds. The synthesized reference samples of the impurity compounds were used for the quantitative HPLC determination. These impurities were detected by newly developed gradient, reverse phase high performance liquid chromatographic (HPLC) method. The system suitability of HPLC analysis established the validity of the separation. The analytical method was validated according to International Conference of Harmonization (ICH) with respect to specificity, precision, accuracy, linearity, robustness and stability of analytical solutions to demonstrate the power of newly developed HPLC method.

Accounting for phase drifts in SSVEP-based BCIs by means of biphasic stimulation.

PubMed

Wu, Hung-Yi; Lee, Po-Lei; Chang, Hsiang-Chih; Hsieh, Jen-Chuen

2011-05-01

This study proposes a novel biphasic stimulation technique to solve the issue of phase drifts in steady-state visual evoked potential (SSVEPs) in phase-tagged systems. Phase calibration was embedded in stimulus sequences using a biphasic flicker, which is driven by a sequence with alternating reference and phase-shift states. Nine subjects were recruited to participate in off-line and online tests. Signals were bandpass filtered and segmented by trigger signals into reference and phase-shift epochs. Frequency components of SSVEP in the reference and phase-shift epochs were extracted using the Fourier method with a 50% overlapped sliding window. The real and imaginary parts of the SSVEP frequency components were organized into complex vectors in each epoch. Hotelling's t-square test was used to determine the significances of nonzero mean vectors. The rejection of noisy data segments and the validation of gaze detections were made based on p values. The phase difference between the valid mean vectors of reference and phase-shift epochs was used to identify user's gazed targets in this system. Data showed an average information transfer rate of 44.55 and 38.21 bits/min in off-line and online tests, respectively. © 2011 IEEE

Analytical validation and establishment of reference intervals for a 'high-sensitivity' cardiac troponin-T assay in horses.

PubMed

Shields, E; Seiden-Long, I; Massie, S; Passante, S; Leguillette, R

2016-06-13

Cardiac troponin-I assays have been validated in horses.'High-sensitivity' cardiac troponin assays are now the standard in human cardiology. Appropriately validate the'high-sensitivity' cardiac Troponin-T (hscTnT) assay for clinical use in horses, establish reference intervals, determine the biological variation, and demonstrate assay utility in selected clinical cases. Analytical validation of the Roche hscTnT assay included within- and between-run precision, linear dose response, limit of quantitation (LoQ), stability, and comparison with cTn-I (iSTAT). Reference intervals and biological variation were determined using adult, healthy, Non-Competition Horses (N = 125) and Racing-Thoroughbreds (N = 178). HscTnT levels were measured in two horses with cardiac pathology. The hscTnT demonstrates acceptable within-run (L1 = 6.5 ng/L, CV 14.9 %, L2 = 10.1 ng/L, CV 8.7 %, L3 = 15.3 ng/L, CV 5.4 %) and between-run precision (L1 = 12.2 ng/L, CV 8.4 %, L2 = 57.0 ng/L, CV 8.4 %, L3 = 256.0 ng/L, CV 9.0 %). The assay was linear from 3 to 391 ng/L. The LoQ was validated at 3 ng/L. Samples demonstrated insignificant decay over freeze-thaw cycle. Comparison with cTnI assay showed excellent correlation (range: 8.0-3535.0 ng/L, R(2) = 0.9996). Reference intervals: The upper 95(th) and 99(th) percentile of the hscTnT population distribution were 6.8 and 16.2 ng/L in Non-Competition Horses, and 14.0 and 23.2 ng/L in Racing-Thoroughbreds. Between-breed, diurnal effect, and between-day variation was below LoQ. Two clinical cases with presumed cardiac pathology had hscTnT levels of 220.9 ng/L and 5723.0 ng/L. This benchmark study is the first to comply with CLSI guidelines, thus further establishing the performance characteristics of the hscTnT assay, and reference intervals in healthy horses. Two clinical cases demonstrated further the clinical utility of the assay.

Reference Gene Validation for RT-qPCR, a Note on Different Available Software Packages

PubMed Central

De Spiegelaere, Ward; Dern-Wieloch, Jutta; Weigel, Roswitha; Schumacher, Valérie; Schorle, Hubert; Nettersheim, Daniel; Bergmann, Martin; Brehm, Ralph; Kliesch, Sabine; Vandekerckhove, Linos; Fink, Cornelia

2015-01-01

Background An appropriate normalization strategy is crucial for data analysis from real time reverse transcription polymerase chain reactions (RT-qPCR). It is widely supported to identify and validate stable reference genes, since no single biological gene is stably expressed between cell types or within cells under different conditions. Different algorithms exist to validate optimal reference genes for normalization. Applying human cells, we here compare the three main methods to the online available RefFinder tool that integrates these algorithms along with R-based software packages which include the NormFinder and GeNorm algorithms. Results 14 candidate reference genes were assessed by RT-qPCR in two sample sets, i.e. a set of samples of human testicular tissue containing carcinoma in situ (CIS), and a set of samples from the human adult Sertoli cell line (FS1) either cultured alone or in co-culture with the seminoma like cell line (TCam-2) or with equine bone marrow derived mesenchymal stem cells (eBM-MSC). Expression stabilities of the reference genes were evaluated using geNorm, NormFinder, and BestKeeper. Similar results were obtained by the three approaches for the most and least stably expressed genes. The R-based packages NormqPCR, SLqPCR and the NormFinder for R script gave identical gene rankings. Interestingly, different outputs were obtained between the original software packages and the RefFinder tool, which is based on raw Cq values for input. When the raw data were reanalysed assuming 100% efficiency for all genes, then the outputs of the original software packages were similar to the RefFinder software, indicating that RefFinder outputs may be biased because PCR efficiencies are not taken into account. Conclusions This report shows that assay efficiency is an important parameter for reference gene validation. New software tools that incorporate these algorithms should be carefully validated prior to use. PMID:25825906

Reference gene validation for RT-qPCR, a note on different available software packages.

PubMed

De Spiegelaere, Ward; Dern-Wieloch, Jutta; Weigel, Roswitha; Schumacher, Valérie; Schorle, Hubert; Nettersheim, Daniel; Bergmann, Martin; Brehm, Ralph; Kliesch, Sabine; Vandekerckhove, Linos; Fink, Cornelia

2015-01-01

An appropriate normalization strategy is crucial for data analysis from real time reverse transcription polymerase chain reactions (RT-qPCR). It is widely supported to identify and validate stable reference genes, since no single biological gene is stably expressed between cell types or within cells under different conditions. Different algorithms exist to validate optimal reference genes for normalization. Applying human cells, we here compare the three main methods to the online available RefFinder tool that integrates these algorithms along with R-based software packages which include the NormFinder and GeNorm algorithms. 14 candidate reference genes were assessed by RT-qPCR in two sample sets, i.e. a set of samples of human testicular tissue containing carcinoma in situ (CIS), and a set of samples from the human adult Sertoli cell line (FS1) either cultured alone or in co-culture with the seminoma like cell line (TCam-2) or with equine bone marrow derived mesenchymal stem cells (eBM-MSC). Expression stabilities of the reference genes were evaluated using geNorm, NormFinder, and BestKeeper. Similar results were obtained by the three approaches for the most and least stably expressed genes. The R-based packages NormqPCR, SLqPCR and the NormFinder for R script gave identical gene rankings. Interestingly, different outputs were obtained between the original software packages and the RefFinder tool, which is based on raw Cq values for input. When the raw data were reanalysed assuming 100% efficiency for all genes, then the outputs of the original software packages were similar to the RefFinder software, indicating that RefFinder outputs may be biased because PCR efficiencies are not taken into account. This report shows that assay efficiency is an important parameter for reference gene validation. New software tools that incorporate these algorithms should be carefully validated prior to use.

Reference values of elements in human hair: a systematic review.

PubMed

Mikulewicz, Marcin; Chojnacka, Katarzyna; Gedrange, Thomas; Górecki, Henryk

2013-11-01

The lack of systematic review on reference values of elements in human hair with the consideration of methodological approach. The absence of worldwide accepted and implemented universal reference ranges causes that hair mineral analysis has not become yet a reliable and useful method of assessment of nutritional status and exposure of individuals. Systematic review of reference values of elements in human hair. PubMed, ISI Web of Knowledge, Scopus. Humans, hair mineral analysis, elements or minerals, reference values, original studies. The number of studies screened and assessed for eligibility was 52. Eventually, included in the review were 5 papers. The studies report reference ranges for the content of elements in hair: macroelements, microelements, toxic elements and other elements. Reference ranges were elaborated for different populations in the years 2000-2012. The analytical methodology differed, in particular sample preparation, digestion and analysis (ICP-AES, ICP-MS). Consequently, the levels of hair minerals reported as reference values varied. It is necessary to elaborate the standard procedures and furtherly validate hair mineral analysis and deliver detailed methodology. Only then it would be possible to provide meaningful reference ranges and take advantage of the potential that lies in Hair Mineral Analysis as a medical diagnostic technique. Copyright © 2013 Elsevier B.V. All rights reserved.

Validated age-specific reference values for CSF total protein levels in children.

PubMed

Kahlmann, V; Roodbol, J; van Leeuwen, N; Ramakers, C R B; van Pelt, D; Neuteboom, R F; Catsman-Berrevoets, C E; de Wit, M C Y; Jacobs, B C

2017-07-01

To define age-specific reference values for cerebrospinal fluid (CSF) total protein levels for children and validate these values in children with Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis (ADEM) and multiple sclerosis (MS). Reference values for CSF total protein levels were determined in an extensive cohort of diagnostic samples from children (<18 year) evaluated at Erasmus Medical Center/Sophia Children's Hospital. These reference values were confirmed in children diagnosed with disorders unrelated to raised CSF total protein level and validated in children with GBS, ADEM and MS. The test results of 6145 diagnostic CSF samples from 3623 children were used to define reference values. The reference values based on the upper limit of the 95% CI (i.e. upper limit of normal) were for 6 months-2 years 0.25 g/L, 2-6 years 0.25 g/L, 6-12 years 0.28 g/L, 12-18 years 0.34 g/L. These reference values were confirmed in a subgroup of 378 children diagnosed with disorders that are not typically associated with increased CSF total protein. In addition, the CSF total protein levels in these children in the first 6 months after birth were highly variable (median 0.47 g/L, IQR 0.26-0.65). According to these new reference values, CSF total protein level was elevated in 85% of children with GBS, 66% with ADEM and 23% with MS. More accurate age-specific reference values for CSF total protein levels in children were determined. These new reference values are more sensitive than currently used values for diagnosing GBS and ADEM in children. Copyright © 2017 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

The Psychometric Properties of Classroom Response System Data: A Case Study

ERIC Educational Resources Information Center

Kortemeyer, Gerd

2016-01-01

Classroom response systems (often referred to as "clickers") have slowly gained adoption over the recent decade; however, critics frequently doubt their pedagogical value starting with the validity of the gathered responses: There is concern that students simply "click" random answers. This case study looks at different…

Reference genes for real-time PCR quantification of messenger RNAs and microRNAs in mouse model of obesity.

PubMed

Matoušková, Petra; Bártíková, Hana; Boušová, Iva; Hanušová, Veronika; Szotáková, Barbora; Skálová, Lenka

2014-01-01

Obesity and metabolic syndrome is increasing health problem worldwide. Among other ways, nutritional intervention using phytochemicals is important method for treatment and prevention of this disease. Recent studies have shown that certain phytochemicals could alter the expression of specific genes and microRNAs (miRNAs) that play a fundamental role in the pathogenesis of obesity. For study of the obesity and its treatment, monosodium glutamate (MSG)-injected mice with developed central obesity, insulin resistance and liver lipid accumulation are frequently used animal models. To understand the mechanism of phytochemicals action in obese animals, the study of selected genes expression together with miRNA quantification is extremely important. For this purpose, real-time quantitative PCR is a sensitive and reproducible method, but it depends on proper normalization entirely. The aim of present study was to identify the appropriate reference genes for mRNA and miRNA quantification in MSG mice treated with green tea catechins, potential anti-obesity phytochemicals. Two sets of reference genes were tested: first set contained seven commonly used genes for normalization of messenger RNA, the second set of candidate reference genes included ten small RNAs for normalization of miRNA. The expression stability of these reference genes were tested upon treatment of mice with catechins using geNorm, NormFinder and BestKeeper algorithms. Selected normalizers for mRNA quantification were tested and validated on expression of quinone oxidoreductase, biotransformation enzyme known to be modified by catechins. The effect of selected normalizers for miRNA quantification was tested on two obesity- and diabetes- related miRNAs, miR-221 and miR-29b, respectively. Finally, the combinations of B2M/18S/HPRT1 and miR-16/sno234 were validated as optimal reference genes for mRNA and miRNA quantification in liver and 18S/RPlP0/HPRT1 and sno234/miR-186 in small intestine of MSG mice. These reference genes will be used for mRNA and miRNA normalization in further study of green tea catechins action in obese mice.

Evaluation of bone formation in calcium phosphate scaffolds with μCT-method validation using SEM.

PubMed

Lewin, S; Barba, A; Persson, C; Franch, J; Ginebra, M-P; Öhman-Mägi, C

2017-10-05

There is a plethora of calcium phosphate (CaP) scaffolds used as synthetic substitutes to bone grafts. The scaffold performance is often evaluated from the quantity of bone formed within or in direct contact with the scaffold. Micro-computed tomography (μCT) allows three-dimensional evaluation of bone formation inside scaffolds. However, the almost identical x-ray attenuation of CaP and bone obtrude the separation of these phases in μCT images. Commonly, segmentation of bone in μCT images is based on gray scale intensity, with manually determined global thresholds. However, image analysis methods, and methods for manual thresholding in particular, lack standardization and may consequently suffer from subjectivity. The aim of the present study was to provide a methodological framework for addressing these issues. Bone formation in two types of CaP scaffold architectures (foamed and robocast), obtained from a larger animal study (a 12 week canine animal model) was evaluated by μCT. In addition, cross-sectional scanning electron microscopy (SEM) images were acquired as references to determine thresholds and to validate the result. μCT datasets were registered to the corresponding SEM reference. Global thresholds were then determined by quantitatively correlating the different area fractions in the μCT image, towards the area fractions in the corresponding SEM image. For comparison, area fractions were also quantified using global thresholds determined manually by two different approaches. In the validation the manually determined thresholds resulted in large average errors in area fraction (up to 17%), whereas for the evaluation using SEM references, the errors were estimated to be less than 3%. Furthermore, it was found that basing the thresholds on one single SEM reference gave lower errors than determining them manually. This study provides an objective, robust and less error prone method to determine global thresholds for the evaluation of bone formation in CaP scaffolds.

Validity of two alternative systems for measuring vertical jump height.

PubMed

Leard, John S; Cirillo, Melissa A; Katsnelson, Eugene; Kimiatek, Deena A; Miller, Tim W; Trebincevic, Kenan; Garbalosa, Juan C

2007-11-01

Vertical jump height is frequently used by coaches, health care professionals, and strength and conditioning professionals to objectively measure function. The purpose of this study is to determine the concurrent validity of the jump and reach method (Vertec) and the contact mat method (Just Jump) in assessing vertical jump height when compared with the criterion reference 3-camera motion analysis system. Thirty-nine college students, 25 females and 14 males between the ages of 18 and 25 (mean age 20.65 years), were instructed to perform the countermovement jump. Reflective markers were placed at the base of the individual's sacrum for the 3-camera motion analysis system to measure vertical jump height. The subject was then instructed to stand on the Just Jump mat beneath the Vertec and perform the jump. Measurements were recorded from each of the 3 systems simultaneously for each jump. The Pearson r statistic between the video and the jump and reach (Vertec) was 0.906. The Pearson r between the video and contact mat (Just Jump) was 0.967. Both correlations were significant at the 0.01 level. Analysis of variance showed a significant difference among the 3 means F(2,235) = 5.51, p < 0.05. The post hoc analysis showed a significant difference between the criterion reference (M = 0.4369 m) and the Vertec (M = 0.3937 m, p = 0.005) but not between the criterion reference and the Just Jump system (M = 0.4420 m, p = 0.972). The Just Jump method of measuring vertical jump height is a valid measure when compared with the 3-camera system. The Vertec was found to have a high correlation with the criterion reference, but the mean differed significantly. This study indicates that a higher degree of confidence is warranted when comparing Just Jump results with a 3-camera system study.

Clinical Validation of a Smartphone-Based Adapter for Optic Disc Imaging in Kenya.

PubMed

Bastawrous, Andrew; Giardini, Mario Ettore; Bolster, Nigel M; Peto, Tunde; Shah, Nisha; Livingstone, Iain A T; Weiss, Helen A; Hu, Sen; Rono, Hillary; Kuper, Hannah; Burton, Matthew

2016-02-01

Visualization and interpretation of the optic nerve and retina are essential parts of most physical examinations. To design and validate a smartphone-based retinal adapter enabling image capture and remote grading of the retina. This validation study compared the grading of optic nerves from smartphone images with those of a digital retinal camera. Both image sets were independently graded at Moorfields Eye Hospital Reading Centre. Nested within the 6-year follow-up (January 7, 2013, to March 12, 2014) of the Nakuru Eye Disease Cohort in Kenya, 1460 adults (2920 eyes) 55 years and older were recruited consecutively from the study. A subset of 100 optic disc images from both methods were further used to validate a grading app for the optic nerves. Data analysis was performed April 7 to April 12, 2015. Vertical cup-disc ratio for each test was compared in terms of agreement (Bland-Altman and weighted κ) and test-retest variability. A total of 2152 optic nerve images were available from both methods (also 371 from the reference camera but not the smartphone, 170 from the smartphone but not the reference camera, and 227 from neither the reference camera nor the smartphone). Bland-Altman analysis revealed a mean difference of 0.02 (95% CI, -0.21 to 0.17) and a weighted κ coefficient of 0.69 (excellent agreement). The grades of an experienced retinal photographer were compared with those of a lay photographer (no health care experience before the study), and no observable difference in image acquisition quality was found. Nonclinical photographers using the low-cost smartphone adapter were able to acquire optic nerve images at a standard that enabled independent remote grading of the images comparable to those acquired using a desktop retinal camera operated by an ophthalmic assistant. The potential for task shifting and the detection of avoidable causes of blindness in the most at-risk communities makes this an attractive public health intervention.

Design and validation of an open-source library of dynamic reference frames for research and education in optical tracking.

PubMed

Brown, Alisa; Uneri, Ali; Silva, Tharindu De; Manbachi, Amir; Siewerdsen, Jeffrey H

2018-04-01

Dynamic reference frames (DRFs) are a common component of modern surgical tracking systems; however, the limited number of commercially available DRFs poses a constraint in developing systems, especially for research and education. This work presents the design and validation of a large, open-source library of DRFs compatible with passive, single-face tracking systems, such as Polaris stereoscopic infrared trackers (NDI, Waterloo, Ontario). An algorithm was developed to create new DRF designs consistent with intra- and intertool design constraints and convert to computer-aided design (CAD) files suitable for three-dimensional printing. A library of 10 such groups, each with 6 to 10 DRFs, was produced and tracking performance was validated in comparison to a standard commercially available reference, including pivot calibration, fiducial registration error (FRE), and target registration error (TRE). Pivot tests showed calibration error [Formula: see text], indistinguishable from the reference. FRE was [Formula: see text], and TRE in a CT head phantom was [Formula: see text], both equivalent to the reference. The library of DRFs offers a useful resource for surgical navigation research and could be extended to other tracking systems and alternative design constraints.

In vitro vaccine potency testing: a proposal for reducing animal use for requalification testing.

PubMed

Brown, K; Stokes, W

2012-01-01

This paper proposes a program under which the use of animals for requalification of in vitro potency tests could be eliminated. Standard References (USDA/CVB nomenclature) would be developed, characterized, stored and monitored by selected reference laboratories worldwide. These laboratories would employ scientists skilled in protein and glycoprotein chemistry and equipped with state-of-the-art instruments for required analyses. After Standard References are established, the reference laboratories would provide them to the animal health industry as "gold standards". Companies would then establish and validate a correlation between the Standard Reference and the company Master Reference (USDA/CVB nomenclature) using an internal in vitro assay. After this correlation is established, the company could use the Standard References for qualifying, monitoring and requalifying company Master References without the use of animals. Such a program would eliminate the need for animals for requalification of Master References and the need for each company to develop and validate a battery of Master Reference Monitoring assays. It would also provide advantages in terms of reduced costs and reduced time for requalification testing. As such it would provide a strong incentive for companies to develop and use in vitro assays for potency testing.

Bioinformatics approach for choosing the correct reference genes when studying gene expression in human keratinocytes.

PubMed

Beer, Lucian; Mlitz, Veronika; Gschwandtner, Maria; Berger, Tanja; Narzt, Marie-Sophie; Gruber, Florian; Brunner, Patrick M; Tschachler, Erwin; Mildner, Michael

2015-10-01

Reverse transcription polymerase chain reaction (qRT-PCR) has become a mainstay in many areas of skin research. To enable quantitative analysis, it is necessary to analyse expression of reference genes (RGs) for normalization of target gene expression. The selection of reliable RGs therefore has an important impact on the experimental outcome. In this study, we aimed to identify and validate the best suited RGs for qRT-PCR in human primary keratinocytes (KCs) over a broad range of experimental conditions using the novel bioinformatics tool 'RefGenes', which is based on a manually curated database of published microarray data. Expression of 6 RGs identified by RefGenes software and 12 commonly used RGs were validated by qRT-PCR. We assessed whether these 18 markers fulfilled the requirements for a valid RG by the comprehensive ranking of four bioinformatics tools and the coefficient of variation (CV). In an overall ranking, we found GUSB to be the most stably expressed RG, whereas the expression values of the commonly used RGs, GAPDH and B2M were significantly affected by varying experimental conditions. Our results identify RefGenes as a powerful tool for the identification of valid RGs and suggest GUSB as the most reliable RG for KCs. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Validation of reference genes for RT-qPCR analysis in Herbaspirillum seropedicae.

PubMed

Pessoa, Daniella Duarte Villarinho; Vidal, Marcia Soares; Baldani, José Ivo; Simoes-Araujo, Jean Luiz

2016-08-01

The RT-qPCR technique needs a validated set of reference genes for ensuring the consistency of the results from the gene expression. Expression stabilities for 9 genes from Herbaspirillum seropedicae, strain HRC54, grown with different carbon sources were calculated using geNorm and NormFinder, and the gene rpoA showed the best stability values. Copyright © 2016 Elsevier B.V. All rights reserved.

Biology Curriculum Reform in Venezuela.

ERIC Educational Resources Information Center

Rondon, Leonor Mariasole

2001-01-01

Describes science in the Venezuelan school system which reflects on the process of development followed to design and validate the Biology Study Programs (BSP) with the emphasis on the relevance of curricular changes proposed in biological science for secondary education. (Contains 19 references.) (ASK)

Research Diagnostic Criteria for Temporomandibular Disorders: Validity of Axis I Diagnoses

PubMed Central

Truelove, Edmond; Pan, Wei; Look, John O.; Mancl, Lloyd A.; Ohrbach, Richard K.; Velly, Ana; Huggins, Kimberly; Lenton, Patricia; Schiffman, Eric L.

2011-01-01

AIMS To estimate the criterion validity of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I TMD diagnoses. METHODS A combined total of 614 TMD community and clinic cases and 91 controls were examined at 3 study sites. RDC/TMD Axis I diagnoses were algorithmically derived from an examination performed by calibrated dental hygienists. Reference standards (Gold Standards) were established by means of consensus diagnoses rendered by 2 TMD experts using all available clinical data, including imaging studies. Validity of the RDC/TMD Axis I TMD diagnoses was estimated relative to reference-standard diagnoses (gold standard diagnoses). Target sensitivity and specificity were set a priori at ≥ 0.70 and ≥ 0.95, respectively. RESULTS Target sensitivity and specificity were not observed for any of the 8 RDC/TMD diagnoses. The highest validity was achieved for Group Ia myofascial pain (sensitivity 0.65, specificity 0.92) and Group Ib myofascial pain with limited opening (sensitivity 0.79, specificity 0.92). Target sensitivity and specificity were observed only when both Group I diagnoses were combined (0.87 and 0.98, respectively). For Group II (disc displacements) and Group III (arthralgia, arthritis, arthrosis) diagnoses, all estimates for sensitivity were below target (0.03 to 0.53), and specificity ranged from below to on target (0.86 to 0.99). CONCLUSION The RDC/TMD Axis I TMD diagnoses did not reach the targets set at sensitivity of ≥ 0.70 and specificity of ≥ 0.95. Target validity was obtained only for myofascial pain without differentiation between normal and limited opening. Revision of the current Axis I TMD diagnostic algorithms is warranted to improve their validity. PMID:20213030

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.

Model-Free Primitive-Based Iterative Learning Control Approach to Trajectory Tracking of MIMO Systems With Experimental Validation.

PubMed

Radac, Mircea-Bogdan; Precup, Radu-Emil; Petriu, Emil M

2015-11-01

This paper proposes a novel model-free trajectory tracking of multiple-input multiple-output (MIMO) systems by the combination of iterative learning control (ILC) and primitives. The optimal trajectory tracking solution is obtained in terms of previously learned solutions to simple tasks called primitives. The library of primitives that are stored in memory consists of pairs of reference input/controlled output signals. The reference input primitives are optimized in a model-free ILC framework without using knowledge of the controlled process. The guaranteed convergence of the learning scheme is built upon a model-free virtual reference feedback tuning design of the feedback decoupling controller. Each new complex trajectory to be tracked is decomposed into the output primitives regarded as basis functions. The optimal reference input for the control system to track the desired trajectory is next recomposed from the reference input primitives. This is advantageous because the optimal reference input is computed straightforward without the need to learn from repeated executions of the tracking task. In addition, the optimization problem specific to trajectory tracking of square MIMO systems is decomposed in a set of optimization problems assigned to each separate single-input single-output control channel that ensures a convenient model-free decoupling. The new model-free primitive-based ILC approach is capable of planning, reasoning, and learning. A case study dealing with the model-free control tuning for a nonlinear aerodynamic system is included to validate the new approach. The experimental results are given.

Design, development, testing and validation of a Photonics Virtual Laboratory for the study of LEDs

NASA Astrophysics Data System (ADS)

Naranjo, Francisco L.; Martínez, Guadalupe; Pérez, Ángel L.; Pardo, Pedro J.

2014-07-01

This work presents the design, development, testing and validation of a Photonic Virtual Laboratory, highlighting the study of LEDs. The study was conducted from a conceptual, experimental and didactic standpoint, using e-learning and m-learning platforms. Specifically, teaching tools that help ensure that our students perform significant learning have been developed. It has been brought together the scientific aspect, such as the study of LEDs, with techniques of generation and transfer of knowledge through the selection, hierarchization and structuring of information using concept maps. For the validation of the didactic materials developed, it has been used procedures with various assessment tools for the collection and processing of data, applied in the context of an experimental design. Additionally, it was performed a statistical analysis to determine the validity of the materials developed. The assessment has been designed to validate the contributions of the new materials developed over the traditional method of teaching, and to quantify the learning achieved by students, in order to draw conclusions that serve as a reference for its application in the teaching and learning processes, and comprehensively validate the work carried out.

Age-related reduction of trunk muscle torque and prevalence of trunk sarcopenia in community-dwelling elderly: Validity of a portable trunk muscle torque measurement instrument and its application to a large sample cohort study

PubMed Central

Sasaki, Shizuka; Chiba, Daisuke; Yamamoto, Yuji; Nawata, Atsushi; Tsuda, Eiichi; Nakaji, Shigeyuki; Ishibashi, Yasuyuki

2018-01-01

Trunk muscle weakness and imbalance are risk factors for postural instability, low back pain, and poor postoperative outcomes. The association between trunk muscle strength and aging is poorly understood, and establishing normal reference values is difficult. We aimed to establish the validity of a novel portable trunk muscle torque measurement instrument (PTMI). We then estimated reference data for healthy young adults and elucidated age-related weakness in trunk muscle strength. Twenty-four university students were enrolled to validate values for PTMI, and 816 volunteers from the general population who were recruited to the Iwaki Health Promotion Project were included to estimate reference data for trunk muscle strength. Trunk flexion and extension torque were measured with PTMI and KinCom, and interclass correlation coefficients (ICC) were estimated to evaluate the reliability of PTMI values. Furthermore, from the young adult reference, the age-related reduction in trunk muscle torque and the prevalence of sarcopenia among age-sex groups were estimated. The ICC in flexion and extension torque were 0.807 (p<0.001) and 0.789 (p<0.001), respectively. The prevalence of sarcopenia increased with age, and the prevalence due to flexion torque was double that of extension torque. Flexion torque decreased significantly after 60 years of age, and extension torque decreased after 70 years of age. In males over age 80, trunk muscle torque decreased to 49.1% in flexion and 63.5% in extension. In females over age 80, trunk muscle torque decreased to 60.7% in flexion and 68.4% in extension. The validity of PTMI was confirmed by correlation with KinCom. PTMI produced reference data for healthy young adults, and demonstrated age-related reduction in trunk muscle torque. Trunk sarcopenia progressed with aging, and the loss of flexion torque began earlier than extension torque. At age 80, trunk muscle torque had decreased 60% compared with healthy young adults. PMID:29471310

Age-related reduction of trunk muscle torque and prevalence of trunk sarcopenia in community-dwelling elderly: Validity of a portable trunk muscle torque measurement instrument and its application to a large sample cohort study.

PubMed

Sasaki, Eiji; Sasaki, Shizuka; Chiba, Daisuke; Yamamoto, Yuji; Nawata, Atsushi; Tsuda, Eiichi; Nakaji, Shigeyuki; Ishibashi, Yasuyuki

2018-01-01

Trunk muscle weakness and imbalance are risk factors for postural instability, low back pain, and poor postoperative outcomes. The association between trunk muscle strength and aging is poorly understood, and establishing normal reference values is difficult. We aimed to establish the validity of a novel portable trunk muscle torque measurement instrument (PTMI). We then estimated reference data for healthy young adults and elucidated age-related weakness in trunk muscle strength. Twenty-four university students were enrolled to validate values for PTMI, and 816 volunteers from the general population who were recruited to the Iwaki Health Promotion Project were included to estimate reference data for trunk muscle strength. Trunk flexion and extension torque were measured with PTMI and KinCom, and interclass correlation coefficients (ICC) were estimated to evaluate the reliability of PTMI values. Furthermore, from the young adult reference, the age-related reduction in trunk muscle torque and the prevalence of sarcopenia among age-sex groups were estimated. The ICC in flexion and extension torque were 0.807 (p<0.001) and 0.789 (p<0.001), respectively. The prevalence of sarcopenia increased with age, and the prevalence due to flexion torque was double that of extension torque. Flexion torque decreased significantly after 60 years of age, and extension torque decreased after 70 years of age. In males over age 80, trunk muscle torque decreased to 49.1% in flexion and 63.5% in extension. In females over age 80, trunk muscle torque decreased to 60.7% in flexion and 68.4% in extension. The validity of PTMI was confirmed by correlation with KinCom. PTMI produced reference data for healthy young adults, and demonstrated age-related reduction in trunk muscle torque. Trunk sarcopenia progressed with aging, and the loss of flexion torque began earlier than extension torque. At age 80, trunk muscle torque had decreased 60% compared with healthy young adults.

Statistical methodology: II. Reliability and validity assessment in study design, Part B.

PubMed

Karras, D J

1997-02-01

Validity measures the correspondence between a test and other purported measures of the same or similar qualities. When a reference standard exists, a criterion-based validity coefficient can be calculated. If no such standard is available, the concepts of content and construct validity may be used, but quantitative analysis may not be possible. The Pearson and Spearman tests of correlation are often used to assess the correspondence between tests, but do not account for measurement biases and may yield misleading results. Techniques that measure interest differences may be more meaningful in validity assessment, and the kappa statistic is useful for analyzing categorical variables. Questionnaires often can be designed to allow quantitative assessment of reliability and validity, although this may be difficult. Inclusion of homogeneous questions is necessary to assess reliability. Analysis is enhanced by using Likert scales or similar techniques that yield ordinal data. Validity assessment of questionnaires requires careful definition of the scope of the test and comparison with previously validated tools.

Validity of the Brazilian version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire.

PubMed

João, Thaís Moreira São; Rodrigues, Roberta Cunha Matheus; Gallani, Maria Cecília Bueno Jayme; Miura, Cinthya Tamie Passos; Domingues, Gabriela de Barros Leite; Amireault, Steve; Godin, Gaston

2015-09-01

This study provides evidence of construct validity for the Brazilian version of the Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ), a 1-item instrument used among 236 participants referred for cardiopulmonary exercise testing. The Baecke Habitual Physical Activity Questionnaire (Baecke-HPA) was used to evaluate convergent and divergent validity. The self-reported measure of walking (QCAF) evaluated the convergent validity. Cardiorespiratory fitness assessed convergent validity by the Veterans Specific Activity Questionnaire (VSAQ), peak measured (VO2peak) and maximum predicted (VO2pred) oxygen uptake. Partial adjusted correlation coefficients between the GSLTPAQ, Baecke-HPA, QCAF, VO2pred and VSAQ provided evidence for convergent validity; while divergent validity was supported by the absence of correlations between the GSLTPAQ and the Occupational Physical Activity domain (Baecke-HPA). The GSLTPAQ presents level 3 of evidence of construct validity and may be useful to assess leisure-time physical activity among patients with cardiovascular disease and healthy individuals.

Steps to standardization and validation of hippocampal volumetry as a biomarker in clinical trials and diagnostic criteria for Alzheimer’s disease

PubMed Central

Jack, Clifford R; Barkhof, Frederik; Bernstein, Matt A; Cantillon, Marc; Cole, Patricia E; DeCarli, Charles; Dubois, Bruno; Duchesne, Simon; Fox, Nick C; Frisoni, Giovanni B; Hampel, Harald; Hill, Derek LG; Johnson, Keith; Mangin, Jean-François; Scheltens, Philip; Schwarz, Adam J; Sperling, Reisa; Suhy, Joyce; Thompson, Paul M; Weiner, Michael; Foster, Norman L

2012-01-01

Background The promise of Alzheimer’s disease (AD) biomarkers has led to their incorporation in new diagnostic criteria and in therapeutic trials; however, significant barriers exist to widespread use. Chief among these is the lack of internationally accepted standards for quantitative metrics. Hippocampal volumetry is the most widely studied quantitative magnetic resonance imaging (MRI) measure in AD and thus represents the most rational target for an initial effort at standardization. Methods and Results The authors of this position paper propose a path toward this goal. The steps include: 1) Establish and empower an oversight board to manage and assess the effort, 2) Adopt the standardized definition of anatomic hippocampal boundaries on MRI arising from the EADC-ADNI hippocampal harmonization effort as a Reference Standard, 3) Establish a scientifically appropriate, publicly available Reference Standard Dataset based on manual delineation of the hippocampus in an appropriate sample of subjects (ADNI), and 4) Define minimum technical and prognostic performance metrics for validation of new measurement techniques using the Reference Standard Dataset as a benchmark. Conclusions Although manual delineation of the hippocampus is the best available reference standard, practical application of hippocampal volumetry will require automated methods. Our intent is to establish a mechanism for credentialing automated software applications to achieve internationally recognized accuracy and prognostic performance standards that lead to the systematic evaluation and then widespread acceptance and use of hippocampal volumetry. The standardization and assay validation process outlined for hippocampal volumetry is envisioned as a template that could be applied to other imaging biomarkers. PMID:21784356

Measuring ideas of persecution and social reference: the Green et al. Paranoid Thought Scales (GPTS).

PubMed

Green, C E L; Freeman, D; Kuipers, E; Bebbington, P; Fowler, D; Dunn, G; Garety, P A

2008-01-01

Paranoia is increasingly being studied in clinical and non-clinical populations. However there is no multi-dimensional measure of persecutory ideas developed for use across the general population-psychopathology continuum. This paper reports the development of such a questionnaire: the 'Green et al. Paranoid Thought Scales'. The aim was to devise a tool to assess ideas of persecution and social reference in a simple self-report format, guided by a current definition of persecutory ideation, and incorporating assessment of conviction, preoccupation and distress. A total of 353 individuals without a history of mental illness, and 50 individuals with current persecutory delusions completed a pool of paranoid items and additional measures to assess validity. Items were devised from a recent definition of persecutory delusions, current assessments of paranoia, the authors' clinical experience, and incorporated dimensions of conviction, preoccupation and distress. Test-retest reliability in the non-clinical group was assessed at 2 weeks follow-up, and clinical change in the deluded group at 6 months follow-up. Two 16-item scales were extracted, assessing ideas of social reference and persecution. Good internal consistency and validity was established for both scales and their dimensions. The scales were sensitive to clinical change. A hierarchical relationship between social reference and persecution was found. The data provide further evidence for a continuum of paranoid ideas between deluded and healthy individuals. A reliable and valid tool for assessing paranoid thoughts is presented. It will provide an effective way for researchers to ensure consistency in research and for clinicians to assess change with treatment.

Utility of NIST Whole-Genome Reference Materials for the Technical Validation of a Multigene Next-Generation Sequencing Test.

PubMed

Shum, Bennett O V; Henner, Ilya; Belluoccio, Daniele; Hinchcliffe, Marcus J

2017-07-01

The sensitivity and specificity of next-generation sequencing laboratory developed tests (LDTs) are typically determined by an analyte-specific approach. Analyte-specific validations use disease-specific controls to assess an LDT's ability to detect known pathogenic variants. Alternatively, a methods-based approach can be used for LDT technical validations. Methods-focused validations do not use disease-specific controls but use benchmark reference DNA that contains known variants (benign, variants of unknown significance, and pathogenic) to assess variant calling accuracy of a next-generation sequencing workflow. Recently, four whole-genome reference materials (RMs) from the National Institute of Standards and Technology (NIST) were released to standardize methods-based validations of next-generation sequencing panels across laboratories. We provide a practical method for using NIST RMs to validate multigene panels. We analyzed the utility of RMs in validating a novel newborn screening test that targets 70 genes, called NEO1. Despite the NIST RM variant truth set originating from multiple sequencing platforms, replicates, and library types, we discovered a 5.2% false-negative variant detection rate in the RM truth set genes that were assessed in our validation. We developed a strategy using complementary non-RM controls to demonstrate 99.6% sensitivity of the NEO1 test in detecting variants. Our findings have implications for laboratories or proficiency testing organizations using whole-genome NIST RMs for testing. Copyright © 2017 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Selection of Suitable Reference Genes for RT-qPCR Normalization under Abiotic Stresses and Hormone Stimulation in Persimmon (Diospyros kaki Thunb)

PubMed Central

Wang, Peihong; Xiong, Aisheng; Gao, Zhihong; Yu, Xinyi; Li, Man; Hou, Yingjun; Sun, Chao; Qu, Shenchun

2016-01-01

The success of quantitative real-time reverse transcription polymerase chain reaction (RT-qPCR) to quantify gene expression depends on the stability of the reference genes used for data normalization. To date, systematic screening for reference genes in persimmon (Diospyros kaki Thunb) has never been reported. In this study, 13 candidate reference genes were cloned from 'Nantongxiaofangshi' using information available in the transcriptome database. Their expression stability was assessed by geNorm and NormFinder algorithms under abiotic stress and hormone stimulation. Our results showed that the most suitable reference genes across all samples were UBC and GAPDH, and not the commonly used persimmon reference gene ACT. In addition, UBC combined with RPII or TUA were found to be appropriate for the "abiotic stress" group and α-TUB combined with PP2A were found to be appropriate for the "hormone stimuli" group. For further validation, the transcript level of the DkDREB2C homologue under heat stress was studied with the selected genes (CYP, GAPDH, TUA, UBC, α-TUB, and EF1-α). The results suggested that it is necessary to choose appropriate reference genes according to the test materials or experimental conditions. Our study will be useful for future studies on gene expression in persimmon. PMID:27513755

An administrative data validation study of the accuracy of algorithms for identifying rheumatoid arthritis: the influence of the reference standard on algorithm performance.

PubMed

Widdifield, Jessica; Bombardier, Claire; Bernatsky, Sasha; Paterson, J Michael; Green, Diane; Young, Jacqueline; Ivers, Noah; Butt, Debra A; Jaakkimainen, R Liisa; Thorne, J Carter; Tu, Karen

2014-06-23

We have previously validated administrative data algorithms to identify patients with rheumatoid arthritis (RA) using rheumatology clinic records as the reference standard. Here we reassessed the accuracy of the algorithms using primary care records as the reference standard. We performed a retrospective chart abstraction study using a random sample of 7500 adult patients under the care of 83 family physicians contributing to the Electronic Medical Record Administrative data Linked Database (EMRALD) in Ontario, Canada. Using physician-reported diagnoses as the reference standard, we computed and compared the sensitivity, specificity, and predictive values for over 100 administrative data algorithms for RA case ascertainment. We identified 69 patients with RA for a lifetime RA prevalence of 0.9%. All algorithms had excellent specificity (>97%). However, sensitivity varied (75-90%) among physician billing algorithms. Despite the low prevalence of RA, most algorithms had adequate positive predictive value (PPV; 51-83%). The algorithm of "[1 hospitalization RA diagnosis code] or [3 physician RA diagnosis codes with ≥1 by a specialist over 2 years]" had a sensitivity of 78% (95% CI 69-88), specificity of 100% (95% CI 100-100), PPV of 78% (95% CI 69-88) and NPV of 100% (95% CI 100-100). Administrative data algorithms for detecting RA patients achieved a high degree of accuracy amongst the general population. However, results varied slightly from our previous report, which can be attributed to differences in the reference standards with respect to disease prevalence, spectrum of disease, and type of comparator group.

The evaluation of lumbar multifidus muscle function via palpation: reliability and validity of a new clinical test.

PubMed

Hebert, Jeffrey J; Koppenhaver, Shane L; Teyhen, Deydre S; Walker, Bruce F; Fritz, Julie M

2015-06-01

The lumbar multifidus muscle provides an important contribution to lumbar spine stability, and the restoration of lumbar multifidus function is a frequent goal of rehabilitation. Currently, there are no reliable and valid physical examination procedures available to assess lumbar multifidus function among patients with low back pain. To examine the inter-rater reliability and concurrent validity of the multifidus lift test (MLT) to identify lumbar multifidus dysfunction among patients with low back pain. A cross-sectional analysis of reliability and concurrent validity performed in a university outpatient research facility. Thirty-two persons aged 18 to 60 years with current low back pain and a minimum modified Oswestry disability score of 20%. Study participants were excluded if they reported a history of lumbar spine surgery, lumbar radiculopathy, medical red flags, osteoporosis, or had recently been treated with spinal manipulation or trunk stabilization exercises. Concurrent measures of lumbar multifidus muscle function at the L4-L5 and L5-S1 levels were obtained with the MLT (index test) and real-time ultrasound imaging (reference standard). The inter-rater reliability of the MLT was examined by measuring the level of agreement between two blinded examiners. Concurrent validity of the MLT was investigated by comparing clinicians' judgments with real-time ultrasound imaging measures of lumbar multifidus function. Inter-rater reliability of the MLT was substantial to excellent (κ=0.75 to 0.81, p≤.01) and free from errors of bias and prevalence. When performed at L4-L5 or L5-S1, the MLT demonstrated evidence of concurrent validity through its relationship with the reference standard results at L4-L5 (rbis=0.59-0.73, p≤.01). The MLT generally failed to demonstrate a relationship with the reference standard results from the L5-S1 level. Our results provide preliminary evidence supporting the reliability and validity of the MLT to assess lumbar multifidus function at the L4-L5 spinal level. Additional research examining the measurement properties and utility of this test should be undertaken before confident implementation with patients. Copyright © 2015 Elsevier Inc. All rights reserved.

The State of the Art in Self-Study of Teacher Education Practices: A Systematic Literature Review

ERIC Educational Resources Information Center

Vanassche, Eline; Kelchtermans, Geert

2015-01-01

This article reports on a systematic review of the Self-Study of Teacher Education Practices research literature published between 1990 and 2012. Self-study research refers to teacher educators researching their practice with the purpose of improving it, making explicit and validating their professional expertise and, at the same time,…

A proposed new test for aptitude screening of air traffic controller applicants.

DOT National Transportation Integrated Search

1972-05-01

The study concerns the development and experimental validation of a novel aptitude test, referred to as 'Directional Headings' (or DHT), for the selection of Air Traffic Control Specialist (ATCS) trainees. The test requires the subject to rapidly int...

The Amsterdam wrist rules: the multicenter prospective derivation and external validation of a clinical decision rule for the use of radiography in acute wrist trauma.

PubMed

Walenkamp, Monique M J; Bentohami, Abdelali; Slaar, Annelie; Beerekamp, M Suzan H; Maas, Mario; Jager, L Cara; Sosef, Nico L; van Velde, Romuald; Ultee, Jan M; Steyerberg, Ewout W; Goslings, J Carel; Schep, Niels W L

2015-12-18

Although only 39 % of patients with wrist trauma have sustained a fracture, the majority of patients is routinely referred for radiography. The purpose of this study was to derive and externally validate a clinical decision rule that selects patients with acute wrist trauma in the Emergency Department (ED) for radiography. This multicenter prospective study consisted of three components: (1) derivation of a clinical prediction model for detecting wrist fractures in patients following wrist trauma; (2) external validation of this model; and (3) design of a clinical decision rule. The study was conducted in the EDs of five Dutch hospitals: one academic hospital (derivation cohort) and four regional hospitals (external validation cohort). We included all adult patients with acute wrist trauma. The main outcome was fracture of the wrist (distal radius, distal ulna or carpal bones) diagnosed on conventional X-rays. A total of 882 patients were analyzed; 487 in the derivation cohort and 395 in the validation cohort. We derived a clinical prediction model with eight variables: age; sex, swelling of the wrist; swelling of the anatomical snuffbox, visible deformation; distal radius tender to palpation; pain on radial deviation and painful axial compression of the thumb. The Area Under the Curve at external validation of this model was 0.81 (95 % CI: 0.77-0.85). The sensitivity and specificity of the Amsterdam Wrist Rules (AWR) in the external validation cohort were 98 % (95 % CI: 95-99 %) and 21 % (95 % CI: 15 %-28). The negative predictive value was 90 % (95 % CI: 81-99 %). The Amsterdam Wrist Rules is a clinical prediction rule with a high sensitivity and negative predictive value for fractures of the wrist. Although external validation showed low specificity and 100 % sensitivity could not be achieved, the Amsterdam Wrist Rules can provide physicians in the Emergency Department with a useful screening tool to select patients with acute wrist trauma for radiography. The upcoming implementation study will further reveal the impact of the Amsterdam Wrist Rules on the anticipated reduction of X-rays requested, missed fractures, Emergency Department waiting times and health care costs. This study was registered in the Dutch Trial Registry, reference number NTR2544 on October 1(st), 2010.

The validity and reliability of the Arabic version of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU): A prospective cohort study.

PubMed

Selim, Abeer; Kandeel, Nahed; Elokl, Mohamed; Khater, Mohamed Shawky; Saleh, Ashraf Nabil; Bustami, Rami; Ely, E Wesley

2018-04-01

Accurate diagnosis for Arabic speaking critically ill patients suffering from delirium is limited by the need for a valid/reliable translation of a standardized delirium instrument such as the Confusion Assessment Method for the ICU (CAM-ICU). To determine the validity and reliability of the Arabic version of the CAM-ICU. A prospective cohort study design was used to conduct the current study. Data collection took place in Geriatric, Emergency and Surgical intensive care units. Fifty-eight adult patients met the inclusion criteria and participated in the study. Among the participants 22(38%) patients were on mechanical ventilation. After translating the CAM-ICU into Arabic language, the Arabic CAM-ICU was administered by two well-trained critical care nurses and compared with reference standard assessments by delirium experts using the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM -IV-TR), along with assessment of severity of illness using Sequential Organ Failure Assessment (SOFA). Concurrent validity was assessed by calculating sensitivity, specificity and positive and negative predictive value (PPV and NPV) for the two Arabic CAM-ICU raters, where calculations were based on considering the DSM-IV-TR criterion as the reference standard. The convergent validity of the Arabic CAM-ICU was explored by comparing the Arabic CAM-ICU ratings and the total score of SOFA (severity of illness) and MMSE (cognitive impairment). A total of 58 ICU patients were included, of whom 27 (47%) were diagnosed with delirium during their ICU stay via DSM-IV criteria. Interrater reliability for the Arabic CAM-ICU, overall and for mechanically ventilated patients assessed using Cohen's kappa (κ) were 0.82 and 1, respectively, p < 0.001. The sensitivities (95% CI) for the two critical care nurses when using the Arabic CAM-ICU compared with the reference standard were 81% (60%-93%) and 85% (65%-95%), respectively, whereas specificity (95% CI) was 81%(62%-92%) for both nurses. High sensitivity and specificity measures were also observed across subgroups; 100% for mechanically ventilated patients, 88% (60%-98%) and 79% (49%-94%) for those aged 65 years or older and 82% (56%-95%) and 75% (43%-93%) for those with SOFA scores at or above the median value. The Arabic CAM-ICU appeared to be valid and reliable tool for diagnosing delirium. Future investigations may lead to a better understanding of the prevalence, predictors, and consequences of delirium among critically ill Arabic speaking patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

The role of observational reference data for climate downscaling: Insights from the VALUE COST Action

NASA Astrophysics Data System (ADS)

Kotlarski, Sven; Gutiérrez, José M.; Boberg, Fredrik; Bosshard, Thomas; Cardoso, Rita M.; Herrera, Sixto; Maraun, Douglas; Mezghani, Abdelkader; Pagé, Christian; Räty, Olle; Stepanek, Petr; Soares, Pedro M. M.; Szabo, Peter

2016-04-01

VALUE is an open European network to validate and compare downscaling methods for climate change research (http://www.value-cost.eu). A key deliverable of VALUE is the development of a systematic validation framework to enable the assessment and comparison of downscaling methods. Such assessments can be expected to crucially depend on the existence of accurate and reliable observational reference data. In dynamical downscaling, observational data can influence model development itself and, later on, model evaluation, parameter calibration and added value assessment. In empirical-statistical downscaling, observations serve as predictand data and directly influence model calibration with corresponding effects on downscaled climate change projections. We here present a comprehensive assessment of the influence of uncertainties in observational reference data and of scale-related issues on several of the above-mentioned aspects. First, temperature and precipitation characteristics as simulated by a set of reanalysis-driven EURO-CORDEX RCM experiments are validated against three different gridded reference data products, namely (1) the EOBS dataset (2) the recently developed EURO4M-MESAN regional re-analysis, and (3) several national high-resolution and quality-controlled gridded datasets that recently became available. The analysis reveals a considerable influence of the choice of the reference data on the evaluation results, especially for precipitation. It is also illustrated how differences between the reference data sets influence the ranking of RCMs according to a comprehensive set of performance measures.

Selection of Reference Genes for Quantitative Gene Expression in Porcine Mesenchymal Stem Cells Derived from Various Sources along with Differentiation into Multilineages

PubMed Central

Lee, Won-Jae; Jeon, Ryoung-Hoon; Jang, Si-Jung; Park, Ji-Sung; Lee, Seung-Chan; Baregundi Subbarao, Raghavendra; Lee, Sung-Lim; Park, Bong-Wook; King, William Allan; Rho, Gyu-Jin

2015-01-01

The identification of stable reference genes is a prerequisite for ensuring accurate validation of gene expression, yet too little is known about stable reference genes of porcine MSCs. The present study was, therefore, conducted to assess the stability of reference genes in porcine MSCs derived from bone marrow (BMSCs), adipose (AMSCs), and skin (SMSCs) with their in vitro differentiated cells into mesenchymal lineages such as adipocytes, osteocytes, and chondrocytes. Twelve commonly used reference genes were investigated for their threshold cycle (Ct) values by qRT-PCR. The Ct values of candidate reference genes were analyzed by geNorm software to clarify stable expression regardless of experimental conditions. Thus, Pearson's correlation was applied to determine correlation between the three most stable reference genes (NF3) and optimal number of reference genes (NFopt). In assessment of stability of reference gene across experimental conditions by geNorm analysis, undifferentiated MSCs and each differentiated status into mesenchymal lineages showed slightly different results but similar patterns about more or less stable rankings. Furthermore, Pearson's correlation revealed high correlation (r > 0.9) between NF3 and NFopt. Overall, the present study showed that HMBS, YWHAZ, SDHA, and TBP are suitable reference genes for qRT-PCR in porcine MSCs. PMID:25972899

LinkEHR-Ed: a multi-reference model archetype editor based on formal semantics.

PubMed

Maldonado, José A; Moner, David; Boscá, Diego; Fernández-Breis, Jesualdo T; Angulo, Carlos; Robles, Montserrat

2009-08-01

To develop a powerful archetype editing framework capable of handling multiple reference models and oriented towards the semantic description and standardization of legacy data. The main prerequisite for implementing tools providing enhanced support for archetypes is the clear specification of archetype semantics. We propose a formalization of the definition section of archetypes based on types over tree-structured data. It covers the specialization of archetypes, the relationship between reference models and archetypes and conformance of data instances to archetypes. LinkEHR-Ed, a visual archetype editor based on the former formalization with advanced processing capabilities that supports multiple reference models, the editing and semantic validation of archetypes, the specification of mappings to data sources, and the automatic generation of data transformation scripts, is developed. LinkEHR-Ed is a useful tool for building, processing and validating archetypes based on any reference model.

The Importance of Measurement Errors for Deriving Accurate Reference Leaf Area Index Maps for Validation of Moderate-Resolution Satellite LAI Products

NASA Technical Reports Server (NTRS)

Huang, Dong; Yang, Wenze; Tan, Bin; Rautiainen, Miina; Zhang, Ping; Hu, Jiannan; Shabanov, Nikolay V.; Linder, Sune; Knyazikhin, Yuri; Myneni, Ranga B.

2006-01-01

The validation of moderate-resolution satellite leaf area index (LAI) products such as those operationally generated from the Moderate Resolution Imaging Spectroradiometer (MODIS) sensor data requires reference LAI maps developed from field LAI measurements and fine-resolution satellite data. Errors in field measurements and satellite data determine the accuracy of the reference LAI maps. This paper describes a method by which reference maps of known accuracy can be generated with knowledge of errors in fine-resolution satellite data. The method is demonstrated with data from an international field campaign in a boreal coniferous forest in northern Sweden, and Enhanced Thematic Mapper Plus images. The reference LAI map thus generated is used to assess modifications to the MODIS LAI/fPAR algorithm recently implemented to derive the next generation of the MODIS LAI/fPAR product for this important biome type.

Glossary of reference terms for alternative test methods and their validation.

PubMed

Ferrario, Daniele; Brustio, Roberta; Hartung, Thomas

2014-01-01

This glossary was developed to provide technical references to support work in the field of the alternatives to animal testing. It was compiled from various existing reference documents coming from different sources and is meant to be a point of reference on alternatives to animal testing. Giving the ever-increasing number of alternative test methods and approaches being developed over the last decades, a combination, revision, and harmonization of earlier published collections of terms used in the validation of such methods is required. The need to update previous glossary efforts came from the acknowledgement that new words have emerged with the development of new approaches, while others have become obsolete, and the meaning of some terms has partially changed over time. With this glossary we intend to provide guidance on issues related to the validation of new or updated testing methods consistent with current approaches. Moreover, because of new developments and technologies, a glossary needs to be a living, constantly updated document. An Internet-based version based on this compilation may be found at http://altweb.jhsph.edu/, allowing the addition of new material.

A system of equations to approximate the pharmacokinetic parameters of lacosamide at steady state from one plasma sample.

PubMed

Cawello, Willi; Schäfer, Carina

2014-08-01

Frequent plasma sampling to monitor pharmacokinetic (PK) profile of antiepileptic drugs (AEDs), is invasive, costly and time consuming. For drugs with a well-defined PK profile, such as AED lacosamide, equations can accurately approximate PK parameters from one steady-state plasma sample. Equations were derived to approximate steady-state peak and trough lacosamide plasma concentrations (Cpeak,ss and Ctrough,ss, respectively) and area under concentration-time curve during dosing interval (AUCτ,ss) from one plasma sample. Lacosamide (ka: ∼2 h(-1); ke: ∼0.05 h(-1), corresponding to half-life of 13 h) was calculated to reach Cpeak,ss after ∼1 h (tmax,ss). Equations were validated by comparing approximations to reference PK parameters obtained from single plasma samples drawn 3-12h following lacosamide administration, using data from double-blind, placebo-controlled, parallel-group PK study. Values of relative bias (accuracy) between -15% and +15%, and root mean square error (RMSE) values≤15% (precision) were considered acceptable for validation. Thirty-five healthy subjects (12 young males; 11 elderly males, 12 elderly females) received lacosamide 100mg/day for 4.5 days. Equation-derived PK values were compared to reference mean Cpeak,ss, Ctrough,ss and AUCτ,ss values. Equation-derived PK data had a precision of 6.2% and accuracy of -8.0%, 2.9%, and -0.11%, respectively. Equation-derived versus reference PK values for individual samples obtained 3-12h after lacosamide administration showed correlation (R2) range of 0.88-0.97 for AUCτ,ss. Correlation range for Cpeak,ss and Ctrough,ss was 0.65-0.87. Error analyses for individual sample comparisons were independent of time. Derived equations approximated lacosamide Cpeak,ss, Ctrough,ss and AUCτ,ss using one steady-state plasma sample within validation range. Approximated PK parameters were within accepted validation criteria when compared to reference PK values. Copyright © 2014 Elsevier B.V. All rights reserved.

A Practical Approach to Governance and Optimization of Structured Data Elements.

PubMed

Collins, Sarah A; Gesner, Emily; Morgan, Steven; Mar, Perry; Maviglia, Saverio; Colburn, Doreen; Tierney, Diana; Rocha, Roberto

2015-01-01

Definition and configuration of clinical content in an enterprise-wide electronic health record (EHR) implementation is highly complex. Sharing of data definitions across applications within an EHR implementation project may be constrained by practical limitations, including time, tools, and expertise. However, maintaining rigor in an approach to data governance is important for sustainability and consistency. With this understanding, we have defined a practical approach for governance of structured data elements to optimize data definitions given limited resources. This approach includes a 10 step process: 1) identification of clinical topics, 2) creation of draft reference models for clinical topics, 3) scoring of downstream data needs for clinical topics, 4) prioritization of clinical topics, 5) validation of reference models for clinical topics, and 6) calculation of gap analyses of EHR compared against reference model, 7) communication of validated reference models across project members, 8) requested revisions to EHR based on gap analysis, 9) evaluation of usage of reference models across project, and 10) Monitoring for new evidence requiring revisions to reference model.

BRSCW Reference Set Application: Karen Abbott -University of Arkansas (2014) — EDRN Public Portal

Cancer.gov

Our earlier glycoproteomic studies have identified bisecting glycoslyation and core fucosylation changes on particular glycoproteins in endometrioid ovarian cancer tissues and plasma (Abbott et al, 2010, Proteomics). We have validated that these glycan changes occur on the same glycoproteins in serous ovarian cancer plasma using a lectin-pull down western blot assays. We would like to used pooled reference samples to develop a sensitive magnetic bead-based assay to detect these glycoproteins with bisecting and core fucosylation changes.

Validity Is an Action Verb: Commentary on--"Clarifying the Consensus Definition of Validity"

ERIC Educational Resources Information Center

Lissitz, Robert W.; Calico, Tiago

2012-01-01

This paper presents the authors' critique on "Clarifying the Consensus Definition of Validity" by Paul E. Newton (this issue). There are serious differences of opinion regarding the topic of validity. Newton is aware of these differences, as made clear by his choice of references and particularly his effort to respond to the various Borsboom…

Validating Test Score Meaning and Defending Test Score Use: Different Aims, Different Methods

ERIC Educational Resources Information Center

Cizek, Gregory J.

2016-01-01

Advances in validity theory and alacrity in validation practice have suffered because the term "validity" has been used to refer to two incompatible concerns: (1) the degree of support for specified interpretations of test scores (i.e. intended score meaning) and (2) the degree of support for specified applications (i.e. intended test…

Validation of the preschool and primary school form of a questionnaire assessing parents' childrearing behavior.

PubMed

Meunier, Jean-Christophe; Roskam, Isabelle

2009-01-01

This study presents a validation of a scale that assesses parents' childrearing behavior toward young children. The scale was validated on 565 parents of 2- to 7-year-old children. The current results replicated the factor solution of the original scale designed for parents of school-aged children. The scale demonstrated good psychometric properties: moderate to high internal consistency, the expected relations with criterion variables (parental self-efficacy beliefs, child's behavior and personality), and discriminative properties according to the parents' gender and educational level, the child's age and gender, and the difference between referred and nonreferred children.

MicroRNAs are suitable for assessment as biomarkers from formalin-fixed paraffin-embedded tissue, and miR-24 represents an appropriate reference microRNA for diffuse large B-cell lymphoma studies.

PubMed

Culpin, Rachel Emily; Sieniawski, Michal; Proctor, Stephen John; Menon, Geetha; Mainou-Fowler, Tryfonia

2013-03-01

Tissue biopsy specimens in the form of formalin-fixed paraffin-embedded tissue (FFPET) represent a valuable resource for biomarker identification and validation. However, to date, they remain an underused asset due to uncertainty regarding RNA extraction and the reliability of downstream techniques, including quantitative RT-PCR. Recently, much interest has emerged in the study of microRNAs; small single-stranded RNAs with a role in transcriptional regulation, that are thought to be well preserved in FFPET. In this study, we show that microRNA expression is comparable between FFPET and matched fresh-frozen samples (miR-17-5p: p=0.01, miR-92: p=0.003), and demonstrate that no significant deterioration in expression occurs over prolonged FFPET storage (p=0.06). Furthermore, microRNA expression is equivalent dependant on RNA extraction method (p<0.001) or DNAse treatment of total RNA (p<0.001). Finally, we validate miR-24 as a suitable reference microRNA for diffuse large B-cell lymphoma (DLBCL) FFPET studies.

Methods to compute reliabilities for genomic predictions of feed intake

USDA-ARS?s Scientific Manuscript database

For new traits without historical reference data, cross-validation is often the preferred method to validate reliability (REL). Time truncation is less useful because few animals gain substantial REL after the truncation point. Accurate cross-validation requires separating genomic gain from pedigree...

Development of a computerized intervertebral motion analysis of the cervical spine for clinical application.

PubMed

Piché, Mathieu; Benoît, Pierre; Lambert, Julie; Barrette, Virginie; Grondin, Emmanuelle; Martel, Julie; Paré, Amélie; Cardin, André

2007-01-01

The objective of this study was to develop a measurement method that could be implemented in chiropractic for the evaluation of angular and translational intervertebral motion of the cervical spine. Flexion-extension radiographs were digitized with a scanner at a ratio of 1:1 and imported into a software, allowing segmental motion measurements. The measurements were obtained by selecting the most anteroinferior point and the most posteroinferior point of a vertebral body (anterior and posterior arch, respectively, for C1), with the origin of the reference frame set at the most posteroinferior point of the vertebral body below. The same procedure was performed for both the flexion and extension radiographs, and the coordinates of the 2 points were used to calculate the angular movement and the translation between the 2 vertebrae. This method provides a measure of intervertebral angular and translational movement. It uses a different reference frame for each joint instead of the same reference frame for all joints and thus provides a measure of motion in the plane of each articulation. The calculated values obtained are comparable to other studies on intervertebral motion and support further development to validate the method. The present study proposes a computerized procedure to evaluate intervertebral motion of the cervical spine. This procedure needs to be validated with a reliability study but could provide a valuable tool for doctors of chiropractic and further spinal research.

[The validity of radioimmunologic determination of bioavailability of beta-escin in horse chestnut extracts].

PubMed

Schrödter, A; Loew, D; Schwankl, W; Rietbrock, N

1998-09-01

The bioavailability under steady state conditions of a standard, slow-release horse chestnut seed extract (HCSE)-containing product was compared with that of an analogous, fast-release test preparation (Noricaven novo) in a prospective, randomised, double-blind study in a double cross-over design. The serum concentration of beta-escin (CAS 6805-41-0) was measured by radioimmunoassay. In addition, the biopharmaceutical properties of the HCSEs present in the products were investigated, the amount and composition of the active ingredient, escin, being analysed with a validated HPLC method. The pharmacokinetics of this study were compared with the corresponding data of a similar investigation carried out under analogous conditions concerning study design, analytical methods and reference preparation. Comparison of the similar studies revealed differences in characteristic pharmakokinetic values of beta-escin in terms of a shift of the concentration time curves as could be demonstrated for the reference product. The total amounts of escin in the two products investigated did not differ significantly. However, quantitative and qualitative differences were detected in the constituents of the two different extract preparations. It is concluded that the high specificity of the validated beta-escin radioimmunoassay leads to analytical imprecision due to the variable constituents of the extract preparations used. It is necessary to test whether this problem can be solved using an analytical approach, which is specific for each extract.

The Renilla luciferase gene as a reference gene for normalization of gene expression in transiently transfected cells.

PubMed

Jiwaji, Meesbah; Daly, Rónán; Pansare, Kshama; McLean, Pauline; Yang, Jingli; Kolch, Walter; Pitt, Andrew R

2010-12-31

The importance of appropriate normalization controls in quantitative real-time polymerase chain reaction (qPCR) experiments has become more apparent as the number of biological studies using this methodology has increased. In developing a system to study gene expression from transiently transfected plasmids, it became clear that normalization using chromosomally encoded genes is not ideal, at it does not take into account the transfection efficiency and the significantly lower expression levels of the plasmids. We have developed and validated a normalization method for qPCR using a co-transfected plasmid. The best chromosomal gene for normalization in the presence of the transcriptional activators used in this study, cadmium, dexamethasone, forskolin and phorbol-12-myristate 13-acetate was first identified. qPCR data was analyzed using geNorm, Normfinder and BestKeeper. Each software application was found to rank the normalization controls differently with no clear correlation. Including a co-transfected plasmid encoding the Renilla luciferase gene (Rluc) in this analysis showed that its calculated stability was not as good as the optimised chromosomal genes, most likely as a result of the lower expression levels and transfection variability. Finally, we validated these analyses by testing two chromosomal genes (B2M and ActB) and a co-transfected gene (Rluc) under biological conditions. When analyzing co-transfected plasmids, Rluc normalization gave the smallest errors compared to the chromosomal reference genes. Our data demonstrates that transfected Rluc is the most appropriate normalization reference gene for transient transfection qPCR analysis; it significantly reduces the standard deviation within biological experiments as it takes into account the transfection efficiencies and has easily controllable expression levels. This improves reproducibility, data validity and most importantly, enables accurate interpretation of qPCR data.

Validation of the EULAR definition of arthralgia suspicious for progression to rheumatoid arthritis.

PubMed

Burgers, Leonie E; Siljehult, Filip; Ten Brinck, Robin M; van Steenbergen, Hanna W; Landewé, Robert B M; Rantapää-Dahlqvist, Solbritt; van der Helm-van Mil, Annette H M

2017-12-01

Recently a EULAR-taskforce defined arthralgia suspicious for progression to RA, in order to allow inclusion of homogeneous sets of arthralgia patients in clinical studies. This longitudinal study aimed (i) to validate this definition in arthralgia patients in whom rheumatologists felt that imminent RA was more likely than other arthralgias [clinically suspect arthralgia (CSA)], that is, the target population fulfilling the entry criterion, and (ii) to explore the performance in arthralgia patients who were referred to secondary care prior to rheumatological evaluation, hence ignoring the entry criterion. The definition was assessed in 241 Dutch patients identified with CSA by rheumatologists and 113 patients referred to the Umeå university hospital with recent-onset arthralgia in small joints. The external reference was arthritis development <2 years' follow-up. CSA patients with a positive definition (⩾3/7 parameters present) had an increased risk for developing arthritis compared with definition-negative CSA patients (hazard ratio = 2.1, 95% CI: 0.9, 4.7). The sensitivity was 84% and the positive predictive value 30%. In arthralgia patients in whom the definition was applied before rheumatological evaluation, a positive definition was neither sensitive (10%) nor predictive (positive predictive value 3%). The EULAR definition of arthralgia suspicious for progression to RA is sensitive when used to support the rheumatologist's opinion on imminent RA. This validation study shows that the definition, when used as designed, further homogenizes patients that rheumatologists consider at risk for RA. To arrive at a high specificity, the clinical definition needs to be combined with biomarkers. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Early Relapse of Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Defines Patients at High Risk for Death: An Analysis From the National LymphoCare Study

PubMed Central

Casulo, Carla; Byrtek, Michelle; Dawson, Keith L.; Zhou, Xiaolei; Farber, Charles M.; Flowers, Christopher R.; Hainsworth, John D.; Maurer, Matthew J.; Cerhan, James R.; Link, Brian K.; Zelenetz, Andrew D.; Friedberg, Jonathan W.

2015-01-01

Purpose Twenty percent of patients with follicular lymphoma (FL) experience progression of disease (POD) within 2 years of initial chemoimmunotherapy. We analyzed data from the National LymphoCare Study to identify whether prognostic FL factors are associated with early POD and whether patients with early POD are at high risk for death. Patients and Methods In total, 588 patients with stage 2 to 4 FL received first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Two groups were defined: patients with early POD 2 years or less after diagnosis and those without POD within 2 years, the reference group. An independent validation set, 147 patients with FL who received first-line R-CHOP, was analyzed for reproducibility. Results Of 588 patients, 19% (n = 110) had early POD, 71% (n = 420) were in the reference group, 8% (n = 46) were lost to follow-up, and 2% (n = 12) died without POD less than 2 years after diagnosis. Five-year overall survival was lower in the early-POD group than in the reference group (50% v 90%). This trend was maintained after we adjusted for FL International Prognostic Index (hazard ratio, 6.44; 95% CI, 4.33 to 9.58). Results were similar for the validation set (FL International Prognostic Index–adjusted hazard ratio, 19.8). Conclusion In patients with FL who received first-line R-CHOP, POD within 2 years after diagnosis was associated with poor outcomes and should be further validated as a standard end point of chemoimmunotherapy trials of untreated FL. This high-risk FL population warrants further study in directed prospective clinical trials. PMID:26124482

A comparative uncertainty study of the calibration of macrolide antibiotic reference standards using quantitative nuclear magnetic resonance and mass balance methods.

PubMed

Liu, Shu-Yu; Hu, Chang-Qin

2007-10-17

This study introduces the general method of quantitative nuclear magnetic resonance (qNMR) for the calibration of reference standards of macrolide antibiotics. Several qNMR experimental conditions were optimized including delay, which is an important parameter of quantification. Three kinds of macrolide antibiotics were used to validate the accuracy of the qNMR method by comparison with the results obtained by the high performance liquid chromatography (HPLC) method. The purities of five common reference standards of macrolide antibiotics were measured by the 1H qNMR method and the mass balance method, respectively. The analysis results of the two methods were compared. The qNMR is quick and simple to use. In a new medicine research and development process, qNMR provides a new and reliable method for purity analysis of the reference standard.

Development of a validated questionnaire to measure the self-perceived competence of primary health professionals in providing nutrition care to patients with chronic disease.

PubMed

Ball, Lauren E; Leveritt, Michael D

2015-12-01

Nutrition is an important aspect of chronic disease prevention and management by primary health professionals, including GPs, dietitians, practice nurses, diabetes educators and exercise professionals. In order to better understand how to improve the delivery of nutrition care, it is important to have valid and reliable tools to measure self-perceived competence. This study aimed to develop a valid, structured, questionnaire that measures the self-perceived competence of primary health professionals to provide nutrition care to patients with chronic disease. The development of the questionnaire was carried out in four stages (1): preparation of scope and structure, through a literature review and consultation with an expert reference group (2); development of questionnaire items, which were refined through feedback from the reference group and 18 primary health professionals (3); investigation of internal consistency and concurrent validity through a pilot study on 118 primary health professionals (4) and investigation of test-retest reliability through a pilot study on 33 primary health professionals who completed the questionnaire twice, 2-3 weeks apart. Stages 1 and 2 resulted in four constructs and 35 questions in the questionnaire. Stage 3 confirmed internal consistency, with Cronbach's α ranging from 0.88 to 0.98 for each construct and 0.98 for all items combined. Dietitians scored significantly higher than speech pathologists (P < 0.05) in each construct, confirming concurrent validity. Stage 4 confirmed test-retest reliability, with correlation coefficients ranging from 0.89 to 0.94 for each construct and 0.95 for all items combined. The NUTrition COMPetence (NUTCOMP) questionnaire is a valid, reliable and suitable tool that can be used to directly inform professional development and identify opportunities to support safe and effective practice. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Evaluation of a multiplex PCR to identify and serotype Actinobacillus pleuropneumoniae serovars 1, 5, 7, 12 and 15.

PubMed

Turni, C; Singh, R; Schembri, M A; Blackall, P J

2014-10-01

The aim of this study was to validate a multiplex PCR for the species identification and serotyping of Actinobacillus pleuropneumoniae serovars 1, 5, 7, 12 and 15. All 15 reference strains and 411 field isolates (394 from Australia, 11 from Indonesia, five from Mexico and one from New Zealand) of A. pleuropneumoniae were tested with the multiplex PCR. The specificity of this multiplex PCR was validated on 26 non-A. pleuropneumoniae species. The multiplex PCR gave the expected results with all 15 serovar reference strains and agreed with conventional serotyping for all field isolates from serovars 1 (n = 46), 5 (n = 81), 7 (n = 80), 12 (n = 16) and serovar 15 (n = 117). In addition, a species-specific product was amplified in the multiplex PCR with all 411 A. pleuropneumoniae field isolates. Of 25 nontypeable field isolates only two did not yield a serovar-specific band in the multiplex PCR. This multiplex PCR for serovars 1, 5, 7, 12 and 15 is species specific and capable of serotyping isolates from diverse locations. Significance and impact of the study: A multiplex PCR that can recognize serovars 1, 5, 7, 12 and 15 of A. pleuropneumoniae was developed and validated. This novel diagnostic tool will enable frontline laboratories to provide key information (the serovar) to guide targeted prevention and control programmes for porcine pleuropneumonia, a serious economic disease of pigs. The previous technology, traditional serotyping, is typically provided by specialized reference laboratories, limiting the capacity to respond to this key disease. © 2014 The Society for Applied Microbiology.

Internal Validity: A Must in Research Designs

ERIC Educational Resources Information Center

Cahit, Kaya

2015-01-01

In experimental research, internal validity refers to what extent researchers can conclude that changes in dependent variable (i.e. outcome) are caused by manipulations in independent variable. The causal inference permits researchers to meaningfully interpret research results. This article discusses (a) internal validity threats in social and…

Experimental validation of beam quality correction factors for proton beams

NASA Astrophysics Data System (ADS)

Gomà, Carles; Hofstetter-Boillat, Bénédicte; Safai, Sairos; Vörös, Sándor

2015-04-01

This paper presents a method to experimentally validate the beam quality correction factors (kQ) tabulated in IAEA TRS-398 for proton beams and to determine the kQ of non-tabulated ionization chambers (based on the already tabulated values). The method is based exclusively on ionometry and it consists in comparing the reading of two ionization chambers under the same reference conditions in a proton beam quality Q and a reference beam quality 60Co. This allows one to experimentally determine the ratio between the kQ of the two ionization chambers. In this work, 7 different ionization chamber models were irradiated under the IAEA TRS-398 reference conditions for 60Co beams and proton beams. For the latter, the reference conditions for both modulated beams (spread-out Bragg peak field) and monoenergetic beams (pseudo-monoenergetic field) were studied. For monoenergetic beams, it was found that the experimental kQ values obtained for plane-parallel chambers are consistent with the values tabulated in IAEA TRS-398; whereas the kQ values obtained for cylindrical chambers are not consistent—being higher than the tabulated values. These results support the suggestion (of previous publications) that the IAEA TRS-398 reference conditions for monoenergetic proton beams should be revised so that the effective point of measurement of cylindrical ionization chambers is taken into account when positioning the reference point of the chamber at the reference depth. For modulated proton beams, the tabulated kQ values of all the ionization chambers studied in this work were found to be consistent with each other—except for the IBA FC65-G, whose experimental kQ value was found to be 0.6% lower than the tabulated one. The kQ of the PTW Advanced Markus chamber, which is not tabulated in IAEA TRS-398, was found to be 0.997 ± 0.042 (k = 2), based on the tabulated value of the PTW Markus chamber.

Comparative Validity and Reproducibility Study of Various Landmark-Oriented Reference Planes in 3-Dimensional Computed Tomographic Analysis for Patients Receiving Orthognathic Surgery

PubMed Central

Lin, Hsiu-Hsia; Chuang, Ya-Fang; Weng, Jing-Ling; Lo, Lun-Jou

2015-01-01

Background Three-dimensional computed tomographic imaging has become popular in clinical evaluation, treatment planning, surgical simulation, and outcome assessment for maxillofacial intervention. The purposes of this study were to investigate whether there is any correlation among landmark-based horizontal reference planes and to validate the reproducibility and reliability of landmark identification. Materials and Methods Preoperative and postoperative cone-beam computed tomographic images of patients who had undergone orthognathic surgery were collected. Landmark-oriented reference planes including the Frankfort horizontal plane (FHP) and the lateral semicircular canal plane (LSP) were established. Four FHPs were defined by selecting 3 points from the orbitale, porion, or midpoint of paired points. The LSP passed through both the lateral semicircular canal points and nasion. The distances between the maxillary or mandibular teeth and the reference planes were measured, and the differences between the 2 sides were calculated and compared. The precision in locating the landmarks was evaluated by performing repeated tests, and the intraobserver reproducibility and interobserver reliability were assessed. Results A total of 30 patients with facial deformity and malocclusion—10 patients with facial symmetry, 10 patients with facial asymmetry, and 10 patients with cleft lip and palate—were recruited. Comparing the differences among the 5 reference planes showed no statistically significant difference among all patient groups. Regarding intraobserver reproducibility, the mean differences in the 3 coordinates varied from 0 to 0.35 mm, with correlation coefficients between 0.96 and 1.0, showing high correlation between repeated tests. Regarding interobserver reliability, the mean differences among the 3 coordinates varied from 0 to 0.47 mm, with correlation coefficients between 0.88 and 1.0, exhibiting high correlation between the different examiners. Conclusions The 5 horizontal reference planes were reliable and comparable for 3D craniomaxillofacial analysis. These reference planes were useful in standardizing the orientation of 3D skull models. PMID:25668209

Comparative validity and reproducibility study of various landmark-oriented reference planes in 3-dimensional computed tomographic analysis for patients receiving orthognathic surgery.

PubMed

Lin, Hsiu-Hsia; Chuang, Ya-Fang; Weng, Jing-Ling; Lo, Lun-Jou

2015-01-01

Three-dimensional computed tomographic imaging has become popular in clinical evaluation, treatment planning, surgical simulation, and outcome assessment for maxillofacial intervention. The purposes of this study were to investigate whether there is any correlation among landmark-based horizontal reference planes and to validate the reproducibility and reliability of landmark identification. Preoperative and postoperative cone-beam computed tomographic images of patients who had undergone orthognathic surgery were collected. Landmark-oriented reference planes including the Frankfort horizontal plane (FHP) and the lateral semicircular canal plane (LSP) were established. Four FHPs were defined by selecting 3 points from the orbitale, porion, or midpoint of paired points. The LSP passed through both the lateral semicircular canal points and nasion. The distances between the maxillary or mandibular teeth and the reference planes were measured, and the differences between the 2 sides were calculated and compared. The precision in locating the landmarks was evaluated by performing repeated tests, and the intraobserver reproducibility and interobserver reliability were assessed. A total of 30 patients with facial deformity and malocclusion--10 patients with facial symmetry, 10 patients with facial asymmetry, and 10 patients with cleft lip and palate--were recruited. Comparing the differences among the 5 reference planes showed no statistically significant difference among all patient groups. Regarding intraobserver reproducibility, the mean differences in the 3 coordinates varied from 0 to 0.35 mm, with correlation coefficients between 0.96 and 1.0, showing high correlation between repeated tests. Regarding interobserver reliability, the mean differences among the 3 coordinates varied from 0 to 0.47 mm, with correlation coefficients between 0.88 and 1.0, exhibiting high correlation between the different examiners. The 5 horizontal reference planes were reliable and comparable for 3D craniomaxillofacial analysis. These reference planes were useful in standardizing the orientation of 3D skull models.

A new methodology for automatic detection of reference points in 3D cephalometry: A pilot study.

PubMed

Ed-Dhahraouy, Mohammed; Riri, Hicham; Ezzahmouly, Manal; Bourzgui, Farid; El Moutaoukkil, Abdelmajid

2018-04-05

The aim of this study was to develop a new method for an automatic detection of reference points in 3D cephalometry to overcome the limits of 2D cephalometric analyses. A specific application was designed using the C++ language for automatic and manual identification of 21 (reference) points on the craniofacial structures. Our algorithm is based on the implementation of an anatomical and geometrical network adapted to the craniofacial structure. This network was constructed based on the anatomical knowledge of the 3D cephalometric (reference) points. The proposed algorithm was tested on five CBCT images. The proposed approach for the automatic 3D cephalometric identification was able to detect 21 points with a mean error of 2.32mm. In this pilot study, we propose an automated methodology for the identification of the 3D cephalometric (reference) points. A larger sample will be implemented in the future to assess the method validity and reliability. Copyright © 2018 CEO. Published by Elsevier Masson SAS. All rights reserved.

PedsQL gastrointestinal symptoms module feasibility reliability and validity

USDA-ARS?s Scientific Manuscript database

The objective of this study was to report on the measurement properties of the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module for patients with functional gastrointestinal (GI) disorders (FGIDs) and organic GI diseases, hereafter referred to as "GI disorders," for pati...

A Validation Study of the School Attitude Assessment Survey.

ERIC Educational Resources Information Center

McCoach, D. Betsy

2002-01-01

This article describes the development of the School Attitude Assessment Survey (SAAS), an instrument that measures self-concept, self-motivation and self-regulation, attitude toward school, and peer attitudes to predict the academic achievement of adolescents. (Contains 43 references and 5 tables.) (Author)

The 2006 Kennedy Space Center Range Reference Atmosphere Model Validation Study and Sensitivity Analysis to the Performance of the National Aeronautics and Space Administration's Space Shuttle Vehicle

NASA Technical Reports Server (NTRS)

Burns, Lee; Decker, Ryan; Harrington, Brian; Merry, Carl

2008-01-01

The Kennedy Space Center (KSC) Range Reference Atmosphere (RRA) is a statistical model that summarizes wind and thermodynamic atmospheric variability from surface to 70 km. The National Aeronautics and Space Administration's (NASA) Space Shuttle program, which launches from KSC, utilizes the KSC RRA data to evaluate environmental constraints on various aspects of the vehicle during ascent. An update to the KSC RRA was recently completed. As part of the update, the Natural Environments Branch at NASA's Marshall Space Flight Center (MSFC) conducted a validation study and a comparison analysis to the existing KSC RRA database version 1983. Assessments to the Space Shuttle vehicle ascent profile characteristics were performed by JSC/Ascent Flight Design Division to determine impacts of the updated model to the vehicle performance. Details on the model updates and the vehicle sensitivity analyses with the update model are presented.

Score Reliability and Construct Validity of the Flinn Performance Screening Tool for Adults With Symptoms of Carpal Tunnel Syndrome

PubMed Central

Flinn, Sharon R.; Pease, William S.; Freimer, Miriam L.

2013-01-01

OBJECTIVE We investigated the psychometric properties of the Flinn Performance Screening Tool (FPST) for people referred with symptoms of carpal tunnel syndrome (CTS). METHOD An occupational therapist collected data from 46 participants who completed the Functional Status Scale (FSS) and FPST after the participants’ nerve conduction velocity study to test convergent and contrasted-group validity. RESULTS Seventy-four percent of the participants had abnormal nerve conduction studies. Cronbach’s α coefficients for subscale and total scores of the FPST ranged from .96 to .98. Intrarater reliability for six shared items of the FSS and the FPST was supported by high agreement (71%) and a fair κ statistic (.36). Strong to moderate positive relationships were found between the FSS and FPST scores. Functional status differed significantly among severe, mild, and negative CTS severity groups. CONCLUSION The FPST shows adequate psychometric properties as a client-centered screening tool for occupational performance of people referred for symptoms of CTS. PMID:22549598

Pharmacokinetics of propafenone hydrochloride sustained-release capsules in male beagle dogs.

PubMed

Pan, Liping; Qian, Yafang; Cheng, Minlu; Gu, Pan; He, Yanna; Xu, Xiaowen; Ding, Li

2015-01-01

This paper describes the development and validation of a liquid chromatography-mass spectrometric assay for propafenone and its application to a pharmacokinetic study of propafenone administered as a new propafenone hydrochloride sustained-release capsule (SR-test), as an instant-release tablet (IR-reference) and as the market leader sustained-release capsule (Rythmol, SR-reference) in male beagle dogs (n=8). In Study A comparing SR-test with IR-reference in a crossover design T max and t 1/2 of propafenone for SR-test were significantly higher than those for IR-reference while C max and AUC were lower demonstrating the sustained release properties of the new formulation. In Study B comparing SR-test with SR-reference the observed C max and AUC of propafenone for SR-test (124.5±140.0 ng/mL and 612.0±699.2 ng·h/mL, respectively) were higher than for SR-reference (78.52±72.92 ng/mL and 423.6±431.6 ng·h/mL, respectively) although the differences were not significant. Overall, the new formulation has as good if not better sustained release characteristics to the market leader formulation.

Quantitative imaging biomarkers: a review of statistical methods for computer algorithm comparisons.

PubMed

Obuchowski, Nancy A; Reeves, Anthony P; Huang, Erich P; Wang, Xiao-Feng; Buckler, Andrew J; Kim, Hyun J Grace; Barnhart, Huiman X; Jackson, Edward F; Giger, Maryellen L; Pennello, Gene; Toledano, Alicia Y; Kalpathy-Cramer, Jayashree; Apanasovich, Tatiyana V; Kinahan, Paul E; Myers, Kyle J; Goldgof, Dmitry B; Barboriak, Daniel P; Gillies, Robert J; Schwartz, Lawrence H; Sullivan, Daniel C

2015-02-01

Quantitative biomarkers from medical images are becoming important tools for clinical diagnosis, staging, monitoring, treatment planning, and development of new therapies. While there is a rich history of the development of quantitative imaging biomarker (QIB) techniques, little attention has been paid to the validation and comparison of the computer algorithms that implement the QIB measurements. In this paper we provide a framework for QIB algorithm comparisons. We first review and compare various study designs, including designs with the true value (e.g. phantoms, digital reference images, and zero-change studies), designs with a reference standard (e.g. studies testing equivalence with a reference standard), and designs without a reference standard (e.g. agreement studies and studies of algorithm precision). The statistical methods for comparing QIB algorithms are then presented for various study types using both aggregate and disaggregate approaches. We propose a series of steps for establishing the performance of a QIB algorithm, identify limitations in the current statistical literature, and suggest future directions for research. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

CLSI-derived hematology and biochemistry reference intervals for healthy adults in eastern and southern Africa.

PubMed

Karita, Etienne; Ketter, Nzeera; Price, Matt A; Kayitenkore, Kayitesi; Kaleebu, Pontiano; Nanvubya, Annet; Anzala, Omu; Jaoko, Walter; Mutua, Gaudensia; Ruzagira, Eugene; Mulenga, Joseph; Sanders, Eduard J; Mwangome, Mary; Allen, Susan; Bwanika, Agnes; Bahemuka, Ubaldo; Awuondo, Ken; Omosa, Gloria; Farah, Bashir; Amornkul, Pauli; Birungi, Josephine; Yates, Sarah; Stoll-Johnson, Lisa; Gilmour, Jill; Stevens, Gwynn; Shutes, Erin; Manigart, Olivier; Hughes, Peter; Dally, Len; Scott, Janet; Stevens, Wendy; Fast, Pat; Kamali, Anatoli

2009-01-01

Clinical laboratory reference intervals have not been established in many African countries, and non-local intervals are commonly used in clinical trials to screen and monitor adverse events (AEs) among African participants. Using laboratory reference intervals derived from other populations excludes potential trial volunteers in Africa and makes AE assessment challenging. The objective of this study was to establish clinical laboratory reference intervals for 25 hematology, immunology and biochemistry values among healthy African adults typical of those who might join a clinical trial. Equal proportions of men and women were invited to participate in a cross sectional study at seven clinical centers (Kigali, Rwanda; Masaka and Entebbe, Uganda; two in Nairobi and one in Kilifi, Kenya; and Lusaka, Zambia). All laboratories used hematology, immunology and biochemistry analyzers validated by an independent clinical laboratory. Clinical and Laboratory Standards Institute guidelines were followed to create study consensus intervals. For comparison, AE grading criteria published by the U.S. National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) and other U.S. reference intervals were used. 2,990 potential volunteers were screened, and 2,105 (1,083 men and 1,022 women) were included in the analysis. While some significant gender and regional differences were observed, creating consensus African study intervals from the complete data was possible for 18 of the 25 analytes. Compared to reference intervals from the U.S., we found lower hematocrit and hemoglobin levels, particularly among women, lower white blood cell and neutrophil counts, and lower amylase. Both genders had elevated eosinophil counts, immunoglobulin G, total and direct bilirubin, lactate dehydrogenase and creatine phosphokinase, the latter being more pronounced among women. When graded against U.S. -derived DAIDS AE grading criteria, we observed 774 (35.3%) volunteers with grade one or higher results; 314 (14.9%) had elevated total bilirubin, and 201 (9.6%) had low neutrophil counts. These otherwise healthy volunteers would be excluded or would require special exemption to participate in many clinical trials. To accelerate clinical trials in Africa, and to improve their scientific validity, locally appropriate reference ranges should be used. This study provides ranges that will inform inclusion criteria and evaluation of adverse events for studies in these regions of Africa.

[Perception scales of validated food insecurity: the experience of the countries in Latin America and the Caribbean].

PubMed

Sperandio, Naiara; Morais, Dayane de Castro; Priore, Silvia Eloiza

2018-02-01

The scope of this systematic review was to compare the food insecurity scales validated and used in the countries in Latin America and the Caribbean, and analyze the methods used in validation studies. A search was conducted in the Lilacs, SciELO and Medline electronic databases. The publications were pre-selected by titles and abstracts, and subsequently by a full reading. Of the 16,325 studies reviewed, 14 were selected. Twelve validated scales were identified for the following countries: Venezuela, Brazil, Colombia, Bolivia, Ecuador, Costa Rica, Mexico, Haiti, the Dominican Republic, Argentina and Guatemala. Besides these, there is the Latin American and Caribbean scale, the scope of which is regional. The scales ranged from the standard reference used, number of questions and diagnosis of insecurity. The methods used by the studies for internal validation were calculation of Cronbach's alpha and the Rasch model; for external validation the authors calculated association and /or correlation with socioeconomic and food consumption variables. The successful experience of Latin America and the Caribbean in the development of national and regional scales can be an example for other countries that do not have this important indicator capable of measuring the phenomenon of food insecurity.

Teaching and Learning Activity Sequencing System using Distributed Genetic Algorithms

NASA Astrophysics Data System (ADS)

Matsui, Tatsunori; Ishikawa, Tomotake; Okamoto, Toshio

The purpose of this study is development of a supporting system for teacher's design of lesson plan. Especially design of lesson plan which relates to the new subject "Information Study" is supported. In this study, we developed a system which generates teaching and learning activity sequences by interlinking lesson's activities corresponding to the various conditions according to the user's input. Because user's input is multiple information, there will be caused contradiction which the system should solve. This multiobjective optimization problem is resolved by Distributed Genetic Algorithms, in which some fitness functions are defined with reference models on lesson, thinking and teaching style. From results of various experiments, effectivity and validity of the proposed methods and reference models were verified; on the other hand, some future works on reference models and evaluation functions were also pointed out.

CSAHi study-2: Validation of multi-electrode array systems (MEA60/2100) for prediction of drug-induced proarrhythmia using human iPS cell-derived cardiomyocytes: Assessment of reference compounds and comparison with non-clinical studies and clinical information.

PubMed

Nozaki, Yumiko; Honda, Yayoi; Watanabe, Hitoshi; Saiki, Shota; Koyabu, Kiyotaka; Itoh, Tetsuji; Nagasawa, Chiho; Nakamori, Chiaki; Nakayama, Chiaki; Iwasaki, Hiroshi; Suzuki, Shinobu; Tanaka, Kohji; Takahashi, Etsushi; Miyamoto, Kaori; Morimura, Kaoru; Yamanishi, Atsuhiro; Endo, Hiroko; Shinozaki, Junko; Nogawa, Hisashi; Shinozawa, Tadahiro; Saito, Fumiyo; Kunimatsu, Takeshi

2017-08-01

With the aim of reconsidering ICH S7B and E14 guidelines, a new in vitro assay system has been subjected to worldwide validation to establish a better prediction platform for potential drug-induced QT prolongation and the consequent TdP in clinical practice. In Japan, CSAHi HEART team has been working on hiPS-CMs in the MEA (hiPS-CMs/MEA) under a standardized protocol and found no inter-facility or lot-to-lot variability for proarrhythmic risk assessment of 7 reference compounds. In this study, we evaluated the responses of hiPS-CMs/MEA to another 31 reference compounds associated with cardiac toxicities, and gene expression to further clarify the electrophysiological characteristics over the course of culture period. The hiPS-CMs/MEA assay accurately predicted reference compounds potential for arrhythmogenesis, and yielded results that showed better correlation with target concentrations of QTc prolongation or TdP in clinical setting than other current in vitro and in vivo assays. Gene expression analyses revealed consistent profiles in all samples within and among the testing facilities. This report would provide CiPA with informative guidance on the use of the hiPS-CMs/MEA assay, and promote the establishment of a new paradigm, beyond conventional in vitro and in vivo assays for cardiac safety assessment of new drugs. Copyright © 2017 Elsevier Inc. All rights reserved.

The Swedish version of the multidimensional scale of perceived social support (MSPSS)--a psychometric evaluation study in women with hirsutism and nursing students.

PubMed

Ekbäck, Maria; Benzein, Eva; Lindberg, Magnus; Arestedt, Kristofer

2013-10-10

The Multidimensional Scale of Perceived Social Support (MSPSS) is a short instrument, developed to assess perceived social support. The original English version has been widely used. The original scale has demonstrated satisfactory psychometric properties in different settings, but no validated Swedish version has been available. The aim was therefore to translate, adapt and psychometrically evaluate the Multidimensional Scale of Perceived Social Support for use in a Swedish context. In total 281 participants accepted to join the study, a main sample of 127 women with hirsutism and a reference sample of 154 nursing students. The MSPSS was translated and culturally adapted according to the rigorous official process approved by WHO. The psychometric evaluation included item analysis, evaluation of factor structure, known-group validity, internal consistency and reproducibility. The original three-factor structure was reproduced in the main sample of women with hirsutism. An equivalent factor structure was demonstrated in a cross-validation, based on the reference sample of nursing students. Known-group validity was supported and internal consistency was good for all scales (α = 0.91-0.95). The test-retest showed acceptable to very good reproducibility for the items (κw = 0.58-0.85) and the scales (ICC = 0.89-0.92; CCC = 0.89-0.92). The Swedish version of the MSPSS is a multidimensional scale with sound psychometric properties in the present study sample. The simple and short format makes it a useful tool for measuring perceived social support.

Evaluation of Reference Genes for RT-qPCR Studies in the Seagrass Zostera muelleri Exposed to Light Limitation

PubMed Central

Schliep, M.; Pernice, M.; Sinutok, S.; Bryant, C. V.; York, P. H.; Rasheed, M. A.; Ralph, P. J.

2015-01-01

Seagrass meadows are threatened by coastal development and global change. In the face of these pressures, molecular techniques such as reverse transcription quantitative real-time PCR (RT-qPCR) have great potential to improve management of these ecosystems by allowing early detection of chronic stress. In RT-qPCR, the expression levels of target genes are estimated on the basis of reference genes, in order to control for RNA variations. Although determination of suitable reference genes is critical for RT-qPCR studies, reports on the evaluation of reference genes are still absent for the major Australian species Zostera muelleri subsp. capricorni (Z. muelleri). Here, we used three different software (geNorm, NormFinder and Bestkeeper) to evaluate ten widely used reference genes according to their expression stability in Z. muelleri exposed to light limitation. We then combined results from different software and used a consensus rank of four best reference genes to validate regulation in Photosystem I reaction center subunit IV B and Heat Stress Transcription factor A- gene expression in Z. muelleri under light limitation. This study provides the first comprehensive list of reference genes in Z. muelleri and demonstrates RT-qPCR as an effective tool to identify early responses to light limitation in seagrass. PMID:26592440

Selecting and validating reference genes for quantitative real-time PCR in Plutella xylostella (L.).

PubMed

You, Yanchun; Xie, Miao; Vasseur, Liette; You, Minsheng

2018-05-01

Gene expression analysis provides important clues regarding gene functions, and quantitative real-time PCR (qRT-PCR) is a widely used method in gene expression studies. Reference genes are essential for normalizing and accurately assessing gene expression. In the present study, 16 candidate reference genes (ACTB, CyPA, EF1-α, GAPDH, HSP90, NDPk, RPL13a, RPL18, RPL19, RPL32, RPL4, RPL8, RPS13, RPS4, α-TUB, and β-TUB) from Plutella xylostella were selected to evaluate gene expression stability across different experimental conditions using five statistical algorithms (geNorm, NormFinder, Delta Ct, BestKeeper, and RefFinder). The results suggest that different reference genes or combinations of reference genes are suitable for normalization in gene expression studies of P. xylostella according to the different developmental stages, strains, tissues, and insecticide treatments. Based on the given experimental sets, the most stable reference genes were RPS4 across different developmental stages, RPL8 across different strains and tissues, and EF1-α across different insecticide treatments. A comprehensive and systematic assessment of potential reference genes for gene expression normalization is essential for post-genomic functional research in P. xylostella, a notorious pest with worldwide distribution and a high capacity to adapt and develop resistance to insecticides.

Geographic and temporal validity of prediction models: Different approaches were useful to examine model performance

PubMed Central

Austin, Peter C.; van Klaveren, David; Vergouwe, Yvonne; Nieboer, Daan; Lee, Douglas S.; Steyerberg, Ewout W.

2017-01-01

Objective Validation of clinical prediction models traditionally refers to the assessment of model performance in new patients. We studied different approaches to geographic and temporal validation in the setting of multicenter data from two time periods. Study Design and Setting We illustrated different analytic methods for validation using a sample of 14,857 patients hospitalized with heart failure at 90 hospitals in two distinct time periods. Bootstrap resampling was used to assess internal validity. Meta-analytic methods were used to assess geographic transportability. Each hospital was used once as a validation sample, with the remaining hospitals used for model derivation. Hospital-specific estimates of discrimination (c-statistic) and calibration (calibration intercepts and slopes) were pooled using random effects meta-analysis methods. I2 statistics and prediction interval width quantified geographic transportability. Temporal transportability was assessed using patients from the earlier period for model derivation and patients from the later period for model validation. Results Estimates of reproducibility, pooled hospital-specific performance, and temporal transportability were on average very similar, with c-statistics of 0.75. Between-hospital variation was moderate according to I2 statistics and prediction intervals for c-statistics. Conclusion This study illustrates how performance of prediction models can be assessed in settings with multicenter data at different time periods. PMID:27262237

Validation and quantification of [18F]altanserin binding in the rat brain using blood input and reference tissue modeling

PubMed Central

Riss, Patrick J; Hong, Young T; Williamson, David; Caprioli, Daniele; Sitnikov, Sergey; Ferrari, Valentina; Sawiak, Steve J; Baron, Jean-Claude; Dalley, Jeffrey W; Fryer, Tim D; Aigbirhio, Franklin I

2011-01-01

The 5-hydroxytryptamine type 2a (5-HT2A) selective radiotracer [18F]altanserin has been subjected to a quantitative micro-positron emission tomography study in Lister Hooded rats. Metabolite-corrected plasma input modeling was compared with reference tissue modeling using the cerebellum as reference tissue. [18F]altanserin showed sufficient brain uptake in a distribution pattern consistent with the known distribution of 5-HT2A receptors. Full binding saturation and displacement was documented, and no significant uptake of radioactive metabolites was detected in the brain. Blood input as well as reference tissue models were equally appropriate to describe the radiotracer kinetics. [18F]altanserin is suitable for quantification of 5-HT2A receptor availability in rats. PMID:21750562

Clinical prediction models for mortality and functional outcome following ischemic stroke: A systematic review and meta-analysis

PubMed Central

Crayton, Elise; Wolfe, Charles; Douiri, Abdel

2018-01-01

Objective We aim to identify and critically appraise clinical prediction models of mortality and function following ischaemic stroke. Methods Electronic databases, reference lists, citations were searched from inception to September 2015. Studies were selected for inclusion, according to pre-specified criteria and critically appraised by independent, blinded reviewers. The discrimination of the prediction models was measured by the area under the curve receiver operating characteristic curve or c-statistic in random effects meta-analysis. Heterogeneity was measured using I2. Appropriate appraisal tools and reporting guidelines were used in this review. Results 31395 references were screened, of which 109 articles were included in the review. These articles described 66 different predictive risk models. Appraisal identified poor methodological quality and a high risk of bias for most models. However, all models precede the development of reporting guidelines for prediction modelling studies. Generalisability of models could be improved, less than half of the included models have been externally validated(n = 27/66). 152 predictors of mortality and 192 predictors and functional outcome were identified. No studies assessing ability to improve patient outcome (model impact studies) were identified. Conclusions Further external validation and model impact studies to confirm the utility of existing models in supporting decision-making is required. Existing models have much potential. Those wishing to predict stroke outcome are advised to build on previous work, to update and adapt validated models to their specific contexts opposed to designing new ones. PMID:29377923

An Amotivation Model in Physical Education

ERIC Educational Resources Information Center

Shen, Bo; Wingert, Robert K.; Li, Weidong; Sun, Haichun; Rukavina, Paul Bernard

2010-01-01

Amotivation refers to a state in which individuals cannot perceive a relationship between their behavior and that behavior's subsequent outcome. With the belief that considering amotivation as a multidimensional construct could reflect the complexity of motivational deficits in physical education, we developed this study to validate an amotivation…

The Measurement of Translation Ability.

ERIC Educational Resources Information Center

Stansfield, Charles W.; And Others

1992-01-01

Variables that constitute translation ability are discussed, based on a two-year development and validation study of job-related tests of translation ability for the Federal Bureau of Investigation. The project involved the development of two parallel forms of the Spanish into English Verbatim Translation Exam (SEVTE). (five references) (LB)

Modeling Learning Processes in Lexical CALL.

ERIC Educational Resources Information Center

Goodfellow, Robin; Laurillard, Diana

1994-01-01

Studies the performance of a novice Spanish student using a Computer-assisted language learning (CALL) system designed for vocabulary enlargement. Results indicate that introspective evidence may be used to validate performance data within a theoretical framework that characterizes the learning approach as "surface" or "deep." (25 references)…

Sequencing and Validation of Reference Genes to Analyze Endogenous Gene Expression and Quantify Yellow Dwarf Viruses Using RT-qPCR in Viruliferous Rhopalosiphum padi

PubMed Central

Wu, Keke; Liu, Wenwen; Mar, Thithi; Liu, Yan; Wu, Yunfeng; Wang, Xifeng

2014-01-01

The bird cherry-oat aphid (Rhopalosiphum padi), an important pest of cereal crops, not only directly sucks sap from plants, but also transmits a number of plant viruses, collectively the yellow dwarf viruses (YDVs). For quantifying changes in gene expression in vector aphids, reverse transcription-quantitative polymerase chain reaction (RT-qPCR) is a touchstone method, but the selection and validation of housekeeping genes (HKGs) as reference genes to normalize the expression level of endogenous genes of the vector and for exogenous genes of the virus in the aphids is critical to obtaining valid results. Such an assessment has not been done, however, for R. padi and YDVs. Here, we tested three algorithms (GeNorm, NormFinder and BestKeeper) to assess the suitability of candidate reference genes (EF-1α, ACT1, GAPDH, 18S rRNA) in 6 combinations of YDV and vector aphid morph. EF-1α and ACT1 together or in combination with GAPDH or with GAPDH and 18S rRNA could confidently be used to normalize virus titre and expression levels of endogenous genes in winged or wingless R. padi infected with Barley yellow dwarf virus isolates (BYDV)-PAV and BYDV-GAV. The use of only one reference gene, whether the most stably expressed (EF-1α) or the least stably expressed (18S rRNA), was not adequate for obtaining valid relative expression data from the RT-qPCR. Because of discrepancies among values for changes in relative expression obtained using 3 regions of the same gene, different regions of an endogenous aphid gene, including each terminus and the middle, should be analyzed at the same time with RT-qPCR. Our results highlight the necessity of choosing the best reference genes to obtain valid experimental data and provide several HKGs for relative quantification of virus titre in YDV-viruliferous aphids. PMID:24810421

E&V (Evaluation and Validation) Reference Manual, Version 1.0.

DTIC Science & Technology

1988-07-01

references featured in the Reference Manual. G-05097a GENERAL REFERENCE INFORMATION EXTRACTED , FROM * INDEXES AND CROSS REFERENCES CHAPTER 4...at E&V techniques through many different paths, and provides a means to extract useful information along the way. /^c^^s; /r^ ^yr*•**•»» * L...electronically (preferred) to szymansk@ajpo.sei.cmu.edu or by regular mail to Mr. Raymond Szymanski . AFWAUAAAF, Wright Patterson AFB, OH 45433-6543. ES-2

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

EPA Pesticide Factsheets

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

Validating the food behavior questions from the elementary school SPAN questionnaire.

PubMed

Thiagarajah, Krisha; Fly, Alyce D; Hoelscher, Deanna M; Bai, Yeon; Lo, Kaman; Leone, Angela; Shertzer, Julie A

2008-01-01

The School Physical Activity and Nutrition (SPAN) questionnaire was developed as a surveillance instrument to measure physical activity, nutrition attitudes, and dietary and physical activity behaviors in children and adolescents. The SPAN questionnaire has 2 versions. This study was conducted to evaluate the validity of food consumption items from the elementary school version of the SPAN questionnaire. Validity was assessed by comparing food items selected on the questionnaire with food items reported from a single 24-hour recall covering the same reference period. 5 elementary schools in Indiana. Fourth-grade student volunteers (N = 121) from 5 elementary schools. Agreement between responses to SPAN questionnaire items and reference values obtained through 24-hour dietary recall. The agreement between the questionnaire and the 24-hour recall was measured using Spearman correlation, percentage agreement, and kappa statistic. Correlation between SPAN item responses and recall data ranged from .25 (bread and related products) to .67 (gravy). The percentage agreement ranged from 26% (bread and related products) to 90% (gravy). The kappa statistic varied from .06 (chocolate candy) to .60 (beans). Results from this study indicate that the SPAN questionnaire can be administered in the classroom quickly and easily to measure many previous day dietary behaviors of fourth graders. However, questions addressing consumption of "vegetables," "candy," and "snacks" need further investigation.

Fatigue in children: reliability and validity of the Dutch PedsQL™ Multidimensional Fatigue Scale.

PubMed

Gordijn, M Suzanne; Suzanne Gordijn, M; Cremers, Eline M P; Kaspers, Gertjan J L; Gemke, Reinoud J B J

2011-09-01

The aim of the study is to report on the feasibility, reliability, validity, and the norm-references of the Dutch version of the PedsQL™ Multidimensional Fatigue Scale. The study participants are four hundred and ninety-seven parents of children aged 2-18 years and 366 children aged 5-18 years from various day care facilities, elementary schools, and a high school who completed the Dutch version of the PedsQL™ Multidimensional Fatigue Scale. The number of missing items was minimal. All scales showed satisfactory internal consistency reliability, with Cronbach's coefficient alpha exceeding 0.70. Test-retest reliability was good to excellent (ICCs 0.68-0.84) and inter-observer reliability varied from moderate to excellent (ICCs 0.56-0.93) for total scores. Parent/child concordance for total scores was poor to good (ICCs 0.25-0.68). The PedsQL™ Multidimensional Fatigue Scale was able to distinguish between healthy children and children with an impaired health condition. The Dutch version of the PedsQL™ Multidimensional Fatigue Scale demonstrates an adequate feasibility, reliability, and validity in another sociocultural context. With the obtained norm-references, it can be utilized as a tool in the evaluation of fatigue in healthy and chronically ill children aged 2-18 years.

Self-administered structured food record for measuring individual energy and nutrient intake in large cohorts: Design and validation.

PubMed

García, Silvia M; González, Claudio; Rucci, Enzo; Ambrosino, Cintia; Vidal, Julia; Fantuzzi, Gabriel; Prestes, Mariana; Kronsbein, Peter

2018-06-05

Several instruments developed to assess dietary intake of groups or populations have strengths and weaknesses that affect their specific application. No self-administered, closed-ended dietary survey was previously used in Argentina to assess current food and nutrient intake on a daily basis. To design and validate a self-administered, structured food record (NutriQuid, NQ) representative of the adult Argentine population's food consumption pattern to measure individual energy and nutrient intake. Records were loaded onto a database using software that checks a regional nutrition information system (SARA program), automatically quantifying energy and nutrient intake. NQ validation included two phases: (1) NQ construct validity comparing records kept simultaneously by healthy volunteers (45-75 years) and a nutritionist who provided meals (reference), and (2) verification of whether NQ reflected target population consumption (calories and nutrients), week consumption differences, respondent acceptability, and ease of data entry/analysis. Data analysis included descriptive statistics, repeated measures ANOVA, intraclass correlation coefficient, nonparametric regression, and cross-classification into quintiles. The first validation (study group vs. reference) showed an underestimation (10%) of carbohydrate, fat, and energy intake. Second validation: 109 volunteers (91% response) completed the NQ for seven consecutive days. Record completion took about 9min/day, and data entry 3-6min. Mean calorie intake was 2240±119kcal/day (42% carbohydrates, 17% protein, and 41% fat). Intake significantly increased in the weekend. NQ is a simple and efficient tool to assess dietary intake in large samples. Copyright © 2018 SEEN y SED. Publicado por Elsevier España, S.L.U. All rights reserved.

Noninvasive Classification of Hepatic Fibrosis Based on Texture Parameters From Double Contrast-Enhanced Magnetic Resonance Images

PubMed Central

Bahl, Gautam; Cruite, Irene; Wolfson, Tanya; Gamst, Anthony C.; Collins, Julie M.; Chavez, Alyssa D.; Barakat, Fatma; Hassanein, Tarek; Sirlin, Claude B.

2016-01-01

Purpose To demonstrate a proof of concept that quantitative texture feature analysis of double contrast-enhanced magnetic resonance imaging (MRI) can classify fibrosis noninvasively, using histology as a reference standard. Materials and Methods A Health Insurance Portability and Accountability Act (HIPAA)-compliant Institutional Review Board (IRB)-approved retrospective study of 68 patients with diffuse liver disease was performed at a tertiary liver center. All patients underwent double contrast-enhanced MRI, with histopathology-based staging of fibrosis obtained within 12 months of imaging. The MaZda software program was used to compute 279 texture parameters for each image. A statistical regularization technique, generalized linear model (GLM)-path, was used to develop a model based on texture features for dichotomous classification of fibrosis category (F ≤2 vs. F ≥3) of the 68 patients, with histology as the reference standard. The model's performance was assessed and cross-validated. There was no additional validation performed on an independent cohort. Results Cross-validated sensitivity, specificity, and total accuracy of the texture feature model in classifying fibrosis were 91.9%, 83.9%, and 88.2%, respectively. Conclusion This study shows proof of concept that accurate, noninvasive classification of liver fibrosis is possible by applying quantitative texture analysis to double contrast-enhanced MRI. Further studies are needed in independent cohorts of subjects. PMID:22851409

Efficacy of a Deep Learning System for Detecting Glaucomatous Optic Neuropathy Based on Color Fundus Photographs.

PubMed

Li, Zhixi; He, Yifan; Keel, Stuart; Meng, Wei; Chang, Robert T; He, Mingguang

2018-03-02

To assess the performance of a deep learning algorithm for detecting referable glaucomatous optic neuropathy (GON) based on color fundus photographs. A deep learning system for the classification of GON was developed for automated classification of GON on color fundus photographs. We retrospectively included 48 116 fundus photographs for the development and validation of a deep learning algorithm. This study recruited 21 trained ophthalmologists to classify the photographs. Referable GON was defined as vertical cup-to-disc ratio of 0.7 or more and other typical changes of GON. The reference standard was made until 3 graders achieved agreement. A separate validation dataset of 8000 fully gradable fundus photographs was used to assess the performance of this algorithm. The area under receiver operator characteristic curve (AUC) with sensitivity and specificity was applied to evaluate the efficacy of the deep learning algorithm detecting referable GON. In the validation dataset, this deep learning system achieved an AUC of 0.986 with sensitivity of 95.6% and specificity of 92.0%. The most common reasons for false-negative grading (n = 87) were GON with coexisting eye conditions (n = 44 [50.6%]), including pathologic or high myopia (n = 37 [42.6%]), diabetic retinopathy (n = 4 [4.6%]), and age-related macular degeneration (n = 3 [3.4%]). The leading reason for false-positive results (n = 480) was having other eye conditions (n = 458 [95.4%]), mainly including physiologic cupping (n = 267 [55.6%]). Misclassification as false-positive results amidst a normal-appearing fundus occurred in only 22 eyes (4.6%). A deep learning system can detect referable GON with high sensitivity and specificity. Coexistence of high or pathologic myopia is the most common cause resulting in false-negative results. Physiologic cupping and pathologic myopia were the most common reasons for false-positive results. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Validation of equations and proposed reference values to estimate fat mass in Chilean university students.

PubMed

Gómez Campos, Rossana; Pacheco Carrillo, Jaime; Almonacid Fierro, Alejandro; Urra Albornoz, Camilo; Cossío-Bolaños, Marco

2018-03-01

(i) To propose regression equations based on anthropometric measures to estimate fat mass (FM) using dual energy X-ray absorptiometry (DXA) as reference method, and (ii)to establish population reference standards for equation-derived FM. A cross-sectional study on 6,713 university students (3,354 males and 3,359 females) from Chile aged 17.0 to 27.0years. Anthropometric measures (weight, height, waist circumference) were taken in all participants. Whole body DXA was performed in 683 subjects. A total of 478 subjects were selected to develop regression equations, and 205 for their cross-validation. Data from 6,030 participants were used to develop reference standards for FM. Equations were generated using stepwise multiple regression analysis. Percentiles were developed using the LMS method. Equations for men were: (i) FM=-35,997.486 +232.285 *Weight +432.216 *CC (R 2 =0.73, SEE=4.1); (ii)FM=-37,671.303 +309.539 *Weight +66,028.109 *ICE (R2=0.76, SEE=3.8), while equations for women were: (iii)FM=-13,216.917 +461,302 *Weight+91.898 *CC (R 2 =0.70, SEE=4.6), and (iv) FM=-14,144.220 +464.061 *Weight +16,189.297 *ICE (R 2 =0.70, SEE=4.6). Percentiles proposed included p10, p50, p85, and p95. The developed equations provide valid and accurate estimation of FM in both sexes. The values obtained using the equations may be analyzed from percentiles that allow for categorizing body fat levels by age and sex. Copyright © 2017 SEEN y SED. Publicado por Elsevier España, S.L.U. All rights reserved.

School Age Populations Research Needs - NCS Dietary Assessment Literature Review

Cancer.gov

Drawing conclusions about the validity of available dietary assessment instruments in school age children is hampered by the differences in instruments, research design, reference methods, and populations in the validation literature.

Validation of a new algorithm for the BPM-100 electronic oscillometric office blood pressure monitor.

PubMed

Wright, J M; Mattu, G S; Perry, T L; Gelferc, M E; Strange, K D; Zorn, A; Chen, Y

2001-06-01

To test the accuracy of a new algorithm for the BPM-100, an automated oscillometric blood pressure (BP) monitor, using stored data from an independently conducted validation trial comparing the BPM-100(Beta) with a mercury sphygmomanometer. Raw pulse wave and cuff pressure data were stored electronically using embedded software in the BPM-100(Beta), during the validation trial. The 391 sets of measurements were separated objectively into two subsets. A subset of 136 measurements was used to develop a new algorithm to enhance the accuracy of the device when reading higher systolic pressures. The larger subset of 255 measurements (three readings for 85 subjects) was used as test data to validate the accuracy of the new algorithm. Differences between the new algorithm BPM-100 and the reference (mean of two observers) were determined and expressed as the mean difference +/- SD, plus the percentage of measurements within 5, 10, and 15 mmHg. The mean difference between the BPM-100 and reference systolic BP was -0.16 +/- 5.13 mmHg, with 73.7% < or = 5 mmHg, 94.9% < or = 10 mmHg and 98.8% < or = 15 mmHg. The mean difference between the BPM-100 and reference diastolic BP was -1.41 +/- 4.67 mmHg, with 78.4% < or = 5 mmHg, 92.5% < or = 10 mmHg, and 99.2% < or = 15 mmHg. These data improve upon that of the BPM-100(Beta) and pass the AAMI standard, and 'A' grade BHS protocol. This study illustrates a new method for developing and testing a change in an algorithm for an oscillometric BP monitor utilizing collected and stored electronic data and demonstrates that the new algorithm meets the AAMI standard and BHS protocol.

Development of a Reference Data Set (RDS) for dental age estimation (DAE) and testing of this with a separate Validation Set (VS) in a southern Chinese population.

PubMed

Jayaraman, Jayakumar; Wong, Hai Ming; King, Nigel M; Roberts, Graham J

2016-10-01

Many countries have recently experienced a rapid increase in the demand for forensic age estimates of unaccompanied minors. Hong Kong is a major tourist and business center where there has been an increase in the number of people intercepted with false travel documents. An accurate estimation of age is only possible when a dataset for age estimation that has been derived from the corresponding ethnic population. Thus, the aim of this study was to develop and validate a Reference Data Set (RDS) for dental age estimation for southern Chinese. A total of 2306 subjects were selected from the patient archives of a large dental hospital and the chronological age for each subject was recorded. This age was assigned to each specific stage of dental development for each tooth to create a RDS. To validate this RDS, a further 484 subjects were randomly chosen from the patient archives and their dental age was assessed based on the scores from the RDS. Dental age was estimated using meta-analysis command corresponding to random effects statistical model. Chronological age (CA) and Dental Age (DA) were compared using the paired t-test. The overall difference between the chronological and dental age (CA-DA) was 0.05 years (2.6 weeks) for males and 0.03 years (1.6 weeks) for females. The paired t-test indicated that there was no statistically significant difference between the chronological and dental age (p > 0.05). The validated southern Chinese reference dataset based on dental maturation accurately estimated the chronological age. Copyright © 2016 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

The Validity of US Nutritional Surveillance: USDA's Loss-Adjusted Food Availability Data Series 1971-2010

PubMed Central

Archer, Edward; Thomas, Diana M.; McDonald, Samantha M.; Pavela, Gregory; Lavie, Carl J.; Hill, James O.; Blair, Steven N.

2016-01-01

The purpose of this study was to examine the validity of the 1971-2010 United States Department of Agriculture's (USDA's) loss-adjusted food availability (LAFA) per capita caloric consumption estimates. Estimated total daily energy expenditure (TEE) was calculated for nationally representative samples of US adults, 20-74 years, using the Institute of Medicine's predictive equations with “low-active” (TEE L-ACT) and “sedentary” (TEE SED) physical activity values. TEE estimates were subtracted from LAFA estimates to create disparity values (kcal/d). A validated mathematical model was applied to calculate expected weight change in reference individuals resulting from the disparity. From 1971-2010, the disparity between LAFA and TEE L-ACT varied by 394 kcal/d—(P < 0.001), from −205 kcal/d (95% CI: −214, −196) to +189 kcal/d (95% CI: 168, 209). The disparity between LAFA and TEE SED varied by 412 kcal/d (P < 0.001), from −84 kcal/d (95% CI: −93, −76) to +328 kcal/d (95% CI: 309, 348). Our model suggests that if LAFA estimates were actually consumed, reference individuals would have lost ∼1-4 kg/y from 1971-1980 (an accumulated loss of ∼ 12 to ∼36kg), and gained ∼ 3-7 kg/y from 1988-2010 (an accumulated gain of ∼42 to ∼98 kg). These estimates differed from the actual measured increments of 10 kg and 9 kg in reference men and women, respectively, over the 39-year period. The USDA LAFA data provided inconsistent, divergent estimates of per capita caloric consumption over its 39-year history. The large, variable misestimation suggests that the USDA LAFA per capita caloric intake estimates lack validity and should not be used to inform public policy. PMID:27914522

Identification and validation of suitable reference genes for RT-qPCR analysis in mouse testis development.

PubMed

Gong, Zu-Kang; Wang, Shuang-Jie; Huang, Yong-Qi; Zhao, Rui-Qiang; Zhu, Qi-Fang; Lin, Wen-Zhen

2014-12-01

RT-qPCR is a commonly used method for evaluating gene expression; however, its accuracy and reliability are dependent upon the choice of appropriate reference gene(s), and there is limited information available on suitable reference gene(s) that can be used in mouse testis at different stages. In this study, using the RT-qPCR method, we investigated the expression variations of six reference genes representing different functional classes (Actb, Gapdh, Ppia, Tbp, Rps29, Hprt1) in mice testis during embryonic and postnatal development. The expression stabilities of putative reference genes were evaluated using five algorithms: geNorm, NormFinder, Bestkeeper, the comparative delta C(t) method and integrated tool RefFinder. Analysis of the results showed that Ppia, Gapdh and Actb were identified as the most stable genes and the geometric mean of Ppia, Gapdh and Actb constitutes an appropriate normalization factor for gene expression studies. The mRNA expression of AT1 as a test gene of interest varied depending upon which of the reference gene(s) was used as an internal control(s). This study suggested that Ppia, Gapdh and Actb are suitable reference genes among the six genes used for RT-qPCR normalization and provide crucial information for transcriptional analyses in future studies of gene expression in the developing mouse testis.

Joint Transform Correlation for face tracking: elderly fall detection application

NASA Astrophysics Data System (ADS)

Katz, Philippe; Aron, Michael; Alfalou, Ayman

2013-03-01

In this paper, an iterative tracking algorithm based on a non-linear JTC (Joint Transform Correlator) architecture and enhanced by a digital image processing method is proposed and validated. This algorithm is based on the computation of a correlation plane where the reference image is updated at each frame. For that purpose, we use the JTC technique in real time to track a patient (target image) in a room fitted with a video camera. The correlation plane is used to localize the target image in the current video frame (frame i). Then, the reference image to be exploited in the next frame (frame i+1) is updated according to the previous one (frame i). In an effort to validate our algorithm, our work is divided into two parts: (i) a large study based on different sequences with several situations and different JTC parameters is achieved in order to quantify their effects on the tracking performances (decimation, non-linearity coefficient, size of the correlation plane, size of the region of interest...). (ii) the tracking algorithm is integrated into an application of elderly fall detection. The first reference image is a face detected by means of Haar descriptors, and then localized into the new video image thanks to our tracking method. In order to avoid a bad update of the reference frame, a method based on a comparison of image intensity histograms is proposed and integrated in our algorithm. This step ensures a robust tracking of the reference frame. This article focuses on face tracking step optimisation and evalutation. A supplementary step of fall detection, based on vertical acceleration and position, will be added and studied in further work.

Standards for testing and clinical validation of seizure detection devices.

PubMed

Beniczky, Sándor; Ryvlin, Philippe

2018-06-01

To increase the quality of studies on seizure detection devices, we propose standards for testing and clinical validation of such devices. We identified 4 key features that are important for studies on seizure detection devices: subjects, recordings, data analysis and alarms, and reference standard. For each of these features, we list the specific aspects that need to be addressed in the studies, and depending on these, studies are classified into 5 phases (0-4). We propose a set of outcome measures that need to be reported, and we propose standards for reporting the results. These standards will help in designing and reporting studies on seizure detection devices, they will give readers clear information on the level of evidence provided by the studies, and they will help regulatory bodies in assessing the quality of the validation studies. These standards are flexible, allowing classification of the studies into one of the 5 phases. We propose actions that can facilitate development of novel methods and devices. Wiley Periodicals, Inc. © 2018 International League Against Epilepsy.

Assessment of the psychometric properties of the Spanish language version of questionnaire ICIQ-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).

PubMed

Castro-Díaz, D M; Esteban-Fuertes, M; Salinas-Casado, J; Bustamante-Alarma, S; Gago-Ramos, J L; Galacho-Bech, A; García-Matres, M J; Rodríguez-Toves, L A; Zubiaur-Líbano, C; Collado-Serra, A; Batista-Miranda, J E; Ortiz-Gámiz, A

2014-03-01

To evaluate the psychometric properties of the Spanish version of the ICIQ-Male Lower Urinary Tract Symptoms Questionnaire (ICIQ-MLUTS): Feasibility (% of completion and ceiling/ground effects), reliability (Test-retest), convergent validity (vs Bladder Control Self-Assessment Questionnaire [BSAQ] and vs International Prostate Symptom Score [I-PSS]) and criterion validity (according to presence or absence of symptoms). This was an observational, non-interventionist and multicenter study. 223 male patients with lower urinary tract symptoms (LUTS), predominantly storage symptoms and aged 18-65, took part in the study. Patients completed the ICIQ-MLUTS (test), I-PSS and BSAQ questionnaires and referred their urinary symptoms in a single visit, with the exception of a subgroup composed by 49 patients that completed the questionnaire again 15 days after initial visit to evaluate test-retest reliability. The questionnaire includes 13 items divided in 2 sub-scales: Voiding symptoms (V) from 0-20 and Incontinence symptoms (I) from 0-24. Percentage of patients that completed all items: 98.84%. Ground effect is 0 and ceiling effect was under 6% in both sub-scales. Test-retest reliability: Intraclass correlation coefficient (ICC) ranged from 0.68 to 0.88, except on Delay. Kappa shows a good agreement, between 0.60 and 0.81, except for Nocturia. Convergent validity: Correlation (Spearman) between the questionnaire sub-scales scores and the rest of measures is statistically significant (P < .01 and P < .05). Criterion validity: Statistically significant differences (P < .05) between scores on ICIQ-MLUTS, from patients that refer experiencing symptoms and those who do not. The Spanish version of the ICIQ-MLUTS questionnaire shows adequate feasibility, reliability and validity. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

Good validity of the international spinal cord injury quality of life basic data set.

PubMed

Post, M W M; Adriaansen, J J E; Charlifue, S; Biering-Sørensen, F; van Asbeck, F W A

2016-04-01

Cross-sectional validation study. To examine the construct and concurrent validity of the International Spinal Cord Injury (SCI) Quality of Life (QoL) Basic Data Set. Dutch community. People 28-65 years of age, who obtained their SCI between 18 and 35 years of age, were at least 10 years post SCI and were wheelchair users in daily life. MEASURE(S): The International SCI QoL Basic Data Set consists of three single items on satisfaction with life as a whole, physical health and psychological health (0=complete dissatisfaction; 10=complete satisfaction). Reference measures were the Mental Health Inventory-5 and three items of the World Health Organization Quality of Life measure. Data of 261 participants were available. Mean time after SCI was 24.1 years (s.d. 9.1); 90.4% had a traumatic SCI, 81.5% a motor complete SCI and 40% had tetraplegia. Mean age was 47.9 years (s.d. 8.8) and 73.2% were male. Mean scores were 6.9 (s.d. 1.9) for general QoL, 5.8 (s.d. 2.2) for physical health and 7.1 (s.d. 1.9) for psychological health. No floor or ceiling effects were found. Strong inter-correlations (0.48-0.71) were found between the items, and Cronbach's alpha of the scale was good (0.81). Correlations with the reference measures showed the strongest correlations between the WHOQOL general satisfaction item and general QoL (0.64), the WHOQOL health and daily activities items and physical health (0.69 and 0.60) and the Mental Health Inventory-5 and psychological health (0.70). This first validity study of the International SCI QoL Basic Data Set shows that it appears valid for persons with SCI.

Selection of reference genes for gene expression studies related to intramuscular fat deposition in Capra hircus skeletal muscle.

PubMed

Zhu, Wuzheng; Lin, Yaqiu; Liao, Honghai; Wang, Yong

2015-01-01

The identification of suitable reference genes is critical for obtaining reliable results from gene expression studies using quantitative real-time PCR (qPCR) because the expression of reference genes may vary considerably under different experimental conditions. In most cases, however, commonly used reference genes are employed in data normalization without proper validation, which may lead to incorrect data interpretation. Here, we aim to select a set of optimal reference genes for the accurate normalization of gene expression associated with intramuscular fat (IMF) deposition during development. In the present study, eight reference genes (PPIB, HMBS, RPLP0, B2M, YWHAZ, 18S, GAPDH and ACTB) were evaluated by three different algorithms (geNorm, NormFinder and BestKeeper) in two types of muscle tissues (longissimus dorsi muscle and biceps femoris muscle) across different developmental stages. All three algorithms gave similar results. PPIB and HMBS were identified as the most stable reference genes, while the commonly used reference genes 18S and GAPDH were the most variably expressed, with expression varying dramatically across different developmental stages. Furthermore, to reveal the crucial role of appropriate reference genes in obtaining a reliable result, analysis of PPARG expression was performed by normalization to the most and the least stable reference genes. The relative expression levels of PPARG normalized to the most stable reference genes greatly differed from those normalized to the least stable one. Therefore, evaluation of reference genes must be performed for a given experimental condition before the reference genes are used. PPIB and HMBS are the optimal reference genes for analysis of gene expression associated with IMF deposition in skeletal muscle during development.

Advantages of a dual-tracer model over reference tissue models for binding potential measurement in tumors

PubMed Central

Tichauer, K M; Samkoe, K S; Klubben, W S; Hasan, T; Pogue, B W

2012-01-01

The quantification of tumor molecular expression in vivo could have a significant impact for informing and monitoring immerging targeted therapies in oncology. Molecular imaging of targeted tracers can be used to quantify receptor expression in the form of a binding potential (BP) if the arterial input curve or a surrogate of it is also measured. However, the assumptions of the most common approaches (reference tissue models) may not be valid for use in tumors. In this study, the validity of reference tissue models is investigated for use in tumors experimentally and in simulations. Three different tumor lines were grown subcutaneously in athymic mice and the mice were injected with a mixture of an epidermal growth factor receptor- (EGFR-) targeted fluorescent tracer and an untargeted fluorescent tracer. A one-compartment plasma input model demonstrated that the transport kinetics of both tracers were significantly different between tumors and all potential reference tissues, and using the reference tissue model resulted in a theoretical underestimation in BP of 50 ± 37%. On the other hand, the targeted and untargeted tracers demonstrated similar transport kinetics, allowing a dual-tracer approach to be employed to accurately estimate binding potential (with a theoretical error of 0.23 ± 9.07%). These findings highlight the potential for using a dual-tracer approach to quantify receptor expression in tumors with abnormal hemodynamics, possibly to inform the choice or progress of molecular cancer therapies. PMID:23022732

An approach to an acute emotional stress reference scale.

PubMed

Garzon-Rey, J M; Arza, A; de-la-Camara, C; Lobo, A; Armario, A; Aguilo, J

2017-06-16

The clinical diagnosis aims to identify the degree of affectation of the psycho-physical state of the patient as a guide to therapeutic intervention. In stress, the lack of a measurement tool based on a reference makes it difficult to quantitatively assess this degree of affectation. To define and perform a primary assessment of a standard reference in order to measure acute emotional stress from the markers identified as indicators of the degree. Psychometric tests and biochemical variables are, in general, the most accepted stress measurements by the scientific community. Each one of them probably responds to different and complementary processes related to the reaction to a stress stimulus. The reference that is proposed is a weighted mean of these indicators by assigning them relative weights in accordance with a principal components analysis. An experimental study was conducted on 40 healthy young people subjected to the psychosocial stress stimulus of the Trier Social Stress Test in order to perform a primary assessment and consistency check of the proposed reference. The proposed scale clearly differentiates between the induced relax and stress states. Accepting the subjectivity of the definition and the lack of a subsequent validation with new experimental data, the proposed standard differentiates between a relax state and an emotional stress state triggered by a moderate stress stimulus, as it is the Trier Social Stress Test. The scale is robust. Although the variations in the percentage composition slightly affect the score, but they do not affect the valid differentiation between states.

Clinical Validation of Targeted Next Generation Sequencing for Colon and Lung Cancers

PubMed Central

D’Haene, Nicky; Le Mercier, Marie; De Nève, Nancy; Blanchard, Oriane; Delaunoy, Mélanie; El Housni, Hakim; Dessars, Barbara; Heimann, Pierre; Remmelink, Myriam; Demetter, Pieter; Tejpar, Sabine; Salmon, Isabelle

2015-01-01

Objective Recently, Next Generation Sequencing (NGS) has begun to supplant other technologies for gene mutation testing that is now required for targeted therapies. However, transfer of NGS technology to clinical daily practice requires validation. Methods We validated the Ion Torrent AmpliSeq Colon and Lung cancer panel interrogating 1850 hotspots in 22 genes using the Ion Torrent Personal Genome Machine. First, we used commercial reference standards that carry mutations at defined allelic frequency (AF). Then, 51 colorectal adenocarcinomas (CRC) and 39 non small cell lung carcinomas (NSCLC) were retrospectively analyzed. Results Sensitivity and accuracy for detecting variants at an AF >4% was 100% for commercial reference standards. Among the 90 cases, 89 (98.9%) were successfully sequenced. Among the 86 samples for which NGS and the reference test were both informative, 83 showed concordant results between NGS and the reference test; i.e. KRAS and BRAF for CRC and EGFR for NSCLC, with the 3 discordant cases each characterized by an AF <10%. Conclusions Overall, the AmpliSeq colon/lung cancer panel was specific and sensitive for mutation analysis of gene panels and can be incorporated into clinical daily practice. PMID:26366557

JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: II. Summary of definitive validation study results.

PubMed

Uno, Yoshifumi; Kojima, Hajime; Omori, Takashi; Corvi, Raffaella; Honma, Masamistu; Schechtman, Leonard M; Tice, Raymond R; Beevers, Carol; De Boeck, Marlies; Burlinson, Brian; Hobbs, Cheryl A; Kitamoto, Sachiko; Kraynak, Andrew R; McNamee, James; Nakagawa, Yuzuki; Pant, Kamala; Plappert-Helbig, Ulla; Priestley, Catherine; Takasawa, Hironao; Wada, Kunio; Wirnitzer, Uta; Asano, Norihide; Escobar, Patricia A; Lovell, David; Morita, Takeshi; Nakajima, Madoka; Ohno, Yasuo; Hayashi, Makoto

2015-07-01

The in vivo rodent alkaline comet assay (comet assay) is used internationally to investigate the in vivo genotoxic potential of test chemicals. This assay, however, has not previously been formally validated. The Japanese Center for the Validation of Alternative Methods (JaCVAM), with the cooperation of the U.S. NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)/the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the European Centre for the Validation of Alternative Methods (ECVAM), and the Japanese Environmental Mutagen Society/Mammalian Mutagenesis Study Group (JEMS/MMS), organized an international validation study to evaluate the reliability and relevance of the assay for identifying genotoxic carcinogens, using liver and stomach as target organs. The ultimate goal of this exercise was to establish an Organisation for Economic Co-operation and Development (OECD) test guideline. The study protocol was optimized in the pre-validation studies, and then the definitive (4th phase) validation study was conducted in two steps. In the 1st step, assay reproducibility was confirmed among laboratories using four coded reference chemicals and the positive control ethyl methanesulfonate. In the 2nd step, the predictive capability was investigated using 40 coded chemicals with known genotoxic and carcinogenic activity (i.e., genotoxic carcinogens, genotoxic non-carcinogens, non-genotoxic carcinogens, and non-genotoxic non-carcinogens). Based on the results obtained, the in vivo comet assay is concluded to be highly capable of identifying genotoxic chemicals and therefore can serve as a reliable predictor of rodent carcinogenicity. Copyright © 2015 Elsevier B.V. All rights reserved.

A New Look at Bias in Aptitude Tests.

ERIC Educational Resources Information Center

Scheuneman, Janice Dowd

1981-01-01

Statistical bias in measurement and ethnic-group bias in testing are discussed, reviewing predictive and construct validity studies. Item bias is reconceptualized to include distance of item content from respondent's experience. Differing values of mean and standard deviation for bias parameter are analyzed in a simulation. References are…

Mystery in Milwaukee: Early Intervention, IQ, and Psychology Textbooks.

ERIC Educational Resources Information Center

Sommer, Robert; Sommer, Barbara A.

1983-01-01

Textbooks in developmental and abnormal psychology were examined for references to the Milwaukee study of the effects of early intervention on intelligence. The absence of citations to articles in refereed journals shows how research data of questionable validity can seep into the research literature without going through the journal review…

Traveling reference spectroradiometer for routine quality assurance of spectral solar ultraviolet irradiance measurements.

PubMed

Gröbner, Julian; Schreder, Josef; Kazadzis, Stelios; Bais, Alkiviadis F; Blumthaler, Mario; Görts, Peter; Tax, Rick; Koskela, Tapani; Seckmeyer, Gunther; Webb, Ann R; Rembges, Diana

2005-09-01

A transportable reference spectroradiometer for measuring spectral solar ultraviolet irradiance has been developed and validated. The expanded uncertainty of solar irradiance measurements with this reference spectroradiometer, based on the described methodology, is 8.8% to 4.6%, depending on the wavelength and the solar zenith angle. The accuracy of the spectroradiometer was validated by repeated site visits to two European UV monitoring sites as well as by regular comparisons with the reference spectroradiometer of the European Reference Centre for UV radiation measurements in Ispra, Italy. The spectral solar irradiance measurements of the Quality Assurance of Spectral Ultraviolet Measurements in Europe through the Development of a Transportable Unit (QASUME) spectroradiometer and these three spectroradiometers have agreed to better than 6% during the ten intercomparison campaigns held from 2002 to 2004. If the differences in irradiance scales of as much as 2% are taken into account, the agreement is of the order of 4% over the wavelength range of 300-400 nm.

Routine development of objectively derived search strategies.

PubMed

Hausner, Elke; Waffenschmidt, Siw; Kaiser, Thomas; Simon, Michael

2012-02-29

Over the past few years, information retrieval has become more and more professionalized, and information specialists are considered full members of a research team conducting systematic reviews. Research groups preparing systematic reviews and clinical practice guidelines have been the driving force in the development of search strategies, but open questions remain regarding the transparency of the development process and the available resources. An empirically guided approach to the development of a search strategy provides a way to increase transparency and efficiency. Our aim in this paper is to describe the empirically guided development process for search strategies as applied by the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, or "IQWiG"). This strategy consists of the following steps: generation of a test set, as well as the development, validation and standardized documentation of the search strategy. We illustrate our approach by means of an example, that is, a search for literature on brachytherapy in patients with prostate cancer. For this purpose, a test set was generated, including a total of 38 references from 3 systematic reviews. The development set for the generation of the strategy included 25 references. After application of textual analytic procedures, a strategy was developed that included all references in the development set. To test the search strategy on an independent set of references, the remaining 13 references in the test set (the validation set) were used. The validation set was also completely identified. Our conclusion is that an objectively derived approach similar to that used in search filter development is a feasible way to develop and validate reliable search strategies. Besides creating high-quality strategies, the widespread application of this approach will result in a substantial increase in the transparency of the development process of search strategies.

Performance of a Blood Pressure Smartphone App in Pregnant Women: The iPARR Trial (iPhone App Compared With Standard RR Measurement).

PubMed

Raichle, Christina J; Eckstein, Jens; Lapaire, Olav; Leonardi, Licia; Brasier, Noé; Vischer, Annina S; Burkard, Thilo

2018-06-01

Hypertensive disorders are one of the leading causes of maternal death worldwide. Several smartphone apps claim to measure blood pressure (BP) using photoplethysmographic signals recorded by smartphone cameras. However, no single app has been validated for this use to date. We aimed to validate a new, promising smartphone algorithm. In this subgroup analysis of the iPARR trial (iPhone App Compared With Standard RR Measurement), we tested the Preventicus BP smartphone algorithm on 32 pregnant women. The trial was conducted based on the European Society of Hypertension International Protocol revision 2010 for validation of BP measuring devices in adults. Each individual received 7 sequential BP measurements starting with the reference device (Omron-HBP-1300) and followed by the smartphone measurement, resulting in 96 BP comparisons. Validation requirements of the European Society of Hypertension International Protocol revision 2010 were not fulfilled. Mean (±SD) systolic BP disagreement between the test and reference devices was 5.0 (±14.5) mm Hg. The number of absolute differences between test and reference device within 5, 10, and 15 mm Hg was 31, 53, and 64 of 96, respectively. A Bland-Altman plot showed an overestimation of smartphone-determined systolic BP in comparison with reference systolic BP in low range but an underestimation in medium-range BP. The Preventicus BP smartphone algorithm failed the accuracy criteria for estimating BP in pregnant women and was thus not commercialized. Pregnant women should be discouraged from using BP smartphone apps, unless there are algorithms specifically validated according to common protocols. URL: https://www.clinicaltrials.gov. Unique identifier: NCT02552030. © 2018 American Heart Association, Inc.

User Manual for Whisper-1.1

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

Brown, Forrest B.; Rising, Michael Evan; Alwin, Jennifer Louise

2017-01-26

Whisper is a statistical analysis package developed in 2014 to support nuclear criticality safety (NCS) validation [1-3]. It uses the sensitivity profile data for an application as computed by MCNP6 [4-6] along with covariance files [7,8] for the nuclear data to determine a baseline upper-subcritical-limit (USL) for the application. Whisper version 1.0 was first developed and used at LANL in 2014 [3]. During 2015- 2016, Whisper was updated to version 1.1 and is to be included with the upcoming release of MCNP6.2. This document describes the user input and options for running whisper-1.1, including 2 perl utility scripts that simplifymore » ordinary NCS work, whisper_mcnp.pl and whisper_usl.pl. For many detailed references on the theory, applications, nuclear data & covariances, SQA, verification-validation, adjointbased methods for sensitivity-uncertainty analysis, and more – see the Whisper – NCS Validation section of the MCNP Reference Collection at mcnp.lanl.gov. There are currently over 50 Whisper reference documents available.« less

Validation of reference genes for quantifying changes in gene expression in virus-infected tobacco.

PubMed

Baek, Eseul; Yoon, Ju-Yeon; Palukaitis, Peter

2017-10-01

To facilitate quantification of gene expression changes in virus-infected tobacco plants, eight housekeeping genes were evaluated for their stability of expression during infection by one of three systemically-infecting viruses (cucumber mosaic virus, potato virus X, potato virus Y) or a hypersensitive-response-inducing virus (tobacco mosaic virus; TMV) limited to the inoculated leaf. Five reference-gene validation programs were used to establish the order of the most stable genes for the systemically-infecting viruses as ribosomal protein L25 > β-Tubulin > Actin, and the least stable genes Ubiquitin-conjugating enzyme (UCE) < PP2A < GAPDH. For local infection by TMV, the most stable genes were EF1α > Cysteine protease > Actin, and the least stable genes were GAPDH < PP2A < UCE. Using two of the most stable and the two least stable validated reference genes, three defense responsive genes were examined to compare their relative changes in gene expression caused by each virus. Copyright © 2017 Elsevier Inc. All rights reserved.

[Validation of the Spanish version of the Frankfurt Emotion Work Scales].

PubMed

Ortiz Bonnín, Silvia; Navarro Guzmán, Capilla; García Buades, Esther; Ramis Palmer, Carmen; Manassero Mas, M Antonia

2012-05-01

This study presents the validity and reliability analysis of a questionnaire that assesses emotion work in the service sector. Emotion work is a term introduced by Hochschild (1983) and it refers to the expression of organizationally desirable emotions to influence the interactions with clients at work. The results show a 6-factor structure: Requirement to display Positive, Negative and Neutral Emotions, Sensitivity Requirements, Interaction Control and Emotional Dissonance. The analysis of the sub-scale scores reveals that the most frequently expressed emotions are positive, whereas negative emotions are expressed less frequently.

Using Ground-Based Measurements and Retrievals to Validate Satellite Data

NASA Technical Reports Server (NTRS)

Dong, Xiquan

2002-01-01

The proposed research is to use the DOE ARM ground-based measurements and retrievals as the ground-truth references for validating satellite cloud results and retrieving algorithms. This validation effort includes four different ways: (1) cloud properties on different satellites, therefore different sensors, TRMM VIRS and TERRA MODIS; (2) cloud properties at different climatic regions, such as DOE ARM SGP, NSA, and TWP sites; (3) different cloud types, low and high level cloud properties; and (4) day and night retrieving algorithms. Validation of satellite-retrieved cloud properties is very difficult and a long-term effort because of significant spatial and temporal differences between the surface and satellite observing platforms. The ground-based measurements and retrievals, only carefully analyzed and validated, can provide a baseline for estimating errors in the satellite products. Even though the validation effort is so difficult, a significant progress has been made during the proposed study period, and the major accomplishments are summarized in the follow.

Characterizing diurnal and seasonal cycles in monsoon systems from TRMM and CEOP observations

NASA Technical Reports Server (NTRS)

Lau, William K. M.

2006-01-01

The CEOP Inter-Monsoon Study (CIMS) is one of the two main science drivers of CEOP that aims to (a) provide better understanding of fundamental physical processes in monsoon regions around the world, and (b) demonstrate the synergy and utility of CEOP data in providing a pathway for model physics evaluation and improvement. As the data collection phase for EOP-3 and EOP-4 is being completed, two full annual cycles (2003-2004) of research-quality data sets from satellites, reference sites, and model output location time series (MOLTS) have been processed and made available for data analyses and model validation studies. This article presents preliminary results of a CIMS study aimed at the characterization and intercomparison of all major monsoon systems. The CEOP reference site data proved its value in such exercises by being a powerful tool to cross-validate the TRMM data, and to intercompare with multi-model results in ongoing work. We use 6 years (1998-2003) of pentad CEOP/TRMM data with 2deg x 2.5deg latitude-longitude grid, over the domain of interests to define the monsoon climatological diurnal and annual cycles for the East Asian Monsoon (EAM), the South Asian Monsoon (SAM), the West Africa Monsoon (WAM), the North America/Mexican Monsoon (NAM), the South American Summer Monsoon (SASM) and the Australian Monsoon (AUM). As noted, the TRMM data used in the study were cross-validated using CEOP reference site data, where applicable. Results show that the observed diurnal cycle of rain peaked around late afternoon over monsoon land, and early morning over the oceans. The diurnal cycles in models tend to peak 2-3 hours earlier than observed. The seasonal cycles of the EAM and SAM show the strongest continentality, i.e, strong control by continental processes away from the ITCZ. The WAM, and the AUM shows the less continentality, i.e, strong control by the oceanic ITCZ.

Characterizing Diurnal and Seasonal Cycles in Monsoon Systems from TRMM and CEOP Observations

NASA Technical Reports Server (NTRS)

Lau, William K. M.

2007-01-01

The CEOP Inter-Monsoon Study (CIMS) is one of the two main science drivers of CEOP that aims to (a) provide better understanding of fundamental physical processes in monsoon regions around the world, and (b) demonstrate the synergy and utility of CEOP data in providing a pathway for model physics evaluation and improvement. As the data collection phase for EOP-3 and EOP-4 is being completed, two full annual cycles (2003-2004) of research-quality data sets from satellites, reference sites, and model output location time series (MOLTS) have been processed and made available for data analyses and model validation studies. This article presents preliminary results of a CIMS study aimed at the characterization and intercomparison of all major monsoon systems. The CEOP reference site data proved its value in such exercises by being a powerful tool to cross-validate the TRMM data, and to intercompare with multi-model results in ongoing work. We use 6 years (1998-2003) of pentad CEOP/TRMM data with 2 deg x 2.5 deg. latitude-longitude grid, over the domain of interests to define the monsoon climatological diurnal and annual cycles for the East Asian Monsoon (EAM), the South Asian Monsoon (SAM), the West Africa Monsoon (WAM), the North America/Mexican Monsoon (NAM), the South American Summer Monsoon (SASM) and the Australian Monsoon (AUM). As noted, the TRMM data used in the study were cross-validated using CEOP reference site data, where applicable. Results show that the observed diurnal cycle of rain peaked around late afternoon over monsoon land, and early morning over the oceans. The diurnal cycles in models tend to peak 2-3 hours earlier than observed. The seasonal cycles of the EAM and SAM show the strongest continentality, i.e, strong control by continental processes away from the ITCZ. The WAM, and the AUM shows the less continentality, i.e, strong control by the oceanic ITCZ.

Validation of Medical Tourism Service Quality Questionnaire (MTSQQ) for Iranian Hospitals.

PubMed

Qolipour, Mohammad; Torabipour, Amin; Khiavi, Farzad Faraji; Malehi, Amal Saki

2017-03-01

Assessing service quality is one of the basic requirements to develop the medical tourism industry. There is no valid and reliable tool to measure service quality of medical tourism. This study aimed to determine the reliability and validity of a Persian version of medical tourism service quality questionnaire for Iranian hospitals. To validate the medical tourism service quality questionnaire (MTSQQ), a cross-sectional study was conducted on 250 Iraqi patients referred to hospitals in Ahvaz (Iran) from 2015. To design a questionnaire and determine its content validity, the Delphi Technique (3 rounds) with the participation of 20 medical tourism experts was used. Construct validity of the questionnaire was assessed through exploratory and confirmatory factor analysis. Reliability was assessed using Cronbach's alpha coefficient. Data were analyzed by Excel 2007, SPSS version18, and Lisrel l8.0 software. The content validity of the questionnaire with CVI=0.775 was confirmed. According to exploratory factor analysis, the MTSQQ included 31 items and 8 dimensions (tangibility, reliability, responsiveness, assurance, empathy, exchange and travel facilities, technical and infrastructure facilities and safety and security). Construct validity of the questionnaire was confirmed, based on the goodness of fit quantities of model (RMSEA=0.032, CFI= 0.98, GFI=0.88). Cronbach's alpha coefficient was 0.837 and 0.919 for expectation and perception questionnaire. The results of the study showed that the medical tourism SERVQUAL questionnaire with 31 items and 8 dimensions was a valid and reliable tool to measure service quality of medical tourism in Iranian hospitals.

A longitudinal evaluation of performance of automated BCR-ABL1 quantitation using cartridge-based detection system.

PubMed

Enjeti, Anoop; Granter, Neil; Ashraf, Asma; Fletcher, Linda; Branford, Susan; Rowlings, Philip; Dooley, Susan

2015-10-01

An automated cartridge-based detection system (GeneXpert; Cepheid) is being widely adopted in low throughput laboratories for monitoring BCR-ABL1 transcript in chronic myelogenous leukaemia. This Australian study evaluated the longitudinal performance specific characteristics of the automated system.The automated cartridge-based system was compared prospectively with the manual qRT-PCR-based reference method at SA Pathology, Adelaide, over a period of 2.5 years. A conversion factor determination was followed by four re-validations. Peripheral blood samples (n = 129) with international scale (IS) values within detectable range were selected for assessment. The mean bias, proportion of results within specified fold difference (2-, 3- and 5-fold), the concordance rate of major molecular remission (MMR) and concordance across a range of IS values on paired samples were evaluated.The initial conversion factor for the automated system was determined as 0.43. Except for the second re-validation, where a negative bias of 1.9-fold was detected, all other biases fell within desirable limits. A cartridge-specific conversion factor and efficiency value was introduced and the conversion factor was confirmed to be stable in subsequent re-validation cycles. Concordance with the reference method/laboratory at >0.1-≤10 IS was 78.2% and at ≤0.001 was 80%, compared to 86.8% in the >0.01-≤0.1 IS range. The overall and MMR concordance were 85.7% and 94% respectively, for samples that fell within ± 5-fold of the reference laboratory value over the entire period of study.Conversion factor and performance specific characteristics for the automated system were longitudinally stable in the clinically relevant range, following introduction by the manufacturer of lot specific efficiency values.

Validation of stationary phases in (111)In-pentetreotide planar chromatography.

PubMed

Moreno-Ortega, E; Mena-Bares, L M; Maza-Muret, F R; Hidalgo-Ramos, F J; Vallejo-Casas, J A

2013-01-01

Since Pall-German stopped manufacturing ITLC-SG, it has become necessary to validate alternative stationary phases. To validate different stationary phases versus ITLC-SG Pall-Gelman in the determination of the radiochemical purity (RCP) of (111)In-pentetreotide ((111)In-Octreoscan) by planar chromatography. We conducted a case-control study, which included 66 (111)In-pentetreotide preparations. We determined the RCP by planar chromatography, using a freshly prepared solution of 0,1M sodium citrate (pH 5) and the following stationary phases: ITLC-SG (Pall-Gelman) (reference method), iTLC-SG (Varian), HPTLC silica gel 60 (Merck), Whatman 1, Whatman 3MM and Whatman 17. For each of the methods, we calculated: PRQ, relative front values (RF) of the radiopharmaceutical and free (111)In, chromatographic development time, resolution between peaks. We compared the results obtained with the reference method. The statistical analysis was performed using the SPSS program. The p value was calculated for the study of statistical significance. The highest resolution is obtained with HPTLC silica gel 60 (Merck). However, the chromatographic development time is too long (mean=33.62minutes). Greater resolution is obtained with iTLC-SG (Varian) than with the reference method, with lower chromatographic development time (mean=3.61minutes). Very low resolutions are obtained with Whatman paper, essentially with Whatman 1 and 3MM. Therefore, we do not recommend their use. Although iTLC-SG (Varian) and HPTLC silica gel 60 (Merck) are suitable alternatives to ITLC-SG (Pall-Gelman) in determining the RCP of (111)In-pentetreotide, iTLC-SG (Varian) is the method of choice due to its lower chromatographic development time. Copyright © 2012 Elsevier España, S.L. and SEMNIM. All rights reserved.

Comparative assessment of bioanalytical method validation guidelines for pharmaceutical industry.

PubMed

Kadian, Naveen; Raju, Kanumuri Siva Rama; Rashid, Mamunur; Malik, Mohd Yaseen; Taneja, Isha; Wahajuddin, Muhammad

2016-07-15

The concepts, importance, and application of bioanalytical method validation have been discussed for a long time and validation of bioanalytical methods is widely accepted as pivotal before they are taken into routine use. United States Food and Drug Administration (USFDA) guidelines issued in 2001 have been referred for every guideline released ever since; may it be European Medical Agency (EMA) Europe, National Health Surveillance Agency (ANVISA) Brazil, Ministry of Health and Labour Welfare (MHLW) Japan or any other guideline in reference to bioanalytical method validation. After 12 years, USFDA released its new draft guideline for comments in 2013, which covers the latest parameters or topics encountered in bioanalytical method validation and approached towards the harmonization of bioanalytical method validation across the globe. Even though the regulatory agencies have general agreement, significant variations exist in acceptance criteria and methodology. The present review highlights the variations, similarities and comparison between bioanalytical method validation guidelines issued by major regulatory authorities worldwide. Additionally, other evaluation parameters such as matrix effect, incurred sample reanalysis including other stability aspects have been discussed to provide an ease of access for designing a bioanalytical method and its validation complying with the majority of drug authority guidelines. Copyright © 2016. Published by Elsevier B.V.

Avoiding pitfalls of internal controls: validation of reference genes for analysis by qRT-PCR and Western blot throughout rat retinal development.

PubMed

Rocha-Martins, Maurício; Njaine, Brian; Silveira, Mariana S

2012-01-01

Housekeeping genes have been commonly used as reference to normalize gene expression and protein content data because of its presumed constitutive expression. In this paper, we challenge the consensual idea that housekeeping genes are reliable controls for expression studies in the retina through the investigation of a panel of reference genes potentially suitable for analysis of different stages of retinal development. We applied statistical tools on combinations of retinal developmental stages to assess the most stable internal controls for quantitative RT-PCR (qRT-PCR). The stability of expression of seven putative reference genes (Actb, B2m, Gapdh, Hprt1, Mapk1, Ppia and Rn18s) was analyzed using geNorm, BestKeeper and Normfinder software. In addition, several housekeeping genes were tested as loading controls for Western blot in the same sample panel, using Image J. Overall, for qRT-PCR the combination of Gapdh and Mapk1 showed the highest stability for most experimental sets. Actb was downregulated in more mature stages, while Rn18s and Hprt1 showed the highest variability. We normalized the expression of cyclin D1 using various reference genes and demonstrated that spurious results may result from blind selection of internal controls. For Western blot significant variation could be seen among four putative internal controls (β-actin, cyclophilin b, α-tubulin and lamin A/C), while MAPK1 was stably expressed. Putative housekeeping genes exhibit significant variation in both mRNA and protein content during retinal development. Our results showed that distinct combinations of internal controls fit for each experimental set in the case of qRT-PCR and that MAPK1 is a reliable loading control for Western blot. The results indicate that biased study outcomes may follow the use of reference genes without prior validation for qRT-PCR and Western blot.

Ionospheric foF2 at EIA region: comparison between observations and IRI model

NASA Astrophysics Data System (ADS)

Chuo, Y. J.; Lee, C. C.

We have used data from an equatorial ionization anomaly area station in the western Pacific region to study the monthly variability of foF2 Diurnal seasonal and solar activity effects were investigated The data established by this study are proposed as valid input values for the development of URSI and CCIR options for the International Reference Ionosphere

Validation of virtual learning object to support the teaching of nursing care systematization.

PubMed

Salvador, Pétala Tuani Candido de Oliveira; Mariz, Camila Maria Dos Santos; Vítor, Allyne Fortes; Ferreira Júnior, Marcos Antônio; Fernandes, Maria Isabel Domingues; Martins, José Carlos Amado; Santos, Viviane Euzébia Pereira

2018-01-01

to describe the content validation process of a Virtual Learning Object to support the teaching of nursing care systematization to nursing professionals. methodological study, with quantitative approach, developed according to the methodological reference of Pasquali's psychometry and conducted from March to July 2016, from two-stage Delphi procedure. in the Delphi 1 stage, eight judges evaluated the Virtual Object; in Delphi 2 stage, seven judges evaluated it. The seven screens of the Virtual Object were analyzed as to the suitability of its contents. The Virtual Learning Object to support the teaching of nursing care systematization was considered valid in its content, with a Total Content Validity Coefficient of 0.96. it is expected that the Virtual Object can support the teaching of nursing care systematization in light of appropriate and effective pedagogical approaches.

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.

OVERFLOW Validation for Predicting Plume Impingement of Underexpanded Axisymmetric Jets onto Angled Flat Plates

NASA Technical Reports Server (NTRS)

Lee, Henry C.; Klopfer, Goetz

2011-01-01

This report documents how OVERFLOW, a computational fluid dynamics code, predicts plume impingement of underexpanded axisymmetric jets onto both perpendicular and inclined flat plates. The effects of the plume impinging on a range of plate inclinations varying from 90deg to 30deg are investigated and compared to the experimental results in Reference 1 and 2. The flow fields are extremely complex due to the interaction between the shock waves from the free jet and those deflected by the plate. Additionally, complex mixing effects create very intricate structures in the flow. The experimental data is very limited, so these validation studies will focus only on cold plume impingement on flat and inclined plates. This validation study will help quantify the error in the OVERFLOW simulation when applied to stage separation scenarios.

Exploring valid reference genes for quantitative real-time PCR analysis in Sesamia inferens (Lepidoptera: Noctuidae).

PubMed

Sun, Meng; Lu, Ming-Xing; Tang, Xiao-Tian; Du, Yu-Zhou

2015-01-01

The pink stem borer, Sesamia inferens, which is endemic in China and other parts of Asia, is a major pest of rice and causes significant yield loss in this host plant. Very few studies have addressed gene expression in S. inferens. Quantitative real-time PCR (qRT-PCR) is currently the most accurate and sensitive method for gene expression analysis. In qRT-PCR, data are normalized using reference genes, which help control for internal differences and reduce error between samples. In this study, seven candidate reference genes, 18S ribosomal RNA (18S rRNA), elongation factor 1 (EF1), glyceraldehyde-3-phosphate dehydrogenase (GAPDH), ribosomal protein S13 (RPS13), ribosomal protein S20 (RPS20), tubulin (TUB), and β-actin (ACTB) were evaluated for their suitability in normalizing gene expression under different experimental conditions. The results indicated that three genes (RPS13, RPS20, and EF1) were optimal for normalizing gene expression in different insect tissues (head, epidermis, fat body, foregut, midgut, hindgut, Malpighian tubules, haemocytes, and salivary glands). 18S rRNA, EF1, and GAPDH were best for normalizing expression with respect to developmental stages and sex (egg masses; first, second, third, fourth, fifth, and sixth instar larvae; male and female pupae; and one-day-old male and female adults). 18S rRNA, RPS20, and TUB were optimal for fifth instars exposed to different temperatures (-8, -6, -4, -2, 0, and 27°C). To validate this recommendation, the expression profile of a target gene heat shock protein 83 gene (hsp83) was investigated, and results showed the selection was necessary and effective. In conclusion, this study describes reference gene sets that can be used to accurately measure gene expression in S. inferens.

Selection of Valid Reference Genes for Reverse Transcription Quantitative PCR Analysis in Heliconius numata (Lepidoptera: Nymphalidae)

PubMed Central

Chouteau, Mathieu; Whibley, Annabel; Joron, Mathieu; Llaurens, Violaine

2016-01-01

Identifying the genetic basis of adaptive variation is challenging in non-model organisms and quantitative real time PCR. is a useful tool for validating predictions regarding the expression of candidate genes. However, comparing expression levels in different conditions requires rigorous experimental design and statistical analyses. Here, we focused on the neotropical passion-vine butterflies Heliconius, non-model species studied in evolutionary biology for their adaptive variation in wing color patterns involved in mimicry and in the signaling of their toxicity to predators. We aimed at selecting stable reference genes to be used for normalization of gene expression data in RT-qPCR analyses from developing wing discs according to the minimal guidelines described in Minimum Information for publication of Quantitative Real-Time PCR Experiments (MIQE). To design internal RT-qPCR controls, we studied the stability of expression of nine candidate reference genes (actin, annexin, eF1α, FK506BP, PolyABP, PolyUBQ, RpL3, RPS3A, and tubulin) at two developmental stages (prepupal and pupal) using three widely used programs (GeNorm, NormFinder and BestKeeper). Results showed that, despite differences in statistical methods, genes RpL3, eF1α, polyABP, and annexin were stably expressed in wing discs in late larval and pupal stages of Heliconius numata. This combination of genes may be used as a reference for a reliable study of differential expression in wings for instance for genes involved in important phenotypic variation, such as wing color pattern variation. Through this example, we provide general useful technical recommendations as well as relevant statistical strategies for evolutionary biologists aiming to identify candidate-genes involved adaptive variation in non-model organisms. PMID:27271971

Reference values for 27 clinical chemistry tests in 70-year-old males and females.

PubMed

Carlsson, Lena; Lind, Lars; Larsson, Anders

2010-01-01

Reference values are usually defined based on blood samples from healthy men or nonpregnant women in the age range of 20-50 years. These values are not optimal for elderly patients, as many biological markers change over time and adequate reference values are important for correct clinical decisions. To validate NORIP (Nordic Reference Interval Project) reference values in a 70-year-old population. We studied 27 frequently used laboratory tests. The 2.5th and 97.5th percentiles for these markers were calculated according to the recommendations of the International Federation of Clinical Chemistry on the statistical treatment of reference values. Reference values are reported for plasma alanine aminotransferase, albumin, alkaline phosphatase, pancreas amylase, apolipoprotein A1, apolipoprotein B, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, creatine kinase, C-reactive protein, glucose, gamma-glutamyltransferase, HDL-cholesterol, iron, lactate dehydrogenase, LDL-cholesterol, magnesium, phosphate, potassium, sodium, transferrin, triglycerides, urate and urea. Reference values calculated from the whole population and a subpopulation without cardiovascular disease showed strong concordance. Several of the reference interval limits were outside the 90% CI of a Scandinavian population (NORIP). 2009 S. Karger AG, Basel.

Validity of Dietary Assessment in Athletes: A Systematic Review

PubMed Central

Beck, Kathryn L.; Gifford, Janelle A.; Slater, Gary; Flood, Victoria M.; O’Connor, Helen

2017-01-01

Dietary assessment methods that are recognized as appropriate for the general population are usually applied in a similar manner to athletes, despite the knowledge that sport-specific factors can complicate assessment and impact accuracy in unique ways. As dietary assessment methods are used extensively within the field of sports nutrition, there is concern the validity of methodologies have not undergone more rigorous evaluation in this unique population sub-group. The purpose of this systematic review was to compare two or more methods of dietary assessment, including dietary intake measured against biomarkers or reference measures of energy expenditure, in athletes. Six electronic databases were searched for English-language, full-text articles published from January 1980 until June 2016. The search strategy combined the following keywords: diet, nutrition assessment, athlete, and validity; where the following outcomes are reported but not limited to: energy intake, macro and/or micronutrient intake, food intake, nutritional adequacy, diet quality, or nutritional status. Meta-analysis was performed on studies with sufficient methodological similarity, with between-group standardized mean differences (or effect size) and 95% confidence intervals (CI) being calculated. Of the 1624 studies identified, 18 were eligible for inclusion. Studies comparing self-reported energy intake (EI) to energy expenditure assessed via doubly labelled water were grouped for comparison (n = 11) and demonstrated mean EI was under-estimated by 19% (−2793 ± 1134 kJ/day). Meta-analysis revealed a large pooled effect size of −1.006 (95% CI: −1.3 to −0.7; p < 0.001). The remaining studies (n = 7) compared a new dietary tool or instrument to a reference method(s) (e.g., food record, 24-h dietary recall, biomarker) as part of a validation study. This systematic review revealed there are limited robust studies evaluating dietary assessment methods in athletes. Existing literature demonstrates the substantial variability between methods, with under- and misreporting of intake being frequently observed. There is a clear need for careful validation of dietary assessment methods, including emerging technical innovations, among athlete populations. PMID:29207495

In-depth analysis of internal control genes for quantitative real-time PCR in Brassica oleracea var. botrytis.

PubMed

Sheng, X G; Zhao, Z Q; Yu, H F; Wang, J S; Zheng, C F; Gu, H H

2016-07-15

Quantitative reverse-transcription PCR (qRT-PCR) is a versatile technique for the analysis of gene expression. The selection of stable reference genes is essential for the application of this technique. Cauliflower (Brassica oleracea L. var. botrytis) is a commonly consumed vegetable that is rich in vitamin, calcium, and iron. Thus far, to our knowledge, there have been no reports on the validation of suitable reference genes for the data normalization of qRT-PCR in cauliflower. In the present study, we analyzed 12 candidate housekeeping genes in cauliflower subjected to different abiotic stresses, hormone treatment conditions, and accessions. geNorm and NormFinder algorithms were used to assess the expression stability of these genes. ACT2 and TIP41 were selected as suitable reference genes across all experimental samples in this study. When different accessions were compared, ACT2 and UNK3 were found to be the most suitable reference genes. In the hormone and abiotic stress treatments, ACT2, TIP41, and UNK2 were the most stably expressed. Our study also provided guidelines for selecting the best reference genes under various experimental conditions.

Identification of suitable qPCR reference genes in leaves of Brassica oleracea under abiotic stresses.

PubMed

Brulle, Franck; Bernard, Fabien; Vandenbulcke, Franck; Cuny, Damien; Dumez, Sylvain

2014-04-01

Real-time quantitative PCR is nowadays a standard method to study gene expression variations in various samples and experimental conditions. However, to interpret results accurately, data normalization with appropriate reference genes appears to be crucial. The present study describes the identification and the validation of suitable reference genes in Brassica oleracea leaves. Expression stability of eight candidates was tested following drought and cold abiotic stresses by using three different softwares (BestKeeper, NormFinder and geNorm). Four genes (BolC.TUB6, BolC.SAND1, BolC.UBQ2 and BolC.TBP1) emerged as the most stable across the tested conditions. Further gene expression analysis of a drought- and a cold-responsive gene (BolC.DREB2A and BolC.ELIP, respectively), confirmed the stability and the reliability of the identified reference genes when used for normalization in the leaves of B. oleracea. These four genes were finally tested upon a benzene exposure and all appeared to be useful reference genes along this toxicological condition. These results provide a good starting point for future studies involving gene expression measurement on leaves of B. oleracea exposed to environmental modifications.

Evaluation of the Thermo Scientific SureTect Listeria species assay. AOAC Performance Tested Method 071304.

PubMed

Cloke, Jonathan; Evans, Katharine; Crabtree, David; Hughes, Annette; Simpson, Helen; Holopainen, Jani; Wickstrand, Nina; Kauppinen, Mikko; Leon-Velarde, Carlos; Larson, Nathan; Dave, Keron

2014-01-01

The Thermo Scientific SureTect Listeria species Assay is a new real-time PCR assay for the detection of all species of Listeria in food and environmental samples. This validation study was conducted using the AOAC Research Institute (RI) Performance Tested Methods program to validate the SureTect Listeria species Assay in comparison to the reference method detailed in International Organization for Standardization 11290-1:1996 including amendment 1:2004 in a variety of foods plus plastic and stainless steel. The food matrixes validated were smoked salmon, processed cheese, fresh bagged spinach, cantaloupe, cooked prawns, cooked sliced turkey meat, cooked sliced ham, salami, pork frankfurters, and raw ground beef. All matrixes were tested by Thermo Fisher Scientific, Microbiology Division, Basingstoke, UK. In addition, three matrixes (pork frankfurters, fresh bagged spinach, and stainless steel surface samples) were analyzed independently as part of the AOAC-RI-controlled independent laboratory study by the University ofGuelph, Canada. Using probability of detection statistical analysis, a significant difference in favour of the SureTect assay was demonstrated between the SureTect and reference method for high level spiked samples of pork frankfurters, smoked salmon, cooked prawns, stainless steel, and low-spiked samples of salami. For all other matrixes, no significant difference was seen between the two methods during the study. Inclusivity testing was conducted with 68 different isolates of Listeria species, all of which were detected by the SureTect Listeria species Assay. None of the 33 exclusivity isolates were detected by the SureTect Listeria species Assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside of the recommended parameters open to variation, which demonstrated that the assay gave reliable performance. Accelerated stability testing was additionally conducted, validating the assay shelf life.

Evaluation of the Thermo Scientific™ SureTect™ Listeria species Assay.

PubMed

Cloke, Jonathan; Evans, Katharine; Crabtree, David; Hughes, Annette; Simpson, Helen; Holopainen, Jani; Wickstrand, Nina; Kauppinen, Mikko

2014-03-01

The Thermo Scientific™ SureTect™ Listeria species Assay is a new real-time PCR assay for the detection of all species of Listeria in food and environmental samples. This validation study was conducted using the AOAC Research Institute (RI) Performance Tested MethodsSM program to validate the SureTect Listeria species Assay in comparison to the reference method detailed in International Organization for Standardization 11290-1:1996 including amendment 1:2004 in a variety of foods plus plastic and stainless steel. The food matrixes validated were smoked salmon, processed cheese, fresh bagged spinach, cantaloupe, cooked prawns, cooked sliced turkey meat, cooked sliced ham, salami, pork frankfurters, and raw ground beef. All matrixes were tested by Thermo Fisher Scientific, Microbiology Division, Basingstoke, UK. In addition, three matrixes (pork frankfurters, fresh bagged spinach, and stainless steel surface samples) were analyzed independently as part of the AOAC-RI-controlled independent laboratory study by the University of Guelph, Canada. Using probability of detection statistical analysis, a significant difference in favour of the SureTect assay was demonstrated between the SureTect and reference method for high level spiked samples of pork frankfurters, smoked salmon, cooked prawns, stainless steel, and low-spiked samples of salami. For all other matrixes, no significant difference was seen between the two methods during the study. Inclusivity testing was conducted with 68 different isolates of Listeria species, all of which were detected by the SureTect Listeria species Assay. None of the 33 exclusivity isolates were detected by the SureTect Listeria species Assay. Ruggedness testing was conducted to evaluate the performance of the assay with specific method deviations outside of the recommended parameters open to variation, which demonstrated that the assay gave reliable performance. Accelerated stability testing was additionally conducted, validating the assay shelf life.

Validity and reliability of the NAB Naming Test.

PubMed

Sachs, Bonnie C; Rush, Beth K; Pedraza, Otto

2016-05-01

Confrontation naming is commonly assessed in neuropsychological practice, but few standardized measures of naming exist and those that do are susceptible to the effects of education and culture. The Neuropsychological Assessment Battery (NAB) Naming Test is a 31-item measure used to assess confrontation naming. Despite adequate psychometric information provided by the test publisher, there has been limited independent validation of the test. In this study, we investigated the convergent and discriminant validity, internal consistency, and alternate forms reliability of the NAB Naming Test in a sample of adults (Form 1: n = 247, Form 2: n = 151) clinically referred for neuropsychological evaluation. Results indicate adequate-to-good internal consistency and alternate forms reliability. We also found strong convergent validity as demonstrated by relationships with other neurocognitive measures. We found preliminary evidence that the NAB Naming Test demonstrates a more pronounced ceiling effect than other commonly used measures of naming. To our knowledge, this represents the largest published independent validation study of the NAB Naming Test in a clinical sample. Our findings suggest that the NAB Naming Test demonstrates adequate validity and reliability and merits consideration in the test arsenal of clinical neuropsychologists.

The Multiple-Use of Accountability Assessments: Implications for the Process of Validation

ERIC Educational Resources Information Center

Koch, Martha J.

2014-01-01

Implications of the multiple-use of accountability assessments for the process of validation are examined. Multiple-use refers to the simultaneous use of results from a single administration of an assessment for its intended use and for one or more additional uses. A theoretical discussion of the issues for validation which emerge from…

Validity of Bioelectrical Impedance Analysis to Estimation Fat-Free Mass in the Army Cadets.

PubMed

Langer, Raquel D; Borges, Juliano H; Pascoa, Mauro A; Cirolini, Vagner X; Guerra-Júnior, Gil; Gonçalves, Ezequiel M

2016-03-11

Bioelectrical Impedance Analysis (BIA) is a fast, practical, non-invasive, and frequently used method for fat-free mass (FFM) estimation. The aims of this study were to validate predictive equations of BIA to FFM estimation in Army cadets and to develop and validate a specific BIA equation for this population. A total of 396 males, Brazilian Army cadets, aged 17-24 years were included. The study used eight published predictive BIA equations, a specific equation in FFM estimation, and dual-energy X-ray absorptiometry (DXA) as a reference method. Student's t-test (for paired sample), linear regression analysis, and Bland-Altman method were used to test the validity of the BIA equations. Predictive BIA equations showed significant differences in FFM compared to DXA (p < 0.05) and large limits of agreement by Bland-Altman. Predictive BIA equations explained 68% to 88% of FFM variance. Specific BIA equations showed no significant differences in FFM, compared to DXA values. Published BIA predictive equations showed poor accuracy in this sample. The specific BIA equations, developed in this study, demonstrated validity for this sample, although should be used with caution in samples with a large range of FFM.

Determining optimal parameters of the self-referent encoding task: A large-scale examination of self-referent cognition and depression.

PubMed

Dainer-Best, Justin; Lee, Hae Yeon; Shumake, Jason D; Yeager, David S; Beevers, Christopher G

2018-06-07

Although the self-referent encoding task (SRET) is commonly used to measure self-referent cognition in depression, many different SRET metrics can be obtained. The current study used best subsets regression with cross-validation and independent test samples to identify the SRET metrics most reliably associated with depression symptoms in three large samples: a college student sample (n = 572), a sample of adults from Amazon Mechanical Turk (n = 293), and an adolescent sample from a school field study (n = 408). Across all 3 samples, SRET metrics associated most strongly with depression severity included number of words endorsed as self-descriptive and rate of accumulation of information required to decide whether adjectives were self-descriptive (i.e., drift rate). These metrics had strong intratask and split-half reliability and high test-retest reliability across a 1-week period. Recall of SRET stimuli and traditional reaction time (RT) metrics were not robustly associated with depression severity. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Construction and validation of the midsagittal reference plane based on the skull base symmetry for three-dimensional cephalometric craniofacial analysis.

PubMed

Kim, Hak-Jin; Kim, Bong Chul; Kim, Jin-Geun; Zhengguo, Piao; Kang, Sang Hoon; Lee, Sang-Hwy

2014-03-01

The objective of this study was to determine the reliable midsagittal (MS) reference plane in practical ways for the three-dimensional craniofacial analysis on three-dimensional computed tomography images. Five normal human dry skulls and 20 normal subjects without any dysmorphoses or asymmetries were used. The accuracies and stability on repeated plane construction for almost every possible candidate MS plane based on the skull base structures were examined by comparing the discrepancies in distances and orientations from the reference points and planes of the skull base and facial bones on three-dimensional computed tomography images. The following reference points of these planes were stable, and their distribution was balanced: nasion and foramen cecum at the anterior part of the skull base, sella at the middle part, and basion and opisthion at the posterior part. The candidate reference planes constructed using the aforementioned reference points were thought to be reliable for use as an MS reference plane for the three-dimensional analysis of maxillofacial dysmorphosis.

Validation of chronic obstructive pulmonary disease (COPD) diagnoses in healthcare databases: a systematic review protocol.

PubMed

Rimland, Joseph M; Abraha, Iosief; Luchetta, Maria Laura; Cozzolino, Francesco; Orso, Massimiliano; Cherubini, Antonio; Dell'Aquila, Giuseppina; Chiatti, Carlos; Ambrosio, Giuseppe; Montedori, Alessandro

2016-06-01

Healthcare databases are useful sources to investigate the epidemiology of chronic obstructive pulmonary disease (COPD), to assess longitudinal outcomes in patients with COPD, and to develop disease management strategies. However, in order to constitute a reliable source for research, healthcare databases need to be validated. The aim of this protocol is to perform the first systematic review of studies reporting the validation of codes related to COPD diagnoses in healthcare databases. MEDLINE, EMBASE, Web of Science and the Cochrane Library databases will be searched using appropriate search strategies. Studies that evaluated the validity of COPD codes (such as the International Classification of Diseases 9th Revision and 10th Revision system; the Real codes system or the International Classification of Primary Care) in healthcare databases will be included. Inclusion criteria will be: (1) the presence of a reference standard case definition for COPD; (2) the presence of at least one test measure (eg, sensitivity, positive predictive values, etc); and (3) the use of a healthcare database (including administrative claims databases, electronic healthcare databases or COPD registries) as a data source. Pairs of reviewers will independently abstract data using standardised forms and will assess quality using a checklist based on the Standards for Reporting of Diagnostic accuracy (STARD) criteria. This systematic review protocol has been produced in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) 2015 statement. Ethics approval is not required. Results of this study will be submitted to a peer-reviewed journal for publication. The results from this systematic review will be used for outcome research on COPD and will serve as a guide to identify appropriate case definitions of COPD, and reference standards, for researchers involved in validating healthcare databases. CRD42015029204. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The integral inventory for depression, a new, self-rated clinimetric instrument for the emotional and painful dimensions in major depressive disorder.

PubMed

Dueñas, Héctor; Lara, Carmen; Walton, Richard J; Granger, Renee E; Dossenbach, Martin; Raskin, Joel

2011-09-01

To assess the reliability and validity of the Integral Inventory for Depression (IID) scale using post hoc analyses of data from a multi-country study (ClinicalTrials.gov: NCT00561509) of patients with major depressive disorder (MDD). Patients (N = 1629) completed the IID (comprising two separate dimensions for emotional and physically painful symptoms; maximum score of 65) and a reference scale (16-item Quick Inventory of Depressive Symptomatology Self-Report) at baseline and at follow-up (8 and 24 weeks). Physicians rated MDD symptoms using the Clinical Global Impressions of Severity scale at each visit. Inter-item correlation, internal consistency, external validity, factor structure, and exploratory analysis of an optimal severity cut-off point were assessed. The IID displayed two distinct dimensions (i.e. painful and emotional) with little item redundancy and good internal consistency (Cronbach's α > 0.83 at each visit). The IID displayed good external validity (Pearson's correlations coefficients >0.60 at each visit) and statistically significant agreement (McNemar's test; P < 0.001 at follow-up) with the reference scale. Results suggest that a cut-off score of ≤24 had adequate precision (>80%) to identify patients with and without moderate MDD. Results suggest that the IID may be a reliable and valid tool for assessing emotional and painful symptoms of MDD.

Selection of suitable reference genes for gene expression studies in Staphylococcus capitis during growth under erythromycin stress.

PubMed

Cui, Bintao; Smooker, Peter M; Rouch, Duncan A; Deighton, Margaret A

2016-08-01

Accurate and reproducible measurement of gene transcription requires appropriate reference genes, which are stably expressed under different experimental conditions to provide normalization. Staphylococcus capitis is a human pathogen that produces biofilm under stress, such as imposed by antimicrobial agents. In this study, a set of five commonly used staphylococcal reference genes (gyrB, sodA, recA, tuf and rpoB) were systematically evaluated in two clinical isolates of Staphylococcus capitis (S. capitis subspecies urealyticus and capitis, respectively) under erythromycin stress in mid-log and stationary phases. Two public software programs (geNorm and NormFinder) and two manual calculation methods, reference residue normalization (RRN) and relative quantitative (RQ), were applied. The potential reference genes selected by the four algorithms were further validated by comparing the expression of a well-studied biofilm gene (icaA) with phenotypic biofilm formation in S. capitis under four different experimental conditions. The four methods differed considerably in their ability to predict the most suitable reference gene or gene combination for comparing icaA expression under different conditions. Under the conditions used here, the RQ method provided better selection of reference genes than the other three algorithms; however, this finding needs to be confirmed with a larger number of isolates. This study reinforces the need to assess the stability of reference genes for analysis of target gene expression under different conditions and the use of more than one algorithm in such studies. Although this work was conducted using a specific human pathogen, it emphasizes the importance of selecting suitable reference genes for accurate normalization of gene expression more generally.

Selection and validation of reference genes for quantitative gene expression analyses in various tissues and seeds at different developmental stages in Bixa orellana L.

PubMed

Moreira, Viviane S; Soares, Virgínia L F; Silva, Raner J S; Sousa, Aurizangela O; Otoni, Wagner C; Costa, Marcio G C

2018-05-01

Bixa orellana L., popularly known as annatto, produces several secondary metabolites of pharmaceutical and industrial interest, including bixin, whose molecular basis of biosynthesis remain to be determined. Gene expression analysis by quantitative real-time PCR (qPCR) is an important tool to advance such knowledge. However, correct interpretation of qPCR data requires the use of suitable reference genes in order to reduce experimental variations. In the present study, we have selected four different candidates for reference genes in B. orellana , coding for 40S ribosomal protein S9 (RPS9), histone H4 (H4), 60S ribosomal protein L38 (RPL38) and 18S ribosomal RNA (18SrRNA). Their expression stabilities in different tissues (e.g. flower buds, flowers, leaves and seeds at different developmental stages) were analyzed using five statistical tools (NormFinder, geNorm, BestKeeper, ΔCt method and RefFinder). The results indicated that RPL38 is the most stable gene in different tissues and stages of seed development and 18SrRNA is the most unstable among the analyzed genes. In order to validate the candidate reference genes, we have analyzed the relative expression of a target gene coding for carotenoid cleavage dioxygenase 1 (CCD1) using the stable RPL38 and the least stable gene, 18SrRNA , for normalization of the qPCR data. The results demonstrated significant differences in the interpretation of the CCD1 gene expression data, depending on the reference gene used, reinforcing the importance of the correct selection of reference genes for normalization.

Dental age estimation in Japanese individuals combining permanent teeth and third molars.

PubMed

Ramanan, Namratha; Thevissen, Patrick; Fleuws, Steffen; Willems, G

2012-12-01

The study aim was, firstly, to verify the Willems et al. model on a Japanese reference sample. Secondly to develop a Japanese reference model based on the Willems et al. method and to verify it. Thirdly to analyze the age prediction performance adding tooth development information of third molars to permanent teeth. Retrospectively 1877 panoramic radiographs were selected in the age range between 1 and 23 years (1248 children, 629 sub-adults). Dental development was registered applying Demirjian 's stages of the mandibular left permanent teeth in children and Köhler stages on the third molars. The children's data were, firstly, used to validate the Willems et al. model (developed a Belgian reference sample), secondly, split ino a training and a test sample. On the training sample a Japanese reference model was developed based on the Willems method. The developed model and the Willems et al; model were verified on the test sample. Regression analysis was used to detect the age prediction performance adding third molar scores to permanent tooth scores. The validated Willems et al. model provided a mean absolute error of 0.85 and 0.75 years in females and males, respectively. The mean absolute error in the verified Willems et al. and the developed Japanese reference model was 0.85, 0.77 and 0.79, 0.75 years in females and males, respectively. On average a negligible change in root mean square error values was detected adding third molar scores to permanent teeth scores. The Belgian sample could be used as a reference model to estimate the age of the Japanese individuals. Combining information from the third molars and permanent teeth was not providing clinically significant improvement of age predictions based on permanent teeth information alone.

Serum prolactin revisited: parametric reference intervals and cross platform evaluation of polyethylene glycol precipitation-based methods for discrimination between hyperprolactinemia and macroprolactinemia.

PubMed

Overgaard, Martin; Pedersen, Susanne Møller

2017-10-26

Hyperprolactinemia diagnosis and treatment is often compromised by the presence of biologically inactive and clinically irrelevant higher-molecular-weight complexes of prolactin, macroprolactin. The objective of this study was to evaluate the performance of two macroprolactin screening regimes across commonly used automated immunoassay platforms. Parametric total and monomeric gender-specific reference intervals were determined for six immunoassay methods using female (n=96) and male sera (n=127) from healthy donors. The reference intervals were validated using 27 hyperprolactinemic and macroprolactinemic sera, whose presence of monomeric and macroforms of prolactin were determined using gel filtration chromatography (GFC). Normative data for six prolactin assays included the range of values (2.5th-97.5th percentiles). Validation sera (hyperprolactinemic and macroprolactinemic; n=27) showed higher discordant classification [mean=2.8; 95% confidence interval (CI) 1.2-4.4] for the monomer reference interval method compared to the post-polyethylene glycol (PEG) recovery cutoff method (mean=1.8; 95% CI 0.8-2.8). The two monomer/macroprolactin discrimination methods did not differ significantly (p=0.089). Among macroprolactinemic sera evaluated by both discrimination methods, the Cobas and Architect/Kryptor prolactin assays showed the lowest and the highest number of misclassifications, respectively. Current automated immunoassays for prolactin testing require macroprolactin screening methods based on PEG precipitation in order to discriminate truly from falsely elevated serum prolactin. While the recovery cutoff and monomeric reference interval macroprolactin screening methods demonstrate similar discriminative ability, the latter method also provides the clinician with an easy interpretable monomeric prolactin concentration along with a monomeric reference interval.

Validating automated kidney stone volumetry in computed tomography and mathematical correlation with estimated stone volume based on diameter.

PubMed

Wilhelm, Konrad; Miernik, Arkadiusz; Hein, Simon; Schlager, Daniel; Adams, Fabian; Benndorf, Matthias; Fritz, Benjamin; Langer, Mathias; Hesse, Albrecht; Schoenthaler, Martin; Neubauer, Jakob

2018-06-02

To validate AutoMated UroLithiasis Evaluation Tool (AMULET) software for kidney stone volumetry and compare its performance to standard clinical practice. Maximum diameter and volume of 96 urinary stones were measured as reference standard by three independent urologists. The same stones were positioned in an anthropomorphic phantom and CT scans acquired in standard settings. Three independent radiologists blinded to the reference values took manual measurements of the maximum diameter and automatic measurements of maximum diameter and volume. An "expected volume" was calculated based on manual diameter measurements using the formula: V=4/3 πr³. 96 stones were analyzed in the study. We had initially aimed to assess 100. Nine were replaced during data acquisition due of crumbling and 4 had to be excluded because the automated measurement did not work. Mean reference maximum diameter was 13.3 mm (5.2-32.1 mm). Correlation coefficients among all measured outcomes were compared. The correlation between the manual and automatic diameter measurements to the reference was 0.98 and 0.91, respectively (p<0.001). Mean reference volume was 1200 mm³ (10-9000 mm³). The correlation between the "expected volume" and automatically measured volume to the reference was 0.95 and 0.99, respectively (p<0.001). Patients' kidney stone burden is usually assessed according to maximum diameter. However, as most stones are not spherical, this entails a potential bias. Automated stone volumetry is possible and significantly more accurate than diameter-based volumetric calculations. To avoid bias in clinical trials, size should be measured as volume. However, automated diameter measurements are not as accurate as manual measurements.

Adolescent Populations Research Needs - NCS Dietary Assessment Literature Review

Cancer.gov

As with school age children, it is difficult to make conclusions about the validity of available dietary assessment instruments for adolescents because of the differences in instruments, research designs, reference methods, and populations in the validation literature.

Performance of genomic prediction within and across generations in maritime pine.

PubMed

Bartholomé, Jérôme; Van Heerwaarden, Joost; Isik, Fikret; Boury, Christophe; Vidal, Marjorie; Plomion, Christophe; Bouffier, Laurent

2016-08-11

Genomic selection (GS) is a promising approach for decreasing breeding cycle length in forest trees. Assessment of progeny performance and of the prediction accuracy of GS models over generations is therefore a key issue. A reference population of maritime pine (Pinus pinaster) with an estimated effective inbreeding population size (status number) of 25 was first selected with simulated data. This reference population (n = 818) covered three generations (G0, G1 and G2) and was genotyped with 4436 single-nucleotide polymorphism (SNP) markers. We evaluated the effects on prediction accuracy of both the relatedness between the calibration and validation sets and validation on the basis of progeny performance. Pedigree-based (best linear unbiased prediction, ABLUP) and marker-based (genomic BLUP and Bayesian LASSO) models were used to predict breeding values for three different traits: circumference, height and stem straightness. On average, the ABLUP model outperformed genomic prediction models, with a maximum difference in prediction accuracies of 0.12, depending on the trait and the validation method. A mean difference in prediction accuracy of 0.17 was found between validation methods differing in terms of relatedness. Including the progenitors in the calibration set reduced this difference in prediction accuracy to 0.03. When only genotypes from the G0 and G1 generations were used in the calibration set and genotypes from G2 were used in the validation set (progeny validation), prediction accuracies ranged from 0.70 to 0.85. This study suggests that the training of prediction models on parental populations can predict the genetic merit of the progeny with high accuracy: an encouraging result for the implementation of GS in the maritime pine breeding program.

Experimental investigations into visual and electronic tooth color measurement.

PubMed

Ratzmann, Anja; Treichel, Anja; Langforth, Gabriele; Gedrange, Tomasz; Welk, Alexander

2011-04-01

The present study aimed to examine the validity of the visual color assessment and an electronic tooth color measurement system by means of Shade Inspector™ in comparison with a gold standard. Additionally, reproducibility of electronic measurements was demonstrated by means of two reference systems. Ceramic specimens of two thicknesses (h=1.6 mm, h=2.6 mm) were used. Three experienced dental technicians using the VITAPAN Classical(®) color scale carried out all visual tests. Validity of the visual assessment and the electronic measurements was confirmed separately for both thicknesses by means of lightness and hue of the VITAPAN Classical(®) color scale. Reproducibility of electronic measurements was confirmed by means of the VITAPAN Classical(®) and 3D-Master(®). The 3D-Master(®) data were calculated according to lightness, hue and chroma. Intraclass correlation coefficient (ICC) was used in assessing validity/reproducibility for lightness and chroma, Kappa statistics were used for hue. A level ≥0.75 was pre-established for ICC and ≥0.60 for the Kappa index. RESULTS OF VISUAL COLOR ASSESSMENT: Validity for lightness was good for both thicknesses; agreement rates for hue were inconsistent. ELECTRONIC MEASUREMENT: Validity for lightness was fair to good, hue values were below 0.60. Reproducibility of lightness was good to very good for both reference systems. Hue values (VITAPAN Classical(®)) for 1.6 mm test specimens were upside, for 2.6 mm below 0.60, Kappa values for 3D-Master(®) were ≥0.60 for all measurements, reproducibility of chroma was very good. Validity was better for visual than for electronic color assessment. Reproducibility of the electronic device by means of the Shade Inspector™ was given for the VITAPAN Classical(®) and 3D-Master(®) systems.

A Bayesian framework for adaptive selection, calibration, and validation of coarse-grained models of atomistic systems

NASA Astrophysics Data System (ADS)

Farrell, Kathryn; Oden, J. Tinsley; Faghihi, Danial

2015-08-01

A general adaptive modeling algorithm for selection and validation of coarse-grained models of atomistic systems is presented. A Bayesian framework is developed to address uncertainties in parameters, data, and model selection. Algorithms for computing output sensitivities to parameter variances, model evidence and posterior model plausibilities for given data, and for computing what are referred to as Occam Categories in reference to a rough measure of model simplicity, make up components of the overall approach. Computational results are provided for representative applications.

Validating long-term satellite-derived disturbance products: the case of burned areas

NASA Astrophysics Data System (ADS)

Boschetti, L.; Roy, D. P.

2015-12-01

The potential research, policy and management applications of satellite products place a high priority on providing statements about their accuracy. A number of NASA, ESA and EU funded global and continental burned area products have been developed using coarse spatial resolution satellite data, and have the potential to become part of a long-term fire Climate Data Record. These products have usually been validated by comparison with reference burned area maps derived by visual interpretation of Landsat or similar spatial resolution data selected on an ad hoc basis. More optimally, a design-based validation method should be adopted that is characterized by the selection of reference data via a probability sampling that can subsequently be used to compute accuracy metrics, taking into account the sampling probability. Design based techniques have been used for annual land cover and land cover change product validation, but have not been widely used for burned area products, or for the validation of global products that are highly variable in time and space (e.g. snow, floods or other non-permanent phenomena). This has been due to the challenge of designing an appropriate sampling strategy, and to the cost of collecting independent reference data. We propose a tri-dimensional sampling grid that allows for probability sampling of Landsat data in time and in space. To sample the globe in the spatial domain with non-overlapping sampling units, the Thiessen Scene Area (TSA) tessellation of the Landsat WRS path/rows is used. The TSA grid is then combined with the 16-day Landsat acquisition calendar to provide tri-dimensonal elements (voxels). This allows the implementation of a sampling design where not only the location but also the time interval of the reference data is explicitly drawn by probability sampling. The proposed sampling design is a stratified random sampling, with two-level stratification of the voxels based on biomes and fire activity (Figure 1). The novel validation approach, used for the validation of the MODIS and forthcoming VIIRS global burned area products, is a general one, and could be used for the validation of other global products that are highly variable in space and time and is required to assess the accuracy of climate records. The approach is demonstrated using a 1 year dataset of MODIS fire products.

Evaluation and Validation of Housekeeping Genes as Reference for Gene Expression Studies in Pigeonpea (Cajanus cajan) Under Drought Stress Conditions

PubMed Central

Sinha, Pallavi; Singh, Vikas K.; Suryanarayana, V.; Krishnamurthy, L.; Saxena, Rachit K.; Varshney, Rajeev K.

2015-01-01

Gene expression analysis using quantitative real-time PCR (qRT-PCR) is a very sensitive technique and its sensitivity depends on the stable performance of reference gene(s) used in the study. A number of housekeeping genes have been used in various expression studies in many crops however, their expression were found to be inconsistent under different stress conditions. As a result, species specific housekeeping genes have been recommended for different expression studies in several crop species. However, such specific housekeeping genes have not been reported in the case of pigeonpea (Cajanus cajan) despite the fact that genome sequence has become available for the crop. To identify the stable housekeeping genes in pigeonpea for expression analysis under drought stress conditions, the relative expression variations of 10 commonly used housekeeping genes (EF1α, UBQ10, GAPDH, 18SrRNA, 25SrRNA, TUB6, ACT1, IF4α, UBC and HSP90) were studied on root, stem and leaves tissues of Asha (ICPL 87119). Three statistical algorithms geNorm, NormFinder and BestKeeper were used to define the stability of candidate genes. geNorm analysis identified IF4α and TUB6 as the most stable housekeeping genes however, NormFinder analysis determined IF4α and HSP90 as the most stable housekeeping genes under drought stress conditions. Subsequently validation of the identified candidate genes was undertaken in qRT-PCR based gene expression analysis of uspA gene which plays an important role for drought stress conditions in pigeonpea. The relative quantification of the uspA gene varied according to the internal controls (stable and least stable genes), thus highlighting the importance of the choice of as well as validation of internal controls in such experiments. The identified stable and validated housekeeping genes will facilitate gene expression studies in pigeonpea especially under drought stress conditions. PMID:25849964

Evaluation and validation of housekeeping genes as reference for gene expression studies in pigeonpea (Cajanus cajan) under drought stress conditions.

PubMed

Sinha, Pallavi; Singh, Vikas K; Suryanarayana, V; Krishnamurthy, L; Saxena, Rachit K; Varshney, Rajeev K

2015-01-01

Gene expression analysis using quantitative real-time PCR (qRT-PCR) is a very sensitive technique and its sensitivity depends on the stable performance of reference gene(s) used in the study. A number of housekeeping genes have been used in various expression studies in many crops however, their expression were found to be inconsistent under different stress conditions. As a result, species specific housekeeping genes have been recommended for different expression studies in several crop species. However, such specific housekeeping genes have not been reported in the case of pigeonpea (Cajanus cajan) despite the fact that genome sequence has become available for the crop. To identify the stable housekeeping genes in pigeonpea for expression analysis under drought stress conditions, the relative expression variations of 10 commonly used housekeeping genes (EF1α, UBQ10, GAPDH, 18SrRNA, 25SrRNA, TUB6, ACT1, IF4α, UBC and HSP90) were studied on root, stem and leaves tissues of Asha (ICPL 87119). Three statistical algorithms geNorm, NormFinder and BestKeeper were used to define the stability of candidate genes. geNorm analysis identified IF4α and TUB6 as the most stable housekeeping genes however, NormFinder analysis determined IF4α and HSP90 as the most stable housekeeping genes under drought stress conditions. Subsequently validation of the identified candidate genes was undertaken in qRT-PCR based gene expression analysis of uspA gene which plays an important role for drought stress conditions in pigeonpea. The relative quantification of the uspA gene varied according to the internal controls (stable and least stable genes), thus highlighting the importance of the choice of as well as validation of internal controls in such experiments. The identified stable and validated housekeeping genes will facilitate gene expression studies in pigeonpea especially under drought stress conditions.

Validity and reliability of the Persian version of the Brief Aging Perceptions Questionnaire in Iranian older adults

PubMed Central

Sadegh Moghadam, Leila; Foroughan, Mahshid; Mohammadi Shahboulaghi, Farahnaz; Ahmadi, Fazlollah; Sajjadi, Moosa; Farhadi, Akram

2016-01-01

Background Perceptions of aging refer to individuals’ understanding of aging within their sociocultural context. Proper measurement of this concept in various societies requires accurate tools. Objective The present study was conducted with the aim to translate and validate the Brief Aging Perceptions Questionnaire (B-APQ) and assess its psychometric features in Iranian older adults. Method In this study, the Persian version of B-APQ was validated for 400 older adults. This questionnaire was translated into Persian according to the Wild et al’s model. The Persian version was validated using content, face, and construct (using confirmatory factor analysis) validities, and then its internal consistency and test–retest reliability were measured. Data were analyzed using the statistical software programs SPSS 18 and EQS-6.1. Results The confirmatory factor analysis confirmed construct validity and five subscales of B-APQ. Test–retest reliability with 3-week interval produced r=0.94. Cronbach’s alpha was found to be 0.75 for the whole questionnaire, and from 0.53 to 0.77 for the five factors. Conclusion The Persian version of B-APQ showed favorable validity and reliability, and thus it can be used for measuring different dimensions of perceptions of aging in Iranian older adults. PMID:27194907

Reproduction accuracy of articulator mounting with an arbitrary face-bow vs. average values-a controlled, randomized, blinded patient simulator study.

PubMed

Ahlers, M Oliver; Edelhoff, Daniel; Jakstat, Holger A

2018-06-21

The benefit from positioning the maxillary casts with the aid of face-bows has been questioned in the past. Therefore, the aim of this study was to investigate the reliability and validity of arbitrary face-bow transfers compared to a process solely based on the orientation by means of average values. For optimized validity, the study was conducted using a controlled, randomized, anonymized, and blinded patient simulator study design. Thirty-eight undergraduate dental students were randomly divided into two groups; both groups were applied to both methods, in opposite sequences. Investigated methods were the transfer of casts using an arbitrary face-bow in comparison to the transfer using average values based on Bonwill's triangle and the Balkwill angle. The "patient" used in this study was a patient simulator. All casts were transferred to the same individual articulator, and all the transferred casts were made using type IV special hard stone plaster; for the attachment into the articulator, type II plaster was used. A blinded evaluation was performed based on three-dimensional measurements of three reference points. The results are presented three-dimensionally in scatterplots. Statistical analysis indicated a significantly smaller variance (Student's t test, p < 0.05) for the transfer using a face-bow, applicable for all three reference points. The use of an arbitrary face-bow significantly improves the transfer reliability and hence the validity. To simulate the patient situation in an individual articulator correctly, casts should be transferred at least by means of an arbitrary face-bow.

Imaging Gravity Waves in Lower Stratospheric AMSU-A Radiances. Part 2: Validation Case Study

DTIC Science & Technology

2006-08-14

Ortland, 2003) and temperatures from the 1986 COSPAR International Reference Atmosphere (CIRA; Fleming et al., 1990): for algorithm details, see Eck ...Soc., 130, 1505–1530, 2004. Webster, S., Brown, A. R., Cameron , D. R., and Jones, C. P.: Im- provements to the representation of orography in the Met

A Review of Information and Communication Technology Enhanced Social Work Interventions

ERIC Educational Resources Information Center

Chan, Chitat; Holosko, Michael J.

2016-01-01

Objectives: Information and communications technology (ICT) has impacted almost all human service disciplines and currently is evolving in social work. This study provides a systematic review of ICT-enhanced social work interventions, with particular reference to their intervention fidelity (IF), validity, and the role of ICT in the helping…

Validation of the MODIS Collection 6 MCD64 Global Burned Area Product

NASA Astrophysics Data System (ADS)

Boschetti, L.; Roy, D. P.; Giglio, L.; Stehman, S. V.; Humber, M. L.; Sathyachandran, S. K.; Zubkova, M.; Melchiorre, A.; Huang, H.; Huo, L. Z.

2017-12-01

The research, policy and management applications of satellite products place a high priority on rigorously assessing their accuracy. A number of NASA, ESA and EU funded global and continental burned area products have been developed using coarse spatial resolution satellite data, and have the potential to become part of a long-term fire Essential Climate Variable. These products have usually been validated by comparison with reference burned area maps derived by visual interpretation of Landsat or similar spatial resolution data selected on an ad hoc basis. More optimally, a design-based validation method should be adopted, characterized by the selection of reference data via probability sampling. Design based techniques have been used for annual land cover and land cover change product validation, but have not been widely used for burned area products, or for other products that are highly variable in time and space (e.g. snow, floods, other non-permanent phenomena). This has been due to the challenge of designing an appropriate sampling strategy, and to the cost and limited availability of independent reference data. This paper describes the validation procedure adopted for the latest Collection 6 version of the MODIS Global Burned Area product (MCD64, Giglio et al, 2009). We used a tri-dimensional sampling grid that allows for probability sampling of Landsat data in time and in space (Boschetti et al, 2016). To sample the globe in the spatial domain with non-overlapping sampling units, the Thiessen Scene Area (TSA) tessellation of the Landsat WRS path/rows is used. The TSA grid is then combined with the 16-day Landsat acquisition calendar to provide tri-dimensonal elements (voxels). This allows the implementation of a sampling design where not only the location but also the time interval of the reference data is explicitly drawn through stratified random sampling. The novel sampling approach was used for the selection of a reference dataset consisting of 700 Landsat 8 image pairs, interpreted according to the CEOS Burned Area Validation Protocol (Boschetti et al., 2009). Standard quantitative burned area product accuracy measures that are important for different types of fire users (Boschetti et al, 2016, Roy and Boschetti, 2009, Boschetti et al, 2004) are computed to characterize the accuracy of the MCD64 product.

Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways

PubMed Central

Hill, Jonathan C; Kang, Sujin; Benedetto, Elena; Myers, Helen; Blackburn, Steven; Smith, Stephanie; Hay, Elaine; Rees, Jonathan; Beard, David; Glyn-Jones, Sion; Barker, Karen; Ellis, Benjamin; Fitzpatrick, Ray; Price, Andrew

2016-01-01

Objectives Current musculoskeletal outcome tools are fragmented across different healthcare settings and conditions. Our objectives were to develop and validate a single musculoskeletal outcome measure for use throughout the pathway and patients with different musculoskeletal conditions: the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ). Setting A consensus workshop with stakeholders from across the musculoskeletal community, workshops and individual interviews with a broad mix of musculoskeletal patients identified and prioritised outcomes for MSK-HQ inclusion. Initial psychometric validation was conducted in four cohorts from community physiotherapy, and secondary care orthopaedic hip, knee and shoulder clinics. Participants Stakeholders (n=29) included primary care, physiotherapy, orthopaedic and rheumatology patients (n=8); general practitioners, physiotherapists, orthopaedists, rheumatologists and pain specialists (n=7), patient and professional national body representatives (n=10), and researchers (n=4). The four validation cohorts included 570 participants (n=210 physiotherapy, n=150 hip, n=150 knee, n=60 shoulder patients). Outcome measures Outcomes included the MSK-HQ's acceptability, feasibility, comprehension, readability and responder burden. The validation cohort outcomes were the MSK-HQ's completion rate, test–retest reliability and convergent validity with reference standards (EQ-5D-5L, Oxford Hip, Knee, Shoulder Scores, and the Keele MSK-PROM). Results Musculoskeletal domains prioritised were pain severity, physical function, work interference, social interference, sleep, fatigue, emotional health, physical activity, independence, understanding, confidence to self-manage and overall impact. Patients reported MSK-HQ items to be ‘highly relevant’ and ‘easy to understand’. Completion rates were high (94.2%), with scores normally distributed, and no floor/ceiling effects. Test–retest reliability was excellent, and convergent validity was strong (correlations 0.81–0.88). Conclusions A new musculoskeletal outcome measure has been developed through a coproduction process with patients to capture prioritised outcomes for use throughout the pathway and with different musculoskeletal conditions. Four validation cohorts found that the MSK-HQ had high completion rates, excellent test–retest reliability and strong convergent validity with reference standards. Further validation studies are ongoing, including a cohort with rheumatoid/inflammatory arthritis. PMID:27496243

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

PubMed

Stern, K I; Malkova, T L

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

Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: A systematic review

PubMed Central

Kyte, Derek; Cockwell, Paul; Marshall, Tom; Gheorghe, Adrian; Keeley, Thomas; Slade, Anita; Calvert, Melanie

2017-01-01

Background Patient-reported outcome measures (PROMs) can provide valuable information which may assist with the care of patients with chronic kidney disease (CKD). However, given the large number of measures available, it is unclear which PROMs are suitable for use in research or clinical practice. To address this we comprehensively evaluated studies that assessed the measurement properties of PROMs in adults with CKD. Methods Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the methodological quality of the included studies and to inform a best evidence synthesis for each PROM. Results The search strategy retrieved 3,702 titles/abstracts. After 288 duplicates were removed, 3,414 abstracts were screened and 71 full-text articles were retrieved for further review. Of these, 24 full-text articles were excluded as they did not meet the eligibility criteria. Following reference list and citation searching, 19 articles were retrieved bringing the total number of papers included in the final analysis to 66. There was strong evidence supporting internal consistency and moderate evidence supporting construct validity for the Kidney Disease Quality of Life-36 (KDQOL-36) in pre-dialysis patients. In the dialysis population, the KDQOL-Short Form (KDQOL-SF) had strong evidence for internal consistency and structural validity and moderate evidence for test-retest reliability and construct validity while the KDQOL-36 had moderate evidence of internal consistency, test-retest reliability and construct validity. The End Stage Renal Disease-Symptom Checklist Transplantation Module (ESRD-SCLTM) demonstrated strong evidence for internal consistency and moderate evidence for test-retest reliability, structural and construct validity in renal transplant recipients. Conclusions We suggest considering the KDQOL-36 for use in pre-dialysis patients; the KDQOL-SF or KDQOL-36 for dialysis patients and the ESRD-SCLTM for use in transplant recipients. However, further research is required to evaluate the measurement error, structural validity, responsiveness and patient acceptability of PROMs used in CKD. PMID:28636678

The development and validation of a multivariable model to predict whether patients referred for total knee replacement are suitable surgical candidates at the time of initial consultation.

PubMed

Churchill, Laura; Malian, Samuel J; Chesworth, Bert M; Bryant, Dianne; MacDonald, Steven J; Marsh, Jacquelyn D; Giffin, J Robert

2016-12-01

In previous studies, 50%-70% of patients referred to orthopedic surgeons for total knee replacement (TKR) were not surgical candidates at the time of initial assessment. The purpose of our study was to identify and cross-validate patient self-reported predictors of suitability for TKR and to determine the clinical utility of a predictive model to guide the timing and appropriateness of referral to a surgeon. We assessed pre-consultation patient data as well as the surgeon's findings and post-consultation recommendations. We used multivariate logistic regression to detect self-reported items that could identify suitable surgical candidates. Patients' willingness to undergo surgery, higher rating of pain, greater physical function, previous intra-articular injections and patient age were the factors predictive of patients being offered and electing to undergo TKR. The application of the model developed in our study would effectively reduce the proportion of nonsurgical referrals by 25%, while identifying the vast majority of surgical candidates (> 90%). Using patient-reported information, we can correctly predict the outcome of specialist consultation for TKR in 70% of cases. To reduce long waits for first consultation with a surgeon, it may be possible to use these items to educate and guide referring clinicians and patients to understand when specialist consultation is the next step in managing the patient with severe osteoarthritis of the knee.

The development and validation of a multivariable model to predict whether patients referred for total knee replacement are suitable surgical candidates at the time of initial consultation

PubMed Central

Churchill, Laura; Malian, Samuel J.; Chesworth, Bert M.; Bryant, Dianne; MacDonald, Steven J.; Marsh, Jacquelyn D.; Giffin, J. Robert

2016-01-01

Background In previous studies, 50%–70% of patients referred to orthopedic surgeons for total knee replacement (TKR) were not surgical candidates at the time of initial assessment. The purpose of our study was to identify and cross-validate patient self-reported predictors of suitability for TKR and to determine the clinical utility of a predictive model to guide the timing and appropriateness of referral to a surgeon. Methods We assessed pre-consultation patient data as well as the surgeon’s findings and post-consultation recommendations. We used multivariate logistic regression to detect self-reported items that could identify suitable surgical candidates. Results Patients’ willingness to undergo surgery, higher rating of pain, greater physical function, previous intra-articular injections and patient age were the factors predictive of patients being offered and electing to undergo TKR. Conclusion The application of the model developed in our study would effectively reduce the proportion of nonsurgical referrals by 25%, while identifying the vast majority of surgical candidates (> 90%). Using patient-reported information, we can correctly predict the outcome of specialist consultation for TKR in 70% of cases. To reduce long waits for first consultation with a surgeon, it may be possible to use these items to educate and guide referring clinicians and patients to understand when specialist consultation is the next step in managing the patient with severe osteoarthritis of the knee. PMID:28234616

Is the corticomedullary index valid to distinguish human from nonhuman bones: a multislice computed tomography study.

PubMed

Rérolle, Camille; Saint-Martin, Pauline; Dedouit, Fabrice; Rousseau, Hervé; Telmon, Norbert

2013-09-10

The first step in the identification process of bone remains is to determine whether they are of human or nonhuman origin. This issue may arise when only a fragment of bone is available, as the species of origin is usually easily determined on a complete bone. The present study aims to assess the validity of a morphometric method used by French forensic anthropologists to determine the species of origin: the corticomedullary index (CMI), defined by the ratio of the diameter of the medullary cavity to the total diameter of the bone. We studied the constancy of the CMI from measurements made on computed tomography images (CT scans) of different human bones, and compared our measurements with reference values selected in the literature. The measurements obtained on CT scans at three different sites of 30 human femurs, 24 tibias, and 24 fibulas were compared between themselves and with the CMI reference values for humans, pigs, dogs and sheep. Our results differed significantly from these reference values, with three exceptions: the proximal quarter of the femur and mid-fibular measurements for the human CMI, and the proximal quarter of the tibia for the sheep CMI. Mid-tibial, mid-femoral, and mid-fibular measurements also differed significantly between themselves. Only 22.6% of CT scans of human bones were correctly identified as human. We concluded that the CMI is not an effective method for determining the human origin of bone remains. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Validation of Reference Genes for Gene Expression Studies in Virus-Infected Nicotiana benthamiana Using Quantitative Real-Time PCR

PubMed Central

Han, Chenggui; Yu, Jialin; Li, Dawei; Zhang, Yongliang

2012-01-01

Nicotiana benthamiana is the most widely-used experimental host in plant virology. The recent release of the draft genome sequence for N. benthamiana consolidates its role as a model for plant–pathogen interactions. Quantitative real-time PCR (qPCR) is commonly employed for quantitative gene expression analysis. For valid qPCR analysis, accurate normalisation of gene expression against an appropriate internal control is required. Yet there has been little systematic investigation of reference gene stability in N. benthamiana under conditions of viral infections. In this study, the expression profiles of 16 commonly used housekeeping genes (GAPDH, 18S, EF1α, SAMD, L23, UK, PP2A, APR, UBI3, SAND, ACT, TUB, GBP, F-BOX, PPR and TIP41) were determined in N. benthamiana and those with acceptable expression levels were further selected for transcript stability analysis by qPCR of complementary DNA prepared from N. benthamiana leaf tissue infected with one of five RNA plant viruses (Tobacco necrosis virus A, Beet black scorch virus, Beet necrotic yellow vein virus, Barley stripe mosaic virus and Potato virus X). Gene stability was analysed in parallel by three commonly-used dedicated algorithms: geNorm, NormFinder and BestKeeper. Statistical analysis revealed that the PP2A, F-BOX and L23 genes were the most stable overall, and that the combination of these three genes was sufficient for accurate normalisation. In addition, the suitability of PP2A, F-BOX and L23 as reference genes was illustrated by expression-level analysis of AGO2 and RdR6 in virus-infected N. benthamiana leaves. This is the first study to systematically examine and evaluate the stability of different reference genes in N. benthamiana. Our results not only provide researchers studying these viruses a shortlist of potential housekeeping genes to use as normalisers for qPCR experiments, but should also guide the selection of appropriate reference genes for gene expression studies of N. benthamiana under other biotic and abiotic stress conditions. PMID:23029521

A comparative study of multi-focus image fusion validation metrics

NASA Astrophysics Data System (ADS)

Giansiracusa, Michael; Lutz, Adam; Messer, Neal; Ezekiel, Soundararajan; Alford, Mark; Blasch, Erik; Bubalo, Adnan; Manno, Michael

2016-05-01

Fusion of visual information from multiple sources is relevant for applications security, transportation, and safety applications. One way that image fusion can be particularly useful is when fusing imagery data from multiple levels of focus. Different focus levels can create different visual qualities for different regions in the imagery, which can provide much more visual information to analysts when fused. Multi-focus image fusion would benefit a user through automation, which requires the evaluation of the fused images to determine whether they have properly fused the focused regions of each image. Many no-reference metrics, such as information theory based, image feature based and structural similarity-based have been developed to accomplish comparisons. However, it is hard to scale an accurate assessment of visual quality which requires the validation of these metrics for different types of applications. In order to do this, human perception based validation methods have been developed, particularly dealing with the use of receiver operating characteristics (ROC) curves and the area under them (AUC). Our study uses these to analyze the effectiveness of no-reference image fusion metrics applied to multi-resolution fusion methods in order to determine which should be used when dealing with multi-focus data. Preliminary results show that the Tsallis, SF, and spatial frequency metrics are consistent with the image quality and peak signal to noise ratio (PSNR).

Conventional Energy and Macronutrient Variables Distort the Accuracy of Children’s Dietary Reports: Illustrative Data from a Validation Study of Effect of Order Prompts

PubMed Central

Baxter, Suzanne Domel; Smith, Albert F.; Hardin, James W.; Nichols, Michele D.

2008-01-01

Objective Validation-study data are used to illustrate that conventional energy and macronutrient (protein, carbohydrate, fat) variables, which disregard accuracy of reported items and amounts, misrepresent reporting accuracy. Reporting-error-sensitive variables are proposed which classify reported items as matches or intrusions, and reported amounts as corresponding or overreported. Methods 58 girls and 63 boys were each observed eating school meals on 2 days separated by ≥4 weeks, and interviewed the morning after each observation day. One interview per child had forward-order (morning-to-evening) prompts; one had reverse-order prompts. Original food-item-level analyses found a sex-x-order prompt interaction for omission rates. Current analyses compared reference (observed) and reported information transformed to energy and macronutrients. Results Using conventional variables, reported amounts were less than reference amounts (ps<0.001; paired t-tests); report rates were higher for the first than second interview for energy, protein, and carbohydrate (ps≤0.049; mixed models). Using reporting-error-sensitive variables, correspondence rates were higher for girls with forward- but boys with reverse-order prompts (ps≤0.041; mixed models); inflation ratios were lower with reverse- than forward-order prompts for energy, carbohydrate, and fat (ps≤0.045; mixed models). Conclusions Conventional variables overestimated reporting accuracy and masked order prompt and sex effects. Reporting-error-sensitive variables are recommended when assessing accuracy for energy and macronutrients in validation studies. PMID:16959308

Validity of the Acti4 software using ActiGraph GT3X+accelerometer for recording of arm and upper body inclination in simulated work tasks.

PubMed

Korshøj, Mette; Skotte, Jørgen H; Christiansen, Caroline S; Mortensen, Pelle; Kristiansen, Jesper; Hanisch, Christiana; Ingebrigtsen, Jørgen; Holtermann, Andreas

2014-01-01

The validity of inclinometer measurements by ActiGraph GT3X+ (AG) accelerometer, when analysed with the Acti4 customised software, was examined by comparison of inclinometer measurements with a reference system (TrakStar) in a protocol with standardised arm movements and simulated working tasks. The sensors were placed at the upper arm (distal to the deltoid insertion) and at the spine (level of T1-T2) on eight participants. Root mean square errors (RMSEs) values of inclination between the two systems were low for the slow- and medium-speed standardised arm movements and in simulated working tasks. Fast arm movements caused the inclination estimated by the AG to deviate from the reference measurements (RMSE values up to ∼10°). Furthermore, it was found that AG positioned at the upper arm provided inclination data without bias compared to the reference system. These findings indicate that the AG provides valid estimates of arm and upper body inclination in working participants. Being inexpensive, small, water-resistant and without wires, ActiGraph GT3X+ seems to be a valid mean for direct long-term field measurements of arm and trunk inclinations when analysed by the Acti4 customised software.

A systematic review of validated methods to capture acute bronchospasm using administrative or claims data.

PubMed

Sharifi, Mona; Krishanswami, Shanthi; McPheeters, Melissa L

2013-12-30

To identify and assess billing, procedural, or diagnosis code, or pharmacy claim-based algorithms used to identify acute bronchospasm in administrative and claims databases. We searched the MEDLINE database from 1991 to September 2012 using controlled vocabulary and key terms related to bronchospasm, wheeze and acute asthma. We also searched the reference lists of included studies. Two investigators independently assessed the full text of studies against pre-determined inclusion criteria. Two reviewers independently extracted data regarding participant and algorithm characteristics. Our searches identified 677 citations of which 38 met our inclusion criteria. In these 38 studies, the most commonly used ICD-9 code was 493.x. Only 3 studies reported any validation methods for the identification of bronchospasm, wheeze or acute asthma in administrative and claims databases; all were among pediatric populations and only 2 offered any validation statistics. Some of the outcome definitions utilized were heterogeneous and included other disease based diagnoses, such as bronchiolitis and pneumonia, which are typically of an infectious etiology. One study offered the validation of algorithms utilizing Emergency Department triage chief complaint codes to diagnose acute asthma exacerbations with ICD-9 786.07 (wheezing) revealing the highest sensitivity (56%), specificity (97%), PPV (93.5%) and NPV (76%). There is a paucity of studies reporting rigorous methods to validate algorithms for the identification of bronchospasm in administrative data. The scant validated data available are limited in their generalizability to broad-based populations. Copyright © 2013 Elsevier Ltd. All rights reserved.

Validation of Student and Parent Report Data on the Basic Grant Application Form: Institution Referral Study, Pre-established Criteria Study, Overpayment Recovery. Final Report, Volume 2.

ERIC Educational Resources Information Center

Vogel, Ronald J.; And Others

The types and ranges of errors made on applications to the Basic Educational Opportunity Grant (BEOG) program were studied, along with procedures used in recovering overpayments. The objective was to assess the scope and nature of misreporting and misuse of the BEOG program. A 1975-1976 study reviewed cases referred to the U.S. Office of Education…

Reference curve for the first-year growth response to growth hormone treatment in prepubertal children with idiopathic growth hormone deficiency: validation of the KIGS first-year growth response curve using the Belgian Register for the Study of Growth and Puberty Problems.

PubMed

Straetemans, Saartje; Roelants, Mathieu; Thomas, Muriel; Rooman, Raoul; De Schepper, Jean

2014-01-01

Comparing observed and expected growth after first-year growth hormone (GH) therapy is useful for identifying a poor growth response to GH. To generate a first-year, age-specific growth response reference curve for prepubertal Belgian children with idiopathic growth hormone deficiency (iGHD) treated with a standard weight-adjusted GH dose and to compare this national reference with the response references derived from KIGS. First-year height data of 357 prepubertal children (240 males) with iGHD were analyzed. Smooth reference curves of first-year height velocity (HV) in relation to age were created. Differences with the KIGS targets were evaluated after z-score transformation. The observed first-year HVs were log-normal distributed by age and decreased significantly with age (p<0.001). No GH dose or gender effect was observed (p=0.5). Distance to target height, severity of GHD and occurrence of multiple pituitary hormone deficiencies had a positive effect (p<0.01) on the calculated HV SDS. When applying the KIGS targets for severe iGHD, mean HV SDS was close to zero (-0.09±0.84). The developed age-specific growth response curves enable rapid identification of poor response to first-year GH treatment in prepubertal iGHD children. Our results validate the published growth targets derived from the KIGS database. © 2014 S. Karger AG, Basel.

The characterization and certification of a quantitative reference material for Legionella detection and quantification by qPCR.

PubMed

Baume, M; Garrelly, L; Facon, J P; Bouton, S; Fraisse, P O; Yardin, C; Reyrolle, M; Jarraud, S

2013-06-01

The characterization and certification of a Legionella DNA quantitative reference material as a primary measurement standard for Legionella qPCR. Twelve laboratories participated in a collaborative certification campaign. A candidate reference DNA material was analysed through PCR-based limiting dilution assays (LDAs). The validated data were used to statistically assign both a reference value and an associated uncertainty to the reference material. This LDA method allowed for the direct quantification of the amount of Legionella DNA per tube in genomic units (GU) and the determination of the associated uncertainties. This method could be used for the certification of all types of microbiological standards for qPCR. The use of this primary standard will improve the accuracy of Legionella qPCR measurements and the overall consistency of these measurements among different laboratories. The extensive use of this certified reference material (CRM) has been integrated in the French standard NF T90-471 (April 2010) and in the ISO Technical Specification 12 869 (Anon 2012 International Standardisation Organisation) for validating qPCR methods and ensuring the reliability of these methods. © 2013 The Society for Applied Microbiology.

[The requirements of standard and conditions of interchangeability of medical articles].

PubMed

Men'shikov, V V; Lukicheva, T I

2013-11-01

The article deals with possibility to apply specific approaches under evaluation of interchangeability of medical articles for laboratory analysis. The development of standardized analytical technologies of laboratory medicine and formulation of requirements of standards addressed to manufacturers of medical articles the clinically validated requirements are to be followed. These requirements include sensitivity and specificity of techniques, accuracy and precision of research results, stability of reagents' quality in particular conditions of their transportation and storage. The validity of requirements formulated in standards and addressed to manufacturers of medical articles can be proved using reference system, which includes master forms and standard samples, reference techniques and reference laboratories. This approach is supported by data of evaluation of testing systems for measurement of level of thyrotrophic hormone, thyroid hormones and glycated hemoglobin HB A1c. The versions of testing systems can be considered as interchangeable only in case of results corresponding to the results of reference technique and comparable with them. In case of absence of functioning reference system the possibilities of the Joined committee of traceability in laboratory medicine make it possible for manufacturers of reagent sets to apply the certified reference materials under development of manufacturing of sets for large listing of analytes.

Challenges in Implementing National Systems of Competency Validation with Regard to Adult Learning Professionals: Perspectives from Romania and India

ERIC Educational Resources Information Center

Sava, Simona Lidia; Shah, S. Y.

2015-01-01

Validation of prior learning (VPL), also referred to as recognition, validation and accreditation of prior learning (RVA), is becoming an increasingly important political issue at both European and international levels. In 2012, the European Council, the UNESCO Institute for Lifelong Learning (UIL) and the Organisation for Economic Co-operation…

Constructing a Validity Argument for the Objective Structured Assessment of Technical Skills (OSATS): A Systematic Review of Validity Evidence

ERIC Educational Resources Information Center

Hatala, Rose; Cook, David A.; Brydges, Ryan; Hawkins, Richard

2015-01-01

In order to construct and evaluate the validity argument for the Objective Structured Assessment of Technical Skills (OSATS), based on Kane's framework, we conducted a systematic review. We searched MEDLINE, EMBASE, CINAHL, PsycINFO, ERIC, Web of Science, Scopus, and selected reference lists through February 2013. Working in duplicate, we selected…

A multi-site cognitive task analysis for biomedical query mediation.

PubMed

Hruby, Gregory W; Rasmussen, Luke V; Hanauer, David; Patel, Vimla L; Cimino, James J; Weng, Chunhua

2016-09-01

To apply cognitive task analyses of the Biomedical query mediation (BQM) processes for EHR data retrieval at multiple sites towards the development of a generic BQM process model. We conducted semi-structured interviews with eleven data analysts from five academic institutions and one government agency, and performed cognitive task analyses on their BQM processes. A coding schema was developed through iterative refinement and used to annotate the interview transcripts. The annotated dataset was used to reconstruct and verify each BQM process and to develop a harmonized BQM process model. A survey was conducted to evaluate the face and content validity of this harmonized model. The harmonized process model is hierarchical, encompassing tasks, activities, and steps. The face validity evaluation concluded the model to be representative of the BQM process. In the content validity evaluation, out of the 27 tasks for BQM, 19 meet the threshold for semi-valid, including 3 fully valid: "Identify potential index phenotype," "If needed, request EHR database access rights," and "Perform query and present output to medical researcher", and 8 are invalid. We aligned the goals of the tasks within the BQM model with the five components of the reference interview. The similarity between the process of BQM and the reference interview is promising and suggests the BQM tasks are powerful for eliciting implicit information needs. We contribute a BQM process model based on a multi-site study. This model promises to inform the standardization of the BQM process towards improved communication efficiency and accuracy. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

A Multi-Site Cognitive Task Analysis for Biomedical Query Mediation

PubMed Central

Hruby, Gregory W.; Rasmussen, Luke V.; Hanauer, David; Patel, Vimla; Cimino, James J.; Weng, Chunhua

2016-01-01

Objective To apply cognitive task analyses of the Biomedical query mediation (BQM) processes for EHR data retrieval at multiple sites towards the development of a generic BQM process model. Materials and Methods We conducted semi-structured interviews with eleven data analysts from five academic institutions and one government agency, and performed cognitive task analyses on their BQM processes. A coding schema was developed through iterative refinement and used to annotate the interview transcripts. The annotated dataset was used to reconstruct and verify each BQM process and to develop a harmonized BQM process model. A survey was conducted to evaluate the face and content validity of this harmonized model. Results The harmonized process model is hierarchical, encompassing tasks, activities, and steps. The face validity evaluation concluded the model to be representative of the BQM process. In the content validity evaluation, out of the 27 tasks for BQM, 19 meet the threshold for semi-valid, including 3 fully valid: “Identify potential index phenotype,” “If needed, request EHR database access rights,” and “Perform query and present output to medical researcher”, and 8 are invalid. Discussion We aligned the goals of the tasks within the BQM model with the five components of the reference interview. The similarity between the process of BQM and the reference interview is promising and suggests the BQM tasks are powerful for eliciting implicit information needs. Conclusions We contribute a BQM process model based on a multi-site study. This model promises to inform the standardization of the BQM process towards improved communication efficiency and accuracy. PMID:27435950

Internal validation of the RapidHIT® ID system.

PubMed

Wiley, Rachel; Sage, Kelly; LaRue, Bobby; Budowle, Bruce

2017-11-01

Traditionally, forensic DNA analysis has required highly skilled forensic geneticists in a dedicated laboratory to generate short tandem repeat (STR) profiles. STR profiles are routinely used either to associate or exclude potential donors of forensic biological evidence. The typing of forensic reference samples has become more demanding, especially with the requirement in some jurisdictions to DNA profile arrestees. The Rapid DNA (RDNA) platform, the RapidHIT ® ID (IntegenX ® , Pleasanton, CA), is a fully automated system capable of processing reference samples in approximately 90min with minimal human intervention. Thus, the RapidHIT ID instrument can be deployed to non-laboratory environments (e.g., booking stations) and run by trained atypical personnel such as law enforcement. In order to implement the RapidHIT ID platform, validation studies are needed to define the performance and limitations of the system. Internal validation studies were undertaken with four early-production RapidHIT ID units. Reliable and concordant STR profiles were obtained from reference buccal swabs. Throughout the study, no contamination was observed. The overall first-pass success rate with an "expert-like system" was 72%, which is comparable to another current RDNA platform commercially available. The system's second-pass success rate (involving manual interpretation on first-pass inconclusive results) increased to 90%. Inhibitors (i.e., coffee, smoking tobacco, and chewing tobacco) did not appear to affect typing by the instrument system; however, substrate (i.e., swab type) did impact typing success. Additionally, one desirable feature not available with other Rapid systems is that in the event of a system failed run, a swab can be recovered and subsequently re-analyzed in a new sample cartridge. Therefore, rarely should additional sampling or swab consumption be necessary. The RapidHIT ID system is a robust and reliable tool capable of generating complete STR profiles within the forensic DNA typing laboratory or with proper training in decentralized environments by non-laboratory personnel. Copyright © 2017 Elsevier B.V. All rights reserved.

Determination of the purity of pharmaceutical reference materials by 1H NMR using the standardless PULCON methodology.

PubMed

Monakhova, Yulia B; Kohl-Himmelseher, Matthias; Kuballa, Thomas; Lachenmeier, Dirk W

2014-11-01

A fast and reliable nuclear magnetic resonance spectroscopic method for quantitative determination (qNMR) of targeted molecules in reference materials has been established using the ERETIC2 methodology (electronic reference to access in vivo concentrations) based on the PULCON principle (pulse length based concentration determination). The developed approach was validated for the analysis of pharmaceutical samples in the context of official medicines control, including ibandronic acid, amantadine, ambroxol and lercanidipine. The PULCON recoveries were above 94.3% and coefficients of variation (CVs) obtained by quantification of different targeted resonances ranged between 0.7% and 2.8%, demonstrating that the qNMR method is a precise tool for rapid quantification (approximately 15min) of reference materials and medicinal products. Generally, the values were within specification (certified values) provided by the manufactures. The results were in agreement with NMR quantification using an internal standard and validated reference HPLC analysis. The PULCON method was found to be a practical alternative with competitive precision and accuracy to the classical internal reference method and it proved to be applicable to different solvent conditions. The method can be recommended for routine use in medicines control laboratories, especially when the availability and costs of reference compounds are problematic. Copyright © 2014 Elsevier B.V. All rights reserved.

Impact of rain gauge quality control and interpolation on streamflow simulation: an application to the Warwick catchment, Australia

NASA Astrophysics Data System (ADS)

Liu, Shulun; Li, Yuan; Pauwels, Valentijn R. N.; Walker, Jeffrey P.

2017-12-01

Rain gauges are widely used to obtain temporally continuous point rainfall records, which are then interpolated into spatially continuous data to force hydrological models. However, rainfall measurements and interpolation procedure are subject to various uncertainties, which can be reduced by applying quality control and selecting appropriate spatial interpolation approaches. Consequently, the integrated impact of rainfall quality control and interpolation on streamflow simulation has attracted increased attention but not been fully addressed. This study applies a quality control procedure to the hourly rainfall measurements obtained in the Warwick catchment in eastern Australia. The grid-based daily precipitation from the Australian Water Availability Project was used as a reference. The Pearson correlation coefficient between the daily accumulation of gauged rainfall and the reference data was used to eliminate gauges with significant quality issues. The unrealistic outliers were censored based on a comparison between gauged rainfall and the reference. Four interpolation methods, including the inverse distance weighting (IDW), nearest neighbors (NN), linear spline (LN), and ordinary Kriging (OK), were implemented. The four methods were firstly assessed through a cross-validation using the quality-controlled rainfall data. The impacts of the quality control and interpolation on streamflow simulation were then evaluated through a semi-distributed hydrological model. The results showed that the Nash–Sutcliffe model efficiency coefficient (NSE) and Bias of the streamflow simulations were significantly improved after quality control. In the cross-validation, the IDW and OK methods resulted in good interpolation rainfall, while the NN led to the worst result. In term of the impact on hydrological prediction, the IDW led to the most consistent streamflow predictions with the observations, according to the validation at five streamflow-gauged locations. The OK method performed second best according to streamflow predictions at the five gauges in the calibration period (01/01/2007–31/12/2011) and four gauges during the validation period (01/01/2012–30/06/2014). However, NN produced the worst prediction at the outlet of the catchment in the validation period, indicating a low robustness. While the IDW exhibited the best performance in the study catchment in terms of accuracy, robustness and efficiency, more general recommendations on the selection of rainfall interpolation methods need to be further explored.

Impact of rain gauge quality control and interpolation on streamflow simulation: an application to the Warwick catchment, Australia

NASA Astrophysics Data System (ADS)

Liu, Shulun; Li, Yuan; Pauwels, Valentijn R. N.; Walker, Jeffrey P.

2018-01-01

Rain gauges are widely used to obtain temporally continuous point rainfall records, which are then interpolated into spatially continuous data to force hydrological models. However, rainfall measurements and interpolation procedure are subject to various uncertainties, which can be reduced by applying quality control and selecting appropriate spatial interpolation approaches. Consequently, the integrated impact of rainfall quality control and interpolation on streamflow simulation has attracted increased attention but not been fully addressed. This study applies a quality control procedure to the hourly rainfall measurements obtained in the Warwick catchment in eastern Australia. The grid-based daily precipitation from the Australian Water Availability Project was used as a reference. The Pearson correlation coefficient between the daily accumulation of gauged rainfall and the reference data was used to eliminate gauges with significant quality issues. The unrealistic outliers were censored based on a comparison between gauged rainfall and the reference. Four interpolation methods, including the inverse distance weighting (IDW), nearest neighbors (NN), linear spline (LN), and ordinary Kriging (OK), were implemented. The four methods were firstly assessed through a cross-validation using the quality-controlled rainfall data. The impacts of the quality control and interpolation on streamflow simulation were then evaluated through a semi-distributed hydrological model. The results showed that the Nash–Sutcliffe model efficiency coefficient (NSE) and Bias of the streamflow simulations were significantly improved after quality control. In the cross-validation, the IDW and OK methods resulted in good interpolation rainfall, while the NN led to the worst result. In term of the impact on hydrological prediction, the IDW led to the most consistent streamflow predictions with the observations, according to the validation at five streamflow-gauged locations. The OK method performed second best according to streamflow predictions at the five gauges in the calibration period (01/01/2007–31/12/2011) and four gauges during the validation period (01/01/2012–30/06/2014). However, NN produced the worst prediction at the outlet of the catchment in the validation period, indicating a low robustness. While the IDW exhibited the best performance in the study catchment in terms of accuracy, robustness and efficiency, more general recommendations on the selection of rainfall interpolation methods need to be further explored.

Evidence of Construct Validity in the Assessment of Hebephilia.

PubMed

Stephens, Skye; Seto, Michael C; Goodwill, Alasdair M; Cantor, James M

2017-01-01

Hebephilia refers to a persistent intense sexual interest in pubescent children. Although not as widely studied as pedophilia, studies of hebephilia have indicated convergence in self-report and sexual arousal. The present study expanded on previous work by examining convergent and divergent validity across indicators of hebephilia that included self-report, sexual behavior, and sexual arousal in a sample of 2238 men who had sexually offended. We included men who denied such interest and specifically examined the overlap between hebephilia and pedophilia and examined pedohebephilia (i.e., sexual interests in both prepubescent and pubescent children). Results indicated that there was considerable convergence across indicators of hebephilia. The results suggested poor divergent validity between hebephilia and pedophilia, as there was substantial overlap between the two constructs across analyses. Finally, a distinct pattern of sexual arousal was found in offenders with pedohebephilia. The results of the present study were discussed with a focus on implications for the assessment of sexual interest in children and the conceptualization of pedohebephilia.

Validation of Medical Tourism Service Quality Questionnaire (MTSQQ) for Iranian Hospitals

PubMed Central

Qolipour, Mohammad; Torabipour, Amin; Khiavi, Farzad Faraji; Malehi, Amal Saki

2017-01-01

Introduction Assessing service quality is one of the basic requirements to develop the medical tourism industry. There is no valid and reliable tool to measure service quality of medical tourism. This study aimed to determine the reliability and validity of a Persian version of medical tourism service quality questionnaire for Iranian hospitals. Methods To validate the medical tourism service quality questionnaire (MTSQQ), a cross-sectional study was conducted on 250 Iraqi patients referred to hospitals in Ahvaz (Iran) from 2015. To design a questionnaire and determine its content validity, the Delphi Technique (3 rounds) with the participation of 20 medical tourism experts was used. Construct validity of the questionnaire was assessed through exploratory and confirmatory factor analysis. Reliability was assessed using Cronbach’s alpha coefficient. Data were analyzed by Excel 2007, SPSS version18, and Lisrel l8.0 software. Results The content validity of the questionnaire with CVI=0.775 was confirmed. According to exploratory factor analysis, the MTSQQ included 31 items and 8 dimensions (tangibility, reliability, responsiveness, assurance, empathy, exchange and travel facilities, technical and infrastructure facilities and safety and security). Construct validity of the questionnaire was confirmed, based on the goodness of fit quantities of model (RMSEA=0.032, CFI= 0.98, GFI=0.88). Cronbach’s alpha coefficient was 0.837 and 0.919 for expectation and perception questionnaire. Conclusion The results of the study showed that the medical tourism SERVQUAL questionnaire with 31 items and 8 dimensions was a valid and reliable tool to measure service quality of medical tourism in Iranian hospitals. PMID:28461863

Breast Reference Set Application: Chris Li-FHCRC (2015) — EDRN Public Portal

Cancer.gov

We propose to evaluate nine candidate biomarkers for ER+ breast cancer in samples from the EDRN Breast Cancer Reference Set. These biomarkers have been preliminarily validated in preclinical samples. The intended clinical applications of these markers are to: 1. Inform timing of a subsequent mammogram in women with a negative screening mammogram; 2. Inform continuation of mammographic screening among women 75-79 years; 3. Prioritize women who should be screened with mammography in areas with limited resources. Testing the reference samples would further expedite addressing these intended clinical applications by providing further validation data to support requests for samples from other sources for further Phase 3 evaluation (e.g., WHI, PLCO, and samples collected at the time of mammographic screening from the University of Toronto and UCSF).

Global Land Product Validation Protocols: An Initiative of the CEOS Working Group on Calibration and Validation to Evaluate Satellite-derived Essential Climate Variables

NASA Astrophysics Data System (ADS)

Guillevic, P. C.; Nickeson, J. E.; Roman, M. O.; camacho De Coca, F.; Wang, Z.; Schaepman-Strub, G.

2016-12-01

The Global Climate Observing System (GCOS) has specified the need to systematically produce and validate Essential Climate Variables (ECVs). The Committee on Earth Observation Satellites (CEOS) Working Group on Calibration and Validation (WGCV) and in particular its subgroup on Land Product Validation (LPV) is playing a key coordination role leveraging the international expertise required to address actions related to the validation of global land ECVs. The primary objective of the LPV subgroup is to set standards for validation methods and reporting in order to provide traceable and reliable uncertainty estimates for scientists and stakeholders. The Subgroup is comprised of 9 focus areas that encompass 10 land surface variables. The activities of each focus area are coordinated by two international co-leads and currently include leaf area index (LAI) and fraction of absorbed photosynthetically active radiation (FAPAR), vegetation phenology, surface albedo, fire disturbance, snow cover, land cover and land use change, soil moisture, land surface temperature (LST) and emissivity. Recent additions to the focus areas include vegetation indices and biomass. The development of best practice validation protocols is a core activity of CEOS LPV with the objective to standardize the evaluation of land surface products. LPV has identified four validation levels corresponding to increasing spatial and temporal representativeness of reference samples used to perform validation. Best practice validation protocols (1) provide the definition of variables, ancillary information and uncertainty metrics, (2) describe available data sources and methods to establish reference validation datasets with SI traceability, and (3) describe evaluation methods and reporting. An overview on validation best practice components will be presented based on the LAI and LST protocol efforts to date.

Age and sex variation in serum albumin concentration: an observational study.

PubMed

Weaving, Gary; Batstone, Gifford F; Jones, Richard G

2016-01-01

In the UK, a common reference interval for serum albumin is widely used irrespective of age or sex. Implicit in this is that laboratories produce analytically similar results. This paper challenges the validity of this approach. A three-week collection of results sent to all primary care centres in England has been analysed by age, sex and laboratory. In all, 1,079,193 serum albumin reports were included in this analysis. The mean population serum albumin concentration increases to peak at around age 20 years and then decreases with increasing age. Values in females decrease more rapidly but become close to male values at 60 years. The variation between laboratories was large and potentially clinically significant. Reference intervals for serum albumin should be stratified by age and sex. Until there is greater methodological standardization, laboratories should determine their own reference intervals and not accept a single consensus reference interval. © The Author(s) 2015.

The validity of the Health-Relevant Personality Inventory (HP5i) and the Junior Temperament and Character Inventory (JTCI) among adolescents referred for a substance misuse problem.

PubMed

Hemphälä, Malin; Gustavsson, J Petter; Tengström, Anders

2013-01-01

The aim was to study the validity of 2 personality instruments, the Health-Relevant Personality Inventory (HP5i) and the Junior Temperament and Character Inventory (JTCI), among adolescents with a substance use problem. Clinical interviews were completed with 180 adolescents and followed up after 12 months. Discriminant validity was demonstrated in the lack of correlation to intelligence in both instruments' scales. Two findings were in support of convergent validity: Negative affectivity (HP5i) and harm avoidance (JTCI) were correlated to internalizing symptoms, and impulsivity (HP5i) and novelty seeking (JTCI) were correlated to externalizing symptoms. The predictive validity of JTCI was partly supported. When psychiatric symptoms at baseline were controlled for, cooperativeness predicted conduct disorder after 12 months. Summarizing, both instruments can be used in adolescent clinical samples to tailor treatment efforts, although some scales need further investigation. It is important to include personality assessment when evaluating psychiatric problems in adolescents.

Making Organisms Model Human Behavior: Situated Models in North-American Alcohol Research, 1950-onwards

PubMed Central

Leonelli, Sabina; Ankeny, Rachel A.; Nelson, Nicole C.; Ramsden, Edmund

2014-01-01

Argument We examine the criteria used to validate the use of nonhuman organisms in North-American alcohol addiction research from the 1950s to the present day. We argue that this field, where the similarities between behaviors in humans and non-humans are particularly difficult to assess, has addressed questions of model validity by transforming the situatedness of non-human organisms into an experimental tool. We demonstrate that model validity does not hinge on the standardization of one type of organism in isolation, as often the case with genetic model organisms. Rather, organisms are viewed as necessarily situated: they cannot be understood as a model for human behavior in isolation from their environmental conditions. Hence the environment itself is standardized as part of the modeling process; and model validity is assessed with reference to the environmental conditions under which organisms are studied. PMID:25233743

Reference Standards, Judges, and Comparison Subjects

PubMed Central

Hripcsak, George; Wilcox, Adam

2002-01-01

Medical informatics systems are often designed to perform at the level of human experts. Evaluation of the performance of these systems is often constrained by lack of reference standards, either because the appropriate response is not known or because no simple appropriate response exists. Even when performance can be assessed, it is not always clear whether the performance is sufficient or reasonable. These challenges can be addressed if an evaluator enlists the help of clinical domain experts. 1) The experts can carry out the same tasks as the system, and then their responses can be combined to generate a reference standard. 2)The experts can judge the appropriateness of system output directly. 3) The experts can serve as comparison subjects with which the system can be compared. These are separate roles that have different implications for study design, metrics, and issues of reliability and validity. Diagrams help delineate the roles of experts in complex study designs. PMID:11751799

Determination of Perfluorinated Alkyl Acid Concentrations in Biological Standard Reference Materials

EPA Science Inventory

Standard reference materials (SRMs) are homogeneous, well-characterized materials used to validate measurements and improve the quality of analytical data. The National Institute of Standards and Technology (NIST) has a wide range of SRMs that have mass fraction values assigned ...

Plans and progress for building a Great Lakes fauna DNA barcode reference library

EPA Science Inventory

DNA reference libraries provide researchers with an important tool for assessing regional biodiversity by allowing unknown genetic sequences to be assigned identities, while also providing a means for taxonomists to validate identifications. Expanding the representation of Great...

A study in the founding of applied behavior analysis through its publications.

PubMed

Morris, Edward K; Altus, Deborah E; Smith, Nathaniel G

2013-01-01

This article reports a study of the founding of applied behavior analysis through its publications. Our methods included hand searches of sources (e.g., journals, reference lists), search terms (i.e., early, applied, behavioral, research, literature), inclusion criteria (e.g., the field's applied dimension), and (d) challenges to their face and content validity. Our results were 36 articles published between 1959 and 1967 that we organized into 4 groups: 12 in 3 programs of research and 24 others. Our discussion addresses (a) limitations in our method (e.g., the completeness of our search), (b) challenges to the validity of our methods and results (e.g., convergent validity), and (c) priority claims about the field's founding. We conclude that the claims are irresolvable because identification of the founding publications depends significantly on methods and because the field's founding was an evolutionary process. We close with suggestions for future research.

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.

A Study in the Founding of Applied Behavior Analysis Through Its Publications

PubMed Central

Morris, Edward K.; Altus, Deborah E.; Smith, Nathaniel G.

2013-01-01

This article reports a study of the founding of applied behavior analysis through its publications. Our methods included hand searches of sources (e.g., journals, reference lists), search terms (i.e., early, applied, behavioral, research, literature), inclusion criteria (e.g., the field's applied dimension), and (d) challenges to their face and content validity. Our results were 36 articles published between 1959 and 1967 that we organized into 4 groups: 12 in 3 programs of research and 24 others. Our discussion addresses (a) limitations in our method (e.g., the completeness of our search), (b) challenges to the validity of our methods and results (e.g., convergent validity), and (c) priority claims about the field's founding. We conclude that the claims are irresolvable because identification of the founding publications depends significantly on methods and because the field's founding was an evolutionary process. We close with suggestions for future research. PMID:25729133

The Confusion Assessment Method (CAM): A Systematic Review of Current Usage

PubMed Central

Wei, Leslie A.; Fearing, Michael A.; Sternberg, Eliezer J.; Inouye, Sharon K.

2008-01-01

Objectives To examine the psychometric properties, adaptations, translations, and applications of the Confusion Assessment Method (CAM), a widely-used instrument and diagnostic algorithm for identification of delirium. Design Systematic literature review Setting NA Measurements Electronic searches of PubMED, EMBASE, PsychINFO, CINAHL, Ageline, and Google Scholar, augmented by reviews of reference listings, were conducted to identify original English-language articles utilizing the CAM from January 1, 1991 to December 31, 2006. Two reviewers independently abstracted key information from each article. Participants NA Results Of 239 original articles, 10 (4%) were categorized as validation studies, 16 (7%) as adaptations; 12 (5%) as translations, and 222 (93%) as applications. Validation studies evaluated performance of the CAM against a reference standard. Results were combined across 7 high quality studies (n=1071), demonstrating an overall sensitivity of 94% (95% confidence interval, CI, 91–97%), and specificity of 89% (95% CI, 85–94%). CAM has been adapted for use in ICU, emergency, and institutional settings, and for scoring severity and subsyndromal delirium. CAM has been translated into 10 languages where published articles are available. In application studies, CAM-rated delirium is most commonly used as a risk factor or outcome, but also as an intervention or reference standard. Conclusions The CAM has helped to improve identification of delirium in clinical and research settings. To optimize performance, the CAM should be scored based on observations made during formal cognitive testing, and training is recommended. Future action is needed to optimize use of the CAM and to improve the recognition and management of delirium. PMID:18384586

A hybrid deconvolution approach for estimation of in vivo non-displaceable binding for brain PET targets without a reference region

PubMed Central

Mann, J. John; Ogden, R. Todd

2017-01-01

Background and aim Estimation of a PET tracer’s non-displaceable distribution volume (VND) is required for quantification of specific binding to its target of interest. VND is generally assumed to be comparable brain-wide and is determined either from a reference region devoid of the target, often not available for many tracers and targets, or by imaging each subject before and after blocking the target with another molecule that has high affinity for the target, which is cumbersome and involves additional radiation exposure. Here we propose, and validate for the tracers [11C]DASB and [11C]CUMI-101, a new data-driven hybrid deconvolution approach (HYDECA) that determines VND at the individual level without requiring either a reference region or a blocking study. Methods HYDECA requires the tracer metabolite-corrected concentration curve in blood plasma and uses a singular value decomposition to estimate the impulse response function across several brain regions from measured time activity curves. HYDECA decomposes each region’s impulse response function into the sum of a parametric non-displaceable component, which is a function of VND, assumed common across regions, and a nonparametric specific component. These two components differentially contribute to each impulse response function. Different regions show different contributions of the two components, and HYDECA examines data across regions to find a suitable common VND. HYDECA implementation requires determination of two tuning parameters, and we propose two strategies for objectively selecting these parameters for a given tracer: using data from blocking studies, and realistic simulations of the tracer. Using available test-retest data, we compare HYDECA estimates of VND and binding potentials to those obtained based on VND estimated using a purported reference region. Results For [11C]DASB and [11C]CUMI-101, we find that regardless of the strategy used to optimize the tuning parameters, HYDECA provides considerably less biased estimates of VND than those obtained, as is commonly done, using a non-ideal reference region. HYDECA test-retest reproducibility is comparable to that obtained using a VND determined from a non-ideal reference region, when considering the binding potentials BPP and BPND. Conclusions HYDECA can provide subject-specific estimates of VND without requiring a blocking study for tracers and targets for which a valid reference region does not exist. PMID:28459878

A detailed kinetic mechanism including methanol and nitrogen pollutants relevant to the gas-phase combustion and pyrolysis of biomass-derived fuels

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

Coda Zabetta, Edgardo; Hupa, Mikko

2008-01-15

A detailed chemical kinetic mechanism for the simulation of the gas-phase combustion and pyrolysis of biomass-derived fuels was compiled by assembling selected reaction subsets from existing mechanisms (parents). The mechanism, here referred to as ''AaA,'' includes reaction subsets for the oxidation of hydrogen (H{sub 2}), carbon monoxide (CO), light hydrocarbons (C{sub 1} and C{sub 2}), and methanol (CH{sub 3}OH). The mechanism also takes into account reaction subsets of nitrogen pollutants, including the reactions relevant to staged combustion, reburning, and selective noncatalytic reduction (SNCR). The AaA mechanism was validated against suitable experimental data from the literature. Overall, the AaA mechanism gavemore » more accurate predictions than three other mechanisms of reference, although the reference mechanisms performed better occasionally. The predictions from AaA were also found to be consistent with the predictions of its parent mechanisms within most of their range of validity, thus transferring the validity of the parents to the inheriting mechanism (AaA). In parametric studies the AaA mechanism predicted that the effect of methanol on combustion and pollutants is often similar to that of light hydrocarbons, but it also showed that there are important exceptions, thus suggesting that methanol should be taken into account when simulating biomass combustion. To our knowledge, the AaA mechanism is currently the only mechanism that accounts for the chemistry of methanol and nitrogen relevant to the gas-phase combustion and pyrolysis of biomass-derived fuels. (author)« less

Case definitions for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review

PubMed Central

Brurberg, Kjetil Gundro; Fønhus, Marita Sporstøl; Larun, Lillebeth; Flottorp, Signe; Malterud, Kirsti

2014-01-01

Objective To identify case definitions for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), and explore how the validity of case definitions can be evaluated in the absence of a reference standard. Design Systematic review. Setting International. Participants A literature search, updated as of November 2013, led to the identification of 20 case definitions and inclusion of 38 validation studies. Primary and secondary outcome measure Validation studies were assessed for risk of bias and categorised according to three validation models: (1) independent application of several case definitions on the same population, (2) sequential application of different case definitions on patients diagnosed with CFS/ME with one set of diagnostic criteria or (3) comparison of prevalence estimates from different case definitions applied on different populations. Results A total of 38 studies contributed data of sufficient quality and consistency for evaluation of validity, with CDC-1994/Fukuda as the most frequently applied case definition. No study rigorously assessed the reproducibility or feasibility of case definitions. Validation studies were small with methodological weaknesses and inconsistent results. No empirical data indicated that any case definition specifically identified patients with a neuroimmunological condition. Conclusions Classification of patients according to severity and symptom patterns, aiming to predict prognosis or effectiveness of therapy, seems useful. Development of further case definitions of CFS/ME should be given a low priority. Consistency in research can be achieved by applying diagnostic criteria that have been subjected to systematic evaluation. PMID:24508851

CRISPR/Cas9 Technology-Based Xenograft Tumors as Candidate Reference Materials for Multiple EML4-ALK Rearrangements Testing.

PubMed

Peng, Rongxue; Zhang, Rui; Lin, Guigao; Yang, Xin; Li, Ziyang; Zhang, Kuo; Zhang, Jiawei; Li, Jinming

2017-09-01

The echinoderm microtubule-associated protein-like 4 and anaplastic lymphoma kinase (ALK) receptor tyrosine kinase (EML4-ALK) rearrangement is an important biomarker that plays a pivotal role in therapeutic decision making for non-small-cell lung cancer (NSCLC) patients. Ensuring accuracy and reproducibility of EML4-ALK testing by fluorescence in situ hybridization, immunohistochemistry, RT-PCR, and next-generation sequencing requires reliable reference materials for monitoring assay sensitivity and specificity. Herein, we developed novel reference materials for various kinds of EML4-ALK testing. CRISPR/Cas9 was used to edit various NSCLC cell lines containing EML4-ALK rearrangement variants 1, 2, and 3a/b. After s.c. inoculation, the formalin-fixed, paraffin-embedded (FFPE) samples from xenografts were prepared and tested for suitability as candidate reference materials by fluorescence in situ hybridization, immunohistochemistry, RT-PCR, and next-generation sequencing. Sample validation and commutability assessments showed that all types of FFPE samples derived from xenograft tumors have typical histological structures, and EML4-ALK testing results were similar to the clinical ALK-positive NSCLC specimens. Among the four methods for EML4-ALK detection, the validation test showed 100% concordance. Furthermore, these novel FFPE reference materials showed good stability and homogeneity. Without limitations on variant types and production, our novel FFPE samples based on CRISPR/Cas9 editing and xenografts are suitable as candidate reference materials for the validation, verification, internal quality control, and proficiency testing of EML4-ALK detection. Copyright © 2017 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Development and validation of a cerebral oximeter capable of absolute accuracy.

PubMed

MacLeod, David B; Ikeda, Keita; Vacchiano, Charles; Lobbestael, Aaron; Wahr, Joyce A; Shaw, Andrew D

2012-12-01

Cerebral oximetry may be a valuable monitor, but few validation data are available, and most report the change from baseline rather than absolute accuracy, which may be affected by individuals whose oximetric values are outside the expected range. The authors sought to develop and validate a cerebral oximeter capable of absolute accuracy. An in vivo research study. A university human physiology laboratory. Healthy human volunteers were enrolled in calibration and validation studies of 2 cerebral oximetric sensors, the Nonin 8000CA and 8004CA. The 8000CA validation study identified 5 individuals with atypical cerebral oxygenation values; their data were used to design the 8004CA sensor, which subsequently underwent calibration and validation. Volunteers were taken through a stepwise hypoxia protocol to a minimum saturation of peripheral oxygen. Arteriovenous saturation (70% jugular bulb venous saturation and 30% arterial saturation) at 6 hypoxic plateaus was used as the reference value for the cerebral oximeter. Absolute accuracy was defined using a combination of the bias and precision of the paired saturations (A(RMS)). In the validation study for the 8000CA sensor (n = 9, 106 plateaus), relative accuracy was an A(RMS) of 2.7, with an absolute accuracy of 8.1, meeting the criteria for a relative (trend) monitor, but not an absolute monitor. In the validation study for the 8004CA sensor (n = 11, 119 plateaus), the A(RMS) of the 8004CA was 4.1, meeting the prespecified success criterion of <5.0. The Nonin cerebral oximeter using the 8004CA sensor can provide absolute data on regional cerebral saturation compared with arteriovenous saturation, even in subjects previously shown to have values outside the normal population distribution curves. Copyright © 2012 Elsevier Inc. All rights reserved.

MolProbity: More and better reference data for improved all-atom structure validation.

PubMed

Williams, Christopher J; Headd, Jeffrey J; Moriarty, Nigel W; Prisant, Michael G; Videau, Lizbeth L; Deis, Lindsay N; Verma, Vishal; Keedy, Daniel A; Hintze, Bradley J; Chen, Vincent B; Jain, Swati; Lewis, Steven M; Arendall, W Bryan; Snoeyink, Jack; Adams, Paul D; Lovell, Simon C; Richardson, Jane S; Richardson, David C

2018-01-01

This paper describes the current update on macromolecular model validation services that are provided at the MolProbity website, emphasizing changes and additions since the previous review in 2010. There have been many infrastructure improvements, including rewrite of previous Java utilities to now use existing or newly written Python utilities in the open-source CCTBX portion of the Phenix software system. This improves long-term maintainability and enhances the thorough integration of MolProbity-style validation within Phenix. There is now a complete MolProbity mirror site at http://molprobity.manchester.ac.uk. GitHub serves our open-source code, reference datasets, and the resulting multi-dimensional distributions that define most validation criteria. Coordinate output after Asn/Gln/His "flip" correction is now more idealized, since the post-refinement step has apparently often been skipped in the past. Two distinct sets of heavy-atom-to-hydrogen distances and accompanying van der Waals radii have been researched and improved in accuracy, one for the electron-cloud-center positions suitable for X-ray crystallography and one for nuclear positions. New validations include messages at input about problem-causing format irregularities, updates of Ramachandran and rotamer criteria from the million quality-filtered residues in a new reference dataset, the CaBLAM Cα-CO virtual-angle analysis of backbone and secondary structure for cryoEM or low-resolution X-ray, and flagging of the very rare cis-nonProline and twisted peptides which have recently been greatly overused. Due to wide application of MolProbity validation and corrections by the research community, in Phenix, and at the worldwide Protein Data Bank, newly deposited structures have continued to improve greatly as measured by MolProbity's unique all-atom clashscore. © 2017 The Protein Society.

Selection of reliable reference genes for quantitative real-time PCR gene expression analysis in Jute (Corchorus capsularis) under stress treatments

PubMed Central

Niu, Xiaoping; Qi, Jianmin; Zhang, Gaoyang; Xu, Jiantang; Tao, Aifen; Fang, Pingping; Su, Jianguang

2015-01-01

To accurately measure gene expression using quantitative reverse transcription PCR (qRT-PCR), reliable reference gene(s) are required for data normalization. Corchorus capsularis, an annual herbaceous fiber crop with predominant biodegradability and renewability, has not been investigated for the stability of reference genes with qRT-PCR. In this study, 11 candidate reference genes were selected and their expression levels were assessed using qRT-PCR. To account for the influence of experimental approach and tissue type, 22 different jute samples were selected from abiotic and biotic stress conditions as well as three different tissue types. The stability of the candidate reference genes was evaluated using geNorm, NormFinder, and BestKeeper programs, and the comprehensive rankings of gene stability were generated by aggregate analysis. For the biotic stress and NaCl stress subsets, ACT7 and RAN were suitable as stable reference genes for gene expression normalization. For the PEG stress subset, UBC, and DnaJ were sufficient for accurate normalization. For the tissues subset, four reference genes TUBβ, UBI, EF1α, and RAN were sufficient for accurate normalization. The selected genes were further validated by comparing expression profiles of WRKY15 in various samples, and two stable reference genes were recommended for accurate normalization of qRT-PCR data. Our results provide researchers with appropriate reference genes for qRT-PCR in C. capsularis, and will facilitate gene expression study under these conditions. PMID:26528312

Which symptom assessments and approaches are uniquely appropriate for paediatric concussion?

PubMed

Gioia, G A; Schneider, J C; Vaughan, C G; Isquith, P K

2009-05-01

To (a) identify post-concussion symptom scales appropriate for children and adolescents in sports; (b) review evidence for reliability and validity; and (c) recommend future directions for scale development. Quantitative and qualitative literature review of symptom rating scales appropriate for children and adolescents aged 5 to 22 years. Literature identified via search of Medline, Ovid-Medline and PsycInfo databases; review of reference lists in identified articles; querying sports concussion specialists. 29 articles met study inclusion criteria. 5 symptom scales examined in 11 studies for ages 5-12 years and in 25 studies for ages 13-22. 10 of 11 studies for 5-12-year-olds presented validity evidence for three scales; 7 studies provided reliability evidence for two scales; 7 studies used serial administrations but no reliable change metrics. Two scales included parent-reports and one included a teacher report. 24 of 25 studies for 13-22 year-olds presented validity evidence for five measures; seven studies provided reliability evidence for four measures with 18 studies including serial administrations and two examining Reliable Change. Psychometric evidence for symptom scales is stronger for adolescents than for younger children. Most scales provide evidence of concurrent validity, discriminating concussed and non-concussed groups. Few report reliability and evidence for validity is narrow. Two measures include parent/teacher reports. Few scales examine reliable change statistics, limiting interpretability of temporal changes. Future studies are needed to fully define symptom scale psychometric properties with the greatest need in younger student-athletes.

[Instrumental, directive, and affective communication in hospital leaflets].

PubMed

Vasconcellos-Silva, Paulo Roberto; Uribe Rivera, Francisco Javier; Castiel, Luis David

2003-01-01

This study focuses on the typical semantic systems extracted from hospital staff communicative resources which attempt to validate information as an "object" to be transferred to patients. We describe the models of textual communication in 58 patient information leaflets from five hospital units in Brazil, gathered from 1996 to 2002. Three categories were identified, based on the theory of speech acts (Austin, Searle, and Habermas): 1) cognitive-instrumental utterances: descriptions by means of technical terms validated by self-referred, incomplete, or inaccessible argumentation, with an implicit educational function; 2) technical-directive utterances: self-referred (to the context of the source domains), with a shifting of everyday acts to a technical terrain with a disciplinary function and impersonal features; and 3) expressive modulations: need for inter-subjective connections to strengthen bonds of trust and a tendency to use childish arguments. We conclude that the three categories displayed: fragmentary sources; assumption of univocal messages and invariable use of information (idealized motivations and interests, apart from individualized perspectives); and assumption of universal interests as generators of knowledge.

Reference interval for thyrotropin in a ultrasonography screened Korean population

PubMed Central

Kim, Mijin; Kim, Soo Han; Lee, Yunkyoung; Park, Su-yeon; Kim, Hyung-don; Kwon, Hyemi; Choi, Yun Mi; Jang, Eun Kyung; Jeon, Min Ji; Kim, Won Gu; Shong, Young Kee; Kim, Won Bae

2015-01-01

Background/Aims The diagnostic accuracy of thyroid dysfunctions is primarily affected by the validity of the reference interval for serum thyroid-stimulating hormone (TSH). Thus, the present study aimed to establish a reference interval for TSH using a normal Korean population. Methods This study included 19,465 subjects who were recruited after undergoing routine health check-ups. Subjects with overt thyroid disease, a prior history of thyroid disease, or a family history of thyroid cancer were excluded from the present analyses. The reference range for serum TSH was evaluated in a normal Korean reference population which was defined according to criteria based on the guidelines of the National Academy of Clinical Biochemistry, ultrasound (US) findings, and smoking status. Sex and age were also taken into consideration when evaluating the distribution of serum TSH levels in different groups. Results In the presence of positive anti-thyroid peroxidase antibodies or abnormal US findings, the central 95 percentile interval of the serum TSH levels was widened. Additionally, the distribution of serum TSH levels shifted toward lower values in the current smokers group. The reference interval for TSH obtained using a normal Korean reference population was 0.73 to 7.06 mIU/L. The serum TSH levels were higher in females than in males in all groups, and there were no age-dependent shifts. Conclusions The present findings demonstrate that the serum TSH reference interval in a normal Korean reference population was higher than that in other countries. This result suggests that the upper and lower limits of the TSH reference interval, which was previously defined by studies from Western countries, should be raised for Korean populations. PMID:25995664

Validating archetypes for the Multiple Sclerosis Functional Composite.

PubMed

Braun, Michael; Brandt, Alexander Ulrich; Schulz, Stefan; Boeker, Martin

2014-08-03

Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions.This case study provides evidence that both community- and tool-enabled review processes, structured in the Clinical Knowledge Manager, ensure archetype quality. It offers a pragmatic but feasible way to reduce variation in the representation of clinical information models towards a more unified and interoperable model.

Validating archetypes for the Multiple Sclerosis Functional Composite

PubMed Central

2014-01-01

Background Numerous information models for electronic health records, such as openEHR archetypes are available. The quality of such clinical models is important to guarantee standardised semantics and to facilitate their interoperability. However, validation aspects are not regarded sufficiently yet. The objective of this report is to investigate the feasibility of archetype development and its community-based validation process, presuming that this review process is a practical way to ensure high-quality information models amending the formal reference model definitions. Methods A standard archetype development approach was applied on a case set of three clinical tests for multiple sclerosis assessment: After an analysis of the tests, the obtained data elements were organised and structured. The appropriate archetype class was selected and the data elements were implemented in an iterative refinement process. Clinical and information modelling experts validated the models in a structured review process. Results Four new archetypes were developed and publicly deployed in the openEHR Clinical Knowledge Manager, an online platform provided by the openEHR Foundation. Afterwards, these four archetypes were validated by domain experts in a team review. The review was a formalised process, organised in the Clinical Knowledge Manager. Both, development and review process turned out to be time-consuming tasks, mostly due to difficult selection processes between alternative modelling approaches. The archetype review was a straightforward team process with the goal to validate archetypes pragmatically. Conclusions The quality of medical information models is crucial to guarantee standardised semantic representation in order to improve interoperability. The validation process is a practical way to better harmonise models that diverge due to necessary flexibility left open by the underlying formal reference model definitions. This case study provides evidence that both community- and tool-enabled review processes, structured in the Clinical Knowledge Manager, ensure archetype quality. It offers a pragmatic but feasible way to reduce variation in the representation of clinical information models towards a more unified and interoperable model. PMID:25087081

Iowa Hydrologic and Environmental Validation Site: A Proposal to the Community

NASA Astrophysics Data System (ADS)

Bradley, A. A.; Ciach, G. J.; Eichinger, W. N.; Hornbuckle, K. C.; Illman, W.; Krajewski, W. F.; Kruger, A.; Patel, V. C.; Weirich, F. H.; Zhang, Y.

2002-05-01

We present a proposal to the hydrologic research community to establish a validation site in eastern Iowa. Many hydrological and meteorological variables observed using remote sensing techniques or predicted using numerical simulation models require validation. Validation, understood as quantification of the uncertainty, is difficult and often even impossible using operationally available in-situ observations. Specialized high-density networks of sensors with well-established error characteristics are required to serve as reference. We propose to establish a well-instrumented site for validation of several hydrometeorlogical and environmental variables near Iowa City, Iowa. We foresee this site as a national resource of detailed information collected in partnership with federal, state, and local agencies but independent of their routine mission oriented operations. The data would be distributed in real-time via the Internet to the research community nation wide to support model validation and development studies. In the presentation we justify the need for such sites, we make the case for setting a prototype site in Iowa, and we present preliminary considerations for the site's design and the data distribution system.

Treatment Acceptability of Behavioral Interventions for Children: An Assessment by Mothers of Children with Disruptive Behavior Disorders.

ERIC Educational Resources Information Center

Jones, Melanie L.; Eyberg, Sheila M.; Adams, Christina D.; Boggs, Stephen R.

1998-01-01

Study assesses the acceptability of six child-management interventions as rated by mothers (N=20) of children referred for treatment for a disruptive-behavior disorder. Positive reinforcement was rated as a more acceptable treatment than response time, time-out, differential attention, overcorrection, and spanking. Results validate findings of…

A Measurement of Student Teachers' Parent-Teacher Communication Competences: The Design of a Video-Based Instrument

ERIC Educational Resources Information Center

De Coninck, Karen; Valcke, Martin; Vanderlinde, Ruben

2018-01-01

This study reports on the design of a video-based instrument to assess student teachers' parent-teacher communication competences (PTCC) in a reliable and valid way. PTCC refer to the competences needed to communicate successfully with parents during conversations such as parent-teacher conferences. Taking into account both conceptual and…

Impact of Dysphoria and Self-Consciousness on Perceptions of Social Competence: Test of the Depressive Realism Hypothesis

ERIC Educational Resources Information Center

Chau, Phuong M.; Milling, Leonard S.

2006-01-01

Depressive realism refers to a cognitive style wherein depressed people sometimes have more accurate perceptions of reality than nondepressed people. The notion of depressives being "sadder yet wiser" was controversial when first presented, and continues to be heavily debated. Self-perception studies provide maximum external validity,…

Validity of the WISC-IV Spanish for a Clinically Referred Sample of Hispanic Children

ERIC Educational Resources Information Center

San Miguel Montes, Liza E.; Allen, Daniel N.; Puente, Antonio E.; Neblina, Cris

2010-01-01

The Wechsler Intelligence Scale for Children (WISC) is the most commonly used intelligence test for children. Five years ago, a Spanish version of the WISC-IV was published (WISC-IV Spanish; Wechsler, 2005), but a limited amount of published information is available regarding its utility when assessing clinical samples. The current study included…

Global Reference Atmosphere Model (GRAM)

NASA Technical Reports Server (NTRS)

Woodrum, A. W.

1989-01-01

GRAM series of four-dimensional atmospheric model validated by years of data. GRAM program, still available. More current are Gram 86, which includes atmospheric data from 1986 and runs on DEC VAX, and GRAM 88, which runs on IBM 3084. Program generates altitude profiles of atmospheric parameters along any simulated trajectory through atmosphere, and also useful for global circulation and diffusion studies.

Assessing the Generalizability of Estimates of Causal Effects from Regression Discontinuity Designs

ERIC Educational Resources Information Center

Bloom, Howard S.; Porter, Kristin E.

2012-01-01

In recent years, the regression discontinuity design (RDD) has gained widespread recognition as a quasi-experimental method that when used correctly, can produce internally valid estimates of causal effects of a treatment, a program or an intervention (hereafter referred to as treatment effects). In an RDD study, subjects or groups of subjects…

Between a ROC and a Hard Place: Decision Making and Making Decisions about Using the SCQ

ERIC Educational Resources Information Center

Corsello, Christina; Hus, Vanessa; Pickles, Andrew; Risi, Susan; Cook, Edwin H., Jr.; Leventhal, Bennett L.; Lord, Catherine

2007-01-01

Background: The Social Communication Questionnaire (SCQ), formerly the Autism Screening Questionnaire (ASQ), is based on a well-validated parent interview, the Autism Diagnostic Interview (ADI). It has shown promise as a screening measure for autism spectrum disorders (ASDs) in a research-referred older sample, though recent studies with younger…

Development and Validation of a Learning Analytics Framework: Two Case Studies Using Support Vector Machines

ERIC Educational Resources Information Center

Ifenthaler, Dirk; Widanapathirana, Chathuranga

2014-01-01

Interest in collecting and mining large sets of educational data on student background and performance to conduct research on learning and instruction has developed as an area generally referred to as learning analytics. Higher education leaders are recognizing the value of learning analytics for improving not only learning and teaching but also…

Examining the Validity of the Autism Spectrum Rating Scales with a Preschool Population Referred for Special Education Evaluation

ERIC Educational Resources Information Center

Cunningham, Sean

2012-01-01

Early identification and intervention of an Autism Spectrum Disorder (ASD) can have beneficial effects that extend into later life. However, currently used instruments have difficulties detecting children who may have an ASD. The current study investigated the utility of a newly published measure, Autism Spectrum Rating Scales (ASRS). Participants…

Discriminant and Convergent Validity of the Anxiety Construct in Children with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Renno, Patricia; Wood, Jeffrey J.

2013-01-01

Despite reports of high anxiety in children with autism spectrum disorders (ASD), there is controversy regarding differential diagnosis of ASD symptoms and anxiety symptoms. This study examined 88 children, aged 7-11 years, with ASD referred for concerns about anxiety. A multitrait-(social anxiety, separation anxiety, overall anxiety severity, and…

Morningness-Eveningness and Educational Outcomes: The Lark Has an Advantage over the Owl at High School

ERIC Educational Resources Information Center

Preckel, Franzis; Lipnevich, Anastasiya A.; Boehme, Katharina; Brandner, Lena; Georgi, Karsten; Konen, Tanja; Mursin, Katharina; Roberts, Richard D.

2013-01-01

Background: Chronotype refers to individuals' preference for morning or evening activities. Its two dimensions (morningness and eveningness) are related to a number of academic outcomes. Aims: The main goal of the study was to investigate the incremental validity of chronotype as a predictor of academic achievement after controlling for a number…

Diagnosing Childhood Thought Disorder: Do Parent Checklists Yield False Positives?

ERIC Educational Resources Information Center

Longeway, K.; Johnson, S.; Garwood, M.; Davis, L.

This study examined the validity of using the Child Behavior Checklist (CBCL) Thought Problem sub-scale with urban low-income children (N=46) referred to a hospital-based mental health clinic. It was hypothesized that cultural, linguistic, or socio-economic status (SES) factors may influence the manner in which parents understand and respond to…

AMOVA ["Accumulative Manifold Validation Analysis"]: An Advanced Statistical Methodology Designed to Measure and Test the Validity, Reliability, and Overall Efficacy of Inquiry-Based Psychometric Instruments

ERIC Educational Resources Information Center

Osler, James Edward, II

2015-01-01

This monograph provides an epistemological rational for the Accumulative Manifold Validation Analysis [also referred by the acronym "AMOVA"] statistical methodology designed to test psychometric instruments. This form of inquiry is a form of mathematical optimization in the discipline of linear stochastic modelling. AMOVA is an in-depth…

Validation of an administrative claims-based diagnostic code for pneumonia in a US-based commercially insured COPD population

PubMed Central

Kern, David M; Davis, Jill; Williams, Setareh A; Tunceli, Ozgur; Wu, Bingcao; Hollis, Sally; Strange, Charlie; Trudo, Frank

2015-01-01

Objective To estimate the accuracy of claims-based pneumonia diagnoses in COPD patients using clinical information in medical records as the reference standard. Methods Selecting from a repository containing members’ data from 14 regional United States health plans, this validation study identified pneumonia diagnoses within a group of patients initiating treatment for COPD between March 1, 2009 and March 31, 2012. Patients with ≥1 claim for pneumonia (International Classification of Diseases Version 9-CM code 480.xx–486.xx) were identified during the 12 months following treatment initiation. A subset of 800 patients was randomly selected to abstract medical record data (paper based and electronic) for a target sample of 400 patients, to estimate validity within 5% margin of error. Positive predictive value (PPV) was calculated for the claims diagnosis of pneumonia relative to the reference standard, defined as a documented diagnosis in the medical record. Results A total of 388 records were reviewed; 311 included a documented pneumonia diagnosis, indicating 80.2% (95% confidence interval [CI]: 75.8% to 84.0%) of claims-identified pneumonia diagnoses were validated by the medical charts. Claims-based diagnoses in inpatient or emergency departments (n=185) had greater PPV versus outpatient settings (n=203), 87.6% (95% CI: 81.9%–92.0%) versus 73.4% (95% CI: 66.8%–79.3%), respectively. Claims-diagnoses verified with paper-based charts had similar PPV as the overall study sample, 80.2% (95% CI: 71.1%–87.5%), and higher PPV than those linked to electronic medical records, 73.3% (95% CI: 65.5%–80.2%). Combined paper-based and electronic records had a higher PPV, 87.6% (95% CI: 80.9%–92.6%). Conclusion Administrative claims data indicating a diagnosis of pneumonia in COPD patients are supported by medical records. The accuracy of a medical record diagnosis of pneumonia remains unknown. With increased use of claims data in medical research, COPD researchers can study pneumonia with confidence that claims data are a valid tool when studying the safety of COPD therapies that could potentially lead to increased pneumonia susceptibility or severity. PMID:26229461

Validation of an administrative claims-based diagnostic code for pneumonia in a US-based commercially insured COPD population.

PubMed

Kern, David M; Davis, Jill; Williams, Setareh A; Tunceli, Ozgur; Wu, Bingcao; Hollis, Sally; Strange, Charlie; Trudo, Frank

2015-01-01

To estimate the accuracy of claims-based pneumonia diagnoses in COPD patients using clinical information in medical records as the reference standard. Selecting from a repository containing members' data from 14 regional United States health plans, this validation study identified pneumonia diagnoses within a group of patients initiating treatment for COPD between March 1, 2009 and March 31, 2012. Patients with ≥1 claim for pneumonia (International Classification of Diseases Version 9-CM code 480.xx-486.xx) were identified during the 12 months following treatment initiation. A subset of 800 patients was randomly selected to abstract medical record data (paper based and electronic) for a target sample of 400 patients, to estimate validity within 5% margin of error. Positive predictive value (PPV) was calculated for the claims diagnosis of pneumonia relative to the reference standard, defined as a documented diagnosis in the medical record. A total of 388 records were reviewed; 311 included a documented pneumonia diagnosis, indicating 80.2% (95% confidence interval [CI]: 75.8% to 84.0%) of claims-identified pneumonia diagnoses were validated by the medical charts. Claims-based diagnoses in inpatient or emergency departments (n=185) had greater PPV versus outpatient settings (n=203), 87.6% (95% CI: 81.9%-92.0%) versus 73.4% (95% CI: 66.8%-79.3%), respectively. Claims-diagnoses verified with paper-based charts had similar PPV as the overall study sample, 80.2% (95% CI: 71.1%-87.5%), and higher PPV than those linked to electronic medical records, 73.3% (95% CI: 65.5%-80.2%). Combined paper-based and electronic records had a higher PPV, 87.6% (95% CI: 80.9%-92.6%). Administrative claims data indicating a diagnosis of pneumonia in COPD patients are supported by medical records. The accuracy of a medical record diagnosis of pneumonia remains unknown. With increased use of claims data in medical research, COPD researchers can study pneumonia with confidence that claims data are a valid tool when studying the safety of COPD therapies that could potentially lead to increased pneumonia susceptibility or severity.

Bench-to-bedside review: the importance of the precision of the reference technique in method comparison studies--with specific reference to the measurement of cardiac output.

PubMed

Cecconi, Maurizio; Rhodes, Andrew; Poloniecki, Jan; Della Rocca, Giorgio; Grounds, R Michael

2009-01-01

Bland-Altman analysis is used for assessing agreement between two measurements of the same clinical variable. In the field of cardiac output monitoring, its results, in terms of bias and limits of agreement, are often difficult to interpret, leading clinicians to use a cutoff of 30% in the percentage error in order to decide whether a new technique may be considered a good alternative. This percentage error of +/- 30% arises from the assumption that the commonly used reference technique, intermittent thermodilution, has a precision of +/- 20% or less. The combination of two precisions of +/- 20% equates to a total error of +/- 28.3%, which is commonly rounded up to +/- 30%. Thus, finding a percentage error of less than +/- 30% should equate to the new tested technique having an error similar to the reference, which therefore should be acceptable. In a worked example in this paper, we discuss the limitations of this approach, in particular in regard to the situation in which the reference technique may be either more or less precise than would normally be expected. This can lead to inappropriate conclusions being drawn from data acquired in validation studies of new monitoring technologies. We conclude that it is not acceptable to present comparison studies quoting percentage error as an acceptability criteria without reporting the precision of the reference technique.

Validating Large Scale Networks Using Temporary Local Scale Networks

USDA-ARS?s Scientific Manuscript database

The USDA NRCS Soil Climate Analysis Network and NOAA Climate Reference Networks are nationwide meteorological and land surface data networks with soil moisture measurements in the top layers of soil. There is considerable interest in scaling these point measurements to larger scales for validating ...

Selection of reference genes for gene expression studies in virus-infected monocots using quantitative real-time PCR.

PubMed

Zhang, Kun; Niu, Shaofang; Di, Dianping; Shi, Lindan; Liu, Deshui; Cao, Xiuling; Miao, Hongqin; Wang, Xianbing; Han, Chenggui; Yu, Jialin; Li, Dawei; Zhang, Yongliang

2013-10-10

Both genome-wide transcriptomic surveys of the mRNA expression profiles and virus-induced gene silencing-based molecular studies of target gene during virus-plant interaction involve the precise estimation of the transcript abundance. Quantitative real-time PCR (qPCR) is the most widely adopted technique for mRNA quantification. In order to obtain reliable quantification of transcripts, identification of the best reference genes forms the basis of the preliminary work. Nevertheless, the stability of internal controls in virus-infected monocots needs to be fully explored. In this work, the suitability of ten housekeeping genes (ACT, EF1α, FBOX, GAPDH, GTPB, PP2A, SAND, TUBβ, UBC18 and UK) for potential use as reference genes in qPCR were investigated in five different monocot plants (Brachypodium, barley, sorghum, wheat and maize) under infection with different viruses including Barley stripe mosaic virus (BSMV), Brome mosaic virus (BMV), Rice black-streaked dwarf virus (RBSDV) and Sugarcane mosaic virus (SCMV). By using three different algorithms, the most appropriate reference genes or their combinations were identified for different experimental sets and their effectiveness for the normalisation of expression studies were further validated by quantitative analysis of a well-studied PR-1 gene. These results facilitate the selection of desirable reference genes for more accurate gene expression studies in virus-infected monocots. Copyright © 2013 Elsevier B.V. All rights reserved.

Standardization, evaluation and early-phase method validation of an analytical scheme for batch-consistency N-glycosylation analysis of recombinant produced glycoproteins.

PubMed

Zietze, Stefan; Müller, Rainer H; Brecht, René

2008-03-01

In order to set up a batch-to-batch-consistency analytical scheme for N-glycosylation analysis, several sample preparation steps including enzyme digestions and fluorophore labelling and two HPLC-methods were established. The whole method scheme was standardized, evaluated and validated according to the requirements on analytical testing in early clinical drug development by usage of a recombinant produced reference glycoprotein (RGP). The standardization of the methods was performed by clearly defined standard operation procedures. During evaluation of the methods, the major interest was in the loss determination of oligosaccharides within the analytical scheme. Validation of the methods was performed with respect to specificity, linearity, repeatability, LOD and LOQ. Due to the fact that reference N-glycan standards were not available, a statistical approach was chosen to derive accuracy from the linearity data. After finishing the validation procedure, defined limits for method variability could be calculated and differences observed in consistency analysis could be separated into significant and incidental ones.

Validation of streamflow measurements made with acoustic doppler current profilers

USGS Publications Warehouse

Oberg, K.; Mueller, D.S.

2007-01-01

The U.S. Geological Survey and other international agencies have collaborated to conduct laboratory and field validations of acoustic Doppler current profiler (ADCP) measurements of streamflow. Laboratory validations made in a large towing basin show that the mean differences between tow cart velocity and ADCP bottom-track and water-track velocities were -0.51 and -1.10%, respectively. Field validations of commercially available ADCPs were conducted by comparing streamflow measurements made with ADCPs to reference streamflow measurements obtained from concurrent mechanical current-meter measurements, stable rating curves, salt-dilution measurements, or acoustic velocity meters. Data from 1,032 transects, comprising 100 discharge measurements, were analyzed from 22 sites in the United States, Canada, Sweden, and The Netherlands. Results of these analyses show that broadband ADCP streamflow measurements are unbiased when compared to the reference discharges regardless of the water mode used for making the measurement. Measurement duration is more important than the number of transects for reducing the uncertainty of the ADCP streamflow measurement. ?? 2007 ASCE.

Comparison of CORA and EN4 in-situ datasets validation methods, toward a better quality merged dataset.

NASA Astrophysics Data System (ADS)

Szekely, Tanguy; Killick, Rachel; Gourrion, Jerome; Reverdin, Gilles

2017-04-01

CORA and EN4 are both global delayed time mode validated in-situ ocean temperature and salinity datasets distributed by the Met Office (http://www.metoffice.gov.uk/) and Copernicus (www.marine.copernicus.eu). A large part of the profiles distributed by CORA and EN4 in recent years are Argo profiles from the ARGO DAC, but profiles are also extracted from the World Ocean Database and TESAC profiles from GTSPP. In the case of CORA, data coming from the EUROGOOS Regional operationnal oserving system( ROOS) operated by European institutes no managed by National Data Centres and other datasets of profiles povided by scientific sources can also be found (Sea mammals profiles from MEOP, XBT datasets from cruises ...). (EN4 also takes data from the ASBO dataset to supplement observations in the Arctic). First advantage of this new merge product is to enhance the space and time coverage at global and european scales for the period covering 1950 till a year before the current year. This product is updated once a year and T&S gridded fields are alos generated for the period 1990-year n-1. The enhancement compared to the revious CORA product will be presented Despite the fact that the profiles distributed by both datasets are mostly the same, the quality control procedures developed by the Met Office and Copernicus teams differ, sometimes leading to different quality control flags for the same profile. Started in 2016 a new study started that aims to compare both validation procedures to move towards a Copernicus Marine Service dataset with the best features of CORA and EN4 validation.A reference data set composed of the full set of in-situ temperature and salinity measurements collected by Coriolis during 2015 is used. These measurements have been made thanks to wide range of instruments (XBTs, CTDs, Argo floats, Instrumented sea mammals,...), covering the global ocean. The reference dataset has been validated simultaneously by both teams.An exhaustive comparison of the validation test results is now performed to find the best features of both datasets. The study shows the differences between the EN4 and CORA validation results. It highlights the complementarity between the EN4 and CORA higher order tests. The design of the CORA and EN4 validation charts is discussed to understand how a different approach on the dataset scope can lead to differences in data validation. The new validation chart of the Copernicus Marine Service dataset is presented.

Validation of Reference Genes for Robust qRT-PCR Gene Expression Analysis in the Rice Blast Fungus Magnaporthe oryzae.

PubMed

Che Omar, Sarena; Bentley, Michael A; Morieri, Giulia; Preston, Gail M; Gurr, Sarah J

2016-01-01

The rice blast fungus causes significant annual harvest losses. It also serves as a genetically-tractable model to study fungal ingress. Whilst pathogenicity determinants have been unmasked and changes in global gene expression described, we know little about Magnaporthe oryzae cell wall remodelling. Our interests, in wall remodelling genes expressed during infection, vegetative growth and under exogenous wall stress, demand robust choice of reference genes for quantitative Real Time-PCR (qRT-PCR) data normalisation. We describe the expression stability of nine candidate reference genes profiled by qRT-PCR with cDNAs derived during asexual germling development, from sexual stage perithecia and from vegetative mycelium grown under various exogenous stressors. Our Minimum Information for Publication of qRT-PCR Experiments (MIQE) compliant analysis reveals a set of robust reference genes used to track changes in the expression of the cell wall remodelling gene MGG_Crh2 (MGG_00592). We ranked nine candidate reference genes by their expression stability (M) and report the best gene combination needed for reliable gene expression normalisation, when assayed in three tissue groups (Infective, Vegetative, and Global) frequently used in M. oryzae expression studies. We found that MGG_Actin (MGG_03982) and the 40S 27a ribosomal subunit MGG_40s (MGG_02872) proved to be robust reference genes for the Infection group and MGG_40s and MGG_Ef1 (Elongation Factor1-α) for both Vegetative and Global groups. Using the above validated reference genes, M. oryzae MGG_Crh2 expression was found to be significantly (p<0.05) elevated three-fold during vegetative growth as compared with dormant spores and two fold higher under cell wall stress (Congo Red) compared to growth under optimal conditions. We recommend the combinatorial use of two reference genes, belonging to the cytoskeleton and ribosomal synthesis functional groups, MGG_Actin, MGG_40s, MGG_S8 (Ribosomal subunit 40S S8) or MGG_Ef1, which demonstrated low M values across heterogeneous tissues. By contrast, metabolic pathway genes MGG_Fad (FAD binding domain-containing protein) and MGG_Gapdh (Glyceraldehyde-3-phosphate dehydrogenase) performed poorly, due to their lack of expression stability across samples.

Pediatric Cancer Survivorship Research: Experience of the Childhood Cancer Survivor Study

PubMed Central

Leisenring, Wendy M.; Mertens, Ann C.; Armstrong, Gregory T.; Stovall, Marilyn A.; Neglia, Joseph P.; Lanctot, Jennifer Q.; Boice, John D.; Whitton, John A.; Yasui, Yutaka

2009-01-01

The Childhood Cancer Survivor Study (CCSS) is a comprehensive multicenter study designed to quantify and better understand the effects of pediatric cancer and its treatment on later health, including behavioral and sociodemographic outcomes. The CCSS investigators have published more than 100 articles in the scientific literature related to the study. As with any large cohort study, high standards for methodologic approaches are imperative for valid and generalizable results. In this article we describe methodological issues of study design, exposure assessment, outcome validation, and statistical analysis. Methods for handling missing data, intrafamily correlation, and competing risks analysis are addressed; each with particular relevance to pediatric cancer survivorship research. Our goal in this article is to provide a resource and reference for other researchers working in the area of long-term cancer survivorship. PMID:19364957

Measuring Psychobiosocial States in Sport: Initial Validation of a Trait Measure

PubMed Central

Bertollo, Maurizio; Ruiz, Montse C.; Bortoli, Laura

2016-01-01

We examined the item characteristics, the factor structure, and the concurrent validity of a trait measure of psychobiosocial states. In Study 1, Italian athletes (N = 342, 228 men, 114 women, Mage = 23.93, SD = 6.64) rated the intensity, the frequency, and the perceived impact dimensions of a psychobiosocial states scale, trait version (PBS-ST), which is composed of 20 items (10 functional and 10 dysfunctional) referring to how they usually felt before an important competition. In Study 2, the scale was cross validated in an independent sample (N = 251, 181 men, 70 women, Mage = 24.35, SD = 7.25). The concurrent validity of the PBS-ST scale scores were also examined in comparison with two sport-specific emotion-related measures and a general measure of affect. Exploratory structural equation modeling and confirmatory factor analysis of the data of Study 1 showed that a 2-factor, 15-item solution of the PBS-ST scale (8 functional items and 7 dysfunctional items) reached satisfactory fit indices for the three dimensions (i.e., intensity, frequency, and perceived impact). Results of Study 2 provided evidence of substantial measurement and structural invariance of all dimensions across samples. The low association of the PBS-ST scale with other measures suggests that the scale taps unique constructs. Findings of the two studies offer initial validity evidence for a sport-specific tool to measure psychobiosocial states. PMID:27907111

Validation of the psychometrics properties of a French quality of life questionnaire among a cohort of renal transplant recipients less than one year.

PubMed

Beauger, Davy; Fruit, Dorothée; Villeneuve, Claire; Laroche, Marie-Laure; Jouve, Elisabeth; Rousseau, Annick; Boyer, Laurent; Gentile, Stéphanie

2016-09-01

Renal transplantation is considered as the treatment of choice for patients with end-stage renal disease. Health-related quality of life (HRQoL) of renal transplant recipients (RTR) is very important to assess, especially during the first year after transplantation. To provide new evidence about the suitability of HRQoL measures in RTR during the first post-transplant year, we explored the internal structure, reliability and external validity of a French specific HRQoL instrument, the Renal Transplant Quality of life Questionnaire Second Version (RTQ V2). The data were issued from the French multicenter cohort of renal transplant patients followed during 4 years (EPIGREN). The HRQoL of RTR was assessed five times (at 1, 3, 6, 9 and 12 months after transplantation) with the RTQ V2, a specific instrument consisting of 32 items describing five dimensions. Socio-demographic information, clinical characteristics and HRQoL (i.e., RTQ V2 and SF-36) were collected. For the five times, psychometric properties of the RTQ V2 were compared to those reported from the reference population assessed in the validation study. Three hundred and thirty-four patients were enrolled. The proportions of well-projected items, item-internal consistency, item-discriminant validity, floor and ceiling effects, Cronbach's alpha coefficients and item goodness-of-fit statistics were satisfactory for each dimension at the five times of the study. The suitability indices of construct validity were higher than 90 % for each time (minimum-maximum: 90.8-97.4 %). The external validity was less satisfactory, with a suitability indices ranged from 46.7 % at M1 to 66.7 % at M12. However, the discrepancies with the reference population (mainly for the gender) appeared logical considering the scientific literature on HRQoL of RTR during the first post-transplant year and may not compromise the external validity. These results support the validity and reliability of the RTQ V2 for evaluating HRQoL in RTR during the first post-transplant year, and confirm that the RTQ V2 is a useful tool to assess the HRQoL precociously after transplant.

Selection and testing of reference genes for accurate RT-qPCR in rice seedlings under iron toxicity.

PubMed

Santos, Fabiane Igansi de Castro Dos; Marini, Naciele; Santos, Railson Schreinert Dos; Hoffman, Bianca Silva Fernandes; Alves-Ferreira, Marcio; de Oliveira, Antonio Costa

2018-01-01

Reverse Transcription quantitative PCR (RT-qPCR) is a technique for gene expression profiling with high sensibility and reproducibility. However, to obtain accurate results, it depends on data normalization by using endogenous reference genes whose expression is constitutive or invariable. Although the technique is widely used in plant stress analyzes, the stability of reference genes for iron toxicity in rice (Oryza sativa L.) has not been thoroughly investigated. Here, we tested a set of candidate reference genes for use in rice under this stressful condition. The test was performed using four distinct methods: NormFinder, BestKeeper, geNorm and the comparative ΔCt. To achieve reproducible and reliable results, Minimum Information for Publication of Quantitative Real-Time PCR Experiments (MIQE) guidelines were followed. Valid reference genes were found for shoot (P2, OsGAPDH and OsNABP), root (OsEF-1a, P8 and OsGAPDH) and root+shoot (OsNABP, OsGAPDH and P8) enabling us to perform further reliable studies for iron toxicity in both indica and japonica subspecies. The importance of the study of other than the traditional endogenous genes for use as normalizers is also shown here.

Selection and testing of reference genes for accurate RT-qPCR in rice seedlings under iron toxicity

PubMed Central

dos Santos, Fabiane Igansi de Castro; Marini, Naciele; dos Santos, Railson Schreinert; Hoffman, Bianca Silva Fernandes; Alves-Ferreira, Marcio

2018-01-01

Reverse Transcription quantitative PCR (RT-qPCR) is a technique for gene expression profiling with high sensibility and reproducibility. However, to obtain accurate results, it depends on data normalization by using endogenous reference genes whose expression is constitutive or invariable. Although the technique is widely used in plant stress analyzes, the stability of reference genes for iron toxicity in rice (Oryza sativa L.) has not been thoroughly investigated. Here, we tested a set of candidate reference genes for use in rice under this stressful condition. The test was performed using four distinct methods: NormFinder, BestKeeper, geNorm and the comparative ΔCt. To achieve reproducible and reliable results, Minimum Information for Publication of Quantitative Real-Time PCR Experiments (MIQE) guidelines were followed. Valid reference genes were found for shoot (P2, OsGAPDH and OsNABP), root (OsEF-1a, P8 and OsGAPDH) and root+shoot (OsNABP, OsGAPDH and P8) enabling us to perform further reliable studies for iron toxicity in both indica and japonica subspecies. The importance of the study of other than the traditional endogenous genes for use as normalizers is also shown here. PMID:29494624

A Novel Multilayer Correlation Maximization Model for Improving CCA-Based Frequency Recognition in SSVEP Brain-Computer Interface.

PubMed

Jiao, Yong; Zhang, Yu; Wang, Yu; Wang, Bei; Jin, Jing; Wang, Xingyu

2018-05-01

Multiset canonical correlation analysis (MsetCCA) has been successfully applied to optimize the reference signals by extracting common features from multiple sets of electroencephalogram (EEG) for steady-state visual evoked potential (SSVEP) recognition in brain-computer interface application. To avoid extracting the possible noise components as common features, this study proposes a sophisticated extension of MsetCCA, called multilayer correlation maximization (MCM) model for further improving SSVEP recognition accuracy. MCM combines advantages of both CCA and MsetCCA by carrying out three layers of correlation maximization processes. The first layer is to extract the stimulus frequency-related information in using CCA between EEG samples and sine-cosine reference signals. The second layer is to learn reference signals by extracting the common features with MsetCCA. The third layer is to re-optimize the reference signals set in using CCA with sine-cosine reference signals again. Experimental study is implemented to validate effectiveness of the proposed MCM model in comparison with the standard CCA and MsetCCA algorithms. Superior performance of MCM demonstrates its promising potential for the development of an improved SSVEP-based brain-computer interface.

An appraisal of the psychometric properties of the Clinician version of the Apathy Evaluation Scale (AES-C).

PubMed

Clarke, Diana E; Van Reekum, Robert; Patel, Jigisha; Simard, Martine; Gomez, Everlyne; Streiner, David L

2007-01-01

This article examines the psychometric properties of the clinician version of the Apathy Evaluation Scale (AES-C) to determine its ability to characterize, quantify and differentiate apathy. Critical appraisals of the item-reduction processes, effectiveness of the administration, coding and scoring procedures, and the reliability and validity of the scale were carried out. For training, administration and rating of the AES-C, clearer guidelines, including a more standardized list of verbal and non-verbal apathetic cues, are needed. There is evidence of high internal consistency for the scale across studies. In addition, the original study reported good test-retest and inter-rater reliability coefficients. However, there is a lack of replication on these more stable and informative measures of reliability and as such they warrant further investigation. The research evidence confirms that the AES-C shows good discriminant, convergent and criterion validity. However, evidence of its predictive validity is limited. As this aspect of validity refers to the scale's ability to predict future outcomes, which is important for treatment and rehabilitation planning, further assessment of the predictive validity of the AES-C is needed. In conclusion, the AES-C is a reliable and valid measure for the characterization and quantification of apathy. Copyright (c) 2007 John Wiley & Sons, Ltd.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30: factorial models to Brazilian cancer patients

PubMed Central

Campos, Juliana Alvares Duarte Bonini; Spexoto, Maria Cláudia Bernardes; da Silva, Wanderson Roberto; Serrano, Sergio Vicente; Marôco, João

2018-01-01

ABSTRACT Objective To evaluate the psychometric properties of the seven theoretical models proposed in the literature for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), when applied to a sample of Brazilian cancer patients. Methods Content and construct validity (factorial, convergent, discriminant) were estimated. Confirmatory factor analysis was performed. Convergent validity was analyzed using the average variance extracted. Discriminant validity was analyzed using correlational analysis. Internal consistency and composite reliability were used to assess the reliability of instrument. Results A total of 1,020 cancer patients participated. The mean age was 53.3±13.0 years, and 62% were female. All models showed adequate factorial validity for the study sample. Convergent and discriminant validities and the reliability were compromised in all of the models for all of the single items referring to symptoms, as well as for the “physical function” and “cognitive function” factors. Conclusion All theoretical models assessed in this study presented adequate factorial validity when applied to Brazilian cancer patients. The choice of the best model for use in research and/or clinical protocols should be centered on the purpose and underlying theory of each model. PMID:29694609

Development and validation of a stock addiction inventory (SAI).

PubMed

Youn, HyunChul; Choi, Jung-Seok; Kim, Dai-Jin; Choi, Sam-Wook

2016-01-01

Investing in financial markets is promoted and protected by the government as an essential economic activity, but can turn into a gambling addiction problem. Until now, few scales have widely been used to identify gambling addicts in financial markets. This study aimed to develop a self-rating scale to distinguish them. In addition, the reliability and validity of the stock addiction inventory (SAI) were demonstrated. A set of questionnaires, including the SAI, south oaks gambling screen (SOGS), and DSM-5 diagnostic criteria, for gambling disorder was completed by 1005 participants. Factor analysis, internal consistency testing, t tests, analysis of variance, and partial correlation analysis were conducted to verify the reliability and validity of SAI. The factor analysis results showed the final SAI consisting of two factors and nine items. The internal consistency and concurrent validity of SAI were verified. The Cronbach's α for the total scale was 0.892, and the SAI and its factors were significantly correlated with SOGS. This study developed a specific scale for financial market investments or trading; this scale proved to be reliable and valid. Our scale expands the understanding of gambling addiction in financial markets and provides a diagnostic reference.

Selection of reference genes for quantitative real time RT-PCR during dimorphism in the zygomycete Mucor circinelloides.

PubMed

Valle-Maldonado, Marco I; Jácome-Galarza, Irvin E; Gutiérrez-Corona, Félix; Ramírez-Díaz, Martha I; Campos-García, Jesús; Meza-Carmen, Víctor

2015-03-01

Mucor circinelloides is a dimorphic fungal model for studying several biological processes including cell differentiation (yeast-mold transitions) as well as biodiesel and carotene production. The recent release of the first draft sequence of the M. circinelloides genome, combined with the availability of analytical methods to determine patterns of gene expression, such as quantitative Reverse transcription-Polymerase chain reaction (qRT-PCR), and the development of molecular genetic tools for the manipulation of the fungus, may help identify M. circinelloides gene products and analyze their relevance in different biological processes. However, no information is available on M. circinelloides genes of stable expression that could serve as internal references in qRT-PCR analyses. One approach to solve this problem consists in the use of housekeeping genes as internal references. However, validation of the usability of these reference genes is a fundamental step prior to initiating qRT-PCR assays. This work evaluates expression of several constitutive genes by qRT-PCR throughout the morphological differentiation stages of M. circinelloides; our results indicate that tfc-1 and ef-1 are the most stable genes for qRT-PCR assays during differentiation studies and they are proposed as reference genes to carry out gene expression studies in this fungus.

Measurement Properties of Instruments for Measuring of Lymphedema: Systematic Review.

PubMed

Hidding, Janine T; Viehoff, Peter B; Beurskens, Carien H G; van Laarhoven, Hanneke W M; Nijhuis-van der Sanden, Maria W G; van der Wees, Philip J

2016-12-01

Lymphedema is a common complication of cancer treatment, resulting in swelling and subjective symptoms. Reliable and valid measurement of this side effect of medical treatment is important. The purpose of this study was to provide best evidence regarding which measurement instruments are most appropriate in measuring lymphedema in its different stages. The PubMed and Web of Science databases were used, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Clinical studies on measurement instruments assessing lymphedema were reviewed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) scoring instrument for quality assessment. Data on reliability, concurrent validity, convergent validity, sensitivity, specificity, applicability, and costs were extracted. Pooled data showed good intrarater intraclass correlation coefficients (ICCs) (.89) for bioimpedance spectroscopy (BIS) in the lower extremities and high intrarater and interrater ICCs for water volumetry, tape measurement, and perometry (.98-.99) in the upper extremities. In the upper extremities, the standard error of measurement was 3.6% (σ=0.7%) for water volumetry, 5.6% (σ=2.1%) for perometry, and 6.6% (σ=2.6%) for tape measurement. Sensitivity of tape measurement in the upper extremities, using different cutoff points, varied from 0.73 to 0.90, and specificity values varied from 0.72 to 0.78. No uniform definition of lymphedema was available, and a gold standard as a reference test was lacking. Items concerning risk of bias were study design, patient selection, description of lymphedema, blinding of test outcomes, and number of included participants. Measurement instruments with evidence for good reliability and validity were BIS, water volumetry, tape measurement, and perometry, where BIS can detect alterations in extracellular fluid in stage 1 lymphedema and the other measurement instruments can detect alterations in volume starting from stage 2. In research, water volumetry is indicated as a reference test for measuring lymphedema in the upper extremities. © 2016 American Physical Therapy Association.

The Ca(2+)-EDTA chelation as standard reaction to validate Isothermal Titration Calorimeter measurements (ITC).

PubMed

Ràfols, Clara; Bosch, Elisabeth; Barbas, Rafael; Prohens, Rafel

2016-07-01

A study about the suitability of the chelation reaction of Ca(2+)with ethylenediaminetetraacetic acid (EDTA) as a validation standard for Isothermal Titration Calorimeter measurements has been performed exploring the common experimental variables (buffer, pH, ionic strength and temperature). Results obtained in a variety of experimental conditions have been amended according to the side reactions involved in the main process and to the experimental ionic strength and, finally, validated by contrast with the potentiometric reference values. It is demonstrated that the chelation reaction performed in acetate buffer 0.1M and 25°C shows accurate and precise results and it is robust enough to be adopted as a standard calibration process. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparison of Two Predictive Models for Short-Term Mortality in Patients after Severe Traumatic Brain Injury.

PubMed

Kesmarky, Klara; Delhumeau, Cecile; Zenobi, Marie; Walder, Bernhard

2017-07-15

The Glasgow Coma Scale (GCS) and the Abbreviated Injury Score of the head region (HAIS) are validated prognostic factors in traumatic brain injury (TBI). The aim of this study was to compare the prognostic performance of an alternative predictive model including motor GCS, pupillary reactivity, age, HAIS, and presence of multi-trauma for short-term mortality with a reference predictive model including motor GCS, pupil reaction, and age (IMPACT core model). A secondary analysis of a prospective epidemiological cohort study in Switzerland including patients after severe TBI (HAIS >3) with the outcome death at 14 days was performed. Performance of prediction, accuracy of discrimination (area under the receiver operating characteristic curve [AUROC]), calibration, and validity of the two predictive models were investigated. The cohort included 808 patients (median age, 56; interquartile range, 33-71), median GCS at hospital admission 3 (3-14), abnormal pupil reaction 29%, with a death rate of 29.7% at 14 days. The alternative predictive model had a higher accuracy of discrimination to predict death at 14 days than the reference predictive model (AUROC 0.852, 95% confidence interval [CI] 0.824-0.880 vs. AUROC 0.826, 95% CI 0.795-0.857; p < 0.0001). The alternative predictive model had an equivalent calibration, compared with the reference predictive model Hosmer-Lemeshow p values (Chi2 8.52, Hosmer-Lemeshow p = 0.345 vs. Chi2 8.66, Hosmer-Lemeshow p = 0.372). The optimism-corrected value of AUROC for the alternative predictive model was 0.845. After severe TBI, a higher performance of prediction for short-term mortality was observed with the alternative predictive model, compared with the reference predictive model.